[Federal Register Volume 65, Number 220 (Tuesday, November 14, 2000)]
[Rules and Regulations]
[Pages 68262-68870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28854]



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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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / 
Rules and Regulations

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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;

    <bullet> A critical review by NIOSH of more than 600 
epidemiological studies addressing the effects of exposure to workplace 
risk factors (1997);
    <bullet> 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:
    <bullet> High levels of exposure to ergonomic risk factors on the 
job lead to an increased incidence of work-related MSDs among exposed 
workers;
    <bullet> Reducing exposure to physical risk factors on the job 
reduces the incidence and severity of work-related MSDs;
    <bullet> Many work-related MSDs are preventable; and
    <bullet> 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:
    <bullet> 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'';
    <bullet> 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;
    <bullet> 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;
    <bullet> OSHA's state consultation programs, which will provide 
free on-site consultation services to employers requesting help in 
implementing their ergonomics programs; and
    <bullet> 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.

------------------------------------------------------------------------
 
------------------------------------------------------------------------
                       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.
------------------------------------------------------------------------

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:
    <bullet> Grants to train workers and employees about hazards and 
hazard abatement.
    <bullet> Three training courses in ergonomics through the OSHA 
Training Institute available for OSHA compliance officers, one of which 
is open to the public;
    <bullet> One day training for nursing home operators, at more than 
500 nursing homes in each of seven targeted states;
    <bullet> 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.
    <bullet> 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:

    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> Nurse
    <bullet> Home health care aide
    <bullet> Nurses' aide
    <bullet> Package delivery
    <bullet> Package sorting
    <bullet> Meatpacking and poultry processing
    <bullet> Office clerical worker
    <bullet> Internet publishing
    <bullet> Machinists
    <bullet> Sewing machine operator
    <bullet> Truck driver
    <bullet> Food warehousing and distribution
    <bullet> Grocery store cashier
    <bullet> Physical therapist
    <bullet> Mail carrier
    <bullet> Letter sorter
    <bullet> Teacher
    <bullet> Teachers' aide
    <bullet> Auto assembly
    <bullet> Molding and casting machine operator
    <bullet> Reporter
    <bullet> Grocery shelf stocker
    <bullet> Sonographer
    <bullet> Television film editor
    <bullet> 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):
    <bullet> Postal workers
    <bullet> Materials handlers
    <bullet> Computer operators
    <bullet> Grocery checkout clerks
    <bullet> Meat processors
    <bullet> Assemblers
    <bullet> Seamstresses
    <bullet> Telephone operators
    <bullet> Pipefitters
    <bullet> Customer service agents
    <bullet> Machine operators
    <bullet> Automotive manufacturing workers
    <bullet> Aircraft manufacturing workers
    <bullet> Optical scanners
    <bullet> Graphic artists
    <bullet> Restaurant workers
    <bullet> Bakers
    <bullet> Plumbers
    <bullet> 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:
    <bullet> Chemical manufacturing
    <bullet> Pharmaceutical manufacturing
    <bullet> Automotive manufacturing
    <bullet> Automotive repair
    <bullet> Boat manufacturing
    <bullet> Textile manufacturing
    <bullet> Clothing manufacturing
    <bullet> Printing
    <bullet> Dental
    <bullet> Meatpacking
    <bullet> Electric utility
    <bullet> Hospitals
    <bullet> Office workers
    <bullet> Hotel/motel
    <bullet> Emergency medical services
    <bullet> Furniture manufacturing
    <bullet> Oil and gas drilling
    <bullet> Moving and storage
    <bullet> Fabricare
    <bullet> Nursing homes
    <bullet> Telephone operation and installation
    <bullet> Funeral and cemetery
    <bullet> Insurance
    <bullet> Solid waste removal and recycling
    <bullet> Paint manufacturing
    <bullet> Poultry processing
    <bullet> Food warehousing and distribution
    <bullet> Beverage delivery
    <bullet> Assembly line
    <bullet> Grocery store
    <bullet> Retail clothing
    <bullet> 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:
    <bullet> Newspaper
    <bullet> Luggage manufacturing
    <bullet> Meatpacking
    <bullet> Packaging
    <bullet> Papermaking
    <bullet> Plumbing supply
    <bullet> Route sales and delivery
    <bullet> Film products manufacturing
    <bullet> Hospitals
    <bullet> Heavy appliance manufacturing
    <bullet> Automobile manufacturing and subassembly
    <bullet> Furniture manufacturing
    <bullet> Paper and pulp products
    <bullet> Forest products
    <bullet> Food service
    <bullet> Clerical
    <bullet> Electronics
    <bullet> Clothing and textile manufacturing
    <bullet> Baking
    <bullet> Restaurant
    <bullet> Home and office furniture manufacturing
    <bullet> Hospitality--hotel/motel
    <bullet> Fiber manufacturing
    <bullet> Logistic and supply warehousing
    <bullet> Telecommunication
    <bullet> Textile and apparel manufacturing
    <bullet> Metal forging and cast metals
    <bullet> Electronics manufacturing
    <bullet> Health care
    <bullet> Petroleum
    <bullet> Electrical manufacturing
    <bullet> Airline freight handling
    <bullet> Steel manufacturing
    <bullet> Fishing
    <bullet> Aircraft manufacturing
    <bullet> Gas and electric utility
    <bullet> Flooring products
    <bullet> Computer and computer accessory manufacturing
    <bullet> Plumbing fixtures manufacturing
    <bullet> Food products manufacturing and processing
    <bullet> Chemical manufacturing
    <bullet> Printing
    <bullet> Waste treatment
    <bullet> Plastic manufacturing
    <bullet> Clothing retail
    <bullet> Power plants
    <bullet> Research laboratories
    <bullet> Transportation
    <bullet> Printing
    <bullet> Upholstery
    <bullet> Rubber manufacturing
    <bullet> Welding
    <bullet> Mail sorting and delivery
    <bullet> Transportation
    <bullet> Electronics
    <bullet> 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):
    <bullet> They consist primarily of jobs of short duration,
    <bullet> Employees work under a variety of adverse environmental 
and workplace conditions (e.g., cold, heat, confined spaces, heights),
    <bullet> At non-fixed workstations or non-fixed work sites,
    <bullet> On multi-employer work sites,
    <bullet> They involve the use of ``day laborers'' and other short-
term ``temporary workers,'
    <bullet> Involve situations in which employees provide their own 
tools and equipment, and
    <bullet> 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:
    <bullet> Mechanical container lifts,
    <bullet> Limits on container size and weight and requirements for 
container handles,
    <bullet> Carts, dollies and other mechanical assists for pushing, 
carrying and lifting containers,
    <bullet> Collection trucks designed for use in narrow alleys and 
streets to eliminate carrying containers long distances,
    <bullet> 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),
    <bullet> Training in proper lifting techniques,
    <bullet> Work practice controls (e.g., training not to lift 
overweight loads),
    <bullet> 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

    <bullet> Agricultural services
    <bullet> Soil preparation and crop services, including crop 
planting, cultivating and protecting
    <bullet> Crop harvesting
    <bullet> Veterinary services
    <bullet> Lawn and garden services
    <bullet> Ornamental shrub and tree service
    <bullet> Tree trimming
    <bullet> Landscaping and horticultural services
    <bullet> Oil and gas drilling/extraction operations
    <bullet> Health care employees
    <bullet> Truck driving
    <bullet> Office workers employed by general industry 
establishments
    <bullet> Office workers employed by agricultural services 
establishments
    <bullet> Utility line operations including maintenance, repair, 
installation, construction, alteration and improvement operations
    <bullet> Power plant maintenance operations including repair, 
alteration and improvements
    <bullet> Boat building and repair
    <bullet> Airline baggage handlers
    <bullet> Airline reservation and ticket agents
    <bullet> Airline maintenance crews
    <bullet> Railroad equipment building and rebuilding
    <bullet> Maintenance of equipment or structures
    <bullet> Forestry services
    <bullet> Forestry nurseries and gathering of forest products
    <bullet> Commercial fishing
    <bullet> Fish hatcheries and preserves
    <bullet> Hunting and trapping
    <bullet> Game propagation
    <bullet> State and municipal employees (in State Plan States) 
performing general industry operations
    <bullet> U.S. Postal Service
    <bullet> Federal government employees performing general 
industry operations

Industries and Jobs This Standard Does Not Cover

    <bullet> Construction employment and operations
    <bullet> Agriculture employment and operations
    <bullet> Farm labor and management services
    <bullet> Livestock and animal specialty services
    <bullet> Maritime employment and operations
    <bullet> Ship building and repair
    <bullet> Longshoring
    <bullet> Office workers employed by construction, agriculture or 
maritime establishments
    <bullet> Maintenance workers employed by construction, 
agriculture or maritime establishments
    <bullet> Work at the employee's own home
    <bullet> Railroad work
    <bullet> Railroad terminal and switching
    <bullet> Airline attendants
    <bullet> 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:
    <bullet> 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).
    <bullet> 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).
    <bullet> 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.
---------------------------------------------------------------------------

    <bullet> 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).
    <bullet> 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).
    <bullet> 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):
    <bullet> OSHA's VPP, SHARP, and consultation programs;
    <bullet> The safety and health programs mandated by 18 states;
    <bullet> 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);
    <bullet> 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;
    <bullet> 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:
    <bullet> The [proposed] basic obligation section for Hazard 
Information and Reporting * * * does not [include] any requirement 
to provide employees information about MSD hazards.
    <bullet> 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.
    <bullet> The [proposed] basic obligation for Medical Management 
* * * does not require that medical evaluations be conducted by a 
health care provider.
    <bullet> 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:
    <bullet> 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);
    <bullet> 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);
    <bullet> 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);
    <bullet> 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);
    <bullet> 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);
    <bullet> 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:

    <bullet> 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.
    <bullet> 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:

    <bullet> 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;
    <bullet> 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
    <bullet> 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:
    <bullet> Involves a work restriction, or
    <bullet> Requires medical treatment beyond first aid, or
    <bullet> 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

[[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:
    <bullet> Management leadership,
    <bullet> Employee participation,
    <bullet> MSD management,
    <bullet> Job hazard analysis,
    <bullet> Hazard reduction and control,
    <bullet> Training, and
    <bullet> 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:
    <bullet> 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.
    <bullet> Policies that require every employee reporting an MSD or 
MSD signs and symptoms to submit to a drug or alcohol test.
    <bullet> 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:
    <bullet> Obtaining information about the specific tasks or actions 
the job involves;
    <bullet> Obtaining information about the job and problems in it 
from employees who perform the job;
    <bullet> Observing employees performing the job;
    <bullet> Identifying specific risk factors in the job; and
    <bullet> 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,
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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:
    <bullet> Repeat the same motion for the longest continuous period 
during the workshift;
    <bullet> Lift the heaviest objects or packages or the most objects 
per workshift;
    <bullet> Have the greatest degree of flexion or extension of their 
wrists;
    <bullet> Use vibrating hand tools for the most time during the 
workshift; and

[[Page 68338]]

    <bullet> 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:
    <bullet> 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.
    <bullet> Development of simplified non-expert approaches to 
measurement of risk factors (checklists)
    <bullet> 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.
    <bullet> Validation of symptom surveys and discomfort surveys 
(psychophysical measures) as risk factor identification tools
    <bullet> 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

[[Page 68342]]

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 (<radical>) 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

[[Page 68343]]

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

[[Page 68344]]

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,

[[Page 68345]]

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

[[Page 68346]]

three options. Employers are in compliance with this paragraph when the 
controls they have implemented:
    <bullet> 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,
    <bullet> 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
    <bullet> 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:
    <bullet> Materially reduce MSD hazards in the problem job using the 
incremental abatement process;
    <bullet> Reduce MSD hazards in the problem job to the extent 
feasible; or
    <bullet> 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:
    <bullet> 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;
    <bullet> Putting the desk on blocks; or
    <bullet> 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

[[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:
    <bullet> Its efficacy in practice depends on human behavior (the 
manager's, supervisor's and worker's),
    <bullet> Studies have shown that the effectiveness of PPE is highly 
variable and inconsistent from one worker to the next,
    <bullet> The protection provided cannot be measured reliably,
    <bullet> PPE must be maintained and replaced frequently to maintain 
its effectiveness,
    <bullet> It is burdensome for employees to wear, because it 
decreases mobility and is often uncomfortable,
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> 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).
    <bullet> Asking the industry trade associations for suggestions 
(the food retail industry, for example, worked as a group to reduce 
package weights (Tr. 4948).
    <bullet> Attending ergonomics conferences and trade shows.
    <bullet> Talking to the company's insurance agent about solutions 
that have worked for other companies.
    <bullet> 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:
    <bullet> Which control achieves the greatest reduction in employee 
exposure to the MSD hazard
    <bullet> Which is likely to be accepted and used by employees
    <bullet> Which takes the least amount of time to implement
    <bullet> 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:
    <bullet> Reductions in severity (measured as fewer days away from 
work)
    <bullet> Reductions in the number of symptoms reported in a 
symptoms survey
    <bullet> Reductions in workers' compensation costs
    <bullet> 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:
    <bullet> 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
    <bullet> 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:
    <bullet> 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,
    <bullet> Providing clearer criteria for hazard identification and 
control (i.e., the Basic Screening Tool) and compliance ``endpoint'' 
(i.e., the levels in Appendix D),
    <bullet> Ensuring that employees receive training in using the 
implemented controls so that the Quick Fix is more likely to be 
successful, and
    <bullet> 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:
    <bullet> No more than 1 prior MSD incident has occurred in the job 
in which another MSD incident is reported, and
    <bullet> 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:
    <bullet> Providing prompt MSD management to the injured employee 
(paragraph (o)(2)(i));
    <bullet> Talking with employees to identify those tasks they 
associate with the MSD incident (paragraph (o)(2)(ii));
    <bullet> Observing employees performing the job to identify the 
risk factors likely to have caused the MSD incident (paragraph 
(o)(2)(iii));
    <bullet> Asking employees for their ideas for reducing exposure to 
the MSD hazards (paragraph (o)(2)(iv));
    <bullet> Implementing measures within 90 days to control or reduce 
the MSD hazards (paragraph (o)(2)(v));
    <bullet> Training employees in using the controls implemented 
(paragraph (o)(2)(vi)); and
    <bullet> 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:
    <bullet> 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]]

    <bullet> 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:
    <bullet> promptly provide effective MSD management at no cost to 
the employee,
    <bullet> provide employees with access to a health care provider 
(HCP),
    <bullet> provide work restrictions the employer or the HCP find 
necessary,
    <bullet> provide the HCP with information about MSD management and 
the employee's job,
    <bullet> obtain a written opinion from the HCP about the MSD,
    <bullet> provide the employee with the HCP's opinion, and
    <bullet> 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:
    <bullet> MSD management is provided under different circumstances 
(only when a worker has an MSD incident and the job rises above the 
action trigger),
    <bullet> MSD management is no longer described as being for the 
purpose of ``to prevent their (the employee's) condition from getting 
worse'',
    <bullet> the employer is not required to determine the need for 
work restrictions or other actions before consultation with a health 
care provider,
    <bullet> the employer must provide slightly different information 
to the health care provider,
    <bullet> the health care provider is not afforded a right to walk 
through the employers workplace,
    <bullet> minor editorial changes to the numbering, language and 
sequence of the requirements to simplify the sections and reduce 
duplication, and
    <bullet> 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:
    <bullet> 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);
    <bullet> 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);
    <bullet> Medical management is addressed in other OSHA standards 
(1910.151 Medical services and first aid.) (Exs. 30-3765);
    <bullet> 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);
    <bullet> 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);
    <bullet> 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);
    <bullet> 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);
    <bullet> The proposed provisions would interfere with existing 
collective bargaining agreements (see, e.g., Exs. 30-3284, 30-3765, 32-
266-1);
    <bullet> 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
    <bullet> 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:
    <bullet> 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).
    <bullet> 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.
    <bullet> Spieler E. Perpetuating Risk? Workers' Compensation and 
the Persistence of Occupational Injuries, 31 Houston Law Rev. 119-264 
(1994).
    <bullet> 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:
    <bullet> The scope of the training provision,
    <bullet> The number of employees to be trained,
    <bullet> Whether supervisory employees should be trained, and
    <bullet> 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:
    <bullet> Many workers experience problems in less than a year (Ex. 
32-198-4-1/42).
    <bullet> Training should be required annually and whenever jobs or 
conditions change (Ex. 30-3686).
    <bullet> 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:
    <bullet> 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).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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):
    <bullet> The employer's ergonomics program and their role in it;
    <bullet> The signs and symptoms of MSDs and ways of reporting them;
    <bullet> The risk factors and MSD hazards present in the employee's 
job, as identified by the Basic Screening Tool and the job hazard 
analysis;
    <bullet> The employer's plan and timetable for addressing the risk 
factors and hazards identified;
    <bullet> How to use engineering, work practice, and administrative 
controls, or any PPE, that will be used in the job; and
    <bullet> 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:
    <bullet> 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).
    <bullet> Work Restriction Protection should be explained during the 
initial training (Exs. 30-4538, 32-339-1).
    <bullet> First-line supervisors as well as the program manager 
should have hazard analysis training (Ex. 30-3826).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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:
    <bullet> Allow the use of electronic media, telephone reviews, and 
videos (see, e.g., Exs. 30-3826, 30-3765, 30-434, 30-3392).
    <bullet> 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).
    <bullet> 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).

[[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:
    <bullet> 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:

    <bullet> Part A, Description of Biomechanical Risk Factors;
    <bullet> Part B, Overview of the Health Effects Evidence;
    <bullet> Part C, Evidence on Neck and Shoulder Disorders;
    <bullet> Part D, Evidence on Upper Extremity Disorders;
    <bullet> Part E, Evidence on Back Disorders;
    <bullet> Part F, Evidence on Lower Extremity Disorders; and
    <bullet> 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:

    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> National Research Council. (1999) Work-Related 
Musculoskeletal Disorders: Report, Workshop Summary, and Workshop 
Papers. National Academy Press. (Ex. 26-37);
    <bullet> National Institute for Occupational Safety and Health. 
(1997) Musculoskeletal Disorders and Workplace Factors. Centers for 
Disease Control and Prevention (Ex. 26-1);
    <bullet> National Institute for Occupational Safety and Health. 
(1998) Elements of Ergonomics Programs, A Primer Based on Workplace 
Evaluations of Musculoskeletal Disorders. (Ex. 26-2);
    <bullet> European Agency for Safety and Health at Work. Work-
related neck and upper limb musculoskeletal disorders (1999). (Ex.500-
71-28);
    <bullet> Department of Labor and Industries, Washington State. (5/
25/00) Concise Explanatory Statement, WAC 296-62-051, Ergonomics (Ex. 
500-71-93);
    <bullet> 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);
    <bullet> National Codes of Practice for the Prevention of 
Occupational Overuse Syndrome-Worksafe Australia [NOHSC:2013(1994)], 
(Ex. 500-71-2);
    <bullet> National Standard for Manual Handling and National Code of 
Practice for Manual Handling, Worksafe Australia. 1990 (Ex. 500-71-4);
    <bullet> Occupational Overuse Syndrome: Guidelines for Prevention 
and Management, Occupational Safety and Health Services, Department of 
Labor, New Zealand (Ex. 500-71-12);
    <bullet> Ergonomics (MSI) Requirements, British Columbia, Canada 
(Ex. 32-339-1-6);

[[Page 68438]]

    <bullet> Regulations and Code of Practice, (Manual Handling) 
Occupational Health and Safety Regulations 1988. Victoria, Canada. (Ex. 
500-71-17);
    <bullet> European Communities Council Directive on Manual Handling 
(Ex. 32-339-1-12);
    <bullet> 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);
    <bullet> American Conference of Governmental Industrial Hygienists. 
1987. Ergonomic Interventions to Prevent Musculoskeletal Injuries in 
Industry (Ex. DC-386, Tr. 16291-335);
    <bullet> American Industrial Hygiene Association. 1994. Ergonomic 
Guide Series (Ex. 32-133-1);
    <bullet> 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:

    <bullet> The participation rate was <gr-thn-eq> 70%. This 
criterion limits the degree of selection bias in the study.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> High levels of static contraction, prolonged static loads, 
extreme working postures involving the neck/shoulder muscles and an 
increased risk for neck/shoulder MSDs;
    <bullet> Exposure to a combination of risk factors (e.g., force and 
repetition, force and posture) and CTS;
    <bullet> Job tasks that require a combination of risk factors 
(e.g., highly repetitious, forceful hand/wrist exertions) and hand/
wrist tendinitis;
    <bullet> High level exposure to hand-arm vibration and vascular 
symptoms of hand-arm vibration syndrome;
    <bullet> Work-related lifting and forceful movements;
    <bullet> Exposure to whole-body vibration and low-back disorder.
    2. Evidence exists for the following associations:
    <bullet> 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;
    <bullet> Forceful exertion and neck MSDs, with ``forceful work'' 
involving forceful arm or hand movements, which generate loads to the 
neck/shoulder area;
    <bullet> Highly repetitive work and shoulder MSDs;
    <bullet> Repeated or sustained shoulder postures with greater than 
60 degree of flexion or abduction and shoulder MSDs;
    <bullet> Highly repetitive work, both alone and in combination with 
other factors and carpal tunnel syndrome;
    <bullet> Work involving hand/wrist vibration and CTS;
    <bullet> Any single factor (repetition, force and posture) and 
hand/wrist tendinitis;
    <bullet> Work-related awkward postures and low-back disorders.
    3. Insufficient evidence of work-relatedness exists for the 
following associations:
    <bullet> Vibration and neck disorders;
    <bullet> Force and shoulder MSDs;
    <bullet> 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:
    <bullet> Temporal ordering requires that the cause be present 
before the effect is observed.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:

    <bullet> 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;
    <bullet> 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;
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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):

    <bullet> 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.
    <bullet> 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.
    <bullet> Research clearly demonstrates that specific 
interventions can reduce the reported rate of musculoskeletal 
disorders for workers who perform high-risk tasks.
    <bullet> 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:
    <bullet> American Association of Occupational Health Nurses (Ex. 
30-2387)
    <bullet> American College of Occupational and Environmental 
Medicine (Ex. 30-4468, Tr. 7637-7690)
    <bullet> American Conference of Governmental Industrial Hygienists 
(Ex. DC-386, Tr. 16291-335)
    <bullet> American Industrial Hygiene Association (Ex. 32-133-1, Tr. 
16464-72, Tr. 16518-27)
    <bullet> American Nurses Association (Ex. 30-3686, Tr. 15875-95)
    <bullet> American Occupational Therapy Association (Ex. 30-4777, 
Tr. 18095-18121)
    <bullet> American Public Health Association (Ex. 30-626, Tr. 17649-
17704)
    <bullet> American Society of Safety Engineers (Ex. 32-21-1-2; Tr. 
11612)
    <bullet> Human Factors and Ergonomics Society (Ex. 502-472)
    <bullet> National Association of Orthopedic Nurses (Tr. 10578-
10588)
    <bullet> 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) <SUP>1</SUP>
----------------------------------------------------------------------------------------------------------------
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.
<SUP>1</SUP> 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 <Register> = 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

[[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:
    <bullet> Group 1, very low force, low repetition;
    <bullet> Group 2, low force, very high repetition;
    <bullet> Group 3, moderate force, moderate repetition;
    <bullet> Group 4, high force, moderate repetition; and
    <bullet> 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)<SUP>1</SUP>
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
<SUP>*</SUP> =p0.05.
<SUP>1</SUP> 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/s<SUP>2</SUP> 
to 2 m/s<SUP>2</SUP>. 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/s<SUP>2</SUP> * * * 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 <gr-thn-eq> 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 
(OR<gr-thn-eq>3) 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 (OR<gr-thn-eq>5) 
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:
    <bullet> 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.
    <bullet> There is a strong biological plausibility between the 
incidence of MSDs and the causative exposure factors in high 
exposure occupational settings.
    <bullet> 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:
    <bullet> 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).
    <bullet> 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).
    <bullet> 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).
    <bullet> 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.
    <bullet> 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-
                                                       <gr-thn-eq>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%
                                                       <gr-thn-eq>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)
                                                       <gr-thn-eq>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%
                                                       <gr-thn-eq>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)
                                                       <gr-thn-eq>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)
                                                       <gr-thn-eq>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)
                                                       <gr-thn-eq>
----------------------------------------------------------------------------------------------------------------
                                                  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-
                                                       <gr-thn-eq> 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%
                                                       <gr-thn-eq>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-<gr-thn-eq>8 hr:  2.1 (1.3-3.6)
                                                       <gr-thn-eq>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.             <gr-thn-eq>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)
                                                       <gr-thn-eq>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 (r<SUP>2</SUP>=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-<plus-minus>)
                                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)
                                                       <gr-thn-eq>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)
                                                       <gr-thn-eq>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)
                                                       <gr-thn-eq>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)
                                                       <gr-thn-eq>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)
                                                       <gr-thn-eq>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)
                                                       1<ls-thn-eq>LI <ls-thn-eq>3:  3.57
                                                        (0.86)
                                                       LI>3:  4.07 (0.73)
                                                       RWL*=0:  3.86 (0.75)
                                                       ANOVA (<greek-a>=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 <ls-thn-eq>1:  1.1 (0.2-5.3)
                                                       1LI <ls-thn-eq>2:  1.5 (0.6-3.8)
                                                       2LI <ls-thn-eq>3:  2.5 (1.3-4.9)
                                                       LI <gr-thn-eq>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
                                                       <gr-thn-eq>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-
                                                       <gr-thn-eq>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 <gr-thn-eq>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 <gr-thn-eq>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 <gr-thn-eq>60
                                                        deg. (% of time) [unadj]:
                                                       Cases=1, controls=0 (p=0.04)
                                                       Median elevation <gr-thn-eq>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......  <gr-thn-eq>10%:  5.1 (p=0.0001)
                                                       >0%-10%:  1.7
                                                       <gr-thn-eq>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)
                                                       <gr-thn-eq> 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)
                                                       <gr-thn-eq> 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
                                                       <gr-thn-eq>10%:  6.1 (p=0.014)
                                                       Severe flexion:
                                                       0%:  1.0
                                                       0-10%:  4.4
                                                       <gr-thn-eq>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)
                                                       <gr-thn-eq>60 min:  1.8 (1.1-3.1)
                                                       Women
                                                       1-59 min:  1.1 (0.8-1.6)
                                                       <gr-thn-eq>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)                        .....................
                                 <gr-thn-eq> 1.
                                Vascular stage <gr-    1.10 (p0.05)                        .....................
                                 thn-eq> 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 <gr-thn-eq> 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)
                                                       <gr-thn-eq> 20 hr/week:  0.5 (0.2-
                                                        1.4)
                                                       <gr-thn-eq> 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.             <ls-thn-eq> 2 factors:  1.0          al.(1997: Ex. 38-
 plus parity <gr-thn-eq> 3).                           3 factors:  5.6 (1.6-24.5)           396)
                                                       4 factors:  93.7 (13.4-93.8)
                                                       <gr-thn-eq> 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

[[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<Register> 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:
    <bullet> Use of different measurement scales;
    <bullet> Use of different analytical strategies to categorize risk 
levels; and

[[Page 68523]]

    <bullet> 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 <greek-b>: 0.06-
                                                                                                                               0.16; Psychosocial <greek-
                                                                                                                               b>: 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 <greek-b>: 0.16-
                                                                                                                               0.21; Psychosocial <greek-
                                                                                                                               b>: 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 <greek-b>: n.s.;
                                                                                                                               Psychosocial <greek-b>:
                                                                                                                               .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 (R<SUP>2</SUP> 
changes 0.11-

[[Page 68525]]

0.15), with smaller additions to model R<SUP>2</SUP>s from 
psychological demands, decision latitude, and employee relationship 
with the supervisor (R<SUP>2</SUP> changes 0.03-0.12). The effects of 
postural variables on upper torso pain and stiffness were greater than 
those for pain and numbness (R<SUP>2</SUP> changes 0.19-0.32), while 
psychosocial effects were reduced (R<SUP>2</SUP> changes 0.01-0.08). 
Interaction terms between keyboard height and psychosocial variables 
added to the model R<SUP>2</SUP>s (R<SUP>2</SUP> 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 tissues involved.

    The text goes on to cover epidemiologic evidence; pathophysiology 
of biomechanical loads, connective tissue, muscle and nerve. Chapters 
on rehabilitation of the wrist, elbow and shoulder all indicate that 
time limited periods of rest may be indicated for acute MSDs. The book 
is the result of a workshop organized by the National Institute of 
Arthritis and Musculoskeletal and Skin Disease, NIH. Co-sponsors 
included NIOSH, CDC, Orthopedic Research and Education Foundation, the 
National Center for Medical Rehabilitation Research, and others. One 
expert witness Dr. Stanley Bigos, who testified on behalf of one 
industry group organized in opposition to OSHA's proposed standard in 
general, is a member of AAOS.
    In June 1998, Clinical Orthopedics and Related Research (Exs. 26-
1310, 26-1322, 26-1316) covered Cumulative Trauma Disorders of the 
Upper Extremity through a joint sponsorship of the Association of Bone 
and Joint Surgeons, the Academic Orthopedic Society, the Hip Society, 
the Musculoskeletal Tumor Society, and the Knee Society. This text 
again covered sections regarding the effects of physical work factors 
(i.e. repetition) on nerve, muscle, joints, and certain clinical 
conditions.
    Similarly, the National Academy of Sciences, in 1999, (Ex. 26-37) 
published the results of a workshop they sponsored on work-related 
MSDs. While there was some variance in opinions about the contribution 
of physical work factors to MSDs, there was agreement among most that 
physical work factors contribute to MSDs. ``MSDs are multifactorial, 
with work and biomechanical aspects of work being important 
contributors.'' The NAS reviewers also explained the concepts behind 
temporary rest or activity modification for injured tissues.
    Contrary to the view of NAS, Dr. Stanley Bigos provided the 
following comment:

    Contrary to ergonomists' beliefs, usage is a prerequisite to 
health--using the body, even vigorously using the body, is not 
intrinsically harmful. That is why repetitive motion that fatigues 
musculoskeletal tissues is medically prescribed, to the point of 
being the preferred method of treatment even of tissues that have 
sustained traumatic injury or age-related degeneration. Properly 
conditioned; a traumatically injured joint may be restored to full 
function by the protection of muscles stronger than before the 
injury. [Ex. 32-241-3-4]

    Dr. Bigos' statement that ``repetitive motion that fatigues 
musculoskeletal tissues is medically prescribed, to the point of being 
the preferred method of treatment even of tissues that have sustained 
traumatic injury or age-related degeneration,'' while having elements 
of validity, again fails to look at the various work-related MSDs as 
well as the stage and severity of the condition. There is supporting 
literature and consensus, including clinical practice guidelines (e.g. 
ACOEM; Ex. 38-234) that recommend periods of splinting and rest for 
MSDs like acute tendonitis or stenosing tenosynovitis, DeQuervain's 
disease and carpal and cubital tunnel syndromes. A comparison could be 
made to a patient who experiences an acute myocardial infarction with 
muscle damage. In this scenario, rehabilitation often includes 
carefully controlled exercise appropriate to the stage of recovery and 
level of function of the remaining heart muscle. It would not be 
reasonable to presume that a patient one day after a significant 
myocardial would be improved if forced to run a marathon. Neither would 
a worker benefit from intensive and uncontrolled exercise after the 
onset of an acute MSD with significant inflammation, degeneration and 
loss of function.
    The same commenters stated that OSHA's use of the term ``rest'' in 
the proposal implied that OSHA recommends or promotes bed rest for 
workers with MSDs. This statement is incorrect and fails to recognize 
the purpose and application of the standard. This standard is not 
intended as a guideline for the medical treatment of MSDs. Medical 
treatment is left to the licensed health care provider, utilizing sound 
medical judgement, and evidence based literature and clinical practice 
guidelines.
    What OSHA did intend when it used the term ``rest'' was appropriate 
activity modification. The standard supports return to work where there 
are effective controls of biomechanical factors causing or contributing 
to the MSD. The preamble to the proposal stated:

    Although some covered MSDs are at such an advanced state that 
complete removal from the work environment is the appropriate 
treatment, it should usually be the recommendation of last resort. 
Where appropriate, work restrictions that allow the employee to 
continue working (e.g., in an

[[Page 68536]]

alternate 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.

Dr. Stanley Bigos argued that the proposed ergonomics rule was at odds 
with the recommendations of the AHCPR guidelines, in that the proposed 
rule recommended rest, reduced work, and inactivity in response to 
pain, while the AHCPR guidelines recommend increased activity and 
conditioning (Ex. 32-241-4).
    The AHCPR guidelines (Ex. 32-241-3-93) do recommend that adults 
with acute low back pain maintain activity. However, the guidelines do 
not suggest that patients with acute low back pain immediately return 
to work involving physical task 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: ``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, 
``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.)''
    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 recognized 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]

    As to the duration of activity modification, the AHCPR guidelines 
(Ex. 32-241-3-93) demonstrate an understanding of the impact that the 
physical demands of work have on recovery and modified activity. They 
state that ``The nature and duration of limitations will depend on the 
clinical status of the patient and the physical requirements of the 
job.''
    While the AHCPR guidelines (Ex. 32-241-3-93) did not find evidence 
that bed rest was beneficial for the majority of individuals with acute 
low back pain, the panel did acknowledge that, in some circumstances, 
bed rest may be required for select patients with acute low back pain 
(``The majority of low back patients will not require bed rest. Bed 
rest for 2 to 4 days may be an option for patients with severe initial 
symptoms of primarily leg pain.'')
    Program elements in OSHA's proposal are also consistent with the 
British guidelines, that 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. [Ex. 500-118-2]

    Some commenters appeared to confuse the concepts relevant to the 
practice of sports medicine with concepts relevant to the prevention of 
MSDS in workers. For example, Gibson, Dunn & Crutcher state

    Increase in physical activity (compared to past activity level) 
is a guiding principle in musculoskeletal rehabilitation, and has 
been the primary intervention and treatment in many musculoskeletal 
disorders. These treatment protocols include many of the physical 
stresses that OSHA recommends avoiding. [Ex. 500-118]

    This again is an overly simplistic statement, since there are 
differences in the intensity, duration, and/or frequency of guided 
rehabilitation of an injury that is tailored to the individual's type 
of injury, severity of the condition, stage of rehabilitation and the 
individual's conditioning, as opposed to intensity, duration, and/or 
frequency of physical job factors that are based upon delivery of goods 
or services and have no bearing upon individual capabilities or 
injuries. Dr. Tapio Videman, another expert witness for the UPS 
attempted to explain the importance of physical activity as follows:

    Sports medicine--and much of modem mainstream medicine--views 
physical loading as a means of increasing fitness, strength, and 
function, and is part of most related intervention today. Why would 
physical loading be harmful in work but beneficial in leisure time? 
* * * Physical activity can promote physical adaptation to loading, 
and restore and maintain functional capacity. This may explain why 
there is some evidence of the benefits of exercise for spinal 
disorders. [32-241-30-20]

    However, comparisons of workers with young and highly skilled 
athletes is not appropriate. This is pointed out by the ISSLS text on 
the Lumbar Spine (Wiesel et al.1996; Ex. 26-1620). The following quote 
is from the chapter on biomechanics:

    Comparison of athletic exercises with industrial labor is 
complicated because, in the athletic field, (1) one deals with 
young, healthy subjects; (2) there is a selection of individuals for 
the specific tasks; (3) the specific task is always accompanied by 
remedial exercises. In industrial labor, one is dealing with the 
average population. There is almost no selection of the individuals, 
and there are many monotonous tasks that are not interrupted by 
remedial exercise. [Ex. 26-1620]

    Dr. Michael Vender explained his belief that soft tissue has almost 
limitless capacity to recover from injury.

    We cannot explain the natural process of aging and gradual 
deterioration of all body parts by the concept of cumulative trauma. 
The most basic flaw in this logic revolves around the comparison of 
the human body to a piece of metal [as reflected in the 
biomechanical model espoused by ergonomists). [Unlike metal], the 
body, when stressed or even injured, has the ability to heal and 
recover.--When one repeatedly bends a piece of plastic, it becomes 
permanently deformed. When one repeatedly exercises a muscle, it 
becomes stronger and more functional. [Ex. 32-241-3-19]

    This belief is in contrast to the opinion of the NAS workshop 
(1999) (Ex. 26-37) noted above, and fails to recognize concepts of 
muscle disruption, tendon and ligament viscoelastic deformation and 
creep discussed in the Health Effects Preamble.
7. Additional Criticisms of Epidemiological Studies Raised by 
Commenters
    Gibson, Dunn & Crutcher in their post-hearing comments (Ex. 500-
118, Section B, pgs. 65-81) supply critiques of additional ``studies on 
which OSHA relies or may rely in support of the proposed rule.'' (id., 
pg. 65). OSHA's response to these critiques is given below.
    Gibson Dunn & Crutcher criticize the study by Latza et al. (2000, 
Ex. 38-424) that examined occupational risk factors of low back pain 
among construction workers. Among their criticisms, Gibson Dunn & 
Crutcher argue that the authors drew causal inferences from a study 
that is only an exploratory analysis. Further, they claim that the 
researchers were vague in their methods and did not come up with a 
single promising association.
    OSHA disagrees with these criticisms. First, the study as a whole 
cannot be

[[Page 68537]]

fairly characterized as an ``exploratory analysis.'' This study is an 
adequately designed longitudinal epidemiological study where 
construction workers who reported no low back pain at baseline were 
followed for three years. The ``exploratory approach'' reported by the 
authors refers not to the study as a whole but rather to a detailed 
analysis of the data to identify potential risk factors that might be 
used to predict low back pain. The authors describe a detailed process 
for focusing on factors most likely to have caused the observed reports 
of low back pain. Second, OSHA disagrees that the authors were vague in 
their methods. Various aspects of the study, such as the selection of 
study subjects, data collection, and data analysis, were described in 
clear enough detail that would allow the reader to assess the results 
reported. Finally, the authors noted that causality cannot be 
established with this study. However, the purpose of the study was to 
identify possible risk factors for low back pain among these workers 
that might aid in the identification of hazardous components in the 
work that can guide effective primary intervention. In this regard, the 
authors report positive associations that show that certain 
occupational risk factors can be predictive of low back pain.
    Gibson, Dunn & Crutcher criticize a study by Punnett et al. ``A 
comparison of Approaches to Modeling the Relationship between Ergonomic 
Exposures and Upper Extremity Disorders'' (2000, Ex. 500-71-43). This 
is a methodology study concerning approaches for combining independent 
and dependent variables for the purpose of exposure-response analysis. 
This study uses the information on upper extremity disorders in vehicle 
manufacturing found in an earlier Punnett et al. (1998, Ex. 26-38) 
study), which these same commenters criticized previously (Ex. 32-241-
4, pg. 144). OSHA has responded to those criticisms elsewhere in this 
preamble.
    Gibson, Dunn & Crutcher have two main criticisms of the Kurppa et 
al., (1991, Ex. 26-53) study concerning the incidence of tenosynovitis 
or peritendinitis and epicondylitis in a meat-processing factory. The 
commenters claim that the diagnostic definition of the response 
tenosynovitis or peritendinitis (agreed to by the plant physician), 
``boils down to focal soreness/tenderness and nothing more specific or 
mysterious than that.'' (Ex. 500-118, pg. 71). In response, OSHA notes 
that, in order to be included as a response in the study, the condition 
needed to be severe enough in each case to qualify for sick leave (Ex. 
26-53, pg. 33). As a result, OSHA believes that the response is a 
meaningful health effect, i.e., because it was serious enough to 
warrant time away from work for recuperation. Gibson, Dunn & Crutcher 
(Ex. 500-118 pg 71) also claim that, ``By its very nature, a 
surveillance study perturbs the experience of discomfort.'' However, 
this type of physiological biasing factor would appear to have only a 
minimal or no effect on the end results since the rate of occurrence of 
tenosynovitis or peritendinitis and epicondylitis, for both men and 
women, was shown typically to be an order of magnitude higher for 
strenuous compared to non-strenuous meat processing jobs (Ex. 26-53, 
pg. 34).
    Gibson Dunn & Crutcher correctly point out (Ex. 500-118, pg. 72-73) 
that the utility of participatory ergonomics was not evaluated in the 
Roquelaure et al. (1997, Ex. 38-96) study. However, OSHA used this 
study only to show an association between stress variables and carpal 
tunnel syndrome (CTS). The role of participatory ergonomics in reducing 
CTS was not alluded to by OSHA.
    Gibson Dunn & Crutcher correctly point out (Ex. 500-118, pg. 73) 
that in the Viikari-Juntura et al. (1994, Ex. 26-873) study what is 
defined as severity of neck trouble is in fact the frequency of self-
reported symptoms (pain, ache, stiffness or numbness). As a result, 
Gibson Dunn & Crutcher believe the possibility exists that the 
subject's statements concerning severe neck trouble could be 
misleading. OSHA used the Viikari-Juntura et al. study to only show an 
association between neck symptoms and stress factors. OSHA did not 
comment on the severity of the symptoms.
    Gibson Dunn & Crutcher note (Ex. 500-118, pgs. 73-74) that the 
authors of the Kearns et al. (2000, Ex. 500-71-34) study did not intend 
that the results of the study on the prolongation of median motor and 
sensory nerve latency be generalized beyond the effects of work related 
to pork processing. OSHA agrees that the study supplies limited 
information about the relationship between workplace physical factors 
and CTS.

