65:68261-68870 - Ergonomics Program; Final Rule
Part II
Department of Labor
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Occupational Safety and Health Administration
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29 CFR Part 1910
Ergonomics Program; Final Rule
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
[Docket No. S-777]
RIN 1218-AB36
Ergonomics Program
AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.
ACTION: Final rule.
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SUMMARY: The Occupational Safety and Health Administration is issuing a
final Ergonomics Program standard (29 CFR 1910.900) to address the
significant risk of employee exposure to ergonomic risk factors in jobs
in general industry workplaces. Exposure to ergonomic risk factors on
the job leads to musculoskeletal disorders (MSDs) of the upper
extremities, back, and lower extremities. Every year, nearly 600,000
MSDs that are serious enough to cause time off work are reported to the
Bureau of Labor Statistics by general industry employers, and evidence
suggests that an even larger number of non-lost worktime MSDs occur in
these workplaces every year.
The standard contains an ``action trigger,'' which identifies jobs
with risk factors of sufficient magnitude, duration, or intensity to
warrant further examination by the employer. This action trigger acts
as a screen. When an employee reports an MSD, the employer must first
determine whether the MSD is an MSD incident, defined by the standard
as an MSD that results in days away from work, restricted work, medical
treatment beyond first aid, or MSD symptoms or signs that persist for 7
or more days. Once this determination is made, the employer must
determine whether the employee's job has risk factors that meet the
standard's action trigger. The risk factors addressed by this standard
include repetition, awkward posture, force, vibration, and contact
stress. If the risk factors in the employee's job do not exceed the
action trigger, the employer does not need to implement an ergonomics
program for that job.
If an employee reports an MSD incident and the risk factors of that
employee's job meet the action trigger, the employer must establish an
ergonomics program for that job. The program must contain the following
elements: hazard information and reporting, management leadership and
employee participation, job hazard analysis and control, training, MSD
management, and program evaluation. The standard provides the employer
with several options for evaluating and controlling risk factors for
jobs covered by the ergonomics program, and provides objective criteria
for identifying MSD hazards in those jobs and determining when the
controls implemented have achieved the required level of control.
The final standard would affect approximately 6.1 million employers
and 102 million employees in general industry workplaces, and employers
in these workplaces would be required over the ten years following the
promulgation of the standard to control approximately 18 million jobs
with the potential to cause or contribute to covered MSDs. OSHA
estimates that the final standard would prevent about 4.6 million work-
related MSDs over the next 10 years, have annual benefits of
approximately $9.1 billion, and impose annual compliance costs of $4.5
billion on employers. On a per-establishment basis, this equals
approximately $700; annual costs per problem job fixed are estimated at
$250.
DATES: This final rule becomes effective on January 16, 2001.
Compliance. Start-up dates for specific provisions are set in
paragraph (w) of Sec. 1910.900. However, affected parties do not have
to comply with the information collection requirements in the final
rule until the Department of Labor publishes in the Federal Register
the control numbers assigned by the Office of Management and Budget
(OMB). Publication of the control numbers notifies the public that OMB
has approved these information collection requirements under the
Paperwork Reduction Act of 1995.
ADDRESSES: In compliance with 28 U.S.C. 2112(a), the Agency designates
the Associate Solicitor for Occupational Safety and Health, Office of
the Solicitor, Room S-4004, U.S. Department of Labor, 200 Constitution
Avenue, NW., Washington, DC 20210, as the recipient of petitions for
review of the standard.
FOR FURTHER INFORMATION CONTACT: OSHA's Ergonomics Team at (202) 693-
2116, or visit the OSHA Homepage at www.osha.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
The preamble and standard are organized as follows:
I. Introduction
II. Events Leading to the Standard
III. Pertinent Legal Authority
IV. Summary and Explanation
V. Health Effects
VI. Risk Assessment
VII. Significance of Risk
VIII. Summary of the Final Economic Analysis and Final Regulatory
Flexibility Analysis
IX. Unfunded Mandates Analysis
X. Environmental Impact Statement
XI. Additional Statutory Issues
XII. Procedural Issues
XIII. Federalism
XIV. State Plan States
XV. OMB Review under the Paperwork Reduction Act of 1995
XVI. List of Subjects in 29 CFR Part 1910
XVII. The Final Ergonomics Program Standard
References to documents, studies, and materials in the rulemaking
record are found throughout the text of the preamble. Materials in the
docket are identified by their Exhibit numbers, as follows: ``Ex. 26-
1'' means Exhibit 26-1 in Docket S-777. A list of the Exhibits and
copies of the Exhibits are available in the OSHA Docket Office.
I. Introduction
A. Overview
This preamble discusses the data and events that led OSHA to issue
the final Ergonomics Program standard (Section II), and the Agency's
legal authority for promulgating the rule (Section III). This
discussion is followed by a detailed paragraph-by-paragraph summary and
explanation of the final rule, including the Agency's reasons for
including each provision and OSHA's responses to the many substantive
issues that were raised in the proposal and during the rulemaking
(Section IV).
The summary and explanation of the standard is followed by a
lengthy discussion of the evidence on the health effects that are
associated with worker exposure to MSD hazards (Section V). The next
section discusses the nature and degree of ergonomic-related risks
confronting workers in general industry jobs (Section VI), and assesses
the significance of those risks (Section VII). The preamble also
contains a summary of the Final Economic and Final Regulatory
Flexibility Analysis (Section VIII). Finally, the preamble describes
the information collections associated with the final standard (Section
XV).
B. The Need for an Ergonomics Program Standard
Work-related musculoskeletal disorders (MSDs) currently account for
one-third of all occupational injuries and illnesses reported to the
Bureau of Labor Statistics (BLS) by employers every year. Although the
number of MSDs reported to the BLS, like all occupational injuries and
illnesses, has declined by more than 20% since 1992,
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these disorders have been the largest single job-related injury and
illness problem in the United States for the last decade, consistently
accounting for 34% of all reported injuries and illnesses. In 1997,
employers reported a total of 626,000 lost worktime MSDs to the BLS,
and these disorders accounted for $1 of every $3 spent for workers'
compensation in that year. This means that employers are annually
paying more than $15 billion in workers' compensation costs for these
disorders, and other expenses associated with work-related MSDs, such
as the costs of training new workers, may increase this total to $45
billion a year. Workers with severe MSDs often face permanent
disability that prevents them from returning to their jobs or handling
simple, everyday tasks like combing their hair, picking up a baby, or
pushing a shopping cart. For example, workers who must undergo surgery
for work-related carpal tunnel syndrome often lose 6 months or more of
work.
Thousands of companies have taken action to address and prevent
these problems. OSHA estimates that 46 percent of all employees but
only 16 percent of all workplaces in general industry are already
protected by an ergonomics program, because their employers have
voluntarily elected to implement an ergonomics program. (The difference
in these percentages shows that many large companies, who employ the
majority of the workforce, already have these programs, and that many
smaller employers have not yet implemented them.) Based on its review
of the evidence in the record as a whole, OSHA concludes that the final
standard is needed to protect employees in general industry workplaces
who are at significant risk of incurring a work-related musculoskeletal
disorder but are not currently protected by an ergonomics program.
C. The Science Supporting the Standard
A substantial body of scientific evidence supports OSHA's effort to
provide workers with ergonomic protection (see the Health Effects, Risk
Assessment, and Significance of Risk sections (Sections V, VI, and VII,
respectively) of this preamble, below). This evidence strongly supports
two basic conclusions: (1) There is a positive relationship between
work-related musculoskeletal disorders and employee exposure to
workplace risk factors, and (2) ergonomics programs and specific
ergonomic interventions can substantially reduce the number and
severity of these injuries.
In 1998, the National Research Council/National Academy of Sciences
found a clear relationship between musculoskeletal disorders and work
and between ergonomic interventions and a decrease in the number and
severity of such disorders. According to the Academy, ``Research
clearly demonstrates that specific interventions can reduce the
reported rate of musculoskeletal disorders for workers who perform
high-risk tasks'' (Work-Related Musculoskeletal Disorders: The Research
Base, ISBN 0-309-06327-2 (1998)). A scientific review of hundreds of
peer-reviewed studies involving workers with MSDs by the National
Institute for Occupational Safety and Health (NIOSH 1997) also supports
this conclusion.
The evidence, which is comprised of peer-reviewed epidemiological,
biomechanical and pathophysiological studies as well as other published
evidence, includes:
II. More than 2,000 articles on work-related MSDs and workplace risk
factors;
II. A 1998 study by the National Research Council/National Academy of
Sciences on work-related MSDs;
A critical review by NIOSH of more than 600
epidemiological studies addressing the effects of exposure to workplace
risk factors (1997);
A 1997 General Accounting Office report of companies with
ergonomics programs;
I. Other evidence and analyses in the Health Effects section of the
preamble to the final rule;
II. Hundreds of case studies from companies with successful ergonomics
programs; and
I. Testimony and evidence submitted to the record by expert witnesses,
workers, safety and health professionals, and others, which is
discussed throughout the preamble to the final rule.
Taken together, this evidence indicates that:
High levels of exposure to ergonomic risk factors on the
job lead to an increased incidence of work-related MSDs among exposed
workers;
Reducing exposure to physical risk factors on the job
reduces the incidence and severity of work-related MSDs;
Many work-related MSDs are preventable; and
Ergonomics programs are demonstrably effective in reducing
risk, decreasing exposure and protecting workers against work-related
MSDs.
As with any scientific field, research in ergonomics is ongoing.
The National Academy of Sciences is currently undertaking another
review of the science in order to expand on its 1998 study. OSHA has
examined all of the research results in the record of this rulemaking
in order to ensure that the final Ergonomics Program standard is based
on the best available and most current evidence. Although more research
is always desirable, OSHA finds that more than enough evidence already
exists to demonstrate the need for a final standard. In the words of
the American College of Occupational and Environmental Medicine, the
world's largest occupational medical society, ``there is an adequate
scientific foundation for OSHA to proceed * * * and, therefore, no
reason for OSHA to delay the rulemaking process * * *.''
D. Information OSHA Is Providing To Help Employers Address Ergonomic
Hazards
Much literature and technical expertise on ergonomics already
exists and is available to employers, both through OSHA and a variety
of other sources. For example:
Information is available from OSHA's ergonomics Web page,
which can be accessed from OSHA's World Wide Web site at http://
www.osha.gov by scrolling down and clicking on ``Ergonomics'';
Many publications, informational materials and training
courses, which are available from OSHA through Regional Offices, OSHA-
sponsored educational centers, OSHA's state consultation programs for
small businesses, and through the Web page;
Publications on ergonomics programs, which are available
from NIOSH at 1-800-35-NIOSH. NIOSH's Web page is also ``linked'' to
OSHA's ergonomics Web page;
OSHA's state consultation programs, which will provide
free on-site consultation services to employers requesting help in
implementing their ergonomics programs; and
OSHA-developed compliance assistance materials, which are
available as non-mandatory appendices to the standard, electronic
compliance assistance training materials (e-cats) on specific tasks
(e.g., lifting) or work environments (e.g., nursing homes). OSHA is
also making several publications available on the web, such as the Easy
Ergonomics Booklet, Fact Sheets, and so on. These materials can be
obtained by accessing OSHA's Internet home page at www.OSHA.gov.
II. Events Leading to the Development of the Final Standard
In this final standard, OSHA has relied on its own substantial
experience with ergonomics programs, the
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experience of private firms and insurance companies, and the results of
research studies conducted during the last 30 years. Those experiences
clearly show that: (1) Ergonomics programs are an effective way to
reduce occupational MSDs; (2) ergonomics programs have consistently
achieved that objective; (3) OSHA's standard is consistent with these
programs; and (4) the standard is firmly grounded in the OSH Act and
OSHA policies and experience. The primary lesson to be learned is that
employers with effective, well-managed ergonomics programs achieve
significant reductions in the severity and number of work-related MSDs
that their employees experience. These programs also generally improve
productivity and employee morale and reduce employee turnover and
absenteeism (see Section VI of this preamble, and Chapters IV
(Benefits) and V (Costs of Compliance) of OSHA's Final Economic
Analysis (Ex. 28-1)).
OSHA's long experience with ergonomics is apparent from the
chronology below. As this table shows, the Agency has been actively
involved in ergonomics for more than 20 years.
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OSHA Ergonomics Chronology
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March 1979................... OSHA hires its first ergonomist.
Early 1980s.................. OSHA begins discussing ergonomic
interventions with labor, trade
associations and professional
organizations. OSHA issues citations to
Hanes Knitwear and Samsonite for
ergonomic hazards.
August 1983.................. The OSHA Training Institute offers its
first course in ergonomics.
February 1986................ OSHA publishes ``Working Safely with
Video Display Terminals,'' its first
publication concerning ergonomics as it
applies to the use of computer
technology
May 1986..................... OSHA begins a pilot program to reduce
back injuries through review of injury
records during inspections and
recommendations for job redesign using
NIOSH's Work Practices Guide for Manual
Lifting.
October 1986................. The Agency publishes a Request for
Information on approaches to reduce back
injuries resulting from manual lifting.
(57 FR 34192)
November 1988................ OSHA/Iowa Beef Processors reach first
corporate-wide settlement to reduce
ergonomic hazards at 8 IBP locations
nationwide.
July 1990.................... OSHA/UAW/Ford corporate-wide settlement
agreement commits Ford to reduce
ergonomic hazards in 96 percent of its
plants through a model ergonomics
program.
August 1990.................. The Agency publishes ``Ergonomics Program
Management Guidelines for Meatpacking
Plants.''
Fall 1990.................... OSHA creates the Office of Ergonomics
Support and hires more ergonomists.
November 1990................ OSHA/UAW/GM sign agreement bringing
ergonomics programs to 138 GM plants
employing more than 300,000 workers.
Throughout the early 90s, OSHA signed 13
more corporate-wide settlement
agreements to bring ergonomics programs
to nearly half a million more workers.
July 1991.................... OSHA publishes ``Ergonomics: The Study of
Work,'' as part of a nationwide
education and outreach program to raise
awareness about ways to reduce
musculoskeletal disorders.
July 1991.................... More than 30 labor organizations petition
Secretary of Labor to issue an Emergency
Temporary Standard on ergonomics.
January 1992................. OSHA begins a special emphasis inspection
program on ergonomic hazards in the
meatpacking industry.
April 1992................... Secretary of Labor denies petition for an
Emergency Temporary Standard but commits
to moving forward with section 6 (b)
rulemaking.
August 1992.................. OSHA publishes an Advance Notice of
Proposed Rulemaking on ergonomics.
1993......................... OSHA conducts a major survey of general
industry and construction employers to
obtain information on the extent of
ergonomics programs in industry and
other issues.
March 1995................... OSHA begins a series of meetings with
stakeholders to discuss approaches to a
draft ergonomics standard.
January 1997................. OSHA/NIOSH conference on successful
ergonomic programs held in Chicago.
April 1997................... OSHA introduces the ergonomics web page
on the Internet.
February 1998................ OSHA begins a series of national
stakeholder meetings about the draft
ergonomics standard under development.
March 1998................... OSHA releases a video entitled
``Ergonomic Programs That Work.''
February 1, 1999............. OSHA begins small business (Small
Business Regulatory Enforcement Fairness
Act (SBREFA) review of its draft
ergonomics rule, and makes draft
regulatory text available to the public.
March 1999................... OSHA/NIOSH/Institute of Industrial
Engineers hold Applied Ergonomics
Conference in Houston
April 30, 1999............... OSHA's Assistant Secretary receives the
SBREFA report on the draft ergonomics
program proposal, and the Agency begins
to address the concerns raised in that
report.
November 23, 1999............ OSHA publishes its proposed ergonomics
program standard.
March 2000................... OSHA/NIOSH/Institute of Industrial
Engineers hold Applied Ergonomics
Conference in Los Angeles
March-May 2000............... OSHA holds 9 weeks of public hearings and
receives 18,337 pages of testimony from
714 witnesses.
November 23, 1999 through OSHA receives nearly 11,000 comments and
August 10, 2000. briefs consisting of nearly 50,000 pages
collectively, into the docket of the
ergonomics rulemaking.
October 27, 2000............. The Occupational Safety and Health Review
Commission finds that manual lifting of
nursing home patients is a known and
recognized risk factor for lower back
pain.
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A. Regulatory and Voluntary Guidelines Activities
In 1989, OSHA issued the Safety and Health Program Management
Guidelines (54 FR 3904, Jan. 26, 1989), which are voluntary program
management guidelines to assist employers in developing effective
safety and health programs. These program management guidelines, which
are based on the widely accepted safety and health principles of
management commitment and employee involvement, worksite hazard
analysis, hazard prevention and control, and employee training, also
serve as the foundation for effective ergonomics programs. In August
1990, OSHA issued the Ergonomics Program Management Guidelines for
Meatpacking Plants (Ex. 2-13), which utilized the four program
components from the safety and health management guidelines,
supplemented by other ergonomics-specific program elements (e.g.,
medical management). The ergonomic guidelines were based on the best
available scientific evidence, the best practices of successful
companies with these programs, advice from the National Institute for
Occupational Safety and Health (NIOSH), the scientific literature, and
OSHA's experience with enforcement
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actions. Many commenters in various industries have said that they have
implemented their ergonomics programs primarily on the basis of the
OSHA ergonomics guidelines (Exs. 3-50, 3-61, 3-95, 3-97, 3-113, 3-121,
3-125), and there has been general agreement among stakeholders that
these program elements should be included in any OSHA ergonomics
standard (Exs. 3-27, 3-46, 3-51, 3-61, 3-89, 3-95, 3-113, 3-119, 3-160,
3-184).
OSHA also has encouraged other efforts to address the prevention of
work-related musculoskeletal disorders. For example, OSHA has actively
participated in the work of the ANSI Z-365 Committee, which was
entrusted with the task of developing a consensus standard for the
control of cumulative trauma disorders. The Agency also has sponsored
and participated in more than 11 Ergonomics Best Practices conferences.
1. Petition for Emergency Temporary Standard
On July 31, 1991, the United Food and Commercial Workers Union
(UCFW), along with the AFL-CIO and 29 other labor organizations,
petitioned OSHA to take immediate action to reduce the risk to
employees of exposure to ergonomic hazards (Ex. 2-16). The petition
requested that OSHA issue an emergency temporary standard (ETS) on
``Ergonomic Hazards to Protect Workers from Work-Related
Musculoskeletal Disorders (Cumulative Trauma Disorders)'' under section
6(c) of the Act. The petitioners also requested, consistent with
section 6(c), that OSHA promulgate, within 6 months of issuance of the
ETS, a permanent standard to protect workers from cumulative trauma
disorders in both general industry and construction.
Based on the statutory constraints and legal requirements governing
issuance of an ETS, OSHA calculated that the basis to support issuance
of an ETS was not sufficient. Accordingly, on April 17, 1992, OSHA
decided not to issue an ETS on ergonomic hazards (Ex. 2-29). OSHA
agreed with the petitioners, however, that available information,
including the Agency's experience and information in the ETS petition
and supporting documents, supported the initiation of a rulemaking,
under section 6(b)(5) of the Act, to address ergonomic hazards.
2. Advance Notice of Proposed Rulemaking
At the time OSHA issued the Ergonomic Program Management Guidelines
for Meatpacking Plants (Ex. 2-13), the Agency also indicated its
intention to begin the rulemaking process by asking the public for
information about musculoskeletal disorders (MSDs). The Agency
indicated that this could be accomplished through a Request for
Information (RFI) or an Advance Notice of Proposed Rulemaking (ANPR)
consistent with the Administration's Regulatory Program. Subsequently,
OSHA formally placed ergonomics rulemaking on the regulatory agenda
(Ex. 2-17) and decided to issue an ANPR on this topic.
In June 1991, OSHA sent a draft copy of the proposed ANPR questions
for comment to 232 parties, including OSHA's advisory committees, labor
organizations (including the petitioners), trade associations,
occupational groups, and members of the ergonomics community (Ex. 2-
18). OSHA requested comments on what questions should be presented in
the ANPR. OSHA received 47 comments from those parties. In addition,
OSHA met with the Chemical Manufacturers Association, Organization
Resources Counselors, Inc., the AFL-CIO and several of its member
organizations. OSHA reviewed the comments and submissions received and
incorporated relevant suggestions and comments into the ANPR.
On August 3, 1992, OSHA published the ANPR in the Federal Register
(57 FR 34192), requesting information for consideration in the
development of an ergonomics standard. OSHA received 290 comments in
response to the ANPR. Those comments have been carefully considered by
the Agency in developing the final ergonomics program standard.
3. Outreach to Stakeholders
In conjunction with the process of developing the proposed
ergonomics rule, OSHA established various communication and outreach
efforts. These efforts were initiated in response to requests by
individuals who would be affected by the rule (stakeholders) that they
be provided with the opportunity to present their concerns about an
ergonomics rule and that they be kept apprized of the efforts OSHA was
making in developing a proposed rule. For example, in March and April
1994, OSHA held meetings with industry, labor, professional and
research organizations covering general industry, construction,
agriculture, healthcare, and the office environment. A list of those
attending the meetings and a record of the meetings has been placed in
the public record of this rulemaking (Ex. 26-1370).
In March, 1995, OSHA provided a copy of an early draft proposed
ergonomics rule and preamble to these same organizations. Thereafter,
during April 1995, OSHA met again with these groups to discuss whether
the draft proposed rule had accurately responded to the concerns raised
earlier. A summary of the comments has been placed in the public record
(Ex. 26-1370).
During 1998, OSHA met with nearly 400 stakeholders to discuss ideas
for a proposed standard. The first series of meetings was held in
February in Washington, D.C. and focused on general issues, such as the
scope of the standard and what elements of an ergonomics program should
be included in a standard. The second series of meetings, held in July
in Kansas City and Atlanta, focused on what elements and activities
should be included in an ergonomics program standard. The third set of
meetings was held in September in Washington, D.C. and emphasized
revisions to the elements of the proposal based on previous stakeholder
input. A summary of those meetings was placed on the OSHA web site and
in the public docket (Ex. 26-1370). OSHA solicited input from its
stakeholders again the next year, when it posted a working draft of its
ergonomics standard after its release for Small Business Regulatory
Enforcement Fairness Act (SBREFA) Panel review.
4. Small Business Regulatory Enforcement Fairness Act (SBREFA) Panel
In accordance with SBREFA and to gain insight from employers with
small businesses, OSHA, the Office of Management and Budget (OMB), and
the Small Business Administration (SBA) created a Panel to review and
comment on a working draft of the ergonomics program standard. As
required by SBREFA, the Panel sought the advice and recommendations of
potentially affected Small Entity Representatives (SERs). A total of 21
SERs from a variety of industries participated in the effort. The
working draft and supporting materials (a brief summary of a
preliminary economic analysis, the risk assessment, and other
materials) were sent to the SERs for their review. On March 24-26,
1999, the Panel participated in a series of discussions with the SERs
to answer questions and receive comments. The SERs also provided
written comments, which served as the basis of the Panel's final report
(Ex. 23). The final SBREFA Panel Report was submitted to the Assistant
Secretary on April 30, 1999. The findings and recommendations made by
the Panel are addressed in the proposed rule, preamble, and economic
analysis (see the discussion in Section
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VIII, Summary of the Final Economic Analysis and Regulatory Flexibility
Analysis).
5. Issuance of Proposed Rule
On November 23, 1999, OSHA published a proposed ergonomics program
standard to address the significant risk of work-related
musculoskeletal disorders (MSDs) confronting employees in various jobs
in general industry workplaces (64 FR 65768). The proposed standard
would have required general industry employers covered by the standard
to establish an ergonomics program containing some or all of the
elements typical of successful ergonomics programs: management
leadership and employee participation, job hazard analysis and control,
hazard information and reporting, training, MSD management, and program
evaluation, depending on the types of jobs in their workplace and
whether a musculoskeletal disorder covered by the standard had
occurred. Employers whose employees perform manufacturing or manual
handling jobs were required to implement a basic ergonomics program in
those jobs.
The basic program would have included the following elements:
management leadership and employee participation, and hazard
information and reporting. If an employee in a manufacturing or manual
handling job experienced an OSHA-recordable MSD determined by the
employer to be covered by the standard, the employer would have been
required to implement a full ergonomics program for that job and all
other jobs in that establishment involving the same physical work
activities. The full program would have included, in addition to the
elements in the basic program, a hazard analysis of the job; the
implementation of engineering, work practice or administrative controls
to eliminate or substantially reduce the hazards identified in that
job; training the employees and their supervisors in that job; and
providing MSD management, including where appropriate, temporary work
restrictions and access to a health care provider or other professional
if a covered MSD occurred. General industry employees in jobs other
than manufacturing or manual handling who experienced a covered MSD
determined by the employer to be covered by the standard also would
have been required by the proposal to implement an ergonomics program
for those jobs.
6. Solicitation of Public Comment on the Proposed Rule
The notice of proposed rulemaking invited public comment on any
aspects of the proposed ergonomics standard until the close of the
comment period ending on February 1, 2000.
After receiving a number of requests for an extension of the
written comment period, OSHA published a Federal Register notice (65 FR
4795) to extend the deadline for public, pre-hearing comments to March
2, 2000 and to reschedule the informal public hearings in Washington,
D.C. to begin March 13, 2000 and run through April 7, 2000.
Subsequently, the Agency published a Federal Register notice (65 FR
19702) to re-schedule and extend the hearings in Portland, OR by 2
days, from April 24, 2000 through May 3, 2000. In addition, a final
week of informal public hearings (65 FR 13254) was scheduled to take
place in Washington, D.C. from May 8, 2000 through May 12, 2000.
During the early stages of the public comment period, it was
brought to OSHA's attention that the proposed ergonomics program
standard published on November 23, 1999 (64 FR 65768) did not provide
an analysis of the economic impacts of the rule on State and local
governments, the United States Postal Service, or the railroads. To
provide this additional information and analysis, OSHA published a
supplement (65 FR 33263) to the Agency's Preliminary Economic Analysis
and Initial Regulatory Flexibility Analysis (Ex. 28-1) of the economic
impact of the Ergonomics Program Rule. OSHA also established pre-
hearing and post-hearing comment periods ending June 22, 2000 and
August 10, 2000, respectively, to address the analysis of economic
impacts in those three industries. An informal public hearing was held
in Atlanta, GA on July 7, 2000, to provide an opportunity for witnesses
to question the OSHA Panel on the supplemental analysis.
Collectively, the public hearings concerning the proposed
ergonomics program standard generated 18,337 pages of transcript based
on testimony from 714 hearing witnesses, including those representing
public entities, private industry, industry associations, labor unions
and private individuals.
More than 5,900 pre-hearing comments were filed in response to the
proposed ergonomics program standard. A 45-day post-hearing comment
period and a 45-day summary and brief period were established, with
final briefs due to be postmarked no later than August 10, 2000. A
total of 240 post hearing submissions were received. Collectively, a
total of nearly 11,000 exhibits consisting of nearly 50,000 pages were
submitted over the whole period.
B. Other OSHA Efforts In Ergonomics
In 1996, OSHA developed a strategy to address ergonomics through a
four-pronged program including training, education, and outreach
activities; study and analysis of the work-related hazards that lead to
MSDs; enforcement; and rulemaking.
1. Training, Education, and Outreach
a. Training. The OSHA ergonomics web page has been an important
part of the Agency's education and outreach effort. Other OSHA efforts
in training, education and outreach include the following:
Grants to train workers and employees about hazards and
hazard abatement.
Three training courses in ergonomics through the OSHA
Training Institute available for OSHA compliance officers, one of which
is open to the public;
One day training for nursing home operators, at more than
500 nursing homes in each of seven targeted states;
Booklets on ergonomics, ergonomics programs, and computer
workstations, such as ``Ergonomics Program Management Guidelines for
Meatpacking Plants'' and ``Ergonomics: the Study of Work,'' both of
which are available on OSHA's Website.
Videotapes on ergonomics programs in general industry and
specifically in nursing homes.
OSHA has awarded almost $3 million for 25 grants addressing
ergonomics, including lifting hazards in healthcare facilities and
hazards in the red meat and poultry industries. These grants have
enabled workers and employers to identify ergonomic hazards and
implement workplace changes to abate these hazards.
Some grant program highlights follow:
The United Food and Commercial Workers International
Union (UFCW) conducted joint labor-management ergonomics training at
a meatpacking plant that resulted in a major effort at the plant to
combat cumulative trauma disorders. The program was so successful
that management asked the UFCW to conduct the ergonomics training
and work with management at some of its other facilities.
The University of California at Los Angeles (UCLA) and
the Service Employees International Union (SEIU) both had grants for
preventing lifting injuries in nursing homes. SEIU developed a
training program that was used by UCLA to train nursing home workers
in California. UCLA also worked with some national back injury
prevention
[[Page 68267]]
programs. At least one of the nursing home chains has replicated the
program in other states.
Mercy Hospital in Des Moines, Iowa, had a grant to
prevent lifting injuries in hospitals. It trained over 3,000
hospital workers in Des Moines and surrounding counties. It had a
goal of reducing lost work days by 15 percent. The goal was
surpassed, and, six months after the training, none of those trained
experienced a lost workday due to back injury.
Hunter College in New York City trains ergonomics
trainers for the United Paperworkers International Union. The
trainers then return to their locals and conduct ergonomics training
for union members. As a result of this training, changes are being
made at some workplaces. Examples include purchasing new equipment
that eliminates or reduces workers' need to bend or twist at the
workstation, rotating workers every two hours with a ten-minute
break before each rotation, and modifying workstations to reduce
worker strain.
b. Education and Outreach. To provide a forum to discuss ergonomic
programs and to augment information in the literature with the
experience of companies of different sizes and from a variety of
industries, OSHA and NIOSH sponsored the first in a series of
conferences that brought industry, labor, researchers, and consultants
together to discuss what works in reducing MSDs. The 1997 OSHA and
NIOSH conference was followed by 11 more regional conferences across
the country. OSHA and NIOSH held the second national conference on
ergonomics in March of 1999. More than 200 presentations were given at
the conferences on how companies have successfully reduced MSDs.
Presentations were made by personnel from large and small companies in
many different industries.
Other examples of successful ergonomics programs have come from
OSHA's Voluntary Protection Program (VPP). The VPP program was
established by OSHA to recognize employers whose organizations have
exemplary workplace safety health programs. Several sites that have
been accepted into VPP have excellent ergonomics programs.
In addition to OSHA's enforcement efforts, the Agency's Ergonomics
Program Management Guidelines for Meatpacking Plants (``Guidelines'')
(Ex. 2-13) are viewed by many as essential to the implementation of
successful workplace programs addressing ergonomic hazards. For
example, in contrasting OSHA's proposal to the Guidelines, IBP Inc.'s
Bob Wing acknowledged that the Guidelines had been successful (Ex. 30-
4046, p.1). Similarly, the American Meat Institute (``AMI''), the main
representative for the U.S. meat industry, including 276 meat packers
and processors, who operate 559 facilities, acknowledged that the
industry worked with OSHA on the Guidelines, and has been using them
for nearly ten years (Ex. 30-3677, p.1). The AMI notes that the
Guidelines work and that the industry has made substantial progress in
addressing ergonomic issues since development of the Guidelines (id. at
1-4). The AMI recommended that the Guidelines be extended throughout
general industry (id. at 4). The utility of OSHA's Guidelines also was
hailed by the United Food and Commercial Workers' Union, which noted
that upon publication of the Guidelines, industry began to respond both
from the standpoint of technology as well as ergonomics programs (Ex.
32-210-2, pp. 25-26). The success of the Guidelines led to their use
and acceptance in other industries. The poultry industry appears to
have secured substantial reductions in chronic MSDs from adherence to
the principles in the document (Ex. 30-3375, p.1.).
2. Ergonomics Best Practices Conferences
During the period from Sept. 17, 1997 through Sept. 29, 1999, OSHA
and its Regional Education Centers co-sponsored 11 Ergonomics Best
Practices Conferences. These Conferences were designed to provide good
examples of practical and inexpensive ergonomics interventions
implemented by local companies. The concept was that if OSHA and its
Regional partners could initiate the development of a network of local
employers, contractors, and educators to provide practical information
to solve ergonomics problems, it would be assisting employers in
providing a workplace for employees that would be ``free of recognized
safety and health hazards.'' To date, attendance has exceeded 2,400
participants, including employers, contractors, and employees. Finally,
OSHA has made hundreds of outreach presentations to labor, trade
associations, large and small businesses, and professional
organizations during the development of the proposed rule.
3. Enforcement
In the absence of a federal OSHA ergonomics standard, OSHA has
addressed ergonomics in the workplace under the authority of section
5(a)(1) of the OSHAct. This section is referred to as the General Duty
Clause and requires employers to provide work and a work environment
free from recognized hazards that are causing or are likely to cause
death or serious physical harm.
OSHA has successfully issued over 550 ergonomics citations under
the General Duty Clause. In the majority of these cases, cited
employers have recognized that the implementation of ergonomics
programs is in their best interest and that of their employees.
Examples of companies cited under the General Duty Clause for
ergonomics hazards and which then realized a substantial reduction in
injuries and illnesses after implementing ergonomics programs include:
the Ford Motor Company, Empire Kosher Foods, Sysco Foods, and the
Kennebec Nursing Home.
Two cases have been decided so far by the Occupational Safety and
Health Review Commission.
In the first general duty clause case litigated by the Occupational
Safety and Health Review Commission, Pepperidge Farm, the Review
Commission recognized that excessive lifting and excessive repetitions
were recognized ergonomic hazards that had caused and were likely to
cause serious physical harm to employees whose work tasks required such
activity. The Commission specifically noted that carpal tunnel syndrome
and other soft tissue injuries found at the cited plant were caused by
work tasks; the Commission relied principally on direct medical
evidence, expert medical opinion, the incidence of injury, and the
epidemiological studies and testimony in the record in reaching this
finding. The Commission also agreed that an employer could be required
to undertake a process-based, incremental approach to abating ergonomic
hazards. The citations relating to the excessive lifting hazard were
affirmed by the Commission, while those relating to the excessive
repetitions were vacated based on a finding that the Secretary had
failed to prove feasible means of abatement in addition to those found
to have been undertaken by the company.
In the second general duty clause case litigated by the Commission,
Beverly Enterprises, the Commission held that the company's practices
for lifting patients in its nursing homes exposed its nursing
assistants to a serious recognized hazard. Beverly's nursing assistants
suffered a disproportionate number of cases of lower back pain, which
was often so severe that the employee would be off work for long
periods of time, in some cases six months to over a year. The
Commission found that manual lifting of nursing home residents is a
known and recognized risk factor for lower back pain and that the
company recognized the hazard.
[[Page 68268]]
When serious physical harm cannot be documented in the work
environment but hazards have been identified by OSHA, compliance
officers both discuss the hazards with the employer during the closing
conference of an inspection and write a letter to the employer. These
letters are called ``Ergonomic Hazard Alert Letters.'' From fiscal year
1997 through October 3, 2000, approximately 498 such letters have been
sent to public and private sector employers under Section 20 of the OSH
Act. These letters involve no penalty and are strictly consultative in
nature; they reflect OSHA's responsibility to provide consultation on
ergonomics to employers. Ergonomic Hazard Alert Letters have been sent
to employers in approximately 50% of OSHA's ergonomic inspections.
Since ergonomic solutions vary from one industry to another, OSHA
has provided both general and industry-specific training to its
compliance officers. Currently, the OSHA Training Institute (OTI) in
Des Plaines, IL, offers three main ergonomic courses to OSHA compliance
staff: Principles of Ergonomics Applied to Work-Related Musculoskeletal
and Nerve Disorders (#225); Ergonomics Compliance (#325), an advanced
ergonomics course; and Nursing Home Enforcement Training (#840). A
fourth course, Healthcare (#336), has been in development and will be
piloted on November 14, 2000 through November 17, 2000. That course
will be designed to help OSHA compliance officers, as well as
employers, to identify ergonomic and other hazards within healthcare
facilities, with a specific emphasis on hospitals. Over 600 OSHA
compliance staff members have been trained in these courses within the
past three years alone. The courses typically cover three weeks of
material.
Currently, the Principles of Ergonomics Applied to Work-Related
Musculoskeletal and Nerve Disorders course also is open to the public
through OTI's 12 Regional Education Centers throughout the United
States. Since that course has been available nationwide, public
interest has been high, and the Education Centers have been scheduling
courses on a regular basis to meet the constant demand. Although the
new Healthcare Course is available currently only to OSHA compliance
officers, after the pilot period ends it will be open to the public on
a limited basis.
In addition to education and training opportunities, OSHA has
appointed one Regional Ergonomics Coordinator in each of OSHA's 10
regional offices, and one Area Office Ergonomics Coordinator in each
area office. These coordinators meet on a monthly basis to discuss
recent inspections, case developments, and scientific literature on
ergonomics; to share knowledge of ergonomic solutions; and to ensure
that enforcement resources are provided to compliance staff for
enforcement. A PhD level, professionally certified ergonomist serves as
the National Ergonomics Enforcement Coordinator in OSHA's Directorate
of Compliance Programs.
4. Corporate-Wide Settlement Agreements
Among the companies that have been cited for MSD hazards, 13
companies covering 198 facilities agreed to enter into corporate-wide
settlement agreements with OSHA. These agreements were primarily in the
meat processing and auto assembly industries, but there also were
agreements with telecommunications, textile, grocery warehousing, and
paper companies. As part of these settlement agreements, the companies
agreed to develop ergonomics programs based on OSHA's Meatpacking
Guidelines (Ex. 2-13) and to submit information on the progress of
their programs.
OSHA held a workshop in March 1999, in which 10 companies described
their experience under their settlement agreement and with their
ergonomics programs. All the companies that reported results to OSHA
showed a substantially lower severity rate for MSDs since implementing
their programs (Ex. 26-1420). In addition, most companies reported
lower workers' compensation costs, as well as higher productivity and
product quality. A report from the March 1999 workshop on corporate-
wide settlement agreements summarizing the results achieved by the 13
companies involved has been placed in the docket (Ex. 26-1420). Only 5
of the 13 companies consistently reported the number of MSD cases or
MSD case rates. All five companies that reported data on MSD-related
lost workday rates showed a significant decline in the number of lost
workdays. None of the companies that reported severity statistics
showed an increase in lost workdays as a result of the ergonomics
program.
Similarly, the success of OSHA enforcement coupled with settlements
requiring comprehensive ergonomics programs was confirmed by the United
Food and Commercial Workers International Union. The union recognized
that ``* * * [t]he majority of our successful programs in the
meatpacking and poultry industries were propelled by OSHA enforcement.
Ergonomic settlement agreements and corporate-wide settlement
agreements (CWSAs) * * * demonstrate industry recognition of the
existence of MSD hazards and the elements of a program to prevent
worker injuries arising from exposure to these hazards'' (Ex. 32-210-2,
p. 5). The UFCW confirmed the efficacy of these agreements and
resulting programs through a number of examples. One was that of IBP's
Dakota City meatpacking plant that implemented a comprehensive program
as a result of citations and subsequent settlement agreement. Cost
savings attributed to the program ``* * * were realized in the
following areas: [employee] turnover was down significantly * * *;
[MSD] incidence dropped dramatically; surgeries fell; [and] workers'
compensation costs were reduced significantly'' (id. at 9).
C. Summary
As this review of OSHA's activities in the last 20 years shows, the
Agency has considerable experience in addressing ergonomics issues.
OSHA also has used all of the tools authorized by the Act--enforcement,
consultation, training and education, compliance assistance, the
Voluntary Protection Programs, and the issuance of voluntary
guidelines--to encourage employers to address musculoskeletal
disorders, the single largest occupational safety and health problem in
the United States today. These efforts, and the voluntary efforts of
employers and employees, have led to the recent 5-year decline in the
number of reported lost workday ergonomics injuries. However, in 1997,
there were still more than 626,000 lost workday MSD injuries and
illnesses reported.
Promulgation of an ergonomics program standard will add the only
tool the Agency has so far not deployed against this hazard--a
mandatory standard--to these other OSHA and employer-driven
initiatives. Over the first 10 years of the standard's implementation,
OSHA predicts that more than 3 million lost workday musculoskeletal
disorders will be prevented in general industry. Ergonomics programs
can lead directly to improved product quality by reducing errors and
rejection rates. In an OSHA survey of more than 3,000 employers, 17
percent with ergonomics programs reported that their programs had
improved product quality. In addition, a large number of case studies
reported in the literature describe quality improvements. Thus, in
addition to better safety and health for workers, the standard will
save employers money, improve product quality, and
[[Page 68269]]
reduce employee turnover and absenteeism.
Section III. Legal Authority
A. General Criteria for OSH Act Standards
The purpose of the Occupational Safety and Health Act (``OSH Act'')
is ``to assure so far as possible every working man and woman in the
nation safe and healthful working conditions and to preserve our human
resources.'' 29 U.S.C. 651(b). To further this goal, Congress
authorized the Secretary of Labor to promulgate and enforce
occupational safety and health standards. Section 6(b) of the OSH Act,
29 U.S.C. 655(b) (authorizing promulgation of standards pursuant to
notice and comment); 654(b) (requiring employers to comply with OSH Act
standards). This standard is being issued pursuant to section 6(b).
The OSH Act defines an ``occupational safety and health standard''
as ``a standard which requires conditions, or the adoption or use of
one or more practices, means, methods, operations, or processes,
reasonably necessary or appropriate to provide safe or healthful
employment and places of employment.'' Section 3(8) of the Act, 29
U.S.C. 652(8).
A standard is ``reasonably necessary or appropriate'' within the
meaning of section 3(8) if it (1) substantially reduces or eliminates a
significant risk of material impairment to worker health, safety, or
functional capacity; (2) is technologically and economically feasible
to implement; (3) is cost effective; (4) is consistent with prior
agency action or supported by a reasoned justification for departing
from prior agency action; (5) is supported by substantial evidence; and
(6) is at least as protective as any applicable national consensus
standard. 58 FR 16612, 16614 (March 30, 1993). To fulfill the
congressional purpose underlying the Act, all OSH Act standards must be
highly protective. Id. at 16614-15.
OSHA's determination that a particular level of risk is
``significant'' is based largely on policy considerations. See
Industrial Union Dep't, AFL-CIO v. Marshall, 448 U.S. 607, 656 n. 62
(1980) (Benzene). The factors that enter into such a determination
include the seriousness of the injuries or illnesses a standard will
prevent, the likelihood that a particular employee will contract such
an injury or illness, and the total number of employees affected. Where
the standard seeks to prevent fatal illnesses and injuries, OSHA has
generally considered an excess risk of 1 death per 1000 workers over a
45-year working lifetime as clearly representing a significant risk.
See Benzene, 448 U.S. at 646; UAW v. Pendergrass, 878 F.2d 389, 393
(D.C. Cir. 1989) (Formaldehyde); Building & Constr. Trades Dep't v.
Brock, 838 F.2d 1258, 1264 (D.C. Cir. 1988) (Asbestos). But nonfatal
injuries and illnesses are often disabling and debilitating, and death
is clearly not a precondition to a finding of significant risk of
material impairment. See American Textile Mfrs. Inst. v. Donovan, 452
U.S. 490, 506 n. 25 (1981) (Cotton Dust) (upholding OSHA's finding that
cotton dust exposure at levels that caused chronic and irreversible
pulmonary disease presented a significant risk to workers); AFL-CIO v.
OSHA, 965 F.2d 962, 975 (11th Cir. 1992) (upholding OSHA's finding that
``there is a level at which [sensory] irritation becomes so severe that
employee health and job performance are seriously threatened.'');
Formaldehyde, 878 F.2d at 396-399 (upholding OSHA's finding that
exposure limit of 1 ppm would eliminate significant risk of sensory
irritation due to formaldehyde exposure); United Steelworkers v.
Marshall, 647 F.2d 1189, 1245-51 (D.C. Cir. 1980), cert. denied, 453
U.S. 913 (1981) (Lead I) (upholding OSHA's determination that it was
appropriate and necessary to lower lead exposures to reduce cases in
which workers experience subclinical effects of lead exposure because
such subclinical effects are precursors of serious, lead-related
disease); Forging Indus. Ass'n v. Secretary of Labor, 773 F.2d 1436,
1444-46 (4th Cir. 1985) (en banc) (Noise) (upholding OSHA's significant
risk finding that a substantial percentage of workers exposed to
existing workplace noise levels would suffer material noise-induced
hearing loss). See also American Dental Ass'n v. Martin, 984 F.2d 823,
826 (7th Cir.), cert. denied, 510 U.S. 859 (1993) (Bloodborne
Pathogens) (noting that, in addition to causing death, AIDS and
Hepatitis B cause protracted pain and disability).
A standard is technologically feasible if the protective measures
it requires already exist, can be brought into existence with available
technology, or can be created with technology that can reasonably be
expected to be developed. See Cotton Dust, 452 U.S. at 513; Lead I, 647
F.2d at 1272; American Iron & Steel Inst. v. OSHA, 939 F.2d 975, 980
(D.C. Cir. 1991) (Lead II).
A standard is economically feasible if industry can absorb or pass
on the costs of compliance without threatening the industry's long-term
profitability or competitive structure. See Cotton Dust, 452 U.S. at
530 n. 55; Lead I, 647 F.2d at 1272; Lead II, 939 F.2d at 980.
A standard is cost effective if the protective measures it requires
are the least costly of the available alternatives that achieve the
same level of protection. Cotton Dust, 453 U.S. at 514 n. 32; UAW v.
OSHA, 37 F.3d 665, 668 (D.C. Cir. 1994) (Lockout/Tagout II).
Within the framework of these principles, OSHA has considerable
discretion (``virtually unlimited discretion,'' in the words of the
Lead I decision, 647 F.2d at 1230) in choosing the measures that are
reasonably necessary or appropriate to reduce significant risk. A
standard may address the hazards associated with an industry (e.g.,
logging, 29 CFR 1910.266), a kind of work (e.g., hazardous waste
cleanup, 29 CFR 1910.120), a category of equipment (e.g., respirators,
29 CFR 1910.134); an environmental area (e.g., confined spaces, 29 CFR
1910.146), a lack of information (e.g., hazard communication, 29 CFR
1910.1200), a class of harmful agents (e.g., bloodborne pathogens, 29
CFR 1910.1030), or may require general measures reasonably necessary
and appropriate for safety (e.g., safety and health programs for
construction, 29 CFR 1926.20(b)). Depending on the nature of the safety
and health issues, some standards require highly specific control
measures. E.g., 29 CFR 1926.652 (excavations). Others require the
employer to conduct a hazard assessment and establish measures meant to
address the problems found. E.g., 29 CFR 1910.119 (process safety
management). A typical standard for a toxic chemical will contain
permissible exposure limits, a control hierarchy for reaching those
limits, and provisions for assessing exposure, medical examinations,
medical removal, and training. E.g., 29 CFR 1910.1025 (lead). Some
toxic chemical standards also mandate specific work practices that must
be used to control exposures. E.g., 29 CFR 1910.1029 (coke oven
emissions); 29 CFR 1926.1101 (asbestos). Vaccination against Hepatitis
B is one of the protective measures required by the bloodborne
pathogens standard, 29 CFR 1910.1030. Medical removal protection
benefits have been mandated when they are needed to encourage employees
to participate in medical surveillance. 29 CFR 1910.1025 (lead); 29 CFR
1910.1027 (cadmium); 29 CFR 1910.1048 (formaldehyde); 29 CFR 1910.1052
(methylene chloride). Job hazard analysis and employee training are
cornerstones of some OSHA standards. E.g., 29 CFR 1910.147 (lockout/
tagout).
[[Page 68270]]
Section 6(b)(7) of the Act, 29 U.S.C. 665(b)(7), requires standards
to include provisions warning employees of hazards, the means needed to
protect themselves against those hazards, and, where appropriate,
medical examinations or tests to determine whether the health of
employees has been adversely affected:
Any standard promulgated under this subsection shall prescribe
the use of labels or other appropriate forms of warning as are
necessary to insure that employees are apprised of all hazards to
which they are exposed, relevant symptoms and appropriate emergency
treatment, and proper conditions and precautions of safe use or
exposure. Where appropriate, such standard shall also prescribe
suitable protective equipment and control or technological
procedures to be used in connection with such hazards and shall
provide for monitoring or measuring employee exposure at such
locations, and in such manner as may be necessary for the protection
of employees. In addition, where appropriate, any such standard
shall prescribe the type and frequency of medical examinations or
other tests which shall be made available, by the employer or at his
cost, to employees exposed to such hazards in order to most
effectively determine whether the health of such employees is
adversely affected by such exposure.
B. Section 6(b)(5)
Standards dealing with ``toxic materials or harmful physical
agents'' must, in addition to meeting the ``reasonably necessary or
appropriate'' test of section 3(8), conform to section 6(b)(5) of the
Act, 29 U.S.C. 655(b)(5). That section provides:
The Secretary, in promulgating standards dealing with toxic
materials or harmful physical agents under this subsection, shall
set the standard which most adequately assures, to the extent
feasible, on the basis of the best available evidence, that no
employee will suffer material impairment of health or functional
capacity even if such employee has regular exposure to the hazard
dealt with by such standard for the period of his working life.
The standards that are governed by section 6(b)(5) are sometimes
referred to as ``health'' standards, while non-6(b)(5) standards are
often referred to as ``safety'' standards. In enacting section 6(b)(5),
Congress recognized ``that there were special problems in regulating
health risks as opposed to safety risks. In the latter case, the risks
are generally immediate or obvious, while in the former, the risks may
not be evident until a worker has been exposed for long periods of time
to particular substances. It was to ensure that the Secretary took
account of these long-term risks that Congress enacted Sec. 6(b)(5).''
Benzene, 448 U.S. at 649 n. 54. According to its legislative sponsor,
section 6(b)(5) is intended to require OSHA to take into account the
potential that an employee may be exposed to the hazard for his entire
working lifetime ``so that we can get at something which might not be
toxic now, if he works in it a very short time, but if he works in it
the rest of his life it might be very dangerous.'' (Remarks of Senator
Dominick in colloquy with Senator Williams, Leg. Hist. at 503).
Section 6(b)(5) directs OSHA to set the standard which will, to the
extent feasible, protect employees from material impairment to their
health even if they are exposed regularly to the toxic chemical or
harmful physical agent for their entire working life. Section 6(b)(5)
thus requires that any standard governed by that section must reduce
significant risk to the lowest feasible level. See Cotton Dust, 452
U.S. at 509. Safety standards, which are not governed by section
6(b)(5), need not reduce significant risk to the lowest feasible level
but must provide a high degree of employee protection to be consistent
with the purpose of the Act. 58 FR at 16614-15. Safety standards may
therefore ``deviate only modestly from the stringency required by
Sec. 6(b)(5) for health standards.'' Lockout/Tagout II, 37 F.3d at 669.
The most important consideration in construing the scope of section
6(b)(5), as with any statutory provision, is the language of the
statute itself. In many cases, it is obvious whether a hazard is a
``toxic material'' or ``harmful physical agent'' subject to section
6(b)(5). Other hazards are less clear cut. OSHA has looked to several
factors in determining whether a standard fits within section 6(b)(5).
These include: Is the hazard likely to cause harm promptly or after a
short period of exposure, or does harm occur only after a lengthy
period of exposure? Is the connection between exposure and harm
apparent, or is it hidden and subtle? Is the harm coincident with
exposure, or is there a latency period with harm frequently manifesting
itself long after exposure has ended? See Benzene, 448 U.S. at 649 n.
54; UAW v. OSHA, 938 F.2d 1310, 1313 (D.C. Cir. 1991) (Lockout/Tagout
I); National Grain & Feed Ass'n v. OSHA, 866 F.2d 717, 733 (5th Cir.
1989) (Grain Dust).
Because the hazardous exposures regulated by this standard cannot
be neatly categorized by the factors discussed above, whether this
standard is governed by section 6(b)(5) poses difficult legal issues.
Some commenters supported characterizing the rule as a section 6(b)(5)
rule (Ex. 32-339-1 at p. 15 (AFL-CIO), while others opposed it. Ex. 32-
368-1 at p. 41-44 (National Coalition on Ergonomics); Ex. 32-206-1 at
p. 32 (American Iron & Steel Institute); Ex. 22-337-1 at pp. 3-7
(Integrated Waste Service Association); Ex. 30-1722 at pp. 33-35
(Chamber of Commerce). For a variety of reasons, OSHA concludes that
the standard is not subject to section 6(b)(5).
First, the language of the statute itself suggests that this rule
is not governed by section 6(b)(5). That provision applies to ``toxic
materials or harmful physical agents.'' The ``toxic materials'' to
which section 6(b)(5) refers include chemicals that are harmful if
breathed and/or ingested, such as asbestos, lead, and mercury. S. Rep.
No. 91-1282, 91st Cong., 2d Sess. at 2, reprinted in Committee Print,
Legislative History of the Occupational Safety and Health Act of 1970,
(Leg. Hist.) at 142. Ergonomic risk factors are clearly not a toxic
material. The ``harmful physical agents'' to which Congress referred
include laser radiation, ultrasonic energy, ionizing radiation, noise,
and vibration. Id. at 142-43. Of the harmful physical agents mentioned
by Congress, only vibration is a risk factor addressed by the
ergonomics standard. The remaining risk factors addressed by this
standard--force, repetition, awkward postures, and contact stress---are
fundamentally dissimilar from the harmful physical agents discussed by
Congress in that they relate to the position, movement, and loading on
the tissues of a worker's body rather than an external agent acting on
the body. See Pulaski v. California Occupational Safety & Health
Standards Board, 90 Cal. Rptr. 2d 54, 66 (Cal. Ct. App. 1999) (``a
repetitive motion injury is neither a `toxic material' nor a `harmful
physical agent.' ''). Therefore, the language and legislative history
of the Act indicate that the majority of the risk factors addressed by
this rule are not the type of hazards Congress intended to regulate
under section 6(b)(5).
In addition, the hazards addressed by the rule differ from those
addressed by section 6(b)(5). A lengthy period of exposure--years,
decades, or a working lifetime--is not necessary to create a
substantial risk of MSDs. As discussed below, both acute and chronic
exposures to ergonomic risk factors can result in MSDs. And, although
MSDs frequently develop gradually as a result of exposure over time,
the period of time necessary can be days, weeks, or months, rather than
the working lifetime referred to in the text of section 6(b)(5).
Moreover, MSDs are unlike illnesses, such as cancer, damage to the
reproductive system, and kidney failure, that can result from exposure
to toxic chemicals and appear long after the
[[Page 68271]]
exposure ceased even though the exposure caused no overt symptoms while
it was occurring. An employee who is beginning to suffer a work-related
MSD will frequently recover fully after the exposure to ergonomic risk
factors ceases. For that reason, the standard requires that an employee
who develops a work-related MSD be restricted from participating in
work activities or removed from exposure that will worsen the
condition.
The ability of employers and employees to generally recognize a
cause-and-effect relationship between ergonomic risk factors and many
MSDs also indicates that this final standard is a non-6(b)(5) rule. In
recent years, as both employers and employees have become more aware of
the connection between workplace risk factors and MSDs (see Tr. 5817-
19), employers have reported over 600,000 work-related MSDs that result
in lost workdays each year (64 FR at 65931). Employees themselves are
often able to recognize when MSDs result from exposure to risk factors
in the workplace. As OSHA noted in the proposal: ``Many employers have
told OSHA that talking with employees is a quick and easy way to find
out what kind of problems are in the job. They said that talking with
employees is often the best way to identify the causes of the problem
and to identify the most cost-effective solutions to it.'' 64 FR at
65805 (citing Ex. 26-1370). Testimony at the public hearing made the
same point. Dr. Suzanne Rodgers, a physiologist with 32 years'
experience in industrial ergonomics, testified that the companies she
had worked with learn about ergonomic problems by having employees tell
them when a problem exists. (Tr. 2144). Similarly, David Alexander, a
certified professional ergonomist with more than 25 years experience,
testified that encouraging employees to report early signs and symptoms
of developing MSDs was a key feature of a successful ergonomics
program. (Tr. 2145-46).
Further, Congress provided for special treatment of health hazards
in section 6(b)(5) because it recognized that employers had little
incentive to control exposures to toxic chemicals and harmful physical
agents when there is a long period between exposure to a hazard and the
manifestation of an illness. ``In such instances a particular employer
has no economic incentive to invest in current precautions, not even in
the reduction of workmen's compensation costs, because he seldom will
have to pay for the consequences of his own neglect.'' Leg. Hist. at
144. However, in this respect too, the ergonomics standard is more like
a typical safety standard than a health standard because many of the
costs of such injuries in terms of workers' compensation claims and
lost productivity are borne by employers as MSDs occur. Thus, the
ergonomics standard does not implicate section 6(b)(5)'s concern about
hazardous exposures that lead to illnesses after lengthy exposure and
therefore require special attention because employers can defer or
avoid the costs associated with such illnesses.
Finally, the type of information on which this standard is based is
far more characteristic of a safety standard than a section 6(b)(5)
health standard. The risk assessment for this standard, as for a
typical safety standard, is based on the number of injuries that have
resulted from past exposures to the hazard being regulated and the
percentage of those injuries that are preventable. By contrast, for a
typical health standard, the risk assessment is based on mathematical
projections to determine the significance of the risk at various levels
of exposure. See, e.g., Formaldehyde, 878 F.2d at 392-96 (discussing
OSHA's quantitative risk assessment for formaldehyde exposure). In the
proposal, OSHA recognized that the risk assessment methodology for this
standard was similar to that for a safety standard rather than a
typical health standard:
There is no need, in the case of musculoskeletal disorders, for
OSHA to engage in risk modeling, low-dose extrapolation, or other
techniques of projecting theoretical risk to identify the magnitude
of the risk confronting workers exposed to ergonomic risk factors.
The evidence of significant risk is apparent in the annual toll
reported by the Bureau of Labor Statistics, the vast amount of
medical and indemnity payments being made to injured workers and
others every year * * * and the lost production to the U.S. economy
imposed by these disorders.
64 FR at 65979.
In the NPRM, OSHA preliminarily concluded that the proposed
ergonomics standard was a section 6(b)(5) standard. The NPRM stated
that MSDs are caused by chronic and not by short-term exposures. 64 FR
at 66057. Some commenters contended that this statement was
inconsistent with OSHA's proposed definition of MSD and the inclusion
of ``traumatic'' injuries in its risk assessment. Ex. 22-337-1 at p. 7
(Integrated Waste Service Association); Ex. 32-241-4 at pp. 197-99
(Anheuser-Busch & United Parcel Service); Ex. 32-300-1 at pp. 15-16
(Edison Electric Institute). The proposed definition of MSD included
musculoskeletal disorders other than those caused by accidents and was
intended to include, e.g., back injuries caused by lifting (for
employees for whom manual handling is a core job element) without
regard to whether the injury resulted from a particular exertion or the
cumulative effect of numerous lifting exertions. As OSHA elsewhere
explained:
The pathogenesis of work-related MSDs can refer to either
single, point-in-time injuries, associated with work tasks that
result in activities in which tissue tolerance is acutely exceeded,
or circumstances in which the performance of specific work tasks or
combinations in which the performance of specific work tasks or
combinations of tasks over a prolonged period of time result in
small and repeated tissue damage.
64 FR at 65900.
Moreover, the BLS injury and illness data on which OSHA based its
proposed risk assessment (see 64 FR at 65931, Table VI-3) indicates
that many of the injuries considered MSDs resulted from short-term
rather than chronic exposures. OSHA has reexamined its reasoning in
light of these comments and agrees that the acute-chronic distinction
it drew in the proposal is inappropriate when describing MSDs and
therefore does not afford a proper basis for classifying this rule as a
section 6(b)(5) standard.
As discussed in more detail in the risk assessment section, the
injury and illness data reported by BLS categorizes each incident by
type of injury or illness and the nature of the exposure event leading
to the injury or illness (BLS 1992, Ex. 26-1372). Under the BLS data
collection system, employers are instructed to report musculoskeletal
injuries and illnesses under various codes, some of which represent
musculoskeletal system and connective tissue diseases and disorders
that result from repetitive activity and some of which represent other
types of exposure events. The BLS category that accounts for most of
the reported injuries and illnesses, 021, includes sprains, strains,
and tears of muscles, joints, tendons, and ligaments. The category is
described as representing traumatic injuries, which generally result
from a single event or exposure. Ex. 26-1372 (BLS Occupational Injury
and Illness Classification Manual).
In its preliminary risk assessment, the agency closely examined the
BLS data, excluded from its analysis injuries caused by accidents
(i.e., slips, trips, falls, and being struck by objects), and included
those codes that predominantly represented work-related MSDs, including
021, that were reported under the exposure event categories
[[Page 68272]]
most closely representing ergonomic risk factors. 64 FR at 65928. The
largest number of these injuries were classified under the exposure
category for ``overexertion,'' which includes primarily lifting,
lowering, pushing, pulling, and carrying. 64 FR at 65932. OSHA has
followed this same approach in its final rule and in the supporting
risk assessment, i.e., excluding musculoskeletal injuries due to
accidents but including those resulting from ergonomic risk factors. In
OSHA's view, when MSDs result from exposure to ergonomic risk factors,
any distinction between acute and chronic exposures is unimportant.
OSHA notes that the classification of these disorders as traumatic is
in part a convention of the recordkeeping system. OSHA's general
recordkeeping guidelines for back disorders instruct that because the
specific event causing such a disorder cannot always be pinpointed, to
keep recordkeeping determinations as simple and equitable as possible,
all back disorders should be classified as (traumatic) injuries rather
than (cumulative exposure) illnesses. BLS, Recordkeeping Guidelines for
Occupational Injuries and Illnesses (April 1986), at p. 38. Similarly,
OSHA's Ergonomics Program Management for Meatpacking Plants states that
all back cases are to be classified as injuries even though some back
conditions may be triggered by an instantaneous event and others
develop as a result of repeated trauma. Ex. 32-210-2-2 at p. 14.
Moreover, a number of experts testified in the hearings that a
substantial part of the MSD injuries classified under the BLS system as
traumatic in fact represent cumulative exposure. (Tr. 2175-77; 2236-44;
5802-04). In short, even though an MSD may be classified as
``traumatic'' in origin, it will often be the case that, while the
onset of the injury was sudden, the cause was exposure to ergonomic
risk factors over some period of time. However, it is neither necessary
nor meaningful to limit the standard's reach to MSDs that only occur
because of exposures that take place over some period of time. The
purpose of this standard is to reduce the number and severity of MSDs
by protecting workers against excessive exposure to ergonomic risk
factors and MSD hazards, and for that purpose it is irrelevant whether
those excessive exposures are ``acute'' or ``chronic.''
On reflection, OSHA has determined that other considerations relied
on in the NPRM are likewise unpersuasive. Although the standard
protects against one risk factor--vibration--that qualifies as a
``harmful physical agent,'' OSHA does not believe that factor alone
makes this a section 6(b)(5) standard. The standard is not a
``vibration'' standard but one that addresses the multifactorial causes
of MSDs. The risk factors that are not ``harmful physical agents''--
force, repetition, awkward posture, and contact stress--together
contribute substantially more to the vast majority of MSDs than does
vibration.
Similarly, that a provision in OSHA's standard governing access to
employee exposure and medical records (29 CFR 1910.1020(c)(13)) defines
``toxic substance or harmful physical agent'' as including ``repetitive
motion'' does not establish that repetitive motion is a harmful
physical agent within the meaning of section 6(b)(5). See Ex. 32-339-1
at p. 15 (AFL-CIO). Whether repetitive motion is a harmful physical
agent was not central to that rulemaking, which dealt with the access
of employees and OSHA personnel to employee records and did not
regulate particular hazards. In that rulemaking, interested parties had
no reason to argue whether a standard that regulates repetitive motion
is a section 6(b)(5) standard, and OSHA had no occasion to address that
issue. Moreover, the records access rule was not issued under section
6(b)(5) but under OSHA's general authority to issue standards (section
6(b)) and regulations (section 8(g)). And it was upheld in court as a
section 8(g) regulation rather than a section 6(b) standard. Louisiana
Chem. Ass'n v. Bingham, 731 F.2d 280 (5th Cir. 1984), aff'g 550 F.
Supp. 1136 (W.D. La. 1982). Therefore, the fact that the records access
rule applies to repetitive motion cannot be regarded as establishing an
OSHA policy that repetitive motion is a harmful physical agent for
purposes of section 6(b)(5).
C. This Final Rule Does Not Regulate non-Workplace Activities
Some commenters have pointed out that MSDs can result from personal
activities as well as from workplace exposures. Ex. 32-368-1 at p. 40
(National Coalition on Ergonomics); Ex. 32-241-4 at p. 49 (Anheuser-
Busch & United Parcel Service). They argue that OSHA is attempting
through this rule to regulate the nonwork activities that may
contribute to MSDs and that the rule is therefore outside OSHA's
authority. However, the rule regulates only conditions or activities in
workplaces, and OSHA clearly has the authority to issue the rule.
Many adverse health conditions can be caused or aggravated by both
work and nonwork exposures. For example, exposures to high noise levels
both inside and outside the workplace can contribute to a worker's
hearing loss. Nevertheless, OSHA has the authority to regulate harmful
noise levels in the workplace as long as the workplace exposures create
a significant risk of material impairment of health. Forging Indus.
Ass'n v. Secretary of Labor, 773 F.2d 1436, 1442 (4th Cir. 1985) (en
banc) (Noise).
Noise dealt with a challenge to the Hearing Conservation Amendment
to OSHA's occupational noise standard. That amendment establishes
certain requirements that must be met to reduce the incidence of and/or
prevent hearing impairment due to occupational noise exposure. Before
issuing the amendment, OSHA found that 10-15% of workers exposed to
noise levels below the permissible exposure limit (PEL) would suffer
material hearing impairment. 773 F.2d at 1443. OSHA based this finding
on a ``panoply of scientific reports and studies,'' including studies
done by the National Institute for Occupational Safety and Health
(NIOSH) and the Environmental Protection Agency (EPA). Id. OSHA also
found that those employees who had suffered a hearing decrement of 10
decibels in either ear faced a greater risk from continued exposure to
high levels of workplace noise than workers whose hearing was
unimpaired. Id. OSHA's Hearing Conservation Amendment provided hearing-
endangered workers with protection in the workplace in order to
decrease the risk of hearing impairment.
The Forging Industry Association (FIA) argued that ``because
hearing loss may be sustained as a result of activities which take
place outside the workplace--such as listening to loud music, age, or
engaging in certain recreational activities--OSHA acted beyond its
statutory authority by regulating non-occupational conditions or
causes.'' Noise, 773 F.2d at 1442. The court found ``no merit'' in
FIA's argument. The court ruled that OSHA properly relied on ``the
extensive and thorough research of several scientific institutions in
defining the problems related to industrially-caused hearing loss in
designing its proposal.'' Id. at 1443. The court also stressed that
OSHA excluded non-occupational hearing loss from the rule. Id. at 1444
(``To be sure, some hearing loss occurs as a part of the aging process
and can vary according to non-occupational noise to which employees are
exposed. The amendment, however, is concerned with occupational noise--
a hazard of the workplace.''). The court ruled that the fact that non-
occupational hazards may contribute to hearing loss does not mean that
OSHA should refrain from
[[Page 68273]]
regulating workplace conditions that are shown to cause such loss:
The amendment provides that non-occupationally caused hearing
loss be excluded from its regulation. See 29 CFR 1910.95(g)(8)(ii),
1910.95(g)(10)(ii) (1984). Assuming, however, that some loss caused
by aging or smaller amounts of noise sustained for shorter periods
also aggravates the hearing loss incurred by an individual employed
in a high noise-producing industry, that is scant reason to
characterize the primary risk factor as non-occupational. Breathing
automobile exhaust and general air pollution, for example, is
damaging to lungs, whether healthy or not. The presence of unhealthy
lungs in the workplace, however, hardly justifies failure to
regulate noxious workplace fumes. Nor would there be logic to
characterizing regulation of the fumes as non-occupational because
the condition inflicted is aggravated by outside irritants.
Noise, 773 F.2d at 1444.
Like the Hearing Conservation Amendment to the Noise standard, this
final ergonomics rule regulates workplace hazards. As discussed in the
health effects section of this preamble, this rule addresses only
exposure to ergonomic risk factors that occurs in the workplace. The
MSDs that trigger action under the rule must be work-related and they
must have occurred in workers whose jobs place them at a heightened
risk of incurring a MSD because they are exposed to risk factors at the
levels in the Basic Screening Tool.
A decision by the Occupational Safety and Health Review Commission
supports OSHA's conclusion that the Act can properly address work-
related ergonomic hazards even though employees can also be exposed to
such hazards outside the workplace. In Pepperidge Farm, Inc., 17 O.S.H.
Cas. (BNA) 1993 (1997), the Commission held that where work was shown
to be a substantial contributing factor to MSDs, the fact that non-work
factors may also play a role did not preclude OSHA from requiring the
employer to abate the workplace hazards. In that case, Pepperidge Farm
contested a number of citations for ergonomic violations that OSHA had
issued under section 5(a)(1) of the Act. In order to prove a section
5(a)(1) violation, OSHA had to show that a condition or activity in the
employer's workplace presents a ``hazard to employees.'' 17 O.S.H. Cas.
(BNA) at 2009 (emphasis added). The company argued that section 5(a)(1)
should not apply to MSD workplace hazards because, among other things,
``non-workplace factors may cause or contribute to the illnesses at
issue and that individuals differ in their susceptibility to potential
causal factors.'' Id. at 2013. The Commission held that such factors
should not ``ipso facto'' preclude the possibility of enforcement under
section 5(a)(1). Id. The Commission also analyzed a significant amount
of evidence that showed a causal relationship between MSDs and
workplace hazards, including testimony from medical personnel who
examined injured workers, epidemiological data, and injury incidence at
a Pepperidge Farm plant. Id. at 2020-26. The Commission ultimately
found that there was a causal connection:
We therefore conclude that the Secretary has established on this
record a causal connection between [MSDs] affecting the employees at
Downington [a Pepperidge Farm plant] and their work on the biscuit
lines. In doing so, we are mindful that many of these injuries may
have had more than one causal factor and of the experts who contend
that the specific cause of such injuries is, essentially, unknowable
or presently unknown. As is the case with many occupational ills
with multiple possible causes, employees are more or less
susceptible to injury on the job because of the individual
attributes and backgrounds they bring to the workplace. As with
these other ills, the Secretary is not thus foreclosed from
attempting to eliminate or significantly reduce the hazard by
regulating what is shown to be a substantial contributing factor to
the worker injuries.
17 O.S.H. Cas. (BNA) at 2029.
The Commission's holding in Pepperidge Farm that the susceptibility
of some employees to a particular ailment does not preclude OSHA from
regulating workplace conditions or practices that cause or contribute
to that type of ailment is supported by other cases. In the asbestos
rulemaking, OSHA based its significant risk determination, in part, on
epidemiologic studies that included workers who smoked and were
therefore significantly more likely to contract cancer than those who
did not. Asbestos, 838 F.2d at 1265. The court held that OSHA was
justified in doing so. Smokers were not, the court said, ``so far
beyond the pale as to require OSHA to ignore them in computing the
risks of asbestos.'' Id. (emphasis added). See also Reich v. Arcadian
Corp., 110 F.3d 1192, 1198 (5th Cir. 1997) (Congress intended Act's
general duty clause to protect all employees, including those who are
especially susceptible). Thus, workers who engage in activities outside
the workplace that expose them to ergonomic risk do not thereby forfeit
on-the-job protection against exposure to excessive ergonomic risk
factors.
IV. Summary and Explanation
(a) What Is the Purpose of This Rule?
The first paragraph of the final standard sets out the purpose of
this ergonomics program standard. OSHA did not propose a purpose
paragraph, and thus no comments on this topic were received. OSHA has
decided to include a purpose statement in the final rule to clearly
indicate the goal of the standard and to differentiate between those
musculoskeletal disorders (MSDs) that are covered by the standard and
those that are not. It clarifies that the standard's purpose is to
reduce the number and severity of MSDs that are caused by occupational
exposure to ergonomic risk factors (also called ``ergonomic
stressors'') on the job.
As discussed in more detail below, the disorders addressed by this
rule include those of the muscles, nerves, tendons, ligaments, joints,
cartilage, blood vessels, and spinal discs occurring in the neck,
shoulder, forearm, wrist, hand, abdomen (hernias only), back, knee,
ankle, and foot. They include conditions classified by the Bureau of
Labor Statistics in its Annual Survey as illnesses (e.g., carpal tunnel
syndrome) and as injuries (e.g., low back pain), because MSDs include
many different disorders, affect many tissues and areas of the body,
and may be described by a wide range of medical diagnoses.
The terms used to describe this group of conditions have varied
over time and geographic region. For example, in Australia, MSDs are
often called ``Occupational Overuse Syndrome'' injuries. Other
frequently used terms include ``repetitive stress injuries,''
``cumulative trauma disorders,'' and ``soft tissue injuries.'' In
recent years, however, the term ``musculoskeletal disorders'' has
gained widespread acceptance by the scientific community, and OSHA uses
this term, or its abbreviation, MSD, throughout the regulatory text and
supporting analyses.
Paragraph (a) makes explicit that OSHA's ergonomics program
standard does not apply to injuries or illnesses caused by motor
vehicle accidents, slips, trips, falls, or similar accidents that
result in traumatic injuries on the job. By ``other similar
accidents,'' OSHA means, for example, caught in or caught between
injuries or other accidents resulting in blunt trauma. (Throughout this
notice, OSHA uses the terms ``work-related,'' ``caused by,''
``musculoskeletal disorders,'' ``risk factors,'' and ``exposure.'' For
a detailed discussion of these terms, see the relevant sections of the
Health Effects (Section V of the preamble), Summary and Explanation
(Section XI), and Legal Authority (Section III) sections of this
preamble.)
As stated in paragraph (a), the purpose of this standard is to
reduce the number and severity of MSDs caused by
[[Page 68274]]
workplace exposure to ergonomic risk factors, such as force, awkward
postures, or repetition, either alone or in combination. The standard
requires employers to implement an ergonomics program to address risk
factors in jobs that pose an MSD hazard to the employees in those jobs.
As discussed in detail in Section VI of the preamble, Risk Assessment,
ergonomics programs have been shown to reduce the number and severity
of MSDs in old and new facilities, in large and small workplaces, and
in a wide variety of jobs ranging from computer use to solid waste
handling, from assembly line operations to patient handling, and from
beverage distribution to meat processing.
Reducing the number and severity of MSDs in the workplace is the
goal of successful ergonomics programs everywhere. As the more detailed
discussions in this preamble and in the Agency's economic analysis will
show, this goal cannot be achieved overnight, although positive results
are generally observed soon after program implementation. One effect of
a new ergonomics program, which at first glance may not appear to be a
positive one, is that the number of MSDs and MSD signs and symptoms
reported in the first months after the implementation of the program
may actually increase. This initial increase in the number of MSD
reports reflects the heightened awareness of ergonomics, the importance
of early reporting, and the value of conservative treatment that
routinely accompanies program implementation. In most workplaces, this
increase is short-lived, generally lasting less than a year and almost
never more than two years. The severity of the MSDs reported, however,
generally decreases in the first few months after program initiation
and declines steadily thereafter, before leveling off as the program
matures. Thus, OSHA intends and expects the final rule to reduce the
number and severity of MSDs in the workplaces covered by the standard
over the first few years after the standard is fully in effect; OSHA is
aware that the standard's purpose will not be fully achieved in the
short run. When ergonomic programs mature, they continue to demonstrate
ongoing reductions in the number of MSDs caused by workplace risk
factors and in the severity of those MSDs that do occur.
The standard's purpose paragraph also reflects OSHA's awareness
that work-related MSDs will continue to occur in many workplaces even
after implementation of an effective ergonomics program that complies
fully with this final rule. The standard being issued today is thus not
a ``zero-risk'' standard. It recognizes that substantially reducing the
number and severity of these disorders is possible in most, if not all
workplaces, although many establishments may not be able to eliminate
MSDs completely. (For a discussion of OSHA's analysis of the standard's
projected effectiveness, see the Risk Assessment section of the
preamble (Section VI) and Chapter IV, Benefits, of the Final Economic
and Regulatory Flexibility Analysis.)
Paragraph (b)--Does This Standard Apply To Me? (Scope and Application)
Discussion of the scope and application of the final rule is
divided into three parts. Part I discusses which employers and
operations the standard covers. Part II explains the exclusions from
coverage of the rule and OSHA's authority to limit the standard's
coverage to general industry. Part III addresses other scope and
application issues raised during the rulemaking.
Part I--Scope and Application of Standard to General Industry
Employers
A. Scope of Coverage
Paragraph (b) states that the standard applies to general industry
employment, which means all employment except for railroads and
employment covered by OSHA's agriculture, construction, and maritime
standards. Unlike other OSHA general industry standards, however, this
standard does not cover general industry work performed incidentally to
or in support of construction, maritime, or agricultural employment or
railroad operations. This means that functions such as office work,
management and support services are not covered by the standard, and
that, for example, a construction company office or a marine terminal
cafeteria would not be covered. However, a construction company real
estate division engaged in selling the finished properties would not be
performing functions directly in support of the construction operations
and would be within the scope of the standard.
The final rule thus imposes coverage based on the business category
in which the employer belongs, e.g., general industry as opposed to
construction. This marks a departure from the Agency's past practice of
imposing coverage based solely on the job that an employee is
performing. The approach adopted in this standard, i.e., basing
coverage on the industry classification of the employer, is appropriate
here because of the unique nature of ergonomic problems and solutions.
The requirement to implement an entire program when an MSD incident
occurs in a job that meets the Action Trigger is more practical
administratively if employers are required to take this broad approach.
Moreover, the standard does not apply to jobs or operations that
are normally covered exclusively by the construction, agriculture and
maritime standards, even if those operations are performed in a general
industry establishment or for a general industry employer. Thus a
construction crew whose sole job is to build in-plant structures in a
steel mill is engaged in construction and is not covered by this
standard, even though the steel mill itself is a general industry
operation. This is consistent with the operation of other OSHA
standards.
Although the proposal also applied only in general industry, its
scope provision stated that coverage was further limited to general
industry manufacturing jobs, manual handling jobs, and jobs with MSDs.
Manufacturing jobs were defined as ``production jobs'' in which the
activities of producing a product made up a ``significant amount'' of
the employee's worktime. Manual handling jobs were those in which the
employee performed ``forceful'' lifting (i.e., lifting or lowering,
pushing or pulling, or carrying) and the forceful lifting tasks were a
``core element'' of the employee's job. Jobs with MSDs were defined as
jobs in which an OSHA recordable MSD occurred in a job in which the
physical work activities and conditions were reasonably likely to cause
that type of MSD, and the activities were a core element of the job or
accounted for a significant amount of the employee's worktime (64 FR
65779-82).
The proposal explained that OSHA was focusing on general industry
in this first ergonomics rulemaking because the problems in general
industry are particularly severe and the solutions are well-understood
(64 FR 65776). Some commenters agreed with the proposed rule's scope,
and its emphasis on manufacturing and manual handling jobs (Exs. 31-3,
31-71, 31-180, 31-252, 31-284, 32-300). More, however, argued either
that the rule should not exempt construction, maritime and agricultural
employment (Exs. 30-400, 30-1294, 31-14, 31-105, 31-143, 31-156, 31-
345, 31-352, 32-198-4, 32-210, 32-359-1, 32-461-1, 30-1294, 500-218),
or that the rule should exempt even more industries or jobs (Exs. 30-
372, 30-494, 1-248, 31-280, 32-77-2, 32-78, 32-234, 30-2208, 30-3167,
32-77-2, 601-X-1, Tr. 3126).
[[Page 68275]]
Many of the commenters who believed that the scope of the proposed
rule was too broad argued that it incorporated a ``one size fits all''
approach that was inappropriate for the wide variety of operations
found in general industry (Ex. 30-494, see also Exs. 30-380, 30-372,
30-531, 30-3167, Tr. 3126, 3332). Some of these commenters pointed out
that there was great variation in MSD rates, prevalence of ergonomic
risk factors, and levels of exposure to those risk factors across
general industry (Exs. 30-541, 30-3167). Others pointed out that jobs
differed greatly within and across industries, and claimed that OSHA
did not have enough information about effective controls in all
industries (Exs. 30-425, 30-3167, 32-77, 32-211-1, 32-2208). The focus
of both these groups of comments was that OSHA did not have enough
knowledge or evidence to find that the same approach to controlling
ergonomic hazards would be appropriate in all of these disparate
circumstances.
A number of commenters suggested ways to limit the standard's
scope. Some urged OSHA to focus the rule more narrowly on those jobs or
industries with the highest MSD rates or those deemed to have high risk
potential (Exs. 30-13, 30-425, 30-2208, 30-3167, 31-248, 31-280, 32-78,
32-234, Tr. 2729-30). For example, Larry Leahy of Ruth Constant &
Associates, a home health care service agency, questioned why OSHA was
covering all of general industry when 60 percent of the MSDs occurred
in industries representing a fairly small percentage of the national
workforce (Ex. 30-611). Todd McCracken, of National Small Business
United, argued:
There is a need to focus on particular types of jobs . . . There
are specific types of jobs in specific industries where MSDs are
much more likely to occur (Tr. 2729-30).
Similarly, Organization Resources Counselors, Inc. (ORC)
recommended that the rule only cover high risk occupations or employers
whose MSD incident rates were above the national background level (Ex.
32-78; see also Tr. 10633-35). The Small Business Administration's
Office of Advocacy suggested covering only manual handling jobs, which
it claimed accounted for 78 percent of all MSDs (Ex. 601-X-1).
As discussed in detail throughout this preamble, OSHA believes that
the record supports coverage of all of general industry within the
overall scope of the standard. The final standard does not, however,
prescribe a one-size-fits-all solution for a wide range of problems in
diverse jobs and industries. Even in those situations where significant
ergonomic hazards exist, the commonality of the response required by
this standard is to implement an ergonomics program. The specific focus
of that program will be targeted to the particular hazards and
conditions at each workplace. The control strategies for ergonomic
hazards will be targeted even more specifically to the needs of each
workplace. And the extent of each employer's compliance obligation will
be determined by the extent of the problem at that employer's
workplace. Thus the fact that the rule applies to a variety of hazards
at differing workplaces does not in any way mean that the employers in
all of those workplaces need to take the same actions.
Work-related MSDs are widespread throughout general industry. They
occur in every single sector within general industry, according to the
Bureau of Labor Statistics (BLS). In 1996, according to BLS, there was
no industry sector that did not report the occurrence of at least
several hundred work-related MSDs, with a large number of industries
reporting tens of thousands of work-related MSDs. Moreover, high
concentrations of work-related MSDs are reported in a wide variety of
occupations that are found throughout general industry establishments.
BLS data for 1996 show that general industry truck drivers, laborers,
and janitors, occupations found widely dispersed throughout general
industry sectors, experienced more than 48,000, 38,000 and 15,000 lost
workday (LWD) MSDs, respectively. (See Section VII (Risk Assessment) of
this preamble.)
Evidence submitted by rulemaking participants confirms the broad
distribution of MSDs and MSD hazards throughout general industry. For
example, the Service Employees International Union (SEIU) submitted
evidence that union members working in a variety of health care
settings (e.g., hospitals, nursing homes, private homes, pharmacies)
have suffered MSDs (Ex. 32-311-1). These health care workers include
registered nurses, licensed practical nurses, nurses' aides, orderlies,
physical therapists, radiology technicians, housekeepers (maids and
housemen), laundry workers, laundry machine operators, maintenance
workers, kitchen and food preparation workers, central supply workers,
and janitors and cleaners. In addition, SEIU said that other union
members such as janitors and cleaners working in a variety of other
industries, including hotels/motels, restaurants, offices have also
experienced MSDs (Ex. 32-311-1).
At the rulemaking hearing, many employees testified that they had
suffered serious work-related MSDs. Occupations in which these
employees were working when they became injured include:
Nurse
Home health care aide
Nurses' aide
Package delivery
Package sorting
Meatpacking and poultry processing
Office clerical worker
Internet publishing
Machinists
Sewing machine operator
Truck driver
Food warehousing and distribution
Grocery store cashier
Physical therapist
Mail carrier
Letter sorter
Teacher
Teachers' aide
Auto assembly
Molding and casting machine operator
Reporter
Grocery shelf stocker
Sonographer
Television film editor
Electrical workers
(Exs. 30-4200, 32-185-3, 32-210-2, 32-198-3, 32-311, 500-218, Tr.
4009-10, 4235, 4240, 4234, 6004, 6009, 6319, 6321-22, 6333, 7320-21,
7335-37, 7341-42, 17950).
Doctors and other health care professionals (HCPs) also testified
that they had treated employees in many different jobs and industries
for work-related MSDs (Exs. 37-12, 37-28, Tr. 14973, 15045-46, 16819,
16829). Dr. Robert Harrison testified that, in his research and
practice, he had diagnosed and treated over 1,000 patients with work-
related MSDs from a wide variety of industries and occupations,
including (Ex. 37-12):
Postal workers
Materials handlers
Computer operators
Grocery checkout clerks
Meat processors
Assemblers
Seamstresses
Telephone operators
Pipefitters
Customer service agents
Machine operators
Automotive manufacturing workers
Aircraft manufacturing workers
Optical scanners
Graphic artists
Restaurant workers
Bakers
Plumbers
Letter sorters
[[Page 68276]]
Dr. Robin Herbert, the medical co-director of the Mt. Sinai Center for
Occupational and Environmental Medicine, testified that she had treated
or supervised the treatment of more than 2,000 patients with upper
extremity MSDs in the past 12 years:
My patients have included journalists, computer graphic artists,
health care workers, technicians for telephone companies, automobile
manufacturing workers, cashiers, garment workers, meat wrappers,
dental hygienists, secretaries, and chefs. Industries from which I
have seen patients include publishing, journalism, entertainment,
manufacturing, health care, transportation, and telecommunications
(Ex. 37-28).
Dr. George Piligian, who also works at the Mount Sinai Center,
testified about finding and treating MSDs in dancers, musicians,
editors, secretaries, telephone operators, sewing machine operators and
hospital workers (Tr. 7813-20).
Similarly, insurance companies, employers and trade associations
representing the following industries testified about the
implementation of ergonomics interventions and programs because work-
related MSDs were occurring among workers in the following
environments:
Chemical manufacturing
Pharmaceutical manufacturing
Automotive manufacturing
Automotive repair
Boat manufacturing
Textile manufacturing
Clothing manufacturing
Printing
Dental
Meatpacking
Electric utility
Hospitals
Office workers
Hotel/motel
Emergency medical services
Furniture manufacturing
Oil and gas drilling
Moving and storage
Fabricare
Nursing homes
Telephone operation and installation
Funeral and cemetery
Insurance
Solid waste removal and recycling
Paint manufacturing
Poultry processing
Food warehousing and distribution
Beverage delivery
Assembly line
Grocery store
Retail clothing
Foundry
(see, e.g., Tr. 3337-9, Tr. 5104, Tr. 8458-8480, Tr. 16553-57).
Finally, several of the ergonomists who appeared as OSHA's expert
witnesses, including David Alexander (Ex. 37-7), David Caple (Ex. 37-
20), Dennis Mitchell (Ex. 37-11), Maurice Oxenburgh (Ex. 37-24),
Suzanne Rodgers (Ex. 37-25), and John Rosecrance (Ex. 37-26), testified
that employers in the following different industries had hired them to
help reduce the incidence of work-related MSDs among employees:
Newspaper
Luggage manufacturing
Meatpacking
Packaging
Papermaking
Plumbing supply
Route sales and delivery
Film products manufacturing
Hospitals
Heavy appliance manufacturing
Automobile manufacturing and subassembly
Furniture manufacturing
Paper and pulp products
Forest products
Food service
Clerical
Electronics
Clothing and textile manufacturing
Baking
Restaurant
Home and office furniture manufacturing
Hospitality--hotel/motel
Fiber manufacturing
Logistic and supply warehousing
Telecommunication
Textile and apparel manufacturing
Metal forging and cast metals
Electronics manufacturing
Health care
Petroleum
Electrical manufacturing
Airline freight handling
Steel manufacturing
Fishing
Aircraft manufacturing
Gas and electric utility
Flooring products
Computer and computer accessory manufacturing
Plumbing fixtures manufacturing
Food products manufacturing and processing
Chemical manufacturing
Printing
Waste treatment
Plastic manufacturing
Clothing retail
Power plants
Research laboratories
Transportation
Printing
Upholstery
Rubber manufacturing
Welding
Mail sorting and delivery
Transportation
Electronics
Medical products manufacturing
All of this evidence supports OSHA's decision to provide the
protections of this standard to all general industry employees. On the
other hand, OSHA recognizes that there may be some general industry
employers with few or no MSD hazards. Until an MSD is reported, the
employer's obligation is limited to distributing the information in
paragraph (d).
B. Application of Requirements
Unlike the proposal, this final standard does not differentiate
among general industry employers. Under the proposal, employers of
employees engaged in manufacturing or manual handling would have been
required to implement some elements of an ergonomics program whether or
not their employees had suffered any MSDs. Other general industry
employers would not have had to take any action until a ``covered MSD''
occurred, and a covered MSD was defined differently for them than for
manufacturing and manual handling employers (64 FR 65782-84, 65791). In
this final standard all general industry employers are required, as
specified in paragraph (d), to provide basic information on ergonomics
and the standard to their employees. The employer has no further
obligation until the employee reports an MSD or the signs or symptoms
of an MSD (see paragraph (e)).
OSHA developed its bifurcated proposal because about 60 percent of
all reported MSDs occurred in manufacturing and manual handling jobs,
even though those jobs accounted for less than 30 percent of general
industry employment. Although some commenters agreed that this might
justify a focus on manufacturing and manual handling (Ex. 30-4837),
very few expressed satisfaction with the proposed approach (Exs. 30-
400, 31-78, 32-198, 32-210, 32-461, 500-218, Tr. 3224). Many commenters
said that manufacturing and manual handling jobs should not be singled
out because MSD hazards were present and MSD rates were high in other
jobs and industries (Exs. 30-626, 30-2208, 31-156, 500-218). For
example, participants said that there were many MSD hazards and MSDs in
``any job involving regular computer use,'' therefore, programming,
journalism, data entry, system administration, accounting, analysis,
and insurance jobs should have been included by name (Exs. 30-49, 30-
400, 31-3, 31-12, Tr. 2783, 2932). Likewise, other commenters argued
that custodians and supermarket employees including cashiers, bakery
personnel, baggers and
[[Page 68277]]
stockers should be treated on par with manufacturing and manual
handling jobs because they involved the same hazards (Ex. 31-23, 32-
210; see also Exs. 30-400, 31-78, 32-198, 32-210, 32-461, 500-218, Tr.
3224).
Another group of commenters opposed requiring any employers to take
any type of action before a work-related MSD is reported (Ex. 30-240,
32-300, 30-542, 601-X-1) on the grounds that it was a ``waste of
resources'' to require a basic program for employers with manufacturing
and manual handling jobs that have no MSDs (Ex. 30-542). For example,
one said:
If an employer is in one of the targeted industries but has not
had MSDs, why force the bureaucracy of program implementation upon
him or her * * * (Ex. 30-240).
And while some participants found the definitions of manufacturing
and manual handling jobs adequate to identify whether a particular job
was covered (Exs. 30-3934, 30-4837, 31-38, 31-36, 31-113, 31-173, 31-
205, 31-229, 31-347), most disagreed (Exs. 30-5, 30-46, 30-75, 30-293,
30-1722, 30-3032, 30-3853, 31-4, 31-27, 31-92, 31-106, 31-125, 31-135,
31-211, 31-245, 31-246, 32-78, 32-300, 32-337). Many said that the
definitions, particularly the definition of manual handling jobs, were
too vague (Exs. 30-137, 30-425, 30-1722, 30-3167, 31-77, 31-180, 31-
225, 31-227, 31-248, 31-260, 31-342, 32-78, 32-300, 32-337, Tr. 3255-
56). For example, one commenter said:
The definitions of manufacturing and manual handling jobs
covered by the standard are guaranteed to leave employers as much in
the dark as they are now. What constitutes ``forceful'' manual
handling? How much force must be involved to be covered? Should the
strength capabilities of individual employees be considered? (Ex.
31-211)
Others were concerned that the definitions were too broad and could
include any job or ``almost every employer'' (Exs. 31-135, 31-180, 31-
342).
Many participants told OSHA that they did not know what the terms
used in the definitions (``forceful'' lifting, ``core element,'' and
``significant amount'' of worktime) meant (Exs. 30-46, 30-293, 30-300,
30-3032, 30-3853, 30-4837, 31-187, 31-202, 31-223, 31-260, 31-289, 32-
337, Tr. 3337). For example:
How much is significant? 6 hours per 8-hr shift? 4 hours per 8-
hr. shift? 2 hours per 8-hr. shift? Or 2 2-hr. periods per 8-hr.
shift? (Ex. 30-4837)
Moreover, commenters did not find the examples of manufacturing and
manual handling jobs to be of use:
[T]he examples of jobs are not very helpful. A careless reader
could conclude that the lists were exhaustive and, not seeing the
jobs in this workplace named, decide he had to do nothing. A more
thorough reader would note the disclaimer to the effect that ``* * *
each job must be considered on the basis of its actual physical work
condition * * *'' and correctly conclude that there is no standard
against which to compare the actual physical work conditions'' (Ex.
31-211).
(See also Exs. 30-3032, 30-3853, 32-300.)
OSHA is accounting for these concerns in this restructuring of the
standard's scope and application provisions. This final rule applies to
all general industry employers, but no employer is required to evaluate
or implement control measures or MSD management until an MSD incident
occurs in a job that involves exposure to risk factors at levels
meeting those in the Basic Screening Tool in Table 1. The only
obligation employers have until that point is to provide information
about ergonomics and the standard to their employees. And, as explained
in the discussion of paragraph (d) below, OSHA is providing that
information in Appendices A and B and on its website.
OSHA believes that these changes respond to most complaints about
the scope and application provisions of the proposal. By eliminating
the additional requirements for manufacturing and manual handling
employment, OSHA is eliminating both the need to define those terms and
much of the complexity and vagueness commenters found in the proposal.
By limiting employers' obligations in establishments that have not
experienced MSD incidents, OSHA is also taking account of the facts
that not all manufacturing and manual handling jobs involve more
significant ergonomic hazards than do other general industry jobs, and
that some of those other jobs are also hazardous.
The minimal burden in paragraph (d) for all general industry
employers to disseminate information is necessary so that employees
will know how and when to report MSDs. Given the importance of
providing information at the earliest possible point and the minimal
burden this requirement will impose, OSHA believes that it is
appropriate to apply the initial requirement to all general industry
employers. (The issue of the need for information is discussed in more
detail below in the summary and explanation on paragraph (d)).
II. Industries/Employment/Operations Excluded From the Final Rule
Like the proposal, the final standard does not cover construction,
agriculture, and maritime employment. Although many participants agreed
with this exclusion (Exs. 30-3032, 30-3752, 31-68, 31-160, 31-187, 31-
207, 31-219, 31-245, 31-252, 31-259, 32-300), a number favored
expanding the scope of the rule to cover all industries regulated by
OSHA (Exs. 30-400, 30-428, 30-1294, 32-210, 500-218, Tr. 2859, 3224,
5592, 9080, 13445, 113745, 14002, 17362, 17652). Their arguments fell
into three categories.
First, many of these commenters pointed to the high number and rate
of MSDs, especially back injuries, occurring in industries excluded
from the proposed rule (Exs. 30-626, 30-2208, 31-156, 31-183, 31-225,
500-218). The Mount Sinai Center for Occupational and Environmental
Medicine Construction Hygiene and Ergonomics Program (CHEP) pointed out
that, aside from the transportation industry, construction has the
highest rate of back injury of any industry:
Every year 1 in 100 construction workers will miss between 7 and
30 days of work due to back injuries * * * At one surveyed worksite
all wallcoverers who had worked 15 years or more in the trade had
required surgery or medical intervention for problems including
carpal tunnel syndrome, pain in the neck, shoulder and back, and
knee problems (Ex. 31-183).
Some commenters also favored expanding coverage because they said
that employees in construction, agriculture and maritime are exposed to
the same risk factors and MSD hazards as are employees in general
industry (Exs. 30-626, 31-22, 31-183, 31-263, 31-303, 500-218). They
said there was no reason to distinguish coverage by industries if the
rule was also incorporating an MSD trigger because, as one put it,
``[a]n injury is an injury, and I have no doubt there are always ways
to handle these jobs just as safely as any others'' (Ex. 31-19).
A number of commenters said that at least jobs in construction,
agriculture and maritime that are essentially the same as in general
industry, primarily manual handling jobs, should be added to the rule
(Exs. 31-14, 31-19, 31-65, 31-98, 31-192, 31-219, 31-307, Tr. 2850-51).
For example:
Many jobs, especially manual handling jobs, have similar if not
identical hazards to that of general industry. If an employee is
performing lifting that requires excessive force it does not matter
in which industry he is performing the lifting. The actions to
reduce the risk of injury would be similar for each industry (Ex.
31-307).
See also (Ex. 31-19; 31-65).
Another group of participants said that the record contains
sufficient
[[Page 68278]]
evidence on the availability and effectiveness of ergonomic
interventions to support expanding the rule to the construction,
agriculture and maritime industries (Exs. 31-183, Tr. 2849-51, 7478-80,
7482, 7485, 15761-71, 17540-41, 17561). Members of this group pointed
to a number of articles and studies about effective controls in those
industries, especially construction (Tr. 15761-71). For example, Nancy
Clark, co-director of Mt. Sinai CHEP, said:
Practical interventions are available for many identified risk
factors. Many workers devise quick fix, homemade solutions to reduce
the impact of musculoskeletal stress and promote self-preservation.
They use team lifting, mechanized material handlers when available,
floor padding for kneeling and standing on, stacking supplies to
bring the work closer, and alternating work tasks or body position
(Ex. 31-183)
Scott Schneider, director of occupational safety and health for the
Laborers Health and Safety Fund of North America, testified:
[T]here have been many tool manufacturers who have jumped on the
ergonomic bandwagon and hired ergonomists to develop better and
safer tool designs, from ergonomic hammers with more comfortable
shock-absorbing handles to pliers with soil handles and spring
returns to reduce the stress of opening them after each use. The use
of portable power tools has increased dramatically in construction
as batteries have gotten lighter and more powerful. Cordless screw
guns have become commonplace in construction over the past few
years, reducing the repetitive use of screwdrivers by hand and the
force that had to be used. There are simple pieces of equipment,
like drywall carrying handles, which I have here, and a mortar-pan
stand to raise the height of the pan, which cost less than $50 and
can make the work much easier. A D-handle attachment for a shovel,
which I have here, costs less than $20, and has been shown to reduce
awkward postures during shoveling. There are simple carts for moving
glass or drywall, vibration-dampened jackhammers and equipment for
moving them on and off of trucks. (Tr. 15762-63).
These commenters also pointed out that many of the controls used in
general industry, such as manual handling aids, were applicable or
readily adaptable to construction, agriculture and maritime industries
(Ex. 31-183). Moreover, tool and equipment interventions are becoming
more widely available ``as manufacturers are responding to the need for
better ergonomically designed tools'' (Ex. 3-183; see also Tr. 15761-
62, 17561).
Finally, several participants were concerned that OSHA's stated
intent to promulgate an ergonomics standard for the excluded industries
in the future would never come to fruition:
OSHA's standard-setting history during the past 30 years raises
serious doubt that workers excluded from this standard will ever
have legal protection from MSD hazards. When OSHA has excluded
workers from coverage under a promulgated standard, only in two
cases has the Agency followed up to extend coverage to those
workers--Hazard Communication and Construction. But those actions
were as the result of a court decisions and order (hazard
communication) * * * or legislative mandate by Congress (lead) (Ex.
500-218, p. 132-33).
These participants said that if OSHA does not cover construction,
agriculture and maritime in the current rulemaking, the Agency should
begin further rulemaking immediately and even establish a deadline for
completing that project (Exs. 30-400, 30-576, 30-4837, 31-12, 31-263).
OSHA is aware that there is significant evidence in the record
indicating that work-related MSDs exist in operations and employment
beyond general industry (Exs. 31-183, 500-218, Tr. 7475, 7484-85,
17538-39). Indeed, the problem appears to exist in virtually every
industry. Nonetheless, for several reasons OSHA believes its decisions
to regulate MSD hazards through sequential rulemaking proceedings, and
to limit the first proceeding to general industry, is appropriate and
supported by the record.
A primary basis for the Agency's decision to limit the scope of
this rulemaking to general industry is that most of the available
evidence and data relating to ergonomic interventions addresses general
industry. For example, the vast majority of the studies reviewed in
both the NIOSH and NAS reports pertained to general industry (Exs. 26-
1, 26-37). Similarly, the majority of case studies on the effectiveness
of ergonomics programs and control interventions that OSHA had gathered
focused on general industry (64 FR 65954-75). Although some
participants submitted evidence on ergonomics programs and controls in
the excluded industries, mostly in construction (Exs. 32-339-1-25, 32-
3888, 38-65, 38-66, 500-210), most of the available evidence continues
to pertain to general industry jobs, operations and workplaces.
If it included construction, agriculture and maritime within the
scope of this rule, OSHA would have had to delay issuing the rule for
general industry while it gathered and analyzed the necessary evidence.
Because it is likely that the rule would have a significant impact on
small employers in construction, agriculture and maritime, OSHA would
also have had to convene a small business review panel pursuant to
SBREFA. Further, in order to include construction, agriculture, and
maritime in its final rule, OSHA, in the interest of fair notice, would
have had to amend the ergonomics proposal or re-propose to include
these industries and hold additional hearings. Expanding the rule to
cover agriculture, construction and maritime would seriously delay
addressing the urgent need for protection for general industry
employees, who work in the jobs in which more than 90 percent of MSDs
are reported.
In addition, as the proposal pointed out, work conditions and
factors present in agricultural, construction and maritime employment
often differ from those in general industry. OSHA listed a number of
aspects of construction work to illustrate this statement (64 FR
65787):
They consist primarily of jobs of short duration,
Employees work under a variety of adverse environmental
and workplace conditions (e.g., cold, heat, confined spaces, heights),
At non-fixed workstations or non-fixed work sites,
On multi-employer work sites,
They involve the use of ``day laborers'' and other short-
term ``temporary workers,'
Involve situations in which employees provide their own
tools and equipment, and
Involve employees who may be trained by unions or other
outside certifying organizations, rather than by the employer.
OSHA did not mean to imply that the mere existence of any of these
factors, alone or in combination, would be enough to justify excluding
an entire industry from the rule. This fact was apparently not clear to
some commenters, however, who argued that the presence of some of the
listed factors in their industries meant that they too should be
excluded from the standard (Exs. 30-297, 30-626, 31-147, 32-234, 32-
300). For example, Broccolo Tree and Lawn Care Inc., pointed out that
landscaping jobs involve short-duration tasks and no fixed workstations
(Ex. 31-147). The National Solid Waste Management Association (NSWMA)
said that its employees are also exposed to adverse environmental
conditions and work at non-fixed work sites (Ex. 32-234, p. 6-7).
In the proposal, OSHA discussed its discretion to set appropriate
rulemaking priorities, and to promulgate standards applicable to less
than all of American industry. 64 FR 65786-65788. General industry
accounts for more than 90 percent of the more than 620,000 LWD MSDs
reported each year. By
[[Page 68279]]
promulgating a standard addressing general industry first, OSHA is
giving ``due regard to the urgency of the need'' for a standard to
protect general industry employees. 29 U.S.C. 655(b)(7). OSHA has thus
ensured that the greatest number of MSD hazards will be addressed by
this final rule, while the Agency determines appropriate regulatory
approaches for other industries. For example, OSHA has been working
closely with NIOSH on a study of ergonomic hazards and solutions in the
maritime industry. In addition, OSHA recently published an ergonomics
best practices guide for the construction industry on its Web page.
OSHA has also provided training grant money targeted to ergonomic
hazards in the construction industry.
OSHA intends to develop ergonomics rules that can be tailored to
the conditions that are unique to the firms in these industries. OSHA
agrees with commenters who have said that the experience the Agency
gains from this first phase will provide valuable assistance in
developing an effective ergonomics rule for the construction,
agriculture, and maritime industries (see, e.g., Ex. 31-252).
As noted earlier, OSHA has decided that the final standard should
not cover work performed by persons employed incidentally to or in
support of construction, agriculture and maritime operations,
regardless of what type of activity they perform. To illustrate, the
standard does not cover employees of a residential home building
company performing office work in support of construction activities,
even though office work is a general industry operation under other
OSHA standards. Similarly, the final rule does not cover janitorial
workers employed by a shipyard or employees performing regular
maintenance on power industrial trucks in a marine terminal. Applying
the rule to general industry jobs of a construction employer (the
office manager of a construction company, for example) would present
the employer with logistical difficulties. Requiring construction,
agriculture and maritime employers to set up an ergonomics program for
the few general industry employees performing ancillary functions in
their workplaces would not be an efficient allocation of safety and
health resources. Several commenters have told OSHA that it is most
efficient to set up an ergonomics program on a company-wide basis (see,
e.g., Exs. 26-1370). Doing so allows employers to implement program
elements such as providing employee information and training more
efficiently.
B. Railroad Work
Paragraph (b)(3) states that this standard does not cover railroad
work. Although some railroad operations are normally covered by OSHA
general industry standards, other railroad work is regulated by the
Federal Railway Administration (FRA) and not by OSHA. 29 U.S.C.
653(b)(4). In addition, the Preliminary Economic Analysis indicated
that the standard would not cover any railroad employment, and this
statement caused some uncertainty among affected parties as to the
Agency's intent (Ex. 28-1, chapter II, p.3).
In a May 23, 2000 Federal Register notice (65 FR 33263), OSHA
provided an analysis of the economic impacts of the proposed rule on
railroads. On July 7, 2000, OSHA also held a supplemental hearing on
this economic analysis, in which the Association of American Railroads
(AAR) participated. AAR's comments and testimony, however, highlighted
the complexity of the OSHA/FRA jurisdictional issues (Ex. 703-3, Tr.
18272, 18313-16, 18321). OSHA has determined that it needs to gather
additional information and conduct further analysis on these issues
before it can decide whether and how to address ergonomic hazards in
the railroad industry. Therefore, OSHA has decided not to cover any
aspect of railroad work at this time.
C. Other Exemptions Requested.
A number of other rulemaking participants also requested that
certain jobs, industries or employers be excluded from this rule (e.g.,
ambulances, landscaping, transfer and storage, petroleum and chemical
industries, forging industry). Many requesting exemptions did not
provide any reasons why they should be excluded (see, e.g., Exs. 30-
303, 30-491, 30-2102, 30-3005, 30-4439, 30-4444, 30-4598, 601-X-1163,
601-X-1438). Some merely said they had ``many work conditions and
factors present in the industries OSHA has chosen to exempt,'' but did
not discuss either what those factors were or why they supported an
exclusion (see, e.g., Exs. 30-2348, 30-3005, 30-3186, 30-3311 30-3462,
30-3482, 30-3582, 33-1181). OSHA does not find any basis for excluding
those industries from this rule.
A few requests that included more discussion supporting an
exemption are discussed individually:
1. Solid Waste Management
The National Solid Waste Management Association (NSWMA) urged OSHA
to exempt the trash collection industry from the standard (Ex. 32-234).
NSWMA said an exemption was warranted because, like the construction
industry, its working conditions include non-fixed worksites, limited
supervisory oversight, adverse environmental conditions, and high
employee turnover. In addition, according to NSWMA, ``uncontrollable''
factors, such as variable load weights, municipal regulations, and its
members' lack of control over the location of the garbage they collect,
also support an exemption. Finally, NSWMA also argued that there is
little available information about health effects and effective
solutions in the industry. The West Coast Refuse and Recycling
Coalition and the Municipal Waste Management Association (MWMA),
representing municipal solid waste agencies in larger cities, requested
an exemption for some of the same reasons (Ex. OR 323, Tr. 17972-73).
Although OSHA recognizes that employers in this industry face
particular challenges in implementing some types of ergonomic controls,
it does not believe that the arguments presented compel exemption of
the solid waste and recycling industry from this standard.\1\
---------------------------------------------------------------------------
\1\ A number of participants who argued that compliance with an
ergonomics standard would be infeasible in their industries also
submitted examples of industry ``best practice'' guidelines and
similar recommendations to the record. The participants said that
even these ``best practices'' do not result in enough of a reduction
in employee exposure to MSD hazards that further MSDs are
``unlikely.'' OSHA recognizes that some industries will not be able
to control exposures completely. OSHA also, however, approves of the
steps these industries are taking to control MSD hazards to the
extent they can, and commits to working with the industries in the
future. This type of arrangement will help provide employees in
these industries with as much protection as possible, while
reassuring their employers that OSHA understands the limits of their
capabilities.
---------------------------------------------------------------------------
As noted above, OSHA does not believe that the fact that some
aspects of an industry's working conditions are similar to some of the
conditions in exempted industries necessarily warrants exempting those
industries. In any event, the working conditions in the solid waste
industry differ significantly from those in construction. In the solid
waste industry employees repeat the same routes every week or more
frequently. The route is a fixed worksite that the employee gets to
know. Because the route is fixed, the employer is able to anticipate
and plan for the hazards that the employees might encounter. Likewise,
the fixed routes enable employers to plan for how the changing seasons
will affect collection on the route. NSWMA's testimony that a ``vast
majority * * * if not all'' of its member
[[Page 68280]]
companies have safety and health programs that include addressing
ergonomic hazards on a ``day to day'' basis indicates that most
industry employers already are taking these steps (Tr. 18074).
Although NSWMA argued that high turnover in the industry supports
exemption in the same way that the use of ``day laborers'' in the
construction industry does, NSWMA did not provide any evidence on
turnover rates in its industry, or on how those rates compare to other
industries this rule covers. Nor did NSWMA explain why high turnover
rates pose the same issues as day laborers. Other solid waste
associations and employers did not indicate that high turnover rates
are a problem in the industry. The solid waste industry has the
opportunity to train its workers; in fact NSWMA and MWMA testified that
their members already provide training (Tr. 13404-405, 18079). It
explained that this training is the most effective way to deal with the
fact that its workers are often unsupervised:
MR. BEDERMAN: No, the most important way to monitor this type of
thing is actually not to monitor it, but * * * actually good
training (Tr. 18079).
The record also does not support industry claims that solid waste
industry employers have little control over their employees' working
conditions. For example, NSWMA said that, because of municipal
ordinances, its members have no control over the weight and location of
the garbage they collect and that municipalities were ``very hesitant''
to make changes (Ex. 32-234-2, Tr. 18041). But 60 percent of
residential collection is privately controlled (Tr. 18046). For the 40
percent of trash collection that is under the control of
municipalities, as noted below, the testimony of NSWMA and MWMA suggest
there is not a significant problem.
NSWMA testified that a majority of municipalities have already
implemented container requirements (Tr. 18071; see also Tr. 13402).
Both NSWMA and MWMA testified that the growing trend is toward
requiring customers to place garbage containers at the curbside (to
eliminate the need for employees to carry heavy containers) and
limiting container size (to reduce injury associated with heavy
lifting) (Tr. 18070-71, 13402-3; see also Tr. 12019). Bruce Walker, of
Portland's solid waste and recycling agency, said that such weight
limits had been positively received in that city (Tr. 12014-15). NSWMA,
MWMA and Mr. Walker also said that employers are instructing their
employees not to lift containers that exceed the weight limits (Tr.
12014, 13404-06, 18073). In addition, container size and location
issues are regularly addressed as part of contract negotiations between
private collectors and municipalities (Tr. 18041). All of this evidence
suggests that solid waste employers should not have difficulties
continuing to negotiate contracts that will assist them in complying
with this final standard.
And contrary to NSWMA's argument, the record contains abundant
evidence on MSD hazards and ergonomic solutions in this industry (Ex.
32-234-2). The industry recognizes that lifting heavy loads creates a
hazard for employees (Tr. 13406, 13413, 18009). Industry
representatives testified that their workers experience work-related
MSDs, particularly MSDs of the lower back (Tr. 13379, 13396, 13412,
18009). In fact, NSWMA submitted a manual of recommended ergonomic
practices developed by Environmental Industry Associations (EIA),
NSWMA's parent organization, that identified lifting bulky loads and
twisting and carrying loads as risk factors for the industry and
identified back pain, hernias and strains, sprains and tears as common
MSDs in the industry (Ex. 32-234-2-1). EIA also recommended that
employers establish ergonomics programs for trash collection and
recycle operations (Ex. 32-234-2-1).
The record also includes evidence on a wide range of controls that
are successfully in use in the industry. The EIA manual on ergonomic
practices said the industry ``has many options'' for addressing
ergonomic hazards, including weight limits built into residential
contracts, the use of lifting devices, and training (Ex. 32-234-2-1).
The record indicates that the following controls are also in use in the
industry:
Mechanical container lifts,
Limits on container size and weight and requirements for
container handles,
Carts, dollies and other mechanical assists for pushing,
carrying and lifting containers,
Collection trucks designed for use in narrow alleys and
streets to eliminate carrying containers long distances,
Changes in municipal collection regulations to reduce
lifting hazards (e.g., curbside service, container size and weight
limits, reduction in loads through increases in collections per week,
separate collections for large bulky items),
Training in proper lifting techniques,
Work practice controls (e.g., training not to lift
overweight loads),
Changes in compensation systems to eliminate incentives
for hazardous work speed and lifting (Tr. 12017, 13402-06, 17969,
18212).
John Legler, of Waste Equipment Technology Association, added that
garbage trucks are being retrofitted with mechanical lifts ``quite
regularly'' (Tr. 18012-13). Bruce Walker, of Portland's residential
solid waste and recycling agency, testified that enforcing container
weight limits had been established had led to low MSD rates (Tr. 11968-
70).
This evidence not only does not support exemption, it is clear
evidence that effective ergonomic programs and controls are
technologically and economically feasible for the industry as a whole.
OSHA recognizes that some of the hazards facing waste industry
employees cannot be eliminated completely. But the standard only
requires employers to control MSD hazards ``to the extent feasible.''
It expects NSWMA's member companies to continue to implement the type
of safety programs they are already using, and to continue improving
those programs as knowledge and technology advance.
2. Utility Workers
Utility companies asked OSHA to exempt utility line workers and
power plant maintenance workers from the standard for two reasons.
First, they pointed out that line workers face some of the same
conditions as construction, agriculture and maritime (e.g., adverse
environmental conditions). They also argued that these jobs involve
both general industry and construction activities because utility line
workers not only maintain and repair utility lines, a general industry
activity, but also they install, alter, and improve lines, activities
which are governed by OSHA construction standards (Exs. 30-3853, 32-
300, Tr. 2893-95). Edison Electric Institute (EEI) testified:
As you know, a line worker working on a pole may at one moment
be engaged in what is considered to be construction work under
1910.12(b) and under 1926(b) and at the next moment be engaged in
what is considered to be general industry work under 1910.269. That
is to say that if a person is doing work for the improvement of the
facility, that is construction as defined by OSHA and the Review
Commission. And if not, then general maintenance (Tr. 97-98).
EEI also pointed out that it would not be practical for its employees
to be covered by the standard for only some of their tasks:
EEI recommends that OSHA clarify that to perform a job hazard
analysis means to analyze a job, not a task. A job may not involve
only one task, but may involve multiple tasks depending upon the
nature of
[[Page 68281]]
the work on that given day (Ex. 32-300, p. 29).
OSHA agrees with EEI that determining whether a job exposes an
employee to an MSD hazard requires looking at all of the tasks and
activities that comprise that job. That is what this job-based standard
requires. But as EEI itself pointed out, some utility companies already
have programs in place for analyzing and controlling MSD hazards (Ex.
30-2725, Tr. 2384, 2396-98). Presumably, these companies analyzed the
entire jobs of utility line workers and power plant maintenance
personnel rather than just the general industry tasks in those jobs.
None of the utility companies indicated that construction activities
constitute the primary operations of utility companies. Thus, including
all rather than part of the tasks of these jobs in the ergonomics
program this rule requires should not impose a substantial additional
burden for utility companies. OSHA requires utility companies to
protect their employees, including those that spend part of their days
performing construction work.
3. Building Materials Distributors
A number of building materials distributors argued that they should
be exempted because a large portion of their business involves
delivering supplies to construction sites and to various places on
construction sites (Exs. 30-541, 30-4267, 30-4351). Because of this,
they said, their employees are exposed to the same ergonomic risk
factors and adverse working conditions that justified an exclusion for
the construction industry. OSHA has never excluded general industry
employers from standards because they provide equipment or materials
for exempted industries. Thus, while marine terminals are excluded from
this standard, manufacturers and transportation companies that deliver
new equipment to marine terminals are still covered.
In addition, almost every comment received from building materials
distributors indicated that the industry has already taken substantial
steps to control MSD hazards. For example, Panther Building Materials,
Inc., said that it provides hydraulics crane, carts and other material
handling equipment in order to safely deliver supplies (Ex. 30-4351).
It also provide at least two employees per truck crew in order to
minimize carrying.
4. Home Health Care.
The American Association for Homecare (AAHomecare), asked that the
home health care industry be exempted from the standard because home
health care employees perform work in private homes that are not under
the employer's control.
AAHomecare said its industry should be exempted because OSHA has
indicated that it will not impose OSHA standards on private homes,
unless they are being used as part of the ``manufacturing process''
(Ex. 30-3862). But the OSHA policy AAHomecare refers to only addresses
work that employees perform in their own homes.
AAHomecare also argues that the court in the Bloodborne Pathogens
decision (American Dental Association. v. Martin, 994 F.2d 823 (7th
Cir. 1993)), held that the OSH Act ``does not authorize OSHA to impose
work-site related standards on home work sites that are not under the
employers control'' and that the Agency's directive limiting the
application of the Bloodborne Pathogens rule at home-based worksites
(CPL 2-2.44D) should apply to this standard as well (Ex. 30-3862). But
the Seventh Circuit did not make as broad a holding as AAHomecare
suggests. The court said only that OSHA has an ``obligation to consider
such questions and the general issue that they present before
imposing'' a standard. American Dental Assn., 984 F.2d at 830.
In this case, OSHA is considering these issues and addressing them
here. In general, employers sending their employees to work at sites
they do not control are required to do everything within their control
to protect those employees, but will not be held liable for the
existence of conditions they cannot control. Thus home health care
agencies must provide their employees with the information required by
paragraph (d), provide those employees with MSD management where an MSD
incident occurs in a job that meets the levels in the Basic Screening
Tool, and perform job hazard analyses when necessary. In addition, they
must comply with the other programmatic elements of the standard, in
particular providing the employees with necessary training and
equipment to minimize ergonomic hazards.
But employers' control obligations will be limited by the control
they have over their employees' actual working conditions. Thus an
employee who is expected to move patients in their own homes should be
taught how to do so as safely as possible. For example, evidence was
submitted to the record that portable lifting devices and other control
measures are available for use in home settings (Ex. 37-4, Tr. 11743-
45). According to witnesses, some portable lifting devices have been
designed especially for home settings (Tr. 11743-45). The witnesses
said that these devices allow mechanical transfer in and out of bed,
onto a toilet, and even into a tub (Tr. 11745). Other control measures
described in the record include friction reduction sheets, gait belts,
toilet and shower chairs, slide boards, and convertible chairs and
wheelchairs (Ex. 37-4). To the extent these controls are feasible, and
employers find them to be effective, employers could provide them to
their home health worker employees. But an employer is not expected to
change the configuration of a patient's bedroom or bathroom, although
it must provide the worker with the training and controls necessary to
allow him or her work as safely as possible in that location.
5. Small Businesses
A number of commenters said OSHA should exempt small businesses
because compliance would be too burdensome (Ex. 30-3167, Tr. 3126-27,
3332). They said that small businesses do not have the knowledge or
resources to hire outside experts to help identify and address MSD
hazards (Tr. 3127). They also said that MSD rates were low for small
businesses (Exs. 30-3167, 600-X-1, Tr. 3332). National Small Business
United (NSBU) said that for the majority of small businesses the
occurrence of an MSD was rare (Ex. 30-3167). By contrast, another
participant (Ex. 26-1370) at OSHA's stakeholder meetings for Ergonomics
Program Standard Development specifically supported the inclusion of
small employers in the rule, saying that the rule was particularly
needed in these facilities because they were less likely already to
have either an ergonomics or a safety and health program (Exs. 26-
1370).
OSHA considered whether to apply alternative regulatory provisions
to small employers as part of the analysis required by SBREFA and the
Regulatory Flexibility Act (64 FR 66040-53). OSHA does not believe the
record supports such an approach for small business. First, employees
who work for small businesses are experiencing work-related MSDs, and
they need the protection this standard will provide. According to BLS,
employees in establishments of all sizes have reported MSDs that are
serious enough to involve days away from work.
In a number of industries comprised predominantly of small
businesses, the risk of MSDs is particularly high. This is especially
true in the health care industry. For example, many medical
sonographers are employed by small businesses. Joan Baker, of the
Society of Diagnostic Medical Sonographers,
[[Page 68282]]
testified that the MSD prevalence rate among sonographers exceeds 80
percent and that the frequency and severity of these MSDs appears to be
increasing (Tr. 11881-82). Dr. Linda Morse, chief of occupational
medicine at Kaiser San Francisco, said that the injury rate among
ultrasound technicians in Northern California was almost 100 percent
(Tr. 15045). Many nurses, nurses' aides, and orderlies are also
employed by small businesses, including small nursing homes and small
health care agencies. According to BLS, in 1996 about 15 percent (more
than 103,000) of all MSDs resulting in days away from work were
reported by health care workers. In addition, the American Nurses
Association and the Service Employees International Union, among
others, testified that the occurrence of MSDs among home health workers
is particularly high (Exs. 32-274-1, 502-215).
OSHA does not believe this standard will be too burdensome for
small businesses. The record shows that many small businesses have
successfully implemented ergonomics programs (see, e.g., Exs. DC 66,
500-208-3, Tr. 17350-17355). These programs have paid for themselves in
terms of reductions in medical costs, lost workdays and product reject
rates (Tr. 17354). Moreover, if small businesses have low rates of
MSDs, the obligations for those employers will be commensurately small
(Ex. 30-3167). The only obligation that many small employers will have
is a one-time requirement to provide basic information to their
employees. And these employers can satisfy that burden by copying,
distributing, and posting the information sheets in Appendices A and B.
The record shows that small businesses are easily able to get the
information they need to address MSD hazards. A number of organizations
have developed and are providing model programs, checklists, ``best
practices'' guides and control information to small businesses (see,
e.g., Exs. 32-234-2-1, OR 351). A number of organizations have
developed and are providing model programs, checklists, ``best
practices'' guides and control information (Exs. 32-234-2-1, OR 351 ).
For example, the American Dental Association and state affiliates, such
as the Oregon Dental Association, have developed and disseminated
information on ergonomics for its members and held a ``Dental
Ergonomics Summit Conference'' this year (Ex. OR 351). A number of
trade associations are also providing ergonomics training for small
businesses (Ex. 37-25, OR 351). For example, Suzanne Rodgers, an
ergonomist with 32 years of experience assisting a wide range of
companies in addressing MSD hazards, said that she has provided
training to small businesses at various conferences organized by the
Chamber of Commerce (Ex. 37-25).
There are also other sources of information and assistance for
small employers. OSHA and NIOSH provide free hazard evaluation services
for small employers. OSHA will be providing additional information in
the appendices to this final rule and other materials on the OSHA
Webpage (www.osha.gov). Many other Internet sites also provide free
ergonomics information.
III. Other Scope and Application Issues
A. Jobs Involving Both General Industry and Non-General Industry Tasks
Several commenters raised questions about whether this standard
applies when an employee's job involves both general industry and non-
general industry activities (Exs. 30-3853, 32-300, Tr. 2893-95). As
explained above in reference to utility workers, because this is a job-
based standard, OSHA intends employers to include all employees who
perform general industry work within this standard, even if those
employees also perform some work that may be classified as
construction, agriculture, or maritime. Thus, employers engaged in
landscaping or lawn and garden services, a general industry
classification, are covered by this standard even if their employees'
jobs include some harvesting of sod or trees, an agricultural
classification. On the other hand, nurseries and tree farms, which are
agricultural classifications, need not comply with the standard even if
their employees perform some minor landscaping or horticultural
services. Comments by the AFL-CIO best sum up the need for defining the
application of the standard in this way:
Since this is a job-based standard, it is important that jobs in
fact are covered. To apply the standard in some aspects of a job and
not others would leave workers without protection and make
compliance and enforcement confusing and difficult (Ex. 500-218, p.
133).
In addition, as stated in the discussion of utility line workers,
the only way an employer can determine whether a job exposes an
employee to an MSD hazard is to look at all the tasks and activities
that comprise that job. Eliminating some tasks from this analysis may
prevent identification of risk factors that are causing or contributing
to the hazard. If employers do not have that information, the controls
they implement may not be successful. Therefore, in order to ensure
that an employee is protected from MSD hazards while performing the
general industry tasks, it may be necessary to control risk factors for
the job as a whole.
B. Multiple Employer Worksites and Contract or Shared Employee
Situations
A number of participants asked how the standard would apply at
multi-employer worksites. Similar situations arise under many
standards, and OSHA has published a ``Multi-Employer Citation Policy''
that discusses the allocation of responsibility among various
categories of employers. CPL-0.124 (Eff. Dec, 10, 1999). OSHA has not
historically discussed the operation of this policy in rulemaking
documents, viewing it as an enforcement issue. In a challenge to OSHA's
Bloodborne Pathogens standard, however, the United States Court of
Appeals for the Seventh Circuit held that, where parties to a
rulemaking raise issues about the application of the standard in this
circumstance, OSHA should discuss the application of this policy.
American Dental Ass'n. v. Martin, 984 F.2d 823 (7th Cir. 1993). Such a
discussion is particularly useful with respect to some of the issues
raised by this standard.
Under the multi-employer worksite policy, employers are generally
required to take whatever steps are within their power to protect their
own employees, and also to abate hazards within their control when
other employees are exposed to those hazards. This means that an
employer whose employees are working at a location controlled by
another employer, for example a temporary services agency, must provide
its employees with the information required by paragraph (d). Both
employers will need to know if an employee reports an MSD, and must
implement measures to share this information. They should consult to
determine whether the report qualifies as an MSD incident under this
standard, but the employer with control over the workplace must screen
the job to determine whether further action is required. If so, the
employer with control over the workplace must also implement the
program elements required by this standard. And if such an employer
hires a temporary worker to work in a job for which an ergonomics
program under this standard is already in place, that employer must
provide the temporary employee with any necessary training. The
employing agency, however, will necessarily be responsible for
providing the employee
[[Page 68283]]
with any necessary MSD management, including WRP. OSHA believes that
this is basically how businesses are currently operating. OSHA expects
that they may pay more attention to these issues and address them
explicitly in their contracts after the standard is in effect.
C. United States Postal Service
Questions were also raised as to the effect of this standard on the
United States Postal Service. In 1998, Congress amended Section 3(5) of
the OSH Act to include the United States Postal Service within the
Act's definition of employer. 29 U.S.C. 652(5). Postal Service
Enhancement Act, P.L. 105-241. As a result, this standard applies to
all USPS operations that are not construction, agriculture or maritime
operations.
D. Municipalities
A number of municipalities asked whether the standard applies to
local governments. States and their political subdivisions are not
employers under the OSH Act, and they are not covered by this final
rule or any other federal OSHA standards. However, the 23 States and 2
Territories with approved State Plans are required by Section 18(c)(2)
of the OSH Act to issue standards that are ``at least as effective'' as
Federal standards. 29 U.S.C. 667. Therefore, State Plan States must
adopt ergonomics program standard within six months of the publication
of this standard. Under Section 18(c)(6), State Plan States must apply
such standards to State employees and to employee's of the State's
political subdivisions. (See State Plan States section of this preamble
for the list of State plan States.)
Industries and Jobs This Standard Covers
Agricultural services
Soil preparation and crop services, including crop
planting, cultivating and protecting
Crop harvesting
Veterinary services
Lawn and garden services
Ornamental shrub and tree service
Tree trimming
Landscaping and horticultural services
Oil and gas drilling/extraction operations
Health care employees
Truck driving
Office workers employed by general industry
establishments
Office workers employed by agricultural services
establishments
Utility line operations including maintenance, repair,
installation, construction, alteration and improvement operations
Power plant maintenance operations including repair,
alteration and improvements
Boat building and repair
Airline baggage handlers
Airline reservation and ticket agents
Airline maintenance crews
Railroad equipment building and rebuilding
Maintenance of equipment or structures
Forestry services
Forestry nurseries and gathering of forest products
Commercial fishing
Fish hatcheries and preserves
Hunting and trapping
Game propagation
State and municipal employees (in State Plan States)
performing general industry operations
U.S. Postal Service
Federal government employees performing general
industry operations
Industries and Jobs This Standard Does Not Cover
Construction employment and operations
Agriculture employment and operations
Farm labor and management services
Livestock and animal specialty services
Maritime employment and operations
Ship building and repair
Longshoring
Office workers employed by construction, agriculture or
maritime establishments
Maintenance workers employed by construction,
agriculture or maritime establishments
Work at the employee's own home
Railroad work
Railroad terminal and switching
Airline attendants
Airline pilots
Paragraph (c)--How Does This Standard Apply if I Already Have an
Ergonomics Program in Place When the OSHA Ergonomics Program Standard
Becomes Effective?
Paragraph (c) of the final standard is a grandfather clause, which,
under certain conditions, permits an employer who has already
implemented and evaluated his or her ergonomics program by the date on
which the final rule becomes effective to continue that program instead
of complying with the OSHA standard. This paragraph permits employers
to do this only if the program: is in writing, contains the core
elements of basic ergonomics programs, and is demonstrably effective.
The criteria for judging whether an employer's program adequately
addresses the core elements are contained in paragraphs (c)(1)(i)
through (v). Examples of criteria for judging the effectiveness of the
program are contained in paragraph (c)(1)(v). Paragraph (c)(2) requires
that, within 1 year of the standard's effective date, grandfathered
programs have in place an MSD management policy that meets the
requirements of paragraphs (p) through (s) of the final rule. Final
paragraph (c)(3) denies grandfather status to employers who have
policies or procedures that discourage employees from participating in
the program or reporting signs or symptoms of MSDs or the presence of
MSD hazards in the workplace.
In the final rule, OSHA is requiring that grandfathered programs be
in writing. The final rule's grandfather clause requires the employer
to demonstrate program effectiveness and, like the proposal, to have a
program that includes the core elements of effective programs. The
Agency believes that this can best be accomplished with a written
program. Further, both OSHA and the employer will find compliance with
the grandfather clause easier to demonstrate if the program is written.
By ``written,'' OSHA also intends that the program can be maintained
electronically.
Final paragraph (c)(1) requires grandfathered programs to include
the core elements of effective ergonomics programs: management
leadership and employee involvement; job hazard analysis and control;
training; and program evaluation. This paragraph also indicates the
subelements within each core element that OSHA believes are essential
to the proper functioning of that core element. These subelements are
stated broadly. For example, a subelement of management leadership
(paragraph (c)(1)(i)) that OSHA considers essential is the
establishment of an effective reporting system that permits employees
to report the signs and symptoms of MSDs and to receive prompt
responses to their reports. The employer's program must include all of
the subelements of the core elements to qualify for grandfather status.
The following discussion explains the subelements comprising each
of the core elements. Employers are free to include additional elements
or subelements in their program, and doing so will not interfere with
the program's grandfather status, provided that the program includes
the core elements identified by paragraphs (c)(1)(i) through (v), and
the subelements associated with them.
The proposed rule would have required an existing program to meet a
``basic obligation'' provision for each core element. Basic
obligations, which were intended to capture the essence of the more
detailed subelements proposed for each core element, were proposed for
each program element. Table 1 compares the proposed rule's basic
obligations sections with the corresponding subelements of the final
rule's grandfather clause. The following discussion also explains
OSHA's
[[Page 68284]]
reasons for revising the basic obligations proposed.
Final paragraph (c)(1)(i) states that grandfathered programs must
include management leadership and identifies the subelements for that
core element. Employers are required to demonstrate management
leadership of their ergonomics program through the following
subelements: an effective MSD reporting system and prompt responses to
employee reports, the assignment of clear program responsibilities, and
regular communication with employees about the ergonomics program.
OSHA's experience has shown that, to be effective, management
leadership must be active rather than passive. Leadership that is
limited to a ``paper program'' with written policies and procedures but
is not translated into practice by management would not meet the intent
of this provision. On the other hand, management leadership that is
known throughout the organization because of management's active
engagement in the ergonomics process and appropriate follow-through on
commitments would clearly fulfill this intent. The final rule's
management leadership subelements are equivalent to those of the
proposed basic obligation for this core element, except that OSHA has
added ``regular communication with employees'' and ``prompt'' responses
to reports to the subelements of the final rule's grandfather clause.
The Agency has added these subelements to make sure that management
leadership is responsive to employee reports and that management's
commitment to the ergonomics program is communicated from top
management down to the employees performing the work and implementing
the program. Taken as a whole, OSHA believes that the subelements in
final paragraph (c)(1)(i) will ensure that grandfathered programs have
active rather than passive management leadership.
Final paragraph (c)(1)(ii) requires that grandfathered programs
include employee involvement, as demonstrated by the early reporting of
MSDs and active employee involvement in the implementation, evaluation,
and future development of the employer's ergonomics program. OSHA has
vigorously advocated employee participation in workplace safety and
health issues for many years and is pleased by the growing recognition
of the importance of employee participation on the part of private-
sector companies, trade associations, safety and health professionals,
and employees themselves. OSHA supports employee participation because
employees have the most direct interest in their safety and health on
the job, they have an in-depth knowledge of the tasks they conduct at
the worksite, they often have excellent ideas on how to solve ergonomic
problems, and their interest in the program is vital to its success. If
employees do not report their MSD signs and symptoms or MSD hazards,
any ergonomics program will fail. OSHA has specifically included in
paragraph (c)(1)(ii) a provision that employees be involved in the
implementation, evaluation, and future development of grandfathered
programs to make it clear that employee involvement extends to every
element of the program, including program evaluation and future
modifications to the program to reflect changes over time.
Final paragraph (c)(1)(iii) requires grandfathered programs to
contain job hazard analysis and control, as demonstrated by a process
for identifying, analyzing, prioritizing (if necessary), and
controlling MSD hazards in affected jobs and following up to ensure
control effectiveness. This is the heart of any ergonomics program. For
employees to be protected from MSD hazards, it is obvious that those
hazards must be eliminated or controlled. A note following this
paragraph explains that personal protective equipment (PPE) may be used
as a supplement to engineering, work practice, and administrative
controls. The employer may only use PPE alone where other controls are
not feasible. In addition, the note explains that, if PPE is used, the
employer must provide it at no cost to employees.
As can readily be seen from Table 1, this provision has been
changed substantially from the corresponding requirement in the
proposal. The job hazard analysis and control subelements in the final
rule's grandfather clause are designed to be less prescriptive and more
flexible than those proposed and to fit better with the way rulemaking
participants (see, e.g., Ex. 32-77, Tr. 14723, Tr. 4973) described this
process in their existing ergonomics programs.
The final rule's grandfather clause requires employers to use a
process for identifying, analyzing, and controlling MSD hazards in
problem jobs. Employers may also prioritize jobs identified as having
MSD hazards and then follow their prioritization scheme when
controlling these hazards. Employers with grandfathered programs must
also follow up on their hazard control measures to ensure that the
controls implemented are effective. This is the process that
participants in the rulemaking told OSHA they use in their existing
ergonomics programs. Companies like the Dow Chemical Company (Ex. 32-
77; Tr. 5297), Levi Strauss (Tr. 14723, 14736, 14746), the Consolidated
Edison Company of New York (Tr. 4644), and IBP, Inc. (Tr. 4973)
described a process that includes these job hazard analysis features.
As discussed in the summary and explanation for the standard's job
hazard analysis and control requirements (paragraphs (j) through (m))
later in this section of the preamble, the rulemaking record
demonstrates that, currently, employers with existing programs do not
always fix all problem jobs, nor do they eliminate all MSDs. To address
these facts, the final rule's grandfather clause (1) permits employers
to bring all problem jobs into their programs, and (2) acknowledges
that employers will not eliminate all MSDs. Employers with
grandfathered programs must, however, implement controls that (1)
control the MSD hazards, (2) reduce MSD hazards to the levels specified
in Appendix D, or (3) reduce MSD hazards to the extent feasible. These
are the same compliance endpoints specified in paragraph (k)(1) of the
final rule. These endpoints are explained in the summary and
explanation for that paragraph.
Thus, the grandfather clause in the final rule will enable
employers with existing programs that only address certain jobs to
qualify for the grandfather clause if they include all problem jobs in
their program before the standard's effective date. Thus, even programs
that do not currently address all problem jobs would not be precluded
from qualifying for grandfather status, providing that they revise
their approach to include all such jobs before the standard is in
effect.
Final rule paragraph (c)(1)(iv) requires grandfathered programs to
provide for the training of managers, supervisors, and employees in the
employer's ergonomics program and their role in it; the recognition of
MSD signs and symptoms; the importance of early reporting; the
identification of MSD hazards, and methods that the employer is using
to abate them. Training is to be provided at no cost to the employees
trained. Training is necessary to ensure that employees in problem
jobs, their supervisors, and the individuals who set up and manage the
ergonomics program are provided with the knowledge and skills necessary
to recognize MSD signs, symptoms, and hazards in their workplace and to
effectively participate in the ergonomics program. These individuals
also need to be trained in the need for early reporting. The length and
frequency of training is determined
[[Page 68285]]
by the needs of the workplace. Periodic training is necessary to
address new developments in the workplace and to reinforce and retain
the knowledge already acquired in previous training, but to make this
element as flexible as possible, OSHA is not specifying the frequency
with which training must be provided.
Final rule paragraph (c)(1)(v) requires grandfathered programs to
include evaluations of the program, as demonstrated by regular reviews
of the elements of the program, the effectiveness of the program as a
whole, and the correction of identified deficiencies. This means that
employers must, at a minimum, assess the functioning of their
ergonomics program, compare its provisions to the elements and
subelements specified in the grandfather clause, identify any
deficiencies in the program, and correct them. Employers are required
to make sure that the ergonomics program they have implemented is
eliminating or controlling the MSD hazards in jobs in their workplace.
A program designed for a large site with many different jobs, for
example, is likely to be more formal and extensive than one designed
for a small site with one or two high-risk jobs. Similarly, an
ergonomics program that fits a manufacturing facility may not be
appropriate for a work environment in the service sector. To make the
evaluation requirements for grandfathered programs as flexible as
possible, OSHA is not specifying the frequency with which evaluations
must be conducted. However, employers do need to reevaluate their
programs periodically to ensure that they are performing up to
expectations.
Final rule paragraph (c)(1)(v) also requires the program evaluation
to review the effectiveness of the program, using such measures as:
reductions in the number or severity of MSDs, increases in the number
of jobs in which ergonomic hazards have been controlled, reductions in
the number of jobs posing MSD hazards to employees, or any other
measure that demonstrates program effectiveness.
Lastly, final rule paragraph (c)(1)(v) requires the employer to
conduct at least one review of the elements and effectiveness of the
program before January 16, 2001. This provision, which is discussed in
detail below, ensures that only effective programs are grandfathered.
Although paragraph (c)(1)(v) requires employers to correct deficiencies
in the program, OSHA would not consider an employer who uncovers major
deficiencies in the program elements or whose evaluation does not
demonstrate the overall effectiveness of the program to be in
compliance with this paragraph. Requiring any program that is
grandfathered to be demonstrably effective is basic to employee
protection and to ensuring that grandfathered programs are at least as
effective as the programs required by the standard OSHA is promulgating
for all general industry employers and employees.
The final rule's grandfather clause does not identify specific
rates of MSDs or other similar measures of effectiveness that a
grandfathered program must achieve because OSHA is aware that the
programs grandfathered in will be at many different stages of program
development and because OSHA wishes to recognize as wide a range of
existing effective programs as possible. Although the grandfather
clause does not set a specific reduction goal, employers are required
by paragraph (c)(1)(v) to demonstrate the effectiveness of their
programs.
Paragraph (c)(2) of the final rule requires employers with
grandfathered programs to institute an MSD management policy (including
work restriction protection) that meets paragraphs (p) through (s) of
the final rule within 12 months of the effective date of the standard.
Thus, the final rule's grandfather clause is designed to recognize
existing ergonomics programs that are effective even if they do not
have an MSD management policy until a year after the effective date of
the standard.
OSHA believes that all successful ergonomics programs depend on the
early reporting of and intervention with regard to MSD signs and
symptoms; this is as true for grandfathered programs as for those that
are not grandfathered. As discussed at length in connection with
paragraph (r), OSHA has found, both on this record and in the records
of many other OSHA standards, that wage and benefit protection is
essential to early reporting and employee participation in the
employer's program. Without such protection, employees fear economic
loss and often simply do not report their signs and symptoms until the
injury has progressed to the point where work (and perhaps full
recovery) is no longer possible. In addition, as fully explained in the
summary and explanation for paragraphs (p) through (s) of the final
rule, when an employee reports an MSD, early intervention is required
to ensure appropriate treatment, work restrictions, and follow up. OSHA
anticipates that many existing programs will be able to meet the
requirements of paragraph (s) by use of the dispute resolution
mechanisms described in paragraph (s)(5).
Final rule paragraph (c)(3) states that an ergonomics program of an
employer who has policies or procedures that discourage employee from
participating in the program or reporting the signs or symptoms of MSDs
or the presence of MSD hazards in the workplace does not qualify for
grandfather status. This provision, which is equivalent to paragraph
(h)(3) of the final rule, ensures that employees are as free to
participate fully in grandfathered programs as employees in programs
that are not grandfathered. As discussed at length in connection with
paragraph (h)(3), OSHA has found that employee participation is
essential to a program's effectiveness and that a prohibition on
policies that inhibit that participation is warranted.
Table 1--Comparison of Proposed Basic Obligations with Final Grandfather
Clause Program Element Core Elements and Subelements
------------------------------------------------------------------------
Corresponding core elements and
Proposed basic obligation subelements of the final
grandfather clause
------------------------------------------------------------------------
Proposed Management Leadership Final Sec. 1910.900(c)(1)(i)
Obligation and (ii) and (c)(3): [Your
program must contain the
following elements:]
You must demonstrate management (c)(1)(i) Management
leadership of your ergonomics leadership, as demonstrated by
program. Employees (and their an effective MSD reporting
designated representatives) must system and prompt responses to
have ways to report MSD signs and reports, clear program
MSD symptoms; get responses to responsibilities, and regular
reports; and be involved in communication with employees
developing, implementing and about the program;
evaluating each element of your (c)(3) An employer who has
program. You must not have policies or procedures that
policies or practices that discourage employees from
discourage employees from participating in the program
participating in the program or or reporting the signs or
from reporting MSD signs or symptoms of MSDs or the
symptoms. presence of MSD hazards in the
workplace does not qualify
under paragraph (c) of this
section.
[[Page 68286]]
Proposed Employee Participation
Obligation:
You must set up a way for employees (c)(1)(ii) Employee
to report MSD signs and symptoms participation, as demonstrated
and to get prompt responses. You by the early reporting of MSDs
must evaluate employee reports of and active involvement by
MSD signs and symptoms to employees and their
determine whether a covered MSD representatives in the
has occurred. You must implementation, evaluation,
periodically provide information and future development of your
to employees that explains how to program;
identify and report MSD signs and [See also paragraph
symptoms. (c)(1)(iv).]
Proposed Job Hazard Analysis and Final Sec.
Control Obligation: 1910.900(c)(1)(iii): [Your
program must contain the
following elements:]
You must analyze the problem job to Job hazard analysis and
identify the ergonomic risk control, as demonstrated by a
factors that result in MSD process that identifies,
hazards. You must eliminate the analyzes, and uses feasible
MSD hazards, reduce them to the engineering and administrative
extent feasible, or materially controls to control MSD
reduce them using the incremental hazards or to reduce MSD
abatement process in this hazards to the levels
standard. If you show that the MSD specified in Appendix D or to
hazards only pose a risk to the the extent feasible, and
employee with the covered MSD, you evaluates controls to assure
may limit the job hazard analysis that they are effective.
and control to that individual Note to Paragraph (c)(1)(iii):
employee's job. Personal protective equipment
(PPE) may be used to
supplement engineering and
administrative controls, but
you may only use PPE alone
where other controls are not
feasible. Where PPE is used
you must provide it at no cost
to employees.
Proposed Training Obligation: Final Sec. 1910.900(c)(1)(iv):
[Your program must contain the
following elements:]
You must provide training to Training of managers,
employees so they know about MSD supervisors, and employees (at
hazards and your ergonomics no cost to these employees) in
program and measures for your ergonomics program and
eliminating or materially reducing their role in it; the
the hazards. You must provide recognition of MSD signs and
training initially, periodically, symptoms; the importance of
and at least every 3 years at no early reporting; the
cost to employees. identification of MSD hazards
in jobs in your workplace; and
the methods you are taking to
control them.
Proposed MSD Management Obligation: Final Sec. 1910.900(c)(2):
[Your program must contain the
following elements:]
You must make MSD management By January 16, 2002, you must
available promptly whenever a have implemented a policy that
covered MSD occurs. You must provides MSD management as
provide MSD management at no cost specified in paragraphs (p),
to employees. You must provide (q), (r) and (s) of this
employees with the temporary section.
``work restrictions'' and ``work
restriction protection (WRP)''
this standard requires.
Proposed Program Evaluation Obligation: Final Sec. 1910.900(c)(1)(v):
[Your program must contain the
following elements:]
You must evaluate your ergonomics Program evaluation, as
program periodically, and at least demonstrated by regular
every 3 years, to ensure that it reviews of the elements of the
is in compliance with this program; regular reviews of
standard. the effectiveness of the
program as a whole, using such
measures as reductions in the
number and severity of MSDs,
increases in the number of
jobs in which ergonomic
hazards have been controlled,
or reductions in the number of
jobs posing MSD hazards to
employees; and the correction
of identified deficiencies in
the program. At least one
review of the elements and
effectiveness of the program
must have taken place prior to
[insert date 60 days after the
publication date of this
standard].
------------------------------------------------------------------------
The following paragraphs discuss the comments, evidence and
testimony received on the proposed grandfather clause and present
OSHA's reasons for accepting or rejecting the rulemaking participants'
suggestions and for including the final rule's grandfather clause
requirements.
1. Whether the Proposed Standard Would Recognize Existing Effective
Programs
Many rulemaking participants said that the proposed rule's
grandfather clause would not, as drafted, recognize existing effective
programs (see, e.g., Exs. 30-574, 30-973, 30-1722, 30-3765, 30-3813,
30-3815, 30-3845, 30-3853, 30-3934, 30-3956, 30-4185, 31-297, 32-141;
500-188; Tr. 3320, 4137, 11265, 11290, 11615). Most of these commenters
argued that the proposed standard would only permit existing programs
that already met all of the details of the program required by OSHA's
standard to be grandfathered (see, e.g., Exs. 30-1722, 30-3853, 30-
3934, 30-3956, 32-141; Tr. 11265, Tr. 11290, Tr. 11615). According to
these commenters, the basic obligation OSHA proposed for each core
element would in actuality have required an employer to meet each of
the proposed subrequirements under that core element. Thus, they
reasoned that the proposed grandfather clause would only recognize
existing programs that already met all of the particulars of the
program envisioned by OSHA's proposed standard even in cases where the
employer's program had been demonstrated to be effective in preventing
MSDs. For example, the U.S. Chamber of Commerce stated this view as
follows:
OSHA claims that employers who already have ergonomics programs
in place ``may continue that program, even if it differs from the
one [the proposed] standard requires'' if the program meets certain
requirements * * *. The Proposed Rule requires that ergonomics
programs that were implemented and evaluated before the effective
date of the Proposed Rule must, among other things, (1) satisfy the
``basic obligation'' of each of the standard's six program elements;
and (2) demonstrate that the elements of the preexisting program are
``functioning properly * * *.'' This provision is completely
inadequate to assist employers with preexisting programs. The
qualifications
[[Page 68287]]
written in to this provision essentially require that employers
reconstruct their existing programs, even if any given program is
effective in addressing supposed ``MSD hazards,'' so that it mirrors
the Proposed Rule's notion of an appropriate ergonomics program.
[A]n employer is supposed to ensure that his program satisfies
the ``basic obligation'' of each program element. The ``basic
obligation'' of each [proposed] element is so broadly written that
it encompasses all requirements enumerated under that particular
element. Thus, employers, including those Chamber members who have
[spent] a great deal of effort and money to establish voluntary
ergonomics programs, will be forced to [alter] their preexisting
programs to comply with the Proposed Rule (Ex. 30-1722).
Edison Electric Institute's (EEI's) comments were similar:
EEI supports the concept of a ``grandfather'' clause. However,
the proposed version is more illusory than real, for it appears to
require that all newly proposed controls be put in place before the
effective date of the standard. It is unrealistic and unfair to
``grandfather'' only those programs that track the proposed
standard. It is as if OSHA is saying, ``You don't have to do
anything, provided that you have done everything.'' A true
``grandfather'' provision would give credit for effective past
programs, regardless of whether those programs conform to the scheme
of the proposed program (Ex. 30-3853).
The American Hotel and Motel Association gave examples of how an
effective existing program might fail OSHA's proposed grandfather test:
OSHA does not allow for any variation from OSHA's regulation if
a [company's] ergonomics program does not satisfy ``the basic
obligation section of each program element in this standard.'' An
ergonomics program that is proven to be 100 percent effective would
fail if it only offered, for example, training every five years. An
ergonomics program also would likely fail if it provided program
evaluation only upon a report of an ergonomic injury yet did not
have a reportable injury in less than three years (Ex. 30-3233).
The Center for Office Technology noted that none of the exemplary
ergonomics programs that have won the Center's ergonomics award have
requirements for work restriction protection, which would have been
required by the proposed standard to be in place by the standard's
effective date in order for a program to be grandfathered (Ex. 30-
2208). Thus, the Center pointed out that these very good programs would
not meet OSHA's proposed grandfather clause. The Center recommended
that OSHA include in the final rule a grandfather clause that would
allow any program to be grandfathered in that was reducing MSD
incidence and severity rates and educating employees about how to
minimize discomfort on and off the job.
The National Association of Manufacturers (NAM) and others noted
that some companies have adopted effective ergonomics programs under
OSHA's Voluntary Protection Program (VPP) or through corporate
settlement agreements (see, e.g., Exs. 30-3392, 30-3815, 30-3819, 30-
4499). These rulemaking participants observed that these ergonomics
programs would not be acceptable under the proposed grandfather clause
even though they have been recognized as effective by the Agency in the
past. NAM urged OSHA in the final rule to grant employers' existing
ergonomics programs greater acceptance for grandfather status based on
the results they achieve.
Similarly, Organization Resources Counselors, Inc. (ORC) noted that
a recent General Accounting Office (GAO) study recommended that OSHA
adopt a flexible approach in its ergonomics standard (Ex. 500-214). ORC
argued that OSHA ignored this GAO recommendation in drafting the
proposed grandfather clause. As evidence, ORC pointed out that even the
best ergonomics programs would not qualify for status under the
proposal's grandfather clause, stating:
OSHA has predicated its proposed Ergonomics Program Standard on
its observations that many businesses are successfully addressing
ergonomics issues using similar approaches. In recognition of this
conclusion and in order to focus its own scarce resources on the
areas of greatest need, OSHA has proposed a ``limited grandfather
clause'' for employers with existing ergonomics programs that meet
certain criteria. OSHA's proposal made numerous references to the
1997 General Accounting Office (GAO) study of several companies with
ergonomics programs which found that the companies' programs reduced
work-related MSDs and associated costs, and that the programs and
controls selected by employers to address ergonomic hazards in the
workplaces were not necessarily costly or complex. As a result, OSHA
said, ``GAO recommended that OSHA use a flexible regulatory approach
in its ergonomics standard that would enable employers to develop
their own effective programs.'' OSHA claimed that the standard it
proposed reflects this recommendation and ``builds on the successful
programs that thousands of proactive employers have found successful
in dealing with their ergonomic problems'' (64 FR 65770).
Unfortunately, in crafting the proposed grandfather clause, OSHA
ignored a major finding of the GAO report: that although there were
common elements in each of the employer's programs studied, there
was significant variety in the way each program element was
implemented (GAO/HEHS-97163, page 4). There was no evidence in the
GAO study that one method of implementation was better than another,
yet OSHA has drafted a rule that makes only one program approach--
OSHA's--acceptable.
* * * [A]s written, virtually no employer would qualify under
[the proposed grandfather clause's] terms, rendering it a nullity.
As was attested to by several industry representatives during the
public hearings, even those programs that OSHA has acknowledged as
being among the best in industry today would not be in compliance
with the proposal. As pointed out in ORC's oral testimony, it is
unlikely that any of the approximately 150 member companies of ORC's
occupational safety and health groups, whose safety and health
programs are among the most sophisticated and effective in the
world, would meet the criteria under section 908 of the proposal.
This is because of the proposed requirement that an employer must
meet all of the ``basic obligation'' sections of each program
element. Virtually all of the proposed ``basic obligations'' are too
prescriptive and should be simplified as described more fully in
ORC's written comments. In particular, many ORC employers would not
meet the provisions of [proposed] sections 911, 917, 923 or 929,
individually, and almost none would meet all four (Ex. 500-214).
Summing up the concerns of commenters wanting a more flexible
grandfather clause, the American Dental Association argued that the
proposal would reject alternative programs that might be equally or
even more effective (Ex. 32-141). The Association recommended that OSHA
establish a standard based on objective measures or performance and
leave the methods of achieving those objectives to employers.
Several employer representatives illustrated how various effective
existing ergonomics programs would fail to meet the proposed
grandfather clause (see, e.g., Ex. 30-4185; Tr. 8634, 9181, 11265). For
example, IBP, Inc., which has a corporate-wide ergonomics settlement
agreement with OSHA, identified several aspects of the proposed program
that their program does not address: responses to every MSD symptom,
communication with the health care provider, and WRP (Tr. 4929, Tr.
5041). In the hearings, an IBP representative stated that its program
would not meet the grandfather clause because of proposed requirements
in these three areas (Tr. 5041). Many other employer representatives
also noted that their programs did not include provisions providing for
work restriction protection and, consequently, would not qualify under
the grandfather clause (Tr. 8634, Tr. 9181).
Constangy, Brooks and Smith stated that their clients could not
meet the hazard control endpoints in the proposed standard (Ex. 30-
4185). They argued that, as drafted, the proposal
[[Page 68288]]
would mean that the occurrence of even a single MSD would require their
clients to implement new engineering controls. Consequently, they
believed that their clients' programs would not qualify under the
proposed grandfather clause. Other commenters also noted that their,
their members', or their clients' programs would not meet the proposed
standard's grandfather clause for similar reasons (see, e.g., Exs. 30-
3344, 30-3347, 30-3368, 30-3845, 30-4137).
One witness at the hearing, Thomas J. Durbin of PPG Industries,
noted that since no one would benefit from the grandfather clause as it
was proposed, OSHA should either put in a true grandfather clause that
recognizes programs containing the six core elements or eliminate it
altogether (Tr. 3135, Tr. 3147). In questioning, he stated that he
interpreted the proposal to require the full program as long as MSDs
continued to occur (Tr. 3140).
The Boeing Company argued that the restrictive nature of the
proposal's grandfather clause ran counter to the intent of the OSH Act
(Ex. 30-1547). In support of their position, they pointed to section
6(d) of the Act, which provides for a variance procedure to recognize
alternative approaches to compliance with OSHA standards, provided that
the alternative provides equivalent employee protections. Boeing was
particularly concerned that the standard, as proposed, would deny
grandfather status to an employer who had a program but who had not yet
completed the implementation of all of the control measures required by
the proposal.
On the other hand, many rulemaking participants indicated that the
proposed standard's grandfather clause would allow ineffective programs
to be grandfathered (see, e.g., Exs. 30-4200, 32-111, 32-182, 32-198,
32-210, 32-339; Tr. 3477). For example, the United Steelworkers of
America and others were concerned that employers whose program
evaluations failed to identify deficiencies simply because the
evaluations were not done properly could be grandfathered in under the
proposed standard (see, e.g., Exs. 32-111, 32-182). They recommended
that OSHA develop additional regulatory text to strengthen the program
evaluation provisions. The Union of Needletrades, Industrial and
Textile Employees (UNITE) was also very concerned that the proposed
grandfather clause would inadequately protect employees (Ex. 32-198),
stating:
The acceptability of existing programs depends largely on the
criteria used to determine acceptability. Therefore, the correctness
of the current criteria--compliance solely with the ``basic
obligation'' provisions--is critical to the protection of workers
from OSHA's approval of programs which are in fact ineffective. For
the reasons [summarized by OSHA] below, UNITE does not believe that
these criteria will provide the appropriate level of workers
protection (Ex. 32-198).
Several unions, including UNITE and the United Food and Commercial
Workers International Union (UFCW), gave the following reasons why the
proposal's grandfather clause was inadequate:
The detailed provisions implementing each of the proposed
program elements, which would not be required for grandfathered
programs, are necessary for adequate protection of employees. UNITE
pointed to OSHA's extensive justification for each of these proposed
provisions in the preamble and indicated that the justification applied
just as well to programs in existence before the rule becomes effective
as to programs implemented afterward (Ex. 32-198).
The proposed basic obligation sections for the management
leadership and training elements, which would be the only requirements
employers with grandfathered programs would have to meet, would allow
poorly trained managers to make determinations that their program
complies with the standard. The unions noted that training for managers
was not included as part of the proposed basic obligation for these
elements. They were particularly concerned that inadequate training of
managers would result in improper program evaluations (see, e.g., Exs.
30-4200, 32-198, 32-210, 32-421).
Job hazard analysis and control and quick fixes could be
performed without the input of employees because employee participation
is not a part of the proposed basic obligation of those provisions.\2\
The unions argued that, without feedback from employees, a provision
not addressed in the proposed basic obligation for the job hazard
analysis section, employers would be likely to improperly identify risk
factors or select improper hazard controls (see, e.g., Exs. 30-4200,
32-198, 32-210, 32-461).
---------------------------------------------------------------------------
\2\ UNITE also noted that the proposed quick fix section had no
basic obligation section at all.
---------------------------------------------------------------------------
The proposed MSD management basic obligation is missing a
requirement for health care professionals to be provided with
information about the workplace and the employee's job (Ex. 32-198).
According to UNITE, which has had first-hand experience with programs
that do not require such information sharing, this omission would
result in ill-conceived recommendations from the health care
professional (Ex. 32-198).
The basic obligation for the proposed job hazard analysis
and control section omitted requirements that limited the use of
personal protective equipment and mandated that employers provide it at
no cost to employees (Ex. 32-210).
The proposal's requirements for program evaluation were
inadequate and would allow employers to overlook serious program
deficiencies (see, e.g., Exs. 30-4200, 32-198, 32-210). The unions
believed that, because the rule's evaluation provisions are the primary
means for determining the acceptability of an existing program under
the grandfather clause, these provisions should be revised in the final
rule to prevent employers from inappropriately approving unacceptably
weak programs for grandfather status. (Also see the summary and
explanation for paragraph (u), later in this section of the preamble.)
The International Brotherhood of Teamsters (IBT) observed that the
proposed standard would consider any new ergonomics program coming into
effect to comply with the standard as deficient if the new program did
not meet one or more of the standard's requirements (Exs. 30-4200, 32-
461). The IBT argued that existing programs should be held to the same
standard:
Any program grandfathered under this proposal would essentially
be judged by a different set of criteria than a program developed
after the effective date. The grandfathered program would be
considered to be in compliance despite having missing components,
provided that the [proposed] basic obligations as currently defined,
are met. An identical program, that was developed after the
effective date and was not grandfathered would not be considered to
be fully in compliance and would be cited by compliance officers for
each component of the standard that was lacking, despite meeting the
very same basic obligations that the grandfathered program met. This
weakness can not be used as an argument that compliance is too
difficult to determine, but rather must be viewed as an argument
that the grandfathering provision, as it currently stands, has
serious flaws and must be significantly improved such that every
worker is provided the same protections under this standard (Ex. 32-
461).
At the hearing, OSHA stated that the Agency's intent in the
proposal was to include a grandfather provision that recognized
existing effective ergonomics programs:
Other requirements of the proposal that OSHA has designed to be
flexible include a grandfather clause that permits employers who
have already implemented an
[[Page 68289]]
Ergonomics Program to continue to operate that program as long as it
meets minimal requirements (Tr. 19).
It is readily apparent from the rulemaking record that very few, if
any, existing ergonomics programs would be able to fulfill the
requirements of the proposed grandfather clause. Although OSHA drafted
the language in the proposed standard generally and in the grandfather
clause specifically to be flexible, the Agency recognizes that the
grandfather clause, as proposed, was not sufficiently flexible to allow
existing programs that are effective in protecting employees from MSD
hazards to be grandfathered in. On the other hand, OSHA agrees with
many of the union comments, discussed above, that it is important that
the grandfather clause not recognize programs that are ineffective in
protecting employees from MSD hazards. OSHA has structured the final
rule's grandfather clause to strike an appropriate balance between
flexibility, on the one hand, and program effectiveness, on the other.
In drafting the proposed and final rules, OSHA has relied heavily
on the Agency's experience with effective ergonomics programs that
proactive employers have implemented; in fact, the final rule is
modeled after such programs. OSHA has concluded that it is reasonable
for the Agency to include in the final rule a grandfather clause that
is less prescriptive than the one proposed and is more closely focused
on the effectiveness of existing programs. The Agency has made several
changes to the final rule's grandfather clause to achieve this end.
First, OSHA has streamlined the subelements (called ``basic
obligations'' in the proposed rule) under each core element and has
removed some of the more prescriptive requirements. For example, the
final rule has not carried forward the proposal's provision that
periodic training and program evaluations in grandfathered programs be
conducted at intervals of no more than 3 years. Second, OSHA is
permitting employers to add or strengthen elements of their programs,
provided that they do so, and evaluate the program at least once,
before the effective date of this rule. Third, because so many
commenters with otherwise effective programs reported that their
program would not qualify for grandfather status solely because it did
not have a WRP component, the final rule gives employers a year from
the effective date of the standard to add such protections (which are a
part of MSD management) to their existing programs. Fourth, OSHA has
included, in the final rule, examples of some of the specific measures
that employers may use to demonstrate that their programs are
effective. These changes will enable more employers' programs to
qualify for the grandfather clause but will also ensure that only
effective existing programs are recognized. The changes also shift the
focus from compliance with the rule to effectiveness in preventing
MSDs. Although OSHA believes that having all six elements is vital to
qualify a program for grandfather status, OSHA is not interested in
technical compliance but in real effectiveness.
2. Whether Effectiveness of an Ergonomics Program Is All That Matters
Many rulemaking participants believed that it would be more
appropriate for the standard to simply accept proven, effective
programs than to require that grandfathered programs also include the
core elements of successful programs (see, e.g., Exs. 30-523, 30-1090,
30-1901, 30-1722, 30-2208, 30-3211, 30-3765, 30-3813, 30-3934, 30-3956;
Tr. 3319, 15657). In their view, effectiveness is the only part of the
program that matters, and therefore any existing program that is
effective should be grandfathered. Doerle Food Services, Inc.,
exemplified many of these comments:
OSHA has made its position clear, at 64 Fed. Reg. 65791, in
which it states that the agency believes ``enforcement of the
standard will be more consistent and more equitable * * * if the
test of an employer's program is whether it contains the core
elements, rather than whether it is effective.'' This is, we submit,
an incredible statement, and reflects OSHA's devotion to its
mandated program and ``control'' strategy, as opposed to actual
effective programs. It is this outlook which is at the core of the
``grandfather'' provision, since it does not accord recognition in
any meaningful way to a pre-existing effective program that can be
shown to have minimized the conditions that are at issue. This
portion of the standard clearly needs to be reconsidered and
expanded (Ex. 30-523).
The Washington Aviation Group gave examples of how an employer's
ergonomics program might be effective without meeting the proposal's
grandfather criteria:
There are a variety of reasons why a company might experience
few or no ergonomics problems. The business owner may have an
intuitive sense of how to promote comfort among the employees that
has a beneficial effect on ergonomics issues. The nature of the work
might be such that it does not lend itself to repetitive motion
disorders or other ergonomics problems. Management may have
established an effective rapport with the employees that is
sufficiently responsive so that potential problems are generally
resolved in an expedient manner before they represent hazards. While
all of these are approaches that can support safety in an effective
and expedient manner, none of these would represent sufficient
ergonomics programs under the proposal; and that is part of the
problem with the proposal: it discounts systems that work, but that
are not as comprehensive or well-documented as the proposal (Ex. 30-
3849).
Some rulemaking participants recommended that programs be
grandfathered based solely on one or more measures of effectiveness
(see, e.g., Exs. 30-1901, 30-3211, 30-3344, 30-3348, 30-3361). For
example, Armstrong World, Inc., recommended accepting for grandfather
status programs based on the employer's injury incidence rates:
Employers should be exempt from any proposed standard based on
their performance in preventing such injuries. We would suggest
using 50% of the employers' industry's respective SIC Code rates for
Total Recordable Cases and Cases With Days Away From Work as a
meaningful measure of accepting existing employer ergonomics
processes as they are (Ex. 30-1901).
Other rulemaking participants also recommended using injury rates,
either in absolute terms or in terms of showing a reduction, as a
measure of effectiveness and qualification for grandfather status (see,
e.g., Exs. 30-3344, 30-3348, 30-3361). For example, the Exxon Mobil
Production Company suggested that the standard grandfather a program if
the employer's records demonstrate that the program is preventing MSDs
and is managing ergonomic concerns (Ex. 30-2433). John W. Braddock
suggested that employers be permitted to produce evidence that the
existing program was working and that there is an effective early
reporting mechanism in place and to qualify for grandfather status on
this basis (Ex. 30-4301).
ORC argued that there are a number of ways to measure program
effectiveness, which should be the true gauge of the worthiness of any
ergonomics program (Ex. 30-3813; Tr. 4112). They suggested several
possible ways to measure effectiveness:
OSHA might place the initial burden of demonstrating
effectiveness of the program on the employer and include in a non-
mandatory appendix a number of types of performance measures and
approaches that OSHA would consider appropriate. OSHA mentions some
in the preamble, e.g., decreases in the numbers or rates of MSDs and
decreases in severity. Other measures might include reduced workers'
compensation claims for MSDs, use by the employer of periodic
symptoms surveys and other indicia of effective early reporting, or
[[Page 68290]]
demonstration that risk factors have been reduced and/or tools and
equipment have been modified. An employer might demonstrate
effectiveness based on periodic program evaluation that measures
effectiveness based on an internal ``score card'' that looks at a
number of appropriate effectiveness measures.
* * * * *
ORC believes strongly that OSHA should be focusing its attention
on results or performance, not methodology (Ex. 30-3813).
However, even though ORC objected to the proposed grandfather clause's
emphasis on core elements and their basic obligations, they did agree
with OSHA that there is a need to ensure that any demonstration of
effectiveness that relies on numbers or rates of MSDs not mask any
underreporting of MSDs (Exs. 30-3813, 32-78).
Unisea, Inc. suggested the following language for OSHA to use in
the final rule to recognize existing ergonomics programs based on
effectiveness:
If a company is able to show by operation redesign with
ergonomics considerations made, or injury records or near-miss
reports that a reduction of reported MSD's has occurred, that
company shall be considered in compliance of the standard and its
intent.
OR, If a company is able to show a steady overall reduction of
injuries, either by total number or incident rate, that company
shall be considered in compliance of the standard and its intent
(Ex. 500-158).
Abbott Laboratories argued along similar lines and submitted data
in support of its position. According to a comment in the record,
Abbott Laboratories instituted ergonomics programs at three
laboratories in the late 1980's (Ex. 500-153). Abbott's comment
presented the OSHA-recordable illness rates at those facilities over
the last 9 years. These data are shown in Table 2. Abbott states that
the fall in rates over that period reflected ergonomic improvements
made at each facility and should qualify these establishments for
grandfather status.
Table 2.--OSHA Recordable Illness Case Rates at Three Abbott
Laboratories Plants
------------------------------------------------------------------------
Year Plant A Plant B Plant C
------------------------------------------------------------------------
1999...................................... 1.03 1.44 1.46
1998...................................... 0.47 1.90 2.87
1997...................................... 1.02 1.81 2.50
1996...................................... 0.43 1.00 2.30
1995...................................... 0.71 3.27 2.74
1994...................................... 2.69 3.13 3.47
1993...................................... 3.70 4.27 4.51
1992...................................... 3.25 2.52 6.68
1991...................................... 4.41 4.54 7.06
------------------------------------------------------------------------
Source: Ex. 500-153.
Another point raised by commenters concerned the proposed
requirement that grandfathered programs must be in place and be judged
effective by the time the standard is effective in order to be
grandfathered. The Departments of Defense and Navy recommended that the
standard provide employers wishing to grandfather their programs in
with sufficient time to conduct a statistically significant evaluation
of the effectiveness of the program even if the evaluation did not take
place until after the effective date (Ex. 30-3818; Tr. 3228). They were
concerned that it would not be possible to perform such an evaluation
before the effective date of the standard, as the proposal required. In
addition, they suggested that the standard clarify what effectiveness
measures or evaluation points OSHA would accept for each program
element in grandfathered programs (Ex. 30-3818; Tr. 3228).
Other commenters suggested a variety of indicators of program
effectiveness. For example, the American Industrial Hygiene Association
(Ex. 32-133) stressed measures of effectiveness other than injury
rates:
OSHA needs to be more specific on what constitutes an equivalent
program so that mediocre programs do not pass compliance, but
programs showing improvements will have a reasonable chance to be
considered acceptable. The evaluation of quality of the program
should rely on real evidence of hazards identified and risk
reduction. Specifically, have physical risk factors been reduced and
have ergonomics improvements been made? Indeed, this is the ``bottom
line.'' Other things to look at include whether training has been
done, and if there is a reduction in MSDs and associated workers'
compensation costs (Ex. 32-133).
Herman Miller, Inc., listed several measures that employers could
use to measure effectiveness: ``Reduction in MSD hazards, MSD severity
rates, lost workdays or benchmarked improvements in employee
satisfaction rates'' [Ex. 30-518]. They suggested leaving the specific
protocol to the discretion of the employer and noted that OSHA
compliance officers would need to be given proper training and tools so
that they could make logical and qualitative assessments of ergonomics
programs and determine whether they were effective enough to qualify
for grandfather status.
Dennis Morikawa, testifying on behalf of Morgan, Lewis and Bockius,
did not specify a particular measure of effectiveness but recommended
instead that OSHA make the grandfather clause widely available to
employers to encourage as many of them as possible to adopt programs
before the final rule's effective date (Tr. 15657). He argued that this
approach would further OSHA's real goal: The reduction in the number of
MSDs experienced by workers.
In their post-hearing submission, the U.S. Chamber of Commerce
criticized the proposed grandfather clause's reliance on the proposed
core elements' basic obligations instead of effectiveness:
The Agency claims that existing programs will be evaluated upon
the existence of the core elements rather than a program's
effectiveness * * * because it will make such evaluation ``less
time-consuming'' and ``administratively simpler'' for both OSHA and
the employers. 64 Fed. Reg. at 65791. Of course, the real reason
that the Agency has chosen to focus on content is that OSHA simply
cannot judge effectiveness and has no idea what it means to be an
effective program. Indeed, in order to qualify under the Grandfather
Clause, an employer's existing program must not only contain the
core elements of the Proposed Rule, but must also be ``functioning
properly.'' And although according to the Preamble ``effectiveness''
is not a measure of whether or not the program is ``functioning
properly,'' 64 Fed. Reg. at 65791, Marthe Kent testified to
precisely the opposite effect:
And further [proposed 1910.908], which says the evaluation
indicates that the program elements are functioning properly, what
we mean there is [that the elements] are effective. I mean, you
cannot have a program with the elements functioning properly and it
not be effective.
Tr. at 1-182. Thus, not only can the Agency not determine what
``effectiveness'' means, it also apparently cannot decide whether or
not ``effectiveness'' means the same thing as ``functioning
properly.'' Until the Agency sorts out this conundrum in some
understandable way, there can be no real Grandfather Clause in the
Proposed Rule (Ex. 500-188).
OSHA did not propose a grandfather clause that relied heavily on
injury rate goals to demonstrate effectiveness because, as the Agency
noted in the proposal (see 64 FR 65980 et seq.), MSDs are currently
substantially underreported, and relying on reported rates would
therefore, in many cases, overstate effectiveness. Some commenters,
however, argued that MSD rates were appropriate for this purpose (see,
e.g., Exs. 30-2989, 30-3845). For example, the Forum for a Responsible
Ergonomics Standard stated:
If OSHA is concerned with how to measure ``effectiveness,'' it
can prescribe the manner in which effectiveness is to be measured,
such as reductions in the number and severity of MSDs. OSHA
contends, however, that most means of measuring ``effectiveness''
have built-in incentives to discourage reporting. See id. This
contention ignores the fact that companies are subject to regulatory
requirements in the proposed rule, backed up by OSHA fines and
penalties, to facilitate employee reporting (Ex. 30-3845).
[[Page 68291]]
A. O. Smith Corporation commented that, in its experience, few
employers discourage reporting of workplace injuries:
The provisions in the standard that allude to the employer
having programs in place that discourage the reporting of MSD
injuries tends to suggest that entire safety and health awareness
and accident prevention programs would be construed as disincentives
to reporting. We do not accept this premise and find that most
employers work hard at making sure their employees are provided a
safe work environment and a mechanism to report injuries should they
occur (Ex. 30-2989).
Other rulemaking participants agreed with the approach taken in
OSHA's proposal and opposed basing the grandfather clause solely on a
measure of the reduction in the number of MSDs in a workplace (see,
e.g., Exs. 30-2387, 32-339, 500-207). For example, the AFL-CIO stated
that the elements that OSHA included in the proposal's grandfather
clause are widely recognized as the basic elements of an effective
program (Ex. 32-339). The International Brotherhood of Teamsters argued
that, to be grandfathered, an existing program needed to be
comprehensive and to provide workers and their representatives with
full information and rights of participation in addition to being
effective in reducing the number of MSDs (Ex. 500-207).
In response to these comments, OSHA finds that the record evidence
demonstrates that the Agency should emphasize the effectiveness of
grandfathered programs much more in the final rule than it did in the
proposal. Record evidence also demonstrates that the core elements are
essential to effectiveness (see the discussion of the core elements
below). If a program is not demonstrably effective in protecting
employees from MSD hazards, OSHA believes that such a program should
not qualify for grandfather status and should instead have to comply
with all the requirements of the final rule. On the other hand, if an
existing ergonomics program has the core elements and is truly
effective in protecting employees, it merits grandfather status. The
central question then becomes how to measure effectiveness; if
effectiveness measures are not carefully chosen, ineffective programs
will be grandfathered in and the employees in the establishments
covered by such ineffective programs will be inadequately protected.
One widely used method of measuring effectiveness is the tracking
of MSD incidence and severity rates. However, MSD incidence and
severity rates can be misleading if efforts are not made to ensure that
the rates reported are accurate and that the use of such rates is
appropriate for the workplace. Some of the problems with various
objective measures of effectiveness are described below.
(a) Incidence rates are dependent on accurate reporting. An
employer's recordkeeping system must accurately count work-related MSDs
if incidence rates are to be a meaningful index of effectiveness. An
employer whose employees are reluctant to report, or one who does not
record all MSDs, will appear to have a lower incidence rate than a
comparable employer with an accurate recordkeeping system, and the
incidence rate in the first employer's establishment will bear no
relationship to program effectiveness. There are many reasons why MSDs
are underreported (see the discussion of this issue in the summary and
explanation for MSD management). If there are disincentives to
reporting, employees may not report all MSDs. If an employee is not
well informed about MSD signs and symptoms, he or she probably will not
realize that the signs and symptoms of an MSD are work-related and will
fail to report them. Employees also fail to report MSDs in some cases
because they do not want to submit a claim to the workers' compensation
system. Thus, incidence rates must be used with care.
(b) Severity rates are dependent on consistency in return-to-work
policies. Severity rates are typically measured in terms of days away
from work or days on restricted duty. Changes in how employers treat
injured workers can affect severity rates. For example, if an employer
who has traditionally measured severity in terms of lost workdays
institutes a new policy of placing employees with MSDs on restricted
duty rather than removing the employee from work, the number of days
away from work will decrease. Thus, severity rates must also be used
carefully to ensure that they are not reflecting a change in the
employer's MSD management process rather than a true decrease in MSD
severity.
(c) The randomness inherent in injury and illness statistics may
make incidence rates an unreliable indicator of effectiveness. Injuries
and illnesses are events that occur based on probability. In other
words, hazards do not automatically lead to injuries or illnesses; the
presence of hazards simply increases the probability that an injury or
illness will occur. Just as a coin flipped 10 times will not
automatically land heads up 5 times, a workplace with an average MSD
incidence rate of 19.3 per 1000 employees \3\ will experience an MSD
incidence rate that varies about that number from year to year. If
employee exposure to MSD hazards at this workplace remains relatively
constant, the actual incidence rate in any one year (assuming that the
number of employees and other factors also remain constant) will
probably be reasonably close to that value. In one year, for example,
17 of the 1000 employees could suffer an MSD, while in the next year,
21 might be injured. This variability can be seen in the Abbott
Laboratories data in Table 2, especially in the last 5 years, after the
program had matured.
---------------------------------------------------------------------------
\3\ This is the overall MSD incidence rate for SIC 283.
---------------------------------------------------------------------------
Variability is even more pronounced in a workplace with few
employees. If the employer in the earlier example had 10 full-time
employees and the same overall average MSD incidence rate, the
establishment could be expected to have 0, 1, or 2 MSDs in a given
year.\4\ The corresponding incidence rates per 1000 employees, however,
would be 0, 100, and 200. If incidence rates alone were used as the
measure of effectiveness at such a facility, the program would be rated
very effective in one year and in need of major correction in the other
years.
---------------------------------------------------------------------------
\4\ It would take 100 years for this firm to have 1000 employee-
years of experience. If the employer had an incidence rate of 17
MSDs per 1000 full-time employees, the employer would see 17
incidents over 100 years. Over that period, in most years, no MSDs
would occur. In other years, one or maybe two MSDs would occur.
---------------------------------------------------------------------------
In the context of the grandfather clause, this year-to-year
variability poses problems for OSHA and for employers. If the final
rule were to identify a specific rate as the sole criterion for
grandfathering existing programs, then an employer whose program was
acceptable one year might be unacceptable the next simply as a result
of this variability. For example, suppose that the final rule selected
1.45 as the maximum acceptable incidence rate for a grandfathered
program. Abbott Laboratories Plant A (from Table 2) would have had an
acceptable program in terms of grandfathering since 1995 (Ex. 500-153).
Abbott's Plant C program (from Table 2) would never have met the
incidence rate limit in this period and would therefore have had to
comply with the ergonomics standard. Abbott's Plant B (from Table 2)
could have had its program grandfathered in 1996 and 1999, but would
have had to comply with the standard in 1997 and 1998. From this
example, it can be seen that some employers' programs, after initially
qualifying for the grandfather
[[Page 68292]]
clause, would subsequently be required to comply with the ergonomics
standard in at least some years.\5\ This ``sometimes in and sometimes
out'' phenomenon is not what OSHA or employers with existing ergonomics
programs want from a grandfather clause.
---------------------------------------------------------------------------
\5\ Using a rolling average incidence rate would help smooth
out, but would not eliminate the year-to-year variability.
---------------------------------------------------------------------------
Alternatively, the final rule could mandate that, to be
grandfathered, the employer's MSD incidence rates had to decrease over
time, as suggested by some rulemaking participants (see, for example,
the comments of Unisea, Inc., Ex. 500-158, above). Again, the Abbott
Laboratories data in Table 2 show that this approach would also be
problematic (Ex. 500-153). All three of Abbott Laboratories' plants
experienced increasing rates in some years in the period reported.
Although the overall trend over the full 9-year period is downward for
all of the Abbott plants, this is not the case for all time periods.
For example, Plant C's incidence rates went up over the 4-year period
from 1995 to 1998 (see Table 2). In fact, OSHA's experience is that, as
an employer's ergonomics program matures, incidence rates begin to
level off, albeit at a much lower rate than before the program was
established (see Chapter IV of the Economic Analysis).
Other ``objective'' measures of effectiveness recommended by
rulemaking participants (see e.g., Ex. 30-3813; Tr. 4112) pose similar
problems. Decreases in the rate of workers' compensation claims have
the same problems as incidence rates when they are used as
effectiveness measures. Symptom surveys, although valuable as an early
reporting tool, vary from one workplace to another and therefore cannot
be used for different sites. Reductions in employee exposure to MSD
hazards is a good measure of whether an ergonomics program is working
but, OSHA has no benchmark that adequately describes the performance of
an effective program. Without a benchmark, reductions in employee
exposure to MSD hazards cannot be used as the sole criterion for
grandfathering programs at different sites.
In addition, OSHA has concluded that the core elements (management
leadership and employee participation, hazard identification and
assessment, hazard prevention and control, MSD management, training,
and evaluation) are essential to a properly functioning ergonomics
program. These elements are included in the safety and health programs
recommended or used by many different organizations (the ergonomics
standard uses slightly different terminology for some of these
elements):
OSHA's VPP, SHARP, and consultation programs;
The safety and health programs mandated by 18 states;
The safety and health programs recommended by insurance
companies for their insureds (many of which give premium discounts for
companies that implement these programs or impose surcharges on those
that do not);
The safety and health programs recommended by the National
Federation of Independent Business, the Synthetic Organic Chemical
Manufacturers Association, the Chemical Manufacturers Association, the
American Society of Safety Engineers, and many others;
The strong recommendations of OSHA's Advisory Committees
(NACOSH, ACCSH, and MACOSH), which consider these program elements
essential to effective worker protection programs.
OSHA also is including WRP, or equivalent protections against wage
loss, as a requirement for all programs (both those that are
grandfathered and those complying with the standard) because, without
it, OSHA believes that many employees will be reluctant to report their
MSDs because they fear economic loss. There is strong evidence that
such underreporting is currently taking place, as well as evidence that
protecting workers from wage loss increases reporting (see the
discussion of underreporting in the summary and explanation for MSD
management). OSHA's purpose in including a WRP provision, both in the
grandfather clause and in the standard, is to ensure employee
participation and free and full reporting of MSDs and MSD hazards.
Effective ergonomics programs depend on such reporting, and the
standard also depends on employee reporting for its effectiveness.
Absent such reporting, no ergonomics program will achieve its worker
protection goals.
For these reasons, OSHA has concluded that quantitative
effectiveness measures alone cannot be the sole basis for judging
whether an employer's program should be grandfathered. The Agency's
experience over the last two decades, and that of private industry and
insurance companies, is that safety and health programs, and ergonomics
programs, containing the core elements are effective in lowering injury
and illness rates. These programs work because they involve everyone in
the organization in finding and fixing hazards. They also establish
two-way communication in the form of reporting and response systems.
OSHA finds that the core elements are essential to effective ergonomics
programs, and the record provides ample evidence of this (see the
discussion below on whether the core elements are necessary). Employee
participation, for example, is a prominent component of the programs of
many leading companies (see, e.g., Exs. 32-77, 32-185, 32-210; Tr.
4973, Tr. 5339). The core elements also help to ensure that employees
are reporting their MSDs, that management is responding to these
reports, that jobs are being analyzed and fixed, and that the program
is functioning as it should. The core elements thus help to ensure that
programs are not focusing too heavily on quantitative measures of
effectiveness, which, as the discussion above shows, are often
misleading.
OSHA agrees, however, that effectiveness measures can be useful in
determining the degree to which an ergonomics program is working.
Employers and authors of effectiveness studies routinely rely on them
as evidence that an ergonomics program is having a positive effect. Of
the measures available, incidence and severity rates are most commonly
used and were most often recommended in the rulemaking record (see,
e.g., Exs. 30-1901, 30-2208, 30-3344, 30-3348, 30-3361). If one of
these measures is used, the employer must take care to ensure that the
calculated incidence or severity rate accurately reflects conditions at
the workplace. First, the effectiveness measure chosen must be
appropriate for the size and nature of the workforce and the employer's
MSD experience. For example, as explained earlier, an employer with few
employees will not find incidence rates useful to measure
effectiveness. Instead, such employers could examine whether employee
exposure to MSD hazards has been reduced. Second, the employer must
check to ensure that some MSDs are not going unreported. If employees
are failing to report MSDs, the employer's calculated incidence and
severity rates will not accurately reflect the injury experience at the
workplace. Third, the employer should check rates over a variety of
periods to ensure an overall downward trend in the data. Looking at
data over a single period can be misleading.
OSHA finds, based on the evidence in the record as a whole, that
reliance on both qualitative (the core elements) and quantitative
(effectiveness measures) components will best assure that any program
that is grandfathered deserves this status and will continue to operate
[[Page 68293]]
effectively in the future. Consequently, the final rule's grandfather
clause requires that grandfathered programs contain the core elements
of effective ergonomics and be demonstrably effective. Employers may
use any of a broad range of measures, including reductions in the
number or severity of MSDs, increases in the number of jobs in which
ergonomic hazards have been controlled, reductions in the number of
jobs posing MSD hazards to employees, or any other measure that
demonstrates program effectiveness to meet the grandfather clause's
requirement for a demonstration of program effectiveness.
3. Whether the Core Elements Are Necessary
Some industry representatives objected to the proposed requirement
that grandfathered programs contain all the core elements of the
proposed standard (see, e.g., Exs. 30-1722, 30-3853, 30-3956; Tr.
5699). They argued that any program that was effective in reducing MSD
rates should be accepted for grandfather status, even if it did not
include all the core elements.
For example, the Washington Legal Foundation was particularly
concerned that employee participation was proposed as a required
component of grandfathered programs and of the program required by the
standard (Tr. 11265). They argued against mandatory employee
participation:
OSHA's proposed ergonomic standard perhaps more so than any
other standard mandates full employee involvement in every aspect of
its requirements.
In many ways, the proposed standard places employees in the
driver's seat.
Certainly many companies have determined that a [cooperative]
relationship with their employees is beneficial on both a safety and
a production level.
Other companies, however, have reached a different conclusion.
And certainly, the conclusion to be reached may differ depending on
the type of work involved, the size of the company, the
characteristics of the work force, and other factors.
The Washington Legal Foundation does not believe that it is its
place to determine that some of these [employers] are right and
others are wrong nor is it the place of the federal government to
mandate a specific mode of employer/employee relations (Tr. 11265).
On the other hand, some union representatives argued strongly in
favor of the core elements (see, e.g., Exs. 32-210, 32-461, 500-218).
The International Brotherhood of Teamsters noted that they had worked
with various employers through the collective bargaining process to
address ergonomic hazards and that some employers' programs took a
piecemeal rather than comprehensive approach to the problem and should
therefore not be granted grandfather status (Exs. 30-4200, 32-461). The
UFCW argued that the proposed core elements are recognized as the basic
elements of a good ergonomics program (Ex. 32-210). They presented
their experience with successful ergonomics programs as follows:
The six elements OSHA is proposing in the ergonomics program
standard are included in all successful company programs! Further,
the experience of the myriad of companies who have successfully
tackled the problem through these elements attests to the
feasibility of the methods. The settlement agreements OSHA has
entered into with IBP, Sara Lee, Cargill, ConAgra Poultry, John
Morrell & Co., Empire Kosher, Marshall Durbin Companies, National
Beef, Worthington Packing and Tyson Foods contain these six
elements--all work, and all are feasible. Many of the companies used
ergonomists, they analyzed the jobs and developed engineering
solutions to address the most egregious jobs. They developed medical
protocols so that workers can get to treatment early rather than
waiting until they were crippled and needed surgery. They protect
workers wages and benefits when they report MSDs. And in our
represented companies, all this included the union in a fundamental
way. In order to be effective, ergonomics programs by their very
nature must be participatory and include workers at many levels,
including those that do the problem jobs (Ex. 32-210).
Mr. Bawan Saravana-Bawan, a representative from the Canadian
province of British Columbia, described how that province handled
existing programs when its ergonomics standard came into effect (Tr.
14260). He stated that existing programs needed to incorporate any
missing elements in order to be accepted. On the basis of his
experience, he stated that any ergonomics program needed to have all
the core elements (management leadership and employee participation,
information dissemination, hazard identification, hazard assessment and
control, training, and program evaluation) to be successful.
The Department of Defense (DoD) also argued that the program
elements are essential. The DoD noted that the success of their program
is due to the elements of the program, including, in particular,
management leadership, employee participation, hazard prevention and
control, and monitoring injury records and responding to potential
problem areas (Ex. 30-3826).
OSHA has concluded that it is essential for ergonomics programs,
whether grandfathered or not, to address all of the core elements:
Management leadership and employee participation, hazard information
and reporting, job hazard analysis and control, training, MSD
management, and program evaluation. (The Agency has presented evidence
supporting each of these core elements in the summary and explanation
for the corresponding provisions of the standard, below.) Further, the
Agency finds that it is as important for a grandfathered program to
include all of the core elements as it is for a program brought into
existence to comply with the final rule to include these elements.
Although some commenters, as discussed above, argued that a program
could be effective without all of the core elements, OSHA finds their
arguments unpersuasive, based both on the record and the Agency's own
experience with successful programs.
The Agency believes that the core elements provide assurance that
the program will work as intended--management leadership will ensure
that the program has the continued backing of management, which is
essential to continued success; employee participation in the program
will help ensure that ergonomic hazards do not go undetected; hazard
information and reporting will ensure that employees are informed about
MSD symptoms and how to report them so that work-related MSDs are not
ignored; work restriction protection helps to ensure that workers
report signs and symptoms as early as possible; job hazard analysis and
control are needed to ensure that ergonomic hazards are found and
abated; MSD management is necessary so that MSDs are managed
appropriately and injured employees get well as soon as possible; and
program evaluation is necessary for the correction of deficiencies in
the program. Without the checks and balances the core elements provide,
OSHA believes that ineffective programs may be judged effective on the
basis of an inappropriate measure, and once-successful ergonomics
programs could deteriorate over time and leave employees unprotected.
Some rulemaking participants agreed that grandfathered programs
should include the core elements but argued that compliance with the
proposed basic obligation sections for each core element was not
essential to having an effective program (see, e.g., Exs. 30-1294, 30-
3813, 30-3723, 30-3765). These commenters believe that many employers
have effective programs that would not be recognized by the proposed
standard because they would not meet the proposed basic obligation
sections. ORC reflected the thrust of these comments as follows:
[[Page 68294]]
Equally important, contrary to OSHA's contention in the
preamble, the ability of an employer to continue applying an
existing program should not be based on whether the ``basic
obligation section of each program element in this standard'' is
satisfied. OSHA has provided no objective evidence that the
requirements of the proposed standard will be any more effective
than other programs already in place. There is certainly no basis
for compelling an employer to rework an effective program to force
it to meet the specifics even of the proposed basic obligations (Ex.
30-3813).
Dow, ORC, and others suggested that OSHA simply require
grandfathered programs to address the six basic elements of the program
instead of requiring them to meet the proposal's full basic obligation
for each core element (see, e.g., Exs. 30-2134, 30-2725, 30-3171, 30-
3765, 30-3813, 32-77). ORC noted that the proposed work restriction
protection requirements were particularly troublesome, since
``[v]irtually none of ORC's member companies, whose ergonomics programs
are among the most sophisticated and effective in the country, would
meet this requirement * * *'' (Ex. 30-3813). Dow was concerned that the
language in the proposal would not recognize their program, which is
tailored to fit their management structure. They stated:
The so-called Grandfather clause that OSHA has proposed is so
demanding in its requirements that companies that have existing and
successful ergonomics programs, such as Dow, will not be able to
take advantage of this provision to maintain their current programs.
The Grandfather clause is so limited that already functioning and
successful programs, tailored to the needs of a particular company,
business or workplace, will not be able to satisfy the requirement.
For example, in Dow's case, we would not be able to satisfy the
extensive recordkeeping requirements or elements of the WRP section
(since it goes beyond that required by Workers' Compensation laws.)
Similarly, given Dow's management structure, we would not satisfy
OSHA's communication and training requirements wherein they intend a
more archaic management structure, such as one having
``supervisors'' and the like, than what Dow utilizes. So even though
Dow has had a successful ergonomics program for years and has a
lower than average MSD incidence rate, we would have to scrap our
efforts and use a program which will not fit our needs or management
structure, just to comply with this standard. Dow believes this is
unacceptable.
Instead, Dow urges OSHA to delete the proposed Grandfather
clause and replace it with a provision that allows for an
``acceptable'' or ``appropriate equivalent'' program. Such a concept
is not foreign to OSHA or the regulated community as other OSHA
standards, such as the Process Safety Management (``PSM'') standard,
utilize this concept so that companies that have existing programs
that are functioning successfully can continue to use them. This
concept also allows companies who may not yet have an existing
program to create one tailored to their own needs, rather than use a
more ``one size fits all'' program as envisioned by this proposal.
``Acceptable (or appropriate) Equivalence'' would include those
programs who have the basic elements of a program, but not all the
mandated details or documentation. Such a concept embodies
``performance-oriented mandates'' at their best as they allow an
employer to employ those methods of prevention that best meets the
needs of its particular workforce and/or workplace. OSHA should only
be concerned with the results (i.e. lower injury rates) rather than
the methodology a particular employer used to obtain that goal (Ex.
30-3765).
At the hearing and in their notice of intention to appear at the
public hearing, Dow described their ergonomics program and detailed how
they believe their program would fall short of the proposal's
requirements (Ex. 32-77; Tr. 5339). Dow expressed concern that,
although their program meets the spirit of the proposed standard, it
would not meet the letter of the law.
In response to Dow's concern, OSHA reviewed the perceived
discrepancies between the proposed rule and Dow's description of their
program. In every respect except one, Dow's program would have
satisfied the proposed grandfather clause; the discrepancies Dow was
concerned about were apparently the result of misinterpretation rather
than deficiencies on the part of Dow's program. For example, Dow stated
that, in its program, employees report MSDs using the company's
existing injury and illness reporting system rather than a separate
system set up just for MSDs; Dow evidently believed that a separate
system would have been required by the proposal (Ex. 32-77; Tr. 5340).
However, the proposed standard would not have required employers to set
up a separate system for reporting MSDs as long as their existing
system included a system for the reporting of MSDs. On the other hand,
Dow was correct in stating that their program did not include the
proposed work restriction protection provisions and would therefore not
have been eligible for grandfather status under the proposed rule.
In its post-hearing submission, Edison Electric Institute argued
that the specificity of the proposal's basic obligations is counter to
the goal of flexibility, and the Institute recommended that the final
rule reduce the detail in the basic obligation sections to allow
employers greater latitude (Ex. 500-33).
The Mead Corporation suggested that, if the Agency's safety and
health program rule was not promulgated before the ergonomics rule,
OSHA should alter the grandfather clause in the ergonomics rule in one
of two ways: (1) Make the basic obligations less prescriptive and
detail acceptable alternatives for prevention-oriented programs, or (2)
permit employers with effective programs to maintain them without
making sweeping changes (Ex. 30-2216).
On the other hand, the AFL-CIO argued that the standard should
require employers to meet the proposed basic obligations for each core
element before being grandfathered in (Ex. 32-339; Tr. 3477). The AFL-
CIO pointed out, however, that the basic obligation sections for
several of the proposed core elements left out important requirements
that were included under the core elements:
The AFL-CIO believes that employers with existing programs
should be permitted to continue with these programs if they are
comprehensive, provide workers and their representatives full
information and rights of participation, and are effectively
reducing MSDs and exposure to hazards. However, as proposed, the
``grandfather'' provisions are deficient in a number of respects and
will permit employers to continue programs that do not provide
adequate protection.
First, the [proposed] basic obligation requirements which all
programs must meet, exclude a number of elements that in our view
are essential for an effective program. For example:
The [proposed] basic obligation section for Hazard
Information and Reporting * * * does not [include] any requirement
to provide employees information about MSD hazards.
The [proposed] basic obligation on training * * *
excludes any requirement for training supervisors or individuals
responsible for the ergonomics program, thus permitting programs to
be ``grandfathered'' even if persons responsible for the program do
not have the necessary training. The basic obligation for training
also fails to provide for job specific training on MSD hazards and
control measures.
The [proposed] basic obligation for Medical Management
* * * does not require that medical evaluations be conducted by a
health care provider.
The [proposed] basic obligation for Program Evaluation
* * * does not require consultation with employees in problem jobs
or their designated representatives to determine their views on the
effectiveness of the program (Ex. 32-339).
As noted earlier, other rulemaking participants also urged OSHA to
strengthen the proposed basic obligations sections (see, e.g., Exs. 30-
4200, 32-198, 32-210, 32-461). These commenters criticized the proposed
rule's lack of basic obligation
[[Page 68295]]
requirements for the training of managers and for employee
participation in job hazard analysis and control. UNITE decried the
omission from the proposal of a requirement for the health care
provider to be furnished with information about the workplace and the
employee's job (Ex. 32-198). Another commenter objected to the omission
from the proposal of requirements that limited the use of personal
protective equipment and required employers to provide it at no cost to
employees (Ex. 32-210).
Another group of commenters were particularly concerned about the
fact that the proposal would not have permitted their otherwise
excellent programs from being grandfathered because they did not have
work restriction protections now (see, e.g., Ex. 30-3723, 30-3765, 30-
3813). SBC Communications, Inc., represented those who opposed the
proposed grandfather clause's requirement for work restriction
protection:
In order to meet the grandfather clause, a company must have a
``functioning properly'' Wage Protection Program. Through our
extensive research and benchmarking, no company has this element to
their ergonomics program. Nor did OSHA provide any evidence of the
Wage Protection Program being trialed, researched, and/or tested at
a company. OSHA has made it nearly impossible for any company to
meet the requirements of the grandfather clause (Ex. 30-3723).
On the other hand, the AFL-CIO noted that the hearing testimony
demonstrates that some employers do currently provide wage protection
for employees who suffer MSDs:
The hearing record shows that some employers indeed are
maintaining the full wages of workers who are put on medical
restrictions as a result of MSDs (Tr. 16014, Tr. 14357) (Ex. 500-
218).
The General Electric Company argued that employers who have
employee involvement and an environment free of barriers to reporting
should not be required to follow the rule's requirements for WRP (Ex.
30-1071). Novartis Corporation went further, suggesting that the entire
MSD management element be removed from the standard (Ex. 30-3092). They
also recommended that compliance with the endpoint provisions not be a
condition for grandfathering existing programs.
The AFL-CIO recommended that OSHA permit existing programs without
work restriction protection to be grandfathered as long as the employer
incorporates such protections into the ergonomics program before the
effective date of the standard (Ex. 500-218). They believed that this
would help alleviate the concerns of employers whose programs were
missing only that one element.
Although the AFL-CIO provided evidence that some employers do
provide wage protection for their employees, OSHA believes, based on
the record, that very few employers' existing ergonomics programs
incorporate work restriction protection in the form required by the
proposed standard. Despite the fact that many employers have policies
(such as sick leave, short-term disability, and so on) that assure
employees that they will not experience economic loss if they are
injured, the record of this rulemaking indicates that many workers fear
they will lose wages and benefits if they report their injuries (see
the detailed discussion of the record in the summary and explanation
for paragraph (r) below). The Agency therefore concludes that
grandfathered programs must protect against such loss if they are to
achieve the early reporting that is essential to program success.
Consequently, in paragraph (c)(2) of the final rule, OSHA is allowing
existing ergonomics programs that otherwise meet the criteria of the
grandfather clause up to an additional 12 months to adopt an MSD
management policy, including work restriction protection. The MSD
management policy must meet paragraphs (p) through (s) of the final
rule. The MSD management requirements in the final rule contain many
inter-related provisions that are key to a successful ergonomics
program. (See the summary and explanation for paragraphs (p) through
(s) of the final rule.) The Agency has concluded that, because of the
many interdependencies in final rule paragraphs (p) through (s),
employers need to follow all of the detailed requirements of those
paragraphs. However, to ensure that existing programs will still be
able to qualify for grandfather status even if they do not meet the
final rule's MSD management requirements, OSHA is allowing employers up
to a year to meet those provisions.
Based on a review of the evidence in the record, OSHA has concluded
that the proposed standard's basic obligation requirements failed to
provide employers with effective existing programs sufficient
flexibility with regard to grandfather status. Accordingly, in
paragraph (c)(1) of the final rule, OSHA has not carried forward the
proposed requirement that employers' programs satisfy the basic
obligation of each element and instead requires that those programs
simply contain the core elements and certain subelements, which the
Agency has pared to the minimum necessary to ensure the continued
effectiveness of grandfathered programs. In particular, OSHA has
streamlined and made more flexible the provisions that rulemaking
participants claimed were most problematic such as the employee
participation and WRP provisions. OSHA also has placed the required
subelements in the text of the grandfather clause itself rather than in
the basic obligations sections for each of the core elements, as
proposed. OSHA believes that these changes will make the core elements
that grandfathered programs must currently have as flexible as possible
while still ensuring that the basic components that make each core
element effective are present.
In addition to considering the comments of industry representatives
objecting to the core elements and their subelements, OSHA has reviewed
the list of subelements that several labor organizations believed were
essential to determine whether they should be included in the final
rule's grandfather clause requirements (Exs. 32-198, 32-339; Tr. 3477).
The Agency has included several improvements in the final rule's
grandfather clause as a result of this review. First, the grandfather
clause's training element now contains a requirement that employees be
trained in MSD risk factors (see paragraph (c)(1)(iv)). This provision
ensures that employees will be informed of MSD hazards in their
workplace. Second, OSHA has added a requirement for the training of
managers and supervisors to this core element. Third, OSHA has included
language specifically requiring employees to be involved in program
evaluation to the core element for employee participation (see
paragraph (c)(1)(ii)). These additions will help ensure that
ineffective programs are not accepted under the grandfather clause.
The remaining suggestions from these commenters, such as UNITE's
recommendation to include a requirement for the health care provider to
be furnished with information about the workplace and the employee's
job (Ex. 32-198), have been accommodated by paragraph (c)(2) of the
final rule. Existing programs need not currently have MSD management as
a core element in order to qualify for grandfather status. However,
grandfathered programs will need to add an MSD management element
meeting paragraphs (p) through (s) within 1 year after the final
standard's effective date. Thus, grandfathered programs will have to
meet the same MSD management requirements as programs that are not
grandfathered.
[[Page 68296]]
4. Whether the Language of the Grandfather Clause Is Vague
Some rulemaking participants argued that the language in the
proposed grandfather clause was vague (see, e.g., Exs. 30-494, 30-2208,
30-3922, 30-4467; Tr. 16470). They thought that this language would
make it difficult for an employer to determine if he or she qualified
under the grandfather clause. For example, Dennis Morikawa of Morgan,
Lewis, and Bockius stated:
These vague requirements do not inform employers which ergonomic
programs OSHA would accept. Specifically, OSHA does not explain what
a ``basic obligation'' is; nor does the Proposed Rule specify the
level of detail employers must achieve when they attempt to comply
with a basic obligation. Moreover, the grandfather clause does not
make clear whether an effective, existing program without a single-
incident trigger would be acceptable. For example, if programs that
satisfy the CAL/OSHA standard discussed above would be accepted
under the grandfather clause, then most companies would seek to
design and install ergonomics programs before the effective date of
the new Proposed Rule. But if a two-incident trigger would not
satisfy a ``basic obligation,'' employers would be forced to re-
design existing programs in order to meet the Proposed Rule, thereby
creating a double standard of compliance. This, of course, would
effectively eviscerate the notion of a grandfather clause. OSHA
needs to specify which aspects of the Proposed Rule would be
considered basic obligations, and the amount of attention to detail
that employers must pay when adhering to these basic obligations.
Without an assurance from the agency that an adherence to basic
obligations would not require major overhauls of effective programs,
the grandfather clause is illusory (Ex. 30-4467, p. 13).
Some rulemaking participants stated that the vagueness of the
grandfather clause would force employers to refer to the more detailed
provisions of the standard to understand their compliance obligations
(see, e.g., Exs. 30-494, 30-4340). They argued that the effect of this
vagueness would be that employers would be forced to comply with the
entire standard, which would render the grandfather clause useless.
Even some of those who supported OSHA's proposal in general agreed
that the proposed grandfather clause was vague (see, e.g., Exs. 30-
4538, 32-210). These rulemaking participants and others urged the
Agency to provide compliance assistance material, such as flowcharts,
checklists, and other tools, to help employers determine whether their
programs qualified under the grandfather clause (see, e.g., Exs. 30-
4538, 32-210, 32-339, 500-207). For example, the International
Brotherhood of Teamsters stated:
[W]e strongly urge OSHA to provide checklists and evaluation
tools to assist employers with the evaluation of their programs.
Employers who want to take advantage of the ``grandfather''
provisions should be required to use a checklist based on objective
criteria to demonstrate that their program is effectively reducing
exposures to ergonomic risk factors, reducing the incidence and
severity of musculoskeletal disorders, and complies with the
standard's basic obligations. These materials are currently used by
many ergonomics programs and could be made available by OSHA through
its website (Ex. 500-207).