Stenlund et al.studies, Exs. 26-733 and 26-1479

    Gibson Dunn & Crutcher (Ex. 500-118 pg. 70-71) have criticized the 
1992 study by Stenlund et al. (Ex. 26-733) of osteoarthrosis and the 
1993 Stenlund et al. (Ex. 26-1459) of shoulder tendinitis. First, the 
1992 Stenlund et al. study is criticized for its conclusion that 
radiographic evidence of osteophytes (spurs) in the acromioclavicular 
joint is a predictor of osteoarthrosis causing cartilage loss and 
abnormal reparative processes. Gibson Dunn & Crutcher argue that in 
other joints, such as the knee, increased usage leads to osteophytosis 
(spurs) and increased preservation of cartilage, which is good. They 
question whether the Stenlund et al. (1992) paper is detecting a 
``bad'' outcome. Gibson Dunn & Crutcher also criticize the 1993 
Stenlund et al. paper for using shoulder tendinitis as an adverse 
effect measure, arguing that shoulder tendinitis is subject to overt 
reporting and recording bias. They conclude that these types of outcome 
measures are not appropriate to be used in epidemiological studies.
    With regard to the 1992 Stenlund et al. study, the critics are 
comparing minimal changes commonly observed with habitual usage of a 
joint such as the knee (e.g., increased preservation of cartilage) to 
severe osteoarthrosis, from heavy manual work and vibration, of a 
joint, in this case the shoulder. In the Stenlund study, radiographs 
were classified into 5 grades of osteoarthrosis (0 = normal; 1= minimal 
changes; 2 = moderate changes, more severe changes to cartilage and 
bone structure begins to be affected; 3 = severe osteoarthrosis, and 4 
= totally destroyed joint). Those classifying the radiographs were 
blinded as to exposure. The authors did not find significant 
differences in lower grade changes. However, they did observe that 
among rock blasters and bricklayers who had exposure to heavy load and 
vibration compared to foremen who did not, there was a significant 
increase in grade 2 and 3 osteoarthrosis. Therefore, OSHA believes that 
Gibson Dunn & Crutcher are actually confusing two different health 
outcomes in their criticism. The study by Stenlund et al. (1992) would 
support the hypothesis that normal habitual use of the shoulder might 
cause increased preservation of the cartilage. However, shoulder joints 
exposed to heavy loads and vibrations such as those examined in the 
study show radiographic evidence of severe osteoarthrosis.
    With regard to the 1993 Stenlund et al. study, the authors noted 
the potential for misclassification when using tendinitis as a measure 
of outcome. They agree that in some epidemiological studies, clinical 
diagnosis of tendinitis may not be an appropriate measure of prevalence 
in the population, since some individuals with tendinitis may not see a 
physician for their symptoms, thus creating a selection bias. However, 
the authors assert that this type of bias is overcome in their study by 
the use of a cross sectional study design. In order to further lessen 
the potential for misclassification, the authors also

[[Page 68538]]

included symptoms of pain during the last year that could have 
originated from structures other than the tendons or muscle attachment 
inflamation in addition to using palpation and isometric contraction. 
They reasoned that persons experiencing pain in their shoulder in the 
last year and who on examination have pronounced pain reaction to 
palpation and contraction, have probably had a disorder in the muscle 
attachment or tendon, that in clinical practice would have been 
classified as tendinitis. OSHA believes that, with proper study design 
and control for misclassification, as was done in the Stenlund study, 
clinically diagnosed shoulder tendinitis is an adequate measure of 
effect. Thus, the Stenlund et al., 1993 study can be used with other 
studies in the record to form a reliable weight of evidence on which to 
base the agency's health effects conclusions.
    Gibson Dunn & Crutcher also criticized the 1990 study on 
degenerative disc disease among concrete workers and house painters by 
Riihimaki et al. (Ex. 502-455). They argue that the results of this 
study are ``not compelling'' because the authors found insignificant 
risk ratios and, thus, are very likely to be influenced by unmeasured 
variables. OSHA finds this argument unconvincing for the following 
reasons. Number one, the authors did, in fact, find a statistically 
significant risk of detectable degenerative changes in the lumbar spine 
among concrete workers (38%) compared to house painters (26%). 
(Relative Risk=1.4, (CI 1.1-1.8; p0.01)) In this study, concrete 
reinforcement workers were compared to house painters. The authors 
noted that the load on the back is distinctly different among concrete 
workers compared to house painters. The authors also note that in 
Finland, persons in these trades have very similar socio-economic 
status and lifestyles, thus making it more likely that the detected 
difference between these groups is due to occupational exposures rather 
than other factors. Moreover, as a part of the study design the 
concrete reinforcement workers and house painters were matched by age, 
earlier back accidents, height, body mass index and smoking. These 
covariates were included in a mutivariate logistic regression to 
perform the statistical analysis to control for possible confounding 
factors likely to affect disc degeneration. After controlling for these 
factors, the authors still reported statistically significant effects. 
In addition, the authors noted that workers, to be included in the 
study, had to have at least 5 years seniority, thus creating the 
possibility for negative bias due to health-based self-selection of 
workers in the more physically demanding job (i.e. concrete workers). 
The effect of this negative bias, however, would underestimate the risk 
ratios. In an attempt to understand the underlying etiology of this 
disc degeneration, the authors did additional analyses looking at 
different segments of the lumbar region and different degenerative 
spinal changes (e.g. disc space narrowing, spondylophytes, and endplate 
sclerosis). In some of these sub-analyses for certain lumbar regions, 
there was no statistically significant effect. Overall, however, the 
authors found a significant association between work and disc 
degeneration while controlling for confounders. Therefore, OSHA does 
find these results compelling and generally supportive of its health 
effects assessment.
    Gibson Dunn & Crutcher criticized the 1994 study of sciatic pain 
among men in machine operating, dynamic physical work and sedentary 
work by Riihimaki et al. (1994, Ex. 26-1188). They claim that the 
associations observed in this study are ``barely significant'' (Ex. 
500-197, pg. 69) and are no more significant than the associations 
observed with physical exercise. In addition, they state that the 
observed increases are negatively influenced by workers' self reporting 
of tasks, ``an inadequate definition of sciatica'' and recall bias.
    OSHA is unsure as to what these critics mean by ``barely'' 
significant. The authors reported a statistically significant increase 
in sciatic pain among machine operators and carpenters compared to 
office workers. For machine operators the relative risk =1.6 (95% CI 
1.2-2.2) and for carpenters was 1.7 (95% CI 1.3-2.4). This statistical 
significance remained even after controlling for a variety of risk 
factors (e.g., age, seniority, education, physical exercise, smoking, 
car driving, and prior back accidents). Adjusted relative risks were 
1.4 and 1.5.
    The authors do acknowledge that the reporting of symptoms of 
sciatica can be subjective, as can a worker's perception of physical 
task. In order to minimize this type of bias, they used explicit 
descriptions of symptoms and tasks to ensure uniform understanding of 
the concepts. The authors also recognize the potential of recall bias 
to negatively influence the results. However, they note that this 
misclassification also depends not only on the recall error but also 
the incidence rate of the symptoms. They conclude that the recall error 
bias in the observed risk ratios is small if ``by the end of follow-
up'' the rate of reporting symptoms among the misclassified subjects 
does not deviate much from the overall incidence rate. Thus, while OSHA 
acknowledges the potential bias pointed out by the critics of this 
study, the agency believes that these sources of bias have been taken 
into consideration in this study to such an extent that the observed 
increased risk ratios can be accepted with some confidence. In 
addition, OSHA believes that these observed risk ratios are more than 
barely significant and, when viewed in the context of other positive 
epidemiological evidence, contribute to the weight of evidence and the 
strength of the agency's overall health effects assessment.
    Gibson Dunn & Crutcher also criticize four other epidemiology 
studies OSHA relied on in contributing to the strength of the agency's 
overall health effects assessment: two studies by Silverstein et al. 
(Exs. 26-34 and 26-1404), a study by Venning et al. (Ex. 500-41-49), 
and a study by Punnett et al. (Ex. 26-39). OSHA responds to criticisms 
of these 4 studies in on Section G:3-Exposure-Response.

VI. Risk Assessment

A. Introduction

    The United States Supreme Court, in the Benzene decision 
(Industrial Union Department, AFL-CIO v. American Petroleum Institute, 
448 U.S. 607 (1980)), has ruled that the OSH Act requires, prior to the 
issuance of a new standard, that a determination be made that there 
exists a significant risk of material impairment and that issuance of 
the new standard will substantially reduce that risk. The Court stated 
that ``before he can promulgate any permanent health or safety 
standard, the Secretary is required to make a threshold finding that a 
place of employment is unsafe in the sense that significant risks are 
present and can be eliminated or lessened by a change in practices'' 
(448 U.S. 642). The Court also stated that ``the Act does limit the 
Secretary's power to require the elimination of significant risks'' 
(448 U.S. 644).
    In the Cotton Dust case (American Textile Manufacturers Institute 
v. Donovan, 452 U.S. 490 (1981)), the Court reaffirmed the position it 
had previously taken in the Benzene decision that a risk assessment is 
not only appropriate but required to identify significant health risks 
in workers and to determine if a new standard will reduce those risks. 
Although the Court did not require OSHA to perform a quantitative risk 
assessment in every case, the Court implied, and OSHA as

[[Page 68539]]

a matter of policy agrees, that assessments should be put into 
quantitative terms to the extent possible.
    The weight of evidence presented in the Health Effects section of 
this preamble (Section V) demonstrates a causal relationship between 
exposure to workplace risk factors and work-related musculoskeletal 
disorders. As discussed in that section, the major workplace risk 
factors include exposure to repetitive motion, force, awkward postures, 
contact stress, and segmental vibration. The Health Effects section 
also demonstrates that the risk associated with occupational exposure 
to these risk factors increases with frequent or prolonged exposure to 
these risk factors, and that the risk is increased when workers are 
exposed to more than one risk factor in a job.
    OSHA has determined that there is substantial evidence that 
exposure to these biomechanical stressors at work can cause or 
contribute to the development of MSDs and that reductions in these 
stressors can reduce the number and severity of these work-related 
MSDs. The underlying evidence falls into three broad categories:

    Studies of groups of workers showing a relationship between 
exposure to biomechanical risk factors in the workplace and an 
increased incidence or prevalence of MSDs;
    Biomechanical studies that show that adverse tissue reactions 
and damage can occur when tissues are subjected to high forces and/
or a high number of repetitive movements, which occur when workers 
are substantially exposed to biomechanical risk factors; and
    Scientific and case studies that demonstrate that workplace 
interventions designed to reduce exposures to biomechanical risk 
factors are effective in reducing the internal forces imposed upon 
tissues and the incidence and severity of MSDs.

    In the Health Effects section of this preamble, OSHA summarizes 
data and findings from more than 170 epidemiological studies of the 
incidence or prevalence of MSDs in groups of workers who are exposed to 
physical risk factors in their jobs. In most of these studies, the MSD 
prevalence of a group of exposed workers is compared to that in another 
worker group that is not exposed to the risk factors of interest. If 
the exposed group shows a higher MSD prevalence than does the reference 
group, the study provides evidence of an association between exposure 
and an increased risk of developing MSDs, particularly if the study is 
of good quality and adequately controlled for potentially confounding 
factors (such as age and gender) and biases.
    Many of these epidemiological studies were reviewed by the National 
Institute for Occupational Safety and Health (NIOSH) in 1997 (Ex. 26-1) 
to evaluate the strength of the evidence for a causal relationship 
between several types of MSDs and the workplace risk factors of force, 
repetitive motion, awkward posture, and vibration. More than 600 peer-
reviewed studies were critically reviewed, making this one of the 
largest human data bases ever built to examine work-related adverse 
health outcomes. NIOSH found that for most combinations of MSDs and 
risk factors, the evidence in humans that a causal relationship existed 
between workplace exposure to risk factors and the development of MSDs 
was either ``sufficient'' or ``strong.'' For a few MSD/risk factor 
combinations, there was insufficient evidence of a causal relationship, 
but in no case did NIOSH determine that there was evidence for the 
absence of a relationship between exposure to workplace risk factors 
and the development of MSDs. NIOSH concluded that `` * * * a 
substantial body of credible epidemiologic research provides strong 
evidence of an association between MSDs and certain work-related 
physical factors when there are high levels of exposure and especially 
in combination with exposure to more than one physical factor * * *'' 
(NIOSH 1997, ES p. xiv, Ex. 26-1).
    A similar conclusion was reached by the experts participating in a 
workshop conducted by the National Academy of Sciences/National 
Research Council (NRC) (Ex. 26-37). For the NRC report, a panel of 
experts critically reviewed the methods used to select and evaluate the 
human studies relied on in the 1997 NIOSH study (Ex. 26-1). The 1999 
NRC report concluded as follows:

[the association between MSDs and exposure to risk factors at work 
that have been] identified by the NIOSH review * * * as having 
strong evidence are well supported by competent research on heavily 
exposed populations.
    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. (Ex. 26-37)

    In this context, NAS's use of the phrases ``heavily exposed'' and 
``high level of exposure'' does not refer to any specific 
quantitatively defined level of exposure to biomechanical risk factors, 
but simply reflects that, in the epidemiological studies, groups of 
workers who were considered to be ``exposed'' to biomechanical risk 
factors experienced higher intensities and durations of exposure than 
did the comparison, or referent, groups of workers. In general, workers 
in the exposed groups were exposed to biomechanical risk factors on a 
nearly daily basis, and were usually exposed for most of each work 
shift. However, as shown by OSHA's summary of exposure-response data in 
the Health Effects section (Section V), many of these epidemiological 
studies placed workers in the exposed group even if they were exposed 
for only about one-quarter to one-half of the work shift. Later in this 
section, OSHA defines ``higher-risk'' workers as those who are exposed 
in excess of the final rule's job screening criteria, which generally 
reflects those workers as having two or more hours per shift of 
exposure to biomechanical risk factors.
    Since the NIOSH and NAS reports, many additional epidemiological 
studies have been published and are contained in the rulemaking record. 
These studies have been reviewed by OSHA in detail in the Health 
Effects section, and their results add to the already substantial 
weight of evidence originally evaluated by NIOSH and NAS. OSHA is not 
alone in its determination that the epidemiological data base for 
ergonomics convincingly establishes a causal relationship between 
workplace exposure to risk factors and MSDs. Many experts who provided 
testimony in the record and appeared at OSHA's informal hearing agreed 
that sufficient epidemiological evidence exists to conclude that 
biomechanical factors at work cause or contribute to MSDs. These 
experts included researchers, medical professionals, and ergonomists 
(Exs. 37-1, 37-2, 37-9, 37-10, 37-13, 37-10, 37-15, 37-16, 37-17, 37-
18, 37-21, 37-27; Tr. 843, Tr. 1048; Tr. 1112, Tr. 1103-1103, Tr. 1367, 
Tr. 9808-9809, Tr. 16802, Tr. 17566-17567, Tr. 8261, Tr. 2834, Tr. 
9297, Tr. 16145, Tr. 1959-1960, Tr. 17358, Tr. 13330-13331, Tr. 3412).
    That exposure to workplace risk factors can cause or contribute to 
MSDs is made more plausible by the growing body of studies of 
biomechanical effects, also summarized in the Health Effects section 
(Section V of this preamble), that are designed to explore how tissues 
react to mechanical stress and how those reactions are related to 
disease processes. OSHA presented detailed scientific information on 
the biomechanics and pathophysiology of MSDs in its Health Effects 
Appendicies, prepared at the time of the proposed rule (Ex. 27-1); the 
discussion below briefly summarizes the information

[[Page 68540]]

reviewed in the Health Effects Appendicies and in the Health Effects 
section.
    Although all soft musculoskeletal tissue can tolerate certain 
physical loads, these tissues will respond adversely if the load 
becomes excessive. Muscles, ligaments, tendons, and tendon sheaths can 
become inflamed with repetitive or prolonged loading, cartilage can 
deteriorate when subjected to abnormal loads, and nerves can exhibit 
dysfunction and eventually permanent damage if compressed or subjected 
to extended tension. Other studies have shown that the kinds of risk 
factors present in many industrial occupations can impose internal 
forces on soft musculoskeletal tissue sufficient to cause the kinds of 
physiologic responses described above. The relationships between 
external and internal loads have been demonstrated using both 
biomechanical models and direct measurement and observation in the 
workplace (see Section V, Health Effects).
    Finally, evidence of the work-relatedness of MSDs comes from 
several studies and case reports that document the effectiveness of 
ergonomic interventions in reducing exposures to risk factors and the 
successes of individual companies' ergonomics programs in reducing the 
incidence or prevalence of MSDs and the severity of MSDs among their 
workers. After reviewing intervention studies, including both field and 
laboratory studies, the NRC (1998, Ex. 26-37) concluded that

    * * * specific interventions can reduce the reported rate of 
musculoskeletal disorders for workers who perform high-risk tasks. 
No known single intervention is universally effective. Successful 
interventions require attention to individual, organizational, and 
job characteristics, tailoring the corrective action to those 
characteristics.

The scientific evidence and case studies demonstrating that ergonomic 
interventions reduce excessive tissue loads and the associated tissue 
pathology, and reduce MSD incidence and severity, are summarized later 
in this section).
    In addition to biomechanical risk factors present at work, the risk 
of developing an MSD is also influenced by individual, organizational, 
and social factors. Factors that affect individual susceptibility 
include age, general conditioning, and pre existing medical conditions. 
Although some of these individual factors have been identified in human 
studies as being statistically significant predictors of disease, they 
are generally much weaker predictors than are biomechanical factors of 
force, repetition, posture, and vibration (NRC 1998, Ex. 26-37). 
Organizational factors that have been linked to MSDs include poor job 
content (e.g., lack of job variety) and job demands (e.g., excessive or 
highly variable workload and time pressure). The importance of poor job 
content is difficult to evaluate, since this factor can coexist with 
biomechanical factors (for example, excessive workload can result in a 
worker needing to increase repetitive movement and/or force). Social 
factors refer to a lack of social support from management and 
supervisors, which can lead to psychological stress and dissatisfaction 
with work, both associated with an increased prevalence of MSDs. 
However, after evaluating the nature of psychosocial factors and their 
role in contributing to the risk of MSDs, OSHA has determined that, 
although psychosocial factors appear, at least in some studies, to have 
some relationship to the observed increases in the incidence of MSDs 
among workers exposed to risk factors, their effect is independent of 
that of biomechanical factors and is generally not as predictive of MSD 
risk as are biomechanical factors. The evidence reviewed by the Agency 
suggests that psychosocial factors may have a greater influence in 
determining the length of disability following development of an MSD 
than do biomechanical factors, but have shown weaker associations with 
the prevalence or incidence of MSDs than have biomechanical factors 
(see Section V.G.5 of the Health Effects Section for a discussion of 
the literature dealing with psychosocial effects). OSHA's finding is in 
accord with that of the NAS review (1999, Ex. 26-37).
    OSHA believes that the human epidemiologic studies, the 
biomechanical and physiological studies, and the studies of the 
effectiveness of workplace ergonomic interventions together constitute 
a compelling body of evidence that demonstrates that exposure to risk 
factors at work is a major factor in the development of MSDs, and that 
reducing or eliminating exposures to these risk factors will reduce the 
number and severity of these MSDs.
    The epidemiological data base that describes the associations 
between exposure to workplace risk factors and increased prevalence or 
incidence of MSDs is vast. The nature of the hazard and of the 
available data require OSHA to perform a different type of risk 
assessment than it performs to assess occupational risks from chemical 
exposures. There are many reasons for this, in particular the complex 
interactions among different kinds of exposures that lead to tissue 
injury and disorders and the difficulty of defining exposure metrics 
that reflect all of the various combinations of risk factors to which 
workers are exposed across industry. This is not to say that exposure-
response relationships have not been observed or cannot be defined in 
specific circumstances; in fact, there are many cases in which the risk 
of MSDs has been quantitatively related to the degree and intensity of 
exposure. In the Health Effects section of this preamble (Section V), 
OSHA describes scientific studies that demonstrate a positive 
association between the magnitude and/or duration of exposure to 
workplace risk factors and the prevalence of MSDs, including upper 
extremity disorders and back injuries. OSHA concludes that these 
studies provide compelling evidence of the work-relatedness of MSDs, 
since a finding of positive exposure-response trends is one of the key 
findings necessary to establish a causal relationship between exposure 
and disease.
    Using data on the incidence of work-related MSDs, risk can be 
quantified using a population-based approach similar to the one used by 
OSHA to quantify the risk of Hepatitis B among workers with frequent 
occupational exposure to blood and other potentially infectious 
material (56 FR 64004). For this final ergonomics program rule, OSHA 
uses a similar approach in its final risk assessment. In this 
assessment, OSHA relies on data from the Bureau of Labor Statistics 
(BLS) to estimate the annual incidence of work-related MSDs in 
different industry sectors and occupations, by type of injury and type 
of exposure. A description of these data and OSHA's analytical approach 
are described in part B below, and the results of this analysis appear 
in part C.
    Having quantified the risk, it is important to determine the extent 
to which the standard is likely to reduce that risk. In the case of 
this ergonomics program standard there is abundant evidence of the 
effectiveness of ergonomic programs. This evidence comes from a variety 
of published studies, articles, and unpublished data that describe the 
reductions in risk ergonomics programs have actually achieved in the 
workplace. Most commonly, this evidence is expressed in terms of 
reductions in injury rates and decreases in the numbers of lost 
workdays caused by MSDs. OSHA's discussion of these data appears in 
part D, below. The Agency presents the results of its risk analysis in 
parts C and D; comments on the preliminary risk

[[Page 68541]]

assessment (64 FR 65926) follow these sections.

B. Data Sources and Analytical Approach

    The annual Survey of Occupational Injuries and Illnesses conducted 
by the Bureau of Labor Statistics (BLS) is the principal data source 
for evaluating the risks to employees of developing a work-related 
musculoskeletal disorder. This survey is conducted under a joint 
federal/state program that collects workplace injury and illness data 
from about 165,000 private industry establishments. The survey requests 
information only on non-fatal injuries and illnesses, and excludes the 
self-employed, farms with fewer than 11 employees, private households, 
and employees in federal, state, and local government agencies.
    For this survey, selected employers are required to provide 
statistics on the total number of injuries and illnesses recorded on 
the OSHA Form 200 (the ``OSHA Log''), as well as information describing 
the nature and causes of their lost workday injuries and illnesses. 
Thus, according to the BLS, the data provided by employers ``* * * 
reflect not only the year's injury and illness experience, but also the 
employer's understanding of which cases are work-related under current 
record keeping guidelines of the U.S. Department of Labor.'' 
Information from employers is provided in sufficient detail to permit 
the BLS to systematically code each reported case and develop estimates 
of the numbers and incidence of each specific type of LWD injury and 
illness for the United States as a whole, by industry sector and by 
occupation.
    Although the BLS data are the best available data on the number and 
kinds of job-related injuries and illnesses occurring among U.S. 
workers in any given year, there is no single BLS-reported number that 
represents all employer-reported musculoskeletal injuries and illnesses 
occurring in that year. Instead, employer-reported injuries and 
illnesses are coded by the BLS according to a classification system 
that categorizes each incident by type of injury or illness and by 
nature of the exposure event leading to the injury or illness (Ex. 26-
1372). The types of disorders that are addressed by the standard fall 
into several of these BLS injury and illness categories.
    To use these data, OSHA identified the kinds of cause-specific 
injuries and illnesses, as coded by the BLS, that reflect MSDs of the 
kinds that will be covered by the ergonomics program standard. An OSHA 
panel, which included an occupational physician and two professional 
ergonomists, examined the BLS listing of occupational injury and 
exposure event codes and their definitions from the manual provided to 
state personnel who code the data from the BLS employer survey. The 
table contained in Appendix VI-A at the end of this Risk Assessment 
section provides the list of injury categories that were initially 
selected by this panel as being likely to include at least some work-
related MSDs. From this initial list, the panel selected a subset of 
injury categories that predominately included work-related MSDs of the 
type that has been associated with exposure to the biomechanical risk 
factors addressed by the final rule; these categories appear in Table 
VI-1. Of the injury categories selected, OSHA chose to base its 
analysis exclusively on six injury categories that were deemed by these 
experts to be most relevant and most likely to represent a large 
proportion of lost workday MSDs; in other words, OSHA deliberately 
excluded several categories such as ``traumatic injuries to bones, 
nerves, and spinal cord,'' ``symptoms involving nervous and 
musculoskeletal systems, unspecified,'' and ``disorders of the 
peripheral nervous system, unspecified.'' The injury categories 
included by OSHA for the risk assessment were:

Sprains, Strains, and Tears;
Back Pain, Hurt Back;
Soreness, Hurt, except back;
Carpal tunnel syndrome;
Hernia; and
Musculoskeletal and connective systems diseases and disorders.

[[Page 68542]]

[GRAPHIC] [TIFF OMITTED] TR14NO00.000


[[Page 68543]]


[GRAPHIC] [TIFF OMITTED] TR14NO00.001

    For this analysis, OSHA is interested in capturing only those 
injuries and illnesses that are associated with exposure to the risk 
factors addressed in the final rule. These risk factors are repetitive 
motion, excessive force,

[[Page 68544]]

awkward postures, contact stress, and segmental vibration. The annual 
BLS survey does not break out the causes of injuries and illnesses 
captured by the survey in a manner that precisely matches the kinds of 
risk factor exposures covered by the rule. However, the OSHA panel did 
identify the three exposure event categories defined by the BLS that 
are the most closely related to these risk factors. These are:
    <bullet> ``Repetitive motion,'' which reflects the risk factors of 
repetitive motion, sometimes combined with force and/or awkward 
posture, and contact stress, which is a combination of repetitive 
motion and force;
    <bullet> ``Overexertion,'' which includes activities such as 
lifting/lowering, pushing/pulling, holding/carrying, and throwing, and 
thus reflects the risk factor of force, sometimes combined with 
repetitive motion and/or awkward posture; and
    <bullet> A subcategory of ``bodily reaction'' that includes 
``bending, climbing, crawling, reaching, twisting,'' which reflects the 
risk factor of awkward posture.
    The BLS definitions for these exposure event categories appear in 
Table VI-2. Note that musculoskeletal injuries and illnesses caused by 
acute events such as slips, trips, falls, being struck by objects, or 
by motor vehicle accidents are excluded from the data relied on in 
OSHA's risk analysis (because they are not included in the coverage of 
the final rule (see paragraph (a) of the regulatory text)). The process 
used by OSHA to identify those injury and exposure event categories 
from which to select the BLS data represents the closest approximation 
possible from the data available to OSHA of the MSDs that the final 
rule will actually cover.
    The BLS injury and illness coding system also includes two exposure 
event categories that reflect exposure to vibration involving damage to 
the nerves or circulatory system (Ex. 26-1372). They include:
    <bullet> Event code 05, rubbed or abraded by friction or pressure; 
this code includes injuries caused by rubbing or abrasion by ``objects 
being handled,'' and includes ``superficial injuries such as blisters, 
scratches, or abrasions,'' as well as those involving nerve or 
circulatory damage, and
    <bullet> Event code 06, rubbed, abraded, or jarred by vibration, 
which includes injuries caused by vibration of mobile equipment or 
vehicles, as well as other machines or equipment.

[[Page 68545]]

[GRAPHIC] [TIFF OMITTED] TR14NO00.002


[[Page 68546]]


[GRAPHIC] [TIFF OMITTED] TR14NO00.003

    MSDs caused by segmental vibration are thus included with those 
caused by whole-body vibration in both event categories, which makes it 
difficult to separate out those vibration-induced injuries and 
illnesses related only to

[[Page 68547]]

segmental vibration, one of the risk factors covered by the standard. 
The BLS estimated that a total of 5,465 injuries related to exposure 
events classified under these two categories (excluding injuries 
involving the eyes) had occurred in 1996 (see BLS Table R32 for 1996, 
available at http://www.bls.gov/oshc_d96.htm). Because it is not 
possible to identify the number of injuries associated with segmental 
vibration, OSHA has included in its analysis only those MSDs related to 
the three event codes of overexertion, repetitive motion, and the 
subcategory of bodily reaction described above. The injury/illness and 
event codes used by OSHA in the Risk Assessment and Significance of 
Risk sections for the final rule are the same as those used to support 
these analyses of the proposed rule. OSHA's decision not to include 
vibration-induced injuries and illnesses in the universe of MSDs means 
that the risks estimated in the final Risk Assessment section, and the 
estimates in the Significance of Risk section, are understated.
    OSHA received numerous comments on its selection of injury/illness 
and exposure event codes from those used in the BLS classification 
system. In particular, several commenters objected to OSHA's inclusion 
of injuries categorized as ``strains, sprains, and tears,'' because, in 
their view, such injuries reflect acute injury events, while OSHA's 
ergonomics program standard was intended to address injuries that arise 
from cumulative damage through long-term exposure to risk factors. 
These commenters include, among others, the Chamber of Commerce (Ex. 
30-1722), the American Iron and Steel Institute (Exs. 30-3951, 32-206), 
Gibson, Dunn, & Crutcher on behalf of numerous clients (Exs. 500-197, 
32-241), the National Coalition on Ergonomics (Ex. 32-368), the 
American Forest & Paper Association (Ex. 30-3865), the AEI-Brookings 
Joint Center (Ex. 30-3911), Edison Electric Institute (Ex. 32-300-1), 
the Center for Office Technology (Ex. 30-2208), Integrated Waste 
Services Association (Ex. 30-3853), Organization Resources Counselors 
(Ex. 30-3813), the American Meat Institute (Ex. 30-3677), Guilford 
Mills (Tr. pp. 11519-11520, 11566-11567), the Puerto Rico Manufacturers 
Association (Ex. 30-3348), and the National Paint and Coatings 
Association (Ex. 30-4340). In support of their views, these commenters 
point to the BLS's definition of ``strains, sprains, and tears,'' which 
appeared on Table VI-1 of the preamble to the proposal (64 FR 65928--
65929) and reads as follows:

    This nature group classifies cases of sprains and strains of 
muscles, joints, tendons, and ligaments. Diseases or disorders 
affecting the musculoskeletal system, including tendinitis and 
bursitis, which generally occur over time as a result of repetitive 
activity should be coded in Musculoskeletal System and Connective 
Tissue Diseases and Disorders, major group 17. (Ex. 26-1372)

Based on this definition, Gibson, Dunn, & Crutcher conclude that cases 
classified as sprains, strains, and tears represent single-incident 
traumatic injuries and ``are not MSDs'' (Ex. 500-197, p. I-166).
    To further support their view that strains, sprains, and tears 
reflect acute injury events and not cumulative trauma, Gibson, Dunn, & 
Crutcher note that most of the strain, sprain, and tear injuries 
described in OSHA's preliminary risk assessment were associated with 
overexertion, which is defined by the BLS as follows:

    Overexertion applies to cases, usually non-impact, in which the 
injury or illness resulted from excessive physical effort directed 
at an outside source of injury or illness * * * Free bodily motions 
that do not involve an outside source of injury or illness are 
classified either in major group 21, Bodily Reaction, or in major 
group 23, Repetitive Motion. (Ex. 26-1372)

Thus, Gibson, Dunn, and Crutcher argue that

    Clearly, nothing in this definition suggests that overexertion 
injuries develop gradually over time. To the contrary, this 
definition expressly excludes injuries that result from repetitive 
motion. There is simply no evidence that sprains, strains, and tears 
associated with overexertion meet the definition of an MSD. (Ex. 
500-197, p. I-167)

Similarly, the Chamber of Commerce stated: ``It is not difficult to 
imagine that many, if not most of these injuries * * * may well have 
occurred as the result of a single instantaneous event.'' (Ex. 30-1722)
    Gibson, Dunn & Crutcher (Ex. 500-197), AISI (Exs. 32-206, 30-3951), 
the American Forest & Paper Association (Ex. 30-3865), the American 
Meat Institute (Ex. 30-3677), and the Hon. David M. McIntosh of the 
U.S. House of Representatives (Ex. 30-542) all objected to the 
inclusion of cases from BLS category 0972 (back pain, hurt back) in the 
universe of MSDs on the grounds that these are traumatic injuries as 
well. To support this position, Gibson, Dunn, & Crutcher pointed to 
OSHA's Record Keeping Guidelines for Occupational Illnesses and 
Injuries, commonly known as the ``Blue Book.'' These guidelines 
instruct employers how to record occupational injuries and illnesses on 
their OSHA 200 logs. Gibson, Dunn & Crutcher argued that, in the Blue 
Book, OSHA ``concedes'' that back cases should be categorized as 
injuries rather than illnesses. According to Gibson, Dunn and Crutcher 
(Ex. 500-197):

    OSHA states that back cases are ``injuries'' that are ``usually 
triggered by an instantaneous event'' for purposes of OSHA 200 
recording, [but] converts them into ``illnesses'' that develop 
``gradually over time'' for purposes of its MSD statistics * * * The 
bottom line is that OSHA has no reliable data regarding the causes 
of back pain and back injuries. OSHA allows employers to 
``generalize'' about back pain for purposes of OSHA 200 recording 
precisely because its causes are often indeterminate.

    OSHA has carefully considered these comments and finds them 
unpersuasive. It is necessary and appropriate to include these BLS 
categories to arrive at an accurate estimate of the risk posed by the 
biomechanical risk factors addressed in this standard.
    First and foremost, OSHA is issuing its final ergonomics program 
standard because of substantial evidence that workers who are regularly 
exposed to biomechanical risk factors are at an increased risk of MSDs 
and the pain and disabilities associated with them. Whether these 
injuries and illnesses come about because of an acute event or because 
of pathology that develops over a longer term is not germane to the 
issue of whether workers who are regularly exposed need protection. The 
sole consideration is that increased exposure to biomechanical risk 
factors increases the risk to the worker. For example, a worker whose 
job involves heavy lifting on a regular basis is at an elevated risk of 
suffering a low back disorder. Such a disorder may arise either because 
repeated lifting is causing cumulative wear resulting in degenerative 
changes to the disc, or because the stress imposed on the spine during 
lifting can overcome the capacity of the disc to withstand compression, 
resulting in acute structural failure (see Section V.E on the health 
evidence for low-back disorders). Although a worker who lifts heavy 
loads infrequently may be at risk from acute failure, the worker who 
lifts frequently as part of their regular job is at greater risk via 
either mechanism.
    Furthermore, there is substantial evidence in the record that many 
of the injuries coded as strains, sprains, and tears in fact develop 
gradually over time. Several commenters believed that it was 
appropriate for OSHA to include statistics on strains, sprains, and 
tears in its assessment of MSD risks. For example, the AFL-CIO, in 
their post-hearing brief, stated that


[[Page 68548]]


    The industry is just plain wrong on this point [that back 
injuries are traumatic injuries]. The BLS survey is based on 
employer reports of injuries. To simplify recording, OSHA recording 
criteria specifically specify that back injuries, one major source 
of MSDs, should be recorded as injuries, even if they result from 
chronic exposure conditions. Disorders related to repeated trauma, 
including carpal tunnel syndrome are to be recorded as illnesses. * 
* * Thus, it is OSHA's recording criteria and BLSs coding rules and 
definitions that result in many MSDs, particularly back injuries, 
being classified as sprains, strains, and tears. This category 
includes injuries that may result from a single exposure and those 
that result from repeated activities. OSHA has limited the types of 
strains, sprains, and tears that are covered [in its risk 
assessment] to those * * * associated with] exposures that are 
covered by the rule (e.g., overexertion, repetition). (Ex. 500-218, 
p. 13-14)

Testimony from Dr. Frank Mirer of the United Auto Workers, who is also 
a member of the BLS Labor Research Advisory Committee, explained why 
MSDs of the back are frequently recorded as sprains and strains:

    You have to understand the reality of this BLS database, which 
is derived from [the] OSHA 101 form submitted by management medical 
departments to OSHA or to the BLS. Now when a worker goes up to the 
medical department * * * all they know is they hurt. And most of 
them see a nurse and their disorder is just thrown into a bin. Back 
conditions are all injuries. They come as strain and sprain * * *. 
[W]e have acute flare ups, just as a back injury is a chronic 
condition and has an acute flare up. So standard practice in the 
industry * * * is [that] cases [considered to be] of ergo interest * 
* * [include] sprain and strain injuries that are not accompanied by 
a fall or some other traumatic [event] * * *. (Tr. 5896-5897)

When asked whether strains and sprains due to overexertion or 
repetition were likely to be related to the risk factors covered by the 
standard, both Dr. Rosecrance and Mr. Alexander agreed. Dr. Rosecrance 
testified that injuries classified as sprains or strains are 
appropriately considered MSDs, depending on the events leading to the 
injury:

    * * * I look at an MSD * * * as a disorder affecting muscles, 
tendons, ligaments, bone, connective tissue. And certainly in my 
definition of MSD, a sprain would meet that because a sprain is a 
tear to a ligament * * * [It] perhaps [might] be a traumatic one or 
from an acute injury like a slip or a trip * * *. When we review, 
let's say, the OSHA 200 Log and there is a strain or sprain on 
there, I will ask * * * what was the cause of that sprain or strain? 
Was the strain from repetitive use or was it a strain from an acute 
type of injury?

    Some rulemaking participants provided evidence to the record 
documenting that back disorders were frequently recorded as strains and 
sprains without regard to the nature of the exposure or events 
associated with each case. For example, the post-hearing submission of 
the United Food and Commercial Workers Union (UFCW) (Ex. 500-133), 
which contained copies of OSHA-200 logs (Ex. 500-133-2), reported 
finding MSDs categorized as strains and sprains, back pain, hurt back, 
carpal tunnel syndrome, hernia, and disorders associated with repeated 
trauma. According to the UFCW, retail stores primarily categorized such 
MSDs as sprains and strains, back pain and hurt backs, and injuries, 
and seldom classified MSDs as illnesses. In contrast, the UFCW stated 
that meatpacking industry logs more often accurately record MSDs as 
illness, reflecting the greater experience this industry has in dealing 
with ergonomic issues. A review of OSHA 200 logs submitted by the 
Teamsters (Ex. 500-146) also shows that disorders that are clearly 
recognized as MSDs, such as carpal tunnel syndrome and tendinitis, are 
nevertheless often recorded by employers as injuries, which in turn 
would be described in the BLS statistics as strains and sprains.
    Other rulemaking participants described the use of sprain and 
strain injury categories for ergonomic injuries in other injury 
classification systems. In describing the province of Victoria's 
(Australia) 1999 ergonomics regulation, which combined Victoria's 
earlier manual handling and occupational overuse syndrome (OOS) 
regulations, Mr. David C. Caple, Director, David Caple & Associates Pty 
Ltd., testified that both repetitive injuries and back injuries were 
combined under one generic sprain and strain category by that 
regulation (Tr. 2723-2724). The Ford Motor Company's injury 
classification system also combines strain and sprain injuries with 
cumulative trauma disorders and other disorders of interest to the 
company's ergonomics committee (Tr. 5826). When asked whether sprains 
and strains are included within the category of repetitive motion 
disorders under Oregon's workers' compensation law, Mr. Goodman replied 
that they are often classified in that category, depending on the 
events leading to the injury. He explained that Oregon's law defines an 
injury as ``sudden and unexpected in onset'; thus, strains and sprains 
would be considered repetitive motion disorders if the onset was slow 
and insidious rather than sudden (Tr. 13694).
    As described by the AFL-CIO submission and Dr. Frank Mirer's 
testimony, all back disorders are classified as injuries rather than 
illnesses, under OSHA's recordkeeping rules; as a result, back 
disorders are commonly classified as strains and sprains, regardless of 
whether the disorder arose from an acute, traumatic event or from 
cumulative damage caused by prolonged exposure to risk factors. 
Evidence in the record indicates that most cases of back pain arising 
from exposure to risk factors of the type covered by the final rule do 
not develop suddenly but are instead cases involving gradual onset, 
which makes it difficult to identify or relate the back pain to a 
single precipitating event. OSHA's witness, Dr. Stover Snook, testified 
that

    I am of the view and most scientists are of the view that that 
is not typically how low back pain develops through traumatic things 
like playing football on a weekend. It usually develops gradually 
and insidiously, most of it, not all of it, but most of it does. 
(Tr. 884)

In a study of back braces, Walsh and Schwartz (Ex. 30-3857-7) also 
characterized the nature of work-related back disorders as being of 
gradual onset:

    Most back injuries are not the result of a single traumatic 
incident but rather a compilation of minor traumatic events 
occurring during normal working conditions for reasons that are 
seldom obvious to the individual worker. Successive injuries result 
in more severe impairment and increase the probability of long-term 
disability * * *. In fact, improper body mechanics and unhealthy 
work habits may take their toll on a daily basis. In recent years, 
there has evolved a body of evidence that suggests that the etiology 
of most but not all back pain is due to insidious and chronic 
deterioration of the intervertebral disc, facet joints, and 
ligaments in the back caused by biomechanical wear and tear. (Ex. 
30-3857-7, p. 245)

OSHA's analysis of the biomechanical and pathological literature 
dealing with work-related back pain leads to conclusions that are 
consistent with these characterizations (see Section V, Health 
Effects).
    Because back disorders are recorded as injuries, notwithstanding 
the mechanistic evidence described above that characterizes most back 
disorders as being of chronic onset, practicing ergonomists believe 
that it is important to investigate the underlying events associated 
with recorded cases of strain or sprain to determine whether the injury 
is related to excessive exposure to ergonomic risk factors. This 
practice was described in the testimony of Dr. John Rosecrance, 
Assistant Professor, University of Iowa and Mr. David Alexander, 
President of Auburn

[[Page 68549]]

Engineers, Inc. and reflects an understanding that the classification 
of back disorders as strains and sprains often does not mirror the true 
nature of these disorders.
    OSHA's final risk assessment (like its proposed assessment) relies 
on statistics for strains and sprains that are associated only with 
overexertion (i.e., lifting/lowering, pushing/pulling, holding/
carrying), repetitive motion, and bodily reaction (i.e., awkward 
postures). Thus, OSHA's treatment of the BLS data exclude strains and 
sprains that were determined by ergonomists or health care 
professionals to arise from accidents, such as slips or falls. Based on 
the evidence and testimony reviewed above, strains and sprain injuries 
captured by the BLS system and classified under these three exposure 
event codes properly reflect musculoskeletal disorders that arise as a 
result of exposure to the risk factors covered in the final rule. 
Further, as described below in part C of the risk assessment, OSHA has 
refined its analysis, based on data in the record, to estimate the 
number and incidence of MSDs occurring among those workers who are 
exposed to risk factors at levels that meet the final rule's screen; 
OSHA believes that this refinement will ensure that the Agency is 
accurately stating the risks posed to employees covered by the final 
rule.
    The United Auto Workers (Ex. 32-185), argued that OSHA was 
underinclusive, not overinclusive, in its choice of the BLS categories 
that represent MSDs. In addition to the six categories chosen by OSHA, 
the UAW argued that OSHA should have included a substantial fraction of 
the injuries and illnesses categorized as ``other'' and ``multiple 
injuries'' as well. OSHA agrees that these injury categories contain 
MSDs that are relevant to OSHA's risk analysis. However, since data are 
not available to describe the proportion of the injuries classified 
under these categories that are, in fact, MSDs, the Agency has not 
included them in its revised risk assessment. This decision also means 
that the risks presented by OSHA in its Risk Assessment section and 
estimated in the Significance of Risk section are understated.
    As explained by OSHA in its preliminary risk assessment for the 
proposed rule, risk estimates based on the BLS data understate the true 
risk of incurring a work-related MSD posed to employees who are exposed 
to workplace risk factors that are associated with the development of 
MSDs, for several reasons. First, the BLS data include only those lost 
workday (LWD) cases that resulted in at least 1 day spent away from 
work, and thus do not capture either non-lost workday MSD cases nor MSD 
cases that resulted in the employee being temporarily reassigned to 
another job. Second, some LWD MSDs reported to the BLS by employers are 
likely to have been coded in BLS injury categories that are excluded 
from OSHA's categories of overexertion, repetition, and bodily reaction 
(bending, climbing, crawling, reaching, twisting); for example, 
injuries due to segmental vibration are included in BLS event 
categories other than those included by OSHA in its analysis, and, as 
pointed out by the UAW (Ex. 32-185), the non-specific BLS injury 
categories of ``other'' and ``multiple injuries'' are also likely to 
contain MSDs.
    Finally, the incidence of MSDs reported by the BLS is the reported 
incidence of MSDs occurring among all workers in the industries 
surveyed (on a full-time-equivalent basis); that is, the incidence for 
each industry sector is calculated by BLS as the number of MSD cases 
reported in 1996 divided by the total number of full-time equivalent 
employees in that industry sector in 1996. Expressing the incidence in 
this way has the effect of diluting the estimated incidence of 
disorders that are actually occurring among exposed employees, i.e., 
those who routinely are exposed to workplace risk factors that have 
been associated with the development of work-related MSDs. The risk to 
exposed employees is substantially higher than the risk reflected by 
the BLS estimates of MSD incidence, because most of the injuries 
reported to the BLS will in fact have occurred among that subset of 
workers whose jobs expose them to these risk factors (that is, if the 
incidence were calculated using the much smaller denominator that 
reflects the number of exposed employees, the resulting incidence 
estimate would be higher). Evidence that workers exposed to workplace 
risk factors are at substantially higher risk than other workers in 
their industry comes from the large data base of formal scientific 
studies of exposed worker populations that have demonstrated a positive 
relationship between exposure to workplace risk factors and the 
relative risk of developing an MSD (see the Health Effects section of 
this preamble). These studies show that the prevalence of MSDs among 
exposed employees is often 2- or 3-fold higher, and can be as much as 
10 to 20 times higher, as the prevalence among workers who are not so 
exposed.
    In the next part of the Final Risk Assessment, OSHA presents two 
alternative approaches to quantifying risks posed to workers who are 
exposed to biomechanical risk factors on the job. The first approach is 
the same as that used in the Preliminary Risk Assessment presented in 
with the proposed rule. In that approach, OSHA's estimates of the risk 
are based on the numbers and incidence of MSDs reported by BLS (based 
on OSHA's definition of MSDs) by industry sector and by occupation. 
OSHA's second approach responds to a number of comments made in the 
record that the Agency's Preliminary Risk Assessment did not (1) 
properly subtract out MSD cases that occurred among employees who were 
not heavily exposed to physical risk factors, and (2) did not properly 
account for background risk (i.e., that part of the risk that could not 
be attributed to workplace exposure or that occurs among the general 
population). To address these comments, the Agency was able to use data 
that became available in the record to more precisely characterize the 
MSD risk in the subset of employees who are the most heavily exposed to 
risk factors covered in the final rule, and to account for background 
risk. OSHA's underlying rationale is explained fully in part C below.

C. Results

    Table VI-3 provides the BLS estimates of the number of injuries and 
illnesses reported nationwide by employers for 1996, by nature of 
injury and type of workplace exposure, for all injury and exposure 
event categories determined by OSHA to represent the MSDs covered by 
the standard. Overall, OSHA estimates that there were a total of 
647,344 lost workday MSDs that occurred in 1996, as derived from 
employer reports of thoseTable VI-3 here illnesses and injuries. These 
disorders represent about 34.4 percent of the 1.88 million LWD injuries 
and illnesses reported by employers in 1996 (BLS press release 97-453, 
12/17/97).