OSHA believes that the grandfather clause in the final standard is
clear. For example, the training element requires the training of
managers, supervisors, and employees in: (1) The employer's ergonomics
program and their role in it; (2) the recognition of MSD signs and
symptoms; (3) the importance of early reporting; (4) the identification
of MSD risk factors and methods that may be used to abate them; and (5)
the risk factors in problem jobs in the workplace and methods of
controlling them. To provide employers flexibility, the standard does
not address the details of how that training is provided, but it is
clear about the topics the training must cover.
Other elements provide clear direction about how an employer is to
demonstrate compliance. For example, the employer must evaluate the
program, as demonstrated by regular reviews of the elements of the
program, the effectiveness of the program as a whole, and the
correction of identified deficiencies. Again, this language provides
clear criteria that employers' evaluations must meet in order to be
grandfathered in.
There are two aspects to Mr. Morikawa's comments (Ex. 30-4467)
about the acceptability for grandfather clause status of programs
meeting the California standard's two-incident trigger. The first
relates to Federal OSHA's acceptance of the California ergonomics rule
under the Act's provisions for ensuring that state standards developed
by the State Plan States are as effective as the Federal standard. OSHA
will, after it promulgates this final ergonomics program standard,
evaluate the ergonomic standards developed by State Plan States (such
as California and Washington) to determine whether they are ``as
effective as'' the Federal standard. OSHA clearly could not have made
such a determination at the time of the proposal, as Mr. Morikawa
suggests, because the form and content of the final OSHA rule could not
be known at that time. However, OSHA is unlikely to find any standard
that delays protection to employees, including those in small firms, or
that provides less protection to employees overall, as effective as the
final rule.
The second relates to the details of grandfathered programs.
Paragraph (c) of the final rule does not attempt to dictate precisely
what form a grandfathered program must have, beyond stating that it
must have the core elements of successful programs, be demonstrably
effective, and be evaluated and in place by the final rule's effective
date. OSHA has not mandated such program specifics because
grandfathered programs will take many different forms, be at many
different stages of development, and be taking various approaches to
achieving success. The grandfather clause thus insists on the
fundamentals but leaves the specifics to employers.
The final standard also requires the employer to demonstrate that
an existing program is effective before that program qualifies under
the grandfather clause (see paragraph (c)(1)(v)). The employer is free
to use one of the measures specified in the standard itself (that is,
reductions in the number or severity of MSDs, increases in the number
of jobs in which ergonomic hazards have been controlled, reductions in
the number of jobs posing MSD hazards to employees) or any other valid
measure that the employer chooses to evaluate the program and
demonstrate effectiveness. The Agency currently provides some
compliance assistance materials that include ways to measure the
effectiveness of ergonomic interventions. For example, the ``Ergonomic
Program Management Guidelines for Meatpacking Plants'' (Ex. 2-13)
provides a method for monitoring trends in cumulative trauma disorders
that may be used for this purpose. OSHA's 1989 Voluntary Safety and
Health Program Management Guidelines (Ex. 2-12) also describe effective
program evaluations. These documents are available on OSHA's Website
(http://www.osha.gov). OSHA also intends, as resources permit, to
provide additional compliance assistance materials that will help
employers determine whether or not their programs are effectively
addressing MSDs.
In sum, OSHA believes that the final grandfather clause provides
sufficient information for employers to determine if their programs
qualify for the grandfather clause. OSHA compliance officers also will
be able to assess whether the employer's program qualifies for
grandfather status. OSHA will include directions on how this is to be
done in a compliance directive to be
[[Page 68297]]
issued soon after promulgation of the final rule.
5. Alternatives and Revisions to the Grandfather Clause
Several rulemaking participants suggested approaches that would
permit alternative programs developed after the standard is in effect
to be followed by employers in lieu of compliance with the standard
(see, e.g., Exs. 30-2216, 30-3765; 30-3813, 32-339, 500-44; Tr. 3477).
Many of these commenters argued that their recommendations would
address the previously discussed concerns with the proposed rule's
grandfather clause--concerns such as the perceived illusory nature,
vagueness, and subjectivity of the proposed grandfather clause. The
alternatives or revisions to the proposed grandfather clause suggested
by these commenters included:
Revising the clause to allow programs that are incomplete
at the time of the effective date to be grandfathered (see, e.g., Ex.
30-3813; Tr. 4111);
Revising the clause to make clear that a company whose
program had been grandfathered could extend that program (and
grandfather status) to establishments newly built or owned, or acquired
through mergers or acquisitions (see, e.g., Exs. 30-3813, 30-3922, 32-
78; Tr. 5538);
Revising the clause to allow any program developed by an
employer at any time, including after the standard has become
effective, to be implemented without fear of citation for noncompliance
with the OSHA standard (see, e.g., 30-429, 30-1090; Tr. 15657);
Revising the clause to specify that OSHA will certify or
approve employers' programs as qualified for grandfather status (see,
e.g., Ex. 32-133, 500-139);
Revising the clause to recognize for grandfather status
any program that complies with either the Washington State or the
California standard (see, e.g., Exs. 30-429, 30-434, 30-973, 30-1090,
30-1547, 30-1671, 30-2835, 30-3813, 30-4134, 31-337, 32-311);
Delete the grandfather clause and substitute instead
provisions giving employers credit for already having performed some of
the required elements, such as training, before the effective date
(see, e.g., Exs. 30-1547, 32-185, 32-311, 32-339, 32-461, 500-207; Tr.
6423, 11129, 13092).
For example, ORC made several suggestions along these lines (Ex.
30-3813; Tr. 4111). First, they recommended that OSHA rename this
section ``Alternative Programs Provision.'' They also suggested that,
as a stimulus to innovation, OSHA allow employers who do not now have
fully developed programs to qualify for grandfather status in the
future when they do have such programs. DuPont SHE Excellence Center
made a similar recommendation:
[One] improvement in the flexibility would be to allow whichever
elements that have been put in place to be grandfathered and those
which are not in place to be added. The grandfather clause should
not be an ``all-or-nothing'' clause (Ex. 30-2134).
In addition, ORC, along with other rulemaking participants,
recommended allowing an employer's program to be grandfathered after
the effective date of the standard, which would permit employers
involved in mergers and acquisitions to put their already grandfathered
programs into place in new establishments (see, e.g., Exs. 30-3813, 30-
3922, 32-78; Tr. 5538). ORC also recommended that OSHA permit employers
to extend existing grandfathered programs to new establishments
operated by the same employer (Ex. 500-214).
The rulemaking participants who recommended that the standard
permit future alternative ergonomics programs to be grandfathered did
not address how an employer might avoid noncompliance while developing
the program or in the period before the employer had demonstrated the
effectiveness of the new program. OSHA does not believe that such an
approach would be workable. First, it would be administratively
difficult (if not impossible) to enforce. Second, OSHA is issuing a
final standard addressing ergonomic injuries because the varied
approaches and often isolated interventions that many employers have
adopted have not effectively addressed the problem, and a uniform and
comprehensive approach to this most serious of occupational safety and
health issues is clearly necessary. The approach recommended by the
commenters would mean that, while employers try different programmatic
approaches, employees would continue to be exposed to ergonomic hazards
with no guarantee that the employers would ever qualify for
``grandfather'' status. Third, OSHA is loathe to require the
expenditure of resources to make existing, effective programs
containing all the core elements meet all the requirements being
imposed by the full ergonomics standard. Employers without programs and
employers with ineffective programs or programs missing key elements
would need to expend resources to meet whatever requirements OSHA
imposed on alternative programs. The Agency believes that these
resources should be expended to meet the final standard in all its
details so as to ensure adequate protection for employees.
OSHA agrees, however, that a company that meets the rigorous
standards of paragraph (c) and thus qualifies for grandfather status
should be permitted to apply the same excellent program that was
grandfathered to new plants it builds or acquires by merger or
acquisition. OSHA believes that permitting a grandfathered program to
be extended in this way makes sense from two perspectives: first, it
ensures that the new establishments will benefit from the expertise in
ergonomics programs that the parent company brings, and, second, it
ensures that the company will have a single, cohesive corporate
ergonomics program. For these reasons, OSHA has decided to extend
grandfather status to the programs implemented in newly acquired or
built plants of a corporation that already has a grandfathered program.
The American Industrial Hygiene Association (Ex. 32-133)
recommended that employers formally request OSHA to recognize their
programs:
As the standard puts much of the burden on employers to adapt
the program to their own needs, it would be appropriate for OSHA to
say that employers can ask to have their program ``grandfathered''.
This would require them to formally document their program and
compare it with the OSHA requirements. This should not be a problem
if the company has a functional program (Ex. 32-133).
Kaiser Permanente made the same recommendation in their post-hearing
comments (Ex. 500-139).
However, OSHA's resources do not permit it to evaluate employers'
programs for grandfather status; in addition, a ``paper'' review of a
program is not adequate to determine how it is working in practice.
OSHA continues to believe that employers are in the best position to
determine whether their programs qualify for grandfather status.
The Eastman Kodak Company (Exs. 30-429, 30-1090) suggested that the
Agency adopt a flexible grandfather clause that recognizes good faith
on the part of employers:
We believe that what OSHA needs is a ``good faith'' grandfather
clause that recognizes employers for a positive effort and ongoing
solutions. We believe that it should be sufficient for an employer
to have a written active program and show intent, to be compliant.
The existing program rule (WAC 296-62-05110) of the Washington State
proposed standard is better suited to this end and is recommended
for incorporation (Ex. 30-429).
[[Page 68298]]
Other rulemaking participants also recommended that OSHA adopt the
proposed Washington State approach towards existing programs (see,
e.g., Exs. 30-434, 30-2835, 30-3813, 30-4134, 31-337, 32-311). They
argued that Washington's approach, which accepts alternative programs
when the employer can demonstrate that the alternate methods taken as a
whole are as effective as the requirements of the standard, would
grandfather far more effective programs than OSHA's proposal. They also
noted that this approach would focus the Agency's efforts on results
rather than on details they perceived as minor.
The Washington State standard's grandfather clause reads as
follows:
WAC 296-62-05110 When Do Employers' Existing Ergonomics Activities
Comply With This Rule?
Employers may continue to use effective alternative methods
established before this rule's adoption date. If used, the employer
must be able to demonstrate that the alternative methods, taken as a
whole, are as effective as the requirements of this rule in reducing
the WMSD hazards of each job and providing for employee education,
training and participation (Ex. 500-71).
Other commenters (see, e.g., Ex. 30-4467) urged OSHA to accept
compliance with the California ergonomics standard as constituting
acceptance under the grandfather clause.
Again, as discussed above, formal recognition of the ``as effective
as'' status of these two State-plan State standards must await a formal
determination by Federal OSHA. However, since acceptance under the
final rule's grandfather clause depends on program effectiveness,
confirmation of that effectiveness through evaluation, and the
inclusion in the program of the core elements, many proactive
California and Washington employers' programs are likely to meet the
final standard's requirements for grandfather status. The programs of
many employers in these states may not meet these requirements,
however, since neither State standard requires all of the core
elements.
The AFL-CIO, the International Brotherhood of Teamsters, and others
suggested that OSHA give employers credit for steps, such as training
and job hazard analysis, they have taken toward controlling ergonomic
hazards or for controlling hazards in problem jobs in their workplaces
(see, e.g., Exs. 30-1547, 32-185, 32-311, 32-339, 32-461, 500-207; Tr.
6423, Tr. 11129, Tr. 13092). These commenters believed that such credit
could substitute for a true grandfather clause.
The final ergonomics standard does give credit to employers who
have already carried out certain procedures or voluntarily complied
with portions of the standard. For example, employers who have already
performed job hazard analysis in some jobs would not have to re-analyze
those jobs (see paragraph (j)(1) of the final rule). Likewise,
employers who have already trained their employees in the ergonomic
control measures they instituted would not have to duplicate that
training (see paragraph (t)(5) of the final rule).
Some rulemaking participants suggested that OSHA recognize for
grandfather status any ergonomics program in effect at the time the
final rule becomes effective (see, e.g., Exs. 30-494, 30-2989, 30-3781,
500-213; Tr. 10089). These commenters believe that these employers
should be rewarded for their proactive stance toward ergonomics. For
example, the National Council of Agricultural Employers said, ``a
grandfather clause should recognize and exempt forward-thinking
employers that have already implemented an ergonomics program'' [Ex.
30-3781]. The National Association of Convenience Stores went further
to suggest that OSHA also grandfather trade-association-provided
programs: ``OSHA [should] consider grandfathering existing risk
management programs or industry-specific programs which trade
associations may be able to provide to their members' (Tr. 10089). The
Air Conditioning Contractors of America recommended that OSHA recognize
virtually any existing ergonomics program under the grandfather clause
(Ex. 500-53). It said that OSHA could require grandfathered programs to
be improved at such time in the future as MSD hazards became better
understood.
As explained earlier, OSHA believes that it is essential for
grandfathered ergonomics programs to include all of the core elements
of successful ergonomics programs and to meet demonstrable
effectiveness criteria. OSHA agrees that employers who have already
adopted existing programs are proactive; however, some of these
employers are likely to have programs that are not as protective as the
program OSHA is requiring or programs that do not include those
elements shown to be essential to program effectiveness. It would
therefore be inappropriate for OSHA to grandfather these programs.
Several hearing participants provided OSHA with alternative
regulatory language for the grandfather clause in their post-hearing
submissions (Exs. 500-44, 500-78, 500-80). Southwestern Bell
recommended the following language (Ex. 500-78):
How does this standard apply if I already have an ergonomics
program?
If you already have an ergonomics program for the jobs this
standard covers, you may continue that program provided:
(a) You have a written program that contains:
(i) Defined roles and responsibilities;
(ii) Training on the prevention of work-related MSD's; and
(iii) Procedures for completing job hazard analysis for work-
related MSD's.
(b) The controls implemented are intended to reduce or eliminate
risk factors for work-related MSD's;
(c) You have a program evaluation process; and you have implemented
your program before the effective date of the final rule (Ex. 500-78).
OSHA has considered Southwestern Bell's suggested language but has
rejected it because the programs that would be grandfathered in by such
language would be missing several important elements--employee
participation, hazard information and reporting, and MSD management,
for example. As explained earlier, OSHA considers these elements
essential to any successful ergonomics program. In addition,
Southwestern Bell's approach does not contain any requirement that the
program be effective, be achieving positive results, or be reducing the
number of MSDs.
The American Petroleum Institute (API) proposed language that would
accept an employer's existing program if it contained the following
seven elements: (1) Management leadership and employee participation,
(2) hazard information and reporting, (3) job hazard analysis and
control, (4) training, (5) MSD management, (6) program evaluation, and
(7) recordkeeping (Ex. 500-80). API's proposal also would require
grandfathered programs to contain subelements under each element. For
example, under job hazard analysis and control, API's language included
the following provisions: ``Jobs in the workplace must be assessed to
identify the potential for MSD hazards. Consistent with the job
assessment, an action plan is developed to control identified or
potential MSD hazards determined to present a significant risk.'' Their
language also suggested that grandfathered programs demonstrate
effectiveness via measures such as the following: Decreases in the
frequency of reported MSDs, decreases in the severity of MSDs, reduced
workers' compensation claims related to MSDs, symptoms surveys, and a
reduction of MSD risk factors. API did not include
[[Page 68299]]
work restriction protection among the elements grandfathered programs
must have.
API's suggested grandfather clause had two other features. First,
it specifically recognized any program meeting the requirements of an
employer's State OSHA ergonomics standard. Second, it recognized
existing programs in both existing workplaces and newly acquired or
built plants of a corporation that has a grandfathered program (Ex.
500-80).
API's approach is similar to the one OSHA is taking in the final
standard's grandfather clause. The final standard includes all of API's
recommended elements, and also requires the employer to demonstrate
that the ergonomics program is effective. API's suggested criteria for
determining effectiveness are also similar to those listed as examples
in the final standard. Further, the final rule permits employers with
grandfathered programs to extend those programs to new corporate
plants.
On the other hand, OSHA is not, as discussed above, automatically
grandfathering in employers' programs that comply with State-plan State
ergonomics programs. In addition, API's suggested regulatory text would
not require employers to provide WRP to employees who suffer work-
related MSDs. As discussed earlier, OSHA has concluded that WRP is an
essential part of any ergonomics program whether it is grandfathered or
not.
The Dow Chemical Company also provided alternative language for a
grandfather clause (Ex. 500-44). Their alternative provided criteria
for seven core elements that ergonomics programs would have to meet to
be grandfathered: hazard communication, MSD reporting, hazard
identification, hazard evaluation and prioritization, risk mitigation
or control, appropriate knowledge and skills (that is, training), and
program evaluation. Dow included specific criteria for each of these
elements and an explanation of how the criteria could be met for each
of the elements. Dow likened their proposal to OSHA's Process Safety
Management Standard (Sec. 1910.119), which sets the basic elements of a
process safety management program and requires the employer to spell
out the details.
However, OSHA is not adopting Dow's alternative grandfather clause
approach in the final rule, for several reasons. First, Dow's language
does not address several elements of ergonomics programs that OSHA
considers essential, including management leadership, employee
participation, and MSD management. Second, Dow's alternative is overly
detailed. For example, the hazard communication element incorporates
separate provisions on general information regarding MSDs and general
information on warning signs associated with MSDs. It also includes a
provision for providing specific information on potential ergonomic
hazards in an employee's work area. Third, Dow's suggested grandfather
clause appears to be designed to tightly match the company's own
program rather than to fit a more widely recognized model ergonomics
program, such as that in OSHA's meatpacking guidelines, a program
lauded by many rulemaking participants who had experience with
ergonomics programs (see, e.g., Exs. 30-1294, 30-2216, 30-3046, 30-
3677, 32-185; Tr. 14713). OSHA believes that more employers with
effective existing programs will be able to qualify under OSHA's final
grandfather clause, which is modeled after the Meatpacking Guidelines
program, than those required by Dow's alternative.
Dow also commented on the enforcement implications of a
performance-based grandfather clause:
The verification of compliance to a performance language
regulation is most effectively achieved when the method used for
prescriptive regulation compliance verification is modified. The
method used by Compliance Officers for a prescriptive regulation is
based on the Officer's knowledge of what is specified by the
regulation to be the practice, i.e. guard rail specification.
However, for performance language regulations, such as the Process
Safety Management regulation and the language suggested by Dow for
this proposed regulation. The Compliance Officer only knows what
elements are to be addressed by an employer's program: They will not
know what to expect for practices. The means to address those
elements are left to the employer so that they can use whatever
means best match their workplace needs and the local culture. The
Compliance Officer can only gain an understanding of that workplace
program from the employer. This, we believe, is where the
modification in approach should occur (Ex. 500-44).
OSHA believes that, like a true performance standard, the final
grandfather clause is not prescriptive in nature and leaves the details
of compliance to employers to determine. OSHA compliance personnel will
look first to the employer's demonstration that the program includes
the core elements and subelements and second that the program is
effectively addressing MSDs. Compliance officers also may assess
whether the employer's program in practice matches the written program
that the employer has developed.
Magnus Farley, Inc., did not provide alternative language for the
grandfather clause; however, they did recommend that OSHA develop
revised language and publish it for comment before adopting a final
rule (Ex. 500-102). They argued that this would give industry time to
evaluate the new provision and respond to it. OSHA finds a re-proposal
unnecessary, because participants had ample opportunity to provide
comments on the proposed grandfathered clause. The sheer volume of
comments received on this topic provides evidence of this fact. Further
the final rule's grandfather clause is a logical outgrowth of the
proposal. In fact, the final rule responds to the overwhelming public
comment that OSHA should focus on effectiveness and recognize existing
programs that do not look exactly like the one required by the rule.
Some rulemaking participants supported the proposal's approach
toward existing programs with only minor modification (see, e.g., Exs.
30-973, 30-1547, 30-2387, 30-3748, 32-85, 32-111, 32-339, 500-207; Tr.
15893). For example, the American Association of Occupational Health
Nurses supported the proposed grandfather clause, but recommended that
OSHA provide guidance for employers to use in evaluating their programs
(Ex. 30-2387). The American Nurses Association supported the proposed
requirement that existing program meet the basic obligation of each of
the core elements of an ergonomics program (Ex. 30-3686). They did,
however, recommend allowing employers up to 6 months to modify their
programs so that they meet these basic obligations.
As noted earlier, program evaluation guidance is already available
from the Agency. In addition, OSHA will be providing additional
compliance assistance materials in the period following publication of
the final rule. These materials will help employers judge whether their
programs are effective and whether they qualify for grandfather status.
The final grandfather clause essentially accommodates the American
Nursing Association's suggestion. Employers who, through one of the
measures given in paragraph (c)(1)(v), can demonstrate that their
programs are effective are free to add features that will bring them
into compliance with the criteria given in paragraph (c)(1) any time
before the effective date of the final standard. In addition, employers
are given an extra 12 months to incorporate work restriction protection
into their programs.
[[Page 68300]]
The Eastman Kodak Company argued that the proposal's grandfather
clause would have required employers to fix all problem jobs before
their programs were recognized (Exs. 30-429, 30-1090). The Boeing
Company also noted that employers may have an acceptable program that
covers some, but not all, of the jobs covered by the standard (Exs. 30-
973, 30-1547). Boeing suggested allowing employers up to 2 years after
the effective date to cover all such jobs.
As noted earlier, the final grandfather clause would permit
employers to extend an ergonomics program that was successful in
addressing some problem jobs to all problem jobs. In addition, because
the final rule's compliance endpoints do not contain a set compliance
deadline, employers may prioritize jobs for analysis and control if all
jobs could not be controlled by the final rule's effective date.\6\
Thus, the final standard addresses the concerns of these two rulemaking
participants.
---------------------------------------------------------------------------
\6\ Even though the final rule's grandfather clause does not
contain a fixed deadline for implementing controls for a problem
job, an employer with a grandfathered program is expected to
institute permanent controls as soon as possible. An employer who
postponed the control of MSD hazards beyond a reasonable amount of
time would have difficulty demonstrating the effectiveness of the
program.
---------------------------------------------------------------------------
Some rulemaking participants suggested making the grandfather
provisions more comprehensive (see, e.g., Exs. 32-182, 32-198, 32-210,
32-339, 32-461). First, as noted earlier, the AFL-CIO and others
recommended strengthening the basic obligations for four of the six
core elements (see, e.g., Exs. 32-198, 32-210, 32-339). Second, some
participants urged OSHA to develop and publish checklists and
evaluation tools to assist employers with the evaluation of their
programs (see, e.g., Exs. 32-85, 32-210, 32-339). Without these tools,
they argued, an employer's program could be grandfathered without any
solid demonstration that it is effective. The AFL-CIO argued that the
standard should be as protective as, and consistent with, existing
effective ergonomics programs, OSHA general duty clause settlement
agreements, and OSHA and NIOSH recommended practice (Ex. 32-339). In
keeping with this goal, they developed principles that they believe
should guide OSHA in casting the final standard:
The standard should codify and reflect the good industry
practices and programs implemented by employers who have effectively
addressed ergonomic hazards. It should build on the agency's
enforcement actions and settlement agreements on ergonomic hazards
under the general duty clause. The standard also should be
consistent with the measures used in other agency standards on toxic
substances and physical agents such as the lead and formaldehyde
standards and those which follow a programmatic approach, such as
the Process Safety Management and Hazard Communication Standards
(Ex. 32-339).
OSHA believes that the final rule's grandfather clause is
comprehensive enough to ensure that inadequate programs do not qualify
and is flexible enough to permit many different kinds of effective
programs to qualify. As explained previously, the Agency believes that
requiring programs to meet a combination of essential program elements
and recognized effectiveness measures will prevent inadequate
ergonomics programs from achieving grandfather status. On the other
hand, OSHA does not agree that it is necessary to codify the precise
practices used in the most effective programs, as the AFL-CIO suggests.
Doing so would unnecessarily limit an employer's flexibility in
complying with the final standard. The Agency believes that the final
rule has achieved a balance between flexibility and comprehensiveness
that will recognize effective ergonomics programs and deny grandfather
status to inadequate ones.
6. Other Comments on the Proposed Grandfather Clause
The National Soft Drink Association objected to the requirement
that the employer's program be evaluated and found to be functioning
properly before the effective date of the standard (Ex. 30-3368). The
trade association argued that a thorough evaluation of any program will
probably uncover areas that could be improved. Other rulemaking
participants also recommended that the standard allow employers to
modify their programs so that they could be improved (see, e.g., Exs.
30-1547, 30-3765, 30-4130, 30-4537). For example, the Boeing Company
was concerned that an employer would not be able to improve an existing
program without falling out of compliance with the grandfather clause
(Ex. 30-1547). In response, OSHA recognizes that all ergonomics
programs will need to be modified over time to correct deficiencies.
The standard not only accommodates this, but requires it in paragraph
(c)(1)(v).
Some commenters stated that the proposed grandfather clause would
force existing programs to include the six core elements if they wished
to be grandfathered even if the employer did not have an employee with
an MSD that triggered the standard (see, e.g., Exs. 30-715, 30-3678).
In response, OSHA considers it most unlikely that an employer with an
effective existing program would not have employees experiencing MSDs.
Some rulemaking participants suggested that OSHA strengthen the
grandfather clause in various ways (see, e.g., Exs. 30-2039, 30-4538,
32-182, 32-185). For example, the American Federation of Government
Employees recommended that employers have a documented program in place
for at least 2 years before being eligible and that a grandfathered
program be required to comply with the full standard if any MSDs occur
(Ex. 30-4538). They also urged OSHA to require that, in evaluating the
program, the employer determine that it is effective in addition to
functioning properly. The American Federation of State, County, and
Municipal Employees recommended that OSHA require that all elements of
an employer's ergonomic program be effective before the employer is
eligible under the grandfather clause (Ex. 32-182). Mr. Howard Egerman
was concerned that having the employer evaluate its own program was
bound to be ineffective because the employer could not be disinterested
(Ex. 30-115). Communication Workers of America Local 2222 recommended
that the standard require employees to agree with the employer's
evaluation before an existing program would be acceptable and that OSHA
mediate any disputes (Ex. 30-2039).
OSHA believes that the grandfather clause in the final rule will be
protective of employees' safety and health without the addition of
these suggestions. The Agency is therefore not setting a minimum time
period that an employer's program must have been in place to be judged
effective to qualify for the grandfather clause. The final grandfather
clause requires the employer to be able to demonstrate that the program
is effective and to evaluate its elements and correct any deficiencies
identified before the effective date. \7\ This will ensure that only
relatively mature programs qualify for grandfathering.
---------------------------------------------------------------------------
\7\ However, as explained earlier, the final grandfather clause
does permit an employer to incorporate work restriction protection
in the ergonomics program within 12 months of the effective date.
---------------------------------------------------------------------------
Many rulemaking participants testified that MSDs still occur in
workplaceswith the best ergonomics programs in place (Exs. 30-3765; 30-
4046; Tr. 14730). OSHA agrees that this is often the case, and the
final rule specifically notes that the occurrence of MSDs does not
constitute a violation of
[[Page 68301]]
the standard (see the note to paragraph (k)).
Although the employer will be evaluating the program, OSHA believes
that Mr. Egerman's concern is unfounded, because paragraph (c)(1)(v)
requires the employer to be able to demonstrate that the program is
effective. This provision, and the inclusion of the core elements,
should ensure that the evaluation is appropriate. In addition, the
final grandfather clause requires qualifying programs to include
employee participation in program evaluation. This will also act as a
check on the accuracy of the evaluation process. For these reasons, the
Agency believes that the grandfather clause in the final ergonomics
standard will provide an appropriate level of protection for employees.
Some rulemaking participants objected to language in the proposal
that required the employer to show that their program complies with the
basic obligations and is functioning properly (see, e.g., Exs. 30-541,
30-562, 30-1355, 30-1547, 30-3117, 30-3783, 30-4607). They argued that
the burden should be on OSHA's compliance staff to address ergonomic
hazards rather than on the employer to demonstrate that its program
qualifies. Some of these rulemaking participants argued that placing
the burden on employers to demonstrate program effectiveness would
disproportionately affect small employers, who do not have the
resources of larger ones (see, e.g., Exs. 30-3117, 30-3783).
Caterpillar, Inc. stated that the subjective nature of the grandfather
clause would lead to uneven enforcement across employer groups and
across the nation (Ex. 30-4607).
The American Apparel Manufacturers Association also was concerned
about enforcement and gave the following example of how an employer's
interpretation of what constitutes a problem job could differ from that
of an OSHA compliance officer:
An apparel manufacturer may see two sewing jobs as extremely
different, involving different activities and physical requirements,
but an OSHA inspector with no experience in the apparel industry may
well see them as the same. This ambiguity of language may cause
penalties against companies who believed they were, in good faith,
running a successful ergonomics program (Ex. 30-4470).
The Boeing Company was also concerned about being second guessed by
OSHA enforcement personnel (Exs. 30-973, 30-1547). They recommended
that the standard unambiguously recognize programs addressing the basic
obligations. In particular, Boeing urged OSHA to clarify that an
employer who is complying with a written program that meets the
grandfather clause is in compliance with the standard (Ex. 30-1547).
They argued as follows:
Where employers are already undertaking what can reasonably be
done in good faith to minimize problem jobs, they should be
protected from second-guessing by inspectors. OSHA's limited
resources are better used focusing on worksites where ergonomic
hazards have yet to be addressed, not on worksites which have
already implemented effective ergonomics programs (Ex. 30-1547).
Others believed that it is appropriate for OSHA to require
employers to demonstrate the effectiveness of their programs (see,
e.g., Exs. 30-429, 30-2835, 30-3813, 30-4134, 31-337, 500-214). These
commenters argued that this was the approach taken by Washington State
in its ergonomics standard, and they believed that it was reasonable.
OSHA finds, based on a review of the evidence in the record as a
whole, that the final grandfather clause is not likely to lead to
uneven enforcement. It is true that employers will need some method of
assuring themselves that their ergonomics program qualifies for the
grandfather clause, and the method chosen also will be useful to OSHA
compliance personnel. However, OSHA will not cite employers who make an
adequate demonstration \8\ that their programs are effective and
include the elements and subelements in paragraph (c)(1). However, if
the Agency finds objective evidence that the employer is basing the
demonstration on inaccurate information, OSHA will not consider that
employer's program as qualifying for grandfather status.
---------------------------------------------------------------------------
\8\ An adequate demonstration is one that touches on all
subelements spelled out in paragraph (c)(1) and that shows
effectiveness using an appropriate measure of effectiveness.
---------------------------------------------------------------------------
OSHA also believes that it is reasonable and appropriate to place
the burden of demonstrating that their programs qualify for grandfather
status on employers because grandfathered programs are the
``exception'' to the standard. Employers who choose to take advantage
of using a program that is not required to meet the full ergonomics
standard in all its details can reasonably be expected to produce
evidence that their programs qualify for the grandfather clause. OSHA
needs assurance that employees in workplaces with grandfathered
programs will be adequately protected by these programs. For these
reasons, the final grandfather clause requires the employer to
demonstrate that their programs qualify for grandfather status.
Some rulemaking participants complained that the proposal would
require employers wanting to take advantage of the grandfather
provision to keep unnecessary records (see, e.g., Exs. 30-2645, 30-
2815, 30-2835, 30-4628). For example, the Chemical Manufacturers
Association and others stated that an unwarranted paperwork burden
would be forced on an employer because it would have to document that
the program met the basic obligations and that the program is
functioning properly (see, e.g., Exs. 30-2835, 30-3356, 30-4628).
The final grandfather clause does not require the employer to
maintain any records. In fact, the final standard does not require
employers whose programs are grandfathered to maintain any of the
records required by the full standard in paragraph (v). Some employers
may choose to maintain certain records to facilitate their
demonstration of effectiveness. However, some effectiveness measures
require no records. For example, the Dow Chemical Company, whose
program involves the evaluation of all tasks in high risk jobs and
control of all ergonomic hazards in those jobs, would need only show
that adequate controls are in place to demonstrate effectiveness. (They
also would need to show that their program includes the elements and
subelements given in paragraph (c)(1).) In addition, most employers
with existing programs are already required, under 29 CFR Part 1904, to
maintain injury and illness records. Employers should be able to use
those records, with little or no modification, to demonstrate
effectiveness. Thus, OSHA has concluded that comments that the
grandfather clause would create an unwarranted paperwork burden are
unfounded.
Some rulemaking participants argued that companies would be forced
to alter their existing safety and health programs to meet the OSHA
ergonomics standard, forcing them to inefficiently allocate resources
away from their safety and health programs (see, e.g., Exs. 30-2216,
30-3845, 30-4818, 31-310; Tr. 11379, 11403). These commenters
apparently believe that two separate and incompatible programs would be
required or that grandfathering would require major restructuring of
their current ergonomics program. For example, the Forum for a
Responsible Ergonomics Standard recommended that OSHA recognize
existing programs that met the goal of reducing or eliminating MSD
hazards regardless of whether or not they met the technical
specifications of the six proposed program elements (Ex. 30-3845).
[[Page 68302]]
Otherwise, they argued, the standard would not only upset the
performance of existing programs but would result in poor allocation of
risk control resources. They gave examples of what they believed might
occur:
[O]ne Forum member, CCE, has spent millions of dollars researching
and developing methods to reduce injuries related to various
warehousing and delivery activities, such as improving new order
fulfillment systems. In this respect, CCE is pioneering achievements
that likely will eventually be adopted throughout its industry.
However, particularly with respect to employee participation in
developing safety programs, CCE is unlikely to meet the strict
requirements for grandfathering. As a result, CCE anticipates that
many of its current efforts will be derailed as resources,
especially the time of its highly trained staff, will have to be
diverted to ensuring compliance with the OSHA standard. Instead of
developing fixes that will prevent injuries, these resources will be
directed towards ``fixing'' the administrative structure of its
program.
Similarly, many NACS members (convenience store operators and
petroleum marketers) incorporate MSD prevention and ergonomics
issues into their general worker safety programs that cover a wide
range of issues, from dealing with slips and falls to robbery
deterrents to customer safety issues. These programs have been
extremely effective in reducing MSD injuries. If not grandfathered,
implementing OSHA's proposed standard would require upsetting and
dramatically changing these already effective programs (Ex. 30-
3845).
Mead Corporation (Ex. 30-2216) made a similar comment:
Responsible employers would be forced to alter achieving
programs and pursue measures that we know are not as effective as
what we are already doing. The resources that are focused on MSD
prevention would be shifted toward less meaningful activities. A new
infusion of MSDs may result at many workplaces that have effectively
controlled these types of accidents to date because of the shift in
emphasis brought on by compliance demands.
Consider:
Many companies utilize periodic risk assessments to
update priorities for ergonomics projects. Risk assessments commonly
include a survey of the workplace, discussions with employees about
potential concerns, and analysis of MSDs. Priorities are established
and incorporated into a work plan for the site's ergonomics/safety
team.
When ergonomics teams in Mead conduct analyses of jobs,
they are encouraged to identify as many opportunities for continuous
improvement (potential risk factors) as possible and then to
prioritize based upon risk. Action plans are developed for high risk
concerns. Lower priorities are not addressed at the time unless they
are low cost. Teams maintain documentation of these items and may
revisit them in the future once higher priority items are resolved
In each of these examples, employers are pursuing activities that
should be recognized as meaningful and exceeding the level of
protection OSHA is currently seeking for the control of MSDs. With the
proposed standard, however:
When persistent symptoms develop at a job considered to
be moderate priority for continuous improvement, higher priority
changes would be delayed, placing more employees at higher risk for
developing MSDs;
Similarly, when partial work aggravation associated
with a low risk task triggers a manufacturing job, high priority
changes recommended by the ergonomics team based upon comprehensive
analysis will be delayed; and
Documentation of MSD prevention activities will be
increasingly scrutinized and restricted due to concerns over how
OSHA would interpret the information (Ex. 30-2216).
On the other hand, the American Society of Safety Engineers stated
that ergonomics programs fit easily into existing safety and health
programs:
The establishment of basic ergonomic management programs,
increasing employee awareness and involvement on these issues is not
a burden to employers when compared to other safety and health
compliance requirements.
In fact, most efficient and effective ergonomic initiatives will
usually dovetail with other existing safety and health programs (Tr.
11611).
The final rule in general, and the grandfather clause in
particular, will not, in OSHA's view, require an inefficient
reallocation of resources. In fact, because MSDs are the leading cause
of on-the-job injuries and illnesses, OSHA believes that the final rule
will ensure that resources will be devoted to areas where significant
improvement in injury and illness rates can be realized.
OSHA agrees with the American Society of Safety Engineers that
ergonomics programs fit well as part of comprehensive workplace safety
and health programs. The final grandfather clause does not require
employers to divorce ergonomics from their existing safety and health
programs. Thus, employers who address ergonomics in existing effective
safety and health programs typically will not need to reinvent their
ergonomics program just to qualify for the grandfather clause.
In addition, as noted earlier, the final rule accommodates
prioritization of the implementation of permanent controls, as Mead
Corporation is doing, where the employer cannot fix all problem jobs at
once. Therefore, OSHA does not believe that the final rule's
grandfather clause will be disruptive or result in an unwarranted
reallocation of resources.
Union Carbide recommended that the standard not require employee
participation in the development of existing programs that would
otherwise qualify under the grandfather clause (Ex. 30-3784). ORC also
identified employee participation in the development of each element of
the program as one area that few of its member companies could comply
with (Tr. 4135).
OSHA agrees with these rulemaking participants that employee
participation in the development of ergonomics programs is not
necessary where an existing program that qualifies for the grandfather
clause is at issue. The primary purpose of the grandfather clause is to
recognize ergonomics programs that employers have already put into
place, i.e., that are already well past the developmental stage.
According to ORC, some of these programs have not involved employees in
the past development, implementation, or evaluation of the program. As
drafted in the final rule, employee participation in these stages of
program implementation is required as appropriate, from this time
forward. In other words, OSHA is not requiring employee participation
in the past development of a program as a condition of the grandfather
clause; it is requiring employee participation in the implementation,
evaluation, and future development of grandfathered programs, however.
Alcoa, Inc., recommended that, for existing capital-intensive
industries and equipment, OSHA allow employers additional time to come
into compliance with the grandfather clause (Ex. 30-3922). They argued
that the implementation of permanent controls within 2 years, as
proposed, was neither realistic nor economically feasible for some
employers. The final rule's grandfather clause allows an employer to
have a process for identifying, analyzing, and controlling MSD hazards
in problem jobs and following up to ensure control effectiveness.
Through a prioritization process, an employer may choose to temporarily
implement interim controls. Although the employer is expected to
institute permanent controls as soon as possible, the final rule does
not provide a date when this must be accomplished. Thus, employers in
all industries with qualifying programs will be able to prioritize
their jobs for control in a rational manner that permits them to take
advantage of the capital involvement and replacement schedules of their
industries.
[[Page 68303]]
Paragraph (d)--What Information Must I Provide to my Employees?
Paragraph (d) of the final rule requires employers to provide their
employees with basic information about five items:
(i) Common musculoskeletal disorders (MSDs) and their signs and
symptoms;
(ii) The importance of reporting MSDs and their signs and symptoms
early and the consequences of failing to report them early;
(iii) How to report MSDs and their signs and symptoms in the
workplace;
(iv) The kinds of risk factors, jobs and work activities associated
with MSD hazards; and
(v) A description of the requirements of OSHA's ergonomics program
standard.
This information must be provided to new employees within 14 days
of hiring, and must be posted conspicuously in the workplace.
Consistent with applicable law, information may be posted or provided
electronically to employees who have electronic access. To assist
employers in meeting their obligation under this paragraph, OSHA has
included nonmandatory Appendices A and B, which contain all the
information needed to comply with this paragraph, except for the
workplace-specific information on reporting MSDs and their signs and
symptoms.
The proposed rule also would have required employers to provide
employees with information on how to recognize MSDs (and their signs
and symptoms); on the importance of early reporting of MSDs; and on how
to report MSDs at their workplace. It also would have required
employees to establish a reporting system for MSDs. These provisions in
the proposed rule, however, would only have applied to manufacturing
and manual handling employers. OSHA expected the provisions to serve
three purposes: to facilitate employees' active participation in their
employers' ergonomics programs; to promote early reporting so that MSDs
could be treated most effectively; and to assure prompt identification
of MSD hazards so that the incident trigger of the standard would work
properly.
There was a great deal of support, in general, for requiring
employers to provide hazard and reporting information to employees
(see, e.g., Exs. 30-2116, 30-3813, 30-3748, 30-3765, 30-3934, 32-339-1,
32-111-4, 32-185-3, 30-3686, 32-461, 32-210-2, 30-3826, 30-3686, 32-
182-1, 30-2116, 30-3748, 30-4564, 32-198-2, 500-33, 32-21-1, 32-450-1,
30-4247 and 32-450-1). Mr. Mark Davidson, Risk Manager for Safeway
Stores testified (Tr. 13674, 13658) that he adamantly supported pre-
injury efforts to train and evaluate people. He stated the fact that
Safeway had produced a video to educate employees on symptoms of soft
tissue injury and had merely shown it to employees across the United
States. Both Akers Logging (Tr. 12325) and Swift Company Timber
Management (Tr. 12315-16) believed that this information could be
incorporated into regular safety meetings, and Mr. Swift testified that
the cost would be nominal, if anything.
In fact, a number of participants urged OSHA to go even further and
require employers to survey their employees to identify existing signs
and symptoms (see, e.g., Exs. 31-113, 31-150, 30-4538, 31-243, 31-186,
30-2387, 31-156, 31-125, 31-105, 31-43, 31-23, and Tr. 4732-33). One
commenter (Ex. 31-186) said that, as well as promoting the early
detection of MSDs, thereby saving employers money and lost work time,
surveys also send the message that the employer cares about employee
health and safety. The American Association of Occupational Health
Nurses (AAOHN) (Ex. 30-2387) also said that MSD symptoms surveys should
be strongly encouraged, if not required.
Other commenters argued that the benefits of this information
provision should not be limited to jobs involving manufacturing and
materials handling (Ex. 30-3826). Since implementation of any
ergonomics program outside manufacturing and manual handling would have
been based on the occurrence of an OSHA-recordable MSD, it made little
sense, these commenters felt, not to provide employees in other jobs
with information on what and how to report:
Employees cannot be expected to report early if they are not
educated on what signs and symptoms of MSDs are and if the employer
is not communicating with them the importance of reporting early.
Also, if employees are not aware of, or do not know the mechanism of
reporting, than it is surely less likely that they will report * *
*. This will be a great disincentive for reporting (Ex. 32-210-2,
pg. 130).
See also, e.g., Exs. 500-126, 32-85-3, 30-4538, 32-198-4, 30-2387.
Some commenters, however, objected that employers should not be
required to provide hazard and reporting information before an MSD
occurred (see, e.g., 30-3723, 30-3867, 30-3086, 30-4465, 30-4607, 30-
1012). These commenters argued that providing the information would be
an unjustified consumption of resources, infrastructure capacity, and
support, adding overhead and cost with no potential benefit. The
General Electric Company (Ex. 30-1071) felt that an employer
proactively identifying ergonomic issues would likely unearth
complaints of MSD signs and symptoms. The American Iron and Steel
Institute (AISI) (Ex. 32-206-1) stated:
The provisions in proposed Sections 1910.914 and 1910.916
requiring the employer * * * to inform workers of the signs and
symptoms of MSDs and how to report them would create an enormous
potential for abuse of the system. The manner in which OSHA is
expected to enforce those provisions will only exacerbate the
problem (Ex. 32-206-1, pg. 40).
Other participants also expressed concern that providing employees
with additional information about MSDs will cause workers to
misattribute benign symptoms to serious injury or disease, thereby
heightening symptoms and distress, or otherwise to make false reports
(Exs. 32-241-3-2, 30-3716, 30-3000, 30-4843, Tr.16087, Tr. 10445-6).
Omni Services Incorporated (Ex. 30-4496-35) believes it would be easy
for employees to report almost any ache or pain as work-related and get
paid time off until they feel better.
The Painting and Decorating Contractors of America (Ex. 30-3716)
voiced concern that the information presented to employees about MSD
signs and symptoms and the importance of reporting them early would not
only require employers to develop expertise in ergonomics-related
injuries, but would encourage employees to classify almost any job-
related ache or pain as an MSD. The Plastics Engineering Company (Ex.
30-2435) stated that the requirements would encourage employees to
report both real and phoney or exaggerated MSDs. The American Road and
Transportation Builders Association (Ex. 30-4676) argued that the
number of work-related MSD claims, and the number determined to be
work-related, would significantly increase. See also Exs. 500-127, 31-
106, 31-344, 32-82-1, 30-3749, 30-3336, 30-3367. The AAOHN (Ex. 30-
2387), however, pointed out that often, after ergonomic training,
employers experience an increase in MSD complaints and should be
prepared for this eventuality. As noted elsewhere in the Preamble,
these are not ``new'' MSDs, but instead the expected earlier reporting
of MSDs that are already occurring.
OSHA does not find evidence that encouraging early reporting of
MSDs promotes abuse. Evidence discussed in other sections of this
Preamble indicates that programs that encourage early reporting of
MSDs, so that employees
[[Page 68304]]
can enter an MSD management program, actually reduce the time employees
are subject to work restrictions. OSHA also has analogous requirements
in other standards, for example, the Bloodborne Pathogens standard (29
CFR 1910.1030) and several of its chemical exposure standards (Cadmium,
29 CFR 1910.1027; 1,3-Butadiene, 29 CFR 1910.1051; Methylene Chloride,
29 CFR 1910.1052), and has seen no evidence that the provisions are
abused. These provisions simply require that the employer provide basic
information to employees; have a system in place for employees to
report possible injuries, illnesses, and exposures; and evaluate and
respond to these reports. As is discussed more fully in connection with
paragraphs (e) and (f), a report of an MSD does not impose any
obligations on employers unless the employer determines that the MSD is
work related and meets the severity criteria, and the job itself meets
the levels of the Basic Screening Tool in Table 1.
OSHA also agrees with the comments discussed above urging that all
general industry employees be provided with this information. It
believes the incident trigger in the standard can only be fully
effective if all employees have basic information about MSDs and how
and why to report them promptly. This means that some general industry
employers, who under the proposal would have had no obligations at all
until receiving a report of an MSD, will now have to provide this
information. OSHA emphasizes, however, the minimal nature of the burden
imposed by this paragraph. All of the information, except that on how
to report MSDs and signs and symptoms to a particular employer, is
contained in Appendices A and B to this standard, and will also be
posted on OSHA's website. Employers need only copy or download the
information for distribution to their employees. This responds to a
number of comments asking OSHA to provide materials to assist employers
in providing information to employees (see, e.g., Exs. 30-429, 30-4492,
30-2987, 30-3232, 30-3853, 32-337-1, 32-210-2, 32-461-1, 32-461-1, 30-
3826, 30-4538, 30-3686, 30-2387).
The requirement that employees be given information on how to
report MSDs and their signs and symptoms is also necessary to ensure
the effectiveness of the standard's exposure trigger. This requirement
is even more basic than that contained in the proposed rule. It does
not require employers to set up any particular reporting system, only
that employees know how to report their MSDs or signs and symptoms.
Particularly for a very small employer, this could be as basic as
telling them to report them to a supervisor or safety official. Larger
employers may use their existing reporting systems (Ex. 30-3826).
Although OSHA intended this option also to be available under the
proposed rule, several commenters interpreted the proposal as requiring
a reporting system specific to MSD signs and symptoms (Exs. 31-78, 30-
240, 30-3723, 30-3765, 32-77-2, Tr. 5340, 30-3853, 32-337-1, 30-716,
30-2215, 500-127). In light of the revised language in the final
standard, these comments are now moot.
Other commenters, however, urged OSHA to adopt a more elaborate MSD
reporting system. The American Federation of Teachers (Ex. 32-326-1)
urged OSHA to strengthen the reporting requirements by stipulating that
employers document a method for encouraging employees to report.
Morgan, Lewis, and Bockius (Ex. 30-4467) expressed concern that
employers would have no sure way of knowing whether a reporting system
would satisfy an OSHA compliance officer's interpretation of the
standard's requirements. OSHA does not agree that more detail is
necessary in this provision.
The final standard allows employers extensive flexibility to tailor
reporting systems to the demands of individual workplaces. Variations
among employers (e.g., size, management structure, number and type of
facilities) could lead to some types of reporting systems being more
effective than others for different employers. Some may choose written
reporting systems, while others may feel that an oral system is a
``better fit'' for their particular situation. OSHA demands only that,
whatever approach is used, it must be accessible and carried out in an
orderly way that is recognized and understood by the involved parties.
A few commenters questioned the requirement to provide employees
with a summary of the standard (see, e.g., Exs. 30-3765, 30-1336, 30-
3782-12, 30-2836, 30-2940, 30-240). The G. Leblanc Corporation (Ex. 30-
4837) stated that, with the exception of this item, the information to
be provided to employees would be very helpful in making the reporting/
response system successful. It also felt that inclusion of the summary
resulted in additional cost and expertise necessary for providing the
information. The Dow Chemical Company (Ex. 30-3765) also commented
that, while it supports telling employees about MSD hazards, signs and
symptoms, the importance of reporting them early, and the mechanics of
how to report them and uses a program that emphasizes the information
envisioned by this provision, it does not support providing a summary
of the requirements of the standard. The Edison Electric Institute (Ex.
32-300-1) also objected to the requirement that supervisors and
employees be trained in the requirements of the standard.
Some of these commenters (see, e.g., Exs. 30-1336, 30-2836, 30-
2940) voiced concern about not knowing how many pages of information
were sufficient to comply with this requirement, while others (see,
e.g., Ex. 30-3782-12) felt that how to interpret a ``summary of the
standard'' and how to provide this to the employee was left to the
employer's imagination. These concerns are addressed by the inclusion
of nonmandatory Appendix B to the standard.
On the other hand, several commenters stated that employees should
receive even more information (Exs. 30-4538, 31-242, 32-461-1, 32-210-
2, 32-182-1, 32-111-4, 32-339-1, 500-218, Tr. 3481-82, 500-126, 31-280,
Tr. 4542-43). For example, the AFL-CIO recommended that the hazard
information and training requirements be restructured to move some of
the training requirements up-front and stated:
Specifically, we recommend that the Hazard Information and
Reporting section require information and awareness initial training
on the following:
1. Common MSD hazards;
2. The signs and symptoms of MSDs and the importance of
recognizing and reporting them early;
3. How to report MSDs, signs and symptoms of MSDs, and MSD
hazards and the prohibition against discouraging employee reports;
4. An explanation of this standard, including ways for employees
to participate and how to get a copy of the standard;
5. An explanation of MSD management, including temporary work
restrictions and work restriction protection; and
6. The principles for controlling common MSD hazards. (Ex. 32-
339-1, pgs. 32-33)
Other commenters suggested that additional topics such as employee
rights to job protection, right to report reporting procedures, symptom
reporting procedures and training be included (see, e.g., Exs. 32-461-
1, 30-4538, 30-3686, 32-198-4, 32-198-4-1, 32-198-4-13)
OSHA has considered these comments and incorporated some of the
suggestions. Other topics are addressed in the context of ergonomics
program training under paragraph (t). The information requirement in
this
[[Page 68305]]
paragraph (d), however, is intended to provide employees with the
minimum amount of information they need to perform their function under
the standard: recognizing and reporting MSDs and their signs and
symptoms, and doing so as early as possible. Employers are free to
provide additional information (e.g., explaining their particular
ergonomics program), but OSHA does not believe that more detailed
information is necessary before any MSD hazards have been found. As
previously discussed, the Agency has attached an information sheet for
the employer to use in providing the required information.
Finally, the issue of the posting of this information was also
raised by several commenters (see, e.g., Exs. 31-70, 31-342, 30-240,
30-1726, 30-1104, Tr. 10586). One commenter (Ex. 31-70) stated that the
final standard should require mandatory posting of information for
employees. Similarly, another commenter (Ex. 31-342) commented that
there should be a requirement to either post a notice that employees
should report possible MSDs promptly or inform employees in another
effective manner. The National Association of Orthopaedic Nurses (Ex.
30-1104, Tr. 10586) supported a readily identifiable posting of MSD
signs and symptoms, who to report to, and how to report. In addition,
the University of Wisconsin Extension (Ex. 30-1726) urged OSHA to
develop ``more boilerplate'' on a policy that encourages reporting and
to require that this policy be posted in the workplace. On the other
hand, August Mack Environmental (Ex. 30-240) argued that posting was
redundant, unnecessary and posed a problem due to often limited space
available for postings. It felt that the currently required OSHA poster
already contains information on how to get additional information about
OSHA standards.
Paragraph (d)(2) of the final standard requires that the
information provided to employees must also be posted in a conspicuous
place. In addition to an employee bulletin board, such places may be
the employee locker room, lunch room, or near the time clock.
Electronic posting is also permissible where all employees have access.
While the Agency realizes that these options are not available in all
facilities, most employers have some area, recognized by employees,
where the employer posts company announcements and information. OSHA
believes the posting requirement is necessary because many employees
may not have immediate access to their original information sheet when
they are beginning to develop an MSD.
In conclusion, OSHA has considered all of the comments and
testimony received on the proposed provisions requiring employers to
provide hazard information and reporting. It has decided to retain the
requirement that employers covered by the final rule to provide minimal
information to employees before an MSD incident occurs. OSHA believes
the final rule provision is adequate without requiring additional
measures such as surveying employees to identify signs and symptoms of
MSDs.
Paragraph (e)--When Must I Take Further Action?
A. Introduction
The final rule incorporates a two-stage action trigger. It requires
further action when (1) an employee experiences a work-related MSD
involving either one or more days away from work, one or more days of
limitations on the work activities of the employee, medical treatment
beyond first aid, or 7 days of persistent MSD signs or symptoms (2) in
a job with exposures to risk factors that meet the Basic Screening Tool
in Table 1. Unless both stages of this action trigger are reached, the
standard does not require employers to take any action beyond providing
the information in paragraph (d) to their employees.
The action trigger in this standard serves a purpose analogous to
that served by action levels in OSHA standards regulating exposures to
air contaminants. Those standards generally require that airborne
levels of the contaminant be kept below a permissible exposure level
(PEL). At a much lower level, however, employers are required to take
actions such as conducting air monitoring and providing training and
medical surveillance to exposed employees, although they do not
actually need to implement controls to reduce exposures to the
regulated substance. Similarly, in this standard, once a job meets the
action trigger, the employer must implement an ergonomics program that
includes job hazard analysis, training, and MSD management (for the
injured employee), although it may not actually be necessary to control
or reduce the MSD hazard.
This concept is similar to the approach OSHA took in the proposed
rule. In the proposal, an employer was required to take further action
if an OSHA-recordable MSD occurred in a job meeting certain ``screening
criteria,'' i.e., the job involved physical work activities and
conditions that were reasonably likely to result in the MSD, and those
activities were either a ``core element'' of the job or accounted for a
``significant amount'' of the employee's worktime. In manufacturing and
manual handling jobs, an OSHA-recordable MSD was not necessary if an
employee reported persistent symptoms and the employer had knowledge of
problems in the job.
OSHA received a large number of comments about the proposal's
triggering mechanism. These comments fell into several categories. Many
parties objected that the single MSD incident trigger included in the
proposal was either too sensitive or not protective enough. Others
objected to the use of an OSHA-recordable MSD, often pointing out that
OSHA has proposed to amend its recordkeeping regulation, and that those
amendments could also affect this ergonomic standard. In addition,
commenters complained that the proposed standard's screening criteria
would be extremely difficult to apply in practice, pointing in
particular to the terms ``core element,'' ``substantial part of the
workday,'' and ``reasonably likely to result in the MSD.''
As explained below, OSHA has made a number of changes in response
to these comments. The triggering mechanism in the final rule has more
precisely defined elements, and OSHA believes it should be much easier
to apply.
A job meets the action trigger in the final standard based on two
criteria. The first is what has been called the ``single-incident
trigger.'' Under this criterion, an employee working in the job must
have incurred either a work-related MSD severe enough to result in a
work restriction, medical treatment beyond first aid, or MSD signs or
symptoms lasting at least 7 consecutive days after being reported to
the employer. A work restriction is defined in the standard as one or
more days away from work, one or more days of limitations on the work
activities of the employee's current job, or one or more days of
temporary transfer to alternative duty (see paragraph (z)). Under the
final rule, an MSD meeting this description is an ``MSD incident.'' The
employer's first duty, after receiving a report of an MSD or MSD signs
or symptoms, is to determine whether the report constitutes an MSD
incident.
The second step of the action trigger, which must only be addressed
after an MSD incident occurs, is based on the employee's exposures to
ergonomic risk factors. If the employee is exposed to one or more of
the risk factors described in the Basic Screening Tool in Table 1 for
longer than the time listed for that
[[Page 68306]]
risk factor, then the job meets the screen.
B. MSD Incident Trigger
1. Incident-Based Approach
The proposed standard also included a single-incident trigger.
Under the proposal, employers of workers engaged in manufacturing and
manual handling would have been required to implement some elements of
an ergonomics program standard soon after the standard took effect,
whether or not MSDs had occurred in their jobs. Once a ``covered MSD''
meeting the screening criteria occurred, those employers would have
been required to adopt a full ergonomics program. Other employers would
not be required to take any action before a ``covered MSD'' meeting the
screening criteria occurred, but once that happened, they also were
required to adopt the full program. In this final rule, OSHA has
clarified that the only action explicitly triggered by an MSD incident
is to apply the Table 1 screen. OSHA finds that the record supports
using an MSD incident for this purpose.
A number of participants objected to the proposal's incident
trigger on the basis that it was reactive and appeared inconsistent
with OSHA's mission ``to prevent the first injury'' (Ex. 500-218, Tr.
9071, 9156, 12277, 12477). A number of labor organizations favored a
proactive approach because, according to the International Chemical
Workers' Union, ``[w]aiting for a covered MSD or persistent MSD
symptoms to arise, versus evaluation and prevention, is a lose-lose
proposition'' (Ex. 32-198-4, 32-461-1, 500-137; see also Ex. 500-218,
Tr. 12365, 17543). The Farm Workers Justice Fund urged OSHA to adopt a
hazard-based approach because in many workplaces employees experience a
great deal of pressure not to report injuries (Tr. 17515).
Some employers and representatives of employers also supported a
hazard-based rather than an incident-based rule (Ex. 30-1294, DC67, Tr.
9070-74, 12277, 13633, 10631, 10636). Mark Davidson, of the Oregon Self
Insurance Association, preferred a proactive approach because:
If the goal is to cut down on the occurrence of MSD complaints,
shouldn't the regulatory effort [focus on] preventing the occurrence
rather than punish it (Tr. 13633).
Anthony Barsotti, of Hoffman Construction Company, said that an
incident-based approach was ``heading backwards in terms of
prevention'' versus reaction:
[H]aving the standard be triggered by the injuries seems
inconsistent with where we have been going, both as a safety
profession and as a society in terms of identifying hazards,
developing systems and processes to control them. And then, kind of
when those systems fail and we have an injury, then what are our
back-up systems and our approaches? (Tr. 12277).
See also (Tr. 9115-16).
OSHA has carefully considered these comments. In response, it has
added a proactive element to the definition of an MSD incident. MSD
signs and symptoms that last for 7 consecutive days since first
reported to the employer are considered MSD incidents under this
standard. Several health care professionals testified that, in most
cases, MSD signs and symptoms are completely reversible when they are
caught at such an early stage (see, e.g., Exs. 37-1; 37-2, pp. 14-15;
37-12, p. 5; 37-16, p. 8; 37-17, p. 4; Tr. 7687-88, 9884, 13397-98,
13410). Thus, OSHA has concluded that its incident-based approach can
prevent employees from experiencing permanent damage or disability,
while at the same time minimizing burdens for employers who have few or
no ergonomics problems (Ex. 16969-70).
Where employers have provided their employees with appropriate
information to allow the employees to recognize MSDs and MSD signs and
symptoms, and have also instituted good reporting systems, and
employees still are not reporting MSDs, a full ergonomics program may
not be necessary. OSHA agrees with commenters who said that a purely
hazard-based approach, which would require all employers to analyze all
jobs, regardless of whether those jobs have ever caused an MSD, might
result in an inefficient use of resources (Exs. 500-1-329, 500-75, Tr.
3095).
This is particularly true because the vast majority of employers
will not have an MSD incident reported in their workplace during any
given year (Exs. 30-542, 30-3167, 500-1-128, Tr. 2980, 3073, 3096). One
report prepared for the Small Business Administration's Office of
Advocacy estimated that as many as 75 percent of manufacturers
employing fewer than 11 employees are not likely to experience any MSD
incident for up to six years. (Ex. 30-542). (See also Ex. 500-67; Final
Economic Analysis, chapters II and IV). The testimony of a number of
hearing participants representing small businesses confirmed this (Exs.
30-3167, 500-1-128). They told OSHA that they had never had a report of
an MSD in their workplace (Tr. 2980), did not have MSDs every year, or
had only isolated or few occurrences (Tr. 3073, 3096). Small employers
comprise 75 percent of all private industry establishments (Final
Economic Analysis, Industry Profile, chapter II), and the incident
trigger ensures that most of these employers will have only minimal
obligations under the final rule.
The record also shows that an incident trigger is a reasonable
proxy for an increased risk of exposure to MSD hazards. For example,
some employers with successful ergonomics or safety and health programs
use reports of MSD symptoms or symptom surveys to identify jobs posing
MSD hazards (Ex. 37-2, Tr. 5503, 5358; Tr. 14707, 14723-26). Dr.
Frederick Gerr, Associate Professor of Environmental and Occupational
Health at the Rollins School of Public Health at Emory University,
testified:
The use of reported cases of illness, such as MSDs, to trigger
investigation into potentially excessive exposure to known MSD
hazards is a well-established method of protecting others with
similar exposures (Ex. 37-2, p. 15).
Many employers also use MSD reports as a way to prioritize their
control activities (Tr. 10631, 14723, 14746). Sean Cady, of Levis
Strauss & Co., testified:
If we have repetitive motion injuries or musculoskeletal
disorders on various jobs that occur at the same time how do we
prioritize which jobs we select for job modification, because we
don't have unlimited resources in the company. So what we do is we
review many factors of that job and we qualitatively prioritize
jobs. And we review things like the number of symptoms reported on a
job, possibly the number of injuries, or the severity of injuries on
a job (Tr. 14723-24).
OSHA has made clear throughout this rulemaking that a portion of its
intent is to require more employers to implement the kinds of effective
programs that are already in place in many industries (64 FR 65770).
Incorporating an approach already in wide use is consistent with this
purpose, and will reduce employer burden while increasing compliance
with the standard.
Other commenters were concerned that OSHA's use of an incident
trigger would doom those preexisting programs that involve what these
participants view as a more proactive method of identifying ergonomic
hazards (Ex. 500-1-452, Tr. 9070-74, 10630-32). But nothing in this
rule prohibits employers from taking action, analyzing jobs or setting
up an ergonomics program before MSD incidents are reported. And the
grandfather clause in paragraph (c) of this standard specifically
allows qualifying employers to continue their preexisting programs.
Based on the record, OSHA expects that many employers who have
established
[[Page 68307]]
ergonomics programs that do not rely on MSD reports to identify MSD
hazards will maintain those programs (Tr. 3130-33, 5539, 9070-74,
10631).
2. One MSD Trigger
A separate group of rulemaking participants complained that the
single-incident trigger in the proposal was too sensitive (Exs. 30-
2208, 31-324, 500-1-27, 500-1-28, 500-1-45, 500-1-128, 500-52, 500-75,
Tr. 5506-07). For instance, the Association of Independent Corrugated
Converters said that the ``one-incident threshold makes full coverage a
virtual certainty for virtually every sizable employer, and for the
vast majority of small employers'' (Ex. 500-1-128, Tr. 16930-31). The
National Tooling and Machining Association also said that a single MSD
incident was too low a threshold:
On its own, a single reported MSD might not be statistically
significant to warrant the corrective measures required by the
proposed regulation. NTMA contends that a trigger mechanism of at
least two MSDs should be the minimum threshold for the full program,
especially for small businesses (Ex. 500-2).
Jack Pohlman, of the American Foundryman's Society, added that a report
of one MSD ``is simply not indicative of systematic problems'' (Tr.
5636). Marathon Ashland Petroleum agreed, saying that a single incident
``is not reflective of the true nature of risk that exists in a given
facility'' (Tr. 5540). And the National Paint and Coating Association
complained that a one MSD trigger was biased against large employers
(Ex. 30-4340).
A number of commenters said that a one MSD trigger also would
unduly burden employers by requiring them to respond to ``every ache
and pain'' an employee reports (Exs. 30-4340, 500-1-18 (``a single
complaint of pain''), 500-1-385, 500-1-386, Tr. 8772 (``perceived minor
problems''), 12256). The National Telecommunications Safety Panel
testified:
Extremely minor conditions with little or no connection to the
workplace may trigger the standard in many facilities (Tr. 8774).
Several commenters said that the one MSD trigger ignores that ``unique
physical characteristics'' or ``predisposing medical conditions'' of
the worker may be involved (Exs. 30-328, 30-1651, 30-2208, Tr. 5560-
61). James Haney, of Wisconsin Manufacturers & Commerce, said:
Thus, the most injury- or illness-prone employee becomes the
benchmark for implementing the proposed standard's requirements (Ex.
500-1-27).
Finally, some commenters argued that imposing a one MSD trigger
would be very costly for employers (Exs. 30-2208, 30-4340, 500-1-26,
Tr. 8772). David Potts of the National Electrical Contractors
Association testified:
[B]ecause [of] the broad scope of what constitutes an MSD, the
program standard's coverage will be easily activated. As such, an
employer could be required to institute costly job analysis and
corrective actions as a result of a single injury illness to an
overly susceptible employee while all other employees in the same
operation or job location has no discernable adverse reaction.
Considering this hair trigger and that the Agency has only offered
general remediation measures in the proposed rule, small business
will surely face burdensome compliance responsibilities and
stressful decisions including where to best place their limited
resources (Tr. 5645).
These commenters urged the Agency to adopt a MSD trigger having a
higher threshold. A number of commenters urged OSHA to increase the
trigger to two or more MSDs (Ex. 30-3731-1, 500-2, 601-X-1). Other
commenters said that incidence rates should be used to trigger action
(Exs. 30-3845, 30-3853, 30-4137, 32-77-2, 500-1-128, Tr. 5370, 8842).
Several commenters recommended that the trigger be a ``pattern'' or
``cluster'' of MSDs or MSD reports (Ex. 32-330-1, 500-23-1, 500-92).
Paul Adams, director of ergonomics at Owens-Corning, suggested that
OSHA should adopt a set of alternative triggers from which employers
could choose (Tr. 10630, 10633).
OSHA believes many of these concerns resulted from a
misunderstanding of the screening criteria in the proposal. However,
the Agency also recognizes the validity of the concerns that those
screening criteria were not clear enough to provide adequate assistance
to employers trying to screen out non-work-related MSDs (Exs. 30-1722,
30-3956, 500-18, Tr. 8847, 16969-70). OSHA has addressed these concerns
through the new definition of ``MSD incident'' in paragraph (e)(1) and
the Basic Screening Tool in Table 1. The result is a single-incident
trigger that is only half of the standard's action trigger and does
not, by itself, require employers to implement a full ergonomics
program or impose other substantial obligations on them.
A single-MSD trigger is appropriate for this purpose. Most
important, a one MSD trigger is necessary to prevent the occurrence of
serious and disabling MSDs. There is abundant record evidence that
early detection and intervention can halt the progression of most MSDs,
and reduce their severity (Tr. 7687-88, Ex. 32-450-1). On the other
hand, where medical treatment and ergonomic interventions are delayed,
it is more likely that conservative treatment will be less effective or
will not even be an available option, or that the MSD condition will
not be reversible and the employee will be permanently disabled (Ex.
38-285). For example, if carpal tunnel syndrome and other nerve-related
MSDs go untreated long enough, damage to the nerves will be
irreversible (Ex. 37-17, Tr. 13349 (the nerve dies)). If OSHA included
a multiple-incident trigger, the first employee to be injured could
become permanently disabled while waiting for other MSDs to trigger the
employer's obligations to provide MSD management and ergonomic
intervention. This would be particularly likely in small businesses and
in workplaces where relatively few people perform the same job (Ex. 32-
450-1). In addition, not acting on the first MSD may discourage other
employees from reporting their MSD signs and symptoms (Ex. 32-450-1).
The use of a single MSD trigger is also consistent with employer
practice. Many employers testified that they respond to all employee
reports of injury or illness, including MSDs (Ex. 37-2, Tr. 5358, 5359-
60, 5503, 5539, 14707, 14739, 17312-13). Even employers who recommended
that OSHA adopt a multiple-incident trigger testified that they
themselves conduct investigations of every report of injury, including
MSD signs and symptoms (Tr. 2920, 5503, 5358). For example, James
Lancour, safety and health regulatory consultant with Southern Company
Services, testifying on behalf of Edison Electric Institute, said:
[We] have a reporting mechanism where signs and symptoms are
reported. Then we have, it's turned over to the industrial hygiene
group to go out and do a job assessment. And, again, depending upon
what they find out it may be something that can be unique to that
particular person or workstation, et cetera, or it may require more
in-depth analysis. So basically depending upon the job they take a
look at what they're trying to determine how simple or complex the
problem might be, and then go through and develop an assessment
protocol based on that operation (Tr. 2920).
When questioned, no employer testified that it was company policy to
wait until a second or third employee gets hurt in a job before
investigating the first injury. This suggests that employers understand
the importance of responding to each report of injury and, in practice,
do not consider it appropriate to ignore individual reports of injury.
Other evidence in the record also shows that a one MSD trigger
should not
[[Page 68308]]
impose an undue burden on employers. As discussed above, most small
manufacturing establishments do not experience any injuries or
illnesses in any given year (Exs. 30-542, 30-3167, 500-1-128, Tr. 2980,
3073, 3096). In fact, many establishments do not experience any
injuries or illnesses over a considerable period. According to a report
prepared for the Small Business Administration Office of Advocacy, 75
percent of manufacturing establishments with fewer than 11 employees,
50 percent with 11-50 employees, and 25 percent of those with 50-249
employees would experience almost no MSD incidents in any given 6-year
period. (See also Economic Analysis, chapters III and IV.) If this
standard were to adopt a multiple MSD requirement, particularly one
requiring at least two MSDs in the same job during a single year,
injured employees in many establishments might never be provided with
needed medical intervention or protection from additional injuries
because it would take so long for the triggering event to occur.
The changes in the definition of ``MSD incident,'' and the new
Basic Screening Tool, both discussed below, will also help to address
the concerns of some commenters that significant employer action will
be triggered by the report of ``any ache or pain,'' whether or not it
is work related (Exs. 30-1722, 30-2208, 30-3956, 500-52). P.J.
Edington, executive director of the Center for Office Technology, said:
OSHA assumes any discomfort on the job is work-related. That
leaves all employers in a continuous and costly cycle of trying to
eliminate all ``signs and symptoms'' of MSDs (Ex. 30-2208).
But employers have the right under this final rule to make
reasonable determinations that particular MSDs are not work related.
And only MSDs severe enough to require medical treatment or a job
restriction, or signs and symptoms persistent enough to last for seven
consecutive days, have any triggering effect. Moreover, the standard's
Basic Screening Tool establishes specific thresholds for the duration,
magnitude and frequency of exposure to risk factors that a job must
involve in order for an MSD incident in that job to be one that
triggers the standard's program requirements.
The final rule also takes into account the concerns of commenters
that a single incident trigger ignores the fact that an MSD may be
related to the ``unique physical characteristics'' of the worker (Exs.
30-328, 30-1651, 30-2208, 500-1-27, Tr. 5660-61). For example, where
the employer has reason to believe that only the injured employee is
exposed to awkward postures because he or she is very tall or very
short, the employer can limit the response to that individual
employee's job or workstation. See paragraph (j), below.
3. Definition of ``MSD Incident''
In this standard, the term ``MSD incident'' means either an MSD
that is work-related and:
Involves a work restriction, or
Requires medical treatment beyond first aid, or
Involves MSD signs or symptoms that are work-related and
persist for 7 or more consecutive days after the employee reports them
to the employer.
Work restriction is defined to mean one or more days away from
work, one or more days of limitations on the work activities of the
employee's current job or temporary transfer to alternative duty.
Reducing an employee's work requirements in a new job to reduce muscle
soreness from the use of muscle in an unfamiliar way is not considered
a work restriction under this final rule. Also, the day an employee
first reports an MSD is not considered a day away from work or a work
restriction even if the employee is temporarily removed from work to
recover.
Relationship to Recordkeeping Rule. The proposed rule defined a
``covered MSD'' as an OSHA recordable MSD that occurred in a job in
which the physical work activities and conditions were reasonably
likely to cause or contribute to that type of MSD, and those activities
and conditions were a core element or took up a significant amount of
the employee's worktime. In this final rule OSHA has changed the term
``covered MSD'' to ``MSD incident'' to dispel any implication that any
such MSD immediately triggers a full ergonomics program. Although some
participants found the definition of covered MSD to be ``relatively
clear'' (Exs. 30-3934, 30-4837; 31-173, 31-186, 31-205, 31-229, 31-
347), many more objected that it covered too many MSDs, was too vague,
or was improperly linked to OSHA's recordkeeping rule (Exs. 30-1364,
30-1722, 30-2088, 30-3167, 30-3845, 30-3956, 500-73, 500-104, 32-337-1,
Tr. 4366, 8226, 10000, 12797, 15977). The new definitions of MSD and
Action Trigger in this standard address these concerns.
OSHA received a great deal of comment on the proposal's use of an
OSHA-recordable MSD, i.e., an MSD required by 29 CFR Part 1904 to be
recorded on the employer's injury/illness log, as a trigger for further
action. Many of these comments pointed out potential problems that
could be caused by linking an employer's obligations under this
standard to obligations and interpretations contained in a separate
rule (Exs. 30-3853, 30-4137, 32-77-2, Tr. 10632). This problem was
highlighted by the facts that OSHA has proposed to amend its
recordkeeping rule, so that it has not been clear at any stage of this
ergonomics rulemaking what the definition of an OSHA-recordable MSD
would be, and that OSHA incorrectly described the recordability of one
class of MSDs in the proposal (Exs. 30-3853, 32-78-1, 32-300-1).
Moreover, according to commenters, linking the definition of MSD
incident to the recordkeeping regulations would give employers a strong
incentive to underreport MSDs or would punish employers who already
have effective early intervention programs (Exs. 30-46, 30-75, 30-137,
30-1294, 30-1902, 30-4137, Tr. 8848, 10630-32).
OSHA agrees that these concerns, particularly those related to the
ongoing recordkeeping rulemaking, outweigh any potential benefit
employers would gain from being able to use recordability criteria to
determine whether an MSD report triggers further action under this
standard. Therefore, in this final standard, OSHA has dropped any
reference to the recordkeeping rule's recordability criteria. Although
the definition of an MSD incident in this standard uses criteria
similar to those used in determining recordability, each of the
criteria used in this rule is supported by evidence in this rulemaking
record. This has also allowed OSHA to tailor the definition of an MSD
incident so that it more closely corresponds with the purposes of this
standard.
Definition of ``musculoskeletal disorder.'' For purposes of this
rule, an MSD is a disorder of the soft tissues, specifically of the
muscles, nerves, tendons, ligaments, joints, cartilage, blood vessels
and spinal discs that is not caused by a slip, trip, fall, or motor
vehicle accident. See paragraph (z). This standard covers MSDs
affecting the neck, shoulder, elbow, forearm, wrist, hand, back, knee,
ankle, and foot as well as abdominal hernias. It does not, however,
cover eye disorders, even when associated with jobs involving computer
monitors.
Although some commenters recommended that the standard address
conditions resulting from slips, trips, and falls (Ex. DC 58, DC 405),
those injuries are not caused by exposure to the risk factors this
standard covers. For the same reason the final rule does not cover
computer-related eyestrain, which
[[Page 68309]]
is caused by factors such as glare from lights and windows, computer
flicker and other monitor resolution problems, and by not blinking or
looking away from the screen (Tr. 16159-66).
``Work-related.'' In paragraph (z), ``work-related,'' is defined to
mean that a workplace exposure caused or contributed to an MSD incident
or significantly aggravated a pre-existing MSD. This is a change from
the proposal, which would have considered an MSD work-related if
physical work activities and conditions caused or contributed to an MSD
or aggravated a pre-existing one. Many commenters complained that the
proposed definition of work-related, in essence, established a
presumption of work-relatedness (Exs. 30-1722, 30-3934, 30-3956, DC65,
500-1-28). The Chamber of Commerce said that the rule should not cover
``minimal workplace exposure that merely aggravates non-work
exposures'' (Ex. 30-1722, p. 62). Mike Edmunds, corporate safety
director for Tyson Foods, said:
Even if upper extremity musculoskeletal pain (e.g., wrist pain)
arises solely as a result of non-work-related activities, it is
virtually impossible for an employer or physician to establish that
subsequent work activities did not in some minor way `aggravate' or
`contribute' in some way to the condition--regardless of the job
(Ex. 30-4137).
To address this concern, a number of commenters recommended
incorporating language from various State workers' compensation
regulations so that an MSD would be considered work-related only where
work was the predominant cause of the injury or was more than 50
percent responsible for the injury (Exs. 30-3934, 32-77-2, Tr. 5507).
Others recommended that OSHA adopt the definition of work-relatedness
from California's ergonomics standard, i.e., that work must be 51
percent responsible for the MSD (Ex. 32-300-1). Several suggested that
the MSD incident not include pre-existing MSDs (Tr. 3097-98).
OSHA believes that some of these concerns resulted from a
misunderstanding about what ``contribute to'' means. It does not mean
that an MSD is considered to be work-related if work contributes in
some de minimis (e.g., ``1% contribution'' (Ex. 30-3934)) or vague way.
Rather, work contributes to an MSD if a specific physical work activity
or condition can be identified as having contributed in some
discernable way to the onset of the MSD or the signs or symptoms of an
MSD. If nothing specific can be identified as a factor, then work is
not considered to have contributed to the MSD.
OSHA also has responded to concerns that, once an employee has an
MSD, minor aggravations of the MSD can occur very easily (Tr. 3315). In
the final rule, only ``significant'' aggravation of a pre-existing MSD
is considered to be an MSD incident. ``Significant aggravation'' occurs
only when risk factor exposures in the workplace aggravate a pre-
existing MSD to the extent that it results in an outcome that it would
not otherwise have caused. For example, workplace exposure is
considered to have significantly aggravated an employee's pre-existing
MSD if the MSD would have resolved on its own or with only first aid,
but because of the employee's exposure to identified risk factors in
the workplace, the MSD has progressed to the extent that medical
treatment is now necessary. On the other hand, if an employee
experiences more pain when at work, simply because the employee is
using an injured body part, that extra pain does not constitute
significant aggravation. In addition, workplace exposure aggravates an
MSD only where a specific physical work activity or condition can be
identified as a factor in the progression of the pre-existing MSD.
Although the employer is ultimately responsible for determining
whether an MSD is work-related, employers may consult with others, such
as HCPs or safety and health personnel at the workplace, in making that
determination. Where an employer uses an HCP to provide assistance in
determining the work-relatedness of an MSD, the HCP must use the
definition of work-related in this final rule and not criteria for
determining work-relatedness under workers' compensation.
Another frequent objection to the proposed definition was that it
did not establish an adequate severity threshold and, as a result,
would have captured all the ``aches and pains of life'' that employees
experience while performing work activities (Ex. 30-3956, see also Exs.
30-1722, 30-2208, Tr. 9824). The Chamber of Commerce said that MSD was
``so loosely defined as to cover unverified complaints of pain rather
than just objectively verifiable medical conditions'' (Ex. 30-1722, p.
61). The severity criteria in the final rule address this complaint. In
deciding to include within its definition only those MSDs resulting in
a work restriction, in medical treatment beyond first aid, and in MSD
signs or symptoms lasting at least 7 days after being reported to the
employer, OSHA is adopting appropriate medical severity thresholds.
Work restriction. A work restriction in this context means at least
one full day when the injured employee either must take off the entire
work day for recuperation or medical treatment, or is able to work for
only a portion of the workday or to perform only some job functions,
either regular or alternative tasks, during the recovery period. The
latter category includes job transfer, light duty jobs, and alternative
duty jobs. Employees who cannot work regularly scheduled or mandatory
overtime during the recovery period are also considered to be on work
restriction. Neither the initial day on which the MSD is reported or
occurred, nor any day on which the employee is not scheduled to work,
is counted as a day of work restriction.
On the other hand, the standard now makes clear that work
restrictions do not include situations where an employer adjusts the
work assignments to deal with the temporary muscle soreness that an
employee may experience as a result of starting a job that requires the
use of muscles in an unfamiliar way (paragraph (z)). The record
indicates that some employers have ``conditioning'' programs, most
often lasting about two weeks, to help employees adjust to this type of
new job assignment (64 FR 65955 (Case Study No. 2), (Exs. 26-1175, 30-
4340, Tr. 9225, 9403, 13589). These programs recognize that it is not
uncommon for employees to experience pain or stiffness when they begin
exercising muscle groups in new or more strenuous ways (Exs. 26-1175,
30-4340). In these situations, pain or soreness may not indicate the
presence of an MSD hazard. In most cases these symptoms resolve as the
employee becomes accustomed to the physical activities of the job (Ex.
26-1175). They do not indicate that a hazard needing to be controlled
may exist. OSHA believes that this clarification will help alleviate
the concerns of some commenters that the single-incident trigger would
not only trigger coverage of passing aches and pains, but could also
trigger WRP obligations for employees who experience symptoms while
they are becoming accustomed to a new job (Ex. 30-4340, Tr. 4316-17).
Medical conditions that result in work restrictions are widely
recognized as serious (Exs. 26-1039, 37-1, 37-12, 37-28). Repeatedly,
physicians and other HCPs testified that they consider MSDs that rise
to this level to warrant both medical evaluation and intervention and
job interventions (Exs. 37-1, 37-12, 37-28). Accepted standards of
clinical practice, reflected in guidelines published by medical
associations, also recommend intervention at least at this stage (Exs.
37-12, 500-34, 26-1039). For
[[Page 68310]]
example, guidelines on low back disorders (developed by a panel of
private sector clinicians for the Agency for Health Care Policy and
Research that recommend strategies for assessing and treating low back
problems) defined low back problems as ``activity intolerance due to
low back symptoms,'' such as pain (Ex. 26-1039, p. 1).
The insurance industry also considers conditions that are severe
enough to require work restrictions to constitute medical disability
(Exs. 37-1, 37-6, 37-12, 37-28). These conditions are often compensable
through workers' compensation, and insurance companies consider them to
be serious (Ex. 37-6). According to Stover Snook, former director of
the Ergonomics Laboratories at Liberty Mutual Insurance Company who
conducted ergonomics research at the company for more than 30 years,
the accepted definition of ``low back disability'' in the insurance
industry is ``lost time or restricted duty that results from low back
pain'' (Ex. 37-6, p. 3).
Medical treatment beyond first aid. The definition of MSD incident
includes MSD signs and symptoms that require medical treatment beyond
first aid. This is a familiar concept that is also used in OSHA's
recordkeeping regulation. It also makes no difference whether an
employee obtains medical treatment from his or her own HCP or one
selected by the employer; or whether the employee obtains medical
treatment before or after reporting the MSD signs or symptoms to the
employer. Physicians and other HCPs testified that MSDs that require
medical treatment such as physical therapy, prescription medication or
surgery are more serious than conditions where resting the injured body
area is enough to allow the injury to heal (Exs. 37-1, 37-12, 37-16,
37-17, 37-28).
Persistent MSD signs or symptoms. The third type of MSD incident is
MSD signs or symptoms that persist for at least 7 days after being
reported to the employer. ``MSD signs'' are defined in paragraph (z) as
objective physical findings that an employee may be developing an MSD.
MSD signs include deformity, decreased grip strength or range of
motion, and loss of function. Some signs are readily observable, for
instance, loss of function when an employee with carpal tunnel syndrome
cannot hold a powered hand tool because of muscle atrophy in the hand.
Other signs, commenters said, may not be as observable to non-HCPs (Tr.
7677). For this and other reasons, MSD signs are treated in the same
way as MSD symptoms in the final rule. Under the proposed rule, any MSD
sign would have been a ``covered MSD'' because it is a recordable event
under OSHA's recordkeeping rule. This raised concerns for a number of
commenters, who pointed out that some signs, such as redness, may be
mild and transitory, not warranting a full program response (Exs. 30-
3344, 30-3749, 30-4674, 32-211).
``MSD symptoms,'' as defined in paragraph (z), are other physical
indications that an employee may be developing an MSD. Symptoms include
pain, numbness, tingling, burning, cramping, and stiffness. The
proposed rule would only have addressed persistent symptoms in
manufacturing and manual handling jobs, and then only if the employer
knew that an MSD hazard existed in the injured employee's job.
A number of commenters opposed the proposal's inclusion of
persistent symptoms in its trigger mechanism (Exs. 30-623, 30-898, 30-
1722, 30-4777, 30-4821, 32-78, Tr. 10634). Some recommended at least
limiting the types of symptoms included in the definition of an MSD
incident (Ex. 32-78, Tr. 10634). For example, ORC said:
At a minimum, * * * OSHA must limit coverage to those symptoms
that can be medically verified and that fall somewhere in the
severity range between minor/transient and severe enough to
interfere materially with job performance (Ex. 32-78, p. 17).
Other commenters, however, agreed with the inclusion of persistent
symptoms in the incident trigger (Ex. 500-218, Tr. 12295), and
virtually all of those urged OSHA to extend this criterion to all jobs,
not just those in manufacturing and manual handling (Exs. 32-198, 500-
218). A number of HCPs were among those supporting, including
persistent signs and symptoms in the MSD incident trigger (Exs. 37-1,
37-12, 37-28, Tr. 7660, 13349). They said that persistent signs and
symptoms should be evaluated because, left untreated, they often
progress into more serious disorders and permanent damage (Tr. 7660,
7884, see also Ex. 32-450-1). One study has shown that employees
experiencing MSD symptoms alone are at approximately 2 to 4 times the
risk of being off work as employees without such symptoms (Ex. 500-71-
27). A number of employers now encourage employees to report signs and
symptoms to prevent such results and related costs (Tr. 5539, 5550,
14707, 14739).
The record establishes clearly that MSD signs and symptoms that
persist uninterrupted warrant further investigation (Ex. 30-4468, 500-
71-27, 37-12, Tr. 1531, 13382, 1763-65). Sound medical judgment
supports intervening when an employee has experienced at least a week
of MSD signs or symptoms. Dr. Bradley Evanoff, Assistant Professor of
Medicine at Washington University School of Medicine specializing in
research and clinical practice addressing occupational MSDs, testified:
I think whatever the occupation, whatever the type of work, if
someone has had persistent musculoskeletal symptoms for some period
[of] time, and I think a week is a reasonable period of time, then
they should be evaluated to see if they have a musculoskeletal
disorder (Tr. 1531).
Dr. Robin Herbert, medical director of the Mount Sinai Center for
Occupational and Environmental Medicine, testified that providing early
intervention for employees whose symptoms persist beyond a few days is
``consistent with accepted medical practice'' (Tr. 1653). In fact,
according to ACOEM, such intervention is ``essential'' (Ex. 30-4468).
Dr. Robert Harrison, who has treated more than 1,000 patients with
work-related MSDs over the past 20 years, and has also conducted
research in the area of work-related MSDs, testified that there is
``broad consensus among the medical profession that effective treatment
and prevention of MSDs relies on early reporting of symptoms. * * *''
(Ex. 37-12). He also summed up why 7 days is an appropriate threshold:
[S]even days is early enough to catch the symptoms early but is
late enough so that transient symptoms that may last only two or
three days don't come through as a reportable symptom to a health
care provider. I think it's a reasonable line (Tr. 1764).
The record shows that where signs and symptoms persist beyond a few
days, they are likely to indicate that an MSD has occurred. Dr. Gary
Franklin confirmed that MSDs can develop in a very short period of
time:
If I was taking the history of the person and getting these
kinds of symptoms of numbness and tingling and burning particularly
at night, it would not matter to me whether it was two days or seven
days or 14 days, if I thought clinically the symptoms were correct.
I have seen patients that developed [carpal tunnel syndrome] in a
day or two (Tr. 13382).
HCPs also testified that employees who have had MSD signs or symptoms
for only a short period of time can already be experiencing physiologic
changes or damage (Ex. 37-16). For instance, Dr. Evanoff testified:
I think people who have prolonged symptoms, lasting more than a
few days * * * if you want to use the cut off of a week
[[Continued on page 68311]]
[[pp. 68311-68360]] Ergonomics Program
[[Continued from page 68310]]
[[Page 68311]]
or more, I think that that's very likely to represent some
underlying tissue damage. * * * (Tr. 1563).
Peter Boyle, former professor of orthopedic physical therapy, agreed:
A large amount of force in a short time could create a
pathoanatomic injury causing disruption, and [tissue] failure (Tr.
2797-98).
In addition, persistent signs and symptoms can themselves be severe
enough to interfere significantly with major life activities (Tr.
13356. 13360, 13373). Dr. Connell testified:
A typical carpal tunnel patient would come in complaining of
numbness and tingling in the distribution of the median nerve.
Typically it occurs initially at night and wakes one out of a sleep
for some reason--4 a.m. seems to be the magic number (Tr. 2817).
Moreover, the persistence of signs and symptoms can be an
indication that an MSD is worsening, and early detection and
intervention are ``critical to prevention of more serious disorders,''
in the words of Dr. Robert McCunney, president of the American College
of Occupational and Environmental Medicine (ACOEM) (Tr. 7660). Dr. Marc
Connell, an orthopedic surgeon at Georgetown University Hospital,
added: ``I think that's common medical sense that the earlier the
treatment is rendered the less severe will be the MSD'' (Tr. 2833). Dr.
Edward Bernacki, vice-president of ACOEM, said:
Obviously, the earlier you pick up a problem, the more
reversible it is, so obviously, the encouragement of employees to
come in at the first signs of a problem, so that we could work it
up, and then basically start treating the illness when it is
reversible, in other words, if you have irreversible nerve damage,
that is basically too late. Then, you need surgical intervention.
However, for example, in carpal tunnel early on when the disease is
reversible, mere splinting and restriction of activities are fine,
it takes care of the problem, it disappears (Tr. 7687-88).
(See also Exs. 26-1367, 32-450-1, 37-24, Tr. 1530, 1697-98, 2853, 2833,
7649-50, 7687-88, 7883-84, 9831.)
In addition to reducing the severity of MSDs, early intervention
has been shown to reduce MSD rates and associated medical costs (Exs.
32-12, 32-339-1-87, 32-399-1-4, 32-450-1 (citing Hales et al. 1993)).
Dr. Bernacki described a study of the effect on 22,000 employees at
Johns Hopkins Hospital and University of an ergonomics program that
stressed early reporting of MSD signs and symptoms (Ex. 32-399-1-4, Tr.
7691-92). The study reported an 80 percent reduction in MSDs after the
program and early intervention were implemented.
Early intervention also increases the availability and
effectiveness of conservative therapy. Several HCPs told OSHA that,
when MSDs are treated early, symptoms ``have been completely resolved
with a brief period of restricted work activities'' (Ex. 37-12, Tr.
13345-46). Dr. Harrison said:
Employees often rapidly and completely recover from their MSD
with simple modification of the work process or change of job duties
to minimize or reduce exposure to ergonomic risk factors (Ex. 37-12,
p. 5).
Dr. Franklin added that where employees with carpal tunnel syndrome are
provided with early intervention they should be able to return right
away to modified work and that work restrictions should not be needed
for a prolonged period of time (Tr. 13345-46). Dr. Bernacki testified
that, as a result of the early reporting and intervention program at
Johns Hopkins, there had been only one surgery for work-related carpal
tunnel syndrome during the past 5 years, compared with 26 such
surgeries in the previous three years (Exs. 32-399-1-4, p. 7-8).
Early intervention also is likely to be more effective in helping
patients recover fully (Exs. 37-12, 38-222, 38-451, 500-71-57). Dr.
Harrison said:
At an early stage of symptom management, treatment with anti-
inflammatory medications, splints, and rest of the affected body
part often results in complete clinical improvement without any
permanent injury (Ex. 37-12, p. 5).
Dr. Michael Erdil, medical director of the Connecticut Occupational
Health Network, said that both scientific evidence and his own clinical
experience show that conservative therapy is much more likely to be
effective as an early intervention (Ex. 37-16, citing Kruger et al.
(1991) (Ex. 26-910), Gelberman et al. (Ex. 26-916) (1980), Quebec
(1987), Zigenfus et al. (2000) (Ex. 38-285). Zigenfus found that
patients with low back injuries who were provided with medical
treatment earlier (i.e., less than 8 days after injury) required fewer
days away from work and restricted work and had shorter case duration
(Ex. 38-285). Dr. Evanoff explained that the medical literature
consistently shows that:
[C]onservative management of MSDs is most effective when begun
in early stages of these disorders, and that patients who are
treated only after a prolonged symptomatic period are less likely to
respond favorably than those treated earlier (Ex. 37-1, citing
Dellon (1989), Stern (1990), Rystrom & Eversman (1991)).
Similarly, Dr. McCunney of ACOEM testified that:
ACOEM supports the requirement of a mechanism for employees to
report MSD signs and symptoms since early detection is critical * *
* [M]y colleague and I can regale you with all sorts of anecdotes
about people who have waited too long to seek medical treatment, and
then once they come for medical treatment, the treatment is not as
effective as it could have been were they to have come earlier (Tr.
7649-50).
Dr. Harrison discussed the case of one worker who did not receive early
intervention:
[A] twenty-five year old machine operator recently came into my
office for treatment of severe hand pain and swelling. She had
worked 9 months in a job that required her to use excessive force to
press a lever over 20,000 times per day, using her hands in a pinch
grip with her wrist in an awkward posture. She had developed
symptoms after three months of work, but had not seen a health care
provider after her supervisor told her that she would ``feel
better'' after she ``got used to the job.'' By the time she finally
came to see me, she was unable to drive her car, shake my hand or
open a door. My examination showed marked swelling and redness of
the right wrist, and the pain was so severe she cried [at] my touch
or gentle movement. My diagnosis was chronic, stenosing
tenosynovitis. I had little option but to remove her from work
completely for four weeks to let the hand rest. Unfortunately, she
was unable to return to work in spite of corticosteroid injections,
splints, analgesic medication and physical therapy. She required
surgery to release the tendon, and is now in a prolonged
rehabilitation program.
This case is not unusual. (Ex. 37-12).
By including persistent signs and symptoms within the standard's
definition of an MSD incident, OSHA assures that early intervention can
occur and that medical outcomes like that described by Dr. Harrison
will not occur.
For these reasons, a number of HCPs and employers said that they
investigate MSD signs or symptoms as soon as they are reported (Exs.
30-390, 30-398, 500-218, Tr. 5539, 5550, 9906, 13382). Dr. Franklin
stated:
If I was taking the history from the person and getting these
kinds of symptoms of numbness and tingling and burning particularly
at night, it would not matter to me whether it was two days or seven
days or 14 days, if I thought clinically the symptoms were correct.
I have seen patients that developed [carpal tunnel] in a day or two
(Tr. 13382).
Several employers said that their standard response is to investigate
any report of MSD signs or symptoms (Tr. 5539, 5550, 14715-16). Sean
Cady, of Levi Straus & Co., said:
Well we believe that symptoms could be precursors to a possible
repetitive motion injury. And therefore if we know about a symptom
early we can evaluate a job for ergonomic risk factors and possibly
modify that job to reduce risk factors prior to the
[[Page 68312]]
possible occurrence of an injury. And also, early reporting of
symptoms is a trigger for our quick response system or quick
response process (Tr. 14715-16).
Some employers provide restricted work when an employee reports MSD
signs or symptoms to let the symptoms resolve quickly without medical
treatment, and to allow the employer to examine the job (Ex. 26-1370).
Other employers said their standard practice is to send any employee
who reports MSD signs or symptoms to an HCP immediately (Tr. 3867).
These employers told OSHA that their early intervention programs,
particularly restricted work and light duty, have proven to reduce the
severity and costs of MSDs significantly (Ex. 30-4137). Even after the
rule becomes effective, OSHA believes that employers who have seen the
advantage and effectiveness of such intervention programs will continue
to follow them rather than delaying intervention while they wait to see
whether the employee's MSD signs or symptoms persist. However, for
those employers who have not yet implemented early intervention
programs, including the persistent signs and symptoms criterion in the
final rule will help to ensure that employees are provided with
appropriate MSD management and work restrictions while their condition
is still reversible.
This evidence is part of the reason that OSHA does not agree with
the commenters who argued that signs and symptoms are too subjective
and difficult to verify to be an appropriate trigger for action under
this standard (Exs. 30-1722, 30-3345, 30-4340, 500-1-23, 500-1-117, Tr.
5507). Other evidence establishes that MSD signs are often easily
observable (Tr. 2828). For example, an employee's decreased range of
motion can be identified by the employee's inability to raise his arms
above his shoulders or to bend over to lift an object. Objective
physical findings also include positive results on medical tests such
as nerve conduction velocity tests, CT scans, or x-rays.
The presence of MSD symptoms can also be confirmed through physical
examination by an HCP (Ex. 37-12, 37-28, Tr. 13404). Dr. Robert
Harrison testified that there are several ways to confirm the presence
of both MSD signs and symptoms, including palpation or movement of the
affected body part during the physical examination (Ex. 37-12). Dr.
Gary Franklin, of the University of Washington School of Public Health
and Community Medicine, testified that symptoms of carpal tunnel
syndrome, for instance, can be verified through absence of reflexes and
nerve conduction tests and even the Katz hand paint diagram (Tr. 13380,
13404). According to Dr. Franklin, the best case definition of carpal
tunnel syndrome is the presence of symptoms plus a positive nerve
conduction test. However, Dr. Franklin also said that in some
circumstances HCPs can reliably determine, based on symptoms alone,
whether a patient has carpal tunnel syndrome: ``one could make a
reasonable determination based on symptoms alone if you thought it was
possible that somebody had carpal tunnel syndrome.'' (Tr. 13384-88).
Dr. Margit Bleecker, Director of the Center for Occupational and
Environmental Neurology at Johns Hopkins University, testified:
I think as somebody who has worked many years in this area, you
certainly can diagnose carpal tunnel syndrome by the history and the
physical examination. The only time that you absolutely need to have
the EMG is if you're considering surgery (Tr. 16901).
Dr. George Piligian, who is with the Mount Sinai Center for
Occupational and Environmental Medicine and for the past 10 years has
been treating workers with MSDs, added:
We use principles in medicine, and as you may or may not know,
80 percent of medical diagnoses, all medical diagnoses, not just
work-related ones, are arrived at by history and complaints. Then,
we add to them, the physical diagnosis, and finally, the testing.
This has been the way medicine has gone on for ages, and those who
have written the most respectable textbooks say that, and many
doctors who go right to the objective number, which they worship,
and leave out those 80 percent arrive at the wrong diagnosis, and
thereby give the wrong treatment. So, it is still seeing, listening,
recording, putting it all together that arrives at the medical
diagnosis, and they can be arrived at (Tr. 7851-52).
OSHA has, however, responded to the comments that certain MSD
signs, such as redness, may be transient or may be a sign of something
other than an MSD (Tr. 5507). As mentioned, in this final rule, MSD
signs are treated the same way as MSD symptoms, so that only those
signs that persist for 7 days after being reported to the employer or
that meet the other severity criteria require further action. The
proposal would have required action whenever an employee reported an
MSD sign because all positive signs must be recorded under OSHA's
recordkeeping rule. OSHA has also eliminated the reference in the
proposal to Finkelstein's, Phalen's and Tinel's tests as examples of
the kinds of positive tests that would constitute MSD signs. The record
shows that these tests are not considered reliable by a growing number
of HCPs and, in any event, have been replaced with other medical tests
such as nerve conduction tests (Ex. 37-2, Tr. 13363, 13375).
Other differences between the proposed definition of a ``covered
MSD'' and this final standard's definition of an ``MSD incident''
further show OSHA's intent not to address the type of minor and
transient symptoms that can be expected to resolve spontaneously in a
matter of days even without intervention. The final rule, unlike the
proposal, does not include the diagnosis of an MSD in the definition of
MSD incident. As mentioned, the standard also now makes clear that an
MSD is not work-related unless workplace exposures caused or
contributed to it, or were responsible for a significant aggravation of
a preexisting injury. These changes respond to comments that the
proposal could have required a full ergonomics program in situations
where workplace exposures contributed only trivially to the employee's
condition (Exs. 30-1722, 30-3934, 30-3956, 500-73, Tr. 3097-98).
Clearly, MSDs qualifying as MSD incidents under the definition in
the final rule are the types of conditions that OSHA may act to
prevent. See Occupational Noise Exposure (29 CFR 1910.95, 46 FR 46236),
Occupational Exposure to Formaldehyde (29 CFR 1910.1048, 52 FR 46168,
46234-37), and Section VII (Significance of Risk) of the Preamble. It
is even more clearly within OSHA's authority to require employees to
investigate them further to determine whether they were caused by
hazards that this standard addresses.
Paragraph (f)--How Do I Determine Whether the Employee's Job Meets the
Action Trigger?
Paragraph (f) tells employers how to determine whether a job where
an MSD incident has occurred meets the standard's two-part Action
Trigger. According to paragraph (f)(1)(i), the first part of the Action
Trigger is a determination that an MSD incident has occurred. Paragraph
(f)(1)(ii) states that the second step is a determination that the
injured employee's job meets the Basic Screening Tool in Table 1 of
this standard. Paragraph (f)(2) explains that if the job does not meet
the Action Trigger, the employer has no further obligations with
respect to that job.
The second step of the action trigger requires application of the
Basic Screening Tool in Table 1 to the injured employee's job. A job is
screened in, i.e., is determined to meet the levels in the Basic
Screening Tool, if it regularly involves exposure to one or more of the
risk factors in the Basic Screening Tool at levels above those
specified in the tool. Only where the job is screened in
[[Page 68313]]
does the employer have further obligations under the standard.
The proposed rule also included an exposure screen. The proposed
screen would have ruled out jobs where the ``physical work activities
and conditions'' in the job were not associated with the ``type of MSD
reported,'' or were not ``reasonably likely'' to cause or contribute to
an MSD. It also would have ruled out jobs in which the employee's
exposure to the risk factors was not a ``core'' element of his or her
job, or did not make up a ``significant'' amount of the employee's
workday.
Thus, the proposed standard contained performance-oriented language
(``core element,'' ``significant amount'' of time) to define the terms
of the screening criteria. In the preamble to the proposal, OSHA also
used performance-oriented language in discussing the meaning of core
element, describing the term as a ``regular and routine exposure.'' On
the whole, most commenters supported the concept of an exposure screen,
but many said that OSHA had not provided enough guidance for them to
understand when a nexus existed between an MSD and a job or what the
exposure severity threshold was for a job. For example, they complained
that the terms were too vague and undefined to answer those questions
(see, e.g., Exs. 30-1722, 30-3032, 30-3853, 30-3956, 30-4340, 30-4837,
31-92, 31-125, 31-223, 31-225, 31-260, 31-307, 30-300, 32-337, DC66,
Tr. 3337, 8849, 8850).
The following comments are representative:
The terms ``core element'' and ``significant amount'' are not
clear. While extreme examples can be easily defined, extreme
examples are few and far between in the real world. Most of the
time, examples fall into ``grey'' areas. These terms either need
specific definitions or should be replaced with other terms (Ex. 30-
4837).
Does [core element] indicate that the employee will be required
to perform a manual handling task some time during his/her shift,
i.e., one 50-lb. Lift throughout an 8-hour work shift, or does it
indicate that some repetition is involved with the manual handling
portion of the task, i.e., lifting 20 10-lb. packages per hour for 8
hours? (Ex. 30-4837).
How much is significant? 6 hours per 8-hr shift? 4 hours per 8-
hr. shift? 2 hours per 8-hr. shift? Or 22-hr. periods per 8-hr.
shift? (Ex. 30-4837).
The Rohm and Haas Company said:
[I]t is unclear what OSHA means by the subjective terms used as
shown below. ``* * * significant amount of their worktime * * *'' *
* * [and] ``* * * core element of the employee's job.'' It is
unclear how OSHA would be able to determine consistently the
applicability of the standard in specific situations in the absence
of a criteria to guide decision-making on whether the work time was
significant, the applied force was forceful, or whether the material
handling was a core element of the employee's job. * * * In the
absence of an explanation of what OSHA intends these subjective
terms to mean, it is unclear how to decide whether a particular
activity fits the definitions and therefore whether it is covered by
the standard. (Ex. 31-289)
National Small Business United testified that:
The employers, especially the smaller employer, * * * needs more
specific guidance in terms of the types of jobs to be looking at and
specifically as the types of activities in those jobs and how much
of what kind of activities is too much for what type of person. (Tr.
2746)
Con Ed stated:
Throughout the standard, OSHA uses terms that are vague and open
to interpretation such as: reasonably likely, core job element and
other similar terms. These terms require clarification so OSHA and
employers interpret them consistently. (Tr. at 4628)
In addition, ORC added that:
The proposed trigger simply does not fulfill OSHA's
responsibility to provide adequate guidance with respect to
employer's obligations. * * * OSHA must do a better job of defining
a point at which an employer's obligations are triggered and do a
better job in establishing more objective criteria. (Tr. at 4097)
Similar comments were submitted by EEI (Ex. 32-300-1); Chamber of
Commerce (Ex. 500-188; Tr. at 3044), Color Works (Tr. at 10069),
Indiana Chamber of Commerce (Tr. at 3335), National Roofing Contractors
Association (Tr. at 4905), Food Distributors International (Tr. at
5634-35), and many others.
Commenters further recommended that the screening criteria should
include specific, exposure-based criteria (Ex. 500-218; Ex. 500-214,
Tr. at 17905-6). In particular, ORC stated that:
In place of the proposed screening criteria of section 902, OSHA
would set forth flexible, but objective, risk-based criteria * * *
(Ex. 500-214)
ORC added that such criteria are already contained in the record and
that ``a number of models to define at-risk conditions and work
routines are available in the literature and are cited by OSHA in its
preamble.'' (Ex. 32-78-1)
Similarly, the AFL-CIO stated:
While we believe the content and intent of OSH's proposed
screening criteria were clear from the text and Preamble of the
proposed rule, the AFL-CIO has several recommendations for ways in
which OSHA can respond to industry's requests for more specific
guidance and definitions. We recommend two possible approaches. The
first is to incorporate a list of risk factors and criteria similar
to the ``caution zone job'' criteria included in the state of
Washington's Ergonomic Standard (WAC 296-62-0515) which serve a
similar purpose as the screening criteria in the federal OSHA
proposal. These ``caution zone job'' criteria provide more specific
definitions of risk factors and the amount of time or frequency that
must be exceeded for these risk factors to be covered by the
standard. (Ex. 500-218)
ORC also expressed qualified support for using the state of
Washington's ``caution zone job'' criteria:
Although the Washington State proposal itself contains
significant deficiencies, ORC believes its approach to providing
quantified alternative triggers is a rational one that could be
considered by OSHA. (Ex. 32-78-1)
See also Tr. 9071-74.
A preliminary exposure-based assessment as a trigger for further
actions is also widely used by participants in the rulemaking who
provided testimony on the specifics of their own ergonomics programs
(see, e.g., Ex. 32-300-1, Tr. at 2920-2927; Tr. at 5302, Tr. at 10802;
Tr. at 14142; Ex. 32-339-1-4, Tr. at 16839; Tr. at 4643-4647; Tr. at
5539-5540, 5566-5567, Tr. at 14801; Tr. at 14715). Many of these
commenters use a checklist format which contained specific descriptions
of risk factors. The Dow Chemical Company, for example, uses a short
checklist printed on a pocket size card that contains descriptions of
specific risk factors along with a duration/timing component (see,
e.g., Tr. 5311-5312, 5359, Ex. 32-77-2-1). NIOSH's Elements of an
Ergonomics Program (Ex. 26-2), also contains checklists that have
specific descriptions of risk factors, some with a duration component.
A number of other participants also suggested that OSHA adopt
quantitative methods of defining the screen (Ex. 30-46, 30-75, 30-137,
30-293, 30-328, 30-3032, 30-3284, 30-4837, 31-23, 31-27, 31-95, 31-137,
31-187, 31-31-202, 31-301, 31-307, 31-337). Specific suggestions
included defining a core element of manual handling jobs in terms of
frequency rates for lifts (Ex. 31-337), or saying lifting was a core
element of a job that required one lift per hour (Ex. 31-259).
Suggestions for a definition of the term ``significant amount of
worktime'' included 50 percent or more of the employee's worktime,
Southern California Edison (Ex. 31-23), more than 2 hours a day, UNITE
(Ex. 32-198), or routine performance of the same task 4 hours or more
per shift or 2 hours or more
[[Page 68314]]
continuously per shift, Monsanto (Ex. 30-434).
Some commenters thought that the screen would require them to
conduct a job hazard analysis every time an MSD was reported, just to
know whether the MSD was reasonably likely to have been caused by the
job. Rodney Smith of Freeborn & Peters said:
Identifying ergonomic risk factors is difficult due to the
vagueness of their definition [in the proposed rule]. But how in the
world does my employer tell whether those risk factors constitute a
hazard, as that term has been defined in the standard. That is, risk
factors reasonably likely to cause or contribute to a covered MSD
(Tr. 8850).
Others also complained that it would be virtually impossible for them
ever to establish that it was not reasonably likely that exposure to
risk factors in a job could cause MSDs, when at least one MSD would
have already occurred (Ex. 30-1722, 30-4137, DC 65). In addition,
several commenters found the crucial terms ``extremely subjective,''
and believed they would be ``open to the individual interpretation of
OSHA inspectors'' (Ex. 30-3032, 31-22, 31-303, 31-307, 32-337).
In response to those and other comments, OSHA has further clarified
and operationalized the proposed exposure screen, or severity
threshold. Once the employer determines that an MSD incident has
occurred in a job, the employer must screen the job to determine
whether it meets criteria requiring a job hazard analysis to determine
the potential hazard associated with exposure to risk factors. For ease
of use, the criteria are presented in a ``Basic Screening Tool,'' which
is a chart that contains specific descriptions of the risk factors
covered in the final rule along with duration specifications and
illustrations (see Table 1 of the regulatory text). In jobs where an
MSD incident has occurred and employee exposure to risk factors meets
the criteria laid out in the screen, the employer must proceed with the
program requirements in paragraph (g) of the standard.
Employers with employees who report MSDs in jobs that do not meet
the specific screening criteria are not required to proceed with any of
the remaining requirements of the standard. This could include jobs
that do not involve the risk factors this standard covers or where the
injured employee's work activities do not involve the injured body
area. The screen also allows employers to screen out jobs in which the
employee's work activities do not involve enough exposure to risk
factors to require further action under this standard. In these cases,
the employer need not perform a job hazard analysis, eliminate or
control any MSD hazards, or provide training or MSD management. Where
application of the screening tool results in a job being screened in,
however, employers must implement the ergonomics program described in
paragraph (g).
The Basic Screening Tool has been designed to minimize employer
burdens in screening jobs. It is similar to a number of screening tools
that are already in use (Exs. 26-1008 (Snook Push/Pull Tables), 32-77-
1-2 and Tr. 5336-37 (Dow Chemical), 502-12 (NIOSH Lifting Equation),
502-35 (GM-UAW checklist)). It is limited to five risk factors and, to
streamline the screening process, the tool applies the same duration
criteria to almost every risk factor/activity.
The Basic Screening Tool in the final standard serves the same
function as the screen in the proposed rule, but, instead of
performance language, it contains specific definitions of the risk
factors and exposure durations that define a job requiring further
analysis. The definitions used in this chart are consistent with a
number of approaches and screening tools contained in the rulemaking
record, including the state of Washington's Ergonomic Standard's
``caution zone job'' checklist (Ex. 500-41); the checklists contained
in the NIOSH Elements of an Ergonomics Program (Ex. 26-2); the
checklist developed by tripartite committee of employer, employees and
government representatives for use in conducting a preliminary job
analysis under the British Columbia Ergonomics Standard (Ex. OR-388);
and others (Exs. 500-108; 32-77-2-1, 26-2, OR-348-1; 502-67)
By utilizing language from programs and checklists that have been
used successfully by both employers and employees for many years, OSHA
fully anticipates that employers will have no difficulty in determining
whether a job meets the standard's Action Trigger. Further, as with the
proposed rule, OSHA expects that employers will be able to determine,
quickly and efficiently, if the job activities of any employee
reporting a MSD meet or exceed the criteria of the screen.
Similar to the concept expressed in the proposed rule, the basic
screening tool in the final standard, when coupled with the occurrence
of an MSD incident in a specific job, represents an exposure-based
``action trigger'', that requires the employer to proceed with some
other provisions of the standard (in particular, job hazard analysis
and MSD management). However, jobs where the employer has determined
that an MSD incident occurred and that meet the screening criteria do
not necessarily require corrective action; the need for corrective
action is based on the results of a more detailed job hazard analysis
(see Summary and Explanation, Job Hazard Analysis section). In this
way, the screening criteria concept is similar to action levels
contained in OSHA's health standards (e.g., Benzene, 29 CFR 190.1028;
Ethylene Oxide, 29 CFR 1910.1047; Formaldehyde, 1910.1048.) In those
standards, as in the final ergonomic program standard, the inclusion of
an action level is used to differentiate between more hazardous and
less hazardous work operations, and to identify those operations where
the employer needs to focus resources.
The screening criteria in the final standard consist of the five
risk factors that are covered in the final rule: repetition, force,
awkward postures, contact stress, and vibration. Most of the screening
tools submitted to the record contained similar risk factors. For
example, the screening tools submitted by NIOSH (Ex. 32-30-1-45), UFCW
(Ex. IL-228), the AFL-CIO (Ex. 500-71-70), the Worker's Compensation
Board of British Columbia (Ex. 500-142-12), the UAW/General Motors (Ex.
Or 348-1), Dow (Ex. 502-77-2-1), and the Washington State Department of
Labor and Industries (Ex. 502-313-6) included these same five risk
factors as specific risk categories in their screens or included
narrative questions directly related to or incorporating these same
risk factors. In addition, these are the risk factors addressed in the
epidemiological literature on ergonomics and discussed in the Health
Effects section (Section V) of this preamble.
The proposal also included static postures, whole body vibration,
and cold in the list of risk factors. The evidence discussed in the
Health Effects section of this Preamble has convinced OSHA that these
risk factors should no longer be addressed independently. Static
postures will be covered to some extent by the awkward postures element
of the screen, and employers should be aware that cold temperatures may
aggravate the effects of other risk factors.
To give further guidance to employers, each risk factor in the
chart is clearly described (i.e., descriptions of specific job or task
activities) and includes specific duration, frequency. and magnitude
components. In the chart, repetition includes a separate description
for keyboarding/mouse use; force is broken down into lifting, pushing/
pulling, and pinching and gripping unsupported objects of specified
weights; awkward postures are defined by specific postures, as well as
[[Page 68315]]
pictures; and vibration includes a description for both high vibration
levels from equipment such as chainsaws, and moderate vibration levels
from equipment such as jigsaws, grinders or sanders.
In addition, the chart contains a simple grid for employers to use
in relating the body area affected by an MSD incident to a relevant
risk factor. Thus, the grid serves to further simplify this initial
determination by assisting the employer in focusing on only those risk
factors that have a clear nexus with the MSD incident that triggered
the use of the screening tool; this also reflects OSHA's intent in the
proposal. For example, if an MSD of the back or lower extremity is
reported, the employer, when evaluating the risk factor for repetition,
would focus only on job or task activities where the employee is
performing the same motions every few seconds or repeating a cycle of
motions involving the affected body part more than twice per minute for
more than 2 consecutive hours in a workday. The employer would not need
to consider use of a keyboard and/or mouse in steady manner (the shaded
portion of the chart under the risk factor repetition). Similarly, for
a reported MSD affecting the back or lower extremity, the employer,
when evaluating the risk factor for force, would only need to focus on
job or task activities involving lifting or pushing/pulling and not on
work tasks involving pinching or gripping.
Each job or task activity also includes a duration/frequency limit.
In selecting the duration limit for the risk factors, OSHA based its
decision on balancing the weight of the scientific evidence against the
need for the screening tool to be clear and easy to use. For many items
in the chart, the agency has chosen to use more than 2 hours total per
day as an exposure duration that triggers jobs for job hazard analysis;
this determination is based on an analysis of relevant epidemiological
data contained in the rulemaking record.
Many studies in the epidemiological literature clearly demonstrate
that the incidence of MSDs increase with increased duration of exposure
to certain risk factors or a combination of risk factors. Table IV--
SCREEN lists studies that included duration, either qualitatively or
quantitatively, as a component of the investigation. These studies
reflect a subset of the many studies identified by the Agency that
demonstrate positive exposure-response relationships between the
intensity and/or duration of exposure to biomechanical risk factors and
the prevalence or incidence of MSDs. The results of these studies show
increases in odds ratios or other risk measures with increases in the
daily or weekly duration of exposure for a number of risk factors such
as repetitive precision movements, awkward postures (e.g., hands above
the shoulders, kneeling, stooping), gripping, lifting, and carrying.
For example, Ekberg et al. (Ex. 26-1238) reported that the risk of MSDs
of the neck and shoulder increased with the hours per day that
repetitive precision movements were performed and that arms were lifted
above the head. Similarly, Kelsey et al. (Ex. 26-709) reported an
increased risk of prolapsed lumbar disc when the frequency of lifting
or carrying loads greater than approximately 25 pounds increased from 0
to more than 25 times per day. Similar dose-response observations were
reported by Latza et al. (Ex. 38-424), Matsui et al. (Ex. 26-309),
Smedley et al. (Ex. 500-41-40) and Tola et al. (Ex. 26-1018).
OSHA's review of the studies that quantified duration of exposure
indicate that, in general, the MSD risk in exposed groups of workers
increases above that in unexposed groups when the duration of exposure
to certain risk factors or combinations of risk factors comprises about
one-fourth to one-half of the workday or workweek. For example,
Holmstrom et al. (Exs. 26-1231, 26-36) studied workers using awkward
positions such as stooping, kneeling, and raising the hands above the
shoulder and found an increased risk of low back pain (Odds Ratio of
1.4, 1.9, and 1.5 for stooping, kneeling and hands above the shoulder,
respectively) with 1 to 4 hours per day of exposure. Similarly,
Nordstrom et al. (Ex. 26-900) observed that the risk of carpal tunnel
syndrome began to increase among workers whose jobs involved wrist
bending or twisting after exposures of 3.5 hours compared to groups
exposed for less than 3 hours (Odds Ratios of 1.34 with 0.25-1.75 hours
exposure, 1.23 with 2-3 hours exposure, and 2.33 with 3.5-6 hours of
exposure). Similar quantitative observations were reported by deKrom
(Ex. 26-102) for wrist flexion, Baron et al. (Ex. 26-697) for grocery
checking, and Xu et al. (Ex. 500-71-53) for frequent twisting and
bending and for physically hard work (see Table IV--SCREEN). Other
studies reported results using qualitative ordinal scales that indicate
that risks increase, sometimes substantially, with exposure to risk
factors of one-half a day or more. Ekberg et al. (Ex. 26-1238) reported
ORs of 3.8 and 2.4 for neck/shoulder disorders that were associated
with a ``medium'' duration (in hours per day) of repetitive precision
movement or arms lifted, respectively, compared to workers with ``low''
exposure in terms of daily duration. Stetson et al.(Ex. 26-1221) found
an increased prevalence (65%) of hand/wrist symptoms among workers
using a high grip force (> 6 pounds) for more than half of a shift
(defined as ``frequently'' in the study), compared to the prevalence in
workers with ``some'' (40%) or no (41%) exposure. A study by Viikari-
Juntura et al. (Ex. 500-41-50) of trunk twisting reported a non-
statistically significant elevation in risk of neck disorders (OR =
1.3) among workers having ``little'' exposure (in hours per day), and
statistically significant increases in risk among workers with
``moderate'' (OR=1.9) and ``much'' (OR = 2.3) exposure.
However, there were also studies that showed increased risk of MSDs
associated with exposures of less than 2 hours daily. For example,
Vingard et al. (Ex. 500-41-51) showed an increased risk MSDs of low
back area among workers in jobs involving forward bending for
approximately 1 hour per day (statistically significant for male
workers, but not for female workers). Holmstrom et al. (Ex. 26-36)
found a significantly increased OR (2.4) for severe low back pain with
impairment for less than 1 hour per day of kneeling). DeKrom et al.
(Ex. 26-102) reported a significantly increased OR (1.4) for carpal
tunnel syndrome among workers having 1 to 7 hours per week of wrist
flexion; 1 to 7 hours per week of wrist extension was also associated
with an elevated OR for CTS (1.4), but that result was not
statistically significant. Latza et al. (Ex. 38-24) reported an
increase (not statistically significant) in low-back pain among workers
laying sandstone for less than 2 hours per day compared to unexposed
workers. English et al. (Ex. 26-848) found positive exposure-response
relationships where ORs for carpal tunnel syndrome or hand/wrist
disorders increased by 1.8 and 1.6 per hour worked per day,
respectively, for workers performing tasks involving shoulder rotation
once per minute. These studies, taken as a whole, demonstrate that for
the risk factors listed in the basic screening tool, the risk of MSDs
increased with daily duration of exposure.
The studies described above and contained in Table IV--SCREEN show
that, where researchers have investigated relationships between MSD
risk and daily duration of exposure, the risk of MSDs has been
consistently elevated in groups of workers exposed for half of the
workshift or more (Exs. 26-1238, 26-697, 26-1221, 38-428, 26-
[[Page 68316]]
1231, 26-36, 26-1018, 500-41-50, 26-102, 26-900, 26-58, 500-71-53). For
exposure durations of one-fourth to one-half of the shift, or durations
described as ``some'' or ``moderate,'' several studies showed
statistically significant increases in MSD risk (e.g., Exs. 26-697, 38-
428, 26-1231, 26-36, 500-41-50, 26-102) and others reported increased
ORs that were not statistically significant (e.g., Exs. 26-1018, 500-
41-50, 26-102, 26-58). For exposures of less than 2 hours daily
duration, results from these studies are more equivocal; some reported
significantly increased ORs (e.g., Exs. 500-41-51, 26-848, 26-102, 26-
36) while several found non-statistically significant increases in ORs
(e.g., Exs. 500-41-50, 26-102, 500-41-51, 26-36, 26-1231, 38-24). Based
on these studies, OSHA finds it reasonable to trigger jobs for job
hazard analysis where employees are exposed to the risk factors
indicated on the screen for more than 2 hours during the work shift.
OSHA believes that a 2-hour duration criterion for the screen will
capture those exposure situations where the epidemiological evidence
indicates that MSD risk is most likely to be elevated (i.e., jobs
involving more than 4 hours per day of exposure) as well as those jobs
involving 2 to 4 hours of exposure during the shift where the evidence
suggests that the risk may already be increased, at least in some
situations. The 2-hour trigger will exclude those jobs where the
evidence has been less consistent in finding an elevated risk of MSDs
(i.e., jobs involving less than 2 hours of exposure). This is
consistent with OSHA's statutory mandate to be protective of workers.
However, because the screen does not necessarily trigger an obligation
to control a job, OSHA also is not imposing unnecessary costs on
employers.
In using this 2-hour cutpoint, OSHA does not intend to imply that
all workers will experience significant adverse effects after 2 hours
or more of exposure. Rather, OSHA is using this cutpoint in the screen
criteria to give employers guidance about which jobs might involve a
sufficient duration of exposure such that the job warrants closer
examination. In addition to being supported by the scientific
literature, this value is also administratively simple for employers to
use, thus allowing the screening tool to be used quickly and
consistently for a number of different jobs.
For repetitive motion other than use of a keyboard or mouse, the
screen triggers jobs into the requirements of the standard only if the
exposure occurs for more than 2 consecutive hours in a workday, as
opposed to more than two hours total per day. This reflects OSHA's
belief, based on the health evidence, that 2 hours of repetitive motion
will be less hazardous if spread out over the workday because
musculoskeletal tissue will have an adequate opportunity to recover. By
capturing only those jobs that involve more than 2 consecutive hours of
repetitive motion, the standard will not capture those jobs where
employees change tasks during the day, even if the repetitive motion
occurs for a total of 2 hours over the work shift.
The screening tool departs from the 2-hour duration criterion for a
few items. These include the following: For use of keyboard and mouse
in a steady manner, the duration is set at 4 hours total per workday;
for lifting, the screen sets weight and frequency criteria; and for use
of tools or equipment that typically have high vibration levels (such
as chainsaws, jack hammers, percussive tools, riveting or chipping
hammers) the duration is set at 30 minutes total per day.
For use of a keyboard or mouse in a steady manner, OSHA has set the
duration for more than four hours total per day. In this case, OSHA has
chosen more than four hours based on the epidemiological evidence that
demonstrates that, in general, the risk of MSDs for workers performing
keying activities begins to increase after four hours of exposure (see
Table IV--SCREEN). For example, Bernard et al. (Ex. 26-842) studied
workers typing at video display units and reported an increased risk of
hand/wrist MSDs for exposures of 4 four to six hours. Oxenburgh (Ex.
26-1367), observed an increased prevalence of hand, wrist, forearm and/
or elbow MSDs after 4 hours per day at a keyboard. Similarly, Polanyi
et al. (Ex. 38-3) studied keyboard workers and observed that upper
extremity MSDs significantly increased after exposure durations of
approximately four hours per day. Based on this evidence, OSHA has
determined that it is appropriate to deviate from the 2 hour duration
criterion set for other job or task activities, and to set a greater
than four hours total per day for the use of a keyboard or mouse in a
steady manner.
For using tools or equipment that typically have high vibration
levels (such as chainsaws, jack hammers, percussive tools, riveting or
chipping hammers) OSHA has set the duration at 30 minutes total per
day. This level is based on a time-energy equivalent exposure
determination. For example, the time duration for using tools or
equipment that have moderate vibration levels (such as jig saws,
grinders, or sanders) is set at 2 hours total per day. Vibration level
can be expressed as the amount of energy transmitted by the tool over a
certain period of time (e.g., m/s\2\). OSHA assumes that a moderate
vibration level is approximately 2.5m/s\2\. The duration for moderate
vibration level is more than 2 hours total per day. Assuming that a
high vibration level is approximately 10m/s\2\ (4 times the moderate
vibration), the time-energy equivalent exposure duration level at which
risk is increased for activities involving high vibration levels would
be 30 minutes (i.e., \1/4\ of 2 hours). That is, risks for activities
at four times the vibration level would occur \1/4\ the amount of time.
For lifting, the chart contains specific weight limits, coupled
with a specific limit on the number of times per day the weight can be
lifted. Weight limits are specified for weights lifted from below the
knee, above the shoulder and at arm's length. The limits specified are
as follows: lifting more than 75 pounds at any one time; more than 55
pounds more than 10 times per day; or more than 25 pounds below the
knees, above the shoulder, or at arms' length more than 25 times per
day. OSHA has based these limits on recommendation found in other
screening tools as well as evidence in the epidemiological literature
that shows increased risk of low back disorders when lifting certain
weights at certain frequencies or postures. For example, Arad and Ryan
(Ex. 500-41-7) and Smedley et al. (Ex. 1249) reported an increase in
risk low back MSDs among healthcare workers lifting one to four
patients per day. Kelsy et al. (Ex. 500-41-73) reported increased risks
of lumbar disorder among workers in jobs requiring lifting more than 25
pounds more than 25 times per day compared to workers who did not lift
these weight. Similar findings were reported by Macfarlane et al.(Ex.
500-41).
OSHA finds that the weight of evidence clearly demonstrates that
heavy, frequent or awkward lifting increases the risks for MSDs.
Particular studies, such as those described above, provide support for
the specific weight criteria used in OSHA's screening tool for the
final standard. Washington State has used similar data to support its
``caution zone job criteria'' for lifting (Ex. 500-313-6). OSHA
believes that these are reasonable criteria to use for the screening
purposes of this standard and that, in general, these criteria reflect
the evidence in the record.
The exposure screen also contains an entry for activities involving
pushing and pulling. In a questionnaire survey of insurance company
policyholders,
[[Page 68317]]
Snook et al.(1978) found 9% of low back injuries to be associated with
pushing and 9% to be associated with pulling (Ex. 26-35). NIOSH (1981)
cited evidence that 20% of overexertion incidents involve pushing and
pulling objects (Ex. 26-393). Thus, OSHA finds that it is appropriate
to include pushing and pulling on the screen as a specific exposure
criterion.
For job activities involving pushing or pulling, the chart
specifies 20 pounds of initial force as the trigger criterion. To
provide a basis for determining appropriate workloads for these
activities, Snook and Ciriello (1991) developed tables of maximum
acceptable forces for pushing and pulling (Ex. 26-1008). Maximum
acceptable forces were expressed in terms of the percentage of the
industrial population capable of performing the task. Data were
presented separately for males or females either pushing or pulling,
and were given for both initial forces (the force required to get an
object in motion) and sustained forces (the force required to keep an
object in motion). Variables included frequency, distance, and height
(vertical distance from floor to hands).
The tables were developed based on experiments employing a
psychophysical methodology (Ex. 37-6). This approach assumes that
workers are able to determine with some accuracy their highest
acceptable workload. Subjects were given a task with a set frequency,
distance, and height and were allowed to control the amount of force
used. Subjects were instructed to work as hard as they could without
straining themselves or becoming unusually tired, weakened, overheated,
or out of breath.
Although acute fatigue was the basis of the limitations established
by this series of experiments, the results have been shown to predict
the risk of developing MSDs. Snook et al.(1978) reported that workers
performing manual handling tasks that less than 75% of workers are
capable of performing without overexertion are three times more likely
to suffer from low back injuries than those workers performing manual
handling tasks that more than 75% of workers are capable of performing
(Ex. 26-35).
Other research has also supported a relationship between
psychophysically derived exposure levels and risk of MSDs. Using an
index derived from the tables developed by Snook and applying it to
6,912 workers in 55 industrial jobs, Herrin et al.(1986) found that the
number of overexertion incidents was related to the psychophysical
stress of the job. The severity of these incidents as measured by lost
or restricted work days was also found to be associated with
psychophysical stress (Ex. 26-961). Additionally, Park and Punnett
found psychophysical ratings of ergonomic stressors to predict the
incidence of in-plant medical visits for MSDs among 1064 workers in two
automobile manufacturing plants (Ex. 38-160).
Based on the reported association between pushing and pulling and
the development of MSDs, and the evidence of a relationship between
psychophysically derived exposure limits and reported injuries, OSHA
concludes that an exposure criterion based on psychophysically derived
limits will serve as a reasonable basis for determining when a hazard
analysis is necessary for jobs involving pushing and pulling
activities.
The 20-pound force criterion for pushing and pulling will capture
all jobs that are designed such that less than 75% of workers (male or
female) are capable of performing them without experiencing
overexertion. As explained above, lifting jobs that cannot accommodate
at least 75-percent of the working population's physical capacity have
been associated with a three-fold higher risk of low back disorders.
This suggests that jobs should be subject to more detailed hazard
analysis if an initial screen indicates that a task involving pushing
or pulling is not designed within 75-percent of the working
population's physical capacity.
While the screening threshold for pushing and pulling forces is
based upon an exposure level that is protective of 75 percent of the
industrial population based on psychophysical measurements relating to
overexertion, this should not be construed as an endorsement by the
Agency of exposure to ergonomic risk factors based on what is
considered to be an acceptable level for any given percentage of the
population. The level chosen in this instance resulted from the fact
that the evidence in the record indicates that an increased risk of
developing MSDs exists among workers who perform pushing or pulling
activities at levels above those found to be acceptable to 75 percent
of the industrial population based on psychophysical measurements
relating to overexertion, not because any particular proportion of the
exposed population was considered to be protected from developing MSDs.
The 20-pound force criterion for pushing and pulling tasks is
consistent with the OSHA ``safe harbor'' for pushing/pulling, which is
based on the 90th-percentile values for female workers. Using 20 pounds
as screening criteria will help to ensure that employers are not
screening in jobs for which they have already implemented controls
based on the safe harbor value, but instead are screening in those jobs
where risks may begin to occur and for which a job hazard analysis is
appropriate.
For performing activities that require pinching or gripping
unsupported objects, the chart specifies weights of two pounds or more
per hand for pinching and 10 pounds or more per hand for gripping.
These values are generally supported by studies such as those by Chiang
et al. (Ex. 500-41-25), Stetson (Ex. 500-41-44), English (Ex. 500-41-
30) and Roquelaure et al. (Ex. 500-41-112). These investigators
reported increased risks of carpal tunnel syndrome, thumb disorders,
shoulder disorders, and nerve abnormalities among workers repetitively
pinching objects approximately in the range of two pounds or gripping
objects approximately in the range of 10 pounds. OSHA believes that the
weights specified represent reasonable screening criteria for
identifying conditions likely to cause the type of MSDs reported and
are similar to values recommended in other screening tools. While there
may be more precise ways of measuring force associated with pinching or
gripping, OSHA believes that using the weight of objects handled is
more administratively simple for employers to use and thus will enable
employers to more quickly and consistently evaluate jobs.
Similarly for contact stress, OSHA has specified a frequency of 10
times per hour when using the hand or knee as a hammer. OSHA believes
that this value is also administratively simple and reasonable to use
for the screening purposes of this standard. Studies have shown
increased risk in MSDs among workers using the hand or knee as a hammer
(e.g., Little and Ferguson, Ex. 26-1144 and Thun, Ex. 26-60). However,
little data is available that quantifies the frequency of exposure at
which increased risks are observed. Washington State chose a value of
10 times per hour for their ``caution zone job'' criteria. OSHA
believes that this is a reasonable value to use for screening purposes
and that it gives the employer guidance in identifying work activities
likely to contribute to the type of MSDs reported.
In summary, the specific description of risk factors contained in
the screen, coupled with the duration specifications, all have a
sufficient degree of risk to trigger some simple additional
requirements (job hazard analysis, MSD management, training and
evaluation). It should be kept in
[[Page 68318]]
mind however, that these are not intended to imply that a hazard exists
and requires control be instituted. There is substantial evidence in
the record that supports the agency's choice of risk factors and
duration levels. As with ``action levels''' contained in other health
standards, the duration levels were set at levels where the risk begins
to rise and additional, simple steps are necessary.
The purpose of this screen is to focus on those jobs that are
likely to have caused or contributed to the MSDs that are reported. In
general, activities causing or contributing to such MSDs are more
likely to be ones that make up significant amounts of the employee's
worktime and represent a core element of the employee's job. As such,
these activities are likely to be a foreseeable part of the job that
can be reasonably predicted and thus can be taken into account when
designing an ergonomics program. These are the types of jobs that OSHA
seeks to capture under the final standard so that programs can be put
in place to prevent further MSDs from occurring.
In order to better enable employers to capture such jobs, OSHA is
setting a minimum frequency for job or task activities that must occur
as a part of the screening tool. OSHA is setting this frequency at one
day per week or more. Obviously, there are numerous values that could
be chosen. However, OSHA believes that this value can reasonably be
used to determine those job or task activities that are core element of
an employee's job, and are foreseeable or reasonably predictable. In
addition, a frequency of once a week or more is likely to capture many
work activities that are an element of an employee's job that occur on
a weekly basis (e.g., deliveries or maintenance activities). To meet
the screen, a job must ``routinely'' involve tasks that meet the
designated criterion at least one day a week. This value will also
provide guidance in that it can be used to rule out job or task
activities that are rare occurrences, that are not predictable, or that
result from unusual work circumstances.
In conclusion, in response to the comments received on the proposed
standard, OSHA has developed a screening tool that will provide
employers with quantitative guidance for determining work activities
and conditions that are likely to cause or contribute to MSDs and that
are a core element of a job or make up a significant amount of the
employee's worktime. This screening tool includes specific descriptions
of tasks and durations that will enable employers to evaluate jobs,
quickly and consistently, at their worksites. To the extent possible,
these descriptions and durations were developed using to the extent
possible using the best available epidemiological literature as well as
expert opinion from other groups who have developed very similar
screening tools. This screen is intended to be used in conjunction with
the event of an MSD incident to identify work conditions where exposure
risks may exist such that a job analysis must be conducted to determine
whether job controls are quickly and consistently necessary.
Paragraph (g)--What Actions Must I Take if the Employee's Job Meets the
Action Trigger?
Paragraph (g) of the final rule defines the actions that employers
must take if an employee with an MSD incident is employed in a job that
meets or exceeds the action trigger. The paragraph requires that the
employer must either implement the Quick Fix option in paragraph (o) of
the final rule, or develop and implement an ergonomics program that
includes the following elements:
(i) Management leadership as specified in paragraph (h) of this
section;
(ii) Employee participation as specified in paragraph (i) of this
section;
(iii) MSD management as specified by paragraphs (p), (q), (r), and
(s) of this section;
(iv) Job hazard analysis as specified by paragraph (j) of this
section;
(v) Hazard reduction and control measures as specified in
paragraphs (k), (l), and (m) of this section, and evaluations as
specified in paragraph (u) of this section, if the job hazard analysis
determines that the job presents an MSD hazard;
(vi) Training as specified in paragraph (t) of this section.
A few commenters suggested that the effectiveness of ergonomics
programs in reducing workplace MSD hazards was not demonstrated for the
proposed rule. For example, the post hearing brief submitted on behalf
of the U.S. Chamber of Commerce stated:
None of this ``evidence'' * * * begins to support the
proposition that an Ergonomics Program Standard such as the one
contained in the Proposed Rule will reduce at all the incidence of
workplace musculoskeletal complaints. [Ex. 500-188]
In contrast, the use of ergonomics programs as an effective method for
addressing workplace MSD hazards was endorsed by the vast majority of
commenters in the rulemaking record (see, e.g. Exs. 30-3855, 32-185,
500-209, Tr. 4940, Tr. 1491). For example, Mr. McCauseland,
representing the American Meat Institute (AMI), testified during the
rulemaking hearing: So what has happened in the 10 years since the meat
packing guidelines were issued? Well, a number of things. In our
industry, reduced levels of injuries and illnesses have been
approximately one third of all incidents. Nearly one-half of lost time
incidents have been reduced as well. * * * The guidelines have fostered
proactive efforts to eliminate ergonomic risks and hazards in a wide
ranging number of applications [Tr. 4940].
A complete discussion of the widespread support for the proposition
that ergonomics programs are effective is contained in Chapter III of
the Final Economic Analysis for the final rule. In that chapter, OSHA
discusses the history of successful ergonomics programs and describes
the extensive use of ergonomic programs throughout broad sectors of
industry. In fact, the number, longevity, and extensive use of
ergonomic programs that are similar to those required by OSHA's final
rule clearly validate the Agency's regulatory approach, as well as
demonstrating the inherent feasibility of the standard for covered
employers who establish such programs.
Many of these programs have most or all of the program elements
required by paragraph (g) of the final rule. The wide use of these
elements in current programs is evidence that employers believe them to
be essential, workable concepts. The program elements contained in the
final rule are summarized and explained in other sections of this
preamble and therefore will be discussed only briefly here in the
context of the overall program requirement.
Paragraph (g) of the final rule specifies that if an employee's job
exceeds the action trigger, the employer may implement a quick fix
option for that job under paragraph (o). An employer who qualifies for
the quick fix option does not need to establish an ergonomics program,
although he or she must follow all of the quick fix procedures.
However, if the employer cannot or does not implement a quick fix, then
the standard requires an ergonomics program with the following
elements:
Management leadership,
Employee participation,
MSD management,
Job hazard analysis,
Hazard reduction and control,
Training, and
Evaluation.
Management leadership is critical to the successful implementation
and operation of ergonomics programs.
[[Page 68319]]
Management leadership provides the focus and direction of the program's
effort as well as the needed resources in terms of both personnel
commitment and funding. The requirements for management leadership are
described in the summary and explanation for paragraph (h).
Employee participation is equally important. Employees are
essential sources of information about MSDs, risk factors, and MSD
hazards in their work areas. They have valuable insights into effective
control measures that can be used to reduce risk factors inherent in
their jobs. The requirements for employee participation are described
in the summary and explanation for paragraph (i).
MSD management provides for prompt and appropriate management when
an employee has experienced an MSD incident. MSD management includes
access to a health care professional, work restrictions as needed, work
restriction protection, and evaluation and follow-up of the MSD
incident. MSD management is important largely because it helps ensure
that employees promptly report MSDs and signs and symptoms of MSDs.
This, in turn, ensures that jobs that present MSD hazards will be
included in the ergonomics program. The requirements for MSD management
are described in the summary and explanation for paragraphs (p), (q),
(r) and (s).
Job hazard analysis provides for the identification of the risk
factors for jobs that meet the action trigger. The job hazard analysis
provides a systematic approach to identifying and addressing the risk
factors in the job. The requirements for job hazard analysis are
described in the summary and explanation for paragraph (j).
Hazard reduction and control is the heart of the ergonomics
program. Under this program element, employers control the risk factors
in problem jobs identified during the job hazard analysis. The
requirements for hazard reduction and control are described in the
summary and explanation for paragraphs (k), (l), and (m).
Training provides employees with the information and understanding
that they need to participate effectively in the ergonomics program. In
addition, the training required by the final rule provides the more
detailed information that supervisors, team leaders and other employees
involved in setting up and managing ergonomics programs need to carry
out their program-related responsibilities effectively. The training
requirements are described in the summary and explanation for paragraph
(t).
Evaluation is the process employers use to ensure that the program
they have established is functioning as intended. Employers are
required to evaluate their programs every three years and at other
times if they have reason to beleive that the program is not
functioning properly. The requirements for program evaluation are found
in paragraph (a).
In summary, ergonomic programs similar to OSHA's in structure have
been effectively reducing the incidence and/or the severity of MSDs for
at least 10 years throughout the vast majority of general industry
sectors. Model programs that contain OSHA's program elements have been
implemented by a wide range of employers, such as large and small
manufacturing establishments, utilities, and government agencies (see,
e.g., Exs. 32-185, 500-108, 38-50, Tr. 4693, Tr. 5696, Tr. 6310, Tr.
5931, Tr. 7031, Tr. 7068, Tr. 7074, Tr.7918, Tr. 7934, Tr. 7937, Tr.
7963, Tr.7948, Tr. 7999, Tr. 8826, Tr. 14707, Tr. 17350)
Paragraph (h)--Management Leadership
Paragraph (h) contains the final rule's requirements for management
leadership. It requires that employers assign and communicate
responsibilities for setting up and managing the ergonomics program;
provide the authority, resources, and information necessary to meet
those responsibilities; ensure that existing policies and practices
encourage and do not discourage reporting and participation in the
ergonomics program; and communicate periodically with employees about
the program and their concerns about MSDs.
Paragraph (h) of the final rule is nearly identical in content to
the proposed management leadership section (Section 1910.912). OSHA has
elected to retain the management leadership requirements as proposed
due to evidence in the record that supports the need for management
commitment in any effective ergonomics program. Minor changes have been
made to clarify the provision regarding the assignment and
communication of responsibilities and to allow for more concise
application of the subelement relating to the encouragement of
reporting and participation.
OSHA proposed to require management leadership because the
literature on ergonomics programs consistently cites management
commitment as a vital component of an effective program (see, e.g.,
Exs. 2-13, 26-2, 26-5, 26-9, 26-10, 26-13, 26-14, 26-17, 26-18, 26-22,
26-27). The need for management commitment was also supported by a
number of responses to the ANPR (see, e.g., Exs. 3-27, 3-124, 3-173).
The elements of the proposed and final management leadership
requirements are based on the concept of management leadership
expressed in the literature. OSHA considers the proposed and final
management leadership provisions to be necessary to the exercise of
leadership of the ergonomics program.
Responses to the proposed management leadership provisions
indicated general support for the concept of management leadership.
Comment on the provisions pertaining to the assignment and
communication of responsibilities; provision of authority, resources,
and information; and periodic communication focused on the
interpretation, rather than the concept, and often criticized the
proposal as vague. Comments regarding policies and practices that
discourage reporting and participation revealed sharply divided opinion
on the merits of the proposed provision.
The importance of management leadership as a component of an
effective ergonomics program was supported in a number of comments on
the proposed rule (see, e.g., Exs. 30-2387, 30-3745, 30-3765, 32-78-1,
32-85-3, 32-182-1, 32-198-4, 32-339-1, 30-428, 30-3860, 30-4333, Tr.
3479, Tr. 3565, 32-450-1-18-1, Tr. 8004, Tr. 1496, Tr. 9070). David
LeGrande of the Communications Workers of America, for example, when
asked to indicate what characteristics distinguished successful
ergonomics programs from those that fail, explained that the commitment
of management is the primary factor in determining if a program will
succeed (Tr. 9018).
The inclusion of a distinct requirement for management leadership
in the proposed ergonomics standard, however, was considered by some
parties to be inappropriate (see, e.g., Exs. 32-78-1, 30-2830, 30-3853,
30-3765, 32-368-1, 500-223, 30-3426). Mandating the assignment of
responsibilities and provision of authority, resources, and
information, it was argued, is so vague as to lead to uneven
enforcement by OSHA personnel, according to these commenters (see,
e.g., Exs. 30-74, 30-240, 30-1336, 30-3284, 30-3336, 30-3344, 30-3367,
30-3763, 30-3782, 30-3849, 30-3951, 30-4496, 30-4674, 30-4837, 30-
4247). The Ameren Corporation, for example, stated:
Whether an employer has committed enough ``resources'', has
``ensured'' that they have encouraged their employees to report or
participate, or is communicating often
[[Page 68320]]
enough are all highly subjective judgement calls which cannot be
consistently made by OSHA (Ex. 30-4247).
Bruno's Supermarkets and others (see, e.g., Exs. 30-2836, 30-2837, 30-
2828, 30-2839, 30-2840, 30-2841, 30-2842, 30-2843, 30-2844, 30-2940)
concurred with this assessment, stating:
[The proposed standard] requires that employers communicate
``periodically'' with employees about the ergonomics program.
Suppose, for example, that an employer distributes an annual
ergonomics bulletin. How will the employer know whether an OSHA
inspector will expect us to communicate more frequently, such as
once a week or once a month? This section also requires employers to
provide those managing the ergonomics program with ``resources,''
which are vaguely and broadly defined as ``the provisions necessary
to develop, implement, and maintain an effective ergonomics
program,'' including money, etc. We may feel that we have provided
adequate resources necessary for such an effort, but we will have no
way of knowing whether the OSHA inspector will agree. The lack of
objective, attainable standards will leave employers at the whims of
OSHA inspection personnel. (Ex. 30-2836)
The term ``periodically'' was specifically cited by a number of parties
as being unduly subjective and open to interpretation (see, e.g., Exs.
30-1101, 30-1336, 30-3826, 32-337-1, 30-1671, 30-3336, 30-3367, 30-
3782, 30-4674, 30-3512). Some commenters said that determinations about
the delegation of authority and assignment of resources were outside of
OSHA's expertise and created excessive administrative burdens on
employers (see, e.g., Exs. 32-78-1, Tr. 12250). Such mandates were
believed by some to be beyond the Agency's authority (see, e.g., Exs.
30-2914, 30-4335).
OSHA has decided to retain a requirement for management leadership
in the final rule. Management leadership is widely believed to be one
of the core elements of any effective safety and health (including
ergonomics) program. If no individuals in a given workplace have been
assigned responsibilities for the ergonomics program, it is clearly
unreasonable to expect that a successful program will somehow emerge.
Likewise, if responsibilities are assigned but no authority is granted
and no resources are provided, an ergonomics program is destined to
fail. For example, if an individual is assigned responsibility for
training workers in a problem job, that person needs access to relevant
information about the MSD hazards and controls in the job, sufficient
time to administer the training, and a suitable location for the
training to take place. Communicating periodically with employees about
the program and their concerns about MSDs is similarly essential to
creating an environment where both the employer and employees are fully
aware of issues relating to the ergonomics program. If a regular, two-
way exchange does not take place, it would be impossible for employees
to keep abreast of changes in the ergonomics program, or for the
employer to receive feedback regarding the program. Without full
knowledge, the benefits of the program will be diminished. The
endorsement of management leadership in comments and the incorporation
of this element in successful ergonomics programs supports OSHA's
conviction that management leadership is a critical component of an
ergonomics program.
Those who expressed the sentiment that the management leadership
requirements of the proposal were vague or burdensome appeared to
believe that OSHA compliance personnel would arbitrarily decide if the
authority, resources, and information provided were satisfactory, or if
the frequency of communication was adequate. OSHA reaffirms its belief,
expressed in the proposal, that employers should retain broad
discretion in deciding who should bear responsibility for the various
components of the ergonomics program, and what authority, resources,
and information are necessary and appropriate to meet the assigned
responsibilities in a given workplace.
The frequency of communication with employees is also subject to
wide latitude in order to account for the needs of different
workplaces. The term ``periodically'' is used in the standard to
indicate that communication must be performed on a regular basis that
is appropriate for the conditions in the workplace. A rigid schedule,
however, is not specified, in order to provide flexibility to account
for the circumstances found in different workplaces and even at
different times in the same workplace. Additional discussion of this
topic can be found in the section of this preamble devoted to
additional statutory issues (see Section XII of the preamble).
The general requirements in paragraph (h) of the final rule for the
assignment of responsibilities and provision of authority, resources
and information are designed to complement the more specific
requirements for action found elsewhere in the standard. For instance,
under paragraph (i) of this final rule, employees must receive prompt
responses to reports of MSDs. It is the duty of the employer to assign
the responsibility for providing those responses and to provide the
necessary authority, resources, and information needed to do so. If a
prompt, correct response is given to the employee, then the employer's
assignment of responsibility and provision of authority, resources, and
information will clearly have been satisfactory.
The final rule does not describe how responsibility is to be
allocated or how individuals will be held accountable for their
responsibilities. This is to allow employers the greatest possible
flexibility in adapting the program to their particular situation. A
concern was registered that the proposed requirement for assigning
responsibility would conflict with a management structure that did not
include supervisors (see, e.g., Ex. 30-3765). OSHA does not intend to
prescribe what program responsibilities are vested in any party. An
employer may choose to designate and empower front line employees with
any responsibility associated with the program, so long as the
authority, resources, and information necessary to meet those
responsibilities are provided.
The role that contractors, consultants, and other outside parties
may play in an ergonomics program has also been recognized by the
Agency. Although not required by the standard, OSHA is aware that
outside expertise may be beneficial in some instances. Accordingly, the
final rule allows the employer to chose who is designated with regard
to the assignment of responsibility. Ergonomists, safety professionals,
industrial hygienists, and others may be involved in the employer's
program.
Several commenters suggested that OSHA place requirements on
employees as well as employers in the final rule (see, e.g., Exs. 30-
3765, 30-584, 30-3368). These commenters believe that employees must
take responsibility for their actions. OSHA agrees that active employee
involvement in the ergonomics program is essential to program
effectiveness but does not believe that this principle should be stated
in the standard, for a number of reasons. First, the OSH Act itself, at
Section 5(b), states that ``Each employee shall comply with
occupational safety and health standards and all rules, regulations,
and orders issued pursuant to the OSH Act which are applicable to his
own actions and conduct.'' However, the courts have repeatedly held
that employers are responsible under Section 5(a)(2) of the Act for
ensuring worker protection. For example, the court in Brock v. City Oil
Well Service Co., 795 F. 2d 507, 511 (5th Cir. 1986) held, ``it is the
employer's responsibility to ensure that the
[[Page 68321]]
employees are protected. It may accomplish this objective through
others if it chooses, but the duty to provide the protection remains
the employer's.'' If, for example, an employer has determined that
lifting an 80-pound box poses an MSD hazard to employees, the employer
can establish a policy of requiring employees to use a mechanical lift
to raise such a box and train employees how to do this. The employer
could then hold the employee accountable for adhering to this policy in
the same manner as other policies or rules are enforced.
In addition to providing authority, resources, and information, the
proposed management leadership section included a requirement to
provide the training necessary to meet assigned responsibilities.
Because training for those responsible for setting up and managing the
program is addressed in paragraph (t) of this final rule, training has
been deleted from this paragraph in order to avoid potential confusion.
Some commenters expressed the belief that management leadership is
implicit in an effective ergonomics program, and an independent
requirement for management leadership is therefore unwarranted (see,
e.g., Exs. 30-3765, 30-1293). Dow Chemical, for example, while strongly
supporting the need for management leadership in safety and health
activities, expressed the view that it is not appropriate for OSHA to
attempt to regulate and enforce leadership. By establishing and
evaluating the effectiveness of an ergonomics program, Dow argued, the
employer has in effect demonstrated leadership (Ex. 30-3765).
In a similar vein, some parties argued that the requirements for
management leadership were largely redundant with other sections of the
proposal. They pointed out, for example, that communicating
periodically with employees about the ergonomics program and their
concerns about MSDs was part of the proposed management leadership
provision, while separate, specific requirements for communication with
employees were proposed as part of the provisions pertaining to quick
fix, employee participation, hazard information and reporting, job
hazard analysis and control, training, MSD management, and program
evaluation. This ``duplication,'' it was argued, could subject
employers to being cited twice for a single violation (see, e.g., Exs.
30-3344, 30-4674).
OSHA believes that there is little, if any, overlap with other
parts of this standard. The management leadership and employee
participation elements of the final rule should be considered the
overall conceptual foundation of an effective ergonomics program and a
vital part of the organizational framework of an effective program. By
fully understanding the importance of management leadership and
employee participation, it is expected that program managers will
determine how best to apply these concepts in a particular workplace
and how the individual subelements will work most efficiently in their
environment. Even where some overlap could be perceived, it is not
OSHA's policy to issue duplicate citations for a single violation.
The management leadership element also includes requirements unique
to this paragraph, such as the requirement in paragraph (h)(3). That
requirement specifies that the employer must ensure that their policies
and practices encourage and do not discourage reporting or
participation in the program. OSHA believes that applying this
provision in an ergonomics program is a logical component of
management's effort to direct the ergonomics program in a manner that
will be protective of employee health.
OSHA's proposed requirement for employers to ensure that their
existing policies and practices encourage and do not discourage
reporting and participation in the ergonomics program elicited a
substantial volume of comment. As explained in the preamble of the
proposal, this proposed provision was intended to encourage the early
reporting of MSDs and meaningful employee participation in the
ergonomics program. OSHA believes that employees in all workplaces
should be encouraged by their employers to report injuries, illnesses,
and hazards of all kinds--not just those related to ergonomic issues--
because only full and frank reporting allows employers to identify
hazards and do something about them.
Particular attention was paid by participants regarding the
requirement that employers ensure that their policies and practices do
not discourage reporting and participation in the program, and the
effect of this provision on existing employer programs, including
safety incentive programs and employee drug testing programs.
Policies and practices given in the preamble to the proposal as
examples of those that may discourage reporting included:
Programs that reward or punish employees on the basis of
injury or illness reports by offering incentives or awards based on low
numbers or rates of reported MSDs.
Policies that require every employee reporting an MSD or
MSD signs and symptoms to submit to a drug or alcohol test.
Direct or reasonably perceived threats of retaliation,
including firing or suspension, withholding overtime work for anyone
who reports MSD signs or symptoms, (even from jobs that do not involve
exposure to risk factors), prohibiting the use of sick leave for a
work-related injury; and sending every employee who reports MSD signs
and symptoms home without pay.
Expressed or implied warnings of retaliation for reporting MSDs,
MSD signs and symptoms, or MSD hazards would clearly be considered a
practice that would discourage reporting. If, for example, a supervisor
were to inform employees working the day shift that reporting MSD signs
and symptoms would automatically result in transfer to the night shift,
this action could be reasonably anticipated to suppress reporting. An
example of a situation similar to this was described by the UFCW. The
union explained that employees were reluctant to report injuries in
this situation due to the consequences they would face:
[The company] had established a special ``C'' shift--the
graveyard shift--for employees suffering from work-related injuries,
many of which were cumulative trauma disorders. The purported
purpose of the C shift crew was to assist injured workers with long
term medical restrictions in returning to regular duty. In fact,
however, a number of employees assigned to the crew were taken off
regular duty jobs which they had been performing successfully with
their restrictions. They were then isolated and segregated on the C
shift and assigned degrading, demeaning, make-work tasks such as
picking up cigarette butts in the parking lot at night with
flashlights or scraping rust off of pipes in the rendering
department (Ex. 32-210-2).
Some employers have taken this a step further, pursuing policies
that discipline workers for reporting injuries, without considering the
cause of those injuries. When rewards or punishment are linked to the
reporting of MSDs or MSD signs and symptoms, employee reporting
behavior can clearly be influenced. Punishment for reporting in the
form of wage reductions, loss of overtime, reprimands, suspensions, or
other means can be expected to discourage reporting.
An example of this approach is a system of imposing progressively
more severe penalties when injuries are reported, such as a written
reprimand for the first incident, followed by suspension, and finally
termination (see, e.g., Exs. 32-298-2). Another example is a system
that assigns a point
[[Page 68322]]
value to an incident based on factors such as the cost of the incident
to the employer or whether lost workdays were involved. Progressive
levels of punishment are meted out based upon the number of points that
an employee accumulates (see, e.g., Ex. 500-111-1). Kathy Saumier of
the United Steelworkers described such a program and its results in the
plastics plant where she worked:
The company had a policy to give out points if an employee
missed work even due to work related injury. After an employee
accumulated seven points, the company reduced the employees' pay by
50 cents per hour. If the employee accumulated 15 points an employee
was then terminated. This system caused many workers to go to work
injured for fear of pay reduction or termination (Tr. 10992).
The record also included many instances where, intentionally or
inadvertently, employer policies and practices were said to discourage
employees from reporting MSDs (see, e.g., Exs. 20-626, 32-111-4, 32-
198-4-1, 32-198-4-2, 32-210-2, 32-298-2, Tr. 5598, Tr. 6980, Tr. 7715,
Tr. 7729, Tr. 7387, Tr. 7730, Tr. 8041, Tr. 10153, Tr. 10230, Tr.
10763, Tr. 13870, Tr. 14535, Tr. 15131, Tr. 15453, Tr. 16766).
Incentive programs that offer rewards to employees or groups of
employees based on a low number of reported injuries were also
mentioned as factors inhibiting the reporting of MSDs. Bill Byington of
the IBT described how employees in his workplace were being taken to a
baseball game for completing a month of work without a reported injury;
he was aware, however, that at least one of the members of the group
had sustained an injury and not reported it (Tr. 15453). Sandy Brooks
of the United Steelworkers related her experience with a ``safety
bingo'' program, where employees receive a bingo number each day, and
the employee who wins the bingo game receives cash, weekend trips, and
dinners as prizes. The bingo game ends for all employees, however, when
an OSHA recordable injury is reported. Ms. Brooks was also aware of
workers who did not report injuries because of the incentive program
(Tr. 7703).
An additional factor in group incentive programs that can serve to
coerce employees to refrain from reporting MSDs is the peer pressure
that can be exerted when group awards are at stake. Joe Enos of the UAW
described the result of an incentive program that offered a microwave
oven to a team of workers if they reduced reported injuries 25% from
the previous year:
The group had achieved that goal going into November and they
still had a month to go. And one of the workers got hurt. And the
rest of his coworkers told him, ``Hey, you go to medical, there goes
the microwave.'' And this guy realized that his health was more
important than some microwave. But a good many of his coworkers
wouldn't even talk to him for a couple of weeks as a result of that
(Tr. 15453).
Dr. Richard Bunch of the Industrial Safety and Rehabilitation Institute
told of an injury sustained but not reported early, in order to
preserve workers' chances of winning a barbeque pit:
One company was giving a barbeque pit as a prize if you went so
many months without reporting an injury. And one gentleman had a
back problem and did not report it because the other six members on
his team threatened him with violence. So in that case, he did not
report it, but ended up going to a full blown frank rupture of the
disc (Tr. 11638).
These accounts of individuals support the impression that incentive
programs that tie rewards or punishment to the report of an injury may
result in reductions in reported injuries and illnesses, at least in
part due to lack of reporting rather than an actual reduction in the
number of injuries that occur. Nancy Lessin of the Massachusetts AFL-
CIO espoused this view:
Workers can not control the conditions which lead to most work-
related injuries and illnesses. They can control whether or not they
report an injury or illness. Safety incentive programs manipulate
the thing workers can control--the reporting of workplace injuries
and illnesses * * * (Ex. 32-298-2).
The United Steelworkers concurred with that assessment:
We know better than to believe that worker behavior is the
primary cause of most workplace accidents. We know that exposure to
workplace hazards causes injuries and illness and exposure to
ergonomic hazards causes MSDs. Ergonomic hazards need to be
controlled to eliminate MSDs in the same manner that we address any
workplace hazard. Incentive programs based on injury rates, and
behavior-based safety programs do not correct hazards. In fact,
these programs can make a bad situation worse by diverting attention
from correctable hazards, and promoting the under reporting of
injuries (Ex. 32-111-4).
Several commenters argued that OSHA had not made a determination
that incentive programs result in the underreporting of MSDs (see,
e.g., Exs. 30-4185, 30-1070, 30-3347, 30-4185). The Synthetic Organic
Chemical Manufacturers Association suggested that OSHA obtain data to
support its position, stating:
If OSHA believes that employers are not properly reporting
injuries and illnesses, it should address this issue by gathering
the data to substantiate its position. OSHA should not discourage
employers from utilizing all necessary injury/illness prevention
tools. There is no basis for the proposed Ergonomics Standard to
suggest that these effective programs should be subject to further
scrutiny (Ex. 30-3843).
Sufficient evidence has already been entered in the record,
however, for OSHA to reach the conclusion that MSDs are substantially
underreported (see the discussion of underreporting in the Significance
of Risk section of this preamble as well as the Benefits chapter of the
Final Economic Analysis). Evidence also supports the belief that
employer policies and practices often contribute to this underreporting
by discouraging the reporting of MSDs.
A review of the literature on safety incentives commissioned by
OSHA and published in 1998 divided incentive programs into two
categories based on the behavior they reward. The review found that the
literature strongly indicates that programs that measure safe work
practices, such as wearing safety glasses for eye protection or using a
seat belt when driving, may increase the frequency of such practices.
The literature review further disclosed that incentive programs that
focus on reductions in the number of injuries and illnesses reported do
not improve safety practices. No scientific studies were found
indicating that such programs had either a positive or a negative
impact (Ex. 502-281).
Some policies and practices can affect employee participation in
the ergonomics program, as well as employees' incentive to report.
Employees who are punished or discouraged from reporting MSDs or MSD
signs and symptoms, may also feel discouraged from participating in any
meetings or discussions about ergonomic problems in the workplace and
how to address them. If a worker is threatened with retaliation for
pointing out hazards or for participating in a job hazard analysis,
that worker and his or her co-workers are unlikely to take part in this
activity or future activities. Employees are likely to be discouraged
from requesting information to which they may be entitled, such as
training materials or information about this standard, if they fear
retaliation or if obtaining the information is made inconvenient.
Likewise, if employees in a problem job are asked for recommendations
about eliminating or controlling MSD hazards, but are required to
attend a meeting at an unreasonable time in an inconvenient place, or
that may involve loss of pay in order to submit those recommendations,
the likelihood of those employees
[[Page 68323]]
participating in the process would be diminished.
Some commenters were concerned that a wide variety of employer
policies and practices could have the potential to impact employee
participation and reporting of injuries; even a review of a manager's
or supervisor's performance could be found to constitute a violation of
the standard when performance criteria in that review include the
number of injuries and illnesses recorded by employees under his or her
supervision (Ex. 30-4185).
OSHA is concerned with the effect of a policy on employees'
participation in the ergonomics program and whether the program or
policy discourages reporting. In some cases, making the number of
injuries and illnesses recorded a part of a manager's performance
review can result in a policy the discourages reporting. Larry Hall of
the United Food and Commercial Workers described such a situation.
One of the things that happens with the [manager] bonuses is the
worker reports a problem, and the manager immediately tells them how
that is going to affect their bonus. If you are working for me and I
say, ``Gee, that is going to really affect my bonus. So, for the
rest of your life, you get to work nights,'' these people write
their schedules. They control their lives. If you are going to
displease me and take money out of my pocket, I can really do a lot
to you and stay within the union contract. (Tr 14538)
OSHA finds that the evidence strongly demonstrates that employer
policies and practices that reward non-reporting and punish, threaten,
or otherwise discourage employee reporting of MSD incidents have the
effect, in many instances, of suppressing incident reports. This
conclusion is based on the strong record presented by witnesses and
documentary submissions as well as on the logic that providing
incentives to not report accidents or illnesses is likely to reduce the
number of such reports, but unless the cause of those incidents is
addressed, it is unreasonable to believe that MSD incidents themselves
will be reduced in number. The litany of case reports in the record
where employer policies and practices were said to deter reporting
reinforce this position. The concealment of MSD incidents would in fact
have an effect directly opposed to the purpose of this standard.
Hazards that would otherwise be identified and eliminated or controlled
would remain and continue to threaten employees. MSD incidents that, if
reported, could be limited in severity through rest or treatment would
instead be allowed to progress.
In contrast to the comments describing the pressures on employees
not to report MSDs, a number of parties were concerned that the
proposed prohibition on policies or practices could inadvertently
eliminate widely accepted, sensible, and successful safety practices.
Many commenters indicated concern that the proposed prohibition on
policies or practices that discourage worker reporting could be
interpreted to eliminate demonstrably successful employee incentive
programs (see, e.g., Exs. 30-3765, 32-368-1, 30-656, 30-1048, 30-1070,
30-1349, 30-1551, 30-1567, 30-1616, 30-1652, 30-1671, 30-1901, 30-2038,
30-2050, 30-2061, 30-2499, 30-2514, 30-2799, 30-2811, 30-2812, 30-2814,
30-2815, 30-2846, 30-2988, 30-2990, 30-3086, 30-3174, 30-3177, 30-3336,
30-3349, 30-3353, 30-3354, 30-3678, 30-3721, 30-3736, 30-3745, 30-3819,
30-3848, 30-3951, 30-4122, 30-4185, 30-4334, 30-4496, 30-4540, 30-4607,
30-4674, 30-4702, 30-4818, 30-4822, 30-4839, 30-4843, 31-310, 32-21-1,
32-82-1, 32-120-1, Tr. 10445, Tr. 11502, Tr. 12857, Tr. 16924, Tr.
17461, Tr. 17483, 30-4340, 500-1-28, 500-1-29, 500-1-42, 500-1-69, 500-
1-70, 500-1-79, 500-1-86, 500-1-95, 500-1-106, 500-1-112, 500-1-113,
500-1-114, 500-1-136, 500-1-147, 500-1-181, 500-1-117, 500-1-119, 500-
1-121, 500-1-124, 500-1-125, 500-1-127, 500-1-135, 500-1-137, 500-1-
152, 500-1-193, 500-1-442, 32-258-2, 30-911, 30-1942, 30-3236, 30-3339,
500-219, 601-x-1710, 601-x-1711, 30-4527, 30-980, 30-2668, 30-4565, 30-
3847, 30-2684, L30-4985, 30-4029, 30-4335, 30-4443, 30-1004, 30-1010,
30-1017, 30-1025, 30-1027, 30-1035, 30-1038, 30-1042, 30-1044, 30-1045,
30-1079, 30-1080, 30-1089, 30-1099, 30-1163, 30-1164, 30-1401, 30-1403,
30-1423, 30-1424, 30-1436, 30-1440, 30-1455, 30-1460, 30-1463, 30-1495,
30-1497, 30-1566, 30-1658, 30-1659, 30-1674, 30-1675, 30-1682, 30-1684,
30-1685, 30-1686, 30-1687, 30-1688, 30-1689, 30-1690, 30-1691, 30-1916,
30-2124, 30-2126, 30-2234, 30-2235, 30-2236, 30-2237, 30-2275, 30-2279,
30-2311, 30-2369, 30-2376, 30-2588, 30-2673, 30-2674, 30-2768, 30-2850,
30-2925, 30-3002, 30-3042, 30-3044, 30-3080, 30-3083, 30-3087, 30-3229,
30-3380, 30-344, 30-346, 30-3822, 30-3985, 30-3988, 30-4037, 30-4059,
30-4507, 30-4770, 30-4841, 30-5044, 30-5106, 30-634, 30-636, 30-638,
30-643, 30-649, 30-871, 30-883, 30-891, 30-903, 30-905, 30-918, 30-978,
30-994, 30-995, 600-x-10, 600-x-11, 600-x-12, 600-x-13, 600-x-45, 600-
x-46, 600-x-5, 600-x-6, 600-x-7, 600-x-9, 601-x-1358, 601-x-1363, 601-
x-1364, 601-x-1365, 601-x-1366, 601-x-1367, 30-1416, 30-1453, 30-1457,
30-1616, 30-1998, 30-1999, 30-2131, 30-2142, 30-2184, 30-2233, 30-2250,
30-2304, 30-2395, 30-2396, 30-2423, 30-2431, 30-2736, 30-2829, 30-2889,
30-2891, 30-2992, 30-3003, 30-3254, 30-3334, 30-3393, 30-3551, 30-3597,
30-3791, 30-3882, 30-3936, 30-3944, 30-3974, 30-3977, 30-3999, 30-4464,
30-4532, 30-4539, 30-4544, 30-4629, 30-4657, 30-4667, 30-4669, 30-4980,
30-5034, 30-5076, 30-5095, 30-5101, L30-4952, L30-4953, L30-5096).
Caterpillar Inc., for instance, attested to the favorable impact of
incentive programs in that firm:
Incentive programs have always been an excellent vehicle to
raise awareness, communicate various issues throughout the workplace
and show employer concern about employee safety. While OSHA
considers these programs to be disincentives [to the reporting of
MSDs and MSD signs and symptoms], our experience shows that they
have positive benefits. By increasing awareness and rewarding safe
behaviors through incentive programs, employers have seen a
reduction in all injury categories (Ex. 30-4607).
Nothing in this final rule would prohibit incentive or award
programs. The obligation that an employer would have, should they chose
to adopt an incentive program, would be to ensure that the incentive
program did not discourage the reporting of MSDs, MSD signs and
symptoms, or MSD hazards, or discourage participation in the ergonomics
program. As explained previously, OSHA's concern is that discouraging
full reporting and participation in the ergonomics program will
diminish the effectiveness of the program.
Although incentive programs that are successful in promoting
workplace safety can be expected to result in a reduction in the number
of injuries reported, an unsuccessful program that does not improve
workplace safety can also result in fewer reported injuries. When the
yardstick for measuring the success of the program is only the number
of injuries reported, the program can distort the true state of affairs
and preclude early intervention by inducing employees to avoid
reporting their injuries. This problem is particularly critical with
regard to MSD signs and symptoms, where early intervention can be of
great importance. OSHA encourages employers to focus any incentives on
safe work practices, active participation in safety programs, and
identification of hazards in the workplace. By doing so, the root
causes of injuries and illnesses can be addressed, and a safer
workplace can be
[[Page 68324]]
created. The Incentive Federation described the types of activities
that a safety incentive program can target, rather than using the
number or rate of reported injuries as its objective:
* * * a good safety incentive program often focuses on proactive
behavior. For example, it might encourage employees to make safety
suggestions, attend safety meetings, promote safety awareness,
participate in safety inspections, report safe behavior, report near
misses, and so forth. In addition, self-directed safety teams, where
employees observe each other at work and report good and bad safety
conduct (without necessarily using the names of the specific
employees), encourage safe behavior. Encouraging this type of
employee participation is extremely useful, because employees are
reasonably objective in observing their peers, and they report good
and bad behavior. The conduct observed can then be included in
periodic reports or reviewed in safety meetings to stress safe
behavior. (Ex. 30-1100).
Drug testing programs, when applied to all workers who report MSDs,
were also said to hinder full reporting of injuries. Chuck Monohan of
the International Brotherhood of Electrical Workers explained that a
fear of false positive results was responsible for non-reporting (Tr.
7378). Other commenters also discussed the chilling effect that drug
testing programs can have on reporting injuries (Tr. 5997, Tr. 13869,
Tr. 17509)
A large number of commenters expressed concern that the proposed
prohibition on policies or practices that discourage worker reporting
could be interpreted to eliminate widely accepted drug testing policies
(see, e.g., Exs. 30-536, 30-2208, 32-368-1, 30-3765, 30-419, 30-519,
30-1012, 30-1048, 30-1070, 30-1261, 30-1332, 30-1348, 30-1349, 30-1358,
30-1536, 30-1551, 30-1567, 30-1616, 30-1652, 30-1671, 30-1901, 30-2050,
30-2061, 30-2499, 30-2514, 30-2645, 30-2675, 30-2799, 30-2811, 30-2812,
30-2814, 30-2815, 30-2988, 30-2990, 30-3174, 30-3177, 30-3348, 30-3349,
30-3353, 30-3356, 30-3359, 30-3721, 30-3723, 30-3736, 30-3745, 30-3819,
30-3951, 30-4046, 30-4122, 30-4567, 30-4607, 30-4628, 30-4674, 30-4702,
30-4713, 30-4818, 30-4822, 30-4839, 30-4844, 31-282, 31-298, 31-310,
32-335, Tr. 4335, Tr. 4909, Tr. 6112, Tr. 8350, Tr. 9190, Tr. 10444,
Tr. 12857, Tr. 12958, Tr. 15621, Tr. 15644, Tr. 15976, Tr. 17461, Tr.
17483, 30-3725, 30-4340, 30-4146, 500-1-28, 500-1-42, 500-1-69, 500-1-
70, 500-1-79, 500-1-86, 500-1-95, 500-1-106, 500-1-112, 500-1-113, 500-
1-114, 500-1-136, 500-1-140, 500-1-147, 500-1-181, 500-1-185, 500-1-
117, 500-1-119, 500-1-121, 500-1-124, 500-1-125, 500-1-127, 500-1-135,
500-1-137, 500-1-152, 500-1-193, 500-1-411, 500-1-384, 500-1-385, 500-
1-386, 500-1-413, 500-1-423, 500-1-442, 500-16, 500-52, 500-23-1, 32-
258-2, 30-904, 30-911, 30-1942, 30-3236, 30-3339, 500-219, 30-4550,
601-x-1711, 30-1363, 30-4248, 30-4778, 30-2455, 30-4527, 30-2668, 30-
4565, 30-3847, 30-2684, L30-4985, 30-3472, 30-3582, 30-4029, 30-4335,
30-4443, 30-4475, 30-4528, 30-4688, 30-1004, 30-1010, 30-1017, 30-1025,
30-1027, 30-1035, 30-1038, 30-1042, 30-1044, 30-1045, 30-1079, 30-1080,
30-1089, 30-1099, 30-1163, 30-1164, 30-1401, 30-1403, 30-1423, 30-1424,
30-1436, 30-1440, 30-1455, 30-1460, 30-1463, 30-1495, 30-1497, 30-1566,
30-1658, 30-1659, 30-1674, 30-1675, 30-1682, 30-1684, 30-1685, 30-1686,
30-1687, 30-1688, 30-1689, 30-1690, 30-1691, 30-1916, 30-2124, 30-2126,
30-2234, 30-2235, 30-2236, 30-2237, 30-2275, 30-2279, 30-2311, 30-2369,
30-2376, 30-2588, 30-2673, 30-2674, 30-2768, 30-2850, 30-2925, 30-3002,
30-3042, 30-3044, 30-3080, 30-3083, 30-3087, 30-3229, 30-3380, 30-344,
30-346, 30-3822, 30-3985, 30-3988, 30-4037, 30-4059, 30-4507, 30-4770,
30-4841, 30-5044, 30-5106, 30-634, 30-636, 30-638, 30-643, 30-649, 30-
871, 30-883, 30-891, 30-903, 30-905, 30-918, 30-978, 30-994, 30-995,
600-x-10, 600-x-11, 600-x-12, 600-x-13, 600-x-45, 600-x-46, 600-x-5,
600-x-6, 600-x-7, 600-x-9, 601-x-1358, 601-x-1363, 601-x-1364, 601-x-
1365, 601-x-1366, 601-x-1367, 30-2410, 30-2289, 30-3877, 30-2601, 30-
3160, 30-3598, 30-2912, 30-1332, L30-5025, 30-4280, 30-1416, 30-1453,
30-1457, 30-1616, 30-1998, 30-1999, 30-2131, 30-2142, 30-2184, 30-2233,
30-2250, 30-2304, 30-2395, 30-2396, 30-2423, 30-2431, 30-2736, 30-2829,
30-2889, 30-2891, 30-2992, 30-3003, 30-3254, 30-3334, 30-3393, 30-3551,
30-3597, 30-3791, 30-3882, 30-3936, 30-3944, 30-3974, 30-3977, 30-3999,
30-4464, 30-4532, 30-4539, 30-4544, 30-4629, 30-4657, 30-4667, 30-4669,
30-4980, 30-5034, 30-5076, 30-5095, 30-5101, L30-4952, L30-4953, L30-
5096).
The sentiment that the contribution of drug-testing programs to
workplace safety should not be compromised by the requirements of the
ergonomics standard was expressed by Food Distributors International:
In the view of FDI and its members, the possibility that some
individuals will feel constrained to avoid reporting workplace
injuries or accidents because of a drug test requirement that might
be triggered is not an overriding concern. These fears largely will
relate only to those whose drug use may be discovered, and their
protection should not be the goal of a major OSHA regulatory scheme.
In addition, any such inhibiting effect is more than outweighed by
the workplace accidents and injuries that are avoided through
maintenance of an effective drug-free workplace program (Ex. 30-
3819)
OSHA is not aware of any basis for concluding that the development
of MSDs is in any way associated with the use of drugs or alcohol. The
reporting of MSDs or MSD signs and symptoms covered under this rule,
therefore, cannot be considered by itself to provide any justification
for testing. Although subjecting all parties reporting injuries or all
OSHA recordable cases to testing has sometimes been used by employers
as a matter of administrative convenience in identifying individuals
for testing, the lack of a relationship between drug or alcohol use and
the MSDs covered by this rule, along with the detrimental effect on
reporting behavior that testing can have, combine to make this an
inappropriate practice where MSDs are concerned.
Furthermore, there is no evidence that drug tests discourage
workers from reporting injuries only if they fear that drug use will be
discovered. Adrienne Markowitz of the UFCW described a poultry
processing plant where workers who reported pain in the hands and
wrists were required to be tested for illegal drugs:
This is a church going and religious community. Most people were
not worried that drugs would be found because they didn't take them.
But they weren't happy with having to suffer the indignities of
having someone watch them urinate, were afraid that inaccurate
testing and laboratory practices [would erroneously indicate illegal
drug use], were concerned that the medications they took would show
up as illegal drugs, and [were] fearful that the company supervisors
would doctor the records. Many, for the reasons I have just stated,
refused to take the test and were fired. And many others just never
reported their illnesses (Tr. 5998).
This rule does not in any way prevent an employer from conducting
testing if it is required by law, is based on reasonable suspicion, is
part of the job application process, is part of routine fitness-for
duty examination, is done as follow-up after entering an employee
assistance or drug rehabilitation program, or is administered to assist
in post-accident investigation. A blanket policy that requires all
employees reporting MSDs or signs and symptoms of MSDs to submit to
drug or alcohol testing, however, would hinder the effectiveness of the
ergonomics program if such a policy results in underreporting.
Nor is the fear that a back injury or other MSD may be the result
of an accident caused by drug or alcohol use
[[Page 68325]]
a reason for testing employees for drugs when reporting an MSD or MSD
signs or symptoms. As stated in paragraph (a), this standard does not
address injuries caused by slips, trips, falls, vehicle accidents, or
other similar accidents. The standard addresses injuries that are the
result of exposure to force, repetition, awkward postures, vibration,
and contact stress. Injuries covered by the standard are commonly
associated with prolonged or excessive exposures to these ergonomic
risk factors. There is no reason to believe that drugs or alcohol have
any relevance to the development of these conditions and certainly no
evidence that impairment at the time of reporting has any relevance.
Simply reporting MSD signs and symptoms therefore cannot be viewed as a
legitimate reason to suspect drug or alcohol abuse.
Some commenters argued that if an ergonomics standard did restrict
drug testing programs, this could conflict with regulatory requirements
of the Department of Transportation or Nuclear Regulatory Commission,
or with policies established through collective bargaining (see, e.g.,
Exs. 30-3853, 30-3765, 30-1070, 30-1332, 30-1671, 30-3284, 30-3359, 32-
335, Tr. 15621, 500-1-28, 30-4527, 30-4029, 30-4475, 30-4248).
Restrictions on drug testing were also said to conflict with
requirements for companies with government contracts (see, e.g., Exs.
601-x-1711, 30-4475).
Language in the proposal that could affect certain employer drug
testing policies was said to conflict with state workers' compensation
laws, and thus violate Section 4(b)(4) of the Occupational Safety and
Health Act. State workers' compensation laws, it was said, may require
drug testing in certain instances, allow reduced insurance premiums for
those employers with testing programs, or allow impairment to be used
as a defense in contesting compensation claims (see, e.g., Exs. 500-
104, 500-104-1).
It was argued that restrictions on drug testing programs could
result in liability claims against those employers whose employees
acted in an unsafe manner due to impairment. The New Mexico Self
Insurers Fund stated:
OSHA may have had the best intentions when writing the preamble,
however if state and local government municipal employers were to
neglect the possibility that alcohol and drug use was a factor in an
injury, whether or not it is an MSD, municipal liability would rise
exponentially. The bottom line is that many local governments would
not be immune from lawsuits where gross negligence is alleged. It
would be easy to show negligence on the part of a local government
that allowed ``waivers'' of its alcohol and drug testing ordinances
for employees in order to permit full and free reporting of MSDs
(Ex. 30-4810).
OSHA's concern is that testing not be conducted in a manner that
penalizes individuals reporting MSDs or participating in ergonomics
programs. This final rule does not restrict employers' drug or alcohol
testing policies where such policies are authorized by state or federal
law. It should be noted, however, that DOT regulations, which require
post accident testing and testing of safety sensitive employees and
under certain other circumstances, do not require drug testing when
MSDs or any other type of injury or illness is reported.
Workers compensation and other state and federal laws that require
drug testing following a traffic or other accident, are also not
generally relevant to the application of this standard, because as
explained above, MSDs resulting from accidents, slips, trips and falls
are specifically exempted from this rule.
A number of employee representatives expressed the opinion that
policies or practices that can discourage worker participation in the
ergonomics program, such as incentive programs and post-injury drug
testing, should be explicitly prohibited in the rule (see, e.g., Exs.
32-339-1, 32-111-4, 32-198-4, 32-210-2, 500-50). Absent such a
prohibition, it was argued, an ergonomics standard triggered by
employee reports of injury would be undermined by employers who would
pressure employees to avoid reporting injuries. These commenters argued
that the case-by-case determination approach described in the preamble
to the proposal would be inadequate to deter practices that discourage
participation and reporting, and a blanket prohibition in the rule
itself is necessary.
Some parties indicated that they did not find the proposal
sufficiently clear in indicating what policies or practices would be
considered by OSHA to discourage worker participation in the ergonomics
program (see, e.g., Exs. 30-3853, 30-4185, 32-337-1, 30-653, 30-1350,
30-2216, 30-3233, 30-3344, 32-82-1, 30-1101, 500-33). Concern was
expressed that compliance would be dependent upon whether or not
employees feel discouraged, and would thus be determined by the
subjective perceptions of employees (see, e.g., Ex. 30-3853, 30-4247,
500-33, 32-266-1). TXU Business Services, for example, stated:
Any regulation that has provisions for employees ``not feeling
discouraged'' would be impossible to enforce fairly. For example,
identical employer conduct could be legal in one plant, or part of a
plant, and illegal in another and the employer might never know it
(Ex. 500-1-28).
In order to provide an objective basis for enforcement of this
provision, OSHA has concluded that a pattern of underreporting must be
evident in the workplace before a determination will be made that any
given employer policy or practice discourages reporting of MSDs or
signs and symptoms of MSDs. If underreporting or discouragement of
employee participation in the ergonomics program is found at a
particular establishment as a result of a records review or employee
interviews, OSHA will evaluate the situation to determine if employer
policies and practices have had the effect of discouraging reporting or
participation in the ergonomics program. OSHA's position is that these
policies and procedures are not per se illegal, but they can clearly
discourage reporting and participation. If an employer has policies or
procedures with this potential, the employer must ensure that these
policies and procedures are not actually discouraging reporting or
participation.
OSHA expects that employers will have ample opportunity to discover
whether employees are being discouraged through the periodic
communication that will take place under the standard. If policies and
practices are determined to discourage reporting or participation,
employers would need to take action to remedy this situation.
OSHA considers it important that the employer not only not
discourage, but actively encourage reporting and participation in the
ergonomics program. The Agency believes that this goal can be
accomplished by providing information to employees about the importance
of early reporting in accordance with paragraph (d), along with
effective training on reporting and the ergonomics program in
accordance with paragraph (t) of this final rule.
Several parties asked whether the proposed prohibition on policies
or practices that discourage reporting would apply to an employer's
decision as to whether or not an employee can work overtime (see, e.g.,
Exs. 32-368-1, 30-2208, 30-3765, 30-1671, 30-2050, 30-2499, 30-3344,
30-3348, 30-3356, 30-4628, 30-4674, 500-1-140). Withholding overtime,
it was argued, may be based on a desire to prevent aggravation of the
potential MSD, and limiting the employer's ability to restrict
[[Page 68326]]
overtime would thus conflict with provisions in the proposed standard
that allow employers to use administrative controls (Ex. 30-1671). The
Association of Independent Corrugated Converters stated:
While some employers do not choose to impose such restrictions,
it seems unfathomable that involuntary restrictions on some overtime
work would be deemed an inappropriate management step, both before
and after symptoms reported by employees are analyzed by a health
care provider. The essence of some MSDs, at least in OSHA's own
construct of such conditions, is that overuse in the form of
``excessive'' repeated exposure is the source of problems in many
circumstances. It seems oddly inconsistent that on the one hand, the
overall thrust of the ``incremental abatement'' and job re-design
obligation of OSHA's full ergonomics program will focus on avoiding
or reducing exposures, while on the other, an employer's judgement
to limit additional exposure is retaliatory or aimed at discouraging
reporting (Ex. 500-1-140).
As with incentive programs and drug and alcohol testing policies,
OSHA's concern about withholding overtime is based on the
discriminatory application of this practice to discourage reporting or
participation in the ergonomics program. The Agency realizes that work
restrictions, including limitations on the number of hours worked, are
often necessary to prevent an injured employee's condition from
worsening and to allow damaged tissues to recover. The provision of
work restrictions, however, must be viewed separately from the
reporting of MSDs and MSD signs and symptoms.
If overtime is withheld as a matter of policy simply because a
report of an MSD has been made, this could have the effect of
discouraging reporting. An example of such a situation would be an
employee who uses a keyboard in a steady manner for eight hours per
day, then works an additional two hours as a receptionist and does not
perform any work involving typing or hand activity during that two
hours. If this employee were to report the signs and symptoms of an MSD
of the wrist, and as a matter of policy was denied the opportunity to
work overtime as a receptionist but continued working eight hours at a
keyboard, the effect would be to discourage reporting and would be
evaluated by OSHA as described above.
OSHA does not include production incentives in the category of
policies and practices that may discourage reporting or participation
in the program. Mosely and Associates registered concern as to how such
systems would be viewed, and expressed concern that plants may lose
their competitiveness if piece rate compensation systems or production
incentives are abandoned (Ex. 30-4362).
OSHA recognizes that these systems sometimes cause employees to
expose themselves to MSD hazards in order to achieve higher rates of
compensation. Because piece rate incentives are not directly tied to
reporting or participation in the ergonomics program, however, the
Agency does not view them as potential sources of discouragement to
reporting and participation. With full participation in the ergonomics
program, employees compensated under these systems will be provided
with the protections of the ergonomics standard, including the
information and training that will confer with it the ability to
recognize the potential causes of MSDs and knowledge of the importance
of early intervention.
Several commenters (see, e.g., Exs. 30-3853, 30-4247) argued that
subjecting an employer to citation for maintaining policies or
practices that discourage worker participation would be contrary to the
intent of Congress. These commenters argued that, by placing a
discrimination provision in Section 11(c) of the OSH Act, Congress had
made clear that anti-discrimination provisions should not be included
in standards. These commenters therefore believe it inappropriate for
OSHA to include a discrimination provision in an ergonomics standard.
Paragraph (h)(3) of the final rule is intended to prevent employers
not only from discriminating against employees for reporting and
participating in the ergonomics program, but also to prevent employers
from having policies that discourage employees from reporting and
participating, even where no discrimination has taken place. Paragraph
(h)(3) thus has a different scope than section 11(c). In addition,
insofar as paragraph (h)(3) addresses discrimination, it does so as
part of a broader standard that is reasonably necessary and appropriate
to address a serious hazard . Nothing in Section 11(c) indicates that a
standard issued in accordance with Section 6(b) may not include such a
provision. Provides a different enforcement mechanism than section
11(c), and nothing in section 11(c) indicates that it is the exclusive
means of addressing discriminatory policies.
Paragraph (i)--Employee Participation
Paragraph (i) sets forth the final rule's provisions regarding
employee participation. It requires that employers ensure that
employees and their representatives, if the employees are represented
by a recognized or certified collective bargaining agent, have ways to
report MSDs, MSD signs and symptoms, and MSD hazards; that employees
receive prompt responses to those reports when they are made; that
access to the standard and to information about MSDs and the ergonomics
program be provided to employees; and that employees have ways to be
involved in the development, implementation, and evaluation of the
ergonomics program.
The requirements of paragraph (i) closely correspond with the
requirements of the proposed employee participation section. This
reflects OSHA's determination, based on evidence in the record, that
the involvement of employees and their representatives in an ergonomics
program is critical to the effectiveness of the program. It also
reflects the support for the proposed employee participation provisions
expressed by commenters.
The proposed employee participation requirements were designed to
cover those circumstances where the involvement of workers was
essential to the success of an ergonomics program. The duty to
establish a means of reporting and to provide prompt responses to
reports was included because of the vital importance of an effective
reporting system to the proper function of the injury-based trigger of
the standard. Access to the standard and information about the
ergonomics program was considered by the Agency to be necessary for
employees to participate effectively in the ergonomics program.
Employee input into the development, implementation, and evaluation of
ergonomic programs was considered critical to program success because
of the first-hand knowledge that employees could offer regarding
potential solutions to MSD hazards, the appropriate content and level
of training, and the effectiveness of control measures.
The proposed provisions for employee participation generated a
considerable volume of comment. Support for the concept of involving
employees in the ergonomics program was widespread among commenters,
and few disagreed with the proposed requirements pertaining to
reporting, providing responses, and furnishing access to the standard
and to information. Comment on these provisions in the context of
employee participation was primarily limited to requests for
clarification about how the provisions would apply in practice.
Substantial differences were expressed, however, concerning the level
of employee involvement appropriately included in a final standard.
[[Page 68327]]
The importance of employee participation in the successful
implementation of an ergonomics program was stressed in a number of
comments (see, e.g., Exs. 30-276, 30-428, 30-651, 30-3860, 30-4333, 30-
4468, 32-21-1-2, 32-82-1,Tr. 3479, Tr. 6930, Tr. 3565, Tr. 5596-5597,
Tr. 10202, 32-450-1-18-1, Tr. 11182, Tr. 11380, Tr. 12947, Tr. 14479,
Tr. 14902, Tr. 16526, Tr. 12366, 500-29, 500-117-2, 500-177-2, 500-220,
500-215, 601-x-1587, 20-605). Mark Catlin of the Alice Hamilton
Occupational Health Center, for example, stated:
Our experience has been * * * that when there is true employee
involvement from beginning to end, especially in the development of
solutions, that can be a great benefit in coming up with a program
that works for that specific site that is cost effective and will be
maintained after it is initially set up (Tr. 5597).
The advantages that the knowledge and skills of employees have lent
to successful ergonomics programs were remarked upon by a number of
commentors (see, e.g., Tr. 4084, Tr. 4697, Tr. 6188, Tr. 7011, Tr.
7111, Tr. 7135, Tr. 7142, Tr. 9489, Tr. 10224, Tr. 10547, Tr. 11076,
Tr. 12366, Tr. 12297, Tr. 13004, Tr. 14248, Tr. 14320, 20-406, Tr.
17623). For instance, Dr. Robert McCunney of the American College of
Occupational and Environmental Medicine stated:
In my experience as a physician, I have been impressed with the
knowledge that a lot of workers have about their jobs and the
recommendations that can be made to improve it and reduce factors
associated with illness * * * [Tr. 17633].
One aspect of employee participation included in the proposal was a
means for the employee to inform the employer when MSDs or MSD signs
and symptoms occur. Reporting is essential to allow the employer to
become aware of those job situations where further action is necessary.
For example, if an employee experiences pain and stiffness in the
shoulders and believes this to be the result of workplace factors, the
employer cannot be expected to make changes to the workplace to
mitigate the risk factors unless the employer is aware of the existence
of a problem.
Belief in the importance of employee reporting of MSDs and their
signs and symptoms was expressed in a number of comments on the
proposed rule (see, e.g., Exs. 30-240, 30-1104, 30-2116, 30-2215, 30-
2387, 30-2809, 30-3686, 30-3765, 32-77-2, 30-3813, 30-3826, 30-3849,
30-3859, 30-4185, 30-4468, 30-4538, 30-4548, 30-4562, 30-4564, 30-4837,
31-78, 31-174, 31-192, 31-227, 31-303, 31-353, 32-82-1, 32-85-3, 32-
461-1, 32-111-4, 32-210-2, 32-339-1, 500-33). For example, Shipman and
Goodwin LLP, on behalf of an unnamed client, stated:
Requesting that employees report signs and symptoms encourages
the success of any early intervention program (Ex. 30-2215).
Comments received on this issue are presented in greater detail in
the discussion of paragraph (d), which includes a requirement that
employers provide information to their employees on how to report MSDs
and their signs and symptoms. The ability of employees to report MSDs
and MSD signs and symptoms depends upon their understanding of the
reporting mechanism, and knowledge of what constitutes a possible MSD
or MSD sign or symptom.
The final rule, at paragraph (h), adds ``MSD hazards'' to the list
of things employers must ensure that employees report. OSHA believes
that trained employees will be able to identify MSD hazards in their
workplace before they cause MSDs, and this will result, in turn, in
steps by proactive employers to protect workers at risk even before
they suffer an MSD incident. The reporting of MSD hazards has therefore
been added to paragraph (i)(2) of the final rule.
The specific process employers must establish for reporting MSDs,
their signs and symptoms, and MSD hazards is not prescribed in this
final rule. OSHA anticipates that the process will vary from workplace
to workplace, based on the size and nature of the workplace. A large
facility with an on-site health care professional (HCP), for example,
may choose to handle reports through the HCP. Smaller facilities may
elect to have reports made directly to supervisors. The method of
submitting a report is likewise not specified. Employers may chose to
adopt written, electronic, or other systems for receiving reports.
(Note, however, that employers are required by paragraph (v) to keep
records of employee reports, primarily for evaluation purposes.)
The final rule requires the employer to ensure that employees have
ways ``to promptly report'' their MSDs, signs and symptoms, and
hazards. OSHA received many comments on its use of the word ``prompt''
in the proposed rule (see, e.g., Exs. 30-3826, 30-3853, 30-4467, 30-
3284, 30-3367, 30-4674). These commenters asked OSHA to clarify what
was meant by ``prompt.'' OSHA is using the word to indicate that timely
reporting is required; the effectiveness of the standard and the
employer's program would clearly be compromised if employees did not
report their problems quickly, at a time when preventive action can
still be taken. A rigid time frame, however, is not specified in the
rule, because the Agency recognizes that some flexibility is needed to
account for the circumstances found in different workplaces. In
general, OSHA believes that reports should be received within a few
days in almost all cases, and the Agency expects employers to inform
their employees about the importance of early reporting, as required by
paragraph (d).
OSHA proposed that employers provide prompt responses to employee
reports of MSD signs and symptoms to encourage reporting and provide
feedback. OSHA's reasons for proposing that employer responses to
reports be made promptly was that timely and good faith responses are
essential to reinforcing the information exchange process. Several
commenters asked for clarification of this proposed provision (see,
e.g., Exs. 30-3344, 30-3367, 30-249, 30-3749). The Society for Human
Resources Management, for example, asked OSHA to specify what it would
consider an adequate response. The Society questioned whether OSHA
would consider acknowledgment of receipt of the report, evaluation of
the report, or action to prevent the condition from worsening as
responses to the report. Others asked whether the response must be in
writing or whether alternative methods of communication (e.g., oral)
would be acceptable (see, e.g., Exs. 30-3344, 30-3367, 30-3826).
If an employee experiences persistent MSD symptoms and reports that
condition to the employer but receives no response, that employee is
likely to consider the ergonomics program ineffective. Such a loss of
confidence in the program would clearly discourage future reporting and
participation. If the employer communicates the results of evaluations
made based on the report, or informs the employee of any actions that
are being taken as a result, the reporting employee will better
understand the process and will be more likely to participate in the
future. OSHA also recognizes that employers will sometimes inform the
employee that a given report requires no action, e.g., when an MSD
hazard turns out, on closer examination, not to warrant further action.
OSHA continues to believe that prompt responses to reports are an
essential part of the communication that must occur between employers
and employees in a functioning ergonomics program, and final paragraph
(i)(2) reflects this conviction.
In order to provide flexibility to employers to tailor
communication
[[Page 68328]]
methods to the needs of a particular workplace, the method of providing
a response to employees who report is not specified. Employers may
chose to adopt written, electronic, or other systems for providing
responses, although a record of the response must be maintained, as
required by paragraph (v).
OSHA proposed to require the employer to grant employees access to
the standard and to include information about the ergonomics program.
OSHA proposed this requirement to ensure that employees understood what
the OSHA standard required and how the employer's program worked. The
program was to include assignment of responsibilities in the ergonomics
program; job hazard analysis results; hazard control plans; records of
the occurrence of MSDs and reports of MSD hazards; ergonomic program
evaluation results; and lists of alternative duty jobs, according to
the preamble to the proposed rule [64 FR65799]. This provision
recognized that information is important to full employee understanding
of and participation in the ergonomics program.
OSHA was requested by commenters to define more clearly what was
meant by ``access'' to the standard (Ex. 32-337-1). The Dow Chemical
Company, for example (Ex. 30-3765) felt that employers should not be
required to provide employees access to the standard. Dow argued that
employers were required to comply with the provisions of the rule but
should not be additionally burdened by providing access to the
standard. In Dow's view, employees could be confused by receiving
information both on the employer's ergonomics program and the standard.
The National Coalition on Ergonomics (Ex. 32-368-1) expressed
concern that the employee participation provisions of the proposed
standard would require employers to provide employees with access to
the employer's confidential documents, which might address personnel
issues, financial issues, or safety audits. If this were the case, the
Coalition argued, employees with grudges or those involved in labor
disputes would be able to harass their employer by disclosing or
threatening to disclose proprietary information out of context or in a
fashion that might have an adverse impact on the employer. The
Coalition argued that this would discourage employers from performing
audits with appropriate depth and thoroughness. Concern was also
expressed that employee access might jeopardize medical
confidentiality. (Ex. 500-1-116).
OSHA does not believe that providing employee access to the
ergonomics standard is an unreasonable burden on employers, nor that
providing the standard will confuse employees. Employee access to OSHA
standards that affect them is a longstanding OSHA practice (see, for
example, OSHA's rule's governing lead exposure, noise exposure, and so
on). Access to the standard can be provided in several forms. A printed
copy of the standard may be made available, or an electronic version
may be provided on CD or via internet access to OSHA's web site if
employees have access to a computer. OSHA believes that the standard
will not be confusing to employees because they will be trained to
understand the ergonomics program in their workplace and their role in
it, in accordance with paragraph (t) of the final rule. OSHA does not
believe that employees will flood their employees with requests to
obtain and review the final standard; instead, the Agency believes that
the standard is likely to be used primarily as a reference to compare
the functioning of their workplace ergonomics program with the
provisions of the standard to assure that the program is functioning
properly and is in compliance.
Because of the importance OSHA attaches to employee access to the
standard, and the relative ease of providing it, the final rule adds
the term ``ready'' to the original access provision. This means that
whenever an employee requests access to the standard, the employer must
assure that ready access is provided, i.e., that access is provided
within a reasonable time and place.
Because of the importance OSHA places on employees being able to
easily understand the requirements of the standard, the final rule
requires employers to provide employees with a copy of the summary of
the standard that is required to be made accessible in paragraph (d).
Although the employer is required in paragraph (d) to make this
information available to employees when they start a job, the employee
should receive the summary at the time the program is implemented due
to the fact that the exposures in the employees job have now been shown
to exceed the levels in the Basic Screening Tool and considerable time
may have passed since the employee was informed that he or she had
access to this information. The summary sheet provided in Appendix B
may be used for this purpose.
The Agency is also not persuaded by arguments that confidential
company information or medical records would be distributed if
employers provide employee access to information about the ergonomics
program. The proposal specifically stated [64 FR 65799], and OSHA
reiterates here, that information of a personal nature such as the
medical records of other employees, is not included in the information
to which employees are required to have access. Records of the
occurrence of MSDs, for example, can be presented in a general form and
do not need to include personal details. General injury and illness
information is already available to employees under the provisions of
29 CFR 1904.7 with regard to the Log and Summary of recordable
occupational injuries and illnesses.
OSHA also is not convinced by comments suggesting that proprietary
information would be revealed if employees have access to program
information. The information required to be made available, on request,
is general information. For example, although an employee's detailed
process and production plans might be trade secrets, the information
required by this provision relates only to the control of ergonomic
hazards. Technical information regarding machinery or production
methods is clearly not required to be provided. Reports of MSD hazards
and job hazard analysis results are not confidential and are critical
information for employees if they are to participate meaningfully in
the ergonomics program.
Providing employees with basic information about the common kinds
of MSDs and their signs and symptoms is required by paragraph (d) of
the final rule. The comments pertaining to this paragraph can be found
in the summary and explanation for paragraph (d). OSHA has decided that
information on MSDs and their signs and symptoms is so basic, and so
important to employees, that it must be provided as part of employee
participation as well. The final rule's employee participation
provisions are only triggered when MSD incidents have been reported in
a job that meets the action trigger. This means that the employees
covered by final paragraph (i) are those who work in higher-risk jobs;
these employees clearly need to be informed about MSDs and their signs
and symptoms. Thus paragraph (i)(3) requires employers to inform their
employees with, at a minimum, the information sheet in non-mandatory
Appendix A. OSHA believes that most employers will choose to provide
more detailed and specific information, such as information about the
MSDs and signs and symptoms occurring among employees in jobs in their
establishment.
[[Page 68329]]
The fourth component of the proposed employee participation section
was a broad requirement that ``ways to be involved in developing,
implementing and evaluating each element of the ergonomics program'' be
provided to employees. This component, as explained in the preamble to
the proposal, was designed to allow employers to take advantage of the
knowledge, skills, and abilities that workers could contribute to the
ergonomics program.
The United Steelworkers concurred with OSHA's initial assessment
that employee involvement in each element of the ergonomics program was
appropriate. The union stated:
Workers and their representatives have to be involved in all
aspects of the introduction and implementation of an ergonomics
program in [the] workplace. After all, it is their bodies and lives
that are on the line (Ex. Tr. 11047).
Vagueness was a concern of some commenters. A number of interested
parties indicated that they did not understand what level of employee
involvement would be required under the proposed standard (see, e.g.,
Exs. 30-3344, 30-3848, 30-4607, 30-4674, 30-4713, Tr. 4372). These
commenters stated that the proposal did not make it clear whether an
employer would have unlawfully limited employee participation if, for
example, employee suggestions for ergonomics improvements were rejected
(see, e.g., Exs. 32-78-1, 30-4467, 30-541, 30-627, 30-652, 30-1355, 30-
1697, 30-1717, 30-4843, 601-x-1710). These participants argued that
employers should not be required to follow the recommendations of
employees or obtain their concurrence on a course of action, and should
retain the authority to make all final decisions about compliance with
the requirements of the standard (see, e.g., Exs. 30-3934, 30-2208).
Some industry representatives stated that the level of employee
involvement proposed by the requirement that employers involve
employees in developing, implementing and evaluating each element of
the program was excessive (see, e.g., Exs. 32-368-1, 32-78-1, 30-4467,
30-240, 30-276, 30-368, 30-429, 30-434, 30-541, 30-562, 30-652, 30-
1070, 30-1294, 30-1671, 30-2830, 30-2846, 30-2991, 30-3344, 30-3348,
30-3784, 30-3951, 30-4185, 30-4713, 32-21-1, 32-120-1, Tr. 11679, 500-
33, 30-3744). In the view of these commenters, OSHA did not demonstrate
that this level of employee involvement was necessary for an effective
ergonomics program (see, e.g., Exs. 32-78-1, 30-4467, 30-541, 30-627,
30-1355, 30-1545, 30-1697, 30-1717, 30-2830). Employee involvement,
although commonly acknowledged as often beneficial, was not needed in
every situation, and should therefore not be mandated, according to
these commenters. For example, Dr. Kurt Hegmann stated:
Hazard remediation efforts are frequently enhanced and
accelerated with employee participation since the ones doing the
work 40 hours a week have often thought of the most effective
solution. Yet, requiring employee participation in this and other
aspects of the rule is inappropriate, as these assumptions are not
always true [Ex. 30-4779].
Employee involvement in supervisory training or the evaluation of
management leadership, for example, were cited as program elements
where employee involvement was not considered necessary (Ex. 32-78-1).
In its comments on employee participation, the American College of
Occupational and Environmental Medicine stated:
* * * employee participation in the design, modification, and
evaluation of all aspects of an employer's operation is unnecessary.
In most facilities, manufacturing or industrial engineers
effectively perform many aspects of their jobs without employee
participation. OSHA's requirement for employee participation should
be limited to participation on ergonomics teams and participation in
the job-specific problem solving process [Ex. 30-4468].
Another commenter with a similar view argued that an employer who
is able to eliminate MSD hazards without employee participation should
not be required to consult employees (Ex. 30-4467).
Several practical problems about how the proposed requirements
would actually work in different situations were also raised. Union
Carbide Corporation indicated that such involvement would be difficult
to implement when the ergonomics program is developed on a corporate
level:
Large employers such as Union Carbide develop their ergonomic
programs on a corporate basis using professional staff. Of
necessity, they rely on employees to assist in implementing the
program, and employee evaluation of the program is always welcome.
But where programs are developed on a corporate basis, it is
sometimes difficult to involve employees in that development [Ex.
30-3784].
The Whirlpool Corporation believes that adhering to the
requirements of the standard would hinder the company's ability to
respond to ergonomic hazards when they are first identified. Safety
teams that are trained to quickly identify, assess, and fix a hazard
would be supplanted by the more cumbersome process required by the
standard. Whirlpool believes that the standard requires the employer to
obtain input from people who may have nothing to add to the process,
which would increase the time and expense involved without providing
any assurance that a better solution would be found (Ex. 30-4779).
Some employers interpreted the proposed requirement that employees
be involved in developing the program to mean that, where a current
ergonomics program already exists, the employer would be required to
develop a new program (Ex. 30-3765). The Edison Electric Institute
stated that it is impossible to consistently include employee
involvement in all elements of the ergonomics program, and therefore
recommended that the final rule allow greater flexibility to employers
and only require that employees ``be provided adequate, regular
opportunities to be involved in developing, implementing and evaluating
appropriate elements of the program'' (Ex. 500-33).
The Northwest Food Processors Association expressed concern that
engaging employees and their designated representatives in the
ergonomics program could be inappropriate in some cases because the
ergonomic interventions they suggested might result in the elimination
of jobs or otherwise negatively impact employment opportunities. The
association stated that employers should be given flexibility in the
final rule to determine the appropriate approach to such situations
(see, e.g., Tr. 12198).
Some employers were concerned that employees could disrupt the
program or decline to participate in it. These commenters believe that
employee representatives may attempt to use the standard as a way to
force unnecessary or costly changes for reasons unrelated to safety
(see, e.g., Exs. 30-2208, 30-1294, 30-3348). The Nabisco Company was
concerned that requirements for employee participation could not be met
if employees were unwilling to participate in the program. The company
stated:
Nabisco strongly supports the concept of employee involvement
and encourages participation of employees at all levels of our
organization. However, this requirement assumes that employees and
their representatives will readily volunteer to participate in a
management program. It has been the experience within some of our
locations that union representatives do not
[[Page 68330]]
always encourage employee participation in management programs [Ex.
30-4201].
A common concern expressed by employers with unionized employees
was that the requirements of the proposed standard for employee
involvement could serve to disrupt established collective bargaining
relationships (see, e.g., Exs. 30-3853, 30-3765, 32-337-1, 30-323, 30-
345, 30-538, 30-574, 30-1022, 30-1113, 30-1349, 30-1567, 30-1616, 30-
1652, 30-2426, 30-2725, 30-2773, 30-3086, 30-3184, 30-3284, 30-3344,
30-3951, 31-332, 500-1-128, 32-266-1, 30-3841). Many companies and
their unions, according to these commenters, have well-established
contractual mechanisms for addressing employee safety and health
issues. A typical example is a contract provision establishing a joint
labor-management safety committee. According to the views of these
commenters, requiring the employer to engage individual employees in
the ergonomics program would stimulate resentment and conflict by
forcing the employer to circumvent the union. PEPCO, for example,
expressed this view:
PEPCO, like most utility companies, has a long-established
relationship with a collective-bargaining agent that represents most
of our employees (International Brotherhood of Electrical Workers,
AFL-CIO). PEPCO has well-established contractual mechanisms for
addressing employee safety and health issues. We have joint labor-
management safety committees and include our union in accident
investigations. The proposal would interfere in established
relationships such as these, for in several instances, it would
require the employer to deal with or involve not just the employee
designated representative, but also the individual unionized
employee. This places the employer in the position of having to deal
apart from, or even circumventing, the union in order to avoid the
risk of citation [Ex. 31-332].
Consolidated Edison Company of New York urged OSHA to address this
issue by indicating that the obligations for employee involvement in
the final rule could be met by affording those rights to the union (Ex.
30-2816). Alan Ferranto of the National Association of Letter Carriers,
however, did not believe that collective bargaining relationships would
be affected by the proposed rule:
Inevitably, when a proposal of this nature is put forth, there
are those who will argue that collective bargaining will be
affected. As the safety and health officer for a union which
represents almost a quarter million postal employees, I'm here to
say that this proposal will not affect our collective bargaining
agreement with the postal service. In fact, we are satisfied that
the employee involvement envisioned under OSHA's proposed ergonomic
standard will complement the already agreed-upon procedures in place
to address safety and health issues [Tr. 3570].
A number of labor representatives felt that the proposed
requirement to involve employees and their designated representatives
in developing, evaluating and implementing each element of the
ergonomics program should be modified. Some parties expressed the
opinion that the standard should be revised to add employee
representatives to each provision where rights are granted to
employees. For example, the proposed job hazard analysis provision
would require the employer to ask employees whether performing the job
poses physical difficulties; in the view of these commenters, this
should be changed so that employees and their designated
representatives should be consulted. The unions also suggested that the
proposed control obligation section be revised to add designated
representatives to the requirement to ask employees for control
recommendations (see, e.g., Exs. 32-339-1, 32-182-1, 32-198-4, 32-210-
2, Tr. 3566).
Another commonly expressed concern of the employer community was
that the proposed provision that employers provide employees ways to be
involved in developing, implementing and evaluating each element of the
ergonomics program would conflict with provisions of the National Labor
Relations Act (NLRA) or with state laws addressing labor relations
(see, e.g., Exs. 30-296, 30-323, 30-328, 30-345, 30-368, 30-377, 30-
397, 30-523, 30-532, 30-536, 30-380, 30-538, 30-540, 30-541, 30-562,
30-574, 30-589, 30-594, 30-598, 30-627, 30-630, 30-632, 30-648, 30-688,
30-1022, 30-1113, 30-1131, 30-1216, 30-1294, 30-1296, 30-1332, 30-1349,
30-1355, 30-1356, 30-1357, 30-1358, 30-1367, 30-1370, 30-1413, 30-1545,
30-1551, 30-1552, 30-1567, 30-1584, 30-1616, 30-1652, 30-1683, 30-1697,
30-1717, 30-1727, 30-1898, 30-1901, 30-2049, 30-2050, 30-2054, 30-2061,
30-2062, 30-2133, 30-2134, 30-2427, 30-2499, 30-2506, 30-2645, 30-2773,
30-2799, 30-2811, 30-2812, 30-2813, 30-2814, 30-2824, 30-2830, 30-2896,
30-2990, 30-3061, 30-3062, 30-3086, 30-3095, 30-3131, 30-3174, 30-3177,
30-3210, 30-3231, 30-3233, 30-3284, 30-3336, 30-3344, 30-3716, 30-3745,
30-3765, 30-3845, 30-3853, 32-337-1, 32-368-1, 30-3349, 30-3353, 30-
3356, 30-3364, 30-3367, 30-3473, 30-3513, 30-3622, 30-3723, 30-3728,
30-3819, 30-3849, 30-4122, 30-4143, 30-4153, 30-4158, 30-4167, 30-4187,
30-4355, 30-4499, 30-4607, 30-4628, 30-4674, 30-4702, 30-4818, 30-4843,
31-266, 31-310, 31-332, 32-211-1, 32-234-2, Tr. 4320, Tr. 4908, Tr.
15537, Tr. 8896-8897, 30-3345, 500-1-27, 500-1-28, 500-1-29, 500-1-42,
500-1-79, 500-1-86, 500-1-106, 500-1-112, 500-1-113, 500-1-114, 500-1-
116, 500-1-181, 500-1-117, 500-1-124, 500-1-125, 500-1-193, 500-1-248,
500-1-249, 500-1-307, 500-1-329, 500-1-331, 500-1-411, 500-1-423, 500-
1-442, 500-177-2, 30-1942, 30-3236, 30-3339, 30-4535, 30-2600, 30-2592,
30-2577, 30-2583, 30-2256, 30-2259, 30-2201, 30-2243, 30-2260, 30-2272,
30-3428, 30-3157, 30-3158, 30-3196, 30-3623, 30-2550, 30-2543, 30-2529,
30-2535, 30-4583, 30-2896, 30-2894, 30-2886, 30-2868, 30-2863, 30-2862,
30-2854, 30-4668, 30-4302, 30-2106, 30-2404, 30-2405, 30-2407, 30-2406,
30-2412, 30-2292, 30-2293, 30-2300, 30-2287, 30-2447, 30-2370, 30-2605,
30-2614, 30-2772, 30-2791, 30-2793, 30-2828, 30-2831, 30-4058, 30-2474,
30-2487, 600-x-34, 600-x-36, 30-4762, 30-2901, 30-5036, 30-4566, 30-
1971, 30-1972, 30-1973, 30-2571, 30-4541, 30-4786, 30-5027, 601-x-1370,
601-x-1698, 601-x-1712, 601-x-1439, 601-x-1440, 601-x-1441, 601-x-1442,
601-x-1444, 601-x-212, 601-x-213, 601-x-1368, 500-1-397, 30-3839, 30-
4247, 30-4486, 601-x-1711, 601-x-1360, 30-3858, 30-3923, 30-4778, 30-
2432, 30-3850, 30-2593, 30-3728, 30-2270, 30-1995, 30-2209, 30-3036,
30-2832, 30-2472, 30-2439, 30-2438, 30-2397, 30-2389, 30-4300, 30-4326,
30-1076, 30-4712, 30-2103, 30-3806, 30-1730, 30-1446, 30-3220, 30-3235,
30-4335, 30-4337, 30-4362, 30-4394, 30-4443, 30-4528, 30-4709, 30-1651,
30-2410, 30-2289, 30-3877, 30-2601, 30-3160, 30-3598, 30-2912, 30-1332,
L30-5025, 30-4280, 30-1416, 30-1453, 30-1457, 30-1616, 30-1998, 30-
1999, 30-2131, 30-2142, 30-2184, 30-2233, 30-2250, 30-2304, 30-2395,
30-2396, 30-2423, 30-2431, 30-2736, 30-2829, 30-2889, 30-2891, 30-2992,
30-3003, 30-3254, 30-3334, 30-3393, 30-3551, 30-3597, 30-3791, 30-3882,
30-3936, 30-3944, 30-3974, 30-3977, 30-3999, 30-4464, 30-4532, 30-4539,
30-4544, 30-4629, 30-4657, 30-4667, 30-4669, 30-4980, 30-5034, 30-5076,
30-5095, 30-5101, L30-4952, L30-4953, L30-5096, 30-3497, 30-1938, 30-
1989, 30-2217, 30-2384, 30-2403, 30-2403, 30-2416, 30-2480, 30-2486,
30-2555, 30-2556, 30-2607, 30-2639, 30-2734, 30-2735, 30-2873, 30-2878,
30-3578, 30-3742, 30-3776, 30-4325, 30-4452, 30-4790, L30-4998). A
discussion of the relationship between the requirements of this final
rule and the NLRA can be found in the Legal Issues section of this
preamble.
[[Page 68331]]
As has already been discussed, the potential value of employee
contributions to the development, implementation, and evaluation of an
ergonomics program is well-established. The intent of the proposed
requirement that employees have ways to be involved in developing,
implementing, and evaluating each program element was to allow
employers to take advantage of this potential value to construct and
administer the most effective program possible.
A requirement that employees be involved in the program in no way
abrogates the authority of the employer to manage the workplace or
administer the ergonomics program. Regarding employee suggestions, this
general requirement of the final rule for employee involvement requires
only that employers provide a reasonable opportunity for employees to
be heard, for them to be involved, and for their suggestions to be
fairly considered. An employee recommendation made as part of this
process, in and of itself, does not oblige the employer to take action.
For example, if an employer asks employees in a problem job for
recommendations about eliminating or controlling MSD hazards, the
employer is not compelled to adopt any of the suggestions that the
employees may make. Rather, this is an opportunity for the employer to
draw on the knowledge of these workers in identifying and examining
alternative approaches to addressing hazards. The suggestions of
employees may be used to supplement those of professional staff or
consultants.
Along with the authority for making decisions, the employer retains
the responsibility for ensuring the effectiveness of the program. If
consultation with employees about the effectiveness of the program
reveals, for example, that training has not been understood, then this
deficiency must be promptly corrected (see paragraph (u) of the final
rule).
OSHA realizes that the input of employees will not in every
instance prove to be beneficial to the ergonomics program.
Nevertheless, the evidence in the record shows that contributions to
the success of ergonomics programs have consistently been made by
participating employees. The involvement of employees need not be
cumbersome or time-consuming. Brief discussions are often sufficient to
elicit employee input.
The proposal would have required that employees have ways to be
involved in developing, implementing, and evaluating each element of
the ergonomics program. The final rule requires that employees be
involved in developing, implementing, and evaluating the program;
however, reference to ``each element'' of the program has been deleted.
This change has been made to grant the employer flexibility to adapt
employee involvement to the circumstances in a given workplace. OSHA is
convinced that the proposed level of employee involvement is not
practical or justified in every instance. The Agency never intended for
employee involvement to pervade every aspect of the program. As
explained in the preamble to the proposal, the ``elements'' referred to
were the broad ergonomics program elements (e.g. training, program
evaluation). A requirement for employee participation in each component
of these elements, such as supervisory training, was not envisioned.
OSHA considers, however, that even greater latitude is appropriate in
order to allow the employer to most effectively construct and
administer the ergonomics program. For example, a small employer could
adopt a training presentation developed by a trade association even if
employees in that workplace did not participate in the development of
the presentation. The Agency believes, however, that such circumstances
are the exception rather than the rule, and has retained the
requirement for employee participation in the development,
implementation, and evaluation of the ergonomics program due to the
evidence of the value of worker involvement in each of these stages in
the administration of the program.
OSHA considers that the development of an ergonomics program is not
an event, but a continuing process. The work environment is rarely
static; work methods and equipment often change over time, and as a
result the physical demands upon workers and associated MSD hazards can
change as well. Likewise, hazard control methods and training
procedures can evolve over time. Changes in the workforce can also
impact the effectiveness of an ergonomics program. The program may
require adjustments to account for these changes. For example, if
ergonomics training is conducted in English in a workplace where the
employees speak and understand English, it may be effective. If that
employer subsequently hires employees who do not understand English, an
adjustment would be necessary to provide the training in a language the
employees understand. Similarly, if new equipment is brought into a
workplace, modifications to the ergonomics program may be necessary to
control MSD hazards related to use of the new equipment or to provide
appropriate training. It is in these types of situations, as well as in
the initial creation of the ergonomics program, where the record
demonstrates that the involvement of employees can prove invaluable.
In response to those employers who were concerned that the proposed
standard would necessitate discontinuation of successful programs that
did not incorporate employee involvement in their development, OSHA
does not intend for the requirement in the final rule for employee
participation in the development of ergonomics programs to apply
retroactively to programs that have already been established. The
Agency believes that such a requirement would result in an unnecessary
expenditure of resources to duplicate the existing program. Rather,
OSHA believes that the evaluation of the effectiveness of the existing
program will result in the identification and correction of any
deficiencies which may currently exist, and that employee involvement
in the ongoing development of the program will result in continuous
improvement in the program over time. Moreover, OSHA anticipates that
the grandfather clause in paragraph (c) of this final rule will apply
to many existing programs.
A successful ergonomics program also requires employee involvement
in its implementation. Clearly, hazard controls cannot be effective if
workers do not use them, and MSD management cannot be effective if
injured workers do not report their injuries. A program cannot fulfill
its objectives if it exists only on paper, and is not applied in the
workplace. Ample opportunity is provided to demonstrate employee
involvement in the implementation of the program through compliance
with the specific requirements of the standard. For example, if a job
has been found to be an MSD hazard due to repetition, and the
appropriate control method has been determined to be rotating jobs so
that no single employee spends more than three hours per day in that
job, the employer must ensure that employees carry out the job rotation
in order for it to be effective as a control measure.
Employee involvement in the evaluation of the ergonomics program is
also needed to assure program effectiveness. For instance, workers in
problem jobs are in the best position to determine if control measures
are successfully controlling MSD hazards, or if new hazards have been
created. Employees are also best able to recognize when training is
inadequate
[[Page 68332]]
or when opportunities for reporting of MSD hazards or MSD signs and
symptoms are unsatisfactory. As with employee involvement in the
implementation of the program, opportunities to demonstrate employee
involvement in the evaluation of the program can be found in the
specific requirements for evaluation found in the standard, such as the
requirement of paragraph (m)(4) for consultation with employees
regarding the effectiveness of controls and the requirement of
(u)(1)(i) for consultation with employees on effectiveness and problems
with the program.
OSHA does not believe that employee participation in the ergonomics
program under this final rule will result in adverse repercussions on
collective bargaining relationships. The final rule also does not
require employers in any way to circumvent any process that may
currently exist for employer communication with the employee. The rule
does not specify a precise mechanism that must be used for employee
participation. Where a system is already in place, such as a union/
management safety and health committee, nothing in this rule prohibits
an employer from using that system to meet its employee participation
obligations.
Paragraph (j)--What Must I Do To Determine Whether a Job That Meets
That Action Trigger Poses an MSD Hazard to Employees in That Job?
This paragraph addresses the job hazard analyses employers must
perform to identify those MSD hazards that must be controlled under
this final standard. Paragraph (j)(1) of the final standard requires
employers with jobs that meet the standard's two-part action trigger--
i.e., who have employees who have experienced an MSD incident and who
work in jobs that have risk factors present at levels that meet the
screen in Table W-1--to conduct a job hazard analysis of the job to
determine whether it presents an MSD hazard to employees. (Employers
who qualify for and choose to use the Quick Fix option contained in
paragraph (o) of the standard must follow the procedures of that
paragraph and are not required to conduct the job hazard analysis
specified in this paragraph (j).)
Paragraph (j)(2) tells employers what steps they must include in a
job hazard analysis, and paragraph (j)(3) lists the methods of job
hazard analysis that are acceptable under the rule, including referring
to a number of tools, included in Appendices D-1 and D-2 of the
standard, that employers can use to conduct their analyses. Paragraph
(j)(4) explains that if the job hazard analysis shows that hazards need
to be reduced, the job is terms a ``problem job'' under this standard.
The proposal's job hazard analysis provisions listed the steps
required to analyze a job, and contained a list of 20 physical work
activities and conditions associated with particular risk factors. The
proposal did not provide specific guidance on how to determine whether
the risk factors presented an MSD hazard in any particular case.
Several commenters argued that the proposal's approach was vague and
asked for more specific measures for identifying MSD hazards (see,
e.g., Exs. 500-197, 30-2435, 30-973, 30-1274, 30-2426, 30-1350, 30-
2428, 30-2986, 30-3000, 30-3086, 30-3853, 30-326, 30-546, 30-4189).
Others (e.g., Ex. 30-3593) thought that the requirements in the
proposed job hazard analysis section were too specific, and still
others stated that the table oversimplified the complex interactions
between various risk factors in a job and urged OSHA to eliminate the
table of physical work activities from the final rule (see, e.g., Ex.
30-3436). The argument made by several commenters was that the work
activities and risk factors included in the table in the proposal would
be hard for employers to identify in the workplace (see, e.g., Exs.
500-197, p. III-12, 30-3745, 30-2134, 30-2426, 30-2919).
Although some provisions in final paragraph (j) are essentially the
same as the corresponding sections of the proposed rule, several have
been revised in response to comments that the proposal did not provide
enough information on how employers could determine whether MSD hazards
were present. In particular, the inclusion of the tools in this rule
provides employers with much more assistance in compliance than the job
hazard analysis provisions in the proposal (proposed sections 1910.917
and 1910.918) would have, while preserving a high degree flexibility
for employers who do not choose to use any of the listed tools. In
addition, the final rule has been modified to allow employers
additional flexibility in several aspects of the job hazard analysis
process. The following discussion describes each provision of paragraph
(j) of the final rule and OSHA's responses to the comments received on
the proposed job hazard analysis provisions.
Paragraph (j)(1)
Paragraph (j)(1) of the final rule states that employers must
conduct a job hazard analysis to determine whether a job that meets the
action trigger presents an MSD hazard to employees in that job. This
requirement is essentially identical to the job hazard analysis
obligation in Section 1910.917 of the proposed rule. Like the proposal,
the final rule does not require the employer to perform a job hazard
analysis for every reported MSD, but only for those that meet screening
criteria. Unlike proposed Section 1910.917, however, Paragraph (j)(1)
also permits an employer to rely on a job hazard analysis that was
conducted previously for the job, provided that the analysis was
performed in accordance with the procedures of this paragraph (j) and
is still relevant to the job (i.e., the job has not been altered in the
meantime in a way likely to change or increase exposure).
The purpose of job hazard analysis is threefold: (1) To identify
all the ergonomic risk factors that are associated with the job being
analyzed; (2) to measure the duration, frequency and magnitude of
employee exposure to these risk factors; and (3) to evaluate the risk
factors identified, individually and in combination. This analysis
allows employers to determine if the job poses an MSD hazard to
employees, i.e., is a ``problem job,'' as that term is used in the
standard. The results of the job analysis, which identify the extent of
the risk factors present in the job, can later be used as the benchmark
against which to measure the effectiveness of controls.
The NIOSH publication, Elements of Ergonomics Programs (Ex. 26-2),
describes a job hazard analysis as an examination of the workplace
conditions and individual elements or tasks of a job to identify and
assess the risk factors that are reasonably likely to be causing or
contributing to the reported MSDs. OSHA received many comments
supporting its proposed approach to job hazard analysis (see, e.g., Tr.
5342, Tr. 8978, Exs. 37-1, 37-25, 500-218, 500-137-1-1). OSHA thus
believes that the requirements of paragraph (j) are consistent with the
objectives and steps of job hazard analysis as the process is currently
applied by employers with effective ergonomics programs.
The quality of the job hazard analysis performed is critical to the
success of the entire ergonomics program, as the United Auto Workers
noted:
The heart of an ergonomics program is the measurement of risk
factors on jobs. The presence of risk factors demonstrates that a
reported MSD is related to a job or workstation, while their absence
suggests the MSD arose from other causes. Risk factors predict MSDs
will arise in the future, even if none are currently reported. And,
reductions in risk factors indicate that a job has been improved
(Ex. 500-220).
[[Page 68333]]
A job hazard analysis can also rule out jobs that do not need to be
controlled, and can provide employers with the information they need to
prioritize their efforts on the most hazardous jobs or tasks that pose
the most severe problems. Similarly, a job hazard analysis is an
efficient way to help employers focus their resources on the most
likely causes of a problem. For example, after analyzing a job, the
employer may find that the amount of repetition is acceptable if the
force and awkward posture in the job can be controlled sufficiently.
Despite these benefits, several commenters (see, e.g., Exs. 30-
1393, 30-1275, 30-3061, 30-3062) were concerned that the standard's
requirements for job hazard analysis would be too costly. Typical of
these comments was one from the Navy Federal Credit Union:
The requirement for employers to perform job hazard analyses is
extremely onerous and costly. It requires every employer to perform
hazard analyses on the same or similar jobs within their industry.
OSHA has already amassed a substantial amount of data on the likely
causes and remedies of MSDs that occur in the workplace. The
ergonomics standard should permit employers to rely on OSHA's
identification of hazards and possible remedies for problem
occupations (Ex. 30-1273).
Other employers, such as August Mack Environmental, Inc., disagreed,
however:
I do agree that conducting a hazard analysis, if done properly
and very objectively, requires significant resources. However, if
the result were to find that MSD risk factors were not prevalent,
and the need for full implementation of a comprehensive ergonomics
program were eliminated, this [expense] could easily be justified.
This is due to the estimated amount of resources required for the
hazard analysis compared to the resources required to implement a
formalized ergonomics program and maintain it over time (Ex. 30-
240).
Other record evidence also makes clear that the cost of MSDs far
exceeds the costs of controlling MSD hazards (Tr. 7122, Tr. 10225, Tr.
4811).
Similarly, some commenters also expressed concern that performing
job hazard analysis could be too difficult for small companies (see,
e.g., Exs. 601-x-1, 30-3469, 30-2846). However, OSHA's experience is
that small companies can and do conduct these analyses effectively. For
example, Wood Pro Industries in Cabool, Missouri is a VPP employer with
only 100 employees. Its safety director (David Carroll, who also wears
a number of other hats) began a safety and health program that
identified and controlled ergonomic risk factors several years ago. The
program has resulted in a decrease of almost 40% in workers'
compensation costs (mostly due to reductions in MSD hazards), with
premium costs declining from $103,824 to $61,000, which Mr. Carroll
described as ``not chicken feed for a small company'' (Ex. 502-17).
Based on this record, OSHA agrees with those who commented that an
appropriate job hazard analysis actually limits MSD hazard control
costs, either by determining that no MSD hazard is present or by
identifying risk factors that, in turn, allow the company to focus on
the activities that are associated with the MSD incident.
The UAW also has experience with small companies that have
implemented ergonomics programs:
Employers in the many small facilities have voluntarily or
through the collective bargaining process, adopted a common approach
to preventing ergonomic injuries and abating ergonomic risk factors
in the workplace. The program includes all components established in
the proposed standard, except appropriate medical management and
that can be established without hindering the established processes
at the facilities (Ex. 500-220).
Other commenters argued that the proposed approach to job hazard
analysis would require the employer to hire a consultant (see, e.g.,
Exs. 30-3783, 30-2810, 30-3336, 30-715, 30-2834). For example, the
Texas Association of Business and Chamber of Commerce stated:
Because the proposed standard inadequately defines the alleged
``risk factors'' or ``conditions or activities'' or even to provide
a complete list of the ``conditions or activities'' during which the
``MSD hazards'' allegedly occur, small employers will be forced to
seek assistance--at substantial cost--from those with experience and
knowledge in the ergonomics field. In addition, the proposed
standard does not adequately explain which controls will abate
particular hazards and they will again be forced, and as encouraged
by OSHA, to seek expensive outside help (Ex. 30-2810).
But contrary evidence is also in the record:
I am not an ergonomist and I do not believe you need an
ergonomist to do a general check on the risk factors of most jobs,
that most workers, especially if you give them a framework for
thinking about and analyzing their own job, can tell you where those
risk factors are present, where they're not present, where they're
present in large quantities versus small quantities. You do not need
to be an ergonomist to do that. Many workers are extremely capable,
if you give them a framework for analyzing their own jobs * * * (Tr.
13764).
A recent study in the record (Ex. 500-71-64) reports that trained
workers were able, in 65 to 85% of cases, to identify the same risk
factors as hired ergonomists and to successfully identify solutions.
The job hazard analysis required by Paragraph (j) of the final rule
serves a very different function from the Basic Screening Tool in Table
W-1 of the standard. The Basic Screening Tool is a simple hazard
identification tool that can be used to identify jobs with the
potential to expose workers in them to ergonomic risk factors at levels
that may pose an MSD hazard. It cannot take the place of a job hazard
analysis. It can only point to possible problems with the job; it takes
a job hazard analysis to determine whether controls are actually
necessary. A job hazard analysis identifies specific risk factors, or
combinations of risk factors, that need to be controlled.
Paragraph (j)(1) also allows employers to rely on a previously
conducted analysis of a job if it was performed in accord with the
requirements of this paragraph, and the analysis is still relevant.
This provision responds to concerns expressed by some participants that
employers that the standard would require significant action every time
a new MSD occurred, even if a job hazard analysis that complied with
the standard had already shown that no additional controls are
necessary (e.g., Ex. 30-3956). To take advantage of this provision, the
employer must confirm that the job is still being performed in the same
way, and that the same risk factors are still present. Any changes to
the work methods or equipment may have introduced new MSD hazards, and
a new job hazard analysis would then be required. Additionally, if new
employees are present, the employer must make sure that no new employee
is performing the job in a different way or has physical
characteristics that expose that employee to risk factors not present
for others. For example, a particularly tall or short employee might
need to work in a more awkward position, or reach further than others
in order to perform the same tasks. If that is true, the employer must
analyze the job to identify the risk factors affecting that employee.
The ``new employee'' situation described above is one of the
scenarios addressed by the Note to paragraph (j). That note allows the
employer to limit the job hazard analysis (and response) to the
employee who reported the MSD incident when the MSD hazard is limited
only to that employee. Evidence in the record points to situations in
which the physical work activities or conditions of a job pose a risk
to only a single employee (see, e.g., Exs. 30-
[[Page 68334]]
4709, p. 6, 500-145, 30-2208). For example, a five-foot tall employee
in a commercial bakery may report a back or shoulder MSD related to
extended reaches involved in sorting rolls. However, other, taller,
employees who have performed the job for several years do not have (and
never have had) difficulty performing the physical work activities of
the job. In this case, the employer could conclude, based on the job
hazard analysis, that the problem is limited to the injured employee.
The employer then may limit the further action required by the standard
(e.g., analysis, control, training, recordkeeping, evaluation) to that
employee's workstation.
A similar situation could occur where one employee is much taller
than others in the same job. The tall employee reports persistent back
pain that rises to the level of an MSD incident, and the employer
observes that having to bend much further than the other employees to
work at the work surface is likely to have caused the back problem.
Allowing employers to limit the analysis and control to a single
employee if the analysis reveals that the problem is unique to that
employee is consistent with the approach taken by several commenters
who have successful ergonomics programs (see, e.g., Exs. 30-1071, 30-
3755, 30-3745). As one of these commenters reported, ``we have often
modified the job to fit that one individual--however, modification was
not needed for co-workers at similar or identical duty stations'' (Ex.
30-1071).
Paragraph (j)(2)
Paragraph (j)(2) of the final rule describes the steps the employer
must take in performing the job hazard analysis. Paragraph (j)(2)(i)
states that the employer must talk to the employees who perform the
job, and their representatives, about tasks that may relate to the MSD
incident. Paragraph (j)(2)(ii) requires the employer to observe the
employees performing the job to identify the risk factors and assess
the extent of their exposure (its magnitude, frequency, and duration)
to those risk factors. The employer must include all of the employees
performing the job, or a sample of those with the greatest exposure to
risk factors, in this analysis.
According to the record (see, e.g., Exs. 26-2, 26-5, 26-1370, 37-1,
37-25) effective job hazard analyses have the following steps or
activities in common:
Obtaining information about the specific tasks or actions
the job involves;
Obtaining information about the job and problems in it
from employees who perform the job;
Observing employees performing the job;
Identifying specific risk factors in the job; and
Evaluating those factors (i.e., their duration, frequency
and magnitude) to determine whether they are causing or contributing to
the problem.
The job hazard analysis requirements of the final rule reflect
these steps. Unless the employer qualifies for and chooses the Quick
Fix Option in paragraph (o), the employer must use the job hazard
analysis process in this paragraph to determine whether the physical
work activities and job conditions pose an MSD hazard to workers in
that job. Jobs that pose an MSD hazard to employees are called
``problem jobs,'' and must be controlled in accordance with paragraphs
(k) through (m) of this final rule.
When employers perform a comprehensive job hazard analysis, their
goal is to identify those ergonomic risk factors that impose
biomechanical stress on the worker and evaluate magnitude, frequency,
and duration as required by paragraphs (j)(2)(ii) and (j)(3). Once the
risk factors and their magnitude, frequency, and duration have been
determined, the employer is required to assess whether the risk factors
identified pose an MSD hazard to employees. The standard defines an MSD
hazard as the ``presence of risk factors in a job at a level of
magnitude, frequency, and/or duration that is reasonably likely to
cause MSDs that result in work restrictions or medical treatment beyond
first aid.'' Ergonomic risk factors are the elements of MSD hazards,
and they often work synergistically. That is, jobs that have multiple
risk factors pose a greater risk, all things equal, than a single risk
factor.
Paragraph (j)(2)(i)
Paragraph (j)(2)(i) of the final rule requires employers to talk
with employees and their representatives about the tasks the employees
perform that may relate to MSDs. Much has been written about the value
of employee participation in the identification of risk factors and
controls at the hazard analysis stage (see, e.g., Exs. 3-232, 26-4, 26-
11, 26-15, 26-18, 26-19, 26-21, 26-1370, 26-1420, 32-339-1-42, 38-32).
Studies have shown substantial improvements in health and safety after
participatory ergonomics programs are implements (e.g. Ex. 32-38). A
comment from Johnson & Johnson sums up the opinion of many
participants:
Hazards cannot be addressed efficiently without an accurate
evaluation of the situation. The line employee is one of the best
sources of this information * * * [those employees are] local
process experts (Ex. 3-232).
The record contains considerable evidence that many employers talk to
employees to get insight into the job requirements that only those who
work at the job can provide (see, e.g., Exs. 30-3755, 30-3748, 500-117,
500-137-1-1, 500-137-6-1, 500-218, 500-220, Tr. 3890, 13808). These
commenters stated that talking with employees is often the best way to
identify the causes of the problem and to identify the most cost-
effective solutions to it (see, e.g., Ex. 26-1370). One stated:
Employee participation is vital to this element. Job Safety
Analysis (JSA) [another name for job hazard analysis] has been part
of the safety vocabulary for many years. Many employers are working
with the workers to determine the safest way to do a job.
Controlling a hazard can be a productive tool in many ways. Minimize
lost time; reduce training and overtime; and a positive outlook from
the workplace. A worker who is set up to succeed is a productive
worker. A worker who has to jury rig or perform a task that leaves
him or her in discomfort at the end of every shift can not be
productive for a prolonged period of time. (Ex. 500-137)
Discussions with employers who have set up ergonomics programs in
response to corporate settlement agreements with OSHA also confirm the
need for employee input into the job hazard analysis process (Ex. 26-
1420). A number of these employers said that employees need to be
involved in the analysis and control process because ``no one knows the
job better than the person who does it'' (Ex. 26-1420, See also Ex. 3-
164). Other evidence echoed this concept, confirming that employees
often have the best understanding of what it takes to perform each task
in a job, and thus, what parts of the job are the hardest to perform or
pose the greatest difficulties: ``The people that are closest to doing
the work seem to come up with the best solutions.'' Tr. 4697.
In addition to helping to ensure that the job hazard analysis is
accurate, involving employees can make the job hazard analysis and
control process more efficient, because employees can help employers
pinpoint the causes of problems more quickly. Employees often come up
with some of the most practical, no-cost or cost-effective, solutions
(see, e.g., Ex. 26-Tr. 1370, 2136, 2582, 12297).
Some participants opposed this provision, however (see, e.g., Exs.
30-3344, 30-74, 30-3557). Several expressed concern that asking
[[Page 68335]]
employees about ergonomic problems would influence the employees'
response, with the result that specious problems would be identified:
This section is a regulatory ``Field of Dreams.'' Ask it and
they will answer. Sooner or later, for reasons good, bad, or
indifferent, somebody will answer ``yes'' [when asked if the job
presents physical difficulties]. (Ex. 30-74)
Another participant was concerned that employee comments would vary
from employee to employee and thus not be useful (Tr. 8861). Finally,
several commenters argued that the employer and employee should not
discuss the risk factors present in ``normal job activities'' because
doing so might cause employees to feel that there should be no stress
on the job (Exs. 30-3354, 30-3848).
OSHA continues to believe that employees' views add significant
value to the job hazard analysis process and, in fact, that not asking
employees about their perception of the tasks that may cause MSDs would
be akin to performing a quality survey without involving the customer.
Therefore, the final rule requires the employer to talk with the
employees who perform the task when conducting this step of the job
hazard analysis process.
OSHA is, moreover, providing enough flexibility in this provision
to accommodate employers' concerns. OSHA is not requiring employers to
use any particular method to talk with employees about the tasks they
perform. Employers may do something as simple as talking with employees
informally while observing the job being performed, or they may choose
to talk with employees as part of a regular staff or production
meeting. Alternatively, employers may have affected employees fill out
a survey form or questionnaire. Many employers have developed effective
tools for gathering important job information from employees who do the
job. For example:
AMP Inc., a manufacturer of electronic components, with 300
employees, uses a one-page ``Ergonomic Evaluation Form'' that asks
employees to answer simple ``yes/no'' questions about the employee's
ease and comfort when performing certain job tasks. After the
company's ergonomic team (comprised of line employees) reviews the
form, a member of the team interviews the employee. (Ex. 26-5).
In addition, there are ways to ask questions that respond to the
concerns expressed above. The questions may be posed to minimize bias.
For example, questions like ``Are parts of your job more difficult than
others?'', ``Does your injury hurt more when performing certain
tasks?'', or ``Could you recommend improvements to the job?'' tend to
elicit useful information and do not prejudge the answer (Exs. 32-339-
1-82, 500-121-61). In any event, the employee input is only one aspect
of the job hazard analysis. The employer need not place great weight on
the views of a single employee when those views are inconsistent with
the rest of the information obtained during the analysis.
The final rule adds the language ``and employee representatives''
to this provision consistent with the practice in the rest of the rule
to include the ``employee representative'' language included in each
provision of the standard where OSHA is requiring such participation.
The proposal took a more general approach to this issue, i.e., it would
have required employers to decide when including employee
representatives was important in ``developing, implementing, and
evaluating the employer's program'' (64 FR 66070).
A few commenters also stated that the appropriate focus for a job
hazard analysis is the task rather than the job and objected to OSHA's
use, in the proposal, of the word ``job'' in connection with the
component to be analyzed in a job hazard analysis (see, e.g., Exs. 32-
300-1, 30-3755). OSHA agrees, and the language of the final rule uses
``tasks'' instead of ``jobs'' when referring to the units of analysis
in this process.
Paragraph (j)(2)(ii) requires employers to observe the employees
performing the job to identify the risk factors in the job, and to
evaluate the magnitude, frequency, and duration of exposure to these
risk factors. Job observation allows the employer to see how the
employee does the job and provides information about the workstation
layout, tools, methods, equipment and general environmental conditions
in the workplace. A number of commenters recognized the value of this
step (Ex. 30-3755). This paragraph of the final rule combines
paragraphs (c) and (d) of proposed section 1910.918. Observing the
employees at work is important because it allows employers to see
precisely which tasks may be imposing biomechanical stress on the
worker. Observation is a necessary addition to the discussion required
by paragraph (j)(2)(i) because some things may be overlooked in the
discussion, or employees may not remember to mention certain activities
(particularly those that are short term).
There are several ways employers may comply with the observation
requirement in paragraph (j)(2)(ii) of the standard, and participants
described how they integrate job observations into their job hazard
analysis (see, e.g., Tr. 8171, Tr. 11133). First, employers may simply
observe employees perform the job tasks; this is often all it takes to
identify the problem. For example, watching a data processor reaching
to use the mouse because the keyboard tray is not long enough to
accommodate it may be all it takes to identify the likely cause of the
employee's shoulder pain. Videotaping the job is another common
practice for observing jobs (see, e.g., Ex. 32-198-4). A number of
employers, especially in situations where the work activities are
complex or the causes of the problem not be easily identifiable, report
that they videotape or photograph the job (see, e.g., Ex. 26-1370; Tr.
3059, 4696, 6979, 7075, 5805, 5540, 10183).
The value of simply looking at people performing a job was
demonstrated graphically at the hearing. A law firm representing a
number of participants showed several ergonomist witnesses pictures of
two workers seated at computer workstations (Ex. DC 42), and asked the
witnesses to identify the risk factors observable in the photo.
Virtually all of the witnesses (Tr. 1754, Tr. 1756, Tr. 2249, Tr. 2325-
2327, Tr. 5397, Tr. 9045, Tr. 13228, Tr. 13235, Tr. 13307, Tr. 13762)
explained that it would normally be necessary to ask the employees in
the jobs reflected in the photos pertinent facts about the job before
being able to determine with any certainty whether the exposure
represented in the snapshot posed an MSD hazard to the worker:
Well, again, it would go back to what they were doing. If they
were doing this job for a long period of time (Tr. 928).
Nonetheless, when pressed to give the best answer possible based on
the limited amount of available evidence, the witnesses reviewing the
photos were surprisingly consistent in their identification of
ergonomic risk factors across witnesses. The table below summarizes the
witnesses' responses to the snapshot.
[[Page 68336]]
----------------------------------------------------------------------------------------------------------------
Risk factors--taller
Risk factors--shorter worker Identified by worker Identified by
----------------------------------------------------------------------------------------------------------------
Contact Stress.................... Armstrong (TR. 928), Awkward neck posture. Armstrong (TR. 929),
Alexander (TR. 2249), Alexander (TR. 2250),
Fernandez (TR. 5384), Fernandez (TR. 5380),
LeGrande (TR. 9047), Brossard (TR. 13228),
Brossard (TR. 13221), Rich (TR. 9590).
Robbins (TR. 1362).
Static Posture.................... Armstrong (TR. 928), Static posture....... Fernandez (TR. 5380),
Fernandez (TR. 5384), Rich (TR. (9592).
LeGrande (TR. 4096), Rich
(TR. 9592).
Awkward neck posture.............. Alexander (TR. 2250), Awkward wrist posture Rich (TR. 9598).
Fernandez (TR. 5385),
Brossard (TR. 13224).
Awkward back posture.............. LeGrande (TR. 4096), Awkward back posture. Brossard (TR. 13227).
Brossard (TR. 13225),
Rich (TR. 9601).
Awkward knee posture. Fernandez (TR. 5381),
Brossard (TR. 13226),
Rich (TR. 9596).
Contact Stress....... Brossard (TR. 13230).
----------------------------------------------------------------------------------------------------------------
Although the participants who questioned these experts later
claimed that the exchanges demonstrated ``erratic inconsistency'' in
the identification of MSD hazards among OSHA's own experts (Ex. 500-197
at II-23), OSHA believes they show just the opposite: that it is often
possible to identify risk factors easily even with only limited
knowledge of the employee's activities. If the witnesses had had access
to the extra information they all agreed was necessary, OSHA expects
that there answers would have demonstrated much more uniformity.
``Same Jobs''
Paragraph (j)(2) of the final rule requires that employers include
in the job hazard analysis (and control process) not only the injured
employee's individual job but also all other jobs in the establishment
that are the ``same'' as that job. ``Same jobs'' are jobs that involve
the same physical work activities and tasks as the job that the injured
employee performs, regardless of their job title or classification.
(See the definition of ``job'' in paragraph (z)). All same jobs in the
establishment must be included in the job hazard analysis and control
process, even if they are performed at different locations or on
different shifts. The standard, however, does not require employers to
apply the job hazard analysis and control process to same jobs in other
establishments.
The proposed rule contained an analogous provision, which a number
of commenters supported (Exs. 30-4200, 500-215, Tr. 12894). For
example, Suzanne Rodgers, a nationally recognized ergonomist who has
been helping companies to develop effective ergonomics programs for
more than 32 years, wrote in Occupational Medicine:
The questions asked on site will give a good appreciation of the
overall demands of the job * * * It is important, therefore, to look
at more than one person doing the job, so individual methods can be
assessed and the degree of individual control is known (Ex. 500-121-
61).
Other commenters, however, objected to including all same jobs in
the analysis (Exs. 30-2208, 30-3765, 500-145). For instance, Larry
Feeler, a physical therapist and president of WorkSTEPS, Inc., said
that including all same jobs would be too burdensome and costly for
employers (Ex. 500-145). And P.J. Edington, of the Center for Office
Technology, was concerned that it would be difficult for some employers
to determine whether employees were performing the ``same job'' and
that OSHA compliance officers might mistakenly classify all office work
jobs as the ``same job'' (Ex. 30-2208; see also Ex. 500-197). Some
commenters urged OSHA to limit the job hazard analysis requirement only
to the injured employee's individual job (see, e.g., Exs. 500-145, 30-
2208), or only to other employees on the same shift (see, e.g., 30-
3765).
For several reasons, OSHA believes the requirement to analyze other
jobs that are the same as that in which an MSD incident occurred is
necessary to the final rule. At the same time, OSHA acknowledges the
commenters' concerns and has included additional explanation and
examples of ``same jobs'' in this preamble section, as well as
providing flexibility for employers who have a large number of
employees in the same job. The requirement is important because it
helps to make the final rule more proactive and preventive. It ensures
that employees performing the same physical work activities or tasks as
someone who already has been injured are provided with protection
before they too are hurt. As one commenter put it, the first injured
employee may well be a ``harbinger'' of other MSDs among employees in
the same job (Ex. 30-3755).
Second, it is likely that other employees performing the same job
will need protection since the job has already been shown to involve
exposure levels that are associated with increased risks of injury. As
explained in the discussion of paragraph (f), jobs that meet the Basic
Screening Tool generally pose a risk of MSDs that is three times higher
than jobs that do not. Third, the requirement is necessary to ensure
that employers have complete information about the hazards in the job.
If the job hazard analysis is limited to the injured employee's job,
employers may not get the information necessary to identify the causes
of the problem accurately. Without this information, the control
measures employers implement might not be successful in controlling or
reducing the hazards to the required levels.
In any event, OSHA believes that the ``same job'' requirement will
not impose undue burdens on employers. As the Note to this paragraph
explains, like the proposal, the requirement does not apply where
employers have reason to believe that an MSD hazard only poses a risk
to the employee who experienced the MSD incident. Commenters generally
supported this limitation (Exs. 30-4540, 30-1353, 500-145). Similarly,
where employers have reason to believe that MSD hazards are present in
only a subset of the same jobs, then employers would be permitted to
limit their response to that group. For example, where it is clear that
the size or width of the grip on a knife poses a hazard only for
employees with small hands (i.e., need for high hand force in order to
hold knife), the employer would be free to limit the analysis to
employees with small hands.
In addition, in most establishments, relatively few employees
perform the same job. This is especially true for small employers.
However, even where many employees at an establishment perform the same
job (e.g., telephone operators, letter sorters, package sorters,
package delivery, beverage delivery, trash collectors, janitors, hotel
maids),
[[Page 68337]]
the final rule gives employers the option of including only a sample of
those employees in the analysis.
Some commenters asked OSHA to clarify when jobs are the same (see,
e.g., Ex. 30-3784). Jobs are the same when workers perform the same
physical work activities or same job tasks. Employees perform the same
job when the discrete elements or physical actions they perform are the
same, even if not every aspect of their jobs is identical. For example,
Employees whose jobs involve picking up packages from one
conveyor and putting them onto another are performing the same job,
even if the packages contain different products, or are placed on
different conveyors.
Orderlies whose job tasks involve lifting and moving
patients have the same job even though some characteristics of the
patients, room layout and the purpose of the lift or move may vary each
time.
Garbage collectors who pick up trash cans and recycle
bins, and dump their contents into the garbage truck, have the same job
even though their routes are not identical (e.g., variations in
terrain, traffic, distance from residences).
On the other hand, just because the workstations, tools and
equipment employees use is the same does not mean that these employees
have the same job. For example:
Employees who use VDTs do not have the same job where one
employee's job involves steady typing for most of the workday while the
other employee uses the VDT to read and send electronic messages for
only a few hours a day.
Employees in an automotive assembly plant who use glue
guns or staple guns do not necessarily have the same job if they are
assembling different aspects of the product (installing seats versus
windshields), particularly if they use the tools in different ways,
with different force, and in different positions.
For purposes of this standard, job titles or classifications do not
determine whether employees are in the same job. Where employees are
performing the same physical work activities or tasks, they are in the
same job even if they have different job titles. Often jobs involving
the same physical work activities may have different job titles if
there are working supervisors, some kinds of seniority systems, or
different work shifts. For example, a ``Fabricator II'' on the third
shift may be performing the same physical work activities as a ``Junior
Fabricator II'' or ``Apprentice Fabricator'' on the first shift.
At the same time, just because employees have the same job title
does not mean that the employer must include them in the job hazard
analysis if the job tasks are not the same. This is especially true
when employers have general job classifications, such as office worker,
assembly line workers, production staff. ``Office workers'' may be
assigned to tasks as varied as answering phones, operating copy
machines, filing, or typing. If the MSD incident affected an office
worker typing documents, the employer would only need to include in the
job hazard analysis other office workers whose work task is to type
documents. Likewise, ``lineworkers'' or ``production workers'' in a
poultry processing plant may perform very different tasks.
Sample of Employees
Paragraph (j)(2) also gives employers the option to include in the
job hazard analysis only a sample of the employees in the same job.
Where the employer elects to use a sample of employees, the sample must
include those employees with the greatest exposure to the ``relevant
risk factors'' (i.e., those risk factors that exceed the levels on the
Basic Screening Tool). The proposed rule also included a similar option
and many commenters supported it (see e.g., Exs. 30-3344, 30-3745, 30-
3749).
OSHA believes that this option should help to reduce burdens for
employers while at the same time ensuring that the analysis of risk
factors exposure in the job is accurately characterized and not
underestimated. Some commenters, including Anheuser-Busch and United
Parcel Service reported that they had dozens to hundreds of employees
in their establishments who perform the same job (Exs. 32-241). This
option also should help establishments employing telephone operators,
customer service representatives, catalog sales representatives, data
processors, trash collectors, warehouse selectors, grocery store
cashiers, meatpackers, poultry processors and others. Including every
employee in these ``same jobs'' in the job hazard analysis may be
unnecessarily resource intensive, especially where the workstation
layouts and tools are identical (Ex. 500-145). Employers may be able to
identify the problem and possible controls after analyzing the jobs of
only a handful of employees.
This option will also help in situations where jobs are of short
duration or do not have fixed workstations (e.g., visiting nurses, home
health aides, home repairmen, furniture movers, beverage delivery,
package delivery, utility line workers, trash collectors) (Exs. 30-339-
22, 30-3714, 32-234-2-1, 500-73, 500-147-33, Tr. 14300). Changes in job
locations and job conditions may make it very difficult to analyze the
job of each employee. However, analyzing the job for a sample of
employees allows employers to identify the MSD hazards facing all of
the employees.
OSHA is requiring employers to sample those employees with the
greatest exposure to the relevant risk factors to ensure that exposure
levels in the job are characterized accurately. OSHA has used the
concept of ``representative sampling'' for hazard identification
purposes in several of its standards, such as the asbestos standard (29
CFR 1910.1001), the formaldehyde standard (29 CFR 1910.1048), and the
lockout/tagout standard (29 CFR 1910.147). The principle behind this
concept is that, if the job hazard analysis (or the exposure
monitoring, in the case of chemical exposures) reveals that the
exposures to this group of most highly exposed workers are not at
levels of concern, it is likely that those of other lesser exposed
workers will also not be of concern.
A few participants disagreed that the representative sampling
option would be useful to reduce burdens for employers:
OSHA concedes that ``conducting a job hazard analysis that
covers all employees in a problem job may be burdensome'' * * * It
is not possible for an employer to know of and account for the
multitude of physical factors that affect the way its employees
work. A sample selected, for instance, could inadvertently ignore
the employee with the widest fingers, the smallest feet or the most
sensitive hearing, in violation of the proposed rule. OSHA's
``shortcut'' for performing a job analysis is to us insignificant
and illusory--employers will, in practice, have to observe virtually
every employee in the problem job--a task that even OSHA admits can
be burdensome (Ex. 500-197).
OSHA does not believe that employers will have difficulty
identifying the employees in a job who are most likely to have the
greatest exposure to the risk factors. The specific criteria in the
Basic Screening Tool will be particularly useful in helping employers
identify, for example, those employees who:
Repeat the same motion for the longest continuous period
during the workshift;
Lift the heaviest objects or packages or the most objects
per workshift;
Have the greatest degree of flexion or extension of their
wrists;
Use vibrating hand tools for the most time during the
workshift; and
[[Page 68338]]
Make the longest reaches during the workshift.
In addition, the body location component in the Basic Screening
Tool will help employers identify whether particular physical
capabilities, limitations and characteristics may be relevant in
selecting the sample of employees for the analysis. For example,
employers do not need to consider the width of employees' fingers when
it is kneeling or squatting for more than 2 hours that has triggered
the need for job hazard analysis. And foot size is not relevant when
the risk factors being addressed are vibration, intensive keyboarding,
or high hand force.
Moreover, once the people responsible for conducting job hazard
analyses have been trained in the hazard identification and job hazard
analysis process, their knowledge of ergonomic risk factors and the
causes of MSDs will help them determine which employee physical
capabilities and limitations may be relevant. They will understand
that, if the relevant risk factor is awkward posture associated with
bending down to monitor a gauge positioned close to the floor, the
employees with the greatest exposure would be those who are taller. And
if the risk factor is awkward posture caused by reaching above the
head, then shorter employees and those with short reaches would be the
most exposed.
Risk Factors
Paragraph (j)(2)(ii) requires employers to identify the risk
factors present in the job and to evaluate their magnitude, frequency,
and duration. These risk factors include force, repetition, awkward
postures, vibration, and contact stress. Unlike the proposal, the final
rule does not include cold temperature and static postures as
independent risk factors. In addition, contact stress and vibration are
defined somewhat more narrowly than they were in the proposal. 64 FR
65808.
Force. Force refers to the amount of physical effort that is
required to accomplish a task or motion. Force also refers to the
degree of loading to muscles and other issues as result of applying
force to perform work. Tasks or motions that require the application of
higher force place higher mechanical loads on muscles, tendons,
ligaments, and joints (Ex. 26-2). Tasks involving high forces may cause
muscles to fatigue more quickly. Some commenters were unclear about the
meaning of fatigue in the context of MSDs (see, e.g., Ex. 30-3866). The
common use of fatigue, of course, is as a synonym for ``tired.''
However, ergonomics has its roots in engineering, where fatigue has a
meaning closer to ``breaking point,'' as in metal fatigue. In other
words, fatigue, when used in the context of ergonomics, generally means
that the muscle is no longer able to work and must be allowed to
recover, or that the point of damage or deformation of a tissue has
been reached. Thus, in ergonomics, the term implies more than simply
being tired or uncomfortable. The force required to complete a movement
increases when other risk factors are also involved. For example, more
physical effort may be needed to perform tasks when the speed or
acceleration of motions increases, when vibration is present, or when
the task also requires awkward postures. Hand tools that require use of
pinch grips require more forceful exertions to manipulate the tool than
do those that permit use of power grips.
Force can be assessed qualitatively or quantitatively. Quantitative
measures include strain gauges, spring scales, and electromyography to
measure muscle activity. A qualitative assessment of force is based on
direct observation of the amount of physical exertion required to
complete a task, and is usually graded on an ordinal scale (i.e., low,
medium, high).
Repetition. Repetition refers to the frequency with which a task or
series of motions is repeated over and over again with little variation
in movement. When motions are repeated frequently (e.g., every few
seconds) for prolonged periods such as several hours or an entire work
shift, fatigue and strain of the muscle and tendons can occur because
there may be inadequate time for recovery. Repetition often involves
the use of only a few muscles and body parts, which can become
extremely fatigued even though the rest of the body is unaffected.
Repetitive motions occur frequently in manufacturing operations
where production and assembly processes have been broken down into
small sequential steps, each performed by different workers. Repetition
is also present in many manual handling operations, such as warehouse
operation and baggage handling. Repetition is typically assessed by
direct observation or videotaping or as a percent of task cycle time,
where a cycle is a pattern of motions.
Awkward postures. Awkward postures are positions of the body (e.g.,
limbs, joints, back) that deviate significantly from the neutral
position \9\ while job tasks are being performed. For example, when a
person's arm is hanging straight down (i.e., perpendicular to the
ground) with the elbow close to the body, the shoulder is in a neutral
position. However, when employees are performing overhead work (e.g.,
installing or repairing equipment, grasping objects from a high shelf)
their shoulders are far from the neutral position. Other examples
include wrists bent while typing, bending over to grasp or lift an
object, twisting the back and torso while moving heavy objects, and
squatting. Awkward postures often are significant contributors to MSDs
because they increase the exertion and the muscle force that is
required to accomplish the task, and compress soft tissues like nerves,
tendons, and blood vessels. As used in the final rule's basic screening
tool, awkward postures may be either static postures held for prolonged
periods of time, or they may occur repetitively.
---------------------------------------------------------------------------
\9\ Neutral posture is the position of a body joint that
requires the least amount of muscle activity to maintain. For
example, the wrist is neutral in a handshake position, the shoulder
is neutral when the elbow is near the waist, and the back is neutral
when standing up straight.
---------------------------------------------------------------------------
Awkward posture is the primary ergonomic risk factor to which
employees are exposed when the height of the working surfaces is not
correct. Working in awkward postures increases the amount of force
needed to accomplish an exertion. Awkward postures create conditions
where the transfer of power from the muscles to the skeletal system in
inefficient. To overcome muscle inefficiency, employees must apply more
force both to initiate and complete the motion or exertion. In general,
the more extreme the postures (i.e., the greater the postures deviate
from neutral positions), the more inefficiently the muscles operate
and, in turn, the more force is needed to complete the task. Thus,
awkward postures make forceful exertions even more forceful, from the
standpoint of the muscle, and increase the amount of recovery time that
is needed.
Awkward postures are assessed in the workplace by observing joint
angles during the performance of jobs tasks. Observed postures can be
compared qualitatively to diagrams of awkward postures, such as is done
in many job analysis tools, or angles can be measured quantitatively
from videotape recordings.
Contact stress. Contact stress results from activities involving
either repeated or continuous contact between sensitive body tissue and
a hard or sharp object. The basic screening tool in the final rule
includes a particular type of contact stress, which is using the hand
or knee as a hammer (e.g., operating a punch press or using the knee to
stretch carpet during installation). Thus, although
[[Page 68339]]
contact stress is covered in the final rule as a single risk factor, it
is really a combination of force and repetition. Mechanical friction
(i.e., pressure of a hard object on soft tissues and tendons) causes
contact stress, which is increased when tasks require forceful
exertion. The addition of force adds to the friction created by the
repeated or continuous contact between the soft tissues and a hard
object. It also adds to the irritation of tissues and/or to the
pressures on parts of the body, which can further inhibit blood flow
and never conduction.
Contact stress commonly affects the soft tissue on the fingers,
palms, forearms, thighs, shins and feet. This contact may create
pressure over a small area of the body (e.g., wrist, forearm) that can
inhibit blood flow, tendon and muscle movement and nerve function. The
intensity of exposure to contact stress is usually determined
qualitatively through discussion with the employee and observation of
the job.
Segmental vibration. Vibration refers to the oscillatory motion of
a physical body. Segmental, or localized vibration, such as vibration
of the hand and arm, occurs when a specific part of the body comes into
contact with vibrating objects such as powered hand tools (e.g., chain
saw, electric drill, chipping hammer) or equipment (e.g., wood planer,
punch press, packaging machine). Although using powered hand tools
(e.g., electric, hydraulic, pneumatic) may help to reduce MSD risk
factors such as force and repetition, the tools can expose employees to
vibration. Vibrating hand tools transmit vibrations to the operator
and, depending on the level of the vibration and duration of exposure,
may contribute to the occurrence of hand-arm vibration syndrome or
Raynaud's phenomenon (i.e., vibration-induced white-finger MSDs) (Ex.
26-2).
The level of vibration can be the result of bad design, poor
maintenance, or the age of the powered hand tool. For example, even new
powered hand tools can expose employees to excessive vibration if it
they do not include any devices to dampen the vibration or in other
ways shield the operator from it. Using vibrating hand tools can also
contribute to muscle-tendon contractile forces owing to operators
having to use increased grip force to steady tools having high
vibration.
Vibration from power tools is not easy to measure directly without
the use of sophisticated measuring equipment. However, vibration
frequency rating are available for many recently designed hand tools.
Exposure to a single ergonomic risk factor may be enough to cause
an MSD incident. For example, a task may require the exertion of so
much physical force that, even though the task does not involve
additional risk factors such as awkward postures or repetition, an MSD
is likely to occur. For example, using the hand or knee as a hammer
(e.g., operating a punch press or using the knee to stretch carpet
during installation) alone may expose the employee to such a degree of
physical stress that the employee has a significant risk of a serious
injury.
Generally, however, ergonomic risk factors act in combination to
create an MSD hazard. Evidence in the Health Effects section (Section
V) shows that jobs that involve exposure to multiple risk factors are
likely to cause MSDs, depending on the duration, frequency and/or
magnitude of exposure. Thus it is important that ergonomic risk factors
be considered in light of their combined effect in causing or
contributing to an MSD. This can only be achieved if the job hazard
analysis and control process includes identification of all the
ergonomic risk factors that may be present in a job. If all of the risk
factors are not identified, employers will not have the information
that is needed to determine the cause of the MSD incident or understand
what risk factors need to be controlled to eliminate or reduce the MSD
hazard in the job.
Based on its review of the scientific literature available at the
time of the proposal, OSHA also identified prolonged sitting and
standing (a form of static posture) and whole-body vibration as risk
factors for MSDs; in addition, OSHA identified cold temperatures as a
risk factor because it could require workers to increase the force
necessary to perform their jobs (such as having to grip a tool more
tightly) (64 FR 65808). The final rule does not explicitly include
these risk factors. For prolonged standing and sitting, and for cold
temperatures, although there is evidence of an increased risk of MSDs
with exposure, the available evidence did not permit the Agency to
provide sufficient guidance to employers and employees on the levels of
exposures that warrant attention. For whole-body vibration, there was
substantial evidence of a causal association with low back disorders
(e.g., see NIOSH 1997); however, heavy equipment and trucks, the most
common sources of whole-body vibration, are seldom rated for vibration
frequencies and intensities. In addition, measurement of whole-body
vibration levels requires special equipment and training that would be
difficult for most employers to obtain. Therefore, OSHA determined that
it was appropriate not to include whole-body vibration in the final
rule at this time.
Cold temperatures can, however, increase the effect of other risk
factors. By reducing the dexterity and sensitivity of the hand, cold
temperatures may cause a worker to apply more grip force to hold hand
tools and objects. Also, prolonged contact with cold surfaces (e.g.,
handling cold meat) can impair dexterity and induce numbness. Cold air
blowing from a pneumatic tool, or a draft from the HVAC system, also
can result in localized cold stress on the hands, arms, neck, or
shoulder. Cold also increases the effects of vibration, such as in tree
felling and cutting to length with a chainsaw on a cold day.
Performing a job hazard analysis includes determining the
magnitude, frequency, and duration of employee exposure to the risk
factors described above. These terms are discussed below.
Duration. Duration refers to the cumulative time an employee is
exposed to one or more risk factor(s). The duration of exposure has a
substantial effect on the likelihood of both localized tissue fatigue
and general cardiovascular fatigue. (Again, the word ``fatigue'' is
used in the ergonomics sense.) In general, the longer the period of
continuous work (i.e., the longer the task requires sustained muscle
contraction), the longer the recovery or rest time required (Ex. 26-2).
Changing the sequence of activities or the recovery time and pattern of
exposure may mitigate the effects of long duration. Breaks or short
pauses in the work routine help to reduce the effects of prolonged
exposure.
Frequency. Frequency refers to the number of times the exposure is
repeated within some unit of time, in contrast to duration, which
relates to the cumulative length of exposure. This factor also can be
obtained by observing and counting (either by video tape, in person, or
mechanically) the number of repetitions or the cycle time associated
with each task. The response of muscles and tendons to work is
dependent on the number of times the tissue is required to respond and
the recovery time between these responses. The frequency of an activity
can be measured at the micro level, such as grasps per minute or lifts
per hour. However, there are some tasks, such as lifting a 150-pound
package or pushing a 400-pound beer barrel, where simply knowing that
the activity occurs, say, on one day every week, is sufficient to
establish that an MSD hazard is present.
[[Page 68340]]
Magnitude is a measure of the strength of the risk factor; for
example: how much force, how deviated the posture, how great the
velocity or acceleration of motion, how much pressure due to
compression. Magnitude can be measured either in absolute terms or
relative to an individual's capabilities. There are many qualitative
and quantitative ways to determine the magnitude of exposure to
ergonomic risk factor(s) (some of these measurement tools are provided
in Appendix D-1). In relatively simple cases, one approach is to ask
employees to classify the force requirements or physical difficulties
posed by the job on a scale of 1 to 5, or on a scale as simple as
``low,'' ``medium,'' and ``high.'' When magnitude is assessed
qualitatively, the employee is making a relative rating, i.e., is
rating the perceived magnitude of the risk factor relative to his or
her own capabilities. Relative ratings can be very useful in
understanding whether the job fits the employees currently doing the
job.
There are a number of ways to measure the magnitude of exposure
quantitatively (see, e.g., Exs. 500-218, 500-220). For example, the
NIOSH Lifting Equation is widely used to determine recommended weight
limits for safe lifting and carrying (see, e.g., Exs. 26-521). The
Snook Push-Pull Tables are also used by many employers to evaluate and
design pushing, pulling and carrying tasks (see, e.g., Ex. 26-1008).
For work-related upper extremity MSDs the Rapid Upper Limb Assessment
(RULA) evaluation tool is often used to investigate and evaluate jobs
(see, e.g., Ex. 26-1421). These three tools are included in Appendix D-
1, and are discussed at greater length in connection with that
Appendix.
Paragraph (j)(3)
Paragraph (j)(3) of the final rule requires the employer to use one
of the following methods or tools to conduct the job hazard analysis:
a. One or more of the hazard identification tools listed in
Appendix D-1 of this section, if the tools are relevant to the risk
factors being addressed; or
(ii) The occupation-specific hazard identification tool in Appendix
D-2 of this section; or
III. A job hazard analysis conducted by a professional trained in
ergonomics; or
(iv) Any other reasonable method that is appropriate to the job and
relevant to the risk factors being addressed.
The final rule, like the proposal, requires employers to evaluate
the ergonomic risk factors they have identified to determine whether
the employee's exposure to them is the result of an MSD hazard or
hazards in the job. To make this determination, employers must look at
the duration, frequency and magnitude of the ergonomic risk factors in
the job, as required by paragraph (j)(3). This evaluation may allow the
employer to rule out some risk factors that do not pose a significant
risk of injury, as well as to identify risk factors that do rise to the
level of an MSD hazard. Risk factors are sometimes ruled out because
the exposure does not last long enough, is not repeated frequently
enough, or is not intensive enough to pose a risk. On the other hand, a
job that requires significant bending from a neutral posture for most
of the day would be identified as an MSD hazard by the appropriate
hazard identification tool in Appendix D-1, and the job would therefore
be labeled a ``problem job,'' as noted in paragraph (j)(4) of the
standard.
The approach to hazard identification reflected in paragraph (j)(3)
of the final rule differs from the proposed approach and responds to
comments that objected to the proposed approach (see, e.g., Exs. 32-
300-1, 30-3032). The proposal included a table that listed 20 physical
work activities and job conditions such as ``exerting considerable
physical effort to complete a motion'' and ``using hand and power
tools,'' linked each of these activities to a number of risk factors
likely to be associated with the performance of such activities, and
directed employers to evaluate these risk factors to determine whether
an MSD hazard was present.
The National Telecommunications Safety Panel was one of many
participants who found the proposed hazard identification approach
unhelpful:
The members of the Panel strongly believe that the matrix of
``physical work activities and conditions'' and ergonomic risk
factors that may be present * * * provides insufficient guidance to
be included as a mandatory item in a federal rule. (Ex. 30-3745).
A similar comment was that the proposed job analysis approach shifted
the burden of hazard identification from OSHA to the employer (Ex. 30-
4334). Commenting on this point, however, the AFL-CIO stated:
* * * the obligation placed upon employers in the proposed
ergonomics standard, as with other standards, is to eliminate or
reduce an occupational hazard. In the proposed ergonomics standard,
OSHA has defined ``hazard'' not in numerical terms but in
descriptive terms: ``MSD hazards are physical work activities and/or
physical work conditions,'' in which ergonomic risk factors are
present, that are reasonably likely to cause or contribute to a
covered MSD (Ex. 500-218).
Other commenters argued that the proposed approach to the
identification of risk factors and MSD hazards was vague and that OSHA
should instead provide a permissible exposure limit (PEL) for each risk
factor and each possible combination of risk factors (see, e.g., Exs.
500-197, 30-2435, 30-973, 30-1274, 30-2426, 30-1350, 30-2428, 30-3986,
30-3993, 30-3000, 30-3086). Since some employers have been very
successful in using simple approaches, such as the one proposed, to
identify and control MSD hazards, however, OSHA finds this argument
unpersuasive. Risk factors and MSD hazards are being identified and
addressed in thousands of workplaces every day, and employers and
employees are using a wide variety of approaches to do so.
OSHA recognizes, however, that although certain of the risk factors
described above are easy to identify and understand, others are not as
apparent or observable. Employers who already have ergonomics programs
and persons who manage ergonomics programs generally have no difficulty
identifying risk factors in the workplace, because they have learned to
look for them (see, e.g., Exs. 30-3755, 500-220, 32-359-1, 32-210-2,
32-198-4, 30-3805, Tr. 11427). Because these individuals have training
and experience, ergonomic risk factors are familiar concepts for them.
Through the process of developing and implementing their ergonomics
programs, these individuals have gained a good working knowledge of the
ergonomic risk factors that are most likely to be present in their
workplaces. For those employers who are just beginning their programs
and have little or no training and experience dealing with ergonomic
risk factors, OSHA has tried in the standard to make the process of
identifying them as straightforward and easy as possible. For this
reason, OSHA has provided employers with many different hazard
identification tools in mandatory Appendix D-1 and mandatory D-2.
The large number of risk evaluation tools in the record and the
many comments OSHA received on the proposed list of physical activities
and conditions have led the Agency to include in the final rule several
options for hazard identification that employers may choose from. Many
commenters discussed hazard identification tools that are currently
used by employers (see, e.g., Exs. 500-200, 500-218, 30-3813, 30-276).
Thus, the final rule allows a choice of hazard identification
[[Page 68341]]
approaches, including simple checklists, more structured assessment
tools, and reliance on expert consultants.
The United Automobile Workers (UAW) submitted a number of
checklists that its members use (Exs. 32-185-3-26, 32-185-3-33), and
described several approaches to hazard identification that employers
have used to identify ergonomic risk factors effectively (Ex. 500-220).
These approaches include:
Development of consistent methods to measure the physical
stresses on the body. Stress is determined by the force exerted on a
body part, the frequency of the motion and the posture of the joint.
The Force-Frequency-Posture paradigm is common to both expert and
checklist approach to ergonomics analysis.
Development of simplified non-expert approaches to
measurement of risk factors (checklists)
Formulation of the NIOSH lifting guide and related
biochemical models which take into account the weight of an object,
distance from the body and motion of the body in lifting.
Validation of symptom surveys and discomfort surveys
(psychophysical measures) as risk factor identification tools
Validation of the use of risk factor checklists and
symptom surveys by workforce personnel to identify high risk jobs and
propose abatement methods.
Dr. Don Chaffin, founder of the Center for Ergonomics at the
University of Michigan, testified that the precision of many tools used
to evaluate risk factors is very high (Tr. 8255-8286). Ms. Lisa Brooks,
corporate ergonomist for International Paper, commented that there were
many different analysis tools used throughout the company (Tr. 11427).
The AFL-CIO also commented on the widespread availability of risk
factor evaluation tools (Ex. 500-218):
Testimony and evidence in the record demonstrate the job
analysis tools such as the NIOSH Lifting Equation and Snook--
Ciriello Push-Pull Tables are widely utilized by employers, unions,
consultants and others to evaluate exposure to ergonomic risk
factors throughout a wide range of industries and businesses.
Representatives of International Paper (Tr. 11425-26), Owens-Corning
(Tr. 10856), Conti Group Corp. (Tr. 10788), Coca Cola (Tr. 14356)
and Levi Strauss (Tr. 14710) testified that they routinely used
these tools in their ergonomic programs to analyze jobs for
ergonomic risk factors. Representatives from the UAW and UNITE!
testified how these and other tools such as UAW-GM Check Lists were
used by employers and union representatives to evaluate ergonomic
hazards at Ford (Ex. 32-185-3-42; 46, Tr. 5827, 5828), GM (Tr.
5831), Maytag (Tr. 8062), VF Corp. (Tr. 7074), Owens-Corning (Tr.
10858), Levi Strauss (Tr. 14710), Coca Cola (Tr. 14356), PPG
Industries (Tr. 3131).
OSHA has included several of these tools in Appendix D-1.
Paragraph (j)(3)(i)
Paragraph (j)(3)(i) of the final rule allows the employer to
evaluate ergonomic risk factors using one or more of the hazard
identification tools listed in Appendix D-1 of this section. Appendix
D-1 list eight hazard identification tools: (1) The Job Strain Index
(Ex. 26-883), (2) the NIOSH lifting equation (Ex. 26-572), (3) the UAW-
GM checklist (Ex. 32-185-3-26), (4) the applicable ACGIH threshold
limit values for physical agents (Exs. DC 389, 500-166-1, 502-273), (5)
the Rapid Entire Body Assessment (REBA) (Ex. 500-121-26), (6) the Rapid
Upper Limb Assessment (RULA) (Ex. 26-1421), (7) Appendix B to the final
Washington State ergonomics standard (WAC 296-05174) (Ex. 32-210-2-99),
(8) the Snook Push/Pull Hazard Table (Ex. 26-1008). Tools selected must
be relevant to the risk factors being addressed. This means, for
example, that an employer could not use the NIOSH Lifting Equation,
which is appropriate for employees exposed to certain types of force,
to analyze a job involving repetition and awkward posture.
A number of participants submitted evaluation tools to the record
(see, e.g., Exs. 26-2, 26-5, 32-77-2-1, 502-67, 26-883, IL-162-Q, 32-
185-3-31, 500-142-12, OR-348-1, 32-185-3-26, 500-121-61, 38-260, IL-
218, IL-228, 32-339-1-82, DC 417-6, 500-121-21, 38-93, 500-121-28, 32-
111-1, 32-198-4-27-1), while others (see, e.g., Exs. 500-220, 500-218,
Tr. 5567) suggested that the final rule include tools, such as the
Snook tables and the OSHA Meatpacking Guidelines (Ex. 30-2387). Still
other participants merely asked the Agency to provide more guidance in
the final rule for companies to identify ergonomics risk factors (see,
e.g., Exs. 30-276, 30-3818, 30-4290, 500-197, 500-218, 30-3864, Tr.
11601, Tr. 9070, Tr. 17419), and many commenters suggested that OSHA
provide non-mandatory checklists (see, e.g., Exs. 30-3765, 30-1671, 30-
3284, 30-2387, 32-300-1, 30-519, 30-4844, 30-3032, 30-3748, 30-3813).
Based on this evidence, OSHA has decided to allow employers to
demonstrate compliance with paragraph (j)(3) by using one or more of
the tools in Appendix D-1, assuming it is appropriate to the risk
factors being addressed for job hazard analysis purposes. These hazard
identification tools were suggested by several commenters (see, e.g.,
Exs. 30-276, 32-339-1, 500-218, 30-3813, 500-220, 30-3361, 30-2134, 32-
210-2, 32-210-2, Tr. 5567, Tr. 8706, Tr. 10629, Tr. 16487). For
example, Marathon Oil stated:
Since the proposed rule is job-based (particularly targeted to
problem jobs), OSHA should have reviewed the scientific literature
to identify and publish exposure assessment methods capable of
distinguishing problem jobs from non-problem jobs. In its proposed
rule, OSHA fails to mention existing methods capable of such
prediction (e.g. the Strain Index) or methods that have the
potential for such predictions (e.g. the Revised NIOSH lifting
equation) (Ex. 30-3361).
OSHA selected the tools in Appendix D-1 for several reasons. They
were developed by professionals who have extensive training and
experience in the identification, analysis and control of MSD hazards.
For instance, the Snook Push/Pull Hazard Table was developed by Dr.
Stover Snook , a certified professional ergonomist with a PhD. in
experimental psychology, who has spent 38 years researching MSDs and 25
years teaching ergonomics at the Harvard University School of Public
Health (Ex. 37-6).
The eight tools in Appendix D-1 are also well-documented. They are
based on scientific evidence on the relevant risk factors, and most
been published in peer-reviewed scientific journals (e.g., Job Strain
Index, NIOSH Lifting Equation, RULA, REBA, Snook Push/Pull Hazard
Table). To illustrate, the steps in the Job Strain Index by Moore and
Garg were based on the findings and data of a number of peer-reviewed
studies, including the Borg CR-10 scale (Ex. 26-883). The summary and
explanation of Appendix B to the Washington State Ergonomics Standard
includes extensive discussion and tables documenting the scientific
support for each element in that tool (Ex. 32-210-2-99).
The tools have also been tested, most of them extensively. For
instance, to develop the Rapid Entire Body Assessment (REBA) tool,
three ergonomists/physiotherapists independently coded 144 posture
combinations and then incorporated the sensitizing concepts of load,
coupling and activity scores to produce the final REBA score, with
accompanying action levels (Ex. 500-121-26). Thereafter, two workshops
were held involving 14 occupational safety and health processionals
(including ergonomists, occupational therapists, physiotherapists and
nurses) to code more than 600 additional samples of postures from
several industries (i.e., health care, manufacturing and
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electrical) in order to further refine the REBA scores. There was
between 62 to 85% agreement among the 14 professionals (Ex. 500-121-
26).
Dr. Snook testified at the hearing about the years of extensive
testing he did to develop the Push/Pull Hazard Table:
Most of my experiments were psychophysical investigations of
manual handling tasks, viz., lifting, lowering, pushing, pulling,
and carrying. The purpose of these experiments was to collect hard
data for use in evaluating the risk of manual handling tasks, and to
aid in the redesign of these tasks. At the time, psychophysics was
the only method that could yield usable data for task evaluation.
Psychophysics is a very old method that is concerned with the
mathematical relationship between sensation and their physical
stimuli. Psychophysics has been applied to practical problems in
many areas, including the decibel scale of loudness, and ratings of
perceived exertion (RPEs) * * *
My colleagues and I conducted eleven major manual handling
experiments over a period of 25 years [citations omitted]. Each
experiment lasted two to three years. These experiments were unique
in hat they used realistic manual handling tasks performed by
industrial workers (68 males and 51 females) over long periods of
time (at least 80 hours of testing each subject). Physiological
measurements of oxygen consumption and heart rate were recorded for
comparison with psychophysical measurements. The experimental design
also included 16 to 20 hours of physical conditioning and
psychophysical training. A battery of 41 anthropometric measurements
were recorded for each subject to insure that the sample was
representative of the industrial population. The results of these
experiments were combined and integrated into tables of maximum
acceptable weights and forces for various percentages of the working
population (Ex. 37-6).
These tools were also designed for use by persons with only minimal
training in hazard identification. For example, Washington State said
that it designed Appendix B particularly for small employers with
limited resources who wanted ``maximum clarity and certainty.''
Washington State Appendix B includes illustrations of the relevant risk
factors and a simple 5-step process for determining whether particular
lifting tasks pose a hazard. The other tools in Appendix D-1 use
similar approaches. For instance, the GM-UAW checklist uses a simple
stars and checks approach to those tasks and activities that may
warrant further investigation or controls.
Finally, OSHA has selected these eight tools because they all
include specific and well-defined recommended criteria for when
employers need to take action and when no further action would be
necessary. As such, these tools address commenters' arguments that the
standard must provide clear guidance to employers in identifying risk
factors and knowing when they have done enough to control them (see,
e.g., Exs. 30-276, 30-3818, 30-4290, 500-197, 500-218, 30-3864, Tr.
11601, Tr. 9070, Tr. 17419). These tools specifically and clearly
operationalize the table of physical work activities and conditions in
the proposed rule so they answer commenters' repeated questions about
what proposed terms such as ``over and over,'' ``considerable physical
effort,'' ``long reaches'' and ``heavy'' objects mean. For example, the
Job Strain Index (Ex. 26-883) defines ``over and over'' in terms of
efforts per minute (number of exertions/total observation time). The
NIOSH Lifting Equation defines a ``heavy'' object as weighing 51 pounds
or more, and then shows users how to reduce the amount of weight that
can be lifted within the equation's limits on the basis of particular
conditions in the workplace.
There are tasks for which each of the evaluation techniques in
Appendix D-1 are well suited and tasks where the tool is not
appropriate. The following information explains the limits and
appropriate uses for each tool in Appendix D-1.
Job Strain Index
The Job Strain Index is designed to identify jobs associated with
MSDs of the hand. It does this by measuring or estimating six task
variables: intensity or exertion, duration of exertion per cycle,
efforts per minute, wrist posture, speed of exertion and duration of
task per day (Ex. 26-883). The Job Strain Index and documentation
supporting it was published in a peer-reviewed scientific journal.
Area of the body covered by the Job Strain Index: Hand/wrist.
Risk factors evaluated: Force, awkward postures, repetition (speed
of work).
Examples of jobs that Job Strain Index is applicable to or well-
designed for: Jobs involving high hand repetition, small parts
assembly, keyboarding, inspecting (assembly line), sorting,
meatpacking, sewing, packaging.
NIOSH Lifting Equation
The NIOSH Lifting Equation, which is already widely used, was
developed to evaluate manual lifting demands. It provides an empirical
method for computing a weight limit for manual lifting tasks to prevent
or reduce the occurrence of lifting-related low back pain among
workers. Six factors are used to determine the recommended weight for
the specific working conditions: horizontal distance, vertical
distance, travel distance, frequency, twist, coupling. Then the actual
weight is compared with the recommended weight to determine the
``allowable'' lift index. The NIOSH Lifting Equation and documentation
supporting it has been published in a peer-reviewed scientific journal.
Area of the body addressed by NIOSH Lifting Equation: Lower back.
Risk factors evaluated: Force (distance, coupling), repetition
(frequency), awkward postures (location of the object, travel distance,
twist).
Examples of jobs that NIOSH Lifting equation is applicable to or
well-designed for: manual handling tasks involving objects weighing
more than 10 pounds; forceful lifting tasks in production and assembly
work; package sorting, handling, delivery and pickup.
ACGIH TLV Hand/Arm (Segmental) Vibration TLV
The ACGIH Hand/Arm (Segmental) Vibration TLV describes how to
measure hand tool vibration and provides threshold limit values for
exposure.
Areas of the body addressed: Hands, Arms/Shoulders.
Risk factors evaluated: Vibration.
Examples of jobs that the Hand/Arm (Segmental) Vibration TLV is
applicable to or well-designed for: Jobs involving use of powered and
vibrating hand tools (e.g., grinding, sanding furniture, sawing,
jigsawing, chain saws).
GM-UAW Checklist
The UAW-GM checklist was developed to evaluate a range of risk
factors in production jobs. The checklist uses checks () and
stars (*) to indicate whether the certain activities and conditions are
present for less than or more than one-third of the production cycle or
workday. The number of checks and stars, in conjunction with the report
of an MSD, is used to determine if the job requires further
investigation or control action.
Areas of the body addressed: Hand/wrists, Forearms/elbows,
Shoulders, Neck, Back/Trunk, Legs/knees.
Risk factors evaluated: Force (including manual handling),
Repetition, Awkward Postures (including Static Postures), Vibration,
Contact stress
Examples of jobs that the GM-UAW checklist is applicable to or
well-designed for: cyclical production and assembly work jobs.
RULA
The Rapid Upper Limb Assessment (RULA) was developed to evaluate
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ergonomic exposures of the upper body. The range of motion for each
body part (upper arms, lower arms, wrists, neck) is rated based on the
amount of posture deviation. Posture combinations are ranked to reflect
musculoskeletal loading with force, static work and repetition factors.
RULA and documentation supporting it has been published in a peer-
reviewed scientific journal.
Areas of the body addressed: Wrists, Forearms/elbows, Shoulders,
Neck, Trunk.
Risk factors evaluated: Awkward posture, force, repetition.
Examples of jobs that RULA is applicable to or well-designed for:
assembly and production work, janitorial and maintenance, meatpacking,
restaurant, grocery cashier, telephone operator.
REBA
The Rapid Entire Body Assessment (REBA) is similar to RULA, but it
has been modified to be more useful for the working postures found in
the health care and other service industries. REBA and documentation
supporting it has been published in a peer-reviewed scientific journal.
Areas of the body addressed: Wrists, Forearms/elbows, Shoulders,
Neck, Legs/knees, Trunk, Back
Risk factors evaluated: Awkward posture, force (load and coupling),
repetition.
Examples of jobs that REBA is applicable to or well-designed for:
Patient lifting and transfer, assembly and production work, janitorial
and maintenance work, meatpacking, restaurant work, grocery cashier,
telephone operator.
Washington State Appendix B
The Washington State Appendix B was developed to determine if jobs
that were in the Washington State ``caution zone'' actually pose an MSD
hazard to employees in them. The checklist shows physical risk factors
and lists duration (from 2 to 6 hours) by body part. If the work
activities or conditions apply, the job poses an MSD hazard.
Areas of the body: Shoulders, Neck, Back, Trunk, Knees, Forearms,
Wrists, Hands, Elbows.
Risk factors evaluated: Awkward postures, Force (including manual
lifting and high hand force), Repetition, Contact Stress, Vibration.
Examples of jobs that Washington State Appendix B is applicable to
or well-designed for: very wide range of jobs including patient lifting
and transfer, assembly and production work, janitorial and maintenance,
meatpacking, restaurant, grocery cashier, telephone operator,
keyboarding, manual handling, meatpacking, jobs involving use of
powered and vibrating hand tools, janitorial, solid waste.
Snook Push/Pull Hazard Table
The Snook Push/Pull Table is designed to identify whether pushing,
pulling and carrying activities meet or exceed established maximum
acceptable loads or force levels for those activities. It does this by
examining initial and sustained forces of loads, horizontal distance,
vertical distance, frequency and object weights. These measurements are
compared with the tabled values corresponding to the task and
considered acceptable for 75% and 90% of the adult male and female
population. The Snook Push/Pull Table and documentation supporting it
has been published in numerous peer-reviewed scientific journal
articles. In addition, the table was used in developing the NIOSH
Lifting Equation.
Body areas addressed: Back/Trunk, Legs, Shoulders.
Risk factors evaluated: Force, repetition, awkward posture.
Examples of jobs that Snook Push/Pull Hazard Table is applicable to
or well-designed for: manual handling jobs involving pushing or pulling
objects or carrying objects a long distance, and hospital laundry and
janitorial jobs, among others.
Paragraph (j)(3)(ii)
Paragraph (j)(3)(ii) allows employers to use the video display
terminal (VDT) hazard identification tool in Appendix D-2 of this
section for jobs involving risk factors related to computer use.
Appendix D-2 is a simple checklist to assess the physical activities
and layout of workstations with a VDT. Like the tools in Appendix D-1,
the VDT checklist was added to the final rule to address comments that
the physical activities and conditions listed in the proposal were too
vague to be used for job hazard analysis and control (see, e.g., Exs.
500-197, 30-2435, 30-973, 30-1274, 30-2426, 30-1350, 30-2428, 30-2986,
30-2993, 30-3000, 30-3086, 30-3853, 30-326, 30-546, 30-4189, 30-3845).
The function of the checklist is to determine if the computer
workstation and layout address the risk factors most commonly found in
VDT jobs. The analyst using this checklist would talk with and observe
the worker(s) while they are at the computer workstation. If a
condition or activity in the job merits the checklist's ``Yes,'' the
analyst would check the ``Yes'' box. If there are no more that two
``No'' answers to the checklist questions, the computer workstation
design, layout or equipment needs no further evaluation or control to
be in compliance with paragraph (j)(3)(ii).
Intensive computer use accounts for a significant number of MSDs
each year and occupational computer use is growing. MSDs associated
with computer use are reported in a wide range of industries (e.g.,
telecommunication, telephone, banking, insurance, catalog and telephone
sales, customer service, package delivery service, newspaper) and in
businesses of all sizes, including very small establishments. OSHA
believes that its VDT checklist provides these businesses with an easy
and quick way to identify and control hazards in a large number of
jobs.
OSHA designed this checklist after considering the many examples of
computer workstation checklists in the record (see, e.g., Exs. 26-2,
26-1517, 26-1337, 32-182-1-6, 502-313-3, IL-258, 500-142-10). The
checklist is designed to provide employers with a simple way to
identify the five risk factors this standard covers, as they most
commonly occur in computer work and workstations. All the employer need
do is check whether the risk factor is or is not present in the
employee's working conditions and workstation equipment, and address
those that are present.
The checklist provides clear and specific guidance in how the
employer can provide or adjust a computer workstation so it will be
comply with the control requirements of this standard. Each checklist
item is written to provide the solution to the problem it identifies.
For example, the checklist items addressing awkward neck postures
actually show how to position the computer monitor to eliminate those
postures (e.g., ``Top line of screen is at or below eye level so
employee is able to read it without bending head or neck down/back,''
``Monitor position is directly in front of employee so employee does
not have to twist head or neck,'' ``No reflected glare (e.g., from
windows, lights) is present which might cause employee to assume an
awkward posture to read screen.'').
OSHA expects the VDT checklist to provide significant assistance
for employers in industries where MSD hazards associated with computer
use are the major, or even the only, MSD hazards they face. Unlike
other checklists in the record, which include a range of risk factors
such as vision and general environmental conditions, OSHA's checklist
addresses only those
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risk factors this standard covers. Second, the OSHA VDT checklist is
also more flexible than some other checklists in the record because it
is risk factor-based rather than equipment-based. In equipment-based
checklists, employers get a passing score only if they have purchased
and installed particular equipment at each computer workstation. OSHA's
risk factor-based checklist, however, gives employers the flexibility
of deciding how to best control the identified hazards. For example, an
equipment-based checklist asks employers whether they have provided
adjustable height tables and monitor risers. A risk factor-based
checklist, on the other hand, asks employers whether the employees'
heads and necks are in a straight rather than awkward positions (i.e.,
bent down or back), when they look at the monitor screen. If an
employer can achieve this result without purchasing new adjustable
equipment, this will satisfy the standard. A number of participants
said that they have controlled risk factors at VDT workstations without
purchasing new adjustable equipment (see e.g., Tr. 2707).
OSHA stresses that, like the other tools in Appendix D, its VDT
checklist is only one of a number of methods employers may use to
identify and control MSD hazards related to computer use. Employers are
free to use other checklists in the record or to continue using
whatever method they currently use to identify and evaluate MSD hazards
associated with computer use, provided those methods address the risk
factors this standard covers.
Paragraph (j)(3)(iii)
Paragraph (j)(3)(iii) allows employers to choose to have a job
hazard analysis conducted by a professional trained in ergonomics. By a
``professional trained in ergonomics,'' OSHA means an ergonomist,
safety professional, industrial hygienist, engineer, or other safety
and health professional who has received training in the principles of
ergonomics and their application in job hazard analysis and control.
Reliance on a trained professional or competent person is a concept
used in many OSHA rules, such as the Asbestos Standard (29 CFR
1910.1001), the Process Safety Management Standard (29 CFR 1910.119),
and the Telecommunications Standard (29 CFR 1910.268).
A few commenters suggested that the final rule should require
specific qualifications for those individuals permitted by the rule to
perform job hazard analyses (see, e.g., Exs. 30-4674, 32-210-2). OSHA
rejected this idea because the record contains many examples of cases
where employers and employees are doing an effective job of analyzing
their jobs and then controlling them (see, e.g., Exs. 32-377-2-1, 32-
111-1, 32-198-4-27-1). In fact, OSHA believes that in about 85% of
cases, managers, supervisors, and employees can, with some training in
ergonomic principles and job hazard analysis, perform the required
analysis of jobs in their workplace that have met the action trigger.
Thus, OSHA believes that, in most cases, employers will be able to
perform job hazard analyses without expert outside help, and that the
sheer number of employers who have already established effective
ergonomics programs on their own (Ex. 502-17) is testimony to the
ability of companies to initiate a program without hiring a consultant.
The record has many comments (see, e.g., Exs. 502-17, 500-215, Tr.
11427, Tr. 1008, Tr. 13764) reporting that employers and employees are
``going it alone.''
The hazard identification method permitted by paragraph
(j)(3)(iii), however, is based on the expert judgment of a safety and
health professional trained in ergonomics and its application in the
workplace. This job hazard analysis option, therefore, assumes that the
employer has chosen to seek outside help (unless, of course, the
workplace has such a safety or health professional on staff). Paragraph
(j)(3)(iii) is unlike paragraphs (j)(3)(i) and (ii) in this respect.
OSHA is aware that some employers (see., e.g., Ex. 502-17) currently
rely on outside experts or OSHA's consultation program for job hazard
analyses. For most employers and most jobs, however, OSHA believes that
employers will choose to develop the level of in-house expertise needed
to implement the job hazard and control requirements of the standard.
Paragraph (j)(3)(iv)
Paragraph (j)(3)(iv) allows the employer the flexibility to use any
other reasonable method of job hazard analysis that is appropriate to
the job and relevant to the risk factors being addressed. This method
could consist of a hazard identification tool of the type in Appendix
D, or of a job hazard analysis methodology developed by the company
itself. Many employers utilize trained workplace ergonomic committees
to perform these job analyses. OSHA has included this job hazard
analysis option in the final rule in recognition of the fact that other
hazard identification tools and methods are effective in identifying
MSD hazards, and that many employers have instituted effective
ergonomic programs that include job hazard analysis methods that do not
rely on ergonomist-consultants or on the tools in Appendix D. OSHA does
not wish to stifle creativity or to foreclose the option to use
existing hazard identification tools or methods that will get the job
done.
If employers choose to avail themselves of the option in paragraph
(j)(3)(iv), they must be sure that the method of job hazard analysis
they choose is one that is reasonable and appropriate for the risk
factors present, i.e., the risk factors identified in the job by the
Basic Screening Tool. For example, if the job requires the employee to
sit in a chair and assemble cellular phones for 8 hours a day, then the
method must be appropriate for seated work, hand/arm force, and the
motions that are required by the job. A method that only measures
strain to the back would clearly not be a reasonable method of job
hazard analysis for this phone assembly job. Paragraph (j)(3)(iv)
encourages employers to continue to use their own effective analysis
techniques, provided they are appropriate, or to develop a tool that
fits their needs.
Many participants submitted ergonomic risk factor evaluation tools
that they have used in their workplaces to the record (see, e.g., Exs.
26-2, 26-5, 32-77-2-1, 502-67, 26-883, IL-162-Q, 32-185-3-31, 500-142-
12, OR-348-1, 32-185-3-26, 500-121-61, 38-260, IL-218, IL-228, 32-339-
1-82, DC 417-6, 500-121-21, 38-93, 500-121-28, -3, 32-111-1, 32-198-4-
27-1). For example, the Dow Chemical Company uses a method that
measures posture, repetition, force and duration and takes into
consideration frequency and environmental factors, such as lighting,
for computer workstations (see, e.g., Ex. 32-77-2-1). The Dow Chemical
method provides for scoring of jobs based on the number of words typed
or keystrokes per minute (frequency), the time spent doing the task
(duration), and the amount of force or amount of deviated posture
(magnitude) used by the worker to perform the task (see, e.g., Ex. 32-
77-2-1). The final score on the ``Dow card'' allows the person
performing the job analysis (usually the employee in the job) to
determine if there is a problem.
The United Steelworkers of America developed a survey as a job
hazard analysis tool for bus drivers. The survey includes qualitative
measurements of reach distances for the steering wheel, floor pedals,
clutch, and door handles, as well as the force required to use work
site tools. Seating support and visibility are also evaluated using the
tool that has been developed to evaluate exposures for bus drivers see,
e.g., Ex. 32-111-1). Levi Strauss uses a checklist with measurements by
body part for posture,
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repetition, duration, force, and allows for other factors, such as the
use of PPE, concrete flooring, kneeling, slippery floors, vibration and
temperature that might be found in apparel industry jobs (see, e.g.,
Ex. 32-198-4-27-1). These methods of analysis are applicable to the
tasks and work environments for which they were developed because they
measure the risk factors that are reasonably expected to be found in
those tasks and jobs in their respective industries.
In fact, the record contains many examples of employers who are
identifying and controlling ergonomics risk factors on a daily basis.
Dow Chemical sites across the country have been recognized by OSHA and
the Voluntary Protection Program (VPP) for their outstanding safety and
health efforts. Their programs include the analysis of ergonomics risk
factors:
Dow analyzes tasks utilizing a risk evaluation card. This card
looks at the various ergonomic hazards that may be present in our
workplaces and rates these hazards by a relative risk index or
weighting method. This weighting or indexing approach is consistent
with other risk indices, which OSHA has supported or recommended.
Indexing allows employers like Dow to prioritize its limited safety
and health resources in such a way to get the most ``bang for the
buck'' not only from an economic perspective concerning appropriate
controls, but also from a risk perspective as well. Such an approach
has been successful in our workplaces and has been borne out through
our experience. Dow's recordable rates and incidence of MSDs are
much lower than the general industry experience (Ex. 30-3755).
Employers are free to select the method or tool that best fits
their own jobs, workplace conditions, and culture. A job hazard
analysis is effective as long as it allows the person who is performing
it to determine whether a job has risk factor(s) that rise to the level
of an MSD hazard or does not pose an MSD hazard. Some employers
reported using simple and fairly informal procedures to identify
hazards in a job (see, e.g., Tr. 17353, 2979). This was especially true
for employers who have only limited or isolated ergonomics problems.
A job hazard analysis approach used by many employers is the
narrative approach. This method of hazard identification is similar to
job analyses used to identify other potential safety and health hazards
(see, for example, OSHA's Process Safety Management Standard, 29 CFR
1910.119, which allows employers to use this approach). With the
narrative approach, the employer and employee discuss the job
requirements and the relationship (if any) between the tasks and the
reported MSD. Where the problem identified through the narrative
approach is easy to identify and control and the establishment has few
MSDs, the employer may be able to use the Quick Fix option permitted by
paragraph (o). If the Quick Fix method can be used, the employer does
not need to continue with the job hazard analysis, although he or she
must observe all the steps in the Quick Fix process. For more complex
problems and solutions, the employer is required to comply with the
requirements of paragraphs (k), (l), and (m) to control the MSD hazard
identified.
In other cases, however, the problem may require a more detailed
analysis that could involve breaking the task down into its various
discrete elements or activities and then identifying and evaluating the
extent to which employees are exposed to risk factors in these
activities (see, e.g., Ex. 32-210-2). The quantified risk factors are
then compared to values that have been shown to contribute to the MSD
hazard (see, e.g., Exs. 26-2, 26-1247, 500-121-26, 32-210-2-99, DC-386,
500-121-21).
A job hazard analysis approach that is intermediate between the
narrative approach and the detailed analysis discussed above is the use
of a checklist. Checklists provide more structure than the narrative
approach, but are less time consuming than a detailed job analysis.
Several commenters suggested that OSHA include checklists in the
standard (see, e.g., Exs. 30-3748, 30-3755, 32-182-1, 30-3826, 30-
3818). OSHA agrees that well-designed checklists, when used as
intended, can provide an effective hazard identification approach for a
range of employers, especially small business owners. There are many
ways in which checklists are useful: identifying physical work
activities and conditions, identifying ergonomic risk factors,
evaluating jobs, prioritizing jobs for further analysis, and providing
a method of evaluating the effectiveness of controls. The American
Physical Therapy Association (APTA) endorsed the usefulness of
checklists as a job hazard analysis option:
In APTA's review, checklists would be an extremely helpful
resource to small businesses conducting job hazard analyses. (Ex.
30-3748).
The following example of a job hazard analysis includes a
combination of qualitative and quantitative observations and
measurements (Ex. 38-438):
Title: Turkey processing--thigh boning.
Objective: Remove thigh bones from the turkey carcasses.
Standard: 540 thighs deboned per 8-hour shift, 15 minute a.m.
break, 30 minute lunch, 15 minute p.m. break.
Workstation: Overhead conveyor, shackles 44 inches above the floor.
Equipment: Thigh boning knife; wire mesh glove for non-knife hand;
optional rubber gloves for both hands; hard hat; smock; boots.
Methods: (1) Grasp and position thigh with non-knife hand, (2) Cut
along thigh bone to separate meat from bone 2-3 cuts, (3) Cut remaining
tendinous attachments (bone drops into conveyor as work release meat
and bone.
Environment: Air-conditioned turkey plant; turkeys at 38 deg.F,
ambient air 45 deg.F.
Risk Factors:
1. Forceful exertions--(knife hand) holding knife, cutting thighs,
(non-knife hand) holding thighs for cutting. Force depends on user's
technique, sharpness of the blade, worker's position relative to the
moving turkey. Forces on the cutting hand are greater (up to 38 pounds)
than the hand holding the thigh (up to 19 pounds). Holding hand is
relaxed between cuts, while the knife hand continues to grasp the knife
handle (4 pounds).
2. Repetition--4,320 cuts per hour, holding thigh 1,080 times per
hour.
3. Awkward/Static posture--Wrist bent and forearm rotated while
cutting thighs. The wrist is angled due to the straight knife, type of
cut, location and orientation of the turkey.
Paragraph (j)(4) of the final rule simply states that jobs that
have been determined, through the job hazard analysis process, to pose
an MSD hazard to employees in that job are called ``problem jobs'' for
the purposes of the standard.
OSHA finds, based on the comments, data, and other evidence on job
hazard analysis in the record, that the job hazard analysis approach
adopted in paragraph (j) of the final rule is widely used by employers
and employees and is highly effective. Further, the hazard
identification tools and methods permitted by this paragraph are
commonly used in workplaces large and small, for workers with fixed and
mobile worksites, and in the analysis of both traditional and ``non-
traditional'' jobs.
Paragraph (k)--What Is My Obligation To Reduce MSD Hazards?
Paragraph (k) of the final ergonomics standard tells employers how
far they must go in reducing MSD hazards at the workplace. This
paragraph sets the control endpoint that employers must achieve. Final
paragraph (k) presents
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three options. Employers are in compliance with this paragraph when the
controls they have implemented:
Control the MSD hazards to the extent that they are no
longer reasonably likely to cause MSDs that result in work restrictions
or medical treatment beyond first aid,
Reduce MSD hazards in accordance with or to levels below
those in the hazard identification tools in Appendix D that the
employer used to conduct the job hazard analysis, or
Reduce MSD hazards to the extent feasible.
As described in the Risk Assessment and Economic Analysis sections
of this preamble, much evidence in the record demonstrates that
employers with existing programs are able to successfully control the
MSD hazards in problem jobs to a level where an MSD is reasonably
unlikely to occur.
Paragraph (k) of the final rule does not require employers to
eliminate all MSDs. OSHA recognizes that, in a number of jobs,
workplaces, and physical work activities it may not be possible to
eliminate MSDs. OSHA is also aware that employers who have an effective
ergonomics program may still receive reports of MSDs. The goal of the
final rule is to assure that employers take effective action to control
MSD hazards, and paragraph (k) tells employers how far they must go in
implementing controls.
Paragraph (k)(1)(i)
An employer is in compliance with paragraph (k)(l)(i) when it
reduces MSD hazards to the extent that they are no longer reasonably
likely to cause MSDs that result in work restrictions or medical
treatment beyond first aid. The hazard analysis conducted under
paragraph (j) will have identified the risk factors of concern. To
control the MSD hazard, the employer must reduce the magnitude,
duration, or frequency of the risk factors to the level where they are
reasonably unlikely to cause such MSDs. There are several ways an
employer can achieve this goal.
First, the employer can reduce ergonomic risk factors below the
levels in the Basic Screening Tool. The final standard recognizes that
risk factors below the levels in the screening tool are not reasonably
likely to cause MSDs, and allows an employer to discontinue his or her
ergonomics program if it has reached those levels.
Second, the employer can otherwise control the hazards such that
they are reasonably unlikely to cause MSDs. In some cases, the needed
controls may be obvious or readily discoverable by reference to
compliance assistance materials. In other cases, judgment may be
required. In any event, the employer may refer to the method it used
under paragraph (j) to determine whether the job presents a hazard. For
example, the employer may use a professional trained in ergonomics to
conduct the analysis and determine whether job conditions present a
hazard and to recommend measures to control the hazard. The employer
can also make use of its own knowledge and experience gained under its
program.
The employer may also use hazard identification tools. As described
above in the explanation of paragraph (j), the employer may choose from
a variety of such tools. Appendix D lists a number of specific tools
that provide safe harbors for compliance under paragraph (k)(1)(ii);
however, the employer may also consider other tools that are effective
in identifying hazardous levels of exposure in determining what
controls to implement.
These examples are not intended to be exhaustive. They are intended
to illustrate means employers may use to ``control MSD hazards.''
Several points bear noting. First, the obligation is not to reach a
level of absolute safety or to assure that no further MSDs will occur:
it is to reduce the hazard so that work activities are not reasonably
likely to cause MSDs. Second, the hazard reduction is targeted to MSDs
that result in work restrictions (including days away from work) or
medical treatment beyond first aid. These are serious conditions by any
measure. Finally, the standard allows the employer to take up to two
years to implement permanent controls. This extended period should be
sufficient to allow for situations in which installation of effective
controls requires a period of adjustment.
Paragraph (k)(1)(ii)
The second option is to reduce MSD hazards in accordance with or to
levels below those in the hazard identification tools in Appendix D
that the employer used to conduct the job hazard analysis. This
appendix is intended to give employers specific guidance to help them
determine whether or not they have gone far enough in controlling MSD
hazards. As discussed more fully below, many rulemaking participants
felt that the proposed rule was vague and shifted the burden of
determining how far to control MSD hazards to employers (see, e.g.,
Exs. 30-1722; 30-3956, 35-106; Tr. 4110, 15648-15649) or suggested that
OSHA provide, in the final rule, more guidance on how to make that
determination (see, e.g., Exs. 30-1557, 30-2987, 30-3748, 30-3765, 32-
133, 32-300). OSHA has responded to these comments by allowing
employers the option of controlling MSD hazards to the specific levels
set out in Appendix D.
Paragraph (k)(1)(iii)
Paragraph (k)(1)(iii) of the final rule states that employers are
in compliance with the endpoint if they have reduced the hazard to the
extent feasible. This paragraph applies when it is not feasible for
employers to reach one of the endpoints in paragraphs (k)(1)(i) and
(ii). It is included because OSHA has no authority to require employers
to do what is not feasible or ``capable of being done.'' American
Textile Mfrs. Institute v. Donovan (Cotton Dust), 452 U.S. 490, 509,
513 n. 31, 540 (1981). A control that will reduce a hazard in a job is
feasible if it is achievable within the limits of current technology
and knowledge and the employer's financial resources. An employer's
inability to afford controls will not establish infeasibility if its
level of compliance lags significantly behind the rest of its industry.
See Section IV-A.6.a(4)(a) and (b) of OSHA's Field Inspection Reference
Manual (CPL 2.103). See also, United Steelworkers v. Marshall, 647 F.2d
1189, 1269 (D.C. Cir. 1980).
OSHA is also requiring that employers who meet the compliance
endpoint by being at the limits of feasibility, but have not fully
controlled MSD hazards, periodically check to see whether new
technology has been developed and is available. These checks must be
carried out at least once every 3 years. When additional feasible
controls are identified, the final rule requires employers to implement
them until one of the compliance endpoints given in paragraph (k)(1)(i)
or (k)(1)(ii) is reached. Requiring employers to look for and implement
new control methodology ensures that an employer who has not fully
controlled ergonomic hazards is not relying on obsolete control
measures.
What Happens When a New MSD Is Reported After Controls Have Been
Implemented?
Paragraph (k)(2) of the final rule tells employers what to do if an
employee reports an MSD in a job in which the employer has implemented
MSD hazard controls. If an employee makes such a report, the employer
must check to see if the controls are still in place and are
functioning and being used properly. The employer must also check to
see if any new hazards exist that were not present when the job hazard
analysis was conducted. The employer need not conduct another full job
hazard analysis
[[Page 68347]]
but may undertake a review of the previous job hazard analysis to
determine if it is adequate.
Sometimes, after ergonomic control measures have been implemented
in a problem job, another employee will experience and report an MSD.
The injury could be a sign that the controls are not functioning
correctly or that new hazards have arisen. For example, an employer
might have, among other things, installed adjustable keyboard trays at
each VDT station and trained employees in their use. If one of the
keyboard trays gets out of adjustment, the operator using that tray
might experience and report tendinitis in his or her wrists. An
employer following paragraph (k)(2) of the final rule would check to
ensure that the keyboard tray is still present and is adjusted
properly.
Note to Paragraph (k)
A clarifying note at the end of paragraph (k) explains that the
occurrence of an MSD in a problem job is not in itself a violation of
the standard. This note emphasizes that the focus of the final rule's
compliance endpoint is on the control of MSD hazards and not on the
elimination of MSDs from the workplace. OSHA recognizes that, for a
number of jobs, workplaces, and physical work activities, it may not be
possible to eliminate MSDs. OSHA is also aware that employers who have
effective ergonomics programs may still receive reports of MSDs. The
goal of the final rule is to have employers put a good working system
into place so that they can take effective action to control MSD
hazards.
The Proposed Rule
The proposed rule would have required employers to meet one of
three compliance endpoints:
Materially reduce MSD hazards in the problem job using the
incremental abatement process;
Reduce MSD hazards in the problem job to the extent
feasible; or
Eliminate MSD hazards in the problem job.
OSHA explained the first endpoint with a definition of ``materially
reduce MSD hazards.'' The definition, which was repeated in a note
following proposed Sec. 1910.921(a), read as follows: ``'Materially
reduce MSD hazards'' means to reduce the duration, frequency and/or
magnitude of exposure to one or more ergonomic risk factors in a way
that is reasonably anticipated to significantly reduce the likelihood
that covered MSDs will occur.''
The following paragraphs discuss the comments, evidence, and
testimony received on the proposed compliance endpoint and present
OSHA's reasons for accepting or rejecting the rulemaking participants'
suggestions and for including the final rule's compliance endpoint
requirements.
1. Comments That the Proposed Compliance Endpoint Was Vague
Many of the comments and much of the testimony OSHA received on the
issue of compliance endpoints stated that the language used to set
compliance goals was vague and confusing (see, e.g., Exs. 30-333, 30-
1722, 30-2208, 30-2387, 30-3765, 30-3813, 30-3853,30-3956, 30-4185, 30-
4334, 30-4467, 32-300, 32-337, 440, 500-118, 500-188, 500-197, 500-221;
Tr. 2960, 4109, 14986). In particular, these rulemaking participants
argued that the related terms ``material reduction or elimination of
MSD hazards'' and ``materially reduce the MSD hazards'' were so vague
that employers would not know how far they had to go to control MSD
hazards. For example, ORC said that those terms, together with the
phrase ``reasonably anticipated to significantly reduce the
likelihood'' in the clarifying note following Sec. 1910.921(a), would
prove to be compliance nightmares for employers and enforcement
nightmares for OSHA (Ex 30-3813, 32-78). ORC claimed that the language
in the note would breed unnecessary confusion. Further, Edison Electric
Institute stated that the definition of ``materially reduce MSD
hazards'' uses three terms, ``reasonably,'' ``significantly,'' and
``likelihood,'' that are themselves vague (Ex. 32-300). Several
rulemaking participants believed that this vagueness would lead to
unnecessary litigation (see, e.g., Exs. 30-3813, 30-3956, 30-4185, 30-
3853, 32-337). James Lancour, representing EEI, was concerned that the
vagueness would cause employers difficulty in program and training
development, stating:
To provide reasonable program development and training one must
clearly define the program endpoints and the steps to achieve these
endpoints. The endpoints must also be objectively measurable to
achieve the desired results. This proposed standard is so vague and
ambiguous that neither the endpoints nor the measurement criteria
are specifically defined.
How does one develop an ergonomic program, give guidance in
determining compliance and provide general and specific training to
facility program facilitators, managers and supervisors and
employees when the terms of compliance are so poorly defined? [Tr.
2897]
Some rulemaking participants argued that OSHA left the word
``feasible'' undefined (see, e.g., Exs. 30-3956, 30-4334; Tr. 14986).
For example, United States Senator Kit Bond observed that OSHA ignored
comments from the Small Business Advocacy Review panel about the
vagueness of the word ``feasible'' (Ex. 30-4334). The National
Coalition on Ergonomics (NCE) stated that the lack of a suitable
definition rendered the option to ``implement controls that reduce the
MSD hazards to the extent feasible'' unclear (Ex. 30-3956). The
Coalition said that OSHA had not provided any reliable guidance as to
what ``feasible'' meant from either a technological or an economic
standpoint. The Coalition believed that this left employers with no way
of determining whether a particular hazard control was feasible for
them.
Paul, Hastings, Janofsky, and Walker LLP also argued that the
proposed standard's attempt at flexibility resulted in a standard using
terminology full of ambiguity (Ex. 30-3231). The law firm believed that
OSHA's enforcement staff would likewise struggle to understand the
rule.
The National Coalition on Ergonomics (Ex. 30-3956) went further to
suggest that the proposed language was so vague as to be
unconstitutional:
It is fundamental that ``a statute which either forbids or
requires the doing of an act in terms so vague that men of common
intelligence must necessarily guess at its meaning and differ as to
its application, violates the first essential of due process of
law.'' Connally v. General Constr. Co.. 269 U.S. 385, 39 (1926).
[Footnote omitted.] Thus, an occupational safety and health standard
must give an employer fair warning of the conduct it prohibits or
requires, and it must provide a reasonably clear standard of
culpability to circumscribe the discretion of the enforcing
authority and its agents. Dravo Corp. v. OSHRC, 613 F.2d 1227, 1232,
7 BNA OSHC 2089 (3d Cir. 1980). [Footnote omitted.]
* * * * *
The language and terminology used by OSHA in much of the
proposed standard and Preamble is so vague and ambiguous that it
fails to provide employers with adequate notice of what the standard
will require and prohibit and, accordingly, is unconstitutionally
vague. The proposed standard fails to provide employers with
adequate notice as to the conditions, circumstances or activities in
the workplace that cause MSDs and what employers must do to
eliminate MSDs under the standard.
The following is a partial list of terms which are either vague
and/or undefined and fail to provide employers with notice of the
required performance under the standard--``material reduction or
elimination of MSD hazards * * *'' and ``ergonomic hazard.'' These
terms are so ambiguous as to fail to provide employers * * * notice
of what is required with respect to the fundamental provision of
feasible control measures. [Ex. 30-3956]
[[Page 68348]]
The AFL-CIO (Ex. 500-218) believed that the proposed standard was
clear and that employers would be able to successfully carry out the
obligations imposed by it. The union countered some of the vagueness
arguments in its post-hearing submission:
Employers must control exposure to ergonomic risk factors to the
point that covered MSDs are no longer ``reasonably likely to
occur,'' in other words, to eliminate the ``MSD hazard,'' or reduce
it to the extent feasible. * * *
The record demonstrates that employers will be able to
accomplish this task. Utilizing various tools and other available
guidance, employers have been able to measure and evaluate exposure
to ergonomic risk factors and identify and implement controls to
reduce those exposures. There is plentiful testimony in the record
demonstrating that employers are able to ascertain conditions that
present an ergonomics hazard and to identify and implement measures
to reduce or eliminate the hazard.
* * * * *
The proposed standard is clear, and with the inclusion of the
AFL-CIO's recommendations, will be even clearer, that an employer's
obligation extends only to eliminating hazardous exposures at work.
An employer's obligation to conduct job analysis and institute
controls applies only where there is exposure on the job to an
ergonomic risk factor or risk factors that occurs at a sufficient
level of duration, intensity, or magnitude to present a risk of
MSDs. Under OSHA's proposed screening criteria, an employer is only
required to conduct a job analysis if there are ``physical work
activities and conditions in the job'' that are ``reasonably likely
to cause or contribute to the type of MSD'' being addressed, and
``[t]hese activities and conditions are a core element of the job
and/or make up a significant amount of the employee's worktime.'' *
* * If these screening criteria are not met, the occurrence of an
MSD does not trigger any obligations on the employer's part. And the
proposed standard limits an employer's control obligations to
situations where there is substantial exposure to ergonomic risk
factors on the job. If the employer's job analysis does not show the
existence of a hazard, i.e., exposure to ergonomic risk factors that
are reasonably likely to cause or contribute to a covered MSD, the
employer is under no obligation to institute controls. The standard
clearly limits employers' obligations to situations where there is
significant exposure in the workplace, and limits employers'
obligations to addressing hazardous exposures at work. [Ex. 500-218]
Dr. Frank Mirer of the UAW also believed the proposed rule was
clear based on General Duty Clause ergonomic settlement language that
was similar to that in the proposal (Tr. 5932).
OSHA does not agree that the language of the proposed rule was
impermissibly vague. Nevertheless, OSHA has changed the compliance
endpoints to respond to the vagueness comments and provide greater
clarity. OSHA believes that the language of the final rule's three
endpoints gives employers clear and understandable guidance as to what
they must do. Employers who achieve the objective ``safe harbor''
endpoints in Appendix D are assured they are in compliance. This avoids
the problem most frequently raised by commenters: That the proposal did
not give employers objective criteria by which to measure their
compliance obligations. The objective criteria in the Basic Screening
Tool give employers an alternate clear means of assuring they are in
compliance. OSHA has also sought to clarify the general performance
terms like ``MSD hazard'' and ``control MSD hazards'' used in the
standard. OSHA has clarified that an employer may rely on a safe-harbor
hazard identification tool, a professional consultation, or any other
reasonable method to define whether a hazard exists requiring control.
OSHA has also dropped terms, like ``incremental abatement process'' and
``material reduction,'' that commenters asserted were especially
unclear.
a. Comments that the language used in the proposed standard is so
vague and subjective that it would lead to uneven enforcement. Some
rulemaking participants who claimed the proposed endpoints were vague
were also concerned about the possibility that the alleged vagueness
would lead to uneven enforcement (see, e.g., Exs. 30-333, 30-1274, 30-
3765, 30-3839, 30-3845, 30-4185, 440, 500-188, 500-197; Tr. 3330, 5439,
7211, 17891). They believed that the proposed definition of
``materially reduce'' and the corresponding explanation of that term in
the preamble to the proposal would call for subjective judgments and
would lead to disagreements between employers and OSHA enforcement
staff. For example, The Forum for a Responsible Ergonomics Standard
stated:
Enforcement of the proposed ergonomics program standard would
require a degree of subjectivity in determining compliance
unprecedented in the Agency's history. This is because of the nature
of the area regulated combined with the vagueness of the proposed
standard's requirements.
For example, proposed Section 1910.921 (a) provides that
employers are in compliance if they implement controls that
``materially reduce'' MSD hazards in the job * * * OSHA recognizes
that ``a number of MSD hazards are complex and it may not always be
clear what control(s) will achieve a material reduction in the
probability that MSDs will occur.'' * * * In an attempt to clarify
what constitutes compliance with this requirement, OSHA then
proposes that employers will be considered in compliance ``if they
select and implement the controls that a reasonable person would
anticipate would achieve a material reduction in the likelihood of
injury.'' * * * However, the ``reasonable person'' standard is
hardly a bright-line means of determining whether an OSHA inspector
will find an employer in compliance.
This is only one example of how compliance with the proposed
standard, at best, is dependent on interpretations of vague
standards by OSHA inspection officials--individuals, at least to
date, with little or no training in ergonomics, who inevitably will
establish differing criteria to be applied to employer efforts in
this area. [Footnote omitted.] This approach invites litigation over
the meaning of such vague terms. Indeed, the ``reasonable person''
is a long-standing standard of tort law used by juries to assess the
culpability of an individual; by its nature, it is open to
interpretation.
Forum members fear that the vagaries of complying with the
proposed standard may be held against them during the OSHA
inspection process. By leaving too much to interpretation and
failing to provide significant guidance, inspectors may be able to
cite facilities despite their good faith efforts to comply. The lack
of compliance guidance potentially is a fundamentally fatal flaw
with OSHA's mandatory proposed standard and must be addressed by
OSHA before a reasonable standard can be promulgated. [Ex. 30-3845]
The National Association of Manufacturers' post-hearing submission
(Ex. 500-1) contained a letter from Scott Ward of Windings, Inc. Mr.
Ward presented an analogy with how an existing performance standard is
enforced. He described an example of how the existing standard on
personal protective equipment has led to disagreements with OSHA's
compliance staff and a citation:
[W]e provided gloves and design changes to a material (woven
fiberglass tape) to reduce an irritation--not even a hazard, for
there is no injurious nature to the material--and re-assigned an
employee who suffered the most irritation so as to not aggravate a
skin condition. However, a field inspector cited us for lack of an
effective program even though we had reviewed the material's MSDS,
provided the recommended (not required) personal protection
equipment, accommodated employee's complaints and the inspector's
own testing indicated that the fiberglass dust was well below
exposure level limits. We had begun work on ventilation equipment to
provide extra equipment and this engineer, who doesn't have air
fluid dynamics training, said it wouldn't work. The citation was
reduced but it stood. [Ex. 500-1]
OSHA received comments and testimony that the training of its field
staff would significantly affect the reasonableness of the Agency's
compliance efforts (see, e.g., Ex. 30-
[[Page 68349]]
1107; Tr. 5439, 7210). William Goldsmith, representing the U.S. Chamber
of Commerce, was particularly concerned that the lack of training of
OSHA field staff would lead to enforcement difficulties:
And it also bears noting that the companies at least the ones
that I am familiar with involved in these cases had ergonomics
programs. Dayton Tire did. Hudson Foods did. So when one looks at
the past history of what has happened with trying to enforce the
terms and the concepts that are ripe throughout this proposed
standard, you I think get a fair picture of what will happen if the
proposed standard becomes a final rule.
That is a compliance officer doing the best he or she can will
come into a facility, will probably not be not very well trained
through no fault of his own or indeed the agency's own, but because
resources are limited, be making guesses as to what ergonomics
stressors appear in what jobs and the litigation if that is what it
is, if that is where results will begin. [Tr. 7210]
In their post-hearing submission, the Chamber noted that the American
Society of Safety Engineers (at Tr. 11616) and the AFL-CIO (at Tr.
3498) agreed that training of OSHA's compliance staff would be crucial
to the enforcement of the ergonomics standard (Ex. 500-188). The
Chamber doubted, however, that such training would be successful:
Thus, it is beyond dispute that additional training is required.
Of course, it is difficult to understand how the Agency will
successfully provide such training since * * * even the individuals
who drafted the Proposed Rule do not know what it means. [Ex. 500-
188]
Craig Brightup of the National Roofing Contractors' Association,
which was concerned about the impact on small businesses, expressed
similar concerns:
OSHA's lack of enforcement restraint, coupled with the vagueness
of the ergonomic standard, would be a disaster for small business.
Chairman Talent stated in his comments, and I quote, ``Instead of
developing a standard that gives small businesses guidance and
assistance in implementing physical changes to the workplace that
reduce and eliminate MSDs, OSHA has left it up to employers to
figure out how to prevent or eliminate MSDs. These vast regulatory
crevices into which small businesses will inevitably fall will be
filled by the unfettered discretion of OSHA inspectors as they
determine compliance. (Tr. 3330)
Edison Electric Institute noted the possibility that compliance
officers would second guess employers' decisions on control measures
(Ex. 32-300). The Center for Office Technology was similarly concerned
that the ``subjective terms `reasonable' and `likelihood' make it
impossible for either the employer or the OSHA inspector to know when
an employer is in compliance [Ex. 30-2208].''
Some rulemaking participants went further, arguing that the vague
language in the proposal forces employers to make subjective judgements
about whether they have gone far enough to control hazards (see, e.g.,
Exs. 30-3853, 30-3956, 32-337, 500-27; Tr. 6219). The Integrated Waste
Services Association and the National Coalition on Ergonomics (citing
AFL-CIO v. OSHA, 965 F.2d 962 (11th Cir. 1992) at 976) stated that this
is in conflict with the requirements of section 6(b)(5) of the OSH Act
for the Agency to set standards using objective criteria. The Coalition
stated that the Agency cannot expect an employer to decide about
permissible exposure to MSD hazards when OSHA is unwilling or unable to
make that determination.
Mr. Edward C. Laux of the International Cemetery and Funeral
Association believed that the term ``to the extent feasible'' was
subjective and would present compliance difficulties for employers. Mr.
Laux compared compliance under the proposal's requirement to control
MSD hazards to the extent feasible with the reasonable accommodation
test in Title I of the Americans with Disabilities Act:
[Section 1910.921] provides that businesses must eliminate or
materially reduce musculoskeletal disorder (MSD) hazards in the
workplace ``to the extent feasible.'' This highly subjective
standard presents difficulties of interpretation similar to the
``reasonable accommodation'' test in Title I of the Americans with
Disabilities Act (ADA).
The ADA ``reasonable accommodation'' test at 42 U.S.C. 102(b)(5)
and at 1630.9 of the U.S. Equal Employment Commission regulations
requires employers to make alterations in the workplace for disabled
workers unless the accommodation would impose ``undue hardship'' on
the covered business. Interpretation of the terms ``reasonable
accommodation'' and ``undue hardship'' must be made on a case-by-
ease and business-by-business basis. As a result, interpreting these
ADA terms has been the subject of administrative appeals and
expensive litigation of which small businesses, in particular, are
ill-equipped to afford.
The ICFA believes that the ``feasibility'' provision at 1910.921
of the proposed Ergonomics programs will result in similar conflicts
of interpretation that cannot be resolved in a ``one size fits all''
application. Small businesses, which comprise 87 percent of the
cemeteries and funeral homes in the United States, will be
confronted by OSHA inspectors second-guessing their understanding of
this vague provision and imposing fines on these businesses where
they disagree with their judgment.
At that point, small businesses will be forced to choose between
two highly unattractive alternatives: either to pay expensive
penalties for noncompliance with a vague and subjective standard or
to hire expensive lawyers to appeal and litigate the fines. The
litigious history of similar language in the ADA removes any doubt
that this scenario as applied to the Ergonomics standard is not only
probable but certain. [Ex. 500-27]
b. Comments that the vagueness of the rule is compounded by the
lack of scientific certainty. Some rulemaking participants argued that
the lack of guidance was compounded by the scientific uncertainty of
whether a given control measure would abate the hazards (see, e.g.,
Exs. 30-294, 30-461, 30-494, 30-1722, 30-2986, 30-3853, 32-337, 500-
197; Tr. 3232, 11375). For example, the U.S. Chamber of Commerce
stated, ``At first glance, the `reasonableness' element of these
definitions seems to provide an employer a certain amount of leeway in
eliminating or reducing the hazards. This, however, is not the case.
Under current scientific principles, nobody knows the point at which
the likelihood of an MSD occurring will be reduced.'' The Chamber
alleged that OSHA's experts admitted as much. The Chamber quoted small
portions of two OSHA expert witnesses in Secretary of Labor v. Hudson
Foods and Secretary of Labor v. Dayton Tire to support this point. The
Chamber suggested that the witnesses could not quantify the reduction
in the rate of MSDs resulting from a given control measure. The Chamber
concluded:
These statements were made, it bears repeating, by people called
by OSHA in litigated matters to support particular ergonomics
allegations individuals whom, presumably, OSHA believed qualified
enough to sponsor as experts at trial. Yet neither of them could
support the efficacy of their particular recommended abatements in a
particular workplace cited for particular violations of the General
Duty Clause. Nevertheless, somehow OSHA expects employers * * * even
small employers like the overwhelming majority of the Chamber's
members * * * to develop their own effective control measures.
Although OSHA has shifted to the employer the burden to identify
to what degree a ``risk factor'' must be reduced to prevent an MSD
from occurring, that is a question nobody can answer. Indeed, OSHA
concedes that ``[b]ecause of the multifactoral nature of MSD hazards
it is not always clear whether the selected controls will achieve
the intended reduction in exposure to MSD hazards.'' 64 Fed. Reg. at
65827. Furthermore, in some cases, particular ergonomic controls may
cause more harm than good. 64 Fed. Reg. 65827 ``[m]any employers
evaluate controls within 30 to 60 days after implementation. This
gives employees enough time to get accustomed to the controls and to
see whether the controls
[[Page 68350]]
have introduced other problems into the job.'' (emphasis added).
Because no one, including OSHA, is equipped to identify at what
point an MSD is less likely to occur or to identify which abatement
measures are effective in reducing such likelihood, this requirement
is flawed beyond repair. [Ex. 30-1722]
The National Coalition on Ergonomics (Ex. 500-197) echoed the
Chamber's point and argued that the rulemaking record demonstrated a
lack of consensus regarding what control measures would be effective in
reducing the rate of MSDs:
Ergonomics experts likewise admit the impossibility of
predicting with any degree of accuracy the ergonomic modifications
that will successfully reduce musculoskeletal complaints. [Footnote
omitted.] In fact an expert testifying for OSHA in a general duty
clause enforcement action said he would need a ``crystal ball'' to
determine whether a particular abatement measure would eliminate
ergonomic stressors.\10\ [Footnote: Transcript, April 6, 2000, at
7191-92. In March of 1999, an expert ergonomist hired by OSHA in
another matter confessed that there is simply no way to predict in
advance the outcome of a particular abatement measure. He testified
that it is impossible for an employer to know ahead of time whether
a control measure will materially reduce or even reduce at all the
rate of musculoskeletal complaints. Transcript, April 6, 2000, at
7194.] The lack of consensus regarding appropriate ergonomic
interventions among the people who ultimately would be relied on to
implement the proposed rule surfaced repeatedly in the hearings. The
hearings also revealed the highly uneven track record of ergonomic
interventions in the workplace and the consistent inability of
ergonomics professionals to measure the effects of ergonomic
interventions, or to predict when a particular intervention will be
effective in controlling or abating targeted musculoskeletal
complaints. [Ex. 500-197]
---------------------------------------------------------------------------
\10\ The full text of the transcript cited in the Coalition's
footnote reads as follows:
``With respect to all of your proposed abatements, proposed
possible solutions, as you call them, that if every single one were
implemented with respect to every single job, there would still be
ergonomic stressors in every single job?''
Answer, ``I don't know if there still would be ergonomic
stressors in every single job, but there might be ergonomic
stressors in some jobs, but I can't say that there still would be
ergonomic stressors in every single job. No, sir, I cannot say
that.''
What would it take for you to say one way or another whether
that would be so?''
Answer, ``A crystal ball.''
It is clear from this exchange that the witness was talking
about more than one control measure being applied to more than one
job.
---------------------------------------------------------------------------
The Coalition further contended that no consensus exists as to who
is best situated to identify effective ergonomic solutions (Ex. 500-
197). The Coalition noted that some ergonomics professionals testified
that employees are the best persons to identify controls but that
others, including one of OSHA's expert witnesses, occupational health
professionals, and employees themselves, stated that employees did not
have the expertise necessary to identify control measures. NCE
concluded this argument by stating: ``OSHA has put the cart before the
horse in promulgating a rule that requires employers to produce
solutions that reduce ergonomic hazards when no available or reliable
means exist for predicting or measuring the efficacy of ergonomic
interventions.''
LPA, Inc., also objected to the proposed control endpoints because
ergonomics is not an exact science (Ex. 30-494). LPA noted that the
studies on which NIOSH and OSHA relied did not provide sufficient
information to employers so that they could evaluate jobs, assess
exposure to risk factors, and select controls that will eliminate the
risk factors.
The Honorable David McIntosh, Chairman of the House Subcommittee on
National Economic Growth, Natural Resources, and Regulatory Affairs,
noted that even OSHA admits that most ergonomic fixes are not 100
percent effective (Ex. 30-542, 30-3010). He wrote:
A second problem is the lack of end points or clear criteria for
determining when an employer has fulfilled his obligations. OSHA is
an enthusiastic proponent of ergonomic ``solutions.'' But even OSHA
admits that most ergonomic fixes are not 100 percent effective.
[Footnote omitted.] For example, in shoe manufacturing, installing
armrests and footrests, elevation and tilt equipment, better
designed chairs, and pallet levelers to minimize bending while
lifting reduced the ``number of damaging wrist motions in assembly
jobs by one-third,'' reduced ``disc compression forces in clerical
jobs by about 17 percent,'' and reduced ``disc compression forces
during lifting jobs by more than 50 percent.'' [Footnote omitted.]
Such workstation modifications undoubtedly reduce the risk of MSDs.
But, suppose another MSD occurs after the employer has implemented
those changes. What is the employer's obligation? Must he experiment
with more engineering options? Must he slow the pace of work, or
implement a job rotation system? [Footnote: ``The answer appears to
be `yes.' Here is the regulatory language: `[Y]ou must continue this
incremental abatement process if other feasible controls are
available' (1910.922(c)).''] How practical would that be in a small
establishment? What if the only way to eliminate damaging wrist
motions and disc compression forces is to eliminate the jobs that
require wrist flexion and bending while lifting?
An employer can only guess when his efforts to reduce MSDs are
adequate in OSHA's eyes, because the rule contains no outcome
performance measures or benchmarks. Reducing MSDs by 50 percent or
even 70 percent below current levels is no guarantee that an
employer has done enough. Nor is it clear that reducing MSDs 50-70
percent below national average rates for particular kinds of jobs
assures compliance with the rule. As long as MSDs occur, an employer
remains vulnerable to legal challenge by his employees and OSHA. Yet
eliminating all MSDs is beyond any employer's technical and
financial resources. To say nothing of the fact that ergonomic
``science'' is still in its infancy, many MSDs are caused or
aggravated by activities--sports, yard work, a second job--that may
be completely outside an employer's control. The proposed rule thus
gives OSHA an open-ended pretext to inspect, cite, and prosecute
American companies. [Ex. 30-542]
Mayville Engineering Company, Inc.(Ex. 30-294) noted that it had
difficulty applying controls to abate ergonomic hazards without having
MSD symptoms surface in previously unaffected employees:
We had a facility that had 10 identical workstations that
assembled radiator cores. We had 3 individuals, within a month,
report MSDs. The three individuals had worked at these workstations
less [than] 1 year. One of the individuals had only been doing this
job 6 months. The other individuals working at the other 7
workstations had been working on these jobs from 3-10 years each and
had not reported any MSD symptoms. During the hazard evaluation we
questioned the 7 as to any problems they had with the workstations
and they felt that the workstations were fine the way they were.
We made modifications to all 10 of the workstations based on the
MSDs reported. The other 7 individuals started to report MSD
symptoms with in 3 weeks. How would this be addressed in your
Proposed Standard? [Ex. 30-294]
The National Coalition on Ergonomics noted that the hearing
transcript included evidence of other similar instances that the
Coalition claimed showed that ergonomic interventions were either
ineffectual or created more problems than they solved (Ex. 500-197). On
this point, NCE cited the experience of an office that handles 9-1-1
calls, a municipal solid waste department, the Social Security
Administration, the Communications Workers of America, and Levi Strauss
and Company. The Coalition also cited a passage from Dr. Emil
Pascarelli's book, Repetitive Strain Injury: A Computer User's Guide:
``All the ergonomic equipment in the world won't prevent RSI unless
people who use computer keyboards learn how to type safely, pace
themselves, and care for their upper bodies.''
Ms. Lisa Brooks, testifying on behalf of International Paper
Company, stated that the current science of ergonomics did not support
interpreting the proposed standard consistently for a particular job or
task (Tr. 11375). She
[[Page 68351]]
noted specifically that two lifting guides, Liberty Mutual's manual
handling tables and the 1991 NIOSH lifting equation, provide different
levels of acceptable risk. She was concerned that, if an employee's
condition did not improve after applying the more liberal of the two
guides, OSHA would force an employer to use the more conservative even
though both are nationally recognized. Ms. Brooks argued that the
language in the proposal left the employer in doubt:
Would the determination of the compliance end point change if
the injured employee's condition did not improve?
The answer to this question depends upon the interpretation of
reasonably likely to occur and significantly reduce the likelihood
for a particular job or task.
Some could argue that since the injured employee's condition did
not improve, the facility only materially reduced the
musculoskeletal disorder hazards at the facility and that the
facility must continue in the incremental abatement process and
implement additional feasible controls.
Once in the incremental abatement process, the compliance end
point becomes tied to the recuperation of an individual. [Tr. 11377]
Ms. Brooks concluded by urging OSHA to postpone the promulgation of
the ergonomics standard until it could be written so that compliance
can be consistently and objectively measured (Tr. 11381).
c. Comments that OSHA has not provided sufficient guidance for
employers to comply with the proposed standard's compliance endpoint.
Many rulemaking participants were concerned that the proposed standard
and the preamble discussion of the regulatory text provided little
hazard control guidance for employers (Ex 30-1536, 30-1722, 30-3813,
30-3845, 30-3956, 30-4185, 32-300, 35-106, 500-197). Some were
concerned that employers, particularly small ones, would not have the
resources to implement the requirements in the proposed standard or to
make the judgments it calls for (see, e.g., Exs. 30-1536, 30-2834, 30-
3077, 30-3348, 30-3751; Tr. 3330, 8226). These commenters argued that
this would force many employers to hire an expert.
Some rulemaking participants believed that OSHA should provide
additional guidance for the terms and concepts used in this part of the
standard (see, e.g., Exs. 30-1557, 30-2987, 30-3748, 30-3765, 32-133,
32-300). For example, ORC and Edison Electric Institute urged OSHA to
include a nonmandatory appendix listing risk factors and examples of
acceptable controls (Ex. 32-300). The American Association of
Occupational Health Nurses urged OSHA to provide clarification for
situations in which MSDs are still being reported after all feasible
controls have been implemented (Ex. 30-2387). Dow Chemical Company
suggested that the Agency could put appendix-like material on its Web
site (Ex. 30-3765). Dow also asked for guidance on the type and amount
of improvement that was expected under the incremental abatement
process and on the amount of time that was allowed to pass between
incremental abatement measures. The American Health Care Association
recommended defining ``feasible'' and better explaining the term
``materially reduce'' (Ex. 30-2987). At the hearing, Frank White
described ORC's position as follows:
How do I know when I've achieved compliance? Now I understand
that OSHA struggles with this issue, but the proposed sections 921
and 922 we believe are off the mark.
In ORC's opinion, the difficulty of establishing precise
exposure response relationships between the particular health
effects being regulated and a specific workplace risk factors that
allegedly cause those condition does not relieve OSHA of the [basic]
obligation to provide some quantitative guidance to employers on a
point at which significant risk is substantially reduced.
Only in this way will an employer be able to determine whether
taking action to control particular workplace risk factors is likely
to materially reduce the risk of the specific musculoskeletal
disorder that has occurred. [Tr. 4109]
The American Industrial Hygiene Association (AIHA) supported the
proposed standard's performance-based compliance endpoint (Ex. 32-133).
However, AIHA also believed that OSHA should provide additional
guidance. The Association stated:
AIHA supports the fundamental performance-related elements of
the proposed ergonomics standard.
The requirement to eliminate or materially reduce ergonomic
problems to the extent feasible is a valid performance criterion.
Similarly, the ``incremental abatement process'' is performance-
based and recognizes the complex nature of ergonomic problems.
Whether a risk-based approach is considered or not, OSHA should
add some appropriate examples of risk assessments so that employers
can utilize appropriate guidelines and have an idea of what
compliance officers will be looking for. OSHA should recommend a
variety of risk assessment approaches and describe how enforcement
of the standard will take place. [Ex. 32-133]
The Employment Policy Foundation suggested that OSHA include a
detailed table to serve as a guide to compliance and to facilitate
verification of the Agency's cost estimates (Ex. 30-1557). The
Foundation argued that each of the major compliance elements involves
several subsidiary compliance tasks. The Employment Policy Foundation
provided a table of the tasks that it believed the standard required
and recommended that OSHA include one like it in the final rule. The
Foundation's table included not only compliance endpoint-related tasks,
but tasks related to all aspects of the standard.
d. OSHA's response to these comments. In response to the many
commenters arguing that the proposed compliance endpoints were too
vague and failed to give adequate notice to employers, would lead to
uneven enforcement, OSHA has added objective compliance endpoints to
the final rule. The three acceptable endpoints are: (1) Control of MSD
hazards, (2) reducing MSD hazards in accordance with or to levels below
those in the hazard identification tools in Appendix D that the
employer used to conduct the job hazard analysis, and (3) controlling
hazards to the extent feasible. The Agency has explained each of these
options above.
The second compliance endpoint, reducing MSD hazards in accordance
with or to levels below those in the hazard identification tools in
Appendix D, provides objective criteria to help employers attain an
endpoint. In Appendix D-2, OSHA is providing a chart outlining
reasonably objective measures of acceptable levels of ergonomic risk
factors for VDT operations. In Appendix D-1, OSHA is referencing
existing tools that employers are currently using to identify and
control ergonomic risk factors. OSHA believes that these tools will
provide employers with a bright line method against which they can
judge whether their compliance efforts meet the final standard's
compliance endpoint.
The employer also has the option ``to reduce MSD hazards to the
extent that they are no longer reasonably likely to cause MSDs that
result in work restrictions or medical treatment beyond first aid.''
OSHA is providing sufficient guidance, in the preamble, appendices to
the standard, and compliance assistance materials, to help employers
understand and follow this compliance endpoint. The employer will have
to use some judgment and will need to be knowledgeable about the
relationship between risk factors and the different types of MSDs when
using this endpoint. Many rulemaking participants presented examples of
measures they have used to adequately control
[[Page 68352]]
ergonomics hazards (see, e.g., Exs. 32-274, 500-6, 500-12, 500-50; Tr.
8557, 8579, 11533, 12564, 14972). They clearly understood what needed
to be done to control the hazards and where to find the tools to
accomplish that goal.
The extensive scientific basis for OSHA's standard is discussed in
the Health Effects and Risk Assessment sections of this preamble.
However, it is not necessary for an employer to have a complete grasp
of ergonomics science in order to comply with the final rule. Many
witnesses testified that they had little or no difficulty in addressing
jobs successfully (See, e.g., Ex. 32-274; Tr. 11532, 12461, 14708,
14836, 15046), and OSHA has given employers extensive flexibility in
addressing these hazards, together with many tools and models to use.
In addition, many problems and solutions are readily apparent after
observing a job and talking with employee. The availability of
professionally-developed tools and the compliance assistance tools
being provided by the Agency will also help employers select
appropriate control measures to reduce MSD risk factors sufficiently.
These risk reductions will lead to a corresponding reduction in the
incidence and severity of MSDs at the workplace.
With respect to Mayville Engineering Company's and the National
Coalition on Ergonomics' comments that efforts to control MSD may
create other MSD hazards and lead to more injuries, OSHA notes that it
is possible for certain interventions to increase some risk factors at
the expense of the ones an employer is trying to control. However, it
does not automatically--or normally--follow that decreasing the
duration, frequency, or magnitude of one risk factor will increase
another. If that were the case, ergonomic intervention studies, such as
those depicted in the Risk Assessment section of the preamble, would be
very infrequent, rather than the norm for those employers making a good
faith effort at addressing these hazards. It should also be noted that
in one of the cases cited by the Coalition, the employer saw an overall
decrease in the number of MSDs from the control measures, and further
measures were taken to lower the risk factors causing the new MSDs (Tr.
17822 \11\). In another case, a company representative testified that
the company ``put in place a wide variety of effective controls'' (Tr.
14706).
---------------------------------------------------------------------------
\11\ With respect to the initial ergonomic interventions taken
at the 9-1-1 center, Mr. James August of the American Federation of
State, County and Municipal Employees testified: ``This intervention
drastically reduced the injuries. It did not create more injuries *
* *. [F]rom the entire work force of very high injury rates,
virtually all of the carpal tunnel and wrist injuries were
eliminated.'' (Tr. 17822)
With respect to the follow-up on the few new MSDs that
developed, Mr. August stated:
[T]here were a couple of employees where there were some
shoulder problems that started to surface early on when the
intervention was made * * *. But the same analysis that was done to
identify the original problem was used to quickly remedy the
resulting problem from the intervention.
So it was not a matter of having to junk the whole system that
was put in and start from scratch. This was a refinement which is
what all of us involved in the field of ergonomics do on a
continuous basis. [Tr. 17823]
---------------------------------------------------------------------------
Thus, OSHA has concluded that the final rule's endpoint is
scientifically sound and will help reduce the number and severity of
MSDs in the workplace.
OSHA agrees with commenters, like the National Coalition on
Ergonomics, the AFL-CIO, and the American Society of Safety Engineers
(Tr. 3498, 7210, 11616), who stated that enforcement of the final
ergonomics standard will necessitate extensive training of the Agency's
compliance staff. OSHA compliance officers will need to be educated in
the requirements of the standard, signs and symptoms of MSDs, ergonomic
risk factors, and appropriate control measures, among other things, so
that the Agency can enforce the standard in a uniform and reasonable
manner. Such training, based on the final standard and on the
compliance guidelines contained in this preamble and the appendices to
the final rule, is currently being developed and will be provided
before the compliance deadlines in the standard.
2. Comments on Whether the Proposed Compliance Endpoint Would Illegally
Delegate Rulemaking Responsibility
a. Comments that the proposed rule would shift the burden of
determining the compliance endpoint to employers. Some rulemaking
participants objected that the vagueness inherent in the proposed
language shifted much of the burden placed by the OSH Act on OSHA to
employers (see, e.g., Exs. 30-1722; 30-3956, 35-106; Tr. 4110, 15648-
15649). The U.S. Chamber of Commerce argued that the proposal left to
employers the determination of the safe exposure level and the
appropriate controls (Ex. 30-1722). Even though it recognized that the
proposed standard properly allowed the employer flexibility, the
Chamber stated that the proposal went too far:
Under the Proposed Rule, it is up to the employer to do the
Secretary's job of setting a standard that ``most adequately
assures, to the extent feasible, * * * that no employee will suffer
material impairment of health or functional capacity,'' 29 U.S.C.
Sec. 655(b)(5), from exposure to perceived ergonomic hazards. It is
the employer that must determine when an employee is at risk from
hazards that are ``reasonably likely to cause or contribute to
MSD[s].'' Proposed Secs. 1910.917, 1910.944, 64 Fed. Reg. at 65832.
65864. And it is up to the employer to determine any combination''
controls either to eliminate the hazards or to at least reduce them
``to the extent feasible.'' Proposed Secs. 1910.917, 1910.920(a), 64
Fed. Reg. at 65803, 65828. While the Preamble contends that [t]here
are many qualitative and quantitative ways to determine the
magnitude of exposure,'' * * * the Proposed Rule fails to set
objective levels at which an employer would be required to act.
Moreover, the Proposed Rule fails to identify specific measures that
an employer must implement to control these supposed hazards. The
Act requires the Secretary to make these decisions * * * which the
Secretary concedes are impossible to make * * * and not simply to
foist that obligation on the regulated community under threat of
considerable civil penalties and compliance costs. [Ex. 30-1722]
The National Coalition on Ergonomics made a similar point:
The proposed standard is so vague and ambiguous that arguably,
through its adoption, OSHA will have shifted the burden of
identifying the hazard (which is clearly OSHA's duty) and the
appropriate response to the hazard (which is also clearly OSHA's
duty) to employers. At the same time, the proposed standard fails to
clearly state or place meaningful boundaries on what may be required
by enforcement personnel to such [a] degree that, if adopted, the
standard would represent an unconstitutional delegation of authority
from Congress to OSHA. [Ex. 30-3956]
OSHA believes that the final standard is sufficiently clear to
inform employers of their obligations, and therefore does not place
impossible burdens on employers. The final rule gives employers
options. Employers may, but are not required, to use the objective
criteria in Appendix D to determine the hazard control level. The rule
also gives employers the flexibility to use alternate performance-based
measures.
b. Comments that the proposed rule would shift the burden of
determining feasibility and compliance endpoints to OSHA compliance
staff. The American Iron and Steel Institute (AISI) stated that the
proposed standard improperly delegated rulemaking authority to OSHA's
compliance staff (Ex. 500-223). AISI contended that the proposed rule
was equivalent to requiring each employer to issue an unlimited number
of blank checks for ergonomic control measures and allow OSHA to fill
in the amounts. The Institute argued: ``The mere possibility that the
proposed standard is written in such a way as to permit OSHA to adopt *
* * an unreasonable and impermissible
[[Page 68353]]
enforcement strategy, contrary to applicable Constitutional and
statutory requirements, leads to the unavoidable conclusion that the
proposed standard is fatally defective and should be withdrawn. [Ex.
500-223]''
As noted in the discussion of the previous issue, OSHA has given
employers sufficient guidance so that they can determine, before an
inspection occurs, whether or not they are in compliance with the rule.
In fact, if an employer reduces MSD hazards in accordance with or to
levels below those in the hazard identification tools in Appendix D (or
the more stringent Basic Screening Tool), there is no doubt that an
employer is complying with the final rule's compliance endpoint. OSHA
compliance staff will therefore have no difficulty determining whether
an employer is complying with Appendix D. The remaining endpoints,
controlling MSD hazards and feasibility, give added flexibility to
those employers who believe that they can control MSD hazards by means
other than the endpoints in Appendix D or who cannot feasibly reach
those levels. Consequently, the final rule does not improperly delegate
rulemaking authority to OSHA compliance staff.
3. Comments on Whether the Proposed Compliance Endpoint Would Force
Employers To Go Too Far in Controlling MSD Hazards
a. Comments that the proposed standard would force employers into a
never-ending circle of hazard control improvements. Some rulemaking
participants were concerned that employers would face a never-ending
circle of hazard control improvements (see, e.g., Exs. 30-1722, 30-
3956; Tr. 3171). For example, the National Coalition on Ergonomics
stated that as long as ergonomic complaints \12\ continued, employers
would need to go further and further in the incremental abatement
process (Ex. 30-3956). In addition, the Coalition asserted that, except
where the employer can show the problem is unique to an individual
employee, the employer would be obligated to implement corrective
action not only for the complaining employee but for every employee
doing the same job or another job involving the same or similar work
activities. The Forum for a Responsible Ergonomics Standard went
further, arguing that this portion of the standard was infeasible:
---------------------------------------------------------------------------
\12\ As noted elsewhere in this preamble, the Coalition has
mischaracterized the proposal's use of the term ``covered MSD'' as
``complaints.''
OSHA's proposal is infeasible, however, because it requires an
undefined ``material reduction'' in MSDs, despite the fact that no
technology, work practice, or other type of control exists that will
ensure such reductions. Any mandatory standard must take into
account the fact that numerous controls may be available and,
perhaps, effective to some degree, but that they cannot ensure any
rate of success in reducing MSD injuries or hazard factors.
Employers simply will not be able to guarantee compliance with the
standard, no matter what efforts they make to adhere to OSHA's
---------------------------------------------------------------------------
proposed program. [Ex. 30-3845]
The American Iron and Steel Institute argued that the standard
would necessitate more and more controls as employees deconditioned by
an increasingly sedentary workplace would have less capacity to
tolerate demanding physical activity (Ex. 30-3951, 32-206).
Under questioning at the hearing, Mr. Thomas Durbin of PPG
Industries was concerned that an employer following the incremental
abatement process would need to continue to apply control measures even
after all workplace ergonomic stress factors were eliminated as long as
MSDs continue to occur (Tr. 3171).
These comments are based on the false premise that an employer
would not be finished applying ergonomic control measures until all
MSDs disappear from the workplace. OSHA has drafted the final
ergonomics standard to make it clear that this is not the case. The
goal of the final rule is the reduction in workplace MSD hazards, that
is the reduction in the frequency, magnitude, or duration of the risk
factors causing MSDs in problem jobs. When an employer controls these
risk factors to a level meeting one of the compliance endpoints given
in paragraphs (k)(1)(i) through (k)(1)(iii), the employer does not have
to institute further controls even if MSDs continue to occur.
Consequently, OSHA has concluded that the final compliance endpoints
will not force employers into a never-ending circle of hazard control
improvements.
b. Comments that the proposed standard forces employers to
experiment with control measures until they find one that works. Some
rulemaking participants objected that the incremental abatement process
would require employers to experiment with hazard control technologies
of uncertain efficacy until the employer cannot afford to implement
additional controls (see, e.g., Exs. 30-296, 30-402, 30-1722, 30-2134,
30-4185; Tr. 4906, 5645). For example, the Chamber (Ex. 30-1722) argued
that OSHA has left to employers what the Agency cannot do itself, that
is, determine what controls will reduce significant risk to employees:
In sum, it is plain that the Agency is unable to make the
difficult policy choices that Section 6(b)(5) places squarely in its
hands, and that instead OSHA has chosen to defer these choices to
the regulated community. The only justification that the Agency
proffers for this flawed approach is that OSHA simply cannot
determine broad standards that would be appropriate for the wide
variety of covered industries and jobs. However, OSHA has fared no
better in assessing causation and appropriate abatement when dealing
with individual workplaces and specific jobs in enforcement
proceedings. Thus, as noted above, OSHA has lost on one or both of
those grounds in every ergonomics case it has litigated on the
merits * * *. If, as these cases show, OSHA cannot determine what
causes musculoskeletal complaints in a particular job-and how to
abate them properly, there is no reason to think that employers will
fare any better. [Ex. 30-1722]
The National Coalition on Ergonomics detailed this argument in
their post-hearing submission (Ex. 500-197). The Coalition contended
that ergonomics professionals are unable to articulate effective
solutions to ergonomic problems in other than vague generalities,
leaving employers little choice but to engage in trial and error
experimentation. Because its review of the hearing transcript could not
identify a single witness who was able to identify a particular
ergonomic intervention that is sufficient to satisfy the rule, the
Coalition questioned how well employers would be able to choose
controls that would bring them into compliance.
In its post-hearing submission, Federal Express (FedEx) gave an
example purporting to show how the company would be forced into
experiments to try to reduce ergonomic risk factors further (Ex. 32-
208). Federal Express noted that the existing workspace for package
handlers is optimized so that a single employee reaches as short a
distance as possible given the design of the conveyors, trucks, and
other equipment. FedEx indicated that redesigning the space to
accommodate a second employee would actually increase the distance
packages are handled. The company argued that trading one risk factor
for another, as such a redesign would cause, would have an
unpredictable effect on the number of MSDs for that job.
On the other hand, Mr. Sittichoke Huckuntod, testifying on behalf
of Levi Strauss and Company, acknowledged that industrial safety design
is a system of trial and error by its very nature (Tr. 14747). The
Forum for a Responsible Ergonomics Standard noted that addressing MSD
hazards is an iterative process, often requiring significant trial
[[Page 68354]]
and error before improvements are realized (Ex. 30-3845).
OSHA acknowledges that fully solving ergonomics problems is not
always straightforward. Some employers who have little or no expertise
in ergonomics will indeed need to undergo some trial and error in their
hazard control efforts. As noted by Ms. Sharon Murray, the former
director of Rochester Office of Emergency Communications (a 9-1-1 call
center), employees might not use new equipment intended to reduce risk
factors in the manner anticipated by the employer (Tr. 17819). For
example, when an employer institutes a control measure designed to
reduce awkward wrist postures, it might increase long reaches for some
employees. In Ms. Murray's case, the unanticipated hazard was a
relatively simple problem to resolve (Tr. 17823).
The Agency does not believe that this trial and error is unique to
ergonomic hazards. As Mr. Huckuntod acknowledged, industrial safety
design is a system of trial and error by its very nature (Tr. 14747). A
new ventilation system, for example, might not work as it is designed
to, and the employer might have to modify it after its initial
installation.
OSHA has removed the proposal's incremental abatement option and
believes that employers will be able to meet the final rule's
compliance endpoints with a minimum of experimentation. As the AFL-CIO
(Ex. 500-218) noted, ``Several experts, including David Alexander (Tr.
2518, 2716), David Caple (Tr. 2716), and Dennis Mitchell (Tr. 2530),
testified that in 80-85 percent of cases, ergonomic problems can be
solved with one intervention.'' With the compliance assistance tools
provided by the Agency, even small employers should be able to reduce
MSD risk factors to acceptable levels with a minimum of
experimentation. For these reasons, OSHA concludes that the final rule
will not lead to undue experimentation by employers.
c. Comments that the proposed standard places no limit on how far
an employer must go in controlling MSD hazards. Some rulemaking
participants objected to any compliance endpoint that required an
employer to eliminate MSD hazards from the workplace because such an
endpoint places no limits on how far an employer must go in controlling
MSD hazards (see, e.g., Exs. 30-2208, 30-3765, 30-3956, 30-4185). For
example, Dow Chemical Company noted that there is no such thing as zero
risk and that this approach was inconsistent with OSHA's standards on
toxic chemicals, which set exposure levels that entail some residual
risk to employees (Ex. 30-3765). The National Coalition on Ergonomics
also argued that the open-ended requirement to use all feasible control
methods until the risk of an MSD reaches zero conflicts with well-
established case law to the contrary (Ex. 30-3956). The Center for
Office Technology also believed that OSHA is obligated to set a
threshold above zero risk (Ex. 30-2208). Patrick Tyson of Constangy,
Brooks and Smith asserted that the proposed rule, in essence, defined
an MSD hazard as the existence of even one MSD in a 3-year period (Ex.
30-4185). Mr. Tyson contended that a rate of one OSHA recordable MSD
every 3 years does not constitute a significant risk.
Some rulemaking participants were concerned that the standard
placed no limits on the controls that an employer would be forced to
implement (see, e.g., Exs. 30-494, 30-2208, 30-3765, 32-211, 32-234;
Tr. 10429, 10950). For example, Dow Chemical Company questioned the
extent to which employers would need to go to avoid citations (Ex. 30-
3765). Dow believed that the proposal would require employers to adopt
the latest technology regardless of cost or how great the reduction in
hazards. Mr. Gregory Watchman of Paul, Hastings, Janofsky and Walker
stated that, if MSD signs and symptoms continue to occur, even on a
sporadic basis, the employer would be forced to implement additional
abatement measures indefinitely (Ex. 32-211). Mr. Watchman reasoned
that the duty to implement additional controls would be triggered very
frequently in most workplaces because of the frequency with which
workers experience short-term discomfort, aches, and pains.
Mr. George Page, the owner of a small industrial engineering and
ergonomics consulting firm, provided an example of why he thought the
proposal's compliance endpoints went too far (Tr. 10429). He testified
about a client who had instituted a variety of ergonomic initiatives
with good results. Mr. Page was not sure whether the employer would be
in compliance with the proposed rule.
The American Dental Association provided a theoretical example of
how far the Association would have to go to control MSD hazards at
their headquarters:
The ADA headquarters is located in a building that was built
more than 35 years ago. The work areas were designed and furnished
before the proliferation of modem computing activities. It would not
be cost-effective, or in some cases even possible, to retrofit them
to satisfy the proposed standard. Thus, the ADA could be required to
substantially rebuild or replace affected work areas, furnishings
and equipment in order to comply. It is difficult at this point to
determine the full scope of the ADA's compliance burden, because the
proposed standard would require the ADA to continue to implement
incremental changes to its work environment until it substantially
reduced or eliminated the incidence of covered MSDs. Because 50% of
the ADA's workforce is engaged in the same or similar work
activities, the Association would be required to implement these
changes for 200 employees simultaneously, even though only one
employee reported a problem.
The ADA has made--and will continue to make--adjustments to
keyboards, monitors and other peripheral aspects of its work
environment, but for reasons of providing a more comfortable and
efficient workplace for its employees, not because of some highly
speculative benefit. However, there is no assurance that these
simple measures would be sufficient to achieve compliance under the
standard's incremental approach to compliance. [Ex. 32-141]
Federal Express argued that, because of the unique nature of its
facilities, the company would see no appreciable effect from
incremental changes to its workstations (Ex. 32-208). Federal Express
further argued that only a complete redesign would accomplish anything
more than negligible improvements in the number of workplace MSDs:
While the proposed ergonomics standard provides for incremental
changes to the work environment until ``covered MSD'' are
significantly reduced, [footnote omitted] the unique nature of the
facilities at and the corporate experience of FedEx is such that
incremental changes would have no appreciable effect upon * * *
reducing ``covered MSD,'' and only a quantum change involving
complete redesign and reconstruction of facilities may potentially
yield measurable results. Even then, it is not clear that the
changes in outcome in which OSHA is interested is the result of
these changes. The reason for the nebulous impact of incremental
change is two-fold. First, the nature of the physical facilities
which FedEx operates is such that space limitations do not allow
further design alterations, added equipment, or additional,
extraneous staffing. Second, FedEx's facilities, operational process
and equipment have all been designed and employed with the
application of ergonomic principles for the purpose of improving
productivity. As a result, incremental changes to the workplace in
the context of FedEx's facilities, which are already at or near the
frontier of automation and technical feasibility will fail to have
an appreciable impact upon the reduction rate of ``covered MSD.''
* * * * *
To be sure, some incremental changes can be made. FedEx does not
assert an ``all or nothing'' position, wherein absolutely no space
whatsoever remains for incremental changes to be made in the
existing facilities.
[[Page 68355]]
Rather, FedEx asserts that, to effect a material reduction in work-
related ``covered MSD,'' the changes required would be quantum in
nature, so as to necessitate an entirely new facility. The space
limitation upon the existing facility will admit of some, very
limited incremental changes, but those changes would be so limited
by space, so ephemeral in nature, as to be ineffective in reducing
``covered MSD.''
For example, the design for the existing facilities, while
tailored to the number of employees required to complete a task, is
not precise to the person with regard to every position in the sort
facility or even in the trucks or customer service stations. Rather,
one additional person can, conceivably, be added to the workforce in
some capacity in some facilities, in a manner where he or she will
not detract from the efficiency of FedEx's operations. FedEx
maintains, however, that the increase of one additional individual
is not an administrative or work practice control which will render
a material reduction of any hazard at all. In fact, the effect will
not be noticeable, except on reduced efficiency. Once the workplace
is increased significantly beyond one additional person, however,
the facilities's space limitations operate to reduce both
operational efficiency and workplace safety. [Ex. 32-208]
Patrick Tyson of Constangy, Brooks and Smith objected to the extent
to which the proposed endpoint would require employers to go to reduce
ergonomic hazards (Ex. 30-4185). He stated:
Having stated our objections, not to the need to implement
engineering controls, but to the point at which such controls must
be implemented, we also submit that contrary to OSHA's assertion in
the Preamble that the proposed Standard establishes ``control
endpoints'' which define when an employer is in compliance, there
are two inter-related problems with Sec. 1910.921. First, for any
manufacturing jobs in which employees perform repetitive motion
tasks for a significant part of the work day, as a practical matter,
an employer's legal duty will never be satisfied until employees are
no longer performing the manual tasks. We question whether the
Agency should promulgate a Standard with this result, even if
unintended. Secondly, although Sec. 1910.921 is apparently intended
to state that employers can be in compliance short of automating the
job functions, we believe that there is no objective measure of
compliance short of either automating the job task or function or
eliminating it. [Ex. 30-4185]
He contrasted this with the expectation of OSHA enforcement staff that
employers, under their existing general duty clause obligations, must
institute controls that lead to a reduction in the seriousness of MSDs,
not in their numbers. He also contrasted the standard's requirements
with the experience of one of his firm's clients, who had instituted an
ergonomics program and had 6-years' experience with it. This employer
had spent over $19.5 million in capital improvements to reduce lifting
hazards in six facilities and reduced the number of recordable MSD
cases, including back cases, by less than 50 percent over the last 5
years of the program (through 1999). Mr. Tyson was particularly
concerned that the standard would require this employer to institute
further controls.
Here again, these comments are based on the false premise that an
employer would not be finished applying ergonomic control measures
until all MSDs disappear from the workplace. The final rule's
compliance endpoints do not require employers to go that far in
controlling MSD hazards. In fact, all the compliance endpoints in the
final rule contain discrete stopping points that allow an employer to
stop even if MSDs continue to occur. One of the endpoints, reducing MSD
hazards in accordance with or to levels below those in the hazard
identification tools in Appendix D, provides objective measures against
which an employer can determine whether it has fulfilled its compliance
obligations. When the employer reduces the risk factors below those
levels, he or she is finished instituting control measures. The control
of MSD hazards endpoint, although not as specific, also allows an
employer to stop even if MSDs continue to occur. That endpoint,
paragraph (k)(l)(i), requires reducing the hazard to the level where
MSDs resulting in work restrictions or medical treatment are reasonably
unlikely, not to the level of absolute safety or no MSDs. The endpoint
will not require employers to seek to eliminate all aches and pains or
symptoms of discomfort, as feared by Mr. Watchman. The required hazard
reduction is directed at MSDs that require work restriction or medical
treatment. The last endpoint is reducing MSD hazards to the extent
feasible. When the employer has reached the limits of feasibility, he
or she is in compliance regardless of whether MSDs are continuing to
occur, at least until additional controls become feasible.
d. Comments that requiring employers to go to the limits of
feasibility is unreasonable. Some rulemaking participants were
concerned that the proposed requirement to control hazards to the
extent feasible would require employers to continually review ergonomic
research for the latest in control technology (see, e.g., Exs. 30-2208,
30-2987, 30-4607, 32-234). For example, the Center for Office
Technology argued that this requirement would be very costly as
employers would be forced to replace office furniture every time a new
desk is offered for sale. Concerned that employers would be forced to
conduct constant reviews of new technology, the American Health Care
Association recommended that OSHA provide technology and program
upgrade information (Ex. 30-2987). The Association believed that the
Agency was in a better position to determine when new and credible
research made new control measures available. Caterpillar, Inc., stated
that once ergonomic complaints cease there would be no need to review
new technology (Ex. 30-4607). Caterpillar recommended that the standard
not require the employer to assess additional controls unless a new MSD
occurs.
Federal Express argued that, because an employee must handle every
package at some point in the delivery process, complete elimination of
human involvement cannot be achieved in its line of work (Ex. 32-208).
In addition, Federal Express believes that it has reduced manual
handling at its facilities as much as it can and, thus, is already at
the limits of technological feasibility.
Keller and Heckman, L.L.P. believed that the proposed standard
would require employers to research and develop technology to meet the
proposal's compliance endpoint (Ex. 500-221). The law firm argued that
the approach taken by the proposal was legally indistinguishable from
the research and development requirement that the Third Circuit
invalidated in American Iron & Steel Institute v. OSHA, 577 F.2d 825,
838 (3rd Cir. 1978). In that case, the Court held:
29 U.S.C. Sec. 665(b)(5) grants authority to the Secretary to
develop and promulgate standards dealing with toxic materials or
harmful agents ``based upon research, demonstrations, experiments,
and such other information as may be appropriate.'' Under the same
statutory provision the Secretary is directed to consider the latest
scientific data in the field. As we have construed the statute, the
Secretary can impose a standard which requires an employer to
implement technology ``looming on today's horizon,'' and is not
limited to issuing a standard solely based upon technology that is
fully developed today. Nevertheless, the statute does not permit the
Secretary to place an affirmative duty on each employer to research
and develop new technology. Moreover, the speculative nature of the
research and development provisions renders any assessment of
feasibility practically impossible. In holding that the Secretary
lacks statutory authorization to promulgate the research and
development provision, we note in passing that we need not reach
petitioners' challenge to the provision as fatally vague.
Accordingly, we hold the research and development provision of the
standard to be invalid and unenforceable.
[[Page 68356]]
[American Iron & Steel Institute v. OSHA, 577 F.2d 825, 838 (3rd
Cir. 1978) as quoted by Ex. 500-221]
Paul, Hastings, Janofsky, and Walker LLP stated that the preamble
to the proposal indicated that the standard would be technology
forcing:
The agency's impossibly burdensome definition of technological
feasibility would make compliance * * * virtually impossible. OSHA
asserts that a hazard control methodology is technologically
feasible even if it is not currently available.
Thus, OSHA could issue citations and civil penalties to a small
employer for failing to implement non-existent equipment that ``can
be developed by improving existing technologies'' or that is ``on
the horizon of technological development.'' 64 FR at 65823. [Ex. 30-
3231]
The National Solid Wastes Management Association (Ex. 32-234)
argued that OSHA's description of ``technological feasibility'' would
make compliance with the proposed endpoint virtually impossible:
OSHA asserts that a hazard control methodology is
technologically feasible even if it is not currently available.
Thus, OSHA could issue citations and civil penalties to a small
solid waste industry employer for failing to implement non-existent
equipment that ``can be developed by improving existing
technologies'' or that is ``on the horizon of technological
development.'' 64 FR at 65823. [Ex. 32-234]
The American Transportation Association argued that OSHA could
conclude that the employer had not gone far enough to control hazards
even in the absence of continued MSDs (Ex. 30-4465). In support of this
argument, the Association stated, ``if MSD symptoms persist, even on an
occasional basis, an employer must continue to implement additional
measures until it has exhausted all feasible controls.''
LPA, Inc., and others contrasted the types of controls OSHA has
required when it cited employers for failing to abate ergonomic hazards
under the general duty clause with the types of controls the Agency has
stated that it will accept under the proposed rule (see, e.g., Exs. 30-
494, 32-208). LPA argued as follows:
Once a hazard is identified, an employer must implement
``feasible'' controls to try to eliminate it. A feasible control is
one that is already being used elsewhere in the same job, can be
adapted for the job, or ``is on the horizon of technological
development.'' [Footnote omitted] OSHA insists that the available
controls to fix hazards are usually neither complex nor costly.
Although such controls may be accomplished through physical changes
to the job, changes in work practices, or training in proper work
techniques, [Footnote omitted] the standard expresses a preference
for physically redesigning the job.
When citing ergonomics hazards under the general duty clause,
however, OSHA has often required substantial physical changes, such
as completely redesigning an assembly line and rebuilding the cab of
a large crane. In many cases, these engineering controls favor
automation and result in lost jobs. [Ex. 30-494]
The AFL-CIO noted that requiring employers to eliminate ergonomic
hazards or implement controls to the extent feasible was similar to the
approach OSHA uses in many other standards (Ex. 32-339). The union held
that any incremental abatement process included in the final standard
must have as its goal and endpoint the elimination of MSD hazards or
the reduction of MSD hazards to the extent feasible.
The final rule contains an endpoint that would recognize that an
employer is in compliance when he or she has done all that is feasible
to reduce MSD hazards. This endpoint is statutorily driven. The OSH Act
does not give the Agency the authority to require controls that are not
capable of being done. This endpoint places a technological and
financial limit on how far an employer must go in controlling MSD
hazards.
As demonstrated by its feasibility analyses described in Chapter 3
of the Economic Analysis OSHA believes that most employers will be able
to reach one of the other two endpoints (control MSD hazards or reduce
MSD hazards in accordance with or to levels below those in the hazard
identification tools in Appendix D) using existing technology at a cost
that is economically feasible. The third endpoint, control MSD hazards
to the extent feasible, is not technology-forcing in the sense feared
by some commenters. As discussed earlier, what is feasible under the
standard is determined by the limits of current technology and
knowledge, not the potential for future technology.
Furthermore, OSHA believes that many of the comments on the
corresponding compliance endpoint in the proposal were founded on the
impression that the proposed rule would have required employers to
eliminate MSDs from the workplace subject only to the limits of
feasibility (see, e.g., Exs. 30-3231, 30-3347, 30-3750, 30-4465, 32-
211, 32-234). The language of the final rule's compliance endpoint
makes it clear that this is not the case. The feasibility compliance
endpoint in the final rule supplements the other two and ensures that
no employer is required to go beyond the limits of feasibility.
OSHA has addressed the concerns of the American Health Care
Association that employers would be forced to continually review new
technology (Ex. 30-2987). Paragraph (k)(1)(iii) of the final rule
requires employers to assess whether additional feasible controls are
available every 3 years. This provision limits the frequency with which
an employer would need to review technology, and the assessment could
easily be done as part of the overall program evaluation. The Agency
will be providing information on available control technology on its
Web site and updating this information periodically. Employers should,
however, check other sources of information to ensure that they have
not overlooked new hazard controls that are appropriate for the MSD
hazards in their workplaces.
The final compliance endpoint does not require employers to perform
research and development to extend the limits of technological
feasibility. As explained above, MSD control technology is feasible if
the control method is available or adaptable to the employer's specific
circumstances. Employers are not required to perform research on MSD
control methodology or develop new technology to abate the MSD hazards
in their workplaces.
e. Comments that the proposed rule would force employers to
automate jobs out of existence. Some rulemaking participants argued
that the ergonomics standard will lead to the elimination of jobs (see,
e.g., Exs. 30-1616, 30-3845, 30-3956, 30-4185; Tr. 5701). These
commenters asserted that employers would act to reduce MSD hazards in
the workplace by automating jobs out of existence, shifting jobs
overseas, or converting full-time jobs to part-time to reduce exposure
(see, e.g., Exs. 30-3845, 30-3956). Several rulemaking participants
were concerned about the feasibility of automating certain jobs (see,
e.g., Exs. 30-2208; Tr. 18033). For example, the Center for Office
Technology stated:
To eliminate the hazard one must automate the work environment
thus eliminating any exposure. Those are not OSHA's words but those
are the examples OSHA gives (Fed. Reg. Page 65832). And in the case
of the office, OSHA suggests that the only way an employer of office
workers has eliminated the hazard is to use a voice-activated
computer to eliminate highly repetitive motions. Here is where
OSHA's definition of feasible falls apart for the office industry.
Is it feasible to have voice recognition for computer input when for
many applications, given the state of the technology, it is neither
effective nor an adequate or available solution? Voice activation
technology has come a long way, however, this technology is not at a
point which it can be used for all
[[Page 68357]]
applications. To use a technology that is still evolving and has
limited effectiveness in some applications as an endpoint leaves
employers in a never ending cycle with no true solutions. [Ex. 30-
2208]
OSHA does not believe that this ergonomics standard will result in
the elimination of a significant number of jobs through automation or
in the conversion of full-time jobs to part-time. Employers use
automation to promote efficiency and increase productivity, and
reduction of MSD hazards is often a byproduct. The specific concern
expressed by the Center for Office Technology is unfounded. OSHA
referred to a voice--activated computer as an example of a control that
would eliminate a repetitive motion hazard but did not mean to imply
that all computer input would henceforth need to be done using voice-
activation software. Appendix D makes clear that is not the case.
Automation for the sole purpose of reducing MSD hazards is
typically unnecessary. Testimony by the United Auto Workers indicated
that, in one of their programs covering about 4400 employees and
involving over 1000 processes, only one problem job was fixed by
automation (Tr. 14797). In addition, Mr. David Alexander (Tr. 2564),
one of OSHA's expert witnesses with extensive experience in ergonomics,
testified that most ergonomic solutions were low cost:
In my work, I found that about half of the projects cost less
than $500 and can be done on a standard work order without the need
for detailed justification. Perhaps that is why we do not hear about
many of these low-cost solutions. Only a third of the projects need
to cost more than $1,000. In other words, an ergonomics project is
likely to cost, two times out of three, less than $1,000 and usually
can fit within most budgets. [Tr. 2564]
These control methods do not approach the cost of automation.
Consequently, simple economics will keep most employers from automating
jobs simply to control ergonomic hazards. Mr. Alexander also stated
that for a single set of risk factors as many as five to ten different
solutions can be developed and employers should not be forced to
convert full-time jobs to part-time. If reduction of exposure time is a
control an employer selects, rotating employees among different jobs
would normally be a cost-effective alternative to the use of part-time
workers to replace full-time employees.
4. Comments on Whether the Proposed Compliance Endpoint of Eliminating
MSD Hazards Is Illusory Because MSDs Cannot Be Eliminated
Some rulemaking participants criticized the final means of
compliance, ``eliminating MSD hazards'' (see, e.g., Exs. 30-323, 30-
1107, 30-1722, 30-3845; Tr. 8328). For example, the US Chamber of
Commerce stated that activities that the Agency characterizes as MSD
hazards are ``universal activities of life, both in and out of the
workplace, that can never be completely eliminated.'' The Chamber also
noted that certain risk factors may pose MSD hazards to some employees
but not to others due to their unique susceptibilities and prior
medical history. Thus, the Chamber concluded, ``Without knowing how an
innumerable list of confounding factors might coalesce to cause an MSD
in a given individual, neither OSHA nor an employer can ever say
whether a significant risk of harm exists and, short of eliminating the
job altogether, it will be impossible to say when all possible
ergonomic ``risks'' have been eliminated. [Ex. 30-1722]'' Other
rulemaking participants made similar arguments (see, e.g., Exs. 30-297,
30-323, 30-2208, 30-3765, 30-3845, 30-3934, 30-4185; Tr. 2960, 5342).
These commenters said that nonwork-related factors also cause MSDs and
that some MSDs will continue to occur even after employers control all
work-related hazards. For example, the Forum for a Responsible
Ergonomics Standard stated that employers cannot control the
predisposition of their employees to contract MSDs (Ex. 30-3845). The
Forum asserted that women are susceptible to carpal tunnel syndrome for
a variety of reasons, including because they have smaller wrists and
greater fluid retention. Similarly, Metz Baking Company stated: ``* * *
OSHA's proposal essentially forces companies into the pursuit of
continuous efforts to reconfigure their workplaces and methods of
operation down to a level that is without physical stressors for the
most vulnerable of its employees [Ex. 30-323].'' Some rulemaking
participants noted that the standard did not hold employees accountable
for their own behavior on and off the job (see, e.g., Exs. 30-3355, 30-
3723; Tr. 8328). For example, Mr. Perry Ozburn, the chairman of the
International Warehouse Logistics Association, recounted a case in
which his company had to pay benefits to an employee who Mr. Ozburn
believed was injured off the job (Tr. 8328).
Mike Redman of the National Soft Drink Association argued the fact
that employees in certain jobs will experience MSDs despite the best
efforts of their employers (Tr. 2960). He reasoned that, because the
probability of an MSD occurring in such jobs is always 100 percent, the
employer will not be able to materially reduce the likelihood that an
injury will occur.
Once again, the premise of these comments is that the proposed
standard would have required employers to eliminate MSDs from the
workplace. As noted earlier, the final rule's compliance endpoints stop
short of this and provide clearly defined goals. OSHA realizes that
employers cannot prevent all MSDs. In addition, the final rule, like
the proposal before it, includes a note that the occurrence of an MSD
is not, in and of itself, a violation of the hazard control endpoint.
5. Comments on Whether Some MSD Hazards Are Beyond the Employer's
Control
Some rulemaking participants, particularly those representing the
ambulance service, solid waste, and moving and storage industries, were
concerned that employees were exposed to ergonomic hazards that were
out of the employer's control (see, e.g., Ex. 30-3686, 30-3845; Tr.
8140, 14957, 18030). For example, Mr. Ron Thackery, representing the
American Ambulance Association, testified that not only were the
lifting hazards faced by ambulance crews beyond the control of
employers but that there were no feasible control measures that his
industry could use to meet the compliance endpoint required by the
proposed standard (Tr. 15017).
The final rule's compliance endpoint recognizes that some aspects
of an employer's hazard control efforts may be limited by the
availability of feasible controls. To the extent that the MSD hazards
an employee faces are completely out of the employer's control, the
final rule does not require the employer to control them. (For an
analysis of the comments on the feasibility of controls in various
jobs, see the discussion of technological feasibility in the Economic
Analysis section later in the preamble.) For example, for paramedics
responding to an automobile accident, the employer would have no
control over the weight of the accident victims or their positions at
the accident scene. These factors are highly variable and cannot be
controlled by the employer. However, there are certain administrative
and engineering controls that are available and, to the extent they can
be used, the employer is required to implement them. For
[[Page 68358]]
example, work rules (with associated training) can assure that
employees minimize the risk involved in moving accident victims.
When work rules are used as an administrative control of MSD
hazards, the employer is obligated to institute an adequate work rule,
train employees in it, take steps to find violations, and enforce the
rule uniformly. If the employer has done those things and an employee
violates that rule without the employer's knowledge, then the employer
will not be cited for that violation (see section III.C.8.c(1) of
OSHA's Field Inspection Reference Manual, CPL 2.103.). The courts and
OSHA Review Commission do recognize a defense of unpreventable employee
misconduct. See, e.g., D.A. Collins Constr. Co. v. Secretary of Labor,
117 F.3d 691 (2nd Cir. 1997). Thus, the fears expressed by Guilford
Mills (Ex. 30-2990) and the Oregon Dental Association (Ex. 32-233) that
employers would be held responsible for unpreventable violations of
work rules by their employees is unfounded.
7. Whether the Proposed Incremental Abatement Process Endpoint is
Appropriate
The proposed incremental abatement process (Sec. 1910.922) would
have allowed employers to test solutions in a problem job, so long as
they would result in some hazard reduction and wait and see whether an
additional MSD occurred before trying out further controls.
This proposed provision drew substantial comment on both sides.
Many commenters objected to it as written because they believed it
would permit employers to delay implementing controls that were needed
to protect workers. The AFL-CIO recommended changing the provision to
avoid this problem.
The AFL-CIO believes that any incremental abatement process
included in the final standard must have as its goal and endpoint
the elimination of MSD hazards or the reduction of MSD hazards to
the extent feasible. Employers can eliminate or reduce these hazards
incrementally, focusing first on the high duration, high frequency
and high intensity risk factors identified in the job analysis.
Employee reports of MSDs or symptoms can and should be used to help
set priorities for action and to help determine which jobs need
further attention, but they should not be the endpoint for when and
whether an employer has instituted sufficient controls.
The final standard must also set a compliance deadline for
implementing all feasible controls through the incremental abatement
process. OSHA should make clear that the same compliance deadlines
for permanent controls (i.e., within three years during the startup
period and within one year thereafter) apply, regardless of the
abatement process an employer chooses to utilize. [Ex. 32-339]
The International Brotherhood of Teamsters stated that the
incremental abatement of hazards would be acceptable within a framework
of continuous ergonomic improvement that incorporated symptom
surveillance, reaction to ergonomic complaints, active risk factor
analysis, and continuing training (Ex. 500-207). The IBT also believed,
however, that the final ergonomics standard must specify time frames
and deadlines for the incremental abatement process.
Other rulemaking participants were also concerned about the lack of
a time limit between incremental control steps (see, e.g., Exs. 32-111,
32-210). The United Steelworkers of America suggested that OSHA provide
additional guidance to assist employers in determining how long they
may wait for an injured employee's condition to improve before
implementing additional control measures (Ex. 32-111). The United Food
and Commercial Workers International Union also recommended that the
incremental abatement process have the same endpoint as the other two
compliance options (Ex. 32-210).
On the other hand, the Integrated Waste Services Association urged
the Agency to allow for flexibility in this regard, stating:
The timing of the incremental abatement process will require it
to be very specific to the situation. Consequently, standardized
measures of timeliness would be ineffective and impractical. The
employer should be permitted to gauge its own unique time frame for
each and every WMSD. [Ex. 32-337]
In its post-hearing submission (Ex. 500-218), the AFL-CIO
criticized the provision as allowing an employer to implement minimal
controls for a problem job until a new injury occurs. According to the
AFL-CIO, ``[r]equiring employers only to `significantly reduce the
likelihood that covered MSDs will occur,' and then allowing them to
avoid further intervention until another injury occurs is an
unacceptable, unprotective compliance endpoint that is totally at odds
with the language and purpose of the Act.'' The United Auto Workers
expressed similar concerns. ``The plain meaning of `incremental
abatement' is that all feasible controls will not be implemented in the
first instance. Instead, the employer is permitted to implement some
but not all feasible controls, and then wait for a second employee to
be injured before going the rest of the way.'' (Ex. 32-185).
Other rulemaking participants supported the proposed incremental
abatement process (see, e.g., Exs. 30-434, 32-450; Tr. 14854). For
example, Ms. Barbara Fritz testified that she used an incremental
process of applying a control measure and seeing if it works in her
efforts to abate ergonomic hazards (Tr. 14854). Monsanto Company
stated:
We agree that using an ``incremental abatement process'' is a
valid method of dealing with physical stresses. In some instances
you implement a potential solution to a problem and find that once
in place additional improvements are either necessary or possible.
It is also possible that from a budgeting standpoint you may not be
able to implement the full-scale solution until you can obtain the
necessary capital, so you implement partial solutions until capital
is available. [Ex. 30-434]
NIOSH (Ex. 32-450) also supported the incremental abatement process
in the proposed standard:
We agree that control of MSD hazards can be appropriately
achieved through the use of the incremental hazard abatement process
proposed in Section 1910.922, allowing employers to implement
controls in increments in order to understand which solutions work
among all potentially necessary controls, and to implement only
those controls that are necessary. We believe that it is essential
and standard practice in many existing ergonomic programs for the
routine reassessment of jobs in which initial control measures fail
to reduce the severity or occurrence of MSDs. This reassessment
should trigger implementation of additional feasible control
measures. This process also allows employers to select the best
solutions to eliminate or materially reduce the MSD hazard most
efficiently, and to periodically check for new controls capable of
further material reduction of the hazard. [Ex. 32-450]
Having considered the views expressed by the commenters, OSHA concludes
that it is not necessary to include a separate provision in the
standard on incremental abatement as the time frames for implementing
controls allow employers to follow an incremental abatement process
without a separate provision to that effect. The proposed incremental
abatement provision recognized that the most cost-effective approach to
reducing or eliminating MSD hazards is at times an incremental one.
Employers may try some basic, inexpensive controls and see how well
they work in reducing hazardous exposures before determining whether
additional controls are needed. The proposed incremental abatement
process was intended to make clear that employers are permitted to
follow such an approach. OSHA has concluded, however, that it is not
necessary to include a separate provision about
[[Page 68359]]
incremental abatement in the standard. The standard allows employers up
to 2 years (4 years initially) to control problem jobs, and these time
frames are sufficiently long to enable those employers who wish to do
so to follow an incremental abatement approach. A separate provision on
incremental abatement would therefore be redundant.
Elimination of the incremental abatement provision also
accommodates the concern expressed by the AFL-CIO and UAW that the
provision allowed employers to implement minimal controls and wait
until additional MSDs occur before completing abatement. Under the
final standard, once an employer has identified a problem job, it must
now attain one of the compliance endpoints for all employees in that
job within the time frame set out by the standard. Thus, while the
final standard allows incremental abatement within its time frames,
once a problem job has been identified that the employer must control,
the employer's abatement obligation does not depend on the occurrence
of additional MSDs.
7. Whether the Final Ergonomics Standard Should Allow Employers to
Prioritize the Control of MSD Hazards
Some rulemaking participants were concerned that the proposed
compliance endpoints limited the ability to prioritize the control of
MSD hazards (see, e.g., Ex. 30-3813; Tr. 3135, 14722). For example, PPG
Industries believed that the incremental abatement process outlined in
the proposal limited the employer's ability to prioritize hazards (Tr.
3135).
Sean Cady, representing Levi Straus and Company, testified that the
proposal did not provide sufficient guidance for the employer to
prioritize jobs for the analysis and control of hazards:
Well I would say first that we're here today to talk about our
ergonomic program and what we've learned over the last 10 years of
having a formal program in place. But one of the concerns that comes
to mind is the proposal doesn't seem to provide enough guidance on
how an employer should prioritize jobs for things like hazard
analysis and job modification and control if more than one job is
triggered at the same time. [Tr. 14722]
The United Auto Workers believed that it is important to prioritize
jobs and hazards for control (Ex. 32-185; Tr. 8102-8104). The UAW
suggested that the employer could use tools such as the NIOSH Lifting
Equation, Snook and Ciriello Push-Pull tables, and various checklists,
to identify which job elements and risk factors are most important (Ex.
32-185). The union recommended that employers be required to abate all
risk factors classified as high priority but be allowed to abate other
MSD hazards at a later time. The UAW argued that this was the proper
way for employers to materially reduce risk factors under the
incremental abatement process.
In its post-hearing submission, the AFL-CIO recognized that some
employers may have difficulty in meeting the proposed rule's compliance
endpoints by the deadlines contained in the proposal (Ex. 200-218). To
remedy this problem, the AFL-CIO suggested that the final ergonomics
standard allow employers an additional year to meet the compliance
endpoint if the employer:
(1) Has conducted the job hazard analysis required by the standard,
(2) Has identified MSD hazards,
(3) Has consulted with employees and their designated
representatives, and
(4) Has developed an action plan for eliminating MSD hazards.
According to the union, the action plan should prioritize the control
of MSD hazards and provide for measurable reductions in exposure to
those hazards, and the employer should be required to implement
controls in accordance with the action plan and evaluate whether the
controls have reduced exposures.
The AFL-CIO reasoned that its recommendation, which was consistent
with other OSHA standards, would provide employers with sufficient time
to eliminate MSD hazards without unnecessarily exposing employees to
injury:
The concept of an action plan or compliance program to set forth
the process and means by which an employer will achieve compliance
is an established practice under OSHA standards. The majority of
OSHA's health standards, including standards on lead (1910.1025),
cadmium (1910.1027), arsenic (1910.1018), and methylene dianaline
(MDA) (1910.1050) contain a requirement for the establishment and
implementation of a written compliance program.
Similarly, a number of OSHA standards have recognized that in
some industries or some establishments it may not be possible to
achieve the control endpoint by the compliance date established for
other industries and employers. In these cases, OSHA has on occasion
included provisions to extend the compliance date for the
implementation of controls.
Under the arsenic standard, employers who were unable to achieve
compliance with the PEL through engineering controls and work
practices by the compliance date of December 1, 1979, were required
to include in their compliance plan an analysis of the effectiveness
of controls, and were required to install engineering controls, and
institute work practice controls on the quickest schedule feasible
[1910.1018(g)(2)(ii)(F)].
The AFL-CIO believes that the provision of a one year extension
in the abatement date accompanied by the development and
implementation of an action plan is an appropriate means to address
more complex hazards and is consistent with the practice under other
standards. We recommend that such a provision be included in the
final standard. [Ex. 500-218]
OSHA acknowledges that some employers will have difficulty
controlling MSD hazards in all problem jobs within the deadlines that
would have been imposed by the proposed standard--permanent controls
would have had to be in place within 3 years after the effective date
initially and, if the initial compliance deadline has passed before an
MSD occurs, within 1 year of the incident. To alleviate this problem,
the final ergonomics standard gives employers an additional year to
implement permanent controls--permanent controls must be in place
within 4 years after the effective date initially and, if the initial
compliance deadline has passed before an MSD occurs, within 2 years
after the employer determines that the job meets the Action Trigger.
(These deadlines and the reasoning behind them are explained in more
detail in the summary and explanation for paragraph (x), later in this
section of the preamble.)
OSHA is not, however, providing a prioritization requirement in the
final rule. With the extended deadlines for the implementation of
permanent controls, employers will have sufficient time to install all
controls necessary to meet the final rule's compliance endpoint.
Employers are free to prioritize the installation of permanent
controls within the compliance deadline for MSD problem jobs. There are
many ways of assigning priorities to jobs. Priorities can be assigned
on the basis of risk, severity, cost, or other reasons. As long as all
required permanent controls are in place by the compliance deadline,
the Agency does not believe it is necessary or appropriate for the
standard to specify a prioritization schedule. Consequently, the final
rule contains no requirements on prioritization.
Paragraph (l)--What Kinds of Controls Must I Use to Reduce MSD Hazards?
Paragraph (l) of the final rule requires the employer to use
feasible engineering, work practice, or administrative controls, or any
combination of them, to reduce MSD hazards in problem jobs. The
standard also allows employers to use personal
[[Page 68360]]
protective equipment (PPE) to supplement these controls but stipulates
that PPE may not be used alone unless other controls are not feasible.
In addition, the standard requires any PPE that is provided to be
furnished to employees at no cost.
This paragraph of the standard is almost identical to the parallel
proposed provision, with one exception. A footnote to this paragraph in
the proposal would have prohibited the use of back belts/braces and
wrist braces/splints as PPE; this footnote has been deleted from this
paragraph of the final rule. As explained below, OSHA believes that
evidence in the record suggests that back belts, in some limited
applications, may help to reduce MSD hazards. However, back belts, like
other PPE, may not be used alone if other controls are feasible. Wrist
splints, wrist braces, and back braces, which are post-injury devices
used to speed rehabilitation, are not considered PPE for the purposes
of this standard.
Paragraph (l)(i)--Feasible Controls
Paragraph (l)(i) of the final standard mandates the use of feasible
controls (engineering, work practice, and administrative controls) or
any combination of them to control or reduce MSD hazards in problems
jobs. This paragraph also states that engineering controls, where
feasible, are the preferred method of control. This paragraph of the
final rule is essentially unchanged from the proposal. OSHA is allowing
employers this flexibility in the choice of controls because the
Agency's experience and information in the rulemaking record indicates
that these control approaches have been effective in contributing to
reductions in the number and severity of workplace MSDs. In addition,
OSHA believes that the broad range of jobs to which the standard will
apply, and the great variation in workplace conditions covered, make
compliance flexibility essential.
The final standard defines engineering controls as controls that
physically change the job in a way that controls or reduces MSD
hazards. Examples of engineering controls that are used to address
ergonomic hazards are workstation modifications, changes to the tools
or equipment used to do the job, facility redesigns, altering
production processes, and/or changing or modifying the materials used.
Engineering controls range from very simple to complex: from putting
blocks under a desk to raise the work surface for a taller-than-average
worker to providing a lumbar support pillow or rolled-up towel to a
video display unit (VDU) operator, to redesigning an entire facility to
enhance productivity, reduce product defects, and reduce workplace
MSDs.
When choosing an engineering control to address a particular
ergonomic problem, employers often have many choices, depending on how
much they wish to spend, how permanent a solution they seek, how
extensive a production process change they need, and employee
acceptance and preference (see the discussion of control approaches in
the summary and explanation for paragraph (m)). For example, as MacLeod
(Ex. 26-1425) points out, an employer whose VDU operators are
experiencing neck and shoulder problems has many options available,
including the following:
Raising the height of the monitor by putting it on phone
books, building a monitor stand, buying an adjustable monitor stand,
buying an adjustable wall-mounted monitor stand, or buying an
adjustable desk-mounted monitor stand;
Putting the desk on blocks; or
Providing an adjustable-height desk or workstation.
Work practice controls involve changes in the way an employee does
the job. They are defined by the standard as changes in the way an
employee performs the physical work activities of a job that reduce
exposure to MSD hazards. Work practice controls involve procedures and
methods for safe work. Examples of work practices that reduce the
potential for exposure to ergonomic risk factors are the use of neutral
positions or postures to perform tasks (keeping wrists straight,
lifting close to the body), use of two-person lifts when mechanical
lifts are not available, and the observance of micro-breaks as
necessary to minimize muscle fatigue. In the context of ergonomic
programs, work practice controls are essential, both because they
reduce ergonomic stressors in their own right and because they are
critical if engineering controls are to work effectively. For example,
workers need to be trained to use a power grip rather than a trigger
grip if a new tool is to be successful, and they need to know how to
adjust an ergonomically designed chair properly if it is to
substantially reduce the risk of neck disorders, shoulder tendinitis,
or another type of MSD. Work practices, like learning to vary job
activities during the day (e.g., moving from filing to sorting mail to
using the computer and back again) can often reduce the magnitude and
duration of exposure to the relevant risk factor sufficiently to make
MSDs unlikely. To be effective, the culture at the workplace and
supervisory support and reinforcement are necessary to ensure that safe
work practices are routinely observed.
Administrative controls are work practices and policies implemented
by the employer that are designed to reduce the magnitude, duration,
and/or frequency of employee exposure to risk factors by changing the
way work is assigned or scheduled. Examples of administrative controls
that are used in the ergonomics context are employee rotation, job
enlargement, and employer-initiated changes in the pace of work.
Administrative controls have been effective in addressing MSD
hazards in a number of cases. For example, one case study cited in the
Benefits chapter (Chapter IV of the Final Economic Analysis) describes
a lift team approach that has been effective in reducing work-related
back injuries among nursing personnel in a long-term care facility for
the elderly (Ex. 26-1091). The table of ergonomic program and
intervention case studies in Section VI shows dozens of examples of the
successful use of administrative controls, either alone or in
combination with other controls.
However, administrative controls must be used carefully if they are
to provide effective protection to employees. A well-known ergonomics
book, MacLeod's ``The Ergonomic Edge,'' cautions:
* * * job rotation is only beneficial if the tasks involve
different muscle-tendon groups or if the workers are rotated to a
rest cycle * * *. Furthermore, job rotation alone does not change
the risk factors present in a facility. Although job rotation may
have beneficial effects, engineering changes should remain the goal
of the ergonomics program (Ex. 26-1425).
OSHA agrees, and paragraph (l)(1) notes, that engineering controls
are the preferred method of controlling MSD hazards in cases where
these controls are feasible. In contrast to administrative and work
practice controls or personal protective equipment (PPE), which
traditionally have occupied lower tiers of the hierarchy, engineering
controls fix the problem once and for all.
Many commenters agreed that engineering controls are generally
superior to other controls, i.e., administrative controls, work
practices, or personal protective equipment (see, e.g., Exs. 26-1487,
26-1428, 26-1424, 26-2; 26-1426, 26-1425, 26-1408; and 26-3). For
example, a recent ergonomics text states:
Ergonomic hazards can be effectively eliminated by introducing
engineering
[[Continued on page 68361]]
[[pp. 68361-68410]] Ergonomics Program
[[Continued from page 68310]]
[[Page 68361]]
controls and applying ergonomic principles when developing
workstations, tools, or jobs * * * only engineering controls
eliminate the workplace hazards. Other strategies [work practices,
administrative controls] only minimize the risk of injury (Ex. 26-
1408).
However, a number of commenters mistakenly understood OSHA's
statement in the proposal about the preferred status of engineering
controls. These commenters understood this statement to mean that
administrative or work practice controls could not be used in lieu of
engineering controls. This was not OSHA's intent, nor is the inclusion
of this statement in the final rule to be interpreted that way. In the
final rule, as in the proposal, OSHA is permitting any combination of
controls (except PPE) to be used to control MSDs, either alone or in
combination. OSHA agrees, as these parties (see, e.g., Exs. 30-3344,
30-4628) argued, that in many cases, the use of administrative or work
practice controls alone may eliminate the hazard and thus obviate the
need for more expensive engineering controls. For example, the Milliken
Company stated:
The authorization in [proposed] section 1910.920(a) for
employers to use any combination of engineering, administrative, and
work practice controls is effectively rendered meaningless with the
statement that follows, which specifies that engineering controls
are the preferred method for eliminating or materially reducing MSD
hazards. This provides too much latitude for OSHA area directors to
issue citations when an employer has used administrative and work
practice controls rather than engineering controls (Ex. 30-3344).
Other commenters who misinterpreted the proposed statement about the
preference for engineering controls were concerned that this preference
could greatly increase the costs of compliance if OSHA enforced this
provision. For example, the Rubber Manufacturers Association emphasized
that `` * * * the hierarchy placing engineering controls over other
alternatives * * * restricts employers' discretion to choose less
expensive, non-engineered alternatives'' (Ex. 500-95). Other groups,
such as Pharmteck (Ex. 30-4122) and Southern States Cooperative Inc.
(Ex. 30-394), argued that `` * * * a vast percentage of workplace
injuries result not from exposure that might be limited through
engineering solutions, but from problematic employee behavior and
safety related decisions.'' Issues of feasibility were pointed to by
several commenters (see, e.g., Exs. 30-3368, 30-4264) such as the
National Soft Drink Association, which stated:
Although the employer is allowed to use any combination of
controls, OSHA makes clear that engineering controls are preferred,
where feasible. Lacking any definition or guidance of the term
``feasible'' complicates understanding or complying with OSHA's
intent in this regard. Such ambiguity will undoubtedly lead to
disagreements between employers and OSHA compliance personnel (Ex.
30-3368).
In response, OSHA notes that the hierarchy of controls has been an
established industrial hygiene practice since the 1950s and has been a
longstanding OSHA policy, as evidenced by many of the Agency's
standards (e.g., asbestos, Sec. 1910.1001; benzene, Sec. 1910.1047;
cadmium, Sec. 1910.1027; and methylene chloride, Sec. 1910.1052). As
was stated in the proposal, ergonomists endorse the hierarchy of
controls because they believe that control technologies should be
selected based on their reliability and efficacy in controlling or
reducing the workplace hazard (exposure to risk factors) giving rise to
the MSD. OSHA does not agree that ``problematic employee behavior'' is
the cause of occupational injuries and illnesses, nor that feasibility
will be a concern with this standard, in large part because the
standard allows such flexibility in control approach and requires only
that employers implement feasible controls.
Many groups (see, e.g., Exs. 32-21-1-2-19, 20-69, 20-22, 30-4538,
30-3683) commenting on the proposal strongly supported the hierarchy of
controls. For example, the American Association of Safety Engineers
stated:
We agree that engineering controls should be the first option in
alleviating WMSDs. While this type of approach could be the most
expensive from the short-term perspective, our experience is that
engineering controls are the most efficient/effective approach in
the long-term (Ex. 32-21-1-2-19).
OSHA agrees that the use of engineering controls is the most effective
way of controlling the MSD hazards. However, as discussed above, this
standard permits employers to use any combination of controls, except
PPE alone, to address MSD hazards in their workplace.
Paragraph (l)(2)--Personal Protective Equipment
Paragraph (l)(2) of the final standard permits employers to use
personal protective equipment (PPE) to supplement engineering, work
practice, and administrative controls. However, personal protective
equipment may not be used alone, i.e., as the sole means of employee
protection, unless no other controls are feasible. In addition, any PPE
that is provided must be made available to employees at no cost.
PPE is equipment that is worn by the employee and reduces exposure
to risk factors and MSD hazards in the job. Examples are palm pads and
knee pads to reduce contact stress, vibration-attenuation gloves, and
gloves worn to protect against cold temperatures.
The hierarchy of controls, which, as discussed above, is widely
endorsed by ergonomists, occupational safety and health specialists,
and health care professionals, accords last place to PPE because:
Its efficacy in practice depends on human behavior (the
manager's, supervisor's and worker's),
Studies have shown that the effectiveness of PPE is highly
variable and inconsistent from one worker to the next,
The protection provided cannot be measured reliably,
PPE must be maintained and replaced frequently to maintain
its effectiveness,
It is burdensome for employees to wear, because it
decreases mobility and is often uncomfortable,
It may pose hazards of its own (e.g., the use of
vibration-reduction gloves may also force workers to increase their
grip strength).
One author (Ex. 26-1408) notes that: `` * * * in most cases, the
use of PPE focuses attention upon worker responses and not the causes
of ergonomic hazards.* * * PPE does not eliminate ergonomic hazards * *
* [and] must be considered as the last line of defense against
ergonomic hazard exposure.'' Thus, although the final standard permits
PPE to be used as a supplemental control, it cannot be relied on as a
permanent solution to MSD hazards unless other feasible controls are
unavailable.
In the proposal, OSHA included a note to the proposed section on
the hierarchy of controls that stated that back belts/braces and wrist
braces/splints were not to be considered PPE for purposes of the
standard. This note was added to alert employers to the fact that back
belts and wrist braces, which are widely used in U.S. workplaces, were
not to be considered a control to reduce ergonomic hazards under the
proposed standard. OSHA pointed out that these devices were being
marketed as equipment that could prevent MSDs, although the evidence to
support these claims was inconclusive.
A number of commenters and studies in the record (see, e.g., 32-30-
1-15, 32-30-1-6, 32-30-1-7, 32-30-1-29, 32-30-1-14) suggest that OSHA
should allow the use of back belts as PPE on the grounds that these
devices have been shown to reduce workplace injuries. For
[[Page 68362]]
example, Mr. Jeffrey Whitaker commented that:
As safety professionals we realize that back supports alone are
not a solution and we apply the hierarchy of controls in our work
with our customers on a daily basis. We recommend engineering and
work practice controls be used whenever possible but we all know of
hundreds of workers' whose jobs will never or cannot be changed.
These workers need at least a modicum of support when doing their
jobs. Back supports are used in these situations to provide a basic
line of defense for vulnerable workers (Ex. 30-2724).
Commenters from Chase Ergonomics were of the same opinion:
Back supports should be recognized as an acceptable component of
an overall back safety program under the hierarchy of controls. As
with any PPE, back supports are not the first intervention option.
In many jobs, however, neither engineering controls nor work
practice or administrative controls are feasible or practicable. In
these circumstances, OSHA's PPE standard allows employers to provide
workers with protective equipment that is appropriate for the
hazards present * * * OSHA should clarify that employers may use
back supports as a supplement to their overall back injury
prevention program (Ex. 30-3857).
However, other organizations and commenters cautioned against the use
of back belts as PPE. For example, in a 1994 report reviewing the
available scientific literature on the use of back belts, NIOSH
expressed concern that wearing a belt may alter workers' perceptions of
their capacity to lift heavy workloads (i.e., belt wearing may foster
an increased sense of security, which may not be warranted or
substantiated) (Ex. 15-16). NIOSH does not recommend the use of back
belts as PPE, and neither do a number of professional societies (Exs.
15-15, 15-17, 15-33, and 500-41-99).
However, in response to comments submitted to the record regarding
back belts, OSHA has reviewed the available scientific literature
addressing the efficacy of back belts in reducing MSDs. OSHA has
conducted an extensive review of the evidence in the record on the
effectiveness of back belts in industrial use. The evidence is mixed.