[[Page 68550]]



    Table VI-3.--Estimates of the Number of Lost Workday Musculoskeletal Disorders (MSDs) in 1996, by Nature of Injury and Type of Workplace Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Type of workplace exposure
                                                         -----------------------------------------------------------------------------------------------
            Nature of injury                 BLS Code      Total for all                                   Subtotal  (O       Bodily
                                                             exposures     Overexertion     Repetition        and R)       Reaction \a\      Subtotal
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total for all lost workday injuries.....  ..............  ..............         526,594          73,796         600,390          79,475         679,865
Musculoskeletal Disorders:
    Sprains, Strains, Tears.............             021         819,658         424,290          12,872         437,162          66,068         503,230
    Back Pain, Hurt Back................            0972          52,046          28,046             861          28,907           4,646          33,553
    Soreness, Hurt, except back.........            0973          73,542          17,984           5,811          23,795           2,896          26,691
    Carpal tunnel syndrome..............            1241          29,937  ..............          29,809          29,809  ..............          29,809
    Hernia..............................             153          29,624          25,819             322          26,141             670          26,811
    Musculoskeletal and connective                    17          35,238           7,761          18,278          26,039           1,211          27,250
     system diseases and disorders......
                                         ---------------------------------------------------------------------------------------------------------------
        Total Number of MSDs............  ..............       1,040,045         503,900          67,953         571,853          75,491        647,344
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Data from BLS included only those injuries reporeted to have been associated with ``Bending, climbing, crawling, reaching, twisting.'' Source: BLS-
  reported estimates for BLS nature-of-injury codes 021, 0972, 0973, 1241, 153, and 17, and for BLS exposure events of overexertion, repetition, and
  bodily reaction (1996).

    For 1998, the BLS estimated that there were 592,500 MSDs that 
occurred throughout U.S. industry, representing an 8.5-percent decline 
from 1996 (``Lost-Worktime Injuries and Illnesses: Characteristics and 
Resulting Time Away From Work, 1998,'' U.S. Bureau of Labor Statistics, 
available at http://www.bls.gov/news.release/osh2.nr0.htm). This 
decline is consistent with the pattern seen from 1992-1996, when both 
MSD and overall injury rates declined. For the final risk assessment, 
OSHA has continued to use 1996 BLS data in order to be consistent with 
the economic analysis, which uses 1996 as a base year throughout. For 
example, 1996 is the base year from which data are used to estimate 
numbers of establishments and employees, revenues, profits, and costs 
associated with the final rule.
    About 66 percent of the estimated number of MSDs reported to the 
BLS in 1996 were categorized by BLS coders as ``sprains, strains, and 
tears'' due to overexertion. As discussed in part B above, OSHA 
received many comments on the use of BLS data on injuries classified by 
the BLS as sprains, strains, and tears; these commenters objected to 
including these injuries in the risk assessment on the grounds that 
injuries classified as strains, sprains, and tears reflect acute 
injuries that cannot be considered MSDs. Based on the evidence and 
testimony presented in part B above, however, OSHA has determined that 
it is appropriate to include strains, sprains, and tears that are 
associated with the exposure events of overexertion, repetitive motion, 
and bodily reaction in the universe of relevant MSDs because these 
injuries arise from exposure to relevant risk factors. Furthermore, 
OSHA believes that, when MSDs result from exposure to the biomechanical 
risk factors covered in the final rule, it is not important to make any 
distinction between whether those injuries arose from acute or chronic 
events. The purpose of the standard is to reduce the risk of MSDs 
resulting from exposure to risk factors, regardless of the duration of 
the exposure preceding to those injuries and illnesses.
    As further evidence of the appropriateness of including strain, 
sprain, and tear injuries in the risk assessment, OSHA presented BLS 
data in the preliminary risk assessment that provides additional 
information on the nature of the injuries and the exposure events 
associated with those injuries [64 FR 65931]; these data are reproduced 
in Table VI-4. For this analysis, OSHA obtained from the BLS a breakout 
of the estimated number of injuries, by body part and by type of 
overexertion event. This breakout appears in Table VI-4 and shows that 
about 89 percent of these sprain, strain, and tear injuries (379,615) 
are comprised of injuries due to lifting /lowering, pushing/pulling, 
holding/carrying, or throwing, all of which are activities involving 
force. For the remaining 11 percent of the BLS-coded sprain, strain, 
and tear injuries, the exact nature of the overexertion exposure was 
either not reported by the employer or did not fall into any other 
exposure classification under the BLS system. Of the 379,615 injuries 
for which the nature of the overexertion exposure was reported, the 
majority (88 percent) affected body parts that are consistent with the 
kinds of injuries addressed by the final standard, such as the upper 
extremities, neck and shoulder, lower extremities, and back. Fifty-two 
percent of these injuries represent back injuries due to lifting or 
lowering. Only a small proportion (12 percent) of sprain, strain, and 
tear injuries reported by the BLS in 1996 affected body parts that are 
not relevant to MSDs. Therefore, OSHA is confident that the vast 
majority of BLS-coded sprain, strain, and tear injuries are 
appropriately included in the estimated number of MSDs for 1996, and 
that the judgment of the OSHA expert panel in selecting appropriate BLS 
injury and event categories for Table VI-4 here the risk analysis is 
confirmed by this additional breakout and review of the BLS data.

[[Page 68551]]

[GRAPHIC] [TIFF OMITTED] TR14NO00.004

    The data summarized above have been broken out by the BLS both by 
industry sector and by occupation code. In addition, the BLS provided 
OSHA with estimates of the incidence of MSDs, as defined above by 
injury type

[[Page 68552]]

and cause, for each 2-digit SIC. As explained above, the BLS-calculated 
incidence estimates are based on the incidence among all employees 
(full-time equivalents) in each industry sector, and therefore 
understate the true incidence of work-related MSDs occurring among 
workers who are highly exposed to workplace risk factors, i.e., exposed 
in jobs that meet the standard's action trigger. Nevertheless, OSHA 
believes that these incidence estimates are useful for characterizing 
industry-specific MSD risks and for comparing the extent of the problem 
between industry sectors covered by the ergonomics program standard. 
Table VI-5 provides estimates of the number and incidence of LWD MSDs 
in each general industry 2-digit SIC group for which the BLS provided 
data. Industries having the highest incidence of MSDs include the 
following:

Air transportation (36.6 cases/1,000 workers);
Local and suburban transit (14.7 cases/1,000);
Motor freight transportation and warehousing (14.4 cases/1,000);
Health services (13.8 cases/1,000);
Transportation equipment (13.4 cases/1,000); and
Food and kindred products (12.2 cases/1,000).

    Table VI-6 provides estimates of the number and incidence of LWD 
MSDs by occupation code for the 75 occupations having the highest 
estimated annual incidence of employer-reported MSDs. Because the BLS 
does not provide incidence estimates by occupation, OSHA calculated the 
incidence using employment estimates from the Bureau of the Census 
Employment and Earnings (1996). Occupations having the highest 
incidence include:

Driver--sales workers (42.4 cases/1,000 workers);
Machine feeders and offbearers (34.6 cases/1,000);
Public transportation attendants (32.1 cases/1,000);
Nursing aides, orderlies, and attendants (31.6 cases/1,000);
Punching and stamping machine operators (30.4 cases/1,000 workers);
Laborers, except construction (29.1 cases/1,000);
Sawing machine operators (18.9 cases/1,000);
Furnace, kiln, and oven operators, except food (18.0 cases/1,000);
Grinding, abrading, polishing machine operators (17.9 cases/1,000);
Health aides, except nurses (16.9 cases/1,000); and
Licensed practical nurses (16.5 cases/1,000).

[[Page 68553]]

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[[Page 68554]]


[GRAPHIC] [TIFF OMITTED] TR14NO00.006


[[Page 68555]]


[GRAPHIC] [TIFF OMITTED] TR14NO00.007


[[Page 68556]]


    Of the Census Employment and Earnings (1996). Occupations having 
the highest incidence include:

    Driver--sales workers (42.2 cases/1,000 workers);
    Machine feeders and offbearers (34.6 cases/1,000);
    Public transportation attendants (32.1 cases/1,000);
    Nursing aides, orderlies, and attendants (31.6 cases/1,000);
    Punching and stamping machine operators (30.4 cases/1,000 workers);
    Laborers, except construction (29.1 cases/1,000);
    Sawing machine operators (18.9 cases/1,000);
    Furnace, kiln, and oven operators, except food (18.0 cases/1,000);
    Grinding, abrading, polishing machine operators (17.9 cases/1,000);
    Health aides, except nurses (16.9 cases/1,000; and
    Licensed practical nurses (16.5 cases/1,000).
    Of the 225 occupations for which BLS provided estimates of the 
numbers of employer-reported MSDs and total employment, the annual 
incidence of MSDs was 1 LWD case or more per 1,000 workers per year for 
178 (79 percent) of the occupations. The data described above reflect 
the annual incidence of MSDs estimated to have occurred in 1996 within 
general industry sectors and within occupations within this sector.
    Past risk assessments conducted by OSHA in other health standards 
rulemakings have typically estimated the lifetime risk to workers based 
on the assumption that they are exposed to the hazard in question for a 
full 45-year working lifetime. These past risk assessments dealt 
primarily with chronic, fatal diseases such as cancer. Unlike the 
impairments of health caused by many other OSHA-regulated hazards, 
however, MSDs are not fatal, although they are often debilitating. 
Moreover, a worker can experience more than one work-related MSD over a 
working lifetime. As a result, the lifetime risk associated with 
exposure to risk factors on the job can be expressed in a number of 
ways. One way of doing this is to define lifetime risk as the 
probability that a worker will experience at least one work-related 
musculoskeletal disorder during his or her working lifetime (45 years). 
This probability is calculated as 1-(p),<SUP>45</SUP> where p is the 
probability that a worker will not experience a work-related MSD in any 
given year (i.e., p is one minus the estimated MSD incidence for 1996 
in the industry sector of interest).\1\ For example, the estimated 
incidence of MSDs in 1996 for SIC 80, Health Services, is 13.847 lost 
workday cases per 1,000 workers. The probability that a worker in SIC 
80 will not experience an MSD in any given year is calculated as 
1-.013847, or 0.9862 (almost 99 percent). Over 45 years, the 
probability that a worker will never experience a work-related MSD is 
(.9862)<SUP>45</SUP>, or 0.534 (i.e., 53 percent). Therefore, the 
probability that a worker in SIC 80 will experience at least one work-
related MSD is 1-0.534, or 0.466 (i.e., 466 per 1,000 workers).
---------------------------------------------------------------------------

    \1\ OSHA used two simplifying assumptions when calculating the 
probability of experiencing no work-related MSDs in a working 
lifetime: (1) Employment in an industry was used as a surrogate for 
exposure to ergonomic hazards in that industry. (2) The probability 
of experiencing a work-related MSD in any given industry was treated 
as if it were identical for workers in that industry who had never 
previously experienced a work-related MSD and those who had 
previously experienced a work-related MSD.
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    Alternatively, lifetime risk could be defined as the expected 
number of work-related MSDs an employee entering an industry will 
experience over a working lifetime in that industry. Unlike a 
probability, the expected value in such cases can exceed 1. (That is 
why, in the table below, one industry is identified in which an 
individual who works for 45 years can expect to experience, on average, 
more than one work-related MSD during that time.) The expected value 
represents the experience of the ``average'' individual, a measure that 
reflects the aggregate experience of many individuals.
    Both approaches \1\ taken by OSHA to estimate lifetime risk assume 
that the risk to a worker is independent from one year to the next, 
i.e., that a worker's injury experience in any one year does not modify 
his or her risk in any subsequent year. Although this is a reasonable 
assumption for the purpose of estimating an average lifetime risk, it 
is likely to be the case that the risk will be higher for workers who 
have had an MSD and continue to be exposed since musculoskeletal tissue 
has already been damaged. Among workers who have not experienced 
symptoms of an MSD, the risk to any individual worker in subsequent 
years depends on the amount of tissue damage sustained from exposure to 
risk factors and that worker's individual ability to repair or resist 
continued injury to the point of experiencing an MSD. In addition, 
OSHA's approach also assumes that each worker within a given industry 
sector (defined by 2-digit SIC) has the same risk. For the same reasons 
as discussed above, a relatively small number of workers will, in fact, 
experience injury rates far in excess of the average, while a 
comparatively large number will experience injury rates below the 
average. At this time, data are not available that would allow OSHA to 
determine the lifetime MSD risks for subpopulations of workers within 
each industry sector, i.e., those subpopulations with higher than 
average or lower than average risks, respectively.
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    \1\ In written comments (Ex.32-185-3), the UAW expressed a 
strong preference for estimating the lifetime risk as the 
probability that a worker will experience at least one MSD in a 
working lifetime rather than as an estimate of the lifetime risk 
expressed as the expected number of MSDs a worker will experience in 
a working lifetime.
---------------------------------------------------------------------------

    Another meaning or interpretation of expected value may be more 
intuitive: The expected value is the total number of MSDs that may be 
expected to occur in a cohort of 1000 workers all of whom enter an 
industry sector at the same time and all of whom work for 45 years in 
the industry. The expected value of the number of MSDs occurring among 
these 1,000 workers over 45 years of employment is calculated as the 
annual MSD incidence multiplied by 45. For example, the estimated 
incidence of work-related MSDs in 1996 for SIC 80 (Health Services) is 
13.847 cases per 1,000 workers, or a frequency of 0.01387. The expected 
value of the number of work-related MSDs predicted to occur among those 
1,000 workers over 45 years is estimated to be (0.01387*45), or 0.623 
(623 per 1,000 workers).
    Table VI-7 presents OSHA's estimates of the lifetime risk of 
experiencing work-related MSDs, by industry sector. Based on the 
probability approach, the estimated probability of experiencing at 
least one work-related MSD during a working lifetime ranges from 24 per 
1,000 to 813 per 1,000, depending on the industry sector. Based on the 
expected value approach, the expected number of work-related MSDs that 
will occur in a cohort of workers all entering an industry at the same 
time ranges from 24 per 1,000 to 1646 per 1,000, since this approach 
recognizes that it is possible for a worker to experience more than one 
work-related MSD in a working lifetime.
    Several rulemaking participants criticized OSHA's preliminary risk 
assessment on the grounds that the Agency's risk estimates made no 
allowance or correction for background risk. These participants (see, 
for example, Exs. 32-206, 500-223, Tr. pp.10248-9, Exs. 30-3865, 30-
3356, 32-368, 30-4185, 30-3813, 30-1722, 500-221) argued that MSD risks 
for specific industries and occupations based on

[[Page 68557]]

BLS data should be compared to the background rate of MSD risk in the 
general population to calculate the excess risk associated with work. 
Some of these stakeholders asserted that, because OSHA has not done so, 
the Agency's estimates here represent only the average MSD risk posed 
to a worker in a particular industry or occupation by exposure to ``all 
of life's activities.'' OSHA does not agree; the BLS data reflect only 
cases that employers have deemed to be work-related. It would be 
inappropriate to adjust the MSD rates estimated on the basis of the BLS 
data by subtracting from these rates the MSD rates that have been 
reported in the general population. When excess risk is calculated by 
comparing a population of concern (in this case the employed 
population) to a reference population (e.g., the general population), 
the proper approach is to compare the total incidence in the population 
of concern to the total incidence in the reference population (see 
Rothman and Greenland, Ex. 38-240). That is, to estimate the excess 
risk of MSDs among workers using the approach suggested by these 
commenters, one must have data that describes the incidence of all 
MSDs, both work-and non-work-related, in the working population. 
Assuming that the MSD rate for the general population is the non-work-
related rate, and then subtracting this rate from the BLS-based rate, 
would yield estimates of the work-related, or excess, risk to workers 
only if the BLS data truly represented all MSDs occurring among workers 
(both on the job and off the job). This is clearly not the case, since 
the BLS data are designed only to capture those injuries that are work-
related; the BLS system does not capture those MSDs that occur among 
workers that are unrelated to work. Therefore, adjusting the BLS data 
by subtracting out MSD rates for the general population would not yield 
meaningful estimates of the excess MSD risk to workers.

[[Page 68558]]

[GRAPHIC] [TIFF OMITTED] TR14NO00.008

    Some commenters (see, e.g., Ex. 30-3813, Tr. 4102-4108, Exs. 30-
3356, 30-46-28, 30-4564, 30-3865, 30-4185, 30-3368, 30-1897) argued 
that, despite screening out some of the background risk, the BLS data 
are still overinclusive.

[[Page 68559]]

They pointed out that under the applicable OSHA and BLS guidelines, a 
case is considered ``work-related'' if an event or exposure in the 
workplace made any contribution to the injury or illness, regardless of 
the extent of that contribution. For example, Frank White of ORC 
testified that

    ORC [and others] question OSHA's ability to make quantitative 
determinations of workplace risks based on data that do not allow 
OSHA to differentiate between the respective contributions of 
workplace and non-workplace factors. In the face of OSHA's own 
acknowledgment of the special difficulties associated with 
establishing MSD causation compared ``to more traditional workplace 
exposures and disorders,'' the use of data that inherently include 
conditions caused by both work and non-work exposures to determine 
workplace risk is unacceptable. The result, once again, is an 
overreaching by OSHA--this time in its estimation of the true 
workplace risk--that has the effect of permeating, and effectively 
invalidating, the entire proposal. (Tr. 4102)

OSHA interprets Mr. White's comment as saying that, although strictly 
non-work-related MSDs are not captured by the BLS system, some 
proportion of cases in the system nevertheless represent MSDs that 
occur among workers who are not regularly exposed to risk factors, or 
whose exposures arise from tasks that are not ``core elements'' of the 
job (using the language contained in the proposed rule). In other 
words, although there may be some contribution from work to these 
cases, exposure to risk factors on the job are no greater that those 
encountered during non-work activities.
    In this risk assessment for the final ergonomics program standard, 
OSHA has relied on BLS injury and illness data in much the same way it 
does when evaluating the risks associated with safety hazards. Because 
the statistics relied upon by OSHA reflect work-related injuries and 
illnesses reported by employers and determined by OSHA to have been 
associated with exposure to the risk factors addressed by the final 
rule, there is no ``background'' number of injuries and illnesses in 
the OSHA data in the sense that BLS data are capturing non-work-related 
injuries. In other words, the total number of MSDs that occur in the 
workforce are either work-related or non-work-related; BLS counts the 
first and the second represents background. Thus, OSHA does not agree 
with these commenters that it is necessary to adjust the BLS data per 
se to account for such background risk.
    However, OSHA does recognize that some fraction of the number of 
MSDs estimated from the BLS data represents injuries and illnesses 
occurring among employees in jobs that would not be covered by the OSHA 
standard. That is, some of the MSDs being captured by the BLS's annual 
survey reflect injuries to workers who are not in jobs that meet the 
action trigger, e.g., those who may be exposed to risk factors only 
infrequently or those whose exposures were not of sufficient duration. 
OSHA does not intend the final ergonomics program standard to apply to 
these kinds of jobs. Instead, OSHA intends the standard to apply to 
those jobs where MSDs have occurred and the employee's exposure to risk 
factors was of sufficient duration, magnitude, and frequency to have 
contributed to the injury. This concept is reflected in the final rule 
in the form of the Basic Screening Tool, which explicitly identifies 
those exposure conditions that must be present on the job, along with 
an employee's report of an MSD incident, before the employer is 
obligated to implement the program. Employers have no obligation to 
establish an ergonomics program under the final rule if employees are 
not exposed to risk factors at least at the level(s) reflected in the 
Basic Screening Tool. Thus, OSHA adjusted, as an alternate analysis, 
its estimates of risk based on the BLS data to include only that 
portion of the risk that will be addressed by an ergonomics program 
developed under the final rule, i.e., that portion of the risk that is 
occurring among employees who are exposed to risk factors at least to 
the extent reflected in the final rule's screening tool. OSHA is thus 
estimating the risk of MSDs occurring among employees who would be 
covered in an ergonomics program, i.e., those who are more highly 
exposed to biomechanical risk factors.
    As explained by OSHA above, the BLS-reported incidence of MSDs 
reflects the number of MSDs reported per 1,000 full-time equivalent 
workers employed in industry. This incidence figure distributes the 
MSDs evenly across all workers in an industry sector or occupation. 
However, as demonstrated by the scientific evidence presented in the 
Health Effects section (Section V), OSHA has determined that the work-
related risk of MSDs increases with the intensity and/or duration of 
exposure. Because of this, MSDs are not, in fact, evenly distributed 
across all workers, but are concentrated among the proportion of 
workers who are the more highly exposed to biomechanical risk factors. 
Thus, the incidence of MSDs among the more highly exposed workers is 
greater than that among the lesser-exposed workers; this has been shown 
in the almost 200 epidemiological studies reviewed in the Health 
Effects section. It is for this reason that OSHA believes that the risk 
estimates presented in the first analysis above, which relied on the 
BLS-reported incidence estimates by industry and occupation, understate 
the true risk among the workers who are more highly exposed to physical 
risk factors (while overstating it for workers who are not highly 
exposed to risk factors).
    OSHA's second approach to estimating work-related MSD risks takes 
account of this risk differential between more highly exposed (i.e., 
higher-risk) workers and lesser-exposed (i.e., lesser-risk) workers to 
estimate more precisely the risk among those workers who would most 
benefit from an ergonomics program. In addition, the risk among the 
higher-risk workers is estimated in two forms. One assumes that all of 
the risk among the higher-risk workers can be attributed to their 
exposure to biomechanical risk factors, i.e., all of the risk is work-
related. OSHA believes this is reasonable because the data used to make 
these estimates are the BLS data, which represents MSDs reported by 
employers to be work-related. The second form assumes that, despite the 
fact that the data derive from reports of work-related injuries, only 
part of the risk can be attributed to workplace exposure to physical 
risk factors because of the presence of some ``background'' risk among 
the higher-risk workers. This background risk represents MSDs that are 
not work-related and are attributed to some unknown non-work exposure 
to risk factors. OSHA believes that making such an adjustment to the 
estimated risk among higher-risk workers leads to an overly 
conservative estimate of risk among workers whose jobs will be screened 
in under the final rule; however, the Agency is nevertheless making 
this adjustment in response to addresses the concerns of those 
commenters who argued that OSHA should take account of the 
``background'' incidence of MSDs.
    The first step in OSHA's second approach to estimating work-related 
MSD risks is to estimate the incidence of MSDs for higher-risk and for 
lesser-risk workers. OSHA considers the higher-risk workers to be those 
workers who are exposed to risk factors at levels that meet the final 
rule's basic screening tool; all other workers are considered lower-
risk in the sense that they are exposed to risk factors at levels below 
the final rule's screen.
    To accomplish this analysis, OSHA relied on data contained in the 
record from Washington State's industry-wide survey of workplace 
exposure to

[[Page 68560]]

physical risk factors (Ex. 500-41-118); details of this survey are 
presented in Chapter 3 (Benefits Assessment) of the Final Economic 
Analysis. Data from this survey were used to estimate the percentage of 
employees in each major industry group who are exposed to risk factors 
that at least meet the level of a ``caution zone'' job under Washington 
State's ergonomics standard. The kinds and durations of risk factor 
exposures contained in Washington State's definition of a ``caution 
zone'' job are similar to those contained in OSHA's Basic Screening 
Tool, e.g., generally 2 or more hours per shift of exposure to 
repetitive motions, awkward postures, contact stress, or segmental 
vibration, or 4 or more hours per shift of keyboarding activity. Both 
tools also use the same lifting weight and frequency-of-lift criteria 
to screen jobs for force associated with manual handling. Because of 
the similarities between OSHA's screening tool and the Washington State 
criteria, OSHA believes it reasonable that use of the Washington State 
survey data on workplace exposures to biomechanical risk factors will 
yield reasonable estimates of the numbers of workers who are exposed to 
risk factors at the levels that meet the action trigger of the final 
rule. OSHA has used these data, along with data derived from the 
epidemiology studies reviewed in the Health Effects section (Section V 
of the final rule's preamble), to estimate the number and incidence of 
MSDs occurring annually among employees who are exposed to risk factors 
at levels meeting the action trigger in the final rule. OSHA's Final 
Economic Analysis contains a detailed description of the Washington 
State survey data and OSHA's use of these data to estimate the 
percentage of workers in each covered industry sector who are exposed 
to risk factors at levels that meet the final rule's action trigger.
    OSHA's approach to estimating the excess risk of MSDs among exposed 
workers is summarized in Table VI-8. From the Washington State survey 
data, OSHA estimated the percentage of employees who are exposed to 
risk factors that meet the final rule's screen criteria (Column D of 
Table VI-8) in each 2-digit industry sector, as well as the number of 
higher-risk workers (Column E).
    To estimate the incidence of MSDs separately for higher-risk as 
compared with lower-risk workers, OSHA assumes that the annual 
incidence of MSDs among the higher-risk workers is three times that of 
low-risk workers. The justification for this assumption can be found in 
the many epidemiology studies reviewed in the Health Effects section of 
this preamble (Section V). These studies compared the prevalence or 
incidence of MSDs among workers who are regularly exposed to the risk 
factors addressed by the final rule with the prevalence or incidence 
among the referent (or less-exposed) worker populations. Typically, 
these epidemiological studies report observed differences in these 
rates as ratios (such as odds ratios, incidence ratios, prevalence 
ratios, or other relative risk measures). A compilation of the risk 
measures identified in these studies appears in the form of estimated 
median and mean risk ratios in Table VI-9, separated by part of body. 
As the table shows, median risk ratios for back disorders, neck and 
shoulder disorders, and upper extremity disorders are 1.85, 2.7 to 3.3, 
and 2.8 to 6.6, respectively. Mean values for back disorders, neck and 
shoulder disorders, and upper extremity disorders are 2.4, 4.5 to 5.2, 
and 4.4 to 12.6, respectively. Based on these values, OSHA finds that, 
in general, employees who are regularly exposed to the risk factors 
covered by the final rule are at three times higher risk or, put 
another way, will experience a 3-fold higher incidence of MSDs than is 
the case for workers who are not so exposed.

[[Page 68561]]

[GRAPHIC] [TIFF OMITTED] TR14NO00.009


[[Page 68562]]


[GRAPHIC] [TIFF OMITTED] TR14NO00.010

    Assuming that there is a three-fold higher risk of MSDs among 
higher-risk workers compared with lower-risk workers, the incidence of 
MSDs among higher-risk employees is estimated for

[[Page 68563]]

each industry sector by the following formula:
[GRAPHIC] [TIFF OMITTED] TR14NO00.011

where:

MSDInc<INF>tot</INF> is the MSD incidence among all workers in the 
industry sector;
Pct<INF>E</INF> is the percentage of workers in the industry sector who 
are considered to be regularly exposed to risk factors at levels that 
meet the final rule's screen; and
RR is the risk ratio of 3.

The derivation of this formula appears in Chapter 3 (Benefits) of 
OSHA's Final Economic Analysis.

     Table VI-9.--Summary of Risk Ratios in the Epidemiological Literature for MSDs Reviewed by OSHA, and Estimated Fraction of MSDs Attributable to
                                                                   Workplace Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    Body part affected/disorder
                                         ---------------------------------------------------------------------------------------------------------------
                                             Neck or                                   Carpal
                                              neck/         Only          Elbow        tunnel      Hand/wrist     Hand/arm        Back          Lower
                                            shoulder      shoulder                    syndrome     tendinitis     vibration                   extremity
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Studies Included..............          42            32            18            30            10            12           44              9
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Risk Ratios <SUP>a</SUP>
--------------------------------------------------------------------------------------------------------------------------------------------------------
Median..................................           2.7           3.3           2.8           3.2           3.7           6.6          1.85           2.2
Average.................................           4.5           5.2           5.5           4.4           6.5          12.6          2.66           2.4
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                          Estimated Percent of MSDs Attributable to Exposure to Risk Factors <SUP>b</SUP>
--------------------------------------------------------------------------------------------------------------------------------------------------------
Median..................................          63.0          69.5          63.6          68.5          72.6          84.8         45.9           53.5
Average.................................          77.6          80.6          81.9          77.5          84.6          92.1         62.4           58.9 
--------------------------------------------------------------------------------------------------------------------------------------------------------
<SUP>a</SUP> Risk ratios include odds ratios, prevalence rate ratios, and incidence ratios.
<SUP>b</SUP> Proportion of disorders among exposed workers that is attributable to their exposure at work; calculated as (RR-1)/RR, where RR is the median or
  average risk ratio derived from each group of epidemiological studies.
Source: Data presented in Tables V-1 through V-6 of the Health Effects section (Section V).

    The MSD incidence among lower-risk employees in each industry 
sector is estimated as the ratio of the number of MSDs that occurred in 
1996 among lower-risk employees to the estimated number of lower-risk 
employees in each industry sector (see formula in Table VI-8).
    The portion of the risk for higher-risk employees that can be 
attributed directly to workplace exposure to risk factors (i.e., that 
portion of the risk that is potentially preventable) lies between two 
extremes, the upper and the lower bound of the range of estimated 
risks. OSHA estimated the upper bound of the range to be equal to the 
MSD incidence among higher-risk employees; this bound assumes that the 
BLS data includes no cases reflecting background risk, since all of the 
MSD cases in the BLS data are work-related. The lower bound, on the 
other hand, assumes that the MSD incidence among lower-risk employees 
is entirely attributable to background, i.e., that work did not 
contribute in any of the MSD cases reported among lower-risk workers. 
To estimate the lower bound, OSHA estimated the excess risk among 
higher-risk workers from the general formula that the Agency has used 
in previous risk assessments to estimate excess risk. The general 
formula for estimating excess risk is
[GRAPHIC] [TIFF OMITTED] TR14NO00.012

where P<INF>d</INF> is the probability of injury or illness among 
workers exposed to a hazard and P<INF>0</INF> is the background risk 
that occurs among persons who are not exposed to the hazard. In this 
case, P<INF>0</INF> represents the estimated MSD incidence among 
workers who are either not exposed to risk factors at work or who are 
exposed to risk factors below the level meeting the final rule's 
screen.
    As with the first risk assessment approach discussed above, OSHA 
also estimated the lifetime risk of experiencing a LWD MSD to workers 
who work in jobs that meet the final rule's basic screening tool. 
Estimates representing the risk of experiencing at least one MSD and 
the average number of MSDs per worker (i.e., the expected value) were 
calculated assuming a 45-year working life. Table VI-10 presents OSHA's 
estimates of the lifetime risk of experiencing work-related MSDs, by 
industry sector; lifetime risks were calculated based on both the 
upper- and lower-bound estimates of the MSD incidence among higher-risk 
employees (i.e., those exposed to risk factors at levels meeting the 
final rule's screen). Based on the probability approach, the estimated 
probability that a higher-risk worker will experience at least one 
work-related MSD during a working lifetime ranges from 33 per 1,000 
workers to 926 per 1,000 workers, depending on the industry sector. 
Based on the expected value approach, the expected number of work-
related MSDs that will occur in a cohort of higher-risk workers all 
entering an industry at the same time ranges from 34 per 1,000 workers 
to 2,530 per 1,000 workers, since this approach recognizes that it is 
possible for a worker to experience more than one work-related MSD in a 
working lifetime.

[[Page 68564]]

[GRAPHIC] [TIFF OMITTED] TR14NO00.013


[[Page 68565]]


[GRAPHIC] [TIFF OMITTED] TR14NO00.014

    Several rulemaking participants commented on the results of OSHA's 
preliminary risk assessment and the approaches taken by the Agency to 
estimate the magnitude of MSD risks to employees.

[[Page 68566]]

    In their post-hearing submissions (Exs. 500-221, 500-223), Keller & 
Heckman presented an alternative risk analysis that they believe could 
be used to compare work-related risks to the background risk of MSDs. 
Citing the work of Maizlish et al. (Ex. 26-1186), they stated that the 
background risk of carpal tunnel syndrome (CTS) is 1.05 cases per 1,000 
person-years; this estimate is based on an analysis of medical records 
in Rochester, Minnesota, between 1961 and 1980 (Stevens et al., Ex. 26-
1009). Using OSHA's estimates from the preliminary risk assessment of 
the total number of MSDs in U.S. industry for each of the six injury 
categories selected by OSHA, Keller & Heckman estimated a background 
incidence for each of the six injury types based on the ratio of the 
number of LWD cases for each injury type to the number of LWD CTS 
cases. For example, since OSHA's estimates of the number of LWD 
strains, sprains, and tears is 16.88 times higher than the number of 
LWD CTS cases, Keller & Heckman estimated that the background rate of 
LWD strain, sprain, and tear injuries in the U.S. population is 17.72 
cases per 1,000 people per year (i.e., 16.88  x  1.05). Across all six 
injury types, Keller & Heckman estimated the background rate for all 
LWD MSDs to be 22.83 cases per 1,000 persons per year for the U.S. 
population. They also estimated the MSD rate across the U.S. workforce 
to be 6.55 LWD MSD cases per person-year, by dividing the total 
estimated number of MSDs in 1996 (647,344) by private industry 
employment for 1996 (98,772,900 workers). From this analysis, Keller & 
Heckman concluded that there is no significant excess risk of MSDs in 
private industry, since the estimated background rate of MSDs in the 
general population is about 3.5 times higher than the rate that they 
estimated for the U.S. workforce. They presented similar estimates of 
MSD rates for selected industry sectors at the 3-digit SIC level and 
concluded that (1) only 10 of the hundreds of industry sectors covered 
by the ergonomics program rule have an MSD incidence that exceeds their 
estimated background rate of MSDs, and (2) that there is no excess risk 
of work-related MSDs in either SIC 204 (Grain Mill Products), SIC 206 
(Sugar and Confectionary Products), or SIC 331 (Steel Works, Blast 
Furnaces, and Rolling Mills).
    OSHA believes that the analysis conducted by Keller & Heckman is 
seriously flawed in a number of respects. First, Keller & Heckman make 
an improper comparison between estimated MSD rates in the working 
population, based on the BLS data, and estimated MSD rates in the 
general population, based on community medical records for the rate of 
CTS in Rochester, Minnesota. As explained in part B above, the BLS 
injury and illness survey is not designed to capture all injuries and 
illnesses that occur among workers; it is only designed to capture 
those that employers have determined to be work-related. In contrast, 
the Rochester study on which Keller & Heckman's analysis rests involved 
all cases of CTS that occurred in the community, regardless of whether 
those cases were work-related or not. These two statistics are not 
comparable in any meaningful way. To make a meaningful comparison, one 
would need to have data that permit estimates to be made of the total 
MSD rate in the U.S. workforce, not just the work-related component.
    Second, Keller & Heckman assume that the ratio between the number 
of one type of MSD to that of another will mirror the ratio of the 
incidence rates for the two types of MSDs in the general population. 
However, the ratio between the number of cases of two medical 
conditions can be equal to the ratio of the incidences of those 
conditions only if the cases of both medical conditions are drawn from 
the same population. Clearly, the population from which the BLS data 
are drawn differs from the general U.S. population in many ways. 
Consequently, OSHA believes that it is not possible to reliably 
estimate the background rate of any type of MSD in the general 
population from the ratio between two MSD types seen in the working 
population, and therefore the assumption made by Keller & Heckman in 
conducting their analysis is not supportable.
    Third, Keller & Heckman's analysis interprets the rate of CTS in 
the Rochester, Minnesota, population as the ``background'' rate of CTS. 
However, the study by Stevens et al. (Ex. 26-1009) made no effort to 
evaluate the work-relatedness of the CTS cases identified from the 
medical records, nor was there any mention of the investigators 
collecting work histories or assessing the work status of the cases 
identified. The Maizlish study (Ex. 26-1186) cited by Keller & Heckman 
was a study of a California surveillance system for work-related CTS, 
in which the Rochester CTS rate was used as a reference point for the 
purpose of identifying ``epidemic clusters'' of CTS (defined as a rate 
twice that of the Rochester CTS rate). Although the authors of this 
study refer to the Rochester CTS rate as a ``background'' rate, their 
rate is clearly not a background rate as that term is used in 
occupational epidemiology. It cannot represent the rate of CTS among 
persons without workplace exposure because the CTS cases in the 
Maizlish study were drawn from the entire Rochester population, which 
included both workers and non-workers.
    For these reasons, OSHA finds the analysis provided by Keller & 
Heckman both methodologically flawed and unconvincing. The Agency 
believes that its own risk analysis, which is based on estimates of the 
numbers of higher-risk and lower-risk workers and on the extensive 
epidemiological data presented in Section V of this preamble, 
appropriately takes account of that portion of the MSD rate among 
workers that is attributable to their workplace exposures.
    Keller & Heckman (Exs. 500-221, 500-223) also claim that the 
``aggregate risk (workplace and non-workplace risk combined)'' of a 
U.S. worker experiencing an LWD MSD due to anything that might be 
defined as a harmful physical agent would be no more than 0.7 per 1,000 
workers per year. They arrive at this rate by dividing the 1996 number 
of BLS MSD cases caused by repetition by total private industry 
employment. This estimate ignores the LWD cases attributed in the BLS 
data to overexertion or to awkward postures (i.e., ``bending, climbing, 
crawling, reaching, twisting''), both of which are exposure event codes 
that OSHA has determined to be highly relevant for assessing MSD risks 
to workers. Second, Keller & Heckman characterize their aggregate risk 
rate as reflecting both workplace and non-workplace contributions to 
MSD risk. Since the rate Keller & Heckman use is derived from BLS data, 
which reflects work-related cases exclusively, OSHA does not agree with 
this characterization.
    The National Coalition on Ergonomics (Ex. 32-368) and the American 
Iron and Steel Institute (Ex. 32-206) objected to the fact that OSHA 
did not modify its risk estimates from the BLS data by reducing them to 
account for MSDs that occurred in jobs that would not pass the 
screening criteria in Sec. 1920.902 of the proposal. In the final 
ergonomics program rule, OSHA has modified its screening criteria from 
the performance-oriented language contained in the proposal to be more 
specific in terms of the kinds and durations of exposures to risk 
factors that warrant further hazard analysis by the employer. Employers 
are not expected to conduct job hazard analysis or provide medical 
management of MSDs for employees in jobs where the exposures to risk 
factors are below those in the final rule's action

[[Page 68567]]

trigger. As described above, OSHA has now modified its risk assessment 
to estimate the number and incidence of MSDs that occur each year among 
workers who are in jobs in which exposures meet the action trigger. 
Thus, OSHA's final risk assessment reflects the excess MSD risks among 
the more highly exposed portion of the worker population covered by the 
standard.
    The Center for Office Technology (COT) (Ex. 30-2208) and the Puerto 
Rico Manufacturing Association (Ex. 30-3348) took issue with OSHA's 
statements in the preliminary risk assessment and significance of risk 
analysis for the proposed rule that the BLS data understate risk. For 
example, COT commented that

* * * BLS in their reports state that there is ``95% confidence that 
the `true' incidence rate falls within the confidence interval * * * 
and has an estimated relative standard error of about 0.9 percent.'' 
BLS does not state that their estimates of injury and illnesses 
reflect under reporting. Assistant Secretary Charles Jeffress is 
also on the record supporting the accuracy of the BLS data and is 
quoted * * * as saying ``90% of employers keep accurate records 95% 
of the time, or better.'' (Ex. 2208, p. 19)

    However, OSHA did not base its preliminary determination that work-
related MSDs are seriously underreported on the precision (or lack 
thereof) of the BLS survey. The BLS statement referred to in COT's 
comment simply reflects the fact that the BLS estimates of work-related 
injuries and illnesses in the United States are based on a sampling of 
OSHA 200 logs, not the logs of all employers. Consequently, the 
estimates generated from the sample of logs have some uncertainty 
associated with them, which is characterized by a 95% confidence 
interval around the estimate. The stated precision of the survey data 
provided by the BLS does not address issues related to the accuracy of 
the logs that are sampled, just the precision of the estimates 
generated from the sampled logs. OSHA's determination that MSDs are 
seriously underreported on OSHA logs is based on the findings of 
several scientific studies and other data that compared MSD rates from 
logs to those from medical insurance records, records of sick leave, or 
other sources of data independent from the OSHA logs; these studies 
were reviewed in Table VII-2 of the preamble to OSHA's proposed rule 
(64 FR 65982), and in Table VII-1 and OSHA's discussion of the 
Significance of Risk (Section VII) in this preamble.
    According to NIOSH (Ex. 32-450), OSHA's discussion of the 
limitations on the use of BLS data in the risk assessment section of 
the preamble is methodologically sound. These limitations include the 
following characteristics of reported cases:
    <bullet> The cases reported are only those that employers have 
agreed are work-related,
    <bullet> The cases reported are only those that were serious enough 
to involve at least one day away from work,
    <bullet> The cases reported do not include other types of work-
related MSD cases that rarely, if ever, come to the attention of the 
employer, and
    <bullet> The cases reported do not account for the extended or 
permanent disability that results in employee termination.

In addition, NIOSH points out that some workers with MSD episodes that 
may represent lost workday cases are reassigned to minimal work 
activities in order to avoid recording the case as one involving lost 
workdays. For these reasons, NIOSH agrees that there is a substantial 
likelihood of under-reporting in the BLS system and that the BLS 
estimates represent a lower bound of the true risks of work-related 
MSDs. NIOSH agrees with OSHA that the true incidence of work-related 
MSDs is greater than indicated by the BLS estimates.
    In its pre-hearing comments (Ex. 32-368), the National Coalition on 
Ergonomics objected to the use of BLS data in risk assessment on the 
grounds that the data reflect reports by workers to employers rather 
than medical diagnoses. The BLS data relied on by OSHA in this risk 
assessment is lost-work-day data, which employers provide to the BLS 
along with sufficient information about each injury or illness to 
permit detailed classification of each injury and illness. Thus, the 
data relied on by OSHA do not represent ``reports by workers to 
employers'' but cases that employers have determined to be work related 
and for which they provided detailed descriptions of the nature of the 
events associated with each case. Further, the Coalition's comment 
implies that MSD rates would be much lower if they were based on 
medical diagnoses rather than employer reports. However, evidence in 
the rulemaking record shows that the opposite result is more likely; 
several investigators have actually compared MSD rates from the OSHA 
logs with the rates reflected in other sources of data that report the 
results of medical evaluations of injuries and illnesses, such as 
medical insurance records, compensation claims, medical case records, 
and medical absence records (Exs. 26-28, 26-920, 26-1261, 26-1259, 26-
1260). These studies, reviewed in the Significance of Risk section of 
the preamble (Section VII), have consistently found the MSD rates 
reported on OSHA logs to be several-fold lower than those derived from 
medical records data. Thus, OSHA believes that a risk analysis based on 
accurate reports of the medical diagnoses of work-related MSDs would 
result in higher risk estimates than those in OSHA's analysis.
    The Edison Electric Institute (Ex. 32-300-1) and Southern 
California Edison (Ex. 30-3284) take OSHA's statement in the 
preliminary risk assessment that BLS data ``are not easy to use for 
risk assessment purposes'' to mean that these data are weak. This is 
not the case nor is it what OSHA meant by this statement. OSHA's 
statement that the BLS data are not easy to use for risk assessment 
referred to the fact that the BLS injury and illness classification 
system does not contain a single injury/illness category that contains 
data on all relevant MSDs. This fact required the Agency to select 
injury/illness categories and appropriate exposure event categories to 
represent the kinds of disorders addressed by the final rule. As 
discussed above, OSHA has determined both that the BLS data are the 
best available data for evaluating MSD risks to workers and that OSHA's 
reliance on these data is appropriate. In addition, these two 
stakeholders characterize the employment estimates from the U.S. Bureau 
of the Census as ``another questionable data source'' without providing 
any justification for this characterization. They also stated that 
combining these data to calculate MSD rates by occupation ``compounds 
the flaw.'' In fact, both the BLS and Bureau of Census population data 
have been used by the Agency to analyze the impact of its rules for 
several years, are used extensively by other researchers both within 
and outside the federal government, and represent state-of-the-art 
programs for conducting and analyzing nationwide surveys of working 
populations. OSHA knows of no other data sources that could provide 
more reliable information on occupations and workplace injuries and 
illness in the United States.
    Jesse McDaniel, a Certified Safety Professional from August Mack 
Inc. (Ex. 30-240), commented on OSHA's use of the BLS data and the 
preliminary risk assessment. First, Mr. McDaniel stated that injuries 
that do not involve lost workdays, restricted work, or medical 
treatment (or diagnosis in the case of an illness) are not recordable 
cases under OSHA's recordkeeping rules; he believes that OSHA was 
therefore incorrect in stating in the preliminary risk assessment that 
the BLS data understate the true MSD risk to workers

[[Page 68568]]

because it excludes cases that do not involve days away from work. In 
other words, Mr. McDaniel appears to believe that cases not counted as 
LWD MSDs in the BLS system are not recordable, and that OSHA's claim 
that the data understate the true risk is not warranted. OSHA does not 
agree it was incorrect in making this statement. The data relied on by 
OSHA for both its preliminary and final risk assessment comes from the 
detailed employer survey data, which requires employers to provide 
descriptions of work-related injuries and illnesses only for those 
cases involving days away from work, i.e., the employer is not required 
to provide detailed information on other kinds of recordable injuries 
and illness not involving days away from work. Therefore, OSHA's 
estimates of LWD MSD rates based on the BLS data do not include the 
other kinds of recordable MSDs referred to by Mr. McDaniel. He also 
believes that OSHA inflated its risk estimates by reporting MSD rates 
per 1,000 workers rather than on a per-100-worker basis, which is the 
convention used by BLS in reporting injury rates by industry sector and 
occupation. OSHA used the risk per 1,000 worker metric because OSHA's 
significant risk range is bounded by the Supreme Court's guidance in 
the Benzene decision, as explained in the preliminary risk assessment. 
Mr. McDaniel also provided examples that he believes suggest OSHA's 
estimated LWD MSD rates exceed the BLS-estimated total injury case 
rates for some industry sectors and occupations. However, since the BLS 
case rates are reported per 100 full-time-equivalent employees, and 
OSHA presents its risk estimates conventionally in terms of cases per 
1,000 employees, OSHA's rates, as they appear in this risk assessment, 
must first be divided by 10 to be comparable to the BLS injury case 
rates. When this adjustment is made, the comparisons made by Mr. 
McDaniel show that OSHA's estimated MSD rates are below the BLS's total 
injury case rates.