Several studies (see, e.g., Exs. 32-30-1-21, 32-30-1-22, 32-30-1-2, 32-
30-1-8, 33-30-1-16, 32-31-1-23) of back belt use showed negative
results. For example, a 1996 study by Rafacz and McGill (Ex. 32-30-1-
21) that investigated the effectiveness of back belts in 20 healthy
male subjects found that belt wearing increased diastolic blood
pressure during every task performed by the study subjects. The authors
concluded that ``wearing an abdominal belt may put undue strain on the
cardiovascular system and * * * that screening for cardiovascular
compromise should be conducted before occupational belt-wearing.''
Another study (Alexander et al. 1995) that evaluated belt use in
nursing, dietary, and environmental services workers found no
significant differences in the number of self-reported back injuries.
The authors concluded that ``This finding supports research [showing]
that universal prescription of back belts did not decrease the number
of back injuries and that there [is] no support for uninjured workers
wearing back belts to reduce risk of injury.'' (Ex. 32-30-1-2).
A number of back belt studies in the literature report inconclusive
results (see, e.g., Exs. 32-30-1-22, 32-30-1-8, 32-30-1-24, 32-30-1-
12). For example, a study by Kraus et al.1996 (Ex. 32-30-1-12) reported
a lower acute back injury rate among belt users than non-users, but
cautioned that a number of confounders, such as the inability to
evaluate injury status, job lifting intensity, or length of employment
``may be important confounders or effect modifiers that delimit the
potential effect of back supports.''
However, a number of recent studies (see, e.g., Exs. 32-30-1-25,
32-30-1-6, 32-30-1-7, 32-30-1-14, 32-30-1-19) contain limited evidence
that back belt use can, in certain circumstances, provide some
protection to workers. For example, a 1998 study evaluated trunk
stiffening during flexion and lateral bending and concluded that
``increased spine stability may provide greater protection against
injury following unexpected or sudden loading'' (Ex. 32-30-1-6). A 1995
review of the literature on back belt effectiveness (Ex. 32-30-1-7)
concluded: ``Based on our assessment of the * * * studies reviewed in
this paper, a major finding is that back supports designed solely for
specific purposes could be biomechanically, physiologically, and
psychophysically effective in relieving the loads on the lumbar spine
for employees engaged in many industrial operations.'' A study by one
of OSHA's expert witnesses, Dr. Stephen Lavender (Ex. 32-30-1-14) that
evaluated the effect of lifting belts, foot movement, and lift
asymmetry on trunk motions, concluded that the lateral bending and
twisting motions of the torso are controlled with belt use.
OSHA's review of the voluminous record on the back belt issue shows
that back belts may have protective effects in certain industrial
settings, such as sudden unexpected loading of the spine (Ex. 32-30-1-
14). OSHA is aware that several of these studies had small sample sizes
(e.g., 10 subjects) (Ex. 32-30-1-6), lacked control groups, and were of
short duration. Nevertheless, the Agency is persuaded that the evidence
for the effectiveness of back belts, although limited, exceeds that
available for other types of equipment that workers wear that is
classified as PPE (e.g., palms pads, knee pads). OSHA has therefore
decided not to prohibit the classification of back belts as PPE for the
purposes of this standard. Accordingly, the note to that effect
contained in the proposal does not appear in the final rule. Permitting
back belts to be used as PPE means that employers will be required to
provide them to their workers, if they choose to do so, at no cost to
employees. Further, as with any PPE, back belts used in this manner are
subject to OSHA's standard for PPE (29 CFR 1910.132).
OSHA does not believe that the record in this rulemaking does not
support permitting other devices, such as back braces and wrist braces
or splints, which are generally prescribed as part of a treatment
regimen, to be considered PPE. These devices are generally prescribed
for individuals who have already been injured, and are not intended to
be used in the prevention of injuries. In some cases, they may even
exacerbate an existing MSD hazard. As explained by the AIHA, wrist
splints and braces may present serious problems:
Wrist splints or braces used to keep the wrist straight during
work are not recommended, unless prescribed by a physician for
rehabilitation. * * * using a splint to achieve the same end may
cause more harm than good since the work orientation may require
workers to bend their wrists. If workers are wearing wrist splints,
they may have to use more force to work against the brace. This is
not only inefficient, it may actually increase the pressure in the
carpal tunnel area, causing more damage to the hand and wrist.''
(Ex. 26-1424).
Because these devices are used for treatment after an injury has
occurred and because they are not intended to reduce exposure, OSHA
finds that it would be inappropriate to consider back braces or wrist
braces/splints as PPE under the final standard.
Paragraph (m)--What Steps Must I Take to Reduce MSD Hazards?
Paragraph (m) of the final rule establishes the steps employers
must follow to reduce the MSD hazards in their jobs. The employer's
obligation to control these hazards is established in paragraph (k);
this paragraph (m) sets out the procedures to be followed and the
timelines to be met to achieve the necessary hazard reduction.
The procedures in paragraph (m) are similar to those in proposed
Sec. 1910.919,
[[Page 68363]]
although they have been revised in the final rule to reflect the Action
Trigger and to state what employers must do if the controls they have
implemented are not effectively reducing MSD hazards. The steps
specified in paragraph (m) are widely recognized as basic procedures in
effective control selection and problem-solving. For example, the NIOSH
publication, Elements of Ergonomic Programs, describes a similar
process (Ex. 26-2). Paragraph (m) also sets the deadlines for the
implementation of initial and permanent controls to reduce MSD hazards.
OSHA received very few comments on the proposed control steps
provision.
The corresponding provision in the proposal also contained a
requirement that employers identify and evaluate MSD hazards when they
changed, designed, or purchased equipment or processes in problem jobs.
The final rule contains no similar requirement.
OSHA does not believe that a separate provision is necessary,
because the final rule includes a ``feedback'' loop between paragraph
(m)(4) of the rule and paragraphs (m)(1) and (m)(2). OSHA received only
one comment on this proposed provision (Ex. 32-300-1). This commenter
asked whether OSHA intended this provision to be similar to the
management of change provision in the Process Safety Management
standard (29 CFR 1910.119). Since this proposed provision has not been
carried forward in the final rule, the issue raised by this commenter
is moot.
Paragraph (m)(1)--Ask Employees
This paragraph requires employers who have determined that they
have a problem job to ask the employees in the problem job, and
employee representatives, to recommend measures to reduce the MSD
hazard in the job. This provision is essentially unchanged from the
proposal, except that employee representatives are mentioned
specifically in the regulatory text, which reflects OSHA's decision to
add this language to provisions of the regulatory text where the
involvement of employee representatives is particularly important.
Several commenters (see, e.g., Exs. 32-339-1, 32-182-1) urged OSHA to
include employee representatives in this step of the hazard
identification and control process because of the contribution they
could make. OSHA agrees and has revised the text accordingly.
Asking employees and their representatives for recommendations of
controls that will reduce MSD hazards is an effective and efficient way
of solving ergonomic problems. Many commenters (see, e.g., Exs. 3-112,
3-164, 30-3765, 30-3748, 500-137, 500-220) reported that the employees
who are doing the job are usually the best source of information on the
tasks causing the hazard and ways of solving the problem. For example,
the American Health Care Association stated:
Employers and employees who work in the industry are in the best
possible position to identify risk factors in their workplace and to
develop prevention methods that concentrate on the significant
problems unique to their particular industry's environment (Ex. 3-
112).
In many problem jobs, employees and their representatives will be able
to pinpoint the problem quickly and to suggest easily adopted controls.
In many cases, the solution will become obvious at the job hazard
analysis stage; many problems also can be addressed with simple, off-
the-shelf controls. Examples are:
Eliminating awkward postures (such as bending when leaning
across the workstation to reach a tool) by putting blocks under a work
bench to raise the work surface height.
Eliminating awkward postures of the neck and reducing
stress on the back by putting packages of copy paper under a VDT
monitor to raise it or taking the VDT off the CPU to lower it.
Reducing awkward postures of the neck by moving the light
source or removing the light bulbs that were causing glare on the VDT
monitor screen.
Reducing force by cleaning thread from the wheels of a
cart that has been hard to push. (Many of these controls would qualify
for the Quick Fix option (see paragraph (o).)
Some commenters (see, e.g., Tr. 63354, 9038, 12647), however, were
concerned that consulting with employees and their representatives
could lead to disagreements about the controls selected. OSHA's
experience, and comments to the record (see, e.g., Exs. 3-112, 26-5,
30-3765, 30-3748, 500-137, 500-220, 500-218), do not suggest that this
is a problem. Instead, these commenters point to the value of employee
input. OSHA expects, however, that employers will use their management
experience and judgment to resolve any disagreement that may arise. As
is the case for all OSHA standards, the employer is clearly responsible
for selecting controls and evaluating their effectiveness.
Another commenter (Ex. 32-300-1) argued against involving employees
in the problem-solving and control identification process on the
grounds that doing so might disappoint the employees if their
suggestions were not taken. OSHA's experience suggests just the
opposite, i.e., that nothing disappoints employees more than not being
part of a process that affects their working conditions so directly.
Some employers also report that they bring their in-house resources
(ergonomics committee members, safety and health professionals,
ergonomists) into the process at this stage (see, e.g., Exs. 26-1370,
502-17).
Paragraph (m)(2)--Initial Controls
This provision requires employers to identify and implement initial
controls (referred to as ``interim'' controls in the proposal) to
reduce MSD hazards within 90 days of the time the employer determines
that the job is a problem job. Because the final rule allows employers
to choose from engineering controls, administrative controls, work
practice controls, and--as a supplement to these controls--personal
protective equipment, OSHA believes that employers will be able to meet
this timetable, which is essential to the protection of employees in
problem jobs. OSHA anticipates that many employers, particularly those
whose jobs can be controlled with off-the-shelf controls, will simply
implement permanent controls within 90 days and be done with it.
Others, however, will develop a plan and timetable for permanent
control implementation and may need the full 4 years (2 years after the
standard has been in effect for some time) to reach the control levels
specified in paragraphs (k)(1) or (k)(2) of the final rule.
For these employers, the implementation of initial controls will
generally mean a greater reliance on administrative controls, work
practices, and, in those situations where personal protective equipment
is effective, on PPE, in the period between the 90-day deadline in
paragraph (m)(2) and the permanent control compliance deadline in
paragraph (m)(3). OSHA recognizes that initial controls may not, in all
cases, reach the control levels required by paragraph (k)(1) or (k)(2)
for permanent controls; nevertheless, employers are required to make
good faith efforts to address problem jobs promptly to protect the
employees in them.
OSHA expects employers to implement initial controls that will
substantially reduce employee exposure to the risk factors that are
contributing to the MSD hazard. For example, employers might provide
employees required to manually carry loads from one point to another
with a cart or a hand dolly as an initial control, or they might reduce
the weight of the object
[[Page 68364]]
being carried while waiting to install a permanent conveyor system. In
other cases, an employer might decide to implement a system of employee
rotation while waiting to install new power tools throughout the plant.
Other examples of controls employers often implement initially and then
replace with more permanent controls later are the provision of tools
with longer handles when excessive reaching is involved, anti-fatigue
mats and sit-stand stools when excessive standing is the problem, and
vibration-reduction gloves while waiting for new power tools with lower
vibration levels to be installed. By substantial reduction, OSHA means
that the initial controls must reduce the MSD hazard materially by
decreasing the magnitude, frequency or duration of the employee's
exposure to the relevant risk factors. Examples of controls that would
not meet the employer's obligations under paragraph (m)(2) would be
decreasing the weight of a package that is manually lifted from 90 to
85 pounds (because both weights substantially exceed the weight an
employee should lift alone) or rotating employees into a second job
that has the same risk factors (because this would not reduce the
magnitude or duration of exposure).
The purpose of paragraph (m)(2) is to ensure that the employer
takes steps quickly (i.e., no more than 90 days after the job is
identified as a problem job) to reduce the exposures of at-risk
employees (i.e., those in jobs that have identified MSD hazards).
Waiting until permanent controls are installed, which may take as long
as 4 years, would leave these employees unprotected and increase the
likelihood that another MSD incident will occur. The concept of initial
controls (interim controls) is a well-established principle of worker
safety and health protection and is incorporated in many OSHA
standards, as one commenter noted (Ex. 26-1370).
Paragraph (m)(3)--Permanent Controls
This paragraph requires employers to identify and implement
permanent controls that will achieve the hazard reductions required by
paragraphs (k)(1) and (k)(2) of the standard. This provision is
essentially unchanged from the proposal, except that it has been
revised to reflect the final rule's objective compliance endpoints and
the function of the action trigger.
There are many ways employers can identify permanent controls in
addition to asking employees and their representatives for control
ideas. These include:
Asking other establishments in the company how they have
solved a similar problem; many companies with OSHA corporate-wide
settlements have found this approach useful (see, e.g., Ex. 32-185-3).
Asking the industry trade associations for suggestions
(the food retail industry, for example, worked as a group to reduce
package weights (Tr. 4948).
Attending ergonomics conferences and trade shows.
Talking to the company's insurance agent about solutions
that have worked for other companies.
Reviewing equipment catalogs (one commenter reported using
this approach to identify mechanical alternatives to drum handling (Tr.
6981)).
Several commenters stated that employers are best positioned to
choose their own sources of control information and ideas (see, e.g.,
Exs. 30-434, 30-240, 30-133, 30-3122, 30-3284, 32-300-1), and OSHA
agrees, except that employees in the problem job and their
representatives must also be involved in the process, as required by
paragraph (m)(1).
Employers have many control strategies to choose from when
identifying permanent controls. The controls selected may be any one,
or any combination of, engineering, work practice, or administrative
controls. These controls may be supplemented by PPE, but PPE may not be
used alone unless other feasible controls are not available (see
paragraph (l) of the standard). Among the factors employers consider
when selecting controls are:
Which control achieves the greatest reduction in employee
exposure to the MSD hazard
Which is likely to be accepted and used by employees
Which takes the least amount of time to implement
Which achieves a substantial reduction in exposure at the
lowest cost.
These criteria are included as examples only; the standard does not
require employers to use these criteria because OSHA recognizes that
employers will choose those factors to consider that are most
appropriate to their workplace. The following chart lists many controls
that may be appropriate to reduce employee exposure to the risk factors
that are responsible for MSD hazards, depending on the circumstances of
a particular workplace. This list is illustrative only; it is not
exhaustive but is provided merely to show that there are often many
different control approaches that will reduce the magnitude, duration,
or frequency of risk factor exposure.
------------------------------------------------------------------------
Ergonomic risk factors that may be
present Examples of controls
------------------------------------------------------------------------
Force (Exertions)................. Use powered tools
Change pinch to power grip
Use longer handle
Use appropriate size handle
Use powered lift assist
Counterbalance the weight
Use lift tables
Reduce the weight of the object
Ensure that the center of gravity of
the tool is over the hand
Use a fixture, clamp or jig
Provide periodic tool or equipment
maintenance
------------------------------------------------------------------------
Force (Manual Handling)........... Lighten the load
Use lift assist
Use lift table
Place package in larger containers
that are then mechanically handled
Use two-person lift team
Rely on gravity to move the object
Reduce friction when objects must be
pushed or pulled
Reposition object closer to the
employee
Provide pallet or table that can be
rotated
[[Page 68365]]
Provide space so that the employee
can move closer to the object
Reduce the size of the object
Slide the object closer before
lifting
Place objects to be lifted above
floor level
Use adjustable height tables
Force (Manual Handling)........... Store heavy objects at waist height
Put handles on the object
Modify the process to eliminate or
reduce moves over a significant
distance
Convey the object (e.g., conveyor,
ball casters, air)
Use fork lifts, hand dollies, or
carts
Use appropriate wheels on carts (and
maintain the wheels)
Provide handles for pushing, pulling
or carrying
Arrange workstation so that work is
done in front of the worker
Use conveyors, chutes, slides, or
turntables to change direction of
the object
Provide belt with handholds to
assist in moving patients
Provide gloves that assist in
holding slippery objects
Redesign the handling job to avoid
movement over poor surfaces
Use surface treated with anti-slip
material or anti-skid strips
Provide footwear that improves
friction
------------------------------------------------------------------------
Awkward posture................... Provide workstation adjustability
Raise/lower the worker's position
Raise/lower the workstation
Provide better mechanical advantage,
such as with a longer handle
Design task for smooth movements
Redesign the flow of the workplace
layout
Reposition object to allow for a
neutral posture
Train workers to use less stressful
postures
Provide better access to machinery
Rotate pallet or work surface
Allow short breaks
Position work in front of the worker
Use a tool to extend the reach
Provide lumbar support for a seated
worker
Provide workstation adjustability
Provide tool holders
Provide a strap on the tool handle
to allow the hand to relax while
maintaining control
Provide sit/stand workstations
Rotate workers to jobs that do not
involve the same posture
Provide anti-fatigue mats
Provide foot rests
------------------------------------------------------------------------
Repetition........................ Use power tools
Distribute the work so that less
time is spent at repetitious tasks
------------------------------------------------------------------------
Contact stress.................... Attach a well-designed handle to the
tool
Wrap or coat the handle with
cushioning and non-slip material
Provide a handle that does not press
into the palm
Wear knee pads or palm pads
Use a soft mallet for hand hammering
Vibration......................... Use low vibration tools
Isolate source of vibration from the
worker
Maintain tools regularly
------------------------------------------------------------------------
The final rule allows employers coming into compliance with the
standard initially to take up to 4 years, if necessary, to implement
permanent controls; this period is reduced to 2 years for employers who
identify problem jobs more than 2 years after the standard's effective
date. Several commenters (see, e.g., Exs. 32-339-1, 32-185-3, 32-210-2,
30-3815, 32-368-1) were concerned with the proposed compliance
deadlines for the implementation of controls. The final rule has
extended the permanent control deadline to 4 years from the standard's
effective date; this phase-in drops to 2 years after the standard has
been in effect for 2 years. For OSHA's responses to the record on
compliance deadlines, see the Summary and Explanation for paragraph
(x). OSHA believes that these control implementation deadlines will
provide smaller employers, and employers with more complex control
requirements, the time they need to plan for, obtain, and implement
permanent controls.
Paragraph (m)(4)--Track Progress
Paragraph (m)(4) of the final rule requires employers to make sure
that the controls they have identified and implemented are reducing MSD
hazards and have not unintentionally created new MSD hazards. This
paragraph has been revised from the proposal to include additional
steps employers must take if they discover that their controls are not
achieving the levels required or have introduced new MSD hazards. The
proposal, in contrast, simply required employers to track their
progress but did not specify what they
[[Page 68366]]
were to do if their controls were not working as planned.
OSHA believes that this paragraph is essential, for several
reasons. First, unless employers follow up on their control efforts,
they will not know whether they are protecting their employees and are
in compliance with paragraphs (k)(1) or (k)(2) of the rule. Second, in
establishments with many problem jobs and a job prioritization plan in
place, ascertaining the effectiveness of controls is important to
ensuring that the employer's abatement strategy is an effective one.
Third, control effectiveness is the basis of any effective program, and
thus plays a critical role in evaluating the elements of the program.
For example, an evaluation of work practice controls is an excellent
way of determining whether training in these controls has been
effective.
This step of the control monitoring process requires employers to
consult with employees in the problem job and their representatives to
ensure that the controls have been effective in reducing the physical
difficulties employees associated with the job. The standard does not
require employers to use quantitative or qualitative measures to
evaluate control effectiveness, but many employers use such methods.
Examples of before-and-after approaches used over a longer (i.e., 6-
month) period include:
Reductions in severity (measured as fewer days away from
work)
Reductions in the number of symptoms reported in a
symptoms survey
Reductions in workers' compensation costs
Reductions in MSD incidence rates.
Methods used in shorter-term evaluations, i.e., those conducted
within 30 days, include talking with employees and their
representatives and symptoms surveys. NIOSH (Ex. 26-2) recommends that
employers wait at least 2 to 4 weeks after control implementation to
assess the effectiveness of controls, because this period of time is
often enough to allow employees to tell whether the situation has
improved.
OSHA believes that the process of hazard identification, control
selection, and control evaluation has been greatly facilitated by the
fact that the final rule identifies objective criteria against which
employers can measure the extent of the risk factors present and the
effectiveness of their efforts to control or reduce the hazard.
Employers are not required to use the hazard identification tools
referenced in Appendix D-1 or provided in Appendix D-2, but they are
free to do so. OSHA believes that employers will generally find that
the greater certainty that results from the appropriate use of these
tools enhances their ability to protect their employees and increase
the employer's confidence that the standard's control endpoints are
being met.
Paragraph (o)--May I Use a Quick Fix Instead of Setting up a Full
Program?
Paragraph (o) of the final rule sets out alternative provisions
that employers may follow in lieu of setting up a full ergonomics
program. These alternative provisions are referred to as the Quick Fix
approach. The Quick Fix option allows employers to control an MSD
hazard quickly and more informally without, for example, conducting a
complete job hazard analysis, setting up a training program or a
periodic program evaluation process.
OSHA has included a Quick Fix option in this standard to provide
compliance flexibility for those employers who have:
Only a few isolated MSD hazards (that is, they have had
one prior MSD incident in any job in which an MSD incident is reported
after the effective date and only 2 prior MSD incidents in the
workplace during the 18 months before the new MSD incident is
reported), and
MSD hazards that can be identified easily and addressed
quickly (that is, they can fix the job within 90 days after the MSD
incident is determined to meet the Action Trigger).
OSHA believes that the Quick Fix option is an efficient mechanism
for providing ergonomic protection for employees, while at the same
time reducing regulatory burdens for those employers who have only a
few isolated problems.
The proposed rule also included a Quick Fix provision, which a
number of commenters supported (e.g., Exs. 30-3813, 30-3436, 32-210-1,
30-294, OR 326, 500-218, Tr. 2134, 13642). For example, one commenter
stated, ``I think that the Quick Fix is an outstanding idea that will
reduce the burden of this standard for many companies'' (Ex. 30-3436).
Portland General Electric Company agreed:
We believe that the Quick Fix option is extremely valuable. We
operate on a system of early reporting and effective individual case
management, to the benefit of both the employee and the company (Ex.
OR 326).
Some employers said that they had implemented types of Quick Fix
approaches in their workplaces (see, e.g., Exs. OR 326, Tr. 14715-16).
A number of commenters maintained that the Quick Fix would not be
helpful or would not work. For instance, Integrated Waste Services
Association said: ``While the ``quick fix'' idea sounds reasonable,
quickly `fixing a problem job' is unrealistic and illusory'' (Ex. 30-
3853). Some of these commenters said the Quick Fix approach would not
reduce regulatory burdens for employers (see, e.g., Exs. 30-3853, 30-
2988, 30-3815). And the National Association of Manufacturers (Ex. 30-
3815) said that the Quick Fix ``is next to meaningless for an
establishment of any size.''
Other commenters were more optimistic about the Quick Fix concept,
but said that changes were needed to make it more useful for employers.
Kaiser Permanente, for instance, supported the Quick Fix idea as a
``practical and cost effective idea'' in principle, but argued that the
proposed provision was too limited and too vague to be workable (Ex.
30-3934). Others said the proposed Quick Fix offered an
``inappropriately narrow opportunity'' and urged OSHA to allow more
abatement time and allow more than one Quick Fix in any one job (Ex.
30-2988, 500-145). Some commenters, however, argued that allowing more
than one Quick Fix in a job was not protective enough (see, e.g., Ex.
30-2825, 32-182-1). In addition, AFSCME opposed extending the Quick Fix
option this way because it would be ``encouraging a piecemeal and
disjointed approach to ergonomics'' (Ex. 32-182-1).
On the other hand, some commenters were concerned that the proposed
Quick Fix was not adequately targeted to those workplaces where such an
approach would be appropriate. The AFL-CIO said:
In our view, the quick fix provisions proposed by OSHA are more
properly suited to those workplaces where the number of jobs with
MSD hazards is limited and where there are few MSDs. In those
situations, focused efforts to identify and correct hazards quickly
may be the best solutions, and a full ergonomics program may not be
needed (Ex. 32-339-1).
The AFL-CIO and others also identified specific high hazard
workplaces in which the Quick Fix would not be appropriate, such as
nursing homes, warehouses, automotive assembly plants, and meatpacking
and poultry processing plants (Exs. 32-339-1).
OSHA has made a number of changes to the Quick Fix provision in
this final standard to address these concerns. These changes include:
Focusing the Quick Fix more carefully on those employers
with limited MSD problems by specifying that it applies where there
have been
[[Page 68367]]
only 2 prior MSDs in the workplace in the past 18 months,
Providing clearer criteria for hazard identification and
control (i.e., the Basic Screening Tool) and compliance ``endpoint''
(i.e., the levels in Appendix D),
Ensuring that employees receive training in using the
implemented controls so that the Quick Fix is more likely to be
successful, and
Simplifying the criteria for determining whether a Quick
Fix has been successful or has failed.
Paragraph (o)(1)
Paragraph (o)(1) defines which employers may avail themselves of
the Quick Fix approach instead of implementing a complete ergonomics
program. Employers may use the Quick Fix approach if, within the last
18 months:
No more than 1 prior MSD incident has occurred in the job
in which another MSD incident is reported, and
There have been no more than 2 prior MSD incidents in the
workplace as a whole.
This represents a change from the proposed rule, which would have
allowed employers to use Quick Fix option in every job in the
workplace, but only for the first MSD incident in that job.
OSHA believes that the changes in the final rule provide more
compliance flexibility, and thus will allow more employers to take
advantage of the Quick Fix option. First, changing the Quick Fix
provision to allow employers to use it 2 times in the same job makes
the option available for more jobs. Allowing 2 Quick Fixes in one job
recognizes, as Kaiser Permanente pointed out, that the occurrence of a
second MSD in the same job may not necessarily mean that a previous
control measure has not worked, but rather that a different combination
of risk factors may be present (Ex. 30-3934):
[T]he conclusion in the proposed rule that the ``Quick Fix does
not work'' if another MSD is reported in the same job within 36
months * * * wrongly assumes that the same fix should work for the
same physical work activities and conditions. The fix that works for
one employee's condition may not work for another because of that
employee's physical characteristics or non-work related contributing
factors. A second or third MSD in the same job does not mean the
initial quick fix did not work, and employers should have the option
to apply a quick fix to newly reported MSDs (Ex. 30-3934; see also
Exs. 30-2088, 500-215).
Second, not restricting the 2 MSD incidents to ones caused by
different risk factors, as the proposed rule would have done, will also
make the Quick Fix option available to more jobs. Eliminating this
restriction on the second MSD incident also addresses commenters'
concerns that this provision was not clear enough to be workable (see,
e.g., Exs. 30-1349, 30-358, 30-595, 30-538, 30-323, 30-1022, 30-1551,
30-3745, 30-3723).
Third, halving the Quick Fix time frame to 18 months should make
the Quick Fix option available to more employers because MSDs that
occurred several years ago would not disqualify employers from using
the Quick Fix option. In addition, it makes the Quick Fix option more
attractive, as Kaiser Permanente noted:
[F]or large employers, tracking MSDs to determine whether
another covered MSD is reported in the same job within 36 months
would be cumbersome (Ex. 30-3934).
Organization Resources Counselors, Inc. (ORC), agreed:
The proposed requirement that the employer establish a full
ergonomics program if another similar MSD occurs in the job within
36 months is too rigid because the occurrence of MSDs is so closely
related to individual worker characteristics. If the employer
determines that additional feasible controls will eliminate the
significant risk from that job for that worker, another quick fix
should be permitted (Ex. 30-3812).
OSHA estimates that these changes should allow a large percentage
of jobs, as high as 25 percent of all jobs meeting the Action Trigger,
to be controlled using a Quick Fix. (See Chapter V of the Final
Economic Analysis).
At the same time, limiting the Quick Fix option to employers who
have only 2 MSDs in their workplace during the prior year and a half
also helps to target more precisely the provision to those workplaces
that have only isolated MSD problems. OSHA agrees with commenters that
where only a few MSDs are occurring, employers may be able to address
the problems effectively in an informal way, but that the occurrence of
several MSDs in a workplace in just over a year ``may be indicative of
a bigger problem'' that requires a more systematic approach to
adequately address (Ex. 32-210-2).
Although OSHA believes that targeting the Quick Fix to workplaces
with few isolated MSD hazards will likely make the option most useful
to small businesses, larger employers may also find the Quick Fix a
useful mechanism. For example, large employers who have ergonomics
programs in some jobs would be free to use the Quick Fix option if an
MSD hazard were identified in another job.
Paragraph (o)(2)
Paragraph (o)(2) of the final rule sets up the process that
employers using the Quick Fix option must follow. Employers must use
this process to fix the injured employee's job and all ``same jobs'' in
the establishment. Although this process is informal and flexible, it
nonetheless includes those basic steps that employers who have Quick
Fix or ``quick response'' processes use (Ex. 32-198-4-27-1). This
process includes:
Providing prompt MSD management to the injured employee
(paragraph (o)(2)(i));
Talking with employees to identify those tasks they
associate with the MSD incident (paragraph (o)(2)(ii));
Observing employees performing the job to identify the
risk factors likely to have caused the MSD incident (paragraph
(o)(2)(iii));
Asking employees for their ideas for reducing exposure to
the MSD hazards (paragraph (o)(2)(iv));
Implementing measures within 90 days to control or reduce
the MSD hazards (paragraph (o)(2)(v));
Training employees in using the controls implemented
(paragraph (o)(2)(vi)); and
Keeping records of the Quick Fix (paragraph (o)(2)(vii)).
These provisions of the final rule are similar to steps in the
proposed Quick Fix, although they have been revised in some respects to
respond to comments received.
Same Jobs
Also similar to the proposed rule, those employers who qualify for
and select the Quick Fix option must fix not only the injured
employee's job but also all other ``same jobs'' in the establishment.
This requirement applies both to employers using the Quick Fix and to
those who must implement ergonomics programs. Several commenters
objected to requiring employers to apply the Quick Fix beyond the
injured employee's individual job (see, e.g., Exs. 30-2208, 30-2725,
30-3745, Tr. 9183). Some said having to fix all same jobs was not
necessary and would impose excessive cost. For example, the Center for
Office Technology (Ex. 30-2208) stated:
The Quick Fix section is worded so that if one office worker is
experiencing discomfort and his workstation is changed--the example
given is purchasing an adjustable workstation for a VDT operator--
all the ``same job'' employees at that worksite would also have to
get an adjustable workstation when in fact no other employees may
need them.
OSHA believes this requirement is necessary because it helps to
ensure that
[[Page 68368]]
other employees performing the same physical work activities and
exposed to the same MSD hazards are provided with protection before
they too get hurt. In this sense, the ``same job'' requirement helps to
make the final rule more proactive and preventive. OSHA believes that
controlling other same jobs will also be cost-effective for employers
because it is only a matter of time, in jobs meeting the Action
Trigger, until another MSD incident occurs.
For several reasons, OSHA does not believe that the ``same job''
requirement will impose an undue burden on employers. First, OSHA
believes that the number of ``same jobs'' in the establishments likely
to use the Quick Fix option will be small, because OSHA believes that
many qualifying employers will generally be small businesses. Second,
the final rule allow employers to limit the Quick Fix to the injured
employee's job where the employer has reason to believe that the risk
factors in the job only pose a problem to the injured employee. (See
note to paragraph (j).) Thus, if the case referred to by COT (Ex. 30-
2208) meets the requirements described in the note to paragraph (j),
the employer would only be required to fix that employee's job. This
provision was included in the proposed rule, and a number of commenters
supported it, saying that such an exception was needed because the
individual characteristics of one worker may require controls that
don't work for or are not needed by other workers (see, e.g., Exs. 30-
3745, 30-358).
Finally, even where there are ``same jobs'' that also must be Quick
Fixed, OSHA does not believe that the Quick Fix process will be
burdensome for employers. The Quick Fix process is very informal and
thus provides employers with great flexibility in complying with each
step in the Quick Fix process. In addition, the final rule allows
employers to include a sample of employees, rather than all employees
in the same jobs, in the hazard identification and solution
consultation process. OSHA agrees with commenters that allowing
employers to rely on a sample of the employees who are likely to have
the greatest risk factor exposure in the job should help reduce burdens
for large employers and for employers with many employees in the same
job (Ex. 30-2208).
1. Provide MSD Management
Like employers who must implement an ergonomics program, employers
who select the Quick Fix option must provide the injured employee with
prompt MSD management after they have determined that an MSD incident
has occurred and the job meets the Action Trigger. This includes
providing the injured employee with access to an HCP and work
restrictions during the recovery period, if necessary. Where work
restrictions are needed, employers who select the Quick Fix option also
must provide the work restriction protection (WRP) that this standard
requires. (For further discussion of MSD management requirements, see
summary and explanation for paragraphs (p), (q), (r), and (s) below.)
2. Talk With Employees
Paragraph (o)(2)(ii) requires that, as part of the process of
identifying the MSD hazards, employers using the Quick Fix option must
at least to talk with the employees in the job (and their
representatives). The purpose of this consultation is to ensure that
employers ask those who know the most about the job-those that perform
it-for their help in identifying the physical work activities and job
conditions that they believe are mostly likely to be associated with
the MSD incident. OSHA believes that including this step in the Quick
Fix process will help employers more quickly and fully identify the
problem so they will have the chance to fix the problem within the
Quick Fix deadline.
Many commenters agreed with the importance of including employees
in the hazard identification process (see, e.g., Exs. 500-200, 500-215,
30-1100, Tr. 3565). The record consistently shows that employers with
effective ergonomics programs consult with their employees because
employees know what tasks are contributing to their MSD signs and
symptoms and because they often have the best and least expensive ideas
for solutions (Exs. 30-1100, 500-200, 500-215, Tr. 14903, Tr. 3062).
Talking to other employees who perform the same job as the injured
employee also provides employers with an opportunity to identify the
problems with the job more fully, and this, in turn, will help ensure
that the right solutions will be found to address the problem.
3. Observe the Job
Paragraph (o)(2)(iii) specifies that employers must observe
employees performing the job to identify the MSD hazards that caused
the MSD incident. This step helps to ensure that nothing has been
overlooked in the discussion with employees. In addition, as several
commenters have pointed out, often problems in jobs become readily
apparent as soon as the person responding to the report has an
opportunity to watch employees performing the job (Exs. 30-3436, 26-2,
Tr. 1038).
To provide employers with maximum flexibility in complying with
this step, paragraph (o)(2)(iii) allows employers to select the method
of job observation that works best for the conditions in their
workplace. For example, employers may simply watch employees perform
the job; videotape the job; or use a simple checklist, such as the VDT
checklist in Appendix D-2 or checklists similar to the one developed by
the Dow Chemical Company (Ex. 32-77-2-1 ). In addition, employers are
free to determine in what order they want to conduct the steps of the
Quick Fix process. Some commenters said that they observe the job first
as a way to better focus their discussions with employees.
4. Ask Employees for Solutions
Paragraph (o)(2)(iv) specifies that employers using the Quick Fix
option must ask employees in the problem job for their ideas to fix the
job. OSHA has included this step in the Quick Fix process because time
and again employers have said that their employees often come up with
the best and least expensive solutions to problems (Tr. 8725, 1160,
9508). For example, PPG stated that:
We [management] do not have to look over their shoulders to make
sure that they are implementing every--dotting every I. And it is a
successful program. Essentially, the workers run it (Tr. 3062).
This step also was included in the proposed Quick Fix. Some
commenters asked OSHA to clarify whether employers were obligated to
implement the recommendations that employees make (Ex. 30-595). The
requirement that employers ask employees for their recommendations does
not limit them to implementing only those solutions recommended by
employees. OSHA expects employers to use their judgment when responding
to employee suggestions and to select controls that will achieve the
reduction in MSD hazards mandated by the rule. OSHA notes that the
records shows that employee suggestions for ergonomic improvements are
often both practical and effective.
5. Implement Controls Within 90 Days
Paragraph (o)(2)(v) of the final rule requires employers, within 90
days, to implement measures that either:
Control the MSD hazards (i.e., reduce hazards to the
extent that they are no longer reasonably likely to cause MSDs
requiring days away, work restrictions or medical treatment), or
[[Page 68369]]
Reduce the hazards to the levels indicated in the
appropriate hazard identification tool in Appendix D.
Employers must put controls into place within 90 days of the time
the employer determines that the job meets the Action Trigger.
Employers are free to use any combination of engineering, work practice
or administrative controls to fix the job. As part of the Quick Fix,
employers must also train employees how to use the controls that have
been implemented.
Implement Controls
The proposal would have allowed employers to use the Quick Fix
option only where they could ``eliminate MSD hazards,'' which was
defined as controlling physical work activities and conditions to the
extent that an MSD was not reasonably likely to occur, which was a
higher level of control than for employers who were implementing full
ergonomics programs. Several commenters opposed the proposed Quick Fix
control endpoint, generally saying that it was either too vague to be
workable or impossible to attain (see, e.g., Exs. 30-4290, 30-3812, 30-
2208, Tr. 2998, 8394, 9182). The comment of ORC was typical of this
opposition:
One fundamental change that must be made to this provision is
the revision of the proposed requirement to eliminate MSD hazards;
the formulation is problematic and may be legally impermissible. It
is well established that employers may only be required to take
technologically and economically feasible abatement measures. The
second problem is that employers cannot be required to establish a
risk-free environment, so that to the extent that the terms
``eliminate MSD hazards and eliminate employee exposure'' suggest
that an employer must go beyond reducing the significant risk of
harm in a particular instance, these terms must be revised and
clarified (Ex. 30-3812).
OSHA believes that the changes in this provision address the
commenters' concerns. The final rule's Action Trigger helps to ensure
that employers will only have to take action in higher-risk jobs. As
mentioned in the summary and explanation for paragraph (f), jobs that
meet the Action Trigger (i.e., exceed the exposure levels in the Basic
Screening Tool) are ones that generally pose a risk of MSDs that is
three times higher than those that do not. Second, the control
endpoints employers must meet under the Quick Fix option do not require
the elimination of all risk. For example, employers will be considered
in compliance with the Quick Fix control requirement if they reduce
exposure levels to below those in Appendix B of Washington State's
ergonomics rule. The acceptable exposure levels in the Appendix B are
almost twice as high as those in the Basic Screening Tool. Thus, the
standard does not require employers to achieve a ``risk-free
environment.'' Third, the Quick Fix now contains more specific criteria
for identifying and controlling hazards so that employers more clearly
understand when a hazard is present and when they have done enough to
fix the job. Thus, the final rule is not requiring employers to take
``technologically or economically'' infeasible abatement measures.
90-day Control Time Line
The final rule continues the proposed 90-day time line for
implementing Quick Fix controls, but now specifies that the time begins
to run only after the employer has determined that the job in which the
MSD incident occurred meets the Action Trigger. Comments on the
proposed 90-day time line were mixed. Some commenters testified that
many MSD hazards can be controlled quickly (see, e.g., Exs. 30-3813,
30-3436, 32-210-2, 30-294, Tr. 13642, Tr. 2134), while others said that
controls, especially engineering controls, could not be implemented in
90 days (see, e.g., Exs. 30-3815, 30-240, 31-307, Tr. 4628, 30-3853,
30-1091, 30-1048). As a result, some commenters requested that OSHA
provide extended abatement time for employers who could not implement
Quick Fix within the allotted time frame (Ex. 30-3853).
For several reasons, OSHA believes that the Quick Fix deadline
should not be extended. First, OSHA believes that extending the
deadline negates the principle underlying the Quick Fix concept.
Second, OSHA believes that controls that take longer than 90 days to
implement indicate that the problem may be more complex than originally
anticipated, and therefore, may more appropriately be addressed in the
context of a comprehensive ergonomics program.
Third, OSHA does not believe that extending the 90-day Quick Fix
deadline is necessary, because the record shows that there are many
controls that can be implemented quickly to control or reduce MSD
hazards. Many of these are obvious and low-cost fixes that can be made
to workstations (e.g., raising or lowering work surface or chair,
placing equipment directly in front of an employee to eliminate
extended reaches or awkward postures, providing a platform or box to
stand on as a way to eliminate overhead reaching, putting reams of copy
paper under a monitor as a way to eliminate awkward neck postures),
tools or equipment (e.g., servicing of powered hand tools, changing the
way bags move on a conveyor), and work schedules (e.g., rest breaks,
job rotation, job enlargement) (see, e.g., Tr. 2147, 6510). One
participant discussed the effectiveness of these types of Quick Fix
adjustments in office environments:
If you're looking, say, at the office environment, the quick fix
situation is very often the one that's there in any case, because
you're looking at people who need improvements to their posture and
so on and so forth. And very often, the whole work environment is
already there to be adjusted. It just needs a quick-fix, which in
this case is often training and showing people how they should be
adjusting their workstation for their particular tasks. So very
often, in the office environment, the quick fix is the only way to
do it. (Tr. 2707)
The record also includes information on a wide variety of
inexpensive ``off-the-shelf'' controls and technology that can be put
into place quickly. Some of these measures include telephone headsets;
foot rests; ``anti-fatigue'' mats or other cushioned surfaces; monitor
risers; wider grips for hand tools; knife sharpeners; and carts and
other mechanical devices to assist with lifting, pushing, pulling and
carrying tasks (Tr. 3946). According to David Alexander, a certified
professional ergonomist and president of Auburn Engineers, one reason
why ``off-the-shelf'' controls can be implemented so quickly and
inexpensively is that they do not require ``custom engineering'' (Ex.
37-12). In addition, Mr. Alexander said that many of these controls can
be easily identified and purchased by looking at equipment catalogs,
calling regular vendors, contacting trade associations, and even
searching the Internet (Ex. 37-7). For example, he said that the Job
Accommodation Network, a free service offered by the President's
Commission on Employment of People with Disabilities, has ``a huge
database of specific solutions to accommodation problems,'' many of
which are also solutions to ergonomics problems, that are available to
anyone who calls the network's toll-free number (Ex. 37-12). In
addition, many other examples of quick and inexpensive fixes are in the
cost chapter (Chapter V) of the final economic analysis.
Finally, the fact that employers are free to Quick Fix hazards
using any combination of engineering, work practice and administrative
controls also supports the 90-day time line. Administrative controls,
in particular, should not take long to implement. And employers would
be free to Quick Fix jobs with administrative controls initially and
later substitute engineering controls when they become available.
[[Page 68370]]
In addition to requests for more time to Quick Fix jobs, at least
one commenter urged OSHA to delay the start of the 90-day Quick Fix
deadline until after the MSD incident has been confirmed by the
employer's HCP and perhaps even an ``independent'' HCP, the employee's
medical history has been evaluated, and diagnostic measures have been
conducted (Ex. 30-3853). Paragraph (e) already allows employers to
consult with an HCP in determining whether an MSD incident has
occurred. In addition, after that determination is made, employers have
another 7 days in which to determine whether exposure levels in the job
exceed the levels in the Basic Screening Tool before the 90-day control
time begins to run. Nonetheless, OSHA believes that, in the
overwhelming number of cases, employers rather than HCP's will make the
determination about the work-relatedness and seriousness of the
reported MSD, as they have done for years in the context of the
recordkeeping rule. Therefore, OSHA does not believe that initiation of
the control implementation deadline needs to be delayed.
Finally, one commenter asked OSHA to clarify whether the Quick Fix
option could be used in jobs that do not last for 90 days (Tr. 12179).
OSHA is not clear whether the commenter was referring to (1) the same
short duration job that is repeated (e.g., seasonal work, temp agency
work assignments) or (2) one-time job of short duration (e.g., special
project). OSHA realizes that where an MSD occurs toward the end of a
short duration job that there may be some limits on what measures the
employer may be able to take, that is, the employer may not have enough
time to fully implement either a Quick Fix or an ergonomics program.
Nonetheless, the employer must still implement those measures, such as
interim controls, that are feasible to implement during the remaining
time. (See summary and explanation for paragraph (m) for discussion of
the term ``interim controls.'') In addition, where the short duration
job is repeated on some regular or foreseeable cycle, such as seasonal
fish processing, each cycle is, in essence, a serial ``same job.'' As
such, in order for employers to use the Quick Fix option in these
situations, they will be required to have controls in place before the
next job cycle begins.
Control Training
As part of the requirement to fix jobs, paragraph (o)(2)(v) also
requires employers to train employees in jobs that are Quick Fixed so
that they know how to use the controls that have been implemented. OSHA
added this provision after commenters pointed out that Quick Fix
controls may not be successful, and therefore employees may not be
protected from MSD hazards, if they do not know how to use those
controls correctly (see, e.g., Exs. 32-339-1, Tr. 6985). In fact, a
number of employees who testified at the hearings reported that,
although they had been provided with ergonomically appropriate controls
(e.g., adjustable chairs), they had never been taught how to properly
use or adjust the controls (see, e.g., Tr. 8461).
6. Check Success of the Controls
Paragraph (o)(2)(vi) requires employers, within 30 days after
implementing Quick Fix controls, to review the job to determine whether
the measures implemented have controlled the hazards or reduced them to
the levels in Appendix D. An analogous provision also was included in
the proposed rule. A number of commenters complained that a 30-day time
line for checking the success of the Quick Fix controls was too short
(see, e.g., Exs. 31-307, 30-240, 30-3815, 30-3853, 30-2988, 30-3934,
Tr. 4628). For example, Kaiser Permanente said:
If a person has serious MSD symptoms, the symptoms may not
subside in this short time. Kaiser Permanente recommends that OSHA
modify the proposed Quick Fix deadline for elimination of the MSD
hazard to 120 days from the date of implementation of the hazard
controls.
Likewise, the Tennessee Valley Authority expressed concerns that 30
days might not be long enough to evaluate control effectiveness (Ex.
31-307).
For several reasons, OSHA believes that 30 days provides employers
with sufficient time to check up on whether the controls have been
successful. In its Elements of Ergonomics Programs, NIOSH said that
evaluations of control effectiveness should be made within 2 to 4 weeks
of control implementation. NIOSH's concern was not that 30 days was too
short a period of time for conducting post-implementation followup, but
rather with checking up on controls too quickly:
Because some changes to work methods (and the use of different
muscle groups) may actually make employees feel sore or tired for a
few days, followup should occur no sooner than 1 to 2 weeks after
implementation, and a month is preferable. Recognizing this fact may
help avoid discarding an otherwise good solution (Ex. 26-2).
At the same time, if controls are not working and the employer is
allowed to wait for an extended period of time before checking up on
the job, the injured employee's condition may worsen. Retaining the 30-
day followup helps to ensure that employers initiate further and more
comprehensive action to prevent the employee from suffering permanent
damage or disability. In any event, OSHA believes that the availability
of various tools and checklists as well as the final standard's more
clearly-defined control endpoints will make the control evaluation
process easier and quicker.
7. Keep Records of the Quick Fix
Paragraph (o)(2)(vi) specifies that employers must keep records of
their Quick Fixes for 3 years, or until replaced with updated records.
Paragraph (v), however, limits the recordkeeping requirement to
employers with 11 or more employees. This provision was included in the
proposed rule. While some commenters agreed that such records were
necessary (Ex. 30-710), several commenters opposed this requirement
(see, e.g., Exs. 601-X-1, 30-3755, 30-1019, 30-294, 30-3745, Tr. 2983,
Tr. 5758). Some said the recordkeeping requirement would be burdensome,
especially for small businesses. The Office of Advocacy of the Small
Business Administration (Ex. 601-x-1) submitted the following comment:
The Quick Fix option also limits the one small business
exemption which exists within the ergonomics program standard
proposal. This option states that an employer must keep records of
the Quick Fix controls they implement, when they are implemented and
the results of any evaluations. [The Office of Advocacy of the SBA]
strongly recommends that the language within this option be
clarified to indicate that employers with less than ten employees do
not need to keep records for any provision in the standard. Without
this clarification, the option is not a real one for small business
and will have the [effect] of mandating compliance with the total
rule for employers with less than ten employees.
Paragraph (v) of the final rule does not require employers with
fewer than 11 employees to keep records, including Quick Fix records.
Other commenters said that the recordkeeping requirement added
unnecessary complexity to the Quick Fix option. For example, Dow
Chemical Company (Ex. 30-3755) stated:
The use of this provision should be such that it encourages its
use in order to take advantage of the fact that it exempts an
employer out of the full rigors of the ergonomic program rule. To
insist on, for example, recordkeeping of the quick fix controls will
be a disincentive to its use and thus may defeat its purpose. To
require that such documentation be retained for three
[[Page 68371]]
years is absurd. [Dow] * * * suggests 45 days or until the ``quick
fix'' is implemented and results validated.
OSHA believes that records are necessary where employers substitute
one-time action for a comprehensive approach to controlling MSD
hazards. First, the Quick Fix option does not include the ``checks and
balances'' of a comprehensive program (i.e., management leadership,
employee training, and program evaluation). Second, employers who use
this option will need these records to demonstrate that the Quick Fix
process has been successful in controlling the hazards. In addition,
employers themselves need records to be able to demonstrate that they
continue to qualify for using the Quick Fix option. Finally, OSHA
believes that keeping the Quick Fix records for just 3 years will not
pose a burden for employers, especially since these employers will not
have to put resources into keeping the other records that employers who
have full ergonomics programs must maintain.
Paragraphs (o)(3) and (o)(4)
The last two provisions of the Quick Fix process provide that
employers are not required to take additional action as long as the job
hazards remain controlled or exposures do not exceed the levels in
Appendix D. As long as these control levels are maintained, employers
need only provide training in the use of the controls to new employees
who are assigned to Quick Fixed jobs. If, however, hazards cannot be
reduced to those levels within the Quick Fix time frame, or be
maintained at those levels, employers must implement an ergonomics
program in that job, i.e., if more than one MSD incident has already
occurred in the job. However, if this is the first Quick Fix in that
job, the employer would be free to repeat the Quick Fix to see if a
second effort might be more successful.
The proposed rule, on the other hand, would have adopted a ``wait
and see'' approach, requiring employers to implement a full ergonomics
program if it turned out that the controls did not eliminate the
hazards with the deadline or if another MSD occurred in the job
sometime during the following 36 months. The proposed rule would have
provided one exception to moving onto a full ergonomics program in
those cases where the second MSD incident in the job was caused by
different risk factors.
Several participants commented on this proposed provision (see,
e.g., Exs. 30-3813, 30-3815, 30-710, 30-1107, 30-494, 30-4540, Tr.
14985). Most commenters (see, e.g., Exs. 30-3813, 30-3815) argued that
the 36-month ``wait and see'' period was too long. OSHA has responded
by reducing the ``wait and see'' period to 18 months. This means that
employers continue to qualify to use the Quick Fix option if no more
than 2 MSD incidents have occurred in the past 18 months. MSD incidents
that occurred more than 18 months previously would not be considered in
determining whether the employer could continue to use the Quick Fix
option in that workplace.
MSD Management and Work Restriction Protection
Paragraphs (p), (q), (r), and (s) of the final rule set forth the
final rule's requirements for MSD management and work restriction
protection (WRP). These provisions require employers to set up a
process to manage MSD incidents when they occur. OSHA's final rule
requires that employers make MSD management available promptly to
workers in jobs that meet the action trigger whenever an MSD incident
occurs; provide this MSD management at no cost to the employee; provide
temporary work restrictions and ``work restriction protection'', and
provide a mechanism for multiple health care professional (HCP) review
when health care providers disagree about the proper course of action
the employer should take. The discussion of these sections is divided
into two parts; the first section discusses MSD management, and the
second, worker restriction protection and multiple HCP review.
MSD Management
Under the final rule, employers would be required to make MSD
management available promptly whenever an MSD incident occurs; provide
this MSD management at no cost to the employee; and evaluate, manage,
and follow-up on the MSD incident. Specifically, employers are required
by the final rule to:
promptly provide effective MSD management at no cost to
the employee,
provide employees with access to a health care provider
(HCP),
provide work restrictions the employer or the HCP find
necessary,
provide the HCP with information about MSD management and
the employee's job,
obtain a written opinion from the HCP about the MSD,
provide the employee with the HCP's opinion, and
evaluate, manage and follow-up on the MSD incident.
The final rule's MSD management provisions are quite similar to the
provisions in the proposed rule. The final rule differs from the
proposed rule section in the following ways:
MSD management is provided under different circumstances
(only when a worker has an MSD incident and the job rises above the
action trigger),
MSD management is no longer described as being for the
purpose of ``to prevent their (the employee's) condition from getting
worse'',
the employer is not required to determine the need for
work restrictions or other actions before consultation with a health
care provider,
the employer must provide slightly different information
to the health care provider,
the health care provider is not afforded a right to walk
through the employers workplace,
minor editorial changes to the numbering, language and
sequence of the requirements to simplify the sections and reduce
duplication, and
changes to the work restriction protection (WRP)
requirements reducing WRP payments from 6 months to 3 months, and
allowing the use of sick leave during the WRP period.
These changes reflect OSHA's review and analysis of the many
comments and other evidence in the record pertaining to MSD management,
which are discussed below. OSHA also asked for input on several
specific issues in Section XIV of the proposal, Issues on Which OSHA
Seeks Comment. The comments provided in response to those questions are
included in the discussion of the relevant issues below.
Is MSD Management Needed?
OSHA received many comments on the proposed MSD management section.
Many commenters generally supported the inclusion of MSD management
provisions in the standard (see, e.g., Exs. 30-626, 30-651, 30-2387,
30-3033, 30-3034, 30-3035, 30-3258, 30-3259, 30-3686, 30-3813, 30-3826,
30-4538, 30-3934, 30-4159, 30-4468, 30-4536, 30-4538, 30-4547, 30-4549,
30-4562, 30-4627, 30-4776, 30-4777, 30-4800, 31-23, 31-31, 31-43, 31-
71, 31-92, 31-105, 31-113, 31-150, 31-156, 31-160, 31-161, 31-163, 31-
186, 31-229, 31-243, 31-259, 31-301, 31-309, 31-342, 31-345, 31-347,
32-182-1, 32-210-2, 32-339-1, 32-85-3, 32-111-4, 32-133-1, 32-450-1,
30-4468, DC 75, 30-1104, L-30-4860, 37-12, 37-28).
Several commenters stated that MSD management is an essential
component of an ergonomics program. For example, Lieutenant Colonel
Mary Lopez, of the Department of Defense, reported at the hearing that
healthcare management (i.e., MSD management) is a critical
[[Page 68372]]
element in any ergonomics program (Tr. 3221, Ex. 30-3826-14, 500-218).
The 3M Company stated that ``The need for effective MSD management is
universally accepted'' (Ex. 30-3185). Dr. Robert Harrison stated that
``The medical and scientific literature and my own clinical experience
confirm that MSD management is an essential part of an ergonomics
program'' (Ex. 37-12).
Evidence in the record shows that many companies, through early
intervention and the effective management of MSDs, have achieved
substantial reductions in the number and severity of MSDs, which have
in turn, translated into less lost-work time, fewer lost-workdays,
lower costs per case, and fewer workers' compensation claims (see,
e.g., Exs. 3-56; 3-59; 3-73; 3-95; 3-113; 3-118; 3-147; 3-175; 3-217;
26-23, 26-24, 26-25, 26-26, 30-3185, 500-20-3, 500-71-84, Tr. 14357,
Tr. 14721, Tr. 17431). Representative of these comments, Dr. Colin
Baigel of the Bristol Myers Squibb Company reported at the hearing that
``[o]ne of our keys is early medical intervention with any sorts [of]
symptoms or signs of physical illness'' (Tr. 10516). He commented
further that, in his company's program, they see and evaluate employees
early, modify the workplace, and institute aggressive conservative
treatment if necessary (Tr. 10516).
North Carolina State University discussed the consequences of not
providing prompt MSD management, stating that ``I know of employees who
were ordered by a non-medical supervisor to get back to work after an
injury--in each case the lack of immediate medical care exacerbated
their conditions'' (Ex. 31-163)
Several commenters recommended that OSHA strengthen the provisions
of this section to achieve early detection and a more proactive
approach to MSD management (see, e.g., Exs. 30-626, 30-2387, 30-4583,
32-182-1, 32-339-1, L-30-4860, 500-71-86, 500-218). Many suggested that
MSD management should be triggered when an employee reports the signs
and/or symptoms of MSDs (see, e.g., Exs. 30-3686, 30-4538, 32-111-4,
32-182-1, 32-339-1, 32-210-2, 32-461-1, 32-85-3, L-30-4860). For
example, the American Public Health Association stated that MSD
management should be required for all MSDs reported to the employer
including symptoms of MSDs (Ex. 30-626). The AFL-CIO (Ex. 32-339-1)
argued that, as proposed, the MSD management provided by the proposed
standard would not achieve the goal of early detection and urged OSHA
to rely on employee reports of persistent signs and symptoms to trigger
MSD management for all jobs, rather than relying on covered MSDs to
trigger action in some jobs, as the proposal did. Others recommended
using an even more proactive, risk-based approach to trigger MSD
management, instead of waiting for an employee report of an MSD (see,
e.g., Exs. 30-626, 30-2387, 30-3686).
Several commenters supported the proposed MSD management provisions
with reservations/concerns (Ex. 30-3185, 30-3188, 30-4777). For
example, the American Occupational Therapy Association urged OSHA to
``[p]rovide guidance about the difference between treatment of a
disorder and the management of early symptoms'' (Ex. 30-4777).
Other commenters opposed the approach to MSD management taken in
the proposal (see, e.g., Exs. 30-276, 30-400, 30-1090, 30-1294, 30-
1350, 30-1357, 30-1370, 30-1722, 30-1727, 30-1989, 30-2037, 30-2208,
30-2216, 30-2435, 30-3032, 30-3167, 30-3200, 30-3284, 30-3344, 30-3368,
30-3392, 30-3677, 30-3765, 30-3845, 30-3853, 30-3867, 30-3956, 30-4040,
3-4046, 30-4185, 30-4470, 30-4499, 30-4564, 30-4567, 30-4837, 30-4839,
30-4843, 31-27, 31-77, 31-78, 31-79, 31-125, 31-135, 31-172, 31-180,
31-202, 31-220, 31-225, 31-227, 31-245, 31-246, 31-247, 31-248, 31-252,
31-253, 31-265, 31-280, 31-283, 31-286, 31-307, 31-319, 31-321, 31-337,
32-120-1, 32-300-1, 500-1-127, 500-177-2, 500-208). In a representative
comment, PPG industries recommended that OSHA
Remove these sections completely. These are very onerous
requirements and the cost estimates of OSHA for these issues do not
begin to approximate the real costs to industry to comply with these
provisions. Further, they do nothing to achieve improved ergonomics
in the workplace (Ex. 500-177-2).
Some of these commenters objected to the proposed MSD management
section because it included provisions protecting the wages and
benefits of injured workers (see, e.g., Exs. 30-240, 30-3813, 30-3765,
30-3845, 601-x-1). These comments are discussed in detail below in
conjunction with the comments received on the proposed rule's
provisions on work restriction protection. Other commenters objected
for the following reasons:
The proposed provisions exceed OSHA's legal authority
(see, e.g., Exs. 30-710, 30-1350, 30-3956, 30-1722, 30-2208, 30-3765,
30-3845, 30-3956, 30-4499, 31-319, 32-241-4);
The proposed provisions are unnecessary (Exs. 30-3677, 30-
3765, 30-4185, 500-177-2); employers already have systems in place for
medical management of all injuries (Exs. 30-3677, 30-3765, 30-4185, 31-
79, 31-321, 500-177-2);
Medical management is addressed in other OSHA standards
(1910.151 Medical services and first aid.) (Exs. 30-3765);
The proposed provisions add burden on employers (see,
e.g., Exs. 30-1294, 30-3765, 30-4040, 30-4499, 30-4564, 500-177-2), the
cost for medical assessment of illnesses is too high (see, e.g., 30-
1026, 30-1302, 30-0295, 30-1362, 30-0070, 30-0262, 30-0586, 30-0280,
30-3760), and the proposed requirements are too prescriptive (Ex. 30-
400, 30-1294, 500-177-2);
The proposed provisions are unclear about what the
employer is supposed to do (Ex. 30-3344), fails to tell an employer
when to provide access to an HCP (Ex. 32-120-1), or uses vague terms
(see, e.g., Exs. 30-2987, 30-3364, 30-3677);
The proposed provisions conflict with workers'
compensation laws (see, e.g., Exs. 30-300-1, 30-710, 30-1350, 30-1722,
30-2435, 30-2987, 30-3284, 30-3745, 30-3765, 30-3845, 30-4026, 30-4564,
30-3677, 30-4499, 31-172, 31-180, 31-220, 31-252, 32-206-1);
The proposed provisions create a preferential system for
MSDs and enforces the notion that ergonomics injuries are more
important than other injuries (see, e.g., Exs. 30-1294, 30-3765, 30-
4470, 30-4843, 31-280, 500-177);
The proposed provisions would interfere with existing
collective bargaining agreements (see, e.g., Exs. 30-3284, 30-3765, 32-
266-1);
The proposed provisions would address a problem that was,
in the opinion of these commenters, largely or exclusively non-
occupational in origin (see, e.g., Exs. 30-240, 32-241-4, 30-3167, 30-
3956, 30-3956, 30-4046, 30-4713, 32-241-4); and
The proposed provisions change the traditional
relationship between doctors, patients and employers (Exs. 30-4470) or
inappropriately inject the employer into the employee-patient
relationship (Ex. 30-4567).
In a representative comment, the Dow Chemical Company (Ex. 30-3765)
stated that (1) a management system for work-related injuries already
exists through workers' compensation laws, (2) the proposal may
conflict with some collective bargaining agreements, and (3) a special
work restriction protection is not warranted for MSDs because of their
multifactorial nature. The Anheuser-Busch Companies, Inc. and United
Parcel Service, Inc. added ``[t]he proposed rule is doomed to fail as a
result of its exclusive focus on
[[Page 68373]]
workplace activity'' i.e., on the work-related rather than non-
occupational causes of MSDs (Ex. 32-241-4, p. 182).
The proposed rule would have required employers to provide injured
employees with prompt access to an HCP, when necessary, for evaluation,
management and follow-up. OSHA has reconsidered the issue, and now
believe that any MSD incident is serious enough to warrant MSD
management.
Several commenters recommended that OSHA require an employer to
refer an employee with complaints or signs or symptoms of an MSD to a
HCP for evaluation, management, and follow-up immediately, rather than
``when necessary,'' as proposed (Exs. 30-651, 30-3826, 30-3686, 30-
2387, 30-4468, 32-339-1, 32-111-4, 32-182-1, 30-4538, 32-210-2, 32-461-
1, 32-85-3, 32-210-2, 32-450-1). For example, the United Food and
Commercial Workers (UFCW) argued that having every worker assessed
initially by an HCP would resolve many issues raised by the proposal,
such as ``when to refer the employee to the HCP,'' ``follow-up,'' and
``deciding appropriate work restrictions'' (Ex. 32-210-2). The American
Association of Occupational Health Nurses (AAOHN) (Ex. 30-2387)
commented that ``[e]mployers should automatically be required to refer
employees with MSD complaints to health care professionals for
evaluation and determination about physical capabilities and work
restrictions. Most employers are not qualified to make this
determination.'' The AAOHN also stated that ``[d]ecisions related to
signs and symptoms of MSD[s] and placement of temporary work
restrictions should be made by a health care professional'' (Ex. 30-
2387). Some commenters stated that the phrase ``when necessary'' was
unclear, confusing, and vague (Exs. 30-2987, 30-3782, 30-3826, 30-
3845). Other commenters, however, agreed with the ``when necessary''
language, on the grounds that it gave the employer the flexibility to
decide when an employee needs to be referred to an HCP (see, e.g., Exs.
30-3813, 30-4467, 32-300-1).
OSHA has deleted the ``when necessary'' language from the final
rule. The final rule only applies to specific injuries (those with
restrictions, medical treatment, or persistent signs and symptoms) and
OSHA finds that these injuries should always be followed by medical
management, including access to an HCP. This change clarifies the final
rule and assures prompt medical management for employees who need it.
Several commenters recommended alternative approaches to MSD
management. The Pinnacle West Capital Group suggested OSHA simply leave
MSD management to the employers discretion (Ex. 30-3032). PPG
Industries suggested that OSHA only require an employer to have in
place a system that focuses on early intervention (Ex. 30-1294).
Ashland Distribution Co recommended OSHA:
[d]elete [the] last sentence of 1910.919 and [the] remainder of
MSD management, and add ``You must make MSD management available
promptly whenever a covered MSD occurs. You must provide MSD
management at no cost to employees. A health care professional
should be involved in MSD management when necessary'' (Ex. 30-4628)
(see also Ex. 31-337).
In the final rule, OSHA has decided to carry forward the MSD
management provisions of the proposed rule with only minor
modifications. The MSD management provisions of the final rule
emphasize the prevention of impairment and disability through prompt
evaluation and management of MSD incidents, evaluation by a health care
provider, provision of needed work restrictions, and appropriate
follow-up. The provisions are included because successful ergonomics
programs include MSD management, OSHA has had successful experience
with including MSD management as part of an ergonomics program
agreement with employers, and OSHA therefore believes that MSD
management is essential to the proper functioning of an ergonomics
program.
The MSD management provisions of the final rule are based on the
many successful ergonomics programs that include policies for the
medical management of MSDs, and the final rule contains provisions
similar to those in such programs (see, e.g., Exs. 26-2, 32-450-1). The
MSD management provisions of the final standard are thus built on the
processes that employers with effective ergonomics programs are using
to help employees who have work-related MSDs.
MSD management is recognized by employers, HCPs, and occupational
safety and health professionals as an essential element of an effective
ergonomics program (see, e.g., Exs. 26-1, 26-5, 26-1264, 32-450-1, 30-
4468, 37-12, 37-28). Among employers who have told OSHA that they have
an ergonomics program, most reported that their programs include MSD
management as a key element (see, e.g., Exs. 3-56; 3-59; 3-73; 3-95; 3-
113; 3-118; 3-147; 3-175; 3-217; and Exs. 26-23 through 26-26, 500-71-
84). This approach is also supported by the scientific literature
concerning ergonomics as evidenced by the comments of Robin Herbert, MD
(Ex. 37-28):
The MSD [proposed] management provisions are consistent with
approaches enumerated in a number of medical textbooks and peer-
reviewed papers * * *. The MSD management section recommendations
would be likely to diminish the severity of, and, consequently, the
disability and suffering associated with, MSDs.
The final rule's MSD management provisions are also based on OSHA's
experience with ergonomics over the last 15 years. For example, MSD
management provisions were included in OSHA's 1990 Ergonomics Program
Management Guidelines for Meatpacking Plants (Ex. 26-3). In addition,
MSD management provisions have been included in all of OSHA's corporate
settlement agreements addressing MSD hazards. In a 1999 workshop to
discuss the experience of companies with corporate wide settlement
agreements, the companies who were involved stated that ``[q]uality
healthcare is a must'' for an ergonomics program, and ``[g]ood medical
management allows early reports and reduces surgeries'' (Ex. 26-1420).
Further, to become a member of OSHA's Voluntary Protection Program,
employers are required to include ``Occupational Heath Care Program''
provisions in their safety and health programs that address MSDs and
their management, along with other health hazards.
There are many reasons why MSD management is essential to the
success of an ergonomics program. As mentioned above, MSD management
emphasizes the prompt and effective evaluation and management of MSD
incidents, with appropriate follow-up for the injured employee. When
MSD incidents are managed effectively, they are more likely to be
reversible, to resolve quickly, and not to result in disability or
permanent damage. MSD management also helps to reduce the overall
number of MSDs in a given establishment because it alerts employers to
MSD hazards in their jobs so that they can take action before
additional problems occur. An MSD management process that encourages
early reporting and evaluation of that first MSD helps to ensure that
the analysis and control of the job is accomplished before a second
employee on that job develops an MSD. MSD management thus reduces MSDs
through prevention. In addition, MSD management helps to prevent future
problems through the development and communication of information about
the occurrence of MSDs to employees.
[[Page 68374]]
Finally, where engineering, design and procurement personnel are
alerted to the occurrence of MSDs, they can help to implement the best
kinds of ergonomic controls: those that engineer out MSD hazards in the
design and purchase phases and thus prevent MSD incidents from
occurring.
The final rule does not require the employer to provide MSD
management for all MSDs, but only requires MSD management for MSD
incidents that occur to a worker in a job that exceeds the action
trigger. This helps to assure that MSD management is only required for
work-related MSDs, and that non-occupational MSD cases are excluded.
The final rule does not require the employer to take any action for
non-work-related MSD cases. The only obligation may be to determine the
work-relatedness of an MSD report from an employee to make sure that
the MSD is non-occupational, but no other action is required.
Requiring MSD management only for MSD incidents, as defined by the
final rule, also makes sure that the MSD is a more serious case, and
that MSD management, as well as the other elements of an ergonomics
program, are not being required for cases that involve only minor pain
or soreness but are being provided for disorders that need treatment
and cases with persistent signs or symptoms. Requiring MSD management
under these circumstances also makes sense because all of the program
elements are initiated with the same implementing mechanism; requiring
MSD management without the other elements of an ergonomics program
would be inconsistent and ineffective.
The final rule requires MSD management for all MSD incidents when
the worker's job exceeds the action trigger. OSHA has eliminated the
phrase ``when necessary'' so the MSD management provisions apply to all
MSD incidents. If an MSD has resulted in days away from work,
restricted work, or medical treatment, and the employee's job exceed
the action trigger, there is no further reason for delay. MSD
management is clearly needed for these MSDs, and the final rule
requires it. The final rule does not mandate MSD management for MSDs
that do not rise to that level. For other incidents, the employer will
have to make a decision about what MSD management actions are
appropriate, but the final rule does not require them.
OSHA also believes that the final rule strikes the necessary
balance between being too prescriptive and too vague. The provisions of
OSHA's standard 29 CFR 1910.151 Medical services and first aid merely
require the employer to ``ensure the ready availability of medical
personnel for advice and consultation on matters of plant health'' and
do not provide sufficient guidance for the effective management of MSD
incidents. Likewise, simply leaving MSD management to the discretion of
the employer, or including a simple reference to provide MSD management
``when necessary'' would not provide enough guidance for employers,
health care professionals, or workers. At the same time, the final
rule's provisions requiring employers to provide access to a health
care professional, provide work restrictions, and generally evaluate,
manage and follow-up on an MSD incident provide the flexibility needed
for the variety of MSD cases that employers will encounter. An employee
who has suffered a severe back injury from lifting a heavy object and
is experiencing agonizing pain and an inability to function may need
immediate treatment in an emergency room, while a worker who is
experiencing a gradual worsening of pain in the wrists may require
prompt (but not immediate) treatment by a specialist.
OSHA finds that the arguments that the rule changes the traditional
relationship between doctors, patients and employers (Exs. 30-4470) or
inappropriately injects the employer into the employee-doctor
relationship (Ex. 30-4567) are without merit. Employers have, for many
years, experienced a relationship with the medical community in regards
to employees work and non-work related injuries and illnesses.
Employees commonly obtain written notification from a physician to
explain time off of work for personal illness. Employers frequently
consult with a health care provider when an employee is injured or
becomes ill at work, to determine appropriate time off, restrictions or
medical treatment, and the requirements of the final rule are not much
different. Employers also consult with health care professionals when
they contest workers' compensation claims, during tort litigation, or
when implementing reasonable accommodations for disabled persons as
required by the Americans with Disabilities Act (ADA).
Finally, OSHA believes these requirements are needed to make sure
that employees get the medical attention they need. As the Thermoquest
Corporation stated:
[i]f there are no clear guidelines, many employers may not allow
an employee to seek medical help for various reasons. Also to leave
it up to the employee when to see a physician allow for employee
abuses. The difficulty lies in getting the injured employee the
treatment they need in a timely manner (Ex. 31-301).
OSHA's responses to the comments that the MSD management provisions
exceed OSHA's legal authority, affect workers' compensation, or impact
collective bargaining agreements are addressed in the section of this
preamble dealing with worker removal protection.
Who Provides MSD Management Services?
The preamble to the proposed rule explained that the proposed
ergonomics rule would have permitted ``persons in the workplace and/or
HCPs'' to provide injured employees with evaluation, management, and
follow-up in connection with the MSD management process (64 FR 65838).
The regulatory text required that an employer provide access to a
health care professional for evaluation, management and follow-up
``when necessary'' (64 FR 66073).
Many commenters (see, e.g., Exs. 30-3826, 30-2387, 32-450-1, 32-
210-2, 30-2806, 30-4468) argued that the inclusion of individuals
without medical training and experience in the MSD management process
was inappropriate. For example, the American Association of
Occupational Health Nurses (AAOHN) strongly disagreed with the
proposal's use of the phrase ``or other safety and health professionals
as appropriate'' in the MSD management process on the grounds that
assessing, providing prompt management/treatment to, and following-up
individuals with medical problems are clearly activities within the
scope of health care professionals' professional licenses but are not
included in the scope of practice of other safety and health
professionals. The AAOHN stated that ``[i]t is imperative that the
standard not enable non-licensed individuals to make health assessments
and provide health care services without a professional license'' (Ex.
30-2387).
The National Institute for Occupational Safety and Health (NIOSH)
noted that, although the institute supports ``[e]mployers' efforts to
train employees in the early signs and symptoms of MSDs and to seek HCP
evaluation when appropriate,'' it ``recommend[s] that the standard
preclude non-HCPs and non-licensed HCPs from conducting medical
evaluations.'' In addition, NIOSH noted that, the institute
``[s]upports OSHA's proposal that permits the MSD management programs
to be administered by a variety of licensed HCPs as defined (in the
proposal's
[[Page 68375]]
definition section). However, [it] recommend[s] that the clinical
aspects of the program (medical evaluations of symptomatic workers) be
performed by licensed HCPs under the supervision of HCPs licensed for
independent practice (including physicians, and nurse practitioners and
physicians' assistants in those states where they are so licensed)''
(Ex. 32-450-1). Other commenters (see, e.g., Exs. 30-3826, 32-210-2,
30-4468, 30-2806) agreed that evaluating an employee's complaint of an
MSD or assessing the physical capabilities of the employee to return to
work or his or her need to rest the injured part may require expertise
that an employer or other safety and health professional does not have.
The American College of Occupational and Environmental Medicine
(ACOEM) noted that ``[i]f MSD signs are to be included as part of the
triggering event, the employee must be examined by a physician with
training in medical diagnosis'' (Ex. 30-4468). The ACOEM expressed
concern that ``flexibility'' in allowing non-HCPs to evaluate employee
reports of signs and symptoms ``[w]ould result in employers--who are
not likely qualified--making assessments or diagnoses. * * * Therefore,
ACOEM recommends that the determination of a recordable MSD be made by
a qualified occupational healthcare professional'' (Ex. 30-4468).
The United Food and Commercial Workers (UFCW) agreed that HCPs,
rather than others, should conduct MSD management, arguing that the
OSHA proposal failed to require that an HCP make the initial assessment
of the worker's condition, a crucial element of MSD management in the
union's view. UFCW stated that ``[a]ll successful programs that we have
experience with have this core element'' (Ex. 32-210-2). The UFCW
emphasized this point by stating that, in corporate wide settlement
agreements (CWSAs) between companies and OSHA, ``OSHA and the industry
recognized that lay persons were not capable of assessing symptomatic
employees'' (Ex. 32-210-2). Arguing along similar lines, the American
Association of Orthopaedic Surgeons (AAOS) commented that ``[i]t is
inappropriate to ask the employee and employer to diagnose the
employee's problem and determine if it is or is not related to work and
deserving of further attention from the employer'' (Ex. 30-2806). In
her testimony, Mary Foley, President of the American Nurses Association
(ANA), strongly encouraged:
OSHA to require that employers place the responsibility for
evaluating MSDs with the licensed healthcare providers. Evaluating
signs and symptoms and determining whether an injury has occurred is
the responsibility and within the scope of practice of licensed
health care providers. The supervisor and worker relationship is not
a relationship that should involve or appropriately involves
diagnosing physical injuries. If the employer erroneously decides
that a covered MSD has not occurred, continuing to perform the
hazardous job would result in a delay in evaluation and treatment,
and could intensify the injury or seriously compromise the recovery,
permitting managers and supervisors to assume these activities,
place the employer and/or manager at risk of litigation for
practicing medicine without a license or for denying medical
attention to an injured person (DC 5/8/2000, Tr. 15884).
The final rule requires the employer to provide MSD management to
employees who have suffered an MSD incident, if they are employed in a
job that rises to the level of the action trigger, including prompt
access to an HCP. OSHA agrees with these commenters that non HCPs
should not provide medical services appropriately reserved to a health
care professional. The final rule does not allow a non-HCP to provide
medical services, and it was never OSHA's intent in the proposal to
allow a non-HCP to provide medical services that are only appropriate
to an HCP. Oftentimes, an HCP will have been involved in the MSD case
well before the final rule requires MSD management, while the employer
is determining the work-relatedness of the MSD case, and because the
MSD incident, by definition, must involve days away from work,
restricted work, medical treatment, or persistent signs/symptoms before
it is covered by the MSD management provisions.
However, there are circumstances where an employer may provide a
worker with work restrictions before consultation with an HCP. In some
cases, the restrictions may be obvious. For example, if an employee
injures his or her back, limiting the lifting the employee is required
to perform is a logical action to take. In other instances, the
employer may have had experience with similar MSD cases in the past,
and the types of restrictions that are needed are familiar to the
employer. In the situation where the employer knows what restrictions
may be necessary, the final rule requires the employer to provide such
restrictions. Providing restrictions even before consultation with an
HCP can provide relief to the employee, reduce the severity of the
case, and begin the healing processes at an earlier stage.
The Definition of Health Care Professional
The final rule and the proposal define health care professionals as
``physicians or other licensed health care professionals whose legally
permitted scope of practice (e.g. license, registration, or
certification) allows them to independently provide or be delegated the
responsibility to provide some or all of the MSD management
requirements of this standard.''
Several commenters supported the proposed definition of ``HCP''
(see, e.g., Exs. 3-73, 30-519, 30-2387, 30-2807, 30-3745, 30-3748, 30-
3813, 30-4567, 30-4844, 32-85-3, IL-182). For example, the Rural/Metro
Corporation (Ex. 30-519) stated that the definition of HCP in the
proposal was appropriate because OSHA should not attempt to decide
scopes of practice for HCPs. The AAOHN (Ex. 30-2387) stressed that a
``[k]nowledgeable health care professional, practicing within their
legal scope of practice, establishes procedures, or consults with the
employer in the establishment of procedures, to determine what is to be
done when an employee reports a MSD or persistent MSD symptoms.'' In
her testimony for the AAOHN, Sandy Winzeler stated:
It is appropriate for OSHA to recognize the roles that different
health and safety disciplines play in health and safety programs. *
* * Each discipline has a unique contribution to make to the
program; in this case, the prevention and management of MSDs. It is
only through such collaboration that we are successful. However, it
is inappropriate for OSHA to include language in a standard that
would restrict the practice of any health care professional. As you
are aware, health care professionals are regulated by the States.
The current language used in the proposal defers to State law in
determining whether the individual can fulfill the requirements
under their licensed scope of practice, and AAOHN supports this.
Over half of the States permit nurse practitioners to practice
independently without any requirement for physician supervision or
collaboration. This includes the ability to make independent medical
diagnosis. Registered nurses often work in collaborative
arrangements with physicians especially in the occupational health
setting. It is impractical to expect that a physician will be on
site and available to evaluate every employee, and in fact, it is
usually the occupational health nurse that is on the front line, at
the work site, working with employees every day. OSHA should
recognize the important role that nurses play and by no means should
limit our ability to fully practice within our legally defined scope
[DC 3/29/2000, Tr. 5588-5590].
The American Physical Therapy Association (APTA ) also expressed
support for ``OSHA's recognition of
[[Page 68376]]
licensed nonphysician providers'' and noted that ``[o]ther Federal
programs, such as Medicare, defer to the states to determine licensure
and scope of practice of the providers that participate in the
program'' [30-3748].
Other commenters urged OSHA not to limit employers' choice of HCPs
to specialists, who are often not available in reasonable proximity,
which would delay prompt evaluation, management, and follow-up and make
it much more costly (Ex. 3-73, 36-1370, 30-3745, IL-182). For example,
the American Feed Industry Association, whose members have facilities
in rural areas, expressed concern that the medical profession in a
rural area may not have the expertise to deal with work-related MSDs,
and pointed out that compliance could be a problem if the standard
stipulated that the HCP have a specific background (Ex. 3-73, 30-3745,
IL-182).
Other commenters opposed the proposed definition (see, e.g., Exs.
30-494, 30-991, 30-2208, 30-3004, 30-2208, 30-2676, 30-4468, 30-4699,
30-3749, 30-3783, 30-3781, 30-3937, 30-4025, 30-4467, 30-4538, 30-4843,
32-22-1, 32-339-1, 32-111-4, 32-182-1, 32-210-2, 32-300-1, 32-461-1).
Many of these commenters held the opinion that the definition was too
broad (see, e.g., Exs. 30-991, 30-2208, 30-3004, 30-2208, 30-4468, 30-
4699, 30-3749, 30-3783, 30-3781, 30-3937, 30-4025, 30-4467, 30-4538,
30-4843, 32-22, 32-339-1, 32-111-4, 32-182-1, 32-210-2, 32-300-1, 32-
461-1). The comments of the Combe Inc. company are representative:
``[b]y allowing persons who do not even have a medical degree to
diagnose and treat these disorders, the proposed standard creates an
environment where the potential for misdiagnosis and improper treatment
efforts is dramatically increased'' [Exhibit 30-3004]. The Center for
Office Technology pointed out that because the definition is so broad,
it could include occupations such as emergency medical technicians or
licensed vocational nurses who would not be the appropriate
professionals to make decisions with respect to MSDs [Ex. 30-2208]. The
New Mexico Workers' Compensation Administration argued that a massage
therapist could render an opinion on MSDs (Ex. 32-22).
A number of commenters recommended OSHA limit HCPs to physicians,
nurse practitioners, or physician's assistants (see, e.g., Exs. 32-339-
1, 32-111-4, 32-182-1, 30-4538, 32-210-2, 30-4468, 30-4699, 32-450-1,
30-2806, 32-300-1). Others advised that HCPs be limited only to
physicians [Exhibit 30-351, 30-3749, 30-3344]. Several commenters
acknowledged OSHA's attempt to reduce the cost of the standard, but
noted that fact finders rely heavily upon treating physician's opinions
when litigating causation issues under the various worker's
compensation laws (Exs. 30-3749, 30-3344, 30-4674).
Other commenters argued that the ergonomics rule should require
HCPs to have specific training (see, e.g., Exs. 30-626, 30-3032, 30-
4467, 30-4538, 32-339-1, 30-4468, 30-2806, 30-3934, 30-3745, 30-3937,
32-300-1). For example, the law firm of Morgan, Lewis and Bockius
argued that HCP's not specifically trained in musculoskeletal disorders
would not be able to make accurate diagnoses and that HCPs without MSD
specific training ``[m]ight actually irritate conditions or prescribe
incorrect treatments, or impose unwarranted obligations on employers'
(Ex. 30-4467). The International Association of Drilling Contractors
(Ex. 30-2676) commented that ``According to a recent medical
publication, 82% of medical school graduates failed a valid
musculoskeletal competency examination. (The Journal of Bone and Joint
Surgery, Vol. 80-1, No. 10, October 1998, pp. 1421-1427)'' to argue
that ``This startling statistic makes one question how a general
physician may properly diagnose a MSD'' and the ``[i]nclusion of other
fields under its [OSHA's] definition of HCP is all the more
unacceptable''. However, the International Association of Drilling
Contractors did not submit a copy of the article into the rulemaking
docket, so OSHA is not able to fully evaluate the journal article. It
appears to be a competency examination for a specialized medical field,
and it is unclear that the examination uses the same definition of
musculoskeletal disorder as OSHA's rule, so OSHA does not believe that
the article provides evidence contrary to the final rule's definition
of HCP.
Several commenters encouraged OSHA to define the specific
competencies an HCP should acquire to be qualified to screen, diagnose
and manage MSD cases (see, e.g., Exs. 30-2806, 32-182-1, 32-300-1). For
example, the American Association of Orthopaedic Surgeons (Ex. 30-2806)
found OSHA's proposed definition to be incomplete, and suggested the
ergonomics rule include a requirement to use HCPs who are ``[h]ighly
trained and qualified'' and who are ``[k]nowledgeable in the assessment
and treatment of MSDs'' to ensure appropriate evaluation, management
and follow-up of workers' MSDs.
The American College of Occupational and Environmental Medicine
(ACOEM) recommended the definition of health care professional be
changed to ``occupational physicians or other licensed occupational
health care professionals'', focusing on the HCP's training and
competencies in occupational medicine. ACOEM recognized the important
role of non-physicians such as nurses, physician's assistants, and
other health care providers, but argued that the healthcare provider
must be able to perform four basic functions to perform the duties of
an HCP required by the proposed ergonomics standard:
(1) Make independent diagnoses (which is usually limited to
physicians, except in those states where nurse practitioners and
physician assistants are licensed for independent practice);
(2) Conduct an appropriate physical exam,
(3) Order appropriate treatment, and
(4) Be able to relate musculoskeletal findings to work activities
(which requires an understanding of basic epidemiology).
ACOEM further argued that OSHA's definition was questionable
because other federal agencies have refused to adopt OSHA's definition
of a ``licensed health care professional'' used in other standards.
AECOM cites as examples, a NIOSH policy statement on respirator use, as
well as the Department of Energy (DOE) rule on Beryllium. AECOM also
cited the variability of state health care licensing laws as a reason
for restricting the definition, and that state scope of practice laws
were ``never intended to be the mechanism to protect a worker from a
toxic, carcinogenic, or biological exposure in the workplace'' [Exhibit
30: 4699].
The National Institute for Occupational Safety and Health (NIOSH)
[s]upports OSHA's proposal that permits MSD management programs
to be administered by a variety of licenced HCPs * * * However, we
recommend that the clinical aspects of the program (medical
evaluations of symptomatic workers) be performed by licensed HCPs
under the supervision of HCPs licensed for independent practice
(including physicians, and nurse practitioners and physician's
assistants in those states where they are so licensed) (Exhibit 32-
450-1).
In the final rule, OSHA has carried forward the definition from the
proposed rule:
Physicians or other licensed health care professionals whose
legally permitted scope of practice (e.g. license, registration or
certification) allows them to independently provide or be delegated
the responsibility to provide some or all of the MSD management
requirements of this standard.
[[Page 68377]]
The final rule's definition of HCP is desirable for several
reasons. Perhaps most important is that the HCP definition provides
employers with the flexibility needed to assure that injured employees
receive ``prompt and effective'' MSD management. Specialists and
occupational physicians are not always readily available, and the rule
allows the employer to consult health care professionals with these
qualifications when needed, but does not require the employer to seek
them out for each and every case. In some rural locations, access to
specialized HCP's may be limited, and even in more urban settings, it
may take significant time to get an appointment for an employee to see
a specialist. If the employee can see a physician in general practice
promptly, this may be the better option. Likewise, if an employer has
an occupational health nurse, the nurse can provide services
immediately and avoid delay.
Each MSD case also requires its own level of occupational health
services. In some cases, a registered nurse or physician's assistant
may be able to recommend restrictions and conservative treatment and
resolve the problem. In other cases, the services of a physician or a
medical specialist may be needed to treat the employee. The final rule
does not restrict the employer's option to obtain more specialized
services, and it is a common practice for HCPs to refer cases needing
more specialized care to more qualified HCPs. OSHA sees no reason why
this system will not continue to function as well as it has in the
past.
The HCP definition is consistent with many of OSHA's health
standards. In its most recent health standards (e.g., respiratory
protection, methylene chloride, proposed tuberculosis rule) the Agency
has relied on a broad definition of HCP, to allow HCPs to carry out any
of the regulatory requirements specified in a given standard, provided
that the medical function performed is within their scope of practice,
licensure, or certification. OSHA has not noted any significant
problems with the definition in employers implementation of these
standards, the definition appears to be working as intended, and OSHA's
broad definition of HCP published in the respiratory protection
standard has been upheld in the courts (American Iron and Steel
Institute v. OSHA, 182 F.3d 1261 (11th Cir. 1999)). In addition,
consistency from standard to standard is a desirable feature that makes
it easier for employers and workers to understand and follow the
standards.
The definition also relies on the licensing requirements imposed by
the states. As stated in the proposal (FR 65842), OSHA believes that
issues of HCP qualifications and scope of practice are properly
addressed by State law and professional organizations. The states have
been regulating medical practice for quite some time, and appear to be
doing so effectively, so there is no reason to interfere with the
licensing procedures the states have implemented. Relying on the state
requirements will assure that unqualified or inappropriate individuals
do not provide medical services beyond their training and
qualifications, and the state licensing boards can continue to handle
cases where improper treatment is provided or improper actions are
taken.
The final standard does not contain diagnostic or treatment
protocols. OSHA believes this is an area for the health care
professions to recommend. Also, because standards of care change over
time, it is the responsibility of the treating health care professional
to select treatments in accordance with current acceptable standards of
practice. NIOSH supports OSHA's ``[d]ecision not to include particular
diagnostic tests, treatment protocols, and clinical case definitions in
the MSD management section, or anywhere else in the ergonomic standard.
Standards of care change over time, evolving with new research,
technological innovations, and new therapies. To allow workers to be
provided with current, state-of-the-art clinical care, OSHA is correct
to leave diagnostic and therapeutic decisions to HCPs and their
professional organizations'' [Ex. 32-450-1].
Who Selects the Health Care Professional
Some commenters raised the question of whether the employer or the
employee get to choose the health care professional providing services.
The American Apparel Manufacturing Association remarked
OSHA has also failed to address the issue of choosing doctors.
In some states, patients have the right to choose their own
physicians. In other states, employers choose the doctors. Does the
employer choose the HCP under the proposed federal rule, or could
employees choose a doctor who will diagnose an MSD without real
cause and expose companies to possible fraudulent actions? Does the
proposed law supercede state laws in those states where the patient
may choose? (Ex. 30-4470)
Several commenters recommended that OSHA specify in the standard
that the employer has the right to choose the physician (see, e.g. Exs.
30-3188, 30-3284, 30-4301, 30-4467, 30-4564, 30-4607, 32-300-1, 32-337-
1) In a representative comment, Southern California Edison argued that:
Since the employer is required to follow the HCP's advice, the
employer must be able to trust the diagnosis. However, not all
healthcare providers are qualified by training or experience to
evaluate, treat and provide restrictions for musculoskeletal
disorders. If the employee is permitted to select the healthcare
provider, as they are allowed by some states' workers' compensation
laws, they may not select the provider that will have the time or
experience to work with the company in determining appropriate
restrictions (Ex. 30-3284).
Another group of commenters recommended the opposite, that the
employee should be allowed to select the physician (see, e.g. Exs. 30-
3033, 30-3034, 30-3035, 30-3258, 30-3259, 30-4159, 30-4536, 30-4547,
30-4549, 30-4562, 30-4627, 30-4776, 30-4800, 31-242). A form letter
submitted by a number of individual employees made several arguments,
including ``[t]he HCP must be one of the employee's choosing, not the
employer's (or insurance company's) choosing. Otherwise, a biased
opinion may result, and the employee's condition can easily worsen'';
that general practitioners ``are often the HCPs that are chosen by the
employer or insurance company to diagnose work-related injuries under
the Workers' comp system. It is common to underestimate the seriousness
and long term consequences of MSD injuries, and consequently, not
enough temporary work restrictions are recommended''; and ``HCPs chosen
by someone other than the employee may be biased in favor of the
employer or insurance company in order to obtain future referrals''
(Ex. 30-3332).
The comments from both employers and employees show a large measure
of distrust for health care professionals selected by either. It is for
this reason that the final rule includes provisions for multiple HCP
review. It is OSHA's view that, when the employer provides access to an
HCP under the final rule, the employer has the right to select the HCP.
However, the employee has a right to a second opinion if he or she
disagrees with the employer selected HCP, under the provisions of
paragraph (s). A more detailed discussion of HCP selection is contained
in the discussion of multiple HCP review.
``Prompt'' MSD Management
The proposal would have required employers to respond promptly to
the reports of employees with MSDs, and the final rule includes similar
language. Whenever an employee reports an MSD,
[[Page 68378]]
the key is to take action quickly to help ensure that the MSD does not
worsen. Many commenters agreed that early reporting and prompt response
were the key to resolving MSD problems quickly and without permanent
damage or disability [Exs. 30-4468, 32-78-1, 32-85-3, Tr., p 10516).
For example, the American College of Occupational and Environmental
Medicine (ACOEM) remarked that ``[e]mployers should ensure that injured
employees are provided with `prompt access to health care professionals
or other safety and health professionals as appropriate.' The early
reporting and intervention process is important to the effectiveness of
a medical management program'' (Ex. 30-4468). Other commenters argued
that the first response to any report of MSD should be evaluation by a
health care professional (Exs. 30-651, 30-3826, 30-3686, 30-2387, 30-
3748, 30-4468, 32-339-1, 32-111-4, 32-182-1, 30-4538, 32-210-2, 32-461-
1, 32-85-3, 32-210-2, 32-450-1).
Some commenters stated that ``promptly'' was vague and ill defined,
questioning what the term ``promptly'' meant in the provision directing
employers to respond to employee reports (see, e.g. Exs. 30-115, 30-
2208, 30-33336, 30-3354, 30-3845, 30-3848, 30-4540). Bruce Cunha RN MS
COHN-S (Ex. 31-303) stated that ``Five days should be adequate time to
start the management process. If it is enough time to arrange a visit
with a health care professional is questionable. Since OSHA allows the
employer to choose the health care provider, it should be expected that
it may take longer than 5 days to get an appointment.''
The final rule requires the employer to provide ``prompt'' MSD
management. The term ``prompt,'' as used in this paragraph, means as
soon as possible or within a reasonable period of time, consistent with
the apparent severity of the MSD or with other conditions (e.g.,
accessibility of medical care). OSHA believes, as the proposal
discussed, that employers will almost always be able to provide MSD
management within a one to five day window (64 FR 65840). Action within
this interval will generally prevent the employee's condition from
becoming more severe.
In the final rule, OSHA has provided clear guidance that prompt is
one week. Paragraph (x), Table 2. Compliance Time Frames states that
MSD management must be initiated within 7 calendar days after the
employer determines that a job where an employee experiences an MSD
incident meets the action trigger. OSHA finds that one week is more
than enough time to initiate MSD management, select an HCP, and set an
appointment for the employee to see an HCP.
In some workplaces, an occupational health nurse is available to
take reports of MSDs, and in this case MSD management begins
immediately, so promptness is not an issue. In most cases, however,
employers will not have an on-site HCP, since smaller workplaces make
up the overwhelming majority of all workplaces. In such cases, OSHA is
aware that it may take a few days to arrange an appointment with an
HCP. There are circumstances, however, where immediate evaluation by an
HCP is warranted. For example, an employee experiencing severe shoulder
pain with numbness down her arm, an inability to sleep due to pain, and
decreased range of motion of the arm and shoulder should immediately be
referred to an HCP.
Prompt MSD management helps limit further exposure to the MSD
hazard or hazards associated with the employee's job helps to ensure
that the employee's condition does not worsen while the employer
analyzes the problem job and makes workplace changes to correct the
hazard.
Providing MSD Management at no Cost to Employees
Both the proposed rule and the final rule require the employer to
provide MSD management at ``no cost to employees.'' The requirement to
provide MSD management at no cost drew little comment. Some commenters
supported the no cost clause (see, e.g., Exs 30-4536, 30-4547, 30-4549,
30-4562, 32-78-1). Vicorp Restaurants asked OSHA if the employer is
required to pay even if the report is ultimately determined to be
frivolous, exaggerated, or fraudulent (Ex. 30-3200). Other commenters
argued that the cost for medical assessment of illnesses is too high
(see, e.g., 30-1026, 30-1302, 30-0295, 30-1362, 30-0070, 30-0262, 30-
0586, 30-0280, 30-3760). A few commenters suggested that OSHA clarify
that ``at no cost'' doesn't include loss from production based pay and
bonuses (Ex 30-3354, 30-3848, 30-4530, 30-4799).
As OSHA explained in the preamble (64 FR 65841) the term ``at no
cost to employees'' includes making MSD management available at a
reasonable time and place for employees (i.e. during working hours) and
that the term no cost is interpreted in the same way as OSHA's other
health standards. If an employee's MSD report is found to be
fraudulent, then the employer is not required to pay for MSD
management. A fraudulent claim would be one that is found to be non-
work-related, and MSD management is only required for work-related MSD
incidents. These wages would not include production bonuses or other
premium payments, but for workers who are paid on a piecemeal basis,
the employer must assure that the employee would not lose pay by
visiting an HCP. This can easily be accomplished by paying the worker
the average piecemeal rate he or she had been earning.
OSHA recognizes that MSD management imposes costs on employers, and
these costs are reflected in the economic analyses for the final rule.
However, if employees were made to absorb the costs of MSD management,
they would be less likely to report MSDs to their employer, which would
have a detrimental effect on the overall functioning of the rule.
Follow-up
The final rule, as did the proposal, requires that the employee
receive appropriate follow-up during the recovery period. Follow-up is
defined as the process or protocol the employer, safety and health
professional, or HCP uses to check up on the condition of employees
with covered MSDs when they are given temporary work restrictions or
removed from work to recover.
OSHA received very little comment specific to follow-up. The
Southern California Edison company stated that the proposed rule:
[p]laces the responsibility on the employer to ensure that the
employee goes to the HCP initially and as required thereafter. This
assumes a cooperative employee. The final standard should make clear
that an employer could not be cited because an employee refuses to
see the HCP (Ex. 30-3284).
OSHA has included the requirement for follow-up in the final rule.
Follow-up of injured employees is essential to ensure that MSDs are
resolving. Follow-up generally means additional visits to the HCP to
see if the employee is getting better or is getting worse. This process
helps to ensure that injured employees do not ``slip through the
cracks,'' for example, by being left in alternative duty jobs long
after they have recovered, or by being given work restrictions but
failing to follow up to see whether the restrictions helped. If follow-
up is not provided, neither the employer nor the HCP will know whether
an employee's MSD symptoms are abating or becoming worse. Where follow-
up is not provided or the healing process is not properly monitored,
injured employees may never be able to return to their jobs.
The employer need not be fearful of citation if the only reason
follow-up is not completed is because the employee refuses to see an
HCP. The employer is
[[Page 68379]]
required to provide access to an HCP, but is not required to force an
employee who does not wish to see the HCP to do so.
Medical Treatment
During the course of reviewing the comments to the proposed
ergonomics standard, OSHA has noticed that some commenters believed
that the proposed rule would require the employer to provide medical
treatment as part of its MSD management provisions (see, e.g., Exs 30-
564, 30-1251, 30-2425, 31-353). Roy Gibson (Ex. 30-2526) remarked that
``Once employees are aware that medical treatment is an option open to
them, they will request treatment.'' Allfirst Bank (Ex. 30-1251) asked
``How can we assure `effective' treatment?''
OSHA wants to make it clear that the final rule does not require
the employer to provide medical treatment to injured employees. While
specific medical treatment may be appropriate, such as medicines,
physical therapy, chiropractic care, or even surgery, the final rule
does not require the employer to provide such services. The rule
requires the employer to provide access to an HCP, provide needed
restrictions, provide information to HCP's and employees, and provide
WRP, but the standard does not address the medical treatment afforded
employees. Therefore, if an injured employee needs medical treatment,
the employer is not required to pay for them.
Temporary Work Restrictions
The final rule, like the proposal, requires the employer to provide
temporary work restrictions, where necessary, to employees with MSDs.
Work restrictions include any limitation placed on the manner in which
an injured employee performs a job during the recovery period, up to
and including complete removal from work.
Many commenters supported the requirement of providing temporary
work restrictions, when necessary (see, e.g., Exs. 30-3686, 30-3813,
32-339-1, 32-111-4, 32-185-3-1, 32-182-1, 30-4538, 31-353, 32-461-1,
32-198-4, 32-450-1, 37-12). NIOSH described the role of work
restrictions as the first line of defense in addressing MSDs (Ex. 32-
450-1) and that ``[c]ompanies should be able to continue the practice
of placing symptomatic workers in temporary positions until a prompt
evaluation by an HCP can be performed * * * '' (Ex. 32-450-1). Dr.
Robert Harrison stated that:
Data from several studies suggest that job modification is
significantly associated with improvement in clinical outcome. These
studies have been summarized in a critical appraisal of the
effectiveness of modified work programs (Krause 1998). This
comprehensive review found that modified work programs facilitate
return to work for temporarily and permanently disable workers.
Employees with access to modified work return to work after a
disabling injury about twice as often as employees without access to
any form of modified duty . . . The findings from these studies
conclusively show that early intervention and case management,
including modified/restricted duty, will help prevent prolonged
disability (Ex. 37-12).
However, some commenters argued against restrictions and
recommended deleting the work restriction and work restriction
protection provisions from the final rule (see, e.g., Exs. 30-1294, 30-
3765, 30-3813, 30-3956, 30-3845, 32-300-1). For example, the Edison
Electric Institute argued that providing work restrictions
[m]ay conflict with existing collective bargaining agreements
and current or future company philosophies on accommodating
employees on restricted duty when there is no work available which
they can perform under the indicated restrictions. This is
especially true given the current climate of mergers, divestitures
and competition in the electric utility industry (Ex. 32-300-1).
Other commenters asked what an employer is to do if there is no
alternative work at the establishment (Exs. 30-2208, 30-3826) or no
productive work (Ex. 30-240) available for the employee with the MSD.
The Department of Defense stated that it may not be possible to provide
work within an employee's work restrictions at some federal agencies
(Ex. 30-3826).
A number of commenters stated that it was inappropriate for an
employer to determine if an employee needs work restrictions before the
employee is seen by a HCP (see, e.g., Exs. 30-3033, 30-3034, 30-3035,
30-3185, 30-3188, 30-3258, 30-3259, 30-3284, 30-3765, 30-4046, 30-4159,
30-4536, 30-4547, 30-4549, 30-4562, 30-4607, 30-4647, 30-4713, 30-4776,
30-4800, 32-300-1, 500-163). For example, IBP Inc. argued that ``[a]s a
rule, [they] are unable to determine an appropriate work restriction
until the medical evaluation is completed. As a result, it is
impossible to advise the HCP of available work restrictions'' (Ex. 30-
4046). The Edison Electric Institute (EEI) argued that:
An HCP is better qualified to make an initial determination of
an employee's physical limitations (i.e., lift no more than 10
pounds, do not stand for more than 4 hours, etc.). The employer then
is best qualified to determine appropriate work restrictions taking
into account the physical limitations described by the HCP. OSHA
provides no valid reason to complicate the process by having the HCP
make the choice of work restrictions.
EEI recommends that Sec. 1910.931(b) be deleted. Additionally,
the phrase ``temporary work restrictions'' should be replaced with
``physical limitations'' in Sec. 1910.932(b). This would then
require only that the HCP provide a written recommendation of
physical limitations. Additionally, the wording of Sec. 1910.933(a)
should be changed to reflect that the employer must take the HCP's
physical limitations information and select the proper temporary
work restriction that best addresses the limitations (Ex.32-300-1).
The Organization Resource Counselors suggested that there may be
circumstances where the HCP makes errors and recommends inappropriate
restrictions, suggesting OSHA add the phrase ``[e]xcept when you
determine those recommendations to be clearly erroneous based on review
of the written opinion by a physician or other HCP with specific
training and experience in diagnosing and managing MSDs'' (Ex. 30-
3813).
The United Mine Workers of America (UMWA) commented that complete
removal from the workplace ``is an unacceptable response to the
problem'' and that by including this in the definition of work
restriction OSHA ``[h]as tacitly authorized the termination of
employees who suffer from MSDs.'' The UMA goes on to recommend that all
such language be deleted from the standard (Ex. 500-71-86).
However, under the final rule, the employer must provide
restrictions deemed to be necessary by either the employer or the
health care professional. Both the employer and the employee whose work
has been restricted need to understand (1) what jobs or tasks the
employee can perform during the recovery period, (2) whether the
employee is permitted to perform these jobs or tasks for the entire
workshift, and/or (3) whether the employee needs to be removed from
work entirely in order to recuperate. Employees for whom restrictions
have been assigned must be properly matched with those jobs that
involve work activities that will accommodate the requirements of the
restriction and thus facilitate healing of the injured tissue.
If an HCP recommends restricted work, employers must follow such
restrictions. Thus, in those instances where the employer refers the
employee to an HCP, the employer has to follow the temporary work
restriction recommendations, if any, included in the HCP's opinion. If
the employer receives a restricted work recommendation they believe to
be inappropriate, the employer may refer
[[Page 68380]]
the employee to an HCP with specialized training for further
evaluation, but until the employer receives a new recommendation for
restrictions, the employer must follow the recommendation of the first
HCP. The provision of work restrictions to injured employees is a vital
component of MSD management. Work restrictions provide necessary time
for the injured tissues to recover. They are often considered one of
the most effective means of resolving MSDs, especially if restrictions
are provided at the earliest possible stage. If work restrictions are
not provided, it may not be possible for the employee to recover, and
permanent damage or disability may result.
For work restrictions to be effective, employers must ensure that
they fit the functional needs of the injured employee. For example,
work restrictions are only effective if they reduce or eliminate the
employee's exposure to the workplace risk factors that caused or
contributed to the MSD, or significantly aggravated a pre-existing MSD.
To find the right fit, employers may need to examine potential
alternative duty jobs to ensure that the employee will still be able to
rest the affected area while performing the temporary job. Identifying
appropriate work restrictions may require the collaboration of
different persons such as HCPs, safety and health personnel, persons
involved in managing the ergonomics program, and the injured employee.
The final rule's use of the term ``work restrictions'' includes
both restrictions that keep the employee at work, such as half-days or
job modifications, as well as full days away from work. This is in
contrast to OSHA's recordkeeping rule, which defines restricted work
separately from days away from work. Several of the commenters failed
to recognize this important definitional aspect of the proposal.
Because days away from work are included, the employer is not required
to invent restricted duty assignments that keep the employee at work.
If the employer does not have restricted work available, restricted
work conflicts with collective bargaining agreements, or the employer
simply wishes to do so, the employer may use days away from work to
meet the requirement to provide restricted work. Of course, if the
employee is sent home, he or she must provide WRP benefits as required
by paragraph (r) of the final rule.
Although some covered MSDs could be at such an advanced stage that
days away from work are the appropriate treatment, such removal is
usually the recommendation of last resort. A recent study (Ex. 600-)
suggests that removal from the workplace is assigned by HCPs in only
about three percent of all MSD cases. Where appropriate, work
restrictions that allow the employee to continue working (e.g., in an
alternative job, or by modifying certain tasks in the employee's job to
enable the employee to remain in that job) are preferable during the
recovery period. These types of restrictions allow employees to remain
within the work environment. Studies indicate that the longer employees
are off work, the less likely they are to return (Exs. 26-685, 26-919,
26-923, 26-924). A case study of a nursing home's early return to work
program ``saved approximately $1 million in financial losses and
improved injured workers' morale'' (Ex. 502-486).
If employers provide the HCP with accurate and detailed information
about the employees job and, at a minimum, informs the HCP that the
employer is willing to accept the employer back into the workplace with
job restrictions, it is more likely that the HCP will recommend
restricted activity at work rather than complete removal. Employers
need to communicate with HCPs and supervisors to coordinate the
provision of work restrictions.
Under this provision, employers are not required to provide the
employee with the alternative job or work restrictions simply because
the employee requests them. Therefore, if an HCP recommends that the
employee not perform lifting tasks or not engage in repetitive motions
during the recovery period, the employer is free to provide any form of
work restriction that effectuates that work restriction recommendation.
For example, if the recommended work restriction requires fewer
repetitive motions, the employer can move the employee to an
alternative duty job as a way of achieving this restriction. Or the
employer might reduce the number of repetitions expected to be
performed in the employee's current job in a number of ways: by
reducing the amount of time the employee performs repetitive motions,
by reducing the speed at which the employee performs the tasks, or by
eliminating certain repetitive tasks during recovery. In the case of
lifting jobs, the work restriction can be as simple as limiting the
types or weights of objects the employee must move or lift.
The OSH Act prohibits employers from terminating an employee for
reporting an MSD (or any injury or illness). OSHA does not condone the
inappropriate termination of any employee for reporting an MSD (or any
other injury or illness). ``Complete removal from the workplace''
simply denotes the provision of time completely off of work (days away
from work) to allow the employee to recuperate from the MSD. Of course,
some employees may become completely disabled and have to terminate
employment. OSHA believes that these cases are fairly infrequent, and
the ergonomics programs required by final rule should make them even
more so.
Written Opinion From the HCP
The final rule, as did the proposal, requires the employer to
obtain a written opinion from the HCP and provide a copy to the
employee. This paragraph also instructs the employer that he or she
must inform the HCP that the written opinion is not to contain any
medical information not related to workplace exposure to risk factors,
and that the HCP may not communicate such information to the employer,
except when authorized by state or federal law. Paragraph (q) discussed
below, then instructs the employer as to the specific items the written
opinion must contain.
This section of the proposal received very little comment. A few
commenters supported the written opinion requirement (Ex. 30-3813, 30-
3686). The American Nurses Association supported the proposed
requirement for a written opinion, remarking that ``The PLHCP should
inform the employee and the employer, in writing, of the results of the
evaluation, temporary work restrictions and medical conditions
resulting from exposure to ergonomic hazards'' (Ex. 30-3686).
Other commenters objected to the requirement for an employer to
obtain a written opinion (see, e.g., Exs. 30-1070, 30-3231, 30-3336,
30-3347, 30-3392, 30-3765, 30-4185, 30-4470, 30-4496, 31-353). Several
commenters objected to the burden of obtaining a written opinion from
the HCP (see, e.g., Exs. 30-3336, 30-4185, 30-4470, 30-4496). Tyson's
foods believed that the requirement would be particularly onerous
because
[t]he proposed MSD management provisions also contemplate
separate opinions for each MSD case. Under OSHA's injury and illness
recordkeeping requirements, the identical condition may result in
numerous OSHA recordable cases * * * requiring a separate written
opinion for each case has the very real potential to create a
mountain of paperwork for the same condition which may repeat itself
throughout the year. (Ex. 30-4185).
Other commenters argued that the employer should not be required to
tell the HCP what to provide (see, e.g., Exs
[[Page 68381]]
30-1070, 30-2350, 30-4470, 30-4674, 32-234-2) and believed that if the
HCP's opinion is incomplete, the employer should not be cited or
otherwise be held accountable (see, e.g., Exs 30-1070, 30-4470, 30-
4674). The American Apparel Manufacturing Association asked ``If the
HCP's written opinion fails to include all elements stated in
[proposed] Sec. 1910.932, should the HCP or the employer choosing that
HCP be held responsible?'' (Ex. 30-4470). The Uniform and Textile
Services Association added ``[e]mployers retain the responsibility for
the opinions content but not the control over it. Employers will have
no choice but to pay whatever fees HCPs impose to prepare reports * *
*'' (Ex. 30-3336).
Other commenters stated that HCPs are reluctant to provide written
opinions, and that HCPs are too busy to provide written documentation
(see, e.g., Exs 30-2350, 30-3231, 32-234-2). On the other hand, Tyson's
Food remarked that the written opinion is not necessary because HCP's
already keep written medical records and provide employees with access
under the OSHA Standard 1910.1020 Access to medical records (Ex. 30-
4185). Tyson's Food (Ex 30-4185) and Johnson & Johnson (Ex. 30-3347)
provided identical comments expressing concern about which HCP needs to
provide an opinion, remarking that:
[f]or any given MSD complaint, there may be a nurse, in-plant
physician, physical therapist, chiropractor, outside specialist
physician, and outside physician selected by the employee, who are
all involved in the treatment of a case * * * It is not clear who
``the'' [emphasis in original] HCP is when there are multiple HCPs
involved in a case.
OSHA has carried forward the provisions that require the employer
to obtain a written report from the HCP and provide a copy to the
employee. A written report is needed so it is clear to all parties what
needs to be done to resolve the employee's MSD. This opinion must be
written because oral communication is more susceptible of
misinterpretation. Employers must keep a record, and the easiest way to
do this is if the opinion is in writing. OSHA recognizes that the
requirement adds burden to the final rule, but believes that the need
for the requirement outweighs the minimal burden imposed. OSHA does not
find the argument that HCP's will be uncooperative or charge excessive
fees to be persuasive. The employer has the right to select the HCP,
and if the HCP is uncooperative or charges excessive fees, the employer
is free to choose another HCP.
The written opinion must explain what actions the HCP recommends to
resolve an MSD. These recommendations may include temporary work
restrictions or the work the employee may do during the recovery period
as well as the follow-up necessary to ensure that the MSD resolves. It
is important that the HCP's opinion be provided in writing to the
employer or the person(s) at the workplace who are responsible for
carrying out the MSD management requirements of the standard. Employers
need to know about the employee's medical condition to ensure that the
restricted work activity they provide satisfies the HCP's
recommendations, and whether the employee requires time away from work.
The HCP's written opinion is especially important for the on-site
person who is responsible for follow-up. That person needs to
understand the HCP's plan for follow-up to make sure that the plan is
implemented effectively. The information is also needed by the safety
and health personnel who will be making workplace corrections. As the
Organization Resource Counselors stated:
OSHA seems to assume that an HCP will always be designated by
the employer to take a key role in finding and fixing MSD hazards.
In fact, in most cases, other professionals will be designated by
the employer to assume this role. Therefore, they must be provided
with meaningful information regarding the employee's capacity to
perform various tasks (Ex. 30-3813).
As to the need to obtain a separate HCP opinion for each recordable
MSD, the final rule does not use a recordable MSD as a trigger and the
point is no longer valid. An HCP opinion is required only when an MSD
incident occurs that exceed the action trigger. Likewise, it is not
necessary for each and every HCP that is involved with the case to
provide a written opinion. A written opinion from the primary treating
HCP is needed to provide the employer with the basic information
required by paragraph (q) of the final rule. If the initial is an
occupational health nurse, and the case is referred immediately to a
physician, there is no need for the occupational health nurse to
provide a written opinion, the opinion of the physician will be
adequate. Likewise, it makes no sense for a physical therapist or some
other HCP who is strictly providing treatment to provide a written
opinion. However, if the employer sends the employee to a specialist, a
written opinion to the employer would be useful to see if the more
specialized knowledge of the specialist HCP changes the need for
restrictions, results in a different diagnosis, etc.
This paragraph also requires an employer to ensure that the
employee promptly receives a copy of the opinion sent to the HCP.
Several commenters opposed this provision (Exs. 30-3765, 30-4185, 30-
4567), arguing that 29 CFR Part 1910.1020 gives better access to
medical info (Exs. 30-4185), that oral communication between HCP and
employee is adequate (Exs. 30-4185, 30-4567), that the employer should
not be accountable for communications between the HCP and the employee,
(Exs. 30-3765, 30-4567), and that similar problems in the bloodborne
pathogens standard cause problems (Ex. 30-4567). In a representative
comment, the American Ambulance Association stated that:
A similar provision exists in the Bloodborne Pathogen standard
and has been the cause for numerous violations by OSHA inspectors.
This proposal will produce the same consequence. Note that during an
examination and treatment by a healthcare professional, the employee
and healthcare professional are present, while the employer is not.
It is appropriate to assume that the healthcare provider
communicates with the employee, just as healthcare professionals
ordinarily communicate with patients.
To interject the employer into the communications is ludicrous.
To further require the physician to produce a written document, that
is not produced in the ordinary course of business, and to require
the employer to obtain that document and furnish it to the employee
is a process fraught with error. If OSHA's intent is to assure that
employees receive a written document from a healthcare provider,
then OSHA should require the healthcare provider to produce the
document and hand it to the employee (Ex. 30-4567).
It appears that these commenters did not realize that the only
requirement put upon the employer is to simply provide a copy of the
written opinion the employer receives to the employee. A separate
written report for the employee is not required. OSHA continues to
believe that a copy of the written report is essential if the employee
is to participate in his or her own protection. It is particularly
important for the employee to be knowledgeable about what work
restrictions, if any, he or she has been assigned and for how long they
will apply. Therefore, OSHA has included the requirement in the final
rule.
Confidentiality for Non-Workplace Information
Paragraph (p)(5) requires employers to instruct the HCP that any
findings, diagnoses, or information unrelated to workplace exposure to
risk factors must not be included in the written opinion or
communicated to the employer,
[[Page 68382]]
except when authorized by state or federal law. The proposed rule
contained a similar provision. This requirement is intended to
encourage employees to disclose to the HCP all information about their
health, and their activities both on and off the job, that could have a
bearing on the MSD.
Full disclosure by employees will assist HCPs in evaluating the
causal role of occupational risk factors and in determining the nature
and duration of appropriate work restrictions. HCP's need this
information to recommend work restrictions and follow-up that fit the
employee's capabilities. This information will also enable the HCP to
inform employees about activities, including non-work activities, that
could aggravate the MSD and delay or prevent recovery. It is important
for employees to know about any changes they can make to their on-and-
off the job activities that will reduce their exposure to MSD hazards
so that they may participate effectively in the recovery process. An
example of an activity that sometimes must be postponed is a
recreational activity that could place stress on the injured area of
the body during the recovery period.
Employees will be reluctant voluntarily to disclose information
about their health or outside activities if confidentiality is not
maintained. MSDs may be associated with a variety of conditions,
including hypertension, diabetes, kidney disorders and pregnancy, as
well as the use of certain prescription drugs. See Ex. 30-3004 at p. 5;
Ex. 30-3167. However, many employees would not want this health
information revealed to their employers. The privacy protection
accorded medical records under state and federal laws reflects general
agreement that disclosure of information about a person's health status
could result in embarrassment, stigmatization and discrimination in the
workplace and elsewhere. See Doe v. City of New York, 15 F.3d 264, 267
(2d Cir. 1994) (``Extension of the right to confidentiality to personal
medical information recognizes that there are few matters that are
quite so personal as the status of one's health, and few matters the
dissemination of which one would prefer to maintain greater control
over.'') Similarly, information about employees' private off-the-job
activities could be embarrassing and harmful if disclosed. Therefore,
OSHA believes that it is important to preserve the confidentiality of
personal information revealed by employees to the HCP that is not
related to workplace exposure to MSD risk factors.
OSHA explained the need for this kind of privacy protection in the
proposed rule, as follows:
The confidentiality provision is necessary to ensure that
employees will be willing to provide complete information about
their medical condition and medical history. Employees will not
divulge this type of personal information if they fear that
employers will see it or use it to the employee's disadvantage. For
example, employees may fear that their employment status could be
jeopardized if employers know that they have certain kinds of
medical conditions, which may be completely unrelated to work or
exposure to MSD hazards, or if they are taking certain kinds of
medication (e.g., seizure medication, an anti depressant). In this
sense, the ergonomics rule is * * * intended to be consistent with
the confidentiality requirements of the Americans with Disabilities
Act. 64 Fed. Reg. 65844.
OSHA recognizes that information subject to protection under the
final rule may, in some circumstances, be disclosable under state or
other federal law. For example, many state laws authorize the
disclosure of medical information to employers in connection with
workers' compensation claims. The agency does not intend the final
rule's confidentiality requirement to conflict with state or federal
law authorizing disclosure, and has included language to that effect in
paragraph (p)(5).
The AFL-CIO supported the confidentiality requirement, noting that
it is consistent with similar provisions in other OSHA standards and
with guidelines in the American College of Occupational and
Environmental Medicine (ACOEM) Code of Ethical Conduct (Ex. 500-218,
p.117). Other comments were also supportive (See, e.g. Exs. 30-3686,
32-185-3-1). However, a substantial number of commenters were critical
of the provision. These parties argued that prohibiting HCPs from
disclosing information about the contribution of non-occupational risk
factors will make it impossible for employers; (i) to determine whether
a reported MSD is work-related, (ii) to comply with the final rule's
requirements to monitor the condition of an employee with a work
restriction to determine whether the MSD is resolving, and to institute
effective hazard control measures for the problem job, and (iii) to
evaluate a claim for workers' compensation benefits arising from the
MSD. These arguments, and OSHA's responses, are discussed below.
1. Confidentiality and Work-Relatedness Determinations
A number of commenters argued that the confidentiality requirement
would seriously hamper the employer in making determinations required
by this final rule, and by the Recordkeeping rule in 29 C.F.R. Part
1904, about whether reported MSDs are work-related (see, e.g. Exs. 30-
3004, 30-3061, 30-3086, 30-3167, 30-3177, 30-3231, 30-4334, 30-4564,
30-4674, 30-4713, 30-4843, 30-4844). Combe Inc. argued that:
The unreasonable restraints the Proposed Standard places on the
employer's ability to obtain information to meaningfully evaluate
the work-relatedness of an employee's MSD claim further creates an
environment of uncertainty and will force the employer into possibly
unnecessary or deficient decision-making. Section 1910.932(a) of the
Proposed Standard expressly provides that the HCP must be instructed
`that any findings, diagnoses or information not related to
workplace exposure to MSD hazards must remain confidential and must
not be put in the written opinion or communicated to the employer.'
Thus, if Combe were to receive a single carpal tunnel syndrome
complaint from an employee on one of its assembly lines * * * It
would be barred from learning whether this employee has any of the
non-occupational risk factors the scientific literature associates
with the development of carpal tunnel syndrome * * * . Because the
Proposed Standard would prohibit Combe from learning this essential
non-occupational risk factor information or even from learning if
the HCP inquired about this critical data or evaluated it properly,
Combe would be unable to determine if the new claim is, in fact, the
result of non-occupational factors or a deficiency in its heretofore
successful ergonomic interventions (Ex. 30-3004, pp. 5-6).
In a similar vein, the Chamber of Commerce argued:
[T]he fact that employers cannot receive any information related
to non-work factors necessarily means that they will conclude that
an employee complaint is work-related. After all, if employers are
deprived of information about possible non work-related causes, what
is left for them to consider? Regardless of the real cause of the
muscluloskeletal complaint, in many cases employers will be forced
to conclude that the injury is [work-related] because there will
be--and because there can be--no evidence of exposures outside the
workplace (Ex. 30-1722, p. 78).
These commenters correctly point out that employers must sometimes
consider non-occupational factors, including pre-existing medical
conditions, in deciding whether events or exposures at work ``caused or
contributed'' to an MSD. See definition of the term Work-related in
paragraph (z). However, they misunderstand the MSD management provision
in arguing that the confidentiality requirement will deprive employers
of information necessary to make work-relatedness determinations. The
MSD Management
[[Page 68383]]
provisions in paragraph (p), including the confidentiality requirement,
apply when an employee has experienced an MSD Incident in a job that
meets the Action Trigger. ``MSD Incident'' is defined to include only
work-related MSDs meeting certain criteria. See paragraph (z).
Therefore, the employer must decide that an MSD is work-related before
it is required to implement the MSD Management requirements in
paragraph (p).
Moreover, OSHA believes that it will rarely be necessary to delve
into employees' private lives to make this determination. In most
cases, employers will be able to decide if work is a contributing
causal factor based on the type of injury and the nature of the
employees' work activities. The final rule will facilitate this process
because it includes a Basic Screening Tool that allows employers to
determine whether risk factors are present in the job at levels of
concern. In these cases, confidentiality protection is necessary to
assure full disclosure to HCPs.
2. Confidentiality and the Employer's Duty To Follow-Up on the
Employee's Recovery and To Control MSD Hazards
Some parties argued that the confidentiality requirement is
fundamentally inconsistent with the duty imposed on the employer to
check up on the progress of an employee with a work restriction to see
that the injury is resolving, and to control the MSD hazards in problem
jobs. The comment submitted by Layflat Products, Inc. is
representative:
OSHA cannot have it both ways. * * * Employers should not be
forced to undertake workplace accommodations designed, at least in
part, to enable the employee to continue to work without aggravating
an MSD, or to provide an opportunity to recover, while at the same
time effectively barring employers from having any effective means
to prevent an employee from continuing to engage in conduct outside
of work which the treating HCP has concluded and advised the
employee will aggravate or prolong the MSD and, thereby, nullify the
remedial efforts which the proposed standard would mandate the
employer to take. * * * The preamble to the proposed rule also at
least suggests that the employee's progress in recovery may have
some bearing on the determination whether a proper ``job fix'' has
been accomplished (Ex. 30-3061).
The NSBU voiced concern that ``numerous [health] conditions make
contributions to musculoskeletal complaints. * * * In addition a vast
number of outside activities engaged in by employees may contribute
equally or much more substantially to such complaints. Yet employers--
who would be required to march their workplaces along the path of
incremental abatement at great cost and disruption--are not allowed to
even contemplate the potential role of such individual pursuits,
activities or conditions'' (Ex. 30-3167). (See also Exs. 30-1722, 30-
3211, 30-3231, 32-337-1)
OSHA acknowledges that the confidentiality requirement is a
compromise. At the same time, OSHA believes that confidentiality is
essential to ensure employees' willingness to disclose personal health
and other private information to HCPs, who, in many cases, make the
initial recommendation about work restrictions. In OSHA's view,
assuring that HCPs have access to information necessary to fulfill
their central role in the MSD Management process is of overriding
importance.
OSHA also believes that maintaining confidentiality in the personal
information employees provide to HCPs will not seriously disadvantage
employers. The purpose of work restriction requirements is to ensure
that the injured employee's exposure to workplace risk factors is
reduced or eliminated during the recovery period. The employer must
know of the specific activities or motions to be restricted and what
jobs, if any, satisfy these restrictions. Once the employee has been
placed in a job that rests the affected area, or is removed from work
entirely to recover, the employer's compliance obligation is satisfied,
even if the employee's recovery is complicated by non-occupational
factors. Thus, the confidentiality requirement should not hamper the
employer's ability to comply with MSD Management requirements.
It is true that employers have a financial interest in ensuring
that employees do not engage in non-work activities that could prolong
the period for which WRP benefits must be paid. However, the final rule
contains mechanisms to shield employers from the costs of prolonged
WRP. The rule provides a procedure for HCPs to inform employees about
medical conditions associated with exposures to risk factors, and any
non-work activities that could impede their recovery. This information,
conveyed directly by the HCP, will go far toward encouraging employees
to seek appropriate treatment, and to refrain from potentially harmful
outside activities during recovery. The rule also reduces the maximum
duration of WRP benefits from six months, as proposed, to ninety
calendar days.
OSHA has also addressed the concerns of some commenters that the
confidentiality requirement could undermine employer's efforts to
control MSD hazards. Under the proposed rule, employers could have been
required to institute control measures incrementally when MSDs occurred
in problem jobs. Commenters correctly pointed out that if the success
of ergonomic interventions is to be measured by the occurrence of MSDs
in problem jobs, employer knowledge about non-occupational factors
associated with those MSDs assumes greater significance.
However, the final rule establishes different and more definite
criteria for reducing MSD hazards. As explained in the preamble
discussion of paragraph (k), the final rule sets out concrete steps
that employers may take to reduce MSD hazards to acceptable levels.
When employers take these steps, the occurrence of an MSD in the job
does not require further action as long as the controls are still in
place and functioning and no new hazards have arisen. OSHA believes
that these changes, reflected in paragraph (k), address the concerns
raised about the effect of the confidentiality requirement on the
employer's hazard control obligation. For these reasons, OSHA concludes
that preserving the confidentiality of information unrelated to
occupational exposure to risk factors is necessary to effectuate the
purposes of the standard and will not work an undue hardship on
employers.
3. Confidentiality and Workers' Compensation
Finally, some commenters argued that the restrictions imposed upon
HCPs' disclosure of information could preclude employers from
evaluating workers' compensation claims arising from MSDs (see, e.g.,
Ex. 30-4564, 31-324, 31-338). However, the final rule makes clear that
the confidentiality requirement does not apply when disclosure is
authorized by state or federal law. Thus, in a case involving a claim
for workers' compensation benefits, the HCP is subject to the ordinary
processes and procedures established by the state for obtaining
relevant information. Nothing in the final rule is intended to conflict
with, or hamper the operation of, state workers compensation systems.
Providing Information to the HCP
The final rule, like the proposed rule, requires the employer to
provide information about the job and workplace conditions to the HCP
conducting the assessment. The employer must provide the HCP with a
description of the employee's job and information about the MSD hazards
in
[[Page 68384]]
the job and a copy of the ergonomics standard. These requirements to
provide information to the HCP are slightly different than the proposed
rule. The final rule does not carry forward the proposed requirements
to provide a summary of the standard to the HCP, the requirement to
provide workplace walkthroughs to the HCP, or the requirement to
provide a description of available work restrictions.
Many commenters supported the proposed provisions pertaining to the
information that must be provided to the HCP about the workplace (see,
e.g., Exs. 30-710, 30-3826, 30-3686, 30-4540), whereas others stated
that some or all of the provisions in this paragraph should be deleted
(see, e.g., Exs. 30-3765, 30-3813, 32-300-1, 30-652). For example, the
Dow Chemical Company suggested that OSHA delete this entire section,
because (1) developing job descriptions would be burdensome, (2)
gathering the information would create a time delay in getting an
employee to an HCP, and (3) this information would not impact the
quality of the care the injured employee receives (Ex. 30-3765).
Some commenters thought the requirement to provide information to
the HCP was redundant with other requirements in the proposal or other
existing OSHA regulations (see, e.g., Exs. 30-3813). Others stated that
creating and providing this material places a burden on employers (see,
e.g., Exs. 30-2725, 30-4567, 30-4607).
Information About the Employees Job and the MSD Hazards Within the Job
Both the final rule and the proposal require the employer to
provide the HCP with a description of the employee's job and
information about the MSD hazards in the job. This provision received
very little specific comment. The only specific objection, made by
several commenters, was that detailed job descriptions are not
available (see, e.g., Exs. 30-2725, 30-3392, 30-3765).
Paragraph (p)(3)(i) of the final rule requires employers to provide
a description of the employee's job and information about the hazards
in it. This information is needed to assist HCPs in providing both
accurate assessment and effective management of MSDs. Without such
information the HCP may not be able to make an accurate evaluation
about the causes of the MSD or may not be able to prescribe appropriate
restricted work activity. OSHA believes that providing HCPs with
information about the results of any job hazard analysis that has been
done in that job ensures that the HCP has the most complete and
relevant information for evaluating and managing the recovery of the
injured employee. Many stakeholders have told OSHA that they already
provide this type of information to the treating HCP in order to
familiarize the provider with the employee's job and associated
workplace risk factors and ultimately to facilitate resolution of the
MSD (Exs. 26-23 through 26-26).
If the HCP is already on site, he or she is likely to be familiar
with the jobs in the workplace, the MSD hazards identified in the
hazard determination of the employee's job, and what jobs or temporary
alternative duty may be available. However, HCPs who are not routinely
on site generally do not have this workplace-specific information and
employers must provide it in these cases. It is essential that HCPs
charged with the responsibility for MSD management know or be provided
with this information if they are to successfully manage the cases of
the injured workers. Because employers will have tested the injured
employees job against the job hazard screen in paragraph (f), the
employer will already have some idea of the hazards in the employee's
job, and it should not be difficult to pass this information on to the
HCP.
While some companies routinely keep detailed written job
descriptions, other companies (especially small firms) may not have
detailed written job descriptions immediately available. It is not
vital that the employer provide the HCP with an enormously detailed
description of the employee's job. A general description of the
employee's job duties that contains enough detail to help the HCP
perform an appropriate evaluation and develop an informed opinion of
the case will suffice.
OSHA recognizes that this requirement places burdens on employers.
However, the Agency believes these burdens are more than outweighed by
the benefits that accrue from providing the HCP with information about
the employees jobs and the MSD hazards in that job. As a recent journal
article stated ``To make appropriate recommendations about return to
work, the health care provider should know the physical demand
characteristics of the job the worker is expected to perform'' (Ex.
502-284). Of course, the costs associated with this requirement have
been included in the economic analyses for the final rule.
Copy of the Standard and a Summary of the Standard
The proposed rule would have required the employer to provide a
copy of the ergonomics standard, as well as a summary of the standard,
to the health care professional. The final rule simply requires the
employer to provide a copy of the standard. Several commenters objected
to the proposed requirements (Exs. 30-3765, 30-4567), arguing that they
are not needed for diagnosis or treatment (Ex. 30-3765), are burdensome
(Ex. 30-4567). The American Ambulance Association asked what would
suffice for a summary of the standard (Ex. 30-4567). A few commenters
suggested that OSHA create a non-mandatory appendix containing the
required summary of the Standard (Ex. 30-3284, 30-3686, 31-307).
Several commenters suggested deleting the requirement for a summary
(Ex. 30-2216, 30-3813, 30-3922). For example, the Organization Resource
Counselors argued that ``[t]he standard should be sufficiently
straightforward [so] that the HCP can understand it without needing a
special `summary' of the standard'' (Ex. 30-3813). The A.O. Smith
Corporation suggested that, as an alternative, OSHA could offer
training to medical providers and certify them for this practice area
(Ex. 30-2989).
OSHA has included the requirement to provide a copy of the standard
to the HCP in order to assure that HCPs know how quickly employers must
provide employees with access to the HCP and that employers must
analyze any job in which an MSD incident is reported. Further, the HCP
needs to be informed about the information they are to provide in the
written report required by paragraph (q) of the final rule. OSHA has
not included the proposed requirement to provide a summary of the
standard to the HCP, finding that the summary is a redundant
requirement that is not needed, since the standard itself is reasonably
short and is easily read.
Descriptions of Available Restrictions
The proposed rule would have required employers to provide
information on work restrictions that were available during the
recovery period and that were reasonably likely to fit the employee's
capabilities during the recovery period. OSHA believed that providing
this information to HCP would help facilitate the appropriate matching
of the employee's physical capabilities and limitations with a job that
would allow an employee to adequately rest the injured area while still
remaining productive in other capacities. Employers with ergonomics
programs have discovered that the more detailed information and
communication provided to the HCP about available alternative duty
jobs, the better the HCP understands the causes
[[Page 68385]]
of the problem and knows what work capabilities remain. As a result,
these employers have found that the HCP is more likely to recommend
restricted work activity rather than removal from work during the
recovery period. In addition, it is more likely that HCPs are able to
recommend much shorter removal periods when removal is combined with
restricted work activity as a means of facilitating recovery.
A number of commenters argued that the employer cannot determine
the need for restricted work, before an evaluation by a health care
professional. (Exs. 30-1091, 30-1671, 30-3033, 30-3034, 30-3035, 30-
3185, 30-3188, 30-3258, 30-3259, 30-3284, 30-3392, 30-3765, 30-3813,
30-4159, 30-4536, 30-4547, 30-4549, 30-4562, 30-4607, 30-4647, 30-4713,
30-4776, 30-4800, 32-300-1) In a representative comment, the Southern
California Edison company remarked that:
First, this calls for the employer to somehow anticipate the
HCP's diagnoses and evaluation of physical limitations before the
employer has even seen the HCP. Second, an HCP is better qualified
to make an initial assessment of an employee's physical limitations
(i.e., lift no more than 10 pounds, do not stand for more than 4
hours, etc.). The employer then is best qualified to determine
appropriate work restrictions taking into account the physical
limitations described by the HCP (Ex. 30-3284).
OSHA agrees with these commenters that, for at least some MSD
incidents, it is difficult to provide information about appropriate
restrictions to the HCP, and that the HCP is in a better position to
tell the employer what restrictions or physical restrictions must be
implemented while the employee is recuperating from an MSD injury.
Therefore, this provision has not been included in the final rule.
However, the employer is required to implement any restrictions he or
she finds necessary, and OSHA believes that there are some
circumstances where the employer can implement restrictions before
consultation with an HCP. The employer will also benefit from good
communications with the HCP about what types of restricted work may be
available, and should try to work cooperatively with the HCP to
determine appropriate work.
Walkthrough Rights for the Health Care Professional
The proposed rule included a provision that would have required the
employer to allow the health care professional to visit the
establishment and walk through the establishment if the HCP wished to
do so (64 FR 66073). OSHA's intent was to provide HCPs with
opportunities to look at the problem job and the available alternative
duty jobs. This would have allowed the HCP to become familiar with the
physical work activities the injured employee performs, and allow that
the HCP to see if available alternative duty jobs would allow the
employee to rest the injured area during the recovery period. OSHA did
not intend to require employers to provide HCPs walkthroughs throughout
the entire facility, and expected that workplace walkthroughs could be
either informal or formal. Several commenters supported the HCP
walkthrough provisions (see, e.g., Exs. 3-52, 3-107, 30-4301, 31-242).
The Washington Federation of State Employees Local 1488--AFSCME also
recommended that the employer should be required to pay for the HCP's
time and travel expenses for a walkthrough (Ex. 31-242). The Dow
Chemical Company said that it was not opposed to the proposed
provision, and that DOW encourages HCPs to visit their worksites (Exs.
30-3765). Southern California Edison stated that they also did not
object to the proposed requirement, but recommended that OSHA specify
that the employer is under no obligation to pay the HCP for the
walkthrough (Ex. 30-3284).
A few commenters opposed the proposed walkthrough rights
requirement (Ex. 30-3348, 30-3749, 30-4713, 30-5674). Freeborn and
Peters argued that the walkthrough rights are not needed (Ex. 30-4713).
The Society for Human Resources Management stated that the proposed
requirement:
[w]ould be particularly burdensome for smaller employers who
rarely have the kind of a relationship with an HCP that such a
walkthrough would be practical. If OSHA chooses to maintain such a
requirement, its application should be limited to larger employers
and only for those HCPs whom the employer expects to use regularly *
* * (Ex. 30-3749).
The Puerto Rico Manufacturing Association remarked that the
proposed provision ``[n]eeds to be narrowed, because it is disruptive
to many operations * * * '' and asked ``[w]hat if every employee with a
sign or symptom wanted his own HCP to assess his job?'' (Ex. 30-3348).
OSHA has decided not to include an HCP walkthrough right in the
final rule. While HCP walkthroughs have significant advantages in
helping the HCP determine appropriate restrictions for injured workers,
they are not absolutely necessary and could result in added burden to
employers. As OSHA acknowledged in the proposal, there are other ways
HCPs can acquire more in-depth information about the employee's job and
the MSD hazards in it. For example, employers can provide HCPs with the
results of the job hazard analysis, photographs of the job, or
videotapes of the job being performed.
Paragraph (q). What Information Must the HCP's Opinion Contain?
Paragraph (q) describes the types of information that should be
included in the HCP's written opinion. This information includes: (1)
the HCP's assessment of the employee's medical condition as related to
MSD hazards in the employee's job; (2) any recommended work
restrictions, including, if necessary, removal from work to allow for
recovery, and any follow-up needed; (3) a statement that the HCP has
informed the employee of the results of the evaluation, the process to
be followed to effect recovery, and any medical conditions associated
with exposures to risk factors; and (4) a statement that the HCP has
informed the employee about work-related or other activities that could
impede recovery from the injury.
These four elements to be addressed in the HCP's opinion were
included in the proposal, and OSHA received no significant comment
requiring discussion in the final rule. OSHA notes that ``work
restrictions'' are defined in paragraph (z) of the final rule as
limitations on the employee's exposure to risk factors present in the
job giving rise to the MSD incident, and may include limitations on
work activities in the current job, transfer to an alternative duty
job, or complete removal from work to permit recovery. OSHA reiterates
here the point made in the proposal about the importance of specific
work restriction recommendations. 64 Fed. Reg. 65,845. The HCP should
describe in as much detail as possible the nature and duration of work
restrictions so that employers will have maximum flexibility to ensure
that employees can remain productive while resting the affected area.
Paragraph (r) What Must I do if Temporary Work Restrictions or Removal
>From Work are Needed?
Paragraph (r) describes the actions required when an MSD incident
has occurred in a job with risk factors that exceed the action level,
and the employer or HCP determines that temporary work restrictions or
removal from work are needed.
Paragraph (r)(1) first makes clear that the employer must either
determine the work restriction or removal himself or herself, or comply
with the recommendations of an HCP, either by
[[Page 68386]]
temporarily placing the injured employee in an appropriate alternative
or ``light duty'' job, or, if necessary, by temporarily removing the
employee from work.
Paragraphs (r) (2) and (3) require the employer to maintain the
injured employee's wages and benefits when work restrictions are
necessary.
Work Restriction Protection (WRP)
A. Necessity for WRP
``Work restriction protection'' or ``WRP'' refers to the
requirements in paragraphs (r)(2) and (3) for maintaining an injured
employee's employment rights, wages and benefits when temporary work
restrictions are necessary. As explained in the proposed rule, 64 FR
65848-65852, and in the discussion below, WRP requirements are designed
to encourage employees to report MSDs and their signs and symptoms as
early as possible, and to participate actively in MSD management. Early
reporting of MSDs by employees will contribute to the success of the
final rule in several important ways. First, unlike other OSHA
standards, the rule does not require employers to monitor their
workplaces for hazards, but rather to evaluate employee reports of MSD
signs or symptoms to determine whether further action is necessary.
Employee reports must be evaluated to determine whether an MSD incident
has occurred in a job with risk factors exceeding the standard's action
level. If the job has risk factors that exceed the action level, the
employer must implement several elements of an ergonomics program,
including job hazard analysis, and must provide necessary work
restrictions (including work removal, if necessary) and MSD management.
This approach depends upon employees' willingness voluntarily to
report when they first experience signs or symptoms at work. As the
agency noted in the proposed rule, ``[i]f employees are not willing to
come forward and report MSDs, serious MSD hazards in that job will go
uncontrolled, thus potentially placing every employee in that job at
increased risk of harm.'' 64 FR 65861. Early reporting permits
employers to identify problem jobs and institute corrective measures
before other employees in those jobs become injured. Thus, timely
reporting by employees is central to the final rule's hazard
identification and control mechanisms.
Early reporting is also crucial in maximizing the standard's
benefits for injured employees and in minimizing costs to employers and
employees. The record establishes that MSD treatment is more likely to
be successful if provided early, before the disorder has become
debilitating (see e.g., Exs. 3-56; 3-59; 3-179; 3-184. See also
Testimony of Dr. Evanoff (Tr. 1530-31; 1628); Dr. Herbert (Tr. 1698-
99); Dr. Connell (Tr. 2833); Dr. McCunney (Tr. 7649-50); Dr. Bernacki
(Tr. 7687); Dr. Piligian (Tr. 7883-5); Dr. Frank (Tr. 1388); Dr.
Cherniak (Tr. 1234-5). Early detection and intervention also reduces
the severity of MSDs and the level of treatment required to address
them (see e.g., Exs. 3-23; 3-33; 3-50; 3-56; 3-59; 3-121; 3-124; 3-151;
3-162; 3-179; 3-184) and reduces the number of days employees must
spend on restricted duty or away from work entirely (see Ranney 1993,
Ex. 26-913; Day 1987, Ex. 26-914; Oxenburgh 1984, Ex. 26-1367).
Consequently, the early reporting of MSDs substantially reduces both
the physical and economic toll of these disorders.
The participants in the rulemaking had conflicting views on
whether, and to what extent, WRP is needed to ensure early reporting of
MSDs. After a careful review of the literature, testimony and comments
on this issue, OSHA finds persuasive evidence that, without WRP,
employees will be reluctant to report MSDs and their signs and symptoms
at an early stage. In the preamble to the proposed rule, OSHA discussed
a variety of studies in the scientific literature indicating that MSDs
are underreported in federal and state occupational injury and illness
statistics. These studies show that a substantial percentage of work-
related MSDs are not recorded on the OSHA log of occupational injuries
and illnesses, and are therefore excluded from the Bureau of Labor
Statistics (BLS) data (see e.g., Exs. 26-28; 26-1258; 26-920; 26-922;
26-1259; 26-1261; 26-1260). They also demonstrate that large numbers of
workers with medically confirmed MSDs do not file claims for workers'
compensation benefits (see e.g., Exs. 26-1258; 26-1212; 26-920). See
also 64 FR 65851-52; 65980-83 and Table VII-2. Based on this and other
evidence, OSHA preliminarily estimated that at least half of all work-
related MSDs are not reflected in the BLS statistics. 64 FR 65981.
Researchers, physicians, and workers themselves supported OSHA's
finding that MSDs are underreported at the federal and state levels.
NIOSH agreed that there is a substantial likelihood that the actual
number of MSDs exceeds the BLS estimates, and that this is due in part
to underreporting of the true number of work-related health problems on
the OSHA 200 logs (Ex. 32-450-1). Other commenters highlighted the
growing literature in the workers' compensation field, including recent
studies confirming that only a small percentage of workers with back,
upper extremity and other MSDs file claims for benefits (see e.g., Ex.
37-14, p. 9 [Emily Spieler, citing, e.g., Morse 2000]; Ex. 500-203 [Dr.
Michael Erdil, citing, e.g., Rosenman 2000]; Ex. 32-339-1, Ex. 500-218;
Tr. 2399-2301 [Dr. Boden]).
Physicians and researchers testified that the findings in the
literature were consistent with their experiences (Tr. 839-40 [Dr.
Armstrong]; Tr. 1021 [Dr. Punnett]; Tr. 1115 [Dr. Erdil]; Tr. 1886-87
[Dr. Owen]; Tr. 2399-2401 [Dr. Boden]). Dr. Michael Erdil stated that
``my clinical experience as an occupational physician treating
thousands of patients with MSDs is consistent with these studies'
finding that employees often do not report MSDs they believe to be
caused by work.'' Tr. 1115. Emily Spieler, an author and lecturer on
workers' compensation issues, and a former Commissioner of the West
Virginia Workers' Compensation Fund, wrote that
[t]he findings regarding under-filing are consistent with my own
observations regarding workers' claims filing behaviors. Many
workers with compensable injuries do not file claims for benefits.
Both my own experience and current literature suggest that under
filing far exceeds overreporting in workers compensation systems.
There are serious implications regarding the prevention and
compensation of MSDs that flow from this.
Ex. 37-14, p. 10.
Workers have given a variety of reasons for not reporting MSDs to
their employers or failing to seek workers' compensation benefits for
these disorders (see 64 FR 65849-50; 65980-81). Many workers expressed
the fear that if they report a work-related injury, they will lose
their job or be transferred to an alternative job at reduced pay and
benefits, or suffer other forms of job discrimination (see Exs. 3-121;
3-151; 3-183; 3-184; 3-186). Employees voiced these concerns repeatedly
during the hearing (see Tr. 3602 [Corey Thompson]; Tr. 5820 [Dave
[S]aksewski]; Tr. 5832 [Scott Bean]; Tr. 6022 [Dennis Norton]; Tr.
5901-02 [Victor Henderson]; Tr. 7733-34 [Sandy Brooks]; Tr. 7736-37
[Jeanette Di Florio]; Tr. 7545-46 [Penny Siedner]; Tr. 7998 [Al Close];
Tr. 8013 [Bob Zielonka]; Tr. 9561 [Robert Wabol]; Tr. 10,720-21
[Richard Sorokas]; Tr. 12,530 [Buzz Vsetecka]). Dave [S]aksewski
recounted his experience at an automobile assembly plant:
[[Page 68387]]
As I was new in the facility, I received many less than
desirable jobs. On many of the assembly jobs my hands or arms ached
at the end of the shift or my back was so sore from lifting that I
could not do the things on weekends that I would have enjoyed doing
and I had normally done in the past. Things like fishing or playing
ball went on the back burner until I felt like I could do them
without further hurting myself.
I never reported any of these problems to the medical department
because as a probationary employee you just did not complain about
anything, even if I was a union member. * * * The end result of a
complaint from me would have been no overtime, maybe a job
restriction, or a disputed compensation claim that I had injured
myself at home working in the garden.
I can tell you from personal experience that people do not
report MSDs until they get bad enough where they can no longer
tolerate the job.
Tr. 5822-23. Autoworker Al Close agreed, stating ``employees are still
reluctant to report early symptoms of injury. This is due to
intimidation by middle management and by the fact that they will get
work restrictions or be sent home with the loss of pay.'' Tr. 7998.
Employee representatives from a broad spectrum of industries echoed
these sentiments (see e.g., Ex. 32-182-1 [AFSCME]; Ex. 32-185-3 [UAW];
Exs. 32-339-1; 500-218 [AFL-CIO]; 32-198-4 [UNITE]).
Employers, physicians, and others acknowledged that concerns about
economic loss and retaliation influenced employees' decisions not to
report their MSDs or to seek treatment or compensation for them. Peter
Meyer, Human Resource Director for Sequins International testified:
It is true that workers in most situations don't report pain and
work-related injuries, especially when they are concerned about
their jobs. They are continually concerned about the hours that they
are going to work so it makes sense that workers wouldn't report
something that they might think jeopardizes their jobs.
Tr. 17350. Dr. George Piligian testified that the most common reason
given by employees for delaying treatment for MSDs was the fear of
losing income. He stated, ``[t]his was the biggest obstacle, especially
in those that were not high-paying sectors of the work force.
Therefore, wage replacement, especially when you first have symptoms,
is vital. People will not come forth.'' (Tr. 7822-3). See also Tr. 1115
(Dr. Erdil); Tr. 1724 (Dr. Robin Herbert).
This evidence demonstrating that economic concerns are a powerful
motivating factor in workers' behavior affecting their health is
consistent with that adduced in previous OSHA rulemakings. For example,
OSHA commented on the evidence that lead-exposed workers would be
reluctant to participate in medical surveillance program, as follows:
Much of the evidence in the lead proceeding documents the extent
to which worker participation is adversely affected by the fear that
adverse employment consequences will result from participation in
medical surveillance programs. This problem was emphasized by the
testimony of many workers and worker representatives. * * * Evidence
concerning the issue of worker fear impeding participation, however,
was not confined simply to testimony from worker representatives. A
wide variety of experts verified the existence of this problem, as
did several industry representatives. The evidence suggests that
economic disincentives to worker participation are currently a
problem in the lead industry.
43 FR 54442.
OSHA believes that the two patterns of employee behavior discussed
above--the failure to report work related MSDs to employers, and the
failure to claim workers' compensation benefits for these disorders--
underscore the need for WRP in the final rule. OSHA's recordkeeping
regulations in Part 1904 already require employers to inform employees
of the need to report injuries and illnesses promptly, and to have a
clear procedure for reporting. Moreover, section 11(c) of the OSH Act
protects employees who report their injuries from acts of
discrimination or retaliation by employers. In view of the evidence
that these provisions do not eliminate underreporting on the OSHA logs,
it is unreasonable to believe that similar requirements and protections
in the final rule, standing alone, will be sufficient. Indeed, without
wage protection, the standard's MSD management provisions, including
mandatory work restrictions or work removal when recommended by an HCP,
will likely increase the pressure on employees not to inform their
employers of work-related MSDs, and thereby exacerbate an already
serious problem.
The evidence on employees' dissatisfaction with workers'
compensation benefits, and avoidance of workers' compensation systems,
is also relevant. There was substantial testimony that employees view
the workers' compensation system as ineffective and cumbersome to use
(see e.g., Ex. 500-218 ). Emily Spieler summarized these problems as
follows:
There are several tiers of problems with the adequacy of
compensation, for both compensatory and deterrent effects. First,
many people do not file claims that, if filed, might be compensable.
Second, in some states, many claims involving work-related MSDs may
not be compensable, even if filed. Third, payment in apparently
compensable claims for MSDs, and in particular for repetitive
stress-related MSDs, may not be paid due to controversion, or may be
delayed, or may be settled for compensation below the statutory
amounts.
The result is twofold. First, workers may be discouraged from
filing workers' compensation claims or from otherwise alerting their
employers to developing MSDs. Second, workers compensation fails to
provide employers with adequate incentives for the prevention of
disabling MSDs.
Ex. 37-14, p. 10. This evidence demonstrates that the potential
availability of workers' compensation benefits alone is insufficient to
ensure full and timely reporting of MSDs and their signs and symptoms,
and further underscores the need for a requirement protecting
employees' wages and benefits during periods when work restrictions are
necessary.
In contrast, OSHA was not convinced by those commenters who argued
that the record does not demonstrate the need for WRP. The evidence and
argument presented by these commenters was not as concrete or specific.
They maintained principally that: (i) OSHA's own audits conducted in
1996 and 1997, and statements made by some OSHA officials and experts,
demonstrate that employer logs are accurate; (ii) there is no need for
WRP because most MSDs require little or no time away from work; and
(iii) OSHA itself concluded that WRP will not rectify underreporting.
These arguments are discussed below.
In 1998 and 1999, OSHA performed audits of employers' injury and
illness records. The 1998 audit examined a sample group of employers'
1996 records, while the 1999 audit examined records for 1997 (see Ex.
500-168, Appendices A and B). A number of commenters argued that the
results of these audits undermined OSHA's finding of widespread
underreporting of MSDs on employers' logs (see e.g., Exs. 500-168; 30-
3347; 32-78-1; Ex. 30-1722; Ex. 30-3956). The AISI's comment is
representative:
OSHA went to extensive lengths to perform a statistically
significant audit of the accuracy of OSHA 200 recordkeeping. The
results of the official OSHA audits of OSHA 200 logs for 1996 and
1997 are compelling. OSHA found that, at the 95% threshold of
accuracy, the percentage of establishments with accurate records
[for total recordable cases (TR) and for lost workday cases (LW)]
was [for 1996, 87.96% TR and 86.57% LW; for 1997, 91.93% TR and
89.69% LW] * * *. Based on * * * review of the studies cited by OSHA
[in the proposal], it is clear that they do not support OSHA's
allegation of a substantial and widespread underreporting of
occupational injuries and illnesses. Rather than looking back to
limited reviews of
[[Page 68388]]
``ancient history,'' OSHA is required to look at the best available
evidence, which is the 1996 and 1997 audit reports. They demonstrate
an extremely high level of accuracy in OSHA 200 recordkeeping from
samples determined to be representative * * *.
Ex. 500-168, pp. 9-10, 21. The ORC also pointed to OSHA's audits:
[t]he [audit] process is centered around comprehensively
checking both occupational and nonoccupational injury and illness
records to identify misreporting and under reporting. Employee
interviews are also used when the compliance staff deems them
necessary. The results from the audits provide the only
statistically reliable insights available into the quality of the
OSHA data and the accuracy of employee reporting and employer
recording practices.
Ex. 32-78-1 at 27. ORC noted that most of the studies cited by OSHA
examine data that is more than a decade old and that may not reflect
improvements due to the Agency's stepped-up recordkeeping enforcement
efforts and recent guidance on the proper recording of cumulative
trauma disorders (Ex. 32-78-1, p. 26). ORC and others also noted that
Agency officials, including Assistant Secretary Charles Jeffress, have
expressed confidence in the accuracy of BLS statistics (see e.g., Exs.
32-78-1, p. 27; 30-1722, p. 75-76; 30-3347).
OSHA's recent recordkeeping audits were designed to measure whether
employer records accurately reflect injuries and illnesses that
employees reported to them. Therefore, the auditors examined
occupational records to identify the work-related injuries and
illnesses that may have occurred to employees, including, where
available, medical records, workers' compensation records, insurance
records, payroll records, company safety incident reports, first-aid
logs, and light duty rosters (Ex. 500-168-1, Appx. Analysis of Audits
on 1996 Employer Injury and Illness Recordkeeping, Audit Protocol at 6,
(v)). The audit protocol did not require the auditors to examine non-
workplace records to determine whether employees within the sample
group had suffered work-related MSDs which were not reported because
the employees did not seek treatment from the employer or the
employers' health insurance, file a worker's compensation claim, take
leave, or otherwise enter the employer's records. Id. By contrast, a
number of studies in the record examine non-workplace records and other
sources in determining that MSDs are not accurately reflected in the
OSHA logs. For example, in performing health hazard evaluations (HHEs)
at several establishments, NIOSH found that a high proportion of MSDs
reflected in the records of employees' private health care providers,
in confidential interviews, and in standardized questionnaires and
surveys were not included in the employers' logs. NIOSH reported that:
These HHEs compared the OSHA 200 logs with work-related MSDs
ascertained via the following mechanisms: (1) confidential medical
interviews; (2) review of employee medical records of private health
care providers; (3) health surveys utilizing standardized MSD
symptom questionnaires; (4) health surveys defining cases as those
with work-related symptoms and positive physical findings conducted
by physicians performing physical examinations targeted to the
musculoskeletal systems. We have no reason to believe that these
HHEs are not representative of the likely widespread under-reporting
of work-related MSDs.
Ex. 32-450-1. Moreover, several of the studies discussed in the
proposed rule examine data sources that appear to be different from
those considered in OSHA's audits (see e.g., Exs. 26-28; 26-1261; 26-
1259; 26-1250).
For these reasons, OSHA believes that the recent audits do not
undercut the findings in the literature that widespread underreporting
exists. The logs are a reasonably accurate reflection of those injuries
and illnesses actually reported by employees at work.\13\ OSHA believes
that many recordable MSDs are omitted from OSHA logs and other
workplace records because employees do not inform their supervisors, do
not file a claim for workers' compensation, or do not seek treatment
from the employer's medical staff or health insurance provider. This is
apparent not only from the studies examining the logs, but also from
the evidence on employee reporting behavior in the workers'
compensation field, and the direct testimony of many workers themselves
during the hearing. Considering the record as a whole, OSHA finds that
there is reliable, persuasive evidence that MSDs are currently
underreported in the OSHA injury and illness records.
---------------------------------------------------------------------------
\13\ The audits show that approximately 10% or more of injuries
and illnesses reported by employees are not recorded in the logs.
---------------------------------------------------------------------------
Employer representatives also argued that OSHA's estimate in the
proposed rule that ``most MSDs do not result in any days away from
work'' (64 FR 65853) undermines the need for WRP (Exs. 32-211-1; 30-
1722). The Chamber of Commerce argued that ``[b]oth * * * propositions
cannot be true: either large numbers of employees are refraining from
reporting lost-time injuries to avoid significant financial losses,
thus requiring WRP, or few such losses are occurring--which means that
[the] WRP provision is unnecessary.'' (Ex. 30-1722, p. 77.).
OSHA does not believe that the two propositions cited by the
Chamber are inconsistent. As discussed above, a significant factor
motivating employees not to report MSDs is the fear that they will be
placed in a restricted duty job with reduced pay and benefits, and that
they may also lose seniority or ``bidding'' rights. Thus, employees'
concern about being out of work altogether is not the only, or
necessarily the predominant, factor to be considered in evaluating the
need for WRP. Moreover, there is no fundamental tension between OSHA's
conclusion that workers' fear of economic loss is a significant
contributing factor to the high level of underreporting observed in the
literature, and its estimate that most MSDs will not result in time
away from work. As discussed further in the Significance of Risk and
the Benefits chapter of the Final Economic Analysis supporting this
rule, a significant proportion of all MSDs (approximately one-third)
will result in some lost work time, and certain types of MSDs, such as
carpal tunnel syndrome, require nearly a month to recover sufficiently
to return to work (median length of time away is 25 days). Therefore,
the prospect of losing work due to an MSD is a tangible one, and serves
as a powerful stimulus to employees. Indeed, the record evinces strong
and deeply held beliefs by many employees across industry sectors that
reporting MSDs and their signs and symptoms will result in loss of pay
and benefits, or other adverse employment action. Accordingly, concrete
wage and benefit protections are necessary to counter employees'
concerns about reporting MSDs.
Some commenters argued that there is no justification for requiring
WRP in light of OSHA's preliminary conclusion that WRP would not
increase the MSD reporting rate (see e.g., Exs. 32-211-1, p. 9; 32-234-
2, p. 27). In the Preliminary Economic Analysis of the proposed rule,
OSHA explained that it was then unable to quantify the incentive
effects of WRP on employee reporting of MSDs, and therefore had no
basis to estimate the costs and benefits attributable to increased
numbers of MSDs reported (64 FR 66001). However, the agency
``welcome[d] data and comments on the extent of MSD under reporting,
possible increases in the reporting of MSDs that may occur after
employers implement an ergonomics program, and on the incentive effects
of the proposed standard on employee reporting of MSDs.'' Id.
[[Page 68389]]
As explained in the Final Economic Analysis, OSHA has identified
several studies from the economics literature permitting the Agency to
develop a methodology that enables it to estimate the impact of WRP on
MSD reporting rates. Because wage and benefits protection requirements
will likely substantially increase the number of employees who will
report MSDs and their signs and symptoms, WRP is a reasonably necessary
and appropriate component of the final rule.
B. Legal Authority for WRP
1. The OSH Act and Past OSHA Practice Require That OSHA Include WRP In
This Standard
It is now well established that OSHA's authority to promulgate
occupational safety and health standards ``reasonably necessary or
appropriate to provide safe or healthful employment and places of
employment,'' 29 U.S.C. Sec. 652(8), encompasses the authority, in
appropriate cases, to include WRP provisions in those standards.
Section 6(b)(7) provides that a standard should, ``[w]here appropriate
* * * prescribe suitable * * * control * * * procedures'' to prevent
hazards. 29 U.S.C. Sec. 655(b)(7), and Section 8(g)(2) of the OSH Act
provides that ``[t]he Secretary * * * shall * * * prescribe such rules
and regulations as he may deem necessary to carry out his
responsibilities'' under the statute. 29 U.S.C. Sec. 657(g)(2). These
provisions give OSHA broad authority to require employers to implement
practices, such as WRP, that are reasonably necessary or appropriate to
achieve OSHA's statutory mission--providing safe or healthful
employment and places of employment. See 64 FR 65848-53 (Nov. 23,
1999).
Relying on both this statutory language and the OSH Act's
legislative history, the D.C. Circuit affirmed a WRP provision in
OSHA's 1978 lead standard requiring employers to maintain an employee's
earnings and other rights and benefits during a work removal period of
up to 18 months. United Steelworkers of America v. Marshall (Lead), 647
F.2d 1189, 1230 (D.C. Cir. 1980), cert. denied, 453 U.S. 913 (1981).
[Note: In the lead standard, the provision at issue was termed medical
removal protection (MRP).] The court held that (1) the OSH Act gives
OSHA broad authority to include WRP where necessary or appropriate to
protect the health of workers, and (2) OSHA's inclusion of WRP in the
lead standard was supported by the rulemaking record. Id. at 1228-40.
The court held that ``OSHA's statutory mandate is, as a general matter,
broad enough to include [WRP].'' Id. at 1230. The court also found that
OSHA had met its burden of demonstrating that WRP was reasonably
necessary and appropriate by providing evidence that employees would
resist cooperating with the medical surveillance program in the lead
standard absent assurances that they would have economic protection in
the event of a medical removal. Id. at 1237.
OSHA has followed a consistent practice of including WRP provisions
in standards when the rulemaking records show that the provision is
useful or necessary to achieve the purposes of the standard. OSHA has
included similar WRP provisions in numerous other standards. See e.g.,
29 CFR 1910.1025 (Lead); 29 CFR 1910.1027 (Cadmium); 29 CFR 1910.1028
(Benzene); 29 CFR 1910.1050 (Methylenedianiline); 29 CFR 1910.1052
(Methylene Chloride). OSHA's inclusion of WRP in those standards was
based upon findings that absent some wage protection employees would
not participate in the medical surveillance provisions of the
standards. See e.g., Lead preamble, 43 FR 5440 (Nov. 21, 1978).
In 1987, OSHA omitted a WRP provision from its formaldehyde
standard on the bases that the ``nonspecificity of signs and symptoms
[made] an accurate diagnosis of formaldehyde-induced irritation
difficult,'' the symptoms of formaldehyde exposure often quickly
resolved, and some employees would never be able to return to a work
environment that contained any formaldehyde. 52 FR 46168, 46282 (Dec.
4, 1987). On review, however, the D.C. Circuit held that these
justifications, which it characterized as ``feeble'' or ``vague and
obscure,'' were inadequate to justify OSHA's ``swerve'' from past
practice. See International Union v. Pendergrass (Formaldehyde), 878
F.2d 389, 400 (D.C. Cir. 1989). The court remanded the issue for OSHA's
further consideration. OSHA eventually included a WRP provision in the
standard:
On reconsideration, the Agency has concluded that [WRP]
provisions can contribute to the success of the medical surveillance
programs prescribed in the formaldehyde standard. Unlike some other
substance-specific standards, the formaldehyde standard does not
provide for periodic medical examination for employees exposed at or
above the action level. Instead, medical surveillance is
accomplished in the final rule through the completion of annual
medical questionnaires, coupled with affected employees' reports of
signs and symptoms and medical examinations where necessary. This
alternative depends on a high degree of employee participation and
cooperation to determine if employee health is being impaired by
formaldehyde exposure. OSHA believes these new [WRP] provisions will
encourage employee participation in the standard's medical
surveillance program and avoid the problems associated with
nonspecificity and quick resolution of signs and symptoms that
originally concerned the agency. 57 FR 22290, 22293 (May 27, 1992).
Formaldehyde makes clear that OSHA may not decline to include WRP
in standards absent specific findings justifying such a ``swerve'' from
past practice. The rulemaking record here does not support such a
``swerve'; to the contrary, it shows that WRP could serve functions
strikingly similar to those it serves in the formaldehyde standard.
Substantial evidence shows that MSDs are currently underreported and
that a significant reason for this underreporting is employees' fear
that they will lose income, or even their jobs. In order to encourage
employees to report MSDs, report them at an early stage, and
participate in MSD management, OSHA must include WRP in this standard.
Despite the legal principles described above, however, a number of
rulemaking participants argued that OSHA does not have authority to
include WRP in this standard. Their reasons ranged from factors
specific to this rule to more general assertions that OSHA never has
authority to require WRP, and that the cases holding to the contrary
were wrongly decided. OSHA responds to these comments below.
Some commenters stated that OSHA does not have authority to include
WRP (or even provisions for work restrictions) in this standard because
there are no ``objective'' triggers for removal. See e.g., Ex. 500-188,
p. 87. These commenters contended that in every other standard where
OSHA has included a WRP provision, OSHA established (1) an
``objective'' exposure level for removal, and (2) ``objective'' medical
criteria for removal. In this standard, they argued, employers will be
forced to remove employees from work based solely on reports of
``subjective symptoms.'' Ex. 30-4467, pp. 17-18.
This argument is based on erroneous conceptions of the WRP
provisions in both OSHA's earlier standards and this one. First, other
standards frequently require removal based upon a physician
determination that removal is appropriate, even without ``objective''
triggers. In the lead standard, for example, an employee can be removed
from work when ``a final medical determination results in a medical
finding * * * that the employee has a detected medical condition which
[[Page 68390]]
places the employee at increased risk of material impairment to health
from exposure to lead.'' 29 CFR 1910.1025(k)(1)(ii). This determination
does not have to be based on objective tests; rather, it can be based
upon a physician's independent judgment. In the Cadmium standard, an
employee can be removed based upon ``signs or symptoms of cadmium-
related dysfunction or disease, or any other reason deemed medically
sufficient by [a] physician.'' 29 CFR 1910.1027(11)(i)(A); see also
Methylenedianiline 29 CFR 1910.1050(9)(i)(B)(1) (removal shall occur
``on each occasion that there is a final medical determination or
opinion that the employee has a detected medical condition which places
the employee at increased risk of material impairment to health from
exposure to MDA'').
Second, this standard does not require employers to provide WRP to
employees based solely on employee reports of ``subjective'' symptoms.
The employer makes the determination of whether an employee's report
qualifies as an MSD incident under this standard. See Paragraph (e).
Employers can seek assistance in making these determinations by
referring employees to a health care professional. In the end, however,
it is the employer's decision. Moreover, this final standard includes
an Action Trigger in paragraph (f). If an employee who has suffered an
MSD incident is not exposed on his or her job to risk factors at levels
that exceed those on the screening tool in Table 1, the employer has no
WRP obligations. See Paragraph (f).
In any event, neither the OSH Act nor any of the court decisions
interpreting OSHA's authority suggest that OSHA's WRP authority is
limited to protecting workers only against conditions that are easy to
diagnose. On the contrary, the OSH Act gives OSHA broad authority to
include provisions in standards that are reasonably necessary and
appropriate to effectuate its statutory mandate. OSHA has found, based
upon substantial evidence in the rulemaking record, that WRP is
necessary to the effectiveness of this standard. This finding is not
affected by the presence (or absence) of ``objective'' baseline tests
for certain MSDs or the presence (or absence) of ``objective'' or
baseline levels for removal.
Some commenters argued that OSHA does not have authority to include
WRP in this standard because employees are exposed to some of the
hazards at issue outside of the workplace. See e.g., Ex. 500-197, p.
III-76. But while it is true that OSHA may only regulate ``conditions
that exist in the workplace,'' Industrial Union Dep't, AFL-CIO v.
American Petroleum Institute et al.(Benzene), 448 U.S. 607, 642 (1980),
OSHA is not precluded from regulating such conditions just because they
may also exist outside the workplace. Forging Industry Assn. v.
Secretary of Labor (Noise), 773 F.2d 1436, 1442 (4th Cir. 1985). OSHA's
Occupational Noise standard, for example, establishes certain
requirements that must be met to prevent or reduce the incidence of
hearing impairment, a condition that can also be caused by exposure to
excessive noise levels outside of work. And OSHA has previously
required WRP where employees are also exposed to the hazard at issue
outside of the workplace. For example, employees may be exposed to
lead, cadmium, methylene chloride, and formaldehyde in varying degrees
outside of work. In this case, OSHA has properly exercised its
authority to regulate ergonomic hazards in the workplace. The OSH Act
thus does not prevent OSHA from including WRP in this standard merely
because employees may be exposed to some ergonomic risk factors outside
of work.
OSHA also does not agree that it may not include a WRP provision in
a standard that is not promulgated pursuant to section 6(b)(5) of the
OSH Act. Ex. 500-223, pp. 81-82. OSHA's authority to include WRP in
this standard derives from numerous provisions of the OSH Act,
including sections 3(8), 6(b)(7), and 8(g)(2). These provisions give
OSHA broad authority to implement measures reasonably necessary or
appropriate to effectuate its statutory goal. OSHA's authority to
include WRP is not granted by section 6(b)(5) of the OSH Act or limited
to standards promulgated pursuant to section 6(b)(5). Section 6(b)(5)
applies to toxic materials and harmful physical agents and requires
OSHA to ``set the standard which most adequately assures, to the extent
feasible * * * that no employee will suffer material impairment of
health or functional capacity even if such employee has regular
exposure to the hazard * * * for the period of his working life.'' 29
U.S.C. 655(b)(5).
To be sure, OSHA has previously required WRP only in section
6(b)(5) standards. But the reason for that inclusion was record
evidence that absent some wage protection employees would not
participate in the medical surveillance or medical management programs
of those standards. Non-section 6(b)(5) standards, on the other hand,
do not include medical surveillance provisions. OSHA has thus found it
unnecessary to include WRP in those standards. OSHA's past practice
does not indicate that WRP can only be included in section 6(b)(5)
standards; rather, it demonstrates that WRP can only be included in
standards based upon findings that it is reasonably necessary or
appropriate. OSHA has made those findings here.
Some commenters argued that Congress' establishment of the National
Commission on State Workmen's Compensation Laws (National Commission)
in the OSH Act to examine the effectiveness of state workers'
compensation systems suggests that Congress did not want to
``federalize'' workers' compensation through a provision such as WRP.
Ex. 30-3811, pp. 15-16. But Congress established the National
Commission to provide an ``objective evaluation of State work[ers']
compensation laws in order to determine if such laws provide an
adequate, prompt, and equitable system of compensation for injury or
death arising out of or in the course of employment.'' See 29 U.S.C.
676. In Lead, the D.C. Circuit examined whether Congress's
establishment of the National Commission demonstrated a legislative
hostility to WRP. The court held that it did not. Lead, 647 F.2d at
1235 n.70. Of particular importance to the court was that WRP did not
``federalize'' workers' compensation, rather it left the state workers'
compensation scheme wholly intact as a legal matter. Id. Thus, even if
Congress evinced a hostility to the ``federalization'' of workers'
compensation through the OSH Act, the WRP provision at issue did not
effect such ``federalization.'' Id.
Similarly and as explained in more detail below, WRP in this
standard will not affect or supersede workers' compensation systems;
nor will WRP have a great practical effect on workers' compensation.
WRP is not designed to ``compensate'' workers who suffer from MSDs, to
provide them with medical treatment for their work-related injuries or
illnesses, or to determine the extent of their disability, all
functions reserved to workers' compensation; WRP is designed to
encourage employees to report MSDs early and participate in MSD
Management. In that sense, WRP serves as an administrative control,
working to prevent injuries from becoming disabling and compensable.
NCE et al.also claimed to find additional evidence that Congress
did not intend OSHA to have authority to require WRP in Congress'
refusal to include the ``Daniels Amendment'' in the OSH Act. Ex. 500-
197, pp. III-73-
[[Page 68391]]
80. The Daniels Amendment would have required the Secretary of Health,
Education, and Welfare to publish an annual list ``of all known or
potentially toxic substances and the concentrations at which such
toxicity is known to occur,'' and to determine whether the levels of
toxic substances present in individual workplaces posed a hazard to
employees. It then would have prohibited employers from requiring
employees to work in areas that had been determined to be hazardous
without certain listed protections, ``unless such exposed employee may
absent himself from such risk or harm for the period necessary to avoid
such danger without loss of regular compensation for such period.'' See
Lead, 647 F.2d at 1233.
In the first place, it is difficult to read significant
congressional intent not to grant regulatory authority into the failure
of the Congress to enact a provision in the Agency's enabling Act. See
U.S. Ex. Rel. Stinson v. Prudential Insurance, 944 F.2d 1149, 1157 (3d.
Cir. 1991); see generally 2A Sutherland Statutory Construction
Sec. 48.18. This is especially true when the provision is not identical
to the regulation requirement at issue. And the Daniels Amendment has
little in common with OSHA's WRP provisions. It would have provided the
grounds for removal from work based upon informal action by the
Secretary of Health, Education, and Welfare. WRP, however, results from
OSHA rulemaking involving notice and comment procedures. See Lead, 647
F.2d at 1233. Further, WRP depends in large measure on a health care
professional's determination that removal is appropriate, and the
standard also contains a dispute resolution procedure to address
disagreements among health care professionals. See Paragraph (s). More
important, the Daniels Amendment would have allowed an employee to make
an individual judgment that the grounds for removal applied; employees
could thus effectively remove themselves from the workplace. Lead, 647
F.2d at 1233. Under WRP, however, removal occurs when certain criteria
are met, and may even occur against an employee's will. See Paragraphs
(e), (f), and (r). Because of these differences, the D.C. Circuit held
in Lead that the Daniels Amendment ``would probably invite controversy
and abuse in a way that [WRP] would not, so the reasons for which
Congress rejected the [Daniels Amendment] may well not apply to
[WRP].'' Lead, 647 F.2d at 1233-34.
Even so, NCE et al.argued that the Lead decision was incorrect
because it misinterpreted a 1980 Supreme Court decision, Whirlpool
Corp. v. Marshall, 445 U.S. 1 (1980). Ex. 500-197. OSHA is not
convinced by this argument. The D.C. Circuit did not rely on the
Whirlpool decision in holding that the Daniels Amendment violated
congressional intent. Rather, the D.C. Circuit examined independently
the language and history of the Daniels Amendment in reaching its
conclusions. See Lead, 647 F.2d 1233-34 n.69. Although the court
discussed Whirlpool, which it found consistent with its interpretation
of the Daniels Amendment, its analysis did not rely on the Whirlpool
decision. Id. Furthermore, the D.C. Circuit did not misread Whirlpool
by noting the context of the Supreme Court's holding--that the Daniels
Amendment would have allowed employees to unilaterally leave work at
full pay under certain circumstances. Id.
Commenters also argued that WRP is barred by the Executive Order on
Federalism (Executive Order), specifically sections 2(i) and 3(b). Ex.
30-3811, pp. 16-18. Section 2(i) of the Executive Order states that
``[t]he national government should be deferential to the States when
taking action that affects the policymaking discretion of the States
and should act only with the greatest caution where State or local
governments have identified uncertainties regarding the constitutional
or statutory authority of the national government.'' Section 3(b)
provides that ``[n]ational action limiting policymaking discretion of
the States shall be taken only where there is constitutional and
statutory authority for the action and the national activity is
appropriate in light of the presence of a problem of national
significance. Where there are significant uncertainties as to whether
national action is authorized or appropriate, agencies shall consult
with appropriate State and local officials to determine whether Federal
objectives can be attained by other means.'' 64 FR 43255 (Aug. 10,
1999). The Executive Order sets forth fundamental federalism
principles, federalism policymaking criteria, and provides for
consultation by federal agencies with state or local governments when
policies are being formulated which potentially affects them. [Note:
Section XIII of this preamble describes the Executive Order in more
detail and discusses OSHA's interactions with State and local
governments in the development of this rule. It also contains a
certification by the Assistant Secretary that OSHA has complied with
the applicable requirements of the Executive Order.]
WRP is not ``barred'' by the Executive Order. First, there is no
``uncertainty'' with respect to OSHA's authority to include WRP in this
standard. As explained above, the OSH Act gives OSHA broad authority to
include WRP where necessary or appropriate to effectuate its statutory
mandate. Indeed, the rulemaking record requires OSHA to include WRP in
this standard. Second, OSHA has found that ``national action'' is
necessary to deal with the significant risk of MSDs in the workplace.
As shown in great detail in the Risk Assessment and Significance of
Risk sections, the problem of MSDs is national in scope. See Sections
VI and VII below. Under these circumstances, a national standard to
prevent MSDs is appropriate under the OSH Act and entirely consistent
with the federalism policies set forth in the Executive Order.
Third and finally, OSHA consulted with stakeholders, including
representatives from State and local governments, on WRP (and the
standard in general). Numerous representatives from State and local
governments testified at the hearing. See e.g., 502-476 (Testimony of
The Honorable Eliot Spitzer, New York State Attorney General; Testimony
of National League of Cities). These same commenters and many others
also submitted written comments on the proposed rule, including
comments on WRP. See Section XIII for a larger discussion of the
participation of State and local governments in the rulemaking
proceedings. OSHA considered these comments in developing the final
standard. OSHA also specifically sought comment from the public
(including State and local governments) on whether the objectives of
WRP could be attained by other non-regulatory means. 64 FR 65858 (Nov.
23, 1999). OSHA considered the various alternatives suggested; OSHA
ultimately concluded, however, that those alternatives would be unable
to accomplish the objectives of WRP (see Chapter VIII, Non-Regulatory
Alternatives, of the Final Economic Analysis).
Finally, representatives of the insurance industry also argued that
the McCarran-Ferguson Act prevents OSHA from including WRP in this
standard. Ex. 30-3811, pp. 38-39. The McCarran-Ferguson Act states, in
pertinent part: ``No Act of Congress shall be construed to invalidate,
impair, or supersede any law enacted by any State for the purpose of
regulating the business of insurance, or which imposes a fee or tax
upon such business, unless such Act specifically relates to the
business of insurance.'' 15 U.S.C. Sec. 1012(b). Congress passed the
McCarran-Ferguson Act in reaction to
[[Page 68392]]
the Supreme Court's decision in United States v. South-Eastern
Underwriters Assn. (South-Eastern), 322 U.S. 533 (1944). In South-
Eastern, the Supreme Court held that ``insurance transactions were
subject to federal regulation under the Commerce Clause, and that the
antitrust laws, in particular, were applicable to them.'' SEC v.
National Securities, Inc., 393 U.S. 453, 457 (1969). The McCarran-
Ferguson Act was an attempt to ``turn back the clock [to the time
before the Supreme Court decision], to assure that the activities of
insurance companies in dealing with their policyholders would remain
subject to state regulation.'' Id. at 458-59.
The McCarran-Ferguson Act does not prevent OSHA from acting
pursuant to its own authority under the OSH Act. OSHA derives its
authority to issue standards from the OSH Act; OSHA is authorized to
implement standards ``reasonably necessary or appropriate'' to
accomplish its statutory goal. As explained in detail above, OSHA is
operating well within its statutory authority by including WRP in this
standard. The McCarran-Ferguson Act has no bearing on that authority.
See Women in City Government United et al. v. City of New York, 515 F.
Supp. 295, 303 (S.D.N.Y. 1981) (The McCarran-Ferguson Act was not
intended to be applied ``indiscriminately to subsequent federal
legislation * * * solely because legislation fails specifically to
state that it is applicable in circumstances where insurance interests
are implicated.'').
And, as explained more fully below in the discussion of section
4(b)(4) of the OSH Act, WRP will not invalidate, impair, or supersede
any workers' compensation law or system. The operation of workers'
compensation laws will remain unchanged after the standard is
promulgated. WRP also will not supersede workers' compensation systems
by encouraging or discouraging claims in those systems. The McCarran
Ferguson Act does not prevent OSHA from issuing WRP.
2. Section 4(b)(4) Does Not Prohibit OSHA From Including WRP and Other
Provisions in This Standard.
(a). Section 4(b)(4) does not prohibit OSHA from including WRP in
this standard.
The most persistent criticism of WRP is that Section 4(b)(4) of the OSH
Act forbids OSHA from imposing any type of wage continuation
requirement. Section 4(b)(4) provides:
``Nothing in this Act shall be construed to supersede or in any
manner affect any workmen's compensation law or to enlarge or
diminish or affect in any other manner the common law or statutory
rights, duties, or liabilities of employers and employees under any
law with respect to injuries, diseases, or death of employees
arising out of, or in the course of, employment.'' 29 U.S.C.
653(b)(4).
In the preamble to the proposed rule, OSHA explained in detail how
the proposed WRP provision did not violate section 4(b)(4) of the OSH
Act. Section 4(b)(4) of the OSH Act was intended to bar ``workers from
asserting a private cause of action against employers under OSHA
standards,'' and to prevent any party in an employee's claim under a
workers' compensation law or other State law from asserting that an
OSHA regulation or the OSH Act itself preempts any element of State
law. Lead, 647 F.2d at 1235-36. In short, section 4(b)(4) prohibits
OSHA from legally preempting state workers' compensation law. Id. Thus,
even if WRP were to have a ``great practical effect'' on state workers'
compensation systems, it would not violate section 4(b)(4) so long as
it left the state scheme ``wholly intact as a legal matter.'' Id. at
1236 (emphasis in original).
The rulemaking record confirms that WRP in this standard will not
change the legal scheme of state workers' compensation systems.
Professor Emily Spieler, who is one of the nation's leading scholars on
state workers' compensation systems and their interaction with other
federal and state laws, submitted written comments and testified at
great length on the effects of WRP on state workers' compensation
systems. As noted above, Professor Spieler served as the Commissioner
of the West Virginia Workers' Compensation Fund, responsible for
setting insurance premium rates, premium collection from employers,
initial claims review, and adjudication. She has lectured extensively
on employment law and public health issues, and has authored and/or co-
authored numerous articles on workers' compensation, see Ex. 37-14,
Curriculum Vitae of Emily A. Spieler, including:
Spieler E. Is Workers' Compensation the Only Legal Remedy
for Workers Who Are Injured at Work? In Occupational Health:
Recognition and Prevention of Work-Related Disease and Injury (4th ed.
(Lippincott, Williams & Wilkins, Levy BS, Wegman, DW, eds., 2000).
Spieler E. Dispute Resolution in Workers' Compensation
Managed Care. Report prepared for Robert Wood Johnson funded project, A
Guide to Evaluating the Effectiveness of Managed Care Programs in
Workers' Compensation.
Spieler E. Perpetuating Risk? Workers' Compensation and
the Persistence of Occupational Injuries, 31 Houston Law Rev. 119-264
(1994).
Spieler E. Injured Workers, Workers' Compensation, and
Work, 95 W.Va. Law Rev. 333-467 (1992-93).
Professor Spieler stated that WRP would not alter or affect the
legal scheme of state workers' compensation systems; nor would it
``supersede'' those systems. Specifically, she stated:
(1) WRP would in no way change the eligibility criteria for
obtaining workers' compensation benefits in the state workers'
compensation systems. In fact, she noted that the eligibility
criteria for WRP and the eligibility criteria for state workers'
compensation were substantially different.
(2) WRP would in no way change the filing requirements for state
workers' compensation claims. Thus, an employee report of an MSD
under the standard would not constitute the filing of a workers'
compensation claim. Every state has its own procedures for filing
workers' compensation claims; these would remain unchanged by WRP.
(3) WRP would in no way change the benefit payments paid through
workers' compensation systems. Workers' compensation benefits are
set by state statute; WRP would not affect the payment of those
benefits.
(4) WRP would in no way change the review and adjudication
process governing workers' compensation claims. ``Because of the no-
fault principle of the workers' compensation program[], the level of
hazard in the workplace and the general treatment of the injured
worker is irrelevant to workers' compensation proceedings. In fact,
OSHA rules have largely remained outside of workers' compensation
discussions and proof. The existence of an ergonomics standard will
not change that.''
(5) WRP would not cause an increase in workers' compensation
premiums or change the calculation of workers' compensation premium
rates.
Id. at 15-18; Ex. 500-140, pp. 1-2.
In summary, Professor Spieler stated that ``the proposed ergonomics
standard [including WRP would] not interfere with, undermine, or
federalize workers' compensation systems or illegally or
inappropriately undermine the exclusivity doctrine.'' Id. at 18. See
also Ex. 500-26 (Lynn Marie-Crider).
The Attorney General of New York State, Eliot Spitzer, echoed these
same points with respect to the New York State workers' compensation
system. General Spitzer stated that WRP would leave New York's workers'
compensation system ``wholly intact as a legal matter.'' Ex. DC 75, p.
3. Specifically, WRP would not affect workers' compensation eligibility
criteria in New York. Id. at 5. Neither would employers in New York
State be effectively admitting liability under the state system by
making certain
[[Page 68393]]
determinations required by the standard, ``such as whether an employee
has a covered MSD, whether that employee should be referred to a
healthcare provider, or whether a WRP payment should be made.'' Id. at
6. General Spitzer also stated that WRP would not affect state workers'
compensation laws by obstructing the states' return-to-work objectives.
On the contrary, he stated that ``by encouraging early diagnosis and
treatment of covered injuries * * * WRP would promote, not obstruct,
rehabilitation and early return to work.'' Id. at 9. Finally, General
Spitzer stated that WRP would not interfere with the exclusivity
doctrine of workers' compensation: ``In my view there is no
interference with these provisions because WRP is not providing
remedies for injuries. Instead, by reducing the financial risks
associated with reporting injuries, the income maintenance provisions
of WRP would promote early reporting and treatment of the covered
injuries and prompt adjustments in workplace conditions for similarly
situated workers.'' Id. at 9-10. In making these observations, General
Spitzer noted that similar WRP provisions in other OSHA standards have
not interfered with the functioning of the New York State workers'
compensation system. See Tr. 3385-3407.
Eighteen Attorneys General submitted post-hearing letters agreeing
with the testimony of General Spitzer that WRP would leave state
workers' compensation schemes wholly intact as a legal matter and not
``affect'' or ``supersede'' state systems in violation of section
4(b)(4). See Ex. 500-48.
There is also no record evidence to support the assertion that WRP
will have a significant practical effect on state workers' compensation
systems. Injured workers will still have numerous incentives to file
for workers' compensation. First, neither WRP nor other provisions of
the standard require employers to pay for or provide medical treatment.
If a worker is injured on the job and requires medical treatment, that
worker will need to file for workers' compensation. As noted by
Professor Spieler, and consistent with the injury data described in
Section VII, a large proportion of MSD claims in workers' compensation
systems are for medical benefits only. Ex. 37-14, p. 16. Those
individuals who are seeking only medical treatment through workers'
compensation will not be affected by WRP. Second, WRP only requires
employers to maintain 90% of a removed employee's gross earnings and
benefits for up to 90 days. See Paragraph (r)(3). If a worker requires
benefits for longer than that period of time, the worker will need to
file for workers' compensation. Currently, 80% of workers' compensation
indemnity benefits are for permanent disability. Id. Ex. 37-14, p. 16.
Many of the workers receiving permanent disability benefits would not
be eligible for WRP.
At the same time, OSHA does not expect that the number of workers'
compensation claims will rise dramatically with WRP. As Professor
Spieler stated in her written comments, ``the existence of the WRP
provision is very unlikely to discourage--or encourage--the filing of
workers' compensation claims.'' Id. This has been confirmed by earlier
WRP provisions in other health standards where there has been no
dramatic observable increase or decrease in the short run in the number
of workers' compensation claims filed for conditions covered by WRP and
state workers' compensation systems. See generally id. at 18; Ex. 500-
218, p. 128.
For all of these reasons, WRP does not violate section 4(b)(4) of
the OSH Act. Some commenters argued the opposite, however. Some argued
that the language of section 4(b)(4) is unambiguous on its face: it
precludes ``any interference [with State workers' compensation
systems], whether of a legal, economic, public policy, practical or
other kind.'' Ex. 30-3811, p. 14. These representatives also argued
that the Lead decision was incorrectly decided; courts today, they
argued, would interpret section 4(b)(4) differently. Id.; see also Ex.
32-22-1, pp. 34-35; Ex. 30-4467, p. 17. In addition, some commenters
argued that numerous factual differences exist between WRP in this
standard and WRP in the lead standard that make OSHA's reliance on the
Lead decision misplaced. See Ex. 500-223, pp. 81-82; Ex. 30-4467, pp.
17-22. One important difference, according to these commenters, was
that few employees under the lead standard would be eligible for both
workers' compensation and WRP, whereas many employees under this
standard will be eligible for both workers' compensation and WRP. See
Ex. 500-223, pp. 84-85.
OSHA does not believe that section 4(b)(4) can be interpreted to
prohibit OSHA from having any impact, either directly or indirectly, on
state workers' compensation systems. Such an interpretation would
prevent OSHA from enacting any occupational safety and health standard,
for, as the court noted in Lead, ``any health standard that reduces the
number of workers who become disabled will of course `affect' and even
`supersede' worker's compensation by ensuring that those workers never
seek or obtain work[ers'] compensation benefits.'' Lead, 647 F.2d at
1235. Congress obviously did not intend section 4(b)(4) to so limit
OSHA's standard-setting authority. Instead, section 4(b)(4) is intended
to prevent OSHA from affecting or superseding any state workers'
compensation law; as the court noted in Lead, it is intended to ``bar[]
workers from asserting a private cause of action against employers
under OSHA standards,'' and to prevent a worker or employer from
asserting in a state proceeding ``that any OSHA regulation or the OSH
Act itself preempts any element of state law.'' Id. at 1236. OSHA has
shown that WRP does neither.
Furthermore, there are not ``numerous'' factual differences between
WRP in the lead standard and WRP in this standard. In fact, as
explained above, there are a substantial number of similarities. To be
sure, there may be a greater number of workers who qualify for WRP and
state workers' compensation benefits under this standard than under the
lead standard. Like the lead standard, however, these numbers will
decline after the standard is in place. OSHA predicts that by
encouraging early reporting, employees will report signs and symptoms
of MSDs before they become disabling and compensable under state
workers' compensation systems. Thus, the only ``effect'' of WRP will be
that fewer employees will become disabled under state workers'
compensation systems. As the court correctly noted in Lead, this is
precisely the effect OSHA standards are intended to have. Lead, 647
F.2d at 1235.
Several commenters argued that WRP improperly ``supersedes'' the
exclusive remedy provisions of state workers' compensation laws,
essentially giving employees additional ``litigation rights'' before
the Occupational Safety and Health Review Commission and the federal
courts. Ex. 30-3811, pp. 19-22; see also Ex. 32-22-1, pp. 11-12.
Workers' compensation systems were initially designed to provide
the sole remedy for injuries and illnesses covered by the systems. Of
primary importance was that employees would no longer be permitted to
assert a negligence claim against employers for injuries arising out of
and in the course of employment. Ex. 37-14, p. 12 (Spieler). ``Notably,
workers' compensation continues to bar alternative tort-based legal
actions against employers that involve negligently caused physical
injuries arising out of and in the course of employment.'' Id. This has
been termed the ``exclusivity'' doctrine.
[[Page 68394]]
As explained by Professor Spieler, however, a number of federal and
state laws have expanded the rights of injured workers.
``[A] wide variety of legal rights have developed since workers'
compensation laws were initially passed. These include federal
employment-based laws (such as OSHA, the Americans with Disabilities
Act, the Family Medical Leave Act) that provide additional rights to
people with work-related health conditions; state employment-based
laws (such as anti-retaliation rights under the public policy
exception to the at-will employment doctrine and disability
discrimination laws); state common law torts that provide remedies
for employer actions other than the specific negligence that caused
the injury (such as fraud); and, in a growing minority of states,
some expansion of the definition of intentional actions that remove
injuries from the state exclusivity provisions. All of these legal
developments represent an expansion of workers' rights when they are
injured at work. Id.
Thus, while the ``exclusivity'' doctrine still exists in workers'
compensation, it exists within the broader framework of other Federal
and State rights granted workers by Congress and state legislatures.
These rights have not been held to violate or contradict in any way the
exclusivity doctrine of state workers' compensation systems; ``[t]hey
do not change the exclusive nature of workers' compensation for the
specific purpose of shielding employers from common law tort actions
based on negligence.'' Id.
Neither does WRP. WRP provides employees some wage protection in
order to encourage them to report signs and symptoms of MSDs early.
``WRP does not create any common law tort remedy for [an] occupational
injury.'' Ex. 500-140, p. 2 (Spieler). WRP does not give employees any
additional procedural or substantive legal rights; WRP places a
requirement on employers to provide some wage protection to employees
when they are placed on temporary work restrictions. WRP does not give
employees a right to file a cause of action against an employer for WRP
benefits; WRP does not give an employee the right to file a cause of
action against an employer for failure to pay WRP. To be sure, the OSH
Act confers some procedural rights upon employees and/or their
designated representatives to participate in OSHA enforcement
proceedings; however, these rights were given employees by Congress and
are very limited. Indeed, employees may only question the Secretary of
Labor's exercise of prosecutorial discretion in an enforcement case
before the Occupational Safety and Health Review Commission on the
issue of abatement dates in a citation. 29 U.S.C. 659. WRP does not
violate the exclusivity doctrine of state workers' compensation
systems.
WRP also does not conflict with, or frustrate the return-to-work
policies of state workers' compensation systems. Ex. 30-3811, pp. 22-
24; Ex. 32-22-1, pp. 16-18. Most state workers' compensation systems
provide temporary total disability (TTD) benefits to injured workers in
the amount of 66 2/3rds of their average weekly wage. These payments
are not taxed. Dr. Leslie Boden testified at the informal public
hearing that OSHA's proposed WRP provision was approximately equal to
the amount of TTD benefits provided in state workers' compensation
systems. See Ex. DC-47. The vast majority of workers who receive WRP
because they are removed entirely from work, therefore, will receive
approximately the same amount of money with WRP as they would under
most state workers' compensation systems. Because WRP and TTD benefits
are approximately equal, WRP is no more repugnant to the ``return-to-
work'' philosophy than are state workers' compensation systems.
Even so, many injured workers currently receive supplemental
payments above and beyond workers' compensation. Some states
specifically authorize such a practice. According to Lynn-Marie Crider,
a former member of the Oregon Workers' Compensation Board and an expert
in workers' compensation:
``[T]here is nothing in any workers' compensation system with
which I am familiar that forbids workers from receiving greater wage
replacement payments than are provided for by the workers'
compensation system. Workers may receive supplementary payments from
the employer by tapping sick leave benefits, under a disability
insurance plan, and so forth. These additional payments are
specifically authorized by Oregon law. ORS 656.118. So, at least in
this state, it would be impossible to argue * * * that any
additional payments that a worker might receive under the WRP
provisions of the proposed rule violate an expectation that a worker
will receive no more than the maximum benefit amount established for
temporary disability compensation.'' Ex. 500-26, p. 4.
OSHA is unaware of any commenter who has argued that these supplemental
benefits are repugnant to the ``return-to-work'' philosophy of workers'
compensation.
Furthermore, current data indicates that 82% of workers with MSDs
are returned productively to work by HCPs and only 3% are removed
entirely from the workplace. See Ex. 500-118. By encouraging employees
to report signs or symptoms of MSDs early, OSHA believes that even
fewer workers will need to be removed entirely from work. In this
respect, this standard (including WRP) actually promotes the ``return-
to-work'' philosophy.
Finally, the record does not show that ``return-to-work'' is a
basic philosophy of workers' compensation. While many representatives
of the insurance industry aggressively argued that it is, Professor
Spieler had a contrary observation:
``[I]t is important to note that it is simply incorrect to say
that `return-to-work' is one of the `foundational concepts of
workers' compensation law.' Until the last 25 years, there was
absolutely no evidence that return-to-work was a basic component of
the workers' compensation world. Workers who collected benefits
under the workers' compensation systems had no right to return to
work; employers had no obligation to return them to work; and in
many cases workers who collected benefits were simply terminated
from employment. Recent judicial and legislative developments,
combined with an expanded understanding that aggressive return-to-
work efforts can increase productivity and decrease workers'
compensation costs, has led to a change in the way that this issue
is discussed in workers' compensation circles.'' Ex. 500-140, p. 3
(internal citations omitted).
Commenters also argued that WRP ``supersedes'' state workers'
compensation systems by eliminating injury requirements and lessening
causation requirements. See Ex. 30-3811, pp. 24-28; Ex. 32-22-1, pp.
12-13.
WRP will not directly change, alter, affect, or eliminate the
injury requirements or causation requirements of any state workers'
compensation law. States will continue to operate their systems in the
manner they deem appropriate. WRP will also not indirectly coerce
states to change or alter their injury and causation requirements. As
stated by Professor Spieler, ``[t]here is no logic to the claim that
WRP would force complete revision of state workers' compensation laws.
Workers' compensation [will] continue to process claims exactly as they
have always done.'' Ex. 500-140, p. 3. Furthermore, the fact that WRP
imposes (or does not impose) certain requirements on employers that are
different from workers' compensation in certain ways does not mean that
WRP ``supersedes'' such systems. In the words of Professor Spieler,
these differences ``underscore the fact that WRP leaves workers'
compensation unaffected.'' Id.
For the same reasons, OSHA also disagrees with those commenters who
argued that WRP would ``supersede'' state standards in workers'
compensation for determining the
[[Page 68395]]
amount of compensation. See Ex. 30-3811, p. 29-33. WRP will not change,
alter, or eliminate those state standards. The mere fact that WRP has a
``different'' benefit level and does not contain maximum or minimum
levels does not mean that it ``supersedes'' or ``affects'' state
workers' compensation systems; as explained above, it means just the
opposite.
Some commenters argued that WRP would drastically increase the
number of state workers' compensation claims, thus ``affecting'' state
systems in violation of section 4(b)(4). See e.g., Tr. 9786 (Nelson).
Other commenters, however, argued just the opposite: because WRP
provides ``greater benefits'' to injured workers, workers will not file
workers' compensation claims, thus ``affecting'' state workers'
compensation in violation of section 4(b)(4). See e.g., Ex. 30-4467,
pp. 19-20.
OSHA has addressed this issue in great detail above. OSHA does not
believe that claims for workers' compensation will increase
dramatically after the standard is promulgated; past experience with
other standards that include WRP supports this. See Ex. DC-75, p. 11.
On the other hand, OSHA does not believe that injured or disabled
workers will stop filing valid workers' compensation claims. See id. at
11-12. In order to receive medical benefits or benefits after 90 days,
employees will need to file for workers' compensation. As stated by
Professor Spieler, ``the existence of the WRP provision is very
unlikely to discourage--or encourage--the filing of workers'
compensation claims.'' Ex. 37-14, p. 16.
Some commenters argued that WRP ``affects'' or ``supersedes'' state
workers' compensation systems by providing for double recovery for
injured workers. See e.g., Ex. 32-22-1, p. 19-20. These commenters
specifically argued that state systems do not permit the attachment of
state workers' compensation payments; thus employers would have no
mechanism for retrieving from employees payments made pursuant to WRP.
Id.
As explained more fully below, WRP does not provide for double
recovery for injured workers. WRP includes a provision which allows
employers to reduce their WRP payments when an employee receives
payments from workers' compensation. It is immaterial in this respect
whether states permit or prohibit attachment of workers' compensation
payments. WRP does not speak to the issue of attachment of these
payments. Rather, WRP permits employers to reduce their WRP payments by
the amount received by the employee from other sources. This prevents
an employee from receiving ``double recovery.'' See also Discussion of
offset provision below.
Some commenters argued that WRP violates section 4(b)(4) because it
creates a conflict of interest between employers and insurance
carriers. See e.g., Tr. 6472-73 (McGowen).
OSHA is not convinced that WRP will create a conflict of interest
between insurance companies and employers. Both employers and their
insurance carriers have a common interest: reducing injuries and
illnesses at work. Reducing the incidence of MSDs will reduce WRP
payments as well as workers' compensation costs. OSHA believes that
both employers and insurance carriers currently share this goal and
will continue to share this goal after the standard is promulgated.
Even if the standard did introduce some conflict between insurance
carriers and employers with respect to any particular workers'
compensation claim, however, OSHA does not believe this violates
section 4(b)(4). Once again, section 4(b)(4) prohibits OSHA from
preempting, in whole or in part, the legal scheme of state workers'
compensation systems; any potential conflict of interest does not
directly or indirectly affect the legal scheme of any state system.
Two commenters suggested WRP violates section 4(b)(4) because it
will (1) Result in ``blatant forum shopping by employees and their
representatives,'' (2) serve as ``res judicata'' or ``collateral
estoppel'' in a later state workers'' compensation proceeding, (3)
create incentives for state administrators to encourage employees to
``file'' for WRP and not file a state workers'' compensation claim, and
(4) create disincentives for states to cover MSDs. See Exs. 32-300-1,
pp. 12-13; 30-3853, pp. 27-28.
First, OSHA does not understand how WRP, a uniform federal
requirement, would encourage ``blatant forum shopping'' by employees.
As shown, state requirements for filing of workers' compensation claims
will remain unchanged after the standard is promulgated. WRP would not
give employees any additional rights to file for workers' compensation
claims in other forums or allow employees to choose in which forums to
file workers' compensation claims.
Second, WRP will not serve as ``res judicata'' or ``collateral
estoppel,'' or otherwise be improperly used in any state workers''
compensation proceeding. The Attorney General of New York State
addressed this issue in his testimony at the informal public hearing:
``[E]mployers would not effectively admit liability under state
workers' compensation laws by making certain determinations required
by the WRP such as whether an employee has a covered MSD, whether
that employee should be referred to a health care provider, or
whether a WRP payment should be made. None of these determinations
would constitute an admission of liability under New York's Workers'
Compensation scheme.'' Ex. DC75, pp. 6-7; see also Ex. 37-14, p. 16.
Indeed, Professor Spieler stated in her written testimony that in
the past OSHA rules ``have largely remained outside of workers'
compensation discussions and proof.'' Ex. 37-14, p. 16. This, of
course, makes sense given that the no-fault principle of workers'
compensation makes ``the level of the hazard in the workplace and the
general treatment of the injured worker'' irrelevant to the state
proceeding. Id.
Third, OSHA does not anticipate that inclusion of WRP in the
standard will provide an incentive for state administrators to
encourage workers to ``file'' for WRP instead of for workers'
compensation benefits. It is important to reiterate that workers do not
file for WRP, as they do under state workers' compensation systems.
Employers (and in certain circumstances HCPs) make the determination of
whether work restrictions are necessary and thus whether WRP is
appropriate; this determination is not made through an employee
``filing.'' State administrators thus could not encourage workers to
file for WRP. Furthermore, employees have an independent incentive to
file for workers' compensation, an incentive unaffected by the actions
of state administrators--WRP does not pay for medical treatment, or for
any benefits after 90 days. And finally, these commenters did not
explain how state administrators could actually encourage individual
workers to file for WRP. While it is true that in most state systems
workers' compensation administrators become involved at certain stages
of claims proceedings, the determination of whether to initiate a
workers' compensation claim is typically made at the plant level, where
the injury occurred.
Fourth, WRP will not discourage--or encourage for that matter--
states from covering MSDs. As Professor Spieler stated, ``[t]here is no
logic to the claim that WRP would force complete revision of state
workers' compensation laws.'' Ex. 500-140, p.3. The decision by a
particular state system as to whether a certain injury or illness
should be covered is a decision made appropriately by state
legislatures after consideration of a number of factors.
[[Page 68396]]
Inclusion of WRP in this standard will not independently affect this
decisionmaking process.
Some commenters argued that the standard violates section 4(b)(4)
by denying employees and employers due process in making a claim for
WRP under the standard. See e.g., Ex. 32-22-1, pp. 14-16.
Once again, employees do not make a ``claim'' for WRP under this
standard. In this respect, WRP is fundamentally different from workers'
compensation. Under this standard, employers make the determination as
to whether work restrictions are appropriate; if they are, employers
must provide WRP. If an employer is cited for failing to provide WRP,
the OSH Act provides an opportunity for the employer to contest the
citation. Employers are thus not denied due process with respect to
WRP.
That said, OSHA has included a dispute resolution mechanism in the
final standard that was not included in the proposed rule in order to
address concerns raised both by employer and employee groups. See
Paragraph (s). Many commenters from both labor and industry asked OSHA
to include some dispute resolution mechanism in the standard so that
employers and employees could more efficiently handle disputes related
to work restrictions. See e.g., Exs. 500-218, p. 124; 32-300-1, p. 30;
Tr. 7654. OSHA has responded to these comments and included such a
mechanism in the final standard. See Discussion below. OSHA notes,
however, that it is not aware of any employee group that alleged that
the proposed standard violated constitutional due process by failing to
have a dispute resolution mechanism in the proposed standard for
appealing various employer determinations.
Some commenters argued that the standard violates section 4(b)(4)
because it does not permit employers to stop paying WRP if it is
determined that a worker is engaging in practices that delay or prevent
his/her recovery. See e.g., Ex. 32-22-1, p. 26.