D. Analysis of Ergonomic Program Effectiveness

    In the preliminary risk assessment, OSHA evaluated information and 
data that described the effectiveness of ergonomic interventions and 
programs similar to those of the proposed ergonomics program standard 
[64 FR 65943-65975]. These data were drawn from three sources. First, 
OSHA searched for and evaluated studies that investigated the effect of 
ergonomic interventions on reducing exposures to workplace risk 
factors. These included both field and laboratory studies. Second, OSHA 
compiled a large database of published and unpublished data from case 
studies that describe the effect of implementing ergonomic programs on 
workplace MSD injury rates. Finally, OSHA used the findings from the 
epidemiological studies contained in the NIOSH (1997, Ex. 26-1) review 
to estimate the potential effectiveness of ergonomics programs. Since 
publication of the proposal, a substantial number of additional 
scientific and ergonomic case studies were entered into the record; 
OSHA has relied on these to revise its effectiveness analysis. The 
additional information and data entered into the record confirm OSHA's 
preliminary determination in the proposal that ergonomic programs and 
interventions are effective both in reducing those forces on the 
musculoskeletal tissue that have been associated with the development 
of tissue pathology, and in reducing the incidence of MSDs. In this 
section, OSHA summarizes these studies and evidence and analyzes the 
data from these studies to estimate the overall reduction in MSD rates 
that is likely to occur when employers implement ergonomic programs 
like the program required by this standard.
    The record contains much testimony from scientific experts that 
ergonomic programs designed to reduce biomechanical load are effective 
in reducing MSD risk. In its pre-hearing testimony, NIOSH agreed with 
OSHA's preliminary conclusion that ergonomic programs are effective:

* * * [T]here are numerous companies which have reported success in 
using ergonomic programs as a cost-effective way to prevent or 
reduce work-related MSDs, and reduce lost time by workers with MSDs. 
Some of these companies also report increases in productivity and 
workplace morale. The studies--in part summarized in OSHA's 
preamble, reviewed by the NAS panel--illustrate that interventions, 
including redesign of tools, machines, and work stations, can reduce 
workplace hazards and the resulting MSDs. * * *
    The effectiveness of ergonomics programs was a resounding 
message echoed by labor, industry, business, universities, health 
care, and professional societies at two conferences co-organized by 
NIOSH and OSHA to stimulate an exchange of information about 
preventing work-related MSDs. * * * The conferences, attended by 
over 1,700 people, featured workshops and presentations by industry, 
labor, and government representatives sharing their successful 
ergonomics programs and how they have reduced lost work time and cut 
costs due to injuries and illnesses in a variety of industries and 
workplaces. * * *
    NIOSH believes that the evidence in the scientific literature 
showing the success of an ergonomics program approach to workplace 
hazards is strong. Likewise, NIOSH's experience in evaluating the 
risks of MSDs in a variety of workplaces and our review of 
information from a variety of sizes of industries has generally 
shown that using ergonomic programs is an effective way to prevent 
or reduce work-related MSDs.

(Ex. 32-450-1, pp. 8-10)

    Many expert witnesses also testified that, from their experience, 
ergonomic programs are effective in reducing MSD risks. For example, 
Dr. Snook testified on the effectiveness of ergonomic programs for 
reducing the disability from back pain:

    Now, this is what we know about ergonomics and low back 
disorders. First of all, we know that in heavy manual handling jobs, 
there is an increased disability from low back pain, as measured in 
lost work days and restricted duty.
    The second thing that we know is that there have been several 
guidelines developed to help identify the high risk manual handling 
jobs.
    Third, that when these jobs are designed according to the 
guidelines, the disability from low back pain decreases.
    And finally, employers who have used ergonomics programs to 
identify and control high-risk jobs have found them to be cost 
effective.
    I also believe it is important to acknowledge what we do not 
know. We simply do not know the * * * [etiology] or the cause of 
most low back pain.
    Some have suggested that this lack of knowledge must constitute 
a stopping point. Others, however, have demonstrated that this is 
not a stopping point, that implementing ergonomic intervention[s] 
and programs to reduce physical loads does reduce the disability 
from low back pain.

(Tr. 846-847)

Dr. Cherniak testified that the volume of published ergonomics 
literature itself is indicative of the success of ergonomics 
interventions:

    The extensive literature review included in this [OSHA's 
proposed] standard and explosion of the ergonomics literature in 
industrial countries are testaments to the seriousness of MSDs, but 
also to the effectiveness of responsive intervention. I would say 
that medical fields that lack components of prevention and 
therapeutics do not usually generate expanding literature. They 
generally lead to dead ends.

(Tr. 1134-1135)

    Many other rulemaking participants provided testimony that 
ergonomics programs reduce disease. Dr. Barbara Silverstein, Research 
Director for the Safety and Health Assessment and Research Team, 
Washington State Department of Labor and Industries, testified that 
``Reducing exposure to hazardous loads does reduce musculoskeletal 
disorder prevalence, incidence, and severity.'' (Tr. 17357) Both Drs. 
Bernacki and McCunney,

[[Page 68569]]

representing the American College of Occupational and Environmental 
Medicine, testified that ergonomics programs instituted at their 
respective universities were very effective in reducing MSD rates and 
severity. (Tr. 7690-7693) Sherri Gibson, representing the American 
Industrial Hygiene Association, testified that ``We know the controls 
and ergonomic programs work, we've seen it time and time again.'' (Tr. 
16466) Under questioning by OSHA, Mr. Fernandez, a practicing 
ergonomist, stated that, although some ergonomic interventions may 
require more than one attempt and some ``tweaking,'' in his experience 
he has never seen a case in which an ergonomic intervention or program 
was ultimately unsuccessful. (Tr. 5427)
    In the preliminary risk assessment that accompanied the proposed 
rule, OSHA relied, in part, on the large body of epidemiological data 
showing consistent associations between exposure to biomechanical 
factors at work and an increased prevalence or incidence of MSDs. 
Although these studies were not designed specifically to determine or 
measure the effectiveness of ergonomic interventions in working 
populations studied, OSHA finds that they nonetheless provide highly 
useful information on the potential for ergonomic interventions to 
reduce injuries and illnesses; these studies provide this information 
because they describe the relationship between exposure to the 
biomechanical risk factors addressed in this final ergonomics program 
rule and the risk to workers of developing MSDs. The Health Effects 
section (Section V of the preamble) summarizes the results of more than 
170 epidemiological studies overall, more than 60 of which demonstrate 
that increased MSD risk is related to increased duration and/or 
magnitude of exposure to biomechanical risk factors. Other 
biomechanical and biological data reviewed in the Health Effects 
section provide evidence that excessive force imposed on 
musculoskeletal tissue, absent sufficient repair and recovery time, is 
associated with tissue damage that is consistent with the kinds of 
disorders seen in the working populations studied; thus, this 
supporting evidence is consistent with the general model that excessive 
biomechanical loading increases the risk of developing MSDs. At the 
public hearings, OSHA presented much expert scientific testimony that 
this general model is supported by high-quality scientific evidence. 
Although there is evidence that other factors, including individual and 
non-biomechanical workplace factors (e.g., psychosocial factors), also 
influence risk, the evidence shows that work-related biomechanical 
factors act independently of these other factors in increasing MSD 
risk.
    Because of the independent relationship between biomechanical and 
other risk factors in the etiology of MSDs, a change in worker exposure 
to biomechanical risk factors would be expected to lead to a 
corresponding change in worker risk of MSDs. One of the basic 
principles of public health is that reducing exposure to a substance, 
agent, or force that has been demonstrated to be harmful to health will 
reduce the risk of harm; this principle has been the scientific 
rationale behind all of OSHA's substance-specific health standards. 
Accordingly, OSHA finds that the strong evidence in the scientific 
literature relating exposure to biomechanical risk factors to an 
increased risk of MSDs is, by itself, sufficient evidence for Agency 
action that will reduce the exposure of workers to biomechanical 
factors in the workplace. OSHA's determination is supported by the 
testimony of its witnesses. In his written testimony, Dr. Wells stated 
that the epidemiological studies involving biomechanical risk factors 
have found strong and consistent relationships between those risk 
factors and MSDs, and therefore that reducing exposures to these risk 
factors is a reasonable strategy for preventing MSDs (Ex. 37-18). 
Similarly, Dr. Frank commented that the epidemiological evidence and 
the results of other investigations on the biology of low back pain 
strongly suggest that reductions in forces exerted on the spine will 
substantially reduce disability (Ex. 37-27). During questioning at the 
public hearing, Dr. Frank explained:

* * * [A]cting on biomechanical risk factors will bring risk 
reductions according to our understanding of the multifactorial 
causal process even if we are unable, for example, at the present 
time to conclusively act to reduce psychosocial factors because we 
still understand them poorly.
    Q: So that given that as a conclusion, then in your opinion does 
that mean that an OSHA standard aimed at reducing exposure to 
biomechanical factors in the work place is likely to reduce lost 
time disability for low back pain?
    Dr. Frank: That is what every epidemiologist who understands 
these methods would say.

    Dr. Punnett also explained the importance of findings that 
biomechanical risk factors act independently from other factors and the 
implication of those findings on intervention strategies:

    Q: What is so important about this finding that the physical job 
factors causing MSD are independent of any of these other factors?
    Dr. Punnett: Well, that I think leads us fairly directly to the 
inference that reducing physical work load all other things being 
equal will reduce the magnitude and/or severity of musculoskeletal 
disorders. * * * That is that the effect is not confounded by those 
other factors. And therefore, we can anticipate a benefit 
proportional to the increase that has been identified with current 
exposures.
    Q: Does this mean that an OSHA standard aimed at reducing 
exposure to MSD hazards [i.e., biomechanical factors] is likely to 
prevent work-related MSDs?
    Dr. Punnett: I believe so, yes.

    Table VI-8 presented summary statistics from the epidemiological 
studies that OSHA selected for the Health Effects section; these 
studies include those contained in the 1997 NIOSH review (Ex. 26-1) as 
well as additional studies in the record. The statistics presented in 
Table VI-8 include the range in risk ratios reported in these studies, 
grouped by type of disorder studied, as well as the median and mean of 
the distribution of these risk ratios. The risk measures in the 
epidemiological studies include odds ratios, prevalence rate ratios, 
and (for a few studies) incidence ratios, and approximate the relative 
risk of musculoskeletal disorders in an exposed worker population 
compared with that in a referent group. Although the risk ratios 
reported in epidemiological studies cannot be used directly to measure 
the effectiveness of ergonomics programs, they do provide information 
on that part of the MSD incidence seen in workers that can be 
attributed directly to their exposure to biomechanical risk factors; 
this portion of the MSD incidence is termed the attributable, or 
etiologic fraction, and is also the fraction of the MSD incidence seen 
in worker populations that is potentially preventable.
    The concept of an attributable or etiologic fraction is standard in 
epidemiology, and the concept has been used previously to estimate the 
attributable fraction of several types of MSDs in working populations. 
Hagberg and Wegman (1987, Ex. 26-32) reviewed the epidemiological 
literature and selected 21 studies in which diagnoses of neck and 
shoulder disorders were made from physical or laboratory examinations. 
Odds ratio measures from studies describing similar disorders were 
pooled across studies for common occupations that involved exposures to 
workplace risk factors, and the authors computed the

[[Page 68570]]

overall odds ratio for each type of occupation and disorder. In 
addition, the authors assessed the effect of the exposure to workplace 
risk factors on MSD risk by computing the etiological fraction in the 
exposed population; the etiologic fraction was computed only from those 
odds ratios that were statistically significantly higher than 1. 
Hagberg and Wegman (1987, Ex. 26-32) found that the etiological 
fraction ranged from 40 to 99 percent, depending on the specific type 
of upper extremity disorder. This study thus provides evidence that the 
potential for ergonomic interventions to reduce MSD incidence among 
workers is quite high, provided that such interventions reduce worker 
exposures to biomechanical risk factors.
    OSHA's own summary of the risk ratios reported in the 
epidemiological database, both in the preliminary and final risk 
assessments, is consistent with the findings of Hagberg and Wegman (Ex. 
26-32). The distribution of risk ratios reported in the epidemiology 
studies relied on by OSHA in the Health Effects section of the preamble 
indicate that, based on the median of the distribution, between 46 
percent (back disorders) and 88 percent (hand-arm vibration syndrome 
(HAVS)) of the MSDs experienced by workers who have substantial 
exposure to biomechanical risk factors (i.e., those workers who 
comprised the exposed cohorts in these studies) can be attributed to 
their exposure to risk factors, and are therefore potentially 
preventable by reducing exposure to the biomechanical risk factors that 
caused them. For upper extremity disorders (excluding HAVS), neck 
disorders, and shoulder disorders, the attributable fractions based on 
the median of the risk ratios is between 55 and 65 percent. The mean of 
the distribution suggests a somewhat higher attributable fraction: 58 
percent for back disorders, 93 percent for HAVS, and between 70 and 80 
percent for all others.
    As discussed above, OSHA has determined that the strength of the 
epidemiological, biomechanical, and biological data reviewed in the 
Health Effects section is sufficient to justify the promulgation of an 
ergonomics program standard to reduce the significant risks of MSDs 
posed to workers who are exposed to biomechanical risk factors on the 
job. Nevertheless, the record contains a substantial body of scientific 
evidence and case reports that demonstrate directly that ergonomic 
programs designed to reduce exposures to biomechanical risk factors do 
reduce the incidence of MSDs in exposed workers. Some of this evidence 
was reviewed in the preliminary risk assessment for the proposed rule; 
however, since publication of the proposal, many additional studies and 
case reports have been made available in the record. The remainder of 
this part of OSHA's final risk assessment reviews these studies and 
reports.
    Intervention studies that employ formal scientific methods are 
particularly compelling and merit special attention. Unfortunately, 
intervention studies for ergonomics programs are infrequently conducted 
because they are complex and scientifically challenging because of the 
lack of control that investigators generally have over workplace 
conditions. Thirty-four reports of ergonomic interventions in 
workplaces were identified in the rulemaking record and are summarized 
in Table VI-11. Each of these 34 reports was characterized by:
    <bullet> A clearly described intervention,
    <bullet> Measurable exposure or health effects endpoints
    <bullet> Acceptable statistical methods, and
    <bullet> Characterization of exposure or health outcomes both prior 
to and after intervention.
    These 34 studies together represent the best available direct 
evidence that practical application of the principles and methods of 
ergonomics in the workplace results in reduced employee exposure to 
hazards and in a reduced incidence of work-related musculoskeletal 
disorders. These studies evaluated the effect of ergonomic 
interventions on risk factor exposure, health outcomes, or both. Of 
these studies, 22 reported that, after the ergonomic intervention, 
exposure was reduced, as measured by the magnitude of external 
stressors (i.e., reductions in repetitions or improved postures) or 
reduced tissue loading; 12 of these studies also documented reduced MSD 
rates as measured by injury records or employee symptom reports. OSHA 
believes that the 12 studies that measured both exposure and outcome 
effects are particularly strong, and their findings particularly 
significant, because they provide direct evidence of a relationship 
between reductions in exposure to biomechanical risk factors and 
reductions in the incidence of MSD cases or symptoms, findings that are 
consistent with the model derived from the epidemiological data, which 
posits that biomechanical risk factors are associated with an increased 
MSD risk independent of other contributing factors. Ten of the 
intervention studies documented outcome measures alone and found that 
injury rates or symptom reports declined following ergonomic 
interventions. Two studies (Bernacki, 1999, Ex. 38-34; Bohr, 1997, Ex. 
38-64) also reported improved recognition of potentially hazardous jobs 
among the participants in the ergonomics programs studied.

                       Table VI-11.--Summary of Scientific Studies Designed To Assess the Effectiveness of Ergonomic Interventions
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                       Health effects
               Study                       Population             Intervention          Analytic method        Exposure outcome           outcome
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aaras (1994) Ex. 502-252; Westgaard  420 female              Reduce postural load:   Longitudinal survival  Decreased postural     Reduction in mean
 (1985) Ex. 26-787; Westgaard         telecommunication       individual adjustment   analysis (1967-        load intensity and     sick leave from 22
 (1984) Ex. 26-1026.                  assembly workers.       of workstation height   1984). Exposure        duration on            days to 1.8 days,
                                                              and angle, increased    evaluated by           trapezius, reduce      Reduced turnover
                                                              legroom, suspending     trapezius static       load in hand,          from 30.1% to 7.6%,
                                                              hand tools, arm         load via EMG,          reduced shoulder       Increased
                                                              supports, limit         postural angles        angles.                productivity.
                                                              vertical dimensions;    Outcome: signs &
                                                              Design work to reduce   symptoms, sick leave
                                                              postural fixity.        due to load-related
                                                                                      MSDs. Survival
                                                                                      analysis.

[[Page 68571]]

 
Aaras (1997) Ex. 26-63.............  20 VDU workers........  Forearm support,        Laboratory study       Trapezius load         .....................
                                                              screen sight angle      using open,            significantly lower
                                                              change.                 randomized Graeco-     with forearm support
                                                                                      Latin squared trial    (both duration and
                                                                                      with five test         intensity) with both
                                                                                      conditions using       sitting and
                                                                                      keyboard and then      standing. No
                                                                                      using mouse,           significant
                                                                                      measurements           differences with 15
                                                                                      included descending    versus 30 degrees
                                                                                      m. trapezius and       sightline.
                                                                                      erector spinae
                                                                                      lumbalis at L3 EMG
                                                                                      and inclinometer.
Aaras (1998) Ex. 26-597............  Male VDU workers, 50    1  new lighting.......  Serial interventions   Reduced trapezius      Reduced trapezius
                                      per group.             2  new workplace         in 2 intervention      load in intervention   pain, in
                                                              design to support       groups, 1 control      groups after forearm   intervention groups,
                                                              forearms.               group, Load measured   support and            no change in forearm
                                                             3  optical exams and     via EMG and            optometric             pain (appeared to be
                                                              corrections.            observation,           corrections, Reduced   associated with
                                                                                      controlled for         glare problems in      increased mouse use,
                                                                                      psychosocial factors   intervention groups.   no change in back
                                                                                      at work and home.                             pain). Headaches
                                                                                                                                    reduced after
                                                                                                                                    lighting change,
                                                                                                                                    borderline
                                                                                                                                    improvement with
                                                                                                                                    optometry, Visual
                                                                                                                                    discomfort improved
                                                                                                                                    with both lighting
                                                                                                                                    and optometry
Bernacki (1999) (Ex. 38-34)........  University employees,   Implementation of a     Longitudinal follow-   Ergonomic assessments  Incidence rate
                                      1992-1998.              program with early      up of employees        (2041), initially      decreased 80% (6.5
                                                              diagnosis and           reporting to the       with those with        in 1992 to 1.3/1000
                                                              treatment, ergonomic    medical department     UEMSDs for job         in 1998), surgery
                                                              assessment and          after policy to        modifications. By      trend also
                                                              correction: wrist       include medical        1994, significantly    decreased.
                                                              supports, document      workup and ergonomic   more assessments on
                                                              holders, foot rests,    assessments for        jobs believed to be
                                                              headsets, alternate     UEMSDs starting in     risky prior to
                                                              keyboards, glare        1992. OSHA 200 logs.   injury.
                                                              screens, chairs, etc.
Bohr (1997) Ex. 38-64..............  600 employees in three  Used participatory      One year longitudinal  14 problems            not assessed.
                                      departments in a        worker-management       evaluation of the      identified and
                                      large metropolitan      ergonomics teams to     ability of ergonomic   potential solutions
                                      medical center.         identify risks and      teams to identify      considered or
                                                              control strategies.     problems and design    identified.
                                                                                      solutions.
Brission 1999 Ex. 38-92............  627 university          Ergonomic training to   Six month              Greater decreases in   Greater decrease in
                                      employees working 5     identify postural       longitudinal           the prevalence of      the prevalence of
                                      or more hours per       stressors and make      comparison of          three postural         musculoskelatal
                                      week with a video       changes in equipment    postural stressors     stressors in the       disorders by both
                                      display unit.           and work activities.    and injury             experimental group     questionnaire and
                                                                                      statistics in          than the control       physical exam in
                                                                                      randomly assigned      group.                 experimental group
                                                                                      experimental (n=284)                          subjects under 40
                                                                                      and control (n=343)                           years of age than in
                                                                                      groups.                                       the control group.

[[Page 68572]]

 
Cook (1999) Ex. 38-205.............  20 meatpackers........  Clamp rather than hand  RMS EMG measurements   Left wrist and finger  .....................
                                                              to hold hog head        if biceps, extrinsic   flexor muscle effort
                                                              while chiseling.        finger and wrist       was significantly
                                                              Modified handle and     flexor muscles after   reduced in chiseling
                                                              tool balance for ham    calibration. Workers   operation (hand
                                                              trimming, Air knife     randomized order of    holding eliminated).
                                                              to cut casings rather   trials between old     Right wrist and
                                                              than pulling casings    and new method by      finger flexor muscle
                                                              by hand.                each worker for 30     effort significantly
                                                                                      minutes (multiple A-   reduced in ham
                                                                                      B-A-B research         trimming. Casing
                                                                                      design).               pulling task showed
                                                                                                             no significant
                                                                                                             reduction in muscle
                                                                                                             effort.
Drury & Wick (1984) Ex. 26-1244;     Shoe manufacturing      Ergonomics program      Pre-post study         Prototype              Body area discomfort
 Wick (1987) Ex. 26-1058.             workers.                including employee      design.                implementation         eliminated (except
                                                              training and            Observational          showed productivity    forearm). Two year
                                                              involvement in          analysis of posture,   increased or           follow-up of
                                                              developing controls,    force, frequency       remained unchanged,    ornament job (Wick)
                                                              systematic process of   every half hour for    awkward wrist          showed no additional
                                                              task analysis,          week pre and post      motions decreased,     injuries reported.
                                                              design, testing,        intervention,          postural stress
                                                              implementation and      postural discomfort    ratings decreased.
                                                              measurement. Tilted     survey, performance
                                                              work surfaces, arm &    measures Data for 5
                                                              foot rests,             jobs presented.
                                                              adjustable chair,
                                                              pneumatic pedal,
                                                              pallet leveller.
Evanoff (1999) Ex. 38-32...........  100-110 orderlies in a  Used a participatory    Two year longitudinal  Not reported.........  Decreased OSHA
                                      1,200 bed urban         worker-management       evaluation of pre                             recordable injury
                                      hospital.               ergonomics committee    and post                                      and lost workday
                                                              to design and           intervention injury                           rates (relative risk
                                                              implement changes in    rates and self                                = 0.64 for all
                                                              training and work       reports of symptoms.                          injuries and 0.4 for
                                                              practices for lifting.                                                lost time injuries
                                                                                                                                    among orderlies,
                                                                                                                                    adjusted for rates
                                                                                                                                    among other hospital
                                                                                                                                    staff. Statistically
                                                                                                                                    significant
                                                                                                                                    reductions in
                                                                                                                                    reports of various
                                                                                                                                    systems.
Garg (1999)........................  Seven nursing homes     Used Participatory      One year longitudinal  Not reported.........  For injuries from
                                      and one hospital,       employee-management     comparison of pre                             patient transfers:
                                      employing 57-136        advisory teams to       and post                                      62% decrease in the
                                      nursing personnel       implement ``zero-lift   intervention injury                           number of injuries,
                                      each.                   programs''.             statistics.                                   86% decrease in lost
                                                                                                                                    workdays, 64%
                                                                                                                                    decrease in
                                                                                                                                    restricted workdays,
                                                                                                                                    84% decrease in
                                                                                                                                    workers'
                                                                                                                                    compensation costs.

[[Page 68573]]

 
Garg & Owen (1992) Ex.-1093 (1994)   57 nursing assistants   Walking belts and       Pre-post study         Significant reduced    Back injury incidence
 Ex. 502-481; Owen & Garg (1994)      in 2 nursing home       mechanical hoists,      design: observed       perceived exertion     rate decreased from
 Ex. 26-1415.                         units.                  shower chairs.          transfer techniques,   with mechanical and    83 to 42 per 100
                                                                                      rate of perceived      belt transfers         FTEs, Severity rate
                                                                                      exertion, OSHA 200     compared to manual     decreased from 634
                                                                                      logs 4 years prior     transfers.             days to 0 days per
                                                                                      to intervention and    Mechanical lifts       100 FTEs [Note:
                                                                                      4 months post          with scales and        short follow-up time
                                                                                      intervention.          shower chairs          reduces strength of
                                                                                                             reduced the number     the study. There was
                                                                                                             of transfers           an increased in
                                                                                                             required per patient.  injury/severity rate
                                                                                                                                    in the first phase
                                                                                                                                    of the intervention
                                                                                                                                    on one unit, but
                                                                                                                                    none of thee
                                                                                                                                    injuries were
                                                                                                                                    related to resident
                                                                                                                                    transfers]
Harms-Ringdahl Ex. 26-630..........  71 Electronic circuit   Suspended arms support  Pre-post intervention  Not reported.........  31 subjects per-3
                                      board assembly          to reduce neck and      design. Symptoms                              months post shoulder
                                      workers.                shoulder muscle         (VAS) 12 months and                           symptoms decreased
                                                              static loading.         one week prior to                             from 62% to 45%, for
                                                                                      intervention, and 3                           neck decreased from
                                                                                      months (n=31) and                             57% to 55%. Mean end
                                                                                      monthly ratings for                           of shift VAS in 1.5
                                                                                      1.5 years post                                year follow-up
                                                                                      intervention (n=71).                          decreased from 46mm
                                                                                                                                    to 24mm, and for
                                                                                                                                    neck 41mm to 19mm.
                                                                                                                                    93% of subjects
                                                                                                                                    using the balancers
                                                                                                                                    after 1.5 years.
                                                                                                                                    [Note: paired
                                                                                                                                    analysis was not
                                                                                                                                    used at 1.5 years].
Jones (1997) Ex. 32-339-1-29.......  12,000 employees in 13  Comprehensive           Five year              Not reported.........  46% and 20% decrease
                                      poultry processing      corporate-wide          longitudinal                                  in UEMSD incidence
                                      plants.                 ergonomics program,     evaluation of                                 rate and severity
                                                              including management    workers'                                      rate, respectively.
                                                              commitment, ergonomic   compensation rates                            50% and 36% decrease
                                                              committees, risk        and costs and                                 in lifting claims
                                                              factor checklists,      overall program                               incidence rate and
                                                              job analysis, medical   assessment scores..                           severity rate
                                                              management, education                                                 respectively.
                                                              and training, and job
                                                              modification.
Kadefors (1996)....................  Auto assembly workers   Increase task           Comparsion of          Reduced time in        Not described; small
                                      in the assembly         variability, increase   factories with and     awkward postures in    sample size in pre-
                                      versus parallel         cycle time, increase    without parallel       each assembly step     full production
                                      assembly.               standing upright.       assembly and tilting   when using tilting     phase limits
                                                                                      car capacity using     device, lower muscle   conclusions.
                                                                                      observational          load with tilt
                                                                                      analysis and EMG.      assembly, reduced
                                                                                                             discomfort.
Loisel, (1997) Ex. 38-28...........  130 employees from      Either occupational     Population based       Not reported.........  The occupational and
                                      various workplaces,     (including ergonomic)   randomized clinical                           the combined
                                      absent from work for    or clinical             trail with three                              intervention groups
                                      more than four weeks    intervention,           intervention groups                           returned to regular
                                      with back pain.         separately and in       and one control                               work 1.5 and 2.4
                                                              combination.            group.                                        times faster than
                                                                                                                                    those in the usual
                                                                                                                                    care intervention
                                                                                                                                    group or the
                                                                                                                                    clinical
                                                                                                                                    intervention group.

[[Page 68574]]

 
Marklin & Wilzbacker (1999)........  Electric utility        (a) Raise location of   Pre-post intervention  Reduced lifting index  Not reported.
                                      warehouse workers.      heavy objects from      assessment of          (a&b), Increased
                                                              below knee to thigh     exposure in jobs       percentage of
                                                              height.                 with historically      population capable
                                                             (b) Replace heavy oak    high injury rates      (c & d), Reduction
                                                              gate with lighter       using NIOSH lifting    in probability of
                                                              pine gate.              equation, 3D Static    back injury reduced
                                                             (c) Modify tool with     Strength Prediction    (e & f), Reduction
                                                              extension and better    Program, Lumbar        in perceived
                                                              drill bit.              Motion Monitor and     exertion (g).
                                                             (d) Maintenance of       Perceived Exertion.
                                                              pulling system.
                                                             (e) Height adjustable
                                                              lift table for
                                                              handling meter
                                                              readers.
                                                             (f) Semiautomated
                                                              pallet wrap machine.
                                                             (g) Power tool for
                                                              opening line clamps.
McKenzie (1985)....................  6,600                   Ergonomics program      Pre-post program       Not reported.........  Dramatic decrease in
                                      Telecommunications      with taskforce,         design using OSHA                             number of cases,
                                      manufacturing workers.  training for            200 logs for                                  lost and restricted
                                                              engineers and           repetitive trauma                             days. Authors
                                                              supervisors, improved   disorder cases, lost                          attribute much of
                                                              workstation and         and restricted days.                          the improvement in
                                                              tools, medical          Program was                                   lost and restricted
                                                              management of           implemented in 1981.                          days to better
                                                              restricted workers.                                                   medical management.
Melhorn (1996) Ex. 38-19...........  212 rivet gun           Random assignment to    Longitudinal           Decreased risk         Not assessed.
                                      employees.              various combinations    evaluation of risk     associated with
                                                              of posture training,    factors among eight    ergonomic posture
                                                              exercise training and   exposure groups        training. Vibration
                                                              rivet gun types.        compared with          dampening rivet guns
                                                                                      controls.              associated with
                                                                                                             decreased risk among
                                                                                                             new hires and
                                                                                                             increased risk among
                                                                                                             previous hires.
Melhorn (1999) Ex. 38-131..........  3152 newly hired sheet  Comprehensive program   Prospective cohort     Not reported.........  Increased recordable
                                      metal mechanics.        of education, job       evaluation with pre                           case incident rate
                                                              placement,              and post                                      and hours worked per
                                                              modifications and       intervention                                  employee. Decreased
                                                              medical management      comparisons.                                  lost time case
                                                              designed for                                                          incident rate, lost
                                                              employees based on                                                    time severity rate,
                                                              individualized risk                                                   and workers'
                                                              assessments.                                                          compensation costs
                                                                                                                                    per employee.
                                                                                                                                    Benefit to cost
                                                                                                                                    ratio of 16.5/1.0.
Meyers et al.(1999)................  194 Wine grape harvest  Substitute smaller      Participatory          Reduced tub weight     Results not reported.
                                      workers in 3            tubs to lower weight    ergonomics             from 57 to 47 pounds.
                                      vineyards.              to below 50 pounds.     intervention study
                                                                                      addressing load
                                                                                      weight and hand
                                                                                      coupling. Used
                                                                                      checklist to
                                                                                      identify tasks and
                                                                                      lumbar motion
                                                                                      monitor and NIOSH
                                                                                      Lifting Equation to
                                                                                      assess physical
                                                                                      load, symptoms
                                                                                      questionnaires and
                                                                                      OSHA logs to assess
                                                                                      health.

[[Page 68575]]

 
Miller (1971) Ex. 26-1250..........  Surgeons and scrub      Added larger surface    Pre-post testing of    Reduced fatigue and    Not applicable.
                                      nurses.                 area to handle of       extensors and          required recovery
                                                              surgical forceps to     flexors with EMG       time.
                                                              increase stability      over 35 procedures
                                                              and decrease load on    by six surgeons.
                                                              fingers.
Moore (1994) Ex. 38-339-1-35.......  5 engine assembly       Participatory           Pre-post case study    Carrying tasks not     UECTD Incidence rate
                                      workers.                ergonomics approach:    of one job. OSHA 200   full eliminated,       decreased 78%, 82%
                                                              eliminate carrying      log incidence data     manual hammering       decrease in
                                                              11.6-14.7 kg parts,     (39 months pre, 30     eliminated Reduction   restricted or lost
                                                              eliminate high impact   months post), Borg     in RPE.                day rates.
                                                              use of brass head       scale, satisfaction,
                                                              hammers.                psychological
                                                                                      demands.
Moore & Garg, (1996) Ex. 38-24;      930 pork slaughtering   Two departmental        Quasi-experimental     Exertions per minute,  Not assessed.
 Moore & Garg, (1997) Ex. 26-21.      plant employees.        ergonomics teams used   design, using post     hand/wrist posture
                                                              to analyze jobs and     intervention           and strain index
                                                              develop ergonomics      comparisons of non-    scores improved for
                                                              interventions.          equivalent groups.     leaf lard pulling
                                                                                                             job. Biomechanical
                                                                                                             stresses to the low-
                                                                                                             back, shoulders and
                                                                                                             guts hand eliminated
                                                                                                             on gut snatch job.
                                                                                                             Percent exertion per
                                                                                                             cycle, exertions per
                                                                                                             minute, and hand/
                                                                                                             wrist postures
                                                                                                             improved on rib pull
                                                                                                             job.
Parenmark (1993)...................  Tool and Equipment      Engineering and         Pre-post design.       Not reported.........  Sick leave decreased
                                      manufacturing.          organizational          Follow-up 18 months                           5%.
                                                              improvements in         after production                             Turnover decreased
                                                              design of new           started in new                                25%.
                                                              factory: adjustable     factory, emg
                                                              work heights, work      biofeedback to keep
                                                              technique training,     load below 15-20%
                                                              job enlargement, work   MVC. Sick leave and
                                                              pace decrease 25%,      turnover rate were
                                                              work organization,      outcome measures.
                                                              flexible work hours,
                                                              wage system,
                                                              rehabilitation.
Rooney et al.(1992) Ex. 26-1056....  400 shoe and canvas     Total quality           Pre and post           373 job                Annual lost time
                                      luggage manufacturing   management program,     intervention job       modifications, 85 of   incident rate
                                      employees.              using an ergonomics     analysis.              which achieved more    reduced from 14.9 to
                                                              team ``to closely                              than 25% reduction     3.3 per 200,000
                                                              follow the proposed                            in force, repetition   hours during four-
                                                              OSHA ergonomics                                or postural stress.    year study period.
                                                              guidelines''.                                                         Not analyzed for
                                                                                                                                    specific
                                                                                                                                    associations with
                                                                                                                                    job modifications.
Rosecrance & Cook (2000) Ex. 38-253  455 Newspaper           Continuous improvement  Pre and post           At least one           Not assessed at 4-6
                                      employees.              process, using an       intervention           intervention           months post
                                                              ergonomics committee    questionnaires and     completed in eleven    intervention.
                                                              to manage a five step   non-structured         of twelve office and
                                                              problem solving         interviews.            production areas,
                                                              method.                                        including
                                                                                                             engineering and
                                                                                                             administrative
                                                                                                             changes to problem
                                                                                                             jobs with static
                                                                                                             postures, repetitive
                                                                                                             tasks and non-
                                                                                                             adjustable
                                                                                                             workstations.

[[Page 68576]]

 
St. Vincent (1998) Ex. 500-71-64...  2 electrical product    Participatory           Pre-post design.       78% of solutions       Not reported.
                                      manufacturing plants.   ergonomics process: 7   Video analysis of      reduced risk factors
                                                              jobs with 50            posture, force,        (postural load,
                                                              solutions               duration, frequency,   forces applied), 14%
                                                              implemented:            impacts.               had no observable
                                                              improving material                             effect, 8% could not
                                                              feed, repositioning                            be evaluated.
                                                              of materials, change
                                                              in work station
                                                              dimensions, change in
                                                              product jigs, tool
                                                              changes, job
                                                              enlargement, handling
                                                              aids.
Shi (1993) Ex. 26-1099.............  County government       One year Back injury    Pre-post randomized    Not reported.........  Nonsignificant
                                      workers.                prevention program:     intervention groups                           frequent back pain
                                                              Individual health       (n=4, 77%                                     prevalence decreased
                                                              risk assessment at      participation) and                            in intervention
                                                              year 1 and year 2 in    control groups (2)                            groups whereas
                                                              intervention group      with similar                                  overall prevalence
                                                              (fitness, job           demographics.                                 significantly
                                                              demands,                Measures:                                     decreased.
                                                              satisfaction,           Satisfaction, HRA                             Significant increase
                                                              demographics),          scores, symptoms                              in job satisfaction.
                                                              training, ergonomic     prevalence, workers                           Significant decrease
                                                              improvements (lifting   compensation rates.                           in HRA risk status
                                                              devices, gait belts,                                                  (not recorded for
                                                              improved seating,                                                     control groups). WC
                                                              minimizing transport).                                                costs per claim
                                                                                                                                    increased in control
                                                                                                                                    groups but decreased
                                                                                                                                    in all intervention
                                                                                                                                    groups. Return on
                                                                                                                                    investment =179%.
                                                                                                                                    Participants
                                                                                                                                    believed ergonomic
                                                                                                                                    interventions
                                                                                                                                    contributed the
                                                                                                                                    most. No attempt to
                                                                                                                                    separate effects of
                                                                                                                                    ergonomics
                                                                                                                                    improvements from
                                                                                                                                    individual health
                                                                                                                                    promotion behavior
                                                                                                                                    in design or
                                                                                                                                    analysis.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Three individual studies are particularly persuasive (Melhorn et 
al.1999, Loisel et al.1997, Brisson et al. 1999). Melhorn et al. (1999) 
reported the results of a 5-step MSD prevention program based on OSHA 
and NIOSH ergonomics guidelines and implemented in a large aircraft 
manufacturing facility. This comprehensive program included education, 
risk factor analysis, job placement (including transitional (or 
``restricted'') work), job modifications and medical management 
designed for employees based on individualized risk assessments. The 
authors followed a group of 3,152 newly hired sheet metal mechanics, 
using a prospective cohort design with pre-and post-intervention 
comparisons. Potential confounders considered included hours worked per 
employee, average number of employees and new hires, and rates in 
otherwise comparable plants without programs. The authors compared 
outcome data for several years pre- and post-program implementation. 
Although the recordable case incidence rate and the hours worked per 
employee increased moderately in the period studied, there was a 
substantial decrease in the lost time case incident rate, lost time 
severity rate, and workers' compensation costs per employee. Workers' 
compensation costs did not decrease in comparison facilities during the 
study. The authors reported a benefit to cost ratio of 16.5/1.0 for 
this program.
    Brisson et al. (1999) conducted a longitudinal comparison of 
postural stressors and injuries in randomly assigned experimental 
(n=284) and control (n=343) groups of university employees keying five 
or more hours per week at a video display unit. The experimental group 
received ergonomic training in the identification of postural stressors 
and in making changes in equipment and work activities. Measurements 
were taken two weeks prior and six months post intervention. Symptoms 
questionnaires and standardized physical examinations

[[Page 68577]]

were used to assess health effects, controlling for individual and 
lifestyle factors. Observational analysis was used to assess risk 
factor reductions. There were significantly greater decreases in the 
prevalence of three postural stressors (twisted neck, height of visual 
target, broken hand-wrist line) in the experimental group after the 
training than in the control group. There was also a greater decrease 
in the prevalence of musculoskeletal disorders as reported both in 
questionnaires and in physical examinations in the experimental group 
subjects under 40 years of age than in the control group. Symptom 
prevalence decreased from 29% to 13% in the experimental group for 
those less than 40 years of age. The prevalence of physical findings 
decreased from 18.8% to 2.9% for those under 40 in the experimental 
group compared to a decrease from 18.3 to 10.8% in the reference group. 
There were no significant differences between the experimental and 
control groups in hours of VDU use, psychosocial work factors, smoking, 
leisure time, or body mass index. The differences between the younger 
and older workers appeared to be related to the duration of symptoms 
with older workers having longer duration.
    Loisel et al. (1997) used a population-based, randomized clinical 
trial design to evaluate 4 return-to work (RTW) approaches for workers 
with acute back problems who were absent from work for more than 4 
weeks. These included occupational intervention (including ergonomics), 
clinical intervention, combined intervention or usual care. One hundred 
thirty employees from 40 different workplaces were followed for 1 year. 
Survival analysis was used to estimate return to work time. The 
occupational (ergonomics) intervention group and the combined 
intervention group returned to work 1.5 and 2.4 times faster, 
respectively, than the usual care group or the clinical intervention 
group.
    OSHA finds that this additional body of scientific intervention 
studies, taken together with the other data presented in the 
preliminary-final risk assessments, provides strong evidence that 
ergonomics programs are effective in reducing MSD risks to workers. 
These studies have documented that reductions in exposure to 
biomechanical risk factors, as well as reductions in the rates of MSD 
cases and symptoms, follow implementation of ergonomic interventions. 
These findings are consistent with the epidemiological and 
biomechanical evidence presented in the Health Effects section that 
demonstrate the role of biomechanical risk factors in the development 
of MSDs.
    OSHA also examined two recent reviews (Linton and Van Tulder, 2000, 
and Lincoln et al., 2000) that concluded that the intervention 
literature provides little or no evidence of the effectiveness of 
ergonomics programs. OSHA finds these reviews unconvincing for the 
following reasons:
    Linton and Van Tulder (2000, Attachment to Ex. 500-118) identified 
900 articles about the prevention of musculoskeletal problems. They 
then restricted their evaluation to 20 studies of randomized controlled 
trial design and 8 studies of non-randomized trial design, each of 
which was designed to study ways of preventing long-term neck or back 
problems in subjects not seeking treatment; the methods used in these 
studies included back school training, exercise programs, etc. None of 
the studies involved workstation modifications, changes in controls or 
work practices, or administrative controls. Not surprisingly, the 
authors concluded that there is no evidence of good quality on the 
effectiveness of ergonomics interventions. OSHA gives this study little 
weight because the authors made an arbitrary decision that studies have 
no validity unless they are ``controlled trials'' (the authors do not 
define the term). The authors also exclude from consideration any 
studies of upper or lower extremity problems and any studies involving 
subjects who sought treatment. Their sweeping conclusion goes far 
beyond what is supportable, based on the very small group of 28 studies 
that meet their inclusion criteria.
    Lincoln et al. 2000 [Ex. 500-118nn] assessed the intervention 
literature related to work-related carpal tunnel syndrome (CTS). 
Twenty-four studies met their inclusion criteria, which included having 
a comparison group; implementing engineering, administrative, personal 
or multiple component interventions; and describing outcome measures 
related to CTS or upper extremity MSDs. Although these authors found 
that multiple component programs were suggestive of positive effect, 
the authors concluded that lack of randomization and lack of control 
for confounding weakened the conclusions to be drawn from these 
studies. OSHA does not agree that this conclusion undermines the 
findings drawn from the many intervention studies reviewed by OSHA. As 
noted above, randomization of engineering controls in intervention 
studies is particularly problematic because very few employers are 
willing to permit investigators to dictate which employee groups 
receive different types of job interventions, or no intervention at 
all. Small sample sizes continue to limit research in this area as 
technology and markets change to more flexible niche market demands and 
as there is an increase in temporary workers limiting long-term follow-
up of outcomes. This real-world phenomenon is not unique to the study 
of work-related musculoskeletal disorders. Frank et al.1996 [Ex. 38-
207] pointed out that most of the study design factors that produce the 
most convincing evidence are outside the control of the researchers in 
occupational settings; such design factors include stable working 
populations and processes; randomization of intervention groups; and 
the need for long-term follow-up, which is made difficult during 
economic downturns, product or process changes, or during labor-
management problems. In most cases, quasi-experimental designs, such as 
those reviewed by OSHA in Table VI-10, which use either concurrent 
comparison groups or historical control groups, present the best 
available evidence of the effectiveness of engineering or 
administrative controls in reducing occupational risks (Zwerling et 
al., 1997, Ex. 500-71-65, Goldenhar & Shulte, 1994, Ex. 26-126). OSHA 
discusses the need for and use of randomized or controlled clinical 
trials in ergonomics research later in this section in response to 
comments that were made to the record.
    In addition to the scientific studies, the record contains a large 
number of case reports documenting the experiences of employers and 
occupational health professionals who have implemented ergonomics 
programs. OSHA reviewed several of these in its preliminary risk 
assessment; however, since publication of the proposal, many additional 
case reports have become available. Generally, these reports, which are 
listed in Appendix VI-B, involve case studies of individual companies 
that have instituted programs that include some or all of the elements 
of the ergonomics program required by the standard; these reports 
describe the results of ergonomic interventions in a wide variety of 
industry sectors, including manufacturing establishments, service 
establishments, health care facilities, as well as in other workplaces 
where jobs routinely involve manual handling. Overall, OSHA identified 
over 300 case studies that quantified the reduction in MSD incidence 
following implementation of ergonomic programs and interventions; of 
these, 262

[[Page 68578]]

provided data on the reduction in MSD numbers or rates. From these 
studies, OSHA's measure of intervention effectiveness is based on 226 
values for the reduction in total (i.e., lost workday and non-lost 
workday) injuries and illnesses, and 81 values for lost workday 
injuries and illnesses. These case studies do not reflect a ``quasi-
experimental'' study design because they do not use control groups and 
there is generally no evaluation of workplace exposures by an 
independent investigator; instead, a company's or establishment's MSD 
rate experience is evaluated before and after implementation of an 
ergonomics program or intervention. Thus, the outcome measure used in 
these studies reflects the measure that is probably most often used by 
employers who wish to evaluate whether their programs are effective. 
Documenting changes in MSD rates before and after implementation of an 
ergonomics program is, in fact, one of the methods listed in the final 
rule by which employers may evaluate the effectiveness of their 
ergonomics programs.
    To characterize the experiences of employers and safety and health 
professionals in implementing these programs, OSHA determined the 
range, median, and mean reduction in MSD case rates for the overall 
data set, using the same approach as was used in the preliminary risk 
assessment. From each of these case studies, OSHA calculated the 
effectiveness of the standard (e.g., employee involvement and training, 
implementation of engineering or work practice controls). These case 
studies of ergonomic interventions measure effectiveness as the percent 
reduction in either lost workday or total number of MSDs prior to and 
after implementation of the program. That is, effectiveness was 
calculated as the ratio
[GRAPHIC] [TIFF OMITTED] TR14NO00.015

where N<INF>B</INF> represents the number or incidence of MSD cases 
prior to implementation of the ergonomic intervention, and 
N<INF>A</INF> represents the number or incidence after the intervention 
\1\.
---------------------------------------------------------------------------

    \1\ Note that, by this definition, the presence of background 
MSD cases (non-work-related cases) will decrease the apparent 
effectiveness of ergonomic interventions since the interventions 
would presumably not have any effect on the background rate of MSDs 
in the working population (i.e., both N<INF>B</INF> and 
N<INF>A</INF> might contain background MSD cases).
---------------------------------------------------------------------------

    OSHA's estimate of the overall effectiveness of ergonomics programs 
is expressed as the median and mean reduction in MSD injury rates 
contained in this data set; Appendix VI-3 to this section tabulates 
OSHA's effectiveness measure for each of the case studies that provided 
quantitative data, and also shows the time interval over which the 
change in injury rate was measured. For all MSDs (i.e., lost workday 
and non-lost workday MSDs), these case studies reported a median 67-
percent reduction in injury rates (mean effectiveness was 64 percent). 
The median and mean reductions for lost workday MSDs only were somewhat 
higher, at 75 percent and 71 percent, respectively. Although the 
effectiveness of individual ergonomics programs varied widely among the 
establishments described in these case studies, most interventions 
(about 87 percent of the case studies) achieved at least a 30 percent 
reduction in MSD injury rates, 61 percent of the case studies reduced 
MSD rates by half or more, and several achieved the total elimination 
of lost workday MSDs (see Appendix VI-B).

E. OSHA's Response to Comments on the Program Effectiveness Evidence

    Gibson, Dunn & Crutcher (Exs. 32-241-4, 500-197) raised several 
issues regarding OSHA's analysis in the proposed rule of the 
effectiveness of ergonomics programs. These issues were
    <bullet> The lack of evidence that ergonomic interventions will 
reduce low back pain, as evidenced by a comprehensive literature 
evaluation conducted to develop the Agency for Health Care Policy and 
Research (AHCPR) medical guidelines for acute low back pain;
    <bullet> The necessity of conducting randomized controlled trials 
to determine whether ergonomics programs will, in fact, be effective;
    <bullet> OSHA's reliance on the epidemiological data in making 
inferences about the effectiveness of ergonomics programs; and
    <bullet> Criticisms of individual case studies relied upon by OSHA 
to demonstrate program effectiveness.
    In their post-hearing comments, from Gibson, Dunn & Crutcher (Ex. 
500-118) stated that ``After conducting an exhaustive study, Dr. Bigos' 
panel, under the auspices of the AHCPR, `failed to find evidentiary 
support for the use of ergonomic interventions to treat back pain 
injury complaints.' '' However, in the Executive Summary for the AHCPR 
low back pain guidelines, the purpose of the effort was clarified as 
follows: ``The Agency for Health Care Policy and Research (AHCPR) 
convened a 23-member, multidisciplinary, private-sector panel to 
develop a guideline for the evaluation and treatment of acute low back 
problems in adults.'' (Emphasis added)
    Under the section entitled Scope and Organization, the following 
statement occurs: ``This Clinical Practice Guideline is intended to 
provide primary care clinicians with information and recommended 
strategies for the assessment and treatment of acute low back problems 
in adults.'' The word ``ergonomic'' appears four times. Twice, this 
term is used to describe back school programs included in the analysis. 
One citation simply points to a review of safe lifting. The final 
citation notes: ``Several ergonomic guidelines on lifting and 
materials-handling tasks are available to help the clinician provide 
ranges of activity alterations at work.'' Thus even the AHCPR panel 
felt it beneficial to employ ergonomic guidelines on lifting and 
materials handling in establishing safe levels of work activity for 
patients with acute low back pain. The section on prevention consists 
of a total of two paragraphs and 195 words, including a just three 
citations, two of which are opinion papers rather than research 
studies. Therefore, the published AHCPR low back pain guidelines do 
not, and do not purport to, have a focus on non-acute low back pain, 
work-related low back pain, ergonomics or prevention of low back pain. 
Citing the AHCPR guidlines as evidence that ergonomics interventions 
are not effective in reducing the risk of low back disorders is 
inconsistent with the cited purpose and scope of the document itself. 
Therefore, OSHA is not persuaded by this argument that the guidelines 
``failed to find evidentiary support for the use of ergomonic 
intervention to treat back pain injury complaints;'' indeed, they would 
hardly have done so because they did not look for such evidence.
    Regarding the second issue, Gibson, Dunn & Crutcher (Exs. 32-241-4, 
500-197) asserted that randomized controlled trials (RCT) and 
controlled clinical trials (CCT) are the only study designs that can 
demonstrate whether ergonomics interventions are effective. They stated 
that:

    The fact that there is no RCT supporting the proposed standard 
is a major weakness in OSHA's position * * *. [W]ithout RCT, OSHA 
cannot show that the alleged risks at issue will be alleviated by 
particular solutions contained in its proposed rule. [Ex. 500-197, 
pp. I-104 to I-105]

They also quote the statements of two of their witnesses, Dr. Bigos and 
Dr. Fisher. Dr. Stanley Bigos, Orthopedic Surgeon and Professor in the 
University of Washington Department of Orthopaedics, called prospective 
RCTs:


[[Page 68579]]


* * * the gold standard for evaluating the efficacy of interventions 
in medicine. * * * This is a widely accepted standard across 
medicine, and across science. * * * The strength of the RCT is that 
both known and unknown risk factors are balanced across treatment 
groups, so that any differences in outcomes are more likely to be 
attributable to specific interventions (Ex. 500-197, pg. I-104).

    Dr. Lloyd Fisher, Professor Emeritus in the Department of 
Biostatistics, University of Washington, likewise claimed that because 
there have been no RCTs on interventions in ergonomics, ``We have no 
evidence that these rules are going to work. They might work. They 
might be harmful.'' (Fisher Tr. 6740). A third witness, Dr. Shekelle, 
stated:

    To my knowledge there is not a single well conducted randomized 
clinical trial of any intervention designed to modify any of the 
ergonomic factors proposed in the OSHA document that has proven to 
have a beneficial effect on disability due to back pain. (Ex. 500-
197, pg. I-104).

    Controlled clinical trials are used principally in medicine to test 
the efficacy of alternative treatments on patients. In a typical 
design, one group of patients that has been diagnosed with a specific 
disease or disorder is given the usual medical care and one or more 
other groups of patients with the same disease or disorder are given 
alternative treatments. The response of the test group(s) to the new 
treatment is compared with the response in the control group to 
determine whether the new treatment(s) were more or less effective than 
the standard for treatment. In a randomized trial design, the patients 
are randomly assigned to the various test or control groups; in a 
controlled, non-randomized clinical trial, assignment of patients to 
the various groups is not made using a purely randomized procedure. The 
randomized trial is considered overall to be the superior design since 
it has the greatest likelihood of controlling for both known and 
unknown confounders, increasing the ability to attribute any observed 
differences in treatment responses between the groups to the treatments 
themselves.
    OSHA has carefully considered these comments that RCT studies in 
ergonomics are necessary to determine the effectiveness of 
interventions in reducing risk (and the related argument that such a 
high standard of scientific evidence is necessary before prevention 
procedures should be required). Although the Agency agrees with Dr. 
Bigos that RCT and CCT are the appropriate statistical designs for 
trials on the safety and efficacy of pharmaceuticals, or for a 
comparison of the effectiveness of different treatments for diseases 
and medical conditions, the study of interventions in ergonomics covers 
many more and different factors. Thus, any ergonomics RCT or CCT would 
require far more complex statistical designsand require many more 
subjects. Another major difference is that intervention studies, unlike 
typical medical or pharmaceutical efficacy studies, would start with 
healthy groups and then test for differences in subsequent risk or 
incidence of MSD. A pharmaceutical study equivalent, for example, would 
be a trial to test a drug that would prevent a specific cancer or 
chronic disease, not just treat it. Such medical RCT prevention trials 
would require a less complex statistical design than a good ergonomic 
intervention, i.e., prevention, study; yet even are such a trial would 
be prohibitively expensive when the disease incidence is fairly low, 
(because many subjects would be required), and this expense would 
increase as the required follow-up time and effort increased.
    As an example of the expense of an RCT ergonomic study, Dr. Frank, 
considering a simpler prospective design than required would be 
required for an ergonomic intervention study, in his testimony related 
his attempt to study physical loads on the back as an independent risk 
factor for workplace lower back pain, controlling for several 
individual characteristics of the worker:

    And in a nutshell, we decided that the key thing was, and it is 
very expensive to do this, to actually measure the physical loads on 
the back. * * * It costs us about $2,000 U.S. dollars per subject. 
And we did well over 300 subjects to simply use a case-control 
design (emphasis added). * * * you cannot afford to do those 
measurements on the 5,000 workers, give or take a few thousand that 
you need to follow if you are going to use a cohort or prospective 
design to see who subsequently develops back pain (Tr. 1341).

    In addition to the expense of RCT intervention studies, conducting 
such studies over a period of time sufficient to make valid 
conclusions, often means that unforeseen changes in conditions occur, 
invalidating the original study design. This is especially true when 
dealing which are often characterized by workplaces with changing 
conditions and workers who can self select on job or life style 
condition changes. For these reasons, and also because the number of 
industry sectors and variety of work conditions is so large, the 
results from the few carefully designed ergonomic RCTs that could be 
conducted over the next 5 to 10 years would be difficult to generalize 
to U.S. industry as a whole.
    For all of these reasons, OSHA believes that sufficient RCT 
intervention studies could not be practically conducted within a 
reasonable time frame to justify delaying regulatory action. Therefore, 
OSHA disagrees with the arguments of the Coalition and its witnesses 
that OSHA should wait to issue its final rule until RCT studies can be 
conducted.
    In estimating risk and risk reduction in this section, OSHA, as it 
has in all of its past rulemaking efforts, relies on the well-founded 
public health concept that, if risk factors can be identified that 
contribute to the etiology of disease, it is reasonable to act to 
reduce exposure to those risk factors to reduce the risk of disease. 
OSHA's logic and rationale in this rulemaking are similar to the 
position taken by Dr. John Frank, Professor, Public Health Sciences, 
University of Toronto (Ex. 500-64). Under the heading ``Standard Public 
Health Practice Regarding Hazard Control'', Dr. Frank poisted three 
conditions as the basis for deciding whether to implement ergonomic 
abatement policies:
    <bullet> ``Is there `reasonable cause' * * * to believe that 
exposure to the putative hazard truly does lead to measurable adverse 
health effects?'';
    <bullet> ``Is there reasonable cause to believe that feasible 
hazard abatement/control intervention * * * e.g. ergonomic job 
modification/design * * * actually reduce exposure to the hazard?'' and
    <bullet> ``Is there reasonable cause to believe that no significant 
harmful consequences of implementing such an intervention will occur * 
* *?'' (Ex. 500-64)
    Regarding the first question, whether the evidence supports causal 
association between exposure to the hazard and workplace MSDs, OSHA has 
concluded in its Health Effects section (Section V) that there is 
substantial evidence that exposure to biomechanical risk factors at 
work--repetitive motion, forceful exertion such as heavy lifting, non-
neutral body postures, contact stress, and segmental vibration--all 
contribute to the risk of MSDs. OSHA has followed the weight-of-
evidence approach for evaluating the best available body of scientific 
evidence on ergonomics, especially the large amount of epidemiologic 
data, and finds that the evidence, as judged by the (Sir Austin 
Bradford) Hill criteria, used by the scientific community for over 
forty years, is convincing. Like Dr. Frank, OSHA especially notes the 
consistency in findings across epidemiologic studies and the 
consistency between the epidemiological studies and the accumulated 
scientific knowledge on

[[Page 68580]]

biomechanics and tissue pathology that provide mechanistic explanations 
of the etiology of work-related MSDs. This body of evidence is also 
coherent in terms respect to temporality, i.e., to the cause and effect 
timing and to the populations in which the effects are most frequent or 
severe. The Health Effects section (Section V) also contains sufficient 
evidence on exposure-response to further confirm these findings.
    Dr. Laura Punnett, an epidemiologist and ergonomist, and member of 
the panel that reviewed the epidemiologic evidence on work-related MSD 
for the National Academy of Sciences, agrees with OSHA's findings:

    In summary, the epidemiologic evidence that links physical and 
ergonomic exposures at work with the risk of MSD is extensive and 
includes a sufficient number of methodologically strong studies to 
[implement] primary prevention activities. In the light of the 
experimental literature, the epidemiology is certainly most 
plausibly interpreted [as] showing a causal effect of occupational 
physical stressors on MSD among people with exposures on the job 
(Punnett, Tr. 874).

    Having found that MSDs are causally related to multiple 
biomechanical risk factors, OSHA rejects the arguments of the 
commenters that OSHA should conduct RCTs in order to determine whether 
or which specific interventions will reduce MSD risk. OSHA believes 
that other types of approaches can be used; in particular, OSHA 
believes that the analogy between ergonomice interventions to address 
the multifactoral nature of ergonomic risk factors and interventions 
for the multiple risk factors associated with the development of 
coronary heart disease (CHD, e.g., blood pressure, weight, smoking, and 
cholesterol) is appropriate. For CHD, risks and risk reductions were 
estimated for these factors long before there were any results from 
controlled prospective trials (Frank, Tr. 1340). OSHA notes the post-
hearing comments of Anheuser-Busch Inc. and United Parcel Service Inc. 
comparison which included Dr. Michael Vender's and Dr. Arthur Barsky's 
objections to Dr. Frank's of CHD and back pain. Dr. Vender states that, 
unlike coronary heart disease, back pain is ``a subjective experience 
and can originate from many sources that are not readily identified or 
measurable, including muscle, ligament, joint and disc.'' (Ex. 500-118, 
Tab Kn pg. 21). OSHA finds Dr. Vender's argument irrelevant, however, 
since the relevant connection in Dr. Frank's analogy is that in the 
case of CHD the medical and public health communities implemented 
interventions to lower CHD risk factors that had been identified 
through study designs that were not RCT, rather than waiting to 
intervene until RCT studies had been conducted.
    OSHA next considers the second question posed by Dr. Frank, whether 
there is reasonable cause to believe that feasible hazard abatement and 
control interventions (e.g., ergonomic job modification/design) will 
actually reduce exposure to the hazard. As with its other rules, OSHA 
finds that, having identified specific biomechanical risk factors that 
contribute to the etiology of MSDs, procedures to reduce exposure to 
those factors will reduce risks. This is the underlying principle that 
has goverened all of OSHA's prior health rulemakings, and it is also 
the principle providing the foundation for public health interventions. 
Moreover, as the discussion earlier in this part of the Risk Assessment 
demonstrates, OSHA has accumulated substantial evidence, both 
scientific in nature and less formal, reflecting employers experiences 
with ergonomic programs, and showing that ergonomic interventions do 
reduce exposures to biomechanical risk factors and do reduce the 
prevalence and incidence of MSDs.
    With respect to the types of studies needed to estimate risk and 
risk reduction, OSHA notes that potential risk reduction is estimated 
in many of the Agency's past rules by extrapolation of study results 
using mathematical dose-response models. None of these risk and risk 
reduction estimations relied on RCT. Several of these estimates were 
derived from modeling studies with retrospective cohort designs. In 
these studies, it was common in the course of the cohort's time frame 
that ``interventions'' occurred, in the industrial hygiene sense, to 
reduce exposures to the putative chemical agent. However, in these 
studies information about the exact interventions or exactly which 
cohort members these interventions affected is usually very limited, 
and the studies could hardly be considered ``controlled.'' Furthermore, 
all estimates for risk reduction required extrapolation beyond the 
range of observation, for which there were no ``interventions.'' This 
methodology is based on the logical rationale that if causes or risk 
factors for adverse health effects are established, a reduction in 
exposures to these factors will lead to a reduction in the adverse 
effects.
    With regard to Dr. Frank's third question, whether there is 
reasonable cause to believe that no significant harmful consequences of 
implementing such an intervention will occur, OSHA has found no 
evidence in the record that implementation of ergonomic programs will 
harm employees; several of the scientific witnesses testifying on 
behalf of the UPS and others raised this possibility (Exs. 32-241-3-4), 
claiming that ergonomic interventions will result in deconditioning of 
the workforce and a resulting increase in the risk of MSDs. OSHA 
discussed this issue in detail in the Health Effects section (Section V 
of the preamble) and rejected this argument. In brief, OSHA finds that 
its final ergonomics program standard is consistent with current 
medical practice and guidelines, will not encourage an unhealthy level 
of inactivity in lieu of returning to a safe level of work following an 
injury, and is therefore unlikely to harm workers by discouraging 
conditioning.
    Finally, several commenters presented arguments that it would be 
unethical to withhold interventions. The ethical arguments was 
summarized by Dr. Frank:

    There is also the moral impropriety of randomizing [for RCT 
studies] a set of communities or set of workplaces to not have a 
putative hazard abated (Ex. 500-64).

Dr. Punnett also testified that controlled trials are inappropriate in 
the context of protecting the public from exposures to hazardous 
agents. When asked whether controlled trials are the only 
scientifically rigorous method for determining causal relationships 
between exposure to risk factors and the risk of MSDs, she replied:

    You know, I really find that quite an extraordinary concept. * * 
* I could hardly imagine that OSHA would have ever been held to 
putting subjects in an exposure chamber and exposing them to coke 
emissions or benzene vapors or cotton dust to see whether they 
developed cancer or lung disease. And the whole idea that this would 
be the kind of evidence that would need to be provided in order for 
OSHA to take preventive action, truly it is astounding to me. And 
there are lots of examples. I mean, I showed international criteria 
documents, the European Union taking action on physical ergonomic 
exposures without ever a mention of such a thing as a randomized 
clinical trial in this area. [Tr. 1001-1002]

    OSHA considers this ethical argument to be valid in that the Agency 
does not desire to delay hazard abatement in order to conduct an RCT, 
the result of which may or may not be generalized to worker populations 
overall. This is especially the case because the Agency already has a 
sound methodology for measuring the extent of current risk and the 
potential that reduction in risk associated with implementation of the 
standard.

[[Page 68581]]

    Gibson, Dunn & Crutcher in their post hearing comments criticized 
OSHA for using epidemiology studies to assess the work-relatedness of 
MSDs and as a source of information and data to estimate the 
effectiveness of ergonomics programs (Ex. 500-118, pp. II-25 to II-36). 
Part of Gibson, Dunn & Crutcher's criticism relates to their claim that 
``a statistical level of `risk association' from an epidemiologic study 
cannot translate into a measure of effectiveness for OSHA's proposed 
program.'' (Ex. 500-118, p. II-27). They provided three reasons to 
support this claim. First, they claim, even assuming that OSHA's risk 
ratio estimates for the work-related MSDs are correct (which they do 
not concede), that by changing the job conditions:

there will still be some level of force or repetition, some movement 
from completely neutral posture * * * that presumably could cause 
`contact stress.' * * * In changing a job to address one `risk 
factor,' moreover, an entirely different concern might be created. * 
* * Yet OSHA's approach would measure the effect as if it were the 
difference between the ``risk'' from the old job and zero. That 
assumption is simply wrong. (id. II-29).

    Second, they claim that `` `deconditioning' from a reduction in 
physical activity may play a very significant role in increasing the 
risk of MSDs. * * * An epidemiologic study that focuses solely on 
alleged `risk factors' in the existing job, however, provides no 
mechanism for taking this into account, or any other change in the 
nature of a job as altered after an intervention.'' (Ex. 500-118, p. 
II-29). The third reason is that ``the `risk ratios' yielded by 
epidemiologic studies control only for factors that each author was 
able to identify and analyze. * * * In the real world, * * * [with many 
other factors to be considered] the `risk ratios' attributable to job 
factors, after fully accounting for all these other variables, would be 
far lower than those reflected in the epidemiologic evidence.'' (Ex. 
500-118, p. II-30). OSHA notes that all of the ``real world'' 
complications pointed to by these commenters are also pertinent to RCF.
    OSHA disagrees with all three of Gibson, Crutcher & Dunn's 
arguments that ergonomic risk factor epidemiology studies may not be 
used for risk reduction estimates. Gibson, Crutcher & Dunn argue that 
reducing one stress factor will either lead to increased risk due to 
exposure to another stress factor (reason one), or, contradictorily, 
lead to increased risk because the body is ``deconditioned'' and, 
therefore, more susceptible to injury (reason two). OSHA's approach for 
estimating the potential effectiveness of ergonomics programs, in both 
the Preliminary and Final Risk Assessments, is to estimate the 
proportion of disease occurring among workers exposed to risk factors 
that can actually be attributed to their exposure. This approach does 
not reflect a risk of ``zero,'' as Gibson, Dunn & Crutcher suggest. 
Instead, this approach explicitly recognizes that only some portion of 
the disease prevalence observed in a population of exposed workers will 
be affected by intervening to reduce the hazardous exposure. The risk 
ratios from epidemiological studies are precisely the kind of data that 
are used to estimate the attributable fraction of disease in an exposed 
population (e.g., see Hagberg and Wegman Ex. 26-32). For example, if an 
epidemiological study reports that the rate of disease in an exposed 
population is twice as high as that seen in an unexposed population, 
(e.g., an OR of 4), then the attributable fraction can be estimated to 
be 0.75, or 75 percent. This means that the rate of disease in the 
exposed population can be reduced by up to 75 percent in response to an 
intervention. The actual result achieved in an intervention may be 
less, depending on the effectiveness of the specific intervention 
employed. These commenters' third reason is that, because the 
epidemiology studies are limited and cannot control for enough risk 
factors, the risk ratio estimates from these studies overstate the risk 
due to the studied risk factor and cannot be generally applied to 
intervention risk reduction estimates. However, it is not always the 
case that study biases lead to an overestimate of the risk. Risk ratio 
estimates may overestimate or underestimate the true risk, depending on 
the study design, the interrelationship of the risk factors involved, 
and the comparison of the exposed and control groups. For example, 
errors in exposure assessment that arise because of the use of 
imprecise measures to characterize exposure (such as job title) leads 
to exposure misclassification, which usually results in an 
underestimate of risk, or even the observed absence of an association 
where one actually exists.
    Gibson, Crutcher & Dunn further argue that, ``even if the 
epidemiologic evidence has some application, OSHA's review of it for 
benefit purposes was fatally flawed.'' (id., pg. II-31). They offer 
several reasons for this opinion; their primary reason is that OSHA 
took an unweighted median or mean risk of ``every `risk ratio' it could 
find in a NIOSH table, even in situations where the majority of study 
ratios--all but eight in one case--did not even satisfy measures of 
statistical significance.''(Ex. 500-118, p. II-33). In short, according 
to Gibson, Dunn & Crutcher, OSHA agglomerated studies of all qualities 
and all significance levels, studies measuring different risk factors, 
using different levels of exposure, and different types of control 
groups. ``The result, in the end, is a mathematically meaningless 
number whose content dependes primarily on happenstance.'' (Ex. 500-
118, pg. II-33).
    OSHA believes that there is a good rationale for applying this 
methodology to estimate median or mean risk ratios from the 
epidemiological data base by weighing each risk ratio equally (64 FR 
65950-65951, see Table VI-9). OSHA believes that the use of 
epidemiological data and such unweighted median and mean risk ratio 
estimates, separately for each body part, using the epidemiological 
data is fair and appropriate, for several reasons. First, the 
epidemiological data, which is drawn largely from the 1997 NIOSH review 
(Ex. 26-1), is an unbiased screened review of the published literature, 
with the result that only higher quality studies are selected. Second, 
estimating risk ratios by body part agglomerates studies that reflect 
similar background rates; this should provide a more even distribution 
of risk ratio estimates than would be the case if all of the studies 
were grouped together.
    Third, including all risk ratios by body part is reasonable, even 
though some studies estimated risks for more than one body part and may 
therefore be included in analyses of more than one body part. Often 
when more than one body part is included in the same study, the risk 
estimates are based on different subgroups of workers. In OSHA's final 
risk assessment any one study is included for each body part only once.
    Finally, OSHA addresses the criticism of combining unweighted odds 
ratios from many different high-quality studies, even though NIOSH may 
have ranked studies according to their quality criteria. OSHA believes 
that, in this case, unweighted or equal-weighted means and unweighted 
medians are appropriate and fair. Most important, this methodology 
gives the same weight to high-quality studies that show no association 
as to those that do, instead of focusing on the highest risk estimate. 
OSHA believes this is fair because the large variety of study designs, 
work situations, and specific disorders addressed in these studies will 
be more representative of the varied nature of working conditions 
across the country. On the other hand, if OSHA were to weight risk 
ratios by some quality

[[Page 68582]]

criteria, where the best designed studies are rated the highest, the 
resulting composite risk estimates would be more reflective of a small 
number of specific exposure conditions, and thus less representative of 
the broad mix of workplaces covered in the final rule. Consequently, 
given OSHA's objective to quantitatively characterize the work-related 
risk of MSDs and the potential effectiveness of ergonomic 
interventions, using the best available data, OSHA finds that its 
approach that makes use of all of the epidemiological data judged by 
the Agency to be of reasonable quality is preferable to relying only on 
a small subset of those data.
    In both their pre- and post-hearing submissions (Exs. 32-241-4, 
500-197), Gibson, Dunn & Crutcher raised several criticisms of some of 
the specific case studies relied on by OSHA in the preliminary risk 
assessment (these case studies were summarized in Appendix VI-B of the 
preamble to the proposed standard, 64 FR 65965-65975). In addressing 
each of these specific comments below, OSHA first identifies the case 
study or studies being addressed in the comment, quotes or summarizes 
the comment, and follows that with a response to the comment.

Group of 24 Case Studies From M. Oxenburgh, Increasing Productivity and 
Profit Through Health & Safety (Ex. 26-1041).

    Comment: Methodology that Dr. Oxenburgh used is biased because he 
only obtained claims of reported success. ``Oxenburgh confirmed that he 
was looking to write a book * * * to demonstrate `the effectiveness * * 
* from an injury reduction perspective' of ergonomic interventions 
[citing Tr. 2646]. Having `made known what [he] was looking for,' 
[citing Tr. 2647] he obtained only reports of success.'' (Ex. 500-197, 
p II-10) ``* * * [T]reatise * * * unabashedly describes itself as an 
assemblage of ergonomic `success stories' designed `to make believers' 
out of management [citing p. 2 of Ex. 26-1041].'' (Ex. 32-241-4, p. 
215).
    OSHA's Response: The introduction to Dr. Oxenburgh's book was 
written by Dr. Stover Snook, who used the quoted phrases ``success 
stories'' and ``to make believers.'' Dr. Oxenburgh actually objected to 
terms such as ``making believers'' and ``success stories,'' because, as 
he stated at the hearings, he compiled ``a series of case studies which 
illustrate the concept of health and safety and productivity running 
together'' (Tr. 2643, ln. 11-13). Gibson, Dunn & Crutcher criticize Dr. 
Oxenburgh's publication as part of their argument that the case studies 
relied on by OSHA (which included some of Dr. Oxenburgh's case studies) 
are not scientific studies (see Ex. 32-241-4, pp. 10-214). However, in 
its preamble to the proposed rule, OSHA did not claim that the case 
studies it relied on represented ``scientific'' studies, but instead 
simply characterized them as sources of ``* * * data on the success of 
ergonomics programs and workplace interventions, * * * [which are in 
turn] supported by data from [other] scientific studies [i.e., 
epidemiological studies and experimental laboratory studies in the 
record] indicating the potential for successful ergonomics programs'' 
(Ex. 28-1, p. IV-4). The 24 case studies from Dr. Oxenburgh's book that 
OSHA used as a source of effectiveness data provide precisely this kind 
of information, and OSHA does not find that the absence of a formal 
study design diminishes the utility of these data in describing the 
beneficial effects that ergonomic interventions have had on MSD rates 
in actual workplaces. In fact, real-world effectiveness studies, almost 
by definition, describe what happens in a particular workplace 
environment when interventions of the kind required by the standard are 
put into effect. OSHA did not in the proposal and does not in the final 
rule claim that these studies do more than report what employers have 
done and the results they have.
    Comment: In his testimony, Dr. Oxenburgh stated that he relied as 
little as possible on written data (citing Tr. 2648), and preferred to 
accept what he was told on site by the people involved in implementing 
and working with the intervention (Exs. 500-197, p. II-11, 32-241-4, p. 
215). Dr. Oxenburgh did not use a methodology that involved to 
verification of his claims (Ex. 500-197, pp. II-11). Oxenburgh was 
willing to accept employer accounts without independent verification 
(Ex. 32-241-4, p. 231). Dr. Oxenburgh's sources were health and safety 
professionals who had much to gain and nothing to lose by making 
exaggerated claims of benefits (Exs. 32-241-4, p. 231; 500-197, p. II-
12).
    OSHA's Response: To obtain information from establishments, Dr. 
Oxenburgh visited facilities to conduct personal interviews and perform 
inspections of the interventions firsthand (Tr. 2648). Although Dr. 
Oxenburgh did inspect some documents on the site visits, he sometimes 
obtained written documentation after the visit ``* * * by which time 
[plant contacts] would have looked up their information.'' (Tr. 2649) 
At the informal hearing, Dr. Oxenburgh testified that the information 
and data he received were reliable:

    I cannot see any reason why they should have told me any lies. 
They were very open with me. When I was going around a workplace, 
there were no restrictions placed on me to say, ``Oh, don't talk to 
the workers,'' or anything like that * * * I have no reason to 
believe that people were not telling me just the facts that were 
there. [Tr. 2714-2715]

    The approach taken by Dr. Oxenburgh is often relied on by 
regulatory agencies (e.g., OSHA and the EPA), academic researchers, and 
other investigators; it involves having individuals with professional 
expertise (in Dr. Oxenburgh's case, in ergonomics and productivity 
measurement) talk to involved individuals, take notes, inspect 
equipment and facilities, and evaluate what has been observed. For 
example, in conducting research to obtain data for the economic and 
technological feasibility analyses to support its standards, OSHA 
conducts many site visits to gather data on control technologies and 
work practices, worker exposures, costs of exposure controls, and 
economic data. In more than 20 years of experience, the Agency has 
never had reason to conclude that the information collected in this way 
is not reliable. In fact, site visits and onsite interviews generally 
provide much more detailed and accurate information than can be 
obtained in written form alone. OSHA believes that this is why Dr. 
Oxenburgh ``relied as little as possible on people's * * * written 
data'' (Tr. 2648): he understands that the answers to specific 
questions and to follow-up questions are far more revealing than the 
information in paper records. OSHA finds that the information and data 
collected by Dr. Oxenburgh and contained in his book are fair and 
accurate reports on the effectiveness of ergonomic interventions, and 
the Agency does not agree with Gibson, Dunn & Crutcher's insinuation 
that the data are unreliable. Further, Gibson, Dunn & Crutcher provide 
no evidence that the information in Dr. Oxenburgh's book is exaggerated 
or was misrepresented by safety and health professionals intent on 
promoting their reputations and careers. OSHA therefore rejects this 
argument as specious.
    Comment: Each case study in Dr. Oxenburgh's book describes 
``health, safety and productivity gains'' in broad generalities and 
rarely provides any quantitative statistics (Ex. 32-241-4, p. 215)
    OSHA's Response: OSHA relied only on the 24 case studies from Dr. 
Oxenburgh's book that did in fact report quantitative changes in the 
number or rate of MSDs; these quantitative data are

[[Page 68583]]

reflected in Appendix VI-B in both the preliminary and final risk 
assessments.
    Comment: ``Oxenburgh holds a doctorate in biochemistry but, after 
15 years in this field, saw a career opportunity during the early 
stages of the infamous Australian repetitive strain injury epidemic of 
the early 1980's and switched disciplines with no further academic 
training.'' (Ex. 32-241-4, p. 214) ``Primarily * * * Oxenburgh 
described his expertise as being based on various consulting activities 
he undertook after becoming ``interested in ergonomics'' and 
``join[ing] the Ergonomics Society of Australia [citing Tr. 2700].'' 
(Ex. 500-197, p. II-12)
    OSHA's Response: Gibson, Dunn, & Crutcher impugn Dr. Oxenburgh's 
professional experience and training but fail to acknowledge that Dr. 
Oxenburgh has in fact worked in the field of occupational health and 
safety since 1976 (Tr. 2700) and has practiced in the field of 
ergonomics for 20 years, since he joined the Ergonomics Society of 
Australia and became a committee member of the New South Wales division 
(Ex. 37-24, Tr. 2700). Dr. Oxenburgh also served for several years as a 
founder and co-ordinator of the Economics and Ergonomics specialist 
group of the International Ergonomics Association. Over the past 12 
years, Dr. Oxenburgh has been an expert witness in more than 700 common 
law injury claims, in which capacity he has appeared about half the 
time on behalf of the employer and half the time in support of the 
plaintiff. Dr. Oxenburgh has also been the principal author on a number 
of research studies, including several seminal works on the 
quantifiable effects of early reporting and medical management (see, 
for example, Exs. 38-188, 26-1405, Winkle and Oxenburgh (1990) cited in 
Ex. 37-24, Oxenburgh (1997) cited in Ex. 37-24, Oxenburgh (1994) cited 
in Ex. 37-24). OSHA made Dr. Oxenburgh available to testify at the 
informal public hearing because of the importance of his work on 
ergonomics and productivity, and finds Gibson, Dunn, & Crutcher's 
characterization of Dr. Oxenburgh's qualifications both inaccurate and 
unjustified.
    Comment: Regarding the robot case study contained in Dr. 
Oxenburgh's book, Dr. Oxenburgh admitted that this is a very unusual 
case (Tr. 2655) and that the workers are no longer performing that job 
at all (Tr. 2653). Consequently, there is no ``compelling justification 
for including it in a case study compilation to broadly represent ways 
in which employers purportedly can achieve `100%' effectiveness through 
ergonomic interventions.'' (Exs. 500-197, p. II-13, 32-241-4, p. 226).
    OSHA's Response: Although the ``robot'' case study is an unusual 
case (because employers generally mechanize jobs but only rarely 
automate them), it is an example of an engineering approach that 
eliminated a job that had previously caused musculoskeletal injuries 
among an extraordinary high percentage of workers (60 to 80 percent of 
the workforce that performed these functions) (Tr. 2654). The 
engineering control (i.e., the robot) was implemented after facility 
personnel determined that other options (e.g., job rotation, increased 
rest breaks, and complete workstation redesign) would not prevent the 
injuries (Tr. 2654-2655, Ex. 26-1041, pp. 156-158). In his testimony, 
Mr. Caple also discussed situations in which robots are used in 
chocolate making and in the automotive industry (Tr. 2624-2625). 
However, both Dr. Oxenburgh's and Mr. Caple's testimony confirm that 
robotics are used rarely to control MSD risks. However, because of the 
unusual nature of the control approach in this case study (i.e., 
robotics), OSHA has deleted it from the case study data set and is not 
relying on it in its effectiveness analysis.
    Comment: ``It is surely no coincidence that 9 of the 24 Oxenburgh 
case studies invoked by OSHA cite General Motors as the source of 
information. At the time * * * General Motors was facing a major 
5(a)(1) ergonomics citation, backed up by considerable pressure from 
its union on the subject of ergonomics * * * [GM] had every incentive 
to look for outlets to publicize that it was committed to ergonomics 
and was achieving results.'' (Ex. 32-241-4, p. 231)
    OSHA's Response: Gibson, Dunn & Crutcher imply that the information 
and data taken from these 9 case studies are unreliable because GM was 
willing to fabricate or distort information to promote its ergonomics 
activities. OSHA does not believe that General Motors operates in this 
way, and the Agency notes that Gibson, Dunn & Crutcher provide no 
evidence of any kind to support their allegations that these 9 case 
studies are anything other than factual accounts of ergonomic 
interventions. Accordingly, OSHA is not persuaded by this comment.

Harley-Davidson Case Study (McGlothlin and Baron, Ex. 26-1080)

    Comment: The case study documents a general upward trend in MSDs 
during the study period. ``The only way a decrease in injury rates 
could be claimed was to pick an aberrational year two to four years 
prior to program implementation and draw comparisons from that single 
statistical quirk'' (Exs. 500-197, p. II-14, 32-241-4, p. 227).
    OSHA's Response: NIOSH initiated this Health Hazard Evaluation in 
1990 and followed up in 1993; the purpose of the evaluation was to 
identify jobs associated with upper-extremity and back MSDs in the 
flywheel milling department, and to make recommendations to reduce MSDs 
in that department. The MSD incidence rates per 100 workers for the 
study period, as presented in Table 8 of the report (Ex. 26-1080), were 
27.6 (1989), 11.5 (1990), 18.7 (1991), 13.4 (1992), and 12.5 (1993) 
(Ex. 26-1080). These data do not appear to support Gibson, Dunn & 
Crutcher's claim of a ``general upward trend in MSDs during the study 
period.'' Gibson, Dunn & Crutcher described the incidence rate of 27.6 
for 1989 as a ``statistical quirk'' because it is substantially higher 
than the incidence rates for 1987 (11.8), 1988 (8.9), and 1990 (11.5) 
(Ex. 32-241-4, p. 227). The case study indicates, however, that this 
increased rate was associated with hiring a nurse between 1988 and 1989 
who ``brought new vigilance to the reporting of musculoskeletal 
disorders'' (Ex. 26-1080, p. 12), suggesting that the lower rates 
reported for 1987 and 1988 reflect the underreporting, rather than low 
incidence, of MSDs. Further, the case study suggested that the MSD 
incidence for 1990, which was substantially lower than that for 1989 or 
1991, may have decreased because of a sudden 20-percent increase in the 
department's workforce: new workers may have under-reported 
musculoskeletal problems, or it is possible that the disorders did not 
become symptomatic until the following year (Ex, 26-1080, pp. 12-13). 
For these reasons, OSHA does not agree that the MSD rate for 1989, 
which is taken as the base year for comparison with post-intervention 
years, is necessarily a statistical aberration, but rather that the 
lower MSD rates for the surrounding years may reflect underreporting of 
MSDs and abrupt increases in the workforce of the establishment. 
However, because of the concern raised about the representativeness of 
the injury rate for 1989, OSHA is basing its estimate of program 
effectiveness from this study on the injury rate for 1991, which 
represents the first year in which interventions were planned and 
implemented.

[[Page 68584]]

Telecommunications (Video Display Terminal (VDT) operator) Case Study 
(Tadano, Ex. 26-1337)

    Comment: ``OSHA attributed significance to a `40.8' percent 
reduction in `Total MSDs' allegedly achieved by an ergonomics program * 
* * [T]his reduction took place after a very substantial increase in 
MSD reports during the preceding period. The article suggests that this 
claimed reduction may have arisen from `a certain operator hysteria 
about * * * catching [repetitive motion sickness], * * * possibly 
connected to sentiments, fueled by union activities, that `management 
was * * * not doing enough * * * to curb this epidemic'' ' (citing Ex. 
30-1337, p. 69). The reported reduction, therefore, might have nothing 
to do with the effectiveness of the ergonomics program and more to do 
with the statistical effect of ``regression to the mean'' (Ex. 500-197, 
pp. II-17-18).
    OSHA's Response: This case study describes an ergonomic 
intervention implemented by a telecommunications establishment to 
address an increase in the rate of upper-extremity MSDs among VDT 
operators. There is nothing in the case study that supports Gibson, 
Dunn & Crutcher's contention that the observed decline in the number of 
upper extremity MSD cases and their associated medical costs was due to 
``regression to the mean'' following an unusual increase in MSD rates, 
nor is there any suggestion by the author that ``operator hysteria'' 
was solely or even primarily responsible for the increase in the MSD 
rate prior to instituting the intervention. When reports of MSDs began 
to increase, the article stated that the ``* * * medical department 
staff was especially concerned, as they were aware that a similar 
department of a company branch in an adjacent state had been faced with 
[repetitive motion syndrome] in `epidemic proportions'.'' (Ex. 26-1337, 
p. 69) The article also stated that ``* * * the job was considered 
stressful and monotonous by many operators,'' and that ``* * * [the] 
labor management relationship had previously been good.'' (Ex. 32-1337, 
p. 69) The author clearly attributed the decline in MSD cases following 
the ergonomic intervention to the intervention itself, and reported 
that ``* * * these results indicate the value of a positive approach to 
prevention of this occupational group [of disorders].'' (Ex. 26-1337, 
p. 70) Therefore, OSHA finds that it is appropriate to rely on this 
case study as part of its data set of ergonomic interventions.
    Comment: ``Tadano also explains at length that CTDs `have a 
multifactorial etiology' and that it is often not possible to attribute 
trends to any single intervention. She concludes:

    In the current study, so many factors were changed * * * that 
success or improvement cannot be attributed to any single factor. 
Also the data were limited, in that the sample size was small and 
the duration of time measured was limited.'' [Citing Ex. 26-1377, p. 
70]

    Yet, OSHA does exactly what Tadano warns it no[t] to do ``it 
attributes the entire * * * success or improvement * * * described in 
the article to the * * * single factor * * * of ergonomic interventions 
in the workplace'' (Ex. 32-241-4, p. 218-219).
    OSHA's Response: Gibson, Dunn & Crutcher omitted an important part 
of the excerpt they quote from the Tadano study. The excerpt should 
read that ``* * * so many factors were changed (i.e., worker methods, 
work-station design, addition of exercises, and mini-breaks) that 
success or improvement cannot be attributed to any single factor.'' The 
factors mentioned by Tadano all relate to the ergonomic interventions 
described in the study, and all would be considered appropriate 
engineering, administrative, and medical management interventions under 
the final rule. Thus, OSHA did not attribute the reduction in the MSD 
rate inappropriately, Gibson, Dunn & Crutcher imply; instead, OSHA, as 
well as the author of the study, attribute the post-intervention 
reduction in MSD rate to the collective effect of all of the components 
of the ergonomic intervention.