OSHA believes that these commenters misunderstood the proposed
rule; OSHA has attempted in this rule to clarify the discussion of MSD
Management with respect to employer obligations to provide WRP. This
standard expressly provides that employers may condition the payment of
WRP on employee participation in MSD management. This includes the
evaluation and follow-up of employees. Thus, an employer may stop WRP
payments if an employee is not participating in the evaluation and
follow-up provided for by MSD Management. See Paragraph (r)(4).
Commenters argued in general that because WRP is different from
state workers' compensation systems (i.e., different standards,
different burdens of proof, different compensation rates, different
dates, the presence of a waiting period, etc.), it creates a parallel
benefits scheme in violation of section 4(b)(4). See Ex. 32-22-1, pp.
12-18; Tr. 6466 (McGowen).
As OSHA explained above, the fact that differences exist between
WRP and state workers' compensation systems demonstrates that WRP does
not violate section 4(b)(4). WRP is a federal requirement separate from
the requirements and procedures of state workers' compensation systems.
It is not intended to replace workers' compensation. It is designed
instead to accomplish very different purposes. Workers' compensation is
designed to compensate workers after an injury has occurred. WRP is
designed to encourage employees to report signs or symptoms of MSDs
early, before they become severe and disabling, and to cooperate with
the standard's MSD management provisions. As such, it is not surprising
that WRP and state workers' compensation systems have different
schemes, etc. The fact that WRP operates differently from state
workers' compensation systems does not mean that it ``supersedes'' or
in any manner ``affects'' workers' compensation. In the words of
Professor Emily Spieler:
``All of the differences * * * between WRP and workers'
compensation underscore the fact that WRP leaves workers'
compensation unaffected. This includes the different process of
selection of the evaluating health care provider (HCP); the
different role of the HCP; the different enforcement mechanisms; the
different standards for evaluation of whether the MSD is covered;
the differences in burdens of proof; and any differences in payment
levels. The very fact that there will be inconsistent outcomes * * *
suggests that WRP will not affect state workers' compensation
programs.'' Ex. 500-140, p. 3.
See also Ex. 500-26, pp. 3-4.
One commenter, Robert Aurbach, General Counsel of the New Mexico
Workers' Compensation Administration, in his capacity as a private
citizen argued that WRP violates the second clause of section 4(b)(4)
by (1) Providing different requirements for HCP choice, (2) eliminating
waiting periods, (3) shifting the burden of proof, (4) requiring
employers to ``fix'' problem jobs, (5) requiring payment for medical
care, (6) creating conflicts of interest between employer and insurance
carriers, (7) creating additional administrative burdens, and (8)
being, in general, overbroad. Ex. 32-22-1, pp. 27-31.
OSHA has addressed some of Mr. Aurbach's specific points above. WRP
and other provisions of the standard do not require employers to pay
for medical care, do not create conflicts of interest between employers
and insurance carriers, and do not affect state workers' compensation
waiting periods or burdens of proof. OSHA also does not believe that
this standard is overbroad--OSHA has carefully tailored this standard
to address exposure to ergonomic risk factors at levels shown to cause
a significant risk of MSDs.
OSHA admits that the standard will place certain requirements upon
employers to ``fix'' problem jobs, and keep some records of their
ergonomics programs. Imposing these requirements on employers, however,
does not violate section 4(b)(4). Virtually every OSHA standard
includes some new requirements or places some administrative burdens on
employers. This is not surprising given that the scheme of the statute,
manifest in both the express language and the legislative history * * *
[permits] OSHA to charge to employers the cost of any new means it
devises to protect workers.'' Lead, 647 F.2d at 1230-31. For example,
OSHA has required employers to install local exhaust ventilation in
numerous health standards, produce and keep medical surveillance
records of employees, provide hazard information to employees, etc.
These requirements have never been held to violate section 4(b)(4).
Indeed, if Mr. Aurbach's interpretation of the second clause of section
4(b)(4) were accurate, section 4(b)(4) would prevent OSHA from issuing
any occupational safety and health standard. Under Mr. Aurbach's
interpretation of the second clause of section 4(b)(4), if OSHA places
any burdens (such as administrative burdens or the requirement to
eliminate hazards in dangerous jobs) on employers not already required
either by statute or the common law, section 4(b)(4) is violated. This
interpretation is not plausible.
Contrary to Mr. Aurbach's assertion, the second clause of section
4(b)(4) must be read in conjunction with the first clause discussed in
detail above. Section 4(b)(4) as a whole prevents OSHA from displacing
or preempting the legal scheme of state workers' compensation. WRP will
do no such thing. Section 4(b)(4) cannot be read to prevent OSHA from
issuing safety and health standards.
(b). Section 4(b)(4) does not prohibit OSHA from including certain
other provisions in this standard, as some commenters argued.
[[Page 68397]]
Several commenters argued that the confidentiality provision
(Paragraph (p)(2)) of the standard ``supersedes'' state workers'
compensation systems because such systems permit the employer to obtain
any information from an HCP related to a workers' compensation claim.
See e.g., Ex. 32-22-1, pp. 25-26.
OSHA admits that the confidentiality provision in the proposal was
not clear. OSHA has changed the language in the final rule to clarify
it. As explained in more detail above, if a state workers' compensation
system requires or even allows employers to obtain information related
to a workers' compensation claim, the MSD management provisions would
not prevent that information from being passed from the HCP to the
employer in any manner. OSHA thus does not ``supersede'' or ``affect''
the different mechanisms provided by the states for the employer to
obtain information from an HCP about a workers' compensation claim.
Commenters also argued that the standard ``supersedes'' state
workers' compensation systems because (1) it allows the employer to
select the initial HCP (whereas in numerous states the employee can
select the initial HCP) and (2) it permits certain HCPs to participate
in MSD management, even though those HCPs would not be qualified under
state law to examine state workers' compensation claimants. See e.g.,
Ex. 30-3811, pp. 34-37; Ex. 32-22-1, pp. 20-26.
This standard does not require employers to select the initial HCP.
As explained above, this standard requires employers to make an HCP
available to injured employees. Employers may choose to satisfy this
requirement by operating within the selection practices of their state
workers' compensation systems. (In fact, OSHA anticipates that most
employers will do this.) Thus, if a state permits an employee to choose
the initial HCP, that practice could continue under this standard.
Furthermore, the fact that OSHA is permitting certain HCPs to
participate in MSD management who may not be permitted to examine
workers' compensation claimants under state workers' compensation
systems does not violate section 4(b)(4). OSHA has determined, based
upon the rulemaking record, that certain ``HCPs,'' operating within
their scope of practice, can perform certain functions under MSD
Management. This is an appropriate exercise of OSHA's authority and one
that OSHA has exercised in other standards. See 29 CFR 1910.1052(b)
(Methylene Chloride). OSHA is not changing the state requirements for
practice of HCPs under workers' compensation laws. Those requirements
remain the same.
Commenters argued in general that the standard ``supersedes'' state
workers' compensation systems because it establishes separate
requirements for the provision of medical care with different cost
structures, treatment guidelines, and regulatory burdens. See e.g., Ex.
30-3811, pp. 34-38.
This standard does not require the employer to pay for or provide
medical care and/or treatment. MSD management only requires employers
to make an HCP available for evaluation and follow-up. The standard
does not establish any cost structures or treatment guidelines, etc.
Indeed, OSHA has expressly declined to include such requirements in the
standard. See Discussion of MSD management above.
Finally, many commenters argued that WRP (and other provisions of
the standard) improperly (1) creates a ``most-favored injury'' by
providing compensation for MSDs at a higher rate than for other
occupational injuries and illnesses, and (2) treats employers and
employees in different states with different compensation systems
differently. See e.g., Tr. 6435-36 (Ewing); 6457 (Situkiendorf).
WRP does not result in workers with MSDs being compensated at a
higher level than workers with other injuries and illnesses. As stated
above, WRP payments are approximately equal to the amount of TTD
payments received by workers through workers' compensation for all
occupational injuries and illnesses. The standard also includes an
offset provision that prevents an employee from receiving both WRP and
workers' compensation. See Discussion of offset provision below. OSHA
is thus not creating a separate class of injured workers and paying
them at a higher rate than injured workers receive under workers'
compensation.
OSHA has acted pursuant to its statutory authority to issue this
standard to reduce the significant risk of employees developing MSDs
from workplace exposure to ergonomic risk factors. The rulemaking
record requires that OSHA include WRP to effectuate the purposes of
this standard. WRP is designed to encourage employees to report MSDs
early and to participate in MSD Management; it is not designed to, nor
will it, compensate injured workers at a higher level than injured
workers receive under state workers' compensation. Simply because OSHA
has singled out certain injuries and illnesses for regulation, but not
others, does not mean that OSHA has acted improperly. OSHA's inclusion
of WRP in other standards has never been ruled ``improper'' because it
somehow created a ``most-favored injury.''
Furthermore, OSHA disputes that by creating a uniform federal
requirement it is treating employers and employees differently in the
various states. On the contrary, WRP applies equally to employers and
employees in general industry. If, for example, two workers from
different states must be removed from work due to the same MSD, they
both will receive at least 90% of their gross earnings and benefits for
up to 90 days. WRP creates no inequality.
To be sure, inequity currently exists in state workers'
compensation systems. But as Professor Spieler stated in her written
comments on the proposed rule, WRP will not introduce, solve, or affect
that inequity:
``One final and important point: Some have argued that the
proposed standard introduces inequity or inequality into the
treatment of workers with occupationally-related MSDs. * * * But the
proposed standard does not introduce inequity or inequality into the
programs that provide protection for the affected workers. Serious
inequities exist already. Currently, eligibility criteria for MSDs
and payment levels in workers' compensation programs vary wildly
from one state jurisdiction to another. So do protections under
state-mandated temporary disability programs and under state
disability rights laws. Some workers will receive medical treatment,
permanent disability benefits, vocational training, and job
placement; others, with equivalent MSDs will not. Irrespective of
the promulgation of the proposed standard, these inequities will
persist. They will persist precisely because state workers'
compensation programs will be unaffected by the promulgation of the
standard.'' Ex. 37-14, p. 19.
3. Section 4(b)(1) Does Not Prevent OSHA From Applying WRP to Federal
Employees.
The United States Postal Service, as well as certain federal
agencies, argued that section 4(b)(1) of the OSH Act prevents OSHA from
applying WRP to federal employees because the Federal Employees
Compensation Act (FECA) occupies the field with respect to compensation
for work-related injuries. Ex. 35-106-1, pp. 14-21.
FECA provides compensation to federal employees injured while in
the performance of their duties. 5 U.S.C. 8102. For totally disabled
individuals, FECA pays 66 2/3% of their monthly pay. 5 U.S.C. 8105(a).
In this respect, FECA is similar to state workers' compensation
systems. FECA also has certain maximum and minimum levels for
compensation, as well as a three day waiting period. Unlike various
state systems, however, FECA contains a
[[Page 68398]]
continuation of pay mechanism (COP) for employees who suffer traumatic
injuries. Under COP, employees may receive a continuation of their pay
``without a break in time'' for up to 45 days. 5 U.S.C. 8118.
Furthermore, the FECA provides that ``[a]n employee may use annual or
sick leave to his credit at the time the disability begins.'' 5 U.S.C.
8118(c). Like state workers' compensation systems, FECA was enacted to
provide federal employees with a quicker and more certain recovery for
work-related injuries.
FECA does not preempt OSHA under section 4(b)(1) of the OSH Act
from applying WRP to federal employees. Section 4(b)(1) of the OSH Act
provides, in pertinent part:
Nothing in this Act shall apply to working conditions of
employees with respect to which other Federal agencies * * *
exercise statutory authority to prescribe or enforce standards or
regulations affecting occupational safety or health. 29 U.S.C.
653(b)(1).
Section 4(b)(1) ousts OSHA from jurisdiction over working
conditions over which another agency has exercised statutory authority.
At the time the OSH Act was passed various federal agencies had
statutory authority to prescribe and enforce standards and regulations
affecting occupational safety and health. To avoid duplication of
effort, Congress included section 4(b)(1) in the OSH Act. Thus, section
4(b)(1)'s broad purpose is to avoid duplicative regulatory burdens
without impairing the OSH Act's primary goal of ``assur[ing] so far as
possible every working man and woman in the Nation safe and healthful
working conditions.'' 29 U.S.C. 651(2)(b).
In order for an agency's action to preempt OSHA under section
4(b)(1), the agency must formally ``exercise'' its statutory authority
to regulate ``particular working conditions,'' or express its view that
no action should occur. See e.g., Baltimore & Ohio R.R. v. OSHRC, 548
F.2d 1052, 1053-55 (D.C. Cir. 1976); Southern Pacific Transp. Co. v.
Usery, 539 F.2d 386, 390-92 (5th Cir. 1976), cert. denied, 434 U.S. 874
(1977). While courts differ slightly in their interpretation of what
constitutes ``working conditions'' for purposes of section 4(b)(1), all
approaches are based on the Supreme Court's definition of that term as
limited to an employee's ``surroundings'' and the `` `hazards'''
incident to his work.'' Southern Pacific Transp., 539 F.2d at 390
(quoting and citing Corning Glass Works v. Brennan, 417 U.S. 188, 202
(1974)). Thus, the courts examine whether the other agency's exercise
of authority is directed to the ``particular'' or ``identical'' working
condition that causes the injury or illness that is addressed by the
OSHA standard at issue. In re Inspection of Norfolk Dredging Co., 783
F.2d 1526, 1530-31 (11th Cir.), cert. denied, 479 U.S. 883 (1986).
In this case, FECA is not directed at all to the working conditions
addressed by this standard. This standard requires employers to
implement an ergonomics program to reduce exposures to ergonomic risk
factors in the workplace. It adopts a comprehensive approach to
reducing the significant risk of MSDs. One critical aspect of that
approach is MSD management and WRP. By encouraging workers to report
signs or symptoms of MSDs early (even before they become recordable or
compensable), WRP prevents serious injuries from occurring. It also
alerts employers to the presence of risk factors in a particular job.
FECA, one the other hand, does not attempt to regulate ergonomic
hazards in the workplace to prevent MSDs from occurring in the first
instance (i.e., regulate ``working conditions'' that cause the injury
or illness). In fact, it is not concerned with targeting and reducing
occupational hazards at all. FECA is a statute that compensates workers
after injury occurs. As such, it has a wholly separate purpose from WRP
(and, indeed, this standard as a whole). To be sure, FECA may
indirectly ``affect'' the occupational safety and health of workers by
providing compensation after injury and encouraging temporary work
restrictions; however, it is not targeted to the working conditions
that cause MSDs. WRP is not preempted by FECA under section 4(b)(1) of
the OSH Act.
C. Other Considerations
1. Non-monetary alternatives
Several commenters argued that non-monetary alternatives can be
effective in increasing reporting of MSDs by employees and are
preferable to WRP (Exs. 30-4467, p. 23; 32-300-1, p. 24). The EEI
wrote:
EEI does not believe that OSHA has sufficiently proven that WRP
is the only effective method to ensure accurate reporting. OSHA
acknowledges that a properly designed incentive plan can be
successful. OSHA reports that a number of stakeholders have said
that employers use various non-monetary incentives to achieve a
safer and more healthful workplace. Some of these incentives include
recognition and nominal rewards (company caps, plaques) for
reporting hazards or presenting ideas to fix problem jobs or reduce
severity rates. These types of incentives can and do increase
employee reporting.
Ex. 32-300-1, p. 24.
OSHA concludes that there are major drawbacks to relying upon non-
monetary alternatives to increase employee reporting and participation
in ergonomics programs. As EEI noted, one type of non-monetary
alternative involves recognition and nominal rewards for reporting
hazards or presenting useful ideas to improve safety. Although OSHA
solicited comment on the issue, there was no consensus even among
employers that this type of non-monetary incentives is an effective
substitute for wage protection policies in motivating employees to
report. While there is some evidence non-monetary inducements to
reporting hazards can be effective as part of a well designed safety
and health program, such programs may also involve full or partial wage
protection, sick leave, or disability benefits if employees must lose
time from work. While many employers have generous benefits policies
that would enhance the effectiveness of non-monetary incentives, many
do not (64 FR 65852). Absent persuasive evidence that non-monetary
incentives for reporting hazards, standing alone, can achieve increased
reporting, OSHA sees no basis to rely on them to the exclusion of WRP.
Another type of incentive plan rewards employees with prizes for
reporting low numbers of injuries or no injuries. As the preamble
discussion of Paragraph (h)(3) makes clear, incentive plans of this
type can effectively deter reporting because employees may value the
prize more than any health or safety benefit that reporting would
produce. See, e.g., Tr. 15453, 10992, 7703). Moreover, in plans that
reward teams of employees for low rates of reported injuries, peer
pressure exerted by the group can be an effective deterrent to
reporting by team members (Tr. 15453, 11638).
For these reasons, OSHA finds that non-monetary incentives would
not be as effective as WRP in encouraging employees to report MSDs.
2. Duration and Level of Benefits
(a). Maximum duration. The proposed rule established a maximum
duration of 6 months for each episode of WRP benefits. Several
commenters supported the agency's preliminary determination that
benefits should be provided for up to six months if necessary (see
e.g., Exs. 500-218, p. 131; 32-185-3, p. 11-10). Other commenters
argued that a six-month duration is unnecessarily long in light of the
data showing that most MSD cases will recover in far less time (Exs.
30-352; 32-300-1; 30-3344). The EEI
[[Page 68399]]
recommended reducing the maximum duration period to 3 months:
Even if OSHA chooses to maintain a WRP provision, it has not
shown sufficient justification for six months of coverage. OSHA
claims that early recognition, diagnosis and treatment interventions
will lead to speedier recoveries from MSDs. Given this premise, the
six-month WRP period of time is inordinately long and may enhance
the tendency for an employee with a mild MSD case to malinger. OSHA
recognizes within the [proposed rule's] preamble a median length of
disability for all MSDs of 99 days with many of these cases
resolving in significantly less time. Reducing the WRP to three
months would be consistent with the anticipated benefits of the
proposed rule and will reduce the cost and complexity of the program
to employers.
Ex. 32-300-1, p. 23.
OSHA preliminarily estimated that while most employees with lost-
work-time MSDs would recover within 3 months, over 12% of all lost
workday cases involved more than 3 months away from work, and that for
some types of serious MSDs, the typical disability duration was more
than 3 months (64 FR 65855). OSHA concluded that a six-month maximum
time for WRP was reasonable because it would allow the majority of
workers with more serious MSDs time to recover before losing their
benefits. Id.
In the final rule, OSHA has revised its estimates of the number of
days employees will be out of work due to MSDs. The agency now
estimates that 90% of all workers who experience lost work-time MSDs
will return to work within 3 months. In addition, OSHA estimates that
in approximately 70% of cases in which workers' compensation claims for
MSDs are filed, benefits will be available to replace up to two-thirds
of the employee's lost wages. See OSHA's Final Economic Analysis. While
a high percentage of workers with MSDs do not currently file claims for
workers' compensation benefits, OSHA expects this rate of under-filing
to decrease with the implementation of WRP, particularly in cases in
which the recovery period exceeds three months. Employees will have an
incentive to pursue benefits since claims-filing will not threaten
immediate economic harm, and may be the only avenue to recovery of
medical expenses and extended wage loss. See Emily Spieler, Ex. 37-14,
pp. 18-19, and Tr. 3353. Employers will also have a greater incentive
to encourage employees to file claims, or to initiate claims themselves
in the majority of states that permit employer-filed claims, because
the final rule permits an offset against WRP for workers' compensation
benefits received by employees. Thus, of the relatively few workers who
will require more than 3 months to recover from their MSDs, a
substantial number will be eligible for workers' compensation benefits
to replace a portion of lost income and to pay for medical expenses.
For these reasons, OSHA concludes that a three month maximum time
period for WRP is appropriate. Based on the estimates discussed above,
OSHA believes that the vast majority of workers with lost-time MSDs
will receive, or be eligible to receive, a substantial portion of their
wages while recovering. OSHA acknowledges that there will be some
workers who will require more than three months to recover, and who
will not receive workers' compensation or other benefits after the
first three months. However, OSHA estimates that this group will
represent a small proportion of all workers with lost-time MSDs.
The Agency does not believe it is appropriate to structure WRP
requirements around this small group of employees. WRP is intended to
provide temporary benefits to encourage employees to report MSDs and to
participate in MSD management. As discussed at length in Section B
above, WRP is not intended as a federal remedy for workers who have
suffered work-related MSDs, or as a supplement to state workers'
compensation systems. Based on the record, OSHA believes that a
requirement to provide WRP for up to 3 months will be effective in
substantially increasing the number of employees reporting MSDs and
their signs or symptoms. While requiring WRP for up to 6 months or
longer would provide a greater degree of economic protection to injured
workers, it would likely produce little if any additional improvement
in reporting. As OSHA noted in the proposal, the available data
indicate that overall, the number of workers out of work for less than
6 months is not significantly greater than the number of workers out of
work for less than 3 months (64 FR 65855).
In the proposal, OSHA considered several alternatives that would
have reduced the maximum duration of MRP benefits to substantially less
than 90 calendar days. OSHA preliminarily concluded that limiting MRP
benefits to no more than seven days would not provide the requisite
protection to employees to encourage them to report MSDs early and to
participate in MSD management. 64 FR 65856. The agency noted that
employees whose injuries do not resolve within the WRP coverage period
would have to rely on workers compensation, and that the effect of the
waiting periods required by state systems could be that some of these
employees would have no protection for several days. Id. In addition,
employees who require more than seven days to recover, but who are not
covered by workers' compensation, would face substantial financial
pressure to return to work early. For these reasons, OSHA preliminarily
concluded that this alternative would have a chilling effect on early
reporting. Id.
OSHA solicited comment on whether the alternatives outlined in the
proposal, or other alternatives would effectively encourage early
reporting and participation. 64 FR 65858. The agency received no
evidence that providing WRP for less than 90 calendar days would
achieve this purpose. Accordingly, the final rule requires that WRP be
provided for up to 90 calendar days.
(b). Interim cutoff points. The final rule permits employers to
terminate WRP benefits before the expiration of the 90 calendar day
maximum period if one of the following occurs: (i) the employee is able
to resume the former work activities without endangering his or her
recovery, or (ii) an HCP determines, subject to the dispute resolution
procedure in paragraph (s), that the employee can never resume his or
her former work activities.
As explained in the preceding discussion, OSHA's data show that in
most cases, work restrictions will not be needed for 3 months because
the employee will have recovered in less time. The standard permits the
employer to end WRP before 3 months if a determination is made that the
employee is recovered and able to return to his or her regular job.
This is consistent with the principle that work restrictions or
removals are temporary and protective in nature, and with OSHA's
practice in other standards containing benefits similar to WRP (see
e.g., Lead, 43 FR 54440, Formaldehyde, 57 FR 22294). No party opposed
the provision that WRP may be ended when the employee is able to return
to his or her regular work.
Employers may also reduce their obligation to provide WRP benefits
by addressing the MSD hazards in the job at an early date. Once the
employer has controlled the MSD hazards so that the employee can resume
his/her regular duties without endangering his/her recovery, work
restrictions or work removal are no longer necessary. Controlling the
MSD hazards in the job quickly is one way that employers may limit the
number of days that MRP benefits must be paid.
The proposed rule contained no provision for ending WRP benefits
once
[[Page 68400]]
it becomes clear that the employee will not recover sufficiently to
return to the job. Several commenters urged OSHA to include such a
provision in the final rule (Exs. 500-218; 32-337-1). The AFL-CIO
stated:
[T]he AFL-CIO recommends that OSHA include [an additional] WRP
cut-off point, consistent with the WRP provisions in other
standards. An employer should be permitted to terminate WRP if and
when it is determined that the employee is unable to return to the
job * * *. At this point, temporary removal no longer serves OSHA's
health protective goal and the worker presumably becomes eligible
for workers' compensation.
Ex. 500-218. pp. 131, 127. OSHA agrees that a work restriction or work
removal is no longer necessary once it is clear that the employee will
not recover sufficiently to be able to return to the job. Accordingly,
the final rule permits employers to end WRP benefits before the
expiration of three months if a determination is made that the employee
is permanently unable to return to his/her regular job.
Some participants suggested that the final rule should contain a
limitation, similar to that in the FMLA, on the maximum number of days
of benefits in any year. The Chamber of Commerce urged this approach,
arguing that under the proposed structure, an employee could
theoretically receive WRP for the maximum period, return to work for a
day, and then receive another round of MRP benefits. By repeating this
cycle, an employee could receive virtually his full annual pay and
benefits while actually working only a few days during the year (Ex.
30-1722, pp. 81-82).
OSHA does not believe that the scenario posited by the Chamber is
realistic. Employers can significantly reduce the likelihood of having
to pay MRP benefits to the same employee on successive occasions by
controlling the MSD hazards in their problem jobs effectively. By
acting promptly to address MSD hazards, and effectively managing the
MSDs that do occur, employers can ensure that, in most cases, injured
employees will be able to return to work at full productivity and
without the need for further restrictions. Moreover, while there may be
some unusual instances in which employees will legitimately need work
restrictions more than once in a year for the same job, employers need
not allow employees to cycle endlessly in and out of WRP. If an
employee requires work restrictions on several consecutive occasions
despite the fact that the MSD hazards have been controlled to the
extent required in the standard, that is a strong indication that the
employee is physically unable to perform the job. As noted above, the
standard permits the employer to end WRP if a determination is made
that the employee is permanently unable to return to his regular job.
For these reasons, OSHA does not believe that an express limitation on
the number of days of WRP during the year is appropriate. The final
rule thus contains safeguards which effectively limit the circumstances
in which an employee could receive WRP benefits at repeated intervals
in a year.
(c). Level of benefits. The final rule requires that the employment
rights and benefits of employees be fully maintained for the duration
of the WRP period. Employers must maintain the earnings of employees
placed in restricted work jobs at their pre-WRP level, and must
maintain the earnings of employees temporarily removed from work at 90%
of their pre-WRP level. The proposed rule contained the same
requirements as the final for maintenance of employment rights and
benefits. However, the proposal required maintenance of either 100% or
90% of ``after-tax earnings,'' depending upon whether the employee was
assigned restricted work or was temporarily removed.
Many participants criticized this provision. Although OSHA intended
the provision to mean that the employee's net earnings should be 90% of
the net earnings the employee would have received by working, a number
of commenters thought the provision meant that the employee's gross WRP
benefits should be equal to 90% of net earnings. Thus, the AFL-CIO
argued that this formulation could result in WRP benefits being taxed
twice, and would be problematic for employers to implement (Ex. 500-
218, pp. 121-122). OSHA agrees, and has deleted the reference to
``after-tax earnings.'' It uses the word ``earnings'' in the final
rule. Earnings generally means gross pay.
The AFL-CIO also objected to providing only 90% of pre-WRP wages to
employees temporarily removed from work, arguing that full wage
protection is necessary to encourage employee reporting and
participation (Ex. 500-218, pp. 122). However, employees who remain at
home do not incur certain expenses, such as commuting and child care
expenses, incurred by employees who must report to work. Therefore,
some reduction from the wages of workers removed from work is
appropriate to balance the cost savings that these workers accrue;
otherwise employees would reap a financial benefit from WRP (Ex. 32-22-
1; p. 17). OSHA considers that restoring 90% of the earnings of
employees removed from work approximates the portion of these
employees' wages actually lost due to MSDs.
3. Offset Provision
The final rule permits an employer to reduce its WRP obligation to
an employee with a work restriction by the amount that the employee
receives in compensation for lost earnings during the period of
restriction from a publicly or employer-funded compensation program, or
receives in income from employment made possible by virtue of the
employee's restriction. This provision is designed to ensure that
employees will not receive more than current earnings as a result of a
work restriction (64 FR 65848).
Several parties maintained that the provision will not achieve its
purpose in preventing injured employees from receiving a double
recovery because WRP payments will generally be paid before the
employee receives workers' compensation benefits and state laws
preclude employers from attaching such benefits (Exs. 32-22-1; 30-
4467). The General Counsel of the New Mexico Workers' Compensation
Administration expressed this view as follows:
Whenever the workers' compensation system delays benefits for
any legitimate reason, the worker is paid WRP under the Proposed
Standard, and then later paid for the same lost work time by the
employer's workers' compensation insurer. The employer has no legal
mechanism for recapturing that portion of the WRP pay that was
supposed to be offset. Since no state law currently has a provision
allowing for reduction of workers' compensation benefits on the
ground that WRP pay was already paid for the same injury, the
various state workers' compensation laws will need to be revised to
make the offset provision for WRP work.
Ex. 32-22-1, pp. 19-20 (emphasis in original).
OSHA does not agree that changes in state laws are needed to
effectuate the offset provision. First, contrary to this commenter's
assertion, some state laws already have adequate provision for
employers to recoup wages paid to employees who later qualify for
workers' compensation. For example, the New York state official charged
with responsibility for the State's workers' compensation system
testified that:
[t]he offset provision would be effective even if the workers'
compensation claim took more than six months to resolve because our
system allows for payments of benefits to employers who have
provided other compensation such as sick leave to employees prior to
the award of compensation benefits.
[[Page 68401]]
Tr. 3354 (Eliot Spitzer). Employers are also free to structure their
employment contracts to allow recovery of wages paid during a period
for which workers' compensation benefits are awarded. Nothing in the
record shows that contractual remedies would not be effective, or that
employers would have greater difficulty in recouping WRP overpayments
than they have in recouping other monies advanced to employees (Ex.
500-218, pp. 128-129). For these reasons, there is no basis to conclude
that the offset provision will be unworkable or ineffective.
4. Fraud
A number of commenters argued that the WRP provision will entice
large numbers of employees to attempt to secure these benefits
fraudulently. These parties were concerned that employees will report
MSDs that are not related to work activities, or will exaggerate their
MSD symptoms to secure work restrictions that are not necessary or to
extend work restrictions longer than needed (Exs. 30-1722; 32-241-4;
30-4467; 32-234-2; Tr. 6470, 9847-8, 14215). NCE et al.stated:
The evidence is clear that the employees most likely to complain
of musculoskeletal discomfort are those who do not like their jobs.
These employees' subjective complaints must be taken as given under
the proposed rule, and cannot be subjected to objective
verification. When these workers are given the additional incentive
of time off at 90 percent pay, or less demanding job tasks at 100
percent of pay, a vast increase in reported musculoskeletal pain is
certain to follow.
Ex. 32-241-4, p. 185. Similarly, the Chamber of Commerce argued that,
based on the extent of workers' compensation fraud nationwide, ``the
only reasonable assumption is that the WRP provision will increase such
fraud because the dollar amounts at issue are greater . . . And this
problem is likely to be especially acute where, as here, the diagnosis
at issue is . . . a loose collection of poorly defined signs and
symptoms'' (Ex. 30-1722, p. 77).
OSHA does not believe that the record bears out these commenters'
concerns. As a threshold matter, there is substantial evidence that
worker-perpetrated fraud is but a very small part of the overall fraud
problem in workers' compensation systems (see Exs. 500-97; 500-97-1;
500-97-2; 500-97-3; 500-218; 502-254; 502-258). The AFL-CIO noted that:
[t]wo states that have devoted significant resources to workers
compensation fraud investigation and reporting, California and
Wisconsin, have found incidences of worker fraud to be minimal. In
California, worker fraud was present in less than 3/10ths of one
percent of total claims (Ex. 500-97-1); in Wisconsin, it was one
tenth of one percent of claims (Ex. DC 78).
Ex. 500-218, p. 131. The former Commissioner of the West Virginia
Workers' Compensation Fund testified that in her experience in
administering claims, there was little evidence that workers prolonged
their benefits by remaining out of work unnecessarily (Tr. 1733-34).
Other witnesses agreed with this assessment (Tr. 3559-60 [James
Ellenberger], Tr. 11001 [Madeline Sherod], Tr. 11102 [Trevor Schnell]).
Accordingly, the experience gained in the worker's compensation field
does not demonstrate a high potential for employee abuse of WRP.
In addition, the final rule contains features that will reduce the
opportunity for fraud in administering WRP. First, work restrictions
are required only for work-related MSDs and only if the employee's job
meets certain objective screening criteria. These requirements are
designed to ensure that there is a close nexus between the injury and
significant exposure to ergonomic hazards at work. Moreover, work
restrictions are not required unless an HCP or the employer itself has
determined that they are necessary. Thus, even if an employee falsely
reports MSD symptoms, work restrictions and WRP are not required unless
the employee's job meets the screen and a medical professional selected
by the employer determines that they are necessary. Therefore,
commenters substantially overstate their case in asserting that
subjective symptoms alone trigger work restrictions.
OSHA believes that HCPs, in particular, will play an important role
in checking abuse. Health care professionals use a variety of
techniques to identify fraud. Nothing in the record supports the notion
that HCPs are frequently duped by false symptoms; to the contrary, HCPs
are adept at evaluating the objectivity of patient claims. Moreover,
data in the record shows that most HCPs are far more likely to
recommend work restrictions than time away from work. (Ex. 500-118).
Further, since 1992, the percentage of restricted workdays for all
occupational injuries and illnesses reported to the BLS has increased
by 50%, while the percentage of lost workdays has decreased by a
substantial margin.
This is not to suggest that instances of fraudulent claims for WRP
benefits will not occur, or that OSHA condones such conduct by
employees. Rather, OSHA believes that the final rule provides effective
safeguards employers can use to prevent employees from receiving WRP
benefits to which they are not entitled. Therefore, the potential for
fraud is not a basis for eliminating WRP.
Paragraph(s) What Must I Do if the Employee Consults His or Her Own
HCP?
Paragraph (s) of the final rule establishes a procedure for
resolving disagreements among HCPs. The proposed rule did not contain a
comparable provision.
Numerous commenters, including both employer and employee
representatives, argued that accurate medical assessments are critical
if parties are to have confidence in decisions about work restrictions
and WRP. A representative of the American College of Occupational and
Environmental Physicians explained:
[t]he central role that [medical] evaluations play in triggering
requirements of the rule make the inclusion of a three-physician
review in the ergonomic standard particularly appealing. We
recommend that the standard provide for multiple physician review to
sort out the differences of opinion and ambiguities in the
diagnosis. The key element to triggering implementation of a program
review should be based again on a bona-fide medical diagnosis in
light of the corresponding duties.
Tr. 7654 (Dr. Robert McCunney). The AFL-CIO argued that multiple
physician review or MPR is necessary to gain the trust and
participation of employees. It asserted,
[w]orkers have always been concerned about the objectivity and
allegiance of employer-chosen physicians * * . MPR is important to
assure workers that physician hostility to WRP will not result in
adverse consequences when workers step forward and report. Without
the possibility that a colleague will review, and possibly take
issue with, a decision denying worker transfers or prematurely
returning workers to hazardous exposures, employer physicians may
feel financial pressure from employers to minimize WRP
participation.
Ex. 500-218, p. 124. See also Exs. 32-111-4 (USWA); 32-85-3 (CWA).
The EEI voiced concern that if employees are allowed to choose the
initial HCP, the person they select may not have the time or experience
to work with employers in determining appropriate restrictions. It
argued that:
[t]he employee's personal healthcare provider may also not
understand that assignment of work hardening and/or returning the
employee to work on restricted duty as soon as possible are
important in the recovery process. The employer is much more likely
to select an HCP that recognizes the need to interface with the
health and safety staff in developing restrictions
[[Page 68402]]
appropriate for the job and who will provide the type of care that
is consistent for all employees at the work location. The employer
will also have more control over the follow-up process, assuring
that the follow-up is appropriate for the specific MSD and that it
is completed in a timely manner.
Accordingly, EEI urges that any final standard clearly provide
that employers shall select the healthcare provider for the WRP
program, at least in the first instance. EEI would not object if the
standard permits an employee to seek a second opinion.
Ex. 32-300-1, p. 30.
The Agency believes that the concerns expressed by all of these
commenters are valid. OSHA agrees with the EEI that the employer should
have the option of selecting the HCP to provide the initial
recommendation on a work restriction. The final rule requires the
employer to implement an MSD management process that includes ``access
to an HCP.'' The employer may fulfill this obligation by arranging for
the injured employee to visit an HCP selected by the employer.
Alternatively, the employer may arrange for the employee initially to
visit an HCP selected by the employee. Employers who choose this option
should assure themselves that the HCP has the appropriate experience to
work with the employer in determining work restrictions.
OSHA also agrees with commenters about the need to assure accuracy
and competence in medical assessments. Accordingly, paragraph (s)(1)
provides that if the employer selects the health care professional to
make a recommendation about a work restriction, the employee may select
a second HCP to review the first HCP's finding. If the employer allows
the employee to select an HCP to make the initial recommendation on a
work restriction, the rule does not provide for further review because
OSHA expects that, in this situation, both parties will have confidence
in the HCP's findings. On the other hand, if the employee has seen an
HCP on his or her own, before the employer has exercised its option to
select an HCP, the employer may refer the employee to a different HCP.
In this case, the employee may rely on the recommendation he or she has
already obtained as the second opinion for purposes of the final rule.
If the second HCP's determination differs from the first, the
employer must take reasonable steps to arrange for the two HCPs to
discuss and resolve their disagreement. This means that the employer
should instruct his HCP to contact the employee's HCP to discuss the
matter directly. If the two HCPs cannot resolve the conflict quickly,
the employer and the employee, through their HCPs, must designate a
third HCP to review the temporary work restriction or work removal
determination. The employer must act consistently with the
determination of the third HCP, unless the employer and employee agree
to a restriction that is consistent with the opinion of at least one of
the HCPs. Paragraph (s)(5) allows the employer and the employee to
agree upon an alternative dispute resolution mechanism to use in lieu
of the one set out in the final rule, if it is at least as protective
of the employee. For example, the employer and employee may agree in
advance that the employee will see a certain HCP, whose recommendation
will be binding. The standard thus allows employers a degree of
flexibility in structuring an alternative dispute resolution process,
provided that the employee's right to a choice in the selection of HCPs
is not compromised, and the process is expeditious. These provisions
are similar to the multiple physician review mechanisms contained in
OSHA health standards, such as lead and formaldehyde. OSHA adopts them
in this final rule because they have proved effective in assuring that
all parties have confidence in the accuracy and fairness of medical
determinations about work restrictions and therefore contribute to the
overall effectiveness of the rule's medical surveillance (MSD
management in this rule) provisions.
Paragraph (t). Training
Training is a critically important element of the final ergonomics
program standard, as it is of virtually every safety and health
standard (Ex. 26-2). In training for ergonomics programs, the goal is
to enable employees at all levels of the organization--managers,
supervisors or team leaders, and employees--to: (1) Recognize the signs
and symptoms of musculoskeletal disorders (MSDs) so that they can
report them early (employees) and respond to them appropriately
(managers, supervisors, and team leaders); (2) identify those job tasks
that pose an increased risk to the worker of developing an MSD; and (3)
have the knowledge and skills necessary to participate in the
establishment's ergonomics program. The success of ergonomics programs
depends to a great extent on the effectiveness of the training in
ergonomics the employer provides.
Most comments on the proposed training provisions were supportive,
although many commenters suggested modifications to the proposed
requirements (see, e.g., Exs. 30-3826, 32-111-4, 32-182-1, 30-3686, 32-
198-4, 30-3765, 32-339-1, 32-198-4-15, 30-4538, 32-77-2, 32-185-3).
Only a few commenters argued that training should not be addressed by
the final rule (see, e.g., Exs. 30-240, 30-541, 30-3867). The following
discussion responds to public comment received and explains OSHA's
reasons for including the requirements in paragraph (t) of the final
rule.
In the proposal, OSHA included, for each core element of the
program, a ``Basic Obligation'' provision. The purpose of these
sections of the proposal was to summarize the more detailed subelements
proposed for each core element. The final rule does not include these
basic obligation provisions, because commenters found them confusing
and not useful. Comments on specific aspects of the Basic Obligation
section are discussed below, in connection with the individual training
requirements of the final rule.
The proposed Basic Obligation section for training provided that
any training required by the rule was to be provided ``at no cost to
employees'' (see the Basic Obligation section for proposed section
1910.923). This proposed language expressed OSHA's intention for the
employer to bear all of the costs associated with OSHA-required
ergonomics training. For example, any training materials given to
employees must be provided to them free of charge. Further, employees
must be compensated at their regular rate of pay for time spent
receiving training during regular work hours, and employees cannot be
required to forfeit their regularly scheduled lunch or rest periods to
attend training sessions. In addition, where training requires
employees to travel, the employer must pay for the cost of travel,
including any travel time occurring when the training activities are
scheduled outside of the employee's normal work hours.
The final rule does not contain this specific proposed language
about the costs of training, because that language is not necessary for
OSHA to impose these costs on the employer. The proposed provision
merely restated OSHA's longstanding policy, which requires employers to
bear the costs of complying with safety and health requirements
promulgated under the Act. OSHA finds it reasonable and appropriate for
employers to bear the costs of training because, under the Occupational
Safety and Health Act of 1970, employers are responsible for providing
a safe and healthful workplace, and training is an integral part of
this responsibility. It is clear that having employees bear such costs
would discourage participation in
[[Page 68403]]
training activities, and would thus limit the effectiveness of the
rule's training requirements.
Several organizations commented on OSHA's interpretation of the
proposed ``at no cost to employees'' language (see, e.g., Exs. 30-3813,
30-3686, 32-339-1). With reference to the preamble to the proposal [64
FR 65833], which explained that employees could not be required to
forfeit regularly scheduled lunch or rest periods to attend training
sessions, one organization stated that OSHA had cited no evidence
showing that employees receiving training on MSDs during ``brown bag''
lunch sessions or during ``scheduled rest periods'' would be harmed by
this practice. This commenter contended further that OSHA's
interpretation of the ``no-cost'' provision was an intrusion into
workplace management and scheduling, which should be the employer's
exclusive prerogative (Ex. 30-3813). In contrast, other organizations
supported the ``no cost to employees'' requirements of the proposed
rule (Ex. 30-3686) and additionally urged OSHA to limit training to
working hours (Ex. 32-339-1).
OSHA has no objection to training during brown bag sessions or
breaks, provided that employees are paid for this time (and, of course,
that no laws governing break times are contravened to comply with this
provision). Many employers do have paid lunch hours or half-hours and
breaks where training can occur without risking non-compliance with
this provision. However, if these time periods belong to employees,
i.e., are not periods that are on the clock, they cannot be used for
the training required by this standard.
Who Should be Trained?
OSHA proposed that employees in ``problem'' jobs (defined in the
proposal as those jobs in which an employee had experienced a covered
MSD and performed activities involving exposure to risk factors for a
substantial amount (or as a ``core element'' of the work shift), their
supervisors, and persons involved in the ergonomics program (except for
outside consultants) be trained initially, periodically as needed, and
at least every three years. The final rule, at paragraph (t)(1),
includes similar requirements, although the final rule's initial and
follow-up training requirements apply only to jobs that meet the Action
Trigger, rather than to ``problem jobs,'' as proposed. In addition,
while the final rule requires initial and 3-year follow-up training, it
does not require ``refresher'' training at other intervals. The
specified initial and follow-up training requirements are well-suited
to the revised format of the standard and the Action Trigger concept.
OSHA's reasoning in including these requirements in the final rule
is that, once employees in jobs meeting the action trigger have been
trained, they will be able to report MSD hazards and problems early
enough to prevent problems from becoming worse and to protect other
employees in the same job from incurring a similar MSD. Early reporting
informs employers of the need to address MSD hazards and provide MSD
management. Trained employees can also participate more effectively in
the program and thus better protect themselves by working safely. OSHA
also believes that the supervisors (or team leaders or lead employees)
of employees in these jobs must be trained because they are the
personnel to whom employees report their symptoms and the presence of
MSD hazards. Supervisors are in a position to ensure that employees in
such jobs understand the conditions that may lead to MSDs and use the
work practices and procedures established by the employer to control
MSD hazards. Also, in many cases, supervisors are in a position to
observe MSD hazards first hand and to recognize when MSDs are
developing in the workers they supervise.
OSHA also believes that training is critical for those individuals
who establish, administer, and implement the employer's ergonomics
program. Because these managers represent the employer, it is in the
employer's best interest that program administrators and others
responsible for implementing the program be as knowledgeable as
possible. Also, as these managers become more knowledgeable, they will
provide better training to their employees in the ergonomics program.
Of course, as the proposal noted, outside consultants do not have to
have employer-provided training because consultants are responsible for
preparing themselves to perform their professional duties.
The question of who should be trained was a significant issue in
the rulemaking. Commenters offered opinions on a variety of issues and
represented conflicting viewpoints. The major issues with respect to
who should be trained under the ergonomics rule were:
The scope of the training provision,
The number of employees to be trained,
Whether supervisory employees should be trained, and
The training and qualifications of trainers.
Some commenters urged OSHA to be more inclusive in the employees
required to be trained. They stated that all workers, or all general
industry employees (see, e.g., Exs. 30-3826, 30-297, 30-4538), or all
workers in the industry (see, e.g., Ex. 30-3686) should be trained.
Some stated that, although all employees should receive training,
employers should conduct more extensive training specifically for those
in problem jobs (see, e.g., Ex. 30-4538). The thrust of these comments,
in general, was that the training required by the standard should be
expanded beyond employees in problem jobs (see, e.g., Exs. 30-3826, 30-
3686, 32-182-1, 30-3765, 32-198-4, 30-297, 30-4538). For example, Dow
Chemical stated,
Employees having an active role in the prevention of MSD
injuries and information on how best to recognize and control MSD
hazards is a necessary component of a successful program. In fact,
Dow encourages such training for employees, beyond whether they are
in a ``problem job'' or not. All work activities involve some bodily
movement and therefore MSD risks are always present. Dow supports
internally a more pro-active sharing of this type of information
rather than waiting for an MSD to present itself (Exhibit 30-3765).
Expanding the scope of the required training to include more
employees, and to include employees who have not experienced an MSD,
would clearly make this program element more proactive, as many
commenters urged (see, e.g., Exs. 30-3826, 32-111-4, 30-3686, 32-182-
1). Some participants argued that the full program, including training,
should be implemented without waiting for workers to report injuries
(see, e.g., Ex. 32-198-4). Others suggested that training be part of
new employee orientation (see, e.g., Ex. 500-180-51) be provided when
workers are transferred (Ex. 32-182-1), or be given when the ergonomics
program is first implemented or new employees are hired (see, e.g., Ex.
32-198-4). One commenter stated that the training requirements of the
proposed rule, unlike the case in other OSHA rules, do not apply to
workers who are only potentially exposed but instead apply only to
workers who are actually exposed (Ex. 32-339-1).
Given the central role of the workers in an effective ergonomics
program (e.g., reporting symptoms and hazards and making
recommendations about controls), we believe that more regular
training is warranted (Ex. 32-339-1).
Another comment addressed the effect that training only some
employees might have on employee morale. This commenter noted that, in
some ergonomics pilot training programs,
[[Page 68404]]
employees who perceived that they were not going to be included in the
program (whether rightly or wrongly) because they were not trained when
others were, felt excluded and were later less cooperative (Ex. 32-194-
4).
OSHA also received comments recommending that: (1) training be
limited to employees with MSDs and the employees' supervisors (Ex. 30-
3813) rather than, as proposed, to all employees with the same job as
the injured employee; (2) different groups of employees be given
different levels of training (Ex. 30-240); and (3) the formal program
apply only to specific employees in jobs where ergonomic issues are
prevalent (Ex. 30-240). One commenter stated that training should be
triggered only when a statistically significant percentage of employees
in a job have incurred, within the year, work-related, HCP-diagnosed
MSDs that resulted in days away from work (Ex. 30-3344).
The final rule's training provisions (paragraph (t)), together with
the informational requirements in paragraph (d), address many of the
issues raised by commenters. First, OSHA has adopted a ``tiered''
approach to training. The Agency agrees that all employees should
receive orientation or awareness training (see, e.g., Exs. 30-3686, 32-
182-1, 32-198-4) but those at greater risk must receive more extensive
training (see, e.g., Exs. 30-3686, 32-339-1, 30-240). Paragraph (d) of
the final rule requires that general awareness information be provided
to all current employees and new hires. This new provision also
addresses the concerns of those commenters (see, e.g., Exs. 30-3826,
30-297, 30-4538, 30-3686, 32-182-1, 30-3715, 32-198-4) who argued that
as many employees as possible should be aware of MSD hazards and how to
prevent them. The awareness information required by final paragraph (d)
also should help to avoid the dampening effect on employee morale noted
by one commenter (Ex. 32-194-4). (The summary and explanation for
paragraph (d), above, provides more detail on the general information
requirements.)
Second, training is required by the final rule for employees in
jobs that meet the standard's Action Trigger. OSHA views the occurrence
of a work-related MSD and the presence of risk factor(s) at the
level(s) indicated by the Basic Screening Tool as an indication that
the job is one that warrants a closer look. Such a job has the
potential to expose workers in the job to MSD hazards. Because the two-
part action trigger in paragraph (e) triggers training for the injured
employee and for all other employees in the establishment with the same
job, the final rule's structure is more like that of other OSHA
standards (e.g., the hearing conservation amendment to the occupational
noise standard, 29 CFR 1910.95), as some commenters suggested (see,
e.g., Ex. 32-339-1). However, because OSHA has designed the final rule
to target those situations where the problem is most serious, the
standard's training requirements are triggered for a job only when the
action trigger has been met for that job, and not, as some commenters
suggested, when the program is first implemented (see, e.g., Exs. 32-
198-4).
The Agency does not agree with those commenters who stated that
training should be required only for injured employees and their
supervisors (Ex. 30-3813), or only for employees in jobs where
ergonomic issues are ``prevalent'' (Ex. 30-240), or only for employees
in jobs that have caused MSDs in a statistically significant percentage
of employees within the prior year (Ex. 30-3344). Restricting the
number of employees receiving training in ways suggested by these
commenters would be, in OSHA's view, both inappropriate and
insufficiently protective. First, limiting training to injured
employees and their supervisors would eliminate one of the standard's
proactive features, i.e., that other employees holding the same job as
the injured employee be trained in the risk factors in that job, the
signs and symptoms associated with the MSDs caused by those risk
factors, and ways to protect themselves from experiencing an MSD. OSHA
believes that this provision of the standard will contribute
substantially to the standard's effectiveness by ensuring that all
employees in these higher risk jobs receive training. A recent study
showed that employers were likely to limit their efforts to control MSD
hazards to the injured worker's job and not to extend preventive
practices to other workers in the establishment who had the same job
(Ex. 30-651-2). OSHA believes that this provision of the standard will
ensure that all at-risk workers in the same job will be protected.
Absent such a provision, this preventive effect would be lost.
Third, limiting training only to employees in jobs where ergonomic
injuries are ``prevalent'' (Ex. 30-240) or where a statistically
significant percentage of employees have had an MSD in the last year
(Ex. 30-3344) would deny the standard's training benefits to all
injured and potentially exposed workers except those working in very
large establishments, since only such establishments would have enough
employees in a given job to meet the prevalence or statistically
significant tests suggested by these commenters. Such an approach is
clearly unprotective for the many thousands of workers in small- or
mid-sized establishments who would not receive training even in cases
where they have experienced an MSD incident.
OSHA concludes, after a comprehensive review of the record on the
issue of who should receive the training required by the final rule,
that paragraph (t)(1) strikes the right balance on inclusiveness. It
does this by requiring training for each employee who has experienced
an MSD and works in a job that meets the Action Trigger, and all other
employees working in that job.
The final rule requires the supervisors or team leaders of these
employees to be trained, so that they will encourage early reporting,
know how to respond to employee reports, reinforce good work practices,
and be familiar with ergonomic principles and practices. Several
commenters (Exs. 30-3765, 32-198-4, 30-3859) commented on the proposed
requirement to train the supervisors of those in higher risk jobs. One
commenter noted that the term ``supervisor'' is no longer used in some
workplaces, which are organized in less traditional management
structures (Ex. 30-3765). This commenter pointed out that some managers
may direct more than a hundred employees, and that these employees may
be widely dispersed geographically. In the view of this commenter, the
rule should state that employers must train ``knowledgeable
resources,'' rather than stipulating that supervisors must be trained.
In the final rule (at paragraph (t)(1)(ii)), OSHA states that employers
are required to train the supervisors or ``team leaders'' of employees
in jobs that meet the Action Trigger. The addition of the term ``team
leaders'' conveys OSHA's intent, which is to require first-level
management personnel to be trained, whatever their official title may
be (supervisor, team leader, team manager, knowledgeable resource, and
so forth). OSHA is also aware that many workplaces rely on members of
an ergonomics committee, joint labor-management, or a trained group of
employees (see, e.g., Ex. 30-115); however, the standard does not
specifically address the training of these employees.
Paragraph (t)(1)(iii) specifies that employers also must train
``other employees involved in setting up and managing'' the employer's
ergonomics program. This provision is similar to the proposed
provision, except that it
[[Page 68405]]
substitutes ``employees'' for ``persons'' (the proposed term). OSHA has
directed this provision to employees rather than persons because doing
so makes it clear that the Agency is not regulating individuals
operating outside of the employment relationship.
Initial and Refresher Training. The proposed rule required that
training be given in accordance with the following timetable:
------------------------------------------------------------------------
------------------------------------------------------------------------
For employees in problem jobs and their (1) When a problem job is
supervisors. defined;
(2) When initially assigned to
a problem job;
(3) Periodically as needed
(e.g., when new hazards are
identified in a problem job or
changes are made to a problem
job that may increase exposure
to MSD hazards); and
(4) At least every 3 years.
For persons involved in setting up and (1) When they are initially
managing the ergonomics program. assigned to setting up and
managing the ergonomics
program;
(2) Periodically as needed
(e.g., when evaluation reveals
significant deficiencies in
the program, when significant
changes are made in the
ergonomics program); and
(3) At least every 3 years.
------------------------------------------------------------------------
In the final rule, OSHA has revised the timetable for initial
training to reflect the addition of the Action Trigger to the standard,
and to allow time for the employer to conduct the job screening process
and implement the ergonomic program. Accordingly, paragraph (t)(4)
provides the fillowing timeframes for initial training: When the
employer determines that an employee's job meets the Action Trigger,
the employer has 45 days from that time to train employees involved in
setting up and managing the program, and 90 days from that time to
train each current employee in that job and their supervisor and team
leader. Also, if the employer assigns a new or current employee to a
job that the employer has already determined meets the Action Trigger,
that employee must be trained prior to starting the job.
Paragraph (t)(1) of the final rule also requires follow-up
training, every three years, for employees whose jobs meet the Action
Trigger. This requirement differs from the corresponding proposed
provision, which did not rely upon the Action Trigger concept.
Several commenters (see, e.g., Exs. 32-198-4, 32-198-1/42, 30-3686,
32-339-1, 30-2116, 30-2825, 30-2847, 30-3001, 30-3033, 30-3034, 30-
3035, 30-3258, 30-3332, 30-4159-30-4536, 30-4546, 30-4547) urged OSHA
to require refresher training more frequently than once every three
years.
Some of the reasons cited by these commenters for more frequent
training included:
Many workers experience problems in less than a year (Ex.
32-198-4-1/42).
Training should be required annually and whenever jobs or
conditions change (Ex. 30-3686).
Employers should train every two years at a minimum
because many employers are already providing training on an annual
basis (Ex. 32-198-4).
Other commenters requested that OSHA require training less often or
require training less often in some situations (see, e.g., Exs. 32-300-
1, 30-3813, 30-3765, 30-327, 30-710, 30-2725, 30-3284, 30-4046). Some
specific reasons given for less frequent retraining were:
There should not be a minimum three year retraining
provision for employees where the reported MSD has resolved within the
three years and no other MSDs (affecting the same part of the body)
have been reported in that job (Ex. 30-3813).
Employees will retain knowledge about their job's core
functions, like how to use controls and work practices properly, even
without training (Exs. 32-300-1, 30-3284).
OSHA should allow employees and supervisors to demonstrate
knowledge retention so that they can be exempt from the three year
retraining requirement (see, e.g., Exs. 32-300-1, 30-327, 30-1671, 30-
328).
Program administrators should be allowed to bypass
portions of initial and refresher training if they already possess
background training. This group could include health and safety
personnel, medically trained personnel, and ergonomists (see, e.g., 32-
300-1, 30-327, 30-1671, 30-3284).
OSHA responds to these comments on the appropriate frequency of
training as follows. First, OSHA believes that refresher training every
three years for those in higher-risk jobs is appropriate, given the
very broad range and diverse nature of businesses covered by this
standard. For example, the number of employees in the average business
covered by this standard is 16; such a business is likely to experience
not more than one or two MSDs in a given year, at most, which means
that one or two employees will receive initial training every year and
one or two will need refresher training (once the standard has been in
effect for a few years). In a business such as this, ergonomics
awareness is likely to be quite high, both because of the amount of
training going on and because of the job hazard anlysis and control
activities being conducted. In other words, the initial training and 3-
year follow-up training requirements will virtually ensure that
ergonomics training will be a regular part of the program for many
employers. In response to those commenters who argued that refresher
training every three years was unnecessary or burdensome, OSHA notes
that the standard allows employers considerable flexibility in the form
that training must take. For example, although all of the required
topics must be addressed in the refresher training, trainers who
observe that trainees ``know the basics'' are free to spend more of the
training time on such workplace-specific topics as changes to
workstations that have taken place since the last training.
Some commenters argued that many workplaces are static rather than
dynamic in nature and therefore that workers in them do not need
refresher training (see, e.g., Exs. 30-2835, 30-3356). OSHA disagrees.
MSDs occur in workplaces with fixed workstations, in service industry
jobs, and in office settings; indeed, one of the striking
characteristics of MSDs is that they occur in all general industry
sectors (see the risk assessment section of this preamble, Section V).
Whenever MSDs occur in jobs that meet the action trigger, OSHA believes
that workers in these jobs should be trained initially, and that they
should also receive follow-up training at least every three years. This
approach ensures that those workers who are clearly at risk have the
knowledge and skills they need to work as safely in those jobs as
possible. The approach taken in the final rule--to require refresher
training only for employees, and the supervisors of employees, in jobs
that meet the Action Trigger--is also responsive to those commenters
who argued that no such training should be required if the problem has
gone away (see, e.g., Ex. 30-3813). OSHA is unsympathetic to those who
believe that employees do not need refresher training because they will
remember what they need to know about the ``core functions'' of their
job (see, e.g., Exs. 32-300-1, 30-3284). This is not OSHA's experience,
and the thousands of fatal and disabling injuries that occur in U.S.
workplaces every year confirm the fact that workers and their
supervisors often do not remember the safe operating procedures in
which they were trained.
[[Page 68406]]
OSHA has not adopted the suggestion of some commenters (see, e.g.,
Exs. 32-300-1, 30-327, 30-1671, 30-328) that employees and supervisors
who can demonstrate that they have retained the information they
learned be exempted from refresher training. OSHA has not done so
because refresher training is only required every three years and the
Agency believes that periodic retraining is appropriate for all
employees in the program. For the same reasons, the standard does not
permit managers and supervisors to demonstrate knowledge and be
exempted from refresher training, as some commenters suggested (see,
e.g., Exs. 32-300-1, 30-327, 30-1671, 30-3284). However, the final rule
does not use the word ``persons,'' as the proposal did, because OSHA
agrees with commenters that persons who are not employees (e.g.,
independent or self-employed ergonomists, safety specialists,
industrial hygienists, and so forth) are responsible for their own
training.
To those commenters who argued that more frequent refresher
training should be required because many employers are already doing it
(see, e.g., Ex. 32-198-4), OSHA responds that employers are always free
to provide more frequent training than OSHA requires. OSHA does not
agree, as some commenters maintained, that employees will continue to
remember the essential elements of their training, such as how to
implement controls, without refresher training. Instead, OSHA believes
that all employees in jobs posing MSD hazards will benefit from the
reminders and updating that refresher training provides.
OSHA also is not persuaded by arguments (see, e.g., Exs. 30-3765,
30-3813) that program managers should not have to be retrained. These
personnel, like employees, will benefit from renewing their knowledge
base and updating their skills every three years, particularly since
they only receive this training if the employees under their
supervision are in jobs that warrant it.
OSHA does agree that training is more difficult in workplaces with
high turnover. The Agency believes that the standard may help employers
to reduce turnover, as good ergonomics programs have done in many
workplaces (see the case study table in Section VI of the preamble).
The difficulties of training short-term employees, some of whom may
only stay with the host employer for a week or less, were discussed by
one commenter (Ex. 30-240). According to this comment, training short-
term employees in a high-turnover environment is both time consuming
and resource-intensive. OSHA agrees that this is the case; however,
ergonomics training is essential for each employee who experiences an
MSD incident in a job that meets the Action Trigger, even if that
employee is only in the job for a few weeks or months. Employers may
also find that training helps to reduce turnover to the extent that
ergonomic stress plays a part in employees' decisions to leave
employment. As discussed below, paragraph (t)(5) also allows that if an
employee has been trained in a topic required by paragraph (t)(2)
within the previous 3 years, the employer need not provide initial
training in that topic. OSHA believes that this provision will reduce
the burden on employers in high-turnover industries, at least to some
extent.
The training and qualifications of the individuals providing the
training required by the final rule was the topic of several comments
(see, e.g., Exs. 32-111-4, 30-3686, 32-194-4, 32-182-1). These
participants stressed the importance of the qualifications of the
trainers to effective ergonomics programs, and one commenter (Ex. 32-
194-4) expressed concern that, if program evaluations were conducted by
untrained managers, inadequate evaluations could result.
OSHA agrees that the knowledge and skills of those administering
ergonomics training play a major role in the effectiveness of the
training. However, the final rule does not specify the credentials or
experience such trainers or program managers must have. Ergonomists,
safety professionals, industrial hygienists, and individuals who have
taken ergonomics courses, attended train-the-trainer sessions, and
learned the basics of ergonomics on-the-job are currently providing the
training being presented in existing, effective ergonomics programs and
have demonstrated their ability to be effective trainers. A recent
study (Ex. 500-71-64) from the International Journal of Industrial
Ergonomics reports that trained workers do an exceptional job in
identifying risk factors and solutions: in 65 to 85 percent of cases,
professional ergonomists and trained workers identified the same risk
factors when they performed job hazard analyses. The authors of this
study concluded that ``users [trained employees] can identify rather
reliably the risk factors in the jobs.''
Train-the-trainer sessions involving employees also have achieved
excellent results; for example, a hospital that introduced patient
handling equipment and conducted extensive train-the-trainer and
employee training credits the program with reducing lost-time injuries
by 64% within the first year (Ex. 500-71-61). The record thus
demonstrates that persons with a wide range of credentials, skills, and
experience can effectively train employees, supervisors, and managers,
provided that they themselves have been well-trained.
Topics for Training. Paragraph (t)(2) of the final rule requires
that the employees identified in paragraph (t)(1) be trained in the
following topics (as appropriate to their responsibilities in the
ergonomics program):
The employer's ergonomics program and their role in it;
The signs and symptoms of MSDs and ways of reporting them;
The risk factors and MSD hazards present in the employee's
job, as identified by the Basic Screening Tool and the job hazard
analysis;
The employer's plan and timetable for addressing the risk
factors and hazards identified;
How to use engineering, work practice, and administrative
controls, or any PPE, that will be used in the job; and
How to evaluate the effectiveness of the control approach
adopted to reduce the risk factors and MSD hazards.
With two exceptions, these are the same training topics (with minor
editorial changes) that OSHA proposed. The two exceptions are specific
training in the requirements of the standard and in the importance of
early reporting of MSD signs and symptoms. OSHA has not included these
topics in the list of training topics in the final rule because the
hazard information provided to employees under paragraph (d) of this
standard already includes this information. Thus all employers covered
by the standard will have access to a summary of the standard and will
be aware of the importance of early reporting.
OSHA believes that training in the topics listed in paragraph
(t)(2) is an important way to ensure that employees at all levels of
the organization have the information and skills they need to
participate effectively in the ergonomics program. Only workers trained
to recognize MSD hazards and MSD signs and symptoms, to use the
controls implemented to reduce these hazards, and to evaluate the
effectiveness of these controls, can make the program work in terms of
reducing work-related MSDs.
There was substantial disagreement among those commenters who
addressed the content of the proposed training requirements. Several
felt that the list of training topics should be
[[Page 68407]]
expanded, while others argued that some requirements should be deleted.
In addition, many commenters submitted data and information showing
that training programs can achieve significant results in reducing
workplace MSD hazards and associated MSDs.
Examples of some of the suggestions commenters had for revising the
proposed training topics included:
OSHA should specifically require that employers provide
training on the requirements for medical management, Work Restriction
Protection, and the standard's prohibition against discouraging workers
reports (Exs. 32-111-4, 32-339-1).
Work Restriction Protection should be explained during the
initial training (Exs. 30-4538, 32-339-1).
First-line supervisors as well as the program manager
should have hazard analysis training (Ex. 30-3826).
Training should include discussions of medical records
confidentiality, job hazard analysis (including ergonomic assessment of
work stations) and disease and disability related to ergonomic injuries
(Ex. 30-3686).
OSHA should include both detailed and more general topics
in initial training, and job-specific training for employees in problem
jobs and their supervisors (Ex. 32-198-4).
Training should cover the importance of height differences
among employees, the training of lift team members, and the importance
of labeling packages with their weights (Exs. 32-461-1, 30-115, 30-
4538).
Other commenters recommended that certain subjects be deleted from
the required training topics. For example, several commenters suggested
that training on the specific requirements of the standard be deleted
from the list (see, e.g., Exs. 30-3765, 32-300-1, 30-240, 30-3284).
These commenters were of the opinion that there is no need to provide
in-depth training on the standard itself, but that the training should
instead focus on elements of the standard only as they specifically
apply to the company's program. Further, these commenters believed that
employees have ample access and opportunity to familiarize themselves
with OSHA standards, including access to OSHA's internet homepage (see,
e.g., Ex. 330-3765).
OSHA agrees that the specific suggestions for additional training
content made by commenters would be useful to employees. However, the
Agency has decided to require only that employees be trained in those
basic topics that are essential to worker protection. The required
topics are general, in order to allow the flexibility needed in
different workplace situations. This approach is consistent with the
training content requirements of other OSHA standards (see, e.g., 29
CFR 1910.1018 and 29 CFR 1910.147). The final rule requires training in
the employer's ergonomics program and each employee's role in it; the
signs and symptoms of MSDs and ways of reporting them; the risk factors
and MSD hazards present in the employee's job, as identified by the
Basic Screening Tool and the job hazard analysis; the employer's plan
for addressing identified hazards, including the employer's timetable
to abate the hazards identified; training in how to use the controls in
the job, including any personal protective equipment; and how to
evaluate the effectiveness of the control approach used.
OSHA believes that the required topics constitute a minimal
training program and recognizes that many employers may choose to
administer more extensive training. OSHA anticipates that many
employers will cover such topics in their training programs as OSHA's
discrimination regulations (Section 11(c) of the Act), Work Restriction
Protection, MSD management, and multiple HCP review. Several of these
topics are briefly addressed in the information on the standard
employees receive in response to the requirements of paragraph (d).
OSHA believes that training under paragraph (t) should concentrate
primarily on MSDs and MSD hazards that are specific to the employee's
job. OSHA has also not included the more detailed topics--package
weight labeling, the importance of height differences among employees,
lift team training, and so forth--suggested by commenters (see, e.g.,
Exs. 32-461-1, 30-115, 30-4538). Such topics are workplace-specific and
thus not appropriate to include in general training requirements that
will apply to all workplaces covered by the standard.
Some commenters recommended that OSHA expand its training
activities by developing outreach training programs and other
compliance assistance materials (see, e.g., Exs. 30-3686, 30-4538, 32-
198-4, 30-3826, 30-614, 30-1037, 30-2806). Some specific suggestions
were that OSHA develop a sample curriculum, including audiovisuals (Ex.
30-4538), or that OSHA provide a curriculum, instructor materials (and
translations), and training videos at minimal cost (Ex. 32-198-4).
Other comments urged OSHA to establish an ``advice line'' for program
managers (those setting up and implementing the program) and urged
employers to work closely with health care professionals. These
commenters were concerned that, without such assistance, managers would
be tempted to buy expensive but ineffective ergonomic fixes and
purchase products that do not address the root cause of the problem
(Exs. 30-614-, 30-898, 30-4139).
Other stakeholders suggested that OSHA train its compliance
officers to have, at a minimum, the same level of knowledge as
consultants advising employers in ergonomics programs (see, e.g., Exs.
30-1037, 30-3922). These commenters urged the OSHA training centers to
make ergonomic certification programs and other courses available to
the public or at least to make employers aware of sample programs that
already exist (see, e.g., Exs. 30-1037, 30-3123, 30-3128).
OSHA does have programs in place to help employers with their
ergonomics programs. The Agency offers free consultation services
through the states. The OSHA consultation program is specifically
designed for small- and medium-size organizations (i.e., employers with
250 employees or fewer per site or 500 per organization). These
services are confidential, and consultants will not issue citations or
propose penalties. OSHA also offers off-site services to larger
organizations and on-site services on a priority basis if resources
permit. OSHA staff are available to answer questions from the public
any time during OSHA working hours. In addition, OSHA makes a wide
range of ergonomics-related materials available on the Agency's
website, www.osha.gov.
With respect to the training of compliance officers and other OSHA
staff, OSHA's Training Institute in Des Plaines, Illinois, provides
basic and advanced ergonomics courses for Federal and State compliance
officers, State consultants, other Federal agency personnel, and
private sector employers, employees and their representatives. Also,
the Training Institute has established Training Institute Education
Centers, which are nonprofit colleges, universities, and other
organizations selected after competition for participation in the
program. In addition, OSHA provides funds to nonprofit organizations
through grants to conduct workplace training. Grants are awarded
annually to grant recipients, who contribute at least 20% of the total
grant cost. OSHA has already trained many of its CSHOs extensively in
ergonomics, and has made regional ergonomics coordinators available in
the regional offices. In addition, OSHA is
[[Page 68408]]
making extensive outreach materials on ergonomics available with the
final standard.
Effectiveness of Training. Some stakeholders submitted data to the
record on the effectiveness of ergonomics training. Several commenters
noted that they had developed training programs, had coordinated
programs through outside organizations such as universities, or were in
the process of developing or testing training programs (see, e.g., Exs.
30-3826, 32-198-4, 32-77-2, 32-185-3, 30-1294, 30-3336, Tr. 2776, Tr.
2761, 30-449, 30-2713, 30-3368, 30-3758, 30-3867, Tr. 3129-3219, Tr.
14969-15072). Stakeholders described some of the achievements of these
programs (see, e.g., Exs. 32-198-4, 32-185-3, 30-449, 30-3336, 30-3758,
30-3867, Tr. 7982), including their contribution to the decrease in the
rate of MSDs observed among their members (Tr. 7982) and continued
reductions in workers' compensation costs even in the face of increases
in wages and health care costs (Exs. 30-3336, 30-3867, 30-4496). The
thrust of these comments is that ergonomically aware workers can help
their co-workers and their employers to prevent MSDs (Ex. 30-3758).
Several studies in the record demonstrate the benefits of
ergonomics training. For example, a study by Parenmark, Engvall, and
Malmkvist showed that workers receiving training had a reduced number
of lost workdays due to MSDs compared with untrained controls (Ex. 26-
6). The number of days lost as a result of arm-neck-shoulder complaints
was reduced by half in the trained new hires compared with the control
group (Ex. 26-6, Table 2).
An AFGE health and safety representative referenced an Ergonomic
Workplace Survey conducted by Rani Lueder, CPE, for the Social Security
Administration in 1997 (Ex. 30-449). The large majority of respondents
who received the training considered the training helpful, and the
trained respondents reported consistently lower rates of discomfort for
all body parts, were more willing to report MSD discomfort to their
supervisors, and were more satisfied than untrained workers with their
supervisors' responses (Ex. 30-499). Also, respondents who were trained
were more likely to adjust their chairs, worktables, and other
equipment to reduce the risk factors present.
Many commenters at the hearings described the training component of
their ergonomics programs (see, e.g., Tr. 12367-12373, Tr. 7977-7982).
The extent of the training being administered varied widely, from very
simple training to comprehensive efforts. OSHA believes that the
training program required by the final rule will do much to increase
the level of ergonomics knowledge and understanding among employees,
their supervisors, and managers. This knowledge, in turn, will
translate in practice to fewer MSDs, improved morale, and greater
productivity. There is evidence in the record that good training
programs operate in just this way. For example, a 1997 article in the
American Journal of Health Promotion [Ex. 500-71-63] reports that
ergonomics training programs lasting about an hour and administered to
computer operators described in the article as ``high risk'' led every
trainee subsequently to make changes either in their workstations or
their work practices. About two-thirds of the trainees made
ergonomically advantageous changes to both.
Another study (Ex. 500-71-59) reports that factory processing line
workers who were trained in MSD hazard recognition were subsequently
better able to recognize hazards and more willing to report them to
their supervisors. OSHA believes that the experiences of these
companies will be repeated frequently once the final rule's training
requirements are implemented.
Retraining of employees who have already received training. The
proposed rule stated that employers do not have to provide initial
training to current employees, new employees and persons involved in
setting up and managing the ergonomics program if they have received
equivalent training in the subjects this standard requires within the
last 3 years. However, the proposal stated that employers must provide
initial training to such individuals in any of the required topics that
their prior training did not cover. The final rule, at paragraph
(t)(5), provides that if an employee has received training in a
required topic within the previous 3 years, the employer need not
provide initial training to that employee in that topic.
Several commenters supported this proposed requirement (see, e.g.,
Exs. 30-3765, 32-300-1, 30-1671, 30-3284). Some organizations asked
OSHA to clarify how the Agency expects an employer to verify such prior
training (Exs. 30-3826, 32-300-1). OSHA does not require employers
availing themselves of this ``portability of training'' provision to
have written documentation of the employee's prior training or to
require the employee to pass an examination (Ex. 30-3826). The Agency
does, however, expect employers who wish to benefit from this provision
to assure themselves that employees have in fact had the prior training
and have sufficient knowledge to work safely.
A number of commenters objected either to the prior training
exemption altogether or to the fact that OSHA proposed to permit
training given in the 3 years prior to the compliance date to qualify
for the portability exemption (see, e.g., Exs. 30-3686, 30-2116, 30-
2809, 30-2825, 30-2847, 30-3001, 30-3033, 30-3035, 30-3258, 30-3332,
30-4159, 30-4536, 30-4546, 30-4547). OSHA has decided in the final rule
to retain the training exemption as proposed, because the Agency
believes that employees who have received all of the required training
elsewhere do not need to be retrained until their refresher training
date comes up. Although employees who have had prior training are not
required to take initial training, all employees in jobs that meet the
Action Trigger must receive refresher training.
OSHA received several non-specific comments only tangentially
related to the proposed training provisions. These primarily concerned
what the commenters perceived as ``vagueness'' in the proposed language
of the regulatory text. For example, some participants believe that
employers will not be able to train their employees because, in their
opinion, the standard isn't clear about the steps that need to be taken
(see, e.g., Exs. 32-368-1, 30-325, 30-494, 30-2846) and assert that
this will make training more difficult and costly than usual (see,
e.g., Exs. 32-368-1, 30-1668, 30-2846, 30-3781, 30-3593).
In the final rule, OSHA has revised the proposed standard's
training requirements extensively and has clarified areas of overlap
and confusion. For example, the basic information requirements in
paragraph (d) now apply to all covered employers and are intended to
ensure that all employees are familiar with the elements of the OSHA
standard, and this topic is no longer also included in the required
training topics.
Some commenters argued that OSHA should phase in compliance
requirements for the training provisions because it will take time to
develop adequate in-house materials. OSHA is aware that it takes time
to develop training materials, but OSHA is also aware that many trade
associations and other organizations, as well as employers, already
have such materials. Further, OSHA is making many outreach materials
available at the time the standard is published and in the months
thereafter. Consequently, OSHA
[[Page 68409]]
believes that the time allowed for employers to come into compliance
with the rule's training requirements (see paragraph (x)) is
appropriate. The Agency is phasing in all elements of the final rule;
therefore, an employer's earliest requirement to train employees under
this standard will not arise for about a year after the publication
date of the final rule.
What employers must do to ensure that employees understand
training. OSHA proposed that employers provide ``training and
information in language that employees understand.'' The proposal also
stated that employers must ``give and receive answers.'' The final
rule, at paragraph (t)(3), contains essentially the same requirements.
These requirements provide individual employers with considerable
flexibility in ways of achieving compliance (e.g., the ``language'' may
be one all trainees understand rather than the trainee's native
language, so long as the trainee understands the language well enough
to fully understand the training). Employees have varying educational
levels, literacy, and language skills, and training must be presented
in a language and at a level of understanding that accounts for these
differences in order to meet the intent of the final requirement that
individuals being trained understand the specified training elements.
The final rule requires that employers provide opportunities for
employees to ask questions and receive answers about the
establishment's ergonomics program and anything covered by the
training. Again, employers have complete flexibility in the methods
they use to comply with this requirement. For example, employers could
choose to to do the training in-house or to use an outside trainer.
Other alternatives would be for the employer to have a qualified
trainer available by phone, or through a classroom video-conference.
Commenters addressed three issues related to the proposed
requirement that training be understandable to the employee and that
employees have the opportunity to ask questions and receive answers
about their training. These issues were: The meaning of
``understanding'; the meaning of ``ask questions and receive answers';
and whether specific training methods should be included in the rule.
Several commenters asked OSHA to explain what it meant by requiring
training to be provided ``in language the employee understands'' (see,
e.g., Exs. 30-3826, 32-198-4, 30-3686, 30-3686, 30-3765, 32-339-1, 30-
1091). Commenters were concerned that, despite their best efforts, some
employees might not understand the training well enough to ``pass'' the
test if CSHOs asked them questions (see, e.g., Exs. 30-429, 30-494, 30-
1090, 30-3122, 30-3557, 30-3593, 30-3781). These employers fear that
they would be vulnerable to citation and penalty in such a
circumstance. Commenters also interpreted OSHA's ``in language the
employee understands'' terminology to mean that they would have to test
employees to ensure adequate comprehension (see, e.g., Ex. 30-3557).
Another commenter specifically suggested that the final rule require
the employer to demonstrate that the employees had understood the
training (Ex. 32-339-1).
Employers were also concerned about having difficulty finding good
translations of training materials (see, e.g., Exs. 30-4538, 30-240,
30-429, 30-1090, 30-3868). One commenter noted, however, that training
materials in Spanish could be obtained from the Labor Occupational
Safety and Health Program at the University of California in Los
Angeles (Ex. 30-4538). Some employers understood the proposed ``in
language the employee understands'' terminology as meaning that they
would have to train in each of the languages native to their workforce
(see, e.g., Exs. 30-240, 30-429, 30-1090, 30-3336, 30-3557), and
expressed concern about the potential costs of such a requirement (Ex.
30-3868).
One commenter (Ex. 30-3336) stated that some companies in their
industry had employees on the payroll who spoke 12 different languages;
this commenter understood the proposal as requiring native speakers in
each of these languages to be available to receive and answer questions
on the content of the training and the ergonomics program. Moreover,
this commenter argued that OSHA's ``multi-lingual'' training
requirement presented an even greater problem for their industry
because it had a history of employing ``mentally challenged''
individuals (Ex. 30-3336).
In response to these comments, OSHA reiterates that the final rule
does not require employers to present training in the native languages
of the employees working in the establishments. In many workplaces,
although employees many have different ``first'' languages, they
understand English or another language well. The rule merely requires
that the employer provide the training in a language the employee
understands. OSHA does not believe that this will be difficult, because
employers are already communicating with their employees about safe
working procedures, tool and equipment care, project requirements, work
schedules, and dozens of other items of daily importance to workplace
operation and productivity. In other words, training is just another
form of communicating important information to employees, a process
that is going on in all U.S. workplaces at the present time. As to the
comment about the difficulty of complying with the rule in workplaces
that employ individuals with mental disabilities (Ex. 30-3336), OSHA
can only emphasize that the same techniques employers use to transmit
other essential workplace information to these individuals can be used
to provide the training required by the standard.
The final rule also does not require employers to test employees'
understanding or comprehension of the training given. However,
employers are free to do so if they wish, and OSHA is aware that many
employers do evaluate the effectiveness of their training immediately
or soon after it is given. Thus, although the training paragraph does
not require employee testing, employers who wish to have some way of
ensuring that their employees understand the training content may
establish any system that works for them. Employers are required by the
standard to evaluate the training component of their programs when they
do their periodic evaluations to ensure effectiveness.
Some commenters (see, e.g., Exs. 30-4538, 30-3686, 32-339-1)
recommended that the final rule's training requirements be revised to
be more consistent with those of other OSHA standards, such as the
Bloodborne Pathogens rule (Exs. 32-4538, 32-339-1), the Process Safety
Management standard (Ex. 32-339-1) or the Hazardous Waste Operations
and Emergency Response standard (Ex. 30-3686). OSHA believes that the
final rule's requirements, in paragraph (t)(3), that the training be in
language the employee understands and that employees be permitted to
ask questions and receive answers will together achieve the objective
desired by these commenters, i.e., assurance that employees understand
the training thoroughly.
Several commenters asked OSHA to clarify the phrase ``ask questions
and receive answers'' (see, e.g., Exs. 30-3826, 32-198-4, 30-3686, 30-
376). These commenters wanted clarification about the methods OSHA
requires them to use to accomplish this (see, e.g., Exs. 30-3765, 30-
3826). Other commenters recommended that the rule specify that
employees be permitted to ask questions and receive answers promptly
even if questions occur to them after the
[[Page 68410]]
training session is over (see, e.g., Exs. 30-2116, 30-2809, 30-2825,
30-2847, 30-3001, 30-3033, 30-3034, 30-3035, 30-3258, 30-3332, 30-4159,
30-4536, 30-4546, 30-4547).
Some commenters suggested that specific training techniques to be
included in the rule. Suggestions included:
Allow the use of electronic media, telephone reviews, and
videos (see, e.g., Exs. 30-3826, 30-3765, 30-434, 30-3392).
Require that training be provided in a supportive
atmosphere that encourages discussion of concerns with respect to MSD-
related working conditions and encourages opportunities for questions
(Ex. 30-3686).
Require training to be administered ``live''; prohibit
written training (Ex. 32-198-4).
A commenter argued for the need for live training as follows:
Employers often do not know at what level their employees are
reading and comprehending. Workers are generally reluctant to share
information about their literacy limitation (Sarmiento and Kay,
``Workers Centered Learning,'' 1990). It is estimated that between
45%-50% of adults in America struggle due to some limitations in
their literacy and/or language proficiency (which result in
limitation of ``understanding'' or ``reasoning''), according to
``Adult Literacy in America'' in publications of the U.S. Department
of Education (1993). In addition, many of those functioning at a
limited literacy level don't see themselves as having these
limitations (Ex. 32-198-4).
The same commenter recommended methods such as visual aids, discussion
and problem solving, and small group ``hands-on'' sessions, and noted
that workers are more likely to trust the employers' programs and
develop confidence if these more oral training methodologies are
implemented (Ex. 32-198-4).
In response to these comments, OSHA restates the position it has
taken consistently in other standards: OSHA's objectives are to require
employers to provide basic training in ergonomics, to ensure that all
trained employees understand the training, and to permit employees to
ask questions if they need further information. The Agency does not
dictate the methods that employers choose to achieve compliance with
these requirements. Properly trained employees will be sufficiently
informed to recognize the signs and symptoms of MSDs and the value of
reporting them early, to identify MSD hazards in their jobs, to know
how to use and evaluate the control measures that the employer
implements to reduce those hazards, and to work in ways that will
reduce the risks in their jobs. The standard also does not state how
long the training must last and when the question and answer periods
must occur; instead, OSHA is leaving such things to the employer's
discretion.
Paragraph (u)--What Must I Do To Make Sure My Ergonomics Program Is
Effective?
The intent of the provisions of the Program Evaluation paragraph of
the final Ergonomics Program standard is to require employers to
evaluate their ergonomics program to ensure that it is effective. Good
management, as well as common sense, suggest that periodic review of a
program's effectiveness is necessary to ensure that the resources being
expended on the program are, in fact, achieving the desired result and
that the program is doing so in an efficient way. Program evaluation is
a tool that can be used to ensure that an ergonomics program is
appropriate for the specific MSD hazards in the employer's problem jobs
and that the program is achieving desired results.
OSHA has long considered program evaluation to be an integral
component of programs implemented to address health and safety issues
in the workplace. For example, the Ergonomics Program Management
Guidelines for Meatpacking Plants (``Meatpacking Guidelines'')
recommend regular program review and evaluation (Ex. 2-13). These
guidelines suggest that procedures and mechanisms be developed to
evaluate the ergonomics program and to monitor progress accomplished.
Program evaluation is described in the Meatpacking Guidelines as a
program component whose use reflects both management commitment and
employee involvement. OSHA's 1989 voluntary Safety and Health Program
Management Guidelines also recommend regular program evaluation as an
integral program component (Ex. 2-12). Further, OSHA's Voluntary
Protection Programs (V.P.P.) and Consultation Program require periodic
evaluations of an employer's safety and health program, including that
portion of the program addressing ergonomic issues.
The proposal contained a ``basic obligation'' section that merely
summarized the proposed program evaluation provisions. The proposed
basic obligation section also stated that employers were to evaluate
their ergonomics program periodically, and at least every 3 years, ``to
ensure that it is in compliance with this standard.'' Because the basic
obligation sections of the proposed standard led to confusion and were
not helpful, OSHA has not included them in the final rule. Since the
basic obligation section only summarized the proposed program
evaluation requirements, comments on that section are discussed below,
in connection with the proposed requirement to which they refer.
The proposed rule contained provisions requiring employers with
programs to review them periodically to ensure their effectiveness;
identified the procedures employers were required to follow when
conducting evaluations; proposed that evaluations be conducted as often
as needed and at least every 3 years; and proposed that program
deficiencies identified during the evaluation be corrected promptly.
The final rule's program evaluation provisions have been revised to
reflect comments received, but are generally similar to those proposed.
Paragraph (u)(1) of the final rule provides for the frequency of
required program evaluations. The methods and procedures employers are
required to use in such evaluations are included in paragraph (u)(1)(i)
through (iv). Provision is made for other events that may trigger
program evaluations at more frequent intervals in paragraph (u)(2). In
addition, the prompt correction of any deficiencies identified during
the evaluation is covered in final rule paragraph (u)(3). The following
discussion presents OSHA's reasons for including revised program
evaluation provisions in the final rule, and summarizes the comments
the Agency received on the proposed program evaluation requirements.
Paragraph (u)(1)--Frequency of Program Evaluations
OSHA received many comments (see, e.g., Exs. 30-240; 30-1671; 30-
3860; 500-71-86; 500-137; 30-3686; 32-210-2; 32-85; Tr. 8982; 30-2116;
30-2809; 30-2825; 30-2847; 30-3258; 30-3035; 30-3001; 30-3033; 30-3034;
30-4159; 30-4534; 30-4536; 30-4800; 30-4776; 30-4546; 30-4547; 30-4548;
30-4549; 30-4562; 30-4627; 30-3332; 30-3259; 30-4801; 30-3898; 30-4270;
30-4498; 30-3813 ; 500-33; 30-3745; 30-3765; 30-3368; 30-4713; 30-4046;
30-4247) on the proposed frequency of ergonomic program evaluations, as
well as on the events that should trigger them. A few commenters (see,
e.g. Exs. 30-240, 30-1671, 30-3860, 500-137) agreed with OSHA's
proposed 3 year time frame, while others stated that they believed a 3-
year interval was too long and that program evaluations should take
place periodically and at least annually (see, e.g., Exs. 30-3686; 32-
210-2; 32-85; and Tr. 8982).
[[Continued on page 68411]]
[[pp. 68411-68460]] Ergonomics Program
[[Continued from page 68410]]
[[Page 68411]]
As mentioned above, OSHA received many comments (see, e.g., Exs.
30-2116; 30-2809; 30-2825; 30-2847; 30-3258; 30-3035; 30-3001; 30-3033;
30-3034; 30-3686; 30-4159; 30-4534; 30-4536; 30-4800; 30-4776; 30-4546;
30-4547; 30-4548; 30-4549; 30-4562; 30-4627; 30-3332; 30-3259; 30-4801;
30-3898; 30-4270; 30-4498; 31-242; 32-210-2; 500-71-86) stating that
program evaluations should take place at least annually. These
commenters generally argued, in the words of Greg Wyatt, an engineer
who suffers from a repetitive stress injury and who offered comments as
an individual, that ``the ergonomics program should be evaluated
regularly (at least once a year) because it is easier and more cost
effective to fix deficiencies early during the implementation phase''
(Ex. 30-3035). In a comment that pertains to all workplaces, the United
Mineworkers of America agreed, ``Routine audits, no less frequently
than once each year, should be performed of the entire workplace and
problem areas reported to the appropriate company representative for
immediate action'' (Ex. 500-71-86).
The need for evaluations at a minimum frequency of less than 3
years was addressed by several commenters (see, e.g., Exs. 30-2116; 30-
2809; 30-2825; 30-2847; 30-3258; 30-3035; 30-3001; 30-3033; 30-3034;
30-3686; 30-4159; 30-4534; 30-4536; 30-4800; 30-4776; 30-4546; 30-4547;
30-4548; 30-4549; 30-4562; 30-4627; 30-3332; 30-3259; 30-4801; 30-3898;
30-4270; 30-4498; 32-210-2; 32-111-4; 32-229; 30-4247), who pointed out
that workplace changes that adversely affect the functioning of a
particular element of the program or of the program as a whole can
occur in the interval between periodic evaluations (or ``regularly
scheduled'' evaluations). For example, the United Steelworkers of
America (UOWA) agreed that employers should evaluate their ergonomics
programs at least every 3 years but asked OSHA to include in the final
rule requirements that would trigger evaluations at more frequent
intervals as well. ``OSHA should provide additional specific
requirements for the employer to respond to concerns raised by workers
between evaluations. For example, employers should review health and
safety committee minutes to determine if ergonomic concerns were
identified, [and] then they should verify that those concerns have been
promptly addressed or address them at that time'' (Ex. 32-111-4).
From a somewhat different perspective, Organization Resources
Counselors, Inc. (ORC) (Ex. 30-3813) and Edison Electric Institute
(EEI) (Ex. 500-33) asked that the standard's language be changed to
reflect their belief that a requirement to evaluate an ergonomics
program both periodically and every three years was excessive. Both
commenters agreed that the employer was in the best position to
determine how often the ergonomics program at a particular worksite
needs to be evaluated to ensure its effectiveness. However, in ORC's
words, ``it is not reasonable that the standard should require both
periodic evaluation as well as an evaluation every three years.'' These
commenters urged OSHA to require employers to evaluate their ergonomics
programs periodically, ``and/or'' at least every 3 years.
Another rulemaking participant, the National Soft Drink Association
(NSDA) (Ex. 30-368) questioned whether performance of a program
evaluation every 3 years also would satisfy the proposed requirement
for periodic evaluations. Because, NSDA believes that the two
provisions are duplicative, it recommended that the term ``periodic''
be eliminated. The Dow Chemical Company (Ex. 30-3765) also opposed the
``at least every 3 years'' language, on the grounds that industry
should be able to decide if and when periodic evaluations should be
carried out but agreed that periodic reviews are necessary: * * *
review on a periodic basis is necessary, especially * * * for dynamic
workplaces with continuous turnover, process changes, etc.'' The
National Telecommunications Safety Panel (Ex. 30-3745) agreed, saying
the proposed rule's prescribed frequency presented particular problems
for them because of their members' geographic sweep and rapidly
changing workplaces and that [determining] ``program evaluation
frequency * * * [should be] the sole responsibility of the employer.''
A few commenters (see, e.g., Exs. 30-4713 and 30-4046) stated that
the proposal's requirements for program evaluation were excessive: ``*
* * a complete evaluation, as required by the rule, cannot be
realistically performed `periodically,' as that term is defined.''
A number of commenters who have themselves experienced MSDs (see,
e.g., Exs. 30-2116; 30-2809; 30-2825; 30-2847; 30-3258; 30-3035; 30-
3001; 30-3033; 30-3034; 30-3686; 30-4159; 30-4534; 30-4536; 30-4800;
30-4776; 30-4546; 30-4547; 30-4548; 30-4549; 30-4562; 30-4627; 30-3332;
30-3259; 30-4801; 30-3898; 30-4270; 30-4498) also urged OSHA to require
in the final rule that ``every time an employee reports persistent MSD
symptoms or an MSD injury, Job Hazard Analysis and Control must be
performed, and the ergonomics program must be re-evaluated.'' In the
view of these commenters, every report of an MSD injury or persistent
MSD symptom points to a deficiency in the ergonomics program that must
be evaluated and corrected. OSHA agrees with these commenters that
significant changes in workplace conditions, such as the introduction
of a new process; changes in management or supervisory personnel,
procedures, or policies; or changes in the form or intensity of
employee involvement, can affect the functioning of the program
substantially and thus may necessitate an evaluation of particular
program elements or of the program as a whole.
However, the Agency has chosen not to shorten the minimum interval
between program evaluations to once a year from every three years
because such a requirement would prove to be too burdensome if imposed
on all of industry. Such a frequency would deprive employers of the
flexibility which was OSHA's goal in drafting the program evaluation
requirements, given the diversity of workplaces covered by this rule.
OSHA also is not persuaded that it would be appropriate to require
employers to evaluate their programs every time an MSD incident occurs
or an ergonomic concern is expressed, as some commenters urged the
Agency to do. Such a requirement would precipitate constant evaluations
for employers with large workforces, where the incidence of MSD
injuries is often high. OSHA does not expect that the program mandated
by the standard will eliminate MDSs in the workplaces covered by the
standard; indeed, as the discussion in Section VI of this preamble
makes clear, OSHA is projecting that, on average, the standard will
prevent about 50% of MSDs in such workplaces. Further, the Agency
believes that employee concerns about ergonomics will be addressed
regularly as a result of the standard's requirements for prompt
responses to employee concerns and regular employer/employee
communications about workers' concerns.
After a review of the evidence in the record on the frequency of
program evaluations, the final rule requires them when there is reason
to believe that the program is not functioning properly, when changes
have occurred that may have increased employee exposure to MSD hazards,
and at least once every three years. The final rule's requirements are
essentially similar to those proposed, although they are somewhat more
specific. OSHA's reasons for retaining provisions for program
evaluation that require such
[[Page 68412]]
evaluations at least once every 3 years and at other times if workplace
conditions warrant them, are: (1) the diversity of conditions in the
workplaces covered by the rule demands the combination of specificity
and flexibility provided by the provisions in paragraphs (u)(1) and (2)
all programs need to be evaluated at least once every 3 years to ensure
that they are functioning optimally and meeting the needs of the
organization over time.
Paragraph (u)(2)--Steps Involved in Program Evaluation
In the proposed section titled ``What must I do to evaluate my
ergonomics program?'', the proposed rule stated that program evaluation
goes beyond a mere inspection or audit of problem jobs. The final rule,
at paragraphs (u)(2)(i), (ii), (iii) and (iv ), contains similar
requirements. For example, the proposed rule would have required
employers to consult with employees in problem jobs to assess their
views about program effectiveness and identify program deficiencies,
paragraph (u)(2)(i) of the final rule requires employers to consult
with employees, ``or a representative sample of them,'' about program
effectiveness and any problems with the program. Paragraph (u)(2)(iii)
requires employers to evaluate the elements of a program to ensure it
is functioning effectively; this language is essentially unchanged
since the proposal. The proposal would have required employers to carry
out evaluations to ensure that the program was ``eliminating or
materially reducing'' MSD hazards, while the final rule at paragraph
(u)(2)(iii) requires the employer to assess whether MSD hazards are
being identified and ``addressed.'' The final rule adds, at paragraph
(u)(2)(iv), a requirement that employers use the evaluation as an
opportunity to assess whether the program as a whole is achieving
positive results. OSHA includes examples of measures of effectiveness,
such as reductions in the number or severity of MSDs, increases in the
number of jobs in which ergonomic hazards have been controlled,
reductions in the number of jobs posing MSD hazards to employees, or
any other measure that demonstrates program effectiveness.
An adequate evaluation asks questions of employers at all levels of
the organization to determine whether the required ergonomics program
elements have been adequately implemented and whether they are
integrated into a system that effectively addresses MSDs and MSD
hazards. Examples of questions an evaluation is designed to explore
are:
--Has management effectively demonstrated its leadership?
--Are employees actively participating in the ergonomics program?
--Is there an effective system for the identification of MSDs and MSD
hazards?
--Are identified hazards being controlled?
--Is the training program providing employees with the information they
need to actively participate in the ergonomics program?
--Are employees using the reporting system?
--Are employees reluctant to report MSDs or MSD hazards because they
receive mixed signals from their supervisors or managers about the
importance of such reporting?
--Is prompt and effective MSD management available for employees with
MSDs?
OSHA finds that these questions, which were included in the
proposal, continue to be appropriate points for program evaluations to
address. The comments OSHA received on the proposed requirements for
conducting evaluations addressed the following topics: the vagueness of
the proposed terms used; the inclusion of core elements in the program
required by the standard and in the standard's requirements for
evaluation; the need for OSHA to specify measures of effectiveness for
employers to rely on; the statement in the basic obligation section of
the proposed rule that programs should be evaluated to ensure that they
are in compliance with the standard itself; who should carry out
program evaluations; the records to be reviewed in a program
evaluation; and the extent of the recordkeeping required by this
provision of the standard. The comments OSHA received on each of these
topics are discussed below.
Vagueness of the rule's terminology: The Center for Office
Technology (COT) complained that some of the terms used in the context
of the proposed evaluation section were vague and ``subjective'' (Ex.
25-710). Specifically, COT pointed to the proposed requirement that
evaluations be conducted ``as often as necessary'' (defined in the
proposal as ``periodically'') as an example of the vagueness of the
proposal's language. COT stated, ``* * * training and program
evaluation must be conducted ``as often as necessary'' and the program
must be ``appropriate'' to workplace conditions. How will compliance
with these vague, undefined and subjective requirements be assessed?''
Inclusion of core elements in the program: The Forum for a
Responsible Ergonomics Standard (Exs. 32-351-1 and 30-3845) and others
(Exs. 30-574; 30-2773; 500-33; 30-4040) were critical of the proposed
Ergonomics Program standard's requirement that employers include in
their programs, and evaluate, six mandatory core elements. By mandating
that ergonomics programs have a certain form, i.e., have specific
elements, instead of requiring only that the program be effective, OSHA
was, according to the Forum, ``elevating form over function, divorcing
its program from [what should be] the goal of achieving reduced MSD
injuries and focusing instead on ensuring that programs fit a
bureaucratic mold that is administratively simple.'' In other words,
the Forum believes that the effectiveness of an ergonomics program
should be the sole measure of its success in any evaluation. The Forum
stated that the proposed approach to program evaluation could lead to
``the perverse possibility'' of an employer with a program that
successfully reduces MSDs being cited for a violation of the standard
merely because the program failed to include a required program
element.
Another commenter (Ex. 31-353) questioned how effective a program
evaluation could be unless the rule required the effectiveness of each
of the individual Ergonomic Program elements to be evaluated. ``Without
determining the effectiveness of all the aspects of the program, an
employer is wasting time and money, and effort.'' Similarly, the
Department of Defense (Tr. 9085-9086) stated, ``If the evaluation is
focused on the presence and function or process elements of the program
then the standard should clarify the essential evaluation points for
each program element.''
Compliance as a measure of effectiveness: The Dow Chemical Company
(Exs. 30-3765 and 32-77-2) asked, ``Is the point of program evaluation
to evaluate compliance with the standard or the program's
`effectiveness'? Or both?'' Dow's comment referred to a statement in
the basic obligation section of the proposed rule to the effect that
the program was to be evaluated to ensure its compliance with the
standard. According to Dow, ``If OSHA maintains the requirement to
evaluate `effectiveness' of a program, then it should indicate the
method an employer can use for measuring `effectiveness.' '' A program
may have all of the required elements and thus be in compliance with
the rule, but not address all potential MSDs'' (Ex. 30-3765). The
Association of Energy
[[Page 68413]]
Servicing Contractors (Tr. 15624) and others (Ex. 30-3839) agreed with
Dow about the need for measurable criteria with which to gauge
compliance with the standard.
Also commenting on this point was the Honorable Senator Christopher
S. Bond, Chairman of the United State Senate Committee on Small
Business, who submitted a study (Ex. 30-4334-4) carried out by the
Regulatory Studies Program of Mercatus Center at George Mason
University, entitled, ``Over Stressing Business: OSHA and Ergonomics.''
The study included the following statement: ``The draft rule requires
employers to evaluate their ergonomics program according to both
activity and outcome measures. Yet in the case of MSDs, neither
activity nor outcome measures are likely to reflect program
effectiveness.''
The final rule does not require employers to evaluate their
programs for compliance with the standard, as proposed, because this
statement confused commenters and is unnecessary. The final rule's
requirements (paragraphs (u)(1)(ii) and (iii)) that employers
``evaluate the elements of the program to ensure they are functioning
effectively'' and ``assess whether the program is achieving results''
will essentially ensure compliance with the standard and eliminate the
confusion caused by the proposed statement. Further, as the Dow
Chemical Company pointed out, programs may be effective even if they do
not contain every sub-element of the OSHA standard; this is certainly
the case with grand fathered programs that were put in place well
before OSHA's standard was promulgated (Exs. 30-3765 and 32-77-2).
Measures of program effectiveness: Many commenters asked OSHA to
identify measures of program effectiveness that the Agency believes are
appropriate. For example, the Dow Chemical Company stated, ``If OSHA
maintains the requirement to evaluate `effectiveness' of a program,
then it should indicate the method an employer can use for measuring
`effectiveness'. A program may have all the required elements and thus
be in compliance with the rule, but not address all potential MSDs''
(Ex. 30-3765). The Oregon Building Industry Association (Ex. 30-562)
and others (Exs. 30-368, 30-541, 30-627, 30-1697, 30-1717, 30-1355, 30-
1545, 30-3783; 31-334: 32-210-2) raised the same issue, and the Oregon
Association also asked, ``Would the occurrence of an injury allow the
OSHA inspector to automatically qualify the program as not effective?''
(Ex. 30-562).
Organization Resources Counselors, Inc. (ORC) (Ex. 30-3813) voiced
a somewhat different concern regarding the need for measures of
effectiveness. ``OSHA expresses particular concern in the preamble that
there is a need to assure that a demonstration of effectiveness does
not mask under reporting of MSDs,'' they wrote. ORC agreed that this
was a real concern and suggested that employers should be required to
provide evidence that there is an effective early reporting mechanism
in place as a part of their demonstration of program effectiveness. In
response to the views of commenters, OSHA notes that the final rule
identifies a number of measures of effectiveness, including reductions
in the number or severity of MSDs, increases in the number of jobs in
which ergonomic hazards have been controlled, reductions in the number
of jobs posing MSD hazards to employees, or any other demonstrably
appropriate measure of effectiveness, that OSHA believes are indicative
of program effectiveness. This list of measures is not exhaustive; it
is meant to be illustrative only. OSHA is aware that employers with
successful programs use other measures, such as reductions in workers'
compensation costs, increases in the number of early reports of MSD
signs and symptoms, and increases in product quality, to evaluate the
effectiveness of their ergonomics programs (DOD Tr. 3296-3297; OR Ex.
32-78-1 p.22; AFL-CIO Ex. 32-339-1-29; Library of Congress Ex. 32-339-
1-33 p.143; Paper, Allied-Industrial, Chemical & Energy Workers
International Union Local 1202 (PACE) Tr.11206; International Paper Ex.
32-61).
As one rulemaking participant, Organization Resources Counselors
(ORC) (Tr. 4147) stated during testimony about the proposed rule, ''* *
* there are many different ways that companies use to evaluate
effectiveness. While they might all have common elements. . .they apply
those elements in very different ways, depending on the circumstances,
the nature of the work, the employees, and the nature of the
workplace.'' In addition, OSHA does not believe that the ``occurrence
of an injury'' automatically qualifies a program as ``ineffective,'' in
the words of the Oregon Building Industry Association (Ex. 30-562).
OSHA recognizes that, especially in large workplaces in industries with
many problem jobs, MSDs may continue to occur. The final rule takes a
comprehensive view of program effectiveness and emphasizes the
importance of the essential elements of the program and their proper
functioning. In response to ORC's comment about the importance of
ensuring that early reporting is present, OSHA agrees that such
reporting is essential to program effectiveness and has accordingly
built several mechanisms that will ensure early reporting'work
restriction protection, multiple HCP review, hazard information and
reporting'into the final rule.
Who should conduct program evaluations?: The preamble to the
proposal stated that program evaluations may be conducted by those
responsible for carrying out the employer's program, but also noted
that evaluations performed by persons who are not involved in the day-
to-day operation of the program are often even more valuable because
these individuals bring a fresh perspective to the task. They often can
identify program weaknesses that those routinely involved in program
implementation may fail to see (64 FR 65858-65859). OSHA received a
number of comments addressing who should perform the required
evaluations (Exs. 30-2809; 30-115; 30-2387; 30-3826; 32-339-1; 601-x-
1587-2). One commenter cautioned that special care must be taken to
ensure continuity within the program when outside entities perform
successive program evaluations (Ex. 30-2809). This commenter stated,
``It is important to keep records from every evaluation of the
ergonomics program so that mistakes are not repeated * * * if a
different company performs the evaluation, lessons learned from the
previous evaluation may not be recorded * * * It is also important to
ensure that all ``action items'' (issues brought up during previous
evaluations) are resolved and not ignored.''
The American Federation of Government Employees (AFGE) (Ex. 30-115)
suggested that OSHA or some neutral third party was the appropriate
entity for evaluating the ergonomics program because ``management
should not have carte blanche to evaluate their own program.''
Similarly, the American Society of Safety Engineers (ASSE) (Ex. 601-x-
1587-2) commented that the level of expertise needed to perform program
evaluation/third party audits under this standard is outside that which
many organizations are able to provide. Therefore, ``in order to meet
the expected need of consultation services, OSHA should consider
reviewing a system for voluntary third party audit and evaluations, and
work with accredited private sector professional certification bodies,
both public and private recognized registries,
[[Page 68414]]
and membership organizations to ensure that consultants have an
acceptable level of competence.''
The American Association of Occupational Health Nurses (AAOHN) (Ex.
30-2387) cautioned OSHA about the need to protect employee privacy
during the collection and review of program records for evaluation
purposes. The AAOHN pointed out that ``individuals who are not part of
the day to day operation of the program can bring a fresh perspective,
however in any evaluation, the employer should ensure that employees'
privacy is protected.'' For example, the AAOHN noted that a co-worker
brought in to evaluate a program must understand the need for
confidentiality concerning her or his co-worker's personal health
information, if such information is part of the program evaluation.
OSHA agrees with the AAOHN that the privacy of employee medical and
exposure records must be protected at all times, including during a
program evaluation. These records are required to be handled at all
times in accordance with 29 CFR 1910.1020, OSHA's Access to Employee
Exposure and Medical Records standard.
In response to the views of these commenters, OSHA notes that the
proposed rule did not specify who was to perform the required program
evaluations; the final rule also does not limit the employer's choice
of program evaluators. OSHA is aware that employers with effective
programs rely on different individuals, both from within and outside
their organizations, to perform this function and that the results of
doing so are often excellent (see, e.g., Exs. 32-339-1-53, 601-X-1711).
Some programs, such as the one at General Motors, rely on trained
employees in a Joint Ergonomics Team, consisting of union and
management members, to conduct program evaluations (Ex. 32-339-1-53),
while other companies, such as Halliburton, Inc. (Ex. 601-X-1711) rely
on a Board Certified Professional Ergonomist or other outside expert or
organization to carry out their program evaluation. OSHA does not agree
either with those commenters who argued that employers are not choosing
appropriate and qualified program evaluators or that the Agency should
narrow the employer's discretion in this regard. OSHA remains convinced
that different approaches are appropriate in different workplaces and
that employers are best suited to decide who should conduct the
required evaluations. The final rule, therefore, leaves the selection
of evaluators to the employer.
Records review in the context of program evaluation: OSHA
recognizes in the final rule, as it did in the preamble to the proposed
rule (64 FR 65859), that the extent of the evaluation called for by the
rule will vary from one workplace to another, based on the
characteristics and complexities of the work environment. However, the
basic tools of evaluation remain the same from workplace to workplace,
even though their application may vary. These tools, which are basic to
the evaluation of any safety and health program, include:
--Review of pertinent records, such as those related to MSDs and MSD
hazards;
--Consultations with affected employees (including managers,
supervisors, and employees) regarding the ergonomics program and its
problems (if any); and
--Reviews of MSD hazards and problem jobs.
Examples of the records that are often included in such reviews
include the following:
--The OSHA 200 log (if the employer is required to keep a log);
--Reports of workers' compensation claims related to MSDs;
--Reports of job hazard analyses and identification of MSD hazards;
--Employee reports to management of MSDs or persistent MSD signs or
symptoms;
--Insurance company reports and audits about ergonomic risk factors or
MSD hazards; and
--Reports about MSD hazards from any ergonomic consultants engaged by
the employer.
Some employers, especially owners of very small businesses, may
have few of these records and will, therefore have to rely on other,
less formal, methods to assess effectiveness. Small employers generally
place more emphasis on employee interviews and such approaches as
surveys of MSD hazards and problem jobs when they perform ergonomics
program evaluations. Records reviews can yield valuable information on
the effectiveness of an ergonomics program when comparisons are made
from year to year and trends are identified. For example, if an
employer compares the list of MSD hazards identified during consecutive
program evaluations and finds that the number of hazards has decreased
over time, the employer may conclude that the program's job hazard
analysis and control activities have been effective. Similarly, a
reduction in the number of MSDs from year to year suggests that the
program may be effective, although numbers alone sometimes can be
misleading. However, program evaluation also must consider the accuracy
and reliability of the records under review. For example, it is
essential to be sure that the identified trends are real and not the
product of under reporting, loss of interest in the program, or loss of
attention to detail. For example, a downward trend in the number of
MSDs or MSD hazards reported may indicate that employees are being
discouraged from reporting or that the employees performing job hazard
analysis and control are not doing an effective job because they are
not adequately trained to do so.
OSHA received a variety of comments about records review in the
context of program evaluation (Exs. 30-3765, 30-276; 30-546; 30-2846;
30-1726). For example, the Dow Chemical Company argued that the
proposed requirement that employers evaluate different elements of the
program would require them to gather records to support this effort and
would thus impose an undue burden on certain employers. Dow argued,
``depending on the size and makeup of the workplace, a review of all
the proposed records by each workgroup would add undue burden on each
group'' (Ex. 30-3765).
Texas A and M University (Ex. 30-276) also found the records review
associated with program evaluation potentially burdensome. ``Record
keeping is not value-added for the employer or employees. It primarily
benefits the regulatory overseer.'' ElectriCities of North Carolina
Inc. (Ex. 30-546) agreed: ``[These sections] speak of compulsory Record
keeping above and beyond the OSHA 200 log of recordable work place
injuries and illnesses * * *''. The Manufactured Housing Institute (Ex.
30-2846) noted that ``Small business is already overwhelmed with
paperwork requirements and OSHA should avoid adding to that burden.''
The University of Wisconsin Extension (Ex. 30-1726) asked OSHA to
require that all MSD reporting forms be retained by employers for
eventual program review. ``If a standard reporting form is required for
all employees to report MSD problems, signs and symptoms, these forms
should be retained and made part of the program review, to follow up
each form filed during the program evaluation period.''
In response to these concerns about the recordkeeping burden
associated with program evaluation records review, OSHA notes that the
final rule does not mandate that employers review specific records when
conducting their evaluations. In fact, the final rule does
[[Page 68415]]
not mandate records review or require the development of new records of
any kind. This preamble discussion on records review simply recognizes
that reviewing records already maintained by the employer for other
purposes is one way of getting the information needed to evaluate a
program.
The Agency believes that employers are best able to determine which
records in their workplace will provide the most valuable information
for evaluation purposes. For example, in a very small firm that is not
required to keep the OSHA 200 Log, the only records available for
review may be employee reports of MSD incidents, workers' compensation
claim information, and records of Quick Fix controls implemented; some
workplaces may not even have these records. In most workplaces,
however, employers will wish to review a variety of records to identify
trends, evaluate the functioning of each program element, and assess
the overall performance of the program. OSHA's approach is consistent
with that taken by a number of employers who conduct evaluations of
their ergonomics programs, in that it allows employers the latitude to
decide how best to conduct evaluations of their workplaces. The United
Technologies Corp. (Ex. 31-334) agrees that such flexibility is
important: ``It is important to encourage creativity and innovation on
the part of employers in meeting the requirements * * *''. This
flexibility also means, of course, that employers such as The
University of Wisconsin Extension (Ex. 30-1726) who wish to develop
standardized MSD reporting forms to use for evaluation and other
purposes are free to do so.
The proposal contained a requirement that program evaluation
include consultations with employees, and the final rule also includes
such a requirement. Affected front-line employees (or a sample of
them), and their supervisors and managers, must be included in this
process. Consultations with employees elicit information on how well
the ergonomics program has been communicated to the people who rely on
it the most.
Paragraph (u)(2)(ii) of the final rule requires employers to
evaluate the elements of their ergonomics programs to ensure that each
of the elements is working properly. If employees cannot explain what
MSD hazards they are exposed to in the course of their work, do not
know what steps their employer is taking to eliminate or control these
hazards, are unclear about the procedures they should follow to protect
themselves from these hazards, or do not understand how to report MSDs
or MSD hazards, the hazard information and reporting and training
components of the program are not working. If a supervisor is unclear
about how to reinforce proper work practices, the management leadership
and training components of the program are both likely to need
improvement. Similarly, if managers are not aware of the MSDs and MSD
hazards employees are reporting and what corrective actions are being
taken, the management leadership and training components of the
ergonomics program should be improved. Because interviews allow the
program evaluator to assess how the elements individually and the
program as a whole is actually working, there is no substitute for
direct input from employees in the evaluation process.
Program evaluation also must include an assessment of MSD hazards
and the extent to which they are being addressed (paragraph
(u)(1)(iii)). This assessment is concerned not only with identifying
MSD hazards but with identifying how well the ergonomic program is
addressing them. If the program evaluation identifies jobs that have
not been analyzed but exceed the Action Level, the job hazard analysis
component of the program needs to be improved. In addition, if jobs
with previously identified MSD hazards have not been corrected or
prioritized for correction, the evaluator may conclude that the job
hazard control component of the program is not effective. Likewise, if
an MSD hazard is identified and controlled in a problem job in one part
of the facility but the same job has not been controlled in another
part of the facility, several program components may need attention:
the management leadership component, which may have failed to
coordinate and disseminate MSD hazard information throughout the
facility, the training component, which may have failed to provide the
employees performing the job hazard analyses with adequate training,
and the control component, which may have failed to prioritize jobs
appropriately for control.
Paragraph (u)(1) (i)-(iv) establishes the steps employers must
follow to evaluate the effectiveness of their ergonomics programs. It
answers the question, ``What must I do to make sure my ergonomics
program is effective?'' This requirement describes the minimal
evaluation procedures necessary to assess whether or not an ergonomics
program is working as intended. Paragraph (u)(1) of the final rules
reads as follows:
(1) You must evaluate your ergonomics program at least every
three years as follows:
(i) Consult with your employees in the program, or a sample of
those employees, and their representatives about the effectiveness
of the program and any problems with the program;
(ii) Review the elements of the program to ensure they are
functioning effectively;
(iii) Determine whether MSD hazards are being identified and
addressed; and
(iv) Determine whether the program as a whole is achieving
positive results, as demonstrated by such indicators as reductions
in the number and severity of MSDs, increases in the number of
problem jobs in which MSD hazards have been controlled, reductions
in the number of jobs posing MSD hazards to employees, or any other
measure that demonstrates program effectiveness.
Paragraph (u)(1)(i) of the final rules requires employers to
``consult with your employees in the program, or a sample of those
employees, and their representatives about the effectiveness of the
program and any problems with the program.'' Employee participation in
the ergonomics program is critical for success, and the involvement of
employees in program evaluation is just one more way that employees can
take an active role in the program. The requirement that employers
consult with employees regarding program evaluation is not unique to
the final Ergonomics Program standard. OSHA recently promulgated a
similar provision in the Respiratory Protection final rule (29 CFR
1910.134).
Employees in jobs that have been identified as problem jobs are in
the best position to judge whether or not job hazard analysis and
control measures are effectively reducing or eliminating MSD hazards.
Perhaps even more importantly, these employees will be most
knowledgeable about whether the implemented controls have introduced
new, unintended MSD hazards to the job. By consulting with employees,
employers also can have direct feedback on the effectiveness of other
ergonomics program elements, such as opportunities for employee
participation, hazard information and reporting, and training. OSHA is
aware that employers sometimes act in good faith to implement
ergonomics program elements, but that the actual result experienced by
employees can differ markedly from the intention. Thus, by checking
directly with their employees, employers can be sure that their
ergonomics program resources are being effectively invested.
Two rulemaking participants commented that the proposed provision
on employee consultation did not require consultations with anyone
other than employees in problem jobs or allow the employer to select a
subset of
[[Page 68416]]
employees with whom to consult. The Department of Defense (Ex. 30-3826)
commented that, for some employers, such as large companies, branches
of the military, etc., the requirement to consult with employees could
be interpreted to mean consultation with tens of thousands of
employees. As a result, DOD requested that the requirement be changed
in the final rule to allow for representative sampling of employees. In
addition, both the DOD (Ex. 30-3826) and the AFL-CIO (Exs. 32-339-1;
500-218) commented that OSHA had neglected to include employee
representatives in the proposed consultation process. The AFL-CIO
suggested (Ex. 32-339-1) that this provision of the final rule ``should
be modified to provide for consultation with the employee
representative, in addition to employees in problem jobs. This
modification is consistent with the requirement of [the proposed
employee participation provision] which calls for both employees and
employee representatives to be involved in all aspects of the
program.''
After reviewing the record on these points, the Agency has revised
paragraph (u)(1)(i) of the final rule to reflect the concerns of larger
employers and to allow them to consult with employees in the program,
or ``a sample of those employees'' about the effectiveness of the
program and any problems with it. In addition, the final rule states
clearly that designated employee representatives are to be involved in
the consultation process (paragraph (u)(1)(i)). Further, employers are,
of course, free to involve other employees in the consultation process
if they wish to do so; however, OSHA is not requiring that employees
other than those in problem jobs be consulted as part of the evaluation
process.
Another concern raised by the Dow Chemical Corp. (Ex. 30-3765) was
its interpretation that OSHA was attempting in the preamble for this
proposed section to mandate the questions employers must ask in
conducting an evaluation: ``Dow does not believe that OSHA should
mandate the specific questions each employer must ask employees during
this review, which it seemingly tries to do in the preamble at page
65858.'' Dow went on to say, ``Scripted questions may not adequately
uncover issues or concerns and, from the perspective of the employee,
may sound more like an interrogation than a fruitful dialogue.'' OSHA
does not intend the discussion questions included in the preamble to be
mandatory. They are presented to provide employers, and particularly
smaller employers who are less likely than a company like Dow to be
experienced in program evaluation, with ideas about the kinds of topics
an evaluator might find useful when consulting with employees.
Some rulemaking participants (Exs. 30-494, 30-3745, 30-3723, 32-
351-1, 30-4467) argued that employee participation in the evaluation
process might be problematic. They evidently believe that requiring
employers to consult with employees in problem jobs could subject the
employer to citations. For example, the Forum for a Responsible
Ergonomics Standard (Ex. 32-351-1) commented, ``If an employee deems
the program ineffective, but the employer disagrees and implements no
measures to improve effectiveness, the proposal appears to grant OSHA
discretion to cite the employer for non-compliance.'' Morgan, Lewis &
Bockius LLP (Ex. 30-4467) also raised concerns about employee
participation in developing, implementing and evaluating the employer's
ergonomics program: ``The latter is the most troublesome; employers
could conceivably receive citations by virtue of a compliance officer's
subjective determination that employees were not allowed to evaluate
every aspect of the program. Moreover, if employees' suggestions for a
program are rejected, the employer arguably could be said to have
unlawfully limited employee participation in the ``development'' of a
program. (Ex. 30-4467). ``
Three other commenters, the Salt River Project (Ex. 30-710), the
Integrated Waste Services Association (Ex. 30-3853), and Southern
California Edison (Ex. 30-3284), argued that the proposed provision to
consult with employees during evaluations was too open to subjective
interpretation: ``The final standard should make clear that the
employer is not required to act on a recommendation from employees if
the employer can document that the recommendation is without merit''
(Ex. 30-3284).
In response to these comments, OSHA notes that, in the Agency's
experience, employee input is invaluable; employees are the best source
of information on how a program is working in practice. However,
employers are expected to use their judgment and to assess the value of
any information they receive in the course of an evaluation, whether
from a records review or employee consultations. Weighing input from
many sources is standard management practice, and the rule anticipates
that employers will continue to use their judgment in these matters.
Further, OSHA intends employee participation in the ergonomics program
to be active and meaningful, but this does not mean, as Morgan, Lewis &
Bockius suggest, that they must be allowed to evaluate ``every aspect
of the program'' (Ex. 30-4467).
Paragraph (u)(1)(ii) of the final standard requires employers to
``review the elements of the program to ensure they are functioning
effectively.'' This requirement is nearly identical to the
corresponding provision proposed. OSHA received a few comments on this
proposed provision (see, e.g., Exs. 30-3031, 30-3813, 30-4334). Tesco
Drilling Technology Inc. (Ex. 30-3031) stated: ``If OSHA does in fact
believe that employers are best able to determine evaluation criteria,
and that employers should be able to define ``functioning properly,''
why is OSHA proposing this cumbersome standard to begin with? If there
is no specific evaluation criteria or goal in each element, how can a
compliance officer issue a citation for noncompliance in any portion of
the program?'' Organization Resources Counselors, Inc. (ORC) (Ex. 30-
3813) stated that the phrase ``functioning properly'' was vague, and
comments received from Senator Bond, Chairman of the United States
Senate Committee on Small Business (Ex. 30-4334), agreed with those of
ORC: ``For an employer to evaluate its ergonomics program, it is to
``evaluate the elements of [its] program to ensure they are functioning
properly; and evaluate the program to ensure it is eliminating or
materially reducing MSD hazards * * * The use of these terms, and
others, throughout the proposed standard means that employers will be
left to their own instinct and resources to decide whether they have
met the obligations and gone far enough.''
OSHA's reason for including this provision in the final rule is
that evaluations of individual elements and their functioning often
reveal program deficiencies that are undermining program effectiveness
but could be difficult to detect if the employer only evaluated the
program as a whole. For example, if employees are not reporting MSD
hazards, it may mean that the management leadership and training
components are not working properly. The final rule thus continues to
require that employers evaluate each program element as well as the
program as a whole. How this is done is left to employers, because the
records, methods to be used, and cultures of workplaces differ markedly
and no one approach is appropriate for all. The final rule does not
include specific effectiveness measures for each element of the
program, because these would vary extensively from one workplace to
another. However, as commenters
[[Page 68417]]
recommended, the final rule does include examples of effectiveness
measures that are useful in evaluating the effectiveness of programs as
a whole.
Paragraph (u)(1)(iii) of the final rule requires employers to
``determine whether MSD hazards are being identified and addressed.''
The primary purpose of implementing an ergonomics program is the
identification and control of MSD hazards. OSHA expects employers to
establish evaluation criteria to assess the success of their program in
meeting this goal. There are a wide variety of methods available to
employers, ranging from a simple count of the number of problem jobs
controlled to more sophisticated analyses, such as year-to-year trend
analyses.
Again, OSHA finds that employers are best able to determine the
specific evaluation criteria that will most effectively tell the story
of their efforts to identify and address MSD hazards. Commenting on the
corresponding proposed paragraph, which would have required employers
to evaluate their program to ensure it is ``eliminating or materially
reducing'' MSD hazards, Milliken & Company (Ex. 30-3344) and others
(Exs. 30-3749, 30-4674) argued that the proposed provision would
require an evaluation to ensure that the program is eliminating MSD
hazards, when a better measure might be the extent to which the program
is reducing the incidence of MSDs. Nucor Corporation and Vulcraft-South
Carolina (Exs. 30-3354, 30-3848, 30-4799, 30-4540, 601-x-1710) asked
OSHA to add ``to the extent feasible'' to this provision on the grounds
that doing so ``would keep the proposed regulation consistent in its
requirements throughout all elements of an ergonomics program.''
The Dow Chemical Co. (Ex. 30-3765) asked OSHA to modify this
paragraph in the final rule by adding specific language at the end of
the paragraph to read, ``or maintaining the risks at an acceptable
level.'' In Dow's view, such a change would make it clear that
instituting the same ``fix'' across the board may not eliminate all MSD
injuries. Dow also was unclear about what the Agency meant by
``materially reducing'' MSD hazards.
The National Telecommunications Safety Panel (Ex. 30-3745)
expressed similar concerns about the proposed phrase ``eliminating or
materially reducing MSD hazards.'' The Panel argued that this language
was misleading because, ``some MSDs exist epidemiologically in any
workplace.'' SBC Communications Inc. (Ex. 30-3723) urged OSHA to delete
the term ``eliminating or materially'' from the final rule because its
use failed to recognize ``that some MSDs may exist epidemiologically in
any workplace and that the program [envisioned by the standard] is
realistic and performance-based.''
Footwear Industries of America Inc. (Ex. 30-4040) commented that
the inclusion of the proposed ``eliminating or materially reducing''
phrase suggested that ``employers will meet their obligations if they
select and implement the controls that a reasonable person would
anticipate would achieve a material reduction in the likelihood of
injury. `` However, according to this commenter, ``the ``reasonable
person'' standard is hardly a bright-line test and provides excessive
enforcement discretion to OSHA inspectors when determining
compliance.''
OSHA has revised many provisions of the final rule in response to
comments received and data submitted to the record. One of the more
important changes is the revision to the language of paragraph (k),
which tells employers what they must do to achieve compliance with the
final rule's control requirements. The final rule no longer uses the
phrase ``materially reduce,'' and paragraph (u)(1)(iii) therefore has
been revised as well. The language of this provision now requires
employers to ``determine whether MSD hazards are being identified and
addressed.'' OSHA believes that this language is responsive to the
concerns of those employers who interpreted the proposed language to
mean that all MSD hazards had to be eliminated before an ergonomics
program could be judged effective. The final rule, at paragraph (k),
makes clear that OSHA will consider an employer to be in compliance
with the standard's control requirements when it has implemented
controls meeting any of the endpoints identified in that paragraph.
There are clearly many ways to assess whether the program is
identifying MSD hazards and dealing with them appropriately, as
discussed above, and any method that is appropriate and accurate in
making this assessment is acceptable to OSHA.
A number of rulemaking participants ( Exs. 32-182, 32-111-4, 30-
167, 30-3826, 32-210-2, 32-85-3, 30-3686, 30-3826, Tr. 9088, Exs. 30-
3284, 30-240, Tr. 16578, Exs. 32-339-1, 500-218, 31-307, 30-3860, Tr.
8982, Tr. 4372, Exs. 30-1726, 30-1726) commented that OSHA would
clarify the proposed evaluation requirements significantly if it
developed guidance materials and model evaluation tools for employers.
For example, Organization Resources Counselors (ORC) (Ex. 30-3813) made
comments that were representative of those of the above group when it
asked OSHA to include a non-mandatory appendix of types of performance
measures and approaches that OSHA would consider appropriate. In
addition to the measures of effectiveness mentioned by OSHA in the
proposed preamble, such as decreases in the numbers or rates of MSDs
and decreases in severity, ORC suggested a few others: ``Measures might
include reduced workers' compensation claims for MSDs, use by the
employer of periodic symptoms surveys and other indicia of effective,
early reporting, or demonstration that risk factors have been reduced
and/or tools and equipment have been modified.''
Two other commenters, the American Federation of State, County and
Municipal Employees (AFSCME) (Ex. 32-182) and the United Steelworkers
of America (Ex. 32-11-4), argued that such tools were necessary. They
criticized the proposed evaluation provisions in general, because they
failed to provide any criteria to aid employers in determining if their
ergonomics programs were effectively eliminating or materially reducing
MSDs. The American Association of Occupational Health Nurses (AAOHN)
(Exs. 30-3686, 30-2387) also urged OSHA to assist employers by
providing standardized evaluation forms.
OSHA agrees that providing employers with evaluation tools and
forms would be helpful to employers, employees, and OSHA Compliance
Officers. In the period between publication of the final rule and the
compliance dates for program evaluation, the Agency plans, if resources
permit, to develop and disseminate such materials.
AM Moving and Storage Association (Ex. 500-82) argued that the
standard as a whole would be infeasible for its member companies: ``if
it is not feasible for movers to implement controls that would
eliminate and materially reduce MSD hazards, then it is equally
impossible for moving and storage companies to monitor and track the
progress of the proposed ergonomics program.'' OSHA is not, in this
standard, requiring employers to implement infeasible controls or to
reach infeasible hazard control endpoints. Instead, OSHA is requiring
employers to take reasonable measures to protect their employees from
MSD hazards. OSHA expects that moving companies also will find
effective ways of reducing the number and severity of their MSD
hazards.
[[Page 68418]]
The Union of Needletrades, Industrial and Textile Employees (UNITE)
(Ex. 32-198-4) argued that the proposed evaluation section would be
ineffective. They commented that the proposed evaluation requirements
overall were too narrow and ``must be expanded to determine actual
effectiveness of the existing program.'' OSHA agrees, and has expanded
the final rule's evaluation requirements to include a requirement that
employers assess their programs using indicators of effectiveness, such
as reductions in the number, rate, or severity of MSDs. OSHA believes
that the final rule's combination of qualitative and quantitative
approaches to program evaluation will ensure the effectiveness of the
programs implemented to comply with this rule.
Paragraph (u)(2)--Program Evaluations at More Frequent Intervals
Triggered by Events
Paragraph (u)(2) of the final rule requires an employer to evaluate
the program, or a relevant part of it, when the employer has reason to
believe that the program, or an element of the program, is not
functioning as intended; when operations in the workplace have changed
in a way that is likely to increase employee exposure to ergonomics
risk factors and MSD hazards on the job; and, at a minimum, once every
three years. Thus, the final rule retains the minimum 3-year evaluation
frequency proposed but provides greater specificity than did the
proposal about the events that trigger evaluation at more frequent
intervals.
The proposed language on the frequency of program evaluation, which
required employers to evaluate their programs ``periodically, and at
least every 3 years,'' was performance-based rather than specific
because of the diversity of workplaces covered by the rule. OSHA
defined periodically in the proposal as a process or activity that is
``performed on a regular basis that is appropriate for the conditions
in the workplace'' and ``is conducted as often as needed, such as when
significant changes are made in the workplace that may result in
increased exposure to MSD hazards.'' Thus, the proposed provision on
the frequency of required evaluations was designed to reduce
unnecessary burdens on employers whose workplaces, for example, changed
little over time, while ensuring that program evaluations, which are
essential to program effectiveness, were conducted at some minimal
frequency. The final rule reflects the same principles but has been
revised to provide the additional specificity requested by commenters.
OSHA continues to believe, as explained in the proposal, that the
employer is in the best position to determine how often the ergonomics
program at a particular work site needs to be evaluated to ensure its
effectiveness. A site undergoing process or production changes, for
example, or one experiencing high turnover, may need more frequent
evaluations than other, less dynamic, workplaces. Workplaces with these
characteristics are addressed by final rule paragraph (u)(2), which
requires employers faced with changes in operations that are likely to
increase employee exposure to evaluate their programs when such changes
occur. Similarly, an increase in the number or severity of MSDs in the
workplace would suggest that a program evaluation is warranted. This
situation is one that would be covered by paragraph (u)(2) of the final
rule; such an increase clearly suggests that the program, or a part of
it, has failed to operate properly. In work environments with a stable
workforce and work operation, program evaluations conducted once every
three years may be sufficient. For these workplaces, the minimum
frequency required by paragraph (u)(1) may apply.
As noted in the proposal, current industry practice as to the
appropriate frequency of ergonomics program evaluations in specific
environments is available from other sources. For example, the
Meatpacking Guidelines (Ex. 2-13) recommend semi-annual reviews by top
management to evaluate the success of the program in meeting its goals
and objectives. In addition, a wide range of companies with successful
ergonomics programs evaluate these programs at regular intervals.
Paragraph (u)(3)--Correcting Program Deficiencies
Paragraph (u)(3) of the final rule requires employers to correct
any deficiencies identified by the evaluation. It also requires that
employers correct such deficiencies promptly. Deficiencies are findings
that indicate that the ergonomics program is not functioning
effectively because, for example, it is not successfully controlling
MSD hazards or is not providing needed MSD management. OSHA requires
employers to respond to deficiencies in the ergonomics program by
taking actions such as: identifying corrective actions to be taken;
assigning the responsibility for these corrective actions to an
individual who will be held accountable for the results; setting a
target date for completion of the corrective actions; and following up
to make sure that the necessary actions were taken. In a very small
workplace, of course, such detailed planning would likely not be
necessary.
Some commenters, including Milliken & Company (Ex. 30-3344) and
(Exs. 30-3749; 30-4674), stated that the proposed requirement to
correct program deficiencies discovered during an evaluation would
create a ``needless second tier of violations on top of the underlying
substantive requirement that is not being met.'' Moreover, they argued
that, ``the requirement to promptly take action to correct deficiencies
does not provide sufficient latitude for employers to implement
corrections within a time frame that will be reasonable in every
case.'' Tesco Drilling Technologies (Ex. 30-3031) also expressed
concern about an employer's liability once program deficiencies have
been identified. Tesco asked, ``What are the criteria by which a
compliance officer can issue a citation under this provision. * * * If
a citation can not be issued, how can this be enforced? If it cannot be
enforced, how can it be a rule?''.
In response, OSHA wishes to emphasize that its primary goal is to
protect employees from MSD hazards, not to hold employers liable for
ergonomics program deficiencies. OSHA expects that even the best
programs will find deficiencies in their ergonomics program at one time
or another. OSHA's concern is whether or not the employer has acted on
the information obtained during the program evaluation and is taking
steps to correct the problems identified. Employers who act in good
faith to correct identified program deficiencies clearly will satisfy
this requirement. However, employers who identify ergonomic program
deficiencies through the evaluation process and then do not act on this
information may not be in compliance with this requirement.
The final rule does not specify the time frame within which
identified program deficiencies must be corrected. The Agency
recognizes that the time needed to correct a program deficiency will
vary according to many factors. For example, the following factors may
influence an employer's response time:
--The nature of the MSD hazard;
--Previous attempts to correct the problem;
--The complexity of the needed controls;
--The expense of the needed controls;
--Whether the hazard is a higher or lower priority in the list of
identified program deficiencies; and
--The expertise needed to control the hazard.
[[Page 68419]]
Some rulemaking participants (Exs. 30-3853, 30-3765, 30-710, 30-
240) commented that OSHA was not clear about what kind of program
deficiencies needed correction or what ``as quickly as possible''
meant. Edison Electric Institute's (EEI) comment (Ex. 30-3853) was
representative of the views of those commenters concerned about the
time frame for correcting deficiencies: EEI stated that the proposed
requirement to correct ergonomics program deficiencies ``as quickly as
possible'' was vague and unenforceable. August Mack Environmental Inc.
(Ex. 30-240) stated that, in many cases, the responsibility for
correcting deficiencies found will be transferred to a program
administrator, who may be so overwhelmed with other duties, including
those of the ergonomics program, that he or she may not be able to
respond in a reasonable period of time. ``My concern is that a
deficiency may be found and assigned to the program administrator who
will work the problem into his or her overall priority system, so that
it can be fixed,'' August Mack posited. ``However, if inspected in the
meantime, OSHA will find that this is not responsive enough.''
Again, OSHA's aim in including program evaluation requirements in
the final rule and in requiring deficiencies identified through
evaluation to be corrected promptly is not to catch employers in
violations but to ensure that the employer's ergonomics program is
working correctly. If employers have identified deficiencies, corrected
those that can be addressed quickly and easily, prioritized those
requiring longer to correct, and are making reasonable progress in
addressing prioritized deficiencies, they likely will be in compliance
with these requirements.
The Dow Chemical Company (Ex. 30-3765) argued that the proposal was
unclear as to what program deficiencies were being addressed. ``Dow
simply does not understand whether the evaluation in this section is
the same evaluation of the program required in other sections as an
employer deals with identified problems or whether it is an evaluation
of the program addressing every element of this regulation. If it is
the first case, then the section is redundant and should be removed. If
it is the latter case or both, then the Preamble and section should be
rewritten to clearly explain this.'' OSHA is unclear about the meaning
of Dow's comment, but believes that the final rule's clear requirements
for program evaluation will shed light on the issues of concern to
them.
Dow (Ex. 30-3765) also voiced concern that the proposed evaluation
section seemed, in their opinion, to unfairly shift the burden of
correcting program deficiencies to the employer without considering the
employee's contribution to such deficiencies. Dow argued that the
burden of correcting deficiencies should not be placed completely on
the shoulders of the employer. ``Because ergonomics is focused on how
an individual interacts with his or her workplace, Dow believes that
the employee must have some responsibility for making appropriate
changes in their activities.'' Dow suggested that OSHA include an
``Employee Responsibility'' section in the final standard that would
state that if employees are not following what they are supposed to do
under the rule, their employers will not be cited for violating this
standard.
OSHA disagrees with Dow's views in the matter of employee
responsibilities. It is the employer, not the employee, who controls
the conditions of work. If an employee, as Dow's comment suggests, is
not observing appropriate work practices, it is the employer's
responsibility to compel compliance. Employers must manage the
conditions in their workplace; they must lead by example, train their
employees in the use of controls and safe work practices, reinforce
such practices, and, if necessary, establish a disciplinary system so
that employees understand that they must follow safe and healthful
practices on the job. However, OSHA does not believe that employers
must be the ``insurers'' of their employees' behavior. If, for example,
an employer establishes, implements, trains employees in, and enforces
safe work practices, and does so in a consistent manner, the employer
will not be liable for an employee's unforeseeable violation of its
safety rules.
In contrast to those commenters who found the proposed provisions
vague, some commenters found the proposed evaluation requirements too
specific. For example, the Eastman Kodak Company (Ex. 30-429) argued
that only the proposed basic obligation should be included in the final
rule and that the specific requirements should be deleted: ``We believe
. . . [these requirements address] general management practices that
should not be mandated but should be provided in a non-mandatory
appendix.''
OSHA believes that the final rule's provisions provide employers
with the steps to follow to conduct an effective and efficient program
evaluation. Absent such provisions, many employers, particularly
smaller ones, would not know how to conduct an evaluation. Accordingly,
the final rule includes paragraphs (u)(1) and (2), which mandate
certain evaluation steps and procedures and establish the minimal
frequencies of periodic program evaluations. Many employers, however,
such as Kodak, who have had ergonomics programs for years, are unlikely
to need such direction.
The Labor Policy Association, Inc. (LPA) (Ex. 30-494), the
Department of Defense (Tr. 9085-9086) and ( Ex. 30-3781) cautioned OSHA
about the difficulties that could arise from doing a program evaluation
shortly after creating a new ergonomics program. Specifically, the LPA
argued that ``newly implemented ergonomics programs typically
experience a spike in reported MSDs that at some point levels off and
begins to drop. However, it can take as long as four years before the
drop starts to occur. Under the standard, an employer whose reported
MSDs were increasing would be required to implement different
mechanisms to correct the program's deficiencies. However, an OSHA
compliance officer could view this as evidence of an ineffective
ergonomics program and launch an in-depth compliance review, even
though the increase in MSDs is a natural outcome of having a new but
effective program.'' Similarly, the DOD argued that time must be
allowed to elapse for ergonomics programs to gather data needed for
evaluations.
OSHA is fully aware that the number of MSDs reported may increase,
and often substantially, in the first year or so after program
implementation. The Agency believes that the examples of effectiveness
measures OSHA includes in final paragraph (u)(1)(iv) are sufficiently
varied to be suitable for workplaces with programs at various stages of
maturity.
Finally, the UFCW (Ex. 32-210-2) asked OSHA to require employers to
respond to and, if warranted, address issues raised by employees during
a program evaluation. ``The employer should be required to take action
to reduce or eliminate hazards uncovered by an evaluation based upon
employee concerns. This type of response and evaluation will only serve
to strengthen the entire ergonomics program by building confidence
among employees that they are a valuable source of information and also
can be part of the evaluation process.'' OSHA believes that employers
will respond to employee concerns during evaluations when they seek
inputs from them about the effectiveness of the program. To do
otherwise would be inefficient as well as non-responsive. This does not
mean, of course, that employers must respond to all employee
suggestions, as some commenters feared (see, e.g., Exs. 30-
[[Page 68420]]
3284, 30-3853, 30-710). Because OSHA believes that such two-way
communication will be encouraged by the final rule's evaluation
provisions, the Agency has decided not to mandate such responses in the
final rule's program evaluation provisions.
Paragraph (v)--What Is My Recordkeeping Obligation?
The final recordkeeping provisions specify that employers (except
those with fewer than 11 employees) must keep those records essential
to any effective ergonomics program. OSHA observed in the proposal (64
FR 65861) and continues to be convinced that occupational injury and
illness records are a vital part of an effective ergonomics program in
all but the very smallest establishments. Records provide employers,
employees, and consultants with valuable information on conditions in
the workplace and can be used to identify trends over time and to
pinpoint problems. However, OSHA also continues to recognize the need
to reduce paperwork burdens for all employers, especially small
employers, to the extent that this can be done without reducing safety
and health protections. OSHA proposed to limit both the kinds of
records employers were required to keep and the applicability of the
standard's recordkeeping requirements to very small employers. With
very few changes, the final rule contains the recordkeeping
requirements that were proposed. OSHA believes that the approach to
recordkeeping in the final rule is consistent with the Paperwork
Reduction Act's emphasis on minimizing paperwork burdens for small
employers whenever possible.
Because larger employers have more complex workplace organizations,
OSHA proposed that larger employers would be required to keep records
of employee reports of MSDs and the employer's responses to them; the
results of job hazard analyses; records of Quick Fix controls; records
of controls implemented in problem jobs; program evaluations; and
records of the MSD management process. OSHA proposed to exempt
employers with fewer than 10 employees from the standard's
recordkeeping requirements because in these very small workplaces,
information can be communicated and retained informally. The final rule
requires that employers with ergonomics programs keep the same records
as those proposed. However, the final rule expands the recordkeeping
size threshold from 10 employees to 11 employees. This expansion will
make the recordkeeping size threshold for this rule consistent with
that for OSHA's recordkeeping rule (29 CFR Part 1904).
The following paragraphs discuss the specific requirements of the
recordkeeping provisions of the final ergonomics rule and the comments
OSHA received in response to the proposed recordkeeping requirements.
OSHA has carefully evaluated participants' comments concerning the
records needed for effective ergonomics programs to assure that the
final standard only requires employers to keep those records that are
necessary, i.e., those records that have utility to employers,
employees, and OSHA.
Paragraph (v) of the final rule, entitled ``What is my
recordkeeping obligation?'' establishes which employers must meet the
rule's requirements for recordkeeping. This provision requires
employers with more than 10 employees at any time during the previous
calendar year to keep records of their ergonomics program. Employees to
be counted toward this total include part-time and seasonal employees
and employees provided through personnel services. Under the proposed
rule, employers with fewer than 10 employees would have been exempt
from having to keep any ergonomics program-related records. As noted
above, the final rule increases this size threshold to ``more than 10
employees.'' OSHA's experience indicates that, because of the absence
of management layers and multi-shift work, informal communication may
be used in very small companies, and formal recordkeeping systems may
not be necessary. A very small establishment may have a very simple and
informal, but nevertheless effective, ergonomics program that does not
need written records.
OSHA proposed, and the final rule includes part-time and seasonal
employees and employees provided through personnel services when they
count the number of employees they employed at any time during the
previous year. As explained in the proposed preamble (64 FR 65861),
these part-time and temporary employees are retained and supervised by
the employer on a daily basis even though this may be the case only for
a limited time. As discussed above, establishments with more than 10
employees generally should be required to keep records because they are
likely to have more than one layer of management and therefore need to
have written procedures. In addition, if these employees were not
counted toward the size threshold for recordkeeping, large workplaces
that operate with few permanent employees but numerous temporary
employees (an organizational structure that is increasingly common)
would not be required to keep records despite several levels of
management and more formal methods of communication.
The proposed rule's exemption for very small employers elicited
several comments. These comments addressed the usefulness of the
standard's small business recordkeeping exemption and argued that part
time, seasonal, or leased employees should not be included in the count
of employees that triggers recordkeeping. In addition, the Department
of Navy commented on the future applicability of the standard to
federal facilities.
Usefulness of the small business recordkeeping exemption. Some
rulemaking participants (see, e.g., Exs. 30-2493, 3596; Tr. 2982-83,
Tr. 8394, Tr. 15522, Tr. 15565) argued that the proposed small business
exemption would not be useful to small businesses because small
employers would choose to keep records anyway. For example, the
National Federation of Independent Business (Ex. 30-3596, pp. 4-5)
stated that
OSHA has touted its paperwork exemption and ``quick fix''
alternatives to the full ergonomics program requirements as
provisions in the ergonomics standard that were revised to appease
small business concerns. Although a ``paperwork exemption'' may
appear to help on its face, a small-business owner would be ill-
advised not to write down and keep records of everything related to
their ergonomics program when faced with the constant possibility of
an OSHA inspection.
This comment echoes statements made by the small entity representatives
who participated in the Small Business Regulatory Enforcement Fairness
Act (SBREFA) panel for this rule. These representatives maintained that
they would choose to keep records even if they were not required by the
standard to do so (Ex. 23). In response to these small business
commenters, OSHA notes that employers are always free to keep any
records that they wish to maintain, but the final rule does not require
them to do so.
Part-time workers should not count toward the total. Some
rulemaking participants (see, e.g., Tr. 3324, Tr. 5638-39) indicated
that the provision describing which employers must keep records needed
to be clarified and simplified to state explicitly that seasonal,
leased, and part-time employees should be included in the total count.
Other commenters (see, e.g., Exs. 30-240, 429, 1090) felt that the
inclusion of temporary, seasonal, and part-time employees in the count
of employees was burdensome or
[[Page 68421]]
unnecessary. For example, The Eastman Kodak Company (Ex. 30-429, p. 8)
remarked that
This creates significant difficulties in that the prior health
histories of such workers are unknown to the contracting employers
and initial health checks are usually not conducted. Personnel
service workers could have pre-existing conditions that could become
aggravated without MSD factors being present in their workplaces.
OSHA's rationale for including these employees is that it is the
number of employees, not the duration or kind of employment
relationship they have with the employer, that necessitates the keeping
of records. The size of the workforce is the factor that makes layers
of management and more formal methods of communication (and therefore
recordkeeping) necessary. In fact, supervising part-time or leased
employees often adds considerable complexity to management planning,
oversight, and recordkeeping. Thus, the final rule uses a workforce of
more than10 employees on any day of the previous calendar year as the
size threshold that triggers compliance with the rule's recordkeeping
requirements.
Applicability to federal facilities. In a comment unique to federal
agencies, the U. S. Department of Navy (Ex. 30-3818, p. 2) recommended
that OSHA ``acknowledge the different recordkeeping requirements for
federal agencies and rewrite * * * [the standard] to include provisions
for the federal facilities recordkeeping program of 29 CFR 1960.'' OSHA
has considered this request, but has decided that a separate provision
stating the applicability of the rule to federal facility recordkeeping
programs is unnecessary because this matter is better addressed in a
compliance directive for affected federal agencies.
Paragraph (v) of the final rule, which corresponds to section
1910.940 of the proposed rule, establishes the final rule's
requirements for keeping the records required by the standard. It
specifies which records employers must keep and how long they must keep
them. OSHA proposed that employers required by the standard to keep
records maintain the following:
Employee reports of MSDs and the employer's responses to
these reports,
II The results of job hazard analyses and Quick Fixes,
II The controls implemented to reduce or eliminate MSD hazards,
II The MSD management process, and
II The results of ergonomics program evaluations.
OSHA also proposed that most ergonomic program records be retained
by the employer for 3 years or until replaced by an updated record, and
the final rule mandates the same retention periods. The final rule,
like the proposal, makes an exception to the 3-year retention period
for MSD management records. These records are required to be maintained
for the length of the injured employee's employment plus 3 years, a
retention period considerably shorter than that required for other
OSHA-mandated medical records. OSHA health standards, for example,
generally require exposure records to be kept for 30 years and medical
surveillance records to be kept for the duration of employment plus 30
years, as required by 29 CFR 1910.1020, OSHA's access to employee
exposure and medical records standard. These lengthy retention periods
are appropriate for many toxic substances and harmful physical agent
standards because of the long latency between exposure on the job and
the onset of disease. However, since the latency period for most
musculoskeletal disorders is shorter than is the case for many of the
chronic conditions and illnesses covered by other OSHA rules, the
Agency believes that a shorter retention period is appropriate for the
ergonomics rule. Also, changes in the workplace, such as equipment or
process changes, often make older ergonomics records irrelevant to
current jobs and the present workplace environment. Employers'
ergonomics programs continue to evolve, with records of the most recent
aspects of that evolution being the most relevant for employee
protection.
The proposed recordkeeping provisions elicited several comments.
Commenters addressed the following issues: the potential burden imposed
by the recordkeeping requirements; the kinds of records employers
should keep; the appropriate retention period for program-related
records; the need to permit employees and designated representatives to
access the records; and electronic recordkeeping. The paragraphs below
discuss the comments; OSHA's responses to the comments follow this
discussion.
Several rulemaking participants agreed with OSHA's proposed
recordkeeping requirements (see, e.g., Exs. 32-339-1, 182-1; Ex. 500-
206; Tr. 3488). Typical of the views of these commenters was the
comment of the AFL-CIO (Tr. 3488) ``The recordkeeping provisions of the
rule * * * are necessary for the effective implementation of the
program.''
Recordkeeping requirements are burdensome. A number of rulemaking
participants (see, e.g., Exs. 30-74, 294, 429, 526, 544, 546, 652, 653,
710, 1070, 1090, 2428, 2433, 2807, 2991, 3284, 3336, 3367, 3557, 3593,
3723, 3745, 3765, 3770, 3781, 4134, 4184, 4185, 4628, 4839; Exs. 32-77-
2, 300-1; Exs. 500-7, 16, 113, 130, 145, 163; Tr. 3136-37, Tr. 5039,
Tr. 5334-35, Tr. 5493, Tr. 5638, Tr. 9207-9209, Tr. 12198-99, Tr.
12770, Tr. 12860, Tr. 16486-87, Tr. 16491, Ex. 500-163) argued that the
proposed recordkeeping requirements were excessive, burdensome and
unnecessary. For example, a commenter for Owens Corning (Ex. 500-163,
p. 7) stated that
The recordkeeping requirements in the proposed standard are
excessive and poorly defined. In addition, the implied documentation
requirements of the proposed standard are inconsistent with the
requirements of * * * [the proposed rulemaking section], i.e., the
real recordkeeping requirements are much more extensive than those
specifically required by this section.
OSHA also received numerous pre-and post-hearing form letters to
the effect that the proposed recordkeeping section was burdensome or
unnecessary (see, e.g., Exs. 30-2252, 2251, 2360, 4226, 4748, 0382,
2973, 2224, 0591, 0422, 1126, 4684, 4794, 2246, 0382, 2747, 3331, 2244,
2337, 2888, 3517, 0176, 2902, 639, 2874, 4624, 3090, 0070, 2794, 5104,
4402, 1073, 2999, 2033, 2097, 2345, 1304, 2908, 4404, 5187, 4718, 2354,
2359, 4269, 4690, 691, 3201, 3400, 2866, 0597, 1806, 0912, 4605, 2343,
2130, 4422, 1931, 2258, 2998, 2827, 0378, 2342, 2939, 2298, 4946, 2787,
3403, 3293, 2938, 2450, 1672, 2995, 4440, 4944, 2317, 4446, 2853, 0569,
2877, 2994, 2953, 2096, 3130, 1603, 2763, 2885, 3451, 1026, 2884, 2924,
4795, 0455, 2336, 0433, 2197, 1540, 2758, 4796, 2972, 2858, 3294, 4416,
2971, 4798, 4432, 1085, 4657, 2755, 5098, 3982, 5080, 5057, 5053, 2977,
2979, 5009, 3852, 5070, 2978, 3970, 4768, 3983, 4806, 2469, 3971, 3935,
5075, 5078, 2974, 2980, 4802, 2976, 3005, 2975, 2981, 5026, 3798, 2982,
2526, 2285, 3995, 4785; Exs. L30-4958, 4964, 4967, 5211; Exs. 601-X-
249, 419, 1298; Exs. 500-1-224, 225, 226, 228, 229, 230, 231, 232, 233,
234, 235, 236, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 249,
250, 251, 252, 253, 254, 255, 256, 257, 259, 260, 261, 262, 263, 264,
265, 266, 267, 268, 269, 270, 271, 272, 273, 273, 274, 275, 276, 277,
278, 279, 280, 281, 282, 283, 284, 285, 286, 287, 288, 289, 290, 291,
292, 293, 294, 295, 296, 297, 298, 299, 300, 301, 302, 303, 304, 305,
306, 307, 309, 310, 311, 312, 313, 314, 315, 316, 318, 319, 320, 321,
322, 323, 324, 325, 326, 327, 328, 329, 331, 332, 333, 334, 335, 336,
337, 338, 339, 340, 341, 342, 343,
[[Page 68422]]
344, 345, 346, 347, 348, 349, 350, 351, 352, 353, 354, 355, 365, 366,
367, 368, 369, 370, 371, 387, 388, 389, 390, 391, 392, 393, 394, 395,
396, 398, 399, 400, 401, 402, 403, 405, 406, 407, 408, 409, 410, 411,
412, 414, 415, 416, 417, 418, 419, 420, 421, 422, 423, 424, 425, 426,
427, 428, 429, 430, 431, 432, 433, 434, 435, 436, 437, 438, 439, 440,
441, 453, 456, 459).
Some proposed records are not required. Some rulemaking
participants questioned the need to keep certain of the records OSHA
proposed that employers retain (see, e.g., Exs. 32-3004, 30-294, 30-
494, 30-2433, 30-1294, 30-3356, 30-4628, 500-177-2). These commenters
argued that the OSHA Log, medical records, and program evaluations were
all that were needed (Ex. 32-300-1), that Quick Fix records were
unnecessary (Exs. 30-294, 30-494, 30-2433), that records of
``preventive'' or ``voluntary'' work restrictions should not have to be
kept (Exs. 30-1294, 30-3356, 30-4628, Ex. 500-177-2), and that employee
reports of MSDs or their signs and symptoms were not needed (Ex. 30-
2433).
The reasons given by these commenters varied. For example, the
Edison Electric Institute (Ex. 32-300-1) believes that only a few
records are needed for effective programs: ``The current required
recordkeeping records including the OSHA 200 Log and medical records
along with the program evaluation should be sufficient to maintain a
current and effective ergonomics program.'' The Exxon-Mobil Corporation
saw no value in keeping records of employee reports of MSDs (Ex. 30-
2433, p. 4), stating that
The [proposed] standard calls for detailed records of job hazard
analyses and hazard control tracking which establishments do not
normally maintain. For example, if a computer monitor is raised 2
inches by use of a monitor block, that action--and any subsequent
adjustment to the height--must be documented and the document
retained. Furthermore, most of the records OSHA proposes to be
maintained are not necessary for an ergonomics program. OSHA should
revisit the recordkeeping requirements and remove the requirements
for employee reports and responses, and quick fix controls.
The Dow Chemical Company (Ex. 30-3765) saw no value in keeping
records of job hazard analyses for 3 years: ``Job hazard analyses
should only be kept while the employer is working through solutions to
reduce the risk of the hazard to an acceptable level.''
The appropriate retention period. The proposed 3-year retention
period also elicited several comments; commenters suggested periods
ranging from 90 days to more than 30 years. Several rulemaking
participants (see, e.g., Exs. 30-297, 3913, 4538; Exs. 32-85-3, 339-1,
(185-3-1); Tr. 3488) stated that the standard's record retention
periods should be set at five years in the final rule, to be consistent
with the retention period for the Log of Injuries and Illnesses and
related records found at 29 CFR 1904.6. The Dow Company commented that
the proposed retention periods were too long, arguing that ``[t]here is
no safety or health reason for keeping records beyond their
usefulness'' and recommending that job hazard analyses ``should only be
kept while the employer is working through solutions to reduce the risk
of the hazard to an acceptable level.'' (Ex. 30-3765, p. 116) August
Mack Environmental Inc. agreed that the proposed 3-year retention
period was appropriate, without providing additional reasons why (Ex.
30-240, p. 367).
Some rulemaking participants (see, e.g., Ex. 30-3686; 31-353)
stated that medical records related to employee exposure to ergonomic
risk factors should be kept for the duration of employment plus 30
years, as OSHA requires for other records covered by 29 CFR 1910.1020,
OSHA's access to employee exposure and medical records standard, while
another commenter (Ex. 30-525) stated that all of the records required
by the standard should be kept according to the requirements of 29 CFR
1910.1020. Another commenter, the National Telecommunications Safety
Panel (Ex. 30-3745, p. 16), expressed concern that the proposed
recordkeeping requirements could potentially conflict with those of 29
CFR 1910.1020 and might raise employee privacy issues because some of
the records could be ``[p]ersonal and individual in nature (e.g. job
hazard analyses to accommodate individual injury or illness)'' and
``[p]rivacy issues beyond mere compliance with [proposed] 1910.940.''
Many commenters (see, e.g., Exs. 30-2116, 2809, 2825, 2847; 3001,
3033, 3034, 3035, 3258, 3259, 3332, 4159, 4534, 4536, 4546, 4547, 4548,
4549, 4562, 4627, 4776, 4800, 4801) maintained that all records other
than MSD management records should be kept for 10 years. Representative
of these comments, Gladys Vereesi argued that a 10 year retention
period would allow an ergonomics program to improve upon past history,
that a 3-year retention period limited the inputs for ergonomics
program evaluation and that ``[i]mportant lessons learned will be lost
(Ex. 30-2116, p. 9).
Access to the records kept. Many rulemaking participants (see,
e.g., Exs. 30-2809, 3001, 2116, 2825, 2847, 3033, 3034, 3035, 3258,
3332, 4159, 4536, 4546, 4547, 4548, 4562, 4627, 4776, 4800; Exs. 32-
339-1, 185-3; Ex. 500-218; Tr. 3488) stated that the final rule should
explicitly provide for access by employees or their designated
representatives to all records required by the standard. Typical of the
views of these commenters is the comment of the United Automobile
Workers (Ex. 32-185-3-1, p. 7), which stated:
Other matters discussed in this section * * * are employee
reports and responses, and control records. First, it should be
clear that these are available to affected employees and their
representatives.
Electronic records. The American Trucking Associations, Inc. (Ex.
30-3330) asked OSHA to add the phrase ``in paper, photographic,
microfilm, microfiche, CD-ROM, electronic or other appropriate format''
to allow employers to ``[t]ake advantage of less costly records storage
alternatives while ensuring retention of the required records * * *''
Responses to comments received. In this section, OSHA specifically
responds to the issues raised by commenters on the proposed
recordkeeping provisions.
First, some commenters (see, e.g., Exs. 30-297, 30-3913, 32-85-3,
32-339-1, Tr. 3488) argued that the ergonomics standard should not have
separate recordkeeping provisions but instead that the Agency's
recording and reporting rule (the ``recordkeeping rule'') (29 CFR Part
1904) should govern such requirements. These commenters are confused
about the purpose of that rule, which is to record all occupational
injuries and illnesses that meet the rule's recordability criteria.
Part 1904 does not address the records necessary for an effective
safety and health program or the records that must be kept by employers
to comply with the Agency's substance-specific or hazard-specific
rules, such as this ergonomics program rule. It is routine and
appropriate for rules addressing specific hazards, such as the confined
spaces rule (29 CFR 1910.146), the lockout/tagout rule (29 CFR
1910.147), and many others, to include recordkeeping requirements
geared to those hazards. Accordingly, OSHA has not adopted this
suggestion.
Many commenters (see, e.g., Ex. 30-2428, Tr. 9207, Ex. 32-21-1-2)
argued that the rule's recordkeeping requirements are unnecessarily
burdensome. OSHA disagrees. Employers must keep records of their
program activities for a variety of reasons: to ensure that the program
is
[[Page 68423]]
working as intended and that resources are not being wasted; to ensure
that MSDs are being addressed effectively, that employees are reporting
their signs and symptoms as early as possible, and that Quick Fix and
other controls are working; and to ensure that MSD management is
helping injured employees to recover as soon as possible. OSHA believes
that the records required by the final rule are the minimum necessary
for an effective program. Simply relying on 200 Logs, medical records,
and evaluation records, as the Edison Electric Institute suggested (Ex.
32-300-1) would mean that an employer would not have records of the
controls implemented, the kinds of MSD signs and symptoms occurring, or
the methods used to conduct job hazard analysis at the establishment.
In this respect, OSHA agrees with the views of one commenter (Tr. 7420)
who noted that there is often a discrepancy between the data on an
establishment's 200 Log and what is happening on the floor: ``When you
actually review the first report of injury, you will conclude that the
OSHA 200 Log * * * has no report of cumulative trauma and/or repetitive
strain injury when in fact musculoskeletal disorders are at epidemic
proportions.'' OSHA believes that most employers would agree that all
of the records required by the final rule will provide information
essential to effective ergonomics programs.
As to the suggestion (see, e.g., Exs. 30-297, 30-3913, 32-185-3-1)
that the retention period be 5 years instead of 3 years to coincide
with OSHA's retention periods under the recordkeeping rule, OSHA notes
that the 3-year retention period specified in the final rule is
consistent with the frequency of required program evaluations, where
these records will be most useful. However, employers are always free
to keep their records for longer retention periods if doing so is
consistent with or beneficial to their management practices. Also, even
where an employer is permitted under paragraph (y) of the final rule to
discontinue the ergonomics program for a job, the employer must still
keep the records required to be kept under paragraph (v) for the amount
of time listed in paragraph (v)(4).
OSHA agrees that employers may keep these records electronically,
and paragraph (v)(1) of the final rule makes this clear.
Some commenters (see, e.g., Exs. 30-1294, 30-3356) urged OSHA not
to require that records of temporary work removals or work restrictions
be kept if such removals or restrictions were ``preventive'' or
``voluntary'' in nature. OSHA is unclear about what the commenters
meant by ``voluntary'' or ``preventive'' restrictions. If the
restriction is assigned after the employee reports signs or symptoms,
the employee has experienced an MSD incident, and removal or
restriction must be treated in accordance with the requirements in
paragraph (v)(1). The restriction or removal of a symptomatic employee
is thus simply a temporary work removal or restriction, as those terms
are used in the final rule. If, on the other hand, the employer assigns
an employee to another job before that employee is symptomatic, the
reassignment is simply an administrative control, i.e., job rotation.
Records of work restrictions or removals are required to be kept by the
final rule; records of routine job reassignments or rotations (i.e.,
those not done as part of the employer's strategy to control or
eliminate MSD hazards) are not.
OSHA agrees with those commenters (see, e.g., Exs. 30-2809, 32-339-
1, 32-185-3, 500-218) who pointed out that the proposal failed to
provide access to records by affected employees and their designated
representatives. The final rule, at paragraph (v)(2) and (v)(3),
corrects this oversight.
Summary. After a review of the rulemaking record, OSHA has decided
in the final rule to retain the proposed 3-year (or until replaced by
an updated record) retention periods for most of the required program
records. The record, as discussed above, contains a wide range of
opinion about the appropriate retention period for these records. OSHA
was not convinced to change the required retention periods either by
comments in favor of very short retention periods (see, e.g., Ex. 30-
3765, which recommends a 90-day comment period) or those arguing for a
retention period of 30 years or more (see, e.g., Ex. 30-525).
Records of job hazard analyses, hazard controls implemented, Quick
Fix controls put in place, ergonomics program evaluations, and MSD
management records must be kept for the employees and jobs covered by
the employer's program. Further, as required by paragraph (v)(2),
employees or their designated representative(s) must be given access to
those records that address their report(s) of MSD incidents and the
employer's response(s) to those reports.
Paragraph (w)--When Does This Standard Become Effective?
In paragraph (w) of the final rule, which corresponds to
Sec. 1910.941 of the proposal, OSHA establishes the date when the final
rule becomes effective. The effective date is the date from which the
compliance deadlines in this section are counted.
In the proposal, OSHA stated that the ergonomics standard would
become effective 60 days after the publication date of the final rule.
OSHA stated that this period would provide sufficient time for
employers to review the final rule, get assistance, and prepare to meet
the initial requirements of the standard as it applied to them.
The proposed effective date section elicited few comments. Some
rulemaking participants (see, e.g., Exs. 30-3686, 32-85-3, Tr. 13132)
agreed with the 60-day effective date. Other commenters (see, e.g.,
Exs. 30-74, 30-3765) felt that 60 days was insufficient. For example,
the Dow Chemical Company (Ex. 30-3765, p. 118) urged OSHA to change the
effective date to 180 days so that companies with existing programs,
like Dow, would have sufficient time to review and make any necessary
changes prior to the standard becoming effective.
OSHA understands that employers with existing programs will need
time to review their programs, either to establish that they qualify
for ``grandfather'' status under paragraph (c) or to modify their
programs to match the requirements of the final rule. However, OSHA
believes that the 60-day date before the final rule takes effect,
together with the additional time allowed for the implementation of the
ergonomics program elements, will allow sufficient time for this
purpose. Moreover, any further delay would unnecessarily deprive
employees of needed protections against MSDs.
George Nagle, the Corporate Senior Director of Environmental Health
and Safety for the Bristol-Myers Squibb Company (Ex. 31-302, p. 1, Tr.
10519-10521) suggested that a pilot program of at least one year should
be implemented in OSHA's national and regional offices prior to
attempting to impose a final ergonomics rule on the regulated
community. However, there was insufficient detail in the suggestion to
determine how such a program would work, or whether such a pilot
program strategy would be beneficial to employees. In addition, there
was little or no support in the record for the implementation of such a
pilot program. OSHA believes that a significant number of companies
have successfully implemented an ergonomics program already; the
economic analysis estimates that approximately 20 percent of general
industry companies have done so. Although it does not believe a pilot
program is necessary, OSHA does intend to provide extensive compliance
[[Page 68424]]
outreach to industry when the standard is published, and has included
useful compliance information in the Appendices to this rule. After
reviewing the record on this issue, OSHA has concluded that the 60-day
effective date is appropriate and sufficient for employers to read and
understand their obligations under this final rule.
Compliance Time Frames
OSHA's approach to compliance deadlines in the proposal differed
from that in other OSHA standards. First, OSHA proposed a long start-up
period so that employers would have time to get assistance before the
compliance deadline. Second, even after the compliance deadlines, OSHA
proposed to give employers newly covered by the standard (e.g.,
employers whose employees develop MSDs after the compliance deadlines
have expired) additional time to set up an ergonomics program and
implement controls. Third, OSHA proposed to allow employers to
discontinue large portions of their ergonomics programs if no MSDs were
reported for a specified period of time.
Paragraph (x)--When Must I Comply With the Provisions of the Standard?
In paragraph (x) of the final rule, which corresponds to proposed
Sec. 1910.942, OSHA establishes deadlines for compliance with the
requirements of the ergonomics standard.
In the proposed rule, OSHA allowed for start-up times for employers
to set up the ergonomics program and implement controls in problem
jobs. The proposal would have required the employer to implement MSD
management promptly when an MSD was reported; to set up management
leadership, employee participation, and hazard information and
reporting within 1 year of the effective date of the final rule; to
implement job hazard analysis, interim controls, and training within 2
years of the effective date of the final rule; and to implement
permanent controls and conduct program evaluation within 3 years of the
effective date of the final rule. The proposed start-up times thus
ranged from 1 to 3 years.
Based on an evaluation of the comments received on the proposed
compliance dates, OSHA has revised them in the final rule. The
compliance deadlines in the final rule are staggered, as they were in
the proposal, although some dates fall earlier and some later than they
did in the proposal. Comments received on the proposed dates, and
OSHA's response to the comments, are discussed below.
Like the proposal, the final rule recognizes that employers need to
begin setting up their ergonomics program soon after the rule is issued
so that they will have an effective process in place in time to meet
the compliance deadlines. Without phased-in start-up periods, some
employers might wait until the last minute to take action. The final
rule's phased-in compliance periods are also designed to ensure that
employees who report MSD signs and symptoms are provided with prompt
intervention (both MSD management and work restrictions) in order to
help resolve the problem quickly and without permanent damage to the
employee. The phase-in approach taken by the Agency was supported by
commenters, such as the AFL-CIO, which stated that ``the overall
timeframes for compliance * * * are more than sufficient'' (Tr. 3488).
Finally, the longer start-up periods will also allow employers to
integrate needed job modifications into their regular production
schedules or processes. The best way to control MSD hazards is often in
the design process; allowing additional compliance time allows
establishments of all sizes to make needed changes to their processes
as part of regular production changes, and perhaps to make those
changes at less cost. The final rule allows an initial period of 4
years for employers to implement permanent controls.
The proposal envisioned two levels of ergonomics programs: a basic
program for manual handling and manufacturing jobs (which included
management leadership, employee involvement, hazard information, and
employee reporting of MSD signs and symptoms) and a full program for
employers whose employees developed work-related MSDs that were covered
by the standard. The full program would have included all of the
elements of the basic program plus job hazard analysis, job controls,
training, and program evaluation. Employers who had manufacturing or
manual handling jobs in their establishments would have had one year
from the effective date of the rule to comply with the basic program
requirements, and later compliance deadlines for other requirements of
the full program (job hazard analysis, job controls, training, and
program evaluation, if a covered MSD is reported).
OSHA has simplified the scope of the final rule by eliminating the
distinction between manual handling and manufacturing jobs and other
jobs. Accordingly, the phased-in compliance deadlines for manual
handling and manufacturing jobs found in the proposal do not appear in
the final rule (see the summary and explanation for paragraph (b)).
Like the proposal, the final rule does not contain different
compliance deadlines for small and large employers. This is the case
because OSHA believes that the compliance deadlines allow enough time
even for very small employers to obtain information about the rule and
ways to implement an ergonomics program. OSHA also believes that the
final rule's 4-year phased-in compliance period for controls is
adequate for larger employers who might have more complex processes,
employees, problem jobs, and controls to implement.
Some rulemaking participants (see, e.g., Exs. 30-3813, 30-3826)
stated that the compliance dates in the proposal were logically
inconsistent and needed to be rewritten. These commenters found this
section on phased-in dates for program requirements to be difficult to
follow and confusing.
Some commenters (see, e.g., Exs. 32-339-1, 182-1, Tr. 383-384)
noted that under the compliance deadlines set forth in the proposal,
some employees with MSDs who had already been removed from their job
might be returned to the problem job before the proposal required the
employer to implement interim controls. OSHA agrees that this could be
the case in some circumstances and has revised the final rule
accordingly.
The compliance time frames in the final rule have been modified as
follows: paragraph (x)(1) gives the employer 9 months after the
standard becomes effective (60 days after promulgation) to provide the
information required in paragraph (d) to employees. This includes
information about MSDs and their signs and symptoms and how to report
MSDs as well as the kinds of risk factors, jobs and work activities
associated with MSDs (see preamble discussion for paragraph (d) for a
more complete discussion of the information required to be
disseminated).
The rest of the compliance time frames are presented in paragraph
(x)(2), Table 2. After an employee reports an MSD (or signs or symptoms
of an MSD), the employer must determine whether the MSD is work
related, whether it requires a work restriction and, where appropriate,
whether the employee's job meets the standard's Action Trigger (see the
preamble discussions for paragraphs (e) and (f) for further details on
these requirements). If an employer determines that an MSD incident has
occurred (i.e., a work-related MSD that requires medical treatment
beyond first
[[Page 68425]]
aid or restricted work, or MSD signs or symptoms that last for 7
consecutive days) (see definition of MSD incident), then the employer
has 7 days in which to determine whether the employee's job meets the
Action Trigger (defined in paragraph (f) of the standard). If the
employee's job meets the Action Trigger, then the employer has 7 days
in which to initiate MSD management, which includes access to a Health
Care Professional (HCP), an evaluation of the employee's condition, any
appropriate work restrictions (including WRP for up to 90 days) (see
preamble discussion of paragraphs (p), (q), (r), and (s) for further
details of the employer's MSD management responsibilities). If the
employee's job meets the Action Trigger, the employer has 30 days in
which to initiate the management leadership element of the program
(assign responsibility for setting up and managing the ergonomics
program and communicating with employees about the ergonomics program)
and the employee participation element (ensuring that employees have
ways to report and receive prompt responses to reported MSDs and have
ways in which to be involved in the development and implementation of
the ergonomics program) (see preamble discussions for paragraphs (h)
and (i) for further details of these requirements).
Within 45 days of determining that a job meets the Action Trigger,
the employer must train employees in setting up and managing the
ergonomics program (see preamble discussion for paragraph (t) for
further details of this requirement). Also, a job hazard analysis of
the problem job must be initiated within 60 days of a determination
that the job meets the Action Trigger (see preamble discussion of
paragraph (j) for further details of this requirement). Within 90 days
after a determination that a job meets the Action Trigger, the employer
must implement interim controls and initiate training for employees,
supervisors and team leaders involved in the ergonomics program (see
preamble discussion of paragraphs (t) and (m)(2) for further details on
these requirements).
Finally, the employer must implement permanent hazard controls to
fix a problem job (so that any MSD hazards presented by the job no
longer are likely to cause MSDs that result in work restrictions or
medical treatment beyond first aid) within 2 years of a determination
that a particular job meets the Action Trigger. The final rule allows
the employer up to 4 years (after a determination that a job meets the
Action Trigger) for initial implementation of the permanent controls
provisions (see preamble discussion of paragraph (m)(3) for further
details of this requirement). The final standard has kept the proposed
requirement to evaluate the effectiveness of the ergonomics program
within 3 years (after a determination that a job meets the Action
Trigger) and to promptly correct any deficiencies in the program that
the evaluation reveals (see preamble discussion of paragraph (u) for
further details of this requirement).
Therefore, the effective date section in the final rule has been
modified to avoid the unwanted results some commenters (see, e.g., Exs.
30-3813, 30-3826) pointed out might have occurred under the proposal's
compliance dates. For example, these commenters noted that, an employee
with a work-related MSD could, under the proposal, be returned to a
problem job before the employer was required to implement interim
controls for that job. In the final rule, the employer has a longer
period than in the proposal--up to 9 months from the effective date of
the rule--to disseminate information to employees about MSDs. After
that date the employer must respond promptly to any reported MSDs by
taking steps to determine if the employee has suffered an MSD incident
(a determination that the MSD is work-related, is persistent, and
requires medical treatment beyond first aid, days away from work or
restricted work). Once it is determined that an MSD incident has
occurred, the employer has 7 days to determine if the employee's job
meets the Action Trigger. If the job meets the Action Trigger, all of
the other requirements of the standard spring from the date of the
Action Trigger determination, and interim controls would need to be
implemented within 90 days of this determination. Therefore under the
final rule, an employee on work restriction or WRP would not have to
face the possibility of returning to an ``unfixed'' job because the WRP
period has expired before the employer has a duty to implement at least
interim controls.
Some rulemaking participants (see, e.g., Ex. 32-339-1, Tr. 3488-
3489) observed that the compliance deadline for management leadership
and employee participation in the proposal fell due before the deadline
for training. Commenters (see, e.g., Ex. 500-218) were concerned that
this phase-in discrepancy would mean that employees would not be able
to fully participate in the ergonomics program because they had not had
training. Although the proposal would not have prevented employers from
training employees prior to the 2-year deadline articulated in the
proposal, OSHA has modified the deadlines for the training requirements
in the final rule to address this concern. The final rule separates the
employer's training obligations into segments (with the awareness
training required by paragraph (d) given earlier than the training
triggered by the Action Trigger). As noted, the final rule includes
some employee awareness training for all general industry employees;
the requirement to provide this training is the first requirement of
the standard to go into effect after the effective date. In addition,
paragraph (h), management leadership, and paragraph (i), employee
participation, have training components (e.g., information on MSDs,
information on the ergonomics program and the requirement to provide
responsible persons with the information and resources necessary to
meet their responsibility under the program).
Some rulemaking participants (see, e.g., Exs. 30-3813, 30-3826)
complained that the terms ``permanent'' and ``interim'' controls used
in the effective date section were undefined. Definitions of
``interim'' and ``permanent'' controls have been included in the final
rule to further clarify the compliance obligations set forth in the
effective date section (see paragraphs (k)(1)(i) and (m)(2)).
A number of commenters (see, e.g., Exs. 30-3745, 30-3913, Tr. 7745-
7746, Tr. 16471) felt that the time periods for compliance given in the
proposal were inadequate. For example, the National Telecommunications
Safety Panel (Ex. 30-3745, pp. 16-17) stated:
Based on previous discussions of individual program elements
within the proposed rule, the Panel believes it would be necessary
for employers with more than 10 worksites and 2500 employees across
those multiple worksites to have two years after a rule becomes
effective to implement ``management leadership'' and ``hazard
information and reporting'' as defined in the rule, three years to
implement ``job hazard analysis,'' ``interim controls,'' and
training, and four years for ``permanent controls'' and ``program
evaluation.'' This reflects the distinct probability that most
telecommunications companies will maintain a corporate ergonomics
program to ensure consistency of compliance, adequate communications
and sharing of ``best practices'' across all of their workplaces.
The National Council of Agricultural Employers (Ex. 30-3781)
indicated that small employers needed a longer phase-in period, which
would allow them to take advantage of innovations undertaken by larger
companies. However, this commenter neither stated what length of time
would be appropriate for small employers nor
[[Page 68426]]
whether more time was needed to comply with all of the provisions of
the standard or just the interim and permanent control provisions. OSHA
also notes that agricultural employment is not covered by this rule
(see the summary and explanation for paragraph (b)). OSHA concludes
that the times given to comply with the program elements in the final
rule are adequate for all employers, including small employers, who
will be able to avail themselves of all of the compliance assistance
materials OSHA is disseminating, the OSHA consultation program, and
other ergonomic resources available.
A number of other comments were received in response to the
compliance date section of the proposal. One rulemaking participant
(Ex. 30-3913) argued that training should be phased-in over 5 years
rather than the proposed 3 years because at present commercially
available ergonomic training materials are of inadequate quality and
more time would be needed to improve the overall quality of such
training materials. OSHA concludes that a wealth of material is already
available that can assist in meeting the training obligations in the
final rule. (See Docket 777, e.g., ``Ergonomics Awareness Manual (Ex.
32-185-3-11);'' ``Trainer's Manual Ergonomics Program (32-111-1-21).'')
In addition even more training materials will become available through
OSHA outreach as well as the market for such materials which the
promulgation of this rule will create. Further, the training
obligations in the final rule are implemented over time, and the
materials for them can thus be developed and implemented piecemeal as
program development occurs within the workplace.
Some participants (see, e.g., Exs. 30-3922, 30-3032, 30-3284, 30-
3922, 32-133-1, 32-300-1, L30-5088, 601-x-1711) thought that the
deadlines for interim or permanent controls were too short. Others
(see, e.g., Exs. 30-526, 30-710, 30-2433) felt that any deadline for
implementing permanent controls was unrealistic, due to the difficulty
of providing permanent controls. For example, Pinnacle West Capital
Corporation (Ex. 30-3032, p. 12) stated:
* * * due to the heavy regulation of the plant modification process
by the Nuclear Regulatory Commission in electric utility nuclear
plants, it is entirely possible that some engineering control
implementation could take more than the [proposed] three year
permanent control deadline. This is particularly true if the
modification can only be accomplished during plant outage times.
This commenter did not indicate how often such plants are off line;
however, OSHA notes that the inability of an employer to comply for
reasons of infeasibility can always be raised in the context of
enforcement. The fact that an employer may confront a highly unusual
situation, such as the one this commenter describes, is no reason for
the implementation dates for all employers to be extended. Another
participant stated that the brick-making industry would have problems
meeting the proposed three-year phase-in period for permanent controls
(Tr. 7745-7746) because they believe that the only permanent controls
for their ergonomics problems is automation. OSHA notes that this
commenter reported making substantial progress in reducing its MSD
hazards, but recognizes that feasibility may be an issue for some
establishments.
The American Industrial Hygiene Association (AIHA) (Tr. 16471)
noted difficulties that might be encountered in meeting the proposed
compliance deadlines for the implementation of interim or permanent
controls by stating that ``[i]n some cases, substantial reductions in
hazards may require reworking an entire material handling system for
even a production line. These types of changes usually require a stage
process that may run over three years.'' Again OSHA understands that
controls can take some time to implement in certain complex cases, and
further that many companies prioritize their jobs for control. OSHA's
compliance staff is trained to address these issues on a case-by-case
basis, and will do so in enforcing this standard as well.
OSHA has determined that, except in rare cases, employers will be
able to meet the compliance deadlines in the final rule. These
deadlines are based on a review of the record on the appropriateness of
the proposed time given to implement permanent controls. As a result of
that review, OSHA has increased the amount of time employers are
allowed to implement permanent controls initially to 4 years after the
final rule goes into effect, and to 2 years thereafter. This means that
the 4-year period is the maximum time that any employer can take to
implement permanent controls. In other words, the employer has 4 years
after the effective date to install permanent controls or 2 years after
the employer determines that a job meets the Action Trigger, whichever
is later. For example, if an employer determines that a job meets the
Action Trigger 1 year after the effective date, that employer will then
have 3 years to install permanent controls. On the other hand, if the
employer makes the Action Trigger determination 3 years after the
effective date (or 4 years or 5 years after), that employer has 2 years
from that date to install permanent controls. This two-tiered approach
to the requirement to implement permanent controls initially was
adopted to allow employers sufficient time to deal with a possible
increase in the number of MSD incidents soon after the standard becomes
effective. The Agency believes, once the standard has been in effect
for several years, there will be fewer MSD incidents, and that a
shorter compliance deadline for permanent controls--2 years--will give
these employers sufficient time to implement permanent controls for
problem jobs.
The few employers who may find the generous compliance times given
in the final rule inadequate also may avail themselves of the temporary
variance procedures provided in the Occupational Safety and Health Act
of 1970.
Many commenters felt that the compliance deadlines were too long
(see, e.g., Exs. 30-2039, 30-2116, 30-2825, 30-2847, 30-3001, 30-3033,
30-3034, 30-3035, 30-3258, 30-3259, 30-30-3332, 30-3686, 30-4159, 30-
4534, 30-4536, 30-4546, 30-4547, 30-4548, 30-4549, 30-4562, 30-4627,
30-4776, 30-4800, 30-4801, 31-242, 31-353, 32-85-3, Tr. 11196, 13133).
Typical of comments stating that the deadlines were too long was
that of the American Nurses Association (ANA) (Ex. 30-3686, p. 22),
which criticized the deadlines on the grounds that they were so long
that they would continue to permit opportunities for thousands of
nurses and HCWs (health care workers) to be injured. Although the
immediate implementation of effective controls on jobs with MSD hazards
would be ideal, OSHA recognizes that employers will need time to find,
implement, and analyze the effectiveness of controls for each job. OSHA
has modified the compliance time frames to address comments such as the
ANA's by significantly shortening the amount of time allowed in the
final rule for employers to address jobs that meet the Action Trigger.
In the final rule, for example, interim controls must be implemented
within 90 days of a determination that a job meets the Action Trigger,
as opposed to the 2 years given in the proposal. Further, the deadlines
in the final rule represent the maximum amount of time employers will
have to comply with the elements of the ergonomics program. Employers
are encouraged to implement effective controls as soon as possible, and
OSHA believes that many employers will do so, because this approach
will benefit both employers and employees by
[[Page 68427]]
reducing the number and gravity of MSD injuries.
Other commenters supported the proposed time frames. For example,
the AFL-CIO (Tr. 3488) stated ``[t]he overall time frames for
compliance we think are more than sufficient, particularly given that
the standard has been under development for so long.'' OSHA understands
that the compliance deadlines given are generous, but has concluded
that some companies will need the extra time to work needed job
modifications into their regular production change schedules. From a
review of the comments on this section, OSHA has determined that the
final rule strikes a rational balance between the need to respond with
due speed to MSD incidents and the benefits of developing remedies to
problem jobs in an orderly fashion. Substantial evidence in the record
supports the compliance time frames adopted in the final rule.
The Communications Workers of America (CWA) (Tr. 13133) supported
the requirement for prompt responses to reported MSDs, but felt that
the remaining requirements (management leadership and employee
participation, hazard information and reporting, job hazard analysis,
training, interim and permanent controls, and program evaluation)
should all begin one year after the effective date of the standard. The
CWA (Tr. 13133) also stated that hazard information training should be
conducted within 30 days after the identification of a problem job. In
the final rule, this initial training is required before the
identification of a problem job. The CWA also suggested that
comprehensive training on MSD hazards, controls, and the employer's
ergonomics program should be required 90 days after the identification
of a problem job. As noted above, in the final rule, all of the
training requirements go into effect within 90 days of a determination
that a job meets the Action Trigger. Several training requirements,
such as the dissemination of MSD awareness information to employees
(paragraph (d)) and the training of employees involved in setting up
the ergonomics program (paragraph (t)) have to be met substantially
sooner.
Some commenters agreed that MSD management should be provided
immediately, or as soon as possible (see, e.g., Exs. 30-2387, 30-4538,
31-105, 31-106, 31-129, 31-170, 31-229, 31-276, 31-309, Tr. 13133).
Other participants (see, e.g., Exs. 30-74, 30-2987) felt that the
requirement for prompt response, i.e., as soon as an MSD is reported
after the effective date, could be disruptive and would result in an
employer having insufficient time to prepare for the implementation of
the overall ergonomic program requirements. The American Health Care
Association (AHCA) (Ex. 30-2987) recommended at least a 1-year delayed
effective date for MSD management. The AHCA stated ``[b]ecause we
anticipate that MSDs will be reported early under this proposed
standard, we envision that the MSD management component deadline will
occur almost immediately after the 60-day start-up. This hardly
provides an opportunity for employers to receive assistance on MSD
management * * * '' In the final rule, the dates in the proposal have
been modified to clarify that, although the employer has 11 months from
the time the standard is published to disseminate information about
MSDs (including their signs and symptoms and how to report them), the
employer need not respond to the employee reports initially until the
11-month period has passed. This initial delay in employer response
obligations is necessary to permit the employer to develop an ergonomic
program in an orderly fashion.
Some commenters felt that after the standard became effective
employers should be given 5 days to respond to MSD reports (see, e.g.,
Exs. 30-400, 30-4837, 31-3, 31-12, 31-113, 31-31-150, 31-160, 31-186,
31-187, 31-192, 31-200, 31-205, 31-243, 31-307, 31-347); others thought
that 2 days would be appropriate (Ex. 31-23). These commenters only
provided their opinions in this matter, without detail. Other periods
of time were also recommended for MSD management deadlines, such as 1
month (Exs. 31-125, 31-265 ), again without detailed explanation. The
proposal (Sec. 1910.942) had merely required that the employer provide
a ``prompt'' response. This requirement has remained essentially the
same in the final rule but has been included in paragraph (e) rather
than in the effective date section (see preamble discussion of
paragraph (e) for a more detailed discussion of the MSD response
requirements).
Some commenters (see, e.g., Exs. 31-27, 31-78, 31-170, 31-180)
argued that medical treatment deadlines for MSDs are addressed in state
workers' compensation laws and that OSHA should not interfere with
those requirements. These commenters misunderstand the rule's MSD
management provisions. The OSHA rule does not require employers to
obtain medical treatment for employees with MSDs; OSHA assumes that
MSDs will continue to be treated under the workers' compensation
system, as they have been. The MSD management required by the standard
requires the employer to provide access to an HCP, if the employee
wishes access, solely for the purposes of evaluation and follow-up and,
if necessary, work restrictions. The MSD management system required by
the standard does not in any way interfere with workers' compensation
(see preamble discussion of paragraph (q)). OSHA included the MSD
management provisions pursuant to its statutory authority under the OSH
Act (see preamble discussion of paragraph (r)). After reviewing a wide
variety of opinions as to how long injured employees should wait before
receiving MSD management, OSHA has concluded that MSD management should
begin within 7 days after a determination can be made that an MSD
incident, as defined by this standard, has occurred. Compliance dates
are necessary to effectuate the MSD management provisions included in
the standard, and OSHA believes that the time frames included in the
final rule for MSD management are appropriate and supported by the
record.
In Sec. 1910.943, OSHA proposed to establish different compliance
time frames for those employers who had not identified a problem job
until after some or all of the start-up compliance deadlines
established in proposed Sec. 1910.942 had passed. This was because the
occurrence of an MSD incident is difficult to predict and may not
occur, in some establishments, for many years, i.e., long after the
standard's initial start-up dates have run.
In proposed Sec. 1910.943, if an employer incurred a compliance
obligation after the compliance start-up deadline for that obligation
had passed, a different timetable applied. OSHA's reasons for this
timetable, which was shorter than the initial compliance timetable, was
that employers in later years would not need as long to implement
ergonomics programs because they could take advantage of program
development and remedies that had been developed by other employers in
the interim. Accordingly, proposed Sec. 1910.943 gave employers with
later incurred compliance obligations some additional time to comply,
but the time frame between the MSD incident and the remedy was shorter
than that proposed for initial compliance when the standard became
effective (see 64 FR at 66074).
From a review of the rulemaking record, it is clear that many
participants did not understand proposed Sec. 1910.943 or how it would
work (see, e.g., Exs. 30-2116, 30-2809, 30-2825, 30-2847, 30-
[[Page 68428]]
3001, 30-3033, 30-3034, 30-3035, 30-3258, 30-3259, 30-3332, 30-3826,
30-4159, 30-4534, 30-4536, 30-4546, 30-4547, 30-4548, 30-4549, 30-4562,
30-4627, 30-4776, 30-4800, 30-4801, Tr. 3236). Additionally, this
section of the proposed rule elicited a number of comments, most of
which were critical (see, e.g., Exs. 32-85-3, 30-297, 30-424, 30-434,
30-1090, 30-2433, 30-3120, 30-3171, 30-4537, 32-85-3, 500-145).
However, few commenters provided detailed reasons for their views.
A few commenters (see, e.g., Exs. 30-4538, 30-3686, 31-353, 32-300-
1) recommended that proposed Sec. 1910.943's requirement that MSDs be
responded to within 5 days be modified to require MSD management
``promptly'' when an MSD is reported. The American Federation of
Government Employees (Ex. 30-4538, p. 8) stated:
OSHA should require medical management sooner than five days. If
an employee experiencing MSD symptoms continues to work in the same
job without medical attention, his condition could get worse. In
general, by the time an employee reports a problem, she has been
experiencing symptoms for some time and should not have to wait
another few days for treatment.
Some rulemaking participants (see, e.g., Exs. 30-240, 30-526, 30-
710, 30-3813, 30-3826, 30-3284, 32-300-1, 501-6) disagreed with the
idea of providing less time for later-year compliance in Sec. 1910.943
than was proposed for initial compliance in Sec. 1910.942. For example,
the Department of Defense (Ex. 30-3826, p. 11) stated ``[i]t is not
clear why two timetables are provided. It seems capricious to allow
some employers up to three years to fully implement their ergonomics
programs, while others will have only one year.''
Another rulemaking participant (Ex. 32-229-1) observed that the
proposed deadline for training expires after the deadline for
management leadership and employee participation, which would mean that
employees would not be trained before they are expected to participate.
In response, OSHA has shortened the deadline for training for employees
who are involved in setting up and managing the ergonomics program in
the final rule from the proposed 90 days to 45 days after the employer
has determined that a job meets the Action Trigger. Employee
participation has a deadline of 30 days after the employer has
determined that the job meets the Action Trigger.
As noted earlier, in the final rule, the events that trigger an
employer's obligations under this standard have been modified since the
proposal. All employers covered by the ergonomics standard must comply
with the minimal requirements in paragraph (d) (informing employees)
within 11 months of the publication of the rule. The remainder of the
rule's obligations and time frames for complying with the various
requirements are incurred after a determination that an MSD incident
has occurred in a job that meets the Action Trigger set forth in
paragraph (f). In view of this altered approach in the final rule, it
is no longer necessary to provide two separate compliance time frames
as was done in the proposal.
Paragraph (y)--When May I Discontinue my Ergonomics Program for a Job?
Paragraph (y) allows employers to discontinue most elements of
their ergonomics program for a job if the risk factors in that job have
been reduced to levels below those in the Basic Screening Tool (Table 1
of the standard). The only obligations the employer continues to have
for jobs that have been controlled to that level are to maintain the
controls that reduce the risk factors, continue to provide the training
related to those controls, and keep records of the job hazard analysis
and the controls implemented for that job.
OSHA proposed to allow employers to discontinue portions of their
ergonomics program when no covered MSD had been reported in a problem
job for 3 years after the problem job was controlled. Paragraph (y) of
the final rule has the same advantages as the proposed provision, but
has been revised to reflect changes made to the design of the final
rule. That is, the approach taken in the final rule recognizes the role
of the Basic Screening Tool in Table 1, which acts, along with the
report of an MSD incident, as a trigger for action under the standard
and, in paragraph (y), as the mechanism for relieving employers of most
of their obligations under the standard.
Some rulemaking participants (see, e.g., Exs. 30-526, 30-710, 30-
3686, 31-242) argued that the 3-year timetable for discontinuing
elements of the program should be eliminated. These commenters felt
that employers with ergonomics programs should be required to maintain
all elements of their ergonomics program indefinitely.
Commenters took issue with the proposed timetable for discontinuing
parts of the program; some thought the time period was too short, while
others argued that it was too long. For example, one rulemaking
participant (Ex. 32-185-3) stated that 3 years is too soon to
discontinue parts of the ergonomics program, because it gives
insufficient time for employers to accurately determine if the controls
implemented have been effective. However, this commenter did not
suggest what amount of time would be appropriate to wait before
discontinuing parts of the program.
On the other hand, some rulemaking participants (see, e.g., Exs.
30-3471, 30-4185, 30-3868, Tr. 3325-3326) thought that 3 years was too
long to wait before discontinuing certain aspects of the program. For
example, Tyson's Foods (Ex. 30-4185, p. 26) stated ``* * * OSHA has set
an unrealistically * * * low threshold * * * by premising the
obligation to implement engineering controls on the existence of * * *
a single reported MSD and then further requiring employers to continue
to search for and implement engineering controls until there are no
more MSDs for at least three years * * *''
Other commenters (see, e.g., Exs. 30-3344, 30-3749, 30-4674, Tr.
3325-3326, Ex. 601-x-1710) recommended using alternative criteria for
discontinuing elements of the program. For example, Abbott Laboratories
(Tr. 3325-3326) stated ``clearly the bar for ending the full program is
too high. We propose that OSHA substitute a performance-based
replacement for the `one MSD in three years' criterion.'' OSHA has
considered this suggestion but has determined that such a performance-
based approach, such as the use of industry averages, would be too
complex to apply and too difficult to verify during enforcement.
Some commenters (see, e.g., Exs. 30-2116, 30-2825, 30-2847, 30-
3001, 30-3035, 30-3258, 30-3259, 30-4159, 30-4534, 30-4536, 30-4546,
30-4547, 30-4548, 30-4549, 30-4562, 30-4627, 30-4801, 32-85-3,
Tr.13134) stated that the proposed rule would permit employers to
discontinue too many elements of the ergonomics program. The
Communications Workers of America (Tr.13134), for example, stated that
management leadership and employee participation, hazard information
and reporting, awareness training, program evaluation, and maintenance
of controls and the training related to those controls should be
continued to ensure the control or prevention of MSDs.
OSHA has considered the possibility of increasing the number of
program elements employers are allowed to discontinue if they have
reduced the MSD hazards in jobs covered by the standard to levels below
those in the screen (Basic Screening Tool in Table 1). However, the
Agency has decided that maintaining the controls that allowed the
employer to control the job,
[[Page 68429]]
continuing the training in the use of those controls for employees in
these jobs and keeping records of the job hazard analysis and controls
for that job are the minimum requirements needed to ensure employee
protection. These are the only program requirements the employer is
required to continue once the risk factors in the job have been reduced
to levels below the screen.
Paragraph (y) contains no time period and no link to the occurrence
of MSD incidents, as the proposal did. Instead, both the ``entrance''
to and ``exit'' from most program obligations is tied to the extent of
the risk factors in the job, as indicated by the screen.
Paragraph (z)--Definitions
Paragraph (z) of the final rule contains a number of definitions of
terms used in this final rule. Most of the definitions are
straightforward and self-explanatory. A general discussion of each of
the terms can be found below; however, clarification of many of the
terms is provided in the summary and explanation sections for the
provisions where the terms are used. OSHA believes that describing
terms where they are used makes it easier for employers and employees
to understand what OSHA means when it uses them.
The following terms are defined in the final rule: ``administrative
controls,'' ``Assistant Secretary,'' ``control MSD hazards,''
``Director,'' ``employee representative,'' ``engineering controls,''
``follow-up,'' ``health care professionals (HCPs),'' ``job,''
``musculoskeletal disorder (MSD),'' ``MSD hazard,'' ``MSD incident,''
``MSD signs,'' ``MSD symptoms,'' ``personal protective equipment,''
``problem job,'' ``risk factor,'' ``work related,'' ``work practices,''
``work restriction protection (WRP),'' ``work restrictions,'' and
``you.''
Several terms were defined in the proposal (64 FR 65864 and 64 FR
66075) but are not defined in the final rule: ``covered MSD,''
``eliminate MSD hazards,'' ``ergonomics,'' ``ergonomic design,''
``ergonomic risk factors,'' ``have knowledge,'' ``manual handling
jobs,'' ``manufacturing jobs,'' ``materially reduce MSD hazards,''
``MSD management,'' ``no cost to employees,'' ``OSHA recordable MSD,''
``periodically,'' ``persistent MSD symptoms,'' ``physical work
activities,'' and ``resources.'' These terms are either not being used
in the final rule, have been replaced by other terms that are defined
(either in this paragraph or where they first appear), or have such
clear meanings that further definition is unnecessary.
General Comments on Definitions
OSHA received many comments on the definitions for terms used in
the proposed ergonomics program standard. A great deal of comment
focused on the perceived vagueness of the terms and definitions, with
commenters raising concerns about their inability to understand these
terms and, thus, their ability to comply appropriately. Others raised
concerns about the cost of compliance, arguing that they would spend
large sums of money trying to comply because they were unsure what the
rule meant (see, e.g., Exs. 32-207-1, 32-206-1, 30-3765, 30-3845, 30-
3813, 32-368-1, and 30-3853). One commenter, Monsanto Corporation (Ex.
30-434), recommended moving the definitions to the front of the
document for clarity. OSHA has not adopted this recommended change,
although a Note to paragraph (a) of the rule states that the
definitions for the standard appear in paragraph (z).
OSHA has arranged its discussion of the comments on definitions so
that the ``general'' comments--those that apply to all definitions--are
discussed first, and the more specific comments--those that pertain to
a particular term or definition--are discussed afterward. Additional
discussion of some terms can be found in the summary and explanation of
the provision where the term is used.
On the overall issue of the vagueness of the definitions,
commenters said that terms were unclear or too broadly defined, which
would make it difficult for them to implement the standard (see, e.g.,
Exs. 30-294, 30-434, 30-1897, 30-3765, 30-2208-2, 30-3845, 30-1722, 30-
3813, 30-4185, 30-3739, 30-4006, 30-2705, 30-4038, 601-X-1379, 30-3889,
30-2540, 30-4760, 30-4021, 33-1455, 30-4599, 33-1463, 33-1462, 30-2751,
30-4982, 30-5009, 30-2598, 30-2569, 30-4149, 30-4963, 30-4222, 30-4023,
30-4224, 30-4060, 30-4063, 30-2280, 30-3793, 30-4235, 30-2540), 500-1-
4, 500-1-5, and 500-1-28).
The comments of the National Automobile Dealers Association are
representative of the comments received on the general issue of the
vagueness of the proposed definitions:
To the extent that the ergonomics rule remains inexorably tied
to the reporting of MSD risks, MSD symptoms, MSDs, OSHA recordable
MSDs, and covered MSDs, [automobile] dealers will be forced to
closely scrutinize reported MSD signs and symptoms, to screen out
those that are not tied to real MSDs, and to avoid identifying OSHA
recordable MSDs. To be sure, proposed section 1910.145 lists
somewhat helpful definitions for each of these terms. Nonetheless,
these definitions are lacking in that they fail to provide
sufficient guidance to enable dealers to make practical, cost
effective, and objective determinations (Ex. 4839).
Some commenters were concerned that the terms lacked objective
criteria (see, e.g., Exs. 32-206-1, 30-3765, 30-1722, 30-4185, 30-3826,
30-4538, 32-300-1, 30-3336, 30-2208-1, 30-3853, 30-3749, and 30-3167).
Some commenters suggested that OSHA should use definitions for certain
terms that had been established by outside organizations (see, e.g.,
Exs. 30-3765, 30-4499, and 30-3167). Another commented that there was
no consensus definition on many of the terms; that experts are not in
agreement on the root cause and true definition of MSDs; and that
scientists find it difficult to explain why different individuals
working on the same job will not experience the same symptoms (Ex. 30-
3167). Some of the commenters disagreed with the way the terms were
defined or offered suggested alternatives (see, e.g., Exs. 30-3765, 30-
4185, 30-3826, 30-2208-2, 30-1722, 32-111-4, 30-4538, 30-3934, 32-198-
4, 32-300-1, 30-2208, 30-4499, 30-3818, 30-3000, 31-242, 30-4499, 30-
3867, 30-3818 and 30-434).
The Department of Defense (DoD) (Ex. 30-3826) suggested that OSHA
eliminate the need for many of the definitions, such as those for
manufacturing jobs, manual material handling, and several terms used
within those definitions, by simply including all general industry
employers in the scope of the standard. OSHA notes that the scope of
the final rule has been revised so that it is no longer necessary to
define ``manufacturing jobs'' and ``manual handling jobs.'' (See the
summary and explanation discussion on Scope, paragraph (b).)
Some commenters argued that the definitions' vagueness meant that
OSHA's cost estimates would be substantially underestimated because
employers would do ``everything'' in an attempt to comply (see, e.g.,
Exs. 32-206-1, 32-141-1 and 30-3813). Another commenter questioned
whether the rule would result in a substantial reduction in MSDs
because it was so unclear (Ex. 32-368-1). Others said that if the
standard cannot be understood, it is not legally defensible, citing
cases such as Kent Nowlin Construction Co. v. OSHRC, Connally v.
General Constr. Co., and Diebold Inc. v. Marshall (Exs. 30-1897, 32-
206-1, 32-368-1 and 30-3336).
In response to these comments, OSHA has redefined many terms in the
final rule, deleted others, and provided greater clarity in several
areas that were particularly singled out for comment
[[Page 68430]]
such as the level of control employers must reach. Revised provisions
of the final rule that provide definite compliance endpoints and ``safe
harbors'' for employers are examples of these changes. The issue of
``fair notice'' (vagueness) is discussed in the section of the preamble
entitled ``Other Statutory Issues''. Thus the final rule addresses the
concerns of employers by providing objective criteria and establishing
clear obligations for employers to follow.
Specific Comments on Definitions
Administrative controls are defined as changes in the way that work
in a job is assigned or scheduled that reduce the magnitude, frequency,
or duration of exposure to ergonomic risk factors. Examples of
administrative controls include employee rotation, employer-designated
rest breaks designed to reduce exposure, broadening or varying job
tasks (job enlargement), and employer-authorized changes in work pace.
The definition of the term administrative controls is essentially
unchanged from the proposal. OSHA received one comment on the
definition (Ex. 30-3748), which noted that the proposed definition was
clear.
The term Control MSD hazards means to reduce MSD hazards to the
extent that they are no longer reasonably likely to cause MSDs that
result in work restrictions or medical treatment beyond first aid. This
is a new term in the final rule. OSHA has included a definition for
this term in the final rule because paragraph (k) of the standard
requires employers to control MSD hazards. Controlling hazards means
that the risk factors that were occurring at a magnitude, duration, or
frequency sufficient to cause an MSD hazard have been reduced to the
extent that they are no longer reasonably likely to cause MSDs that
result in work restrictions or medical treatment beyond first aid.
Employers are to use engineering, work practice, or administrative
controls or personal protective equipment to control MSD hazards.
The proposed rule contained two similar terms--``eliminate MSD
hazards'' and ``materially reduce MSD hazards.'' Commenters alleged
that these terms were vague and incapable of quantification (see, e.g.,
Exs. 30-1897, 32-206-1, 32-368-1, 30-3765, 30-1101 and 30-2986).
Statements in the record said that the term ``eliminate MSD hazards''
should not be used because it is not possible to eliminate hazards so
completely that MSDs will no longer occur. There will always be
ergonomic risks, according to these commenters (see, e.g., Ex. 30-
3765). In addition, there were statements that the term ``eliminate MSD
hazards'' is not really different from ``materially reduce MSD
hazards'' (see, e.g., Ex. 32-300-1). Comments on the term ``materially
reduce MSD hazards'' stated that employers would not be able to
evaluate whether or not material reductions in risks have occurred and
expressed concern that the term could be interpreted differently by
employers, employees, and OSHA inspectors (see, e.g., Ex. 30-3845).