Leiyu Shi Study (Ex. 26-1099)

    Comment: Although this study is a randomized study, there are 
serious flaws including small size and lack of sufficient study period 
to eliminate Hawthorne effect or other variables as potential 
explanations (Tr. 6823; Ex. 32-241-3-7, p.15). The author admits that 
``* * * his analysis `contains a number of limitations,' including the 
need for further examination and empirical testing to establish `the 
reliability and validity' of the methodology he used and the very real 
possibility of `a Hawthorne effect among the participating units' 
because employees knowing they are being studied react unusually and 
their reported behavior change may be more a result of their enthusiasm 
rather than that of an injury prevention program.'' [citing Ex. 26-
1099, p. 210] (Ex. 32-241-4, p. 219).
    OSHA's Response: The Leigu Shi study is a randomized trial of a 
back injury prevention program implemented among county employees; the 
program consisted of a combination of education, training, physical 
fitness activities, and ergonomic improvements. The author acknowledged 
that it was not possible rule out a Hawthorne effect bias in the 
results. However, although the author was aware of the potential for 
some confounding, he made several observations about the effectiveness 
of the back injury intervention program studied:

    The results of the study lend support to the widely held belief 
that health promotion in the workplace can significantly reduce 
employee health risks. * * * [T]he study offers suggestive evidence 
for the initial benefits of a back injury prevention program. 
Whether such interventions will continue to reap benefits in future 
years depends, to a large extent, on a favorable work environment 
and the maintenance and continuation of positive behavioral changes 
(emphasis added) (Ex. 26-1099, pp. 209-210).

    I response to general comments in the record that the case studies 
OSHA used to indicate program effectiveness are seriously biased, OSHA 
does not dispute that these case studies, like all such reports and 
investigations, may reflect some bias; no study can eliminate all 
biases or potential confounders. However, the large number of case 
studies accumulated by the Agency makes it highly unlikely that any 
single unaccounted for confounder, such as the Hawthorne effect, could 
explain the consistent results reported in these studies as well as the 
effect OSHA postulates: that ergonomic interventions work.

Malcolm Pope Case Study of Telecommunications Workers (Ex. 26-1073)

    Comment: As an example of an ``emphatic disclaimer'' OSHA's critics 
claim the authors of the technical articles made and OSHA ignored Pope 
explains in his article [which was used by OSHA in its effectiveness 
analysis] that ``there are other factors involved * * * [in low back 
pain] such as abnormal anatomy, the physical fitness of the individual, 
changes related to age and previous injury.'' (Ex. 32-241-4, p. 219, 
citing Ex. 26-1073, p. 450).
    OSHA's Response: The Pope paper discusses the etiology of work-
related low back pain and approaches for reducing back injury rates. 
Part of this report presents a case study of an ergonomic intervention 
in a telecommunications manufacturing facility. In discussing the 
etiology of low back pain, Pope stated, almost as an aside, that other 
factors may be involved; however, in discussing the etiology of low 
back pain, Pope

[[Page 68585]]

emphasizes the importance of repeated biomechanical load on tissues. 
For example, the article stated that ``all connective and structural 
tissues [i.e., even in those individuals who do not have abnormal 
anatomy, poor physical fitness, or advanced age] will fail if subjected 
to loads that are too high for too long a period of time without an 
opportunity for repair to occur'' (Ex. 26-1073, p. 450). In addition, 
he notes that ``[l]ow back pain has, in most cases [of over-exertion 
injuries reported], occurred due to a mechanical overload to one of the 
tissues of the back'' (i.e., lifting to much, too far, too long, etc.) 
(Ex. 26-1073, p. 450). Dr. Pope concluded the section of his paper on 
etiology by stating that ``The key issue for those involved in the 
prevention of occupational injuries is to use epidemiologic information 
so that the relationships between load, repetition rate and exposure 
can be identified.'' (Ex. 26-1073, p. 450)
    Dr. Pope then described the case study that exemplifies his 
approach (Ex. 26-1073, p. 453, abstract). The results of the case study 
showed that, within one year of implementing an ergonomics program that 
included engineering changes, the incidence rate of significant 
repetitive trauma disorders decreased from 1.1 cases per 100,000 
working hours to 0.26 cases/100,000 working hours and lost work days 
decreased from 1,000 to 129 (i.e., an almost eightfold decrease in lost 
work days). Dr. Pope concluded his paper as follows:

    An ergonomic approach, soundly based on biomechanical 
principles, will be effective in reducing such injuries if the 
correct management approach is taken. [Ex. 26-1073, p. 454]

    Based on Dr. Pope's discussion of the etiology of low back pain and 
the conclusions that accompany the case study, OSHA does not agree that 
the reference to ``other factors'' cited by Gibson, Dunn & Crutcher 
represent an ``emphatic disclaimer'' of the case study's findings.

Westgaard and Aaras Study of a Telecommunications Manufacturer (Ex. 26-
1026)

    Comment: The authors note in this paper that ``musculo-skeletal 
illness may also develop as a result of other factors than work load, 
for instance as a complication because of other illnesses, due to 
general defects of the musculo-skeletal system, due to muscle spasms as 
a consequence of problems of a psychological nature, or to strenuous 
leisure time activities [;t]hus, one should not conclude that the work 
station is the major causal factor for any individual case of musculo-
skeletal disorders' (Ex. 32-241-4, p.219, citing Ex. 26-1026, pp. 173-
174). This statement represents another ``disclaimer'' that weakens the 
case study.
    OSHA's Response: This study was a formal investigation of sick 
leave and medical records to evaluate the effectiveness of ergonomic 
improvements made in 1975 in a telecommunications parts manufacturing 
plant. Although the authors stated that ``* * * one should not conclude 
that the work station is the major causal factor for any individual 
case of [MSD]'' (emphasis added), there is no question that the 
investigators believed that reducing exposures to biomechanical load 
was responsible for reducing the sick leave associated with MSDs:

    There is no doubt that there has been an unusually high rate of 
musculoskeletal illness among the workers * * * in general. * * * It 
is also clear that the work situations have been strenuous, with the 
strain mainly affecting a limited number of muscles in the shoulder 
and neck region * * *. [I]t is very unlikely that those employed at 
the [work station] * * * have a sufficiently different life 
situation to other women of the same age to explain the group 
differences in sick leave due to musculo-skeletal disorders. The 
work load and, specifically, the strain on shoulder and neck 
muscles, must therefore be considered a major causal factor in the 
development of musculo-skeletal disorders among [the] workers 
[Emphasis added]. [Ex.26-1026, p. 174]

    Thus, based on the specific conclusions reached by the authors of 
this study, OSHA finds that it appropriate to include this study among 
the data base of case studies that describe the effectiveness of 
ergonomics programs.

Meatpacking Case Study (Ex. 26-1043)

    Comment: Group is too small to support statistically valid 
conclusions. Baseline of four reported injuries at meatpacking 
operation (Ex. 32-241-4, p. 220, see footnote 805).
    OSHA's Response: This article describes the comprehensive 
ergonomics program implemented by a major meatpacking company. Although 
the program was implemented for ``all plant locations'' of the company, 
the article reports quantitative results only for the bacon department. 
Although the number of MSD cases is small, Gibson, Dunn & Crutcher fail 
to mention that the reduction experienced by the department was a 
decrease from four CTDs in one month to none in the six months 
following the implementation of the program (Ex. 26-1043, pp.138 & 
140), a change that the author clearly attributed to the use of 
employee rotation in the department.

Ice Cream Manufacturer Case Study (Ex. 26-1100)

    Comment: The group is too small to support statistically valid 
conclusions. Baseline of four compensation claims, not necessarily 
attributable to MSDs (Ex. 32-241-4, p. 220, see footnote 805).
    OSHA's Response: This case study of a mid-sized ice cream 
manufacturer (230 workers in summer, 60 in winter) clearly identifies 
the four workers' compensation cases as involving ``soft tissue'' (Ex. 
26-1100, p. 52). All of these claims occurred after the installation of 
six new workstations, whereas in the preceding seven years (before the 
workstations were installed) there had been no such claims. In addition 
to the decrease in the number of claims after the intervention, the 
implementation of ergonomic changes resulted in a decrease in 
absenteeism from ten to four percent, an increase in productivity of as 
much as 55 percent, and an overall increase in morale (Ex. 26-1100). 
Thus OSHA finds it appropriate to include this study in its database.

Cattle Feed Processing Case Study (Ex. 26-1046)

    Comment: Group is too small to support statistically valid 
conclusions. Purportedly scientific article making claims based solely 
on the experience of two cattle feed processing employees without any 
attempt to explore the etiology of the reports (ex. 32-241-4, p. 220, 
see footnote 805).
    OSHA's Response: This study describes a case in which a processing 
plant began producing experimental cattle feed in a manual operation. 
According to the article, the operation ``was apparently initiated 
without either pre-run trials or consideration of occupational health 
and safety issues'' (Ex. 26-1046, p. 27). The injuries sustained by the 
two employees were shown to have been a direct result of these specific 
workplace activities; between two and four weeks after beginning these 
specific workplace activities, both of the workers sustained 
irreversible back injuries. After engineering controls were 
implemented, there were no incidents of reported back pain during three 
subsequent trials of the redesigned process. The author reported that 
``* * * [h]ad such countermeasures been implemented immediately, the 
irreversible injury would have been prevented'' (Ex. 26-1046, p. 28). 
Again, OHSA finds this study is appropriately included.

[[Page 68586]]

Hand Tool Operations Case Study (Ex. 26-1070)

    Comment: Group is too small to support statistically valid 
conclusions: ``the data are inadequate for rigorous statistical 
evaluation'' (Ex. 32-241-4, p. 220, see footnote 805, citing Ex. 26-
1070, p. 678).
    OSHA's Response: This was a formal study of OSHA log and medical 
records at a telecommunications manufacturing facility during the 
implementation of a program to introduce redesigned hand tools and 
provide employee training on ergonomics; one of OSHA's expert 
witnesses, Dr. Thomas Armstrong, was a co-author of this study. The 
plant-wide incidence rate of OSHA reportable repetitive trauma 
disorders prior to the implementation of engineering and administrative 
ergonomic controls was 2.2 cases per 200,000 workhours and 1,000 lost 
workdays. In addition, incidence rates were as high as 4.6 percent in 
some areas of the facility and work restrictions were impeding the 
balance of production lines. Four departments accounted for 68 percent 
of all repetitive trauma injuries, and 48 percent of all repetitive 
trauma injuries occurred among assemblers (Ex. 26-1070, pp. 674, 676-
677).
    After the implementation of controls, repetitive trauma disorders 
decreased to 0.53 per 200,000 workhours and only 129 lost workdays. The 
authors stated that the contribution of the control program to the 
reduction in MSDs seen in the facility ``cannot be statistically tested 
using the available medical data,'' but emphasized that they believe 
the control program was ``an important factor in this reduction'' (Ex. 
26-1070, p. 677) and stated that the program ``appears very promising'' 
(Ex. 26-1070, p. 678). Based on the authors own conclusions, OSHA finds 
that the reported reduction in MSDs in this plant are apprpriately 
attributed to the ergonomic interventions described.

Material Handling at Grocery (OSHA Site Visit) (Ex. 26-1176)

    Comment: Group is too small to support statistically valid 
conclusions. ``From these data, it is not certain that costs associated 
with CTDs, the severity of CTDs (as represented by cost per claim), or 
the impact of CTDs on total medical claims have changed significantly 
for the long term'' (Ex. 32-241-4, p. 220, see footnote 805, citing Ex. 
26-1176).
    OSHA's Response: This case study resulted from an OSHA-sponsored 
site visit to a retail grocery establishment. Although the site visit 
report acknowledges its limitations in predicting long-term effects 
from the employer's newly implemented ergonomics program, it also 
stated the following:


    [I]t appears that [worker CTD compensation] claims have declined 
somewhat, but the program has not really been in place long enough 
to be able to verify a trend * * * It does look promising, however, 
particularly in terms of the number of CTD claims, which have fallen 
even while total employment has risen, and perhaps the average cost 
per claim.
    On a division-wide basis, members of the company CTD committee 
think that, as a result of the CTD strategy implementation, the 
numbers of CTD-related injuries and illnesses have decreased, the 
associated costs of claims (workers' compensation and medical) have 
decreased, employee complaints have been reduced, and employee 
morale has improved (Ex. 26-1176, pp. 12-13).

    Thus, it is clear that this employer representative attributed the 
observed decline in MSDs directly to implementation of the program, and 
OSHA therefore finds it appropriate to include it in the data set being 
relied on by the Agency to evaluate the effectiveness of ergonomic 
interventions.

Garg and Owen Study of Ergonomic Interventions in a Nursing Home (Ex. 
26-1093)

    Comment: Group is too small to support statistically valid 
conclusions. ``[L]arge-scale studies in different nursing homes are 
necessary to confirm the * * * findings'' in the article (Ex. 32-241-4, 
p. 220, see footnote 805, citing Ex. 26-1093).
    OSHA's Response: The study was conducted in two units of a nursing 
home which employed 57 nursing assistants. As a result of the controls 
implemented, the incidence rate for back injury decreased from 83 per 
2,000,000 work-hours to 47 per 2,000,000 work-hours. The authors 
concluded that ``an appropriate ergonomic intervention program offers 
great promise in reducing physical stress and risk of low-back pain to 
nursing personnel.'' OSHA agrees that, as the authors stated in their 
article, the specific findings of this one study may not reflect the 
results achieved in other establishments that implement similar 
ergonomic measures. Garg and Owen explain that implementing such 
measures requires consideration of staffing levels, training, workload, 
and administrative support (Ex. 26-1093). However, the study by Garg 
and Owen is only one of several case studies used by OSHA to examine 
the effectiveness of ergonomics programs in nursing homes and other 
health care industry sectors (see Appendix VI-2 in this section of the 
preamble). These other studies also report reduced MSD rates that are 
attributed to ergonomic interventions, many of them similar to those 
investigated by Garg and Owen (i.e., use of mechanical devices for 
patient lifting, modifying showers and toilets for easier access). 
Therefore, OSHA does not agree that it is inappropriate to include the 
Garg and Owen case study in the database, despite the authors' caution.

Couch, Summary of Six Case Studies (Ex. 26-1086)

    Comment: The importance of non-work factors such as gender and age 
are mentioned as potential contributors. ``The above examples of the 
cost benefits of ergonomics are quite positive and indicate that 
ergonomics does seem to reap monetary rewards as well as improve worker 
well being. However, there are many factors that have not been 
accounted for or controlled in these reports; these factors, such as 
changes in the economy that reduce job turnover or changes in 
production technology and product lines that may eliminate high risk 
jobs or leave only the survivors in remaining jobs, may also contribute 
to the apparent payback. Because ergonomic case studies such as these 
are done `in the field,' it is very difficult to hold these independent 
or external variables constant'' (Ex. 32-241-4, p. 220, see footnote 
805, citing Ex. 26-1086).
    OSHA's Response: OSHA recognizes that the case studies contained in 
Appendix VI-2 are, because of their real-world rather than laboratory 
nature, unable to control for a number of factors that could affect 
injury and illness outcomes; some of these factors are mentioned in the 
Couch article (Ex. 26-1086) and in Gibson, Dunn & Crutcher's comment. 
However, OSHA is not basing its finding that ergonomic interventions 
are effective on any single study or a few case studies. Instead, OSHA 
has identified more than 200 case studies from the record, all of which 
document reductions in MSD numbers or rates following implementation of 
ergonomic interventions. These case studies reflect a wide variety of 
industry sectors, workplace conditions, labor market conditions, and 
technologies. Nevertheless, despite the presence of confounding or 
modifying factors such as those mentioned in the Couch article, all of 
these studies attributed the observed reductions in MSD rates primarily 
to the ergonomic interventions described. Because such a large number 
of case studies yields such

[[Page 68587]]

consistent results, OSHA finds it unlikely that the kinds of factors 
identified by Couch, rather than ergonomic interventions, were 
primarily responsible for the reductions in MSD rates reported in this 
large group of studies.

Automobile Cable Manufacturer (OSHA Site Visit) (Ex. 26-1181)

    Comment: OSHA's estimate of the reduction in the number of MSDs 
pre-and post-intervention are based on numbers of illness cases, lost 
workday cases, and lost work days in 1991 and 1993. However, the 
statistics for 1993 represent only the first 9 months of the year. 
Further, the establishment reported an increase in the total number of 
injuries, which must include some MSDs, from 46 in 1991 to 65 in the 
first 9 months of 1993. OSHA cannot base its effectiveness estimate 
solely on the reduction in illness cases reported (Ex. 32-241-4, p. 
222).
    OSHA's Response: The site visit report clearly states in a footnote 
to the ``1993'' column which of the data ``covers [the] period from 
January to September 1993'' (Ex. 26-1181, p. 10). If the statistics for 
1993 are extrapolated to cover a full year, based on the experience of 
the first 9 months, declines in lost workday cases and illnesses are 
still apparent: lost workday cases decline from 48 (1991) to 36 (1993) 
(a 25-percent reduction); the number of lost workdays decline from 
1,287 (1991) to 367 (1993); and the number of illnesses decline from 47 
(1991) to 23 (1993) (a 51-percent reduction). Although the report 
clearly indicates that the number of total injuries increased from 1991 
to 1993, the report also states that ``[t]he facility believes that 
their ergonomics program has contributed to decreases in the following: 
number of overall illnesses, number and costs of worker's compensation 
claims, number of work days and lost workday cases, medical (i.e., non-
compensated disability) cost, and turnover'' (Ex. 26-1181, p. 9). These 
claims are supported by the data presented in the report. No reason was 
given for the increase in the total number of injuries from 1991 to 
1993, nor was there any evidence in the report to suggest that the rise 
in total number of injuries was attributed to an increase in the number 
of MSDs. It is apparent, however, from the report that the employer 
would have been likely to classify some MSDs as injuries rather than 
illnesses. Therefore, OSHA has revised its analysis for the final rule 
to reflect that lost workday cases declined by 25 percent, and is not 
relying on the illness statistics presented in the report for its 
effectiveness analysis.

Luopajarvi et al.Study of a Food Packing Establishment (Exs. 26-1042, 
26-1090)

    Comment: OSHA attributed to an ergonomics program the elimination 
of hand MSDs from a pre-intervention level of 51 MSDs in 1976. ``The 
claim is false: the exhibit makes no reference to elimination of hand 
MSDs, and the underlying data tables confirm the existence of 
continuing injury reports. Moreover, ergonomic interventions were not 
even proposed at the plant until 1977, a year in which MSDs dropped to 
a level (20) more consistent with the lower rates existent prior to 
this year.'' (Ex. 32-241-4, p. 220).
    OSHA's Response: Tables 3 and 4 of Ex. 26-1090 (p. 430) provide 
data on the numbers of hand MSDs from 1972 to 1984 in this food 
packaging facility. The incidence of hand MSDs increased steadily from 
1972 to a high of 51 cases in 1976 and 20 in 1977; between 1979 and 
1984, the table reported between 0 to 1 MSDs occurring annually, 
indicating that the problem had been virtually eliminated. OSHA has 
revised the entry for this case study in Appendix VI-2 to report the 
study's findings more precisely. With reference to the second part of 
Gibson, Dunn & Crutcher's comment, OSHA did not rely on the hand MSD 
statistics for its overall measure of program effectiveness, but on 
data presented in Table 5 of the article, which reported the number of 
MSDs of the neck and upper extremity in 1977 and 1981 and reflect an 
overall reduction in the number of MSD of 47 percent. Thus, OSHA is 
using 1977 as the baseline year, the year in which ergonomics 
interventions were being proposed.

Footwear Assembly Case Study (Ex. 26-1059)

    Comment: OSHA attributes a 62-percent decline in MSDs over a 2-year 
period to an ergonomics training program. However, the article explains 
that ergonomic remedies were unsuccessful and the ergonomics training 
program ``* * * was actually a `behavioral management' program designed 
to improve worker attitudes and morale'' (Ex. 32-241-4, p. 225). This 
case study is consistent with evidence that ``reports of pain are 
rooted in psychosocial factors rather than workplace `hazards,' [and 
that] the attitude adjustment strategy apparently achieved what 
ergonomics could not.'' [Ex. 32-224-4, pp. 225-226]
    OSHA's Response: This article describes a training program 
implemented at a footwear manufacturing facility that had 700 workers, 
84 percent of whom were involved in repetitive tasks. The company 
experienced a rise in serious and lost-time upper-extremity MSDs 
throughout the early 1980's. The article does not claim, as the comment 
contends, that ``ergonomic remedies were unsuccessful.'' Instead, the 
article stated that several attempts were made to develop a ``safety 
program'' that was not further described (Ex. 26-1059, p. 52). If 
engineering solutions to address MSDs were implemented, they were not 
discussed in the article; instead, the article reported that ``because 
of the expense of workstation redesign in this very old facility, 
almost all human-factors engineering measures were also deemed to be 
impractical'' (Ex. 26-1059, p. 52). Therefore, no claim can be made as 
to the success of an ergonomic intervention based on engineering at 
this facility. The comment states that the program implemented was 
actually `` `a behavioral management program' designed to improve 
worker attitudes and morale.'' Behavior management is defined in the 
article as ``simply the management of people in the work place in such 
a way that they interact with the environment in the most safe and 
efficient manner'' (Ex. 26-1059, pp. 51-52). The training ``attempted 
to educate employees on the causes and effects of [cumulative trauma 
disorders] * * * and the state workers' compensation system.'' (Ex. 26-
1059, p. 53) The final rule requires employers to provide similar 
information to all employees on the causes and characteristics of MSDs. 
The program at the facility also encouraged employee participation, 
another important component of the final rule. OSHA does not agree with 
the comment that the case study demonstrates that psychosocial factors 
are more important that biomechanical factors; OSHA's review of the 
scientific evidence on the role of psychosocial factors is presented in 
the Health Effects section (Section V of the preamble), where the 
Agency finds that, although psychosocial factors play a role in the 
etiology of work-related MSDs, they do not outweigh the significance of 
exposure to biomechanical factors in the workplace and are independent 
of biomechanical efferts.

Sewing and Cutting Operations Case Study (Ex. 26-1060)

    Comment: This is an article written by an OSHA area office employee 
about an inspection of a sewing facility. ``The article actually 
reports, however, that there was a steady decline in reported CTD rates 
beginning long before any ergonomic interventions: 26% in 1987,

[[Page 68588]]

18% in 1988, and 15% in 1989'' [citing Ex. 26-1060, p. 1]. The article 
does not identify exactly when ergonomic controls were implemented, but 
it does state that rates continued to decline to 14.6% in 1990 and 6.8% 
in 1991, but increased to 11% in 1992. The article also noted that 
``there was an increase initially reported'' after ergonomics controls 
were implemented, which could only refer to the jump from 6.8% to 11%. 
Since no statistics are given for years after 1992, these data would 
suggest, if anything, that ergonomic controls reversed a previous trend 
of declining injury reports at this plant, prompting a 62% increase 
from 6.8% to 11%.'' (emphasis in original) [Ex. 32-241-4, p. 223]
    OSHA's Response: This article reports on an OSHA inspection 
conducted at a sewing facility in October of 1989. Since the 
inspection, at least through 1992, the company had been working under 
an abatement plan that required the facility to develop and implement a 
comprehensive ergonomics program ``from the ground up'' (Ex. 26-1060, 
p. 3). In 1992, the year in which the MSD rate increased over that of 
1991, the report stated that there were ``fewer incidents reported 
[overall],'' which suggests that employment in the plant had fallen 
since 1991 (there had previously been about 100 workers at this plant). 
There were also no surgeries reported in 1992, compared to 13 reported 
between 1987 and 1989 (Ex. 26-1060, p. 2). The report concludes that 
the ``lost workday injury rate has been effectively reduced,'' and 
noted that the number of employee complaints of MSD symptoms had fallen 
from 34 in 1991 to 14 in 1992 (Ex. 26-1060, p. 6). Therefore, OSHA does 
not agree with the analysis of this report by Gibson, Dunn & Crutcher, 
which suggests that the ergonomics program led to an increase in the 
rate of MSDs.

Poultry Processing Case Study (Ex. 26-1174)

    Comment: ``OSHA claims that `ergonomic solutions' at a poultry 
plant decreased recordable injuries and illnesses * * * from 10-14/100 
workers (1988-89) to 7/100 workers (1991). * * * [T]he only two notable 
dips in recordable injury rate--which includes all injuries and not 
just MSDs--occurred between 1987 and 1988, when the rate declined from 
14.0 to 10.5, and between 1989 and 1990, when there was a further drop 
from 10.5 to 7.5. The first occurrence took place before ergonomics 
began, and the second occurrence took place before the majority of the 
program was rolled out.'' (Ex. 32-241-4, p. 224) OSHA's attribution of 
the reduction in MSDs to the ergonomics program, when the reduction 
occurred prior to program implementation, and its use of total injury 
rates as if they were MSDs are ``blatant distortions of the truth.'' 
(Ex. 32-241-4, p. 224)
    OSHA's Response: This case study is a site visit report of a 
poultry slaughtering and processing plant. The injury rate history of 
this plant was as follows: 14.0 in 1987, 10.5 in 1988, 10.5 in 1989, 
7.5 in 1990, and 7.0 in 1991 (Ex. 26-1174, p. 17). The comment by 
Gibson, Dunn & Crutcher suggests that the reduction in injury rate that 
occurred in 1990 occurred prior to implemetation of most of the 
ergonomics program. However, the site visit report states clearly that 
$410,000 in capital cost was incurred for engineering controls in 1990, 
compared to $242,500 in 1991, indicating that most engineering 
improvements to address MSDs were made in 1990 (Ex. 26-1174, pp. 9-10). 
Therefore, OSHA does not agree that the 1990 injury rate reflects a 
time when most of the program had not yet been implemented. Further, 
the first drop in injury rate, which occurred in 1988, can be at least 
partly attributed to the large increase in employment in 1988 (from 950 
workers in 1987 to 1,350 workers in 1988) (Ex. 26-1174, p. 17). Because 
of the change in employment in 1988, OSHA used the injury rates from 
both 1987 and 1988 as baseline years to calculate the percent reduction 
in injury rate pre- and post-implementation (i.e., OSHA used an average 
baseline rate of 12 injuries per year). Additional evidence that the 
drop in injury rate in 1990-1991 can be attributed to the ergonomics 
program comes from other statistics provided by the facility that show 
drops in both worker absenteeism and turnover in 1990-1991 compared 
with earlier years; in contrast, there was no drop in absenteeism or 
turnover rates to accompany the drop in injury rate seen from 1987 to 
1988 (Ex. 26-1174, p 17). Therefore, OSHA finds that the decline in 
injury rate seen in the 1990-1991 time period is most likely to have 
been the result of the ergonomic improvements made in 1990 and 1991 at 
this factility.

Packaging Sugar Cubes Case Study (Ex. 26-1041, Case 41)

    Comment: OSHA attributes a 100-percent reduction of MSDs at a sugar 
cube packing operation, where the author of the study, Dr. Oxenburgh, 
stated that ``the risk of serious strain injuries to the hands and 
upper limbs has been virtually eliminated'' (citing Ex. 26-1041, p. 
230, emphasis added). ``The statement only reflects the subjective 
judgement of Dr. Oxenburgh about `risk'; he provides no actual data 
concerning actual injury experience after the change.'' (Ex. 32-241-4, 
p. 225) Further, the numbers are too small for statistical analysis, 
and ``Oxenburgh's unverified hunch about risk has no place in a 
statistical analysis.'' (Ex. 32-241-4, p. 225)
    OSHA's Response: This case study describes a sugar cube packing 
operation in which 5 employees used a tool to pack cubes tightly into 
boxes. Because of the hand posture and pressure required to operate the 
tool, injuries to the hand and upper limbs occurred in about 1 out of 4 
operators (i.e., 25 percent of workers). After implementing an 
engineering and marketing solution that allowed the cubed sugar to be 
packed loosely into bags, productivity increased to the point where 
only 2 workers were required for the packing operation. The complete 
quote partially cited by Gibson, Dunn & Crutcher from the case study 
reads as follows: ``The risk of serious strain injuries to the hands 
and upper limbs has virtually been eliminated and has led to 
considerable savings in sickness absence and workers compensation.'' 
Although no statistics are presented, this is significant because it 
demonstrates a clear benefit from the change to the process. Rather 
than representing an ``unverifiable hunch,'' as Gibson, Dunn & Crutcher 
suggest, OSHA finds it logical to conclude from Dr. Oxenburgh's 
statement that no serious injuries occurred among the two remaining 
operators because the change eliminated the forceful repetitive motion 
(i.e., pressing the sugar cubes together) responsible for the prior 
injuries.

Computer Manufacturer Case Study (Ex. 26-1068)

    Comment: OSHA attributes a 41-percent reduction in upper-extremity 
disorders in 1994-1995 and a further 50-percent reduction in 1995-1996 
to an ergonomics program. However, the program was implemented in 1991, 
after a year (1990) in which the company's upper-limb disorder rate was 
0.5 per 100 workers. This rate increased to a high of 2.5 cases per 100 
workers in 1994, after which they drop in 1995 and 1996. ``Thus, the 
reported declines in 1995 and 1996 brought the company down to 
approximately a 0.7 rate--a 40-percent increase over the experience it 
had during the last year before ergonomic interventions were 
introduced.'' (Ex. 32-241-4, p. 226, emphasis in original)

[[Page 68589]]

    OSHA's Response: Although this computer manufacturer did implement 
an ergonomics program in the early 1990s, according to the case study, 
the program began ``with a reactive approach, addressing individuals.'' 
This isolated approach could be a reason why an immediate reduction in 
upper-limb disorders was not realized. In addition, ``[p]art of the 
increase in the number of CDT cases per year [from 1990 through 1994] 
can be attributed to the company's rapid growth, which more than 
doubled during that period.'' The trend was not reversed until the 
company, beginning in 1993, ``spent at least two days a week performing 
evaluations, held mandatory ergonomic training classes for high risk 
groups including technical publications, order[ed] administration and 
customer technical phone support, and created and distributed a 16-page 
ergonomics brochure.'' Additionally, with the growth in 1994 and 1995, 
the company purchased new furniture ``allowing employees a greater 
range of postures and flexibility.'' It was this expanded and 
comprehensive approach that led to the 41 percent drop in reportable 
upper-limb disorders from 1994 to 1995 and the further decrease of 50 
percent in reportable CDT cases from 1995 to 1996 (Ex. 1068, pp. 7-8). 
Therefore, OSHA finds that the decline experienced in MSD rates 
beginning in 1995 is consistent with the company's implementation of 
ergonomic improvements that consisted of appropriate education and 
training of its workers, as well as workstation modifications.

Medical Device Manufacturer Case Study (Ex. 26-1183)

    Comment: OSHA apparently attributes a 29-percent reduction in MSD 
rates from 1990 (2.1 cases per 100 workers) to 1992 (1.5 cases per 100 
workers) to an ergonomics program (Ex. 32-241-4, p.228, footnote 857). 
However, ``the corporation did not begin to address ergonomic issues 
until 1991, did not formalize the program until 1993, and did not 
conduct training or implement the vast majority of its workplace 
modifications until 1992 or 1993. The result was a very substantial 
increase in `ergonomics incidence rate' to 2.8 [per 100 workers] in the 
first three months of 1993 from * * * pre-intervention levels.'' (Ex. 
32-241-4, p. 228)
    OSHA's Response: This case study is a site visit report to a 
manufacturer that produced suction canisters used to collect blood 
during surgical procedures. The company began to address ergonomic 
issues in 1989 (a year in which their MSD rate was 5.2 cases per 100 
workers), and first began to implement controls in 1991 (Ex. 26-1183, 
p. 2). OSHA used 1990, the first year prior to implementation of 
ergonomic controls, as the base year in its effectiveness analysis. The 
company continued to implement controls in 1992 and 1993. Since injury 
statistics were only available for the first 3 months of 1993, OSHA 
believed that a reliable injury rate could not be determined for that 
year. OSHA does not agree that the statistics available for the first 
quarter of 1993 show that the MSD rate was increasing because it 
reflected too short a period. Consequently, there are no data available 
in the report to permit an assessment of the effect of ergonomic 
interventions implemented in 1992 or 1993 at this facility. OSHA 
attributed the decline in MSD rates from 1990 to 1992 to the 
improvements made in 1991, based on the report's finding that ``[t]he 
facility believes that their ergonomics program has contributed to a 
general decrease in the plant's annual incidence rate for ergonomic-
related injuries and illnesses.'' OSHA believes that this is an 
appropriate interpretation of this study. (Ex. 26-1183, p. 10)

Vehicle Seat Assembly Case Study (Ex. 26-1076)

    Comment: This case study reported that the number of tendinitis and 
carpal tunnel syndrome cases had dropped 93 and 96 percent, 
respectively, but OSHA ignored information that the broader category of 
``strains and sprains'' increased over the same period.
    OSHA's Response: This is a case study of an automobile seat 
manufacturer that began experiencing problems with MSDs shortly after 
beginning full production. The ``slight'' increase in sprains and 
strains reported by the case study occurred during a time when the 
numbers of tendinitis and carpal tunnel syndrome cases dropped 
dramatically. According to the manufacturing manager, the increase in 
strains and sprains ``reflected the employees reporting the discomfort 
and pain [of MSDs] earlier.'' (Ex. 26-1076, p. 66) Because the increase 
in strain and sprain reports was described as ``slight'' by the 
manufacturing manager (Ex. 26-1076, p. 66), OSHA finds that the much 
larger decreases in the numbers of tendinitis and CTS cases fairly 
reflect the results achieved by the company's ergonomics program.

Aircraft Parts Manufacturer Case Study (Ex. 26-1179)

    Comment: OSHA attributes a reduction of 96.2 percent in total MSD 
cases at an aircraft parts manufacturer ``based solely on data 
referring to specific diagnosis of CTS, ignoring information * * * 
clearly stating that the total `number of reportable ergonomic injuries 
and illnesses [not just CTS] has actually increased since the 
ergonomics program began.' '' (Ex. 32-241-4, p. 232, citing Ex. 26-
1179, p. 15, emphasis in original)
    OSHA's Response: This case study is a report of a site visit 
conducted at an aircraft parts manufacturing facility. A formal 
ergonomics program was initiated in 1988, but did not have ``solid 
commitment from upper management and * * * [was] not readily accepted 
by the workforce.'' (Ex. 26-1179, p. 1) In 1991, the facility 
implemented a redesigned program following an OSHA citation, ``which 
[the program] proved to be very successful since it had the support of 
upper management and relied on hourly employees working together to 
identify and implement solutions to ergonomic problems.'' (Ex. 26-1179, 
p. 1) The facility reported that the percentage of total recordable 
injuries represented by ergonomics cases rose from 13.5 percent in 1991 
to 20 percent in 1992 (i.e., MSDs represented a larger proportion of 
all injuries and illnesses in 1992 than in 1991). This does not 
necessarily mean that the number or rate of MSDs increased during this 
period, as Gibson, Dunn & Crutcher claim. In fact, facility 
representatives stated that ``the actual number of [MSD] cases is at 
least holding steady.'' (Ex. 26-1179, p. 15) However, because the site 
visit report makes clear that there were MSD cases that occurred in the 
facility in addition to the CTS cases used by OSHA to calculate program 
effectivness, and because the report provides no statistics or other 
details on the number or rate of these cases, OSHA is no longer relying 
on this case study in its effectiveness analysis for the final rule.

Office Furniture Manufacturing Case Study (Ex. 26-1102)

    Comment: OSHA claimed a 67-percent reduction in MSD rate, 
apparently from a ``passing reference to a claimed reduction in 
``incidence rate'* * * (``incidence of what is not specificed)'' (Ex. 
32-241-4, p. 232). However, the information presented in OSHA's 
Appendix VI-2 shows a reduction only from 21 per 100 workers in 1989 to 
19 per 100 workers in 1991-1992, a change of only 9 percent ``that is 
of dubious statistical significance'' (Ex. 32-241-4, p. 232).
    OSHA's Response: In OSHA's final analysis of the effectiveness of 
ergonomics programs, OSHA is basing

[[Page 68590]]

its measure of effectiveness for this case study on the reported 9-
percent decline in MSD rate. Regarding the comment on statistical 
significance, it was not OSHA's intent to limit its analysis of case 
studies only to those studies where the reported change in MSD rate 
could be shown to be statistically significant, primarily because most 
of the case studies lacked information to perform tests of statistical 
significance. OSHA believes it important to base its analysis on all of 
the experiences reported in the set of case studies, however large or 
small the result attributed to ergonomics interventions, and not to 
limit its analysis to the small group of case studies for which tests 
of significance could be performed.

Freight Truck Terminal Operations Case Study (Ex. 26-1177)

    Comment: OSHA assumes a 46-percent decline based on a table that 
shows 13 MSDs occurred in 1989 and 7 in 1991, ``but it overlooks 
further information in adjacent sections of the report indicating that 
there have been ``no changes'' in overall * * * [MSD] incidence'' and 
that there has been no decrease in MSD-related disabilities (Ex. 32-
241-4, p. 233)
    OSHA's Response: This case study is a site visit report for a truck 
terminal operation. The site visit report was prepared in July, 1992 
and contained a table that reported numbers of MSDs occurring in 1989 
through 1991. OSHA's analysis of ergonomics intervention effectiveness 
was based on these numbers. Although the report stated that no decline 
in MSD-related disabilities had been seen, it also stated that the 
program had been recently implemented (in 1990) and ``its effectiveness 
may not yet be apparent'' (Ex. 26-1177). A follow-up telephone 
interview was conducted in January, 1994, at which time the employer 
indicated subjectively that there were no changes in MSD incidence. 
However, the employer also reported that the company ``had no hard data 
to back that up,'' and that no information was available to track 
changes in workers' compensation claims related to the ergonomics 
program (Ex. 26-1177, pp. 5-7 & 5-8). Therefore, it is clear that the 
employer had not been evaluating the performance of their program after 
1991, and therefore no conclusions can be reached regarding the 
effectiveness of the program after 1991, the last year in which OSHA 
was able to obtain data on MSD injuries. OSHA finds that the quotes 
cited by Gibson, Dunn & Crutcher are not convincing in establishing 
that the ergonomics program was ineffective in the 1989-1991 period.

Materials Handling, Electrical Utility (Ex. 26-1085)

    Comment: OSHA attributes 100-percent effectiveness to an ergonomics 
program based on a ``passing reference'' in the case study to 
eliminating 9 injuries just by getting in and out of vehicles. The 
article explains elsewhere that the total program is in its `infancy 
stage' and the overall asserted effect so far has been to reduce lost-
time injuries from more than one per 100 employees to 0.42, only part 
of which is allegedly attributable to ergonomics.'' (Ex. 32-241-4, pp. 
233-234)
    OSHA's Response: This case study is a published article describing 
the ergonomics program at a major utility company. OSHA based its 
measure of intervention effectiveness on the results of two specific 
interventions discussed in the article. These are not ``passing 
references'' but are examples of the earliest interventions implemented 
by the company:

    ``Downsizing water and ice kegs from 10 to five gallons and 
lowering their placement on trucks is one way we profited from 
ergonomic thinking right away * * * Since making the change, we've 
had no injuries associated with lifting water kegs' (Ex. 26-1085, p. 
25).
    ``[t]hrough the use of ergonomics, `we have reduced sprain 
injuries in several of our operations areas.['] For example, he 
says, `we went from nine injuries last year from just getting in and 
out of trucks and vehicles, to zero this year'' (Ex. 26-1085, p. 25)

    The article also makes clear that the ergonomics program is in its 
`infancy stage' on the corporate-wide level, i.e., that not all 
problems have been addressed at the time the article was published. For 
example, the article makes reference to workers who work at bill 
processing machines for extended periods of time and are at risk of 
developing carpal tunnel syndrome. Because the program had not yet been 
fully implemented, OSHA did not base its effectiveness measure on 
corporate-wide injury statistics (the company reported that total lost-
time injuries declined from more than 1 per 100 workers to 0.42 per 100 
workers) (Ex. 26-1085, p. 27), but instead based it on the proven 
effectiveness of the specific interventions discussed in the case 
study. After considering this comment and reviewing the case study, 
OSHA finds that this is still a reasonable approach and therefore has 
continued to include this study in its database.

Auto Air Conditioner Manufacturer Case Study (Ex. 26-1078)

    Comment: ``[OSHA] * * * recites two examples from self-interested 
company officials claiming `50%' and `100%' reductions in `total MSDs', 
while ignoring a lengthy description in the same article of 
scientifically documented experience at a different company showing 
that `job improvements' cannot be expected to translate to any 
reduction in `the number of back injury claims filed'.'' (Ex. 32-241-4, 
p. 234, citing Ex. 26-1078, p. 30)
    OSHA's Response: The ``scientifically documented experience'' 
referred to by Gibson, Dunn & Crutcher is a short article by Dr. 
Stanley Bigos, University of Washington Department of Orthopaedics, 
describing his results from the Boeing study and the role of 
psychosocial factors in low back disability. OSHA discusses both the 
Boeing study and psychosocial factors at length in the Health Effects 
section (Section V) of this preamble.