Some commenters also objected to some of the phrases used in the
proposal definition of ``materially reduce MSD hazards,'' such as
``magnitude,'' ``likelihood,'' and ``significantly'' (see, e.g., Exs.
30-1897, 30-3765, 30-3866, 32-300-1, 30-4467).
In response to comments in the record, OSHA has decided to delete
the terms ``eliminate MSD hazards'' and ``materially reduce MSD
hazards'' from the final rule. Instead, the Agency has defined
``control MSD hazards'' more clearly and has additionally provided
clear compliance endpoints that essentially cure the vagueness
objections raised.
OSHA also received a comment from the Department of Defense (Ex.
30-3826), which recommended that definitions be developed for
``interim'' and ``permanent controls,'' stating:
The timetable in [proposed] Sec. 1910.943 included reference to
``(e) interim controls'' and ``(g) permanent controls''; however,
there are no corresponding sections nor definitions within section
1910.945 that discusses their distinction. At what point does an
interim control become a permanent control, especially when the
employer is following the incremental abatement process guidance
contained within 1910.922. * * * According to some sources, the only
permanent control for ergonomic hazards is an engineering control--
administrative and work practice controls can almost always be
circumvented in the name of convenience, schedule or production.
Unfortunately, in many cases, there are no feasible engineering
controls for identified ergonomic hazards. Therefore, permanent
controls must be defined, and criteria for determining whether an
employer has fulfilled the requirement must be identified (Ex. 30-
3826).
The final rule does not use the term ``interim'' controls. The terms
used in the standard, ``initial controls'' and ``permanent controls,''
are self-explanatory; they are discussed in the summary and explanation
for paragraph (m).
The term Employee representative means a person or organization
that acts on behalf of an employee. This term was not defined in the
proposal, but is included in the final rule for clarification.
Additional discussion relating to the meaning of this term can be found
in the summary of explanation of paragraph (i).
Engineering controls are defined in the final rule as physical
changes to a job that reduce MSD hazards. Examples of engineering
controls include: changing, modifying, or redesigning workstations,
tools, facilities, equipment, materials, or processes.
The definition of the term ``engineering controls'' has been
changed from the proposal. In the proposal, OSHA defined engineering
controls as physical changes that eliminated or materially reduced the
presence of MSD hazards, a term also defined in the proposal. OSHA
defined the term ``materially reduce MSD hazards'' to mean ``to reduce
the duration, frequency and/or magnitude of exposure to one or more
ergonomic risk factors in a way that is reasonably anticipated to
significantly reduce the likelihood that covered MSDs will occur.''
(See the discussion of these terms above, in the section on ``Control
MSD hazards.'') One commenter stated that the definition of engineering
controls was clear (Ex. 30-3748).
The term Follow-up means the process or protocol an employer or HCP
uses (after a work restriction is imposed) to check on the condition of
employees who have experienced MSD incidents. The definition of the
term ``follow-up'' is essentially the same as the proposed definition,
except that OSHA has removed a sentence from the proposed definition
that explained why ``follow-up'' was necessary. The sentence removed
was ``Prompt follow-up helps to ensure that the MSD is resolving and,
if it is not, that other measures are promptly taken.'' No substantive
comments on this definition were received. Additional discussion
relating to the meaning of this term can be found in the summary and
explanation for paragraph (p).
Health care professionals (HCPs) are physicians or other licensed
health care professionals whose legally permitted scope of practice
(e.g., license, registration or certification) allows them to provide
independently or be delegated the responsibility to provide some or all
of the MSD management requirements of this standard. This definition is
identical to the definition in the proposed rule.
One commenter asked OSHA to clarify the definition to specify which
occupations (physician, nurse, physical therapist, etc.) were included
in the term ``HCP'' (Ex. 30-74). Others were of the opinion that the
definition was too broad (see, e.g., Exs. 30-991, 30-3004, 30-3934, 30-
3937, 30-2208 and 32-22).
[[Page 68431]]
The comments of the Combe Company are representative: ``[b]y allowing
persons who do not even have a medical degree to diagnose and treat
these disorders, the proposed standard creates an environment where the
potential for misdiagnosis and improper treatment efforts is
dramatically increased'' (Ex. 30-3004). In response to these comments,
OSHA notes, first, that the final rule's MSD management section does
not require the diagnosis and treatment of MSDs; these medical aspects
of MSDs are left to the workers' compensation system, as they always
have been. The MSD management envisioned by the standard entails the
evaluation of an MSD to identify the need for work restrictions and
follow-ups to ensure that recovery is progressing. Second, the Agency
is deferring to the states on the issue of permitted scopes of
practice; that is, different states permit different HCPs to perform
different healthcare activities, and employers are expected to
ascertain that the HCPs they rely on to carry out the MSD management
responsibilities under the standard are licensed, registered, or
certified to perform these functions.
Commenters proposed an alternative definition of HCP, i.e., that in
addition to requiring licensing, OSHA require HCPs to have sufficient
training and experience in diagnosing and treating MSD injuries/
illnesses (see, e.g., Exs. 30-3934 and 30-3937). Another organization
pointed out that because the definition is so broad, it could include
occupations such as emergency medical technicians or licensed
vocational nurses who would not be the appropriate professionals to
make decisions with respect to MSDs (Ex. 30-2208). The New Mexico
Workers' Compensation Administration argued that under the proposed
definition, a massage therapist could render an opinion on MSDs (Ex.
32-22). Again, OSHA is confident that the state scope of practice laws
that govern HCPs will ensure that only appropriate personnel are
permitted to carry out the standard's MSD management functions.
Some commenters urged OSHA to limit the term HCP only to physicians
on the grounds that fact finders rely heavily on treating physician's
opinions when litigating causation issues under the various workers'
compensation laws (see, e.g., Exs. 30-3749, 30-3344 and 30-4674).
OSHA's medical management provisions are independent of and unrelated
to the workers' compensation system's procedures for determining
medical treatment, or extent-of -disability determinations (see the
discussion in the summary and explanation for paragraphs (p), (q), (r),
and (s)).
The American College of Occupational and Environmental Medicine
(ACOEM) recommended that the definition of health care professional be
changed to ``occupational physicians or other licensed occupational
health care professionals,'' to focus on the HCP's training and
competencies in occupational medicine. OSHA has not revised the
definition of HCP in this standard, although OSHA believes that many
employers recognize and only rely on the expertise of occupational
physicians and nurses. OSHA's more recent standards (see, e.g., the
Respirator standard and the Methylene Chloride standard) have used the
term HCP, and have defined it in the same way as in this ergonomics
standard; changing it would thus be inconsistent with recent usage. The
other issues raised by ACOEM--such as the kinds of activities
encompassed by the term MSD management--are discussed in the summary
and explanation for that paragraph (paragraph p).
The American Society of Safety Engineers (ASSE) (see, e.g., Ex. 30-
386) asked OSHA to include a definition of ``safety professionals'' in
the rule and to acknowledge the important role of these professionals
in ergonomics programs. The preamble to the final rule does so, and
specifically mentions the role of safety professionals, industrial
hygienists, and other safety and health professionals in ergonomics
program implementation.
The term Job is defined in the final rule to mean the physical work
activities or tasks that an employee performs. For the purpose of this
standard, OSHA considers jobs to be the same if they involve the same
physical work activities or tasks, even if the jobs that require those
activities or tasks have different titles or job classifications. OSHA
is retaining the definition for the term ``job'' unchanged from that in
the proposed rule, except for the addition of the word ``tasks''.
Comments on the definition of ``job'' in the proposal stated that
the definition gave little guidance on how employers were to determine
whether jobs were the same (Ex. 30-3784) and that OSHA should change
the word ``job'' or ``job based'' to ``task'' or ``task based'' (Exs.
30-3765 and 30-3826). The Department of the Navy (Ex. 30-3818) also
recommended that OSHA focus on job tasks rather than the job because
the term ``job'' is frequently associated with titles and position
descriptions. The Department of the Navy also asked OSHA to define the
word ``task'' in the final rule. OSHA believes that the final rule's
definition of a job as the physical activities or tasks that an
employee performs is responsive to the Navy's concerns. For a
discussion of the meaning of tasks in the context of job hazard
analysis, see the summary and explanation for paragraph (j). In
addition, the presence of the Basic Screening Tool will enable
employers to identify jobs that are the same, despite, for example,
differences in job titles.
Musculoskeletal disorders (MSDs) is defined in the final rule as:
a disorder of the muscles, nerves, tendons, ligaments, joints,
cartilage, blood vessels, or spinal discs. For purposes of this
standard, this definition only includes MSDs in the following areas
of the body that have been associated with exposure to risk factors:
neck, shoulder, elbow, forearm, wrist, hand, abdomen (hernia only),
back, knee, ankle, and foot. MSDs may include muscle strains and
tears, ligament sprains, joint and tendon inflammation, pinched
nerves, and spinal disc degeneration. MSDs include such medical
conditions as: low back pain, tension neck syndrome, carpal tunnel
syndrome, rotator cuff syndrome, DeQuervain's syndrome, trigger
finger, tarsal tunnel syndrome, sciatica, epicondylitis, tendinitis,
Raynaud's phenomenon, hand-arm vibration syndrome (HAVS), carpet
layer's knee, and herniated spinal disc. Injuries arising from
slips, trips, falls, motor vehicle accidents, or similar accidents
are not MSDs.
The definition of ``musculoskeletal disorder (MSD)'' in the final
rule differs somewhat from the proposed definition. The final rule
limits the definition to those MSDs involving certain body parts: the
neck, shoulder, elbow, forearm, wrist, hand, abdomen (hernia only),
back, knee, ankle and foot. This definition, and the purpose paragraph
(paragraph (a)) both also make clear that this standard does not cover
injuries caused by slips, trips, falls, motor vehicle accidents, or
other similar accidents (e.g., being caught in moving parts). OSHA has
made these changes in response to criticisms that the proposed
definition was too broad (see, e.g., Ex. 30-1216, 30-2035, 30-3866, 30-
4821, 32-208-1, 32-368-1, 30-3937, 500-1-116, Tr. 15310).
Some commenters raised issues about the MSDs covered by the
standard and their relationship to psychosocial effects and non-
occupational factors (see, e.g., Exs. 500-1-1116, 30-3211, 30-3866).
These comments and issues are discussed in the Health Effects section
of the preamble, Section V, rather than in this definitions section.
Other commenters objected because the acronyms MSD and MSDs are
similar to MSDS, which stands for the Material Safety Data Sheets
required by OSHA's hazard communication standard, 29 CFR 1910.1200
(see, e.g.,
[[Page 68432]]
Exs. 30-2041 and 30-0522). However, because ``musculoskeletal
disorder'' is the scientifically correct term for these conditions and
MSD is the widely known abbreviation for the term, OSHA continues to
use both ``musculoskeletal disorders'' and its acronym in the final
rule.
Some commenters urged OSHA to add other examples such as thoracic
outlet syndrome to the list of examples accompanying the definition
(see, e.g., Exs. 30-2825 and 30-3332). The list of MSDs included in the
final rule is only a list of examples; OSHA recognizes that there are
many other MSDs, such as thoracic outlet syndrome, that could be
included in this list.
There was some comment that OSHA should adopt a definition of MSDs
developed by other organizations such as NIOSH (see, e.g., Exs. 30-3211
and 30-3765). For example, the Dow Chemical Company (Ex. 30-3765)
recommended that OSHA adopt the NIOSH definition of MSD and the Society
for Human Resource Management (Exs. OR-364, Tr. 15310-15311) suggested
that OSHA rely on a medical definition of MSD, such as one taken
directly from Merck's Manual.
OSHA's definition of MSD is, in fact, very similar to NIOSH's
definition, as reflected in the Institute's publication, Elements of
Ergonomics Programs (DHHS, Publication No. 97-117), particularly with
respect to the soft tissues included and the exclusion of accidental
injuries.
MSD hazard means the presence of risk factors in the workplace that
occur at a level of magnitude, duration, or frequency that is
reasonably likely to cause MSDs that result in work restrictions or
medical treatment beyond first aid. The definition of ``MSD hazard'' in
the final rule differs from the definition in the proposed rule; it has
been revised for clarity, as requested by some commenters (see, e.g.,
Ex. 30-2986). Other commenters found the proposed definition of MSD
hazards circular (see, e.g., Exs. 30-3344 and 30-4674). The revised
definition addresses this concern, because it focuses on the magnitude,
frequency, and duration of identified risk factors and their
relationship to MSD hazards.
MSD incident means an MSD that is work related, requires time away
from work, restricted work, or medical treatment beyond first aid, or
involves MSD signs or MSD symptoms that last 7 or more consecutive
days. (See the discussion of the terms MSD signs and MSD symptoms
below.) The definition of MSD incident is new to the final rule. See
the summary and explanation section describing the provisions of
paragraph (e), in which the term ``MSD incident'' is used in
association with the standard's action trigger.
MSD signs are objective physical findings that an employee may be
developing an MSD. Examples of MSD signs are: decreased range of
motion; deformity; decreased grip strength; and loss of muscle
function. The final rule's definition is essentially the same as the
proposed definition, except for minor editorial revisions made for
clarity. Additional discussion of this term appears in the summary and
explanation for paragraph (d) regarding the reporting of MSD incidents,
paragraph (e), the action trigger, and the Health Effects section of
the preamble (Section V).
Most of the comments OSHA received on the list of examples of MSD
signs included in the proposal concerned the role of the health care
professional (HCP) and the phrase ``objective physical findings'' (see,
e.g., Exs. 30-3818, 30-3826, 30-3934, 30-2993, 30-3167, 30-3745, 30-
4814 and 30-434). These commenters argued that the rule should be
structured so that only an HCP, not the employer, can determine whether
a given MSD is associated with objective physical findings. The
Newspaper Association of America objected to the list of signs because
``[O]SHA has inexplicably chosen to provide only four examples of MSD
signs and leaves employers to guess at what may constitute objective
physical findings'' (Ex. 30-2986). In response, OSHA notes that
employers are always free to involve an HCP in their determinations.
However, OSHA does not believe that employers will generally have
difficulty deciding whether an MSD sign is related to an employee
report because, by definition, signs are visible indications observable
both by the employee and the employer.
MSD symptoms are defined in the final rule as physical indications
that an employee may be developing an MSD. Examples of MSD symptoms
are: pain, numbness, tingling, burning, cramping, and stiffness. The
final rule's list of examples is essentially the same as the list in
the proposal, except that it is more clearly written. Most of the
comments relating to this term have already been discussed above under
``musculoskeletal disorder.'' Additional discussion of this term
appears in the summary and explanation for paragraph (e) on the
reporting of MSD incidents.
Personal protective equipment (PPE) is the equipment employees wear
that provides a protective barrier between the employee and an MSD
hazard. Examples of PPE are vibration-reduction gloves and carpet
layer's knee pads. The final rule's definition is essentially identical
to the definition proposed, except that the word ``effective'' before
``protective barrier'' has been deleted because the effectiveness of
PPE depends on the circumstances in a particular workplace and is
therefore not appropriate for a definition. One commenter noted that
the definition of PPE was clear. Additional discussion relating to the
meaning of this term can be found in the summary and explanation of
paragraph (l).
Problem job means a job that the employer has determined poses an
MSD hazard to employees in that job. The definition of the term
``problem job'' has been changed from the definition in the proposal,
which defined a problem job as ``* * * a job in which a covered MSD is
reported. A problem job also includes any job in the workplace that
involves the same physical work activities and conditions as the one in
which the covered MSD is reported, even if the jobs have different
titles or classifications.'' (See the definition of the term ``job''
above.)
Commenters were concerned that the definition unnecessarily
expanded the scope of the standard (see, e.g., Exs. 32-206-1, 32-368-1,
30-294, 30-2208-1, 30-3284 and 31-336), or requested clarification of
ways an employer could use to determine when physical work activities
and conditions were the ``same'' (see, e.g., Ex. 30-3765).
In response, OSHA notes that the Agency intends the ``same job''
requirements to extend the protections provided by the standard to
employees who are fortunate enough not to have experienced an MSD
incident but who are in ``higher-risk'' jobs, as demonstrated by the
fact that one employee in the job has already experienced an incident
and the job has been determined to meet the action trigger. The
standard's ``same job'' requirements are preventive in nature and will
benefit workers in the job as well as saving the employer the costs
associated with the MSDs that are averted by fixing the jobs of other
employees in the same job. As to the concern about how an employer can
know which jobs are the same, OSHA believes that the Basic Screening
Tool will be useful in cases where deciding which jobs are the same is
difficult.
Risk factor, as used in this standard, means force, awkward
posture, repetition, vibration, and contact stress. The term replaces
the term ``ergonomic risk factors,'' which was defined in the proposed
rule. There was considerable comment in response to the definition of
``ergonomic risk factors'' in the proposed rule. Commenters stated that
[[Page 68433]]
the term was vague and too broad (see, e.g., Exs. 30-1011 and 30-2986)
and did not provide employers with enough information to allow them to
determine if the factors are present in particular jobs and, if so, the
duration of exposure to them (see, e.g., Ex. 30-2986). A large number
of commenters expressed concern that they would be unable to quantify
the risk factors in a job based on the amount of information provided
in the proposal (see, e.g., Exs. 30-1722, 30-3032, 30-3336, 30-3765,
30-3813 and 30-3866).
The concerns raised by commenters have largely been addressed by
the final rule, which limits the number of risk factors covered by the
standard to those most often associated with MSDs and additionally
provides clear definitions for each risk factor of the magnitude,
frequency, or duration at which exposure poses a potential risk (the
Basic Screen levels) and the level deemed to pose an MSD hazard (e.g.,
the levels indicated by the hazard identification tools in Appendices
D-1 and D-2).
Some commenters raised legal issues, i.e., the alleged vagueness of
the term ``risk factors'' and the lack of precise quantitative
estimates of the levels at which each risk factor poses risk (see,
e.g., Exs. 32-368-1 and 32-206-1), and the perceived need to establish
quantitative permissible exposure limits for the risk factors (see,
e.g., Ex. 30-3784). These issues are discussed at length in the Other
Stautory Issues and Legal Authority sections of this preamble.
Work practices are changes in the way an employee performs the
physical work activities of a job that reduce exposure to MSD hazards.
Work practice controls involve procedures and methods for safe work.
Examples of work practice controls for MSD hazards include:
(a) Using neutral work postures;
(b) Using lifting teams;
(c) Taking micro-breaks; and
(d) Avoiding lifts involving extended reaches or twisted torso.
(e) Conditioning or work-hardening programs.
The proposed rule defined work practices in essentially the same
way, except that OSHA has added a conditioning or work-hardening
program to the rule in response to comments in the record (see, e.g.,
Exs. 30-1902, 30-3686, 32-22, and 32-210, and 30-4137, Tr. 8720, Tr.
12472-12479). These commenters stated that they use these program to
protect newly assigned workers during the period when they are first
exposed to risk factors on the job. OSHA notes in the definition for
``work restrictions'' that conditioning and work-hardening programs are
not to be considered work restrictions for the purposes of this
standard.
In the Issues section of the proposal, OSHA asked for comment about
the appropriate work practices or controls employers could use to
prevent Computer Vision Syndrome (CVS). In response to this inquiry,
OSHA received several comments (see, e.g., Exs. 30-3032, 30-2387, 30-
2208). One commenter stated that controlling glare, providing adequate
lighting, well-designed software, and regularly shifting the static
fixed focal point of the eye are all approaches that have been used to
address CVS. Other commenters (see, e.g., Exs. 30-3032, 30-2208) urged
OSHA not to include CVS in the list of examples of MSDs in the final
rule. OSHA agrees that not enough is currently known about CVS and its
causes for the final rule to focus on it.
Work related means that an exposure in the workplace ``caused or
contributed'' to an MSD or ``significantly aggravated'' a pre-existing
MSD. ``Work-related'' was not defined in the proposal. The final rule
uses the term ``work related'' in the definition of an MSD incident. In
the proposed rule, OSHA used the term ``work relatedness'' in the
definitions of ``covered MSD'' and ``OSHA recordable MSD.''
A number of commenters objected to the term ``work-related'' in the
context of OSHA recordable injuries and illnesses because they believe
the term is so broad that it often includes non-work related MSDs (see,
e.g., Exs. 500-188, 30-2489, 31-336, 30-2834, 30-2986, 30-1722 and 30-
1037). For example, the Center for Office Technology argued that the
proposal was designed in a way that would permit a program to be
triggered by an episode of weekend overexertion that interfered with
work on Monday (Ex. 30-2208-2), and the International Council of
Shopping Centers (Ex. 30-2489) expressed the same concern. These
commenters are essentially objecting to OSHA's definition of a
recordable injury under Part 1904, the Agency's recordkeeping rule;
that rule defines a work-related injury as one caused, contributed to,
or aggravated by an event or exposure in the workplace, without regard
to the extent of the contribution of work to the injury.
Several participants urged OSHA not to include the concept of work
aggravation of a pre-existing MSD in the final rule (see, e.g., Exs.
30-629, 30-1037, 30-3159, 30-4185 and 31-336). Typical of those
comments was one by Uniservice, Inc. (Ex. 30-2834), which stated,
``[w]e will have to make changes to fix a job for a supposed MSD that
was not caused by workplace exposure in the first place [if OSHA
includes the significant aggravation definition in the standard].''
Other commenters focused their concern about including aggravation in
the concept of work-relatedness on back injuries because back pain is
so common both inside and outside the workplace (see, e.g., Exs. 30-
3784, 30-4185, 31-336 and 30-3937). The final rule does not rely on an
OSHA recordable injury or illness when defining an MSD incident; the
final rule's definition specifies what kinds of MSDs are included
(those involving restricted work, for example). OSHA believes that the
increased clarity of the final rule will alleviate many of these
commenters' concerns.
Work restriction protection (WRP) means the maintenance of the
earnings and other employment rights and benefits of employees who are
on temporary work restrictions. Benefits include seniority, insurance
programs, retirement benefits, and savings plans. In the proposal, OSHA
defined ``work restriction protection'' to mean:
the maintenance of the earnings and other employment rights and
benefits of employees who are on temporary work restriction. For
employees who are on restricted work activity, WRP includes
maintaining 100% of the after-tax earnings employees with covered
MSDs were receiving at the time they were placed on restricted work
activity. For employees who have been removed from the workplace,
WRP includes maintaining 90% of the after-tax earnings. Benefits
mean 100% of the non-wage-and-salary value employees were receiving
at the time they were placed on restricted work activity or were
removed from the workplace. Benefits include seniority, insurance
programs, retirement benefits and savings plans.
The language beginning with ``For employees'' and ending with
``from the workplace'' (outlined in the above quote) has been removed
from the final rule's definition. Additional discussion relating to
both the meaning of this term and the regulatory requirements on work
restriction protection can be found in the summary and explanation of
paragraph (r).
Work restrictions are defined as limitations, during the recovery
period, on an employee's exposure to MSD hazards. Work restrictions may
involve limitations on the work activities of the employee's current
job (light duty), transfer to temporary alternative duty jobs, or time
away from the workplace to recuperate. For the purposes of this
standard, temporarily reducing an employee's work requirements in a new
job in order to reduce muscle soreness
[[Page 68434]]
resulting from the use of muscles in an unfamiliar way is not a work
restriction. Further, the day an employee first reports an MSD is not
considered a day of work restriction, even if the employee is removed
from his or her regular duties for part of the day.
This definition is a revision of the proposed definition. The
proposed definition of work restriction included the sentence: ``To be
effective, work restrictions must not expose the injured employee to
the same MSD hazards as were present in the job giving rise to the
covered MSD.'' This sentence has been removed from the definition
because it is better suited to the summary and explanation for
paragraph (r). See the discussion of the comments received on Work
Restriction Protection in general above and in the summary and
explanation for paragraph (r).
You means the employer, as defined by the Occupational Safety and
Health Act of 1970 (29 U.S.C. 651 et seq.). The final rule's definition
is identical to the proposed definition (64 FR 66078). There were no
comments on this definition.
Several terms that were defined in the proposal are not used in the
final rule. They include ``manual handling jobs,'' ``manufacturing
jobs,'' and ``have knowledge.'' ``MSD management'' was also defined
separately in the proposal but is now discussed in the regulatory text
and summary and explanation for paragraph (p).
Some commenters suggested that OSHA define new terms, including the
term ``employee.'' The Alliance of American Insurers (AAI) (Ex. 30-
3751) objected to the proposal's cross-reference to the definition of
employee contained in the OSH Act. The Alliance asked OSHA to provide
additional clarification about who is or is not an employee under
various types of employer/employee relationships, such as employee
leasing arrangements. The AAI said: ``how is OSHA to make WRP
determinations? What if one entity is held to be responsible for WRP
but the other entity is responsible for workers' compensation
benefits?'' This issue is discussed in detail in the summary and
explanation for paragraph (r).
The DuPont SHE Excellence Center (Ex. 30-2134) recommended the
addition of a definition for workplace, commenting that in the proposed
rule:
``There is no definition of workplace incorporated in this
section [proposed definition of problem job], which creates more
confusion. Is the workplace the specific building the job is
located, the same physical site (which might contain several
buildings), or the entire company with all of its locations within
the U.S. and its territories? Some jobs take place out-of-doors, in
varied locations which can move from place to place. How are these
jobs considered under the ``problem job'' definition?''
The final rule makes clear that the physical establishment that
houses the problem job, or to which the injured employee and other
employees in the same job report, limits the program activities
required by the standard. The standard does not impose corporate-wide
obligations on businesses that have multiple establishments. Instead,
the standard is job-based in the first instance, i.e., employers are
only required to implement the ergonomics program in those jobs
identified as problem jobs. It is establishment-based in the second
instance, i.e., employers are only required to include in their program
the problem job (and the workers in them) within the establishment to
which the problem job is ``attached.'' This means that, where the
workforce is mobile, the establishment to which the injured employee
reports would be considered the establishment, for the purposes of the
standard. Since the standard requires employers to extend the
standard's protections to all employees in the same job, the employer
is required to ``fix'' the MSD hazards in the workstations or work
environments of all employees in the same job who are located in, or
report to, the same establishment.
For the purposes of the standard, OSHA defines an establishment as
a single physical location where business is conducted or where
services or industrial operations are performed. For activities where
employees do not work at a single physical location, such as
construction; transportation; communications, electric, gas and
sanitary services; and similar operations, the establishment is
represented by main or branch offices, terminals, stations, etc., that
either supervise such activities or are the base from which personnel
carry out these activities.
One commenter (Exs. 30-2825 and 30-3332) suggested that OSHA add a
definition of repetitive motion jobs to the final rule. OSHA does not
believe such a definition is necessary because the final rule contains
clear definitions of each of the risk factors (see the Basic Screening
Tool in Table 1).
Several commenters asked OSHA to clarify the definitions of
industries covered and exempted from the final rule (see, e.g., Exs.
30-1897, 30-3818 and 30-4716). For example, the Honorable James Talent,
Chairman of the U.S. House of Representatives Committee on Small
Business (Ex. 30-1897), noted that the proposed rule did not apply to
agriculture, construction, or maritime operations, but did not clarify
each of these terms. Paragraph (b) of the final rule provides clear
definitions of the standard's scope and explicitly states that it does
not apply to maritime, agricultural, railroad, or construction
employment.
Finally, some commenters suggested that OSHA define the term
recovery period, which was used in the definition of work restriction
protection (WRP) (see, e.g., Exs. 30-3749 and 30-3344). OSHA has not
done so because this term is used in the final rule in its everyday
sense, and is therefore clear on its face.
V. Health Effects
In this section, OSHA presents the evidence contained in the
rulemaking record that addresses the causal relationship between
exposure to biomechanical risk factors at work and an increased risk of
developing musculoskeletal disorders (MSDs). This evidence consists of
epidemiological studies of exposed workers in diverse occupational
settings, biomechanical studies describing the relationships between
exposure to risk factors and associated forces imposed on
musculoskeletal tissue, studies of tissue pathology describing the
kinds of tissue alterations that have been seen to result from such
forces, and medical and diagnostic information relating to MSDs. In
making its findings from this evidence, OSHA is relying in part on the
extensive scientific evidence presented in the detailed Health Effects
Appendices to the proposal (64 FR 65865-65926) (Ex. 27-1), located on
OSHA's webpage at http://www.osha.gov and summarized in this section.
In addition, OSHA's analysis includes results from several other
studies placed into the rulemaking record after publication of the
proposed rule, as well as comment and testimony from many distinguished
scientific experts.
This section is divided into the following seven parts:
Part A, Description of Biomechanical Risk Factors;
Part B, Overview of the Health Effects Evidence;
Part C, Evidence on Neck and Shoulder Disorders;
Part D, Evidence on Upper Extremity Disorders;
Part E, Evidence on Back Disorders;
Part F, Evidence on Lower Extremity Disorders; and
Part G, OSHA's Response to Issues Raised in the
Rulemaking.
[[Page 68435]]
A. Biomechanical Risk Factors
Biomechanical risk factors are the aspects of a job or task that
impose a physical stress on tissues of the musculoskeletal system, such
as muscles, nerves, tendons, ligaments, joints, cartilage, spinal
discs, or (in the case of hand-arm vibration syndrome) blood vessels of
the upper extremities. To accomplish motion and work, muscle, nerves,
connective tissue, and skeleton are affected by a number of external
and internal physical demands causing metabolic and compensatory tissue
reactions. External demands can include direct pressure on tissues or
tissue friction. Internal responses can include inflammatory responses
to tissue injury, neurochemical changes, and altered metabolism. The
consequences of these external and internal demands associated with
work activities can include a spectrum of symptoms or clinical
findings. Although some types of tissue, like skeletal muscle, have the
ability to recover after an injury that does not physically disrupt the
tissue, exceeding tissue limits may result in permanent damage to a
tissue. However, skeletal muscle is just one type of tissue that can be
affected; other tissues like tendon, ligament, nerve, and cartilage can
also be damaged by exposure to excessive physical task factors. These
tissues, unlike skeletal muscle, do not have the same capacity for
recover and repair after injury. (Each part of this Health Effects
section briefly summarizes the pathogenesis of MSDs; OSHA's Health
Effects Appendices (Ex. 27-1), developed for the proposed rule,
contains detailed discussions of the scientific literature describing
the pathogenesis of MSDs).
The biomechanical risk factors addressed by this final rule are
repetition, force, awkward postures, vibration to the upper extremity
(i.e., segmental vibration), and contact stress. In occupations where
an increased prevalence or incidence of MSDs has been observed, these
risk factors frequently occur in combination; the level of risk
associated with exposure depends on the intensity and duration of
exposure as well as the amount of recovery time available to the
strained tissues for repair. Soft tissues of the musculoskeletal system
will develop tolerance to physical loading if sufficient recovery time
is provided. Without adequate recovery time, affected tissues can
accumulate damage or become more prone to failure. The need for
adequate recovery time between exposure events means that the pattern
of exposure also has an important influence on risk. The biomechanical
risk factors covered in the final rule are force, repetition, awkward
postures, contact stress, and segmental vibration; the basic screening
tool in the final rule describes criteria for each of these risk
factors that identifies those jobs where there is a potential risk of
MSDs. Each of these risk factors is described below.
Force
Force refers to the amount of physical effort that is required to
accomplish a task or motion. Force also refers to the degree of loading
to muscles and other tissues as a result of applying force to perform
work. Tasks or motions that require application of higher force place
higher mechanical loads on muscles, tendons, ligaments, and joints (Ex.
26-2). The force required to complete a movement increases when other
risk factors are also involved. For example, more physical effort may
be needed to perform tasks when the speed or acceleration of motions
increases, when vibration is present, or when the task also requires
awkward postures. Hand tools that require use of pinch grips require
more forceful exertions to manipulate the tool than do those that
permit use of power grips.
Relationships among external loads, internal tissue loads, and
mechanical and physiological responses have also been studied
extensively, using simulation, direct instrumentation, indirect
instrumentation, and epidemiological studies. In a report on the
Research Base of Work-Related Musculoskeletal Disorders prepared by the
National Research Council (NRC) in response to a request from the
National Institutes of Health (NIH) (Ex. 26-37), the steering committee
provides some rationale for evaluating and controlling biomechanical
risk factors, specifically force:
The concept of force can be generalized to encompass
numerous ways of measuring and characterizing external loads. For
example, force can be measured in terms of the weight of parts, tool
reaction force, perceived exertion, muscle electrical activity, or
observer ratings.
Internal loads can be estimated by using external
loads. For example, a worker must bend or stoop to lift something
from the floor; a worker will exert more force on a stiff keyboard
than a light touch keyboard. Understanding these relationships
allows prediction of internal loads.
Predicted internal loads generally agree with measured
internal and external loads. For example, measurements of muscle
loads during activity using electromyography generally agree with
predicted values.
Force can be assessed qualitatively or quantitatively. Quantitative
measures include strain gauges, spring scales, and electromyography to
measure muscle activity. A qualitative assessment of force is based on
direct observation of the amount of physical exertion required to
complete a task, and is usually graded on an ordinal scale (i.e., low,
medium, high).
Repetition
Repetition refers to the frequency with which a task or series of
motions are repeated with little variation in movement. Although force
and/or awkward postures can combine with repetition to increase the
risk of MSDs over that of repetition alone, acceleration and velocity
of repetitive movement are also important considerations in that they
may ``cause damage that would not be predicted by muscle forces or
joint angles alone'' (Washington State CES, p.20, Ex. 500-71-93).
Repetitive motions occur frequently in manufacturing operations
where production and assembly processes have been broken down into
small sequential steps, each performed by different workers. However,
it also applies to many manual handling operations, such as warehouse
operations and baggage handling. Repetition is typically assessed by
direct observation or videotaping of job tasks. The intensity of
exposure is usually expressed as a frequency of motion or as a percent
of task cycle time, where a cycle is a pattern of motions.
Awkward Postures
Awkward postures refer to positions of the body (e.g., limbs,
joints, back) that deviate significantly from the neutral position
while job tasks are being performed. For example, when a person's arm
is hanging straight down (i.e., perpendicular to the ground) with the
elbow close to the body, the shoulder is said to be in a neutral
position. However, when employees are performing overhead work (e.g.,
installing or repairing equipment, grasping objects from a high shelf)
their shoulders are far from the neutral position. Other examples
include wrists bent while typing, bending over to grasp or lift an
object, twisting the back and torso while moving heavy objects, and
squatting. Awkward postures often are significant contributors to MSDs
because they increase the exertion and the muscle force that is
required to accomplish the task, and compress soft tissues like nerves,
tendons, and blood vessels. As used in the final rule's basic screening
tool, awkward postures may be either static postures held for
[[Page 68436]]
prolonged periods of time, or they may occur repetitively.
Awkward posture is the primary ergonomic risk factor to which
employees are exposed when the height of working surfaces is not
correct. Working at surfaces that are too high can affect several parts
of the body. Employees may have to lift and/or move their shoulders,
elbows and arms (including hands and wrists) into uncomfortable
positions to perform the job tasks on higher surfaces. For example,
employees may have to raise their shoulders or move their elbows out
from the side of their body to do a task on a high working surface.
Also, they may have to bend their heads and necks to see the work they
are doing.
Working surfaces that are too high usually affect the shoulders.
The muscles must apply considerably more contraction force to raise and
hold the shoulders and elbows out to the side, particularly if that
position also must be maintained for more than a couple of seconds. The
shoulder muscles fatigue quickly in this position.
On the other hand, when surfaces are too low, employees may have to
bend their backs and necks to perform their tasks while hunched over
the working surface. They may also have to reach down with their arms
and backs to do the tasks. Where working surfaces are very low,
employees may have to kneel or squat, which places very high forces on
the knees to maintain the position and the weight of the body. Working
surfaces that are too low usually affect the lower back and
occasionally the neck.
Working in awkward postures increases the amount of force needed to
accomplish an exertion. Awkward postures create conditions where the
transfer of power from the muscles to the skeletal system is
inefficient. To overcome muscle inefficiency, employees must apply more
force both to initiate and complete the motion or exertion. In general,
the more extreme the postures (i.e., the greater the postures deviate
from neutral positions), the more inefficiently the muscles operate
and, in turn, the more force is needed to complete the task. Thus,
awkward postures make forceful exertions even more forceful, from the
standpoint of the muscle, and increase the amount of recovery time that
is needed.
Awkward postures are assessed in the workplace by observing joint
angles during the performance of job tasks. Observed postures can be
compared qualitatively to diagrams of awkward postures, such as is done
in many job analysis tools, or angles can be measured quantitatively
from videotape recordings.
Contact Stress
As used in many ergonomics texts and job analysis tools, contact
stress results from activities involving either repeated or continuous
contact between sensitive body tissue and a hard or sharp object. The
basic screening tool in the final rule includes a particular type of
contact stress, which is using the hand or knee as a hammer (e.g.,
operating a punch press or using the knee to stretch carpet during
installation). Thus, although contact stress is covered in the final
rule as a single risk factor, it is really a combination of force and
repetition. Mechanical friction (i.e., pressure of a hard object on
soft tissues and tendons) causes contact stress, which is increased
when tasks require forceful exertion. The addition of force adds to the
friction created by the repeated or continuous contact between the soft
tissues and a hard object. It also adds to the irritation of tissues
and/or to the pressures on parts of the body, which can further inhibit
blood flow and nerve conduction.
Contact stress commonly affects the soft tissue on the fingers,
palms, forearms, thighs, shins and feet. This contact may create
pressure over a small area of the body (e.g., wrist, forearm) that can
inhibit blood flow, tendon and muscle movement and nerve function. The
intensity of exposure to contact stress is usually determined
qualitatively through discussion with the employee and observation of
the job.
Segmental Vibration
Vibration refers to the oscillatory motion of a physical body.
Segmental, or localized vibration, such as vibration of the hand and
arm, occurs when a specific part of the body comes into contact with
vibrating objects such as powered hand tools (e.g., chain saw, electric
drill, chipping hammer) or equipment (e.g., wood planer, punch press,
packaging machine).
Although using powered hand tools (e.g., electric, hydraulic,
pneumatic) may help to reduce risk factors such as force and repetition
over using manual methods, they can expose employees to vibration.
Vibrating hand tools transmit vibrations to the operator and, depending
on the level of the vibration and duration of exposure, may contribute
to the occurrence of hand-arm vibration syndrome or Raynaud's
phenomenon (i.e. vibration-induced white-finger MSDs) (Ex. 26-2).
The level of vibration can be the result of bad design, poor
maintenance, and age of the powered hand tool. For example, even new
powered hand tools can expose employees to excessive vibration if it
they do not include any devices to dampen the vibration or in other
ways shield the operator from it. Using vibrating hand tools can also
contribute to muscle-tendon contractile forces owing to operators
having to use increased grip force to steady tools having high
vibration.
Vibration from power tools is not easy to measure directly without
the use of sophisticated measuring equipment. However, vibration
frequency ratings are available for many recently designed hand tools.
Based on the whole of the scientific literature available at the
time of the proposal, OSHA also identified prolonged sitting and
standing (a form of static posture) and whole-body vibration as risk
factors for MSDs; in addition, OSHA identified cold temperatures as a
risk factor modifier because it could require workers to increase the
force necessary to perform their jobs (such as having to grip a tool
more tightly) (64 FR 65865-65926) (Ex. 27-1). The final rule does not
explicitly include these risk factors. For prolonged standing and
sitting, and for cold temperatures, although there is evidence of an
increased risk of MSDs with exposure (e.g., see Skov, Ex. 26-674), the
available evidence did not permit the Agency to provide sufficient
guidance to employers and employees on the levels of exposure that
warrant attention. For whole-body vibration, there was substantial
evidence of a causal association with low back disorders (e.g., see
NIOSH 1997); however, heavy equipment and trucks, the most common
sources of whole-body vibration, are seldom rated for vibration
frequencies and intensities. In addition, measurement of whole-body
vibration levels requires special equipment and training that would be
difficult for most employers to obtain. Therefore, OSHA determined that
it was appropriate not to include whole-body vibration in the final
rule at this time.
For the biomechanical risk factors of force, repetition, awkward
postures, segmental vibration, and contact stress, OSHA has concluded
that strong evidence exists for a positive relationship between
exposure to these risk factors and an increased risk of developing
MSDs, based on the scientific evidence and testimony described in this
section of the final rule's preamble. The risk factors identified by
the Agency as being causally related to the development of MSDs and
that are covered in the final rule are the same risk factors that have
[[Page 68437]]
been addressed by other reputable scientific and regulatory bodies,
both nationally and internationally, who face the challenge of either
reducing the incidence of MSDs or contributing to the scientific basis
for these actions. The two most current and thorough reviews on this
topic are NIOSH's Critical Review of Epidemiologic Evidence for Work-
Related Musculoskeletal Disorders of the Neck, Upper Extremity, and Low
Back (Bernard, 1997; Ex. 26-1) and the National Research Council/
National Academy of Science's Work-Related Musculoskeletal Disorders:
Report, Workshop Summary, and Workshop Papers (1999; Ex. 26-37).
NIOSH's review focused on repetition, force, posture, and vibration
when evaluating epidemiologic evidence for the neck, shoulder, elbow,
and hand/wrist. For the low-back, the authors looked at the evidence
for heavy physical work, lifting and forceful movements, bending and
twisting (awkward postures), whole body vibration and static work
postures. The ``work factors'' identified by the NRC in their report on
Work-Related Musculoskeletal Disorders are the same as the
``biomechanical risk factors'' identified by OSHA. Although terms may
differ depending upon the part of the body being described, it is easy
to see the relationship between heavy physical work and lifting and the
concept of force/exertion to the back, for example .
The Steering Committee Report for the NRC workshop on ``Examining
the Research Base (for Work-Related MSDs)'', participants agreed there
is
``enough scientific evidence to confirm that strain on
musculoskeletal tissue increases when humans perform activities that
involve forceful manual exertions, awkward postures, repetitive or
prolonged exertions, exposure to vibrations and exposure to cold
temperatures.''
However, in a separate paper prepared for the NRC/NAS workshop,
Radwin and Lavender also discuss ``workplace layout,'' ``interactions
with objects,'work scheduling'' and other ``workplace design factors,''
as factors that these authors, as well as others, have studied in
relation to MSDs. Although there is strong agreement on biomechanical
factors associated with MSDs, the science is still evolving with regard
to other types of factors. Thus, when sources refer to biomechanical
risk factors, all literature reviewed from the rulemaking record
identified the same basic risk factors, all essentially related to
force/exertion, repetition, posture and vibration.
Literature reviews published in the scientific literature also
evaluate these same risk factors. Literature reviews of this type use
selection criteria to capture the best-designed studies with a
particular focus, usually risk factors associated with a specific type
of disorder, for analysis. Burdorf and Sorock reviewed 35 articles that
evaluated risk factors for back disorders and concluded that lifting or
carrying loads (force), whole-body vibration and frequent bending and
twisting (awkward postures) were consistently related to work-related
low-back disorders (1997; Ex. 500-71-24). In a systematic review of 31
studies, Hoogendoorn et al (1997; Ex. 500-71-32) found strong evidence
exists for manual materials handling, bending and twisting (awkward
posture), and whole-body vibration as risk factors for back pain, and
moderate evidence exists for patient handling and physical work.
In their review of the literature on the role of physical load
factors in carpal tunnel syndrome, Viikari-Juntura and Silverstein
found an association with carpal tunnel syndrome and forceful,
repetitive work, extreme wrist postures and vibration (1999; Ex. 32-
339-1-56). Other authors (Ariens et al., 2000; Ex. 500-71-23) found a
relationship between neck pain and neck flexion, arm force, arm
posture, duration of sitting, twisting or bending of the trunk, hand-
arm vibration, and workplace design.
In both written submissions to the record, and in oral testimony,
numerous scientific experts confirmed and substantiated OSHA's position
that sufficient scientific evidence exists, and is contained in the
record, to conclude that workplace exposure to the biomechanical risk
factors described above increase the risk for work-related MSDs (Exs.
37-1; 37-2; 37-3; 37-6; 37-8; 38-9; 37-10; 37-13; 37-15; 37-16; 37-17;
37-18; 37-21; 37-27; 37-28; 26-37). Scientists who testified at the
hearings also confirmed that each of these risk factors are linked to
an increased risk of developing an MSD in exposed workers (Dr. Don
Chaffin, University of Michigan, Tr 8254; Dr. Nicholas Warren,
University of Connecticut Health Center, Tr.1084-85; Dr. Martin
Cherniak, Ergonomics Technology Center of Connecticut, Tr. 1128; Dr.
Richard Wells, University of Waterloo, Tr. 1353-54; Dr. Robert
Harrison, Tr. 1648; Dr. Amadio, Mayo Clinic, Tr. 9815, 98; Dr. Eckardt
Johanning, Eastern New York Occupational and Environmental Health
Center, Tr. 16831-33; Dr. Jim McGlothlin, Purdue University, Dr.
Malcolm Pope, Tr. 16808; Dr. Margit Bleeker, Tr. 16826). This written
and oral testimony from scientific experts provides a compelling case
establishing the link between exposure to biomechanical risk factors
and an increased risk of MSD incidence.
OSHA heard from a number of scientists and physicians during it's
hearing with comments along the lines of that by Dr. Robert Harrison,
from the University of California (Tr. 1649-50):
The jobs and tasks my patients are performing are the ones the
literature has identified as high-risk jobs with exposure to many of
the same physical risk factors. In fact, my patients are exposed to
the identical physical work activities and conditions that have been
identified by OSHA as causing excessive exposure to force, frequent
repetition, awkward posture, contact stress, vibration and cold
temperatures.
The record contains many US and international regulations and
guidelines that reflect the same biomechanical risk factors addressed
in the final rule; some are listed below:
National Research Council. (1999) Work-Related
Musculoskeletal Disorders: Report, Workshop Summary, and Workshop
Papers. National Academy Press. (Ex. 26-37);
National Institute for Occupational Safety and Health.
(1997) Musculoskeletal Disorders and Workplace Factors. Centers for
Disease Control and Prevention (Ex. 26-1);
National Institute for Occupational Safety and Health.
(1998) Elements of Ergonomics Programs, A Primer Based on Workplace
Evaluations of Musculoskeletal Disorders. (Ex. 26-2);
European Agency for Safety and Health at Work. Work-
related neck and upper limb musculoskeletal disorders (1999). (Ex.500-
71-28);
Department of Labor and Industries, Washington State. (5/
25/00) Concise Explanatory Statement, WAC 296-62-051, Ergonomics (Ex.
500-71-93);
Ergonomics for the Prevention of Musculoskeletal
Disorders, Swedish National Board of Occupational Safety and Health on
Ergonomics for the Prevention of Musculoskeletal Disorders. AFS 1998:1;
(Ex. 500-71-14);
National Codes of Practice for the Prevention of
Occupational Overuse Syndrome-Worksafe Australia [NOHSC:2013(1994)],
(Ex. 500-71-2);
National Standard for Manual Handling and National Code of
Practice for Manual Handling, Worksafe Australia. 1990 (Ex. 500-71-4);
Occupational Overuse Syndrome: Guidelines for Prevention
and Management, Occupational Safety and Health Services, Department of
Labor, New Zealand (Ex. 500-71-12);
Ergonomics (MSI) Requirements, British Columbia, Canada
(Ex. 32-339-1-6);
[[Page 68438]]
Regulations and Code of Practice, (Manual Handling)
Occupational Health and Safety Regulations 1988. Victoria, Canada. (Ex.
500-71-17);
European Communities Council Directive on Manual Handling
(Ex. 32-339-1-12);
American Conference of Governmental Industrial Hygienists,
Threshold Limit Value (TLV) Committee, Nov. 13, 1999. Notice of Intent
to Establish a Threshold Limit Value, Hand Activity Level (Ex. 32-339-
1-63);
American Conference of Governmental Industrial Hygienists.
1987. Ergonomic Interventions to Prevent Musculoskeletal Injuries in
Industry (Ex. DC-386, Tr. 16291-335);
American Industrial Hygiene Association. 1994. Ergonomic
Guide Series (Ex. 32-133-1);
American National Standards Institute (ANSI) draft
Ergonomic Standard, Z-365 (1998) (Ex.26-1264).
Furthermore, the vast majority of the many job evaluation tools
found in the record and reviewed by the Agency collectively address
these same risk factors covered under the final rule (Exs. 26-521, 26-
1421, 26-1008, 26-883, 26-500-71-92). Also, studies using specific
interventions to reduce biomechanical load address these same risk
factors (see section VI, Risk Assessment).
B. Overview of Evidence of Health Effects for Work-Related
Musculoskeletal Disorders
A substantial body of scientific evidence supports OSHA's effort to
provide workers with ergonomic protection (see the Health Effects
Appendix of the proposal preamble, and the Health Effects Summary, Risk
Assessment, and Significance of Risk sections of this preamble, below).
This evidence strongly supports two basic conclusions: (1) there is a
positive relationship between exposure to biomechanical risk factors
and development of work-related musculoskeletal disorders and (2)
ergonomics programs and specific ergonomic interventions can reduce
these risks. Although it is recognized that many individual and non-
biomechanical workplace factors (such as psychosocial factors) also
contribute to the total risk, exposure to biomechanical factors has
been shown to contribute to the risk independently from other causal
factors; these findings support the appropriateness of designing
interventions that reduce exposures to biomechanical factors as a
strategy for reducing risk of MSDs.
This section presents an overview of the health evidence summarized
from the proposal (64 FR 65865-65926; Ex. 27-1), updates that evidence
with more recent information brought to the Agency's attention during
the rulemaking process, and presents some additional information and
conclusions as to the adequacy and quality of the overall scientific
data base used for the final rule. In developing its review of the
scientific evidence, the Agency has relied on almost 200
epidemiological studies that describe the prevalence or incidence of
MSDs among workers who have been exposed to biomechanical risk factors.
Several of these (see Part G of the Health Effects sections)
simultaneously evaluated the effects of biomechanical and psychosocial
factors in the workplace; these studies generally represent the most
recent and best-designed epidemiological studies.
In addition to epidemiological studies, OSHA has reviewed a
considerable amount of information and studies that describe the
biomechanical aspects of MSD etiology, along with studies that have
been conducted to elucidate the physiological responses of tissues to
biomechanical stress. Much of this information was presented in detail
in OSHA's Health Effects Appendices (Ex. 26-1), prepared at the time of
the final rule. OSHA has since supplemented this information with
additional material contained in the rulemaking record.
In compiling and evaluating the scientific evidence for its
proposed ergonomic program standard OSHA made use of the two major
reviews of the evidence for work-relatedness of MSDs available at that
time, NIOSH's ``Musculoskeletal Disorders and Workplace Factors: A
Critical Review of the Epidemiologic Evidence for Work-Related
Musculoskeletal Disorders of the Neck, Upper Extremity, and Low Back''
(Bernard, 1997; Ex. 26-1) and the National Research Council/National
Academy of Sciences' ``Workshop on Work-Related Musculoskeletal
Injuries: The Research Base'' (Ex. 26-37). Because OSHA's reliance on
these two important works generated a considerable amount of comment
and testimony, these two reviews are described in detail here. However,
throughout this Health Effects section, OSHA has made use of several
other scientific reviews of the literature as well.
The National Institute for Occupational Safety and Health (NIOSH)
conducted a scientific review of hundreds of peer-reviewed studies, and
evaluated the evidence for work-related musculoskeletal disorders of
the neck, upper extremity, and low back (Bernard, 1997; Ex.26-1). The
focus of this review was the epidemiology literature, the goal of which
is to identify factors that are associated (positively or negatively)
with the development of recurrence of adverse medical conditions. This
evaluation and summary of the epidemiologic evidence focuses chiefly on
disorders that affect the neck and the upper extremity, including
tension neck syndrome, shoulder tendinitis, epicondylitis, carpal
tunnel syndrome, and hand-arm vibration syndrome, which have been the
most extensive studies in the epidemiologic literature. The document
also reviews studies that have dealt with work-related back pain and
that address the way work organization and psychosocial factors
influence the relationship between exposure to physical factors and
work-related MSDs. The literature about disorders of the lower
extremity is outside the scope of the NIOSH review, and OSHA has done
its own analysis of that literature. The NIOSH work is the most
comprehensive review of this scientific literature to date.
A search strategy of bibliographic databases identified more than
2,000 studies. Studies were included if they evaluated exposure so that
some inference could be drawn regarding repetition, force, extreme
joint posture, static loading or vibration, and lifting tasks. Studies
in which exposure was measured or observed and recorded for the body
part of concern were considered superior to studies that used self-
reports or occupational/job titles as surrogates for exposure.
Because of the focus on the epidemiology literature, studies that
were laboratory-based or that focused on MSDs from a biomedical
standpoint, dealt with clinical treatment of MSDs, or had other
nonepidemiologic orientation were eliminated from further consideration
for this document. This strategy yielded over 600 studies for inclusion
in the detailed review process. Population-based studies of MSDs, case-
control studies, cross-sectional studies, longitudinal cohort studies,
and case series were included.
The first step in the analytical process was to classify the
epidemiologic studies by the following criteria:
The participation rate was 70%. This
criterion limits the degree of selection bias in the study.
The health outcome was defined by symptoms and physical
examination. This criterion reflects the preference of most
reviewers to have health outcomes that are defined by objective
criteria.
The investigators were blinded to health or exposure
status when assessing health or exposure status. This criterion
limits
[[Page 68439]]
observed bias in classifying exposure or disease.
The joint (part of body) under discussion was subjected
to an independent exposure assessment, with characterization of the
independent variable of interest (such as repetition or repetitive
work). Studies that used either direct observation or actual
measurements of exposure were considered to have a more accurate
exposure classification scheme, whereas studies that exclusively
used job title, interviews, or questionnaire information were
assumed to have less accurate exposure information.
During review of the studies, the greatest qualitative weight was
given to studies that had objective exposure assessments, high
participation rates, physical examinations, and blinded assessment of
health and exposure status.
The second step of the analytical process was to divide the studies
into those with statistically significant associations between
exposures and health outcomes and those without statistically
significant associations. The associations were then examined to
determine whether they were likely to be substantially influenced by
confounding or other selection bias (such as survivor bias or other
epidemiologic pitfalls that might have a major influence on the
interpretation of the findings). These include the absence of
nonrespondent bias and comparability of study and comparison groups.
The third step of the analytical process was to review and
summarize studies with regard to the epidemiologic criteria for
causality: strength of association, consistency in association,
temporal association, and exposure-response relationship. No single
epidemiologic study will fulfill all criteria to answer the question of
causality. However, results from epidemiologic studies can contribute
to the evidence of causality in the relationship between workplace risk
factors and MSDs. The exposures examined for the neck and upper
extremity were repetition, force, extreme posture, and segmental
vibration.
Using the epidemiologic criteria for causality as the framework,
the evidence for a relationship between workplace factors and the
development of MSDs from epidemiologic studies is classified into one
of the following categories: strong evidence of work-relatedness,
evidence of work-relatedness, insufficient evidence of work-
relatedness, evidence of no effect of work factors. The amount and type
of evidence required for each category is described below:
Strong evidence of work-relatedness. A causal relationship is
known to be very likely between intense or long-duration exposure to
the specific risk factor(s) and MSD when the epidemiologic criteria
of causality are used. A positive relationship has been observed
between exposure to the specific risk factor and MSD in studies in
which chance, bias, and confounding factors could be ruled out with
reasonable confidence in at least several studies.
Evidence of work-relatedness. Some convincing epidemiologic
evidence shows a causal relationship when the epidemiologic criteria
of causality for intense or long-duration exposure to the specific
risk factor(s) and MSD are used. A positive relationship has been
observed between exposure to the specific risk factor and MSDs in
studies in which chance, bias, and confounding factors are not the
likely explanation.
Insufficient evidence of work-relatedness. The available studies
are of insufficient number, quality, consistence, or statistical
power to permit a conclusion regarding the presence or absence of a
causal association. Some studies suggest a relationship to specific
risk factors, but chance, bias, or confounding may explain the
association.
Evidence of no effect of work factors. Adequate studies
consistently show that the specific workplace risk factor(s) is not
related to development of MSD.
The above framework provides an indication of the selection
criteria NIOSH used in identifying studies for inclusion in their
review. Studies were included if the exposed and referent populations
were well defined, and if they involved neck, upper-extremity, and low-
back MSDs measured by well-defined, explicit criteria determined before
the study. Studies whose primary outcomes were clinically relevant
diagnostic entities, generally had less misclassification and were
likely to involve more severe cases. Studies whose primary outcomes
were the reporting of symptoms generally had more misclassification of
health status and a wider spectrum of severity.
Care should be taken when interpreting some study results regarding
individual workplace factors of repetition, force, extreme or static
postures, and vibration. As Kilbom (1994; Ex. 26-1352) stated, these
factors occur simultaneously or during alternating tasks within the
same work, and their effects concur and interact. A single odds ratio
(OR) for an individual risk factor may not accurately reflect the
actual association, as not all of the studies derive ORs for
simultaneously occurring factors. Thus these studies were not only
viewed individually (taking into account good epidemiologic principles)
but together for making broader interpretations about epidemiologic
causality. Many investigators did not examine each risk factor
separately but selected study and comparison groups based on
combinations of risk factors (such as workers in jobs involving high
force and repetition compared with workers having no exposure to high
force and repetition.)
Based on the epidemiologic criteria described above, NIOSH made the
following findings:
Strong evidence of work-relatedness exists for the following
associations:
High levels of static contraction, prolonged static loads,
extreme working postures involving the neck/shoulder muscles and an
increased risk for neck/shoulder MSDs;
Exposure to a combination of risk factors (e.g., force and
repetition, force and posture) and CTS;
Job tasks that require a combination of risk factors
(e.g., highly repetitious, forceful hand/wrist exertions) and hand/
wrist tendinitis;
High level exposure to hand-arm vibration and vascular
symptoms of hand-arm vibration syndrome;
Work-related lifting and forceful movements;
Exposure to whole-body vibration and low-back disorder.
2. Evidence exists for the following associations:
Highly repetitive work and neck and neck/shoulder MSDs,
considering both repetitive neck movements (using frequency and
duration of movements) and repetitive work involving continuous arm or
hand movements;
Forceful exertion and neck MSDs, with ``forceful work''
involving forceful arm or hand movements, which generate loads to the
neck/shoulder area;
Highly repetitive work and shoulder MSDs;
Repeated or sustained shoulder postures with greater than
60 degree of flexion or abduction and shoulder MSDs;
Highly repetitive work, both alone and in combination with
other factors and carpal tunnel syndrome;
Work involving hand/wrist vibration and CTS;
Any single factor (repetition, force and posture) and
hand/wrist tendinitis;
Work-related awkward postures and low-back disorders.
3. Insufficient evidence of work-relatedness exists for the
following associations:
Vibration and neck disorders;
Force and shoulder MSDs;
Extreme posture and CTS.
The NIOSH review (Bernard, 1997; Ex. 26-1) is an authoritative,
systematic, critical review of the epidemiologic evidence regarding
work-related risk
[[Page 68440]]
factors and their relationship to MSDs of the neck, shoulder, elbow,
hand/wrist, and low back. In considering its purpose, the authors
state:
This review of the epidemiologic literature may assist national
and international authorities, academics, and policy makers in
assessing risk and formulating decisions about future research or
necessary preventive measures.
In 1998, the National Institutes of Health asked the National
Academy of Sciences/National Research Council (NRC) to assemble a group
of experts to examine the scientific literature relevant to the work-
related musculoskeletal disorders of the lower back, neck and upper
extremities. A steering committee was convened to design a workshop, to
identify leading researchers on the topic to participate, and to
prepare a report based on the workshop discussions and their own
expertise. Additionally, the steering committee was asked to address,
to the extent possible, a set of seven questions posed by Congress on
the topic of musculoskeletal disorders. The steering committee includes
experts in orthopedic surgery, occupational medicine, epidemiology,
ergonomics, human factors, statistics, and risk analysis (NRC, 1999;
Ex. 26-37). Note: The steering committee's report was published in
1998, and was referred to in OSHA's proposal as Ex. 26-37. In the final
rule, Ex. 26-37 refers to the final report, (Work-Related
Musculoskeletal Disorders: Report, Workshop Summary, and Workshop
Papers, National Research Council, 1999; Ex. 26-37), which includes the
steering committee's report, a summary of the proceedings of the 2-day
workshop (Work-Related Musculoskeletal Injuries: The Research Base),
and the workshop papers.
The charge to the steering committee, reflected in the focus of the
workshop, was to examine the current state of the scientific research
base relevant to the problem of work-related musculoskeletal disorders,
including factors that can contribute to such disorders, and strategies
for intervention to ameliorate or prevent them. The NAS/NRC organized
their examination of the evidence of factors that potentially
contribute to musculoskeletal disorders:
(1) Biological responses of tissues to biomechanical stressors;
(2) Biomechanics of work stressors, considering both work and
individual factors, as well as internal loads;
(3) Epidemiologic perspectives on the contribution of physical
(biomechanical) factors;
(4) Non-biomechanical (e.g., psychological, organizational, social)
factors; and
(5) Interventions to prevent or mitigate musculoskeletal disorders.
For four of these topics, discussions at the workshop centered on a
paper (or papers) commissioned for the workshop, followed by the
comments of invited discussants. For the epidemiology of physical
factors, the steering committee used a panel format to take advantage
of a recent review of this literature, the NIOSH review, published in
1997, and previously discussed here.
Use of this broad approach provided for the examination of evidence
from both basic and applied science and a wide variety of
methodologies, and considered sources of evidence that extend well
beyond the epidemiologic literature alone. In determining whether
scientific evidence supports a causal claim for risk factors and work-
related musculoskeletal disorders, the NAS/NRC steering committee
considered the following five criteria:
Temporal ordering requires that the cause be present
before the effect is observed.
Cause and effect covary. For example, when no force is
applied to a tendon, it remains in a relaxed state; in the presence of
the cause (a force), the tendon responds.
Absence of other plausible explanations for the observed
effect. Adequate controlling of confounding factors by the design of
the experiment or observation makes other explanations for the observed
effect less likely.
Temporal contiguity, amplifies the first (temporal
ordering). To the extent that the effect follows the cause closely in
time, the plausibility that other factors are operative is reduced.
Congruity between the cause and effect, that is the size
of the cause is related to the size or magnitude of the effect.
In its report, the NRC noted that in addressing complex research
questions, such as relationships between risk factors and work-related
musculoskeletal disorders, single studies rarely, if ever, provide
conclusiveness of a causal relationship. Replication and synthesis of
evidence across studies, preferably with studies that use a variety of
methods (each with different strengths and weaknesses) strengthens
causal associations. In performing such synthesis, studies that most
completely satisfy the five criteria specified above should be given
greatest weight. Inferential strength is gained by examining the
evidence from a variety of theoretical perspectives, as well as a
variety of research methods. A major strength of the NRC/NAS review is
that it takes this broad approach toward evaluating the relevant
scientific evidence.
In evaluating the epidemiologic literature and NIOSH's review of
that literature, the NRC/NAS steering committee identified the
following limitations in the epidemiologic evidence:
Temporal contiguity between the stressors and onset of
effects, as well as amelioration after reduction of stressors, could
not always be established, nor could the clinical course of the
observed effects;
Methods used for the assessment of exposures and health
outcomes vary, rendering the task or merging and combining evidence
more challenging than in some other areas of occupational risk
assessment;
Lack of baseline prevalence and incidence data for the
general population.
Despite these limitations, the steering committee reached the
following conclusions regarding the epidemiologic evidence:
Restricting our focus to those studies involving the
highest levels of exposure to biomechanical stressor of the upper
extremity, neck, and back and those with the sharpest contrast in
exposure among the study groups, the positive relationship between
the occurrence of musculoskeletal disorders and the conduct of work
is clear. * * * (T)hose associations identified by the NIOSH review
(NIOSH, 1997; Ex 26-1) as having strong evidence are well supported
by competent research on heavily exposed populations.
There is compelling evidence from numerous studies that
as the amount of biomechanical stress is reduced, the prevalence of
musculoskeletal disorders at the affected body region is likewise
reduced. This evidence provides further support for the relationship
between these work activities and the occurrence of musculoskeletal
disorders.
Evidence of a role for biomechanical stress in the
occurrence of musculoskeletal disorders among populations exposed to
low levels of biomechanical stressors remains less definitive,
though there are some high-quality studies suggesting causal
associations that should serve as the basis for further
investigation. In cases of low levels of biomechanical stress, the
possible contribution of other factors to musculoskeletal disorders
is important to consider. The report then addresses other factors,
including individual factors (e.g., age, prior medical conditions);
and organizational and social factors (e.g., job content and
demands, job control and social support).
The conclusions from the NAS/NRC report (Ex. 26-37) from the
biomechanical literature are presented (in brief) in the previous
discussion of ``force''in Section A.
In setting forth its conclusions on musculoskeletal disorders in
the workplace, NRC/NAS steering committee notes that it has:
supplemented our professional expertise with workshop presentations,
commissioned papers and other submissions, and
[[Page 68441]]
discussions with invited workshop participants.
and, as a result concluded (in summary):
There is a higher incidence of reported pain, injury,
loss of work, and disability among individuals who are employed in
occupations where there is a high level of exposure to physical
loading than for those employed in occupations with lower levels of
exposure.
There is a strong biological plausibility on the
relationship between the incidence of musculoskeletal disorders and
the causative exposure factors in high-exposure occupational
settings.
Research clearly demonstrates that specific
interventions can reduce the reported rate of musculoskeletal
disorders for workers who perform high-risk tasks.
Research can (1) provide a better understanding of the
mechanisms that underlie the established relationships between
causal factors and outcomes; (2) consider the influence of multiple
factors (mechanical, work, social, etc.) on symptoms, injury,
reporting, and disability; (3) provide more information about the
relationship between incremental change in load and incremental
biological response as a basis for defining the most efficient
interventions; (4) improve the caliber of measurements for risk
factors, outcome variables, and injury data collection systems; and
(5) provide better understanding of the clinical course of these
disorders.
The relevant scientific literature has been thoroughly and
systematically evaluated by two highly-reputable and independent
scientific bodies and their experts, who used different approaches to
evaluate the literature from different scientific disciplines (while
allowing for some overlap), using causality criteria from two related
but different frameworks. The NIOSH and NRC/NAS reviews offer two
distinct but consistent sets of conclusions that can be drawn from the
literature on work-related musculoskeletal disorders. Generally, both
reviews agree that the scientific evidence provides compelling support
for a higher risk of work-related musculoskeletal disorders and the
loss of work, and disability among individuals who are employed in
occupations where there is a high level of exposure to physical loading
(biomechanical factors), and that evidence clearly demonstrates that
specific interventions can reduce the reported rate of musculoskeletal
disorders for workers who perform high-risk tasks.
In the face of overwhelming evidence that biomechanical/physical
risk factors in the workplace cause MSDs, some critics, such as UPS
argue that there is not even one study which demonstrates that
repetitive motion causes injury (Ex. 32-241-4). When asked at the
hearing whether he agreed with this UPS position, Dr. Robert McCunney,
representing the American College of Occupational and Environmental
Medicine replied ``I find this statement incredulous'' (Tr. 7662). Dr.
McCunney then continued in his testimony to state that there is
sufficient scientific literature showing that repetitive motion
activities can lead to MSDs. According to Dr. Barbara Silverstein, of
the Washington State Department of Labor and Industries, scientific
researchers who hold to the UPS view that there is no evidence that
repetitive movements causes injury ``are in a minority'' (Tr. 17415).
Likewise, in response to the same question regarding the UPS
contention, Dr. Thomas Armstrong (University of Michigan) defended the
scientific evidence that repetitive movements can result in injury, by
replying:
There are physiological studies looking at repetitive work as it
contributes to muscle fatigue and changes in histology of muscle
tissue. There are epidemiological studies that have looked at the
relationship between various exposures to repetition and a variety
of musculoskeletal types of disorders. These studies from different
disciplines all come together and support the same conclusion.
Professional and scientific organizations supporting OSHA's
determinations regarding the scientific basis underlying the standard
include:
American Association of Occupational Health Nurses (Ex.
30-2387)
American College of Occupational and Environmental
Medicine (Ex. 30-4468, Tr. 7637-7690)
American Conference of Governmental Industrial Hygienists
(Ex. DC-386, Tr. 16291-335)
American Industrial Hygiene Association (Ex. 32-133-1, Tr.
16464-72, Tr. 16518-27)
American Nurses Association (Ex. 30-3686, Tr. 15875-95)
American Occupational Therapy Association (Ex. 30-4777,
Tr. 18095-18121)
American Public Health Association (Ex. 30-626, Tr. 17649-
17704)
American Society of Safety Engineers (Ex. 32-21-1-2; Tr.
11612)
Human Factors and Ergonomics Society (Ex. 502-472)
National Association of Orthopedic Nurses (Tr. 10578-
10588)
The American Society of Plastic and Reconstructive Surgery
(Ex. DC-46, Tr. 1534)
OSHA finds no merit to assertions that there is insufficient
science on which to base its proposal and subsequent final rule.
Rather, the Agency finds that the body of scientific evidence on which
OSHA based this rule is vast and conclusive. This position was
supported by many witnesses and multiple pages of hearing testimony,
and added to the substantial base of scientific literature that OSHA
relied on for the publication of it's proposal. And, although there
have been critics to OSHA's actions, they are in fact, in the vast
minority. The science overwhelmingly supports reducing biomechanical
risk factors in the workplace as an effective approach to reducing
work-related musculoskeletal disorders.
When asked ``whether ACOEM believes that detection and elimination
of these ergonomic risk factors at work can result in a reduction in
the number of these disorders'' during the hearing, Dr. McCunney
replied ``Very much so'' (Tr. 7663).
The following parts of this section discuss the evidence for the
work-relatedness of MSDs. Tables V-1 through V-8 summarize some key
aspects of the epidemiological studies that investigate MSDs, such as
the occupations examined, the biomechanical risk factors they were
exposed to, whether exposures were directly observed or measured during
the study, and whether the health outcomes were verified by trained
medical personnel during physical examination. The last column provides
a quantitative (if available) risk measure or range of risk measures
reported in each study that best captures the strength of the
association between the studied biomechanical risk factor(s) and health
outcome. Study entries with a single odds (or prevalence) ratio
examined the relative risk between an exposed group of workers and
unexposed referent population. For most studies, the risk values and
confidence intervals were obtained from tables found in the 1997 NIOSH
review (Ex. 26-1). For the additional studies not reviewed by NIOSH,
OSHA obtained risk values from the material submitted in the docket.
Many studies reported risk ratios for multiple exposed groups and/
or several indicators of exposure to biomechanical risk factors. In
these cases, the range of reported risk measures were provided in the
summary tables. OSHA did not include in this range; (1) risks ratios
(high or low) that were inherently unstable because they were based on
very low numbers of cases; (2) risk ratios that did not reflect
differences in biomechanical risk factors; and (3) risk ratios in which
the variation in exposure between groups were so small that a
difference in MSD prevalence
[[Page 68442]]
would have been difficult to detect. The 95 percent confidence interval
for the upper end of the risk range were also recorded on the tables.
Some studies on the tables did not report odds (or prevalence)
ratios, even though they may have established a statistically
significant association between biomechanical risk factor and health
outcome. Often, the association was expressed as a regression analysis
between a particular biomechanical measurement and number of MSD cases.
Sometimes, the study did not provide a risk measure but simply reported
the MSD prevalence of different groups of exposed workers. These study
entries were designated with a NR (risk ratio not reported).
C. Disorders of the Neck and Shoulder
MSDs of the neck and shoulder that have been documented in the
scientific literature include the clinically well-defined disorders,
such as tendinitis, and the less clinically well-defined soft tissues
disorders, such as tension-neck syndrome (Gerr 1991, Ex. 26-1208; Moore
1992, Ex. 26-984). MSDs of the neck and shoulder often involve tendons,
muscles, and bursa; nerves and blood vessels may also be affected.
Because of the simultaneous involvement of several regional structures
in neck and shoulder MSDs, there may be positive signs and/or symptoms
in more than one structure. For example, strong abduction or extension
of the upper arm, as well as awkward postures of the neck, can compress
parts of the brachioplexus under the scalene muscles and other
anatomical structures. This compression can result in nerve and/or
blood vessel damage or in eventual damage to the tissues served by
these nerves and vessels.
Neck and Upper Back
In this section, OSHA summarizes the evidence for an increased risk
for musculoskeletal disorders of the neck and upper back associated
with exposure to biomechanical risk factors in the workplace. This
region (neck and upper back) includes the cervical and thoracic spine
(spine above the lumbar or low back) and supporting structures and
tissues. The scientific literature frequently refers to this region as
``Neck and Neck/Shoulder,'' or as ``Neck and Shoulder'' or as ``Neck
and Upper Back.'' With respect to the epidemiologic literature, the
studies NIOSH referred to in it's ``Neck and Neck/Shoulder'' section
are included in this section. A summary of the evidence regarding the
shoulder only is reviewed in the separate section following this one.
For greater detail on the scientific evidence summarized here see 64 FR
65865-65926).
The lifetime prevalence of neck pain is estimated at 40% to 50%,
with a 1-year prevalence of about 20% (Takala et al.1982, Ex. 26-1169).
Using a definition of 2 weeks of neck pain, the prevalence among men
and women aged 25 to 74 years in the NHANES Survey II (1976 to 1980)
was 8.2% (Praemer, Furner, and Rice 1992, Ex. 26-869). Chronic neck
pain is estimated to be present in up to 9% to 10% of males and 12% to
14% of females (Makela et al.1991, Ex. 26-980; Revel et al.1994, Ex.
26-195). Individuals in the 4th to 6th decades of life have the
greatest incidence of neck disorders (Makela et al.1991, Ex. 26-980;
Praemer, Furner, and Rice 1992, Ex. 26-869).
What is known about the course of neck pain? It is estimated that
90% of patients with acute neck pain are improved within 2 months
(Borenstein, Wiesel, and Boden 1996, Ex. 26-1394). The Quebec Spinal
Study (1987, Ex. 26-494) series of individuals with work-related spinal
disorders suggests that 74% recover by 7 weeks. A 10-year outcome study
of patients with neck pain revealed that 79% had less pain and 43% were
pain-free. However, 32% still experienced moderate or severe pain (Gore
et al.1987, Ex. 26-127). With regard to work-related MSDs, some
intervention studies have suggested that workplace modifications may
decrease both symptoms of neck pain and/or muscle activity as recorded
by EMG (Aaras 1994a, Ex. 26-892; Aaras et al.1998, Ex. 26-597; Schuldt
et al.1987, Ex. 26-670).
The extent to which neck pain occurs in or affects workers depends
to a great extent on the terms used to define the pain, in terms of
intensity and duration, and on the methods used in determining the
presence or occurrence (self-report, interview, or physical
examination). Point prevalence of neck pain in a general U.S.
population has been reported at 10%, matching point prevalence reports
of workers in an aeroengineering factory and exceeding a 4% prevalence
reported in a group of textile workers (Palmer et al.1998, Ex. 26-1529
). Other estimates found in the literature include 68% for female and
47% for male Swedish industrial workers performing unskilled tasks (3-
month prevalence of MSDs in the neck and in the thoracic
back)(Bjorksten et al.1996, Ex. 26-604). One-year prevalence of neck
pain or neck and upper-back pain was 16% in a group of electricians,
excluding neck pain associated with traumatic injury, and 38% with a
less restrictive definition (Hunting, et al.199, Ex. 26-1273); 26% and
18%, in the Danish wood and furniture industry respectively
(Christensen, Pedersen, and Sjogaard 1995, Ex. 26-95). Prevalence of
regular discomfort in the posterior neck region was 6.3%, and 9.1% in
the upper-back region, in a group of chicken-processing workers.
However, the lifetime prevalence was 36%, the point prevalence was 18%,
and 9% had sought medical treatment for discomfort (Buckle 1987, Ex.
26-938).
Many studies of neck pain have focused on employees working in
health care. Milerad and Ekenvall (1990, Ex. 26-1291) reported cervical
symptom prevalence of 45% of male dentists and 63% of female dentists,
rates that were 2.6 and 2 times those of male and female pharmacists,
respectively. Twelve-month prevalence of self-reported neck pain was
63.1% in a group of medical secretaries and hospital office personnel
(Linton and Kamwendo 1989, Ex. 26-978).
With regard to work-related cervical spine disorders, the Quebec
Spinal Study (1987, Ex. 26-494) observed an annual incidence of over
0.1%. However, Bjorksten et al.(1996, Ex. 26-604) reported a 68%, 3-
month prevalence for neck pain in industrial workers performing
unskilled tasks, more than double the rate in the general population.
Certain jobs appear to have greater associations with neck pain than
others, with the lifetime prevalence of neck and shoulder symptoms
reaching 81% in machine operators, 73% in carpenters, and 57% in office
workers (Tola et al.1988, Ex. 26-1018). It must be understood that
there may be an underestimation of work-relatedness of neck pain since
the onset of pain may, at times, be delayed and the work relation
uncertain.
Tension neck syndrome is a myofascial (muscle pain) localized in
the shoulder and neck region (Hagberg 1984; Ex. 26-1271). Also called
scapulocostal syndrome (Fine and Silverstein 1998; Ex. 38-444), these
syndromes are often characterized by diffuse tenderness over the
muscle, rather than the tendon origin, and activity limitation. The
pathophysiology is unknown; however, a number of mechanism have been
proposed, including inflammation. Two types of muscle activity may be
important in work-related disorders: low-force, prolonged muscle
contractions (e.g., in office workers moderate neck flexion while
working on a visual display terminal (VDT) for many hours without rest
breaks); and infrequent or frequent high-force muscle contractions
(intermittent use of heavy tools) in
[[Page 68443]]
overhead work). Sustained static contractions can lead to increases in
intramuscular pressure, which in turn may impair blood flow to cells
within the muscle (Hagberg, 1984; Ex. 26-1271).
Motor nerve control of the working muscle may be important in
sustained static contractions since even if the relative load on the
muscle as a whole is low, the active part of the muscle may be working
close to it's maximal capacity. Thus, small areas of large muscles such
as the trapezius may have disturbances in microcirculation that might
contribute or cause the development of muscle damage (red ragged
fibers), reduce strength, higher levels of fatigue, sensitization of
pain receptors in the muscle, and pain at rest (Armstrong, Buckle and
Fine 1993, as cited in Fine and Silverstein 1998, Ex. 38-444). High
levels of tension (strong contractions) can lead to muscle fiber Z-line
rupture, muscle pain, and large, delayed increases in serum creatine
kinase. These changes are reversible and can be completely repaired,
often leading the muscle to be stronger. It is hypothesized that if
damage occurs daily due to work activity, the muscle may not be able to
repair the damage as fast as it occurs, leading to chronic muscle
damage or dysfunction. The mechanism of this damage at the cellular
level is not understood (Armstrong, Buckle and Fine, 1993 as cited in
Fine and Silverstein 1998, Ex. 38-444).
Hagberg (1984, Ex. 26-1271; and Hagberg and Wegman 1987, as cited
in Magnusson and Pope Ex. 38-450) described three possible
pathophysiological mechanisms for occupational muscle-related
disorders, such as tension neck syndrome. The first is mechanical
failure, due to temporary high local stress involving eccentric
contractions on the shoulders, such as in workers unaccustomed to the
work task. The second is local decreased blood flow (ischemia), as seen
in assembly workers whose tasks involved dynamic, frequent contractions
above 10 to 20% of the maximum voluntary contraction and few rest
breaks. Both a reduction in blood flow and pathologic changes were
found to be correlated with myalgia (muscle pain) and ragged red fibers
in 17 patients doing repetitive assembly work (Larsson et al.1990, Ex.
26-1141).
The third pathophysiologic mechanism for muscle pain (Hagberg 1984,
Ex. 26-1271) energy metabolism disturbance, occurs when energy demand
exceeds production. Long-term static contractions of the muscles result
in the prolonged recruitment of limited numbers of motor units, and can
deplete available energy, producing eventual fatigue and injury (Lieber
and Friden 1994, Ex. 26-559). Higher subjective levels of fatigue as
well as electrophysiological evidence of fatigue are more common in
large muscle groups, such as the neck and shoulder muscles, when
activities are static and repetitive rather than dynamic (Sjogaard
1988, Ex. 26-830).
Pain arising from cervical spine skeletal structures may
potentially originate from many locations, since sensory nerve
innervation is present in ligaments, joint capsules, the anterior and
posterior longitudinal ligaments, the outer third of the annulus
fibrosus, and the vertebral body (Bogduk 1982, Ex. 26-1479; Bogduk et
al.1988, Ex. 26-514; Hirsch, Inglemark, and Miller 1963, Ex. 26-471).
The periosteum of the cervical vertebral body may be a source of pain,
although some slowly progressive lesions may destroy a significant
amount of bony tissue before they are recognized (Borenstein, Wiesel,
and Boden 1996, Ex. 26-1394). The spinal nerve roots are the source of
pain when there is compression, ischemia, and inflammatory or chemical
mediators that stimulate nociceptors.
Cervical spondylosis refers to degenerative changes in the cervical
spine that are apparent on radiological examination (Hagberg and Wegman
1987, Ex. 26-32). The pathogenesis of cervical spine degenerative
disease has similarities to many other joint structures, although there
are important differences. The cervical spine has a great deal more
movement, achieved via gliding and sliding on adjacent structures, than
the remainder of the spine. And not being subject to repetitive and
impulsive loading, cervical spinal segments do not require the strength
and stability of the lumbar-sacral spine. However, these zygoapophyseal
joints in the cervical spine have fibrocartilagenous, meniscus-like
structures that are capable of responding with proliferative changes
(Bland 1994, Ex. 26-416 ). As with other joints, aging, repetitive
motion, and some loading result in fissuring of the hyaline cartilage
surfaces. Gradually, the hyaline cartilage develops deeper and downward
fissuring, larger erosions, and general thinning. In the cervical
spine, the chondrocytes proliferate in areas of fibrillation or loosely
textured matrix (Bland 1994, Ex. 26-416). And though the matrix may
demonstrate some attempts at repair, the repair is generally
disorderly. Subchondral bone increases in density, followed by
microfracturing and callus formation. New bone, called osteophytes,
appear at the margins of the articular cartilage, and may protrude into
the joint space or neuroforamen. If large enough, this may cause nerve
compression. Posterior spondylotic bars, especially if combined with
hypertrophy of the ligamentum flavum, have the potential to compress
the spinal cord, causing symptoms of cervical myelopathy. Anatomically,
the C4 to C5, C5 to C6, and C6 to C7 intervertebral disc spaces are
most commonly affected by osteoarthritis and degenerative disc disease.
Thoracic outlet syndrome (TOS) is defined as a ``neurovascular
impingement syndrome at different anatomical levels where the brachial
plexus and subclavian vessels may be entrapped as they pass through, en
route from the cervical spine to the arm.'' (Hagberg et al.1995, Ex.
26-432). The syndrome involves compression of the subclavian artery and
the lower trunk of the brachial plexus, at one or more locations
between the neck and the axilla. Symptoms are experienced in the upper
extremity. Cervical syndrome is defined as ``compressions of the nerve
root by a herniated disc or a narrowed intervertebral foramen''
(Hagberg et al.1995, Ex. 26-432).
Epidemiological Evidence
Several muscles act upon the upper spine and shoulder girdle
together; Scandanavian studies have often combined neck and shoulder
MSDs. Neck pain and MSDs will be discussed here. Those studies that
evaluated neck and shoulder pain and MSDs together will also be
included. Studies that exclusively evaluate pain and MSDs of the
shoulder will be discussed in a subsequent section. Studies that have
evaluated objective findings and/or met diagnostic criteria for
specific disorders have been given greater weight in this analysis.
There have been several reviews that associate neck disorders work
factors, such as repetition, force, static loading, neck posture, and
heavy work (NIOSH 1997, Ex. 26-1; Grieco, et al.1998, Ex. 26-627;
Hagberg et al.1995, Ex. 26-432; Hales and Bernard 1996, Ex. 26-896;
Viikari-Juntura 1997, Ex. 26-905; Hagberg and Wegman 1987, Ex. 26-32).
The majority of neck disorders involve soft tissues (muscle and
ligament strains and sprains). Outcomes studied and reported are often
non-specific, for example, neck pain or/or stiffness. Some studies
relied on combination of symptoms and physical exam confirming
tenderness in neck muscles and tendons upon palpitation and/or
localized pain during neck movement. Many others simply relied on self-
[[Page 68444]]
reported symptoms on a questionnaire. While duration of symptoms and
case definitions were not always completely consistent, all studies
attempted to exclude pain and/or discomfort that was transient or less
than significant intensity.
In a few epidemiological studies, objective exposure measurement
that pertained to the neck region, such as work load assessments,
electromyography, neck angle measurement, was obtained. However in most
studies, exposure assessments were based on job titles or self-reports.
In some investigations the primary interest and measurement strategy
was focused on hand/wrist region, even though neck disorders were
studied as one of the outcomes. Hand/wrist exposures will not
necessarily reflect the biomechanical status of the neck, and,
therefore these studies have potential for considerable exposure
misclassification are given less weight.
Bernard (1997, Ex. 26-1) and NIOSH reviewed epidemiological studies
for evidence of work-relatedness of neck and neck/shoulder
musculoskeletal disorders. In the process of identifying papers for
this review, Bernard (1997, Ex. 26-1) first considered the strength of
each study based on whether it provided clear definitions of exposed
and reference populations and clear definitions of outcomes, as well
whether it evaluated exposures in such a way as to classify them with
regard to force, repetition, posture, or vibration. Papers that met
these standards were then evaluated based on four criteria: a 70% or
better response rate in order to limit response bias, health outcome
defined by symptoms and physical examination (PE)(1), investigators
blinded where appropriate (exposure or health status), and the neck as
a focus of the evaluation. Only one of the studies that focused on the
neck and two that focused on the neck/shoulder region met all four
criteria. The likelihood of bias in each study was examined. Finally,
studies were summarized with respect to strength of association,
demonstration of temporal association, consistency of association among
studies, and exposure-response relationship.
The NIOSH review identified 46 epidemiological studies (1976 to
1995) reporting on the neck and 23 reporting on the neck/shoulder
region. Of these studies, 38 were cross-sectional, 2 were case-control,
and 6 were prospective studies. Table V-1 summarizes some key aspects
of these investigations, such as the occupations examined, the
biomechanical risk factors the workers were exposed to, whether
exposures were directly observed or measured during the study, and
whether the health outcomes were verified by trained medical personnel
during physical examination. Thirteen of the studies directly measured
or observed a combination of repeated arm/shoulder movements, strenuous
work that generates loads to the neck/shoulder muscles, and extreme
static postures. The eleven studies also used physical examination by a
health professional to define workers with neck disorders. OSHA regards
these investigations as more reliable than those in which direct
exposure was not observed or in which neck injuries are self-reported.
Twelve of the thirteen studies reported a statistically significant
association between these disorders and physical work factors (force,
repetitive motion, awkward posture).
Table V-1.--Summary of Epidemiology Studies Examining Neck and Upper Back Musculoskeletal Disorders
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study Job type studies Physical factors Exposure basis Diagnosis Risk Measure (95% CI) \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hunting (1981) Ex. 26-1276......... VDT operation........ R/P observation.......... physical exam........ OR=9.9 *
body posture......... (3.7-26.9)
Veiersted (1994) Ex. 26-1366....... chocolate manufacture F/R?/P EMG.................. physical exam........ OR=6.7-7.2 *
(2.1-25.3)
Ohlsson (1995) Ex. 26-868.......... assembly line........ R/P neck flexion......... physical exam........ OR=3.6 *
cycle time........... (1.5-8.8)
Bergqvist (1995) Ex. 26-1195....... VDT operators........ R/P observation.......... physical exam........ OR=3.6-4.4 *
(1.1-17.6)
Bergvist (1995) Ex. 26-1196........ VDT operators........ R/P observation.......... physical exam........ OR=6.9 *
(1.1-42.1)
Onishi (1976) Ex. 26-1222.......... film rolling......... F?/R/P observation.......... physical exam........ OR=3.8 *
EMG.................. (2.1-6.6)
Norander (1999) Ex. 38-408......... fish processing...... R/P observation.......... physical exam........ OR=3.0 *
cycle time........... (1.5-5.9)
Kukkonen (1983) Ex. 26-1138........ data entry........... R?/P posture.............. physical exam........ OR=2.3 *
observation.......... (1.1-4.6)
Bjelle (1981) Ex. 26-1519.......... industrial plant..... F/R/P flexion.............. physical exam........ NR *
EMG..................
Jonsson (1988) Ex. 26-969; Kilbom electronics F/R/P flexor MVC........... physical exam........ NR *
(1986) Ex. 500-41-75. manufacture. flexion..............
Dimberg (1989) Ex. 26-1211......... automotive........... F/R/P observation.......... physical exam........ NR*
(p0.1)
Sakakibara (1995) Ex. 26-800....... fruit bagging........ F?/R?/P observation.......... physical exam........ OR=1.5
arm elevation........ (1.0-2.3)
Rosecrance (1994) Ex. 38-203....... newspaper work....... F?/P/R questionnaire........ symptoms only........ OR=29 *
Andersen (1993) Ex. 26-1502........ sewing machine....... F/R/P? job titles........... physical exam........ OR=6.8 *
(1.6-28.5)
Baron (1991) Ex. 26-697............ grocery checking..... F/R/P job titles........... physical exam........ OR=2.0
(0.6-2.7)
Bernard (1994) Ex. 26-842.......... newspaper publishing. R?/P observation.......... symptoms only........ OR=1.4 *
(1.0-1.8)
Blader (1991) Ex. 26-1215.......... sewing machine....... R/P questionnaire........ physical exam........ NR *
Hales (1989) Ex. 2-3-pp............ poultry processing... F/R job title............ physical exam........ OR=1.6
(0.4-3.2)
Hales (1994) Ex. 26-131............ telecommunication.... R?/P questionnaire........ physical exam........ OR=3.8*
(1.5-9.4)
[[Page 68445]]
Hunting (1994) Ex. 26-1273......... electrician.......... V/F/R/P questionnaire........ symptoms only........ OR=1.6
(NR)
Kamwendo (1991) Ex. 26-1384........ medical secretary.... R/P questionnaire........ symptoms only........ OR=1.6*
(1.0-2.7)
Kiken (1990) Ex. 26-430............ poultry processing... F/R job title............ physical exam........ OR=1.3
(0.2-11)
Knave (1985) Ex. 26-753............ VDT operation........ R/P questionnaire........ symptoms only........ OR=1.6
(0.4-3.2)
Kuorinka (1979) Ex. 26-639......... scissor production... R/P job title............ physical exam........ OR=4.1*
(2.3-7.5)
Luopajarvi (1979) Ex. 26-56........ food production...... F/R/P? job title............ physical exam........ OR=1.6
(0.9-2.7)
Schibye (1995) Ex. 26-1463......... sewing machine....... F?/R/P? questionnaire........ symptoms only........ OR=3.3*
(1.4-7.7)
Liss (1995) Ex. 26-55............. dental hygienist..... F/R/P? questionnaire........ symptoms only........ OR=1.7*
(1.1-2.6)
Ohlsson (1989) Ex. 26-1290........ auto assembly........ F/R/P? job title............ symptoms only........ OR=1.9
(0.9-3.7)
Andersen (1993) Ex. 26-1451....... sewing machine....... F/R/P? job titles........... symptoms only........ OR=3.2-4.9*
(2.0-12.8)
Eckberg (1995) Ex. 26-1193........ residents............ F?/R/P? questionnaire........ symptoms only........ OR=1.2*
(1.0-1.3)
Eckberg (1994) Ex. 26-1238........ case-control......... F?/R/P questionnaire........ symptoms only........ OR=3.6-15.6*
(3.2-113)
Milerad (1990) Ex. 26-1291........ dentist.............. R/P questionnaire........ symptoms only........ OR=2.1*
(1.2-3.1)
Punnett (1991) Ex. 26-39.......... meat processing...... F/R/P? observation.......... symptoms only........ OR=0.9-1.8
(1.0-3.2)
Rossignol (1987) Ex. 26-804....... computer operation... R/P questionnaire........ symptoms only........ OR=1.8-4.6*
(1.7-13.2)
Viikari-Juntura (1994) Ex. 26-873. machine operation.... F/R?/P/V observation.......... symptoms only........ OR=3.0-4.2*
(2.0-9.0)
Wells (1983) Ex. 26-729............ letter carrier....... F/R?/P job title............ symptoms only........ OR=2.6 *
(1.1-6.2)
Aaras (1994) Ex. 26-892............ telephone assembly... F/R?/P EMG.................. symptoms only........ NR *
muscle load..........
Ferguson (1976) Cited in Ex. 26-1.. telephone interview.. R?/P posture measures..... symptoms only........ NR
Maeda (1982) Ex. 26-1224........... machine operators.... F?/R?/P? questionnaire........ symptoms only........ NR *
Linton (1989) Ex. 26-729........... medical secretary.... R?/P? questionnaire........ symptoms only........ NR
Linton (1990) Ex. 26-977........... multiple industries.. F?/R?/P questionnaire........ symptoms only........ OR=3.5
(2.7-4.5)
Sakakibara (1987) Ex. 26-1199...... fruit bagging........ F?/R/P neck/shoulder flexion symptoms only........ OR=1.6
(0.4-3.2)
Welch (1995) Ex. 26-1268........... sheet metal F?/R/P questionnaire........ symptoms only........ OR=7.5
processing. (0.8-68)
Yu (1996) Ex. 26-696............... VDT operation........ R?/P questionnaire........ symptoms only........ OR=29
(2.8-291.8)
Holmstrom (1992) Ex. 26-36......... construction......... F?/R?/P questionnaire........ symptoms only........ OR=2.0 *
(1.4-2.7)
Ryan (1998) Cited in Ex. 26-1...... data processing...... R?/P shoulder flexion..... symptoms only........ NR*
Ohara (1976) Cited in Ex. 26-1..... cash register........ F?/R?/P? job title............ physical exam........ NR
Tola (1988) Ex. 26-1018............ machine operation.... F?/R?/P job title............ symptoms only........ OR=1.8 *
(1.5-2.2)
Vihma (1982) Ex. 26-789............ sewing machine....... R/P observation.......... symptoms only........ PRR=1.6 *
cycle time........... (1.1-2.3)
Viikari-Juntura (2000) Ex. 500-41- forest industry...... P/R? questionnaire........ symptoms only........ OR=1.4
50.
Botha (1998) Ex. 500-212-10........ nurses............... P/F observation.......... symptoms only........ NR *
Bjork Csten (1996) Ex. 26-604...... metal working........ R/P questionnaire........ symptoms only........ NR
Ignatius (1993) Ex. 26-1389........ typists.............. F/R?/P questionnaire........ symptoms only........ OR=3.4 *
Slov (1996) Ex. 26-674............. sales................ P questionnaire........ symptoms only........ OR=2.8 *
(1.4-5.59)
--------------------------------------------------------------------------------------------------------------------------------------------------------
F=forceful exertions; R=repetitive motion; P=awkward posture; ?=presence of risk factor unclear
OR=odds ratio; PRR=prevalence rate ratio, NR=not reported;
*=p0.05
\1\ 95% confidence interval expressed for the upper end of the risk measure range
[[Page 68446]]
The odds ratios determined from the studies ranged from 1.1 to 9.9.
Several studies deserve special mention. Ohlsson et al.(1995, Ex. 26-
868) compared 82 female industrial workers exposed to short-cycle tasks
(less than 30 seconds) to 64 referents with no exposure to repetitive
work. The OR for tension neck syndrome was 3.6 (95% CI: 1.5-8.8).
The NIOSH authors concluded that there was ``reasonable evidence''
for an association between highly repetitive work and neck/shoulder
MSDs, where repetitiveness was most often defined in terms of hand
activity. They also determined that there was ``reasonable evidence''
for an association between forceful exertion and neck/shoulder MSDs,
where forceful work was conducted by the arms. They concluded there was
``strong evidence'' for an association between static loads and neck/
shoulder MSDs, where ``static load'' referred to a static load of long
duration, high intensity, or extreme amplitude. In many of the
situations under study, workers were exposed to more than one of these
physical risk factors during the course of their jobs. The NIOSH review
found insufficient evidence of an association between vibration and
neck disorders.
In an earlier review, Hales and Bernard (1996, Ex. 26-896)
concluded that neck disorders were associated with work involving
repetitive motions, forceful repetitive work, and constrained or static
postures, based on consistency of association across several studies.
They noted inconsistent findings regarding neck disorder and work pace,
which, they suggested, may be due to the many ways work pace can be
quantified. Hales and Bernard also mentioned a consistent association
between wearing bifocals, awkward neck postures, and neck disorders.
Hagberg et al. (1995, Ex. 26-432) reviewed epidemiological studies
for evidence of work-relatedness of selected musculoskeletal disorders
of the neck: TOS (neurogenic form), cervical syndrome, and tension neck
syndrome. In compiling a list of valid papers for their review, the
researchers considered the strength of each study based on minimization
of bias (selection bias, information or misclassification bias,
confounding or effect modification bias) and study power. Studies that
met their validity criteria were then reviewed for causality (strength
of association, demonstration of temporal association, consistency of
association among studies, predictive power of exposure factors, and
plausibility.
Hagberg et al. found six cross-sectional studies of TOS (published
between 1979 and 1991) that met their inclusion criteria. From those
studies they found the strength of association between work and TOS to
be generally weak, based on low odds ratios (ORs). Since all studies
were cross-sectional in design, temporal associations could not be
confirmed. There seemed to be a consistent association between
repetitive work and TOS across the studies. One study demonstrated a
dose-response relationship between vibration and TOS. The authors also
noted an association between TOS and age. Hagberg et al. (1995, Ex. 26-
432) concluded that the studies demonstrated the existence of a
consistent association between repetitive arm movements, manual work,
and TOS.
In their review, Hagberg et al.(1995, Ex. 26-432) found twelve
cross-sectional studies and one laboratory study of tension neck
syndrome (published between 1976 and 1988) that met their inclusion
criteria. From those studies, Hagberg et al.(1995, Ex. 26-432) found
the strength of association between work and tension neck syndrome to
be moderate, based on ORs from 3 to 7. There seemed to be a consistent
association between work with VDTs and tension neck syndrome across
several studies, including a determination of an OR for tension neck
syndrome of 2.0 in keyboard operators (Hagberg and Wegman 1987, Ex. 26-
32). There also seemed to be consistent associations between tension
neck syndrome and repetitive work and static head and arm postures. The
authors also noted that tension neck syndrome was found more commonly
in women, but that finding may have been confounded by differences in
work. Hagberg et al.(1995, Ex. 26-432) concluded that the studies
demonstrated the existence of a consistent association between
repetitive work and tension neck syndrome caused by constrained head
and arm postures. They also noted that tension neck syndrome had a high
prevalence in both work and reference groups.
Three cross-sectional studies of cervical radiculopathy (published
between 1979 and 1983) met the criteria of Hagberg et al.They observed
that all studies showed a low prevalence for cervical radiculopathy.
Low numbers meant wide confidence intervals, which made results
difficult to interpret. They concluded that more directed research
needed to be conducted in this area.
In a review of the epidemiological evidence for three neck-related
MSDs, the contributors to Kourinka and Forcier (1995 Ex. 26-432) report
consistent associations between exposures to static head and arm
postures and outcomes of tension neck syndrome. They did not find
convincing evidence of a connection between repetition and cervical
radiculopathy.
A recent review of epidemiological studies by Grieco et al.(1998,
Ex. 26-627) concluded that cervical radiculopathy had not been shown to
be associated with data entry work, dockers' work, or food production
assembly line work. In contrast, tension neck syndrome was linked to
static postures and static loads in several studies on populations of
VDT workers, typists, and sewing machine operators. Study selection
criteria were not discussed in that review.
Several individual studies of workers performing heavy work
(including meat carriers and miners) found increased ORs (most adjusted
for age) for cervical spondylosis, as did one study of dentists.
Viikari-Juntura (1997, Ex. 26-905) reviewed both epidemiological and
experimental studies focused on the neck (among other regions). The
author mentioned studies that showed associations between degenerative
changes or neck pain and heavy work, repeated impact loading, or static
work, whereas the OR for cervical spondylosis in cotton workers was
0.66 (protective). The relationships between work factors and cervical
spine arthritis have not been clarified due to (1) few studies of this
subject, (2) a lack of universal acceptance for the criteria (e.g.,
symptoms, signs, imaging) used to make this diagnosis, and (3) cervical
spine degenerative changes are common.
Four additional epidemiological studies that address physical work
factors and neck and neck/shoulder disorders were submitted into the
OSHA docket following publication of the proposal and have been added
to Table V-1 (Nordander et. al. 1999, Ex. 38-408; Viikari-Juntura 2000,
Ex. 500-41-50; Botha and Bridger 1998, Ex. 500-121-10; Rosecrance et al
1994, Ex. 38-203). OSHA found a few additional studies identified in
the NIOSH epidemiological review for other MSDs that also addressed
neck and neck/shoulder and are also included in Table V-1 (Dimberg
1989, Ex. 26-1211; Ignatious 1993, Ex. 26-1389; Skov 1996, Ex. 26-674).
Two other submitted studies contained some serious methodological flaws
and were not included in the table (Leclerc et al., 1999, 500-118-2;
Erikson et al., 1999, 500-118-2).
Nordander et al.1999 (Ex. 38-408) reported on a cross sectional
study of 13 fish processing plants, examining multiple body sites,
including the neck and shoulder. Ninety one male and 165
[[Page 68447]]
female fish industry workers were compared to men and women with more
varied work. The work was partly paid by the work done--piece work.
Health outcome was based on questionnaire and physical examination.
Exposure was assessed by questionnaire, videotaping of jobs, and the
observational method using AET (Arbeitwissenschaftliche
Erbehungverfahren zur Tatigkeitsanalyse) along with the NIOSH lifting
equation. Each work task classified according to three factors: weight
of the materials handled (1, 15, 510, 10-25, >25 kg.), cycle time (5,
5-10, 10-60, >60); and degree of constrained neck postures (low, high,
very high). Neck and shoulder diagnoses among the fish processors was
found to be significantly elevated compared to the referents (OR=3.5;
95% CI 2.3-5.3). There was significantly increased prevalence of
shoulder tendinitis found among women fish processors (OR from 3.4 to
4.65) compared to referents. No significant effects were found due to
age, leisure time and smoking assessed by logistic regression. Job
analysis found that several tasks were repetitive, performed in
constrained work postures, with fast and continuous wrist and hand
movements, mostly with flexed neck, arms raised and lowered
intermittently. Because it involved a direct assessment of exposure and
verification of neck injury by a health professional, OSHA views the
study to be among the more reliable investigations.
Viikari-Juntura et al.2000 (Ex. 502-11) recently published findings
on a longitudinal study of neck pain among a cohort of 5180 workers in
a large forest industry enterprise. Participation rate was only 43% of
the originally selected cohort of 7000. Nonrespondents were also
followed up--there was no difference with regard to potential
predictors except reporting 1.5 times difficulties in coming 5 years
due to musculoskeletal health. Four repeated questionnaires were used
focusing on ``radiating neck pain,'' categorized as healthy (0-7 days),
mild pain (8-30 days), and severe pain (>30 days). Validated exposure
assessment questionnaires and psychosocial questionnaires were used.
There were several variables related to physical strenuousness, awkward
postures, repetitive movements, and stress. Results found a
statistically significant dose-response relationship for neck pain and
increasing number of hours working with the hands above the shoulder.
The risk of neck pain also increased with increasing amounts of
twisting movements, but for the combination of twisting of the trunk
and stress, neck pain decreased with increasing amounts of stress.
Rosecrance (1994, Ex 38-457) conducted a cross-sectional study of
906 office and production workers from three medium sized newspaper
facilities to determine the level of symptomatic workers and to compare
the office and production workers. A participation rate of 72% was
reported. A physical exam was given to 105 participants. Exposure was
assessed by a self-reported job factor survey. The results found that
workers who reported repetitive tasks had an odds ratio of 29 (CI not
reported, p=0.01) of missing work due to neck symptoms compared to
workers who did not report repetitive tasks. Production workers
reported more job risk factors compared to office workers. Neck
symptoms were the most common symptom among production workers.
Faucett and Rempel, 1994 (Ex 38-67) carried out a cross-sectional
study of 150 video display terminal (VDT) operators from large
metropolitan newspaper. Participation rate was low at 56%, however,
non-respondents had no difference in age, duration of employment,
gender, job title, or VDT training. A questionnaire-derived health
outcome using a body diagram was employed. Observational exposure
assessment was performed on 70 VDT workstations, completed by trained
independent observers working in pairs evaluating work posture, wrist,
knee and leg contact with workstation, display and seat height, angle
measures of wrist, elbow, shoulder, head, trunk at the hip and thigh.
Results found that 28% met symptom criteria for MSDs of the upper torso
and extremities. Risk of having a MSD increased with a greater number
of daily hours of VDT use. After controlling for the ergonomic factors,
less decision latitude on the job and less coworker support were found
to be significantly associated with certain symptoms (numbness). The
limitations of this study are the low participation rate, although the
non-responders were followed up and the non-specific nature of the
health outcome.
Leclerc et al., 1999 ( Ex. 500-118-2) conducted a longitudinal
study to evaluate the effects of prevention programs at the workplace
aimed at reducing back, neck, and shoulder morbidity among active
workers. The intervention group (294 workers) and the referent group
(294 workers) were collapsed and analyzed as a whole. Health outcome
was based on two questionnaires. Questions ``focused more on the
potential risk factors for low back pain, such as bending forward and
backward, twisting, and handling of materials.'' The authors note that
``the role of specific occupational risk factors of neck disorders,
such as awkward postures of the head and neck and static postures, was
not studied because these variables were not included in the
questionnaire.'' Analyses were performed with ``occupation'' as a crude
indicator of occupational exposure. Female gender, older age, headaches
or pain in the head, psychological distress, and psychosomatic problems
were predictors of neck pain. This study found that there was no
significant difference in occurrence of neck pain among the different
occupations--hospital workers, warehouse workers, and office workers.
This is not surprising, as many studies have found increased rates of
neck symptoms in these occupational groups. What is lacking in this
study, as admitted by the authors, is adequate assessment of risk
factors known to be associated with neck MSDs. The poor exposure
assessment concerning occupational factors does not detract from the
relationship of exposure to certain work factors and neck disorders.
Because of its failure to address specific work factors related to neck
disorders, OSHA does not regard this study as adequate and it was not
included in Table V-1.
Eriksen et al., 1999 (Ex. 500-118-2) carried out a community-based
4-year prospective study of 1429 working Norwegians who completed a
questionnaire in 1990, and returned a second questionnaire 4 years
later. The participation rate was 67% of original group in 1990; 79.8%
of working group from 1990 responded to 2nd questionnaire in 1994. The
health outcome was based on the Nordic questionnaire, ``presence of any
neck pain during the previous 12 months.'' Workplace exposure also
relied on questionnaire data. Questions concerned work with hands over
shoulder-level, static work positions, repetitive stereotypic
movements, heavy lifting, sitting, standing, and high work pace. The
authors note that the responders in 1994 were ``less inclined to have
jobs that required them to spend a large amount of time with hands
above shoulder level, jobs that required a large amount of standing,
and jobs that required a large amount of heavy lifting.'' This
admission, without providing further data, makes interpretation of
results difficult. It is impossible to tell whether the study sample
reflects the overall original sample population. By loss of those
exposed to heavy lifting or working with hands above shoulder one
cannot assess
[[Page 68448]]
whether this would have minor or major impact on the findings. Changes
in job situations after 1990 were also not recorded, which would weaken
association between job factors and neck pain. In responders without
neck pain during the previous 12 months in 1990, the ``little influence
on own work situation'' factor predicted neck pain during the previous
12 months (odds ratio = 2.21; 95% confidence interval, 1.18 to 4.14)
and previous 7 days in 1994 (OR = 2.85; 95% confidence interval, 1.21
to 6.73) after adjustment for a series of potential confounders.
Because of the serious questions with regard to changes in population
exposure over time, OSHA believes the results are not interpretable and
it was not included in Table V-1.
Biomechanical Evidence
In a series of biomechanical and EMG studies, Harms-Ringdahl (1986,
Ex. 26-1128) demonstrated that considerable stress is generated in the
ligaments and joint capsule of the cervical spine with extreme neck
flexion (more than 45 degrees). The extensor muscle activity is less
than in the neutral position while the load moment (or torque) is 3-4
times greater in extreme flexion.
Many hand-intensive jobs and tasks require static neck contraction
to permit accuracy in task performance. Thus, significant muscle stress
and fatigue may occur with maintenance of static neck postures required
in many office and assembly workplace settings (Hales and Bernard 1996,
Ex. 26-896; Bernard and Fine 1997, Ex. 26-1; Onishi, Sakai, and Kogi
1982, Ex. 26-991; Stock 1991, Ex. 26-1010; Westgaard and Bjorklund
1987, Ex. 26-239). In confirmation of this postulate, several EMG
studies have documented the increase in neck and upper back muscle
activity from static work (Erdelyi et al.1988, Ex. 26-619; Onishi,
Sakai, and Kogi 1982, Ex. 26-991; Schuldt et al.1987, Ex. 26-670).
Hidalgo et al., 1992 (Ex. 26-631) reviewed the biomechanical literature
of the neck and proposed that prolonged static contraction of neck
muscles be limited to force levels at or below 1% of maximum voluntary
contraction (MVC).
It has also been shown that workplace interventions to mitigate
static loading of neck muscles reduce pain, time out of work due to
musculoskeletal problems, and EMG measured loading. Aaraas (1994a, Ex.
26-892; 1994b, Ex. 26-62) evaluated users of video display terminals
(VDTs) and assembly workers before and after ergonomic interventions
consisting of changes in the workstations, tools, and work organization
alterations. In assembly workers, mean static trapezius load decreased
from 4.3% to 1.4% of MVC, and in VDT users, MVC declined from 2.7% to
1.6%. This was accomplished with more accessible tool placement and
support for elevated arms. The median duration for sick leave resulting
from MSDs dropped from 23 to 2 days per person/year. As a result of
interventions, including the reduction in trapezius loading, the VDT
operators also reported less intensity and duration of pain in the neck
and shoulder region. The study design did not permit the determination
of which intervention(s) were responsible for the decline in MVC and
sick leave, but it does support the role of workplace ergonomics.
While epidemiologic studies regarding vibration and non-discogenic
neck and shoulder pain have been inconclusive, there is some
biomechanical evidence that vibration may affect muscle activity, and
therefore could be pathogenic for neck disorders. This is a complex
area, particularly since the most common shoulder diagnoses--
impingement and rotator cuff tendinitis--are clinically useful but
without very specific pathophysiologic meaning. In the following review
(Appendix I, Ex. 27-1), the neck, but not the shoulder, is shown to be
associated with a vibration-related pathology. The separation of
biomechanical, physiologically adaptive, and vibration-specific factors
is especially difficult for the neck and shoulder. Scapular stability
and posture are the heart of large-muscle activation sequences
involving efficient distal muscle group movement (Mackinnon and Novak
1997, Ex. 26-1309). Moreover, static shoulder posture, important for
tool stabilization, is an important contributor to early arm fatigue
(Sjogaard et al.1996, Ex. 26-213). Finally, the quality of a vibratory
stimulus (continuous or discrete) has significant impacts on efferent
recruitment and firing (Maeda et al.1996, Ex. 26-562). The combined
effects of this complexity are not easily modeled. This is all the more
reason why neck/shoulder symptoms should be carefully scrutinized when
a power tool is part of the exposure background. It may prove difficult
in practice to distinguish neck/shoulder symptoms that have their
origins in strictly biomechanical processes from vibration-induced
injuries. However, there is sufficient evidence in support of an
etiology to merit intervention.
As discussed earlier, skeletal muscle activity involves oxygen and
energy consumption and metabolic end-product generation. Repeated
damage from overuse without adequate recovery time for repair therefore
has the potential to cause permanent structural damage to skeletal
muscle (Armstrong et al.1993, Ex. 26-1110). Thus, work pacing can
reasonably be expected to affect muscle function in the neck. Froberg
et al.(1979, Ex. 26-117) compared female production workers performing
piece work vs. salaried work. Piece work was associated with increased
pain in the shoulders, arms, and back, accompanied by elevated
excretion of adrenalin and noradrenalin.
Unfortunately, financial incentives in piece workers may encourage
workers to avoid pacing themselves in an effort to exceed production
levels. Brisson et al.(1989, Ex. 26-937) postulated that the
biomechanical stressors involved with piece work performed by female
garment workers in Quebec, and the time pressures imposed by their
piece work, combined to account for observed disability from MSDs. The
association was related to the number of years performing piece work,
and was independent of age, smoking, education, and total length of
employment. In addition, some researchers suggest that workers may
ignore early warning symptoms of work-related MSDs.
Conclusion
The 1997 NIOSH report concluded the following with regard to
physical work factors and MSDs of the neck/shoulder region:
There is strong evidence that working groups with high levels of
static contraction, prolonged static loads, or extreme postures
involving the neck/shoulder muscles are at increased risk for neck/
shoulder MSDs. Consistently high ORs were found (twelve
statistically significant studies with ORs over 3.0) providing
evidence linking tension neck syndrome with static postures and
static loads (Ex 26-1).
OSHA agrees with NIOSH with regard to the epidemiological evidence for
an association between neck and neck/shoulder MSDs and physical risk
factors related to forceful exertion, repetitive motion and awkward
posture. Twelve out of thirteen well-conducted epidemiological
investigations that directly observed or measured these factors in the
workplace have found a significantly elevated risk of neck/shoulder
MSDs in exposed workers verified by physical exam. This link between
physical work factors and injury has been established across numerous
job areas including VDT operation (Hunting 1981, Ex. 26-1276;
electronics manufacture (Kilbom 1986, Ex. 500-41-75; Jonsson 1988, Ex.
26-969) and fish processing (Nordander 1999, Ex 38-408). Several
reviews have concluded that specific neck disorders, such as tension
neck syndrome, are
[[Page 68449]]
consistently associated with repetitive work and prolonged static loads
and postures of the neck (Hagberg et al.1995, Ex. 26-432; Kourinka and
Forcier 1995, Ex 26-432; Grieco et al.1998, Ex. 26-627).
The epidemiological evidence is supported by what is known about
the biomechanics and pathogenesis of these neck disorders. It has been
consistently shown by EMG that extreme postures and static loads on the
neck/shoulder increase the internal force on the neck muscles Harms-
Ringdahl et al.1986, Ex. 26-136; Higado et al.1992, Ex. 26-631).
Prolonged and frequent stress on these structures leads to muscle
fatigue and reduced blood flow. The combination of high oxygen demand
and low supply creates ischemia of the surrounding tissue and neck
pain. Repeated episodes of stress does not allow adequate recovery time
for repair raising the potential for long-term damage to the neck
muscles (Armstrong 1993, Ex. 26-1110). OSHA concludes that a
combination physical work-related factors, such as repeated movements
of the upper arm and shoulder, static loads on the neck/shoulder, and
extreme postures of the neck, are able to cause substantial and serious
impairment to the neck and shoulder.
Muscoskeletal Disorders of the Shoulder
Much of the evidence that relates physical work factors to shoulder
disorders focuses on shoulder tendinitis. To understand how force,
repetitive motion, and awkward postures lead to tendon injury one must
understand tendon function and repair mechanisms. As muscles contract,
tendons are subjected to mechanical loading and viscoelastic
deformation. Tendons must have both tensile resistance to loading (to
move attached bones) and elastic properties (to enable them to move
around turns, as in the hand). When collagen bundles are placed under
tension, they first elongate without significant increase in stress.
With increased tension, they become stiffer in response to this further
loading. If the load on these structures exceeds the elastic limit of
the tissue (its ability to recoil to its original configuration),
permanent changes occur (Ashton-Miller 1999, Ex. 26-414; Moore 1992a,
Ex. 26-985; Chaffin and Andersson 1991, Ex. 26-420). During subsequent
loading of the damaged tendon, less stiffness is observed. The ultimate
strength of normal tendon and ligament is about 50% of that of cortical
bone (Frankel and Nordin 1980, Ex. 26-1125), but structures that have
exceeded the elastic limit fail at lower limits. In addition, if
recovery time between contractions is too short, deformation can result
in pathologic changes that decrease the tendon's ultimate strength
(Thorson and Szabo 1992, Ex. 26-1171; Goldstein et al.1987, Ex. 26-
953). Tendon exhibits additional viscoelastic properties of relaxation
and creep. That is, when a tendon is subjected to prolonged elongation
and loading, the magnitude of the tensile force will gradually decrease
(relaxation) and the length of the tendon will gradually increase
(creep) to a level of equilibrium (Chaffin and Andersson 1991, Ex. 26-
420; Moore 1992a, Ex. 26-985; Woo et al.1994, Ex. 26-596). During
repetitive loading, the tendon exhibits these properties and then
recovers if there is sufficient recovery time. If the time interval
between loadings does not permit restoration, then recovery can be
incomplete, even if the elastic limit is not exceeded (Goldstein et
al.1987, Ex. 26-953).
Shoulder tendinitis includes supraspinatus and bicipital
tendinitis. Bicipital tendinitis results when the tendon of the biceps
brachii muscle rubs on the lesser tuberosity of the humerus bone, which
occurs with motion of the shoulder (glenohumeral) joint during overhead
arm movements. Persons affected with this disorder experience pain and
tenderness in the shoulder area during shoulder flexion, elbow
extension and forearm supination, or when the elbow and arm are
extended and the forearm is supinated. Supraspinatus tendinitis is also
known as rotator cuff disorder, subdeltoid tendinitis, subacromial
tendinitis, or partial tear of the rotator cuff. Affected individuals
commonly have pain in the front of the shoulder which is accentuated
when they attempt to raise the arm away from the body (abduct the arm),
although other movements may also be painful.
There are multiple plausible theories for the pathogenesis of
disorders of the rotator cuff. For purposes of this review, it is
assumed that supraspinatus tendon tears and calcification represent
endpoints of one pathological process as opposed to separate and unique
endpoints. Mechanisms related to disorders of the rotator cuff complex
with acute onset are excluded from this discussion (e.g., strains,
falls, dislocations).
The presence of a watershed or avascular zone in the supraspinatus
tendon has been described and demonstrated by several investigators
(Moseley and Goldie 1963, Ex. 26-306; Rothman and Parke 1965, Ex. 26-
499; Rathbun and Macnab 1970, Ex. 26-1376). It is believed that the
avascular zone compromises the ability of the tenocytes within this
portion of the tendon to repair damage to collagen fibers or their
matrix. This impaired ability to repair the tendon implies that
degenerative changes within this portion of the tendon will accumulate
over time; therefore, the degree and progression of tendon degeneration
will increase with increasing exposure to potential sources of injury,
age, or both. Potential sources of injury to the tendon's collagen
fibers or matrix may be ischemic, mechanical (impingement), or
physiological (contractile load).
According to the ischemia theory, the function and viability of the
tenocytes within the supraspinatus tendon are compromised because they
are in an avascular zone; therefore, they are unable to sustain the
normal structure of the tendon over one's lifetime. This lack of
maintenance manifests itself as degenerative changes within the
substance of the tendon. The positive correlation between the
prevalence of supraspinatus tendon degeneration and tears with age is
consistent with this theory. It is not clear that task variables
related to work are necessary in this pathogenetic model; however,
Rothman and Macnab (1970, Ex. 26-499) postulated that shoulder
adduction with neutral rotation would subject this avascular portion of
the tendon to pressure from the humeral head, thus ``wringing out'' the
blood from this already avascular area. If this were true, the duration
of shoulder adduction is probably more important than the number of
shoulder adductions.
Neer (1972, Ex. 26-185) proposed that the subacromial bursa and
supraspinatus tendon were mechanically impinged on the underside of the
anterior aspect of the acromion process or coracoacromial ligament as
the shoulder approached 80 degrees abduction or flexion when internally
or externally rotated. Below 80 degrees flexion or abduction, the
greater tuberosity of the humerus is generally not in immediate contact
with the acromion process or the coracoacromial ligament. Beyond this
degree of elevation, the humeral head is displaced down and away from
the acromion and the ligament, thus relieving these structures of this
contact stress. This contact stress is postulated to cause disruption
of collagen fibers within the tendon mechanically. This mechanism of
collagen disruption may (or may not) be combined with the phenomenon of
impaired healing related to the avascular zone. The critical
relationship between this proposed model of supraspinatus tendon
disease and biomechanical task variables is the passage of the shoulder
[[Page 68450]]
through the 80 degrees abduction or flexion arc. Since this
biomechanical stress occurs in a limited portion of these arcs, it is
anticipated that the number of times the shoulder performs this task
(per unit time) is more relevant than the duration of time the shoulder
is in this position. Anatomical variations in the size and shape of the
acromion (particularly type II [curved] and type III [hooked]) as well
as hypertrophy of tissues related to the coracoacromial arch are also
important factors. (Bigliani et al.1991, Ex. 26-603; Fu, Harner, and
Klein 1991, Ex. 26-464).
Posture plays an important role in rotator cuff tendinitis of the
shoulder. Work with the arm elevated more than 60 degrees from the
trunk is more stressful for the supraspinatus than work performed with
the arm at the trunk. As the arm is raised or abducted the
supraspinatus tendon becomes in contact with the undersurface of the
acromion. They are in closest proximity between 60 and 120 degrees of
arm elevation (Amadio 1995, as cited in Fine and Silverstein 1998,
Ex.38-444). The precise pathosphysiology of rotator cuff tendinitis is
not known. However, the role of overhead work, particularly of a static
nature or very forceful exertions, is likely a crucial event (Andersson
1995 and Levitz and Iannotti 1995, as cited in Fine and Silverstein,
1998, Ex. 38-444). Impingement seems important. One suggested
histologic pattern is a reversible inflammatory infiltrate, with
increased vascularity and edema within the rotator cuff tendons,
especially the supraspinatus tendon. This process, if it becomes
chronic, has been postulated as leading to degenerative changes in the
tendons. Eventually, enough degeneration occurs that a minor trauma
causes or seems to cause a partial rotator cuff tear (Fine and
Silverstein 1998, Ex. 38-444).
Another shoulder disorder related to physical work factors is
osteoarthritis of the acromioclavicular joint. Osteoarthritis refers to
degenerative changes in the cervical spine that are apparent on
radiological examination. A combination of high exposure to load
lifting and high exposure to sports activities that engage the arm was
a risk factor for shoulder tendinitis, as well as osteoarthritis of the
acromioclavicular joint (Stenlund et al.1993, Ex. 26-1459). Kennedy,
Hawkins, and Kristof (1978, Ex. 26-1135) found that 15% of competitive
swimmers with repetitive overhead arm movements had significant
shoulder disability, primarily due to impingement from executing
butterfly and freestyle strokes.
Physical work requires both mechanical and physiological responses,
for example, muscle force and energy consumption. The mechanical
responses include connective tissue deformation and yielding within the
muscle; which increases intramuscular pressure. Increased intramuscular
pressure in turn decreases blood flow through the muscle (Armstrong et
al.1993, Ex. 26-1110).
Nerves, vessels, and other soft tissues may be internally
compressed under conditions of high-force exertions, awkward postures,
static postures, and/or high velocity or acceleration of movement. For
example, strong abduction or extension of the upper arm, as well as
awkward postures of the neck, can compress parts of the brachioplexus
under the scalene muscles and other anatomical structures. This
compression can result in nerve and/or blood vessel damage or eventual
damage to the tissues served by these nerves and vessels.
Static postures, postures held over a period of time to resist the
force of gravity or to stabilize a work piece--are particularly
stressful to the musculoskeletal system. More precisely, static
postures are usually defined as requiring isometric muscle force--
exertion without accompanying movement. Even with some movement, if the
joint does not return to a neutral position and continual muscle force
is required, the effect can be the same as a non-moving posture. Since
blood vessels generally pass through the muscles they supply, static
contraction of the muscle can reduce blood flow by as much as 90%. The
consequent reduction in oxygen and nutrient supply and waste product
clearance results in more rapid onset of fatigue and may predispose
muscles and other tissues to injury. The increased intramuscular
pressure exerted on neural tissue may result in chronic decrement in
nerve function. The viscoelastic ligament and tendon tissues can
exhibit ``creep'' over time, possibly reaching failure thresholds
beyond which they are unable to regain resting length.
Chronic reduction of blood flow may be a mechanism by which static
muscle contractions lead to MSDs. Several studies have found that the
small, slow motor units in patients with chronic muscle pain show
changes consistent with reduced local oxygen concentrations (Larsson et
al.1988, Ex. 26-1140; Dennett and Fry 1988, Ex. 26-104). Reduced blood
flow and disruption of the transportation of nutrients and oxygen can
produce intramuscular edema (Sjogaard 1988, Ex. 26-206). The effect can
be compounded in situations where recovery time between static
contractions is insufficient. Eventually, a number of changes can
result: muscle membrane damage, abnormal calcium homeostasis, an
increase in free radicals, a rise in other inflammatory mediators, and
degenerative changes (Sjogaard and Sjogaard 1998, Ex. 26-1322).
Epidemiological Evidence
In its review of the epidemiologic literature on work-related
musculoskeletal disorders of the shoulder, NIOSH identified 38
epidemiologic studies that examined workplace factors and their
relationship to shoulder MSDs (Bernard 1997, Ex. 26-1). These studies
examined the prevalence of shoulder disorders in workers exposed to
repeated abduction extension or flexion of the shoulder in combination
with strenuous work involving heavy loads or elevated arms. The MSDs
were usually shoulder tendinitis or a collection of symptoms defined by
stiffness, pain, and weakness. Table V-2 summarizes some key aspects of
these investigations, such as the occupations examined, the
biomechanical risk factors the workers were exposed to, whether
exposures were directly observed or measured during the study, and
whether the health outcomes were verified by trained medical personnel
during physical examination. Sixteen of the studies relied on direct
observation or measurements of exposure and verification of shoulder
injury by physical exam. EMG of the forearm flexor muscles, frequency
of shoulder movements, or angle of shoulder flexion were quantitatively
measured in some of these studies. Another 24 studies relied either on
job title information or questionnaire to obtain exposure information
and/or used self-reported symptoms to define cases of shoulder MSDs.
OSHA considers these investigations to be less reliable. All twelve
studies with exposure and medical verification reported statistically
significant associations between shoulder disorders and the physical
work factors. The odds ratios reported in these studies ranged between
1.6 and 46. The wide range in risks probably relates to differences in
magnitude of exposure and case definition among the studies.
[[Page 68451]]
Table V-2.--Summary of Epidemiology Studies Examining Musculoskeletal Disorders of the Shoulder
----------------------------------------------------------------------------------------------------------------
Job type Physical Physical Risk measure (95%
Study studied factors Exposure basis exam CI) 1
----------------------------------------------------------------------------------------------------------------
Hughes (1997) Ex. 26-907.... Aluminum F/R?/P Checklist...... Yes......... OR=46 *
smelter. (3-550)
Herberts (1981) Ex. 26-51; Shipyard F/R?/P Observation EMG Yes......... PRR=15-18 *
(1984) Ex. 26-960. welding. (14-22)
Bjelle (1979) Ex. 26-1112... Industry case F?/R/P Observation.... Yes......... OR=10.6 *
control. (2.3-54.9)
Frost (1999) Ex. 500-205-4.. Slaughter-house F/R/P Observation.... Yes......... OR=5.3-7.9 *
(2.9-21.2)
Onishi (1976) Ex. 26-1222... Multiple jobs.. F/R/P Observation Yes......... OR=1.1-6.0 *
cycle time. (3.0-12.2)
Ohlsson (1995) Ex. 26-868... Assembly line.. F?/R/P Flexion cycle Yes......... OR=4.2 *
time. (1.4-13.2)
Baron (1991) Ex. 26-967..... Grocery F/R/P Job titles..... Yes......... OR=3.9 *
checking. (1.4-11.0)
Ohlsson (1994) Ex. 26-1189.. Fish processing F/R/P Observation Yes......... OR=3.5 *
freq./angles. (1.6-7.2)
Nordander (1999) Ex. 38-408. Fish processing F?/R/P Observation.... Yes......... OR=3.5 *
(2.5-5.3)
Punnet (2000) Ex. 500-41-109 Auto workers F/R/P Cycle/ Yes......... OR=1.1-4.0 *
case/control. flexionlift (1.7-9.4)
load.
Chiang (1993) Ex. 26-1117... Fish processing F/R/P? Cycle time EMG. Yes......... OR=1.6-1.8 *
(1.2-2.5)
Kilbom (1987) Ex. 26-1277; Electronics F/R/P MVC, flexion Yes......... NR *
Jonsson (1988) Ex. 26-833. manufacture. cycle time.
Bjelle (1981) Ex. 26-1519... Industrial F/R/P Flexion EMG.... Yes......... NR *
plant.
Sakakibara (1995) Ex. 26-800 Fruit bagging.. F?/R?/P Observation arm Yes......... NR *
elevation.
Zetterberg (1997) Ex. 26-899 Auto assembly.. F/P Cycle time tool Yes......... NR
weight.
English (1995) Ex. 26-848... Patients case/ F/R/P Question- naire Yes......... OR=2.3 *
control. (NR)
Andersen (1993) Ex. 26-1451. Sewing machine. F/R/P? Job titles..... No.......... OR=3.2 *
(1.7-7.4)
Andersen (1993) Ex. 26-1502. Sewing machine. F/R/P? Job titles..... Yes......... NR *
Stenlund (1992) Ex. 26-733; Rockblasting V/F/R? Questionaire... Yes......... OR=0.4-4.0 *
(1993) Ex. 26-1459. bricklaying. (1.8-9.2)
Wells (1983) Ex. 26-729..... Letter carrier. F/R?/P Job title...... No.......... OR=5.7 *
(2.1-17.8)
Hoekstra (1994) Ex. 26-725.. Video terminal. R/P Observation.... No.......... OR=5.1*
(1.7-15.5)
Schibye (1995) Ex. 26-1463.. Sewing machine. F?/R/P? Questionaire... No.......... NR
Burdorf (1991) Ex. 26-454... Riveting....... V Tool No.......... OR=1.5 *
aceleration. (NR)
Bergenudd (1988) Ex. 26-1342 Multiple F/R?/P? Questionnaire.. No.......... NR
industries.
Burt (1990) Ex. 26-698...... Computer entry. R/P Job title...... No.......... OR=2.6-4.1 *
(1.8-9.4)
Floodmark (1992) Ex. 26-1209 Vent shaft F?/R?/P? Job title...... No.......... OR=2.2 *
production. (1.4-4.4)
Hales (1989) Ex. DC-139-D... Poultry F/R Job title...... Yes......... OR=0.9-3.8 *
processing. (0.6-22.8)
Hales (1994) Ex. 26-131..... Telecommunicati R/P Questionnaire.. Yes......... NR
on.
Ignatius (1993) Ex. 26-1389. Postal work.... F/R/P Job title...... No.......... OR=1.8-2.2 *
(1.5-3.1)
Kiken (1990) Ex. 26-430..... Poultry F/R/P? Job title...... Yes......... OR=1.6-4.0
processing. (0.6-29)
Kvarnstrom (1983) Ex. 26- Factory/office. F/R/P? Questionnaire.. Yes......... RR=2.2-5.4
1201. (NR)
McCormick (1990) Ex. 26-1334 Textile........ F/R/P? Job title...... Yes......... OR=1.1-1.3
(0.5-3.8)
Ohara (1976) Ex. 26-1....... Cash register.. F?/R?/P? Job title...... Yes......... OR=1.7-2.2 *
(1.4-3.5)
Ohlsson (1989) Ex. 26-1290.. Auto assembly.. F/R/P? Job title...... No.......... OR=2.0-3.4 *
(1.6-7.1)
Punnett (1985) Ex. 26-995... Garment........ R/P? Job title...... Yes......... OR=2.2 *
(1.0-4.9)
Rossignol (1987) Ex. 26-804. Computer R/P Questionnaire.. No.......... OR=2.5-4.8 *
operation. (1.6-17.2)
Sweeney (1994) Cited Ex. 26- Sign language R/P? Questionnaire.. Yes......... OR=2.5
1. interpreter. (0.8-8.2)
De Zwart (1997) Ex. 26-617.. Various F/R?/P? Questionnaire.. No.......... OR=1.25-2.5 *
occupations. (p0.001)
[[Page 68452]]
LeMasters (1998) Ex. 500-121- Carpenters..... F/R/P Observation, Only small OR=2.3-3.2 * (1.1-
44; Bhattacharya (1997) Ex. measurement. subset. 8.9)
500-121-7; Booth-Jones
(1998) Ex. 500-121-9.
Pope (1997) Ex. 32-137-1-4.. Various F/R?/P Questionnaire.. No.......... OR=2.1-5.5 *
occupations. (1.8-17.4)
Botha (1998) Ex. 500-121-10. Nurses......... F/R?/P Questionnaire, No.......... NR
observation.
De Joode (1997) Ex. 500-121- Ship F/R?/P Strain gauge... No.......... RI=1.7-3.9
72. maintenance. (NR)
----------------------------------------------------------------------------------------------------------------
F=forceful exertions; R=repetitive motion; P=awkward posture; IR=incidence rate; OR=odds ratio; PRR=prevalence
rate ratio; RI=risk index; NR=not reported; ?=presence of risk factor unclear.
* p0.05.
1 95% confidence interval expressed for the upper end of the risk measure range.
The NIOSH noted several well-conducted studies that provided
evidence of an exposure--response and temporal relationships. Chiang et
al.(1993, Ex. 26-1117) divided 207 fish processing workers into three
exposure groups based on EMG measurements of forearm flexor muscles and
cycle time measurements of shoulder movements of representative job
tasks. Exposure groups were: (1) Low force, low repetition (comparison
group); (2) high force or high repetition; and (3) high force and high
repetition. Shoulder girdle pain was the health outcome as defined by
symptoms and palpable hardenings upon physical examination. The results
showed a significant increasing trend in the prevalence of shoulder
pain from group 1 (10 percent) to group 3 (50 percent).
In another cross-sectional study, Ohlsson et al.(1995, Ex. 26-868)
compared a group of 82 women who performed industrial assembly work
requiring repetitive arm movements with static muscular work of the
neck/shoulder with a referent group of unexposed women. The frequency,
duration, and critical angles of movement were measured from videotape
and observation. Shoulder MSDs such as tendinitis, acromicroclavicular
syndrome, and frozen shoulder were determined from symptoms and
physical exam. The risk of shoulder tendinitis in the exposed women was
significantly greater than the unexposed women (OR=4.2; 95% CI 1.4-
13.2). The neck and shoulder disorders were also significantly (p0.05)
associated with the number and duration of shoulder elevations greater
than 60 degrees. The study of Bjelle et al.(1981, Ex. 26-1519) also
found that the frequency of shoulder abduction and forward flexion past
60 degrees was significantly greater (p0.05) for cases with neck/
shoulder disorders than for controls.
In a prospective study design, Kilbom et al.(1986, Ex. 500-41-75;
1987, Ex. 26-1277) assessed the health and exposure status of 06
electronics manufacturing plant employees over a two year period. The
employees were evaluated for maximum voluntary isometric contraction
(MVC) of the forearm flexors and shoulder strength. Videotape was used
to analyze cycle time and working postures and movements. Shoulder MSDs
were determined annually based on interview and physical examination
assessing tenderness on palpation as well as pain and restriction upon
shoulder movement. Symptom severity was also scored. Logistic
regression analysis showed significant relationship (p0.05) between
MSDs and percentage of work cycle time with upper arm elevated. The
number of elevations per hour was a strong predictor for increases in
symptom severity over the study period. A follow-up investigation also
found that the percent of the work cycle spent with the shoulder
elevated was negatively associated with remaining symptom-free (Jonsson
et al.1988, Ex. 26-833).
NIOSH concluded that there was evidence for a positive association
between highly repetitive work and shoulder MSDs. Only three studies
specifically address the health outcome of shoulder tendinitis and
these studies involve combined exposure to repetition with awkward
shoulder postures or static shoulder loads. The other six studies with
significant positive associations dealt primarily with symptoms. There
was evidence for a relationship between repeated or sustained shoulder
posture with greater than 60 degrees of flexion and abduction and
shoulders MSDs. This holds for both shoulder tendinitis and nonspecific
shoulder pain. NIOSH found insufficient evidence for a positive
association between either force or vibration and shoulder MSDs because
the studies that principally examined this risk factor relied on self-
reported questionnaires for assessment of exposure and health outcome.
Twelve studies that address physical work factors and shoulder MSDs
were submitted into the OSHA docket following publication of the
proposal (Zetterberg et al.Ex. 26-899; De Zwart et al.1997, Ex. 500-
121-18; Punnett et al.2000, Ex. 500-41-109; LeMasters et al.Ex. 500-
121-9; Bhattacharya et al.1997, Ex. 500-121-7; Booth-Jones et al.1998;
Ex. 500-121-44; Pope et al.1997, Ex. 500-71-42; Frost and Anderson
1999, Ex. 500-41-57; Burdorf et al.1997, Ex. 500-71-24; Van Wendel de
Joode 1997, Ex. 500-121-72; Botha and Bridger 1998, Ex. 500-121-10).
Many of these studies showed that high physical loads in combination
with elevated shoulder positions were associated with increased
prevalence of shoulder disorders (Ex. 500-121-9; Ex. 500-121-7; Ex.
500-121-44; Ex. 500-41-57; Ex. 500-41-109; Ex. 500-121-18; Ex. 500-121-
10; Ex. 500-121-72; Ex. 26-899). For example, Frost and Anderson (Ex.
500-41-57) found a strong significant association (OR>5) among meat
packers who worked extensively with arm elevation greater than 30
degrees more than 10 times per minute and prevalence of rotor cuff
tendinitis compared to those with no shoulder elevation. The risk
increased with cumulative exposure years. Punnett et al.(Ex. 500-41-
109) reported a significant association between repeated shoulder
abduction/flexion and shoulder disorders. There was evidence of
exposure--response with frequency of shoulder movements to 90 degrees
flexion or abduction. Shoulder
[[Page 68453]]
MSDs were confirmed by physical examination in both studies.
Biomechanical Evidence
Rohmert (1973, Ex. 26-580) found that muscle contractions can be
maintained for prolonged periods if kept below 20% of MVC. But other
investigators (Westgaard and Aaras 1984, Ex. 26-1026) found chronic
deleterious effects of contractions even if they are lower than 5% of
MVC. This latter finding is supported by the observation that low-level
static loading (such as shoulder loading in keyboard tasks) is
associated with shoulder MSDs (Aaras et al.1998, Ex. 26-597). The
supraspinatus muscle, a muscle severely constrained by bone and
ligamentous tissue, demonstrates increased intramuscular pressure
during small amounts of shoulder abduction or flexion (Jarvholm et
al.1990, Ex. 26-285). Tichauer (1966, Ex. 26-1172) looked at the impact
of arm posture on trapezius stress. He noted that arm abduction to 40
degrees increased stress in the upper trapezius muscle eight times as
much as when the arm was abducted to 20 degrees, and 64 times as much
as at a 10 degrees. These study results suggests the possibility of
chronic blood vessel and nerve compression during static tasks. Other
laboratory evidence for muscle and tendon damage in these areas, as
well as secondary compression of blood vessels and nerves, lends
support to the connection between work-related static postural
requirements and the development of these disorders.
Biomechanical studies of shoulder posture show that muscle activity
and subjective fatigue in the shoulder region increases as a function
of shoulder elevation angle and load moment at the shoulder joint.
There is also evidence of localized muscle fatigue based on a shift in
the MPF of the EMG spectrum. Prolonged periods of neck flexion cause
increased levels of discomfort and increased EMG activity in the neck
extensor muscles.
Herberts, Kadefors, and Broman (1980, Ex. 26-1129) measured EMG
activity as a function of static shoulder posture in a laboratory study
using 10 male subjects. The primary independent variable was posture.
Subjects held a 2-kg load in the hand at waist, shoulder, and overhead
heights using different combinations of flexion and abduction at the
shoulder. EMG activity was measured using wire electrodes in the
anterior and posterior portions of the deltoid, the supraspinatus, the
infraspinatus, and the upper portion of the trapezius. Localized
fatigue (a shift in EMG mean power frequency [MPF]) was observed in all
muscle groups during shoulder-level and overhead work (p.05) during the
1-minute trials. Even at waist level, fatigue was observed when the
upper arm was abducted at an angle of 30 degrees.
Hagberg (1981, Ex. 26-955) measured EMG activity and discomfort in
the shoulder in a laboratory study of six female subjects. Surface
electrodes recorded EMG activity in the descending trapezius, anterior
deltoid, and biceps brachii while subjects performed repeated flexion
of the shoulder every 4 seconds to an angle of 90 degrees for a period
of 60 minutes. Heart rate and perceived exertion using Borg's scale was
also recorded. Hand load was the independent variable: weights of 0.6
kg, 1.6 kg, and 3.1 kg were held in the hand (in addition to a no-load
treatment). Heart rate and perceived increased over the course of the
trial. Heart rate and perceived were greater when a load was held in
the hands. EMG activity in the trapezius was closely correlated with
the external moment at the shoulder joint.
Oberg, Sandsjo, and Kadefors (1994, Ex. 26-867) measured EMG
activity and subjective discomfort in the shoulder-neck region in a
laboratory study of 20 subjects (10 male, 10 female). Surface
electrodes measured EMG activity in the right trapezius muscle while
subjects abducted the arm to a 90 degree angle. Subjects reported
fatigue using the Borg 10-point scale. Each subject was tested under
two conditions: a 5-minute test with no load in the hand and a 2.5
minute test with a 2-kg load in the hand. At the no-load level, there
was no change in EMG MPF over the course of the trial; however,
subjective fatigue increased. With the 2-kg. load, there was a small
linear decrease in MPF over the trial and there was a negative
correlation between MPF and the Borg rating = 0.46). The
authors concluded that MPF was not a good proxy for perceived fatigue
during low-intensity static exertions of the shoulder.
Using EMG, several investigators have demonstrated that the
supraspinatus muscle is activated throughout most of the range of
motion of the shoulder. Herberts and Kadefors (1976, Ex. 26-470) and
Herberts et al.(1984), Ex. 26-960 postulated that the level of tension
in the supraspinatus muscle during arm elevation (with or without
holding an object in the hands) was sufficiently high to increase
intramuscular pressure to a point sufficient to compromise
intramuscular circulation. As reported by Edwards, Hill, and McDonell
(1999; Ex. 26-1232), intramuscular pressures of 20 mm Hg may be
sufficient to prevent muscular perfusion. Since many of the blood
vessels within the tendon are longitudinal extensions of the blood
vessels in the muscle belly, reduced perfusion of the intramuscular
blood vessels implies reduced perfusion of the intratendinous blood
vessels. If this reduced perfusion is sustained for sufficient
durations of time, the tenocytes or other tendon components are
susceptible to ischemic injury. In terms of biomechanical task
variables, experimental data suggest that overhead work may cause
intramuscular pressures capable of reducing intramuscular perfusion.
Lifting combined with arm elevation (shoulder load) also contributes to
the magnitude of supraspinatus muscle activation. From a temporal
perspective, this proposed model is more related to the duration of the
intramuscular pressure than to its frequency.
After reviewing the scientific literature, Winkel and Westgaard
(1992a, Ex. 26-1163) recommended less than 4 hours of work requiring
overhead or extended reach postures. For continuous work, they
recommended exposure times of one hour or less, particularly if the
work involved highly repetitive tasks, low worker control, or a lack of
alternating tasks. When large forces are also exerted, they recommended
that the exposure time should be even less.
Wiker, Chaffin and Langolf (1999; Ex. 26-1028) used psychophysical
methods to investigate the relationship between strength capacity of
the shoulder complex and fatigue/discomfort induced by sustained
awkward arm postures in simulated light assembly work. Awkward shoulder
postures (arms above shoulder level) produced severe discomfort at less
than 10% MVC within one hour and were unrelated to subject strength.
These authors recommended elimination of overhead work even in light-
weight manual assembly environments, irrespective of individual worker
strength or anthropometry.
Conclusion
The 1997 NIOSH report made the following statement with regard to
the epidemiological evidence that links physical work factors and
shoulder tendinitis:
The evidence for specific shoulder postures is strongest where
there is combined exposure to several physical factors like holding
a tool while overhead. The strength of the association was positive
and consistent in six studies that used diagnosed cases of shoulder
tendinitis or a combination of symptoms and physical findings
consistent with tendinitis as the health outcome (Ex. 26-1).
[[Page 68454]]
OSHA agrees with NIOSH with regard to the epidemiological evidence for
an association between shoulder tendinitis and a combination of
physical risk factors related to sustained or repeated shoulder flexion
and abduction, particularly when it includes an additional static hand
load such as working overhead. Fifteen out of sixteen well-conducted
epidemiological investigations that directly observed or measured these
factors in the workplace have found a significantly elevated risk of
shoulder MSDs in exposed workers verified by physical exam. This link
between physical work factors and injury has been established across
numerous job areas including assembly line work (Punnett et al.1998,
Ex. 38-155; Ohlsson et. al. 1995, Ex. 26-868), electronics manufacture
(Kilbom 1986, Ex. 500-41-75; Jonsson 1988, Ex. 26-969) and fish
processing (Nordander et al.1999, Ex 38-408; Chiang et al.1993).
The epidemiological evidence is supported by biomechanical studies
and the pathogenesis of these shoulder disorders. It has been
consistently shown by EMG that fatigue in the shoulder muscles occurs
with abduction and flexion of the shoulder. Addition of a static load
or requiring the arm/shoulder motion be performed repeatedly merely
increases both muscle fatigue and perceived discomfort. Over time,
these repeated actions stress the tendons in the shoulder causing
gradual loss of elasticity and strength. Once the damage exceeds the
reparative capacity of the tissue, ischemia sets in and the tendon
becomes inflamed, resulting in a chronic tendinitis. The rotator cuff
is particularly vulnerable to this pathology since muscles and tendons
are already somewhat constrained by ligaments and bone. Severe postures
can result in impingement of nerves and blood vessels further
aggravating the injury. OSHA concludes that sustained or repeated
exertions with the arms and shoulders in awkward postures, such as
raised overhead, can increase the risk of substantial and serious
impairment to the shoulder. During OSHA's hearing on it's proposal, a
nurse who injured her back at work provided compelling testimony.
Maggie Flannigan, a registered nurse with 19 years experience in
various newborn ICUs (intensive care units) across the country told her
story for inclusion in OSHA's rulemaking record. Ms. Flannigan reported
having back, neck and shoulder pain for years while working and also
after work. Then, while moving a 75-pound monitor down from, then back
onto a five-foot high shelf, she sustained a severe injury to her upper
back and shoulders. Ms. Flannigan said that other nurses had been
injured doing similar tasks, but because
when people think of newborn ICU, they think of, okay, you've got a
one-pound baby, so where are your stressors coming from? And they
don't realize that we are responding to alarms in high places, that
we're doing awkward postures and reaches, and we're pushing heavy
equipment, and then sometimes we actually lift heavy equipment
which, in my case, gave me a back injury.
It took Ms. Flannigan eight months of treatment to recover and
she is fearful of re-injury:
I'm fearful of what's going to happen to me as I age. And I'm
also fearful of losing my ability to work as a nurse. I love my
profession. I wouldn't trade it. * * * Since I've been injured at
work, my family really suffered. I couldn't bathe my children. I
couldn't dress them, couldn't do the laundry. My five-year-old
buckled my three-year-old in the car seat if I had to drive. He
pushed the cart at the grocery store--my five-year-old pushed the
shopping cart.
Ms. Flannigan stated further :
I know I'm not the first one hurt at my job, but what I can't
live with is I won't be the last unless we start protecting American
workers immediately with this ergonomic proposal so we can remove
the ergonomic hazards or reduce them in the workplace. American
workers deserve a place of employment free from recognized hazards
because when a worker develops an MSD, it's not just a lost workday.
It can be a life lost forever to pain and disability.
D. Disorders of the Upper Extremities
This section summarizes the evidence that exposure to physical risk
factors at work contribute to the pathogenesis of specific
musculoskeletal disorders (MSDs) of the upper extremities. In this
section, the upper extremities of interest are the elbow, forearm,
wrist, and hand. The bulk of the evidence demonstrating a work-related
risk center around five MSD classifications; these are epicondylitis,
tendinitis of the hand and wrist, carpal tunnel syndrome, hand-arm
vibration syndrome, and hypothenar hammer syndrome. There is an
impressive body of data that address the role of three biomechanical
risk factors in epicondylitis, tendinitis, and carpal tunnel syndrome.
These risk factors are force exerted on the muscle, tendons, and
nerves; repetitive motion involving the hands, wrists, and forearms;
and awkward postures of the wrist and arm. Exposure to these factors
often occurs concurrently in occupational settings and the evidence
shows that the risk of injury is greatest when more than one factor is
present. There are also studies that relate another biomechanical work
factor, vibration from the use of hand-held power tools, to an
increased risk of carpal tunnel syndrome and hand-arm vibration
syndrome. Repeated impact or contact stress, as well as vibration, have
been implicated in the development of hypothenar hammer syndrome.
Contact stress can, itself, be viewed as a specific combination of
repetitive motion and force applied directly to a localized area of
tissue, in this case the palm.
There are several types of evidence that continue to support force,
repetition, awkward posture, and vibration as causative factors for
MSDs of the upper extremities. Information on pathophysiology provides
evidence that links exposure to risk factors to the physiological,
anatomical, and pathological alterations in soft tissues of the upper
extremities. This speaks to the biologic plausibility that work-related
risk factors contribute to these injuries. There is voluminous
epidemiological data that provide evidence of associations between
worker exposure to the identified risk factors and the occurrence of
upper extremity MSDs. Some of these studies recently have been reviewed
by NIOSH (Bernard and Fine 1997, Ex. 26-1) and were discussed by OSHA
in the Health Effects Appendicies to the proposed rule (Ex. 27-1). For
the final rule, OSHA has evaluated many additional epidemiologic
studies that were entered into the record by many rulemaking
participants.
Finally, there is biomechanical and psychophysical laboratory
research that complement and corroborate the epidemiological evidence.
These approaches are able to directly link exposure to ergonomic risk
factors to biomechanical and subjective measurements of tissue response
under a more controlled set of simulated work conditions. This evidence
derives from studies reviewed in the Health Effects Appendices of the
Proposed Rule (Ex. 27-1) and testimony of the many expert scientists
that appeared at OSHA's rulemaking hearing. The evidence for each
specific MSD covered in this section is discussed in the parts that
follow.
Epicondylitis
Epicondylitis is a form of tendinitis that affects the forearm
extensor muscle-tendon units that extend from the hand and wrist to the
epicondyle (elbow). The most common type is lateral epicondylitis
(known as ``tennis elbow'') where the fibrous tissue at the bone-tendon
junction (usually the extensor carpi radialis brevis muscle/tendon) on
the outer elbow is inflamed. This is believed to be caused by repeated
microrupture of the tendon from overuse of the muscles that control the
[[Page 68455]]
wrists and fingers. Clinical case reports have noted that patients with
lateral epicondylitis were often in occupations that involved
repetitive, forceful work, particularly repeated pronation and
supination movements with the elbow fully extended. For example, in one
case series it was reported that 48 percent of patients with lateral
epicondylitis of unknown origin had occupations that involved gripping
tools with consequent repetitive supination/pronation of the forearm
(Sinclair 1965, Ex. 26-736). In a second smaller group of epicondylitis
patients reported on in the same publication, 88 percent worked in jobs
with constant gripping or repetitive movements.
National surveillance data consistently show that the incidence of
this injury is greatest in occupations requiring manually intensive
demands on the upper extremities in a dynamic work environment, such as
mechanics, butchers, and construction workers. This body of evidence
provides ample biological plausibility to the notion that force,
repetition, and awkward posture can contribute to this MSD. The
interplay between pathophysiology and physical work factors is
concisely summarized by Dr. Niklas Krause in his written testimony on
the proposed ergonomic standard (Ex. 37-15).
There always seems to be a mechanical overuse component in MSDs.
Tissues react to mechanical stress or overuse or microtraumitization
(whatever term is being used) with inflammation leading to edema,
swelling, pain, and local repair mechanisms that lead to stiffness
and reduced muscle elasticity (probably due to microadhesions of
muscle and tendon sheets), inactivity, loss of strength, and,
habitual guarding postures, which in turn set the stage for overuse,
and so on, in increments. That is why we call these MSDs
``cumulative trauma disorders''. My work on the pathogenesis of the
tennis elbow measured the impact of these physiological changes,
i.e., increased internal workload or muscle resistance due to
reduced tissue elasticity leading to electromyographically
detectable recruitment of ever more muscle fibers for the same
amount of external workload (which was held constant in these
electromyographic studies of isometric muscle action). This
increased recruitment of more muscle fibers makes the patient more
vulnerable to overexertion at even lower levels of external physical
demands * * * until the patient is unable to even lift a cup. [Ex.
37-15]
In a chapter of the Textbook of Clinical Occupational and Environmental
Medicine (1994, Ex. 38-440), Dr. Martin Cherniak described the symptoms
and disabling nature of epicondylitis:
The characteristic symptoms are pain with lifting , gripping,
and wrist extension.* * * Because grip and extension are so central
to many jobs, lateral epicondylitis is a condition that can be
irreconcilably chronic and produce major and undesirable changes in
life and work, despite its seeming mundane nature. [Ex. 38-440, pp.
384-385]
Epidemiological Evidence
NIOSH reviewed 18 cross-sectional studies and one cohort study that
addressed workplace risk factors and elbow MSDs. Table V-3 summarizes
some key aspects of these investigations, such as the occupations
examined, the biomechanical risk factors to which workers were exposed,
whether exposures were directly observed or measured during the study,
and whether the health outcomes were verified by trained medical
personnel during physical examination. Most of the studies compared the
prevalence of epicondylitis in workers with jobs known to have highly
repetitive, forceful tasks (e.g. meat and fish processing) to those
engaged in less repetitive, forceful work (e.g. office workers). In
some cases, the work also involved awkward hand and wrist postures. In
almost all the studies, workers were concurrently exposed to a
combination of 2 or 3 factors. One study specifically examined
vibration from the use of chain saws. Eleven of the studies based case
definition on physical examination and worker exposure on observational
analysis. Diagnosis of epicondylitis was consistent across studies and
required the presence of pain on palpation of the epicondylar area and
pain at the elbow upon resisted movement of the wrist. The existence of
work-related risk factors was generally made based on job/task
observation. Some studies videotaped job tasks and estimated cycle
times, static loading on the forearm, and wrist posture in order to
qualitatively group workers by exposure intensity. Other studies more
subjectively evaluated risk factor exposure by job observation alone.
Seven cross-sectional studies reviewed by NIOSH relied strictly on
self-reports of symptoms or exposure; OSHA considers these
investigations to be less reliable.
Table V-3.--Summary of Epidemiology Studies Examining Epicondylitis
----------------------------------------------------------------------------------------------------------------
Job type Physical Physical Risk Measure (95%
Study studied factors Exposure basis exam CI) \1\
----------------------------------------------------------------------------------------------------------------
Hughes (1997) Ex. 26-907.... Aluminum F/R?/P Checklist...... Yes......... OR=37*
smelter. (3-470)
Roquelaure (1996) Ex. 500-41- Manufacturing.. F/R/P Checklist...... Yes......... OR=7.7-18.0*
111. (2.2-147)
Kurppa (1991) Ex. 26-53..... Meat processing F/R/P? Observation.... Yes......... IR=6.7*
(3.3-13.9)
Chiang (1993) Ex. 26-1117... Fish processing F/R/P? Cycle time EMG. Yes......... OR=1.2-6.7*
(1.6-32.7)
Moore (1994) Ex. 26-1364.... Meat processing F/R/P Measurement.... Yes......... OR=5.5*
(1.5-62)
Bovenzi (1991) Ex. 26-1433.. Forestry....... V Measurement.... Yes......... OR=4.9*
(1.3-56)
SHARP (1993) Ex. 500-41-116. Poultry F/R/P? Measurement.... Yes......... NR*
processing. (p0.002)
Dimberg (1987) Ex. 26-945... Automotive..... F/R/P Observation.... Yes......... NR*
Dimberg (1989) Ex. 26-1211.. Automotive..... F/R/P Observation.... Yes......... NR
Ritz (1995) Ex. 26-1473..... Utilities...... F/R?/P? Observation.... Yes......... OR=1.2-1.7*
(1.0-2.7)
Luopajarvi (1979) Ex. 26-56. Food production F/R/P Measurement.... Yes......... OR=2.7
(0.7-15.9)
Baron (1991) Ex. 26-697..... Grocery F/R/P Measurement.... Yes......... OR=2.3
checking. (0.5-11)
Viikari-Juntura (1991) Ex. Meat processing F/R/P? Observation.... Yes......... OR=0.88
26-1197. (0.3-2.8)
[[Page 68456]]
Roto (1984) Ex. 26-666...... Meat cutting... F/R/P? Job title...... Yes......... OR=6.4*
(1.0-41)
Hoekstra (1994) Ex. 26-725.. Video terminal. R/P Observation.... No.......... OR=4.0*
(1.2-13)
Burt (1990) Ex. 26-698...... Computer entry. R/P Job title...... No.......... OR=2.8*) Ex. 26-1.4-
5.7)
Punnett (1985) Ex. 26-995... Garment........ R/P? Job title...... No.......... OR=2.4*
(1.2-4.2)
Ohlsson (1989) Ex. 26-1290.. Assembly line.. F?/R/P? Job title...... No.......... OR=1.5-2.8
(0.8-10.7)
Andersen (1993) Ex. 26-1451. Sewing machine. F/R/P? Observation.... No.......... OR=1.7
(0.9-3.3)
McCormack (1990) Ex. 26-1334 Textile........ F/R/P? Job title...... Yes......... OR=0.5-1.2
(0.5-3.4)
Bystrom (1995) Ex. 26-897... Auto assembly.. F/R/P Job title...... Yes......... OR=0.7
(0.04-1.7)
----------------------------------------------------------------------------------------------------------------
F=forceful exertions; R=repetitive motion; P=awkward posture; ?=presence of risk factor unclear.
IR=incidence rate; OR=odds ratio; NR=not reported.
*=p0.05.
\1\ 95% confidence interval expressed for the upper end of the risk measure range.
Seven of the 11 studies that relied on objective exposure
assessments and medical confirmation of epicondylitis found
statistically significant associations between exposure to work-related
risk factors and risk of epicondylitis. The most reliable odds ratios
(ORs) ranged between 1.0 to 5.5. Some studies deserve special mention.
One study was able to divide fish processing workers into a low-force/
low-repetition group, a high-force or high-repetition group, and a
high-force and high-repetition group based on observed cycle times and
hand forces from electromyography (EMG) recordings of the forearm
flexor muscles (Chiang et al.1993, Ex. 26-1117). An increasing trend
was found in prevalence of epicondylitis with increased exposure
intensity (not statistically significant). There was a significant
difference between males in the highest exposed group and males in the
lowest exposed group (OR=6.75; 95% CI 1.6-32.7), but this trend was not
observed among female workers (OR=1.4; 95% CI 0.3-5.6). A prospective
cohort study grouped meat processing workers into those engaged in
strenuous (primarily cutters and packers) and non-strenuous work
(primarily office work) based on repetitive and forceful tasks (Kurppa
et al. 1991, Ex. 26-53). They reported a significantly increased
incidence ratio (6.7; 95% CI 3.3-13.9) of epicondylitis among workers
in strenuous jobs over the 31-month follow-up period. Because of the
prospective study design, this study provided direct evidence of a
temporal relationship between exposure to biomechanical risk factors
and the increased incidence of epicondylitis.
One study evaluated vibration as a risk factor for epicondylitis
and reported a significantly greater prevalence of epicondylitis (OR =
4.9; 95% CI 1.3-56) in forestry operators using chain saws compared to
a comparison group of maintenance workers (Bovenzi et al.1991, Ex. 26-
1433).
Evidence of exposure-response trends in the epicondylitis
literature is limited because of the preponderance of studies that
relied on dichotomous comparisons of exposed versus unexposed workers;
however, one study found an increase (not statistically significant) in
prevalence with the number of hours per week working as a grocery
checker (Baron et al.1991, Ex. 26-697). Another reported a positive
(not statistically significant) exposure-response relationship between
duration of exposure to gas and waterworks jobs regarded as stressful
to the elbow (Ritz 1995, Ex. 26-1473).
Some unusually high ORs that were reported by a few studies and
contained in the NIOSH (1997, Ex. 26-1) review may have been overstated
due to bias. For example, one study of aluminum workers reported an OR
of 37 between elbow/forearm disorders and the number of years of
forearm twisting; however, the overall participation rate in the study
was only 55 percent, leaving open the possibility of selection bias
(Hughs and Silverstein 1997, Ex. 26-53). The cohort study by Kurppa et
al.(1991, Ex. 26-53) reported an epicondylitis incidence rate (IR) of
6.7 for workers performing strenuous tasks but counted recurrences in
the same elbow as if they were new cases. Reanalysis by NIOSH placed
the IR at 5.5 among workers with strenuous jobs versus those with non-
strenuous jobs after correcting for recurrent cases.
A few studies reported ORs between 1-3 that were not statistically
significant (Baron et al.1991, Ex. 26-697; Luopajarvi et al.1979, Ex.
26-56). The low risk ratios reported in these studies may reflect the
likelihood that the occupations studied (grocery checkers and assembly
line food packers) were associated with relatively low forces directed
to the forearm extensors combined with insufficient repetitiveness, as
compared to other jobs that involve higher forces and more repetition,
such as meat cutters/packers where higher prevalence rates of
epicondylitis have been found (Moore and Garg 1994, Ex. 26-1364). In
addition, cross-sectional studies are often subject to the ``healthy
worker'' effect because of the exclusion of injured workers who may
have left the workforce at the time a study was conducted. This can
sometimes lead to an underestimation of prevalence.
Most studies adequately controlled for the important confounder of
age but the contribution of non-occupational injury to the elbow was
often not addressed among groups of workers. The large number of
studies reporting a positive association with exposure make it unlikely
that non-occupational injuries were an important confounder. Dr.
Cherniak emphasized the importance of work rather than non-work
activities in the etiology of epicondylitis: ``Its popular epithet of
tennis elbow notwithstanding, it is a common condition among industrial
workers and
[[Page 68457]]
is not so common among players of racquet sports.'' [Ex. 38-440, p.
384]
NIOSH concluded that there was some evidence of an association
between exposure to force and epicondylitis based on the existence of
several studies with quantitative measures of load on the hand/forearm
that showed strong ORs (>5) for this risk factor (Moore and Garg 1994,
Ex. 26-1364; Chiang et al.1993, Ex. 26-1117). NIOSH concluded there was
insufficient evidence of an association between epicondylitis and
repetition or awkward posture alone based on an inadequate number of
studies that examined these risk factors as the dominant exposure
factor, particularly in any quantitative fashion. However, it is clear
that, in many of the epidmiological studies of epicondylitis,
repetition and, in some cases awkward posture, accompanied exposure to
force (see Table V-3).
Two additional epidemiological studies that address physical work
factors and elbow disorders were submitted to the OSHA docket following
publication of the proposal (Roquelaure et al.1996, Ex. 500-41-111;
SHARP 1993, Ex. 500-41-116), which are summarized below and included in
Table V-3. Both studies followed an adequate study design, directly
observed or measured exposure to workers, and used physical exam to
verify the MSD. OSHA, therefore, finds that the studies add
substantially to the evidence that the combination of forceful
exertion, repetitive motion, and awkward posture increase risk of
injury to the elbow.
The Safety and Health Assessment and Research Program (SHARP) of
the Washington State Department of Labor and Industries (1993, Ex. 500-
41-116) conducted a cross-sectional study of 104 poultry processing
workers. Epicondylitis was assessed by interview and physical
examination. Exposure was assessed by a risk factor checklist that
evaluated repetitiveness, forcefulness, mechanical stress, and wrist
deviation. The study found the prevalence of upper extremity MSD by
interview was 25% and by physical exam and interview was 17%. The
number of repetitive exertions per hour was significantly predictive of
epicondylitis (p=0.002).
Roquelaure et al.(1996, Ex 500-41-111) reported that work
characteristics of greater than 1 kg of hand force, less than 30-second
cycle times, and static hand work in workers were associated with
radial tunnel syndrome (RTS). RTS is a disorder in which the radial
nerve becomes compressed near the elbow causing pain and tenderness,
similar to epicondylitis. Roquelaure used a case-referent study of 21
RTS cases and 21 controls while studying 2,250 television, shoe, and
brake manufacturing workers. Participation rate was not reported.
Referents were age-, gender-, and plant-matched workers selected at
random from the same manufacturing population who had no upper limb
disorder for the previous eight years. Exposure was determined by
direct observation of two trained assessors using a checklist. RTS was
determined by reviewing the past two years of medical files of the
2,250 manufacturing workers. A case of RTS was defined as local
tenderness 4-5 cm distal to lateral epicondyle, pain in forearm
indirectly induced by supination, no peresis or muscle weakness and
positive EMG and nerve conduction studies. For 1 kg or greater of hand
force, an odds ratio of 18.0 (CI: 2.2-147.5, p=0.01) was reported
compared to those cases exposed to less hand force. For workers with
less than 30-second cycle times, an odds ratio of 8.7 (CI: 1.2-23.8,
p=0.03) was reported compared to those who had longer cycle times. For
workers with static hand work, an odds ratio of 7.7 (CI: 1.4-42.7,
p=0.02) was reported compared to those involved in more dynamic work.
This study demonstrates that an increased risk of RTS is associated
with exposure to force, repetition and static posture of the hand.
Two medical experts supplied written testimony on behalf of UPS
indicating that epidemiological evidence to support an association
between combined biomechanical factors (e.g. force, repetition, awkward
posture) and the different types of tendinitis of the upper extremities
(e.g. elbow (epicondylitis), hand/wrist (tenosynovitis)) likely are
flawed because of imprecise case definition. Dr. Peter Nathan wrote:
There is a startling lack of objective evidence to indicate that
actual pathology is involved in many of the soft tissue discomfort
complaints that are included under the umbrella of cumulative trauma
disorders or musculoskeletal disorders--a primary focus of the
ergonomic standard. * * * Dr. Armstrong refers to a Finnish study by
Luopajarvi et al.(1979, Ex. 26-56) which is one of three valid
studies referenced by Dr. Susan Stock in her 1991 meta-analysis of
the literature relating work exposure to conditions of the neck and
upper extremities. The variable representing tendinitis used by
Luopajarvi and his colleagues was primarily symptoms confirmed by
physical examination. This does not correspond to the classic
medical definition of tendinitis, which requires objective evidence
of true inflammation (Ex. 500-118).
Similarly, Dr. Nortin Hadler stated in written testimony:
The health effect in this paper [Kurppa et. al. 1991, Ex. 26-53]
is a sick leave consequent to regional disorders of the elbow or
wrist/hand. The investigators devised their nosology to capture
discomfort about the elbow and distal arm/hand. Essentially, all
they are describing is localized soreness and/or tenderness. The
criterion of swelling or crepitation and tenderness to palpation
along the tendon and pain at the tendon sheath, in the peritendinous
area, or the muscle/tendon junction during active movement of the
tendon boils down to focal soreness/tenderness and nothing more
specific or mysterious than that (Ex. 500-118).
These comments suggest that the two epidemiological studies cited above
exclusively rely on a collection of subjective symptoms indicative of
non-specific soreness and discomfort, rather than objective measurement
of inflammation and tissue pathology. This criticism also applies to
virtually all the existing epidemiological studies that examined
epicondylitis since they used a similar set of criteria to diagnose
this MSD. As a result, the commenters believe OSHA has not made a
sufficient case that true epicondylitis (as well as tenosynovitis) is
associated with workplace exposure to biomechanical risk factors.
OSHA disagrees with the notion that evidence of tissue pathology
among exposed workers is required to infer a causal relationship
between exposure to physical risk factors in the workplace and
epicondylitis. The studies of Luopajarvi et al.(Ex. 26-56) and Kurppa
et al.(Ex. 26-53) were directed by the Institute of Occupational Health
in Helsinki, Finland, which developed systematic methods for screening
and diagnosing a number of occupational neck, shoulder, and upper limb
disorders, including lateral and medial epicondylitis. The examination
procedures and diagnostic criteria have been published in the peer-
reviewed literature (Waris et al.1979, Ex. 26-1218) and they were
devised by a team of clinicians comprised of occupational physicians,
an orthopedist, physiologist, and ergonomist. The diagnosis for lateral
epicondylitis (the most common form of epicondylitis) is not simply
self-reported elbow soreness. The tenderness must be localized over the
lateral epicondyle and there must be pain associated with resisted
extension of the wrist and fingers (resistence test). In the Finnish
studies, these signs were evaluated by either physicians specializing
in occupational health or a trained physiotherapist. Other potential
causes unrelated to physical work factors, such as fractures, acute
trauma, recreational injuries, infection, arthritis, pre-existing
neurological diseases, etc., were assessed and screened out through
[[Page 68458]]
medical histories and personal interview.
The Finnish criteria are consistent with procedures for the
assessment, diagnosis, and management of elbow complaints recommended
by the American College of Occupational and Environmental Medicine
(ACOEM, Ex. 502-240). These guidelines do not call for tissue evidence
of inflammation and pathology in diagnosing lateral epicondylitis, but
rather depend on expert evaluation of unique signs and symptoms by a
trained clinician upon physical examination. The food packers in the
cross-sectional investigation by Luopajarvi et al. (Ex. 26-56) were
examined by a physiotherapist specially trained at the Finnish
Institute of Occupational Health. The meat processors in the
prospective Kurppa et al.(Ex. 26-53) study were primarily diagnosed by
occupational physicians at the plant using the criteria developed by
the Finnish Institute. The same diagnostic approach was also used by
the other key epidemiological studies that found an association between
work-related factors and epicondylitis (Chiang et al.1993, Ex. 26-1117;
Moore and Garg 1994, Ex. 26-1364; Bovenzi et al.1991, Ex. 26-1433).
More specialized diagnostic tools, such as imaging and
electromyography, are only advised if a prudent course of elbow/forearm
rest and pain relief do not adequately correct the disorder or more
serious complications are suspected (e.g. fracture, osteomyelitis,
neurological damage).
OSHA finds that the case definition of epicondylitis used by the
epidemiological investigators is appropriate for diagnosing this MSD.
The evaluations were administered by trained clinicians using specific
and standardized criteria that are uniformly accepted by the medical
community. This was confirmed by testimony from numerous physicians
during the hearings (AFL-CIO, Ex. 500-218). The published clinical
guidelines and testimony from the record cited above make clear that
the criteria of localized tenderness at a critical bone-tendon junction
(MSD symptom) combined with pain upon palpation and extension/flexion
of the wrist during physical examination (positive physical finding)
are sufficient for the proper diagnosis of epicondylitis without the
need for further ``objective evidence of true inflammation.''
Biomechanical Evidence
There is a very limited amount of specific study information
available in the Health Effects Appendices for the proposed rule (Ex.
27-1) that measure the biomechanical forces at the muscle-tendon units
of the elbow. However, as discussed in the Health Effects Appendix,
there is some evidence suggesting that tensile loading on the extensor
carpi radialis brevis (ECRB) muscle created by muscular action in
combination with elbow extension and pronation/supination of the
forearm causes a compressive force at the tendon, ligament, and radial
head of the elbow. Prolonged contact pressure and/or repeated loading
is likely to produce fraying of the ECRB. The resulting cycle of
damage/repair leads to clinical and pathological manifestations of
lateral epicondylitis.
Conclusion
The 1997 NIOSH report concluded the following with regard to the
relationship between work-related physical risk factors and
epicondylitis:
There is strong evidence for a relationship between exposure to
a combination of risk factors (e.g. force and repetition, force and
posture) and epicondylitis. Based on a review of the epidemiologic
studies, especially those with some quantitative evaluation of the
risk factors, the evidence is clear that an exposure to a
combination of exposures, especially at higher levels (as can be
seen in, for example, meatpacking or construction work) increases
the risk for epicondylitis (Ex. 26-1, Emphasis in original).
OSHA agrees with NIOSH that there is a reasonably strong body of
evidence showing a relationship between exposure to combinations of
biomechanical risk factors, usually forceful exertion/repetitive motion
or forceful exertion/repetitive motion/awkward posture, and an
increased risk of epicondylitis. This evidence emanates from the
consistently positive associations in epidemiological studies of
workers from several different industry sectors, especially those
investigations that rely on expert verification of injury and objective
determination of exposure. The epidemiological evidence is supported by
the large number of clinical reports and investigations in the medical
and sports literature. There is biological plausibility that exposure
to combinations of risk factors can lead to epicondylitis since
forceful and repetitive exertion of the forearm muscles and tendons are
also consistent with the pathophysiology of epicondylitis. As described
in the NIOSH review of the epidemiological evidence, there is less
evidence that exposure to repetition or awkward posture alone, is
associated with an increased risk of epicondylitis. OSHA concludes that
workers who perform job tasks requiring repeated forceful movements,
especially flexion, pronation, or supination with the arm extended, are
at increased risk of developing epicondylitis.
Tendinitis of the Hand and Wrist
Most cases of tendinitis of the hand and wrist originate as
inflammation of the synovial sheath that provides protection for the
tendons. This condition is known as tenosynovitis. Inflammation may
occur in the flexor tendons on the palmar aspect of the wrist, extensor
tendons on the back of the wrist, or the small separate collection of
extensor tendons that controls the extension of the thumb. There are a
number of pathophysiological outcomes that result from irritation of
the tendons. If the sheath becomes aggravated, excessive synovial fluid
can build up resulting in swelling along the affected tendon. Sometimes
irritation can occur just proximal to the tendon sheath where there is
no synovial fluid. This causes a dry rubbing of the tendon called
peritendinitis crepitans, so named because of the discernable creaking
sensation. There is also a type of tenosynovitis, known as stenosing
tenovanginitis, caused by a constriction of the tendons at the mouth of
the sheath. If this constriction occurs on the radial aspect of the
wrist involving the extensor tendons to the thumb, it is known as De
Quervain's syndrome. If the site of injury is the flexor tendons to the
fingers, it is known as trigger finger. Stenosing tenovanginitis is
thought to be the result of compression caused by the thickening of the
retinaculum (band of ligaments around the wrist holding the tendons in
place) leading to tendon entrapment.
One publication in the record described the symptoms and prognosis
of patients that have trigger finger or thumb:
The classic picture [of trigger finger/thumb patients] is
painful ``locking'' of the digit in flexion whereby the patient has
difficulty extending the proximal interphalangeal joint. Extension
can be accomplished passively using the other hand and produces a
moderate amount of discomfort and a palpable painful ``snap.'' * * *
The prognosis is excellent for a complete recovery barring the
occurrence of multiple trigger fingers and/or significant
osteoarthritis * * *. In these cases the course is usually
prolonged. Patients tend to question their ability to return to
their old jobs and, on occasion, any job. In general, workers should
be able to return to heavy work, although it may take somewhat
longer after surgery because of a tender palmar scar. [Ex. 38-453,
pp. 105-106]
[[Page 68459]]
Epidemiological Evidence
NIOSH (1997, Ex. 26-1) reviewed seven cross-sectional studies and
one cohort study that addressed workplace risk factors and MSDs that
specifically addressed hand/wrist tendinitis. Table V-4 summarizes some
key aspects of these investigations. In these studies, tendinitis cases
were identified primarily by physical examination, which usually
included localized pain/tenderness at the tendons upon palpation during
movement of the hand/wrist. However, diagnostic criteria varied across
studies depending on the types of tenosynovitis of interest. For
example, some investigations required the presence of swelling along
the tendons of the wrist and/or signs of crepitation. In some cases, a
positive Finkelstein's test was used to diagnose DeQuervain's syndrome.
Because of the differences in case definition, it is difficult to
compare prevalence rates from different studies, although measures of
relative risk should be less affected as long as case definitions were
non-differentially applied to exposed and unexposed groups (NIOSH 1997,
Ex. 26-1).
Exposure assessment was generally restricted to grouping workers in
exposed and unexposed categories based on the existence of a
combination of excessive force, repetitive motion, and awkward posture.
In these studies, most exposed workers were subjected to the combined
effect of at least two risk factors. Five studies relied on direct
observation of job tasks and expert judgment to determine exposure
(Armstrong et. al. 1987, Ex. 26-48; Luopajarvi et. al. 1979, Ex. 26-56;
Bystrom et. al. 1995, Ex. 26-897; Kuorinka et. al. 1979, Ex. 26-639;
Kurppa et. al. 1991, Ex. 26-53). One of these studies quantified force
and repetitiveness for a subset of workers performing different jobs
and grouped them according to these measurements (Armstrong et. al.
1987, Ex. 26-48). Three studies used less reliable methods of assessing
exposure such as self-reports or general knowledge of job tasks.
Table V-4.--Summary of Epidemiology Studies Examining Hand/Wrist Tendinitis
----------------------------------------------------------------------------------------------------------------
Job type Physical Physical Risk measure (95%
Study studied factors Exposure basis exam CI)\1\
----------------------------------------------------------------------------------------------------------------
Kurppa (1991) Ex. 26-53..... Meat processing F/R/P? Observation.... Yes......... IR=14-38.5*
(11-56)
Armstrong (1987) Ex. 26-48.. Manufacturing.. F/R/P? Measurement EMG Yes......... PRR=4.8-17*
(2.3-126)
Moore (2000) Ex. 500-71-41.. Pork processing F/R?P Observation.... Yes......... PRR=7.0*
F/R?/P.
Luopajarvi (1979) Ex. 26-56. Food production F/R/P Observation.... Yes......... PRR=4.1*
(2.6-6.5)
Latko (1999) Ex. 38-123..... Manufacturing.. R/F/P? Measurement, Yes......... OR=3.2*
cycle time. (1.3-8.3)
Bystrom (1995) Ex. 26-897... Auto assembly.. F/R/P Forearm load, Yes......... PRR=2.5*
wrist flex. (1.0-6.2)
Kuorinka (1979) Ex. 26-639.. Scissor F?/R/P Cycle time, Yes......... PRR=1.4
production. wrist flex. (0.8-2.5)
Amano (1988) Cited in Ex. 26- Shoe assembly.. F?/R/P Job title...... Yes......... PRR=3.7-6.2*
1. (2.7-14)
Roto (1984) Ex. 26-666...... Meat cutting... F/R/P? Job title...... Yes......... PRR=3.1*
(1.4-6.7)
McCormack (1990) Ex. 26-1334 Textile........ F/R/P? Job title...... Yes......... PRR=0.4-3.0*
(1.4-6.4)
----------------------------------------------------------------------------------------------------------------
F=forceful exertions; R=repetitive motion; P=awkward posture; ?=presence of risk factor unclear.
IR=incidence rate; PRR=prevalence ratios;
*=p0.05.
\1\ 95% confidence interval expressed for the upper end of the risk measure range.
Of the five studies with the most reliably documented exposure,
four reported statistically significant increases in the prevalence of
hand/wrist tendinitis in workers exposed to physical risk factors
(Armstrong et al.1987, Ex. 26-48; Luopajarvi et al.1979, Ex. 26-56;
Bystrom et al.1995, Ex. 26-897; Kurppa et al.1991, Ex.26-53). In their
review, NIOSH (1997, Ex. 27-1) chose the prevalence ratio (PR) to
represent an estimate of relative risk rather than the more commonly
reported OR for hand/wrist tendinitis, because the OR can overestimate
relative risk when prevalence rates among unexposed groups are high. A
few of the studies on work-related tendinitis reported prevalence rates
greater than 25 percent in exposed groups and greater than 10 percent
in unexposed groups.
The Armstrong et al.(Ex. 26-48) study was able to divide industrial
workers at seven manufacturing plants into a low force/low repetition
group, a high force/low repetition group, low force/high repetition
group, and a high force/high repetition group based on EMG measurements
and observed cycle times. They found exposure-related increases in the
prevalence of tenosynovitis (including stenosing tenovanginitis). The
high-force/low-repetition group and low-force/high-repetition group had
PRs of 4.8 (95% CI 0.6-39.7) and 5.5 (95% CI 0.7-46.3), respectively,
compared to the low-force/low-repetition group, while the high-force/
high-repetition group had a PR of 17.0 (2.3-126.2). The Kourinka et
al.(Ex. 26-639) study of mostly female scissors makers found a non-
statistically significant increase in the prevalence of tenosynovitis
(including peritendinitis) with an increase in the number of pieces
handled per year. The PR was 1.4 (95% CI 0.8-2.5) among all exposed
workers compared to a referent group of department store assistants. In
this study, it is unclear whether cashiers (a potentially exposed
group) were included in the referent population; if so, this would tend
to diminish the association between exposure and outcome. The results
of these two studies suggest the presence of a positive exposure-
response relationship between exposure to biomechanical risk
[[Page 68460]]
factors and the risk of hand/wrist tendinitis.
Luopajarvi et al.(Ex. 26-56) found a significant increase in PR
(4.1; 95% CI 2.6-6.5) of tenosynovitis (including peritendinitis) among
female assembly line food packers compared to department store
assistants (cashiers excluded from the unexposed group). Bystrom et
al.(Ex. 26-897) found a significant increase in PR (2.5; 95% CI 1.0-
6.2) of DeQuervain's syndrome among automobile assembly line workers
compared to randomly selected subjects (adjusted for potential
confounders) from the general population. The prospective cohort study
by Kurppa et al.(Ex. 26-53) found a significant increase in the
incidence of tenosynovitis (including peritendinitis and DeQuervain's
syndrome) over a 31-month period in meat processing workers (primarily
cutters and packers) engaged in strenuous compared to non-strenuous
work (primarily office work). They reported relative risks ranging from
14.0 to 38.5 for different job categories, but these may be
overestimated since recurrences of tendinitis were counted as new cases
and case ascertainment was different for the exposed and referent
groups. This study does provide evidence of a temporal relationship
between exposure to physical work factors and development of
tendinitis. Confounders, such as gender and age, were adequately
controlled for in the key studies.
Two studies that address physical work factors and tenosynovitis
were submitted to the OSHA docket following publication of the proposal
(Moore 2000, Ex. 26-1364; Latko et al.1999, Ex. 38-123). Summary
results of these studies also appear in Table V-4. Moore (Ex. 500-71-
41) found a significant increase in the prevalence of stenosing
tenovanginitis as a result of jobs requiring repetitive and forceful
use of hand tools compared to jobs without exposure to this risk
factor. Latko et al.(Ex. 38-123) reported a significant linear trend
between repetitive work and hand/wrist tendinitis (p0.01) in a cross-
sectional study of 438 manufacturing workers. Worker exposure to
physical work factors were directly observed and measured in this study
and tendinitis cases were confirmed through physical examination by an
occupational physician in both the Moore and Latko studies.
Biomechanical Evidence
Static and dynamic biomechanical models of the wrist have been used
to estimate tensile, normal, and frictional forces in finger flexor
tendons during static and dynamic work involving the hand (Exs. 26-582,
38-418). Pinching and gripping activities produce tensile forces on the
tendons that are three to four times the normal force on the fingers.
Static biomechanical models predict that additional compressive and
frictional forces are exerted on the tendon when the wrist deviates
from a neutral position as the tendon sheaths slide against the bones
of the carpal tunnel and flexor retinaculum. These predictions have
been confirmed by cadaver studies of forces on the tendons, ligaments,
and bones of the hand. A laboratory study showed that peak tensile
forces in the flexor tendons were approximately doubled during a
simulated caulking task with a straight wrist and approximately tripled
during the same task with a flexed wrist (Moore et al.1991, Ex. 26-
183).
When a dynamic component is added to the biomechanical model, it is
predicted that tensile and normal forces on the finger flexor tendons
increase rapidly during rapid wrist accelerations. These predictions
are supported by a preliminary surveillance study that found wrist
acceleration to be substantially higher in jobs with a high rate of
upper extremity cumulative trauma disorders (Marras and Shoenmarklin
1993, Ex. 26-172). The biomechanical and laboratory evidence provides
additional support that biomechanical risk factors, such as sustained/
repetitive forceful exertions and flexion/extension of the wrist, can
create internal strain on tendons that could result in injury
consistent with tenosynovitis.
Conclusion
The 1997 NIOSH report concluded the following with regard to the
relationship between work-related physical risk factors and hand/wrist
tendinitis: ``There is strong evidence that job tasks that require a
combination of risk factors (e.g., highly repetitious, forceful hand/
wrist exertions) increase risk for hand/wrist tendinitis'' (Ex. 26-1).
OSHA also finds clear epidemiologic evidence of a relationship between
a combination of physical risk factors, such as repetitive and forceful
hand activities with a flexed wrist, and tenosynovitis. This evidence
is from the consistently positive associations in the epidemiological
studies described above. There are also laboratory studies that confirm
that hand-intensive work, particularly with a bent wrist, produces
significant load and strain on the flexor tendons. The biomechanical
evidence is consistent with the pathophysiology of tenosynovitis where
sustained and elevated internal force on the tendon sheaths can be
expected to cause synovial fluid accumulation, thickening of the
sheath, tendon entrapment, and other physiological responses that lead
to clinical symptoms associated with this MSD. These biomechanical
studies demonstrate that the increased risk of hand/wrist tendinitis
seen among workers exposed to forceful and repetitive hand activities
is biologically plausible and consistent with the epidemiologic
evidence. OSHA therefore concludes that workers exposed to these risk
factors are at increased risk of developing hand/wrist tendinitis.
Carpal Tunnel Syndrome (CTS)
CTS is a disorder that results from compression of the median nerve
at the point of passage through the carpal tunnel, the narrow opening
in the hand consisting of carpal bones of the wrist on the bottom and
the carpal ligament on top. The carpal tunnel is a relatively ``tight''
compartment filled with flexor tendons as well as the median nerve that
serve to move and enervate the fingers. Forceful contraction of the
flexor tendons in the fingers that occur during repetitive hand tasks
increase the pressure within the carpal tunnel (Ex. 38-444). Chronic
intracarpal pressure limits the vascular flow to the median nerve and
surrounding tissue leading to swelling of the tendon sheath. The
epineural edema leads to compression of the median nerve against the
carpal ligament. The ensuing loss of nerve function initially results
in painful tingling and numbness in the hand. After several years,
eventually the tendon tissue can become fibrotic and result in muscle
weakness, reduced grip strength and loss of finger movement. CTS is
often accompanied by tenosynovitis, which is not surprising given their
common pathophysiology. CTS is a disabling condition that has
frequently required surgery to provide the affected individual with
relief. For example, in Washington State in 1996, more than one-third
of all CTS workers' compensation claimants required surgery as part of
their treatment (Ex. 500-71-47, P. 12). Histologic studies of flexor
tendon sheaths sampled during carpal tunnel surgery support the above
model since vascular changes consistent with ischemia and tissue edema
are commonly observed (Ex. 26-838).
National and international surveillance data have consistently
indicated that the highest rates of CTS occur in occupations and job
tasks (meat processing, assembly line work, intensive use of hand and
power tools, etc.) requiring repeated wrist movements, forceful
exertions, and
[[Continued on page 68461]]
[[pp. 68461-68510]] Ergonomics Program
[[Continued from page 68460]]
[[Page 68461]]
wrist bending or other stressful postures.
Epidemiological Evidence
NIOSH reviewed 30 epidemiological studies that addressed workplace
risk factors and CTS. Exposed workers in theses studies were usually
engaged in job activities involving forceful and repetitive hand/finger
or wrist movements and therefore were concurrently subjected to a
combination of physical factors. These studies are summarized in Table
V-5. Thirteen studies used physical examination or electrophysical
indicators to diagnose CTS as well as direct observation or measurement
of exposure to risk factors during job activities. The remaining
studies either relied on symptom questionnaires to determine health
outcomes or self reports and job title descriptions to evaluate
exposures. CTS was solely determined by the presence of numbness, pain
or tingling in the fingers enervated by the median nerve, and a
positive Tinel's or Phalen's test (symptoms triggered upon wrist
flexion and palpation) in about half the studies. Nerve conduction (NC)
tests were not used in defining cases in these studies. In the other
half of the studies, abnormal median nerve conduction was required in
addition to symptomatology to diagnose CTS. Since normal NC was often
defined and measured differently in various laboratories, CTS case
definition is unlikely to be uniform across studies. Several
investigations quantitatively estimated force, either from EMG
measurements or based on weights of tools or other handled parts, and
recorded job task observations. Repetitive hand/wrist movements were
sometimes quantitatively measured and categorized based on task
frequency, quantity of work performed in a specified time, or ratio of
work time to recovery time.
Of the 13 studies (eleven cross-sectional and two case control)
that relied on both objective determination of exposure and medical
diagnosis of CTS, 10 reported finding statistically significant
associations between CTS and exposure to biomechanical risk factors.
The reported ORs ranged from 1.1 to 21.3. Some cross-sectional studies
provided evidence of an exposure-response relationship with respect to
CTS and exposure to force and repetition. Silverstein et al.studied 652
workers in 39 jobs from 7 different plants (Silverstein et al.1987, Ex.
26-34). Jobs were grouped into high and low repetitiveness and force
categories based on cycle time and EMG measurements, respectively. The
OR for CTS (defined by physical tests/symptoms) in highly repetitive
jobs compared to low repetitive jobs, irrespective of force, was 5.5
(p0.05) in a multiple logistic model that included age, gender, plant
site and years on the job. The corresponding OR for high-force jobs,
irrespective of repetitiveness, was 2.9 (p>0.05) but the OR for
combined exposures to high repetition and force was 15.5 (p0.05).
Table V-5.--Summary of Epidemiology Studies Examining Carpal Tunnel Syndrome
--------------------------------------------------------------------------------------------------------------------------------------------------------
Risk measure (95%
Study Job type studied Physical factors Exposure basis Diagnosis CI)\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bovenzi (1991) Ex. 26-1433......... Forestry............. V Measurement.......... Physical exam........ OR=21*
(NR)
Roquelaure (1997) Ex. 38-396....... Manufacturing........ F/R/P Measurement.......... Physical exam+NC..... OR=9.0*
(2.4-33.4)
Silverstein (1987) Ex. 26-34....... Manufacturing........ V/F/R/P Measurement.......... Physical exam........ OR=1.8-15.5*
(1.7-142)
Chatterjee (1992) Ex. 26-942....... Rock drilling........ V Measurement.......... Physical exam+NC..... OR=10.9*
(1.0-524)
Osorio (1994) Ex. 26-807........... Supermarket.......... F/R/P? Observation.......... Physical exam+NC..... OR=6.7-8.3*
(2.6-26.4)
Barnhart (1991) Ex. 26-1216........ Ski manufacture...... F?/R/P Measurement.......... Physical exam+NC..... OR=1.9-40*
(1.0-15.8)
Frost (1998) Ex. 38-198............ Slaughter house...... F/R/P Measurements......... Physical exam+NC..... OR=4.2*
(1.8-10.1)
Bovenzi (1994) Ex. 26-774.......... Stone drilling....... V Measurement.......... Physical exam........ OR=e.4*
(1.4-8.3)
Baron (1991) Ex. 26-697............ Grocery checking..... F/R/P Measurement.......... Physical exam........ OR=3.7
(0.7-16.7)
Moore (1994) Ex. 26-1364........... Meat processing...... F/R/P Measurement.......... Physical exam+NC..... OR=2.8
(0.2-36.7)
Chiang (1990) Ex. 26-1118.......... Frozen Food Packing.. F?/R/P? Measurement.......... Physical exam+NC..... OR=1.9-11.7*
(2.9-46.6)
Chiang (1993) Ex. 26-1117.......... Fish processing...... F/R/P? Cycle time, EMG...... Physical exam........ OR=1.1-1.8*
(1.1-2.9)
Stetson (1993) Ex. 26-1221......... General industry..... F/R/P Checklist............ NC only.............. NR*
Latko (1999) Ex. 38-123............ Manufacturing........ F/R/P? Measurement.......... Physical exam+NC..... OR=2.3-3.1
(0.9-10.9)
Armstrong (1979) Ex. 26-348........ Sewing machine use... F/R/P EMG, flexion......... Physical exam........ OR=1.1-2.0*
(1.6-2.5)
Nathan (1988) Ex. 26-990........... Multiple industries.. F/R/P Observation.......... NC only.............. PRR=1.0-2.0*
(1.1-3.4)
Nathan (1992) Ex. 26-989........... Multiple industries.. F/R/P Observation.......... NC, symptoms......... PRR=1.0-1.5
(1.0-2.2)
Canon (1981) Ex. 26-1212........... Aircraft plant....... V/R Hand tool measurement Workers' comp........ OR=2.1-7.0*
(3.0-17)
English (1995) Ex. 26-848.......... CTS case/control..... F/R/P Questionnaire........ Physical exam........ OR=0.4-1.8*
(1.2-2.8)
[[Page 68462]]
Feldman (1987) Ex. 26-1210......... Electronics plant.... F?/R/P Cycle time flexion... Questionnaire........ OR=2.3*
(1.4-4.5)
Koskimies (1990) Ex. 26-973........ Forestry............. V Job title............ Physical exam+NC..... NR*
McCormack (1990) Ex. 26-1334....... Textile.............. F/R/P? Job title............ Physical exam........ OR=0.4-0.9
(0.3-2.9)
Morgenstern (1991) Ex. 26-1493..... Grocery cashiers..... F?/R/P Job title............ Questionnaire........ OR=1.9
(0.9-3.8)
Punnett (1985) Ex. 26-995.......... Garment.............. F?/R/P? Job title............ Physical exam........ OR=2.7*
(1.2-7.6)
Schottland (1991) Ex. 26-1001...... Poultry processing... F/R/P Job title............ NC only.............. OR=1.9-2.9*
(1.1-7.9)
Weislander (1989) Ex. 26-1027...... CTS case/control..... V/F/R/P? Questionnaire........ Physical exam+NC..... OR=1.8-3.3*
(1.6-6.8)
Liss (1995) Ex. 26-55.............. Dental hygienist..... F?/R/P Questionnaire........ Questionnaire........ OR=3.7*
(1.1-11.9)
DeKrom (1990) Ex. 500-41-28........ CTS case/control..... F/R?/P Questionnaire........ Physical exam+NC..... OR=5.4-8.7*
(3.1-24.1)
Tanaka (1997) Ex. 26-1185.......... Household survey..... V/P Questionnaire........ Questionnaire........ OR=1.8-5.9*
(3.4-10.2)
Farkkila (1988) Ex. 26-947......... Chair saw use........ V Questionnaire........ Physical exam+NC..... NR*
SHARP (1993) Ex. 500-41-116........ Poultry processing... F/R Measurement.......... Questionnaire........ NR*
(p 0.0004)
Rosecrance (1994) Ex. 38-203....... Newspaper work....... F/P/R/ (pinch) Questionnaire........ Physical exam........ NR*
Rossignol (1997) Ex. 500-205-24.... Manual labor......... F/R?/P? Questionnaire........ Surgery for CTS...... OR=4.1*
(1.5-3.2)
LeClerc (1998) Ex. 500-41-85....... Assembly line........ R/P? Questionnaire........ Physical exam+NC..... OR=3.1-6.6*
Atroshi (1999) Ex. 38-181.......... General Population... F/P/R/V Questionnaire........ Physical exam+NC..... OR=1.0-3.0*
(1.4-6.8)
Gorsche (1999) Ex. 500-121-23...... Meat packing......... V Questionnaire........ Physical exam........ NR
Katz (1998) Ex. 38-393............. CTS case control..... F/R/P Questionnaire........ Physical exam........ NR
Kerns (2000) Ex. 500-71-34......... Pork processing...... F/R/P Job title............ NC only.............. NR
--------------------------------------------------------------------------------------------------------------------------------------------------------
F=forceful exertions; R=repetitive motion; P=awkward posture; V=vibration; ?=presence of risk factor unclear.
NCV=nerve conduction; IR=incidence rate; OR=odds ratio; PRR=prevalence rate ratio; NR=not reported.
*=p0.05.
\1\ 95% confidence interval expressed for the upper end of the risk measure range.
Chiang et al.studied 207 workers from 8 fish processing factories
in Taiwan (Chiang et al.1993, Ex. 26-1117). Jobs were divided into
three groups based on level of repetitiveness and force using cycle
times (upper arm movements, not just wrist) and EMG of the forearm
flexor muscles. There was a statistically significant trend in
prevalence of CTS (defined by physical tests/symptoms) with exposure
from low force/repetition, high force or high repetition, and high
force/repetition. Force alone, but not repetitiveness, significantly
predicted CTS (OR=1.8; 95% CI 1.1-2.9).
Several other epidemiological investigations found physical risk
factors to be significantly associated with prevalence of CTS. In
another Chiang et al.study of 207 workers from 2 frozen food processing
plants, job tasks were grouped by low and high repetitiveness based on
wrist movement cycle time (Chiang et al.1990, Ex. 26-1118). Statistical
modeling that included gender, age, and cold temperatures resulted in
an OR of 1.9 (p0.05) for CTS (defined by physical tests/symptoms/NC
studies). This study stressed the association between CTS and
repetitive movements, although some forceful hand/wrist exertion
probably existed in the study group.
Stetson et al.studied median NC on 103 automotive workers with
symptoms consistent with CTS compared with 137 asymptomatic automotive
workers and an unexposed group of 105 administrative and professional
workers (Stetson et al.1993, Ex. 26-1221). Repetitiveness was evaluated
by cycle times, hand/wrist grip forces were estimated based on weights
of handled tools and parts, and wrist deviation was judged from
videotape analysis. Both symptomatic and asymptomatic workers had
significantly lower median sensory amplitudes and significantly longer
distal latency times than the referent group. The same NC trends were
found between automotive workers in jobs requiring grip force greater
than 6 pounds compared to those requiring less than 6 pounds. This grip
force variable probably combines forceful exertion with wrist
deviation. It was not possible to adequately compare repetitive and
non-repetitive work since this risk factor was present in almost the
entire study group.
Barnhardt et al.found ski manufacturing workers with highly
repetitive job tasks had a statistically elevated OR of 4.0 (95% CI
1.0-15.8) for CTS (defined by physical tests/NC studies) compared to
those workers engaged in non-repetitive tasks (Barnhardt et al.1991,
Ex. 26-1216). Exposure was evaluated by observational analysis and
included repetitive jobs with sustained flexion, extension, or ulnar
deviation of the wrists by 45 degrees. The participation rate for this
study was lower (less than 70 percent) than most of the other
investigations. Armstrong and Chaffin reported that CTS (defined by
physical tests/symptoms) was significantly associated (OR=2.0; 95% CI
1.6-2.5) with pinch force exertion (combination of force and deviated
wrist posture) in female sewing machine operators (Armstrong and
Chaffin 1979, Ex. 26-348). Because of the case-control study design, it
is not clear whether deviated postures contributed to the development
of CTS or whether the CTS symptoms
[[Page 68463]]
led to the use of abnormal postures during work.
Four of the studies addressed CTS and manual work involving
vibrating power tools. A case control study by Chatterjee et al.found a
significant difference (OR=10.9; 95% CI 1.0-524) in the prevalence of
CTS cases (defined by NC studies/symptoms) in rock drillers compared
with controls (Chatterjee et al.1982, Ex. 26-942). The rock drillers
were exposed to vibration frequencies between 31.5 and 62 Hertz. The
highest relative risks (OR=21.3; p0.002) for CTS (defined by physical
tests/symptoms) were found in forestry workers using chain saws
compared to maintenance workers who did not use power tools (Bovenzi et
al.1991, Ex. 26-1433). Differences in ambient temperatures (potential
confounder) between outdoor (chain saw operators) and indoor work
(maintenance workers) may have contributed to the results. Koskimies et
al.reported significant correlations between reductions in NC
velocities in the median and ulnar nerves and number of years of
vibration exposure in forestry workers who used chain saws greater than
500 hours in the previous 3 years (Koskimies et al.1990, Ex. 26-973).
The prevalence of CTS (defined by physical tests/symptoms) in these
workers was 20 percent. In another study, Bovenzi et al.reported an OR
of 3.4 (95% CI 1.4-8.3) for CTS (defined by NC studies/symptoms) among
stone quarry drillers/carvers exposed to hand-transmitted vibration
when compared to polishers who performed manual operations and were not
exposed to vibration (Bovenzi et al., 1994, 26-774). In these four
studies, flexor tendons and the median nerve of the hand were probably
subjected to a considerable degree of forceful exertion as well as
mechanical injury during use of these power tools. Vibration can also
cause direct damage to the digital arteries leading to sensory loss and
numbness.
There were three studies that did not find statistically
significant association between CTS and exposure to physical risk
factors, even though each reported substantially raised ORs. Moore and
Garg found an OR of 2.8 (95% CI 0.2-36.7) for CTS (defined by NC
studies/symptoms) among pork processing workers in hazardous jobs
compared to safe jobs (Moore and Garg 1994, Ex. 26-1033). Jobs were
categorized based on videotape analysis for estimates of force,
repetitition and awkward postures. The possible presence of a healthy
worker effect (most workers were laid off in the year prior to the
study) and the short latency period (8-32 months) limits confidence in
the relative risk estimate.
An OR of 6.7 (95% CI 0.8-52.9) for CTS (defined by NC studies/
symptoms) was reported in a study of supermarket workers rated for high
versus low exposure to repetitive and forceful wrist motions as judged
by an ergonomist and industrial hygienist (Osorio et al.1994, Ex. 26-
807). However, the entire study consisted of only 56 workers grouped
into 3 categories for analysis limiting the power of the study to find
a statistically significant association. Baron et. al. (Ex. 26-697)
also studied CTS (defined by physical tests/symptoms) in 124 grocery
store checkers and reported an OR of 3.7 (95% CI 0.7-16.7) compared to
157 non-checkers. Physical examinations were not done on all workers
and the relative risk measure was based on responses to a standardized
questionnaire. The exposure level for checkers was characterized as
having low peak force and a medium level of repetition; therefore, the
intensity of exposure to physical risk factors was less than that among
workers examined in other studies.
Almost all studies controlled for the obvious confounders of age,
gender, and predisposing medical conditions by selection of an
appropriate referent population, stratification, or use of a multiple
logistic regression model. Many of the cross-sectional studies either
excluded workers with pre-existing CTS prior to employment or excluded
recently hired workers from the study. Therefore, it is unlikely that
the reported associations between CTS and exposure to biomechanical
risk factors reflected preferential employment of those with CTS (i.e.,
the requirements for entry into the cohort made it likely that exposure
preceded the onset of CTS).
NIOSH (1997, Ex. 27-1) concluded that there was epidemiological
evidence of a positive association between CTS and highly repetitive
work, either alone or in combination with other risk factors. They also
found evidence of positive associations between forceful work and work
involving hand/wrist vibration and CTS. However, NIOSH concluded there
was insufficient evidence of an association between CTS and exposure to
extreme postures alone because of individual variability in work
methods and difficulties in measuring postural characteristics. NIOSH
did recognize that there was strong evidence that exposure to a
combination of physical risk factors along with non-neutral wrist
postures was related to the onset of CTS.
A large number of studies that addressed physical work factors and
CTS were submitted into the OSHA docket following publication of the
proposal; those that OSHA found to be of adequate study design are
included in Table V-5 (Frost et al.1998, Ex. 38-198; Roquelaure et
al.1997, Ex. 500-41-111; Latko et al.1999, Ex. 38-123; Rossignol et
al.1997, Ex. 502-420; Leclerc et al.1998, Ex. 500-41-85; Atroshi et
al.1999, Ex. 38-181; Gorsche et al.1999, Ex. 500-121-23; Kearns et
al.2000, Ex. 500-71-34; Katz et al.1998, Ex. 38-393). All but three of
these studies (Ex. 500-121-23; Ex. 500-71-34; Ex. 38-393) found
significantly increased prevalence of CTS among workers exposed to
physical risk factors. The three studies that did not find a
statistically significant association did not rely on independent
assessment or observation of exposure to physical work factors, but
instead used job titles or self-reported survey information to infer
exposure. One of these studies, Gorsche et al.(Ex. 500-121-23), found
an increased prevalence and incidence of CTS in a cross-sectional and
longitudinal study of meat packers but it was not statistically
significant. Kearns et al.(Ex. 500-71-34), who ascertained cases only
by nerve conduction studies and did not rely on symptoms or clinical
evaluation to diagnose CTS, also failed to find a statistically
significant association. Katz et al.(Ex. 38-393) studied factors
associated with long-term disability rather than the development of
CTS.
In contrast, three studies that did measure or observe exposures
and used a combination of symptoms, physical tests, and nerve
conduction velocity measurements to diagnose CTS found strong
associations with exposure to repetition and/or force (Exs. 38-198,
500-41-111, 38-123). Another study, the SHARP study (Ex. 500-41-116) of
poultry processing workers summarized in the hand/wrist tendinitis
section above, found that the number of forceful exertions per hour was
significantly predictive of CTS (p=0.004).
Many studies of CTS contained in the rulemaking docket are not
included in Table V-5 either because it was questionable whether
exposure to physical risk factors occurred or because the study did not
address the relationship between physical risk factors and CTS (Nathan
and Keniston 1993, Ex. 351-14; Stallings et al.1997, Ex 351-20;
Franzblau et al.1994, Ex. 38-175; Nordstrom et al.1988, Ex. 500-25-9;
Zetterberg and Ofverholm 1999, Ex. 500-121-78). Other studies were not
included on OSHA's summary table because they used a flawed study
design or a flawed statistical analysis to examine the relationship
between exposure to biomechanical risk factors and CTS (Malchaive et
al.1996, Ex. 500-
[[Page 68464]]
66-5; Homan et al.1999, Ex. 38-172; Olafsdotti et al. 2000, Ex 38-288.
One of the above studies is among several papers published by Dr.
Peter Nathan and colleagues, which were based on two group of workers
whom they have followed prospectively (Ex. 26-990; Ex. 26-988; Ex. 26-
989; Ex. 26-1294; Ex. 26-517; Ex. 38-437; Ex. 38-13; Ex. 351-14).
Because of the importance of these studies to the ergonomics
rulemaking, they are addressed in detail here. In one of the earlier
studies (Nathan et al.1988, Ex. 26-990), nerve conduction was assessed
on 471 randomly chosen individuals from four industries (steel mill,
meat/food packaging, electronics, and plastics manufacturing). The
group was divided into the following exposure categories:
Group 1, very low force, low repetition;
Group 2, low force, very high repetition;
Group 3, moderate force, moderate repetition;
Group 4, high force, moderate repetition; and
Group 5, high force, high repetition.
No significant difference in median nerve sensory latency values was
found between Group 1 and Group 2, which differed primarily by the
amount of repetition exposure. There was a statistically significantly
higher number of subjects with median nerve slowing in Group 5 compared
to Group 1, but not when compared to Groups 2, 3, or 4. When individual
hands were used to base calculations rather than number of individuals,
only Group 3 showed a significantly higher prevalence of median nerve
conduction slowing. When prevalence ratios were calculated, Groups 3,
4, and 5 had significantly higher PRs compared to Group 1.
This same group of workers was followed up for five years in a 1992
study (Ex. 26-988) and eleven years in a 1998 study (Ex. 38-13). The
study used hands, rather than individuals, as the basis for analysis.
The authors stated that they found no significant difference in the
prevalence of median nerve slowing among any of the exposure groups.
The authors claimed to have confirmed this finding in a second combined
cohort of Japanese and American industrial workers (Ex. 38-437) as well
as validated their exposure categories (Ex. 26-1294). They went on to
show that slowing of nerve conduction was significantly associated with
obesity (Ex. 26-989), body mass index (Ex. 26-517), wrist depth/width
and a number of other non-occupational risk factors (Ex. 351-14).
However, their research has a number of flaws in the study design,
analysis and interpretation of the results, which call their
conclusions into doubt. Chief among these is the failure to adequately
justify and validate their grouping and rank order of occupational hand
use. This provides multiple opportunities for exposure
misclassification and will tend to underestimate the association of
exposure with health outcome. This aspect of the study has been
criticized by several experts (Ex. 26-1010; Ex. 26-952; Tr. 1000).
Despite this potential for misclassification, there was a significant
increase in prevalence between the lowest (Group I) and higher exposure
groups combined (Groups III, IV, and V) in the cross-sectional study
(Ex. 26-990). Others have also concluded that, methodological
shortcomings aside, the articles by Nathan et al.demonstrate a positive
exposure-response relationship between ``occupational hand activity''
and slowed conduction of the median nerve (Tr. 1519-1522; Tr. 9862).
Others have testified that alternative exposure grouping of the data
resulting in less exposure misclassification would result in a clear
exposure-response relationship between job group and median nerve
latency (Punnett testimony, Ex. 37-2; Gerr testimony, 27-2). Some who
testified at OSHA's informal hearing have also stated that Dr. Nathan's
articles use statistical presentation and analysis methods that obscure
the evidence, and that not enough data are presented for the reader to
independently evaluate whether the authors' conclusions are justified
(Tr. 1521; Tr. 7850.). Low participation rates, unusual and
inconsistent case definition, and inappropriate statistical analysis
may also have limited the ability to detect increases in CTS prevalence
over time in these studies with respect to work-related biomechanical
factors. For example, the authors reported in the baseline study that
they randomly selected the study participants (Ex. 26-990). However,
they did not report the proportion of those who were selected and
invited that actually participated. Since the 471 subjects represented
only 26 percent of the total workforce of the participating companies,
the representativeness of the sample is unknown, the ability to
generalize from the data is highly limited, and the potential for
selection bias is substantial. There is no comparative information on
participants and non-participants with respect to demographics,
occupational history or exposure, or medical history. The lack of
clarifying information is particularly problematic because the
direction of the selection bias could be either toward or away from the
null value. This problem affects not only the 1988 baseline study but
all future follow-up studies of the same cohort. Because of these
criticisms, OSHA finds that the Nathan studies do not convincingly
demonstrate a lack of association between workplace exposure to
biomechanical risk factors and CTS.
In his written testimony, Dr. Peter Nathan calls into question the
case definition for CTS relied upon by OSHA in their evaluation of the
epidemiological studies (Ex. 32-241-3-13). He testifies that ``there is
general agreement among experts that classic symptoms associated with
positive electrodiagnostic findings for the median nerve are necessary
for a diagnosis of CTS'' but that ``there is no general agreement that
symptoms, in the presence of negative electrodiagnostic findings is
equivalent to CTS.'' (Id., pg 4). Dr. Nathan then goes on to criticize
OSHA and NIOSH, in their 1997 review, for accepting studies that use
CTS case definitions without electrodiagnostic confirmation. He argues
that longitudinal studies are the only study design of value for
determining causation and concludes ``if one required electrodiagnostic
studies for a valid case definition of CTS, and a longitudinal design
for establishing temporal relationships, then only one [his own] of the
31 studies analyzed by NIOSH would have met standard criteria for
establishing causation.'' (Id., pg 11).
OSHA accepts that specific symptoms determined during clinical exam
in combination with objective evidence of median nerve dysfunction
through electrodiagnostic tests is the most definitive case definition
for CTS at the present time. This has been supported by expert
testimony not only from Dr. Nathan but Dr. Frederick Gerr (Ex. 37-2)
and Dr. Gary Franklin (Tr. 13363). OSHA also does not dispute lack of
agreement among experts on CTS diagnosis when symptoms exist in the
presence of normal median nerve conduction. However, the relevant issue
is whether clinical symptoms and signs in the absence of
electrodiagnostic testing are an invalid CTS case ascertainment for the
purposes of evaluating epidemiological evidence to determine if work-
related physical factors are associated with the disorder. NIOSH
addressed the issue in its 1997 review and cited studies that found
satisfactory correlations between CTS diagnosed by nerve conduction and
the disorder diagnosed by symptom questionnaire and physical
examination (Ex. 26-1501; Ex. 26-439). It was also reported that
clinical examination for CTS diagnosis without the benefit of
[[Page 68465]]
nerve conduction studies has a sensitivity of 84 percent and a
specificity of 76 percent (Ex. 26-1208). This indicates that without
the aid of electrodiagnostics, one would make a CTS diagnosis when the
disorder is not present (false positive) in about one in four subjects.
On the other hand, clinical exam is expected to miss a diagnosis (false
negative) when CTS is present about one in six subjects. While this
degree of sensitivity and specificity may not be acceptable when making
treatment decisions, such as surgery, OSHA does not believe it
introduces substantial bias for purposes of evaluating epidemiological
evidence.
OSHA does not agree with Dr. Nathan's assertion that only
longitudinal studies are relevant in evaluating causation. Longitudinal
prospective cohort studies are indeed the strongest epidemiological
study design, especially for establishing temporal relationships.
However, they often require extended periods of time, are more costly,
and are not as numerous other study designs. Other types of
epidemiology, such as cross-sectional and case-control studies, add
evidence of causality in terms strength and consistency of association
and exposure-response.
OSHA has examined the epidemiological data base and finds that even
if one restricts the evidence to studies that used abnormal median
nerve conduction to establish CTS case ascertainment, there is
reasonable evidence of association between repeated, forceful exertions
of the hand and CTS. There were eleven studies either reviewed by NIOSH
in their 1997 review or submitted to the OSHA docket during the
rulemaking process that found statistically significant associations
between combinations of force, repetitive motion, awkward posture, and
segmental vibration and CTS defined by electrodiagnostic criteria (Ex.
38-396; 26-942; 38-198; 26-1118; 26-1221; 23-1001; 26-1027; 500-41-28;
500-41-85; 38-181; 26-973). The entire body of epidemiological studies
described in the preceding paragraphs is also supported by impressive
biomechanical and psychophysical data, discussed in the following
subsection, that shows sustained force on the flexor tendons along with
flexion/extension of the wrist increases carpal tunnel pressure and
reduces exertion and perceptions of discomfort. In his written
testimony (Ex. 37-2), Dr. Fredric Gerr discussed his evaluation of the
epidemiological studies that used abnormal nerve conduction to diagnose
CTS and made the following statement in his oral testimony at the
hearing:
However, when significant positive associations between work and
carpal tunnel syndrome are observed repeatedly, in study after
study, by investigator after investigator, in country after country
and at many different times, we must ask ourselves why. In my
opinion, after reading these studies and considering all the
possible reasons why so many studies show this relationship, the
most reasonable, plausible, and likely explanation is that work
really did cause the carpal tunnel syndrome observed in these
studies. (Tr. 1525)
Biomechanical and Psychophysical Evidence
Several clinical and cadaver studies confirm that fingertip force,
wrist flexion/extension, repetitive tasks and combinations of the above
are able to raise carpal tunnel pressure (CTP) in a dose-dependant
manner. Mean CTP was raised from 5 mm Hg in a neutral wrist position to
approximately 100 mm Hg at 60 degree wrist extension and 80 mm Hg at 60
degree flexion in a population of CTS patients and controls (Weiss et.
al. 1995, Ex. 26-236). CTP has been shown to significantly increase
with increasing finger tip force (Rempel et. al. 1997, Ex. 26-889) and
with clenching a fist or holding an object in a power grip (Seradge et.
al. 1995, Ex. 26-325). There was a two- to three-fold increase in CTP
when performing a repetitive task involving change in wrist posture 20
times per minute for 5 minutes (Rempel et. al. 1994, Ex. 26-1151). The
elevated CTPs found in these human biomechanical studies are within the
range of neuronal pressures shown to impair blood flow, axonal
transport, and nerve conduction in experimental animals.
Psychophysical data support the biomechanical findings. They show
that maximum acceptable weight (MAW) and torque (MAT) decrease and
perceived exertion and discomfort increase with the frequency and
duration of repetitive wrist motions. The psychophysical method was
used to determine the preferred weights for one-handed horizontal
transfer tasks (e.g. hand/wrist motion used to move an object across a
supermarket scanner). Frequency and duration of the transfer movement
significantly decreased MAW in an exposure-dependent manner and
increased perceived exertion over an eight-hour session (Krawczyk et.
al. 1992, Ex. 26-974). In another study, MAT was reduced over the
course of a seven-hour trial of repeated flexion and extension of the
wrist (Snook et. al. 1995, Ex. 26-212). The magnitude of MAT reduction
correlated with the frequency of the task and perceived discomfort
increased with increasing repetition.
Conclusion
The 1997 NIOSH report concluded the following with regard to the
relationship between work-related physical risk factors and CTS:
Based on the epidemiologic studies reviewed, especially those
with a quantitative evaluation of the risk factors, the evidence is
clear that exposure to a combination of the job factors studied
(repetition, force, posture, etc.) increases the risk of CTS. This
is consistent with the evidence in the biomedical, physiological,
and psychosocial literature (Ex. 26-1).
OSHA also finds convincing evidence that jobs involving repetitive and
forceful movements of the hand and wrist are linked to CTS. The
epidemiological findings are supported by clinical, biomechanical, and
psychophysical studies showing that repetitive tasks involving flexion/
extension of the wrist and force to the flexor tendons result in
substantial increases in CTP, reductions in measured exertion, and
perceptions of discomfort. This evidence is clearly consistent with the
pathophysiology of CTS in which elevated CTP can lead to compression of
the median nerve resulting in the clinical signs and symptoms
characteristic of this MSD. OSHA finds that the epidemiological and
biomechanical literature convincingly demonstrates a causal
relationship between forceful and repetitive exertions to the hand,
especially in combination with a flexed wrist, and an increased risk of
carpal tunnel syndrome. Forceful and repetitive exertion includes
vibration from the use of hand-held power tools.
Hand-Arm Vibration Syndrome
Hand-arm vibration syndrome (HAVS) refers to a collection of signs
and symptoms that occurs when vibration from a tool is transferred to a
worker's hand or arm. The symptoms include numbness, blanching of the
fingers, pain in response to cold exposure, and reduction in grip
strength. These manifestations are similar to Raynaud's phenomenon
triggered by cold temperatures. HAVS symptoms are believed to be the
result of both neurological and circulatory disturbances, probably
occurring independently and by unrelated mechanisms. Vibration may
directly injure (as opposed to indirect damage from compression as in
CTS) peripheral nerve endings and neuroreceptors causing numbness,
tingling and pain in the fingers. Histopathology of persons suffering
from HAVS indicate that
[[Page 68466]]
vibration may also directly damage endothelial cells of the digital
arteries resulting in a lack of response to certain vasodilators and
thickening of the vessel walls. These physiological changes can cause
vascular constriction and ischemia of the surrounding musculoskeletal
and neural tissue. The clinical outcome is blanching of the fingers
(``white finger''), loss of feeling, muscle weakness, and weakened grip
strength.
Epidemiological Evidence
NIOSH reviewed 20 post-1988 epidemiological studies that addressed
workplace risk factors and HAVS. Table V-6 summarizes some key aspects
of these investigations, such as the occupations examined, the
biomechanical risk factors they were exposed to, whether exposures were
directly observed or measured during the study, and whether the health
outcomes were verified by trained medical personnel during physical
examination. Previous investigations were reviewed as part of the 1989
NIOSH criteria document on exposure to HAV (Ex. 26-392). In its 1997
evaluation, NIOSH featured four cross-sectional studies (Bovenzi et
al.1988, Ex. 26-1500; 1994, Ex. 26-1239; 1995, Ex. 26-354; Nilsson et
al.1989, Ex. 26-1148) and one prospective study (Koskimies et al.1992,
Ex. 26-1490), which met most of NIOSH's criteria for high quality.
These investigations determined HAVS based on medical exam and did not
strictly rely on self-reported questionnaires. Standard and relatively
uniform diagnostic criteria were used in defining HAVS cases. This
generally included episodes of cold-provoked, well-demarcated blanching
of the fingers, occurrence of vibration white finger attacks after
employment and following use of power tools, and abnormal digital
artery response to cold provocation. All studies used the Stockholm
Taylor-Palmear scale to grade and stage symptoms. The five
investigations included vibration measurements of exposure on tools
used by the study subjects combined with information on exposure time
obtained by direct interview.
The four cross-sectional studies found statistically significant
positive relationship between exposure to vibration and prevalence of
HAVS. The strength of this association was high with reported ORs
ranging from 6 to 85. The one prospective study showed significant
decreases in HAVS prevalence with decreasing exposure to vibration over
time. All five investigations contributed evidence of exposure-response
relationships between HAVS and vibration acceleration or duration of
exposure. One study also documented a relationship between exposure and
symptom severity.
Table V-6.--Summary of Epidemiology Studies Examining Hand-Arm Vibration
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study Job type studied Physical Factors Exposure basis Diagnosis Risk measure (95% CI)1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nilsson (1989) Ex. 26-1148......... Pulp mill machining.. V Tool acceleration.... Physical exam........ OR=14-85 *
(15-486)
Bovenzi (1995) Ex. 26-354.......... Forestry............. V Chain saw Cold provocation..... OR=6.2-32 *
acceleration. (11-93)
Bovenzi (1994) Ex. 26-1239......... Stone drilling....... V Tool acceleration.... Physical exam........ OR=9.3 *
(4.9-17.8)
Bovenzi (1988) Ex. 26-1500......... Stone cutting........ V Tool acceleration.... Physical exam........ OR=6.1 *
(2.0-19.6)
Brubaker (1987) Ex. 26-762......... Forestry............. V Chain saw Symptoms ischemia.... NR
acceleration.
Koskimies (1992) Ex. 26-1490....... Forestry............. V Chain saw Physical exam........ NR
acceleration.
Brubaker (1983) Ex. 26-763......... Forestry............. V Questionnaire........ Symptoms ischemia.... NR
Dimberg (1991) Ex. 26-1395......... Aircraft machining... V Questionnaire........ Questionnaire........ NR
Krivekas (1994) Cited in Ex. 26-1.. Forestry............. V Questionnaire........ Pyhsical exam........ OR=3.4-6.5 *
(2.4-17.5)
Letz (1992) Ex. 26-384............. Ship-yard............ V Tool acceleration.... Questionnaire........ OR=5.0-40.6 *
(11-176)
McKenna (1993) Ex. 26-745.......... Machine riveting..... V Questionnaire........ Cold provocation..... OR=24 *
(3.1-510)
Mirbod (1992) Ex. 26-1492.......... Forestry............. V Chain saw Physical exam........ NR
acceleration.
Mirbod (1997) Ex. 500-121-49....... Motorcyclists........ V Handlebar Questionnarie........ NR *
acceleration.
Mirbod (1999) Ex. 500-121-48....... Metal grinding....... V Job title............ Physical tests....... NR *
Mirbod (1994) Ex. 26-1491.......... Multiple industries.. V Tool acceleration.... Questionnarie........ OR=3.8 *
(2.1-6.8)
Musson (1989) Ex. 26-743........... Power tool use....... V Tool acceleration.... Questionnaire........ NR
Nagata (1993) Ex. 26-1494.......... Chain saw operation.. V Job title............ Physical exam........ OR=7.1 *
(2.5-19.9)
Saito (1987) Ex. 26-1440........... Chain saw operation.. V job title............ Cold provocation..... NR
Palmer (1998) Ex. 500-121-56....... Pavement breaking.... V estimated tool Physical exam cold OR=2.2-2.6*
acceleration. test. (1.4-4.8)
Palmer (2000) Ex. 500-121-57....... Multiple industries.. V Questionnaire........ Questionnaire........ PRR=1.5-2.2*
(1.9-2.4)
Lindsell (1999) Ex. 500-205-13..... Dockyard work........ V Job title............ Cold provocations.... NR *
McGeoh (2000) Ex. 500-41-96........ Welding.............. V Questionnaire........ Questionnaire........ NR *
Shinev (1992) Ex. 26-836........... Polishing............ V Tool acceleration.... Physical exam........ NR
[[Page 68467]]
Starck (1990) Ex. 26-1510.......... Machining............ V Tool acceleration.... Questionnaire........ NR
Virokannas (1995) Ex. 26-891....... Railway.............. V Questionnaire........ Questionnaire........ NR
Miyashita (1992) Ex. 26-1223....... Construction......... V Questionnaire........ Questionnaire........ OR=0.5
(0.1-11.8)
--------------------------------------------------------------------------------------------------------------------------------------------------------
V=vibration; OR=odds ratio; NR=not reported.
* =p0.05.
1 95% confidence interval expressed for the upper end of the risk measure range.
Bovenzi et al.found a significantly greater prevalence of HAVS in a
group of 222 active forestry workers engaged in chain saw work as
compared to randomly chosen shipyard workers unexposed to hand
vibration (Bovenzi et al.1995, Ex. 26-354). The reported OR was 11.8
(95% CI 4.5-31.1) for all forestry workers and 6.3 (95% CI 2.3-17.1)
for workers only using ``anti-vibration'' saws. The study found a
nearly linear dose-response between HAVS prevalence and both vibration
acceleration and years of exposure. Vibration exposure was determined
from questionnaire reports on frequency of chain saw work and direct
measurement of vibration produced by 30 different saws.
In two earlier studies, Bovenzi et al.examined HAVS in stone quarry
drillers and carvers exposed to vibration from hand-held power tools
along with an unexposed referent group. The first investigation found a
statistically significant HAVS prevalence (OR=6.1; 95% CI 2.0-19.6) in
75 drillers/cutters compared to unexposed mill workers (Bovenzi et
al.1988, Ex. 26-1500). There was a significant association between the
level of vibration acceleration and severity of symptoms. In a much
larger study of 570 quarry drillers/carvers and 258 polishers/machine
operators not using power tools, an OR of 9.3 (95% CI 4.9-17.8) was
reported (Bovenzi et al.1994, Ex. 26-1239). HAVS prevalence showed a
significant increasing trend with estimates of lifetime vibration
exposure.
In the Nilsson study, HAVS was examined in 89 platers and 61 office
workers from a pulp mill machine manufacturing plant (Nilsson et
al.1989, Ex. 26-1148). Prevalence of HAVS (OR=85; 95% CI 15-486) was
much greater for platers with current exposure to vibration than
unexposed office workers. There was a clear dose-response between HAVS
and years of exposure.
Koskimies et al.investigated HAVS in a group of 124 forestry
workers from 1972 to 1990 using a series of ten cross-sectional studies
over time (Koskimies et al.1992, Ex. 26-1490). Their analysis showed a
monotonic decrease in prevalence from 40 percent in 1972 to 6 percent
in 1990. In a subcohort of 57 workers followed prospectively, HAVS
cases decreased from 35 percent in 1975 to 6 percent in 1986. Over the
same time period, modifications in chain saws used by the workers
resulted in a reduction vibration acceleration from 14 m/s2
to 2 m/s2. While it is likely that the decline in HAVS is
due to changes in the vibration acceleration, exposures and outcomes
were never linked for individual workers.
The 1989 NIOSH criteria document (Ex. 26-392) provides some
epidemiological evidence for an exposure-response relationship and
temporal association between HAVS and vibration exposure. NIOSH
analyzed HAV acceleration levels and prevalence of HAV-related vascular
symptoms from 23 cross-sectional studies and found the two variables
linearly correlated (R=0.67; p0.01). Many of these earlier studies
determined latency between vibration exposure and onset of HAVS
symptoms providing some evidence of a temporal relationship.
Unfortunately these data may be subject to recall bias since the mean
latency was about six years and onset of symptomatology was often self-
reported.
Most studies accounted for potential age-related effects by
stratification of the analysis or through the use of multiple logistic
regression. These studies also controlled for non-occupational
disorders that involve symptoms similar to HAVS, such as idiopathic
Raynaud's phenomena, peripheral neuropathy, alcohol-related illness,
etc. According to NIOSH (1997, Ex. 26-1), it does not appear that these
potential confounders account for the fairly strong and consistent
association between HAVS and vibration.
Four studies that address vibration and HAVS were submitted into
the OSHA docket following publication of the proposal (Mirbod et
al.1999, Ex 500-121-48; Mirbod et al.1997; Ex 500-121-49; Ex 500-205-
21; Palmer et al.1998, Ex 500-121-56; McGeoch and Gilmour 2000, Ex.
500-42-96; These are summarized in Table V-6. Studies that either
measured tool acceleration or based HAVS on a combination of symptoms
and medical tests found a significant association between segmental
vibration exposure and this MSD (Ex. 500-121-49; Ex. 500-121-56 Ex.
500-121-48).
Conclusion
The 1997 NIOSH report concluded the following with regard to the
relationship between work-related physical risk factors and HAVS:
The 20 epidemiological studies show strong evidence of a
positive association between high level exposure to hand-arm
vibration and vascular symptoms of hand-arm vibration syndrome
(HAVS). These studies are of workers with high levels of exposures
such as forestry workers, stone cutters or carvers, shipyard
workers, or platers. These workers were typically exposed to HAV
acceleration levels of 5 to 36 m/s2 * * * There is
substantial evidence that as intensity and duration of exposure to
vibrating tools increase, the risk of developing HAVS increases.
[Ex. 27-1, Emphasis in original]
OSHA agrees with the NIOSH statements that intensity and duration
of exposure to vibrating tools is linked to the risk of developing
HAVS. Most of the epidemiological studies show a strong and consistent
association between high-level exposure to HAV and HAVS symptomatology.
The data indicate there are strong exposure-response relationships
between the magnitude and duration of exposure and HAVS prevalence and
severity. Some studies indicate temporal correlation between the
chronic use of vibrating power tools and the onset of the disorder. A
causal association between vibration and HAVS is consistent with
clinical evidence showing that vibration damages nerve tissue and blood
vessels in the fingers leading to symptoms characteristic of this MSD.
Therefore, OSHA concludes that workers exposed to segmental vibration
exposure, such as from long-term use of hand held power tools, are
[[Page 68468]]
at increased risk of developing hand-arm vibration syndrome.
Hypothenar Hammer Syndrome
Hypothenar hammer syndrome (HHS) is a collection of vascular and
neurological signs and symptoms that have been related to repeated
trauma to the hand. HHS is associated with striking or pushing hard
objects with the hypothenar region of the hand using the hook of the
hamate bone as an anvil. At this location, the palmar blood vessels of
the ulnar artery and the sensory branch of the ulnar nerve lie
virtually unprotected near the surface of the skin and become trapped
between ``the hammer'' (i.e. the hard object) and ``the anvil'' (i.e.
the hamate bone). As a result, the blood vessels and nerves are
especially vulnerable to injury by external mechanical stress. The
repeated blunt trauma can lead to ulnar artery spasm, aneurysm
formation, and/or thrombosis. These lesions cause arterial occlusion,
vascular insufficiency, and post-traumatic ischemia of the surrounding
tissue. The damage to neural tissue and reduced blood flow to the
fingers are responsible for the most frequently reported symptoms of
pain, numbness, cold feeling, discoloration and stiffness of the
affected digits. A diagnosis can be made based on symptoms and a
physical examination test of the radial and ulnar arterial blood supply
to the hand, termed the Allen test. This test measures reflow time
through the arteries following compression. Reflow time is
substantially delayed in patients that suffer ulnar artery occlusion.
More recently, arteriography has been used to confirm diagnosis of HHS.
If elimination of the contact stress fails to resolve symptoms,
vascular reconstructive surgery is often performed (Ex. 500-41-29).
There are four case studies of hospital or surgery clinic patients
with HHS in the OSHA docket that have consistently implicated
occupational exposure to repeated palmar trauma as a critical risk
factor (Conn et al.1970 Ex. 26-821; Vayssairet et al.1987 Ex. 500-41-
47; DeMonoco et al.1999 Ex 500-41-39; Ferris et al.2000 Ex. 500-41-33).
These studies report on 58 patients altogether. In almost every case,
the individuals suffering from the disorder reported a history of
repetitive blunt trauma to the hand related to their jobs. Occupations
such as carpenter, metal worker, machinist, and mechanic were most
often cited. More infrequently, the HHS patients were engaged in
hobbies in which the hand was exposed to frequent impact, such as
karate and wood working. It should be noted that use of the hand as a
hammer or to repeatedly apply direct impact to a hard object is a
specialized combination of repetitive motion and mechanical force
applied directly to a specific anatomical region. Other studies have
reported HHS in workers repeatedly exposed to high-frequency mechanical
stress to the palm from occupational use of hand-held vibrating tools
(Nilsson et al.1989 Ex. 26-1148; Kaji et al.1993 Ex. 500-41-70). Thus,
HHS is clearly another example of a work-related injury that occurs as
a result of combined exposure to biomechanical risk factors (e.g.
repetition, force, vibration) associated with other MSDs of the upper
extremities.
Epidemiological Evidence
Besides the case studies mentioned above, there were two cross-
sectional studies in the rulemaking docket that investigated HHS among
workers (Little and Ferguson 1972 Ex. 500-41-89; Kaji et al.1993 (Ex.
500-41-70 ). Little and Ferguson examined 79 male vehicle maintenance
workers from Australia for HHS who self-reported daily use of the hand
as a hammer and 48 employees in the same shops who did not report
habitual hand hammering. HHS was identified by both a positive Allen
and Doppler test. The Doppler test charted blood flow from the radial
artery and had shown good correlation with ulnar artery occlusion as
measured by arteriography. The prevalence of HHS was 14 percent (11 out
of 79) in the exposed workers and 0 percent in the referent population.
The mean duration of employment (29.9 years) was significantly greater
(p0.02) in subjects with HHS than in men exposed to repeated trauma
without the disorder (mean duration of 18.7 years).
Kaji et al.used arteriography to examine the hands of 330 Japanese
workers that used vibrating tools in mining, forestry, and several
other industries. They found a 7.3 percent (24 cases) prevalence of HHS
among the workers. The injured subjects were predominantly coal miners,
rock drillers and forestry workers that reportedly used air and jack
hammers or chain saws. All suffered from HAVS as well as HHS. The mean
duration of vibration exposure was 19.4 years (range 5 to 30 years).
There was no unexposed referent group and no direct observation or
measurements of vibration exposure in the study.
Conclusion
There is clear evidence that repeated and forceful impact between
the hypothenar region of the hand and hard objects, such as hand
hammering while on the job, or frequent exposure to mechanical stress
from use of hand-held vibrating tools increase the risk of developing
HHS. The occluded blood vessels that develop in the palmar region of
the hand as a result of the blunt trauma created by these occupational
risk factors have been cited in numerous case studies. The
pathophysiology that links the initial damage with tissue ischemia and
the characteristic symptoms that define HHS are also well established
in the medical literature. Although limited in terms of numbers and
design, the epidemiological findings are consistent with the clinical
evidence and provide support for a causal association between repeated
and forceful contact stress to the hand and this disorder. OSHA
concludes that workers exposed to repeated and forceful impact between
the hypothenar region of the hand and hard objects, such as hand
hammering while on the job, or frequent exposure to mechanical stress
from use of hand-held power tools, are at increased risk of developing
hypothenar hammer syndrome.
E. Disorders of the Low Back
Low-back pain has long been associated with the performance of
heavy physical work (Hales and Bernard 1996, Ex. 26-896; Klein, Jensen,
and Sanderson 1984, Ex. 26-972; Rowe 1969, Ex. 26-318; 1971, Ex. 26-
319). Studies have demonstrated that back disorder rates vary
substantially by industry, occupation and by job within given
industries or facilities (see Bigos et al.1986a, Ex. 26-871; Riihimaki
et al.1989a, Ex. 26-58; Schibye et al 1995, Ex. 26-1463; Skovron et
al.1994, Ex. 26-795). Recently, a NIOSH review (Bernard and Fine 1997,
Ex. 26-1) concluded that several work-related factors are associated
with low-back disorders. The National Academy of Sciences (NAS 1999,
Ex. 26-37) also concluded that there is an association between certain
work factors and low-back disorders. This section summarizes and
discusses the evidence that physical work-related risk factors
contribute to the pathogenesis of specific disorders of the back. The
risk factors are (1) heavy physical work, (2) lifting and forceful
movement, (3) bending, twisting and awkward posture, (4) static work
postures, and (5) whole body vibration. Exposure to several factors
often occurs concurrently in occupational settings and the evidence
indicates that the risk of injury is greatest when more than one factor
is present, reinforcing the concept that these MSDs are both multi
factorial in etiology and that the joint effects of these risk factors
can be synergistic. The
[[Page 68469]]
terms ``back disorder'' or ``back MSDs'' are used to encompass all
adverse health outcomes related to the back.
There are several types of evidence that interrelate to support the
five risk factors stated above as causative factors for MSDs of the
back. Information on pathophysiology provides evidence that links risk
factors to the physiological, anatomical, and pathological alterations
in soft tissues of the back. This speaks to the biologic plausibility
that work-related risk factors contribute to these injuries. There is
also a large volume of epidemiological data that provides evidence of
an association between worker exposure to the identified risk factors
and the occurrence of MSDs of the back. Finally, there is biomechanical
and psychophysical laboratory research that provides much corroboration
and adds to the plausibility and coherence arguments for a causal
association determination.
Epidemiologic and laboratory-based research methods have both been
used to evaluate the significance of various risk factors associated
with work-related musculoskeletal disorders (MSDs). Epidemiologic
studies are designed to look for significant associations between
exposure to ergonomic risk factors and selected health outcomes
(ranging from medically diagnosed disease entities to subjective
reports of pain or discomfort) in selected populations of workers.
NIOSH (Bernard and Fine, 1997, Ex. 26-1) performed a comprehensive
review of the occupational epidemiology back MSD literature and after
carefully selecting those highest quality studies, performed an
assessment of the 42 studies by type of work-related risk factor. This
evaluation draws from the NIOSH assessment and appends it with
additional and more recent studies added to the record.
Although epidemiologic studies provide important insights into
understanding the causes of MSDs, these studies are sometimes
criticized due to their inability to precisely measure exposures to
risk factors and the associated biomechanical and/or physiological
responses to these exposures. Biomechanical models and laboratory
studies do not replace epidemiological studies. However, these
approaches provide important complementary information toward
understanding the complex process of how exposures to ergonomic risk
factors result in physiological responses that may ultimately lead to
work-related injuries and illnesses. Presented here is a summary of
laboratory studies and biomechanical models of work factors associated
with increased risk of low-back injuries and disorders.
Laboratory studies are controlled scientific investigations of how
humans respond when exposed to specific ergonomic risk factors (e.g.,
forceful exertions, awkward work postures, high repetition, etc.)
during simulated work activities. Responses include both objective
biomechanical/physiological measurements, such as the electromyographic
(EMG) activity of a working muscle, and subjective psychophysical
measurements, such as ratings of perceived exertion. Most of the
studies cited were performed in true laboratory settings. A few studies
were performed in operational workplaces modified as necessary to
collect data under carefully controlled conditions. Because of ethical
issues related to the protection and safety of human subjects,
laboratory studies are designed to keep exposures to risk factors at
levels below the threshold of injury. As a result, these studies are
generally incapable of ``proving'' a relationship between exposure and
injury. Despite this limitation, laboratory studies provide important
scientific insights as to how the body responds to ergonomic stresses.
Combined with pathophysiological models of musculoskeletal injury
mechanisms and epidemiological findings of positive relationships
between exposure to ergonomic risk factors and musculoskeletal injury,
laboratory studies are an essential element in understanding the causes
and prevention of work-related overexertion injuries.
Biomechanical models simulate and/or predict how the
musculoskeletal system responds to work factors such as external loads
placed on the hands, work posture, and movement dynamics. These models
can be used to estimate musculoskeletal stresses in the absence of a
human experiment.
To understand the mechanisms by which work causes or contributes to
the genesis or expression of low-back pain, it is first necessary to
comprehend basic low-back anatomy and potential sources of pain. The
majority of low-back disorders involve soft tissues (muscle and
ligament) or the three-disc complex (the intervertebral disc and two
facets). The latter may involve degenerative disc disease, disc
herniation or osteoarthritic conditions. To understand how the
performance of work causes lumbar disc disease, a review of lumbar
anatomy, disc biochemistry, and disc biomechanics is presented here.
With this foundation, pathogenic models are better appreciated. Several
references are available for additional information (Bogduk and Twomey
1991, Ex. 26-720; Chaffin and Andersson 1991, Ex. 26-420; Williams,
McCulloch, and Young 1990, Ex. 26-1563; Wiesel et al.1996, Ex. 26-
1394). This discussion of the anatomy of the low back region is
followed by a summary of the occupational epidemiology literature on
the low back. This section is followed by a discussion of the
biomechanical and laboratory research literature on stressors on the
back.
The epidemiology literature is examined, to the extent possible, by
grouping by specific work-related stress factor. The biomechanical and
laboratory section discusses specific stressors separately for soft
tissue disorders, disc disorders, and arthritis/spondylosis. In the
conclusion section OSHA makes a determination of causality based on the
consistency and strength of the epidemiology evidence and the coherence
with the biomechanical and laboratory evidence. OSHA makes a
determination of causality on each occupational risk factor examined,
where possible; however, the final determination of work-related back
MSDs is based on the totality of the evidence, not on each factor
separately. OSHA believes that determining causal associations between
individual work-related risk factors and MSDs is helpful, both in
making a final determination of causality and in determining ways to
abate risk. However, in discussing the epidemiology evidence it becomes
clear that work often involves simultaneous exposure to multiple risk
factors, even though in any particular situation exposure to one risk
factor may predominate.
Anatomy of the Low Back
The lumbar spine is required to redistribute forces related to both
intrinsic weight bearing and extrinsic load carrying. It is composed of
five vertebral bodies separated by intervertebral discs acting as shock
absorbers and stabilizers, as well as the posterior vertebral ring
composed of pedicles, laminae, spinous and transverse processes, and
facet joints that enclose and protect the spinal cord and spinal nerve
roots. The lumbar vertebrae are numbered from the upper (cephalad) or
first lumbar vertebra (L1) to the lower (caudad) or fifth lumbar
vertebra (L5). Lumbar vertebrae are larger and wider than those in the
dorsal and cervical spine, with the fifth vertebra generally the
largest. This affords a larger surface area for the intervertebral disc
and for load distribution. Disc anatomy and function will be discussed
further in this section. At the lower end of the lumbar spine is the
sacrum, a large, triangular bone
[[Page 68470]]
representing the fusion of five sacral vertebrae, and the small coccyx.
Consistent with the greater vertebral size, the lumbar pedicles are
shorter and wider than in the dorsal spine. Lumbar facets are posterior
articular processes where the adjacent vertebrae interface. These
joints help permit motion and bear some of the compressive load in
addition to helping maintain stability of the spine against torsion and
shear. Facet joints are synovial, and they contain nerve innervations
in the synovial lining.
Anterior and posterior longitudinal ligaments attach to the
superior and inferior margins of the lumbar vertebrae, and are
innervated by pain fibers. The ligamentum flavum is a non-innervated
structure that runs down the vertebral ring, and may hypertrophy after
injury. This may become significant when a hypertrophied ligament
infolds during spinal extension in an individual with disc bulging and
facet arthropathy, thereby creating relative spinal stenosis. The
interspinous ligament, also non-innervated, runs down the posterior
margins of the spinous processes, posterior projections from the
vertebral ring.
In adults, the spinal cord terminates as the conus medullaris at
about the level of the first lumbar vertebra in the upper lumbar spine.
Branching off from the conus is a bundle of lumbosacral nerve roots
that resemble a horse's tail, called the cauda equina. These nerve
roots pass through the lumbar and sacral portions of the spinal canal
surrounded by the vertebrae, intervertebral discs, pedicles, laminae,
facet joints, and spinal ligaments and eventually emerge as individual
nerve roots through the intervertebral foramina. The neural foramen is
bordered by the transverse processes of adjacent vertebrae, and the
spinal nerve root takes its name from the adjacent (cephalad)
vertebrae. The spinal cord is covered by the thecal sac, composed of
meningeal tissue and cerebrospinal fluid.
Nerve roots in the lumbosacral spine include ventral (motor) and
dorsal (sensory) components. Ventral roots contain motor axons sending
signals to distal areas and control various skeletal muscle motor
functions. Dorsal roots comprise primarily sensory axons receiving
signals from distal areas or dermatomes. Thus, symptoms and signs of
nerve root compression will vary with the location of the compressive
lesion. As the intrathecal nerve roots reach the intervertebral
foramen, the root sleeve gradually encloses the nerve more tightly, and
eventually become extrathecal. Cell bodies for sensory axons are
located in an extrathecal area of swelling called the dorsal root
ganglion. These ganglia are encountered in or close to the
intervertebral foramina. Axons of the nerve roots consist of collagen
tissue called the endoneurium. This is covered by a thin root sheath
that separates the endoneurium from a small amount of cerebrospinal
fluid, and the epineurium and perineurium covering. Blood flow derives
from segmental arteries that divide into three branches when
approaching the intervertebral foramen. Nociceptors are present in
facet synovium and outer layers of annulus (or extension of the
posterior longitudinal ligament).
There are several important muscles of the low back. The psoas
muscles are major spinal flexors that originate at the anterior
vertebral borders and combine with the iliacus from the crest of the
pelvic ilium and insert on the pelvis and lesser trochanter of the hip.
Posteriorly, the erector spinae muscles attach to the spinous processes
and laminae down to the sacrum to act as major spinal extensors. The
interspinales muscles run between the five spinous processes of the
lumbar spine and contribute to extension. Several other coactivating
muscles assist in spinal stabilization and rotation. The rectus
abdominis extends from the lower border of the rib cage to the pelvis
and assist in flexion and maintenance of lordosis. The obliques and
transversus are coactivators, and contribute to the generation of
increased intraabdominal pressure, which some feel helps decrease
compressive loading on the spine. External moments imposed on the
lumbar spine during lifting are proportional to the weight and distance
of the load from the spine and the weight and location of the
individual's body segments. This results in a state of equilibrium
where the external moments are counteracted by internal moments,
primarily created by muscle contractions of flexors balancing extensors
with additional stabilization from co-activators. Ligaments provide
passive resistance or restorative moment to muscles. It is not clear,
however, under what lifting conditions the ligaments play a significant
biomechanical role.
Epidemiology of Work-Related Low Back Disorders
When discussing causal factors for low-back disorders, outcome
measures vary and include low-back pain, impairment, and disability.
Outcome measures may be defined in terms of severity and also whether
the information was based on self-reports (interview or questionnaire)
or objective criteria, e.g., lumbar disc pathology.
Because there are numerous conditions in the low back which may
cause low back pain, regardless of their relationship to work factors,
and, in most cases the cause(s) cannot be determined with any degree of
clinical certainty, the most common form of back disorder is ``non-
specific symptoms,'' which often cannot be diagnosed. Therefore, in its
review of the epidemiologic evidence for work-relatedness of low-back
musculoskeletal disorders NIOSH (Bernard 1997; Ex. 26-1) included
subjectively-defined health outcomes (e.g., ``back pain'') because they
comprise such a large subset of the total. From a total of 42 studies,
24 investigations defined the health outcome only by report of symptoms
on questionnaire or interview, 2 used sick leaves and medical
disability retirements and 6 used injury/illness reports. The NIOSH
review of epidemiologic studies of low-back disorders examined the
following potential risk factors related to physical aspects of the
workplace: (1) Heavy physical work (HPW, work that has high energy
demands or requires some measure of physical strength, jobs that impose
large compressive forces on the spine), (2) lifting and forceful
movements (LFM), (3) bending and twisting (BT, awkward postures), (4)
static work postures (SWP), and (5) whole-body vibration (WBV). These
physical risk factors almost always appear in workplaces in
combinations with other work-related risk factors, as well as a myriad
of personal, psychosocial and other factors. However, to the extent
possible the review seeks to examine the physical factors separately.
Furthermore, since this ergonomics rule does not contain provisions
relating to WBV, this last portion of the NIOSH review will be
substantively omitted from this analysis. Table V-7 contains a listing
of both the higher quality back studies used in the NIOSH 1997 (Ex. 26-
1) review and additional back studies in the record.
[[Page 68471]]
Table V-7.--Summary of Epidemiology Studies Examining Musculoskeletal Disorders of the Back
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study/exhibit number Job type studied Physical factors Exposure basis Physical exam. Risk measure (95% CI)\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Punnett, 1991 Ex. 26-39........... Auto assembly........ HPW/BT LFM Observation Yes............... OR=2.2-8.1*
measurement. (1.4-4.4)
Astrand, 1987 Ex. 26-527.......... Pulp mill............ HPW Questionnaire job Yes............... OR=2.3*
title.
Bigos, 1991 Ex. 26-1242........... Aircraft assembly.... HPW Observation No................ NR*
questionnaire.
Burdorf, 1991 Ex. 26-454.......... Concrete fabrication. HPW/BT LFM Observation No................ OR=2.8*
measurement. (1.3-6.0)
Clemmer, 1991 Ex. 26-1345......... Offshore drilling.... HPW Questionnaire job No................ OR=2.2-4.3*
title.
Hildebrandt, 1995 Ex. 26-1516..... Population based..... HPW Questionnaire job No................ OR=1.2*
title. (1.33-1.55)
Heliovaara, 1991 Ex. 26-959....... Population based..... HPW/LFM Questionnaire job Yes............... OR=1.9-2.5*
title. (1.4-4.7)
Hildebrandt, 1996 Ex. 26-770...... Steel maintenance.... HPW Questionnaire job No................ NR
title.
Johansson, 1994 Ex. 26-1132....... Metal workers........ HPW/BT LFM Questionnaire job No................ PRR=1.76
title. (1.25-2.47)
Leigh, 1989 Ex. 26-750............ Population based..... HPW Questionnaire job No................ OR=1.5*
title. (1.1-2.2)
Masset, 1994 Ex. 26-1470.......... Steel workers........ HPW/BT Questionnaire job No................ NR
title.
Partridge, 1968 Ex. 26-1, pg. 6-81 Dock workers......... HPW Questionnaire job Yes............... OR=1.2
title.
Riihimaki, 1989 Ex. 26-998........ Concrete workers..... HPW/BT Questionnaire job No................ OR/1.0-1.5*
title.
Riihimaki, 1994 Ex. 26-1188....... Heavy equipment BT Questionnaire job No................ NR
operators. title.
Ryden, 1989 Ex. 26-809............ Hospital employees... HPW/BT Questionnaire job No................ OR=2.2*
title. (1.25-4.15)
Svensson, 1989 Ex. 26-732......... Population based..... HPW/BT LFM Questionnaire job No................ OR=1.2*
title.
Videman, 1990 Ex. 26-1023......... Hospital patients.... HPW/SWP LFM Questionnaire job autopsy........... OR=2.8-24.6*
title. (1.5-409)
Bergenudd, 1988 Ex. 26-1342....... Population based..... HPW Questionnaire job No................ OR=1.8*
title. (1.2-2.7)
Burdorf, 1990 Ex. 26-1518......... Crane operators...... HPW/SWP LFM Questionnaire job No................ OR=0.5-4.0
title. (0.8-21.2)
Chaffin, 1973 Ex. 26-876.......... Electronics manufact. LFM Job title............ No................ OR=5.0*
Holmstrom, 1992 Ex. 26-36......... Manual handling...... LFM/BT SWP Questionnaire job Yes............... OR=1.3* for BT (1.1-1.5)
title.
Huang, 1988 Ex. 26-1204........... School lunch workers. LFM Observation No................ NR
measurement.
Kelsey, 1975 Ex. 26-1134.......... Case/control LFM/SWP Questionnaire job No................ NR
herniated lumbar title.
disc.
Kelsey, 1984 Ex. 26-752........... Case/control LFM/BT Questionnaire job Yes............... OR=3.1*
prolapsed lumbar title. (1.3-7.5)
disc.
Knibbe, 1996 Ex. 26-766........... Nurses............... LFM Questionnaire job No................ OR=1.3
title.
Magora, 1972, 1973 Ex. 26-1513.... 8 occupations........ LFM/BT Observation No................ OR=1.0-1.7*
measurement. (1.3-2.1)
Liles, 1984 Ex. 26-33............. Manual handling...... LFM Measurement.......... No................ OR=4.5*
(1.02-19.9)
Marras, 1995 Ex. 26-14-12......... Manufacturing workers LFM/BT/HPW Observation No................ OR=10.7*
measurement. (4.9-23.6)
Toroptsova, 1995 Ex. 26-1, pg. 6- Machine builders..... LFM/BT/SWP Questionnaire job Yes............... OR=1.4*-1.7*
92. title.
Undeutsch, 1982 Ex. 26-731........ Airport baggage LFM Questionnaire job Yes............... NR
handlers. title.
Walsh, 1989 Ex. 26-1437........... Population based..... LFM/SWP Questionnaire job No................ OR=1.5-2.0*
title. (1.1-3.7)
Skov, 1996 Ex. 26-674............. Saleworkers.......... SWP Questionnaire job No................ OR=2.5*
title. (1.2-4.9)
Mandel, 1987 Ex. 500-41-92........ Hospital nurses...... LFM Questionnaire........ No................ OR=1.4*
Thorbjornsson, 1998 Ex. 500-119-7. Random selection from HPW Questionnaire........ Yes............... OR=1.4*
2500 medical exams. (1.0-2.0)
[[Page 68472]]
Kuh, 1993 Ex. 500-41-80........... Population based..... LFM Job title............ No................ RR=1.3*
(1.0-1.7)
Smedley, 1995 Ex. 500-41-40....... Hospital nurses...... LFM Questionnaire........ No................ OR=1.3-1.8*
(1.3-2.5)
Venning, 1987 Ex. 500-41-49....... Nurses............... LFM Questionnaire job No................ OR=1.7-4.3*
title.
Xu, 1997 Ex. 500-119-9............ Population based..... BT/HPW Questionnaire........ No................ OR=1.3-1.7*
(1.51-1.93)
Stobbe, 1988 Ex. 500-41-45........ Hospital nurses, LFM Questionnaire........ No................ OR=1.0-2.7*
LPNs, attendants.
Park, 1997 Ex. 500-41-104......... Population based..... HPW/LFM/BT Questionnaire........ No................ OR=1.88*
(1.64-2.15) for HPW
Latza, 2000 Ex. 500-41-83......... Population based..... HPW/BT/SWP/LFM Questionnaire........ No................ OR=1.77-1.89*
Latza, 2000 Ex. 500-119-6......... Laying sandstone..... HPW/LFm Questionnaire........ Yes............... PR=1.8-2.6*
(1.1-6.5) for hours/shift
Kerr, in press Ex. 500-39......... Automotive workers... LFM/BT Measurement.......... No................ OR=1.7-2.0*
(1.22-3.59) for
biomechanical factors
Krause, 1998 Ex. 500-87-2......... Transit vehicle HPW Questionnaire records Yes............... OR=3.04*
workers. (1.85-5.00)
MacFarlane, 1997 Ex. 500-41-91.... Population based..... LFM Questionnaire........ Yes............... OR=1.1-2.5*
(1.5-4.1)
Waters, 1999 Ex. 500-41-54........ Lifting case/control. LFM Questionnaire No................ OR=2.45*
measurement. (1.29-4.85)
Wang, 1998 Ex. 500-41-52.......... Manual handling...... LFM Measurement.......... No................ Significant correlation
p0.01
Van Poppel, 1998 Ex. 500-121-71... Airline baggage HPW Questionnaire........ No................ NR
handlers.
Vingard, 2000 Ex. 500-41-51....... Population based..... HPW/LFM/BT Questionnaire........ No................ RR=1.4-2.9*
(1.2-6.8)
Luoma, 1998, (2000) Exs. 500-71- Not by identifiable risk factor but by Job title............ Yes............... OR=2.0-8.1*
39, (38). title--office carpenter machine driver (2.4-21.1)
SHARP, 1993 Ex. 30-7.............. Data entry........... SWP Questionnaire........ No................ NR*
(p0.05)
Larese, 1994 Ex. 38-130........... Hospital nurses...... LFM Measurement.......... Yes............... OR=1.9-2.4*
Myers, 1999 Ex. 500-119-10........ Case/control HPW/BT/LFM Questionnaire No................ OR=1.6-2.0*
municipal workers. measurement job (1.13-3.67) for BT
title.
--------------------------------------------------------------------------------------------------------------------------------------------------------
HPW=heavy physical work; LFM=lifting or forceful movements;
BT=bending and twisting or other awkward postures; SWP=static work postures
IR=incidence rate; OR=odds ratio; RR=relative risk; NR=not reported; *=p0.05
\1\ 95% confidence limits expressed for the upper end of the risk measure range.
Heavy Physical Work
The NIOSH summary reviewed the eighteen higher quality studies
which address the association between HPW and LBP (Ex. 26-1, pgs. 6-4
to 6-13). Of these eighteen, 14 were cross-sectional, 3 were
prospective) and one was a case-control (Ryden et al. 1989, Ex. 26-
801). Study populations included individuals working in health care,
office work, manufacturing and construction, and all with different
physical work requirements. Despite the fact that the studies assessed
different groups of workers, defined disorders and assessed exposures
in many ways, nine of these eighteen found statistically significant
positive associations. The relative risk estimates for these
significant associations generally ranged from 1.1 to 4.3, although one
study of cadavers found a significant OR=12.1 (95% C.I. 1.4--107) for
the risk of osteophytosis among those in the HPW category. OSHA notes
that if there were no true associations only one of these eighteen
studies should have shown a statistically significant result.
With regard to temporality, this is usually most easily studied
with a cohort study design. Of these three studies, one had no
association (Bigos et al. 1991, Ex. 26-1241), while two showed
statistically significant increases (Clemmer et al. 1991, Ex. 26-1345;
Bergenudd et al. 1988 Ex. 26-1342). Two cross sectional studies also
considered temporal relationships by including in the analysis only
those MSD-free when starting their current jobs, and both showed
positive associations (Burdorf et al. 1991, Ex. 26-454; Burdorf and
Zondervan 1990, Ex. 26-1518). Thus, these results are consistent with a
positive finding for temporality.
OSHA also notes that the Bureau of Labor Statistics Annual Survey
of
[[Page 68473]]
Injuries and Illnesses as well as other health interview surveys have
found elevated LBP rates and MSDs in typical HPW associated
occupations, (female) nursing aides, orderlies and attendants; personal
care; and air transportation workers (see the risk assessment in
section VI of this preamble). While survey statistics may not be
definitive in themselves, they show a pattern of consistency with the
results from the epidemiology studies discussed above. OSHA notes that
these types of population-based studies can be less reliable than other
epidemiology designs due to generally less knowledge about individual
exposures.
Since OSHA's Ergonomics proposal was published, several other
studies on HPW and LBP have been put into the record. Several are
discussed below:
The Vingard et al., 2000 (Ex. 500-41-114) population-based case-
referent study suggests that prolonged exposure to many years of heavy
work and forward bending (cumulative exposure) increases the risk of
LBP. The Latza et al., 2000 (Ex. 38-424) prospective study, after
adjusting for trade, found exposure-response relationships for hours
per shift laying sandstone (PR=1.8, 95% C.I. 0.7--4.7, for 0 to 2
hours; PR=2.6, 95% C.I. 1.1--6.5, for 2 hours; trend test
p=0.03), and stone load (PR=1.8, 95% C.I. 0.4--9.5, for intermediate
level; PR=4.0, 95% C.I. 0.8--19.8 for high level; trend test p=0.03).
The Krause et al. 1998 study (Ex. 38-272) found that cable car crews
performing the heaviest physical labor had a three-fold increased risk
of spinal injury compared with bus driver (OR=3.04, 95% C.I. 1.85--
5.00). This five year prospective study of 1,871 transit vehicle
operation also found both physical workload and psychosocial job
factors independently predict spinal injury in transit vehicle
operators.
OSHA has also considered three other studies available since the
proposal on HPW. Two of these three studies found at least one
statistically significant association between LBP and HPW while the
third suffered from methodological problems. Myers et al. (1999, Ex.
500-119-10) carried out a case-control study of 274 workers with
symptoms and signs of low back pain from four municipal departments (a
73% participation rate). The stated purpose was to identify factors,
both physical work characteristics and psychosocial factors, associated
with acute low back injury. Two randomly selected controls were chosen,
one matched according to work tasks, which the authors stated ``could
be used to examine importance of non-ergonomic factors'' and one
matched by department. Cases were defined from reports from the city
Occupational Medicine Clinic, and were those who had been assigned
restricted work or had lost work time due to back injury. Further
information was gathered from questionnaire about work history, work
characteristics, work injuries, back pain, psychosocial behaviors, and
demographics. Exposure was assessed by questionnaire and measurement;
the strenuousness of each worker's job classified as light, medium, or
heavy according to weight capacity, frequency and duration of sitting-
standing-walking. Analyses screened for 2-way, 3-way and 4-way
interactions. The variables examined included a work movement index,
which combined twisting, extended reaching, and stooping. Factor
analysis was used to determine the important psychosocial factors from
the Job Content Questionnaire. There was no difference in the
prevalence among the cases and controls regarding physical work demands
(light, medium, and heavy), nor twisting or extended reach. However,
because the cases and controls were matched on job department and/or
job title, the design provided little ability to examine those job
factors. This would also preclude any conclusions pertaining to the
relative strength between psychosocial and physical factors. Although
the authors noted that their ``findings underscore the importance of
adopting a model that does not focus entirely on physical factors in
relation to the multifactorial problem of back injury,'' their study
design did not allow them to focus adequately on the physical factors.
This study focused on the psychosocial aspects of the acute back pain
but did not adequately address work factors.
Park et al. (1997, Ex. 500-41-104) carried out a cross-sectional
study using data from the National Health Interview Survey Occupational
Health Supplement, 1988. In this survey, 30,074 randomly selected
employed persons were asked about back pain occurring every day for a
week or more in the previous 12 months. The response rate was 87%.
Causes of back pain were classified into 3 groups: (1) Injury and/or
repeated activities that occurred at work; (2) injury and/or repeated
activities that occurred outside work; and (3) other reasons (illness,
diseases, unknown). Self-reported work activities included repeated
activities with lifting, pushing, pulling, bending, twisting, or
reaching. Occupation was coded according to the 1980 classified Index
of Industries and Occupations of the U.S. Bureau of Census. Confounders
were controlled for in the regression models. Results found that 17.6%
of workers reported back pain every day for one or more weeks during a
12 month period; 26.9% of these reports were attributed to repeated
activities (RA) at work; 17% to RA and injury, and 8.2% to injury at
work. The majority of back pain found in blue collar workers (OR=1.38,
95% C.I. 1.22--1.54), was attributed to work; whereas the majority of
BP in white-collar workers was not attributed to work conditions. A
higher proportion of workers with work-related back pain caused by
injury or RA had pain in the lower back extending to lower body parts,
had missed work more than 5 days, and had changed jobs than had workers
with non-work related back pain. Other significant variables were
``strenuous physical activities at work more than 4 hours per day
[HPW]'' (OR=1.88, 95% C.I. 1.64--2.15), ``repetitive movements more
than 4 hours per day'' (OR=2.4, 95% C.I. 2.1--2.77) and current smoking
(OR=1.57, 95% C.I. 1.39--1.76), BMI greater than 28 kg/m\2\ (OR=1.35,
95% C.I. 1.2--1.52) and age 35-59 (OR=1.31, 95% C.I. 1.2--1.46). The
strength of this study is the rigorousness used by the National Center
for Health Statistics in their study design and analysis. A weakness is
that it is based on questionnaire data.
Thorbjornsson et al, (1998, Ex. 500-119-7) used data collected over
24 years for its cohort study. 252 women and 232 men were randomly
selected from 2500 for medical examination (a 62% participation rate).
In 1969 these subjects had a questionnaire-based interview and an
examination. LBP was defined as pain, aching, or stiffness in the lower
back in the past 12 months. There was a follow-up a re-examination in
1993. Exposure assessment was based on a questionnaire from 1969 using
a dichotomous scale for 11 work factors (e.g., high mental load (hectic
work, exhaustion at end of day), poor supervisor social support,
monotonous work, full time work; night or shift work, overtime work,
high physical load (40 kg for women, 60 kg for men or physical
exhaustion at end of day), severe vibrations, and non-working
conditions, using a dichotomous scale. (Insufficient or unsatisfactory
leisure time, few or unsatisfactory social contacts, additional
domestic workload). Risk factors for back pain during 1972-1992
included: for women, unsatisfactory leisure time (OR=1.5, 95% C.I.
1.1--2.0); for men, 1972-1993: high physical load (OR=1.4, 95%
C.I.1.0--2.0), vibrations (OR=1.4, 95% C.I. 1.0--2.2), and
unsatisfactory leisure
[[Page 68474]]
time (OR=1.5, 95% C.I. 1.1--2.0). Cumulative incidence ratios for 1972-
1993, adjusted for age, and earlier back pain were 38% for women and
43% for men.
Lifting and Forceful Movements (LFM)
The NIOSH summary reviewed the 18 higher quality studies that
address the association between LFM and LBP (Ex. 26-1, pgs. 6-13 to 6-
21). Of the eighteen studies, 13 were cross-sectional, two were
prospective, and three were case-control designs. Only the one case-
control study of back pain in auto workers (Punnett et al. 1991, Ex.
26-39) fulfilled all four of their quality evaluation criteria. Besides
auto workers, among the study groups which showed increased risks to
workers with high lifting or manual materials handling (MMH) demands
were nursing aides, baggage handlers, workers in manufacturing and
electronics, crane operators, and concrete fabricators, although
several studies focused more on the actual stresses within the job
rather than job title. In all 10 of the eighteen studies showed at
least some statistically significant associations between LFM and LBP,
with the significant risk estimates generally ranging from 1.2 to 5.2
(Ex. 26-1, pg. 6-41). For the most part, higher ORs were observed in
high-exposure populations. The highest risk estimate (OR=10.7) was from
a group of workers in a cross-sectional study by Marras et al., (1993,
Ex. 26-170; 1995, Ex. 26-171). The MMH workers with this highest OR had
the highest combination of exposure measures relating to five specific
risk factors associated with lifting, twisting, frequency, angle, and
force, again strongly suggesting synergism among the risk factors. The
5 studies reviewed for this chapter which showed no association between
lifting and back disorder used subjective measurements of exposure, had
poorly described exposure assessment methodology, or showed little
differentiation within the study group.
With regard to temporality, both the prospective studies which
assessed exposures prior to identification of MSDs, had positive
association. Also, of the four (three cross-sectional and one case-
control) studies which attempted to address temporality, three found
positive relationships between lifting and LBP. OSHA also notes that of
the eight studies which examined exposure-response relationships in
some manner, six found positive associations, including Punnett et al.,
1991, (Ex. 26-39) while two others did not (Ex. 26-1, pg. 6-20).
Since OSHA's Ergonomics proposal was published, several other
studies on LFM have been put into the record. Some are more recent, and
these are discussed first, while several older studies, not part of the
original review, are also discussed below.
With respect to the more recent studies, published since 1996, the
studies of LFM and LBP in a wide variety of industries provide
substantial additional evidence that repetitive lifting is associated
with low back disorders.
There are a limited number of negative studies which provide little
evidence to weaken the overall conclusion from the much large number of
positive studies. Other reportedly negative studies of lifting and low
back disorders have limitations. For example, Feyer, Herbison et al.
(2000, Ex. 26-1499) conducted a prospective study of low back pain
among nursing students, but there was no evaluation of the physical
demands of jobs and there was a 1/3 dropout from the study.
In addition to the more recent studies, six older studies, not in
the proposal, also discussed the relationship between LFM and LBP.
Mandel and Lohman (1987, Ex. 500-41-92) showed an increased risk of
back pain with lifting more than10 patients per week (OR=1.39, 95% C.I.
1.05--1.84) in a cross-sectional study in which 428 registered nurses
in a Midwestern hospital participated (rate was 65%). Fifteen percent
of the nurses had reported experiencing LBP for the first time during
the study year, with most episodes occurring in younger workers.
However, while intensive care unit nurses lifted significantly more
patients, LBP was not associated with work area. The most significant
associations were having LBP prior to the study year and having pain in
another part of the spine. The limitations of this study are its
participation rate and both its exposure assessment and health outcome
definition. However, despite these limitations, it provides support for
patient lifting as a risk factor for LBP in nurses.
Larese and Fiorto (1994, Ex. 38-130) in a cross-sectional study
compared 425 general nursing staff from an urban hospital to 198
oncology nurses (participation rate: 91.4%). LBP cases were based on
clinical examination or X-ray findings. Exposure measurements included
the analysis of working conditions, which revealed both groups of
nurses had to do frequent and heavy lifting, lowering, and pushing-
pulling. Differences were found when analyzing the number of patients
assisted by the different nursing groups: the staff nurses cared for
double the number of patients compared to the oncology nurses.
Calculating crude odds ratios showed that general nurses had an OR=1.9
(95% C.I. 1.32--2.76) for LBP and an OR=2.4 (95% C.I. 1.35--4.27) for
back pain sick leave compared to the oncology nurses. The authors used
the Mantel-Haenzel chi-square statistics to control for age and for
occupation among the two groups, but multivariate analysis to control
for both factors simultaneously was not done. The authors concluded
that ``comparison between the two hospitals suggests factors associated
with the disorders: work tasks and particularly nurses/patients ratio
are more important than age and length of exposure.'' The authors did
not present the data from which they drew these conclusions.
Stobbe et al. (1988, Ex. 500-41-45) carried out a retrospective
study of three hospital groups at a major medical center including 143
licensed practical nurses, 252 nurses aides, and 20 attendants. Two
groups were identified, one exposed to frequent patient lifting, one
not. Health outcome was defined as back injuries, including both lost-
time and non-lost-time injuries. Lifting frequency was determined
through interviews with the nursing director, the head nurse, and
nursing supervisors. High frequency lifting was defined as an average
of more than 5 patient lifts per shift. Low frequency lifting (control
group) was defined as average of less than two patient lifts per shift.
Nursing personnel with estimated exposures of 3-5 patient lifts per
shift were excluded. Lifting frequency (OR=2.7, p=0.009), and length of
employment ( p=0.0085) remained significant in the logistic regression
model, while occupation did not. The authors used a survivor type
conditional analysis which assumed that when a person with a back
injury report resumed work, the future probability of injury was the
same as if there had been no previous injury. This assumption has not
been supported in other studies.
Kuh et al. (1993, Ex. 500-41-80) in their longitudinal study of
3262 same age Great Britain natives (born the first week, 1946), looked
at risk factors for LBP, mainly the association with stature and
height, but also lifting. The study population had been followed every
2 years in childhood, and every 5 years as adults. Participation rate
for this study was only 60.8%. Exposure was assessed using job title
and occupational histories. A matrix assigned jobs to three levels of
lifting--low, intermediate and high. The interaction of height and
occupational lifting as a risk factor for LBP was investigated for men.
The onset
[[Page 68475]]
of back pain symptoms was significantly more common in men whose jobs
were likely to involve heavy lifting (RR=1.3, 95% C.I. 1.0--1.7). The
main occupations of heavy lifting associated with LBP were farming and
construction. There was discussion of reporting bias, recall bias, lack
of direct information about lifting at work. The weakness of this study
is using ``job title'' as surrogate for exposure, but a bias here is
likely to mask true associations.
Smedley et al. (1995, Ex. 500-41-40) conducted a cross-sectional
survey of 2,405 nurses using a self-administered questionnaire to
investigate the risk factors associated with low back pain. The
response rate was sixty-nine percent. Among those who responded to the
survey, 1616 were women. Due to the low number of male respondents,
this study focused on female workers. Low back pain was defined as pain
lasting for longer than a day in an area between the twelfth rib and
the gluteal folds (indicated on a chart). Questions about non-
musculoskeletal symptoms, included in the questionnaire, were designed
to investigate whether psychological factors that influence reporting
of other symptoms also affect reporting of LBP. After adjustment for
age, height and non-musculoskeletal symptoms, significant associations
were found for: frequency of manually moving patients around on the
bed; manually transferring patients between bed and chair; and manually
lifting patients from the floor.
----------------------------------------------------------------------------------------------------------------
Frequency OR 95% C.I. Factors controlled
----------------------------------------------------------------------------------------------------------------
Manual Movement of Patients on Bed
----------------------------------------------------------------------------------------------------------------
5-9 moves................... 1.5 1.1-2.2 Age/height.
5-9 moves................... 1.6 1.1-2.3 Age/height/non-musculoskeletal symptoms.
10+ moves................... 1.7 1.2-2.3 Age/height.
10+ moves................... 1.7 1.2-2.4 Age/height/non-musculoskeletal symptoms.
----------------------------------------------------------------------------------------------------------------
Manual transfer of patients between bed and chair
----------------------------------------------------------------------------------------------------------------
5-9 moves................... 1.7 1.2-2.3 Age/height.
5-9 moves................... 1.8 1.3-2.5 Age/height/non-musculoskeletal symptoms.
10+ moves................... 1.5 1.1-2.1 Age/height.
10+ moves................... 1.5 1.1-2.1 Age/height/non-musculoskeletal symptoms.
----------------------------------------------------------------------------------------------------------------
Evaluation of the task of manually lifting patients from the floor
resulted in similar significantly elevated risks regardless of whether
age and height alone or all three factors, i.e., age, height, non-
musculoskeletal symptoms, were controlled for (OR=1.3, 95% C.I.1.0--
1.6). In this study, nurses who often report non-musculoskeletal
symptoms, such as low mood or stress, were significantly more likely to
report low back pain. For example, frequent low mood was strongly
associated with subsequent back pain (OR=3.2, 95% C.I.. 2.2--4.8).
Specific manual handling tasks were associated with an increased risk
of back pain while no such association was found in this study among
nurses using mechanized patient transfer (with hoists).
A study of personal and job-related factors that may affect the
incidence of back injuries among 5,649 nurses was conducted by Venning
et al. (1987, Ex. 500-41-49). A ``back complaint'' was defined as any
work-related injury or complaint of discomfort in the back and reported
through an employee health office. Nurses were surveyed by
questionnaire and then observed for a 12-month study period. As annual
injury rate of 4.9% was observed. Four factors were found to be highly
statistically significant (p0.01) predictors of back injury. Risk
estimates for all four factors (service area, lifting, job category,
and previously reported back injury), remained significantly elevated
when a forward stepping model of logistic regression was applied. The
observed adjusted odds ratios were: 4.26 for service areas where
lifting occurs most often as compared with areas where lifting occurs
least; 2.19 for daily lifters as compared with light, occasional, and
nonlifters; 1.77 for nursing aides as compared with registered nurses
and supervisory personnel; and 1.73 for individuals who have previously
reported back injury as compared with those who have not reported
previous injury. No other factors, including age, physical activity,
availability of lifting aids, height and weight, and instruction in
back care and lifting procedures, were significantly associated with
reporting of back injury. The influence of service area is not easily
explained. The authors chose to define service area as a work activity.
With an attitudinal measurement, job satisfaction may have also proven
to be a significant factor. The question would then be one of
temporality and association between those factors. It is clear,
however, that service area assignment is a major risk factor. When two
employees who are similar in job category and history of back injury
are assigned to different service areas, the risk of back injury is
dependent on that ward assignment.
In summary, seven of the eight new studies, and all six of the
older studies (all of nurses and nursing assistants who did more
frequent patient lifting), found at least one statistically significant
association between LFM and LBP. When considered with the 10 studies
originally reviewed by NIOSH which found statistically significant
associations, this epidemiology data base provides strong evidence for
a causal association between LFM and LBP.
Bending and Twisting/Awkward Postures (BT)
The NIOSH summary reviewed the 12 higher quality studies which
addressed the association between BT and LBP (Ex. 26-1 pgs. 6-21 to 6-
26). Of the twelve, nine also examined the effects of occupational
lifting, although for all but the Marras et al., (1993, Ex. 26-170;
1995, Ex. 26-171) analysis discussed above the presented comparisons
for LFM and BT are different. As with the analysis for BT above, only
the Punnett et al., 1991 case-control study fulfilled all four of the
quality evaluation criteria. Nine studies were cross-sectional, two
were case-control and one was prospective. Of the twelve studies seven
reported statistically significant associations, with the significant
risk estimates generally ranging from 1.2 to 3.5. However, two of these
ORs were higher; in addition to the previously mentioned OR of 10.7 in
the Marras et al. (Exs. 26-170, 26-171) study, Punnett et al., 1991,
(Ex. 26-39) using a multivariate analysis that adjusted for covariates,
found a statistically
[[Page 68476]]
significant OR=8.09 (95% C.I. 1.4-44) for time in a non-neutral
position for auto workers. Several studies suggested that both lifting
and awkward postures were important co-contributors to risk of low back
disorder.
With regard to temporality and exposure-response, three studies--
one prospective, one case-control, and one cross-sectional--attempted
designs and analysis to investigate temporality. Only the case-control
study of Punnett et al., 1991 (Ex. 26-39) found a strong association
between exposure to awkward postures and back pain. The Riihimaki et
al., 1994 (Ex. 26-1188) prospective study comparing heavy equipment
operators with office workers found a three year prevalence ratio for
LBP of 1.4 (95% C.I. 1.0-1.9) (Ex. 26-1, 6-86). For exposure-response
relationships between posture and low back disorder, five of the six
studies which attempted such an analysis found significant
relationships between some incremental index of LBP and exposures
relating to awkward postures.
Since OSHA's Ergonomics proposal was published, three other recent
studies on BT and LBP have been put into the record. These are
discussed below:
With respect to the two most recent studies, both Latza et al.,
2000, (Ex. 38-424) and Vingard et al., 2000 (Ex. 502-410) have been
discussed above, in both the HPW and LFM sections. The Latza et al.
study, in a logistic regression analysis controlling for several
covariables, found that risk factors for LBP included working in a bent
position, for men, with an OR =1.89 (95% C.I. 1.03-3.46). This OR was
greater than those, computed in the same regression analysis, for
carrying heavy loads, OR=1.47 (95% C.I. 0.97-2.24), and heavy physical
work OR=1.77 (95% C.I.1.06-2.93). For the Vingard et al. study, there
were statistically significant associations for both men and women when
related to both heavy and cumulative exposures. When the combined
physical exposures of ``heavily exposed to forward bending'' and
``manual handling over the last ten years'' were added to current
exposures, the estimated RRs in men was 2.8 (95% C.I. 1.1-7.5) and in
women 2.9 (95% C.I. 1.2-6.8). Multiple logistic analyses adjusting for
a wide range of variables including age, social support at work and
outside work, low back pain earlier, and negative life events, did not
identify many physical or psychosocial factors as significant
predictors. However, for ``forward bending greater than one hour'' the
RR in men was 1.8 (95% C.I. 1.1-3.1), and in women 1.2 (95% CI 0.7-
1.8).
The third recent study, Xu et al., (1997, Ex. 500-119-9), examined
bending and twisting, as well as physically hard work in the Danish
population in a cross-sectional survey conducted in 1990. A random
sample of 5,185 workers with similar sex, age, and occupational
distributions as in the Danish population was selected, with a response
rate of 89.3%. The health outcome was defined as symptoms of back pain
in the past 12 months, assessed by structured interview, and included
conditions of pain, ache, discomfort localized in the lower back,
regardless of intensity and severity. Occupational exposure information
included duration of daily exposure, vibrations affecting the whole
body, physically hard work, frequently twisting or bending, sitting
down, standing up, walking a lot, working with hands raised,
concentration demands, repetition, and lifting heavy loads. The
psychosocial factor ``concentration demands'' was also included in the
model. Confounders controlled for included gender, age group,
educational level, and duration of employment. There was a significant
dose-response trend towards the greater prevalence of LBP with a
greater proportion of the day exposed to the risk factors, for two
physical factors--physically hard work (OR=1.28, 95% C.I. 1.08-1.52),
and frequent twisting or bending (OR=1.71, 95% C.I. 1.51-1.93).
Concentration demands and standing up were also significantly
positively associated with the occurrence of low back pain. The results
indicate that the associations of risk factors with LBP were stronger
among those required to work for 37 or more hours/wk. The authors
addressed issues of recall and participation bias.
In summary, the statistically significant associations of BT and
LBP seen in seven of the 12 NIOSH reviewed studies and in all three of
the more recent studies, provide by strong evidence that the
associations observed are real.
Recent Epidemiology Reviews of Work-Related Low Back Disorders
Since the NIOSH 1997 review, there have been three published
reviews which bear on the epidemiology of the work-related risk factors
for back pain discussed above. The first is the NAS report, discussed
elsewhere in this Health Effects section, which reviews and affirms the
appropriateness of the methodology and the conclusions of the NIOSH
1997 review (Exs. 26-37). The other two are recently published reviews
relating specifically to risk factors, especially physical stress
factors, for back pain. One of these reviews also examines psychosocial
factors (Ex. 500-71-24). These are discussed below.
The Burdorf and Sorock (1997, Ex. 500-71-24) review assessed the
epidemiologic evidence of occupational risk factors for back disorders.
They included only those published studies that clearly described
exposure measures, had quantitative estimates of risk for work-related
factors, and did not have evidence of a serious methodological problem.
In all they included thirty-five articles, which they assessed for
associations with physical factors at work, psychosocial factors at
work, and individual factors. Of the 19 cited studies reporting on
associations between back disorders and lifting or carrying of loads
(LFM), sixteen were positive. The risk estimates ranged from 1.12 to
3.07, with attributable fractions estimated between 11% and 54%. Nine
out of ten studies reported positive associations with frequent bending
or twisting of the trunk (BT), three of which reported exposure-
response relationships. Seven studies examined heavy physical load
(HPW); six of these demonstrated increased risks of 1.54 to 2.58;
however the one large longitudinal study did not demonstrate an
association between physical load and the incidence of back injury
claims during the study period (Ex. 26-1242). For static work postures
(SWP), seven studies were considered and three of these had positive
associations, The authors found some evidence of an association between
the psychosocial factors of job dissatisfaction and low job decision
latitude and back pain, but the evidence was not consistent across
different studies and study designs. The review found that age, smoking
habit, and education may be important confounders, while the individual
characteristics of gender, height, weight, exercise or sport, and
marital status were consistently not associated with back disorders.
The finding that exercise or sport, the one physical individual
characteristic examined, was not associated with back disorders
provides supporting evidence that the physical work-related risk factor
findings are real and are not confounded by leisure time physical
factors.
In making their causality determination, Burdorf and Sorock
acknowledged that the majority of cross-sectional design studies in the
data base precluded a firm determination of the temporal and
specificity criteria of the Hill criteria; they also expressed some
concern that ``the state of the art does not allow unequivocal
conclusions about the contribution of specific work-related risk
factors to the incidence of
[[Page 68477]]
back disorders.'' (Ex. 500-71-24, pg. 253). Nevertheless, they
concluded that:
Despite these methodological concerns, the available literature
has presented persuasive evidence for several risk factors for work-
related back disorders. Various studies with clear differences in
design, methodology, and populations have consistently produced
comparable findings for MMH, frequent BT, heavy physical load and
WBV. With regard to MMH, sufficient biomechanical and physiological
evidence is available to support the biological plausibility of
lifting as a risk factor for back disorders. The results on lifting
do not distinguish between the effect of infrequent lifting of heavy
loads and frequent lifting of light loads. The studies among nurses
indicate that a single lift of a patient is associated with an
increased risk of back pain or back disability [cite to Exs. 500-41-
92, 500-41-70, and 500-41-49]. This finding is consistent with
biomechanical evaluations that predict high compression forces on
the lower back during patient lifting [cite to Ex. 38-141]. Frequent
BT of the trunk was consistently related to back disorders in
various studies. In one case-referent study with detailed exposure
assessment, a clear dose-response relationship was shown [cite to
Ex. 26-39]. The findings for heavy physical load demonstrate that
this is an important work-related risk factor. Several community-
based studies have presented dose-response gradients [cite to Exs.
29-959, and others]. The strength of the gradients is difficult to
assess since self reports have been applied to rank exposure to
physical load on ordinal scales. A second problem is that this
particular risk factor probably includes MMH and frequent BT. Hence,
in epidemiologic surveys, heavy physical load might be a surrogate
measure for other risk factors rather than a separate risk factor
(Ex. 500-71-24, pg. 253).
Finally the review concludes:
This review concludes that there is a clear relationship between
back disorders and physical load, that is, between back disorders
and MMH, frequent BT, HPW, and WBV. * * * the evidence presented
indicates that preventive measure reducing the exposure to these
risk factors will decrease the occurrence of back disorders.
Hoogendoorn et al. (1999, Ex. 500-71-32) conducted systematic
reviews of the literature for physical load as risk factors for back
pain. A rating system was used to assess the evidence based on
methodological quality and consistency of the findings; under this
scheme cross-sectional studies were excluded based on the authors'
quality criteria. The review of studies addressing physical load
examined 28 cohort and 3 case-referent studies. For physical load, the
review found that strong evidence exists for work-related MMH, BT, and
whole-body vibration as risk factors for back pain. Moderate evidence
exists for patient handling (LFM) and HPW, and no evidence was found
for standing, walking, sitting, sports, and total leisure time physical
activity.
OSHA finds that the consistency of findings in the NIOSH 1997 (Ex.
26-1) and the two other recent reviews, all using different study
selection and evaluation criteria, provides confirmation of OSHA's
emphasis on NIOSH's methodology and conclusions for work-related causes
of back pain. The assessment on physical load factors was insensitive
to slight changes in the assessment of findings and the methodological
quality of the studies. Burdorf and Sorock (Ex. 500-71-24), in their
review, also commented that comparable findings were consistently found
for heavy physical work, lifting, twisting and bending, and whole body
vibration at work in various studies with clear differences in design,
methodology, and populations.
Dr. Tapio Videman's Testimony on Twin Back Studies
Dr. Tapio Videman, DrMedSci, University of Helsinki, testified that
a weakness with the OSHA proposal was that in the studies OSHA
examined, the role of genetic factors was not taken into account in
studies estimating the effect of work-related stress factors (Tr.
16996). To make this point, Dr. Videman presented a slide in his
testimony (Tr. 16997) that referred to a published paper he had co-
authored on the determinants of lumbar disc degeneration in a
retrospective cohort study (Ex. 26-71). The study design attempted to
control for the role of genetics by comparing disc degeneration scores
between identical twins with different exposure factors thought to be
associated with back pain. Among the factors examined in the paper were
occupational workload, leisure time physical activities, measures of
aerobic exercise and other sports participation, occupational driving,
and smoking.
The study consisted of 115 pairs of identical twins selected from
the Finnish Twin cohort, who were among the most discordant pairs in
terms of the exposure factors mentioned above. The objective was to
study whether differences in exposure factors correlated with the disc
degeneration scores, controlling for genetic factors. Both
observational and digital summary scores for disc degeneration, based
on an MRI examination, were obtained for both the upper and lower back
regions. Occupational and leisure physical activity responses were
derived via personal interviews.
An important feature of the study design is that of the 115 pairs
of twins only 23 pairs were discordant for heavy work before the age of
20. Also, based on a job scale rating of 1 to 4 to aggregate every job
title and associated task descriptions during a subject's lifetime work
history, the mean absolute job scale difference in these 115 twin pairs
was 0.9. For mean hours working in bending/twisting positions the
absolute mean difference within the 115 pairs was 1.6 hours. This means
that this study had little statistical power to show differences among
physical work factors, after adjusting for genetic factors, since only
discordant pair results factor into an individual matched analysis.
The authors examined the associations between the several exposure
factors and disc degeneration scores using both univariate and
multivariate analyses, and both observational and digital summary
scores for disc degeneration for both upper and lower bask disc
degeneration scores. In the univariate analyses, which apparently did
not factor in the twins matched pair design, only the heavier physical
work job code score and mean total occupational lifting per day were
significantly adversely associated with disc degeneration score, and
then only for the high back discs. Most other increased physical
activity and smoking scores were also associated with increased disc
degeneration scores, but the associations were not statistically
significant. Increased mean time sitting at work was associated with
less disc degeneration for both high and low back, but only the high
back scores showed statistical significance.
To attempt to control for the genetic effect, the authors also used
multiple regression methods in an attempt to explain the observation
summary disc scores. Their results found that, for the upper back, only
the mean job code and age were jointly statistically significant, with
no other specific environmental or behavioral factors contributing
significantly. For the lower back, heavy leisure time physical loading
was the only specific environmental factor of statistical importance;
this one variable explained 2% of the variance in the multiple
regression model.
In an attempt to consider the amount contributed by the genetic
component in the study design, the authors inserted 114 co-twin
(indicator) variables in the model and recalculated the estimates. They
found that together, these 114 variables, ``those of familial
aggregation, reflecting primary genetic and shared early environmental
influences * * * explained nearly 75% of the variability in disc
degeneration score in the upper region and nearly 50% in the lower
lumbar region (id., pg. 2608). The
[[Page 68478]]
authors concluded, as did Dr. Videman in his testimony, that these
``findings suggest that disc degeneration may be explained primarily by
genetic and early environmental influences and unidentified factors. *
* * If disc degenerative changes are associated with symptomatic
conditions, these studies findings suggest a need to rethink future
research and prevention strategies in this area.'' (id., pgs. 2610-
2611).
Dr. Videman and associates made similar findings on the importance
of genetic factors in disc degeneration in a study comparing 20 pairs
of twins with discordant smoking status (Ex. 32-241-3-89; Tr. 16994-
16995). Using the same type of multivariate methodology, with one
variable for smoking and 18 variables for co-twin status, they
concluded, ``Whereas smoking status and age explained 0 to 15% of the
variability on the various degenerative findings in the discs, 26% to
72% of the variability was explained with the addition of a variable[s]
representing co-twin status. These findings are compatible with a
marked genetic influence and warrant further investigation.'' (Ex. 32-
241-3-89).
In his testimony at the hearings, Dr. Videman emphasized the
relative importance of genetic factors over physical work factors,
``(W)e could conclude that, from a blood sample, I can predict MRI
[disc] changes better than having a lifetime work history about another
interview.'' (Tr. 16998).
OSHA has considered Dr. Videman's testimony and publications and
disagrees with his conclusions about the relative importance of
physical work factors and genetics in the prediction of MRI disc
changes. Although the agency agrees that the discordant identical twin
study design is useful to control for genetic and early environmental
factors, other factors in the design are at least as important. As was
seen in the first study discussed above (Ex. 26-71), in a matched
control study the amount of discordance in the exposure variables
within the twin pairs will determine the power of the study to detect
an effect. For example, with little discordance in exposure variables
and few discordant pairs, the study has little ability to detect a true
effect. In fact OSHA believes that in such a situation degenerative
disc summary scores between twins should be very similar. To carry this
example further in that first study, which involved the 115 twin pairs
with little co-twin difference in the exposure variables, it is not
surprising that adding 114 co-twin variables to the analysis, it is
absolutely no wonder that in total these 114 variables will explain
most of the variation in the multiple regression model. OSHA concludes
that Dr. Videman's conclusion on the importance of genetic factors in
his studies is a function of his analysis and his study design. This
type of matched-control study is designed to control for genetic
effects, not to study them.
OSHA also notes that in Dr. Videman's smoking study with 20 twin
matched-pairs and a mean discordance between siblings of 32 pack years,
``a very huge difference'' (Tr. 16994), the disc degeneration
difference was statistically significant at all of the measured disc
levels. Controlling for genetic traits was undoubtedly important, as
suggested by the statistical significance of the 18 covariables (Ex.
32-241-3-89, pg. 1666).
In the hearings, Dr. Videman was questioned by Ms. Seminario about
a study he co-authored that concluded, ``environmental factors
[including physical work factors] account for more than 80 percent of
the [etiology] of sciatica and more than 90 percent in the case of
patients admitted to the hospital.'' (Tr. 17054, see also Dr. Videman's
response to a similar question by Ms. Butterfield, Tr. 17128). Although
Dr. Videman acknowledged the correctness of this statement, he appeared
to contradict these findings by explaining that ``all the data from
that study was based on questionnaire data, so the reliability of the
diagnosis is unclear.'' (Tr. 17129). OSHA notes, however, that in the
actual paper the authors note that ``the cumulative age-specific
incidences of sciatica [were] based on both the questionnaire and the
hospital discharge records,'' and that the results are in ``accord with
the results of a previous Finnish study.'' (Ex. 502-227, pg. 397).
Furthermore, the authors noted that the hospital discharge diagnoses
are given by doctors based on the WHO manual of the International
Statistical Classification of Diseases (id., 394). The authors also
cited studies on the reliability of the nationwide hospital discharge
registry (id., 394).
Thus, because that Dr. Videman's conclusions about the relative
importance of genetics and physical work factors in back disorders were
based on the questionable methodology used in the two twin studies
discussed above, and because Dr. Videman's testimony on another study
which contradicted those conclusions was not supportable, OSHA is
unable to give much weight to Dr. Videman's testimony on this issue.
The Bigos et al., 1991 Back Study
Bigos et al.published several papers on a study (see, e.g., Exs.
500-121-8, 38-280, 26-1241) that assesses the role of work perceptions
and psychosocial factors in predicting the report of back pain
disability. The study group was a cohort of aircraft assembly workers
at the Boeing Company in Everett, Washington who volunteered to
participate. This longitudinal study ultimately analyzed 1326 out of a
cohort of 4027 aircraft assembly workers (33% of the original solicited
population) for the final models.
The health outcome studied was ``back pain disability lasting
longer than 3 months,'' and the authors used three notification
systems--reporting to the company medical department, filing an
incident report, or filing an industrial insurance claim. The study did
not investigate the actual presence of back symptoms or specific back
disorders. At the beginning of the study, subjects answered a series of
questionnaires which addressed demographics, psychosocial factors, and
cardiovascular risks, as well as a take-home questionnaire including
the 566 question Minnesota Multiphasic Personality Inventory (MMPI),
the Health Locus of Control Questionnaire, and a modified Work
Adaptation, Partnership, Growth, Affection, and Resolve (APGAR) survey
(modified from the Family APGAR survey). Other information included
previous medical history, previous back discomfort or problem, back
injury claims in the previous 10 years, and work perceptions. Subjects
were also given a physical examination to assess physical attributes
including anthropometry, lifting strength, aerobic capacity, and
sagittal flexibility. A back examination including reflexes, girths,
sciatic tension, and posture was performed. Thus, each subject provided
individual responses to questions concerning these physical and
psychosocial factors.
In contrast to the above factors, which were collected for each
worker individually, workplace exposure assessment was limited to all
jobs that employed more than 19 workers and was not performed on
individual workers. These jobs were analyzed for tasks that were heavy
and tiring tasks in terms of maximum loads on the spine, based on some
unspecified biomechanical mathematic model. Any worker in a job with
fewer than 19 people did not get physically measured; also, the authors
did not measure workers' cumulative loads. As with the psychosocial
factors, workplace
[[Page 68479]]
exposure was also measured only at initial recruitment.
Subjects were followed for slightly more than four years, during
which 279 subjects reported back problems. After analyzing the data to
determine which factors could best predict these reports, the authors
concluded:
Other than a history of current or recent back problem, the
factors found to be most predictive of subsequent reports in a
multivariate model were work perceptions and certain psychological
responses. * * * Subjects who stated that they ``hardly ever''
enjoyed their job tasks were 2.5 times more likely to report a back
injury (p=0.0001) than subjects who ``almost always'' enjoyed their
job tasks. These findings emphasize the importance of adopting a
broader approach to the multifaceted problem of back complaints in
industry, and help explain why past prevention efforts focusing on
purely physical factors have been unsuccessful.
OSHA notes that one major problem with the interpretation by other
researchers of these results in the Boeing studies is that within the
Boeing studies, ``physical variables'' include only those physical
attribute variables that deal with anthropometry, back examination
indices, and physical capabilities (e.g. flexibility, lifting strength,
aerobic capacity) (Ex. 38-280, Table 1, pg. 25). It is under the
``nonphysical variables'' that the authors included workplace factors--
duration of employment, job classification code, and measured peak
spinal loading--as well as psychological and psychosocial factors.
Other researchers include workplace factors (e.g., measured peak spinal
loading and physical workload) as physical variables. Thus, when Bigos
et al.conclude in their study that none of the physical variables was
important in predicting back pain reports (back disability > 3
months)--they are not referring to the same types of work-related
physical risk factors--lifting/forceful movements, bending/twisting and
awkward postures, heavy physical work, or static work postures--that
OSHA refers to in its standard. Bigos et al.did not directly address
these factors in their study.
OSHA also notes that the overall participation rate for this study
was low, which makes representativeness an issue, especially for the
25% of the group that initially chose not to participate. The
longitudinal study ultimately analyzed 1326 out of a cohort of 4027
aircraft assembly workers (33% of original solicited population) for
the final models. In an attempt to determine whether the voluntary
aspect of the study would create a bias, the authors compared the
reported injury rates for those who returned incomplete data (n=1451)
on their modified APGAR and MMPI packets, with the 1,569 subjects who
did complete the forms. The difference in injury report rates was not
statistically significant, which suggests that this final study group
may be representative of the total.
OSHA also notes that no individual exposure measurements were
carried out, although extensive individual psychosocial and
psychological measurements were done. Workplace exposure assessment was
limited to jobs that employed more than 19 workers, and there was no
accounting for individual inter- or intra-variability. Because the
exposure data represented the ``exposure'' of a group of workers rather
than the measured exposure of individual workers, the authors would not
be able to determine the contribution of physical factors to the
observed outcome in as robust a fashion as they would the contributions
of medical history, psychological surveys, physical exam, or job
satisfaction survey, which were all recorded as individual exposure
data. The authors did not report nor provide information on the
analysis of the exposure data. There was no report on the data
collected on biomechanical loads of the spine. They also did not report
nor provide information on the data collected on the workers' perceived
physical exertion in their jobs.
Dr. Bigos, in his testimony to OSHA during the hearings, stated
that the Schultz model (the only biomechanical model related directly
to human intradiscal measurements) was applied to the evaluation of
mechanical stress on the Boeing subjects, and it found no significant
relationship between mechanical stress on the subjects and the report
of back problems or disability (Tr. 6725-6727). OSHA is addressing back
pain in its final standard, and intradiscal measurement changes,
obtained from the Schultz model, are not directly relevant to the
existence of back pain or back disability.
OSHA also notes that this study did not address heavy lifting, or
even jobs at the moderate or high end of HPW exposure. Bigos et
al.report, ``the study was done in a diverse, highly sophisticated
manufacturing industry where job tasks do not tend to be extremely
stressful for the back.'' (Ex. 500-121-8, pg.5). As Bigos et al.(1991,
Ex. 26-41) state, ``our study may not be representative of workers with
extremely physically demanding jobs, where virtually no one remains
active until retirement age.''
OSHA also has concerns about the interpretation of the results of
the ``Work'' Adaptation, Partnership, Growth, Affection, and Resolve
(APGAR) survey score. The authors added two additional untested items
to the family APGAR: (1) ``I enjoy the tasks involved in my job,'' and
(2) ``please check the column that indicates how well you get along
with your closest immediate supervisor.'' (Ex. 26-1242, pg. 2). Results
found the strongest statistically significant relationship between back
disability and statement (1) ``I enjoy the tasks involved in my job.''
(id., pg. 3). However, this single initial response from a single point
in time, rather than from more reliable repeated measures over time,
was used to explain the outcome over a four-year period.
OSHA also has some concerns about a potential bias due to subjects
who were excluded from strength testing if current back symptoms were
present at the time of testing, or had caused them to miss work in the
previous six months. This strongly influences the ability to draw from
the study conclusions that are related to this variable, i.e.,
eliminating the back pain subjects from the study population creates a
healthy worker effect, which would bias results toward the null.
For the final predictive model, involving 33% of the original
solicited population, the percentage of the overall variability
explained by the model was 2.2% for job satisfaction, 1.9 for
psychological factors, 1.2% for physical examination factors, and 3.3%
for medical history; the sum of these individual components was 8.6%;
7% combined (Ex. 38-280, pg.29). This means that 93% of the variability
was unexplained by this model for predicting industrial back pain
reports (back disability > 3 months).
In sum, with the qualifications discussed above, OSHA acknowledges
the importance of the Bigos et al.prospective study on the role of
psychosocial factors in reports of back injuries. OSHA used this study
in its weight of evidence determination for HPW as a risk factor for
LBP, and found no association. However, OSHA concludes that physical
risk factors were not as well determined in this study as were the
psychosocial risk factors, making their relative contributions
difficult to assess. Furthermore, the lack of truly HPW, according to
the authors, among these workers would further limit the ability to
study this physical risk factor. Thus, OSHA concludes that although
this study found a significant relationship between psychosocial
factors and LBP, this study lacked the ability to concurrently study
the relative contribution of the physical work-
[[Page 68480]]
related risk factors of interest to OSHA. In Section G5 OSHA provides
additional discussion of both the Bigos et al.study and psychosocial
risk factors.
Biomechanical Factors and Laboratory Experiments
For a distilled summary of the literature describing laboratory
experiments and biomechanical models of risk factors associated with
low back pain in table format, see Table II-1 in the health effects
appendices to the proposed rule (Ex. 27-1).
There is some debate as to the exact etiology of low-back pain, and
some authorities suggest that it is possible to make a precise
diagnosis in perhaps only 20% of patients presenting with acute low-
back pain (Frymoyer 1988, Ex. 26-118; Nachemson 1976, Ex. 26-1147;
White and Gordon 1982, Ex. 26-1160). Proposed etiologies for low-back
pain that have been advanced include the roles of nerve compression,
tissue ischemia, sensitization of nerve endings, inflammatory
mediators, spinal instability, and other postulates (Frymoyer 1988, Ex.
26-118; Nachemson 1992, Ex. 26-490). The majority of cases of work-
related low-back pain are attributed to mechanical causes, such as
muscle and ligament strains and sprains and disc herniations.
Degenerative disc or facet disease, spinal stenosis, spondylolisthesis
and compression fractures have also been attributed, at least in part,
to work. Additionally, back disorder is multifactorial in origin and
may be associated with both occupational and nonwork-related factors
and characteristics (Bernard 1997; Ex. 26-1).
One additional difficulty in evaluating the etiology of low-back
pain is that roughly 50% to 60% of patients reporting an episode of
work-related low-back pain note an insidious onset of pain rather than
a single, point-in-time event with immediate low-back pain (Bergquist-
Ullman and Larsson 1977, Ex. 26-933). This study also found that cases
with an insidious onset experienced prolonged recovery. Part of the
explanation for this may lie in the absence of nociceptors in the disc
itself and the facet joints (except for the synovial lining) (Pope et
al.1991, Ex. 502-502). These load-bearing structures may, therefore,
become injured without immediate recognition (e.g., sudden pain), and
the eventual manifestation of low-back pain may only occur after a
series of point-in-time events have sufficiently injured these spinal
structures to the point where nociceptors become irritated (e.g., in
the outer one-third annulus or facet synovium).
Specific Low-Back Disorders
Low-back pain symptoms are caused by a variety of injuries and
disorders. Although the underlying cause of back pain cannot be
determined definitively in up to 90% of patients, work-related cases
are believed to result from the following mechanisms: muscle or
ligamentous (soft tissue) injury; herniation of the intervertebral disc
with irritation of adjacent nerve roots; and degenerative changes
(arthritis/spondylosis) in the intervertebral discs (Deyo, Rainville,
and Kent 1992, Ex. 26-365). Evidence for work-relatedness for low-back
disorders of these three sources of etiology is summarized below.
Soft Tissue/Mechanical Low-Back Disorders
As noted earlier, the exact etiology of low-back pain is unknown in
many cases, and therefore, there is a lack of universal agreement on
the contribution of muscle and ligament sprains and strains to work-
related low-back disorders. In part, the difficulty in diagnosis
relates to the inability to easily palpate deep low-back muscles, the
lack of imaging information on low-back muscle disorders, and the
absence of surgical pathologic specimens to evaluate.
However, in addition to an understanding of muscle anatomy,
consideration of muscle function (static and dynamic loading), and
repair mechanisms contribute to understanding the role of muscle and
ligament sprains and strains in work-related low-back disorders.
Static Loading
In evaluating the pathogenesis of soft-tissue low-back disorders,
there are considerations related to static and dynamic work activities.
Simple maintenance of posture requires balancing of counteracting
mechanical forces about the spine. Static loading affects muscle and
connective tissue. During static trunk flexion, low-back extensor
muscles must progressively increase their activity to maintain trunk
flexion (Schultz et al.1982, Ex. 26-581).
Using myoelectric measurements, Andersson et al.(1974, Ex. 26-346)
ascertained that activity of the erector spinae progressively decreased
as the angle of the back rest advanced from 10 degrees of forward
inclination to backward inclination. This results from a partial
reduction of the lumbar spine load imposed by the upper body as the
load is transmitted to the back rest (Andersson and Marras 1996, Ex.
26-412; Chaffin and Andersson 1991, Ex. 26-420). In addition, during
unsupported sitting, the lumbar spine flattens, and the use of lumbar
supports and back rests can reduce the loss of normal lordosis
(Andersson et al.1979, Ex. 26-1553).
Using a back rest inclination of 110 degrees and a 4 cm lumbar
support, the authors were able to demonstrate that lumbar posture could
be similar to normal standing posture. Maintenance of adequate seated
posture has further implications for the intervertebral disc, with
lower intervertebral disc pressures noted during supported sitting as
opposed to unsupported sitting (Andersson et al.1974, Ex. 26-346).
Inadequate seating can contribute to the development of low-back pain.
Individuals who sit in chairs that are too high and have their feet
unsupported experience elevated pressure on the back of their thighs
(Akerblom 1969, Ex. 26-522; Bush 1969, Ex. 26-455; Schoberth 1962, as
cited in Chaffin and Andersson 1991, Ex. 26-420). Burandt and Grandlean
(1963, Ex. 26-1569) observed the tendency of subjects in high seat pans
to slide forward in their seats to support their feet, negating the
benefit of a back rest.
Dynamic Loading
Dynamic loading of the lumbar spine has other implications for
muscle and ligament. Stresses induced in the low back during manual
materials handling relate to the load weight and the characteristics of
the lift. As a result of their anatomic positions, large spinal
movements are created from relatively small degrees of muscle
shortening. Unfortunately, this results in the generation of relatively
large muscle and joint forces, with potential for tissue overloading
and injury. This could be particularly important during excessive or
rapid movement (Andersson and Marras 1996, Ex. 26-412), or at the point
of muscle fatigue.
A study by Hukins et al.(1990, Ex. 26-143) revealed that greater
forces are exerted on ligaments as the speed of motion increases. In
addition, elastic limits of the ligaments and disc may be exceeded
(Adams and Dolan 1981, Ex. 26-1348). Bush-Joseph et al.(1988, Ex. 26-
939) evaluated the effect of the speed of lifting on the external load
moment. Subjects were asked to lift at slow, medium, and high speeds.
There was a direct linear correlation between increasing speed of
lifting and increased peak moment. Furthermore, a study by Marras and
Mirka (1992, Ex. 26-982) revealed that muscles must generate a higher
percentage of electromyographic (EMG) maximal activity to maintain a
[[Page 68481]]
constant muscle force as the speed of trunk velocity increases with
bending.
Both lifting frequency and load weight affect back muscle work
capacity, in part related to fatigue. Using EMG assessments, Kim and
Chung (1995, Ex. 26-858) observed that lifting at 10% of maximum
voluntary isometric strength (MVIS) at a rate of 6 times a minute was
more fatiguing than lifting at 20% MVIS at a rate of 3 times per
minute.
Frequent loading of the lumbar spine with moderate to heavy weights
can also cause general physical fatigue with elevation in heart rate
and energy expenditure. Uncoordinated muscle activation that could
result from local and systemic fatigue could then place other tissues
at increased risk with continued lifting (Garg 1986, Ex. 26-121).
Postural Issues
Additional postural factors during lifting significantly affect
muscle function and risk of injury. Skeletal muscle is more likely to
rupture during eccentric contraction (Friden and Lieber 1994, Ex. 26-
546), a factor involved in many manual materials-handling tasks. In
addition, muscle length affects the amount of force that muscle can
generate, with maximal force produced when muscles are at their resting
lengths (Andersson and Marras 1996, Ex. 26-412; Chaffin and Andersson
1991, Ex. 26-420). Therefore, lifting in positions where skeletal
muscles are elongated or shortened can increase the risk of injury to
these tissues.
Using EMG evaluation of muscle function during lateral flexion of
the lumbar spine, Andersson, Ortengren, and Herberts (1977, Ex. 26-
1570) demonstrated increased activity on the side contralateral to
bending. Other researchers have determined that asymmetric loading in
lateral flexion and axial rotation causes high levels of antagonistic
activity in abdominal and back extensors. This is associated with
increased myoelectric activity on the side of spine contralateral to
the load, although there is still significant activity on the
ipsilateral side (Astrand 1987, Ex. 26-527; Kelsey 1975, Ex. 26-1134;
Magora 1970, Ex. 26-297; Merriam et al.1983, Ex. 26-299). Andersson
(1977, Ex. 26-449) noted that increased intervertebral disc pressure
and intraabdominal pressure occurs when the trunk is loaded in lateral
flexion and axial rotation, with rotation being the greater factor.
Muscle Velocity and Acceleration
Marras (Ex. 26-1412) has indicated that several trunk muscle
characteristics and demands associated with dynamic lifting may better
assess the risk of developing a low-back disorder from manual materials
handling. The authors analyzed 400 lifting jobs in 48 industries using
a triaxial goniometer (Lumbar Motion Monitor or LMM) that was worn by
working subjects. A combination of five trunk motion and workplace
factors was able to reasonably predict jobs posing high risk for low-
back disorders (Marras et al.1995, Ex. 26-1412). These factors include
the lift frequency, load moment, trunk sagittal range of motion, trunk
lateral velocity and trunk twist acceleration (Marras et al.1995, Ex.
26-1412). A recent NIOSH Health Hazard Evaluation provided additional
verification that the LMM has predictive capacity equal to the NIOSH
Lifting Equation in job analysis (NIOSH 1993, Ex. 26-521), with perhaps
greater ease of administration.
Recently, Marras et al.(1990, Ex. 26-1523; 1993, Ex. 26-170; 1995,
Ex. 26-171) studied the trunk angular motion characteristics of normal
and chronic low-back pain subjects. Used in a clinical setting, the LMM
appears to have good ability to accurately distinguish between normal
individuals and those with chronic low-back pain or structural disease.
The authors used anatomic and pain categories previously selected by
the Quebec Task Force Study on Spinal Disorders (1987, Ex. 26-494).
Normative trunk motion values for age and gender were derived in a
study of 339 males and females from ages 20 to 70 years who had never
experienced significant low-back pain. While wearing the LMM, subjects
performed trunk flexion and extension in five symmetric and asymmetric
motion planes (0 degrees, 15 degrees and 30 degrees right and left)
while trunk angular position, velocity, and acceleration were recorded
with the LMM. In a repeatability study, 20 healthy normal subjects who
had never experienced a low-back disorder were tested with the LMM once
a week for 5 weeks. No statistically significant differences were
observed among the trunk motion characteristics between the five weekly
test sessions using multivariate analysis of variance. Correlation
coefficients were computed to select reliable trunk motion variables to
be used in the next phase of the study. Correlations varied as a
function of the angle of asymmetry and measured variables, with motion
characteristics in the zero plane demonstrating correlation
coefficients of 0.88 to 0.96 (number of conditions performed, twisting
range of motion, sagittal range of motion at 0 degrees, sagittal
extension velocity at 0 degrees, sagittal extension acceleration at 0
degrees, continuous velocity, continuous acceleration, lateral right
range of motion at 0 degrees).
In the next phase, the eight highly reliable trunk motion
characteristics evaluated in the healthy subjects were compared with
measurements in subjects with chronic low-back pain (96 males and 75
females) who were recruited for study from secondary and tertiary
referral practices. These individuals had been symptomatic for at least
7 weeks and had been sufficiently studied, including with appropriate
imaging studies, to permit accurate Quebec classification. Dynamic
trunk motion characteristics were normalized for age and sex, and using
quantitative discriminant analysis, the 510 subjects were correctly
classified in 94% of cases as being either healthy or having chronic
low-back pain(stage-one analysis).
In a stage-two analysis, nine variables (the eight previously
mentioned and continuous position) correctly classified 80% of subjects
into one of eleven groups (normal, low-back pain alone, low-back pain
with proximal or distal radiation, disc herniation with high or low
pain scores, spondylolisthesis, spinal stenosis, postoperative,
nonorganic components, other) via modified classification using
splines. It was also noted that trunk range-of-motion parameters
commonly used to quantify impairment had poor ability to discriminate
normal vs. chronic low-back pain, nor was it useful in classification.
Furthermore, a characteristic pattern of recovery from low-back pain
was noted, with normalization occurring first in range of motion
followed by velocity and later acceleration of dynamic trunk motion. It
was opined that the LMM's ability to quantify unloaded free-dynamic
motion and account for the co-activation of additional structures
(e.g., internal and external obliques, lattissimus dorsi) affecting
erector spinae function was in part responsible for its enhanced
discriminating ability compared to alternate imaging techniques.
Disc Disorders/Disorders of the Three-Joint Complex (Disc and Two
Facets) and the Nerve Root
The three-joint complex refers to the intervertebral disc and two
facet joints. This complex permits the spine to absorb compression and
resist torsion and shear, while permitting translation and rotation of
the spine. Epidemiologic evidence suggests that work exposures
involving heavy lifting or manual materials handling are associated
with
[[Page 68482]]
low-back disorders, including disc disorders (Bernard and Fine 1997,
Ex. 26-1).
Excessive or repeated spinal loading and inadequate rest periods to
permit repair mechanisms to function may be associated with
biomechanical stresses that damage intervertebral disc cartilage
endplates. This may then disturb metabolic transport, hastening the
development of degenerative disc disease and disc herniation with
secondary nerve root compression or inflammation.
Rowe (1971, Ex. 26-319) opined that up to 70% to 80% of recurring,
chronic low-back pain will eventually be diagnosed as discogenic.
Discogenic pain can include clear and consistent symptoms and signs
expected with lumbar disc herniation and specific nerve root pathology,
as well as chronic low-back pain associated with increased pressure in
the intervertebral disc or degenerative disc disease. In patients with
lumbar disc herniations, approximately 90% to 95% occur at the lower
three intervertebral disc spaces (lumbar \3/4\ disc or lumbar 4th nerve
root, lumbar \4/5\ disc or lumbar 5th nerve root, lumbosacral L5/Sl or
sacral 1st nerve root) (Deyo, Rainville, and Kent 1992, Ex. 26-365).
Increased compressive and torsional forces transmitted to the lower
levels of the lumbar spine probably account for this observation. Peak
incidence of lumbar disc herniation occurs in adults during the working
years from ages 30 to 55 (Spangfort 1972, Ex. 26-502). The onset of
symptoms may be acute, subacute, or chronic, and the relationship to a
single lifting incident may not always be obvious (Berquist-Ullman and
Larsson 1977, Ex. 26-933). Symptoms and physical findings depend on the
location of the disc herniation and the degree of nerve compression.
An understanding of disc biochemistry and biomechanics assists in
the understanding of the pathogenesis of work-related lumbar disc
disorders. For ethical reasons the majority of observations on spinal
tolerance have been derived from cadaver spines. However, in vitro and
in vivo comparisons appear to validate these conclusions. There is a
wide biologic variation in human disc and end plate tolerances
(Brinckmann et al., 1988, Ex. 26-1318) related to age, gender,
genetics, prior injuries, and other factors. The maximum axial
compressive force tolerated by the human cadaver lumbar spine has been
measured by Brinckmann et al., 1988 (Ex. 26-1318) to range from 2.1 to
8.8 kN (210 to 880 kg), with 30% fracturing at forces below 4 kN and
63% fracturing below 6 kN. Adams and Hutton (1982, Ex. 26-1379) studied
cadaver discs from male subjects aged 22 to 46 years. The authors
determined that most specimens could withstand an average of 10 kN on
single loading prior to failure, usually at the end plate. In contrast,
Bartelink (1957, Ex. 26-349) noted that discs were fractured from
forces ranging between 1.6 and 6.7 kN, with a mean of 3.1 kN. The wide
inter-individual variation in tissue tolerance makes it difficult to
assign a single value of compressive force against which to engineer
jobs to prevent lumbar disc.
When mechanical failure occurs, it is generally through the
cartilage endplates (Adams and Hutton 1982, Ex. 26-1379; Armstrong
1985, Ex. 26-1070; Brinckmann el al., 1988, Ex. 26-1318; Erdil,
Dickerson, and Chaffin 1994, Ex. 26-424) Disc height, spinal position,
and frequency of bending appear to be risk factors. Creep results in
loss of disc height, increased contact between load-bearing surfaces of
the facet joints, diminished capacity to dissipate forces, and
decreased ability of the spinal column to tolerate loading (Kazarian
1975, Ex. 26-379). Adams and Hutton (1982, Ex. 26-1379) observed
maximal single loading tolerances of up to 10 kN; however, when the
spines were flexed forward, 40% of discs prolapsed at an average of
only 5.4 kN. Repeated lumbar spine loading can cause tissue fatigue
with fracture at lower loads than the spine would tolerate for non-
repetitive loading. Adams and Hutton (1985, Ex. 26-1315) determined
that when repetitive loading was simulated, previously healthy discs
failed at an average of 3.8 kN.
These studies support the clinical observation that the
intervertebral disc is especially vulnerable when loaded in the flexed
position or when subjected to repetitive loading. This becomes more
significant when workers with lower tissue tolerance from prior injury,
degenerative disc disease, or age lift at high rates for prolonged
periods.
Armstrong (1985, Ex. 22-877) noted that small microtears most often
occur in the region of the posterior elements of the annulus fibrosus
and cartilage end plates. As noted, these are the areas subject to the
greatest spinal compressive forces (Gracovetsky and Farfan 1986, Ex.
26-128; Hickey and Hukins 1980, Ex. 26-708; Pope et al.1991, Ex. 26-
1296). With repeated lumbar spinal stresses and/or injuries,
progressive microfractures in cartilage end plates and annular fibers
(annulus fibrosus) may develop in the intervertebral discs (initially
toward the center of vertebral bodies). This causes altered metabolism
and fluid transfer with different mechanical behavior of the disc.
Eventually radial tears result in the development of degenerative
disc disease and/or bulging. As a result of this damage, the capacity
of the lumbar intervertebral discs to tolerate further compressive
loads during lifting is altered. When these smaller tears extend and
form complete annular tears, the nucleous pulposis can protrude (disc
herniation) (Farfan et al. 1970, Ex. 26-113). Over time, sclerosis of
cartilage endplates and altered disc loading can facilitate the
development of facet arthropathy, osteophytic change, stenosis, or
instability. Disc degeneration in combination with facet arthropathy
may also lead to foraminal narrowing with resultant nerve compression
and radicular pain. These observations are consistent with a cumulative
trauma theory that could account for some types of low-back injuries
and is supported by the research and opinions of other authorities
(Erdil, Dickerson, and Chaffin 1994, Ex. 26-424; Pope et al. 1991, Ex.
502-502; Yong-Hing and Kirkaldy-Willis 1983, Ex. 26-405).
While many individuals with degenerative disc disease are
asymptomatic, individuals with greater degrees of degeneration are at
risk for low-back pain. In one study (Vanharanta et al. 1987, Ex. 26-
225) 90% of subjects with severe disc degeneration experienced pain
during discography, while only 23% of those without disc degeneration
reported pain.
Arthritis/Spondylosis
Several studies have suggested a relationship between lumbar
degenerative disease and work activities (e.g., heavy work, repetitive
lifting, and vibration). This association has come from both
radiographic and pathological evaluations in association with work
histories. One difficulty in these evaluations is the observation that
lumbar spine x-ray changes are common, occurring in about 40% of all
low-back x-rays (Rowe 1983, Ex. 26-699). However, the relationship of
many x-ray changes with symptoms of low-back pain is unclear (Andersson
1981, Ex. 26-1480; Himmelstein et al. 1988, Ex. 26-962; Magora and
Schwartz 1976, Ex. 26-389; Rowe 1963, Ex. 26-317; 1969, Ex. 26-318).
Videman, Nurminen, and Troup (1990, Ex. 26-1023) noted an increase in
vertebral osteophytosis in autopsy specimens from workers who performed
heavy work. Of interest is that the heavier work exposures also were
observed in association with increased rates of low-back disability.
[[Page 68483]]
Riihimaki et al. (1991, Ex. 26-966) performed a radiographic study
of the lumbar spine in concrete workers and house painters. Lateral
lumbar x-rays were obtained in 216 concrete reinforcement workers and
201 house painters aged 25 to 54 years. Disc space narrowing was noted
10 years earlier and spondylophytes 5 years earlier in the concrete
workers. Risk ratios for the univariate effect of occupation on disc
space narrowing was 1.8, and for spondylophytes it was 1.6. Potential
cofounders such as age, prior back accidents, body mass index, and
smoking had minimal effect. The authors concluded that heavy physical
work with materials handling and postural loading enhances the
degenerative process of the lumbar spine.
Wickstrom, Nummi, and Nurminen (1978, Ex. 26-1161) evaluated degree
of lumbar flexion, presence of pain, and x-ray findings of degenerative
disc disease in 295 concrete reinforcement workers aged 19 to 64 years.
These workers commonly perform work involving spinal loading in stooped
postures. Radiographic evidence of degenerative disc disease was noted
in two-thirds of the 110 individuals with restricted flexion and in
one-third of those (n=185) with normal flexion.
Kirkaldy-Willis (1983, Ex. 26-431) described a pathophysiologic
spectrum of changes that lead to the development of lumbar spine
degenerative disease. In the first phase, there are early and mild
changes in the posterior complex, with facet synovitis, joint effusion,
capsular stretch, and thickening. Inflamed synovium may become
entrapped in the joint between the cartilage surfaces and initiate
cartilage damage. Meanwhile, the intervertebral disc develops some
circumferential tears in the annulus fibrosus. Tears in the periphery
have at least some potential to heal because of the proximity to
vascularity, but these deeper tears lack this ability by virtue of
their distance from blood flow or metabolic diffusion. As these
circumferential tears enlarge, they develop into large radial tears. As
a result, the nucleus pulposus begins to lose proteoglycan and exhibits
structural changes with grade 1 or 2 degenerative disc disease. Loss of
water and disc height as well as a decline in annular resistance can
cause increased compression forces on the facets. Individuals may be
asymptomatic or have vague low-back pain. However, due to the lack of
nociceptors in the disc and facet joints (except the synovium), a
significant degree of degenerative disease may occur before pain
develops. Lumbar disc herniation may occur at this juncture with
symptoms and signs or radiculopathy.
In the next phase, the posterior joint capsule and annulus fibrosus
develops laxity and instability. The intervertebral disc progresses to
grade 2 or 3 degenerative disease. It may be possible to detect
instability on dynamic x-rays. Subperiosteal bone formation,
calcification of the ligaments, and capsular fibers manifest as
peripheral osteophytes and traction spurs (Dupuis 1987, Ex. 26-1299) in
an attempt to stabilize the motion complex (MacNab 1977, Ex. 26-1367).
If laxity predominates over repair processes, the degenerative
spondylolisthesis (facet laxity) or retrolisthesis (disc laxity) may
occur (Dupuis et al. 1985, Ex. 26-108).
In the final phase, there is fibrosis of the posterior facet
joints, loss of disc material (grade 3 or 4 degenerative disc disease),
and progressive osteophyte formation (Wedge 1983, Ex. 26-1035). This
increases the load-bearing surface of the three-disc complex, although
it decreases motion and results in increased stiffness. The repair
process may create narrowing of the central canal (central spinal
stenosis) from facet arthropathy, disc bulging, and hypertrophy of the
ligamentum flavum. Lateral stenosis may also result from facet
arthropathy and osteophyte formation adjacent to the neuroforamina.
Spinal stenosis is a diagnostic entity that has only recently been
described. A few patients have congenitally small spinal canals;
however, most present with this type of acquired spinal stenosis
secondary to longstanding degenerative disease. Most patients first
become symptomatic after 50 years of age (Turner et al. 1992, Ex. 26-
1455). By virtue of its long-term degenerative nature, spinal stenosis
is not often considered a work-related disorder; however, patients with
spinal stenosis may present with co-existing lumbar disc herniation or
other degenerative changes that have been exacerbated by work factors.
Conclusions
OSHA finds convincing evidence from the confluence of many
investigation on biomechanical models, laboratory research and
epidemiology studies that work related risk factors including (1) heavy
physical work, (2) lifting and forceful movements, (3) bending,
twisting and awkward positions, and (4) static work positions are
causally linked to low back disorders and pain. Work often involves
several of these risk factors concurrently and there is evidence that
the first three of these factors may act together in a synergistic way
to increase the risk. However, OSHA considers that each factor, by
itself, can increase the risk of back disorder.
F. Disorders of the Lower Extremities
Work-related disorders of the lower extremities have not received
the same scrutiny as those of the upper extremities and back. However,
existing information from pathophysiology, epidemiological studies, and
biomechanical investigations implicate physical work factors related to
repetitive, forceful exertion and awkward posture to these disorders,
especially osteoarthritis of the knee and hip. As more completely
described in Health Effects Appendix III.D (Ex. 27-1), osteoarthritis
is considered a disorder of the movable joints characterized by the
disintegration of the articular cartilage that covers the end of the
bones. The articular cartilage and subchondral bone that lies just
beneath the cartilage provide opposing structures and surfaces that are
matched in such a way as to allow transmission of joint loads at the
lowest and most uniform pressures, (Meisel 1984, Ex. 26-1562).
The arthrosis process is thought to begin with disruption at the
thin surface overlying the load-bearing cartilage (Meisel, 1984, Ex.
26-1562). This disruption results in progressive erosion of the
cartilage layer and a joint surface less able to withstand normal loads
and forces. Continual loading on the joint then disrupts the process of
bone/cartilage repair and regeneration, leading to formation of
marginal bone in the shape of spurs (osteophytes). The degenerative
process continues until the cartilage has been completely destroyed;
there is bone-on-bone contact, and the structural integrity of the
joint is lost. The clinical manifestations are joint stiffening, pain
and loss of movement (Meisel 1984, Ex. 26-1562).
It is well recognized that acute trauma can trigger osteoarthritis,
but there is also evidence that less substantial, but repetitive,
forces to the joints can lead to microfractures of the articular
cartilage and subchondral bone. The disruption in structural integrity
results in the onset of the degenerative changes described above (Radin
et al., 1994, Ex. 26-578). This process has been observed in animals
subjected to repetitive impact loading of one or more limbs (Moskowitz,
1992, Ex. 26-1547). Damage to the joints in these animals involve
fibrillation and splitting of the cartilage, evidence of chondrocyte
activity as bone remodeling occurs, progressive erosion of the
cartilaginous layer, and formation of osteophytes.
[[Page 68484]]
Other MSDs of the lower extremity that may be caused by physical
work-related factors include bursitis and tarsal tunnel syndrome. Joint
overuse may lead to bursitis, an inflammation of a fluid-filled sac or
sac-like cavity that serves to reduce friction in a joint (Ex. 502-
317). Repetitive use of the foot may be related to tarsal tunnel
syndrome, a nerve entrapment syndrome of the lower extremity analogous
to carpal tunnel syndrome in the wrists (Day 1996, Ex. 26-615).
In addition to acute and repetitive trauma, MSDs of the lower
extremities have been linked with congenital abnormalities, underlying
genetic or metabolic disorders, and chronic conditions, such as cancer,
diabetes and collagen-vascular disease (Felson 1994, Ex. 26-544; Meisel
1984, Ex. 26-1562).
Epidemiological Evidence
Epidemiological evidence of an association between workplace
factors and MSDs of the lower extremities was discussed in Health
Effects Appendix I. A summary of the risk factors is presented in Table
C-1 (for osteoarthritis of the knee) and Table C-3 (for the hip).
Several work-related activities, such as squatting and kneeling for
more than 30 minutes per day, were significantly associated
(OR3) with osteoarthritis of the knee in a population-based
case-control study (Cooper et al., 1994, Ex. 26-460). This study also
showed that a combination of these activities along with lifting loads
greater than 25 kg (which places an additional load on the lower
extremities) resulted in an even stronger association (OR5)
with this knee disorder. Other epidemiological studies associated
occupations such as construction work, farming, firefighting, laundry/
dry cleaning, and manual labor, with knee osteoarthritis (Anderson and
Felson, 1988, Ex.26-926; Vinguard et al., 1991, Ex. 26-1500).
Three case-control studies reported positive associations between
MSDs of the hip and work tasks involving biomechanical factors (Coggon
et al., 1998, Ex. 26-1285; Croft et al., 1992, Ex. 26-1503; Vinguard et
al., 1997, Ex. 26-1617). One study found that jobs requiring lifting
over 25 kg more than ten times in an average week for more than 20
years raised the odds of developing hip osteoarthritis (Ex. 26-1285).
Farmers, mail carriers, firefighters, and meat processors were
occupations reported to be significantly associated with hip
osteoarthritis in a registry-based cohort study (Ex. 26-400).
Repetitive kneeling, squatting, and lifting are all activities
involving the biomechanical risk factors of repetition, forceful
exertion, and awkward postures of the lower joints. Table V-8
summarizes some key aspects of these investigations, including:
Occupations examined; biomechanical risk factors involved; whether or
not exposures were directly observed during the study, whether the
health outcomes were verified by medical tests, whether evidence
provided of an exposure-response or other temporal relationship between
the risk factor and outcome; and the measure of relative risk used
along with the results of this measure.
In addition to the evidence previously reviewed, Table V-8 includes
five additional studies submitted to the docket that address physical
work factors and disorders of the lower joints, primarily the knee (Ex.
500-41-114; Ex. 500-121-44; Ex. 500-41-69; Ex. 502-317; Ex. 500-41-68;
Ex. 500-121-18. Three of the studies examined the prevalence of knee
disorders among carpet- and floorlayers who spend a substantial amount
of time working in knee straining postures. Kivimaki (1992, Ex. 500-41-
78) compared 96 floor- and carpetlayers to 72 painters with regard to
disorders of the knee. An analysis of videotaped work tasks indicated
that floor- and carpetlayers assume a kneeling posture in their job 42%
of their work time, compared to 3% of work time by painters.
Ultrasonographic examination indicated changes in the prepatellar or
superficial infrapatellar bursa in 49% of the carpet and floor layers
compared to 7% of painters. On a symptom questionnaire, the floor- and
carpetlayers reported a significantly greater prevalence of bursitis in
front of the knee cap, knee pain in a kneeling posture, sudden and
intense swelling of the knee, aspirations of the knee, and injections
to the knee than painters.
Table V-8.--Summary of Epidemiology Studies Examining MSDs of the Lower Extremities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diagnosis/body Risk measure (95%
Study Job type studied Physical factors Exposure basis part Other attributes CI)\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Kivimaki (1992) Ex. 500-41-78.. carpet laying; F/R/P observation questionnaire NR*
floor laying. questionnaire. ultrasound/knee.
Jensen (1997) Ex. 500-41-69..... carpet laying; F/R/P questionnaire questionnaire exposure response OR=1.5-6.4*
carpentry. observation. radiology/knee. (3.2-8.9)
Tanaka (1986) Ex. 502-317....... floor laying; tile F/R/P questionnaire..... questionnaire knee exposure response. PRR=1.1-5.0*
setting. (3.2-7.8)
Sandmark (2000) Ex. 500-41-114.. prosthetic knee F/R/P questionnaire..... surgery/knee...... exposure response. OR=0.7-3.2*
patients. (2.0-5.2)
Cooper (1994) Ex. 26-460........ general population. F/R/P questionnaire..... questionnaire X- OR=0.8-6.9*
ray/knee. (1.8-26.4)
Anderson (1988) Ex. 26-926...... general population. F?/R/P job title questionnaire X- OR=0.8-3.5*
questionnaire. ray/knee. (1.2-10.5)
Vingard (1991) Ex. 26-1400...... various occupations F/R?/P? job title......... hospitalization RR=0.6-3.8*
knee or hip. (1,2-12.1)
Coggon (1998) Ex. 26-1285....... patients case/ F/R/P? questionnaire..... hip replacement.. OR=1.0-2.1*
control. (1.1-3.9)
Croft (1992) Ex. 26-1503........ patients case/ F/R?/P? questionnaire job joint measurement/ OR=0.8-2.5
control. title. hip. (1.1-5.7)
Vingard (1997) Ex. 26-1617...... patients case/ F/R/P? questionnaire..... hip replacement... RR=0.8-2.3*
control. (1.5-3.6)
De Zwart (1997) Ex. 500-121-18.. Various occupations F/R/P job title......... questionnaire temporal NR*
lower limbs. relationship.
--------------------------------------------------------------------------------------------------------------------------------------------------------
F=forceful exertions; R=repetitive motion; P=awkward posture; ?=presence of risk factor unclear;
RR=relative risk; OR=odds ratio; PRR=prevalence rate ratio
*=p0.05
[[Page 68485]]
\1\ 95% confidence interval expressed for the upper end of the risk measure range.
Jensen et al. (1997, Ex. 500-41-69) conducted a larger cross-
sectional study of knee disorders among current and former floor- and
carpetlayers (N=133), carpenters (N=506), and compositors (N=327).
Based on telephone interviews and video recording of work activities,
the authors determined that floor- and carpetlayers spent 56% of their
working time in knee-straining postures. Carpenters were reported to
have spent 25% of their working time in such postures, while
compositors did not spend any working time in knee-straining positions.
Response to a questionnaire revealed that carpenters experienced a
significantly increased frequency of knee complaints within the last 12
months (OR=3.8, 95% CI: 2.7-5.5), within the last seven days (OR=3.6,
95% CI: 2.3-5.8), and for more than 30 days over the preceding 12
months (OR=2.5, 95% CI: 1.6-3.9) when compared to compositors. Floor-
and carpetlayers, the highest exposed group, also reported a
significantly increased frequency of knee complaints within the last 12
months (OR=6.4, 95% CI: 4.0-10.1), within the last seven days (OR=5.7,
95% CI: 3.3-10.1), and for more than 30 days over the preceding 12
months (OR=5.3, 95% CI: 3.1-8.9) when compared to compositors; the odds
ratios reported for floor- and carpetlayers were uniformly higher than
those reported for carpenters. Age, weight, body mass index, smoking,
and sports activities were reported to have had no significant effect
on the incidence of knee complaints. Among 50 floor- and carpetlayers,
51 carpenters, and 49 compositors who had radiological examinations of
their knees, an increased prevalence of osteoarthritis was found in
floor- and carpetlayers (14%) when compared to carpenters (8%) and
compositors (6%).
A third cross-sectional study involving floorlayers by Tanaka et
al. (1986, Ex. 502-317), and also reported by Thun et al. (1987, Ex.
26-60), examined the relationship between work activities involving
strain on the knees and the development of knee disorders. Floorlayers
(N=112) and tilesetters (N=42) who reported frequent kneeling in a
survey questionnaire were compared to a group millwrights, bricklayers,
and decorators (N=243) who did not commonly kneel.
The floorlayers reported more frequent bursitis of the knee (20%
vs. 6%) and more needle aspirations of knee fluid (32% vs. 6%) than the
millwrights and bricklayers. Tilesetters also reported bursitis (11%)
and knee aspirations (31%) in excess of those reported by millwrights
and bricklayers.
In this study questionnaire responses were compared to responses
given by a representative sample of white males to standardized
questions about symptoms of knee disease. When compared to sample,
floorlayers, tilesetters, and millwright and bricklayers all reported a
higher age-adjusted prevalence for each of the seven symptoms than the
sample. This result suggests that the relative risk of knee disorders
in the highly exposed groups may be understated when millwrights and
bricklayers are the reference group since they may, themselves, be at
increased risk relative to the general population.
Physical examination that included radiological tests of a subset
of the workers was performed to validate the questionnaire. The
questionnaire was reported to show low sensitivity (38-44%), but
moderate specificity (82-89%), for both bursitis and arthritis.
Other studies examined the relationship between lower limb MSDs and
physical work factors in more diverse occupational settings. Using a
case-control study design, Sandmark et al. (2000, Ex. 500-41-114)
compared individuals who had received prosthetic knee replacements due
to osteoarthritis to control subjects to examine the relationship
between lifetime physical load from work and the risk of knee
osteoarthritis. A total of 625 individuals who had received prosthetic
knee replacements due to osteoarthritis, and who were between the ages
of 55 and 70 at the time of surgery were compared to 548 age- and
gender-matched individuals randomly selected from the population of the
same geographical area who had not reported osteoarthritis or other
dysfunction of the knee.
Through telephone interview and written questionnaire, the subjects
provided information on workloads from occupational and non-
occupational activities, personal characteristics, and general health
status. The duration and frequency of activities (e.g., kneeling,
sitting, number of stairs climbed) were computed for each individual.
Subjects were then divided into three exposure groups: No or low
exposure comprising the lower quartile; medium exposure comprising the
middle two quartiles; and high exposure consisting of the top quartile.
Analysis of the data revealed that, among men, lifting at work
(OR=3.0, 95% CI: 1.6-5.5), squatting or knee bending (OR=2.9, 95% CI:
1.7-4.9), kneeling (OR=2.1, 95% CI: 1.4-3.3), and jumping (OR=2.7, 95%
CI: 1.7-4.1) were significantly associated with osteoarthritis of the
knee. Individuals who had spent ten or more years in an occupation
considered to involve high physical load on the knee were also more
likely to undergo knee replacement due to osteoarthritis than those who
had not worked in such occupations (men, OR: 2.5, 95% CI 1.7-3.6;
women, OR: 2.5, 95% CI: 1.6-3.9). The analysis controlled for
confounders such as age, body mass index, smoking, and sports
activities.
The findings of Sandmark et al. (Ex. 500-41-114), Jensen et al.
(Ex. 500-41-69) and Tanaka et al. (Ex. 502-317) indicate an exposure--
response relationship between the frequency of work involving strain to
the knees and osteoarthritis, bursitis and other signs of injury to
this joint.
In a longitudinal survey study, de Zwart et al. (1997) (Ex. 500-
121-18) investigated changes in musculoskeletal complaints among
workers performing mentally demanding work (N=4686) and heavy physical
work (N=7324). Job demands were determined by occupational title.
Mentally demanding work was described as sedentary, while heavy
physical work involved tasks such as lifting heavy objects, handling
heavy tools, and stooping in combination with standing or walking. The
subject groups were stratified by age (20-9, 30-9, 40-9, 50-9 years
old). The occurrence of musculoskeletal complaints were compared
between two surveys having a mean interval of approximately four years.
No physical examination or examination of medical records was
performed.
The incidence of musculoskeletal complaints of the lower limbs on
the second survey was higher among those who had not reported
complaints on the first survey for all age groups. However, the
incidence was only statistically significant for the youngest three age
groups. The authors concluded that younger and middle-aged employees
develop musculoskeletal complaints as a result of exposure to heavy
physical work, and that a healthy worker effect served to mask this
effect for the oldest age group. Because of its prospective design,
this investigation provides a temporal link between MSDs of the lower
extremities and heavy physical work.
Lemasters et al. (1998) (Ex. 500-121-44) examined the prevalence
and risk factors for work-related MSDs among carpenters. (N=522) who
completed a
[[Page 68486]]
questionnaire on musculoskeletal symptoms, work history, and
psycholsocial factors. The symptom questions assessed if they
experienced pain, numbness, or tingling in a particular body region.
Generally, as duration of employment increased, the prevalence of
symptoms increased. An adjusted logistic regression analysis showed
that duration of employment in carpentry for at least 20 years was
significantly associated with work-related MSDs of the knees (OR: 3.5,
95% CI: 1.3-9.2). Carpenters who indicated they felt exhausted at the
end of day experienced significant increases of work-related MSDs of
the knees (OR: 1.8, 95% CI: 1.1-3.1). Having minimal influence over
their work schedule was also reported to be a risk factor for work-
related MSDs of the knees (OR: 2.3, 95% CI:1.2-4.1).
A subset of the subject group received a physical examination
including examination of the knees. The authors concluded that reported
disorders, including those of the knee, were significantly associated
with positive findings upon physical examination.
An examination of the reliability of questionnaire responses was
performed by Booth-Jones et al. (1998) (Ex. 500-121-9). Ten percent of
the subjects examined by Lemasters et al. (1998) (Ex. 500-121-44) were
subsequently randomly selected and administered the original
questionnaire for a second time. All positive responses were
categorized as ``yes'' answers and all other responses were categorized
as ``no'' responses. Comparison of the results of the first and second
administrations of the test indicated that the responses were largely
consistent, with overall agreement reported to be 85.6%. This result
provides a strong indication that the questionnaire responses examined
by Lemasters et al. (1998, Ex. 500-121-9) are a reliable representation
of the recollections of the subjects examined.
A significant concern when evaluating studies in which exposure
measurements and health outcome are based on self-reports is the
possibility of recall bias. Among the studies pertaining to the lower
extremities that are described here, those of Sandmark et al. (Ex. 500-
41-114), Jensen et al. (Ex. 500-41-69), Tanaka et al. (Ex. 502-317),
and Lemasters et al. (Ex. 500-121-44) each depend to a greater or
lesser extent upon the accuracy of self-reported exposures to ergonomic
risk factors. Such self-reports have been criticized as being
unreliable (Exs. 30-276, 500-118). Evidence submitted to the docket
regarding the studies discussed above, while not eliminating concerns
about the reliability of self-reports, generally support their
accuracy.
The validity of self-reporting as a means of measuring knee-
straining work postures was examined by Jensen et al. 2000, Ex. 500-41-
68). Self-reports were compared to timed video recordings for 39
carpenters and 33 floorlayers. The carpenters and floorlayers were
videotaped while working and, then immediately afterwards were
requested to estimate the amount of time spent in knee-straining
postures. A close association was reported between the observed and
self-reported durations (Spearman's correlation coefficient: 0.88).
While this report provides evidence that immediate self-reports are
largely accurate, recall bias associated with self-reports of
historical work activities remains a concern.
Biomechanical Evidence
Bhattacharya et al. (1985, Ex. 502-270) examined the biomechanical
forces associated with different working postures involved in carpet
installation when using a knee kicker. The knee kicker is a device
consisting of a plate with a set of teeth in one end that grips the
carpet while an installer kicks the padded end with a knee to stretch
the carpet. A job analysis indicated that carpet installers spend
approximately 75% of their time in a kneeling position, and use the
knee kicker an average of 141 times per hour. Postures were reported to
require near-maximum knee flexion. Knee-flexion angles at impact
averaged about 58 deg., while normal daily activities involve less
flexion (e.g., sitting, 87 deg.; tying shoe laces, 74 deg.; walking
upstairs, 97 deg.). Workers performing the heaviest of the knee kicks
produced peak impact forces averaging over 3000 newtons, equivalent to
approximately four times their body weight. The authors suggested that
the biomechanical demands of installing carpet may be responsible for
the high incidence of knee disorders among these workers.
Conclusion
OSHA concludes that strong evidence is available showing that
steoarthritis of the knee and other MSDs of the lower extremities can
result from exposure to the combined physical work-related factors of
repetition, force, and awkward posture. This evidence comes from the
consistently positive associations in epidemiological studies of
carpet- and floorlayers who spend considerable amounts of time in knee-
straining postures. Biomechanical evidence indicates knee flexion and
impact forces can be substantial during installation of carpet. Other
occupational activities that involve excessive squatting, kneeling, and
climbing stairs have also been shown to be associated with
osteoarthritis of the knee and hip. Some studies indicate an exposure--
response or temporal relationship between physical risk factor and
health outcome. Therefore, it is biologically plaucible that repetitive
impact loading on the joints is consistent with the degenerative
pathophysiology of osteoarthritis. OSHA concludes that the evidence
reviewed in this section demonstrates that workers who perform job
tasks requiring repeated forceful flexion of the knee or other joints
of the lower extremities are at increased risk of serious
musculoskeletal impairment such as osteoarthritis.
G. OSHA's Response to Health Effects Issues Raised in the Rulemaking
1. Comments on OSHA's Use of the NIOSH (1997) and NAS (1999) Reviews
Several commenters (Ex. 30-1722; Ex. 500-109; Ex. 32-368-1; Ex. 32-
241-4; Ex. 500-197) criticized OSHA's reliance on the 1997 NIOSH review
(Ex. 26-1) and the 1999 NAS report (Ex. 26-37) of the evidence for
work-related MSDs. First, the commenters considered the methodology
used by NIOSH to evaluate the epidemiological evidence that work-
related factors were associated with MSDs to be seriously flawed.
Second, they accused OSHA of ignoring obvious limitations of the NIOSH
review and then misrepresenting its conclusions. Finally, the
commenters claimed that the NAS workshop report did not support the
OSHA position with regard to biomechanical risk factors and MSDs. A
more detailed description of each assertion will follow along with
OSHA's response.
The criticisms of the NIOSH methodology were aimed at nearly every
level of evaluation. It was said that NIOSH exercised a ``publication
bias in favor of positive studies'' in its study selection (Ex. 500-
197, pg. I-146). It was said that the NIOSH criteria used to assess
study quality ``emphasize[d] biased and unreliable methodology at the
expense of sound scientific approaches.'' (Ex. 32-241-4, pg. 109). It
was said that there was ``no indication of any systematic method for
assigning weight,'' (Id. pg. 109), and that the weighting could not be
``replicated and, therefore fails to satisfy one of the most basic
tenets of scientific inquiry.'' (Ex. 23-109, pg. 23). It was said that
NIOSH ``failed to adequately consider other confounding factors in
their analysis'' (Ex. 32-368-1, pg. 40). Finally, it was said that
NIOSH was ``forced to draw its conclusions from a larger body of
[[Page 68487]]
literature that included studies meeting only some, or even none of
these criteria.'' (Ex. 500-197, pg. I-148). One commenter summed up the
NIOSH evaluation process as follows:
The report did not conform to the generally accepted scientific
methods for critical analysis. It did not use a weight of the
evidence approach. For example, there is no explanation of how
studies which met NIOSH's criteria standards were regarded
differently than studies which did not. In essence, NIOSH put the
2000 studies into a black box, and out popped 600. Then the 600 went
into another black box, and out popped the conclusions (Ex. 32-368-
1, pg. 36-37).
OSHA strongly disagrees that the approach used by NIOSH to evaluate
the epidemiological studies was flawed or that the conclusions in the
1997 review are weakly supported by the evidence. In the first chapter
of its report, NIOSH describes, in detail, where it retrieved
information on epidemiological studies, how studies were selected for
more detailed review, the procedure used to analyze the overall
strength of work-relatedness, the six criteria (strength of
association, consistency, temporality, exposure-response, coherence,
and role of confounders) employed to evaluate the evidence of
causality, and the four categories to classify the evidence. The 600
studies reviewed by NIOSH [out of more than 2,000 identified in initial
database searches] were published or accepted for publication in the
scientific literature or government reports that had undergone peer
review and were widely available. These had to meet some minimum
requirement in terms of defined study groups, measurable health
outcomes, identifiable exposures related to physical factors, and
adequate study design. The NIOSH selection strategy was a common
screening approach that has been successfully employed by OSHA and many
other groups. There was no bias toward the selection of positive
studies; rather NIOSH selected those only studies that met the above
criteria. OSHA believes that the NIOSH selection process captured the
best epidemiological studies available at the time on which to evaluate
the evidence for a causal association between work-related risk factors
and MSDs.
NIOSH analyzed the reviewed studies in terms of well-accepted
epidemiological principles, such as participation rate, blinded study
design, exposure method, and case definition and gave greater weight in
its evaluation process to those that minimized selection and
observation bias and confirmed the existence of exposure and health
outcome by qualified experts. NIOSH applied the highly-regarded
Bradford Hill criteria (see six criteria above) for judging the
evidence for causation in classifying work-relatedness. These criteria
were not applied to any single investigation but to the entire database
of studies as a whole. NIOSH judged there was evidence of work-
relatedness between biomechanical factors and MSDs when there existed
convincing evidence from several studies for a causal relationship
using the epidemiologic criteria, and for which chance, bias, and
confounding factors were not the likely explanation. OSHA believes that
NIOSH clearly did not use a ``flawed'' methodology and their evaluation
process represents a systematic weight of evidence approach that relies
on an unbiased set of sound and reliable scientific principles.
NIOSH concluded there was evidence that MSDs of the neck, shoulder,
upper extremities, and back that have been subjected to epidemiological
investigation were associated with at least some biomechanical factors
or combination of factors. In several instances, the evidence was
judged to be strong. For most MSDs, there were situations in which the
epidemiological evidence was judged insufficient for certain
biomechanical factors in isolation (e.g. CTS and extreme posture;
epicondylitis and repetitive motion). However, these factors were
usually found to be associated with the MSD when present in combination
with other biomechanical factors (e.g. strong evidence of posture/force
combination and CTS; strong evidence of repetition/force and
epicondylitis). For several MSDs, OSHA found that the strength and
consistency of the associations between biomechanical factors and MSDs
was even stronger, if the evaluation was restricted to studies where
exposure was directly observed or measured and the health outcome was
confirmed by physical exam or medical tests (see Health Effects Section
V). It is important to note that the NIOSH analysis focused primarily
on the epidemiological evidence. OSHA believes these conclusions were
reasonable and based on the selected evaluation criteria.
Since the evaluation process involved expert judgment, weighting of
individual studies cannot be precisely ``replicated'' in the same way
as a scientific measurement, however, substantial evidence in the
rulemaking record supports NIOSH's conclusions. There were a number of
written submissions and oral testimony from scientific experts
supporting the position that sufficient evidence exists that
biomechanical factors can increase the risk of MSDs (e.g., Exs. 30-
3805, 32-57, Tr. 9819, 16317, 17358, 17687). Some notable testimony on
the epidemiological evidence from distinguished experts were as
follows:
There is a significant body of epidemiological and case study
literature that indicate that a high rate of work-related MSDs,
carpal tunnel syndrome, bursitis, tendinitis, and epicondylitis are
significantly higher in jobs that involve repetitive motions,
localized stress, awkward positions, vibrations, and forceful
exertions.
Dr. Robert McCunney (Tr. 17566-67)
OSHA's conclusion that there is an epidemiological evidence of
an association between many work factors and certain MSDs is
consistent with the literature that I've read and my clinical
experience as an occupational medicine physician treating thousands
of patients with MSDs over the past 20 years.
Dr. Michael Erdil (Tr. 1112)
We have, first of all, lots of epidemiological studies that show
physical factors are involved in MSDs. We have actually no
epidemiological study that shows, that proves there is no physical
factor involved.
Dr. Niklas Krause (Tr. 1367)
Some commenters thought that OSHA misrepresented the findings from
the NIOSH review in order to support its own conclusions that exposure
to work-related biomechanical factors increase the risk of serious
musculoskeletal impairment. It was claimed that OSHA had seriously
overstated the NIOSH conclusions as ``having established causation''
(Ex. 32-241-4, pg. 98) between biomechanical factors and MSDs
regardless of the length and intensity of exposure, instead of the true
NIOSH goal of drawing conclusions about the evidence of an association
between risk factor and health outcome under conditions of prolonged
exposure. Commenters argued that OSHA ignored the restricted scope of
the NIOSH analysis that was limited to ``certain objectively defined
MSDs'' and ``examined only certain very specific stressors of highly
repetitive and forceful work, lifting and forceful movements, awkward
and prolonged sustained postures and exposure to vibration.'' (Ex. 500-
109, pg. 24). On the other hand, it was claimed that OSHA used the
NIOSH findings to ``support causal inferences for all other MSDs * * *
which include not only those MSDs studied by NIOSH but also
DeQuervain's disease, trigger finger, Raynaud's syndrome and tarsal
tunnel syndrome'' and ``attempts to broaden the NIOSH exposure
associations to include not only the factors that NIOSH studied, but
also a wide range of other so-called ergonomic risk factors including
among others, contact stress and cold temperatures.'' (Ex. 30-1722, pg.
43).
[[Page 68488]]
OSHA does not agree that the findings of the 1997 NIOSH review have
been misrepresented in any way. The Agency has not stated that the
epidemiological evidence established that MSDs are caused by exposure
to work-related biomechanical factors. Epidemiological studies rarely,
if ever, prove causation. They are designed to identify associations
between two study variables. Depending on the strength and consistency
of the associations and whether the association shows aspects of
temporality and exposure-response, epidemiological data can provide
evidence of a causal relationship. OSHA has stated that there is
convincing scientific evidence that biomechanical factors, usually in
combination, increase the risk of several specific MSDs. These
conclusions are often based, not on epidemiological studies alone, but
also on the pathophysiology of the disorder and biomechanical and
psychophysical research that are able to link ergonomic risk factors to
biomechanical and subjective measurements under a more controlled set
of simulated work conditions.
In general, the conclusions drawn by OSHA based on the entire body
of scientific evidence track closely with those of NIOSH. OSHA does not
stretch the NIOSH findings ``far beyond the breaking point'' to support
causal inferences of the existence of vast numbers of MSDs that are not
examined by the epidemiological studies (Ex. 30-1722, pg. 44). For
example, DeQuervain's disease and trigger finger are forms of hand
tendinitis specifically examined in epidemiological studies (Ex. 26-48;
Ex. 26-53; Ex. 26-897) relied on by NIOSH to conclude evidence of an
association between repetition, force, and awkward posture and hand/
wrist tendinitis. In fact, NIOSH states in its review that
``DeQuervain's disease and other tenosynovitis of the hand, wrist, and
forearm have been associated for decades with repetitive and forceful
hand activities as one of the possible causal factors.'' (Ex. 26-1, pg.
5b-8).
The other two MSDs cited as not being supported by NIOSH findings
are Raynaud's phenomenon and tarsal tunnel syndrome (TTS). Raynaud's
phenomenon refers to blanching of one or several fingers and is a
characteristic sign of vascular damage that occurs in Hand-Arm
Vibration Syndrome (HAVS) due to segmental vibration (Ex. 502-18).
NIOSH concluded that there was strong evidence of a positive
association between segmental vibration and the vascular symptoms of
HAVS. TTS is an MSD of the foot and, therefore, was not addressed in
the NIOSH review. However, it is a nerve impingement disorder analogous
to CTS in the wrist. Like the carpal tunnel, the tarsal tunnel is a
relatively ``tight'' compartment filled with flexor tendons and the
tibial nerve that may be susceptible to compression in response to
increases in intra-tarsal pressure as a result of repeated flexion/
extension of the ankle.
In the Final Rule, OSHA does not broaden the set of biomechanical
risk factors associated with MSDs beyond the four (force, repetition,
posture, and vibration) supported by the 1997 NIOSH review (contact
stress, which is covered by the standard, is a particular combination
of force and repetition). Although OSHA believes that evidence exists
that cold temperatures can aggravate some MSDs, this environmental
factor principally operates to modify exposure to some of the
biomechanical factors listed above and is not regarded as a primary
risk factor. OSHA included contact stress in the final rule's Basic
Screening Tool because there is reasonable evidence that repeated
impact, such as hand hammering, increases the risk of the MSD known as
hypothenar hammer syndrome (see Part D of the Health Effects section).
In addition, repetitive knee hammering has been shown to be associated
with a high risk of bursitis (``carpet layers knee'') (see Part F of
Health Effects section). The final rule makes clear that it is
prolonged and regular exposure to a combination of biomechanical work
factors that presents the greatest potential hazard.
It should also be noted that workplace intervention is not required
by the ergonomic standard unless there is an MSD incident that the
employer has determined to be work-related and there is evidence of
exposure to the biomechanical risk factors defined by the OSHA basic
screening tool. This action trigger serves to limit the number of
stressors and disorders that require action under the OSHA rule.
For the above reasons, OSHA finds that its conclusions with regard
to work-related biomechanical factors and risk of MSDs do not
misrepresent, but are entirely consistent with, the findings in the
1997 NIOSH review. This view was confirmed by written testimony from
the Director of NIOSH, Linda Rosenstock:
OSHA builds on the evidence of the association between workplace
risk factors and the development of MSDs provided in the 1997 NIOSH
review and strengthens the evidence with the supporting data
provided by laboratory and psychophysical studies * * * NIOSH
concurs with OSHA's conclusion from the discussion of the evidence
from the epidemiological studies. OSHA concludes that ``In sum,
although not all of the epidemiological studies reviewed demonstrate
significant associations, the overwhelming majority justify a
conclusion that the risk factors noted in this section, with effects
adjusted by the four modifying factors, cause or exacerbate work-
related MSDs.'' Thus the data justify the conclusion that these
factors cause or exacerbate work-related MSDs (Ex. 32-450-1, pg. 7-
8)
The commenters also claimed that OSHA misrepresented the findings
of the NAS workshop and that the conclusions in their 1999 report
``simply do not support OSHA's broad conclusions linking physical work-
related factors to musculoskeletal complaints.'' (Ex. 32-241-4, pg.
117). They allege numerous inadequacies of the workshop, such as the
fact that the participants included ``only a few scientists who
seriously questioned OSHA's ergonomic hypothesis'' (Ex. 32-368-1, pg.
33). Despite this, the workshop participants supposedly seriously
questioned the NIOSH study and, unlike OSHA, ``admitted that the
evidence of a link between MSDs and physical risk factors at the
workplace is inconclusive at best,'' (Ex. 32-241-1, pg. 118). This led
one NAS panelist, Dr. Howard Sandler, to state ``that the NIOSH
approach to their review of the evidence was sufficiently flawed to
make the conclusions questionable.'' (Ex. 32-241-4, p. 112). Presumably
the NAS report ``actually undermines OSHA's decision to limit its
analysis to physical, work-related factors'' since it cites
``individual, organizational, and social factors * * * which are
possible influences on physiological pathways that lead from soft
tissue to impairment and disability.'' (Ex. 32-241-4, p. 118 ). The
argument for the OSHA misrepresentation of the NAS report is summarized
as follows:
In sum, the [NAS] Steering Committee advised against doing
exactly what OSHA does in its analysis--focusing exclusively on
physical work-related factors: ``Non-biomechanical factors must
[emphasis added] be considered if understanding of the relationship
between biomechanical work factors and MSDs is to expand and inform
in the design of workplace interventions to reduce or prevent such
disorders.'' (Ex. 32-241-4, p.120).
OSHA does not believe the NAS report seriously questions findings
of the NIOSH review or undermines the OSHA position on the evidence
that exposure to biomechanical factors increases the risk of MSDs.
Regarding the epidemiological evidence, the NAS Steering Committee
Report states:
Restricting our focus to those studies involving the highest
levels of exposure to biomechanical stressor of the upper
[[Page 68489]]
extremity, neck, and back and those with the sharpest contrast in
exposure among the study groups, the positive relationship between
the occurrence of musculoskeletal disorders and the conduct of work
is clear. The relevant studies have not precisely determined the
causal mechanical factors involved nor the full clinical spectrum of
the reported MSDs (which are often lumped together nonspecifically
as MSDs of a body region); nonetheless, those associations
identified by the NIOSH review as having strong evidence are well
supported by competent research on heavily exposed populations (Ex.
26-37, pg 15-16).
There is compelling evidence from numerous studies that as the
amount of biomechanical stress is reduced, the prevalence of
musculoskeletal disorders at the affected body region is likewise
reduced. This evidence provides further support for the relationship
between these work activities and the occurrence of musculoskeletal
disorders (Ex. 26-37. p 16).
OSHA believes these NAS conclusions are not ``inconclusive at
best'' but as the commenters claims, instead clearly support those
associations between work-related biomechanical factors and MSDs
identified in the NIOSH review where evidence is strong, namely
combinations of forceful exertions, repetitive motions, awkward
postures, vibration and heavy lifting. The above biomechanical
exposures are the same ones that the OSHA standard seeks to reduce.
The NAS Steering Committee did point out some limitations to the
epidemiological evidence, particularly that ``it was difficult to make
strong causal inferences on the basis of evidence from any individual
study.'' (Ex. 26-37, p. 15; emphasis added). They acknowledged that
``the occurrence of MSDs among populations exposed to low levels of
biomechanical stressors was less definite. * * * In case of low levels
of biomechanical stress, the possible contribution of other factors to
MSDs is important to consider.'' (Ex. 26-37, p. 16). OSHA agrees with
these statements and has not ignored the contribution of individual,
organizational, and psychosocial factors in the etiology of MSDs. The
Health Effects section of the rule emphasizes the multifactorial nature
of MSDs. Substantial evidence in the rulemaking record, however,
demonstrates that biomechanical risk factor show strong associations
with elevated MSD risk when other non-work-related factors are
controlled for. Thus, OSHA does not believe that the existence of other
risk factors should prevent actions that reduce exposures to those
work-related biomechanical stressors.
OSHA agrees that the majority of the NAS participants supported the
ergonomic hypothesis that OSHA is espousing. This is not because the
NAS selection process excluded those with other views, as implied by
the commenters. The NAS prides itself on and is regarded world-wide as
an organization that renders impartial and unbiased expert judgment on
scientific issues. The reason for the NAS participants' support is
simply that most ergonomic experts around the world agree there is
clear evidence that biomechanical work factors increase the risk of
MSDs.
OSHA is aware that one member of the six person panel addressing
physical factors and epidemiology, Dr. Howard Sandler, was critical of
NIOSH's methodology and findings. OSHA does not agree with Dr.
Sandler's statements, and neither did the majority of the other panel
members. In the NAS workshop summary, the consensus of the panel was
that NIOSH had not overlooked any important body of epidemiological
evidence. The panelists generally agreed that the NIOSH analysis
resulted in the review on of high quality studies. With the exception
of Dr. Sandler, the panelists unanimously agreed that a reassessment of
the epidemiological literature would not alter the conclusions drawn by
NIOSH regarding the work-relatedness of MSDs.
Finally, it is important to note that in evaluating all the
evidence, not just the epidemiology, the NAS Steering Committee made
the following conclusions:
Thus, while there are many points about which we would like to
know more, there is little to shake our confidence in the thrust of
our conclusions, which draw on converging results from many
disciplines, using many methods:
There is a higher incidence of reported pain, injury,
loss of work, and disability among individuals who are employed in
occupations where there is a high exposure to physical loading than
for those employed in occupations with lower level of exposure.
There is a strong biological plausibility between the
incidence of MSDs and the causative exposure factors in high
exposure occupational settings.
Research clearly demonstrates that specific
interventions can reduce the reported rate of MSDs for workers who
perform high risk tasks. No single intervention is universally
effective. Successful interventions require attention to individual,
organizational, and job characteristics, tailoring the corrective
actions to those characteristics (Ex. 26-37)
OSHA believes the above NAS conclusions support, not undermine, the
premise that there is convincing evidence that exposure to work-related
physical factors increases the risk of MSDs. There is a higher
incidence of MSDs in exposed individuals; there is strong biological
plausibility that relates these disorders to biomechanical risk
factors; and interventions that reduce exposure to those factors have
been demonstrated to reduce the incidence of the MSDs.
In summary, the methodology used by NIOSH to arrive at its findings
that there is evidence of an association between a number of work-
related physical risk factors and MSDs of the neck, upper extremity,
and back is not a flawed ``black box,'' but a scientifically sound
approach based on well-accepted epidemiological principles. By NIOSH's
own testimony, OSHA's conclusions regarding biomechanical factors and
the risk of MSDs in the workplace reinforce and do not misrepresent the
1997 NIOSH findings. Finally, the conclusions in the 1999 NAS report
are supportive of both the NIOSH analysis and the OSHA position. In
addition, to the NIOSH and NAS, the European Agency for Safety and
Health at Work (Ex. 500-71-28) and Washington State (Ex. 500-71-93)
have evaluated the scientific evidence and also reached similar
conclusions regarding the evidence linking work-related biomechanical
factors with the development of MSDs.
2. Issues Relating to Causal Inference in Epidemiology
Several commenters to the Proposal argued that OSHA had failed to
show causality between exposure to workplace factors and MSDs; one
group of comments emphasized that the types of studies used by NIOSH
and OSHA to evaluate causality of the various MSD risk factors were
inadequate for that purpose because of the studies design (see, e.g.,
Ex. 32-241-4, pg 86-91). Specific comments were:
Only repeated longitudinal prospective studies can establish
causation; OSHA relies instead on methodologies prone to error and
bias. * * * Cross-sectional studies, upon which OSHA heavily relies,
are incapable of providing evidence of cause and effect, because
correlation does not establish causation (Id. pg. 86). Case-control
studies are highly prone to bias. Prospective cohort studies are the
best method of studying etiology, * * * retrospective studies [are
prone to] the hazards of * * * ``recall bias.'' (Id. pg. 87). * * *
In the case of musculoskeletal pain, which OSHA [has] linked to
``awkward postures'' and other biomechanical exposures, recall bias
[in any retrospective design] can be extreme. * * * Cross-sectional
studies are necessarily retrospective and prone to recall bias. (Id.
pg. 87). [Cross-sectional studies] are useful for observing patterns
and correlations, but can only generate hypotheses. A review seeking
evidence of causation must exclude all cross-
[[Page 68490]]
sectional studies, because their methodology is inadequate to test a
hypothesis. (Id. pg. 88)
With respect to case-control study designs, the comments continued:
[C]ase-control studies generally measure exposure to various
hypothesized risk factors retrospectively, and consequently are
prone to a number of biases, particularly in the recall of exposure
to suspected risk factors. * * * Case-control studies are most
suitable for examining rare diseases * * * Musculoskeletal
complaints are hardly `` rare,'' of course, making OSHA's reliance
on retrospective studies particularly unwarranted and puzzling (Id.
pg. 89).
With respect to combining studies for a total weight-of-evidence
assessment, critics were somewhat divided. Some noted that:
[In order to do a proper assessment] only prospective cohort
studies reliably establish etiology, that is, valid scientific
evidence of cause and effect. (Id. pg. 89). * * * Adequate science,
however, requires more than mere association. It demands clinically
accepted, rigorously controlled studies. (Ex. 32-241-3-1, pg.3),
while others, including Dr. Stanley Bigos, felt that case-control
studies could also be used:
To infer causal relationships, one would look for consistent
findings in a number of case-control and prospective cohort studies,
as well as other supporting scientific information. Bradford Hill
published an influential set of guidelines for causal inference.
(Ex. 32-241-3-4, pg. 9).
However, another commenter cautioned about drawing conclusions for
a group of studies:
It should be noted that weaknesses of individual studies cannot
be overcome by synthesizing a large number of studies with different
weaknesses that suggest the same conclusion. (Ex. 32-241-4, pg. 89).
Still another commenter, Dr. Lloyd Fisher, noted a methodology
using a statistical approach for combining studies. This methodology is
termed meta-analysis:
The process for properly formally synthesizing information from
multiple studies of the same thing is described in a textbook I
coauthored. Requirements for a valid meta-analysis include that (1)
all studies in the area be considered, without ``publication bias''
based on treatment effect indicated in the studies; (2) a careful
assessment of study quality should be performed; and (3) study
results should reflect a homogeneity of results. This was not
attempted where possible in the material that I reviewed.
Perhaps the most notable example of meta-analysis discussed by
OSHA is [the NIOSH report]. However, it is not clear that the NIOSH
report satisfies any of the three conditions. Some relevant studies
(such as the Boeing back-injury study) are not included. The quality
of the studies is not directly assessed to any great degree. (Ex.
32-241-3-7, pg. 3).
OSHA has carefully considered these comments on the criteria and
methodology for selecting and combining studies for a weight-of-
evidence approach to evaluating causality and has concluded that OSHA's
approach and the approach used in the NIOSH report (Ex. 26-1) are
scientifically sound. First, with respect to the NIOSH methodology,
OSHA notes that NIOSH did prioritize studies by type of design and did
discuss each design's inherent capabilities, weaknesses, and potential
biases (Ex. 26-1, App. A). NIOSH also included in its criteria for
evaluating the weight of a study the study's population, health
outcome, and exposure: ``the greatest qualitative weight was given to
studies that had objective exposure assessments, high participation
rates, physical examinations, and blinded assessment of health and
exposure status.'' (Ex. 26-1, pg. 1-9 and 1-10).
NIOSH then evaluated the data base of studies using guidelines to
assess causal inference made famous by Bradford Hill (Ex. 26-726).
These consisted of (1) strength of association; (2) consistency of
association; (3) specificity of association; (4) temporality; (5)
exposure-response relationship; and (6) coherence of evidence (a
combination of consistency with other information and biological
plausibility). These guidelines are endorsed in the Reference Manual On
Scientific Evidence (Federal Judicial Center, 2000) that assists
federal judges in interpreting scientific reasoning as it pertains to
litigation and is held up by Gibson, Dunn & Crutcher as an
authoritative source. The Manual states the following about the
application of the Hill criteria:
There is no formula or algorithm that can be used to assess
whether a causal inference is appropriate based on these guidelines.
One or more factors may be absent even when a true causal
relationship exists. Similarly, the existence of some factors does
not ensure that a causal relationship exists. Drawing causal
inferences after finding an association and considering these
factors requires judgment and searching analysis, based on biology,
of why a factor or factors may be absent despite a causal
relationship and vice versa. While the drawing of causal inferences
is informed by scientific expertise, it is not a determination that
is made using scientific methodology. (pg. 375)
NIOSH witness Dr. Larry Fine stated in his testimony:
Again, it's always hard to talk in generalizations, but in a
situation where you have evidence of a biologically plausible
explanation for the relationship between exposure and disease, where
you had a body of cross-sectional studies that had accurate exposure
assessment and accurate health outcomes; in that setting, we believe
that you may well infer causality, particularly if you see, in
studies with a wide range of exposure, a dose-response relationship
(Tr. 2095).
Second, OSHA has considered the NAS review of the NIOSH criteria
for study inclusion and weighting (Ex. 26-37). In the NAS review seven
epidemiologists specializing in ergonomics were asked about the NIOSH
assessment's selection and weighting of studies. Each provided
individual comments (Id., pgs. 152-174). In general they concurred with
the NIOSH approach. Dr. Frederick Gerr, Associate Professor, Rollins
School of Public Health, Emory University, thought that NIOSH had
included all important epidemiological evidence in its review (Id., pg.
159), an opinion shared by Dr. Laura Punnett, Professor, University of
Massachusetts, Lowell (Id., pg. 162), Dr. Alfred Franzblau, Associate
Professor of Occupational Medicine, University of Michigan School of
Public Health (Id., pg. 155), and Dr. David Wegman, Professor,
University of Massachusetts Lowell (Id., pg. 172). With respect to the
four criteria NIOSH chose to use to further qualitatively weight each
study, some of the NAS participants found that these ``criteria for
identifying studies of relatively greater methodological rigor are
reasonable and appropriate'' (Id., pg. 159), and ``that the studies
most heavily relied on by NIOSH in its assessment of workplace factors
and MSDs are of good quality.'' (Id., pg. 156); and ``[t]he quality of
the studies that were most heavily weighted was generally quite high
because they met the multiple criteria set out by NIOSH for weighting.
(Id., pg. 172). One panelist, however, Dr. Howard Sandler (in a study
co-authored with non-panelist Dr. Richard Blume), thought that this
weighting method was neither fully explained nor tested and validated.
(Id., pg.168). Dr. Sandler was scheduled to appear at the OSHA hearing
as an expert for Keller/Heckman but never did so.
Because of the NIOSH assessment's use of cross-sectional studies,
the comments of Dr. Alfred Franzblau in discussing NIOSH's weighting of
cross-sectional studies should be noted:
What some researchers have done is to perform cross-sectional
studies among workers (and jobs) that are known to have been stable
for some minimum period of time (e.g., six months or one year). This
type of cross-sectional design overcomes some of the shortcomings of
cross-sectional studies relative to prospective studies, and serves
to greatly strengthen the confidence one can
[[Page 68491]]
have in the conclusion. Many of the studies that were most heavily
weighted in the NIOSH assessment fall into this category (Ex. 26-37,
pg. 156).
Dr. David Wegman provided the following summary comments:
There is no ``correct'' way to carry out a literature review
particularly with as large a scope as the one undertaken by NIOSH.
The authors of the NIOSH report are to be commended for developing a
methodology that is reasonable, understandable, clearly presented,
open and conservative. It is hard to imagine a more effective way to
summarize this literature (Ex. 26-37, pg. 173).
Third, several witnesses and commenters on OSHA's ergonomics
proposal also addressed the use of multiple types of epidemiological
studies to determine causality. Dr. John Frank, Professor of Public
Health Sciences, University of Toronto, stated in his testimony:
The best design cannot be read from a cookbook which
automatically requires there to be a rank ordering of study design
qualities for all circumstances. Prospective studies can actually
make some mistakes that are overcome in well designed case-control
studies (Tr. 1472).
Dr. Laura Punnett, Professor, University of Massachusetts Lowell,
in support of the conclusions of the NIOSH report pointed out that:
Almost all of the studies considered in the review have been
published in the peer-reviewed scientific literature, meaning that
they had already been through the standard scientific quality
control process prior to their publication and review by NIOSH. (Tr.
864).
In a statement that contradicts the view of several witnesses
stating that medicine must rely on randomized clinical trials (RCT) for
determining causality (e.g., see Ex. 32-241-3-4, pg. 7-10), Dr. Niklas
Krause, of the Public Health Institute, discussed the necessity of
doing a careful evaluation of all the evidence:
So there are design problems in any study. And there is no gold
standard, not even the randomized control trial is the gold standard
as some people say. Epidemiologists say it. It is not the gold
standard. You have to use all the available evidence. It is a
careful evaluation of all the methodological features from
measurement to control group to the timing and going through
criteria that are important for causation as laid down by Hill and
others. There is a discussion among us, you know, [about] which are
the most important ones. But I think we all agree * * * we have
established temporality in another way than doing a longitudinal
study. And it can be established. We have repeated that. Then, all
study designs are equally important. (Tr. 1476). * * * If you
disregard all the cross-sectional studies for causal inference, you
would not have medicine. (Tr. 1411).
When questioned about the cross-sectional design's inability to
establish temporality, a key factor for determining causality, Dr.
Krause further stated that in his studies this was not the case:
To give you an example, in our cross-sectional studies of the
bus drivers, we measured the years of occupational driving. These
years clearly occurred before they said to us I have back pain now.
I have no doubt that these risk factors are [temporal], in a
[temporal] relationship or coming before the back pain. And so this
study qualifies for causal inference as a cross sectional study. I
would not disregard this. (Tr. 1411).
The AFL-CIO post-hearing comments provide their analysis of the
OSHA record with respect to the evidence for causality (Ex. 500-218).
In discussing the types of studies that can be used to determine
causality, they stated:
The record evidence clearly establishes that cross-sectional and
case-control studies have been and can be used to identify causal
relationships between exposures to risk factors and adverse health
outcomes. In fact, the record demonstrates that cross-sectional and
case-control studies have been used with great success to infer
causal relationships addressing some of our nation's most important
public health issues, such as smoking and lung disease, which have
led to life-saving intervention measures in the absence of
prospective studies. The record also does contain prospective
epidemiological studies which have confirmed findings from cross-
sectional and case-control studies that exposure to biomechanical/
physical factors in the workplace cause MSDs among exposed workers.
(Id., pg. 30)
In summary, with respect to the selection, use, and weighting of
studies of multiple designs to make a determination of the causality
between work-related stress factors and MSDs, OSHA concludes that the
NIOSH approach is sound.
With respect to Dr. Fisher's comment that a formal methodology for
combining study results to derive a weighted estimate of effect is a
meta-analysis and that NIOSH did not perform a proper meta-analysis,
OSHA agrees that NIOSH's analysis was not that of a formal meta-
analysis. However, neither Dr. Fisher nor anyone else has provided a
formal meta-analysis of the epidemiological literature to the record.
Furthermore, OSHA notes that a necessary criteria for combining studies
in a successful meta-analysis is that only studies measuring similar
factors and estimating very similar effects should be analyzed
together. OSHA's review of the database has determined that comparisons
both between and within occupations with higher versus lower risk
factors can be made in the various studies in a basic weight-of-
evidence approach. However, a rigorous meta-analytic approach for a
combined risk estimate is much more problematic because of the many
factors being studied and the different response measures.
In addressing NIOSH's reliance on a qualitative evaluation of the
epidemiology rather than a formal meta-analysis, Dr. David Wegman,
Professor, University of Massachusetts Lowell, stated in his review for
the NAS:
Meta-analysis is not appropriate when the question under study
is as broad as the one NIOSH addressed. In my judgement [another
writer] * * * provides the answer which, in his words is: ``I
question whether quantitative methods can ever be as thoroughgoing,
probing and informative as qualitative methods'' [Ex. 26-37].
The NAS Panel's Steering Committee concluded, with respect to the
findings of the seven epidemiology experts on the NAS panel about
combining studies for an overall risk estimate:
Methods used for the assessment of exposures and health outcomes
vary [among studies], rendering the task of merging and combining
evidence more challenging than in some other areas of risk
assessment. But this variability does provide the benefit of
multiple perspective on a common set of problems [Ex. 26-37].
In summary, OSHA finds no support for Dr. Fisher's comment that
NIOSH erred by not performing a proper meta-analysis. Neither Dr.
Fisher nor anyone else has provided any specific evidence to support
his contention that a meta-analysis approach would be appropriate in
this case. Instead, OSHA concurs with the National Academy of Science's
conclusion that a formal meta-analysis would not be the best
methodology in this case.
Gibson, Dunn & Crutcher also claimed that OSHA did not properly
evaluate the epidemiological evidence according to the Reference Manual
On Scientific Evidence (Ex. 500-197). Gibson, Dunn & Crutcher cited the
following alleged weakness: that OSHA characterized the epidemiological
evidence as proving cause while the Manual makes clear that
epidemiological studies address association not causation, and that
OSHA relied on studies of ``employee's recollection of the details of
past job duties * * * and measures such as job titles coupled with the
assumption that job duties were consistent across all job titles.''
(Id., pg. I-55). The Manual criticizes studies that rely on the memory
of subjects and states a preference for measurement of exposure. The
Manual says that the
[[Page 68492]]
outcome or health effect being studied must be clearly defined, yet
OSHA relied on ``studies that examine subjective memories regarding an
individual's experience with or personal tolerance for pain.'' (Id.,
pg. I-56). While NIOSH found that many studies ``did not take into
account [confounding] factors beyond job duties and produced odds or
risk ratios that were not statistically significant'' (Id., pg. I-57),
OSHA ``just picked the ones that purport to show results favoring its
hypothesis'' and ``routinely relied on studies reporting associations
or odds ratios well below 9-10 and indeed often below 2.'' (Id., pg. I-
59). According to Gibson, Dunn & Crutcher, the Manual ``indicates that
where risk ratios are significantly below nine or ten there is a
probability that unmeasured factors are the true causes of the effect
or disease being studied.'' (Id., pg. I-58).
Gibson, Dunn & Crutcher mischaracterized the nature of the
epidemiological studies on which OSHA relied, the criteria used by OSHA
to evaluate those studies, and the conclusions OSHA drew from those
studies. They also misconstrue a key section of the Manual. OSHA did
not simply rely on epidemiological studies in which exposures were
assumed but never measured and in which the health outcome was simply
self-reported memories of pain. For each MSD, OSHA relied primarily on
a subset of studies in which exposure to work-related biomechanical
factors was directly observed or measured and for which the health
outcome was clearly defined by a combination of symptoms and physical
exam. This meets the Manual's preference for objective and uniform
exposure measures and case definition. It is also compatible with the
1997 NIOSH analysis, which quite properly give the greatest weight to
studies that involved objective exposure assessments and physical
examinations in their evaluation of the evidence (Ex. 26-1, pg. 1-10).
For example, in the case of epicondylitis and other elbow MSDs,
thirteen epidemiological studies based case definition on physical
examination and worker exposure determined by observational analysis
(see Table V-3). In these studies, the diagnosis of epicondylitis was
consistent and required both pain on palpation of the epicondylar area
and pain at the elbow with resisted movement of the wrist. Exposures
relied on videotaped analysis of job tasks to group exposed and
unexposed workers, sometimes with quantitative estimates of cycle times
(for repetition), static loading on the forearm (for force), and wrist
posture. Nine of the thirteen studies found statistically significant
associations between epicondylitis and exposure to work-related
physical factors (see, e.g., Exs. 26-907; 500-41-131; 26-53; 26-1117;
26-1364; 26-1433; 500-41-116; 26-945; 26-1473). Six of the studies
reported odds ratios or other risk measures of five or greater (Exs.
26-907; 500-41-111; 26-43; 26-1117; 26-1364; 26-1433). One study found
that the rate of repetitive exertions is highly predictive (p=0.002) of
epicondylitis (Ex. 500-41-116). Two studies reported odds ratios
greater than ten (Exs. 26-907; 500-41-111). This is a much different
pattern of risk ratios than that presented by Gibson, Dunn & Crutcher,
which claims that odds ratios are well below 9-10 and often around 2.
The Manual does not state risk ratios below 10 may indicate that
confounding factors are responsible for the association, as implied by
Gibson, Dunn & Crutcher. The Manual states ``a relative risk of 10 * *
* is so high that it is extremely difficult to imagine any bias or
confounding factor that might account for it.'' (pg. 376). The Manual
goes on to say that ``although lower relative risks can (emphasis
added) reflect causality, the epidemiologist will scrutinize such
associations more closely because there is a greater chance that they
are the result of uncontrolled confounding or bias.'' (Pg 377).
The Manual also discusses the Hill criteria previously cited. OSHA
has evaluated the epidemiological evidence against these criteria. As
mentioned above, the large number of studies reporting significant
associations and risk ratios above five speaks to the strength of the
association and the replicatibility of the findings for MSDs of the
elbow. As further explained in the Health Effects section, there was
one prospective cohort study of meat cutters that provided evidence of
a temporal relationship between repetitive, forceful exertions of the
forearm/elbow and epicondylitis (Ex. 26-53). In addition, several
cross-sectional studies indicated an exposure-response relationship
between the intensity or duration of repetitive exertions and the
prevalence of MSDs (Exs. 500-41-116; 500-41-111; 26-1117; 26-697; 26-
1473). Two studies reported ORs between 1 and 3 that were not
statistically significant, probably because the workers were exposed to
relatively low force directed at the forearm (Exs. 26-56; 26-697).
Another study that did not find an association may have misclassified
exposure, according to NIOSH (Ex. 26-1211). As a group, OSHA found that
the studies relied on generally controlled for important confounders
and bias, although not every individual study did so. Pathology
information that epicondylitis is caused by microrupture of the tendons
resulting from overuse of the forearm muscles, and the well-established
connection between epicondylitis and racquet sports (i.e., tennis
elbow) establish the biological plausibility of the relationship.
The evidence briefly described above led OSHA to conclude that
workers that perform job tasks requiring repeated forceful movements,
especially flexion, pronation, or supination with the arm extended, are
at increased risk of substantial and serious musculoskeletal impairment
to the elbow. In its analysis of the epidemiological literature, NIOSH
also concluded there was strong evidence for a relationship between
exposure to a combination of work-related physical factors and
epicondylitis (Ex. 26-1, pg 4-1 to 4-48). It should be noted that these
OSHA and NIOSH conclusions do not, in fact, speak of causation as
purported by Gibson, Dunn & Crutcher; both OSHA's and NIOSH's
conclusions are careful to conform to the language of the Manual.
In Section V on health effects, OSHA evaluates the epidemiological
evidence for MSDs of the upper extremity, shoulder, neck, back, and
lower extremity, be focusing primarily on the most reliable studies.
This usually means studies where exposures to physical work factors are
directly observed or measured, not assumed based on job title, and the
MSDs have been confirmed by a combination of symptoms, physical exam,
and medical tests as appropriate. In addition to the evidence for
epicondylitis cited above:
Thirteen studies examined neck and neck/shoulder MSDs
using physical exam and direct observation of exposure. All but one
found significant associations between biomechanical risk factors and
health outcome. At least three studies reported odds ratios greater
than five (see Table V-1).
Seventeen studies examined shoulder MSDs (mostly
tendinitis) using physical exam and direct observation of exposure. All
but one found significant associations between biomechanical risk
factors and health outcome. At least six studies reported odds ratios
greater than five (see Table V-2).
Seven studies examined hand/wrist tendinitis using
physical exam and direct observation of exposure. All but one found
significant associations between biomechanical risk factors and health
outcome. At least four studies reported odds ratios greater than five
(Table V-4).
Seventeen studies examined carpal tunnel syndrome using
physical exam
[[Page 68493]]
and/or nerve conduction and direct observation of exposure. Thirteen
found significant associations between biomechanical risk factors and
health outcome. At least five studies reported odds ratios greater than
five.
Six studies examined hand/arm vibration syndrome using
physical exam and vibration measurements. Four found significant
associations between vibration and health outcome; all of which
reported odds ratios greater than five.
OSHA has carefully evaluated the collective data base of studies
for each MSD category using the criteria for causality cited in the
Manual (pg. 374-378). OSHA used the epidemiological data, biomechanical
research studies, and information addressing biological plausibility to
draw its overall conclusions with regard to the evidence that the work-
related biomechanical factors were responsible for the observed
increase in the risk of health impairment. OSHA finds this evidence
compelling and points to the need to take action to provide workers
with necessary protection. OSHA does not believe that it is appropriate
to wait for ``proof of causation'' since scientific evidence cannot
ever establish causation beyond any doubt. As Sir Bradford Hill wrote
over 35 years ago:
All scientific work is incomplete--whether it is observational
or experimental. All scientific work is liable to be upset or
modified by advancing knowledge. That does not confer upon us a
freedom to ignore the knowledge we already have or to postpone the
action that it appears to demand at a give time (Ex. 26-726).
3. Evidence for Exposure Response Relationships
Several submissions, such as those submitted by the U.S. Chamber of
Commerce and experts testifying on behalf of United Parcel Service
(Exs. 30-1722, 32-241-3-19, 32-241-3-13, 30-4184, 30-1552), claimed
that there is no epidemiologic evidence of exposure-response (or
``dose-response'') relationships between MSDs and the physical
ergonomic stressors addressed by the OSHA standard. In their joint
written testimony on the proposed rule, Kellie Truppa and Dr. Michael
Vender, for example, stated:
While it may seem very intuitive that decreasing reported
ergonomic stressors would decrease disorders, there is no scientific
study that has demonstrated a decrease in the incidence of true
disease directly attributable to actual ergonomic changes. Unlike
other risk factors to health (e.g.--smoking) there is no concept of
threshold exposure or dose-response in relating ergonomic risk
exposure to the development of disease. Therefore, there can be no
predictability or guarantee of any benefit with reduction of
ergonomic exposures * * * (Ex. 32-241-3-19).
In the preamble to the proposed rule, OSHA presented results of
several studies that evaluated exposure-response trends; since
publication of the proposal, OSHA has identified many more studies that
provide evidence that, as the level (intensity, frequency or duration)
of exposure increases, so does the risk of MSDs. OSHA summarizes this
evidence in this section of the preamble. Based on these studies, OSHA
finds that there is substantial evidence for a positive relationship
between duration and intensity of exposure to biomechanical risk
factors and the risk of developing MSDs, and that this evidence
strengthens the causal relationship between exposure and risk.
One of the key criteria for demonstrating a causal relationship is
evidence that the prevalence or incidence of a health outcome increases
with an increase in the level of exposure to a hazardous condition. In
occupational epidemiological studies, an exposure-response relationship
is demonstrated when there is a statistical association between the
prevalence or incidence of the health outcome in at least three groups
of workers each with a varying degree of exposure (e.g., no exposure,
low exposure, high exposure). When exposure response relationships are
based on groups of workers, the exposure variable is represented as an
ordinal variable. Alternatively, statistical analysis can be performed
on data for individual members of study cohorts to derive statistical
functions that reflect the exposure-response relationship; in this
case, the exposure variable is represented as a continuous variable.
For this section, studies were included if the risk between
musculoskeletal disorders and exposure to one or more biomechanical
risk factors were examined using either of these two approaches. In the
studies compiled here, the most common presentations of exposure
response relationships are when the prevalence, incidence, odds ratio,
or risk ratio for an MSD increases from one exposure category to the
next. Typically these are accompanied by confidence intervals or a test
of linear trend, as measures of statistical stability. In other
studies, the exposure-response relationship may be expressed in the
form of a statistically significant linear regression coefficient, or
(partial) correlation coefficient, showing that, as exposure increases
so does the prevalence or risk.
An exposure-response relationship, when present, is considered to
strengthen the evidence of a causal relationship because it is believed
to be a characteristic of cause-effect situations, in general, absent
evidence to the contrary. In addition, it is thought that it would be
more difficult for many or most forms of bias or confounding to produce
an artifactual exposure-response relationship than to bias a simple
association such as an odds ratio. However, it is not a sine qua non,
in that an epidemiologic study can provide valuable information even if
both exposure and outcome are represented only as dichotomous variables
(i.e., exposed versus unexposed), nor does it make unnecessary
consideration of methodologic issues that must be addressed when
evaluating a given study. Furthermore, the lack of an exposure-response
relationship is not necessarily evidence against a causal effect.
The studies cited in this section utilized a wide range of exposure
measures, including worker self-reports, observation, and direct
measurement. As several authors have noted, even though exposure units
and scaling vary, there is an overall consistency between self-reports
and other, presumably more objective, measures in these studies (e.g.,
Booth-Jones et al., 1998: Ex. 500-121-9; Jensen et al., 2000: Ex. 500-
41-68; Neumann et al., 1999: Ex. 38-85; Pope et al., 1998: Ex. 500-71-
67). This suggests that worker perception provides a useful guide to
the identification of jobs involving high exposures to physical risk
factors, and that, in general, the jobs that will be identified as
potentially hazardous by workers' own evaluations will generally
correspond to those that would be identified as potentially hazardous
by other measures. The results of studies that have examined exposure-
response relationships are summarized in Tables V-9 through V-13, and
are summarized briefly below.
Work Pace and Repetition
There is substantial evidence of an exposure-response relationship
for MSDs of the neck and shoulders. For example, in a case-control
study of the general population in Sweden, the odds of neck/shoulder
disorders increased markedly with work pace levels from slow to medium
to rushed, as well as with hours per day of performing repetitive
precision movements at work (Ekberg et al., 1994: Ex. 26-1238 ).
Ohlsson et al.found positive associations with both the number of items
handled per hour in repetitive assembly work and the number of years
employed in such work, especially among younger employees (Ohlsson et
[[Page 68494]]
al., 1989: Ex. 26-1290 ). Johansson et al. studied blue- and white-
collar manufacturing employees separately and reported exposure-
response relationships with monotonous movements at work in each group
(Johansson et al., 1994: Ex. 26-1331).
Table V-9.--Evidence of Exposure-Response Relationships for Musculoskeletal Disorders With Exposure to
Repetitive Manual Work
----------------------------------------------------------------------------------------------------------------
Measure of repetitiveness Health outcome/body
(unit) region affected Measure of effect Reference
----------------------------------------------------------------------------------------------------------------
Neck and Shoulder
----------------------------------------------------------------------------------------------------------------
Years sewing machine operator Neck/Shoulder........ Odds Ratio [unadj] Andersen et al.(1993:
(4 categories). 0 (control: 1.0 Ex. 26-1451).
0-7: 2.3 (0.5-11.0)
8-15: 6.8 (1.6-28.5)
>15: 16.7 (4.1-67.5)
Years sewing machine operator Chronic neck pain.... Odds Ratio [adj] Andersen et al.(1993:
(4 categories). 0 (control): 1.0 Ex. 26-1502).
0-7: 1.9 (1.3-2.9)
8-15: 3.8 (2.3-6.4)
>15: 5.0 (2.9-8.7)
Years sewing machine operator Chronic should pain.. Odds Ratio [adj] Andersen et al.(1993:
(4 categories). 0 (control): 1.0 Ex. 26-1502).
0-7: 1.4 (0.9-2.4)
8-15: 3.9 (2.3-6.5)
>15: 10.3 (5.9-17.9)
Years sewing machine operator Chronic neck and/or Odds Ratio [adj] Andersen et al.(1993:
(4 categories). shoulder pain. 0 (control): 1.0 Ex. 26-1502).
0-7: 1.8 (1.2-2.6)
8-15: 4.3 (2.6-6.9)
>15: 8.0 (4.7-13.8)
Data entry at video display Neck (cervical Odds Ratio [adj] Bergqvist et
unit (hours/week). diagnoses). 5-20 hr/wk: 1.2 (0.4-4.3) al.(1995: Ex. 26-
20 hr/wk: 1.7 (0.7- 1195, 500-165-25).
4.3)
Data entry at video display Neck/shoulder........ Odds Ratio [adj] Bergqvist et
unit. Data entry: 1.4 (0.7-2.9) al.(1995: Ex. 26-
Data entry plus limited rest 1195, 500-165-25).
breaks: 4.8 (1.3-18.1)
Typing speed.................. Neck................. Prevalence [unadj] (test of Burt et al.(1990: Ex.
trend): 26-698).
Slow: 10%
Moderate: 14%
Fast: 25% (p0.001)
Percentage of time typing..... Neck................. Odds Ratio [adj] Burt et al.(1990: Ex.
20: 1.0 26-698).
20-39: 2.0 (1.0-7.7)
40-59: 2.6 (1.4-5.0)
60-79: 2.2 (1.0-4.7)
80-100: 2.8 (1.4-5.4)
Typing speed.................. Shoulder............. Odds Ratio [adj] Burt et al.(1990: Ex.
Slow: 1.0 26-698).
Moderate: 2.6(1.1-5.9)
Fast: 4.1 (1.8-9.4))
Percentage of time typing..... Shoulder............. Prevalence [unadj] (test of Burt et al.(1990: Ex.
trend): 26-698).
0-19: 6%
20-39: 10%
40-59: 13%
60-79: 11%
80-100: 15% (p=.10)
Repetitive precision movements Neck/Shoulder........ Odds Ratio [adj] Ekberg et al.(1994:
(hours/day) (3 categories). Low: 1.0 Ex. 26-1238).
Medium: 3.8 (0.7-20)
High: 15.6 (2.2-113)
Work pace (3 categories)...... Neck/Shoulder........ Odds Ratio [adj] Ekberg et al.(1994:
Low: 1.0 Ex. 26-1238)
Medium: 7.6 (1.6-36)
Rushed: 10.7 (2.2-52)
Hour per day of video display Neck, shoulder, upper Odds Ratio [unadj] per hour 1.4 Faucett et al.(1994:
terminal (VDT) use. back (``upper (1.0-2.0) Ex. 38-256)
torso'').
Monotonous working movements Neck (in white collar Partial correlation coefficient Johansson et
(duration of repetitive workers). [adj] 0.38 (p < 0.05) al.(1994: Ex. 26-
movements, static stress and 1331)
sitting).
Monotonous working movements Shoulder (in white Partial correlation coefficient Johansson et
(duration of repetitive collar workers). [adj] 0.32 (p < 0.05) al.(1994: Ex. 26-
movements, static stress and 1331)
sitting).
[[Page 68495]]
Monotonous working movements Shoulder (in blue Partial correlation coefficient Johansson et
(duration of precision collar workers). [adj] 0.15 (p < 0.05) al.(1994: Ex. 26-
movements, repetitive 1331)
movements, and static and
stress).
Years employed in repetitive Neck................. Increasing odds (graphical Ohlsson et al.(1989:
assembly work. presentation only) Ex. 25-1290)
Shoulder............. Increasing odds (p=0.03); below 35 .....................
years of age, p=0.01
Work pace (items/hour) (4 Shoulder............. Odds Ratio [adj] Ohlsson et al. (1989:
categories). < 100: 1.0 Ex. 26-1290)
100-199: est 8.0 (p=0.0006)
200-700: est 9.0 (p=0.0006)
> 700: est 2.0 (p-value not
given)
Hours per day of VDT use (4 Neck................. Prevalence [unadj] (test of Rossignol et
categories). trend): al.(1987: Ex. 26-
0 hr: 7% 804)
0.5-3 hr: 7%
4-6 hr: 12%
7 hr: 19% (p0.00001)
Odds Ratio [adj]
0 hr: 1.0
0.5-3 hr: 1.8 (0.5-6.8)
4-6 hr: 4.0 (1.1-14.8)
7 hr: 4.6 (1.7-13.2)
Hours per day of VDT use (4 Shoulder............. Prevalence [unadj] (test of Rossignol et
categories). trend): al.(1987: Ex. 26-
0 hr: 6% 804)
0.5-3 hr: 5%
4-6 hr: 10%
7 hr: 16% (p=<
0.00001)
Odds Ratio [adj]
0 hr: 1.0
0.5-3 hr: 2.5 (0.7-10.8)
4-6 hr: 4.0 (1.0-16.9)
7 hr: 4.8 (1.6-17.2)
Sewing machine operation Neck................. Odds Ratio [unadj] Schibye et al.(1995:
(years of employment). < 8 yrs: 1.0 Ex. 26-1463)
8-14 yrs: 1.1 (0.4-2.6)
15 yrs: 2.1 (0.8-5.6
----------------------------------------------------------------------------------------------------------------
Shoulder............. < 8 yrs: 1.0 15 yrs: 4.3 (1.5-
8-14 yrs: 1.3 (0.5-3.4) 12.5)
----------------------------------------------------------------------------------------------------------------
Arm and Elbow
----------------------------------------------------------------------------------------------------------------
Data entry at video display Arm/hand............. Odds Ratio [unadj] Bergqvist et
unit (hours/week). 5-20 hr/wk: 1.6 (0.6-4.5) al.(1995: Exs. 26-
20 hr/wk: 1.8 (0.8- 1195, 500-165-25)
3.9)
Percentage of time typing..... Elbow/forearm........ Odds Ratio [adj] Burt et al.(1990: Ex.
20-39%: 1.2 (0.6-22.5) 26-698)
40-59%: 1.7 (0.8-3.5)
60-79%: 1.9 (0.9-4.3)
80-100%: 2.8 (1.4-5.7)
Typing speed.................. Elbow/forearm........ Prevalence [unadj] (test of Burt et al.(1990: Ex.
trend): 26-698)
Slow: 7%
Moderate: 11%
Fast: 13% (p=0.02)
Hours per day of VDT use...... Arm.................. Prevelance [unadj] (test of Rossignol et
trend): al.(1987: Ex. 26-
0 hr: 4% 804)
0.5-3 hr: 2%
4-6 hr: 4%
7 hr: 7% (p=0.01)
----------------------------------------------------------------------------------------------------------------
[[Page 68496]]
Hand and Wrist
----------------------------------------------------------------------------------------------------------------
Typing at video display unit Hand/wrist........... Odds Ratio [adj] Bernard et al.(1994:
(hours/day). 0-2 hr: 1.0 Ex. 500-165-21)
2-4 hr: 1.3 (0.6-1.8)
4-6 hr: 1.3 (0.8-2.2)
6-8 hr: 2.1 (1.3-3.6)
8 hr: 3.3 (1.2-8.9)
Typing speed.................. Hand/wrist........... Odds Ratio [adj] Burt et al.(1990: Ex.
Slow: 0.9 (0.3-2.3) 26-698)
Moderate: 1.3 (0.6-3.1)
Fast: 2.5 (1.0-5.6)
Percentage of time typing..... Hand/wrist........... Prevalence [unadj] (test of Burt et al.(1990: Ex.
trend): 26-698)
0-19: 13%
20-39: 23%
40-59: 27%
60-79: 30%
80-100: 24% (p0.01)
Hours per day of video display Hand and arm......... Odds Ratio [unadj] per hour Faucett et al.(1994:
terminal (VDT) use. 1.5 (1.1-2.0) Ex. 38-256)
Repetition rating (1 unit on 0- Odds Ratio [adj]: Latko et al.(1999:
10 scale). Ex. 38-171)
Dominant wrist/hand/ 1.17 (1.06-1.29)
fingers.
Tendinitis (distal 1.23 (1.04-1.46)
upper extremity).
Carpal tunnel 1.16 (1.00-1.34)
syndrome.
Cycle length (seconds), in Carpal tunnel Odds Ratio [adj] Leclerc et al.(1998:
work performed 4-8 hours per syndrome. 1 min: 1.0 Ex. 500-205-11)
day. 30-59 s: 1.03 (0.56-1.89)
10-29 s: 1.33 (0.75-2.37)
10 s: 1.90 (1.04-3.48)
Years employed in repetitive Hand................. Increasing odds (p=0.002) Ohlsson et
assembly work. al.(1989:Ex. 26-
1290)
Repetitive wrist motions Carpal tunnel Odds Ratio [unadj] Wieslander et
(years of exposure). syndrome. 1 yr: 1.0 al.(1989: Ex. 26-
1-20 yrs: 2.3 (0.7-7.9) 1027)
>20 yrs: 9.6 (2.8-33.0)
----------------------------------------------------------------------------------------------------------------
Multiple Body Regions
----------------------------------------------------------------------------------------------------------------
Piece-rate wage system (years Musculo- skeletal Odds Ratio [adj] Brisson et al.(1989:
of employment). diseases. 0-4 yrs: 1.0 Ex. 26-937)
5-9 yrs: 4.3 (0.5-35.9)
10-14 yrs: 10.0(1.0-79.3)
15-19 yrs. 8.0 (0.8-76.8)
20 yrs: 11.4 (0.9-
137.1)
Hours per week of video Upper extremity and Mean hours per week [unadj] Knave et al.(1985:
display terminal use. back. 30 in cases, 27 in non-cases Ex. 26-753)
(p0.05)
Percentage of recovery time Upper extremity...... Linear regression coefficient Moore et al.(1994:
per work cycle. [unadj]: Ex. 26-1033)
Ln(% recovery): 0.6 (r2=0.49,
p0.001)
Hours per day at keyboard..... Hand, wrist, forearm Prevalence [unadj] (test of Oxenburgh (1987: Ex.
and/or elbow. trend): 26-1367)
3 hr: 21%
4 hr: 24%
6 hr: 45%
6 hr: 50%
>6 hr: 86%(p0.00001)
Keyboarding speed............. Upper extremity...... Prevalence [unadj] (test of Polanyi et al.(1997):
trend): Ex. 500-41-106)
40 wpm: 17%
40-60 wp,: 22%
>60 wpm: 29% (p=0.025)
Daily time keyboarding (hours Upper extremity...... Means (test of difference) Polanyi et al.(1997:
per day). [unadj]: Ex. 500-41-106)
Cases 3.9 hours/day, controls 3.2
hours/day
(p0.001)
----------------------------------------------------------------------------------------------------------------
Note: adj = adjusted for other covariate(s)
unadj = not adjusted for other covariates
[[Page 68497]]
Table V-10.--Evidence of Exposure-Response Relationships for Musculoskeletal Disorders With Exposure to Forceful
Manual Exertion
----------------------------------------------------------------------------------------------------------------
Health outcome/body
Measure of manual force (unit) region affected Measure of effect Reference
----------------------------------------------------------------------------------------------------------------
Neck and Shoulder
----------------------------------------------------------------------------------------------------------------
Grocery checking: hours per Shoulder............. Odds Ration [unadj] Baron et al.(1991:
week of checking work. 20: 1 Ex. 26-697)
20-25: 1
>25: 3.6 (p0.05)
Forearm rotation while Shoulder............. Odds Ration [adj] per unit: Hughes et al.(1997:
exerting very high forces Ex. 26-907)
(Frequency of exposure *
Years of exposure).
Interview............ 92 (7.3-)
Examination.......... 46 (3.8-550)
Light materials handling Shoulder (in white Partial correlation coefficient Johansson et
[factor formed from frequency collar workers). [adj] 0.18 (p 0.05) al.(1994: Ex. 26-
and duration of materials 1331)
handling 0.5-1 kg and 1-5 kg].
Years of carpentry work (10, Shoulder............. Odds Ration [adj] Lemasters et
10 to 20, 20+ years). 10-20 yr: 2.3 (1.0-5.4) al.(1998: Ex. 500-
20+ yr: 3.2 (1.1-8.9) 121-44)
Load lifted (cumulative Shoulder: acromio- Odds Ratio [adj] (per category) Stenlund et al.(1992:
exposure, in 3 categories: 0- clavicular Right side: 1.55 (1.03-2.34) Ex. 26-733)
709; 710-25,999; and >25,999 osteoarthritis. Left side: 2.55 (1.50-4.35)
kg).
Load lifted (cumulative Shoulder tendinitis.. Odds Ratio [adj] (per category) Stenlund et al.(1993:
exposure, in 3 categories: 0- Right side: 1.02 (0.59-1.76) Ex. 502-462
709; 710-25,999; and >25,999 Left side: 1.81 (0.95-3.44)
kg).
----------------------------------------------------------------------------------------------------------------
Arm and Elbow
----------------------------------------------------------------------------------------------------------------
Grocery checking: hours per Elbow................ Elbows Odds Ratio [unadj] Baron et al.(1991:
week of checking work. 20: 1 Ex. 26-697)
20-25: 1.4
>25: 2.8 (p0.05)
Forearm rotation while Elbow/forearm:....... Odds Ratio [adj] per unit: Huges et al.(1997:
exerting very high forces Interview............ 4 (0.2-4) Ex. 26-907)
(Frequency of exposure * Examination.......... 37.0 (3.0-470)
Years of exposure).
Strenuous exertions (years of Epicondylitis........ Odds Ratio [adj] Ritz (1995: Ex. 26-
high exposure). 0 yr: 1.0 1473)
1-14 yr: 1.8(0.6-5.9)
15-38 yr: 3.3 (0.9-12.5)
----------------------------------------------------------------------------------------------------------------
Hand and Wrist
----------------------------------------------------------------------------------------------------------------
Hand forces (finger flexor Carpal tunnel Average force (test of difference Armstrong et
muscles on electromyography). syndrome. in means): al.(1979: Ex. 500-41-
Cases: 4.3 " 3.5 kp 8)
Noncases: 3.8 " 3.2 kp (p0.05)
Grocery checking (years of Hand/wrist........... Odds Ratio [adj] Baron et al.(1991:
exposure). 0-5: 1 Ex. 26-697)
5-10: 2
10+: 6 (p0.05)
Grocery checking (years of Carpal tunnel Odds Ratio [adj] Baron et al.(1991:
exposure). syndrome. 0-5: 1 Ex. 26-697)
5-10: 4
10+: 15 (p0.05)
Grocery checking (hours per Carpal tunnel Odds Ratio [adj] Baron et al.(1991:
week of exposure). syndrome. 20: 1 Ex. 26-697)
20-25: 2.3
>25: 4.8 (p0.05)
Forearm rotation while Hand/wrist:.......... Odds Ratio [adj] per unit Hughes et al.(1997:
exerting very high forces Interview............ 17.0 (2.9-106) Ex. 26-907)
(Frequency of exposure * Examination.......... 9.3 (1.0-90)
Years of exposure).
Years of carpentry work (10, Hand and wrist....... Odds Ratio [adj] Lemasters et
10 to 20, 20+ years). 10-lt;20 yr: 2.4(1.1-5.3) al.(1998: Ex. 500-
20+yr: 3.1(1.1-8.4) 121-44)
Biomechanical index from Carpal tunnel Linear regression [unadj] Loslever et al.(1993:
direct measurements of force syndrome. Flexion 0.017(r=0.62) Ex. 26-161)
and posture. Extension: 0.035(r=0.26)
[[Page 68498]]
Mean relative finger flexor Wrist................ Linear regression coefficient Malchaire et
force (by EMG)/45-90 minute [adj]: al.(1996: Ex. 26-
work sampling period. Mean relative deviation angle 1473)
(p0.05)
Mean relative EMG signal (p0.05)
Seniority (years employed) (p0.05)
Manual force (as % MVC, in 5 Upper extremity...... Linear regression [unadj]: Moore et al.(1994:
categories). Ln (Force: 2.0 (r\2\=0.49, Ex. 26-1033)
p0.001)
Forceful wrist motions (3 Carpal tunnel Prevalence [unadj] (test of trend) Osorio et al.(1994:
categories: low, medium, syndrome By history. Low: 0% Ex. 26-807)
high). Medium: 10%
High: 63% (p=0.00006)
By nerve conduction Low: 0% .....................
velocity. Medium: 7%
High: 33% (p=0.02)
Forceful wrist motions (years Carpal tunnel Linear regression [adj], p0.05 Osorio et al.(1994:
exposed). syndrome. for: Ex. 26-807)
Right median nerve conduction
velocity
Grip >6 lb. per hand (3 Hand/wrist........... Prevalence [unadj] (test of trend) Stetson et al.(1993:
categories of frequency). None: 41% Ex. 26-1221)
Some: 40%
Frequent: 65% (p=0.30)
High load on wrist (years of Carpal tunnel Odds Ratio [unadj] Wieslander et
exposure). syndrome. 1 yr: 1.0 al.(1989: Ex. 26-
1-20 yr: 2.1 (0.8-5.2) 1027)
>20 yr: 6.6 (1.4-14.7)
----------------------------------------------------------------------------------------------------------------
Back
----------------------------------------------------------------------------------------------------------------
Frequency of lifting per shift Low back............. Prevalence [unadj] Arad et al.(1986: Ex.