UPS Case Study (Ex. 26-1084)

    Comment: Steven Thompson, who co-authored a UPS report, ``does not 
believe that it would be legitimate to cite the article as evidence 
that ergonomic interventions pursuant to OSHA's proposal would have the 
effect that OSHA claims'' because, among other things, the article did 
not attempt to link the observed reduction in reported MSD cases to any 
particular cause or to account for the Hawthorne effect (Ex. 32-241-4, 
p. 217).
    OSHA's Response: This case study is a published report of the 
results of an ergonomics program that provided adjustable sit-stand 
workstations to UPS employees using computer stations to perform a 
variety of tasks. Benchmark data collected prior to introducing the 
sit-stand workstations included production levels, absenteeism, survey 
results on operator comfort, and injury and illness rates. The study 
reported that injury and illness rates declined by more than 50 percent 
in the year after introducing the new workstations, and that there were 
no costs associated with the remaining injuries. In addition, the study 
reported an average reduction of 62 percent in symptoms of discomfort. 
There was no change in production level or absenteeism, which the 
authors believed may be partly explained by poor weather at the 
beginning [winter] of the follow-up year. In an attachment to Gibson, 
Dunn & Crutcher's submission, Mr. Thompson of the UPS, one of the co-
authors of the study, stated that the article in question ``did not

[[Page 68591]]

engage in the type of individual cause-and-effect analysis that would 
be necessary to link the observed reduction in reported MSD cases to 
the sit-stand workstation as opposed to other non-ergonomic factors.'' 
Mr. Thompson identifies several factors relating to the moving of the 
office location to a new building from an ``old crowded building.'' 
``The new building had better lighting, ventilation, temperature 
control, windows, modular doors, and an overall open environment.'' 
According to Mr. Thompson's statement, the authors of the report ``did 
not account for the Hawthorne effect in light of these factors'' and 
other factors, some of which are often, in fact, considered engineering 
and administrative ergonomic changes.
    In the original article, published as part of the Proceedings of 
the Human Factors and Ergonomics Society 38th Annual Meeting, the 
authors, Nerhood and Thompson, do discuss moving employees to a new 
building to provide a better working environment and providing 
adjustable sit-stand workstations for those employees ``with the 
heaviest risk of discomfort'' (Ex. 26-1084, p. 668). The authors also 
acknowledge the possibility of a Hawthorne effect being a 
``contributing factor to any production changes'' (Ex. 26-1084, p. 671, 
emphasis added) because ``the study cycle was too short to hypothesize 
long term results [on production]'' (Ex. 26-1084, p. 668); however, 
nowhere in the article do the authors indicate that the Hawthorne 
effect was or could have been responsible for the observed drop in 
injury rate or operator discomfort. Despite the non-ergonomic changes 
in the work environment associated with the new building, the authors 
concluded that ``[t]he commitment from all groups involved was the key 
to the successful implementation of the ergonomics program and 
installation of the new adjustable sit-stand workstations'' (Ex. 26-
1084, p. 671, emphasis added). Thus, in the original study, the authors 
attribute the reduction in operator discomfort and injury rate to the 
ergonomic intervention. Because of the strong conclusion made in the 
original study, OSHA finds it appropriate to retain this study in its 
data set.
    In their post-hearing brief, Gibson, Dunn & Crutcher describe the 
testimony of several witnesses as examples of ergonomic interventions 
that failed (Ex. 500-197, pp. II-20 to II-23). The following summarizes 
these examples and OSHA's response to Gibson, Dunn & Crutcher's 
interpretation of the testimony.

Carl Zipfel, Seton Company

    Comment: ``Carl Zipfel, Director of Environmental Compliance and 
Safety for Seton Company, a supplier of automotive interior leather, 
testified about his company's efforts to help employees who were 
stretching leather hides over a table and began to complain about 
shoulder problems. Seton Company tried every measure that OSHA could 
expect. * * * After all of these efforts no improvements were 
observed.'' (Ex. 500-197, p. II-20)
    OSHA's Response: In his testimony at the informal hearing, Mr. 
Zipfel provided the following information, which explains why no 
improvements were observed:
    <bullet> Under questioning, Mr. Zipfel agreed that Seton had no 
ergonomics program that would either meet the definition of an existing 
program under the grandfather clause or that would meet the 
requirements for an ergonomics program in the standard as proposed (Tr. 
3051-3052).
    <bullet> Although Seton has investigated incidents of MSD symptoms, 
the company has no one trained to do a job hazard analysis (Tr. 3066).
    <bullet> Mr. Zipfel stated that Liberty Mutual and Penn State 
analyzed jobs and prepared reports for Seton regarding the leather 
stretching problem, but he never discussed what remedies were 
recommended in those reports or whether Seton tried to implement any of 
the suggested remedies (Tr. 3059).
    There is no evidence in Mr. Zipfel's testimony that indicates that 
Seton had implemented engineering or administrative controls to address 
the problem at the leather stretching station; thus, OSHA does not 
agree that Seton ``tried every measure that OSHA could expect,'' and 
finds Mr. Zipfel's testimony unpersuasive evidence for the failure of 
ergonomics interventions.

Robert Willoughby, Boral Bricks

    Comment: After implementing Boral's insurance company's suggestion 
of automating certain jobs in some of his facilities, the ``injury 
rates are not significantly better than [at] the plants that [have ] 
more manual [jobs]'' (Ex. 500-197, pp. II-20 to II-21, citing Tr. 
7776).
    OSHA's Response: Mr. Willoughby stated that Boral's insurance 
company recommended the automation of two jobs: setting green, unfired 
brick on kiln cars and hand packaging the finished product (Tr. 7745-
7746). It is clear from Mr. Willoughby's description that the automated 
equipment has contributed significantly to reduction in exposure to 
risk factors. For example, one automated piece of equipment that 
removes brick from the kiln required employees to stand on top of the 
cars and bend below knee level to lift bricks and place them into 
trays. Employees suggested and implemented an approach that prevented 
the need to bend below knee level but still required workers to lift 
bricks at waist height using an extended reach (Tr. 7787-7788). In this 
example, Mr. Willoughby commented without providing evidence, that 
``what we have accomplished [from eliminating the deep bend] is going 
to be offset by the fact of extending the arms'' (Tr. 7788). On the 
other hand, Mr. Willoughby provided two examples of job fixes that he 
believed were worthwhile: one involved using pallets to package brick 
in smaller increments for easier handling, and the other used metal 
strapping bands and magnetic lifts to reduce the need for manual 
handling (Tr. 7790-7791). Regarding Boral's overall ergonomics program, 
Mr. Willoughby testified that he developed a written program a few 
years ago, but it has not been fully implemented; as part of their 
overall safety and health program, Boral currently provides information 
on MSDs, trains employees in recognizing potential hazards, and has 
safety and health committees at its facilities, some of which actively 
inspect the workplace and propose improvements (Tr. 7785-7786). Because 
of the continued exposure of employees to risk factors in jobs that had 
been automated, and Mr. Willoughby's testimony about the value of some 
of the interventions implemented by Boral, OSHA does not agree that the 
experience of Boral Bricks represents a failed ergonomics effort.

Mary Banks, Social Security Administration

    Comment: Ms. Banks, a key operator who was diagnosed with 
DeQuervain's syndrome in 1998, testified that her symptoms have not 
improved at all and have gotten progressively worse in the year since 
she was provided with a new workstation. (Ex. 500-197, pp. II-21 citing 
Tr. 10664).
    OSHA's Response: Ms. Banks described the new furniture as ``too 
little, too late'' for her (Tr. 10690). Her testimony indicated that 
her condition was quite severe:

    This impairment is devastating at times. I feel pain most of the 
time. It is difficult for me to pick up anything that weighs more 
than three pounds. It is hard to reach in back of me, to clap my 
hands even in church. It is difficult to open an envelope. I cannot 
pick up my grandbaby without fear of dropping him. (Tr. 10666-10667)


[[Page 68592]]


    In addition, Ms. Banks was also diagnosed with tendinitis (Tr. 
10667), and used only able to use her right hand to key at the time of 
the hearing (Tr. 10695). She concluded her testimony by stating that, 
if the ergonomics program had been in place, she would not have 
developed her condition (Tr. 10667). OSHA does not find that the lack 
of improvement in Ms. Banks serious upper-extremity disorder after she 
was issued a new workstation (details of which were not described 
during her testimony) constitutes adequate evidence that properly 
designed computer and VDT workstations are ineffective in reducing the 
risk of developing MSDs among healthy workers.

Dr. Charles Roadman for American Health Care Association

    Comment: ``Dr. Roadman testified, however, that `everything that we 
have tried has not decreased the incidents of [carpal tunnel 
syndrome]''' (Ex. 500-197, p. II-21 citing Tr. 4448).
    OSHA's Response: Dr. Roadman was not discussing programs that 
members of the American Health Care Association (AHCA) had instituted 
to handle carpal tunnel syndrome, but was referring to an Air Force 
program he had instituted years before when he had been Surgeon General 
of the Air Force (Tr. at 4448). Although he felt that the interventions 
he had seen tried with computer users did not seem qualitatively to 
reduce the incidence of CTS, he also stated that ``that doesn't mean we 
should not keep trying to do that'' (Tr. 4448). In general, Dr. Roadman 
has positive things to say about ergonomic programs. He discusses 
favorably programs that the AHCA created with the assistance of OSHA 
(Tr. 4355-6). He also stated that ergonomic programs ``can be very 
positive if all the factors are in place and you have good cooperation 
* * * between labor and management and the assessment process. Yes, 
they can be very successful'' (Tr. 4436).
    From the examples above, OSHA is not convinced that the testimony 
cited by Gibson, Dunn & Crutcher demonstrate that ergonomic 
interventions are ineffective, as a general matter.
BILLING CODE 4510-26-P

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BILLING CODE 4510-26-C

[[Page 68752]]

VII. Significance of Risk

    In this section of the preamble, OSHA conducts several analyses and 
presents data and information to demonstrate, first, that 
musculoskeletal disorders (MSDs) constitute material harm under the 
Occupational Safety and Health Act (OSH Act or Act). This discussion 
demonstrates that MSDs are painful, often disabling injuries and 
illnesses that cause lost work time, require medical treatment, involve 
restricted work, and, all too often, result in surgical interventions.
    The Agency then demonstrates the significance of the risk of 
incurring this material harm in the industries and occupations covered 
by the scope of the ergonomics standard. As OSHA's analysis shows, over 
a working lifetime, workers in jobs that meet the final rule's exposure 
screen face risks ranging roughly from 33 cases per 1,000 workers to 
926 cases per 1,000 workers, risks that are clearly significant by any 
reasonable measure. Even on an annual rather than lifetime basis, many 
of the workers who would be covered by the standard are at great risk: 
nursing aides and truck drivers, for example, can expect to suffer 
between 32 and 42 lost-workday musculoskeletal disorders for every 
1,000 workers in every year that they work. Again, that risks of this 
magnitude are significant within the meaning of the Act is not 
disputable.
    Parts A and B below thus demonstrate unequivocally that the first 
two tests OSHA must meet before it can regulate--that the hazard 
regulated by the standard constitutes material harm and that the risk 
posed to workers covered by the standard is significant, as that term 
has been defined in OSHA case law--have been met. OSHA's response to 
comments received on its significance of risk analysis in the proposed 
rule appear in Part C.

A. Material Harm

    The OSH Act requires OSHA to make a threshold finding that a 
significant risk of material harm exists in the workplace before 
issuing an occupational safety or health standard. See Benzene, 448 
U.S. 607, 642; 58 FR 16612, 16614 (Mar. 30, 1993). What constitutes 
``material harm'' in any particular case is, at bottom, a policy 
determination, for ``OSHA is not required to state with scientific 
certainty or precision the exact point at which each type of [harm] 
becomes [material].'' See AFL-CIO v. OSHA (PELs), 965 F.2d 962 (11th 
Cir. 1992). As long as its determination is reasonable, OSHA is 
entitled to deference; however, OSHA must be cognizant of all forms and 
degrees of material harm--not just death or serious physical harm--and 
may act with a ``pronounced bias towards worker safety.'' Building & 
Constr. Trades Dep't., AFL-CIO v. Brock, 838 F.2d 1258, 1266 (D.C. Cir. 
1988).
    Injuries or illnesses that affect a worker's job performance, 
result in lost workdays or restricted work, and/or result in medical 
treatment beyond first aid constitute material harm under the OSH Act. 
See PELs, 965 F.2d at 974-75. This was confirmed by the 11th Circuit 
Court of Appeals in its review of OSHA's Air Contaminants Standard. In 
the Air Contaminants standard, OSHA set permissible exposure limits for 
over 400 substances to prevent the onset of certain health effects, 
including sensory irritation (i.e., stinging, itching, and burning of 
the eyes, tearing (or lacrimation), a burning sensation in the nasal 
passages, rhinitis (nasal inflammation), cough, sputum production, 
chest pain, wheezing, and dyspnea). Id. OSHA found that in certain 
circumstances these effects were fleeting; however, substantial 
evidence in the rulemaking record suggested that these effects could be 
quite serious at times and could affect a person's ability to perform 
at work:

    ``OSHA concludes that exposure limits are needed for those 
substances for which PELs are being established in this rulemaking 
to protect against sensory irritant effects that result in objective 
signs of irritation, such as coughing, wheezing, conjunctivitis, and 
tearing. Such levels of mucous membrane irritation may require 
medical treatment, adversely affect the well-being of employees, and 
place the affected individuals at risk from increased absorption of 
the substance and decreased resistance to infection. Exposing 
workers repeatedly to irritants at levels that cause subjective 
irritant effects may cause workers to become inured to the irritant 
warning properties of these substances and thus increase the risk of 
overexposure.'' 54 FR 2444-45 (Jan. 19, 1989).

Industry representatives challenged OSHA's determination that these 
health effects constituted ``material impairment'' within the meaning 
of section 6(b)(5) of the OSH Act. Id. While OSHA conceded that minor 
irritation would not, by itself, constitute ``material impairment,'' it 
concluded that sensory irritation that resulted in medical treatment or 
affected job performance would constitute such impairment. PELs, 965 
F.2d at 974. The court agreed with this finding:

    ``We interpret this explanation as indicating that OSHA finds 
that although minor irritation may not be a material impairment, 
there is a level at which such irritation becomes so severe that 
employee health and job performance are seriously threatened, even 
though those effects may be transitory. * * * Overall, we find that 
OSHA's determinations of what constitute `material impairments' are 
adequately explained and supported in the record.'' Id. at 975 
(emphasis added).

    The OSH Act also permits OSHA to regulate a hazard to prevent the 
signs or symptoms of an injury or illness from becoming more severe and 
disabling. See Lead, 647 F.2d at 1252 (``We conclude that if OSHA could 
find on the basis of substantial evidence that preventing subclinical 
effects of lead disease would help prevent the true clinical phase of 
lead disease, the statute empowered it to set a blood-lead level goal 
to prevent these effects.''). The OSH Act does not require OSHA to wait 
until an injury or illness becomes so severe that employees become 
disabled before it has authority to regulate. Such an approach would 
turn the OSH Act from a statute designed to prevent injuries and 
illnesses from occurring to one that reacts to injuries and illnesses 
that have already occurred. This was not Congress' intent when it 
tasked OSHA with ``assuring as far as possible every working man and 
woman in the Nation safe and healthful working conditions.'' 29 U.S.C. 
651(2)(b).
    Based on the evidence discussed in this and other sections of the 
preamble, as well as all other evidence gathered by OSHA and placed in 
the public docket of this rulemaking, OSHA has concluded that MSDs as 
defined by this standard constitute material harm under the OSH Act. 
OSHA recognizes that these disorders are not life-threatening and that 
some of these disorders may be reversible, particularly if early 
intervention is provided. Nonetheless, evidence in the record shows 
that these disorders are debilitating (Brisson et al. 1989, Ex. 26-47; 
Vingard et al. 1991, Ex. 26-44; Berg et al. 1988, Ex. 26-46; Liss et 
al. 1992, Ex. 26-55; Webster and Snook 1994, Ex. 26-33; Binder and 
Hazleman 1983, Ex. 26-45; Boshuizen et al. 1990, Ex. 26-40; Blanc et 
al. 1996, Ex. 26-42; Liberty Mutual Research Center for Safety and 
Health, 1998, Ex. 26-54). These disorders cause persistent and severe 
pain, lost worktime, reduction or loss of the worker's normal 
functional capacity both in work tasks and in other of life's major 
activities, loss of productivity, and significant medical expenses. 
Where preventive action or early medical intervention is not provided, 
these disorders can result in permanent damage to musculoskeletal 
tissues, causing such disabilities as the inability to use one's hands 
to perform even the minimal

[[Page 68753]]

tasks of daily life (e.g., lifting a child), permanent scarring, and 
arthritis.
    Furthermore, OSHA is triggering obligations on employers to respond 
to reports of MSDs only when such reports reach the level of severity 
sanctioned by the OSHA Act. Contrary to the allegations of some 
commenters, see e.g., Ex. 30-3865; 500-187, this standard does not 
trigger employer obligations based solely upon employee reports of 
``aches and pains.'' An employer is only required to respond to an 
employee report of an MSD when it: (1) Results in one or more lost 
workdays, one or more days of restricted work, medical treatment beyond 
first aid, or (2) includes signs or symptoms of an MSD that persist for 
7 or more consecutive days, and (3) the employer is exposed to risk 
factors at the levels described in the Basic Screening Tool, which are 
associated with increased risk. MSDs that result in days away from 
work, restricted duty, or medical treatment beyond first aid clearly 
constitute material harm under the OSH Act, as described above. See 
PELs, 965 F.2d at 974-75. Moreover, it is clear that OSHA may trigger 
employer action upon employee reports of signs or symptoms of MSDs that 
persist for seven or more consecutive days. There is substantial 
evidence in the rulemaking record that persistent signs or symptoms of 
MSDs will progress and become more severe and disabling if they are not 
treated and the employee remains in the job unabated. See (Tr. 7660, 
7884, see also (Ex. 32-450-1). OSHA need not wait for signs and 
symptoms of MSDs to become disabling to act; rather, OSHA may ``act to 
`reduce the risk' of serious material impairment [at some point in the 
future].'' See Lead, 647 F.2d at 1253.
    The pain associated with these workers is not the normal muscle 
soreness associated with job break-in or conditioning, or temporary 
muscle strain due to doing new or unusual tasks. Instead, the pain is 
severe and persistent. Many employees must be placed on medication to 
alleviate or at least reduce the intensity of their pain. The pain of 
MSDs may also continue or may even manifest after the employee is 
removed from exposure at the end of the workshift (Ex. 26-1263). In 
addition, the pain usually increases if exposure to the ergonomic risk 
factors continues (Ex. 26-1263). OSHA believes that this type of severe 
and persistent pain, and the tissue damage underlying this pain, 
clearly constitutes material harm under the OSH Act.
    The Chamber of Commerce argued that OSHA should not rely on the 
testimony of injured workers to demonstrate that exposure to the risk 
factors at issue causes a significant risk of material harm because 
this testimony: (1) Includes MSDs that are not included in the rule; 
(2) contradicts trained physicians' findings; and (3) gives no 
consideration to potentially confounding factors. Ex. 500-188. But OSHA 
is not relying on this testimony to demonstrate that work causes MSDs 
or that this particular standard will reduce the incidence of MSDs, as 
the Chamber incorrectly suggested. Other evidence and data (described 
above) in the rulemaking record demonstrates this. The testimony of 
injured workers, however, is particularly probative in demonstrating 
how MSDs significantly affect peoples' lives. For this, statistics, 
epidemiological data, and other evidence are not alone sufficient. The 
testimony of these workers puts a human face on the pain and suffering 
experienced everyday by workers who suffer from these injuries. It also 
convincingly demonstrates that MSDs are not everyday ``aches and 
pains'' experienced by all, but serious, disabling conditions.
    MSDs of most kinds are also recognized as compensable under 
virtually all State workers' compensation plans, and these disorders 
imposed nearly $20 billion in medical costs and industry payments on 
the U.S. economy in 1994 (see the Economic Analysis section of this 
preamble). Under workers' compensation, however, employees are 
reimbursed only where their work-related injury or disorder requires 
medical treatment and/or results in lost workdays. Moreover, payments 
for lost wages are not provided unless the employee's injury or 
disorder results in a certain number of lost workdays (the number 
varies across the States and ranges from one to seven days). According 
to evidence presented in the Economic Analysis, a significant number of 
musculoskeletal disorder workers' compensation claims result in lost 
workdays. For example, according to a study by Webster and Snook (1994, 
Ex. 26-33) based on workers' compensation data from Liberty Mutual 
Insurance Company, the largest underwriter of workers' compensation 
insurance in the country, more than 45 percent of all low back pain 
cases involved indemnity payments for lost workdays. This study also 
indicated that, on average, more than 65 percent of the workers' 
compensation costs for musculoskeletal disorders represented indemnity 
payments for lost workdays. Overall, work-related low back pain 
accounts for 15 percent of all Liberty Mutual workers' compensation 
claims and 23 percent of their costs (Liberty Mutual Research Center 
for Safety and Health, 1998, Ex. 26-54).
    Further evidence of the disabling nature of MSDs comes from the 
Bureau of Labor Statistics (BLS) data for 1996, which show that the 
median number of lost workdays (LWD) per recordable lost-time MSD is 
higher than the median across all lost workday injuries (see Figure 
VII-1). For example, the median number of lost workdays for cases 
classified by BLS as carpal tunnel syndrome, tendinitis or 
tenosynovitis, or musculoskeletal and connective tissue disorders, is 
25, 9, and 10 days, respectively. More than one-half of all carpal 
tunnel LWD cases and one-third of musculoskeletal and connective tissue 
disorder LWD cases result in more than 20 lost workdays, compared to 
less than one-fourth of all LWD injuries. Among workers who received 
compensation awards in 1994 for upper-extremity disorders, the average 
length of disability was 87 days, with 6.8 percent of the claims 
covering one-year or more of disability (Liberty Mutual Research Center 
for Safety and Health, 1998, Ex. 26-54).
    Finally, several individual studies provide additional evidence 
demonstrating the disabling nature of MSDs. A study of female sewing 
machine operators showed an increased prevalence of disability among 
both retired and active workers compared to national rates of 
disability (Brisson et al., 1989, Ex. 26-47). Operators who had left 
their jobs had a greater rate of severe disability when compared to 
workers who had left other types of employment. Vingard et al.(1991, 
Ex. 26-44) found an increased risk of early retirement among workers 
exposed to heavy or medium work loads due to disorders of the lower 
back, neck/shoulder, hip, or knee. An elevated incidence of long-term 
absenteeism and disability due to intervertebral disc disorders was 
found among tractor drivers, with the incidence appearing to increase 
with whole-body vibration dose and duration (Boshuizen et al.1990, Ex. 
26-40). An analysis of data from the National Health Interview Survey 
showed that repetitive bending of the hand or wrist on the job was 
significantly associated with the frequency of self-reported carpal 
tunnel syndrome (CTS), and that work-related disability was common 
among the 544 subjects reporting CTS. The persistence of symptoms 
associated with MSDs is illustrated by two other studies. Berg et 
al.(1988, Ex. 26-46) studied the prevalence of MSD symptoms among 327 
retired shipyard workers who had been engaged in heavy

[[Page 68754]]

physical work and found that the prevalence of symptoms remained 
unchanged over a three-year period. In another study, Binder and 
Hazleman (1983, Ex. 26-45) followed the health status of 125 patients 
with lateral epicondylitis over a 1- to 5-year period after initial 
presentation of the disorder. Over the follow-up period, 40 percent of 
the patients continued to have discomfort that affected some daily 
activities.
    OSHA has promulgated standards where the adverse health effects 
associated with exposure to substances or conditions are serious but 
not necessarily life-threatening, such as health effects that interfere 
with normal daily life or job performance, or that require substantial 
medical intervention. See Cotton Dust (29 CFR 1910.1046), Occupational 
Noise Exposure (29 CFR 1910.95), Occupational Exposure to Lead (29 CFR 
1910.1025), Occupational Exposure to Formaldehyde (29 CFR 1910.1048). 
For example, in promulgating the Hearing Conservation Amendment, OSHA 
determined that ``* * * material impairment of hearing is directly 
related to people's ability to understand speech as it is spoken in 
everyday social conditions * * *.'' (46 FR 46236), including being able 
to understand speech in noisy environments. In the Formaldehyde 
standard, OSHA based its permissible exposure limit (PEL) and ancillary 
provisions, in part, on evidence that employees were at significant 
risk of developing sensory irritation (e.g., burning and tearing of the 
eyes, severe irritation of the nose and throat) and skin diseases at 
the existing PEL, and that these effects were sufficiently severe to 
interfere with the employee's ability to perform job functions (52 FR 
46168, 46234-37).
    This standard is similar to these other OSHA standards in this 
respect. MSDs also result in material harm by causing temporary or 
permanent physical damage to the body. Such damage can include severe 
inflammation of joints and tissues; reduced conduction velocity in 
peripheral nerves; partial or total loss of strength in an extremity; 
tearing of muscles and tendons; numbness; decreased range of motion; 
arthritis; and pain. When this damage occurs, employees are unable to 
perform their jobs at all or at normal performance levels without 
experiencing pain or causing further damage. Accordingly, OSHA 
concludes that MSDs as defined by this standard constitute material 
harm under the OSH Act.

B. Significant Risk

    As stated above, a plurality of the Supreme Court in Benzene held 
that the OSH Act requires a threshold finding that a significant risk 
of material harm exists and that the standard being promulgated will 
substantially reduce that risk. See Benzene, 448 U.S. 607, 642; see 
also 58 FR 16612, 16614 (Mar. 30, 1993). In so holding, the plurality 
noted that ``precise quantification of risks is * * * impossible'' 
given the imperfect state of scientific knowledge. Benzene, 448 U.S. at 
652. Thus, while ``it is OSHA's responsibility to determine, in the 
first instance, what it considers to be a ``significant'' risk, * * * 
the requirement that a ``significant'' risk be identified is not a 
mathematical straitjacket * * * [and] the Agency has no duty to 
calculate the exact probability of harm.'' Id. at 655. Indeed, ``there 
are a number of ways in which the Agency can make a rational judgment 
about the relative significance of the risks associated with exposure * 
* *.,'' id. at 656-57, and ``so long as they are supported by a body of 
reputable scientific thought, the Agency is free to use conservative 
assumptions in interpreting the data * * *, risking error on the side 
of overprotection rather than underprotection.'' Id. at 656.
    Since Benzene, OSHA has adopted a variety of methods for 
determining what constitutes a significant risk. See e.g., Asarco, Inc. 
v. OSHA, 746 F.2d 483, 490-95 (9th Cir. 1984); Public Citizen Health 
Research Group v. Tyson, 796 F.2d 1479 (D.C. Cir. 1986). With respect 
to section 6(b)(5) standards, OSHA has often utilized scientifically-
based mathematical modeling techniques to determine risk at certain 
levels of exposure. This modeling permits OSHA to ``extrapolate [risk] 
* * * into areas where experimental [or observational] data do not 
exist.'' Public Citizen, 796 F.2d at 1496. With respect to non-section 
6(b)(5) standards, however, OSHA has not needed to engage in 
quantitative modeling techniques to determine significant risk because 
it typically has observational data that quantifies the risk faced by 
workers to particular hazards. In the Electric Power Generation 
rulemaking, for example, OSHA found that the generation, transmission, 
and distribution of electric power and the non-use or misuse of 
appropriate electrical protective equipment resulted in 86 fatalities 
and 12,977 injuries annually and that the standard would prevent 61 
fatalities and 1,634 injuries annually. Thus, the OSH Act does not 
require OSHA to construct dose-response relationships or other models 
for every hazard before it can regulate. OSHA has considerable leeway 
to choose a form of analysis appropriate to the available evidence and 
need not attempt to fit the evidence to a preselected analytical 
method.
    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 
(nearly $20 billion in direct costs and as much as $60 billion more in 
indirect costs), and the lost production to the U.S. economy imposed by 
these disorders. Similarly, there is no need for OSHA to turn to 
complex theoretical projections of reductions in risk to demonstrate 
that the standard will substantially reduce this significant risk. 
Ergonomics programs work in practice. The evidence is there in the form 
of hundreds of epidemiological analyses, meta-analyses, and case 
studies reporting the effectiveness of ergonomic programs in reducing 
risk. The following discussion, and the analyses presented below, 
demonstrate the significance of the risk confronting workers in the 
industries and occupations targeted in the standard and make the case 
for the standard's effectiveness.
    In this rulemaking there are, as mentioned above, extensive data on 
the adverse effects on the human musculoskeletal system of exposure to 
workplace risk factors such as repetitive motions; awkward postures; 
and the use of excessive force. As described in the Health Effects and 
Quantitative Risk Assessment sections of this preamble, studies and 
national statistics are available to demonstrate the high incidence and 
prevalence of work-related musculoskeletal disorders occurring or 
existing among workers exposed to ergonomic risk factors. Estimates of 
the risk of harm confronting exposed workers can be based directly on 
the rates of work-related musculoskeletal disorders currently being 
reported, and BLS survey data can be used to demonstrate the degree to 
which work-related musculoskeletal disorders have occurred across 
nearly all major industrial sectors and in numerous occupations.
    The data discussed in the Quantitative Risk Assessment and

[[Page 68755]]

Health Effects sections of the preamble demonstrate that the risk of 
work-related musculoskeletal disorders constitutes a significant risk 
under the OSH Act. For example, OSHA estimates, based on the 1996 BLS 
data, that more than 590,998 lost-workday (LWD) musculoskeletal 
disorders occurred among workers in industries that are within the 
scope of the final rule, and that were recorded and reported by 
employers in 1996 (see Table VI-8 of the Risk Assessment). The 
estimated annual incidence of employer-reported MSDs (both upper-and 
lower-bound estimates), defined as the number of MSDs occurring in a 
given year per 1,000 workers employed in jobs that meet the final 
rule's exposure screen in each industry sector exceeded 1 LWD case per 
1,000 workers for all but 3 of the 2-digit SIC general industry groups 
in 1996; the incidence exceeded 10 LWD cases per 1,000 workers in 15 of 
these industry sectors (see Table VI-5 in the Quantitative Risk 
Assessment section of the preamble). Further, OSHA estimates that the 
annual incidence of employer-reported LWD MSDs reached 1 case or more 
per 1,000 workers for 79 percent of all of the occupational groups for 
which BLS estimated the numbers of MSDs and employees. For 36 of these 
occupations, the estimated annual incidence of LWD MSDs exceeded 10 
cases per 1,000 workers (Table VI-6 in the final Risk Assessment). For 
some high risk occupations, such as practical nurses, nursing aides and 
attendants, laborers, public transportation attendants, and truck 
drivers, annual incidence rates are on the order of 32 to 42 LWD MSD 
cases per 1,000 workers per year. These extremely high incidence rates, 
however, are underestimates of the true incidence of MSDs, because they 
are based only on lost workday cases. OSHA estimates that the number of 
MSDs that do not result in lost workdays is about twice that of LWD 
MSDs.
    In the final Risk Assessment, OSHA also estimated the probability 
that an employee will suffer at least one musculoskeletal disorder due 
to workplace risk factors over a 45-year working lifetime as both an 
upper-and lower-bound estimate. The upper-bound estimate represents the 
lifetime risk to an employee who works in job that meets the final 
rule's exposure screen, and assumes that all of the risk is 
attributable to his or her workplace exposure to physical risk factors. 
The lower-bound estimate represents the lifetime risk to an employee in 
a job that meets the screen, but assumes that only part of that risk is 
attributable to exposure (i.e., the rest of the risk is background). 
The results are presented by 2-digit SIC industry group in Table VI-9 
of the Risk Assessment. The probability of experiencing at least one 
LWD MSD during a working lifetime ranges from 33 per 1,000 workers 
(lower-bound estimate in SIC 62, Security and Commodity Brokers, 
Dealers, Exchanges, and Services) to 926 per 1,000 workers (upper-bound 
estimate in SIC 45, Air Transportation). The expected number of MSDs 
that will occur in a cohort of workers all entering an industry at the 
same time and working for 45 years ranges from 34 per 1,000 workers to 
2,530 per 1,000, depending on the industry sector, since it is possible 
for a worker to experience more than one MSD in a working lifetime.
    The estimates of lifetime risk presented above are based on an 
assumption that workers in jobs that meet the final rule's screen are 
at three-fold higher risk than are workers in jobs that do not meet the 
screen. As explained in the final Risk Assessment, this assumption is 
well-supported by the data base of almost 200 epidemiological studies 
reviewed by the Agency and found to be of acceptable quality (see 
Section V, Health Effects). However, this assumption is not critical to 
the Agency's determination that the risks to workers exposed to 
biomechanical risk factors at the level of the final rule's screen are 
highly significant. In its final risk assessment, OSHA presented 
another analysis that is identical to that presented as part of the 
proposed rule. That analysis relies on BLS-provided estimates of the 
incidence of MSDs that is calculated across the entire working 
population; that is, the BLS-provided incidence figures do not 
recognize any difference in incidence of MSDs that occur between 
higher-risk and lower-risk workers. Even under that assumption, which 
minimizes the estimate of the risk to highly exposed workers, OSHA's 
estimates of lifetime risk are unambiguously significant. Estimates of 
the probability of experiencing at least one MSD over 45 years range 
from 24 to 813 per 1,000 workers, and the average number of MSDs 
predicted to occur over 45 years ranges from 24 to 1,646 per 1,000 
workers (see Table VI-7 in the final Risk Assessment).
    Although these data indicate that the risk of experiencing an MSD 
is clearly significant, OSHA believes that these data seriously 
understate the true risk. First, the BLS data capture only those MSD 
injuries reported by employers as lost workday injuries. MSDs that 
force an employee to be temporarily assigned to alternate duty, as well 
as those work-related MSDs not reported to employers by employees or 
not recorded by employers, are not included in these risk estimates.

Evidence of Underreporting

    There is also evidence that the actual risks attributable to 
occupational exposure to ergonomic risk factors may be much higher than 
is indicated by the BLS statistics. Many peer-reviewed studies have 
been published in the scientific literature in the last 18 years that 
document the underreporting of MSDs on OSHA Logs (McCurdy et al., 1999, 
Ex. 2-2; Silverstein et al., 1997, Ex. 26-28 ; Pransky et al., 1999, 
Ex. 26-922; Park et al., 1992, Ex. 26-1259; Park et al., 1996, Ex. 26-
1261; Nelson et al., 1992, Ex. 26-1260). Table VII-1 summarizes these 
studies. These studies document extensive and widespread underreporting 
on the OSHA Log of occupational injuries and illnesses in general 
(McCurdy et al., 1999, Ex. 2-2) and of MSDs in particular (Silverstein 
et al., 1997, Ex. 26-28; Fine et al., 1986, Ex. 26-920; Pransky et al., 
1999, Ex. 26-922; Park et al., 1992, Ex. 26-1259; Park et al., 1996, 
Ex. 26-1261; Nelson et al., 1992, Ex. 26-1260). Underreporting on the 
Log is directly related to OSHA's significant risk finding, because 
incidents that are not reported on the Log but should have been would 
downwardly bias the BLS annual survey numbers on which OSHA's risk 
estimates depend.
    Since OSHA published the proposed rule, several commenters have 
provided additional information and comment, either through the 
submission of written comments and additional studies on underreporting 
to the docket, or through testimony at the hearing. NIOSH provided 
seven health hazard evaluations (HETAs), as described in the NIOSH pre-
hearing comments (Ex. 32-450-1), that document extensive and widespread 
underreporting on the OSHA Log of occupational injuries and illnesses 
(NIOSH HETA# 88-344-2092, 1991 (Ex. 32-450-1); NIOSH HETA# 90-273-2130, 
1991 (Ex. 32-450-1-13); NIOSH HETA# 92-331, 1993 (Ex. 32-450-1); NIOSH 
HETA# 95-0294-2594, 1996 (Ex. 32-450-1-22); NIOSH HETA# 97-0276-2724, 
1999 (Ex. 32-450-1-2); NIOSH HETA# 96-0101-2476, 1997 (Ex. 32-450-1-
26); NIOSH HETA# 98-0085-2715, 1998 (Ex. 32-450-1-10). These new 
studies have been incorporated into Table VII-1.

[[Page 68756]]



                                 Table VII-I.--Summary of Underreporting Studies
----------------------------------------------------------------------------------------------------------------
                                                              Extent of underreporting
              Study                Measure of underreporting          observed              Additional detail
----------------------------------------------------------------------------------------------------------------
McCurdy, Schenker, and Samuels,    Percentage of cases        40% of all reportable     10 manufacturing
 Am. J. Public Health. 81:85        meeting OSHA reporting     cases not recorded; for   facilities in 6 states
 (1991) Ex. 2-2.                    criteria not recorded on   illnesses, 56% not        from semiconductor
                                    OSHA Log.                  recorded.                 industry with approx.
                                                                                         50,000 employees; 24%
                                                                                         cases met OSHA
                                                                                         recording criteria.
NIOSH. Health Hazard Evaluation    Failure to report lost     Not quantified;           Winding and taping
 Report, HETA 93-0233-2498,         workdays and restricted    ``several'' employees     department of an
 (1995) Ex. 26-1255.                work on OSHA 200 Log.      had surgeries for WMSDs   instrument transformer
                                                               in 5-year period and \1/  manufacturer; 27
                                                               3\ of employee were on    employees in
                                                               restricted work, but no   department.
                                                               LWDIs reported on Log
                                                               over 5-year period.
NIOSH. Health Hazard Evaluation    Percent of medically       5 employees reported to   News department of large
 Report, HETA 93-0860-2438,         confirmed WMSD cases not   NIOSH that they had       metropolitan TV-news
 (1994) Ex. 26-1256.                recorded on OSHA Log or    been diagnoses with       station; video tape
                                    not reported to employer.  carpal tunnel syndrome    editor and other
                                                               (CTS); of these, 2 did    employees.
                                                               not report their
                                                               illness to the
                                                               employer. 1 of the 5
                                                               reported cases were not
                                                               reported on log.
Silverstein, Stetson, Keyserling,  Incidence (per 100         Plant/year; OSHA 200      Four automobile
 and Fine Am. J. Ind. Med. 31:600   workers years) of work-    Log; Self-report:         manufacturing plants.
 (1997) Ex. 26-28.                  related MSDs, reported    Plant 1:................   713 out of 948 workers
                                    on OSHA 200 logs          1986: 1.0; 30.9.........   selected for the study
                                    compared with cases that  1987; 2.7;..............   completed the
                                    received medical          1988; 6.9;..............   questionnaire.
                                    treatment, as identified
                                    by self-administered
                                    questionnaire.
                                                                Plant 2:..............
                                                              1986: 0.9; 40.9.........
                                                              1987; 11.9..............
                                                              1988; 21.4..............
                                                                Plant 3:..............
                                                              1986: 20.3; 47.8........
                                                              1987; 14.6..............
                                                              1988; 19.43.............
                                                                Plant 4:..............
                                                              1986: 0.7; 24.5.........
                                                              1987; 2.1...............
                                                              1988; 9.9...............
Fine, Silverstein, Armstrong,      Incidence (per 100 worker- Plant; 200; OSHA WC,      Data from two large
 Anderson, and Sugano, JOM.         years) of upper-           MAR, MCR:                 automobile
 28:674 (1986) Ex. 26-920.          extremity MSDs reported   B; 0.03; 0.29; 3.04;       manufacturing plants
                                    on OSHA 200 logs           2.03.                     (total employment not
                                    compared with workers'    C: 0.15; 0.45; 1.85;       reported).
                                    compensation (WC),         13.98.
                                    medical absence records
                                    (MAR) and medical case
                                    records (MCR).
Pransky, Snyder, Dembe, and        Percent of workers         Work-related Symptom; %   Questionnaire
 Himmelstein, Ergonomics. 42:171    reporting                  reporting; % on Log:.     administered to 110
 (1999) Ex. 26-922.                 musculoskeletal symptoms  Hand/Wrist; 86%; 6%.....   packers, of whom 98
                                    caused or aggravated by   Arm; 33%; 1%............   responded. Plant
                                    work, compared to OSHA    Neck; 21%; 0............   produces variety of
                                    Log entries.              Back/legs; 28%; 2%......   childrens' products.
                                                              9% of workers reported
                                                               that symptoms resulted
                                                               in lost work days over
                                                               the past year. 6%
                                                               reported they were
                                                               formally assigned light-
                                                               duty work by plant
                                                               nurse. 15% reported
                                                               symptoms resulted in
                                                               information light-duty
                                                               work arranged by co-
                                                               workers..
Park, Krebs, and Mirer JOEM.       Number of claims made in   Only 7 of an estimated    Study of an automotive
 38:1111 (1996) Ex. 26-1261.        a sickness and accident    47 (15%) S&A upper        assembly and stamping
                                    (S&A) disability (sick     extremity LWD cases in    complex employing
                                    leave) system compared     1992 were recorded on     10,000 workers.
                                    to lost-work-day (LWD)     the OSHA Log. For LWD
                                    injuries and illnesses     back injuries, 27 of an
                                    recorded in OSHA log.      estimated 36 (75%) S&A
                                                               cases were recorded.