0/shift: 29% 500-41-7)
1-5/shift: 33%
6-10/shift: 49%
11-20/shift: 55%
>20/shift: 54%
Frequency of lifting >11.3 kg Prolapsed lumbar disc Odds Ratio [adj] (test of trend): Kelsey et al.(1984:
(times per day). 0: 1.0 Ex. 500-41-73)
5: 1.6 (0.4-6.1)
5-25: 2.7 (0.8-9.2)
>25: 4.9 (0.5-47.6) (p=0.02)
Frequency of lifting >11.3 kg Prolapsed lumbar disc Odds Ratio [adj] (test of trend): Kelsey et al.(1984:
(times per day). 0: 1.0 Ex. 500-41-73)
5: 1.2 (0.7-2.0)
5-25: 1.3 (0.7-2.5)
>25: 3.5 (1.5-8.5) (p=0.01)
Frequency of carrying 11.3 kg Prolapsed lumbar disc Odds Ratio [adj] (test of trend): Kelsey et al.(1984:
(times per day). 0: 1.0 Ex. 500-41-73)
5: 1.0 (0.6-1.9)
5-25: 2.1 (1.0-4.3)
>25: 2.7 (1.2-5.8) (p=0.004)
Lifting 11.3 kg while twisting Prolapsed lumbar disc Odds Ratio [adj] (test of trend): Kelsey et al.(1984:
Never or rare: 1.0 Ex. 500-41-73)
Moderate: 2.5 (0.9-6.8)
Often: 3.1 (1.3-7.5) (p=0.002)
Load on spine (12 continuous Low back............. Odds Ratio [adj] for inter- Kerr et al.(2000: Ex.
biomechanical variables: peak quartile spreads: 500-41-74)
and daily integraetd load). Peak lumbar shear (N): 1.7 (1.0-
2.9)
Cumulative lumbar disc compression
(N s/shift): 2.0 (1.2-3.6)
Peak hand force (N): 1.9 (1.2-
3.1)
Index of stone load Low back............. Odds Ratio [adj]: Latza et al.(2000:
(weight*hours/day). None: 1.0 Ex. 500-19-6)
Intermediate: 1.8 (0.3-9.3)
High: 4.0 (0.8-19.8)
[[Page 68499]]
Lifting demands index (``Job Back................. Injury incidence rate, disabling Liles et al.(1984:
Severity Index''). injury incidence, and severity Exs. 26-33, 500-41-
rate increased with JSI 88)
(graphical presentations)
Dynamic trunk motions (31 Low back............. Odds Ratio [adj] for combined Marras et al.(1993:
continuous biomechanical. weighted means of 5 variables: Ex. 500-41-94)
10.7 (4.9-23.6)
Load on spine (12 continuous Low back............. Higher load in cases vs controls, Norman et al.(1998:
biomechanical variables: peak by each variable (all p-values Ex. 38-84)
and daily integrated load). 0.04). Odds ratios [adj] computed
both for full observed ranges of
exposure and more conservatively
for inter-quartile spreads:
Peak shear (N) 1.5 (1.0-2.4)
Peak trunk velocity (deg/sec) 1.6
(1.1-2.5)
Integrated moment (MN m s) 1.4
(1.0-2.0)
Usual hand force (N) 1.7 (1.2-2.6)
Transfer a patient on canvas Low back............. Odds Ratio [adj] Smedley et al.(1995:
and poles (frequency/average 0: 1.0 Ex. 500-41-40)
working shift). 1-4: 1.0 (0.8-1.3)
5: 1.3 (0.8-2.1)
Manually transfer patient Low back............. Odds Ratio [adj] Smedley et al.(1995:
between bed and chair 0: 1.0 Ex. 500-41-40)
(frequency/shift). 1-4: 1.4 (1.1-1.9)
5-9: 1.8 (1.3-2.5)
10: 1.5 (1.1-2.1)
Manually move patient around Low back............. Odds Ratio [adj] Smedley et al.(1995:
on bed (frequency/shift). 0: 1.0 Ex. 500-41-40)
1-4: 1.2 (0.8-1.7)
5-9: 1.6 (1.1-2.3)
10: 1.7 (1.2-2.4)
Manually transfer patient Low back............. Odds Ratio [adj] Smedley et al.(1997:
between bed and chair 0: 1.0 Ex. 500-205-25)
(frequency/shift). 1-4: 1.3 (0.9-1.7)
5-9: 1.6 (1.1-2.3)
10: 1.6 (1.1-2.3)
Transfer patient between bed Low back............. Odds Ratio [adj] Smedley et al.(1997:
and chair with hoist 0: 1.0 Ex. 500-205-25)
(frequency/shift). 1-4: 1.5 (1.0-2.0)
5: 1.6 (0.8-3.0)
Manually move patient around Low back............. Odds Ratio [adj] Smedley et al.(1997:
on bed (frequency/shift). 0: 1.0 Ex. 500-205-25)
1-4: 1.3 (0.8-1.9)
5-9: 1.5 (1.0-2.3)
10: 1.7 (1.1-2.5)
Lift patient in or out of bath Low back............. Odds Ratio [adj] Smedley et al.(1997:
with hoist (frequency/shift). 0: 1.0 Ex. 500-205-25)
1-4: 1.4 (1.0-1.9)
5: 2.1 (1.2-3.6)
Frequent vs. infrequent Back................. Length of time at work without Stobbe et al.(1988:
lifting in patient care. back injury longer for those with Ex. 500-41-45)
infrequent lifting demands (p0.01
in survival analysis)
Lifting frequency (4 Back................. Odds Ratio [adj] Venning et al.(1987:
categories of hospital Area IV: 1.0 Ex. 500-41-49)
service area, from 1, lifting Area III: 1.26 (p>0.05)
most, to IV, lifting least). Area II: 1.73 (p>0.05)
Area I: 4.26 (p0.01)
[[Page 68500]]
NIOSH Lifting Equation Lifting Low back (severity Mean severity (standard Wang et al.1998
Index (LI) (4 categories). rating, range 0-5). deviation): (1998: Ex. 500-41-
LI:1: 0.18 (0.15) 52)
1LI 3: 3.57
(0.86)
LI>3: 4.07 (0.73)
RWL*=0: 3.86 (0.75)
ANOVA (=0.05)
*Recommended Weight Limit
NIOSH Lifting Equation Lifting Low back............. Odds Ratio [unadj] Waters et al.(1999:
Index (LI). 0: 1.0 Ex. 500-121-76)
0LI 1: 1.1 (0.2-5.3)
1LI 2: 1.5 (0.6-3.8)
2LI 3: 2.5 (1.3-4.9)
LI 3: 1.6 (0.7-4.0)
Strenuous physical activity at Back................. Odds Ratio [unadj] Wild (Ex. 26-1104; 26-
work (hours per day). 0-2 hr: 1.0 1107)
2-4 hr: 4.2
4-6 hr: 6.4
6-8 hr: 5.6
8 hr: 6.8
Odds Ratio [adj] per hour of
strenuous work: 1.14
(1.11-1.17)
Physically hard work.......... Low back............. Odds Ratio [unadj] (test of Xu et al.(1997: Ex.
trend): 500-71-53)
No or seldom: 1.0
\1/4\ of the time: 1.3
\1/2\ of the time 2.3
\3/4\ of the time: 2.2
All of the time: 2.5 (p0.001)
----------------------------------------------------------------------------------------------------------------
Lower Extremity or Multiple Body Regions
----------------------------------------------------------------------------------------------------------------
Strength demand of job (3 Knee (radiographic Odds Ratio [adj] Anderson et al.(1988:
categories: none, some, much). osteoarthritis). Men, ages 55-64: 1.9 (0.9-4.0) Ex. 26-926)
Women, ages 55-64: 3.1 (1.0-9.4)
Kneeling, squatting or stair- Knee osteoarthritis.. Odds Ratio [adj] Cooper et al.(1994:
climbing, with and without Neither kneeling nor lifting: 1.0 Ex. 500-41-27)
heavy lifting. Kneeling/squatting: 2.5 (1.1-5.5)
Kneeling and lifting: 5.4 (1.4-
21.0)
Maximum compressive force ``Overexertion Incidence rate (per 200,000 Herrin et al.(1986:
(lb.) on L5/S1 lumbar disc. incidents'' by hours): Ex. 26-961)
clinic visit. 1000 lb: 65
1000-1500 lb: 150
>1500 lb: 208
Index of physically strenuous Overall MSD Linear regression coefficient Leino et al.(1995:
load. morbidity: . [adj]: Ex. 32-241-3-54)
Symptoms............. 0.127 (p=0.002)
Findings............. 0.091 (p=0.026)
Years of carpentry work (10, Knee................. Odds Ratio [adj] Lemasters et
10 to 20, 20+ years). 10-20 yr: 1.9 (0.9-4.1) al.(1998: Ex. 500-
20 yr: 3.5 (1.3-9.2) 121-44)
Lifting at work (kilograms per Knee................. Odds Ratio [adj] Sandmark et al.(2000:
day). Men:................. Medium: 2.5 (1.5-4.4) Ex. 500-41-114)
Women:............... High: 3.0 (1.6-5.5)
Medium: 1.2 (0.7-1.9)
High: 1.7 (1.0-2.9)
----------------------------------------------------------------------------------------------------------------
[[Page 68501]]
Table V-11.--Evidence of Exposure-Response Relationships for Musculoskeletal Disorders of the Neck and Shoulders
With Exposure to Non-Neutral Posture
----------------------------------------------------------------------------------------------------------------
Health outcome/body
Measure of posture region affected Measure of effect Reference
----------------------------------------------------------------------------------------------------------------
Neck and Shoulder
----------------------------------------------------------------------------------------------------------------
Height of video display unit Neck/shoulder........ Linear regression coefficient Bergqvist et
keyboard relative to elbow [unadj] 0.18 (-0.03, 0.40) al.(1995: Ex. 500-
height (centimeters). 165-24)
Duration of shoulder flexion Shoulder/neck........ Ratio for cases vs. controls: Bjelle et al.(1981:
or abduction >60 degrees Right: 2.0 (p 0.005) Ex. 26-1519)
(hours/day). Left: 2.4 (p 0.025)
Frequency of shoulder flexion Shoulder/neck........ Ratio for cases vs. controls: Bjelle et al.(1981:
or abduction >60 degrees Right: 2.0 (p 0.001) Ex. 26-1519)
(times/day). Left: 2.2 (p 0.005)
Arms lifted (hours per day, 3 Neck/shoulder........ Odds Ratio [adj] Ekberg et al.(1994:
categories). Low: 1.0 Ex. 26-1238)
Medium: 2.4 (0.8-7.1)
High: 4.8 (1.3-18)
Elbow flexed >1 time/minute Shoulder............. Odds Ratio [adj] English et al.(1995:
(per hour/day). 1.10 (0.98-1.23) Ex. 26-848)
Head rotation................. Neck, shoulder, upper R-squared [adj] Faucett et al.(1994:
back (``upper Pain: 0.11 (p0.01) Ex. 38-256)
torso''). Stiffness: 0.18 (p0.01)
Keyboard height relative to Neck, shoulder, upper R-squared [adj] Faucett et al.(1994:
elbow. back (``upper Pain: 0.05 (p0.05) Ex. 38-256)
torso''). Stiffness: 0.06 (p0.05)
Years of exposure to Shoulder impingement Increasing prevalence ratio [adj] Frost et al.(1999:
repetitive shoulder flexion syndrome. with cumulative exposure non- Ex. 38-97)
(angle 30 degrees, linear trend, p=0.002 for
600 times/hour) with high quadratic term
forces.
Hands above shoulder level Neck/shoulder pain Prevalence Ratio [adj] Holmstrom et al
(hours per day). with impairment. 1 Hr. 1.1 (0.8-1.5) (1992: Ex. 500-41-
1-4 hr. 1.5 (1.2-1.9) 64)
>4 hr. 2.0 (1.4-2.7)
Stooping (hours per day)...... Neck/shoulder pain Prevalence Ratio [adj] Holmstrom et al
with impairment. 1 Hr. 1.0 (0.8-1.3) (1992: Ex. 500-41-
1-4 hr. 1.4 (1.1-1.8) 64)
>4 hr. 1.5 (1.1-2.1)
Bent work postures Neck (in white collar Partial correlation coefficient Johansson et
[factor=duration of precision workers). [adj] al.(1994: Ex. 26-
movements and head bent 0.20 (p0.05) 1331)
foward; frequency and
duration of trunk forward
flexion (20 deg.-60 deg.)].
Twisted work postures Neck (in white collar Partial correlation coefficient Johansson et
[factor=duration of trunk workers). [adj] al.(1994: Ex. 26-
rotation (>45 deg.) and head 0.23 (p0.05) 1331)
rotation (>45 deg.)].
Extreme work postures Shoulder (in blue Partial correlation coefficient Johansson et
[factor=frequency and collar workers). [adj] al.(1994: Ex. 26-
duration of trunk forward 0.14 (p0.05) 1331)
flexion (>60 deg.); frequency
of trunk forward flexion (20
deg.-60 deg.); and duration
of head rotation (>45 deg.),
trunk rotation (>45 deg.),
and work with hands above
shoulders].
Twisted work postures Shoulder (in white Partial correlation coefficient Johansson et
[factor=duration of trunk collar workers). [adj] al.(1994: Ex. 26-
rotation (>45 deg.) and head 0.16 (p0.05) 1331)
rotation (>45 deg.)].
Percentage of work cycle with Cervicobrachial (neck Odds Ratio [adj] Jonsson et al.(1988:
shoulder elevated. to hand). 1.04 (p0.05) Ex. 26-969)
Neck flexion (percentage of Neck................. Regression coefficient p-value Kilbom et al.(1986:
work cycle). [adj] Ex. 500-41-75)
p0.01
Shoulder elevated (percentage Regression coefficient p-value Kilbom et al.(1986:
of work cycle). [adj] Ex. 500-41-75)
Neck................. p0.05 .....................
Shoulder............. p0.05 .....................
Neck flexion (movements per Neck/shoulder........ Ratio of median for cases vs. Ohlsson et al.(1995:
hour). controls [unadj] Ex. 26-868)
Total movements: 1.3 (p=0.008)
Flexions 30 deg.: 1.3
(p=0.02)
[[Page 68502]]
Frequency of shoulder flexion Neck/shoulder........ Median elevation >30 deg. (% of Ohlsson et al.(1995:
or abduction. time) [unadj]: Ex. 26-868)
Cases=16, controls=9 (p=0.05)
Median elevation >30 deg.
(movements per hour) [unadj]:
Cases=60, controls=9 (p=0.004)
Median abduction 60
deg. (% of time) [unadj]:
Cases=1, controls=0 (p=0.04)
Median elevation 60
deg. (movements per hour)
[unadj]:
Cases=47, controls=0 (p=0.04)
Shoulder flexion or abduction Left shoulder........ Odds Ratio [unadj] (test of trend) Punnett et al.(2000:
>90 degrees (duration, as Right shoulder....... >0%-10%: 2.5 Ex. 500-41-109
percentage of work cycle). Either shoulder...... 10%: 5.1 (p=0.0001)
>0%-10%: 1.7
10%: 2.8 (p=0.002)
Ratio of mean duration in cases
vs. controls [unadj]: 2.6
(p=0.003)
Odds Ratio (95% CI) per 10%
increment [adj]: 1.4 (1.1-1.8)
Twisted or bent postures (4 Neck/shoulder........ Odds Ratio [adj] Tola et al.(1988: Ex
categories). Little: 1.0 26-1018)
Moderate: 1.2 (1.0-1.5)
Rather much: 1.6 (1.4-1.9)
Very much: 1.8 (1.5-2.2)
Twisting of trunk (hours/day) Neck................. Odds Ratio [adj]: Viikari-Juntura et
(4 categories). Not at all: 1.0 al.(2000: Ex. 500-41-
Little: 1.3 (0.7-2.4) 50)
Moderately: 1.9 (1.1-3.5)
Much: 2.3 (1.2-4.3)
Working with hand above Neck................. Odds Ratio [adj]: Viikari-Juntura et
shoulder level (hours/day) (3 0.5 1.0 al.(2000: Ex. 500-41-
categories). 0.5-1: 1.2 (1.0-1.3) 50)
>1: 1.4 (1.3-1.6)
Twisting or bending of trunk Neck................. Odds Ratio [unadj]: Viikari-Juntura et
at work (3 categories). Very or rather little: 1.0 al.(1994: Ex. 26-
Moderate: 1.7 (0.9-9-3.2) 873)
Rather or very much: 1.9 (1.2-
3.2)
----------------------------------------------------------------------------------------------------------------
Hand and Wrist
----------------------------------------------------------------------------------------------------------------
Wrist bending or twisting (per Carpal tunnel Odds Ratio [unadj] Blanc at al. (1996);
2 hours/day). syndrome. 1.5 (1.2-1.7) Ex. 26-42 500-41-16)
Wrist flexion (hours/week) Carpal tunnel Odds Ratio [unadj] De Krom et al.(1990:
(hours truncated at 40). syndrome. 0: 1.0 Ex. 26-102)
1-7: 1.5 (1.3-1.9)
8-19: 3.0 (1.8-4.9)
20-40: 8.7 (3.1-24.1)
Wrist extension (hours/week) Carpal tunnel Odds Ratio [unadj] De Krom et al.(1990:
(hours truncated at 40). syndrome. 0: 1.0 Ex. 26-102)
1-7: 1.4 (1.0-1.9)
8-19: 2.3 (1.0-5.2)
20-40: 5.4 (1.1-27.4)
Shoulder rotation with arm Odds Ratio [adj] English et al.(1995:
elevated, >1 time/minute (per Ex. 26-848)
hour/day).
Wrist/forearm........ 1.6 (1.2-2.3)
Carpal tunnel 1.8 (1.2-2.8) .....................
syndrome.
Shoulder rotation with elbow Finger............... Odds Ratio [adj] English et al.(1995:
flexed, >1 time/minute (per 5.1 (2.0-12.8) Ex. 26-848)
hour/day).
Wrist flexion or extension Thumb................ Odds Ratio [adj] English et al.(1995:
(per 20 repetitions/min). 1.4 (1.1-1.8) Ex. 26-848)
Ulnar abduction (degrees of Forearm.............. Increasing percentage of operators Hunting et al.(1981:
``typical'' work posture). w/medical findings vs. angle of Ex. 26-1276)
ulnar abudction (graphical
presentation only)
[[Page 68503]]
Relative angle of wrist ulnar Wrist................ Linear regression coefficient Malchaire et
or radial deviation/45-90 [adj]: al.(1996: Ex. 26-
minute work sampling period. Mean relative deviation angle 1473)
(p0.05)
Mean relative EMG signal (p0.05)
Seniority (years employed) (p0.05)
Wrist bending or twisting Carpal tunnel Odds Ratio [adj] Nordstrom et
(mean hours/day) (5 syndrome. 0: 1.0 al.(1997: Ex. 26-
categories). 0.25-1.75: 1.34(0.64-2.80) 900)
2-3: 1.23(0.60-2.53)
3.5-6: 2.33 (1.24-4.36)
7-16: 2.47 (1.38-4.43) quadratic
dose-response effect in
alternative model, p=0.03
Wrist deviation (3 categories Hand/wrist........... Prevalence [unadj] (test of trend) Stetson et al.(1993:
of frequency). None: 35% Ex. 26-1221)
Some: 43%
Frequent: 45% (p=0.43)
----------------------------------------------------------------------------------------------------------------
Back
----------------------------------------------------------------------------------------------------------------
Postural load (index of Low back pain........ Odds Ratio [adj] (test for trend) Bovenzi et al.(1994:
frequency and/or duration of Ex. 26-774)
4 postures, in 4 categories).
Lifetime............. Mild: 1.0
Moderate: 1.3(0.8-2.4)
Hard: 1.7(1.0-3.0)
Very hard: 3.6(2.0-6.5) (p=0.001)
12 month pervalence:. Moderate: 1.8 (1.1-3.2)
Hard: 2.2(1.3-3.8)
Very hard: 4.6 (2.6-8.0)
(p=0.0001)
Hands above should level Low back (severe pain Prevalence Ratio [adj]: Holmstrom et
(hours per day). with impairment). 1 hr: 1.1 0.8-1.5) al.(1992: Ex. 500-41-
1-4: 1.5 (1.2-2.0) 65)
>4 hr: 1.6 (1.0-2.6)
Stopping (hours per day)...... Low back (severe pain Prevalence Ratio [adj]: Holmstrom et
with impairment). 1 hr: 1.3 (0.9-1.8) al.(1992: Ex. 500-41-
1-4 hr: 1.9 (1.4-2.6) 65)
>4 hr: 2.6 (1.7-3.8)
Kneeling (hours per day)...... Low back (severe pain Prevalence Ratio [adj]: Holmstrom et
with impairment). 1 hr: 2.4 (1.7-3.3) al.(1992: Ex. 500-41-
1-4 hr: 2.6 (1.9-3.5) 65)
>4 hr: 3.5 (2.4-4.9)
Extreme work postures [factor Low back (in blue Partial correlation coefficient Johansson et
formed from frequency and collar workers). [adj] 0.16 (p0.05) al.(1994: Ex. 26-
duration of trunk forward 1331)
flexionn (>60 deg.);
frequency of trunk forward
flexion (20 deg.-60 deg.);
and duration of head rotation
(>45 deg.), trunk rotation
(>45 deg.), and work with
hands above shoulders].
Monotonuous working movements Low back (in white Partial correlation coefficient Johansson et
[factor formed from duration collar workers. [adj] 0.22 (p0.05) al.(1994: Ex. 26-
of repetitive movements, 1331)
static stress, and sitting].
Driving (hours/week).......... Low back............. Odds Ratio [adj] for prevalence: Pietri et al.(1992:
10: 1.0 Ex. 29-309)
10-14: 1.5 (1.0-2.4)
15-19: 1.2 (0.8-1.9)
20-24: 2.0 (1.3-3.1)
25 2.1 (1.3-3.4)
[[Page 68504]]
Driving (hours/week).......... Low back............. Odds Ratio [adj] for 1 year Pietri et al.(1992:
cumulative incidence: Ex. 38-309)
10: 1.0
10-14: 4.0 (1.1-14.3)
15-19: 4.8 (1.4.8-16.4)
20-24: 3.3 (0.9-12.0)
25 3.7 (0.9-14.0)
Percentage of work cycle in Low back............. Odds Ratio [unadj] (test of trend) Punnett et al.(1991:
trunk flexion (3 categories). Mild flexion: Ex. 26-1289)
0%: 1.0
1-10%: 4.2
10%: 6.1 (p=0.014)
Severe flexion:
0%: 1.0
0-10%: 4.4
10%: 8.9 (p=0.003)
Percentage of work cycle in Back................. Odds Ratio [adj] Punnett et al.(1991:
non-neutral trunk posture 8.09 (1.5-44.0) Ex. 26-1289)
(mild flexion, severe
flexion, twist or lateral
bend).
Twisted or bent postures (4 Low back............. Odds Ratio [adj] Riihimaki et al.
categories). Rather or very little: 1.0 (1989: Ex. 26-58)
Moderate: 1.3 (1.0-1.7)
Rather much: 1.5 (1.2-1.9)
Very much: 1.5 (1.2-1.9)
Forward bending (minutes per Low back............. Odds Ratio [adj]: Vingard et al.(2000:
day). Men Ex. 500-41-51)
1-59 min: 1.6 (1.1-2.5)
60 min: 1.8 (1.1-3.1)
Women
1-59 min: 1.1 (0.8-1.6)
60 min: 1.2 (0.7-1.8)
Repeated bending, twisting, Back................. Odds Ratio [unadj] Wild (Ex. 26-1106; 26-
and reaching at work (hours 0 hr: 1.0 1107)
per day. >0-2 hr: 5.8
2+-4 hr: 8.4
4+-6 hr: 10.4
6+ hr: 14.1
Odds Ratio [adj] per hour of
repeated bending, twisting and
reaching: 1.09 (1.06, 1.13)
Frequent twisting or bending.. Low back............. Odds Ratio [unadj] (test of Xu et al.(1997: Ex.
trend): 500-71-53)
No or seldom: 1.0
1/4 of the time: 1.8
1/2 of the time: 1.9
3/4 of the time: 2.0
All of the time: 2.0 (p0.001)
----------------------------------------------------------------------------------------------------------------
Lower Extremity
----------------------------------------------------------------------------------------------------------------
Knee-bending demand of job (3 Knee: radiographic Odds Ratio [adj] Anderson et al.(1988:
categories: none, some, much). osteoarthritis. Men, ages 55-64: 2.5 (1.2-5.0) Ex. 26-926)
Women, ages 55-64: 3.5 (1.2-10.5)
Kneeling and/or squatting Knee................. Odds Ratio [unadj] Kirkeskov Jensen et
(Floor- and carpetlayers 56%, Compositors: 1.0 al.[Jensen,
carpenters 25%, compositors Carpenters: 3.9 (2.7-5.5) 1977#1975]
0% of working time). Floor- and carpetlayers: 6.4 (4.0-
10.1)
Standing (hours per day)...... Knee................. Odds Ratio [adj] Sandmark et al.(2000:
Ex. 500-41-114)
Men.................. Medium: 1.5 (0.9-2.4) .....................
High: 1.7 (1.0-2.9)
Women................ Medium: 1.2 (0.7-1.9) .....................
High: 1.6 (1.0-2.8)
Squatting or knee bending Knee................. Odds Ratio [adj] Sandmark et al.(2000:
(number per day). Ex. 500-41-114)
Men.................. Medium: 1.3 (0.8-2.2) .....................
High: 2.9 (1.7-4.9)
[[Page 68505]]
Kneeling (minutes per day).... Knee................. Odds Ratio [adj] Sandmark et al.(2000:
Ex. 500-41-114)
Men.................. Medium: 1.4 (0.9-2.2) .....................
High: 2.1 (1.4-3.3)
Jumping (number per day)...... Knee................. Odds Radio [adj] Snadmark et al.(2000:
Ex. 500-41-114)
Men.................. Medium: (0.9-2.4) .....................
High: 2.7 )1.7-4.1)
Jumping (number).............. Hip.................. Odds Ratio [adj] Vingard et al.(1977:
Ex. 26-1617)
Medium: 1.0 (0.5-
2.0)
High: 2.1 (1.1-4.2)
Stairs climbed (flights)...... Hip.................. Odds Ratio [adj] Vingard et al.(1997:
Medium: 1.3 (0.8-2.0) Ex. 26-1616)
High: 2.1 (1.2-3.6)
----------------------------------------------------------------------------------------------------------------
Table V-12.--Evidence of Exposure-Response Relationship for Musculoskeletal Disorders With Exposure to Segmental
Vibration, by Body Region Affected.
----------------------------------------------------------------------------------------------------------------
Measure of vibration exposure Health outcome/body
(unit) region affected Measure of effect Reference
----------------------------------------------------------------------------------------------------------------
Vibration exposure (energy Upper extremity...... Odds Ratio [adj] Bovenzi et al.(1991:
equivalent frequency-weighted 7.5 m/sec \2\ 2.7 Ex. 500-41-18)
acceleration) for 4 hours/day. >7.5 m/sec \2\ 14.1 (p0.005)
Daily vibration exposure Upper extremity...... Odds Ratio [adj] per unit Bovenzi et al.(1991:
(energy equivalent frequency- 1.29 (p0.5) Ex. 500-41-18)
weighted acceleration).
Daily vibration exposure Upper extremity Odds Ratio [adj] per unit Bovenzi et al.(1991:
(energy equivalent frequency- muscle-tendon 1.42 (p0.5) Ex. 500-41-18)
weighted acceleration). syndrome.
Daily vibration exposure Carpal tunnel Odds Ratio [adj] per unit Bovenzi et al.(1991:
(energy equivalent frequency- syndrome. 1.73 (p0.5) Ex. 500-41-18)
weighted acceleration).
Lifetime dose (5 categories of Hand-arm vibration Odds Ratio [adj] per unit Bovenzi et al.(1991:
acceleration \2\ years). syndrome. 0: 1.0 Ex. 500-41-17)
0-19: 4.1 (1.1-16.4)
19-20: 4.7 (1.3-16.1)
20-21: 9.4 (3.1-28.4)
>21: 34.3 (11.9-99.0)
Riveting (years).............. Wrist................ Odds Ratio [adj] per year Burdorf et al.(1991:
1.12 (p0.05) Ex. 500-41-21)
Riveting (years).............. Hand-arm vibration Odds Ratio [adj] per year Burdorf et al.(1991:
syndrome. 1.07 (p0.05) Ex. 500-41-21)
Power tool usage.............. Forearm-hand (right). Median values for workstations Fransson Hall et
with high vs. low symptom al.(1996: Ex. 500-41-
prevalence [unadj] 56)
Holding time: 12 sec. vs 6 secs.
(p0.05)
Total duration: 21 sec. vs 15
secs. (p0.05)
Years of exposure to vibration Vibration-induced Positive association with duration Futatsuka et
(chain saw use). white finger. of exposure al.(1985: Ex. 26-
Higher prevalence and earlier 1430)
onset of symptoms with earlier
first exposure (higher
acceleration levels) (all data
presented graphically)
[[Page 68506]]
Cumulative hours of exposure Median and ulnar Correlation coefficient [unadj] Koskimies et
to vibration. motor and sensory R median motor NCV: 0.274 (p=0.01) al.[Koskimies, 1990
nerve function. L median motor NCV: 0.123 (p>0.05) #1983]
R ulnar motor NCV: 0.259 (p=0.05)
L ulnar motor NCV: 0.389 (p>0.001)
R median distal latency: 0.172
(p=0.05)
L median distal latency: 0.214
Cumulative exposure to Hand-arm vibration Odds Ratio [adj] per common log Letz et al.(1992: Ex.
vibration (log hours). syndrome:. unit 26-384)
Vascular............. 2.9 (1.7-5.0) .....................
Sensorineural........ 1.8 (1.2-2.9) .....................
Tool use (years).............. Hand-arm vibration Odds ratio [adj] per year McGeoch et al.(2000:
syndrome (Stockholm Ex. 500-41-96)
workshop scales):.
Neurological stage 1.09 (p0.05) .....................
1.
Vascular stage 1.
Years of exposure to vibration Hand-arm vibration Odds ratio [adj] per year Nilsson et al. (1989:
syndrome. 1.11 (1.05-1.17) Ex. 26-1148)
Years of exposure to vibration Median nerve latency Odds ratio [adj] per year Nilsson et al.(1994:
at carpal tunnel. Right: 1.12 (1.02-1.23) Ex. 26-1190)
Left: 1.09 (1.00-1.20)
Cumulative vibration exposure Shoulder: Odds Ratio [adj] (per category) Stenlund et al.(1992:
(3 categories: 0-8999; 9000- osteoarthritis of Right side: 1.3 (0.9-1.8) Ex. 26-733)
255,199; and >255,199 energy- the Left side: 1.8 (1.2-2.6)
weighted hours). acromioclavicular
joint.
Cumulative vibration exposure Shoulder tendinitis.. Odds Ratio [adj] (per category) Stenlund et al.(1993:
(3 categories: 0-8999; 9000- Right side: 1.7 (1.1-2.6) Ex. 502-462)
255,199; and >255,199 energy- Left side: 1.8 (1.1-3.1)
weighted hours).
----------------------------------------------------------------------------------------------------------------
Table V-13.--Evidence of Exposure-Response Relationship for MSDs With Combination of Exposures (e.g.,
Repetition, Force and Posture), by Type of Exposure and Body Region Affected.
----------------------------------------------------------------------------------------------------------------
Health outcome/body
Exposure factors region affected Measure of effect Reference
----------------------------------------------------------------------------------------------------------------
Index of physical stress at Neck................. Odds Ratio [adj] Makela et al.(1991:
work (sum of 6 items). Age 30-64 years: 1.26 (1.18-1.33) Ex. 26-980)
Age 65 years: 1.12
(1.00-1.26)
Index of mechanical workload Elbow: epicondylitis. Odds ratio [adj]: Ono et al.(1998: Ex.
(sum of 6 items). Model 2: 1.5 (1.0-2.3) 500-66-4)
Model 3: 1.7 (1.2-2.6)
Repetition; force (4 Hand/wrist: Prevalence Rate Ratio [unadj] Armstrong et
categories: LF = low force; tendinitis. LF LR: 1.0 al.(1987: Ex. 26-48)
LR = low repetition; HF = HF LR: 4.8 (0.6-39.7)
high force; HR = high LF HR: 5.5 (0.7-46.3)
repetition. HF HR: 17.0 (2.3-126.2)
Work at video display unit, Arm/hand............. Odds Ratio [adj] Bergqvist et
with and without specific job Data entry: 1.5 (0.7-3.4) al.(1995: Ex. 26-
features. Data entry plus keyboard too low: 1195 500-165-25)
2.8 (0.9-8.6)
20 hr/week: 0.5 (0.2-
1.4)
20 hr/week plus
limited rest breaks, no lower arm
support: 4.6 (1.2-17.9)
Work at video display unit, Arm/hand............. Odds Ratio [adj] Bergqvist et
with and without specific job Limited rest breaks, plus no lower al.(1995: Ex. 500-
features. arm support, vs. one or neither: 165-24)
10.1 (2.4-43.2)
[[Page 68507]]
Force and repetition of hand Hand: Median nerve Test of positive linear trend: Nathan et al.(1988:
activities (5 classes, from sensory conduction p 0.01 Ex. 26-990)
very light/low to very heavy/ velocity.
high).
Force and repetition of hand Hand: Median nerve Linear regression coefficient Nathan et al.(1992:
activities (5 classes, from sensory conduction [adj]: Ex. 26-988)
very light/low to very heavy/ velocity. Class of hand activity: 0.011 (p
high). 0.05)
Index of physical risk factors Hand: Radial tunnel P 0.001, test for trend Roquelaure et
(sum of 3 items: force; 1 kg, syndrome. al.(1996: Ex. 500-41-
cycle time 30 sec, static 111)
hand work).
Index of physical risk factors Hand: Carpal tunnel Odds ratio [adj] Roquelaure et
(sum of 5 occupational items syndrome. 2 factors: 1.0 al.(1997: Ex. 38-
plus parity 3). 3 factors: 5.6 (1.6-24.5) 396)
4 factors: 93.7 (13.4-93.8)
5 factors: 90.0 (8.0-
366.5)
Repetition; force (4 Hand/wrist........... Odds Ratio [adj] Silverstein et
categories: LF = low force; LF LR: 1.0 al.(1986: Ex. 26-
LR = low repetition; HF = HF LR: 5.2 1404)
high force; HR = high LF HR: 3.3
repetition). HF HR: 29.1 (p 0.05)
Repetition; force (4 Hand: Carpal tunnel Odds Ratio [adj] Silverstein et
categories: LF = low force; syndrome. LF LR: 1.0 al.(1987: Ex. 26-34)
LR = low repetition; HF = HF LR: 1.8
high force; HR = high LF HR: 2.7
repetition). HF HR: 15.5 (p 0.001)
Repetitiveness and forceful Test of positive linear trend: Chiang et al.(1993:
exertions of the upper limbs Ex. 26-1117)
(Group I = neither, Group II
= either, Group III = both).
Neck symptoms........ p = 0.04
Shoulder symptoms.... p = 0.000
Shoulder girdle p = 0.000
diagnosis.
Elbow symptoms....... p = 0.11
Epicondylitis........ p = 0.14
Wrist symptoms....... p = 0.03
Hand symptoms........ p = 0.04
Carpal tunnel p = 0.02
syndrome.
Index of ergonomic stressors Upper extremity Prevalence ratio [adj] Punnett (1998: Ex. 26-
(sum of 9 items, range 0-25). (neck, shoulder/ 0-6: 1.0 38)
upper arm, elbow/ 7-12: 2.0 (1.2-3.4)
forearm, and/or hand/ 13-18: 2.6 (1.6-4.3)
wrist). 19-25: 2.8 (1.6-4.8)
Shoulder/upper arm... 0-6: 1.0
7-12: 2.6 (1.1-6.2)
13-18: 3.6 (1.6-8.3)
19-25: 3.3 (1.3-8.3)
Wrist/hand........... 0-6: 1.0
7-12: 1.9 (1.0-3.8)
13-18: 2.4 (1.3-4.7)
19-25: 2.3 (1.1-4.7)
Index of occupational physical Low back............. Odds Ratio [adj]: Heliovaara et
stress (sum of 5 items, range 0: 1.0 al.(1991: Ex. 26-
0-5). 1: 1.2 (0.9-1.6) 959)
2: 1.7 (1.3-2.1) Lifting >11.3 kg
3: 2.1 (1.6-2.7) while twisting Low
4: 3.2 (2.3-4.5) back: Prolapsed
5: 2.5 (1.4-4.7) lumbar disc Odds
Ratio [adj]:
Knees bent: 2.7 (0.9-
7.9)
Knees straight: 6.1
(1.3-27.9)
Kelsey et al.(1984:
Ex. 500-41-73)
Lifting > 11.3 kg while Low back: Prolapsed Odds Ratio [adj] Kelsey et al.(1984:
twisting. lumbar disc. Knees bent: 2.7 (0.9-7.9) Ex. 500-41-73)
Knees straight: 6.1 (1.3-27.9)
Physical exposure index (sum Low back............. Odds Ratio [adj]: Liira et al.(1996:
of 3 items, range 0-3. 0: 1.0 Ex. 26-748)
1: 1.41 (1.02-1.94)
2: 2.45 (1.63-3.68)
3: 3.18 (1.72-5.81)
Forward bending and manual Low back............. Odds Ratio [adj]: Vingard et al.(2000:
materials handling (MMH) Ex. 500-41-51)
(highly exposed now, 5 and 10
years ago).
[[Page 68508]]
Men
Forward bending: 1.8 (1.0-3.3)
MMH: 2.0 (1.0-4.3)
Bending and MMH: 2.8 (1.1-7.5)
Women
Forward bending: 1.5 (0.8-2.6)
MMH: 1.1 (0.6-2.1)
Bending and MMH: 2.9 (1.2-6.8)
Kneeling, squatting or stair- Knee osteoarthritis.. Odds Ratio [adj]: Cooper et al.(1994:
climbing, with and without Neither kneeling nor lifting: 1.0 Ex. 500-41-27)
heavy lifting. Kneeling/squatting: 2.5 (1.1-5.5)
Kneeling and lifting: 5.4 (1.4-
21.0)
Kneeling, with (floor layers) Knee: bursitis....... Prevalence ratio [adj]: Thun et al.(1987: Ex.
and without (tile/terrazzo Floor layers: 3.2 (1.9-5.4) 26-60)
setters) use of knee kicker. Tile setters: 1.8 (0.8-3.9)
----------------------------------------------------------------------------------------------------------------
In a cross-sectional study of newspaper workers, the risk of both
neck and shoulder disorders increased with typing speed and with
percentage of time working at the keyboard (Burt et al., 1990: Ex. 26-
698). Similarly, several investigators have shown exposure-response
relationships for neck and shoulder disorders among video display unit
operators with the number of hours per day (or week) of VDU work
(Bergqvist et al., 1995: Exs. 26-1195, 500-165-25; Faucett et al.,
1994: Ex. 38-256; Rossignol et al., 1987: Ex. 26-804).
Two different studies of sewing machine operators in the garment
industry have shown increasing prevalence of neck and shoulder
disorders with cumulative years of exposure to repetitive work
(Andersen et al., 1993: Ex. 26-1451; Andersen et al., 1993: Ex. 26-
1502; Schibye et al., 1995: Ex. 26-1463). (Note that Andersen 1993a
(Andersen et al., 1993: Ex. 26-1451) computed both crude and adjusted
odds ratios, and the latter estimates were higher. However, in the
adjusted model, each of the potential confounders had little
association with the risk of neck/shoulder syndromes, so this model was
deemed overly conservative and statistically inefficient, and the
unadjusted ORs are shown in the table.) Andersen et al., (Andersen et
al., 1993: Ex. 26-1502) also computed chi-square tests of trend with
exposure for specific diagnoses. The following had a positive trend
with years of exposure: cervicobrachial fibromyalgia (p0.001); rotator
cuff syndrome (p0.01); and cervical syndrome (p0.001). The probability
of having no MSD symptoms showed a negative trend with years of
exposure (p0.001). These findings are compatible with those of Brisson
et al., (Brisson et al., 1989: Ex. 26-937), who examined long-term
musculoskeletal disability in general, and specifically that due to
arthritic and back disorders, including regular pain in the lower back,
upper back/neck, shoulders, hands/wrists/elbows, or knees/ankles. The
risk of long-term disability, both overall and for musculoskeletal
disorders, increased with years of piece-rate garment work.
Elbow and forearm disorders are typically less prevalent, so there
are fewer opportunities to evaluate exposure-response relationships
with adequate statistical power. Nevertheless, several studies of VDU
operators have shown such associations with speed or daily duration of
VDU work (Bergqvist et al., 1995: Ex. 26-1195, 500-165-25; Burt et al.,
1990: Ex. 26-698; Rossignol et al., 1987: Ex. 26-804).
Intensity and duration of VDU work have shown similar exposure-
response relationships with disorders of the hand and wrist region,
including carpal tunnel syndrome (Bernard et al., 1994: Ex. 500-165-21;
Burt et al., 1990: Ex. 26-698; Faucett et al., 1994: Ex. 38-256), as
well as with cases that include both proximal and distal regions of the
upper extremity (Knave et al., 1985: Ex. 26-753; Oxenburgh, 1987: Ex.
26-1367; Polanyi et al., 1997: Ex. 500-41-106).
In the manufacturing sector, there is also evidence that the risk
of hand and wrist disorders increases with work pace and repetitiveness
(Latko et al., 1999: Ex. 38-171; Leclerc et al., 1998: Ex. 500-41-85)
and with cumulative years of exposure to repetitive manual work
(Ohlsson et al., 1989: Ex. 26-1290; Wieslander et al., 1989: Ex. 26-
1027). Moore et al., (Moore et al., 1994: Ex. 26-1033) showed that the
risk of reported upper extremity disorders decreased with the
percentage of recovery time in each work cycle.
Force
Forceful manual exertions have been characterized by different
investigators with a variety of metrics, some of them involving the
combination of at least two of object weight, frequency of handling,
and duration of exposure. These various approaches have yielded
evidence of the risk of shoulder disorders increasing with exposure in
white collar, construction, and manufacturing jobs (Hughes et al.,
1997: Ex. 26-907; Johansson et al., 1994: Ex. 26-1331; Stenlund et al.,
1993: Ex. 502-462), and similar evidence for elbow disorders, even
though limited by the smaller numbers of cases mentioned above (Hughes
et al., 1997: Ex. 26-907; Ritz, 1995: Ex. 26-1473).
Among grocery store workers, grocery checking has been identified
as a job requiring forceful exertions. In two different studies, the
risk of shoulder, elbow, and wrist/hand disorders, including CTS, was
associated with the level of forcefulness required by each employee's
job, the number of hours of checking work per week, and the cumulative
number of years of checking (Baron et al., 1991: Ex. 26-697; Osorio et
al., 1994: Ex. 26-807). Note that Osorio et al. defined three
categories of exposure, but there were no CTS cases in the low exposure
group, so in multivariate modeling only the odds ratio for low/medium
vs. high exposure could be calculated. These dichotomous
[[Page 68509]]
estimates, adjusted for age, gender, medical history and alcohol
consumption, ranged from 6 to 40.
In other studies of hand and wrist disorders, exposure-response
relationships have been found for finger flexor forces, measured by
electromyography, as well as for simpler estimates of force based on
object weight and on self-report. In particular, these showed trends in
risk of CTS that are compatible with the experimental evidence, as
summarized recently by Viikari-Juntura and Silverstein (Viikari-Juntura
et al., 1999: Ex. 500-121-73).
There is a particularly large number of studies demonstrating that
the risk of back disorders, including prolapsed lumbar disc, increases
with the frequency or duration of manual material handling, with load
weights, and with other indicators of physically strenuous work
including but not limited to lifting and carrying tasks. Again,
exposure has been variously characterized on the basis of observation,
self-report, and bio-instrumentation measures and/or combined into
indices. The volume of evidence is extremely impressive and
demonstrates that such exposure-response relationships have been found
in nursing and other health care work, in construction, in
manufacturing, and in the wide range of jobs encountered in the general
population. For example, Venning et al. (Venning et al., 1987: Ex. 500-
41-49 ) published a prospective study of a closed cohort, which showed
the predictive value of work area classified a priori in terms of
lifting demands. Kerr, Norman, and colleagues (Kerr et al., Ex. 500-41-
74 ; Norman et al., 1998: Ex. 38-84 ) compared cases to controls on 12
continuous biomechanical variables, representing both peak and daily
integrated load on the spine. There was a higher load in the cases by
each variable (all p-values 0.04). There was a moderate amount of
correlation among these variables, so the final regression model was
reduced to four, with adjustment for demographic and psychosocial
factors. The odds ratios, computed both for full observed ranges of
exposure and more conservatively for inter-quartile spreads, showed
that several dimensions of load on the lumbar spine made independent
contributions to risk of back disorders.
It is of particular interest that three different studies (Marras
et al., 1993: Ex. 500-41-94 ; Wang et al., 1998: Ex. 500-41-52; Waters
et al., 1999: Ex. 500-121-76) showed such a relationship when lifting
demands were characterized using the NIOSH lifting index (Waters et
al., 1993: Ex. 26-521). (It should be noted that Waters et al. (Waters
et al., 1999: Ex. 500-121-76) also estimated the odds ratios in a
multivariate logistic regression model that included nine other
covariates. These estimates so obtained were higher for the category of
LI=1-2 and otherwise lower than the crude estimates. However, 7 of the
covariates in the model had little association with LBP, so this model
was deemed overly conservative and the unadjusted ORs were selected as
summary measures of the study results.)
Studies of other, related health outcomes, including knee arthritis
and ``overexertion incidents'' of any body part, provide compatible
findings regarding the effects of strenuous work. In addition, Krause
et al. (Krause et al., 1997: Ex. 26-1281) found that disability
retirement was increasingly frequent from jobs with heavy physical
demands and also showed an exposure-response trend with an index of
repetitive strain that included lifting demands, muscle effort, and
non-neutral postures. The cases of disability retirement were due to
any medical condition; however, a large proportion was caused by
musculoskeletal conditions (see Table 2 of (Krause et al., 1997: Ex.
26-1281)).
Posture
Studies of the effect of non-neutral postures also include a wide
range of exposure measures, including estimated frequency or duration
of specified postures, as well as tasks that imply specific postural
demands (e.g., driving as an indicator of highly constrained static
sitting) and workstation characteristics that directly influence
posture (e.g., VDU keyboard too high). Since the anatomic segments of
the body form a kinematic chain, non-neutral postures may affect not
only the same joint region but also other joints along that chain. For
example, if the work layout requires the trunk to be twisted while the
eyes are facing forward, the neck will also be twisted and health
effects may be found all along the spine. Work with the arms elevated
may alter wrist posture or impose a biomechanical disadvantage on the
arm muscles; it will increase the torque exerted by an object held in
the hands, which in turn increases the compressive forces experienced
in the lumbar spine (Chaffin et al., 1991: Ex. 26-420).
There are a very large number of studies showing that neck and
shoulder disorders exhibit an exposure-response relationship with arm
and neck postures, especially arm elevation to form an included angle
of at least 30 deg. flexion or abduction. Both Bergqvist et al.
(Bergqvist et al., 1995: Ex. 500-165-24 ) and Faucett et al. (Faucett
et al., 1994: Ex. 38-256 ) showed an increasing risk as the height of
the VDU keyboard increased relative to seated elbow height. In a case-
control study within a single automobile assembly plant, Punnett and
colleagues found an increasing risk of shoulder disorders with the
observed proportion of the work cycle in which the included angle at
the shoulder was at least 90 degrees (Punnett et al., 2000: Ex. 500-41-
109). This association was not confounded by gender or other
demographic or medical history factors.
Viikari-Juntura et al. (Viikari-Juntura et al., 2000: Ex. 500-41-
50) carried out a longitudinal study with four repeated questionnaires
among 5180 workers in a large forest industry enterprise. The authors
used a modified Nordic questionnaire (Kuorinka et al., 1987: Ex. 38-
204) for the health outcome of `` radiating neck pain'' and validated
exposure assessment and psychosocial questionnaires. There was a
statistically significant dose-response relationship for radiating neck
pain with the frequency of ``twisting movements of the trunk during a
work day'' (ORs from 1.0 to 2.3), as well as a dose-response
relationship for hands above the shoulder. These estimates were
adjusted for body mass index and high mental stress.
English et al. conducted a study of patients in the general
population seeking medical care for upper extremity disorders (English
et al., 1995: Ex. 26-848 ). Conditions affecting the wrist and hand
showed exposure-response relationships with several different shoulder
and wrist postures (Table 3b). The degree of ulnar deviation has been
reported to be associated with the risk of forearm and wrist disorders
(Hunting et al., 1981: Ex. 26-1276; Malchaire et al., 1996: Ex. 26-
1473). Several authors have found that the risk of carpal tunnel
syndrome increases with the number of hours per day or week in which
the wrist is flexed or extended (Blanc et al., 1996: Exs. 26-42, 500-
41-16; de Krom et al., 1990: Ex. 26-102; Nordstrom et al., 1997: Ex.
26-900).
In studies of back disorders, a number of investigators have
reported exposure-response relationships with trunk forward flexion,
lateral bending, and rotation. These studies address non-neutral
postures in both seated and standing work, and they cover a range of
industries and occupations from tractor driving to construction to
automobile assembly. Similar data for the U.S. general population were
obtained from analysis of the National Health Interview Study (Exs. 26-
1106, 26-1107). There is also evidence of
[[Page 68510]]
increasing risk with static sitting, both assessed directly and through
estimated time or distance driving per week (although the latter may
also involve exposure to whole-body vibration). In the study by Pietri
et al. (Pietri et al., 1992: Ex. 38-309), the odds ratios for both
prevalence and one-year cumulative incidence of low back pain showed
increases with hours of driving per week in multivariate models
adjusted for age, gender, comfortable car seat (y/n), carrying loads
(y/n), standing (y/n), tobacco consumption, and psychosomatic factors.
With regard to disorders affecting the lower extremity, knee-
bending, kneeling, squatting, jumping from one level to another, and
stair-climbing are all found in these studies. In a series of Danish
studies, direct observations showed that the average proportion of time
that was spent kneeling and/or squatting by workers in three different
trades (Jensen et al., 1997: Ex. 500-41-69). The prevalence of knee
disorders among the same three trades increased proportionately to the
exposure prevalences. Anderson and Felson utilized the U.S. Department
of Labor Dictionary of Occupational Titles and characterized each
occupation on the basis of the proportion of job titles within it that
required knee-bending (0%, up to 50%, more than 50%) (Anderson et al.,
1988: Ex. 26-926). Among subjects aged 55 to 64 years, there was a two
to three-fold increase in risk of radiographic osteoarthritis with each
category of knee-bending, adjusted for gender, race, education, and
body mass index. These odds ratios represent the increase in risk
across the three categories, i.e., from no to some and from some to
much knee-bending.
Vibration
Segmental vibration exposure to the distal upper extremity,
especially through holding and operating power tools, is another area
of research where exposure-response relationships have been reported by
numerous authors. Some studies have shown the association with years of
exposure, and others combined work history with direct measurements of
frequency and acceleration to construct biologically informed
cumulative exposure indices. Most of the evidence concerns neurological
and circulatory impairment of the hand and wrist. Three different
investigations reported an odds ratio of about 1.1 for each year of
occupational exposure to hand-arm vibration, which represents a
doubling of risk about every 7 years. In addition to those studies
shown in Table 4a, Nordstrom et al. (Nordstrom et al., 1997: Ex. 26-
900) reported an ``alternative'' multivariate model of CTS in which
there was a positive quadratic dose-response relationship (p=0.01) for
use of power tools or machinery. While this variable was not conclusive
regarding exposure to segmental vibration, it does suggest an exposure-
response trend between segmental vibration and CTS.
In an historical cohort, Futatsuka et al. (Futatsuka et al., 1985:
Ex. 26-1430) found a positive association between the prevalence of
``vibration-induced white finger'' and the duration of exposure to
vibration (chain saw use). In addition, there was an interaction with
year of first exposure: higher prevalences and earlier onset of
symptoms were observed among workers with earlier first exposure, when
the acceleration levels were higher (all data presented graphically).
One study team found similar associations for the risk of shoulder
disorders (Stenlund et al., 1993: Ex. 502-462; Stenlund et al., 1992:
Ex. 26-733).
Several statements contained in submissions by the Chamber of
Commerce and others cited OSHA's statement in the preamble to the
proposal that it had not constructed ``generalized quantitative
exposure-response relationships'' for standard-setting (64 Fed. Reg. at
65927), and that the Agency's reluctance to set permissible exposure
levels for risk factors provided evidence of a lack of exposure-
response relationship in the epidemiologic literature (e.g., Chamber of
Commerce, Ex. 30-1722, p. 46 and Ex. 500-188, pp. 10-11; United Parcel
Service, Ex. 500-197, pp. I-61 to I-62). Such arguments confuse
exposure-response relationships as evidence of a causal relationship
with the last stage of quantitative risk assessment, namely computation
of a permissible exposure level.
It is critical to distinguish between these points. Exposure-
response relationships have been demonstrated in the epidemiologic
literature, using a variety of exposure metrics and for a variety of
health outcomes, and a number of reviewers have cited this evidence in
concluding that there are causal relationships (eg., Armstrong et al.,
1993: Ex. 26-1110; Bernard, 1997: Ex.26-1; Burdorf et al., 1997: Ex.
500-121-13; Hagberg et al., 1992: Ex. 8-1; Hales et al., 1996: Ex. 26-
896; Viikari-Juntura et al., 1999: Ex. 500-121-73). At the same time,
although the indicted exposures and their associations with MSDs are
qualitatively similar across many studies, the variations in
measurement approaches results in very limited numbers of studies with
any single exposure metric. More importantly, there is substantial
evidence of interactions among physical exposures, so that (for
example) jobs requiring both repetitive and forceful motions have a
higher risk than jobs requiring either exposure alone (Armstrong et
al., 1987: Ex. 26-48; Silverstein et al., 1986: Ex. 26-1404;
Silverstein et al., 1987: Ex. 26-34). (Numerous examples of other
additive or multiplicative effects between physical ergonomic exposures
have been listed in Tables V-9 through V-13). Thus, the exposure-
response curve for each exposure should ideally be described as a
function of the level of each other exposure that might also be present
in the same job. This represents an enormous number of combinations of
exposure, of which only some have been studied epidemiologically to
date. Given the available exposure-response relationships, plus
evidence that exposures interact with each other, the decision not to
attempt quantitative risk assessment calculations at this time is
readily justifiable. However, this does not at all imply that the
evidence for exposure-response relationships is insufficient to
conclude that there is a causal relationship between exposure to risk
factors and the risk of MSDs.
Another argument made in the testimony cited above is that if an
exposure-response relationship existed, it would necessarily be linear
or monotonic, and that it would necessarily provide an exposure level
that could be used to differentiate between background risk of MSDs and
an elevated risk (United Parcel Service, Ex. 500-197, pp. I-62 to I-
67). This assertion is false. An exposure-response relationship need
not take the form of a straight line through all data points; it may
conceivably be better described as a logistic curve, or as a step-
function, or as any other of a variety of mathematical functions. As
one example, the analyses presented by Frost et al. (Frost et al.,
1999: Ex. 38-97) clearly show a non-linear exposure-response trend with
cumulative exposure to repetitive and loaded shoulder flexion. Two
among many other illustrations of non-linear, positive exposure-
response relationships can be found in Liles et al., 1984 (Liles et
al., 1984: Ex. 26-33 500-41-88), where the authors suggested that their
graphs provided evidence of exposure thresholds, and Moore et al., 1994
(Moore et al., 1994: Ex. 26-1033), where a log-log transformation
improved the fit of the model. A non-linear relationship, for example,
accommodates the likelihood that some physical activity is beneficial
and that only at more extreme levels do
[[Continued on page 68511]]
[[pp. 68511-68560]] Ergonomics Program
[[Continued from page 68510]]
[[Page 68511]]
adverse health effects occur, a point advanced by several in their
testimony to the docket (e.g., United Parcel Service, Ex. 500-197, pp.
I-68; Vender attachment to UPS post-hearing comments, Ex. 500-118, page
17). Dr. Hadler opined that ``whenever a relationship between exposure
and effect is not linear (not monotonic), you can be sure there are
confounders, * * *.'' (Hadler attachment to UPS post-hearing comments,
Ex. 500-118, page 4). He offered no evidence in support of this
assertion, and in fact there is no requirement in epidemiology that the
relationship must either be linear or monotonic. OSHA has relied on
non-linear dose-response relationships in other health standard
rulemakings (see Formaldehyde, 54 FR46168, Cadmium 57 FR 42101).
Second, most exposure-response relationships do not indicate a
single exposure level that unambiguously differentiates risk from no
risk. This is especially true if exposure is treated as continuous and
the relationship fits a straight line through the origin, in which case
each small increment in exposure increases the probability of an
adverse health outcome and, extrapolated downward, there may be no
discernable point without excess risk above the zero exposure level.
Note that in this regard U.P.S. criticized OSHA for the assumption
that, in fact, UPS had made: ``OSHA has falsely assumed that any
increment of human muscle usage is harmful, * * *.'' (United Parcel
Service, Ex. 500-197, pp. I-68).
On the other hand, when exposures have been categorized and are
ordinally associated with risk of disease, it can be argued that the
first exposure level where an elevated risk is observed above baseline
represents an appropriate point for a permissible exposure level (at
least until subsequent studies clarify whether there is still excess
morbidity occurring below that level). This type of approach was taken
recently by the American Conference of Governmental Industrial
Hygienists (2000), which used essentially the same epidemiologic
evidence available to OSHA--with its variety of exposure metrics--to
determine the proposed new Threshold Limit Value for
occupational hand activity level (see Exs. 38-162, DC-387).
Several authors have called attention to the complexity of the
process of utilizing exposure-response data for quantitative risk
assessment in the multi-dimensional domain of physical ergonomics
(e.g., Armstrong et al., 1993: Ex. 26-1110; Burdorf et al., 1997: Ex.
500-121-13; Frank et al., 1996: Ex. 502-407; Kilbom, 1999: Ex. 38-406;
Viikari-Juntura et al., 1999: Ex. 500-121-73). OSHA finds that it is
reasonable to conclude, as these experts have done, that there is a
need for continuing study of those relationships and interactions,
while at the same time, that it is appropriate to implement the
scientific knowledge in hand in order to reduce the risk of work-
related MSDs.
In the preamble to the proposed rule (64 FR 65768), OSHA presented
the results of several studies that provided evidence for positive
trends between exposure to biomechanical risk factors and the
prevalence or incidence of MSDs. Three commenters critiqued twelve of
these studies, claiming a variety of design or methodological flaws in
the studies, computational errors in the studies, or that OSHA misused
some of the data (Exs. 30-276, 500-79, 32-241-4). The comments are
those of Dr. Steven Moore, Professor, Environmental and Occupational
Health, Texas A&M University (Ex. 30-276), Marathon Ashland Petroleum
LLC (Ex. 500-79), and Gibson, Dunn & Crutcher (Ex. 32-241-4). Marathon
Ashland Petroleum LLC includes Dr. Moore's comments as an Appendix.
Gibson, Dunn & Crutcher summarize the critiques of several experts,
whose statements are attached to their comment. OSHA responds to all
these comments below.
Dr. Moore and Gibson, Dunn & Crutcher criticized the study on risk
factors for CTS by deKrom et al., (1990, Ex. 500-41-28). They claim
that the study does not account for psychosocial factors and that it is
methodologically flawed in relying on self-reported information about
duration of exposure, rendering the results meaningless. With respect
to the lack of analysis on psychosocial factors, OSHA acknowledges that
this case-control study, with cases mostly of hospital outpatients and
controls from the general population, did not examine or control for
psychosocial factors. However, OSHA finds nothing in the design and
analysis of this study that would invalidate the statistically
significant positive associations among work related physical factors
and CTS that the study did find. The authors concluded that activities
with a flexed wrist or with an extended wrist (exposure-related
increased ORs) were risk factors for CTS. Dr. Moore criticized the
duration analysis used to estimate exposure-response as a function of
time, claiming that the survey questionnaire instrument for collecting
exposure information was unreliable. OSHA responds that with little
information about the survey questionnaire in the published paper, the
agency cannot determine the reliability. However, from a description in
the paper of the blindness with which the survey was administered, OSHA
believes that such an imperfect exposure measurement instrument would
yield non-differential exposure misclassification. Such non-
differential misclassification would bias both the ORs and the slope
toward a finding of no increasing trend. The fact the deKrom et al.
study found statistically significant ORs for each incremental number
of weekly hours of activities with extended or flexed wrist separately,
plus finding a statistically significant exposure-response trend for
both duration variables, despite the negative bias, provides strong
evidence that the effect is real. This finding is further strengthened
by the final analysis of de Krom et al. which used a multiple
regression model simultaneously containing both duration of ``flex''
and ``extended'' wrist activities as variables, with both variables
found to be statistically significant for duration-of-exposure-response
trends (Ex. 500-41-28, pg. 1108). The finding of joint statistical
significance of collinear variables when simultaneously modeled
increases confidence in the significance of the separate variables.
OSHA also responds to the criticism that ``in a conclusion that
would devastate OSHA's attempt to redesign the American office, [deKrom
et al.] found no significant risk of CTS related to typing.''OSHA notes
that of the 156 cases of CTS, only 12 cases reported any work-related
typing at all. In a case-control study such as this with only 12 cases
exposed to typing, the statistical ability to determine a significant
result is very small. Either a different study recruitment procedure or
a much larger sample size would be required. With respect to another
criticism by Gibson, Dunn & Crutcher on the apparently spurious finding
of an association of CTS with varicosis in men, the authors reported
this result of their analysis for the scientific world to contemplate,
but found it inconsistent with that of other authors (Ex. 32-241-4).
Dr. Moore also criticizes OSHA's use of the MSD prevalence study by
Luopajarvi et al., (1979, Ex. 26-56) used as part of the agency's
determination of causality for hand/wrist tendinitis. Dr. Moore claims
the study's poor exposure assessment and lack of statistical
comparisons provide poor support. In response, OSHA notes that the same
exposure assessment methods were used in the study comparisons between
the assembly-line packers and the shop assistants, so that the
differences should be unaffected. OSHA also notes that
[[Page 68512]]
these comparison showed that the assembly-line packers had a highly
statistically significant (p0.001) increased prevalence of (1)
syndromes found in the neck, shoulders and elbows; and (2) muscle-
tendon syndromes in the hands (p0.001). The most common neck syndrome
in this study was tension neck and the most common shoulder disorder
was humeral tendinitis. For hands, Luopajarvi et al. noted the
prevalence of tenosynovitis/peritendinitis at 53% in the assembly-line
packers, but only 14% in the shop-assistants (who endured prolonged
standing, but otherwise physically light work). For the assembly-line
packers the authors noted especially the repetitive motions at a high
speed, and fingers and hands constantly used at the pace of the
machine, up to 25,000 cycles per workday. For these packers the authors
also noted difficult static muscle work, extreme work positions of the
hands, and difficult lifting. OSHA believes that this study provides a
good comparison between similar demographic groups, and that it
provides good evidence that work-related physical stress factors were
causing shoulder and upper extremities injuries.
Dr. Moore also claims that errors in the evaluations of two other
studies are materially related to the NIOSH's and OSHA's conclusions
(Ex. 30-276, pg. 2). With respect to the study by Kuorinka and
Koskinen, he criticizes NIOSH for not specifically mentioning the
``non-positive'' finding of no evidence of association of with time
spent in deviated wrist postures per day. OSHA responds that the
Kuorinka and Koskinen study did not specifically mention peritendinitis
and tenosynovitis in its analysis, only the total complex of muscle-
tendon syndrome. Their definition of muscle-tendon syndrome used in
this study came from an accompanying article they coauthored in the
same journal (see Ex. 26-1218); the definition included syndromes of
the shoulder and elbow, along with the wrist and hands. Every one of
the seventeen (out of 93) manual workers with muscle-tendon syndrome
also had tension neck syndrome, but none was specifically identified as
having either peritendinitis or tenosynovitis (Ex. 26-639). While Dr.
Moore is correct that Kuorinka and Koskinen found no correlation
between the number of signs in the wrist and the deviation load of the
wrist joint (1979, Ex. 26-639). OSHA finds too few details in the
analysis for any conclusions with respect to peritendinitis and
tenosynovitis.
Dr. Moore also criticizes the NIOSH 1997 (Ex. 26-1) review for its
failure to include the findings of a second study, Armstrong et al.,
(1987, Ex. 500-41-4) in NIOSH's evaluation on the effect of posture for
hand/wrist tendinitis. Dr. Moore claims that NIOSH rated the Armstrong
et al. study as high quality for other physical risk factors (i.e.
force and repetition, for which the study found highly statistically
significant associations) but didn't include the study at all in the
discussion of the effect of posture. Armstrong et al. reported no
significant associations for differences in posture ``comparing the
percentage of the time spent in various postures between jobs in which
there were workers with tendinitis and those in which there were no
workers with tendinitis'' (Ex. 500-41-4). Dr. Moore claims that this
omission by NIOSH and OSHA is an error in evaluation and that this
error ``would likely have a material impact on the conclusion'' (Ex.
30-276).
OSHA has considered Dr. Moore's claim about NIOSH's evaluation of
the Armstrong et al. study and has concluded that while Dr. Moore is
correct in his claim that Armstrong et al. found no associations with
the posture variable stated above, there is simply not enough detail in
the publication to weight that study highly with regard to the posture
variable. With this study group Armstrong et al. found a highly
statistically significant odds ratio of 29.4 (p0.001) for high force/
high repetitiveness hand/wrist motion compared with a low force/low
repetitiveness motion group. These groups appeared well defined and
well studied with respect to force and repetitiveness, with 652 workers
divided fairly evenly among the four groups increasing the statistical
power to detect an effect if one exists. However, no detail is given
for the posture analysis, only a short paragraph result (Ex. 500-41-4).
To study this same highly force- and repetitiveness-stressed group for
the effect of posture differences on hand/wrist tendinitis, (and CTS,
see Silverstein et al., 1987, Ex. 26-34, and comment in Ex. 32-241-4,
pg.143) would appear to be quite difficult, considering the proven
effect of force and repetitiveness as risk factors in this worker
group. Silverstein et al. (1986) studying essentially the same group,
discussed postures, stating:
(W)rist postures required on a job are often determined by the
height of the work station with respect to the location of the
worker. * * * to test this hypothesis the job of each worker in a
job would have to have been videotaped and analyzed. This was not
done in this investigation. * * * Awkward postures (wrist deviation,
flexion, hyperextension, and finger pinching) * * * were not
controlled for in this investigation. (Ex. 26-1404).
OSHA concludes that NIOSH was correct in not considering the
Armstrong et al. (Ex. 500-41-4) and Silverstein et al.1986 and 1987,
(Exs. 26-1404, 26-34) study further for posture with this particular
study group.
Gibson, Dunn & Crutcher also criticize OSHA's omission that the
Armstrong et al., study ``found no significant association between * *
* vibration and [hand/wrist tendinitis] (Ex.32-241-4, pg. 140). OSHA
responds that the Armstrong et al., 1987, (Ex. 500-41-4) publication
provided less information about vibration in the study group than it
did about posture, and that apparently it was not a well studied factor
in this group.
Dr. Moore also criticizes the ``NIOSH and OSHA reviews [for]
inappropriately generaliz[ing] results of some studies beyond the
constructs used to measure or categorize MSD risk factor [i.e., force
and repetitiveness]'' (Ex. 30-276, pg. 2-3), singling out Armstrong et
al. (Ex. 500-41-4) and Silverstein et al., 1987, (Ex. 26-34). OSHA has
considered this comment and disagrees with Dr. Moore. Most authors
define risk factors slightly differently and the NIOSH analysis had to
categorize the slightly different definitions into categories. OSHA
believes this categorization does not detract from either the NIOSH
analysis or the ability to generalize that force and repetitiveness are
etiologically related to hand/wrist tendinitis. In fact, OSHA believes
that the different studies' abilities to detect significant
associations using different definitions actually make the overall
results more generalizable.
Gibson, Dunn & Crutcher, also criticize the Silverstein et al.,
1986 study of hand wrist cumulative trauma disorders (CTDs, Ex. 26-
1404, and by implication Exs. 26-34 and 500-41-4) for being
methodologically flawed, specifically citing recall bias and observer
bias as leading to an overestimation of the associations between risk
factors and health effect (Ex. 32-241-4, pg. 142-143). They also cite
the study's cross-sectional design, the omission of a number of jobs
from the investigation, and lack of analysis on non-biomechanical
factors as serious flaws.
OSHA has considered this criticism of the methodology, but
disagrees with the characterization that a cross-sectional design
cannot establish causation. In another section of this preamble, OSHA
discusses the value of all the studies together in forming a database
to determine causality. OSHA also notes
[[Page 68513]]
the claims of bias in this study, but agrees with the Silverstein et
al., 1986 study authors who found significant positive and publishable
associations between hand wrist CTDs and high force-high repetitive
jobs:
The findings in this investigation may also have underestimated
the prevalence of hand wrist CTDs in several ways. Firstly, subject
selection was limited to active workers. those away from the job
with CTDs at the time of evaluation (potentially severe cases) would
not have been available for study. Secondly, the one year seniority
criteria for subject selection excluded those who might have had
CTDs and transferred before one year as well as those with CTDs but
not on the job for at least one year. The finding that hand wrist
CTDs were negatively associated with age and years on the job
support the argument of selection/survival bias in the study
population [which would underestimate the effect] (Ex. 26-1404, pg.
784).
Gibson, Dunn & Crutcher criticize the study of shoulder pain in
shipyard workers (welders and steel plate-workers) by Herberts et al.,
1984, (Ex. 26-51), for methodological flaws, including cross-sectional
design, and the lack of demographic matching between the exposed and
control groups. (Ex. 32-241-4, pg. 142). They also criticized OSHA for
not recognizing what Herberts et al. did, have ``chronic shoulder pain
is * * * common in people not necessarily active in arduous physical
work.'' (Ex. 26-51, pg. 167). OSHA responds that the Agency does
recognize that people other than those in HPW have shoulder pain; that
recognition allows researchers, OSHA and other analysts to compare the
prevalence of shoulder pain in workers doing HPW to that in workers not
so engaged, in order to estimate the contribution from HPW. Herberts et
al. also did this and concluded that ``Rotator cuff tendinitis
constitutes a major problem in people with arduous occupations, i.e.,
shipyard welders (PR=18.3%), and steel plate-workers (PR=16.2%).'' By
contrast, of the 57 clerks in the comparison group only one (1.7%)
reported this disorder. Of this highly statistically significant
difference, Herberts et al., note:
Since the clerks are on an average older than the other two
groups, there would be a higher likelihood of age-induced tendinitis
in this [clerks] group. However, the hypothesis is that those with a
high physical workload have tendinitis to a greater extent than
normal. (Ex. 26-51).
Gibson, Dunn & Crutcher also criticize OSHA's use of the Punnett et
al., 1991 (Ex. 26-39) study of back disorders and nonneutral trunk
postures in automobile assembly workers. The study is criticized as
methodologically flawed in that it is a case-control study that does
not consider non-biomechanical variables (Ex. 32-241-4, pg. 140).
Gibson, Dunn & Crutcher quote the authors' own cautions of the
limitations of such a design, which is necessarily retrospective in
recalling exposures and pre-existing conditions. OSHA acknowledges the
limitations of such as design. However, OSHA considers the design,
conduct, and analysis of this study quite persuasive--in terms of
strength of association, temporality, and exposure-response--in the
overall determination of causality of BT and LBP; see OSHA's section on
back disorders in this preamble. The authors in their publication
conclude:
Back disorders were associated with mild trunk flexion (OR=4.9
(p5% C.I. 1.4-17.4), severe trunk flexion (OR=5.7, 95% C.I. 1.6-
20.4), and trunk twist or lateral bend (OR=5.0, 95% C.I. 1.6-21.4).
the risk increased with exposure to multiple postures and increasing
duration of exposure. (Ex. 26-39, pg. 337).
Gibson, Dunn & Crutcher also criticize Dr. Punnett's more recent
study (1998, Ex. 26-38) of upper extremity disorders in vehicle
manufacturing, as being methodologically flawed in that it is a cross-
sectional design and does not include an analysis of the relative
importance of psychosocial factors. OSHA has considered this comment
and disagrees. Even though this study is cross-sectional, OSHA
considers it well-conducted and analyzed. Using a primary exposure
score relating to responses to psychophysical exposure items, Punnett
found both statistically significant PRs and significant exposure-
response relationships for both (1) shoulder and upper arm disorders
and (2) wrist and hand disorders. The results were consistent when the
analyses were done both for the symptom cases and the physical
examination cases. The authors concluded that ``musculoskeletal
disorders of the upper extremities were strongly associated with
exposure to combined ergonomic stressors.'' (Ex. 32-241-4) Gibson, Dunn
& Crutcher also criticize OSHA's use of the prospective study by Liles
and Deivanayagam, 1984 (Ex. 26-33) on job severity index (JSI) for the
evaluation and control of lifting injury of the back. The JSI is a
function of lifting frequency of task, maximum required weight of lift,
adjusted capacity of the individual, and total lifting frequency.
Criticism of the study focuses on a potential bias which Gibson, Dunn &
Crutcher call a ``nocebo effect'', a bias due to differential reporting
of pain symptoms by the subjects, knowing that their symptoms are being
monitored. OSHA responds that such a potential bias is purely
speculative, and, in any case, does not explain either the increasing
injury rate, the cumulative disabling injury rate or the cumulative
severity rates seen with increasing JSI. (Ex. 26-33, pgs. 690-691).
Gibson, Dunn & Crutcher also criticize the study by Snook et al.,
(1978, Ex. 26-35) on three preventive approaches to low back injury.
The study is criticized as being methodologically flawed in that it is
a cross-sectional study which looks solely at biomechanical risk
factors, and cannot establish causation. However, Gibson, Dunn &
Crutcher also quote several portions of the article that it wants OSHA
to recognize: (1) that most cases of industrial back injury have no
known cause, and recovery occurs before any cause is ever found, (2)
some workers never suffer from low back pain regardless of their type
of work, and others seem to get it in spite of what they do; and (3)
``low back injuries are usually not serious; four out of five workers
suffering from low back injuries return to the job within three
weeks.'' (Ex.32-241-4). OSHA responds that this Snook et al., case-
series study of 191 low back injuries is of limited usefulness in
determining causality, but it does suggest that low back injury is
associated with excessive manual handling tasks. OSHA also acknowledges
the general apparent truthfulness of statement (2), by Snook et al.,
but can find no reference for it in the article. Statement (1) of Snook
et al., references a 1970 published article and a 1971 editorial. There
is more recent science available. Statement (3) cites one 1966 study as
its reference.
Gibson, Dunn & Crutcher also criticize a study by (1992, Ex. 26-36)
on low back and neck/shoulder pain in construction workers. They claim
that the study is methodologically flawed in that it is cross-sectional
in design, limiting its ability to show causality. At the same time
they criticize OSHA for failing to discuss the study's findings of
positive associations between LBP and both psychosocial factors and
age, as well as the finding(s) of no significant association between
sitting posture and LBP (and severe LBP). OSHA responds that with
respect to sitting (>4 hours) posture and the Holmstrom et al. (Ex. 26-
36) finding of no significant association with either LBP or severe
LBP, both NIOSH (Ex. 26-1, pg. 6-47) and OSHA (see Table on back
studies considered) do consider the finding of this study as ``no
association'' for SWP and LBP. With respect to specific psychosocial
factors being significant in this analysis, OSHA concurs. However, the
discussion of psychosocial factors
[[Page 68514]]
by Holmstrom et al. fails to mention whether or not the multiple
regression model used also found the physical risk factors
simultaneously statistically significant with these data, which would
suggest that physical and psychosocial factors are independent risk
factors (Ex. 26-36, pg. 667).
4. Comments on the Role of Individual and Non-Work Factors
In their posthearing testimony, Gibson, Dunn and Crutcher assert
that:
In developing its unfounded assertion that biomechanical
workplace factors play a predominant role in the development of
MSDs, OSHA has also ignored a great number of scientifically valid
studies establishing that non-work-related factors, such as genetic
predisposition, age, general health, smoking, social activities, and
psychosocial factors exert a greater influence than biomechanical
factors on the development of MSDs (Ex. 500-118).
Other commenters also expressed concern about the role of non-work
factors in the etiology of MSDs (e.g., Exs. 30-1722, 60-2037, 30-4184,
30-3077, 30-1352, 30-4130, 30-3922, 30-3114, 30-3354).
While some commenters tended to lump individual factors along with
psychosocial factors, these two types of factors are clearly separate
and distinct. OSHA has separated its discussion of individual factors
from that of psychosocial factors, and has fully addressed comments on
psychosocial factors later in this part of the Health Effects section.
In this section OSHA presents it's response to comments in the record
on individual factors, sometimes called ``personal'' factors. The
factors that are discussed in the literature include age,
susceptibility, either by genetic predisposition or medical conditions,
and other factors that may be thought of as those that modify the
capacity of individuals to perform work.
The above post-hearing comment (Ex. 500-18) makes two claims:
(1) that OSHA ignored an entire body of literature relevant to this
rulemaking, and
(2) that had OSHA not ignored this body of literature, it would
have come to an opposite conclusion than that reached by OSHA, i.e.,
that these factors ``exert a greater influence'' presumably than
biomechanical risk factors, on the development of MSDs.
OSHA, in fact, did not ignore the literature on individual factors.
On the contrary, OSHA introduced the appendices to the proposed Health
Effects section with a discussion of ``Individual Factors and
Epidemiology of Work-Related Musculoskeletal Disorders,'' stating that:
The multifactorial nature of MSDs requires a discussion of
individual factors that have been studied to determine their
association with or influence on the incidence and prevalence of
work-related MSDs. These factors include age (Guo et al., 1995;
Biering-Sorensen et al., 1983; English et al., 1995; Ohlsson et al.,
1994); gender (Hales et al., 1994; Johansson, 1994; Chiang et al.,
1993; Armstrong et al., 1987a); anthropometry (Werner et al., 1994;
Nathan et al., 1993; Heliovaara, 1987); physical activity
(Holmstrom, Lindell, and Moritz, 1992; Baron et al., 1991; Craig et
al., 1998); strength (Chaffin and Park, 1973; Chaffin et al., 1977;
Troup, Martin, and Lloyd, 1981); cigarette smoking (Finkelstein,
1995; Owen and Damron, 1984; Svensson and Andersson, 1983; Kelsey,
Golden, and Mundt, 1990; Hildebrandt, 1987); and alcohol, caffeine,
and vitamins (Nathan et al., 1996, Keiston et al., 1997). In
addition, psychosocial factors have been associated with upper-
extremity and back disorders (Ex. 27-1, p. I-1).
OSHA has stated elsewhere that it relied on two major reviews of
the evidence for work-relatedness of MSDs available at that time,
NIOSH's ``Musculoskeletal Disorders and Workplace Factors: A Critical
Review of the Epidemiologic Evidence for Work-Related Musculoskeletal
Disorders of the Neck, Upper Extremity, and Low Back'' (Bernard, 1997;
Ex. 26-1) and the National Research Council/National Academy of
Sciences' ``Workshop on Work-Related Musculoskeletal Injuries: The
Research Base'' (Ex. 26-37). OSHA believes that it was appropriate to
place great weight on these two sources, as they are comprehensive
reviews of recent peer-reviewed scientific literature conducted by
highly-reputable and independent groups of scientists expert in their
respective fields.
To the extent that the studies reviewed by NIOSH considered
exposure to nonoccupational physical activities, such as
nonoccupational VDT use, hobbies, second jobs, and household activities
that might increase risk for MSDs, NIOSH included this information in
its review, and acknowledges that:
a number of factors can influence a person's response to risk
factors for MSDs in the workplace and elsewhere. Among these are the
following: age, gender, smoking, physical activity, strength,
anthropometry.
The literature, as reviewed by NIOSH (NIOSH, 1997; Ex. 26-1): on
each of these individual factors is summarized here:
Age: The prevalence of MSDs increases as people enter their working
years. By the age of 35, most people have had their first episode of
back pain (Guo et al. 1995, Ex. 26-1474; Chaffin 1979, Ex. 26-1489).
Once in their working years (age 25 to 65), however, the prevalence is
relatively consistent (Guo et al. 1995, Ex. 26-1274; Biering-Sorenson
1983, Ex. 26-843). Musculoskeletal impairments are among the most
prevalent and symptomatic health problems of middle and old age.
Nonetheless, age groups with the highest rates of compensable back pain
and strains are the 20-24 age group for men, and the 30-34 age group
for women.
NIOSH acknowledges that age-related degenerative disorders may
result in decreases in musculoskeletal function, and loss of tissue
strength with age may also increase the probability or severity of soft
tissue damage. NIOSH also notes that:
Another problem is that advancing age and increasing number of
years on the job are usually correlated. Age is a true confounder
with years of employment, so that these factors must be adjusted for
when determining relationship with work. Many of the epidemiologic
studies that looked at populations with a wide age variance have
controlled for age by statistical methods.
However,
Several studies found age to be an important factor associated with
MSDs (Guo et al. 1995; Biering-Sorenson 1983; English et al. 1995;
Ohlsson et al. 1994; Riihimaki et al. 1989a; Toomingas et al. 1991)
others have not (Herberts et al, 1981; Punnett et al. 1985). [Ex.
26-1]
Riihimaki et al. (1989, Ex. 26-58) found a significant relationship
between sciatica and age in machine operators, carpenters, and
sedentary workers. Age was also a strong risk factor for neck and
shoulder symptoms in these same groups of workers (Riihimaki et al.
1989, Ex. 26-58).
When a study does not find a relationship between an increased risk
for MSDs and aging, lack of an observed relationship may be due to
``survivor bias.'' If workers who have health problems leave their
jobs, or change jobs to one with less exposure, the remaining
population includes only those workers whose health has not been
adversely affected at their jobs. As an example, in a study of female
plastics assembly workers, Ohlsson et al. (1989, Ex. 26-1290) reported
that the degree of increase in the odds of neck and shoulder pain with
the duration of employment depended on the age of the worker. For the
younger subjects, the odds increased significantly as the duration of
employment increased, but for the older ones no statistical change was
found with length of employment. The older women who had been employed
for shorter periods of time had more reported symptoms than the
[[Page 68515]]
younger ones, while older workers with longer employment times reported
fewer symptoms than younger workers. Ohlsson et al. (1989, Ex. 26-1290)
interviewed 76 former assembly workers and found that 26% reported pain
as the cause of leaving work. This finding supports the likely role of
a survivor bias in this study, the effect of which is to underestimate
the true risk of developing MSDs, in this case in the older workers.
Some studies report observing an increased risk for MSDs with age,
others do not. Where the effects of age have been controlled for in
studies, thus eliminating the influence of ``age'' in the equation, the
physical risk factors discussed here have been consistently shown to be
associated with the development of MSDs in exposed populations. This
means that, regardless of whether or not age plays a role in the
development of a particular MSD in a particular population, the
influence of physical risk factors is independent.
Gender Some studies have found a higher prevalence of some MSDs in
women (Bernard et al. 1994, Ex. 26-842; Hales et al. 1994, Ex. 26-131;
Johansson 1994, Ex. 26-1331; Chiang et al. 1993, Ex. 26-1117). A male-
to-female ratio of 1:3 was described for carpal tunnel syndrome (CTS)
in a population study in which occupation was not evaluated (Stevens et
al. 1988, Ex. 26-1009). However, in the Silverstein et al. (1985, Ex.
26-1173) study of CTS among industrial workers, no gender difference
could be seen after controlling for work exposure. Franklin et al.
(1991, Ex. 26-948) found no gender difference in workers' compensation
claims for CTS. Burt, Hornung, and Fine (1990, Ex. 26-698) found no
gender difference in reporting of neck or upper-extremity MSD symptoms
among newspaper employees using video display terminals (VDTs). Nathan
et al. (1988, Ex. 26-990; 1992, Ex. 26-988) found no gender differences
for CTS. In contrast, Hagberg and Wegman (1987, Ex. 26-32) reported
that neck and shoulder muscular pain is more common among females than
males, both in the general population and among industrial workers.
Whether the gender difference seen with some MSDs is due to
physiological differences or differences in exposure is unclear. One
laboratory study, Lindman et al. (1991, Ex. 26-976), found that women
have more type I muscle fibers in the trapezius muscle than men, and
have hypothesized that myofascial pain originates in these type I
muscle fibers. Ulin et al. (1993, Ex. 26-223) noted that significant
gender differences in work posture were related to stature and
concluded that the lack of workplace accommodation to the range of
workers' height and reach may, in part, account for the apparent gender
differences.
The fact that more women are employed in hand-intensive jobs and
industries may account for the greater number of reported work-related
MSDs among women. Bystrom et al. (1995, Ex. 26-897) reported that men
were more likely to have de Quervain's disease than women; they
attributed this to more frequent use of hand tools.
The reporting bias may exist because women may be more likely to
report pain and seek medical treatment than men (Armstrong et al.,
1993; Hales et al., 1994). Some studies have reported that workplace
risk factors account for increased prevalence of MSDs among women more
than personal factors (e.g., Armstrong et al. 1987, Ex. 26-1110;
McCormack et al. 1990, Ex. 26-1334). In a recent evaluation of Ontario
workers' compensation claims for repetitive strain injury (RSI), Asbury
et al. (1995, Ex. 26-250) reported a relative risk (RR) for female to
male claims ranging from 1.3 to 1.6 across industries. Within five
different broad occupational categories, females were approximately 2
to 5 times as likely to have a lost-time RSI claim. No information on
gender differences in hand-intensive jobs was reported. Many
researchers have noted that men and women tend to be employed in
different jobs.
Smoking. In the Viikari-Juntura et al. (1994, Ex. 26-873)
prospective study of machine operators, carpenters, and office workers,
current smoking (OR: 1.9; 95% CI: 1.0-3.5), was among the predictors
for change from ``no neck trouble'' to ``severe neck trouble.'' In a
study of Finnish adults aged 30 to 64 (Makela et al. 1991, Ex. 26-980),
neck pain was found to be significantly associated with current smoking
(OR: 1.3; 95% CI: 1.0-1.61) when the logistic model was adjusted for
age and gender. However, when the model included mental and physical
stress at work, obesity, and parity, then smoking (OR: 1.25; 95% CI:
0.99-1.57) was no longer statistically significant (Makela et al. 1991,
Ex. 26-980). With univariate analysis, Holmstrom (1992, Ex. 26-36)
found a prevalence rate ratio (PRR) of 1.2 (95% CI: 1.1-1.3) for neck/
shoulder trouble in ``current'' smokers vs. people who ``never''
smoked. But using multiple logistic regression, when age, individual,
and employment factors were in the model, only ``never smoked''
contributed significantly to neck/shoulder trouble.
While investigating reasons for higher compensation claims for CTS
in certain employee groups, Nathan et al. (1996, Ex. 26-882) evaluated
the effects of tobacco, caffeine, and alcohol on the prevalence of
median entrapment neuropathy at the wrist, CTS symptoms, and CTS
confirmed by nerve conduction studies among industrial workers
(nonclaimants and working patients referred for upper-extremity
symptoms) who volunteered for the study. Nathan et al. (1996, Ex. 26-
882) stated that greater use of tobacco combined with greater
consumption of caffeinated beverages and alcohol abuse was associated
with more median nerve slowing, more specific hand/wrist symptoms, and
more electrophysiologically confirmed CTS. However, the effects
explained only a small portion of the total risk.
Toomingas et al. (1991, Ex. 26-1019) found no associations between
multiple health outcomes (including tension neck syndrome, rotator cuff
tendinitis, CTS, or problems in the neck/scapula or shoulder/upper arm)
and nicotine habits among platers, assemblers, and white collar
workers. In a case/referent study, Wieslander et al. (1989, Ex. 26-
1027) found that smoking or using snuff was not related to CTS among
men operated on for CTS.
Several papers have presented evidence that a positive smoking
history is associated with low-back pain, sciatica, or intervertebral
herniated disc (Finkelstein 1995, Ex. 26-369; Frymoyer, Pope, and
Clements 1983, Ex. 26-950; Svensson et al. 1983, Ex. 26-1158; Kelsey et
al. 1984, Ex. 26-152); whereas other papers have found a negative
relationship (Kelsey, Golden, and Mundt 1990, Ex. 26-52; Riihimaki et
al. 1989, Ex. 26-997). Boshuizen et al. (1993, Ex. 26-81) found a
relationship between smoking and back pain only in those occupations
that required physical exertion. In their study, smoking was more
clearly related to pain in the extremities than to pain in the neck or
the back. Deyo and Bass (1989, Ex. 26-105) observed that the prevalence
of back pain increased with the number of pack-years of cigarette
smoking and with the heaviest smoking level. Heliovaara et al. (1991,
Ex. 26-959) only observed a relationship in men and women older than 50
years. Two studies did not find a relationship between sciatica and
smoking among concrete reinforcement workers and house painters
(Heliovaara et al. 1991, Ex. 26-959; Riihimaki et al. 1989, Ex. 26-
997).
Several explanations for the relationship with smoking have been
postulated. One hypothesis is that back pain is caused by coughing from
smoking. Coughing increases the abdominal pressure and intradiscal
pressure and puts strain on the spine. A
[[Page 68516]]
few studies have observed this relationship (Deyo and Bass 1989, Ex.
26-105; Frymoyer et al. 1980, Ex. 26-707; Troup et al. 1987, Ex. 26-
1307). The other mechanisms proposed include nicotine-induced
diminished blood flow to vulnerable tissues (Frymoyer, Pope, and
Clements 1983, Ex. 26-950), and smoking-induced diminished mineral
content of bone causing microfractures (Svensson et al. 1983, Ex. 26-
1158). Similar associations with diminished blood flow to vulnerable
tissues have been found between smoking and Raynaud's disease.
Strength. Some epidemiologic support exists for the relationship
between back injury and a mismatch of physical strength and job tasks.
Chaffin and Park (1973, Ex. 26-1115) found a sharp increase in back
injury rates in subjects performing jobs requiring strength that was
greater than or equal to their isometric strength-test values. The risk
was 3 times greater in the weaker subjects. In a second longitudinal
study, Chaffin et al. (1977, Ex. 26-1111) evaluated the risk of back
injuries and strength and found the risk to be 3 times greater in the
subjects without lower static strength. Keyserling, Herrin, and Chaffin
(1980, Ex. 26-970) strength-tested subjects, biomechanically analyzed
jobs, and assigned subjects to either stressed or non-stressed jobs.
Following medical records for a year, they found that job matching
based on strength criteria appeared to be beneficial. In another
prospective study, Troup, Martin, and Lloyd (1981, Ex. 26-1456) found
that reduced strength of back flexor muscles was a consistent predictor
of recurrent or persistent back pain, but this association was not
found for first-time occurrence of back pain.
Other studies have not found the same relationship with physical
strength. Two prospective studies of low-back pain reports (or claims)
of large populations of blue collar workers (Battie et al. 1989, Ex.
26-72; Leino, Aro, and Hasan 1987, Ex. 26-1142) failed to demonstrate
that stronger (defined by isometric lifting strength) workers are at
lower risk for low-back pain claims or episodes. One study followed
workers for 10 years after strength testing and the other followed
workers for a few years. Neither of these studies included precise
measurement of exposure level for each worker, so the authors could not
estimate the degree of mismatch between workers' strength and task
demands. Battie compared workers with back pain with other workers on
the same job (by isometric strength testing) and did not find that
workers with back pain were weaker. In two studies of nurses (Videman
et al. 1989, Ex. 26-1155; Mostardi et al. 1992, Ex. 26-986), lifting
strength was not a reliable predictor of back pain.
When examined together, these studies reveal the following: the
studies that found a significant relationship between strength and back
pain used more thorough job assessment analysis and focused on manual
lifting jobs. However, these studies only followed workers for periods
of 1 year, and whether this same relationship would hold over a much
longer working period remains unclear. The studies that did not find a
relationship, although they followed workers for longer periods of
time, did not include precise measurements of exposure level for each
worker, so they could not assess the strength capabilities that were
important in the jobs.
Anthropometry. Weight, height, body mass index (BMI) (a ratio of
weight to height squared), and obesity have all been identified in
studies as potential risk factors for certain MSDs, especially CTS and
lumbar disc herniation. Obesity seems to play a small but significant
role in the occurrence of CTS (see Section B.4.a). Anthropometric data
are conflicting, but in general indicate that there is no strong
correlation between stature, body weight, body build, and low-back
pain.
Few studies examining anthropometric risk factors in relationship
to CTS have been occupational epidemiologic studies; most have used
hospital-based populations that may differ substantially from working
populations. Nathan et al. (1988, Ex. 26-990; 1992, Ex. 26-989; 1994,
Ex. 26-517) have published several papers about a single industrial
population and have reported an association between CTS and obesity;
however, the methods employed in their studies have been questioned in
a number of subsequent publications (Gerr and Letz 1992, Ex. 26-384;
Mackinnon et al. 1997, Ex. 26-1309; Stock 1991, Ex. 26-1010; Werner et
al. 1994, Ex. 26-237). Several investigators have reported that their
industrial study subjects with CTS were shorter and heavier than the
general population (Cannon et al. 1981, Ex. 26-1212; Dieck and Kelsey
1985, Ex. 26-944; Falck and Aarnio 1983, Ex. 26-1122; Nathan et al.
1992, Ex. 26-989; Werner et al. 1994, Ex. 26-237; Wieslander et al.
1989, Ex. 26-1027).
Werner et al. (1994, Ex. 26-237) studied a clinical population
requiring electrodiagnostic evaluation of the right upper extremity,
patients classified as obese (BMI > 29) were 2.5 times more likely than
slender patients (BMI 20) to be diagnosed with CTS. These researchers
developed a multiple linear-regression CTS model (with the difference
between median and ulnar sensory latencies as the dependent variable).
The regression highlighted BMI as the most influential variable, but
still only accounted for 5% of the variance in the model. In Nathan's
(1994, Ex. 26-517) logistic model, BMI accounted for 8.6% of the total
risk; however, this analysis used both hands from each study subject as
separate observations, although they are not independent of each other.
Falck and Aarnio (1983, Ex. 26-1122) found no difference in BMI among
17 butchers with (53%) and without (47%) CTS. Vessey, Villard-
Mackintosh, and Yeates (1990, Ex. 26-229) found that the risk for CTS
among obese women was double that for slender women.
Nordstrom et al. (1997, Ex. 26-900), in a study of risk factors for
CTS in a general population, concluded that BMI is one factor that
seems to have a causal relation to CTS. These researchers found that
for each increase of one unit of BMI, about 6 pounds for the average-
sized adult, risk of CTS increases by 8%. Werner et al. (1997, Ex. 26-
718), in a study at five different worksites (four industrial, one
clerical), concluded that obesity (BMI > 29), industrial work, and age
were independent risk factors for median mononeuropathies. Their study,
which did not define specific work-related exposures, showed no
significant interaction between work activity and obesity. However, the
authors caution interpretation of the data and urge more investigation.
It has been suggested that relationship of CTS with BMI involves
increased fatty tissue within the carpal canal or increased hydrostatic
pressure throughout the carpal canal in obese persons compared with
slender persons (Werner 1994, Ex. 26-237).
Two other anthropometric risk factors, carpal tunnel size and wrist
size, have been suggested as risk factors for CTS; however, some
studies have linked both small and large canal areas to CTS (Bleecker
et al. 1985, Ex. 26-934; Winn and Habes 1990, Ex. 26-1029).
Schierhout et al. (1995, Ex. 26-403) found that short stature was
significantly associated with pain in the neck and shoulder but not in
the forearm, hand and wrist, or back, among workers in 11 factories.
Height was not a factor for neck, shoulder, or hand and wrist MSDs
among newspaper employees (Bernard et al. 1994, Ex. 26-842). Kvarnstrom
(1983, Ex. 26-1201) found no relationship between neck/shoulder MSDs
and body height in a
[[Page 68517]]
Swedish engineering company with more than 11,000 workers.
Examples exist where biomechanical or physical risk factors have
been labeled as individual factors. During the hearing for this
rulemaking, Dr. Niklas Krause mentioned two of these examples, the
first refers to people in the military who drive tanks, and found that
tall people have more back pain than short people. A very logical
explanation for the observation of increased back pain was provided by
Dr. Krause:
Well, if you have ever entered a tank, you know that it is not
constructed for very tall people. There is not much room in there.
[Tr. 1378]
And a second example, also provided by Dr. Krause:
And we have actually found in our bus drivers, too, and we
measured. We had their height and their weight. We found that an
ergonomic evaluation of the bus fleet showed that the buses that are
running in San Francisco were constructed for people--that is what
the ergonomics Professor Thompson from Sanford found out when he
looked at them--were constructed for people in the upper 10 percent
of the North American population.
You can imagine if you hire small people, Asians and women for
example, into that work force and put them on this bus that the fit
is bad. And actually, what we see is that over the years, the
percentage of small drivers drops on that work force rapidly.
When they enter, when people take the job, there is about 6
percent of drivers who are small, defined as * * * the lower half of
the population. * * * After one to five years, only 2.9 percent of
these small people are in the workforce. After six to ten years,
only 1.3 percent. And after eleven to fifteen years, only 0.4
percent. This is a statistically significant trend. And it clearly
shows you that people based on their smallness and misfit probably
had to leave the occupation. [Tr. 1378-1380]
When used to determine whether a correlation exists between
stature, body weight, body build and low back pain, anthropometric data
are conflicting, but in general indicate that there is no strong
correlation. Obesity seems to play a small but significant role in the
occurrence of CTS.
Genetics. Another type of factor that affects an individual's
capacity is genetic make-up. While the term ``genetic susceptibility''
is often heard; in reality both the amount of genetic information
involved in the response and the variability of possible responses are
vast and for the most part, not yet understood. The little bit of work
done in this area was done by Videman, and is covered in a brief
discussion in the section on the low back.
A worker's ability to respond to work factors may be modified by
his or her own capacity. The capacity to perform work varies with
gender and age, among workers, and for any individual over time. The
relationship between biomechanical risk factors, both inside and
outside the workplace, these individual as well as other factors and
the resulting risk of injury to the worker is complex, but not unique
to this OSHA standard.
For each of the ``individual factors'' discussed here, some studies
report observing an increased risk for MSDs, others do not. What they
have in common, is their ability to effect the capacity of individuals
independently from biomechanical risk factors. In other words, in those
studies where the effects of age, gender, smoking, etc. have been
controlled for, the physical risk factors discussed here have been
consistently shown to be associated with the development of MSDs in
exposed populations. This means that, regardless of whether or not age
plays a role in the development of a particular MSD in a particular
population, the influence of biomechanical risk factors is independent
from other associated factors. Furthermore, it has been demonstrated
repeatedly, that reducing these biomechanical factors in the workplace
results in reductions in the incidence of work-related MSDs.
The AFL/CIO found that the record provides some additional evidence
that individuals may vary in their susceptibility to developing certain
work-related MSDs, such as carpal tunnel syndrome, based on individual
factors including age, body weight and gender (Ex. 26-1, Ex. 26-37, Ex.
500-71-93). They also found that other evidence in the record indicates
that for back and neck pain or disorders, for example, no association
with age, gender, height or weight has been established (Ex. 500-71-24,
Tr. 1332).
The AFL/CIO point out that:
Obviously the underlying principle of ergonomics is to fit the
job to the worker, and so personal physical characteristics do come
into play when evaluating certain MSD risk factors. A worker who is
5'2" may have a much longer reach to an assembly line than her 6'0"
co-worker. But other than as relevant to evaluating exposure to
known risk factors, personal characteristics and differences in
susceptibility are irrelevant to this rulemaking. This regulation,
and all other OSHA standards, are designed to regulate risks that
are found in the workplace that may result in the development of an
adverse outcome (MSDs) in workers who are exposed to risk factors
which have been demonstrated to cause MSDs. The ergonomics
regulation is consistent with OSHA's responsibility to regulate
hazards which are present in the workplace. To shift the focus
toward personal characteristics, as some industry opponents have
argued, only clouds this issue by blaming the victims. [Ex. 500-218]
On this same subject, Dr. Frederick Gerr, Emory University (Tr.
1525-26):
Some will argue that personal factors, such as gender and body
weight, are the cause of these disorders among American workers,
rather than ergonomics hazards in the workplace. The fact that
personal characteristics can increase the risk for these disorders
in no way undermines the evidence that work has been clearly shown
to increase their risk as well.
The blame-the-victim approach to these disorders is both
scientifically and ethically bankrupt. Virtually all occupational
illnesses, including asthma, cancer, skin disease, peripheral and
central nervous system disorders, and many others, have causes that
extend outside of the workplace. This fact does not lessen the added
burden of disease that occupational exposures produce.
Non-Work Leisure Activities
The commenters (e.g., Exs. 30-2493, 31-324, 30-3368, 30-605, 30-
3783, Tr. 5073) also raise the issue of the relationship of ``non-
work'' to the development of MSDs. By this, OSHA assumes the reference
is to those activities such as nonoccupational VDT use, hobbies, second
jobs, and household activities, activities that may result in
additional exposure to biomechanical factors similar to that the
individual is experiencing at the workplace. If this assumption is
correct, then ``non-work'' may actually refer to exposure to the same
types of physical/biomechanical factors that may be additive to similar
workplace exposure.
And, while it is true that the physical/biomechanical risk factors
which increase the risk of MSDs at work can also be found outside of
work and may lead to MSDs (Ex. 500-71-93). However, according to Dr.
Nicholas Warren from the University of Connecticut (Tr. 1077-78):
It is very seldom the case that home risk factors are
encountered with the same intensity or the same duration as they are
encountered in the workplace.
On the same subject , the AFL/CIO (Ex. 500-218) notes:
Opponents of the standard, while arguing that there is no
evidence that physical factors at work cause MSDs, also
simultaneously argue that it is non-work leisure physical activities
which cause MSDs and that an OSHA standard cannot regulate adverse
health conditions and exposures to risk factors which are partially,
primarily or exclusively the result of non-work activities (Ex. 32-
241-4).
For most musculoskeletal disorder cases, ``workplace factors are
the predominant risk and it is upon these risks, obviously, that the
OSHA proposed rule focuses (Tr.1079). Other evidence in the record
confirms that there is little or no impact on the development of
MSDs related to the back from non-work
[[Page 68518]]
participation in sports, exercise, and leisure time physical
activity (Ex. 500-71-24, Ex. 500-71-32, Ex. 502-510).
The AFL/CIO also states:
Thus the record evidence suggests that the non-work exposures to
risk factors rarely, if ever, occur at the same frequency, duration
or magnitude as workplace exposures. Even where workers are exposed
to non-work risk factors off the job, it is important to point out
that this standard is designed only to decrease exposures to
biomechanic risk factors occurring at the workplace. An analogy may
be drawn to the risks of incurring hearing loss from excessive
exposure to noise. Exposure to noise at levels and durations which
can cause or contribute to noise-induced hearing loss can and do
occur both at the workplace as well as in non-work situations. While
these work and non-work exposures and risks of developing hearing
loss exist, OSHA's noise standard is confined exclusively to
addressing excessive noise exposures in the workplace. [Ex. 500-218]
And from Dr. Nicholas Warren, University of Connecticut (Tr.
1078-79):
When I work with an individual with, for instance, carpal tunnel
syndrome, carrying out forceful, repetitive tasks over most of a
nominal 40 hour work week and then often into another 10 hours of
voluntary overtime, it's painful to hear an insurer gleefully inform
me that this person bowls in a league on Saturday night. It is
equally painful to hear the worker blame him or herself by saying,
``That's probably because I knit,'' when, in fact, a clear objective
assessment of the workplace risk factors reveals that these are much
more important in the etiology of his or her disease.
OSHA concludes that, in general, each individual's capacity is
affected differently by many factors including some of those presented
here: age, gender, smoking, physical activity, strength, anthropometry,
genetic factors and activities outside the workplace. This is also true
in the more specific case of the development of work-related MSDs.
However, it is important to remember that exposure to biomechanical
factors in the workplace is independent of those factors that each
individual brings to the workplace, i.e., when the influence of
individual factors is controlled for in studies, effects due to
exposure to biomechanical factors are still observed . It is also true
that in the vast majority of cases, where exposure to biomechanical
exposures is high, the effects due to biomechanical exposures are far
greater than those associated with these types of individual factors.
5. Role of Psychosocial Factors in the Etiology of MSDs
The role of psychosocial factors in the etiology of MSDs was a
subject of much debate during the rulemaking. Many participants, in
particular the Chamber of Commerce (Ex. 500-188), Gibson, Dunn &
Crutcher (Exs. 32-241-4, 500-197), and several research and medical
scientists who testified on behalf of UPS (Exs. 32-241-3-2, 32-241-3-3,
32-241-3-5, 32-241-3-8, 32-241-3-12), criticized the proposed rule for
its failure to take into account the contribution of psychosocial risk
factors to MSD causation and exacerbation, believing that psychosocial
factors play a significantly greater role than do biomechanical risk
factors in the development of MSDs and the disabilities associated with
them.
Much of the scientific literature that addresses the etiology of
MSDs has examined aspects of the social and psychological environment
that may have a causal or moderating role in MSD development and
exacerbation. In this part of the Health Effects section, OSHA first
discusses what is meant in the literature by the term ``psychosocial
factors.'' Following this discussion, OSHA summarizes the expert
testimony of witnesses and rulemaking participants who have evaluated
the body of psychosocial literature as it relates to the work-related
risk of MSDs. Finally, OSHA presents its own literature review,
summarizing specific studies contained in the rulemaking docket that
have examined and compared the roles of biomechanical and psychosocial
factors in the etiology of MSDs, and summarizes several literature
reviews that have been published on this topic.
Definition of Psychosocial Factors
The study of psychosocial factors as it applies to the study of
work-related MSDs is surrounded by a measure of confusion because there
are several very different definitions of ``psychosocial'' used in
common and in technical parlance. Lack of clarity and consensus in
defining psychosocial factors was addressed by some researchers at the
public hearing (Tr. 867-868, 1306, 17443). There are three general
concepts of psychosocial factors that apply. Most researchers who have
examined the role of psychosocial factors in the etiology of MSDs have
emphasized the external aspects of the psychological and social work
environment that cause the worker to experience ``stress'', a condition
of chronic or prolonged arousal of the human ``flight or fight''
mechanisms that has been linked to a wide variety of negative health
outcomes, including MSDs. The primary aspects of the psychosocial work
environment include level of psychological job demands, level of worker
control over the job process, and level of social support received from
co-workers, supervisors and the organization. Some researchers focus on
additional conceptualizations of psychosocial exposures, including job
security, monotony, and job satisfaction (for example, Krause, 1998,
Ex. 38-242, Bigos, 1991b Ex. 26-1242). Psychosocial factors reflecting
these external aspects of the work environment have been the subject of
investigation in nearly all of the studies and literature reviews
discussed in this section.
As is the case with biomechanical risk factors, proposed exposure-
outcome relationships for psychosocial factors are multifactoral, i.e.,
several of these factors may be in play in any given situation, and may
combine and interact in complex ways that are difficult to study and
understand (Bongers et al., 1993, Ex. 26-1292, Bernard, 1997, Ex. 26-1
Warren et al., 2000a, b, Exs. 38-75, 38-73). It is unlikely that these
psychosocial workplace risk factors occur and act in isolation of
biomechanical risk factors (Tr. 868-869, 1264, 5942-5943, NIOSH 1997
(Ex. 26-1), NAS 1999 (Ex. 26-37)).
A growing body of literature also identifies aspects of
organizational structure, technology, policy, and culture as potential
contributors to occupational disease and characterizes them as
organizational risk factors (Shannon, et al., 1996, Ex. 26-1368, 1997,
Ex. 26-1369, Warren, 1997, Ex. 38-72, Warren et al., 2000a, Ex. 38-75).
Organizational risk factors are proposed as the underlying bases of
work design in the company; through their effect on work organization,
they determine levels of both psychosocial and biomechanical risk
factors experienced by employees. It is this common set of roots that
results in the strong co-variation of psychosocial and biomechanical
risk factors noted below. The second concept of psychosocial factors
that has been used in the literature relates to the internal
characteristics of the worker's psychological makeup that affect how
he/she appraises, processes and reacts to external biomechanical and
psychosocial factors, and thus moderates how these external factors are
experienced internally. There are studies demonstrating that individual
psychological factors can increase susceptibility to MSD development
and affect MSD recognition and reporting (Linton, 2000, Ex. 502-413,
NAS, 1999 Ex. 26-37). Emerging research sugg influence care-seeking and
disability than initial onset of disease (Linton, 1992, 2000, Ex. 502-
413 ests that internal psychological factors more strongly, Waddell &
Burton, 2000, Ex. DC-151-A). Some researchers and physicians combine
internal and external psychological factors in their
[[Page 68519]]
definition of psychosocial factors; for example, Dr. Raymond Bellamy,
an orthopedic surgeon testifying on behalf of UPS et al., included such
factors as dislike of job, recent poor performance evaluation,
depression and anxiety, hypochondriasis, and desire for narcotics in
his description of psychosocial factors (Ex. 32-241-3-3). Dr. Arthur
Barsky, also testifying on behalf of UPS et al., stated that
psychosocial factors (his use of the term conflates external factors
and internal psychological factors) ``exacerbate, perpetuate, and
maintain these [musculoskeletal] symptoms and amplify the disability
they engender'' (post-testimony comments, p.1, Ex. 500-118-1). Thus, it
is not always clear in the literature or in the testimony contained in
the record when the term ``psychosocial factors'' is being used to
refer to external psychological or social workplace factors, internal
psychological makeup of the worker, or both.
The third concept of psychosocial factors relates to aspects of the
legal, insurance and medical environment that influence a worker's
tendency to identify a particular constellation of symptoms as a
disease. At its most extreme, this definition is used to claim that
workers make up and fake disease, for ``secondary gain''. A broader
interpretation is the argument that these aspects of legal and medical
recognition and possible financial gain may subtly, even unconsciously
influence a worker's honest identification of symptoms as a disease and
predisposition to report it.
Although individual psychological factors or medical/legal factors
may affect MSD perception and reporting to a degree, it is unlikely
that they play a major causal role in the etiology of MSDs. This is
because the increased prevalence and incidence of MSDs seen among
workers who are highly exposed to biomechanical risk factors cannot be
adequately explained primarily by psychological factors given the
present state of the evidence. As the discussion in this Health Effects
section has demonstrated, the epidemiological, laboratory,
psychophysical, and intervention literature demonstrating quantifiable
links between biomechanical exposures and MSD outcomes is overwhelming.
Many studies have demonstrated substantial differences in MSD incidence
and prevalence between companies and industry sectors that correlate
strongly with the presence of physical risk factors (for example,
Franklin et al., 1991, Ex. 26-948, NAS, 1999, Ex. 26-37, see also the
Risk Assessment section (Section VI) of this preamble). Thus, it is
highly unlikely that an individual with psychological tendencies
towards negative reactions at work or tendencies to seek out care-
givers would preferentially select themselves into physically demanding
jobs. It is also impossible to imagine how prospects for secondary gain
would be differentially distributed into occupations or industry
sectors that involve highly physical work.
Consequently, this part of the Health Effects section focuses on
the large number of studies that have simultaneously examined the roles
of biomechanical risk factors along with psychosocial factors that
relate to external aspects of the psychological and social work
environment. These studies generally represent the most recent studies
of work-related MSDs in the literature.
Discussion of Testimony on the Psychosocial Literature
Based on these studies, the Chamber of Commerce (Ex. 500-188) and
Gibson, Dunn & Crutcher representing UPS, Anheuser-Busch, the National
Coalition on Ergonomics, and others (e.g., Exs. 32-231-4, 500-197,
32,435, 30-3346, Tr. 3655) were critical of OSHA emphasizing the role
of biomechanical risk factors over psychosocial factors in its
scientific literature review. For example, in their post-hearing brief,
Gibson, Dunn & Crutcher commented that
The science has shown that where psychosocial factors in
particular are considered, they generally overwhelm the weak and
inconsistent associations between biomechanical exposures and the
reporting of MSDs. Yet the * * * [A]gency dismissed the validity of
psychosocial factors in cavalier fashion * * * [Ex. 500-197, p. I-
33]
Similarly, the Chamber of Commerce stated that ``The Agency has
egregiously ignored each and every one of these indisputably relevant
factors * * *'' (Ex. 500-188), and explained the necessity for OSHA to
evaluate the role of psychosocial factors in the workplace:
* * * [D]etermining why individuals feel the need to report and/or
to seek medical care for such complaints is a complex problem
involving not only the physical exposures, but psychosocial factors
such as job satisfaction, ability to control the work environment,
interpersonal relationships at work, and the like * * * And, in the
vast majority of studies that have assessed whether biomechanical
workplace factors and psychosocial factors cause musculoskeletal
complaints, psychosocial factors are just as significant, or more
significant than, biomechanical factors. (Ex. 500-188, p. 41)
In addition, several research and medical scientists testifying on
behalf of UPS et al. stated in written or oral comment that the
scientific literature strongly supported that psychosocial factors play
a dominant role in the etiology of MSDs (Exs. 32-241-3-2,32-241-3-3,
32-241-3-5, 32-241-3-8, 32-241-3-12). For example,
Dr. Alf Nachemson concluded a review of the literature by stating
that
* * * [t]he research indicates that psychosocial factors are not
simply an overlay but rather an integral part of the pain disability
process that includes emotional, cognitive and behavioral aspects *
* * [T]here was strong evidence of the highest level that
psychosocial variables generally have more impact than biomedical or
biomechanical factors on pain disability.'' (Ex. 32-241-3-12, p. 13)
Dr. Norton Hadler stated in written comment that
Associations between disabling regional musculoskeletal symptoms
and psychosocial variables overwhelm and explain away any and all
associations with biomechanical exposures. (Ex.32-241-3-8, p. 18)
Taking a more moderate interpretation of the literature, Dr. Arthur
Barsky agreed that MSDs are not entirely a psychosocial problem;
however, he felt that ignoring them in designing intervention programs
can make the problem worse (Ex. 500-118-1, p. 1). At the public
hearing, he explained that
* * * [workers'] symptoms really are better understood as a social
communication, as a kind of non-verbal way of responding to
difficulties in the workplace--job dissatisfaction, role conflicts,
insecurity around the job, a whole variety of psychosocial work
conditions--and to hear these as a biomedical complaint is to
totally miss the point * * * What really concerns me, is * * * [that
complaints of MSD symptoms are] a kind of social communication * * *
a metaphor for life stress, for psychosocial distress * * * and the
response that too often is made to a symptom like that, is [an
inappropriate] referral to orthopedics. Tr. 17043-17044]
Dr. Barsky illustrated his point with an example of a widowed mother of
two worked two jobs and visited the emergency room of a hospital
complaining of tired feet [Tr. 17043-17044], and viewed the proposed
ergonomics standard as an inappropriate response to such an
``interpersonal communication'' (Tr. 17044).
Other scientists testifying on behalf of the UPS echoed the
conclusions reached by Dr. Nachemson in his literature review and Dr.
Bigos, who referred to
[[Page 68520]]
his groups Boeing study (Ex. 26-1241, 26-1242,26-1393) in contending
that low back pain (LBP) is primarily a psychosocial phenomenon (Exs.
32-241-3-2, 32-241-3-5). Other commenters also remarked on the
importance of psychosocial factors in the development of MSDs (e.g.,
Exs. 32-435, 30-3346, 30-3086, 30-536, 30-4046, 30-1070, Tr. 3655).
Many of OSHA's scientific witnesses disputed these interpretations
of the psychosocial literature, stating that the literature is not in
conflict with the causal relationship that has been demonstrated
between exposure to biomechanical risk factors and development of MSDs,
and that psychosocial factors had generally less of an influence than
biomechanical factors in these studies (Tr. 842, 874, 1087, 1206, 1364,
1537-1540). For example, Dr. Thomas Armstrong testified that
* * * [M]ore than a critical mass of epidemiological literature
shows that biomechanical factors are important predictors of the
occurrence of musculoskeletal disorders and the elevated risk of
harm.
In studies where we have included both psychosocial and physical
risk factors, the physical factors come out as the strongest
predictor. [Tr. 842]
Dr. Laura Punnett testified that ``* * * the impact of physical
exposures at work is beyond that explained by demographics, medical
history, psychosocial features of the work environment or other
factors'' (Tr. 874). Similarly, Dr. Nicholas Warren testified that in
studies that have measured both biomechanical and psychosocial factors
* * * we almost always find that both contributed. If you control
for psychosocial risk factors[,] which well-designed studies allow
you to do, you'll find a strong contribution from biomechanical risk
factors and that it generally, not in all workplaces, but in most
workplaces, is a larger effect than that of the psychosocial risk
factors. [Tr. 1087]
When asked whether he would agree with Gibson, Dunn & Crutcher's
statement in their pre-hearing submission that ``a majority of medical
experts who study the causes of MSDs believe most chronic workplace
pain is caused by psychosocial issues'' (Ex. 32-241-4, p. 36), both Dr.
Bradley Evanoff and Dr. Fred Gerr disagreed. Dr. Evanoff believed the
opposite was true, that ``the majority of people studying work-related
musculoskeletal disorders * * * feel that physical exposures are a very
strong risk factor'' Tr. 1358). Dr. Gerr stated that he was ``aware of
absolutely no basis in the medical or scientific literature that
[would] substantiate that statement'' (Tr. 1538). Both also strongly
disagreed (Tr. 1538-1539) with Dr. Hadler's statement in his written
testimony that psychosocial factors ``overwhelm and explain away any
and all associations with biomechanical factors'' (Ex.32-241-3-8, p.
18).
Several other researchers and medical scientists appearing at the
hearing on their own behalf disagreed with the UPS witnesses
assessments that psychosocial factors predominate in the etiology of
MSDs (Tr. 2838, 2840, 7857-7858, 9504, 9880). Dr. George Piligian of
the Mt. Sinai Center for Occupational and Environmental Medicine, when
asked whether it was appropriate for OSHA to emphasize the role of
biomechanical factors in its proposed rule given the evidence on
psychosocial factors, responded with an analogy:
* * * [Suppose] a person is thirsty and has come from the desert,
and if you have only half a glass of water to offer that person[.] *
* * Someone argued and said * * * I don't think we should give this
person that half a glass of water until it's full * * * I would
venture to say that the person who is thirsty would probably beg you
to give them that half a glass of water, then, go back and fill it *
* * .
We are doing what we can with the knowledge we have rather than
using the argument, which I find actually counterintuitive * * *
that we must have every single thing that we know of in place before
we proceed. [Tr. 7857-7859]
Some of OSHA's expert witnesses who are actively engaged in
research on work-related MSDs testified that an important finding from
the more recent literature is that biomechanical risk factors have been
shown to be associated with MSDs independently from psychosocial
factors (Tr. 1327-1328, 1331-1332, 1335, 1343, 1365, 1412). Dr. Niklas
Krause, in testifying on his own prospective study of public transit
operators and low back disorders (Ex. 500-87-2), stated that
The main result * * * is that both biomechanical and
psychosocial job factors were independently associated with spinal
disorders * * * [I]ndependent positive dose response relationships
were also found for ergonomic problems * * * I conclude from this
new high quality evidence [referring to the Loisel et al.(Ex. 38-28)
randomized trial study] and the literature that has been already
collated by OSHA [in its preamble to the proposed rule and Health
Effects Appendices (Ex. 27-1) that high-quality epidemiological
studies confirm that physical work place factors cause MSDs
independently from individual worker characteristics and
psychosocial job factors * * * [Tr. 1331-1335].
Dr. John Frank testified that the Kerr et al. case-control study (Ex.
38-82) in which he participated also found an association between MSDs
and exposure to biomechanical risk factors independent from
psychosocial factors. When asked about the significance of that
finding, Dr. Frank responded
The importance particularly for the proposed standard or any
public health efforts to reduce biomechanical hazards at work is
that[,] * * * acting on biomechanical risk factors will bring risk
reductions according to our understanding of the multifactorial
causal process even if we are unable * * * at the present time to
conclusively act to reduce psychosocial factors * * * [Tr. 1365-
1366]
Dr. Frank also drew a parallel with successful efforts to control
cholesterol blood levels to reduce heart disease incidence, despite
``two dozen or more'' other risk factors that contribute to heart
disease because high cholesterol levels are independently associated
with an increased risk of heart disease (Tr. 1365-1366).
In the preamble to the proposed rule, OSHA's focus on
identification and control of biomechanical risk factors in the
workplace was based on two considerations. First, OSHA preliminarily
concluded that there was substantial evidence of a clearly demonstrated
causal relationship between exposure to physical risk factors and MSD
outcomes (64 FR 65926), and that most researchers who studied the
etiology of MSDs placed emphasis on biomechanical risk factors. Second,
research into role of psychosocial risk factors in the etiology of MSDs
was considered to be a less mature field than that addressing the role
of biomechanical risk factors, characterized by emerging methodology,
as pointed out by Dr. Martin Cherniak at the hearing (Tr. 1307), and
sometimes by inconsistent results. Thus, most interventions designed to
address work-related MSDs focused on biomechanical, rather than
psychosocial factors.
The 1997 NIOSH review (Ex. 26-1) on which OSHA relied heavily,
examined psychosocial risk factors that might contribute directly and
indirectly to musculoskeletal illness and injury. The review noted that
the results from the literature were not entirely consistent, and that
a lack of consensus on standard measurements and procedures might be
one reason for lack of consistency. Perceptions of intensified
workload, monotonous work, low job control, low job clarity, and low
social support were associated with MSDs in some studies. NIOSH found
that these associations, despite the variance in methods used to assess
these factors, were significant in the better studies; however, the
size of
[[Page 68521]]
effect was relatively weak compared to that of the biomechanical
variables.
In his testimony, Dr. Frank (Tr. 1343-1345, 1397-1398) discussed
the reasons for this inconsistency, relating it to the field being in
the embryonic stage of understanding psychosocial effects, and to
imperfect measurement instruments. He pointed out that the Institute
for Work and Health study discussed below (Kerr et al., 2000, Ex. 38-
82) did not confirm findings of Bigos et al. (1991a, b, Exs. 26-1241,
26-1242, 1992, Ex. 26-1393) or Krause (1998, Ex. 500-87-2) that low job
satisfaction contributed to risk. In contrast, Dr. Frank (Tr. 1344)
noted that, in newer studies that simultaneously assessed the effect of
physical and psychosocial factors, biomechanical loads make a
consistent and generally stronger contribution to MSD outcomes.
Although psychosocial exposure assessment has grown rapidly in the
last decade and is characterized by continually improving
methodological developments, it is still a relatively young field.
Measurement methodologies are not well standardized; this was addressed
by Dr. Barbera Silverstein, who testified that there was no consensus
on the kinds of psychosocial issues that should be studied or how they
could be assessed ``with the same rigor that has been * * * looked at
[for] physical load factors'' (Tr. 17444).
In addition, less is known about the causal relationship between
psychosocial factors and MSDs. Many studies performed so far have been
cross sectional, thus making it difficult to evaluate the temporal
nature of the association (i.e., whether psychosocial factors preceded
the MSD or whether the presence of a disorder led to negative
psychosocial outcomes). Dr. Punnett addressed this issue in her
testimony:
* * * [S]ince psychosocial factors may be perceived and reported
differently by the worker after the development of musculoskeletal
disorders, the reported associations are particularly difficult to
interpret with respect to * * * [etiology].
The occurrence of a work-related musculoskeletal disorder * * *
may itself cause psychosocial strain. And that strain may also
subsequently slow or interfere with the recovery process without
necessarily having been involved in the initial etiology. In this
context, we should note that associations with cross-sectional * * *
[studies] with physical exposures are far less ambiguous. [Tr. 869-
870]
As a result, associations found between psychosocial exposures and
MSD outcomes are, relative to biomechanical associations, less
consistent and generally weaker (NAS, 1999, Ex. 26-37). Further, the
underlying mechanisms are still not nearly as well understood as those
developed for biomechanical associations (Tr. 1344-1345, NAS, 1999, Ex.
26-37). Similarly, understanding and evaluating psychosocial
interventions is also in its infancy, making it difficult to design
appropriate interventions.
None of the studies cited by either proponents or opponents of an
ergonomics standard can demonstrate that any of the risk factors
measured, whether biomechanical, psychosocial, personal, or
demographic, can completely explain an increased prevalence or
incidence of MSD outcomes. (In other words, the combined contribution
of all factors to statistical models never comes close to explaining
100 percent of the variance between exposure groups in the outcome
measure; there are always other, unmeasured factors involved.) Dr.
Tapio Videman (Ex. 32-241-3-20), Dr. Arthur Barsky (Ex. 500-118-1) and
most other researchers agreed that a simple biomechanical model of
tissue wear and tear is not sufficient by itself to explain disease
development in humans, which is characterized by complicated
interactions with external environmental factors and individual
characteristics. In fact, testimony at the hearing (Tr. 868, 1264,
5942-5943) made it clear that considering psychosocial and
biomechanical factors to be separate kinds of exposures is a somewhat
artificial distinction in that the two classes of stressors are
strongly linked, both resulting from core aspects of the organization:
its technology, culture and work organization.
For example, Dr. Punnett testified that
There is also a recognized overlap between some characteristics
of physical and psychosocial work environment.
A repetitive, monotonous job on a machine paced assembly line
can be described equally well by the ergonomist as consisting of
stereotyped repetitive motion patterns with rigid pacing and few
rest breaks or as having poor psychological job content with few
opportunities to make decisions, work collaboratively with co-
workers, utilize existing skills or learn new ones.
And I suggest that the worker performing that job would be hard
pressed to make a distinction between the physical and the
psychosocial characteristics of that job. [Tr. 868-869]
Ms. Sue Rahula, an ergonomist technician with United Auto Workers,
described how biomechanical exposure and the presence of an MSD can
affect worker morale, which can be reflected in negative psychosocial
outcomes:
When you're feeling pain your morale is going to be low, your
discomfort level is low, your attitude is bad, and you may be one of
the silent sufferers. * * * When * * * we take our risk factor
checklist out and we verify that, yes, these postures are awkward
postures and when you add that along with the forces and the
exertions that you're using that that's a possibility it sure could
cause pain. It's no wonder the morale becomes low. And they
[biomechanical and psychosocial factors] do intertwine. But the pain
is usually the cause of [low morale], in my opinion, from what I
see. [Tr. 5942-5943]
These underlying sources of biomechanical and psychosocial exposures
can themselves be seen as a single exposure category known as
organizational exposure (Warren, 1997, Ex. 38-72, Warren et al., 2000a,
b, Exs. 38-75, 38-73, Shannon et al., 1996, 1997, Exs. 26-1368, 26-
1369), which, as Dr. Warren described, recognizes that ``the way work
is organized will have an effect on the levels of both biomechanical
and psychosocial work stresses'' (Tr. 1264).
Summary of Primary Literature on Biomechanical and Psychosocial Factors
OSHA's review of the literature presented below shows that most of
the best studies available suggest that MSDs are the result of a
complicated combination of biomechanical and psychosocial factors, with
the prevalence or incidence of MSDs being generally more strongly
associated with biomechanical risk factors. Given the present state of
research into MSD etiology, there can be little doubt that a
multifactoral model, incorporating both biomechanical and psychosocial
risk factors, would best explain the differences in MSD prevalence or
incidence seen among various groups of workers. Nevertheless, from the
testimony presented above and the review of the literature that
follows, OSHA concludes that biomechanical risk factors contribute
independently from psychosocial factors to MSD etiology, that the
association between the risk of MSDs and exposure to biomechanical risk
factors has been observed to be generally stronger than for
psychosocial factors, and that, consequently, it is reasonable to
design interventions that focus on exposures to biomechanical risk
factors to reduce the risk of MSDs in exposed workers.
Because the scientific literature summarized in this section
addresses the relative strength of association between MSD risk and two
broad categories of workplace factors, and because of the potential for
interacting or modifying effects between biomechanical and psychosocial
factors,
[[Page 68522]]
it becomes particularly important to consider certain elements of
epidemiological study design to ensure that study results are
appropriately interpreted. These design considerations include the
following:
Best study design. Epidemiological studies can be of three general
designs: cross-sectional, case-control, and prospective (longitudinal)
cohort. Dr. Stanley Bigos presented a comprehensive review of the
advantages and disadvantages of each study design (Ex. 32-241-3-4, pps.
7-9). OSHA also addressed general issues regarding study design and
causal inference in a previous part of this Health Effects section. All
researchers agree that prospective studies can most persuasively
establish causality, with cross-sectional studies presenting the most
potential problems in this area. In the absence of any other
information, prospective studies are generally preferable. However,
several factors may recommend against this design: in particular, the
high cost of these studies and the dynamic nature of the modern
workplace, which may change job classifications (and hence workers'
exposures) over the follow-up period of the study.
Although cross-sectional studies identify associations and cannot
by themselves permit a definite attribution of a causal relationship,
it is still possible to draw inferences when one causal direction
(i.e., exposure precedes disease) is much more plausible than the
alternative explanation (i.e., disease precedes exposure). As Dr. Gerr
noted in his testimony (Tr. 1525) the many cross-sectional studies
showing an association between carpal tunnel syndrome and physical
workplace factors strongly indicate that exposure to these workplace
factors causes disease. This conclusion arises in part because it is
illogical to postulate that the presence of CTS would cause exposure to
physical factors (i.e., workers select themselves into physically
harmful jobs on the basis of disease status). Dr Gerr testified that
this would be ``like saying cancer causes smoking. It's as wrong as it
is silly to hear'' (Tr. 1525). However, for psychosocial factors such
as poor job satisfaction or low supervisory support, it is more
difficult to logically infer or exclude a temporal relationship between
a psychosocial factor and an MSD; this was described by Dr. Punnett in
her testimony (Tr. 869). That is, it cannot be known whether having
poor job satisfaction preceded development of the MSD or whether the
presence of the MSD is causing a worker to become less satisfied with
their job. Thus, in evaluating the causal nature of psychosocial
factors, the use of a prospective study design that follows groups of
workers over time becomes particularly important to evaluate the
temporal relationships between exposure to biomechanical risk factors,
psychosocial factors, development of MSDs.
In addition, as was the case with the biomechanical literature
reviewed in earlier parts of the Health Effects section, determination
of exposure and health outcome by objective means, such as direct
observation or measurement of exposure and medical assessment of health
status, is preferable over sole reliance on worker self-reports because
objective measures rule out the possibility of reporting bias (e.g.,
the possibility that a worker's disease status might influence the
self-report of exposure). This design consideration points to another
difficulty in studying the role of psychosocial factors in that they
can only be assessed by administering questionnaires or interviews.
Simultaneous assessment. It is obvious that to accurately assess
the relative contribution of biomechanical and psychosocial risk
factors to MSD causation and exacerbation, both classes of exposure
must be measured.
Address collinearity. Levels of both biomechanical and psychosocial
risk factors are in large part the result of the way work is organized,
the technology and sector of the company, and the organizational
policies and culture that drive work organization. Thus the two classes
of stressor are generally highly correlated in a workplace (Tr. 868-
869, 1264, 5942-5943). Concurrent analysis of exposure-outcome
associations must be very careful to avoid modeling problems that arise
from collinearity.
Assess both stressor categories with equal precision. Some studies
assess both categories of exposure, but assess one with more precision
or detail than the other. The category characterized in more detail
presents fewer opportunities for non-differential exposure
misclassification (which biases results towards a lower effect) and
will thus show artificially elevated relative associations with
outcome. Dr. Wells stated that a factor measured with poor precision in
an epidemiological study will often not appear as a risk factor in
statistical modeling (Tr. 1355).
Ensure adequate variance in all measures. Studies that assess both
categories of exposure, but with little variance between exposure
groups in one or the other category of exposure will generally not find
effects associated with that category or measure. Regression analysis
(a standard modeling method in many studies) cannot assess the
contribution of an exposure if its magnitude or intensity is
essentially the same in all study participants.
Assess both stressor categories at the same individual or group
level. Studies that assess both categories of exposure, but at
different levels of analysis (i.e., the level of the individual worker
versus groups of workers), will generally not find an effect for the
variables measured at a higher (group) level of aggregation; this was
addressed by Dr. Frank in his testimony (Tr. 1364-1365). For example,
the Boeing study (Bigos, et al., 1991a, b, Exs. 26-1241, 26-1242, 1992
Ex. 26-1393) assessed psychological and emotional variables at the
individual level and biomechanical variables at the group level. This
error also reflects violation of the preceding two criteria since
measurement at the group level reduces both precision in the
biomechanical exposure measure (compared to measuring exposure at the
individual level) and variance in biomechanical exposure between
groups. When one variable is aggregated or represented at the group
level, as in the Bigos measurement of biomechanical risk, the
variations in exposure within each group are lost; internal variance
within each group is reduced to zero.
The studies summarized below relied on assessment of both
biomechanical and psychosocial factors in the workplace. Thus, in
accordance with the second criteria described above, studies were
excluded if they did not assess one class of stressor or did not
include both classes in multivariate analysis. Such studies are useless
for the exploration of combined biomechanical and psychosocial effects.
The majority of the studies below demonstrate at least equal, and
often stronger, associations with biomechanical stressors than with
psychosocial. This fact, combined with the independent effects of both
stressor classes, as discussed above, is sufficient to support OSHA's
focus on biomechanical risk factors in the final rule. However,
relative magnitude of the associations for biomechanical and
psychosocial risk factors should only be seen as a qualitative
indicator of relative strength of association with MSD prevalence or
incidence. Actual quantitative effect sizes may not be comparable
within or between studies for a number of reasons, including:
Use of different measurement scales;
Use of different analytical strategies to categorize risk
levels; and
[[Page 68523]]
Use of different outcome measures in different studies.
Table V-14. summarizes the key features of the design of each study
as well as the range of measures of association for biomechanical and
psychosocial factors.
Wickstrom & Pentti 1998 (Ex. 500-121-77). This 2-year prospective
study of 117 white-collar and 189 blue-collar workers in two metal
industry facilities assessed both biomechanical and psychosocial
exposures (4 items each) at baseline, using equivalent levels of
detail. Back pain was assessed twice in the follow-up period by
questionnaire, and data on sick leave attributed to back pain and other
MSDs (doctor diagnosis if over 3 days) was obtained from company
records. The exposure assessment at baseline plus physician diagnosis
at follow-up made this design capable of strongly implying causal
status to both physical and psychosocial risk factors. As predictors of
self-reported LBP, 3 physical exposures were predictive for both white
collar (RRs: 2.82-6.19) and blue-collar workers (RRs: 2.49-3.67). Since
other authors (Marras, 2000, Ex. 500-121-46) have hypothesized that
psychosocial exposures have less effect if the physical load is high,
it is interesting that psychosocial stress was predictive of LBP in
white-collar workers, while none of the 4 psychosocial exposures were
significantly predictive in blue-collar workers. However, sick leave
was predicted for blue-collar workers by both biomechanical exposures
(RRs: 1.72-2.04) and psychosocial (RRs 1.58-1.99). In general, this
study supports the interpretation that MSDs are caused by both classes
of risk factor, with biomechanical showing stronger effects.
Table V-14.--Studies Assessing Both Biomechanical and Physical Risk Factors
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Results: outcome and
Reference subjects Study type Exposure measure Outcome measure Study design effect
--------------------------------------------------------------------------------------------------------------------------------------------------------
Association with Biomechanical Factors Stronger than with Psychosocial Factors (or effect size not reported)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wickstrom & Pentti (1998).......... 306 3 1.................. 1, 2, 3............ all LBP & sick leave due to
LBP; Physical RR: 1.97-
6.19; Psychosocial RR:
1.58-1.59.
Bergqvist et al.(1995)............. 260 1 2.................. 3.................. all UE/LBP sympt./MD diag.;
Physical OR: 3.1-7.4;
Psychosocial OR: 2.1-7.4.
Kerr et al.(2000).................. 381 2 3.................. 1.................. all Reporting of LBP; Physical
OR: 1.7-3.0; Psychosocial
OR: 1.6-2.6.
Koehoorn et al.(1999).............. 4020 3 2.................. 2.................. a, c MSD symptoms & claims;
Physical RR: 1.41-4.65;
Psychosocial RR: 0.45-
2.78.
Krause et al.(1998)................ 1449 3 1, 2............... 2.................. b, c Spinal injury through WC;
Physical OR: 3.04
(driving cable car); 0.37
(part-time driving: 20-30
hrs); Psychosocial OR:
1.50-1.56.
Latko et al.(1997, 1999)........... 352 1 2.................. 1, 3............... all Symptoms, MD Dx of CTS;
Physical OR (high
repetition vs. low rep.):
2.32-3.23; Psychosocial
OR: n.s.
Latza et al.(2000)................. 230 3 1.................. 1.................. all Self-reported LBP;
Physical PR: 1.8-4.0;
Psychosocial PR: n.s.
Leclerc et al.(1998)............... 1210 1 1.................. 3.................. all CTS by signs or NCV;
Physical OR: 1.90-2.24;
Psychosocial OR: 1.59-
2.24.
Linton (1990)...................... 22,180 3 1.................. 1.................. all Neck & LBP symptoms
Univariate ORs; Physical:
0.86-2.95; Psychosocial:
1.15-2.60; Combined ORs:
2.42-3.65.
Ono et al.(1998)................... 575 1 1.................. 3.................. all Epicondylitis, MD Dx;
Physical OR: 1.7;
Psychosocial OR: 1.2.
Videman et al.(1989)............... 199 3 2.................. 1.................. b, c Incidence of back injury;
Low skill OR: 37-156 (if
also 3 hrs. strenuous
working postures)
Bernard et al.(1992, 1994)......... 973 1 1, 2............... 1.................. all UE symptoms; Physical OR:
1.4-2.5; Psychosocial OR:
1.4-1.7.
Faucett & Rempell (1994)........... 150 1 2.................. 1.................. all UE symptom severity,
(effect measured by R \2\
change): Physical: 0.11-
0.15; Psychosocial: 0.03-
.12.
Heliovaara (1987).................. * 592 3 1 (occ.)........... 3.................. none Hospital Admission for
disc herniation/sciatica;
Occupational RR: 2.2-3.0;
Psychic Distress: NR.
Josephson & Vangard, 1998.......... 269 2 1.................. 1.................. all LBP medical visit;
Physical OR: 2.3-8.7;
Psychosocial OR: n.s.
Svensson & Andersson (1981)........ 940 ** 1 1.................. 2.................. all LBP sickness absence;
Heavy Lifting (effect
NR); Reduced overtime/
monotonous work (effect
NR).
Thorbjornsson et al.(2000)......... 484 2 1.................. 1.................. all LBP med. visit or absence;
Physical OR: 1.7-2.2;
Psychosocial OR: n.s.;
Interaction OR: 3.1-3.7.
Vingard et al.(2000)............... 2118 3 1.................. 1.................. a, b Care-seeking for LBP;
Physical RR: 1.8-2.9;
Psychosocial RR: 1.5-1.6.
Warren et al.(2000a)............... 845 2 1.................. 1.................. all NIOSH MSD case def.;
Physical OR: 1.89-2.13;
Psychosocial OR: 1.56-
1.69.
Waters et al.(1999)................ 284 1 1, 2............... 1.................. all Prevalence of LBP; Lifting
Index OR: 1.04-2.20;
Satisfaction OR: 4.57-
7.65.
Burt et al.(1990).................. 834 1 1.................. 1.................. all UE Symptoms; Physical OR:
2.0-4.1; Dissatisfaction
OR: 1.9-2.3.
[[Page 68524]]
Lemasters et al.(1998)............. 522 1 1.................. 3.................. c Pain, all body parts, self-
report and MD Dx;
Physical OR: 2.3-3.5;
Psychosocial OR: 1.6-2.9.
Scov et al.(1996).................. 1306 1 1.................. 1.................. all UE and low back symptoms;
Physical OR: 1.64-2.80;
Psychosocial OR: 1.43-
2.04.
Warren et al.(2000b)............... 7712 1 1.................. 1.................. all MSD symptoms & pain;
Physical : 0.06-
0.16; Psychosocial : 0.04-0.12.
Hales et al.(1992, 1994)........... 533 1 1.................. 1.................. a, b UE MSD symptoms; Physical
OR: 1.1-3.8; Psychosocial
OR: 1.1-3.5.
Hoekstra et al.(1994).............. 108 1 1.................. 1.................. a, b MSD symptoms; Physical OR:
3.5-5.1; High Control: OR
0.6.
Houtman et al.(1994)............... 5865 1 1.................. 1.................. b, c Complaints: muscle/joint &
back; chronic back
problems; Physical OR:
1.36-1.62; Psychosocial
OR: 1.20-1.35.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Association with Psychosocial Factors Stronger than with Biomechanical
--------------------------------------------------------------------------------------------------------------------------------------------------------
Viikari-Juntura & Riihimaki (2000). 5179 3 1.................. 1.................. all Radiating neck pain;
Physical OR: 1.2-2.3;
Psychosocial OR: 1.1-6.1.
Waters et al.(1999)................ 284 1 1, 2............... 1.................. all Prevalence of LBP; Lifting
Index OR: 1.04-2.20;
Satisfaction OR: 4.57-
7.65.
Elberg et al.(1995)................ 637 1 1.................. 1.................. all Neck & shoulder symptoms;
Physical OR: 1.2;
Psychosocial OR: 1.2-1.3.
Sauter (1984)...................... 333 1 1.................. 1.................. all Somatic complaints;
Physical : 0.16-
0.21; Psychosocial : 0.19-0.26.
Warren et al.(submitted)........... 7712 1 1.................. 1.................. all LBP, absenteeism; Physical
OR: 1.45-1.88;
Psychosocial OR: 1.32-
2.27.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Biomechanical Effect Not Significant
--------------------------------------------------------------------------------------------------------------------------------------------------------
Leino & Hanninen (1995)............ 902 3 1.................. 1, 3............... b, c Back/limb symp. & MD Dx;
Physical : n.s.;
Psychosocial :
.110-.146.
Bigos et al.(1991a)................ 3020 3 1, 2............... 2.................. none Reporting back injury;
Physical RR: n.s.;
Psychosocial RR: 1.34-
1.70.
Svensson & Andersson (1989)........ 1746 1 1.................. 1.................. all Low back pain; Physical
n.s.; effect NR; Fatigue,
dissatisfaction, worry;
sig., but effect NR.
--------------------------------------------------------------------------------------------------------------------------------------------------------
n.s.: not significant
NR: controlled for factor, but effect not reported
Table only notes statistically significant effects (p0.05)
Key:
Study Type:
1--Cross sectional
2--Case-control/Referent
3--Cohort/Prospective
Exposure Measure:
1--Worker self-report
2--Observation of job
3--Instrumentation
Outcome Measure:
1--Worker self-report
2--Observation/record
3--Clinical findings
Study Design
a--Biomechanical and psychosocial factors studies with equal precision
b--Biomechanical and psychosocial factors assessed at same individual or group level
c--Adequate variance between groups in all measures
* case 2140 con.
** retro. outcome
Bergqvist, Wolgast, Nilsson, Voss 1995 (Ex. 26-1195). hese
investigators found a number of upper extremity diagnoses to be
consistently associated with standard biomechanical risk factors
(especially postural stressors, ORs 2.2-4.4, and lack of rest breaks,
ORs 2.7-7.4); some personal factors (especially age and presence of
children at home), task flexibility (OR 3.2) and quality of peer
contacts (ORs 2.1-4.5) had independent associations. Although the study
was cross-sectional, confidence in study findings is improved by the
detailed physical examination used to determine outcome and the broad
array of exposure measures (including individual factors, non-work
risks, work organizational factors and biomechanical factors). Muscle
problems in each body location showed a different pattern of personal,
psychosocial and biomechanical stressor associations.
Faucett and Rempel 1994 (Ex. 38-67). his study of 150 newspaper
editorial work found that upper extremity pain and numbness symptoms in
VDT workers were related primarily to postural variables (R2
changes 0.11-
[[Page 68525]]
0.15), with smaller additions to model R2s from
psychological demands, decision latitude, and employee relationship
with the supervisor (R2 changes 0.03-0.12). The effects of
postural variables on upper torso pain and stiffness were greater than
those for pain and numbness (R2 changes 0.19-0.32), while
psychosocial effects were reduced (R2 changes 0.01-0.08).
Interaction terms between keyboard height and psychosocial variables
added to the model R2s (R2 changes 0.04-0.15),
suggesting that the effect of biomechanical variables can be modified
by psychosocial variables. In this study, biomechanical stressors were
clearly the dominant factor, but the size of the effect for interaction
terms may have meaning for the mechanism of psychosocial action as
being an effect modifier.
NIOSH Health Hazard Evaluations (Exs. 26-439, 26-842, 26-725).
Three cross-sectional NIOSH studies, at the L.A. Times (Bernard,
Sauter, Petersen, Fine, & Hales, 1992, Ex. 500-165-20, 1994, Ex. 26-
439), Newsday (Burt, et al., 1990, Ex. 26-842) and two Social Security
Administration teleservice centers (Hoekstra et al., 1994, Ex. 26-725)
found associations of biomechanical risk factors (in particular,
duration of VDU work) with MSD symptoms, while also finding independent
associations of these symptoms with several psychosocial factors.
Another NIOSH HHE at U.S. West Communications (Hales et al. 1992 (Ex.
26-727), 1994 (Ex. 26-131) did not find associations between symptoms
and physical workplace characteristics other than use of bifocal
glasses (OR 3.8), because the standardized workstations presented
virtually no variance in biomechanical measures. Thus, psychosocial
factors were dominant in the models, although work pressure (OR 1.1-
1.2), workload surges (OR 1.2) and information processing demands (OR
1.2) probably represent a combination of physical and psychosocial
exposures. See Table V-14. for strength of association estimated by
multivariate logistic regression models in all these studies.
Kerr, et al.2000 (Ex. 38-82). Researchers at the Institute of Work
and Health (IWH) have carried out several well-designed studies
measuring both biomechanical and psychosocial stressor levels in
detail. These studies demonstrate the independent contributions of
biomechanical, psychosocial and organizational factors to models
explaining back injury and accidents (Shannon et al., 1996, 1997, Exs.
26-1368, 26-1369). The most recent IWH study (Kerr, et al., 2000, Ex.
38-82), performed in concert with the Ontario Universities Back Pain
Study (OUBPS) group, is a case-control study reviewed in detail by John
Frank (Ex. 37-27). Subjects reported levels of physical demands
(including perceived exertion) as well as psychosocial factors. In
addition, videotape analysis and biomechanical modeling provided
quantifiable estimates of actual spinal loading. These biomechanical
measures acted independently to substantially increase risk of workers
reporting new cases of LBP, after controlling for individual and
psychosocial factors. In final models, the biomechanical risk factors
demonstrated ORs of 1.7-3.0, while psychosocial risks were associated
with ORs of 1.6-2.6. This study improved on earlier study designs by
directly measuring forces on back during job performance. The case-
control study also matched controls by actual job, allowing analysis of
the degree to which job exposures influenced self-reported LBP.
Compression, peak shear force, peak hand force were associated with
doubled risk of LBP reporting. These findings are consistent with much
of the other epidemiological data reviewed in this section. Thus this
study strengthens confidence in the results of other studies that rely
on less detailed exposure assessment and/or self-reported exposures and
outcomes.
Krause et al.1997 (Ex. 38-267), 1997 (Ex. 38-266), 1998 (Ex. 500-
87-2). Niklas Krause and colleagues, studying a cohort of San Francisco
drivers, examined relationships between biomechanical and psychosocial
exposures and neck and shoulder outcomes. The cross-sectional analyses
(Krause et al., 1997a, Ex. 38-267, 1997b Ex. 38-266) determined that
both biomechanical and psychosocial job factors were separately and
simultaneously associated with non-disabling neck and back pain. The 5-
year longitudinal follow-up of this cohort (Krause et al., 1998, Ex.
500-87-2) found that workers' compensation cases of spinal injury were
predicted by a combination of biomechanical (measured by hours driving)
and psychosocial risk factors at baseline. (See Krause testimony, Ex.
37-15). The physical risk factors addressed by this measure of hours
spent driving included prolonged sitting, twisting/bending, vibration,
and use of foot pedal (Krause testimony, Tr. 1376, Ex. 37-15). Although
all measures were gathered at the same (individual) level, the
surrogate measure for biomechanical exposure (hours spent driving) was
a more generalized measure than the psychosocial data and thus subject
to greater non-differential misclassification and consequent dilution
of effect in statistical modeling. Psychosocial stressors demonstrated,
on average, higher ORs than the surrogate physical measure of hours
spent driving. This is an example of the fourth study design criterion
discussed above: the factor measured in greater detail has a greater
likelihood of showing stronger associations in the modeling. The fact
that a biomechanical effect still emerged in the modeling strongly
suggests that if physical exposures were measured in the same detail as
psychosocial exposures, they would have demonstrated a larger effect in
modeling; however, it cannot be known whether the resulting size of the
effect for biomechanical factors would have surpassed that for
psychosocial factors. For cable car operators, biomechanical factors
were more strongly associated with back cases than were psychosocial
factors.
In his written comments, Dr. Nortin Hadler (Ex. 32-241-3-8)
demonstrated a basic misunderstanding of the research by taking the
Krause studies to task for showing a biomechanical effect only for
cable car drivers. The data did show that only cable car drivers'
injury rate was significantly elevated when compared to diesel bus
drivers. However, the pooled data for all drivers showed a highly
significant increase (2.7 times) in injury rate between drivers who
worked 20-30 hrs per week compared to those who worked 31-40,
suggesting a significant effect related to biomechanical factors.
Hours-per-week-driven was the study's surrogate measure for exposure to
physical risk factors.
Latko et al.1997 (Ex. 38-122), 1999 (Ex. 38-123). These researchers
performed a cross-sectional study with some of the most detailed
exposure assessments to be found in the literature. The study,
described elsewhere in the testimony (Franzblau, Ex. 37-3, Armstrong,
Ex. 37-21) measured a wide variety of demographic, personal, and
exposure variables, including 13 psychosocial parameters. It is
distinguished by precise measurement of exposure variables and several
levels of outcome measurement objectivity, ranging from symptom
reports, through physical findings, to nerve conduction velocity (NCV)
results. The contribution of the psychosocial variables did not reach
significance in the final modeling, strongly implying that the effect
of biomechanical factors predominates in these 3 manufacturing plants
(testimony
[[Page 68526]]
by Armstrong, Ex. 37-3, Franzblau, Ex. 37-21).
Nortin Hadler (post hearing comments, Ex. 500-118-1, p 7) cited
this study as evidence for a lack of a significant association between
repetitive motion and decrements in median NCV. These results were, in
fact, marginally significant. Moreover, if a more conservative
definition of CTS was used, (i.e., 0.8ms threshold plus positive hand
diagram report), the association was significant (Franzblau testimony,
Ex. 37-21). In addition, Dr. Hadler failed to note either the wide
range of significant associations found for repetition, symptom reports
and tendinitis as indicated by physical exam findings, and that these
associations did demonstrate a positive exposure-response relationship.
Warren 1997 (Ex. 38-72), Warren et al.2000 (Ex. 38-73). Nicholas
Warren and colleagues at the University of Massachusettes at Lowell and
at TNO, the Netherlands, performed analyses on the Dutch Monitor data
set, collected from a broad sample of companies and industry sectors in
1993--a cross-sectional study. The data set contained completed
questionnaires from 7,717 Workers in 528 companies that assessed in
detail both workplace exposure to biomechanical and psychosocial risk
factors and a variety of musculoskeletal and stress outcomes, as well
as reports of extended sick leave. Controlling for gender, education
and tenure on the job, the multivariate linear analyses found roughly
equal contributions of both stressor classes to the pain and MSD
symptom reports, with physical factors having a somewhat larger
magnitude of effect (standardized regression coefficients of 0.06-0.16)
than psychosocial (0.04-0.12). Logistic modeling of low back pain and
absenteeism outcomes found similar results, with biomechanical ORs of
1.35-1.88 and psychosocial ORs of 1.32-1.64, excluding social support.
However, low social support did demonstrate the highest OR (2.27) in
the model explaining low back pain. The study was cross-sectional and
thus could not definitively evaluate temporal associations. However its
large size and wide range of companies and sectors allowed precise
separation of biomechanical and psychosocial exposure-outcome
associations, without collinearity problems.
Dr. Alf Nachemson criticized this study (post-hearing comments, Ex.
500-118-1), confusing it with a completely different study of a
different database submitted to Spine. The results of this study are
reported in a doctoral thesis (Warren, 1997, Ex. 38-72) and an article
submitted to the Scandinavian Journal of Work Environment and Health
(Warren et al., 2000b, 38-73). Contrary to Dr. Nachemson's
mischaracterization, the express purpose of this study was to
simultaneously measure biomechanical and psychosocial MSD risk factors
at the same level and degree of detail.
Warren et al.2000 (Ex. 38-75). Warren and colleagues from the
University of Connecticut Health Center carried out a separate study of
the Connecticut working population, using a random-digit-dialing study
design. This cross-sectional study is one of the few to randomly sample
workers with unreported cases of MSD (using the NHIS definition; Tanaka
et al.1995 (Ex. 26-59)). Psychosocial and biomechanical variables were
assessed at equal levels of detail. Logistic regression analysis found
case status to be associated with a broad mix of psychosocial and
biomechanical stressors, with biomechanical exposures showing somewhat
higher odds ratios. Significant psychosocial ORs ranged from 1.56-1.69,
while biomechanical ORs were between 1.89 and 2.13. Stressors were
measured at equivalent levels of detail and demonstrated independent
effects for psychosocial and biomechanical exposures.
Koehoorn, 1999 (Ex. 500-40). This doctoral thesis used a
retrospective cohort design to follow 4020 health care workers from an
acute-care hospital over a 4-year follow-up period, assessing outcomes
of musculoskeletal symptoms and claims. Results varied by body
location. In multivariate models explaining upper body symptoms, a
biomechanical index showed risk ratios of 1.41-1.84, while psychosocial
variables showed RRs ranging from 0.45-2.78. For lower-body symptoms,
RRs for biomechanical risk factors ranged from 2.12-4.65; psychosocial
variables generally did not reach statistical significance. Outcomes of
compensation claims related to these two body areas showed similar
ranges of effect. In subcohorts analyzed for departmental sicktime and
overtime, increased sick time was associated with symptoms and claims,
but increased overtime was not. The study design assessed detailed
biomechanical factors by observation, but only by occupational title,
while psychosocial factors were assessed by individual questionnaire.
Thus, the relative strength of association may have been underestimated
for biomechanical stressors. This large, carefully designed cohort
study provides evidence for a multifactoral model of MSD causation,
with physical factors being more strongly associated with MSD
incidence.
Waters et al.1999 (Ex. 500-41-54). This study was designed to
provide epidemiologic data linking the NIOSH lifting index (LI, a
quantitative measure of manual lifting stress calculated with the
revised NIOSH lifting equation) to prevalence of low back pain.
Measurements used to calculate the LI were collected on a sample of
workers over a 2-4 day period by trained observers. Workers also
completed a self-administered questionnaire that included psychosocial
items. In multivariate modeling, increasing values of the LI were
associated with increases in period prevalence of LBP over the last 12
months, with an exposure-response relationship that reversed at the
highest LI (>3). The authors noted that this drop in negative outcomes
in the highest exposure category is seen in other studies and seems to
indicate a ``healthy worker'' or survivor effect (representing the
departure of workers with pain or high risk of back injury from highly
stressful jobs). Psychosocial factors of demands, control and social
support did not enter significantly into these models, perhaps because
they were entered as continuous, not categorized, variables. However, a
four-category measure of decreasing work satisfaction showed a
significant exposure-response relationship with LBP. This high-quality
study, which relied on independent measurement of physical job
characteristics, demonstrated the combined contribution of physical and
some psychosocial stressors to prevalence of LBP, with physical effects
predominating in multivariate modeling.
Leclerc et al. 1998 (Ex. 500-41-85). This cross-sectional study of
1210 workers in 3 industry sectors incorporated a sophisticated mixture
of individual measurement of both physical and psychosocial factors,
combined with group-level assessment of cycle time and autonomy. Given
the study design principles outlined above, the effects of these group-
level factors may thus be underestimated. With this caveat, the
research still demonstrated a combined contribution to physician-
diagnosed CTS for cycle times less than 10 seconds (OR 1.90) and
psychological ``problems'' (OR 1.41). Other physical and psychosocial
factors dropped out of this model. In a final model incorporating the
presence of just-in-time production organization at the plant, this
factor replaced cycle time, with an OR of 2.24. Other physical and
psychosocial risk factors were associated with marginal significance.
[[Page 68527]]
The work organization variable of just-in-time production is probably a
surrogate for a combination of increased biomechanical and psychosocial
risk. This study thus demonstrates the combined contribution of both
types of risk. This study also found that industry sector did not enter
significantly into the model when both physical and psychosocial risk
factors were more precisely measured at the individual level.
Latza et al.2000 (Ex. 38-424). This prospective study of
construction workers in Hamburg took detailed observational
measurements of biomechanical stressors associated with a wide variety
of construction tasks. Of the 571 workers who filled out baseline
questionnaires, 285 individuals free of LBP were selected; 230 were
followed up after 3 years. The physical stressors at baseline predicted
subsequent 1-year prevalence of LBP (PRs: 1.8-4.0), while psychosocial
stressors did not enter significantly into the models. This is somewhat
surprising since, although the physical stressors were evaluated in
detail, they were measured at the job level, while psychosocial factors
were measured at the individual level. As noted above, this usually
results in an underestimate of the physical stressor contribution
relative to psychosocial factors.
Vingard et al.2000, MUSIC study (Ex. 500-41-51). The Swedish MUSIC
project has consistently demonstrated combined associations of
biomechanical and psychosocial stressors with back, neck and shoulder,
and other disorders. This study assessed prospectively the individual
and combined effects of physical and psychosocial exposures on
subjects' seeking care for LBP over a 5-year period. Gender
stratification reduced significance levels but demonstrated somewhat
different exposure-outcome associations for males and females. For men,
forward bending and manual material handling time, when compared to
levels 5 and 10 years ago, were significantly predictive (RR 1.8 and
2.0 respectively) with a combined exposure having a RR of 2.8. This
combined exposure was also significant for females (RR of 2.3). For
both genders, a combination of physical stressors including metabolic
stress was also a risk factor. Although included in these multivariate
models, most psychosocial stressors did not enter significantly
(exceptions were low work satisfaction and low skill use for males, RRs
of 1.6 and 1.5, respectively). A subset of the study sample reflecting
a combination of high physical load and high psychosocial load showed
much higher RRs, but the sample size was small. Overall, the MUSIC
study provides well-designed and detailed evidence that physical and
psychosocial exposure combine in the etiology of LBP, with the physical
stressors demonstrating stronger effects.
Houtman et al.1994 (Ex. 26-1230). This paper reported a cross-
sectional analysis of pooled 1977-1986 results from the National Work
and Living Condition Survey in the Netherlands. The study asked one
question on work pace, four on intellectual discretion, and one on
physical load. The items were all assessed at the same level of
precision (dichotomous, yes/no) and at the same analytical level, but
the greater detail in intellectual discretion assessment may have
biased the estimated effects of that particular construct upwards.
Multivariate logistic regression models were constructed to explain
variance in 3 musculoskeletal outcomes: back complaints, muscle/joint
complaints, and chronic back problems. Work pace was consistently
associated with these outcomes (ORs 1.21-1.29) as was heavy physical
load (ORs 1.36-1.62). Of the intellectual discretion items, only one,
monotonous work, was consistently associated with musculoskeletal
symptoms (ORs 1.29-1.35), but when all four items were combined, the
scale demonstrated the strongest association of the study with chronic
back pain (OR 2.10). Thus, in addition to providing more evidence for
independent association of physical and psychosocial stressors with
musculoskeletal outcomes, the study supports the hypothesis that
psychosocial stressors have their strongest effect with duration of
pain, not its inception.
Videman et al.1989 (Ex. 26-1155). This study is difficult to
interpret, but is included because of its relevance to interventions.
The researchers dichotomized graduating nursing students by skill
level. Half the students had received traditional lifting training;
half had received advanced, biomechanically-oriented training. Skill
assessment was performed through video analysis of standardized tasks,
not by simple assignment to trained or untrained groups. Nurses were
also dichotomized by hours/day in strenuous postures (3 hrs/day, >=3
hrs/day). In addition, the study collected extensive anthropometric,
strength and psychological measures. Incidence of back injury was
assessed at a 1-year follow-up. The results seem to confuse training
level and activity level, but a combination of >3 hours/day of
strenuous activity and low skill level significantly predicted self-
reported incidence of back injury (ORs of 37 or 156, further stratified
by high and low abdominal strength, respectively). The authors
emphasized that ergonomic interventions must be coupled with training
and describe the training as resulting in biomechanically less
stressful lifting choices by nurses. They concluded that training is an
effective intervention and ``the biomechanical and ergonomic components
of training in patient-handling appear to be inescapable'' (Ex. 26-
1155).
Thorbjornsson et al. 2000 (Ex. 500-71-49). This retrospective
nested case control study examined a cohort of 484 subjects from the
general population, examined first in 1969 and again, 24 years later,
in 1993. Exposure information was collected retrospectively for the 24-
year period and the 12 months previous to the 1993 interview. Outcomes
measured were LBP that resulted either in a medical visit or sick leave
more than 7 days. The study identified a small number of physical
factors (heavy physical work, sedentary work) and psychosocial factors
(poor social relations and overtime work) associated with LBP, as well
as high load outside of work. Most importantly, the research
demonstrated significant ORs for a wide variety of interaction terms
between workplace biomechanical and psychosocial risk factors (ORs:
2.2-3.5). In final modeling incorporating the interaction terms,
individual psychosocial effects became non-significant, but an
interaction between poor social relations and overtime work showed an
OR of 3.1-3.7 for men, depending on LBP onset time. The finding of
significant interactions between biomechanical and psychosocial factors
suggests that control of biomechanical risk factors in the workplace
should reduce not only the effects associated with biomechanical risk
factors, but the effects of their interaction with psychosocial
exposures.
Boeing Study. (Bigos et al.1991 (Ex. 26-1241), 1991 (Ex. 26-1242), 1992
(Ex. 26-1393)).
These studies were discussed earlier in the Health Effects section. In
addition, several witnesses who appeared at the public hearings (Frank,
Krause, others, e.g. Exs. 37-27, 37-15) have explored the
methodological problems with this study, which explain its finding that
the only significant predictor of back pain reporting found was job
dissatisfaction. In sum, the study assessed physical factors at the
group level (although the articles never make clear the exact
methodology), while assessing psychosocial and psychological variables
at the individual level. Assessed at the group level, the variance
[[Page 68528]]
in predictive physical factors was drastically reduced. For instance,
Dr. Bigos stated (Bigos et al., 1991b, Ex. 26-1242, testimony, Tr.
6908) that no-one was required to lift over 20 lbs., and no-one
actually lifted more than 50. However, the analysis had no way to
assign actual lifting frequency or compressive forces at the individual
level. It is difficult to determine whether even the poor
characterization of physical load approached statistical significance
because the authors elected simply not to report results that were not
significantly associated with outcomes (testimony, Tr. 6786). In
addition to this measurement problem, psychosocial and psychological
factors were measured with much greater precision. As noted above,
these assessment differences virtually ensure the primacy of the
better-measured factors, in this case the psychosocial factors, in
statistical modeling.
In addition, the factors entered in the Boeing study models
explained only an extremely small percentage of variance in the
outcome; job satisfaction explained 2.2 percent and psychological
variables explained 1.9 percent. All of the psychological, physical
exam and medical history variables assessed in the study combine to
explain only 8.6 percent of the variance (Bigos et al., 1992, Ex. 26-
1393). Thus, 91.4 percent of the variance in reporting of back pain is
not explained by the combination of poorly measured physical risk
factors and the more detailed psycho-emotional factors. This suggests
relatively poor characterization of overall exposure.
The flaws noted above also pertain to the psychological factor
assessment in this study. Psychological factors were measured at a much
finer level of detail than physical factors, which were measured at the
group level. Overall explanatory power of any of these measures was
poor. As a minor point, specific to the psychological assessment, the
study used non-standard and out-of-date instruments (Cherniack
testimony, Tr. 1150).
Svensson and Andersson 1989 (Ex. 26-732). This study evaluated the
association of a number of physical and psychosocial and psychological
variables with incidence (retrospective) and prevalence of LBP in
women. Both physical and psychosocial/psychological variables showed
univariate associations with the outcome, but multivariate analysis
found associations only with 3 ``psychological'' variables:
dissatisfaction with the work environment, worry/tension at the end of
the day, and fatigue. The analysis is not helpful to the separation of
physical and psychosocial effects for three reasons. First, the study
only reports the p-value range of the significant associations and does
not report effect size, thus making it impossible to tell if physical
exposures were of near significance and to compare relative strength of
association. Second, it is not at all clear whether variables of
dissatisfaction and worry/tension represent a psychological exposure or
an outcome, resulting from an underlying combination of physical and
psychosocial/psychological workplace factors, or from underlying
symptoms (see, Linton, 2000, Ex. 26-642). Most importantly, it is
clearly a mistake to label ``fatigue'' a psychosocial variable. In
fact, fatigue represents an integrated measure of all stressors,
physical and psychosocial, encountered by the worker and may well be
weighted towards the obvious biomechanical stressors. As such, it is
not surprising that this measure might capture variance from the
individual physical exposures tested in the study. (Recall how the
combined index of psychosocial exposures in the Houtman et al.study,
(1994, Ex. 26-1230) had the highest ORs in the study, while the
individual items composing the index had much lower ORs.) As
confirmation, it is interesting to note that these authors' earlier
research (1983, Ex. 26-1158), which assessed a similar set of exposures
but did not include the fatigue item, did demonstrate a contribution
from a physical stressor (high degree of lifting). Thus, this research
appears to be unable to accurately separate the contribution of
physical and psychosocial/psychological factors to LBP.
Leino and Hanninen 1995 (Ex. 38-76). This paper reported the
results of a prospective study begun in 1973, in 2653 industrial
workers, including managerial and office positions. Nine hundred two of
these participants were reexamined after 10 years. Outcomes were self-
reported musculoskeletal symptoms and evaluations by physiotherapists.
At follow-up, both self-reported symptoms and medical findings were
predicted by one psychosocial scale (social relations, OR 2.63-3.41)
and occupational class (OR 2.67-3.73). The only factor that partly
captures physical load in this model is occupational class. A single,
4-level measure of physical load was also entered into the equation.
However, this measure is much less precise than the 6-question scale
(each item with 5 levels) assessing social relations. This unequal
precision would bias the results towards the exposures measured with
greater precision, the psychosocial factors.
The authors noted that their physical load measure did enter into
the cross-sectional models at baseline, along with more psychosocial
exposures (work content, overstrain) and occupation. It was surprising
to find that physical load (a slightly more precise measure of
biomechanical exposures than exposure) dropped out of final models
while occupation class remained. Both physical load and occupation in
this study represent biomechanical exposures assessed at a much less
precise level than the psychosocial measures. This study, though
provocative, cannot provide useful information about the relative
strength of effect.
Summary of Literature Reviews
Several reviews have been published that have evaluated the
literature dealing with work-related MSDs; many of these reviews
included evaluations of studies that concurrently examined the effects
from exposure to both biomechanical risk factors and psychosocial risk
factors. In this section, OSHA summarizes the reviews contained in the
rulemaking docket.
Burdorf & Sorock 1997 (Ex. 502-232). These authors reviewed 35
studies that collected quantitative information on exposures and back
disorder outcomes. Eight of these studies assessed psychosocial and
biomechanical risk factors simultaneously. Of these, six found positive
associations of back disorders with a combination of physical and
psychosocial exposures and two identified several of the physical
factors to be significantly associated, while the psychosocial factor
measured (job dissatisfaction) did not show a significant association.
The analysis identified lifting or carrying loads, whole-body
vibration, and frequent bending and twisting to be the biomechanical
risk factors having consistent associations with work-related back
disorders. Unlike some other studies (e.g., Leino & Hanninen, 1995, Ex
38-76), height and weight (as well as gender, exercise and marital
status) were consistently not associated with back disorders in these
studies. The review identified low job decision latitude and job
dissatisfaction as possibly important predictors of MSDs, but the
evidence was not consistent across studies with different designs.
Although the majority of these eight studies acknowledged the
importance of psychosocial factors, the generalization that emerges
from them is that biomechanical factors were more
[[Page 68529]]
consistently associated with back disorders.
Punnett and Bergqvist 1997 (Ex. 38-13). This review of a large
international body of literature linking biomechanical and psychosocial
factors to upper extremity symptoms and findings in computer users
(classified by neck/shoulder, arm/elbow, and hand/wrist). The authors
found strong, consistent evidence linking MSD development with
biomechanical factors (hours/day and cumulative years of exposure,
intensive or repetitive data entry, and non-neutral postures due to
poor workstation design), while controlling for work organizational and
psychosocial factors in 7 of the 72 papers included in the analysis.
The work organizational factors included in 3 papers (repetitive work,
work pressure and insufficient rest breaks represent a combination of
physical and psychosocial risks. In 4 papers, this review found
suggestive but inconsistent associations (making generalization
impossible) between MSD symptoms and the psychosocial factors of low
decision latitude, low social support, job insecurity and job
dissatisfaction (Bergqvist et al., 1995, Ex. 26-1195, Faucett &
Rempell, 1994, Ex. 38-67, Kamwendo et al., 1991, Ex. 26-1384, Hoekstra
et al., 1994, Ex. 26-725). The authors also noted the difficulty of
using job dissatisfaction as a predictor for MSDs since it could easily
be either a cause or consequence of an MSD.
Lagerstrom et al. 1998 (Ex. 38-102). In this review of studies
relating to low back problems in nursing, 42 articles passed the
inclusion criteria: 21 cross-sectional, 10 prospective, and 11
intervention (also prospective). One of the reviewers' quality criteria
was that the studies include both physical and psychosocial exposure
information. The authors noted that a problem in many of the studies
was the assessment of physical stressor information at an aggregate or
group level, while psychosocial exposures were assessed at the
individual level. As noted above, this non-comparability would tend to
underestimate biomechanical effect in relationship to psychosocial
effect. Still, the authors conclude from their review that
biomechanical and psychosocial exposures generally combine in their
associations with or (in prospective studies) effects on back disorder
outcomes. Looking at well-designed studies with dual exposure
measurement, the authors report that ``[t]o our knowledge there are no
studies that show that work organizational or psychosocial factors, as
such, cause low-back problems.'' They do acknowledge the importance of
these factors in the ``consequence and maintenance'' of low-back
related disorders, through differences in pain perception and reporting
behavior.
Bongers et al. 1993 (Ex. 26-1292). This article was one of the
earliest reviews of the evidence for an association between
psychosocial factors and MSD outcomes. The authors looked at 29 cross-
sectional and 3 longitudinal studies addressing work-related
psychosocial factors. Of these, 22 measured physical load, and the
authors of this review did not think that the physical load assessment
was of a high enough quality to specifically assign relative
association effects to physical and psychosocial factors. Thus, this
review is included to demonstrate how far the field has moved since
1993. Subsequent reviews and studies addressed in this section show
that research in the intervening 7 years has moved towards more
accurate characterization of biomechanical and psychosocial loads and
defining their associations with MSD outcomes.
National Academy of Sciences, 1999 (Ex. 26-37). The NAS study
(cited by Armstrong, Exs. 37-21, 37-1, 37-9 and others, Ex. 37-15,
testimony) was discussed in OSHA's preamble to the proposed rule and is
described in part B of this Health Effects section. It reviewed a
number of studies that found strong evidence for biomechanical
contribution to MSD etiology, controlling for psychosocial factors.
Linton, 2000 (Ex. 26-642). This paper is a careful literature
review of studies addressing the association between psychological
factors and back and neck pain. The author concentrated on individual
psychological measures (i.e., internal psychological factors) but also
included some external psychosocial factors. Since many of the studies
also assessed outcomes of disability and time to return-to-work (RTW),
the author was able to provide evidence for his suggestion that
psychological factors may play a greater role in these long-term
outcomes.
The findings of this review are strengthened by its assessment of
only prospective studies. This might allow an interpretation that the
positive relationship found between various psychological factors and
the outcomes of pain, disability, RTW time, etc. might represent a
causal connection. However, there are two important caveats. Dr. Linton
noted that longitudinal relationships of this sort may still mask
reverse causal connections. The studies generally cannot determine
whether some psychological ``predictor'' variables and the outcome
variables are not both the result of initial or underlying pain.
Secondly, he noted that the psychological variables identified in the
37 reviewed studies explain only part of the variance in outcome. Thus,
the review's results are consistent with the multifactoral model of MSD
etiology (including biomechanical, psychosocial, psychological and
personal variables).
Despite the care with which the studies were selected and analyzed,
however, the review did not identify the type of biomechanical
exposures assessed in the studies or the level at which they were
studied. Instead, it simply noted that 18 studies controlled for
miscellaneous confounding factors, one of which was ``workplace
factors''. No indication was given as to the nature of these factors
and which of these 18 studies addressed ``workplace factors''. Given
the age of some of the papers, controlling for other factors (instead
of simultaneously assessing their effect) is understandable, but it
renders the review useless in contributing to the central debate
concerning relative contribution of biomechanical and psychosocial
factors (i.e., both external psychological and social workplace factors
and internal psychological factors). To further compromise the utility
of this review, the studies evaluated in this review included several
that measured physical exposure at the wrong analytical level (e.g.,
Bigos et al., 1991, Exs. 26-1241, 26-1242) or at a reduced level of
detail (e.g., Leino & Hanninen, 1995, Ex. 38-76, Viikari-Juntura et
al., 1991, Ex. 26-1219), compared to the psychological factors. This
review, although a significant contribution to the literature overall,
provides no useful information concerning relative contribution of
physical and psychological factors to MSDs.
Nachemson 1999 (Ex. 32-241-3-31). This article is a comprehensive
review of the studies purporting to demonstrate that physical workplace
factors are irrelevant to the development of back pain, injury and
disability. Instead, the studies implicate personal biology and
psychological factors, stress and psychosocial factors in the
workplace, and the monetary incentives of the compensation system. Some
of these studies have been addressed above (e.g., Bigos, 1991b, Ex. 26-
1242). In general, Dr. Nachemson's claim that these factors contribute
to low back disorders is credible. Very few of the researchers cited
above would deny their contribution. What is emphatically not credible
is the claim that physical factors are thus not implicated.
[[Page 68530]]
There are 3 primary problems with this claim. First, many of the
studies cited in the article have not assessed the role of physical
factors at all or have assessed them at levels of analysis or detail
that make examination of their contribution impossible. The results of
these errors have been discussed above. These studies overestimate the
role of non-physical risks and thus cannot address the question or
relative effects of biomechanical and psychosocial exposures in the
workplace.
Second, the basic conceptual gap in the Nachemson review is a
failure to acknowledge and address the implications and mechanism of
multifactoral causation. There is a broad literature of well-designed
studies, both epidemiological and laboratory (reviewed above and in
earlier parts of the Health Effects section) demonstrating that
psychosocial and psychological factors can add to the effects of
physical exposures or even potentiate them (interaction or effect
modification) (see Linton, 1990, Ex. 26-977, for a clear example). Dr.
Nachemson's reluctance to consider such effects is represented by his
citation of the Valfors et al. (1985, Ex. 26-685) examination of LBP.
This study reported that physical risk factors (poorly characterized by
a physiotherapist and a physician) were similar in workplaces of
controls and low back cases, while reporting case/control differences
in psychosocial work environment (again, poorly characterized). Valfors
thus attributed the back injuries in the case group to the psychosocial
factors. The logical fallacy, of course, is to assume that this
difference removes physical exposures from a causal role. The more
logical explanation, especially in light of all the evidence for
multifactoral etiology presented in this section, is that the
combination of physical exposures and psychosocial exposures presented
increased risk. A level of physical risk that is acceptable in a
psychosocially benign work environment can combine with elevated levels
of psychosocial risk to cause disorders.
Finally, many of the studies cited in this article confuse cause
with effect. To continue with Dr. Nachemson's citation, Valfors
concluded that the measured differences in work satisfaction were the
cause of the low back pain episodes, when it is just as likely that the
LBP itself affected patients assessment of their work satisfaction (see
Linton, 2000, Ex. 26-642).
These three errors, together or individually, characterize many of
the studies in the Nachemson article. In sum, this review, while useful
in collecting a wide variety of studies addressing the complex issues
of low back pain, disability, and management, does not demonstrate that
physical workplace factors are not involved in the etiology of LBP. Nor
does it demonstrate that workplace interventions directed towards
reduction of biomechanical risk factors would be ineffective. His
citation of the Daltroy (Daltroy et al., 1997, Ex. 38-57) training
intervention in the postal service, for example, is not a refutation of
the central causal role of biomechanical exposures in the etiology of
back injury. Rather, it is emblematic of the general failure of ``back
schools'', when introduced in the absence of measures directed towards
control of physical risk factors. Dr. Nachemson, himself, states in
this review: ``[I]t is obvious that certain types of lifts and working
positions should be avoided and this in particular applies to twisted
lifts.'' Ideally, this review will advance the development of more
effective intervention techniques that address the combination of risk
factors presented by Dr. Nachemson.
Waddell & Burton 2000 (Ex. DC-151-A). This thorough review of
management protocols for LBP includes evaluation of epidemiological and
clinical studies addressing etiology of LBP. Because the review and
recommendations focus primarily on medical management issues, it is not
surprising that it concentrates on the psychosocial factors involved in
pain perception, sickness absence, disability and return-to work. Most
of the studies addressed above acknowledge the importance of
psychosocial factors in medical management issues, not only for LBP but
also for other musculoskeletal disorders. The evidence reviewed above
corresponds with these authors' conclusions that low job satisfaction,
``unsatisfactory psychosocial aspects of work'' and individual
psychosocial findings are risk factors for onset of LBP, health care
use and work loss, but the size of that association is small to modest
(strong evidence). The authors also noted that physical demands of work
(manual materials handling, lifting, bending, twisting, and whole body
vibration) can be associated with onset of LBP, increased LBP reports,
symptom aggravation, and back ``injury'' (authors'' quotes). However,
they find that the association ``appears to be'' weaker than those of
individual, non-occupational and unidentified factors (strong
evidence).
The authors make an elementary error in ascribing potential LBP
causation only to dynamic back activities. Their noting the high
prevalence of LBP in non-dynamic jobs, and even in the unemployed, is,
of course, related to the well-established research findings that
sedentary and constrained postures are also physical risk factors for
back disorders (Putz-Anderson, 1991, Ex. 26-1255, Hoogendoorn et al.,
1999, Ex. 38-81, Burdorf & Sorock, 1997 Ex. 502-232).
More importantly, the studies used to provide ``strong evidence''
for various conclusions are sometimes categorized as being of high
quality when, in fact, they violate some of the important
epidemiological design criteria cited above. In particular, in making a
case for primarily psychosocial causation, the authors used studies
that measured biomechanical exposures inadequately (e.g., Bigos et al.,
1991b, Ex. 26-1242, and others reviewed above) or studies that did not
include both biomechanical and psychosocial factors in statistical
modeling (Macfarlane et al., 1997, Ex. 500-41-91, Papageorgiou et al.,
1997, Ex. 32-241-3-41). Several reviews are cited that, on closer
examination, are only modest in their assessment of both psychosocial
and biomechanical risk contribution, noting the problems with study
design and, especially, the relatively few studies that assessed both
exposures adequately and at equal levels of precision (Burdorf &
Sorock, 1997, Ex. 500-232, Bongers et al., 1993, Ex. 26-1292, Davis &
Heaney, 2000).
Conclusions
Based on the rulemaking testimony, scientific studies, and
literature reviews considered in this section, OSHA concludes that the
evidence contained in the record supports a combined contribution of
biomechanical and psychosocial risk factors to the onset, development
and prolongation of MSDs. Biomechanical contributions to the etiology
of work-related MSDs have been demonstrated to be more consistent than
psychosocial factors across different study populations, and most well-
designed studies reported stronger associations between exposure to
biomechanical risk factors and an increased MSD prevalence or incidence
than has been observed for psychosocial factors. However, it is not
possible to determine the relative strength of association between
biomechanical and psychosocial factors with any precision because of
differences in measurement techniques used in the various studies to
assess biomechanical and psychosocial factors, and because of the
different ways in which psychosocial factors are defined by various
investigators. Most importantly is the finding by several investigators
that
[[Page 68531]]
biomechanical and psychosocial factors influence MSD risk in
independent fashon, which suggests that reductions in biomechanical
exposures absent any change in psychosocial influences should reduce
the risk of work-related MSDs.
Findings from published literature reviews of studies that conform
to the epidemiologic design principles discussed above are consistent
with the Agency's conclusions. Four reviews (Burdorf, Ex. 502-232,
Punnett, 38-13, Lagerstrom, Ex. 38-102, NAS, Ex. 26-37) reported that
biomechanical risk factors generally showed stronger and/or more
consistent associations with elevated MSD prevalence or incidence than
did psychosocial factors.
Three reviews reached an opposite conclusion (Linton, Ex. 26-642,
Nachemson, Ex. 32-241-3-31, Waddell, DC-151-A); however, these reviews
relied more heavily on studies where biomechanical factors were not
evaluated at all, were evaluated in jobs having little variance in
physical load, or were evaluated at different analytical levels or with
less precision, or than psychosocial factors. All of these design flaws
bias results towards increased psychosocial effects in modeling. It is
on the basis of these reviews and the underlying studies that the
Chamber of Commerce, Gibson, Dunn & Crutcher, and several of their
scientific witnesses base their conclusion that psychosocial factors
outweigh the importance of biomechanical factors in the etiology of
MSDs. Accordingly, OSHA is not persuaded by these arguments, and finds
the preponderance of evidence supports a multifactorial model of MSD
causation involving both biomechanical and psychosocial factors acting
independently on risk.
Moreover, testimony and evidence presented above suggests that
biomechanical and psychosocial risk factors are, to a degree,
inextricable (Punnett, testimony, Tr. 868, Kerr et al., 2000, Ex. 38-
82). The degree of influence each exerts on MSD risk is in large part
determined by company characteristics and work organization, and their
very separation is somewhat artificial. The final rule's focus on
reducing exposures to biomechanical risk factors reflects the
intervention strategy that has been emphasized in the literature and
implemented by many sophisticated companies. Simply less is known about
how to intervene effectively on psychosocial factors. However, this
does not mean that biomechanical intervention will have no effect on
psychosocial factors in the wortkplace. Because of the correlation and
interactions between biomechanical and psychosocial factors in their
associations with MSD outcomes, interventions focused towards
biomechanical stressor reduction are likely to have a positive effect
on levels of psychosocial stress. The arguments of Bellamy and Vendor,
above (testimony) are addressed by the reality of this close
correlation between stressor types.
The intervention literature demonstrates that the very fact of a
company's undertaking even a limited program to control biomechanical
exposures is, de facto, also a psychosocial intervention. If workers
report MSD symptoms and the company responds with workplace
alterations, medical intervention, training, and the other program
elements in the final rule, this response often represents a reduction
in excessive psychological demands, an increased sense of control, and
an improvement in the social support structure of the workplace. In
Sweden, Kvarnstrom (1992, Ex. 38-69) found that changes in the physical
work characteristics, combined with changes in the psychosocial work
environment (increased variety, decision-making latitude, and
individual control over the work situation) in a small department of a
large, multi-national company greatly reduced the high rate of
absenteeism and turnover due to musculoskeletal disease. In the United
States, Smith and Zehel (1992, Ex. 38-70) reported that employee focus
groups identified the need for physically-oriented engineering changes
as well as psychosocial changes in a meat-processing plant; the
combined intervention resulted in decreased physical symptoms for part
of the work force. Worker participation in problem identification and
solution development is a central feature of many successful approaches
to work environment change and is at the core of the proposed rule. For
example, Pasmore & Friedlander (1982, Ex. 38-71), addressing an
outbreak of upper extremity disorders in a United States electronic
assembly facility, designed an intervention in which the employees
determined the data to be collected and solutions based on these data.
While this level of employee involvement focused on reducing
biomechanical risk factors, it also increased employee participation
and task control and altered role relationships within the
organization.
A number of witnesses testified at the hearing that ergonomic
programs designed to address biomechanicla factors have positive
effects on psychosocial factors that have been implicated in MSD
etiology. Dr. Warren explained why this is the case:
I think what happens hypothetically and in my experience is that
when you control a biomechanical workpalce factor, you are de facto
making a small psychosocial intervention in the workplace.
When * * * somebody says [``]my back hurts[''] and it's followed
* * * immediately by [``]and nobody cares[''], you know that there's
a psychological problem in that workpalce. So I think that, yes, * *
* a control of a biomechanical risk factor with no change in a
psychosocial environment would reduce the chance of injury, but that
it would probably also change the psychosocial environment to a
small degree. [Tr. 1265]
Dr. Rosecrance (Tr. 2319-20) presented a specific example. He noted
that the biomechanical intervention in his study of the Cedar Rapids
Gazette resulted not only in reductions of MSDs, but also improvements
in the company social structure.
Mr. Dave Alexander believed that the employee participation
provision of the proposed standard would address psychosocial issues:
* * * the opportunity for worker participation in the form of
contributing information, suggesting solutions, having a mechanism
to report problems would, in fact, tie in with the psychosocial
issues that would be important in the workplace. [Tr. 2713-2714]
Similarly, Dr. Silverstein testified that providing workers with basic
information on MSDs and employee involvement in the ergonomics program
increases the decision latitude for workers [Tr. 17445].
These studies and testimony indicate that the basic precepts of
management commitment and employee participation contained in the final
rule, while forming the administrative infrastructure of an ergonomics
program focused on physical risk abatement, has the potential to have
positive effects on the psychosocial characteristics of the work
environment.
6. Final Rule's Consistency With Medical Guidelines
Several commenters questioned whether the program elements of
OSHA's final rule were consistent with existing medical practice
guidelines, primarily with respect to diagnosing and treating low back
pain, but also diagnosing and treating other MSDs. For example, when
referring to the Agency for Health Care Policy and Research (AHCPR) low
back pain guidelines, Gibson, Dunn and Crutcher stated that the review
of evidence published with the guidelines
contradicts OSHA's ergonomic hypothesis that work causes physical
injury, contradicts OSHA's view that ``ergonomic'' interventions can
alleviate workplace pain, and contradicts
[[Page 68532]]
OSHA's prescription for rest as a response to back pain. [Ex. 500-
118]
OSHA disagrees with these commenters. In reviewing the record, OSHA
finds that the final rule is consistent with the medical literature,
including the AHCPR guidelines, the American College of Occupational
and Environmental Medicine (ACOEM) Occupational Medicine Practice
Guidelines (Ex. 38-234), The Royal College of General Practitioners'
Clinical Guidelines for the Management of Acute Low Back Pain (Royal
College guidelines) (Waddell et al. 1999; Ex. 32-241-3-38), the Faculty
of Occupational Medicine's Occupational Health Guidelines for the
Management of Low Back Pain at Work (British guidelines) (Ex. 500-118-
2), and other evidence-based medical practice.
The first assertion, that the AHCPR guidelines ``contradict[ ]
OSHA's ergonomic hypothesis that work causes physical injury'' is
incorrect for several reasons. The AHCPR guidelines acknowledge that
* * * several studies have identified an increased incidence of low
back problems among individuals whose work involves heavy or
repetitive lifting, exposure to total body vibration (from vehicles
or industrial machinery), asymmetric postures, and postures
sustained for long periods of time. [Ex. 32-241-3-93]
The guidelines also recognize that
Other biomechanical research suggests that certain postures and
activities increase the mechanical stress on the spine. It is not
clear whether these mechanical stresses are the cause of low back
problems. However, once symptoms are present, mechanical stresses
correlate with worsening of symptoms. Prolonged sitting and postures
that involve bending and twisting have been shown to increase the
mechanical stress on the spine according to pressure measurements in
lumbar intervertebral discs. Heavy lifting also appears to increase
mechanical stress on the spine, but this stress can be reduced if
the lifted object is held close to the body rather than at arm's
length. [Ex. 32-241-3-93]
These conclusions are clearly consistent with the conclusions of the
Health Effects section of the final rule that biomechanical factors are
associated with low back pain. It must be recalled that the AHCPR
guidelines were
* * * intended to provide primary care clinicians with information
and recommended strategies for the assessment and treatment of acute
low back problems in adults. [Ex. 32-241-3-93]
They were not intended to provide a comprehensive review of work-
related low back pain, ergonomics or low back pain prevention. There
are few references to ergonomics, and the guidelines promotes the
utility of ergonomics in return to work decision making by stating
that: ``Several ergonomic guidelines on lifting and materials-handling
tasks are available to help the clinician provide ranges of activity
alterations at work.'' (Ex. 32-241-3-93)
Finally, the AHCPR guidelines (Ex. 32-241-3-93) do not suggest that
patients with acute low back pain immediately return to work involving
physical factors that may stress the spine. Rather they advise
appropriate activity modification to assist in the recovery process.
AHCPR guidelines Activity Recommendations panel findings and
recommendations state: (1) ``Patients with acute low back problems may
be more comfortable if they temporarily limit or avoid specific
activities known to increase mechanical stress on the spine, especially
prolonged unsupported sitting, heavy lifting, and bending or twisting
the back while lifting. (Strength of Evidence = D.);'' and (2)
``Activity recommendations for the employed patient with acute low back
symptoms need to consider the patient's age and general health, and the
physical demands of required job tasks. (Strength of Evidence = D.)''
As to the duration of activity modification, the AHCPR guidelines
demonstrate an understanding of the impact that the physical demands of
work have on recovery and modified activity. The guidelines state that
``The nature and duration of limitations will depend on the clinical
status of the patient and the physical requirements of the job.''
Several other components of the final rule are supported by AHCPR
recommendations, including the use of job hazard analysis and medical
management involving communication with the HCP. Pertinent AHCPR
guidelines statements are as follows: (1) ``In recommending activity
modifications for patients who work, the clinician may find it helpful
to obtain from the employer a description of the physical demands of
required job tasks,'' and (2) ``The panel recommends that clinicians
help patients establish activity goals, in consultation with their
employer when applicable.''
As with the AHCPR guidelines (Ex. 32-241-3-93), the commenters
cited above did not accurately represent the findings of the Royal
College guidelines (Ex. 32-241-3-38) and British guidelines (Ex. 500-
118-2) in criticizing OSHA's proposal. They also failed to acknowledge
evidence and recommendations from these reports that are consistent
with the final rule.
The Royal College guidelines (Ex. 32-241-3-38) were developed for
the purpose of disseminating evidence-based recommendations on the
management of acute low back pain to clinicians. The Royal College
guidelines do not purport to relate to, nor were they focused on, the
same purpose as OSHA's proposal, that is to reduce MSDs and control MSD
hazards in the workplace. These guidelines do not contain information
on evidence based conclusions on ergonomics or low back pain
prevention. Several elements of the proposal are supported by the Royal
College guidelines (Ex. 32-241-3-38). For example, under Initial
Assessment Methods, they recommend: ``The patient's age, the duration
and description of symptoms, the impact of symptoms on activity and
work, and the response to previous therapy are important in the care of
back problems.'' Under Information to Patients, the guidelines state:
``About 10% of patients will have some persisting symptoms a year
later, but most of them can manage to continue with most normal
activities. Patients who return to normal activities feel healthier,
use less analgesics and are less distressed than those who limit their
activities.'' The Royal College guidelines suggest that most workers
can manage with most normal activities, but do not suggest that this
includes extremely physical tasks that cause very significant
mechanical loading to the lumbar spine and are associated with elevated
risks of low back pain.
Similarly, the purpose and findings of the British occupational
health low back pain guidelines (Ex. 500-118-2) have also been
misrepresented (e.g., Ex. 32-241-3-20). The British guidelines state:
``These guidelines represent the main recommendations and evidence
statements derived from a detailed Evidence Review and developed by a
multidisciplinary group of practitioners. They concern the clinical
management of workers affected by non-specific low back pain, including
advice on placement, rehabilitation and measures for prevention.'' The
British guidelines further clarify that they were not intended to
disseminate information regarding workplace health and safety, job
design, and ergonomics when they state: ``They focus on actions to be
taken to assist the individual and do not specifically cover legal
issues, health and safety management, job design and ergonomics.''
Again, this is a different focus than the proposal, and conclusions
should be interpreted in that light. Under evidence review methods, the
British guidelines state:
In view of the occupational health focus of the guidelines and
the present review, the following areas were excluded from the
review, except where they impact directly on the guideline
recommendations: chronic
[[Page 68533]]
intractable pain, long-term disability and pain management
programmes; spinal surgery and post-operative states; primary
ergonomic interventions. [Ex. 32-241-3-93]
The British guidelines (Ex. 500-118-2) acknowledge the role of work
in contributing to low back pain in its own preface. In reviewing
challenges for the review the authors state: ``The need for everyone to
recognize that work is only one contributor to back pain but that back
pain whatever its cause can, if poorly managed, have a devastating
effect on a person's ability to work.'' The review goes on to classify
evidence based literature recommendations using the following
classification scenarios:
***Strong evidence--provided by generally consistent findings in
multiple, high quality scientific studies.
**Moderate evidence--provided by generally consistent findings in
fewer, smaller or lower quality scientific studies.
*Limited or contradictory evidence--provided by one scientific
study or inconsistent findings in multiple scientific studies.
--No scientific evidence--based on clinical studies, theoretical
considerations and/or clinical consensus.
Several British guidelines (Ex. 500-118-2) findings are consistent
with the final rule. With respect to the relationship of physical work
factors and work-related low back pain, the guidelines report the
following evidence based findings: There is strong evidence that
Physical demands of work (manual materials handling, lifting,
bending, twisting, and whole body vibration) can be associated with
increased reports of back symptoms, aggravation of symptoms and
``injuries.'' [Ex. 500-118-2]
These guidelines therefore acknowledge potential for physical work
factors to precipitate low back pain episodes, and recognize some
evidence of a cumulative effect of spinal loading. In addition,
management of work-related low back pain, as noted in the AHCPR low
back pain guidelines, may reasonably include elements similar to those
in the OSHA final rule, such as
* * * temporarily limit[ing] or avoid[ing] specific activities known
to increase mechanical stress on the spine, especially prolonged
unsupported sitting, heavy lifting, and bending or twisting the back
while lifting. [Ex. 32-241-3-93]
In summary, the British guidelines (Ex. 500-118-2) state that there is
moderate evidence that ``From an organisational perspective, the
temporary provision of lighter or modified duties facilitates return to
work and reduces time off work.''
The British guidelines (Ex. 500-118-2) go on to cite other
conclusions about work and low back pain using evidence based
literature reviews (Evidence) and consensus opinion (Recommendation).
In making recommendations on prevention and case management, the
authors advise the ``need to be directed at both physical and
psychosocial factors.'' If physical work is not harmful and it does not
contribute to low back pain, then why would the authors advise
addressing the physical task factors of work in prevention efforts?
Similarly, if physical characteristics of work are not significant
issues for workers who return to work after developing a low back
disorder, then why do the authors state the following?
There is a pragmatic argument that individuals at highest risk
of LBP should not be placed in jobs that impose the greatest
physical demands. The basic concern is that workers with physically
(or psychologically) demanding work report rather more low back
symptoms, have more work-related back ``injuries'' and lose more
time off work with LBP. Even if physical demands of work may be a
relatively modest factor in the primary causation of LBP (see
Background above), people who have LBP (for whatever cause) do have
more difficulty managing physically demanding work (T3: (Muller et
al.1999) T2: (Waddell 1998)). It may be argued, therefore, that
avoiding putting people at highest risk of recurrent LBP and
sickness absence into more physically demanding work would be in the
interests of the individual worker, the employer and the total
societal burden of LBP. [Ex. 500-118-2]
Similarly, the ACOEM guidelines (Ex. 38-234) agree with the observation
that specific physical work factors are associated with certain work-
related MSDs.
One of the criticisms raised by a commenter was the limited
reference to the Cochrane Collaboration Back Review Group in low back
sections of the Health Effects section of the preamble to the proposed
rule. However, as a significant contributor to this effort, Dr.
Nachemson clarified that neither work-related back pain nor ergonomics
were the focus of these reviews (Tr. 6779).
Although Dr. Nachemson questioned OSHA's findings of the
relationship of work to the development of work-related low back
disorders, he contradicts this in the chapter he authored for the
International Society for the Study of the Lumbar Spine, entitled
``Future of Low Back Pain'' (Wiesel et al. 1996, Ex. 26-1620). The
chapter has a table compiled on the effects of external load on low
back structures. The table lists extreme loading activity, several
hours of hard training, extreme body position, as having negative
influences on muscle, cartilage, and disc.
Dr. Stanley Bigos admitted that physical work factors could result
in the development of low back pain in an exchange with one of the
questioners.
MS. GWYNN: Doctor, you believe, do you not, that lifting and
bending while lifting and twisting while lifting can aggravate low
back pain?
DR. BIGOS: I believe that it can bring on symptoms in people who
have had prior back problems. And perhaps, it could bring on
symptoms of people who haven't, depending upon the condition they
are in. [Tr. 6916]
Along other lines, some commenters raised issues with OSHA's
inclusion of symptoms in the definition of an MSD. Gibson, Dunn and
Crutcher stated that:
These sensations that the agency treats as tantamount to
musculoskeletal injury are ubiquitous in the general population and
do not warrant interference by the agency. [Ex. 500-118]
OSHA does not agree with this argument. OSHA is not attempting to
regulate common symptoms. Rather, OSHA has proposed strategies to
modify physical workplace factors that are associated with the
development of MSDs, when the physical factors at work are present in
frequency, intensity, and/or duration likely to be responsible for
causing observed MSDs. As required in the final rule, the employer's
responsibility is that it must evaluate employee reports of MSD signs
and symptoms to determine whether an MSD incident has occurred. The
evaluation may include an evaluation by an HCP to determine the nature
of the condition and assist the employer in evaluating the work-
relatedness of the MSD. Many employers presently act in a very similar
manner when an employee reports a potential problem. The employer may
perform an accident or incident investigation, offer temporary modified
duty, correct the problem, and/or refer the employee to a HCP for
evaluation.
Gibson, Dunn, and Crutcher also suggested that paying attention to
subjective complaints would lead to inaccurate diagnoses. They state
that:
One of the challenges presented by MSDs is that, in order to
diagnose an affliction (in an effort to determine what response is
required to comply with the proposed standard), an employer or the
employer's physician must rely principally, if not solely, on
subjective reports of pain from employees. [Ex. 500-118]
These assertions are incorrect, and are not consistent with medical
literature and opinion. A worker's medical history, including
subjective reports like pain, is a key element that has been
[[Page 68534]]
utilized since the beginnings of medicine to help physicians diagnose
medical conditions. The AHCPR guidelines emphasize the role of the
medical history when they state:
A few key questions on the medical history can help ensure that
a serious underlying condition, such as cancer or spinal infection,
will not be missed * * * Symptoms of sciatica (leg pain) or
neurogenic claudication (walking limitations due to leg pain)
suggest possible neurologic involvement. Pain radiating below the
knee is more likely to indicate a true radiculopathy than pain
radiating only to the posterior thigh. A history of persistent
numbness or weakness in the leg(s) further increases the likelihood
of neurologic involvement. The articles indicate that cauda equina
syndrome can be ruled out with a medical history that ascertains the
absence of bladder dysfunction (usually urinary retention or
overflow incontinence), saddle anesthesia, and unilateral or
bilateral leg pain and weakness. [Ex. 32-241-3-93]
The AHCPR guidelines go on to clarify that the examination is used to
confirm clinical impressions derived from the medical history,
including pain characteristics:
The physical examination supplements the information obtained in
the medical history in seeking an underlying serious condition or
possible neurologic compromise. [Ex. 32-241-3-93]
The AHCPR low back pain guidelines also indicate that ``The physical
examination is less useful than the history in searching for underlying
serious conditions.'' Thus OSHA's approach to the use of employee
symptoms is similar to the AHCPR rigorous analysis of the literature on
acute low back pain evaluation and treatment that concluded that
symptoms and history give important information to diagnose and manage
adults with acute low back pain.
Both the Royal College and British guidelines support the role of
history, including symptoms, in the diagnosis and management of low
back pain. The British guidelines state:
The patient's age, the duration and description of symptoms, the
impact of symptoms on activity and work, and the response to
previous therapy are important in the care of back problems. (B:
Moderate research based evidence). [Ex. 500-118-2]
The guidelines confirm AHCPR recommendations by indicating:
The initial clinical history can identify `red flags' of
possible serious pathology. Such inquiries are especially important
in patients over age 55. (B: Moderate research based evidence). [Ex.
500-118-2]
OSHA's approach, in particular the acknowledgment of worker
symptoms, parallels this literature based analysis.
Further validation of the importance of symptom reporting for low
back pain comes from the ACOEM guidelines (Harris et al. 1997; Ex. 502-
240). The ACOEM guidelines included peer review by Dr. Stanley Bigos,
expert witness for UPS and Anheuser-Busch and others. The following
quotes are excerpted from the guidelines:
A focused medical history, work history, and physical
examination are generally sufficient to assess the worker with a
complaint of an apparently job related disorder. [Ex. 502-240]
In this assessment, certain patient responses and findings raise the
suspicion of serious underlying medical conditions.
The patient's description of the mechanism of injury (so far as
is known), his or her presenting symptoms, the duration of symptoms,
exacerbating factors, and the history of previous episodes will help
define the problem. [Ex. 502-240]
In Chapter 14, the ACOEM guidelines state:
Thorough medical and work histories and a focused physical
examination are sufficient for the initial assessment of the worker
with a complaint of potentially work-related low back symptoms. [Ex.
502-240]
These statements from clinical medicine practice guidelines provide
further support for the use of symptoms as a trigger in the final rule.
The practice guidelines make use of the patient history and reports of
symptoms and take a consistent approach to the physical examination
referent to patients with low back pain.
This approach is consistent with the one medical text brought to
OSHA's attention. The International Society for the Study of The Lumbar
Spine publishes a text entitled ``The Lumbar Spine'' (Wiesel, et al.
1996; Ex. 26-1620). In Chapter 3 on clinical evaluation of low back
pain by Jeremy Fairbank and Hamilton Hall (History taking and physical
examination: Identification of syndromes of back pain), the authors
state:
Conventional western medical therapy is practiced on the basis
of a diagnosis that is made from a synthesis of information acquired
from the patient's history, physical examination, and special
investigations. Back pain is a common presenting symptom, and its
diagnosis should be approached in the same manner as that of any
other symptom. [Ex. 26-1620]
They further state that
A detailed history obtained from the patient is essential for
making a diagnosis, assessing disability, and dictating management.
Time spent listening to the patient is not wasted. Back pain has a
wide variety of causes, and many of these can be revealed during
history taking. [Ex. 26-1620]
providing support that
Objective evidence obtained on physical examination should
enhance and support the diagnostic hypotheses arising from the
patient's history. [Ex. 26-1620]
The authors go on to propose a classification system for low back
pain (Pynsent-Fairbank-Hall Classification of Extraspinal Pain), which
is primarily based upon patient symptoms. The acknowledgment of the
importance of symptoms in this text is of particular interest to OSHA
due to the fact that two principal expert witnesses who testified on
behalf of UPS and others that symptoms are not meaningful, Dr. Stanley
Bigos and Dr. Alf Nachemson, are members of The International Society
for the Study of The Lumbar Spine, the organization that published the
above text.
The classification of low back pain primarily upon patient symptoms
is similar to the approach used by the Quebec Task Force (1987; Ex. 26-
494). Dr. Nachemson also served as a member of the task force for this
publication. The Quebec classification included 11 categories, with 1-
4, 8, 9 and 10 based upon symptoms.
The American Medical Association, in its Guides to the Evaluation
of Permanent Impairment, 4th edition, (Ex. 38-246) also include
symptoms in classifying impairment. In particular, Table 72 in that
publication contains a Diagnosis Related Estimate for Lumbosacral
Category II: Minor Impairment (5% whole person impairment). The
guidance used by the AMA for this is ``The clinical history and
examination findings are compatible with a specific injury or illness.
The findings include significant intermittent or continuous muscle
guarding that has been observed and documented by a physician,
nonuniform loss of range of motion, or nonverifiable radicular
complaints. There is no objective sign of radiculopathy and no loss of
structural integrity.'' There is similar guidance for the cervical
spine.
Guidelines for diagnosis and treatment of low back pain that have
been published in the United States include the AHCPR guidelines (Ex.
32-241-3-93) and the ACOEM guidelines (Ex. 38-234). These will be
addressed in the discussion on rest and activity to follow in this
section.
It must also be recognized that low back pain is not the only
potentially covered MSD, and other potential MSDs may present as
symptoms only. For example, it is clear that patients with CTS may have
symptoms of numbness without any physical findings (Erdil and
[[Page 68535]]
Dickerson 1997, Ex. 502-18; Katz et al. 1991, Ex. 38-101; Moore 1992,
Ex. 26-985). Of significance, commonly utilized physical signs to
clinically diagnose carpal tunnel syndrome, such as the Tinel's test
and Phalen's sign, do not have as high a sensitivity or specificity as
the Hand Diagram (Katz and Stirrat 1990; Ex. 500-121-33), a symptom
based tool. Clearly, utilizing symptoms to identify possible cases of
carpal tunnel syndrome and other MSDs is consistent with the knowledge
based upon reviewing the medical literature.
Dr. Malcolm Jayson argued that
* * * if a person has pain in the knee, the most effective form of
treatment is knee exercises. When we rehabilitate back problems we
prescribe[] exercises with a progressive regime to increase physical
capacity. There is now overwhelming evidence that exercise is good
for back problems and damaged joints and rest is harmful. [Ex. 32-
241-3-9]
However, nowhere does OSHA state that all exercise is harmful, nor does
it support rest as the treatment for MSDs. With regard to work factors
like repetition, it is important to recognize that biomechanical
factors that are present in a sufficient intensity, duration, and/or
frequency to cause or contribute to an MSD are addressed. In these
circumstances, OSHA recommends modification of exposure to these
factors. It is clear that, when excessive, repetition and other cited
work factors can cause MSDs. Several studies were presented in the
Health Effects Section of the final rule to demonstrate the pathogenic
mechanisms through which physical work factors can be responsible for
causing or contributing to certain MSDs identified in the epidemiologic
review. Unfairly, this statement simplifies physical factors in work
settings as solely characterized by repetition, without considering the
frequency, duration, and periodicity of the repetitive activities. In
addition, it ignores other factors that have potential to cause MSDs in
the workplace, such as excessive force, awkward posture, contact
stress, and vibration. Also neglected is the observation that
combinations of factors like force, posture, etc. with repetition, may
compound the effect of repetition on musculoskeletal tissues. Finally,
the statement does not differentiate types of tissue affected and
whether the tissue is healthy or damaged.
In the preface to The American Academy of Orthopedic Surgeons' book
entitled ``Repetitive Motion Disorders of the Upper Extremity'' (Gordon
et al. 1995; Ex. 26-1399), the editor states:
There is overwhelming evidence that the number of reported cases
of repetitive motion disorders is rapidly growing. These disorders
have become an extremely costly public health issue. Although some
individuals believe that the underlying issue may be improper
reporting or false claims of a medical problem, the organizers and
most of the participants believe that for the vast majority of
cases, there is an underlying physiologic insult to one or more of
the various t
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