[[Page 68757]]

 
Park, Nelson, Silverstein, and     Medical insurance claims   From 1984 to 1987, OSHA   Conclusion based on
 Mirer, JOM. 34:731. (1992) Ex.     linked to work histories   logs failed to record     authors' own
 26-1259.                           compared to OSHA logs.     between 20 and 80         unpublished data from
                                                               percent of occupational   insurance records of
                                                               MSDs..                    five automotive
                                                                                         manufacturing plants.
                                                                                         These records
                                                                                         identified 11,577 MSD
                                                                                         health claims made by
                                                                                         3,204 workers.
Nelson, Park, Silverstein, and     Medical insurance claims   From 1985 through 1986,
 Mirer, Am. J. Public Health.       linked to work histories   OSHA logs identified 59
 82:1550 (1992) Ex. 26-1260.        compared to OSHA logs..    hand/wrist MSD cases
                                                               compared to 150 cases
                                                               identified in health
                                                               insurance records. For
                                                               all MSDs from 1984
                                                               through 1987, only 9%
                                                               of cases identified
                                                               through insurance
                                                               claims were recorded on
                                                               OSHA logs (the authors
                                                               cite data from Parks et
                                                               al.(1992) indicating
                                                               that about half of the
                                                               upper extremity MSD
                                                               cases from insurance
                                                               claims are attributable
                                                               to work.
NIOSH Health Hazard Evaluation     Percentage of workers      40% of supermarket        W-R MSD's not brought to
 Report, HETA 88-344-2092 (1991)    with work-related (W-R)    checkers with WR UE MSD   the attention of a
 Ex. 32-450-1.                      upper extremity (UE)       did not seek medical      health care
                                    MSDs not seeking medical   care.                     professional (HSP) will
                                    care. W-R UE MSD cases                               not be recorded on the
                                    defined by NIOSH                                     OSHA 200 logs.
                                    standardized symptom
                                    questionnaires and
                                    positive physical
                                    findings from physician-
                                    conducted physical
                                    examinations.
NIOSH Health Hazard Evaluation     Percentage of workers      85% of employees with W-  Jewelry manufacturing
 Report, HETA 90-273-2130 (1991)    with W-R UE MSD not        R UE MSD symptoms were    employees exposed to
 Ex. 32-450-1-13.                   seeking medical care and   not evaluated by a HSP.   repetitive, forceful,
                                    whether they were         A small fraction of        and awkward postures
                                    recorded on the OSHA 200   those with W-R UE MSD     during job tasks (MSD
                                    logs. W-R UE MSD defined   were recorded on the      hazards).
                                    by NIOSH standardized      OSHA logs.
                                    symptom questionnaires.
NIOSH Health Hazard Evaluation     Evaluation to determine    Large numbers of          Red meatpacking plant
 Report, HETA 92-331 (close-out     compliance with OSHA       symptomatic workers       employees exposed to
 letter) (1993) Ex. 32-450-1.       corporate settlement       evaluated by HAPS and     MSD hazards. BLS
                                    agreement. Review of       prescribed a temporary    requires cases
                                    plant's health clinic      job transfer. HSP         involving employees
                                    algorithm to evaluate      deemed these as           with W-R symptoms
                                    and treat symptomatic      ``preventive'' job        assigned a job transfer
                                    workers.                   transfers and did not     to be record onto the
                                                               record these on the       logs.
                                                               OSHA 200 logs.
NIOSH Health Hazard Evaluation     Percentage of workers      75% of employees with W-  Research technicians
 Report, HETA 95-0294-2594 (1996)   with W-R UE MSD not        R UE MSD did not seek     conducting pipetting
 Ex. 32-450-1-22.                   seeking medical care and   medical care.             operations with MSD
                                    whether they wer          A small fraction of        hazards.
                                    recorded on the OSHA 200   those with W-R UE MSD
                                    logs. W-R UE MSD defined   were recorded onto the
                                    by NIOSH standardized      OSHA 200 logs.
                                    symptom questionnaires.
NIOSH Health Hazard Evaluation     Employee health records    23% of employees with W-  Truck frame assumably
 Report, HETA 96-0101-2476 (1997)   and employee interviews    R UE MSD not recorded     employees exposed to
 Ex. 32-450-1-26.                   compared with the          onto the OSHA 200 logs.   MSD hazards.
                                    plant's OSHA 200 logs.
                                   Same method used to        The number of actual      Under-reporting the lost
                                    determined the accuracy    lost or restricted work   or restricted workdays
                                    of the number of lost      days significantly        gives the impression of
                                    and restricted workdays    under-reported.           a less serious
                                    recorded.                                            disorder.
NIOSH Health Hazard Evaluation     Clinic employee report of  Many entries listed on    Fiberglass manufacturing
 Report, HETA 97-0276-2724 (1999)   injury illness forms       the Clinic Employee       plant employees exposed
 Ex. 32-450-1-2.                    compared with the          Report of Injury/         to MSD hazards.
                                    plant's OSHA 200 logs.     Illness forms and many
                                   Employee health records     cases from individual
                                    compared with the          employee health records
                                    plant's OSHA 200 logs..    were not recorded on
                                                               the OSHA 200 logs.
NIOSH Health Hazard Evaluation     Comparison of workers      Several discrepancies     Casket manufacturing
 Report, HETA 98-0085-2715 (1998)   reporting MS symptoms on   between these two         employees exposed to
 Ex. 32-450-1-10.                   a body map diagram with    lists. Employees          MSD hazards.
                                    the OSHA 200 logs.         probably not reporting
                                                               all W-R symptoms to
                                                               employer.
----------------------------------------------------------------------------------------------------------------


[[Page 68758]]

    As stated by NIOSH (Ex. 32-450-1), these HETAs 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; and (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. In one HETA, 
NIOSH estimated the extent of the underreporting of recordable cases of 
MSDs on OSHA Logs as 23 percent of cases among a group of truck frame 
workers (Ex. 32-450-1-26). In other studies, NIOSH quantatively 
characterized the extent of the underreporting in these HETAs as 
ranging from ``a small fraction'' for jewelry workers and research 
technicians to ``many not reported'' for fiberglass manufacturers to 
``large numbers not reported'' for red meatpacking plants; for a group 
of supermarket checkers, NIOSH quantitatively estimated that the 
underreporting amounted to 40% of all cases. NIOSH states that there is 
no reason to believe that these HHEs are not representative of the 
widespread underreporting believed to be associated with work-related 
MSDs. NIOSH suggested that OSHA include these HETAs in the final 
standard, to strengthen the evidence of MSD underreporting.
    The rulemaking record thus contains convincing evidence that MSDs 
are often underreported; this evidence includes the new peer-reviewed 
studies submitted by several rulemaking participants. OSHA finds this 
evidence persuasive and has incorporated this information into this 
final standard, as appropriate.
    Some commenters agreed that OSHA was correct in its assumptions 
about underreporting (see, e.g., Exs. 32-339-1-34, -36 and -43, Tr. 
3588, Tr. 4306-07, 4308, 6336, 7362, 7522, as reported in AFL-CIO, Ex. 
500-218). Other commenters, however, questioned the accuracy of OSHA's 
estimates of the extent of MSD underreporting (see, e.g., Exs. 500-197, 
30-3845, 30-3813).
    For example, Organizational Resources Counselors, Inc. (Ex. 30-
3813) disagreed with OSHA's preliminary finding that MSDs are 
underreported on the grounds that: (1) The studies comparing workers' 
compensation data with OSHA Logs are more than a decade old; (2) OSHA's 
own audits (done in connection with OSHA's Data Initiative) of employer 
injury and illness records indicates a ``satisfactory'' level of 
reporting; and (3) factors such as aging and off-the-job risks affect 
the onset of MSDs and complicate the accurate reporting of work-related 
MSDs. In response, OSHA notes that many of the reports and studies it 
is relying on as evidence of underreporting are recent (late 80's and 
90's) and that in this section of the preamble (Significance of Risk), 
OSHA is relying only on those studies that report underreporting on the 
Log (and thus may affect the BLS survey results). OSHA believes that 
ORC's argument that establishing the work-relatedness of MSDs may make 
them difficult for employees to report accurately only reinforces 
OSHA's point: that they are underreported on the Log. Finally, although 
OSHA agrees that OSHA's Data Initiative audits show a relatively 
accurate level of Log reporting, it is important to note that they do 
show that lost-time injuries are underreported by close to 15%.
    In response to OSHA's request in the proposal for specific 
information on the underreporting or overreporting of MSDs, the AFL-CIO 
submitted additional studies to the docket supporting the 
underreporting of work-related MSDs (Ex. 500-218). Representatives from 
the AFL-CIO support OSHA's statements in the proposed rule to the 
effect that the BLS survey understates the true magnitude of the MSD 
problem by a factor of two (64 FR 65981). The AFL-CIO states that the 
record demonstrates that MSDs are indeed significantly underreported, 
thus supporting OSHA's determination on this point (see Ex. 32-339-1 at 
pp. 3-4). Further, at the hearings several physicians and researchers 
confirmed that there is significant underreporting. (See, e.g., Dr. 
Armstrong, Tr. 839-40; Dr. Punnett, Tr. 1021; Dr. Erdil, Tr. 1115; Dr. 
Owen, Tr. 1886-87; Dr. Boden, Tr. 2399-2401.) Similarly, numerous 
workers explained that workplace injuries often go unreported to 
employers (Tr. 3588, 3602, 3612-13, 4510-11, 4587-89, 4595-97, 5601, 
5820, 5861, 6068-69, 6381, 7546-7550, 7377-78, 7382-83, 7384-88, 7510-
12, 7704). The AFL-CIO submitted testimony from Nancy Foley, a 
journalist from Massachusetts, concerning her fears and how that led 
her not to report her injury, as follows:

    ``In 1993, I began having pain in my neck and weakness in my 
hands. I did not seek medical attention until 1995 when the pain had 
spread into my left shoulder and left arm making it difficult for me 
to sit through the work day. Fear prevented me from seeking medical 
attention sooner. I was a part-time reporter. And I was afraid I 
would never be made full-time if my employer knew the job was 
injuring me (Tr. 7318-9).''

    NIOSH also agrees that the BLS data underestimate the true 
magnitude of the occupational injury and illness problem for two 
reasons: (1) Approximately one-third of industries are not included in 
the BLS annual survey, and (2) underreporting of the true number of 
work-related health problems on the OSHA 200 Logs occurs. NIOSH stated 
that while it is widely accepted that occupational disease is 
underestimated in the U.S., the OSHA 200 Logs are the major data source 
used by BLS to determine the extent of occupational disease in the 
United States. OSHA is persuaded by the evidence in the record that 
work-related MSDs are currently being substantially underreported on 
OSHA Logs. OSHA believes that the number of lost-time, work-related 
MSDs quantified in the Agency's risk assessment on the basis of the BLS 
data is understated by at least a factor of two.

Other Evidence Risks are Significant

    In addition to the BLS data, epidemiologic studies comparing the 
prevalence or incidence of MSDs in exposed populations with the 
prevalence or incidence in referent groups with lesser or no such 
exposure also document the elevated risk confronting employees exposed 
to workplace risk factors. These studies also identify the types of 
workplace risk factors associated with the development of work-related 
musculoskeletal disorders, as well as the duration of exposures found 
to be associated with these disorders. This information further 
supports the occupational origin of the reported disorders.
    For example, the odds of having an upper extremity disorder like 
carpal tunnel syndrome or tendinitis/peritendinitis of the shoulder or 
wrist are 5-30 times greater among workers exposed to combinations of 
risk factors such as high force, repetition and awkward postures (e.g., 
overhead work) then among either unexposed workers or workers who are 
exposed to a single risk factor (e.g., Luopajarvi et al., 1979, Ex. 26-
56; Armstrong et al.,1987, Ex. 26-48; Silverstein et al., 1987, Ex. 26-
34; deKrom et al., 1990, Ex. 26-41; Herberts et al., 1984, Ex. 26-51). 
The odds of experiencing a low back disorder increased 3-8 fold among 
those workers exposed to frequent or forceful manual handling, awkward 
trunk postures (such as severe forward flexion), or to whole body 
vibration (Liles et al., 1984, Ex. 26-33; Kelsey et al., 1990, Ex. 26-
52; Punnett et al., 1991, Ex. 26-39; Wikstrom et al., 1994,

[[Page 68759]]

Ex. 26-61; Tanaka et al., 1995, Ex. 26-59). Hip and knee disorders are 
associated with heavy physical work and awkward postures, such as 
kneeling and squatting, or using the knee as a kicker. Thun et al. 
(1987, Ex. 26-60) reported an increased risk of bursitis in carpet-
layers that was 5 times higher than that of the unexposed workers. In a 
review of 4 studies, Hagberg and Wegman (1987, Ex. 26-32) estimated the 
work-attributable fraction of shoulder tendinitis in the exposed 
population to be 90%. In a review of 15 cross-sectional and 6 case 
control studies of carpal tunnel syndrome, Hagberg et al.(1992, Ex. 26-
50) estimated the work-attributable fraction in the population exposed 
to high force, high repetition, vibration or awkward wrist/hand 
postures to be 50-90%. Olsen et al.(1994, Ex. 26-57) estimated that 40% 
of the cases of coxarthrosis (osteoarthrosis of the hip) seen in the 
exposed working population was due to heavy physical workload. Thus, in 
general, strong and consistent associations have been identified in the 
epidemiologic literature, primarily in cross-sectional and case control 
studies, but also in prospective studies (e.g., Kurppa et al., 1991, 
Ex. 26-53; Riihimaki et al., 1994 Ex. 26-58; Felson et al., 1991, Ex. 
26-49). Exposure-response relationships have been identified in a 
number of studies, although precise quantitative modeling is not yet 
available.
    Based on the various data and studies discussed in the Quantitative 
Risk Assessment and Health Effects sections of the preamble, OSHA finds 
that workers exposed to workplace risk factors are at significant risk 
of developing work-related musculoskeletal disorders, which are harmful 
and often disabling conditions. This is particularly true for workers 
who are exposed to a combination of risk factors over most of the 
workshift.
    The data indicate that this rule would, if promulgated, cause 
employers to implement, for their problem jobs, interventions that 
would reduce the exposure of at-risk workers to workplace risk factors, 
and thus would substantially reduce significant risk. Specifically, the 
requirements to conduct job analyses and implement controls where 
exposure to risk factors is high (i.e., for jobs meeting the Action 
Trigger and/or identified as having MSD hazards) would help to ensure 
that employees are exposed to fewer risk factors over time, or to a 
combination of risk factors for a lesser amount of time, than is now 
the case. A large body of data demonstrates that workplace 
interventions, such as job analysis to identify risk factors and 
implementation of controls to reduce exposures to these risk factors, 
can be very effective in reducing those forces responsible for 
musculoskeletal disease and injury; this has been shown in studies that 
have quantitatively examined the impact of ergonomic interventions on 
exposures to risk factors, as well as studies and reports that have 
documented actual reductions in injury prevalence following the 
implementation of ergonomics programs. Several of the standard's 
provisions, such as MSD management and training, will provide 
additional protection against the significant risk that will remain 
after controls are implemented in problem jobs.

C. OSHA's Response to Additional Comments

    Several commenters argued that OSHA must quantify separately the 
risk posed by each hazard it is regulating (i.e., force, awkward 
posture, vibration, repetition, and contact stress), and must do so in 
every industry below the two-digit SIC code level, in every 
occupational category, and in every job covered by the standard. See 
e.g., Ex. 30-4499; Ex. 500-197; Ex. 500-187; 500-223.
    In the Risk Assessment and Health Effects sections of this 
preamble, OSHA explained in detail its reasons for addressing these 
risk factors together in one standard. Substantial evidence in the 
rulemaking record demonstrates that these factors work together to pose 
a significant risk of material harm to employees. In most of the 
cohorts studied in the epidemiological literature examining these risk 
factors, the employees studied were exposed to combinations of the risk 
factors regulated; rarely would one of the risk factors be studied in 
isolation. In addition, substantial evidence in the rulemaking record 
indicates that ergonomic interventions are most effective when they 
examine an employee's exposure to all of the risk factors at issue at 
one time. The tools used to assess exposure to ergonomic risk factors 
are designed to account for interactions between risk factors. For 
example, the NIOSH lifting equation considers how forces applied by the 
worker (weight), the workers' posture, and lift frequency all interact 
to increase risk. Indeed, it would be inappropriate for OSHA to 
quantify the risk posed by each risk factor alone. Such an approach 
would not provide an accurate representation of the MSD hazard a 
particular employee faces when doing a certain job; indeed, such an 
approach would provide an inaccurate picture of the MSD hazards 
present. The OSH Act's requirement are met if OSHA determines that 
employees are being subjected to a significant risk of material 
impairment of health or functional capacity by the risk factors being 
targeted and that the standard being promulgated will reduce that risk 
substantially. OSHA has done that here.
    Using the best available evidence, OSHA has found that employees 
are currently exposed to a significant risk of material harm from the 
risk factors of force, repetition, awkward posture, contact stress, and 
vibration. The BLS data used by OSHA to calculate significant risk 
included Nature of Exposure Event Codes corresponding to these risk 
factors:
    <bullet> Repetitive motion: This category reflects the risk factor 
of repetition; however, such exposure is often combined with force and/
or posture.
    <bullet> Overexertion: This category reflects the risk factor of 
force; however, such exposure is often combined with repetition and/or 
posture.
    <bullet> Bodily reaction: This category reflects the risk factor of 
posture; however, such exposure is often combined with force or 
repetition.
    While the BLS data did not directly include numbers reflecting 
exposures to the risk factors of vibration and contact stress, OSHA 
believes that some of the MSDs included in the data may also have 
involved exposure to these hazards. Other evidence in the rulemaking 
record also convincingly shows that employees exposed to these two risk 
factors experience a significant risk of material harm. A number of 
epidemiological studies in the rulemaking record demonstrate that 
exposure to vibration at even low levels causes a number of serious 
conditions, including hand-arm vibration syndrome. See the discussion 
of vibration in the Health Effects section; see also Ex. 26-392. 
Indeed, NIOSH specifically found this in its 1997 review of the 
epidemiological literature. See Ex. 26-1. There is also substantial 
evidence in the rulemaking record that contact stress as defined by 
this standard can cause a significant risk of material harm. As 
discussed fully in the Health Effects section, the scientific 
literature strongly shows that contact stress causes such conditions as 
hypoththermal hammer syndrome and carpet layers' knee. Thus, there is 
no question that workers are currently exposed to a significant risk of 
material harm from the risk factors of force, repetition, vibration, 
awkward posture, and contact stress.
    OSHA is also not required to conduct its significant risk analysis 
at a detailed

[[Page 68760]]

industry level, or by occupational category or job. Where a standard 
requires employers to act only when the hazards being regulated are 
present in their workplace, OSHA has no duty to disaggregate risk in 
this manner. See International Union, United Auto Workers v. OSHA (LO/
TO II), 37 F.3d 665, 670 (D.C. Cir. 1994). This was recently confirmed 
by the D.C. Circuit in its review of OSHA's Lockout/Tagout standard. In 
the Lockout/Tagout rulemaking, OSHA found that workers performing 
certain operations across general industry were exposed to a 
significant risk of material harm from the hazard of energy 
unexpectedly being released from certain powered industrial equipment. 
Id. at 667. Certain industry challengers argued that OSHA was under a 
duty to disaggregate the risk faced by workers by SIC code, 
particularly since, they contended, there was zero risk in certain SIC 
codes. The court held that the OSH Act placed no such duty on OSHA: 
``If, as OSHA asserts * * * the regulation applies simply to machines 
that pose a significant risk and to workers subjected to that risk, we 
see no reason why OSHA should be concerned with industry 
classifications that appear essentially irrelevant to its task.'' LO/TO 
II, 37 F.3d at 670 (emphasis added). See also Associated Builders and 
Contractors, Inc. v. OSHA, 862 F.2d 63, 68 (3d Cir. 1988) (``A 
requirement that the Secretary assess risk to workers and need for 
disclosure with respect to each substance in each industry would 
effectively cripple OSHA's performance of the duty imposed on it * * 
*''); American Dental Ass'n v. Martin, 984 F.2d 823, 827 (7th Cir. 
1993) (``[T]he agency [is not] required to proceed workplace by 
workplace, which in the case of bloodborne pathogens would require it 
to promulgate hundreds of thousands of separate rules.'').
    Like OSHA's Lockout/Tagout rule, this standard is not ``industry-
based.'' An employer is required to respond to an employee report of 
signs or symptoms of an MSD only when the employer determines that an 
``MSD incident'' has occurred and the employee's job is one that 
contains risk factors that exceed the standard's screen. OSHA is not 
triggering industry wide obligations; rather, it is triggering 
obligations on employers where there are ergonomic hazards present at 
certain levels in jobs in their workplace. Under these circumstances 
OSHA is not required to disaggregate risk by three or four digit SIC 
code, or by occupational category, or by jobs potentially covered by 
the standard.
    Several commenters argued that because MSDs are not fatal, OSHA 
should deviate from its past practice of considering as ``significant'' 
a ``one in a thousand'' risk that a worker will develop an MSD over a 
working lifetime. See e.g., Ex. 500-223.
    As noted above, a plurality of the Supreme Court in Benzene held 
that, although ``it is OSHA's responsibility to determine, in the first 
instance, what it considers to be a ``significant'' risk, * * * the 
requirement that a ``significant'' risk be identified is not a 
mathematical straitjacket * * * [and] the Agency has no duty to 
calculate the exact probability of harm.'' Id. at 655. While the Court 
noted OSHA's broad discretion to formulate what level of risk it 
considers to be significant, the Court also provided guidance to OSHA 
as to what a reasonable person might consider a significant risk of 
material harm:

    ``Some risks are plainly acceptable and others are plainly 
unacceptable. If, for example, the odds are one in a billion that a 
person will die from cancer by taking a drink of chlorinated water, 
the risk clearly could not be considered significant. On the other 
hand, if the odds are one in a thousand that regular inhalation of 
gasoline vapors that are 2 percent benzene will be fatal, a 
reasonable person might well consider the risk significant and take 
the appropriate steps to decrease or eliminate it.'' Id. at 655.

    In past standards, OSHA has applied that guidance, noting that a 
risk of one in a thousand of dying from an occupational exposure is 
significant. However, OSHA has never quantified the lowest level of 
risk of death that it considers significant, beyond acknowledging that 
the level must be higher than one in a billion. Thus it is not true 
that OSHA takes the position that a risk of dying is necessarily 
insignificant if it is less than one in a thousand.
    OSHA has only infrequently quantified the risks of nonlethal harm 
from workplace exposures. It recognizes, however, that a reasonable 
person might well be willing to accept a greater risk of injury than of 
death, and that there may be cases where even a risk of one in a 
thousand of some types of injuries occurring is insignificant. OSHA 
need not determine whether this is such a case, however, because, 
throughout general industry, the working lifetime risk of developing an 
MSD is extraordinarily high. OSHA has found working lifetime risks to 
be as high as 835 per thousand (Transportation by air), 486 per 
thousand (Local and suburban transit and interurban highway passenger 
transportation), and 206 per thousand (Real estate). Even in SIC code 
62 (Security and Commodity Brokers, Dealers, Exchanges, and Services), 
the SIC code with the lowest risk, 24 out of 1,000 workers are likely 
to suffer at least one MSD during a working lifetime. These risk levels 
are extremely high by any measure or formulation and are clearly 
``significant'' under the OSH Act. Further, the serious and often 
disabling nature of these disorders is attested to by the fact that 
their severity (measured by median number of days away) is greater than 
median for all other injuries and illnesses combined.
    Some commenters argued that the standard is improperly structured 
to reduce all risk, even insignificant risk. See Exs. 30-4185; 30-3951. 
OSHA agrees that this standard will substantially reduce the 
significant risk of material harm faced by workers from exposure to 
ergonomic risk factors. OSHA estimates that the standard will reduce 
the number of lost workday MSDs currently reported to the BLS by 
approximately 50%. This amounts to approximately 300,000 MSDs a year 
and constitutes a substantial reduction in the number of MSDs 
experienced by workers every year across general industry. This 
standard is not designed to reduce ``insignificant'' risk, however. 
OSHA has made some changes to the standard (from the proposed rule) to 
ensure that employers are not required to act when the risk posed to 
their employees from the risk factors at issue is below certain levels.
    First, OSHA has included a screen in the standard that will ensure 
that employers are not required to act in the absence of ``significant 
risk.'' OSHA established the screen based on substantial evidence in 
the rulemaking record showing substantial excess risk of developing 
MSDs above the hazard levels in the screen. If employees are exposed to 
the risk factors at issue below the levels indicated by the screen, 
employers have no obligations to analyze their jobs, implement 
controls, or train their workers.
    Second, OSHA has not included the proposed incremental abatement 
process in the final standard. As explained more thoroughly in section 
IV, above, the incremental abatement process would have allowed 
employers to incrementally implement controls to certain jobs to 
materially reduce MSD hazards. If continued exposure to certain hazards 
in the job prevented an injured employee from recovering, the employer 
was required to implement additional feasible controls. Although this 
approach mirrored what many employers were currently doing in their 
ergonomics programs, it was highly

[[Page 68761]]

criticized during the rulemaking process. One criticism was that it 
effectively required employers to continue to implement controls when 
the risk posed by a certain job was no longer ``significant.'' Although 
OSHA does not agree that the process placed requirements on employers 
to act where there was no significant risk, OSHA has nonetheless 
eliminated the requirement from the final standard in order to, among 
other tings, avoid any implication that employers must abate hazards 
that are not significant.
    Some commenters argued that OSHA improperly relied on the BLS data 
for its significant risk analysis because the data include injuries and 
illnesses that are only 1% caused by work. See Ex. 32-78. These 
commenters miss the point about OSHA's significant risk analysis. The 
appropriate question to be asked is whether the BLS data accurately 
reflect the risk faced by workers exposed to the risk factors being 
regulated and whether the standard will substantially reduce that risk. 
As explained above, the BLS data represent the best available evidence 
on the magnitude of the MSD problem in the United States today, and 
thus on the significant risk faced by workers from exposure to the 
ergonomic risk factors at issue. The BLS survey is a comprehensive one; 
it collects workplace injury and illness data from about 165,000 
private industry establishments. For the survey, selected employers are 
required to provide statistics on the total number of injuries and 
illnesses recorded on the OSHA Form 200, as well as information 
describing the nature and causes of their lost workday injuries and 
illnesses. The information is provided in sufficient detail to permit 
BLS to systematically code each reported case and develop estimates of 
the numbers and incidence of each specific type of LWD injury and 
illness for the United States as a whole, by industry sector and by 
occupation. The data provided reflect the employer's understanding of 
which cases are work-related under current U.S. Department of Labor 
recordkeeping guidelines. OSHA is thus confident that the reported 
cases of MSDs included in the significant risk analysis accurately 
reflect injuries caused by work.
    OSHA has also taken a number of additional steps to ensure that the 
risk assessment and the significant risk analysis have a tight nexus 
with the risk factors being regulated and the structure of the 
standard. As stated, OSHA only included Nature of Exposure Event 
categories in its risk assessment that corresponded to the risk factors 
targeted by the standard. Thus, the MSDs experienced by workers as a 
result of exposure to risks not covered by this standard are not 
included in the Risk Assessment. In addition, for the final standard 
OSHA has conducted a second, alternative analysis that eliminated from 
the risk assessment MSDs caused by exposure to risk factors at levels 
below the screen. See Risk Assessment discussion. This additional 
analysis confirms OSHA's conclusions as to the risk faced by workers 
exposed to the risk factors at issue and demonstrates that the risk of 
developing MSDs for workers exposed to risk factors at levels meeting 
the screen is alarmingly high and, without question, significant.
    One commenter argued that OSHA has improperly considered 
``significant'' risks that represent incident rates much lower than 
those being targeted in the Agency's new enforcement plan. Tr. 10439 
(NCR Corporation). The OSH Act and past OSHA practice provide the 
framework within which OSHA must make its significant risk finding. 
Acting within this framework and on the best available evidence, OSHA 
has found that a significant risk of material harm currently exists for 
workers exposed to the hazards regulated and that the standard will 
substantially reduce that risk. OSHA's enforcement strategy, on the 
other hand, is based on entirely different principles. Because OSHA has 
a limited enforcement budget, OSHA targets its enforcement activities 
to industries where the risk of harm is particularly severe. OSHA 
engages in comprehensive data collection in order to determine where 
certain industries fall within this prioritization scheme. OSHA's most 
recent enforcement initiative focuses on relatively large workplaces 
whose past experience shows that hazards are likely to be present. The 
principles used to support OSHA's enforcement efforts are very 
different from the principles OSHA must abide by in setting 
occupational safety and health standards. For this reason, it is 
entirely appropriate for OSHA to apply different standards for 
determining significant risk and targeting its enforcement activities.

D. Conclusions

    OSHA concludes, based on the evidence discussed above and elsewhere 
in the record, that the scientific data are sufficient to demonstrate 
that exposure to work-related risk factors is associated with the 
development of musculoskeletal disorders of the upper extremities, 
back, and lower extremities. Risk factors identified from this body of 
literature include repetitive motions; use of excessive force; 
segmental vibration; maintaining awkward postures of the neck, wrists, 
arms, trunk, and lower-extremities; and lifting, lowering, pushing, 
carrying, and pulling loads of excessive weight. Depending on the 
specific combinations of risk factors encountered in the workplace, 
musculoskeletal disorders identified as being work-related include 
carpal tunnel syndrome (hand, wrist), trigger finger (hand), De 
Quervains' disease (wrist), tendinitis (hand, wrist, shoulder, ankle), 
epicondylitis (elbow), rotator cuff tendinitis (shoulder and neck), 
sciatica (lower back), osteoarthritis (hip, knee), bursitis (knee), and 
tarsal tunnel syndrome (foot).
    The evidentiary base on which OSHA relies in making these 
conclusions is described fully in the Health Effects section of the 
preamble. This evidence is comprised of several hundred cross-
sectional, case-control, prospective, and case series reports of 
working populations in a variety of industrial settings. Supplementing 
these reports is a large body of scientific literature that provides 
data on the mechanisms by which exposure to these risk factors causes 
musculoskeletal disorders; these data demonstrate the biological 
plausibility of the relationship between exposure to workplace risk 
factors and an elevated risk of MSD injury and illness.
    MSDs have been recognized as compensable under virtually all State 
workers' compensation plans, demonstrating that exposure to work-
related risk factors is already widely recognized as a cause of 
musculoskeletal disorders. Taken together, OSHA believes that the 
scientific and other evidence described in the preamble to this rule 
constitute an evidentiary base of unusual depth and quality.
    Accordingly, OSHA concludes that musculoskeletal disorders 
associated with workplace exposure to workplace risk factors constitute 
material harm under the OSH Act. Further, as demonstrated by the 
evidence discussed in Section B above, the data available to the Agency 
demonstrate clearly that workers in the occupations and industries 
covered by the ergonomics program standard are at significant risk of 
experiencing a work-related MSD over their working lifetime; for many 
occupations and industries, they are at significant risk of 
experiencing a work-related MSD even in a single year of work in their 
job.

[[Page 68762]]

VIII. Summary of the Final Economic Analysis and Regulatory 
Flexibility Analysis

A. Introduction

    OSHA's Final Economic and Regulatory Flexibility Analysis (Ex. 900) 
addresses issues related to the costs, benefits, technological and 
economic feasibility, and economic impacts (including small business 
impacts) of the Agency's ergonomics program rule. The analysis also 
evaluates regulatory and non-regulatory alternatives to this rule.
    This rule is a significant rule under Executive Order 12866 and has 
been reviewed by the Office of Information and Regulatory Affairs in 
the Office of Management and Budget, as required by the executive 
order. In addition, this economic analysis meets the requirements of 
both Executive Order 12866 and the Regulatory Flexibility Act (as 
amended in 1996). The complete Final Economic and Regulatory 
Flexibility Analysis has been entered into the rulemaking docket as Ex. 
900. This Final Economic and Regulatory Flexibility Analysis presents 
OSHA's full economic analysis and methodology, as well as responses to 
comments in the record on the Preliminary Economic and Regulatory 
Flexibility Analysis. The remainder of this section of the Preamble 
summarizes the results of that analysis.
    The purpose of this Final Economic and Regulatory Flexibility 
Analysis is to:
    <bullet> Identify the establishments and industries potentially 
affected by the rule;
    <bullet> Estimate the benefits of the rule in terms of the 
reduction in musculoskeletal disorders (MSDs) employers will achieve by 
coming into compliance with the ergonomics program standard and some of 
the direct cost savings associated with those reductions;
    <bullet> Evaluate the costs, economic impacts and small business 
impacts establishments in the regulated community will incur to 
establish ergonomics programs to achieve compliance with the standard;
    <bullet> Assess the economic feasibility of the rule for affected 
industries;
    <bullet> Evaluate the principal regulatory and non-regulatory 
alternatives to the final rule that OSHA has considered;
    <bullet> Present the Final Regulatory Flexibility analysis for the 
ergonomics program rule; and
    <bullet> Respond to the findings and recommendations made to OSHA 
by the Small Business Regulatory Enforcement Fairness Act (SBREFA) 
Panel convened for this standard.
    The Final Economic Analysis contains the following chapters:

Chapter I, Introduction
Chapter II, Industrial Profile
Chapter III, Technological Feasibility
Chapter IV, Benefits
Chapter V, Costs of Compliance
Chapter VI, Economic Feasibility
Chapter VII, Economic Impacts and Final Regulatory Flexibility Analysis
Chapter VIII, Assessment of Non-Regulatory Alternatives.

B. Introduction and Industrial Profile (Chapters I and II)

    Data from the Bureau of Labor Statistics (BLS) Annual Survey of 
Occupational Injuries and Illnesses for 1996 shows that 626,000 U.S. 
workers across all industries experienced musculoskeletal disorders 
serious enough to require time away from work for recuperation in that 
year (Ex. 26-1413). In addition to these lost workday MSDs, OSHA 
estimates that, on average across all of general industry, about two 
times as many non-lost workday cases involving work-related MSDs occur 
every year in U.S. workplaces.
    In some general industry sectors, lost workday MSD rates reached 37 
cases per 1,000 full-time equivalent (FTE) workers in 1996, and in many 
others, annual incidence rates were greater than 10 per 1,000 FTE (Ex. 
26-1413). If these annual risks are converted into working lifetime 
risks (assuming a 45-year working lifetime), the risks of experiencing 
a lost workday MSD faced by general industry employees over the course 
of their working life, based on OSHA's most conservative estimates, 
range from 24 to 813 per 1,000 workers, depending on the particular 
industry in which the worker is employed (see the Significance of Risk 
section of this preamble). By any reasonable definition, these risks of 
material impairment are significant. Another indicator of the 
significance of work-related MSDs to the economy is the fact that 
employers annually pay out, in direct workers' compensation costs, 
between $15-$18 billion, or about 1 dollar of every 3 workers' 
compensation dollars, for MSD-related claims.
    The extensive evidence available clearly demonstrates that 
ergonomic risk factors--such as repetitive motion, force, awkward 
posture, and vibration--are present in all types of general industry 
workplaces, including small, medium, and large workplaces. In today's 
workplace, the pace of work, the specialization of work, and continued 
reliance on unassisted manual handling require many workers to apply 
excessive force, perform too many lifts and carries, and repeat similar 
motions too often. Many studies cited in the Health Effects section of 
the preamble (Section V) to the final standard demonstrate the presence 
of these risk factors in the workplace, and many biomechanical studies 
show the effects on the soft tissues of the body of these external 
forces: tissue damage, pathophysiology, and outright disease.
    Market mechanisms have been inadequate to address these risks (see 
the discussion in Chapter VIII of this economic analysis). Although 
many firms, and particularly larger firms, have addressed ergonomic 
risk factors and substantially reduced their MSD rates, many firms have 
not. Approximately 60 percent of all general industry employees 
continue to work in establishments that have not yet addressed 
ergonomic risk factors, despite the widespread presence of MSD hazards.
    Because these characteristics of work are not unique to the United 
States, countries of every size and on every continent are also 
experiencing significant numbers of musculoskeletal disorders among 
their workforces. Many of these countries--ranging from the United 
Kingdom and Sweden to Pakistan, Ecuador, and South Africa--have already 
established regulatory requirements designed to address some or all of 
the workplace risk factors giving rise to these disorders. A table 
summarizing the ergonomics rules and guidelines issued by other 
countries and organizations can be found in Chapter I of this Final 
Economic Analysis.
    The standard OSHA is issuing today applies to general industry 
employers and will also affect state and local government entities or 
agencies in OSHA's State-plan States, except that the following 
industries are exempt from the scope of the final standard: 
agriculture; maritime; and construction. In addition, the standard does 
not apply to railroad operations.
    The final ergonomics rule is a program standard, i.e., one that 
requires employers whose employees experience MSDs in jobs determined 
to be higher risk jobs to implement a program that includes the 
elements of any sound safety and health (ergonomics) program. These 
include management leadership and employee participation, job hazard 
analysis to identify musculoskeletal hazards, the implementation of 
controls to reduce the hazards identified, training for employees and 
their supervisors or team leaders in jobs that have MSD hazards, 
management of musculoskeletal disorders when they occur, and regular 
evaluation of the

[[Page 68763]]

program to ensure that it is functioning as intended.
    The final rule contains many features that act to target the 
standard to the most hazardous jobs; to limit the compliance 
obligations of employers as much as possible, consistent with employee 
protection; and to permit employers to adapt the required program and 
its elements to the conditions and circumstances of their particular 
workplaces. Among the standard's flexible provisions are the following:
    <bullet> The programmatic design of the standard itself, which 
requires employers to establish a basic framework with widely agreed-
upon elements but leaves employers free to provide many of the 
establishment-specific details;
    <bullet> A two-step action trigger, which requires the employer to 
take action only if an employee has experienced an MSD incident (one 
involving medical treatment beyond first aid, days away from work or on 
restricted work, or signs or symptoms lasting 7 days or longer) and 
that employee's job is determined to involve heightened exposure to 
ergonomic risk factors;
    <bullet> A Quick Fix provision, which allows employers whose 
employees have experienced only a few MSDs to fix the problem job 
without having to implement the entire program;
    <bullet> Provisions that specify that the employer is only required 
to implement a program for those jobs meet the action trigger, and then 
only to implement the program in that establishment;
    <bullet> A provision permitting employers to use a variety of 
methods to conduct job hazard analysis;
    <bullet> A provision permitting employers to demonstrate that they 
have met their hazard control obligations in any one of a variety of 
ways;
    <bullet> A ``grandfather'' clause that permits employers with 
effective existing programs that contain the basic elements of 
ergonomics programs and that have been evaluated and shown to be 
effective before the standard's effective date to continue to implement 
their programs rather than the program required by the standard;
    <bullet> Provisions stating that an employer's obligation to 
maintain its ergonomics program ceases for employees and jobs once the 
job has been controlled to levels below the screen.
    OSHA believes that the flexibility afforded by the final rule will 
facilitate compliance by employers of all sizes and provide their 
employees with the protections they need against the ergonomic hazards 
that are so prevalent in general industry workplaces today.
    The standard being issued today depends heavily on employee 
reporting for its effectiveness. This is the case because a report of 
an MSD or MSD signs and symptoms is the trigger to further action by 
the employer. Once an employee has reported an MSD, or its signs or 
symptoms, to the employer, the employer must determine whether the MSD 
(or signs or symptoms) meet the standard's definition of an MSD 
incident. An MSD incident is defined by the standard as a work-related 
MSD or MSD sign or symptom that involves persistent signs or symptoms 
(those lasting for 7 or more consecutive days since the time they were 
reported to the employer), or that requires medical treatment beyond 
first aid, one or more days of restricted work, or one or more days 
away from work. If the employee's report of an MSD is determined by the 
employer to be an MSD incident, the employer must then move to the 
second prong of the standard's action trigger: a review of the 
employee's job to determine whether it involves ergonomic risk factors 
(repetition, force, vibration, awkward postures, or contact stress) for 
durations that meet those specified by the Basic Screening Tool in 
Table 1 of the standard for that risk factor. If the relevant risk 
factors in the employee's job do not meet the screen in Table 1, the 
employer is not required to take further action. In other words, unless 
both parts of the action trigger are met (the occurrence of an MSD 
incident and the presence, in that employee's job, of risk factor(s) 
meeting the screen), no ergonomics program is triggered.
    OSHA believes that the action trigger in the final rule is a highly 
effective targeting device because OSHA's data show that only about 37 
percent of all general industry jobs will meet the screen, but that 
about two-thirds of all lost workday MSDs reported to the BLS annually 
occur in those jobs. Put another way, the risk that an employee will 
incur an MSD is about three times greater in a job with risk factors 
that meet the screen than in jobs that do not have such risk factors.
    The standard requires employers who have jobs that meet the action 
trigger to implement an ergonomics program for that job and for all 
employees in the same job within the establishment.\1\ The program 
consists of the following elements: management leadership, employee 
participation, job hazard analysis, employee training, MSD management 
(called medical management by many employers) and if a hazard is 
found--hazard control and program evaluation.
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    \1\ Employers qualifying for and choosing to use the Quick Fix 
provision of the standard do not have to implement a program but may 
instead implement controls and follow other procedures to address 
the risk factors in that job alone.
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    The final rule provides employers with several different hazard 
identification tools that they may use to determine whether a job that 
meets the screen does in fact pose an MSD hazard to employees in that 
job. These tools appear in two appendices (Appendices D-1 and D-2) to 
the standard. OSHA believes that a number of jobs that meet the screen 
will subsequently be shown, by a job hazard analysis, not to present a 
hazard to employees. For example, some jobs will have an ergonomic risk 
factor, or a combination of risk factors, at levels that meet the 
screen; however, use of one of the hazard identification tools in 
Appendix D, such as the Rapid Upper Limb Assessment (RULA), may show 
that the risk factors present in the job are within the ``acceptable'' 
zone on that tool.
    The final rule permits employers to use a variety of hazard 
identification tools, which are included in appendices to the standard. 
Employers may also choose to rely for hazard identification on the 
services of a safety and health professional trained and experienced in 
ergonomics; in addition, they may choose to use any other reasonable 
method that is appropriate to the job and addresses the relevant risk 
factors. If the job hazard analysis identifies MSD hazards in the 
injured employee's job, the employer must then identify and implement 
controls to reduce these hazards.
    The standard also permits employers great flexibility in meeting 
their obligations to control MSD hazards in jobs that have been 
identified as posing MSD hazards to employees. Employers may fulfill 
their obligations by:
    <bullet> Controlling MSD hazards (defined as reducing the hazards 
to the extent they are no longer reasonably likely to cause MSDs that 
result in work restrictions, or medical treatment beyond first aid); or
    <bullet> Reducing MSD hazards in accordance with or to the levels 
indicated by one of the hazard identification tools used by the 
employer in the job hazard analysis; or
    <bullet> Reducing MSD hazards to the extent feasible.
    Employers who control their problem jobs to one of these 
``endpoints'' will be considered to be in compliance with the 
standard's hazard control requirements. OSHA believes that the range of 
control obligation endpoints permitted by the standard will ensure that 
employers will

[[Page 68764]]

be able to control all of their problem jobs.
    Employers are also permitted by the standard to use any combination 
of engineering, work practice, and administrative controls to meet 
their control obligations, although personal protective equipment may 
only be used alone when other kinds of controls are not feasible.
    The standard's requirements for MSD management mandate that 
employers provide employees who have experienced an MSD incident in a 
job meeting the action trigger with: access to a health care 
professional; any work restriction or removal from work deemed to be 
necessary to allow the injured body part to recover; and the 
evaluation, management, and follow-up of the MSD needed to facilitate 
the employee's recovery. In addition, employers are required to 
maintain 100 percent of the wages, benefits, and employment rights of 
employees placed on restricted work to recover from an MSD, and they 
must maintain 90% of the wages, and all benefits and employment rights, 
of employees removed from work to recover. These protections, termed 
``work restriction protections'' (WRP) by the standard, must be 
maintained until the first of the following occurs:
    <bullet> An HCP determines that the employee can never return to 
the former job;
    <bullet> The employee is able to return to the former job without 
endangering his or her recovery; or
    <bullet> Ninety calendar days have passed.
    As discussed at length in the summary and explanation for paragraph 
(r), OSHA has concluded that work restriction protections are required 
to encourage employees to come forward to report their signs and 
symptoms and to participate in the employer's MSD management program.
    The standard also requires employees in problem jobs to be trained, 
initially and periodically, in the employer's ergonomics program and 
their role in it; the MSD hazards present in their jobs; the employer's 
plan for controlling these hazards; the use of these controls; and ways 
of evaluating the effectiveness of the controls selected. The training 
must be provided in language that the employee understands.
    Employers must also evaluate their ergonomics programs, or the 
relevant part of their program, when they believe that the program or 
one of its elements is not functioning properly or that operations in 
the workplace have changed in a way that may increase employee exposure 
to ergonomic risk factors. In addition, program evaluations must be 
conducted every three years, at a minimum.
    The standard requires employers with 11 or more employees to 
maintain records of: Employee reports of MSDs and MSD hazards 
(including employer's response to such reports), Job hazard analyses, 
Controls implemented, Quick fixes, Program evaluations, and Work 
restrictions and HCP written opinions. Required records must be 
accessible to employees and their designated representatives.
    The standard provides a series of extended compliance phase-in 
dates for the various provisions of the standard. These range from 9 
months to 4 years, depending on the particular provision.
    Table VIII-1, based on data from County Business Patterns for 1996, 
shows the three-digit industries covered by the standard and the number 
of employees and establishments in each covered industry within the 
general industry sector (Ex. 28-2). Table VIII-1 also shows the 
estimated annual incidence rates for all MSDs (lost workday, restricted 
work, and non-lost workday) for each industry. These estimates do not 
include the number of MSDs currently underreported that OSHA believes 
will be reported once the standard is in effect or the number of 
reports of MSD signs and symptoms that will qualify under the final 
rule as MSD incidents. Together, these two kinds of MSDs increase the 
number of MSDs shown on Table VIII-1 by 50 percent. These rates differ 
from those shown in the risk assessment section of the Preamble because 
they include an estimate of all MSDs, rather than lost workday MSDs 
only, and because they use County Business Patterns estimates of 
industry employment in computing MSD rates. Table VIII-1 shows that the 
total MSD incidence rates in general industry range as high as 1,448 
per 10,000 workers (in Public building and related furniture (SIC 
253)). A total of about 6.1 million establishments and 102 million 
employees are present in general industry including state and local 
government.
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BILLING CODE 4510-26-C

C. Technological Feasibility (Chapter III)

    Chapter 3 of the economic analysis for the final ergonomics rule 
illustrates the technological feasibility of controlling MSD hazards in 
problem jobs in accordance with the rule. The analysis presented in 
this chapter demonstrates that controlling MSD hazards is feasible in 
the industry sectors included in the scope of the rule.
    OSHA has approached the analysis of technological feasibility for 
the final rule from four perspectives. The four analyses for 
technological feasibility are:
    <bullet> Risk factor analysis--This analysis demonstrates the 
variety of methods available for controlling the five risk factors 
covered by the rule. Information drawn from the rulemaking record 
demonstrates how risk factors can be controlled and how these controls 
can achieve compliance with one or more of the final rule's compliance 
endpoints.
    <bullet> Ergonomic program analysis--This analysis demonstrates the 
feasibility of implementing effective ergonomics programs by 
identifying cases in the rulemaking record where effective programs, 
that have program elements similar to or the same as those required by 
the final rule, have already been implemented.
    <bullet> Model job analysis--This analysis demonstrates how the 
risk factors inherent in model jobs that represent the highest rates of 
lost workday MSDs according to BLS data can be controlled in accordance 
with the final rule's compliance endpoints. This analysis also presents 
a model job analysis for video display terminal (VDT) workstations.
    <bullet> Industry-by-industry analysis--This analysis demonstrates 
the broad applicability of the available control methods to virtually 
all of the covered industries, as described by 3-digit SIC codes.
    Each of these analyses was performed based on information contained 
in the rulemaking record. These analyses demonstrate that compliance 
with the final rule including paragraphs (k)(1)(i) and (k)(1)(ii) is 
technologically feasible for most processes in most workplaces most of 
the time.
    Finally, controlling MSD hazards in accordance with the final rule 
can be accomplished (that is, is feasible) because paragraph 
(k)(1)(iii) of the rule states that employer is only required to reduce 
hazards to the extent feasible. OSHA expects that employers will 
implement feasible controls in the context of their own individual 
workplace. This provision recognizes that, while controlling MSD 
hazards to one of the levels specified in paragraph (k)(1)(i) or 
(k)(1)(ii) is feasible in the majority of workplaces, hazard reduction 
to those levels may not be feasible under certain workplace conditions 
at certain times.

D. Benefits Analysis (Chapter IV)

    In its analysis of both the benefits and costs of the final 
standard, OSHA has estimated MSD rates based on BLS data. However, as 
discussed in Chapter IV of the Final Economic Analysis, there is 
extensive evidence that MSDs are underreported to the BLS. OSHA 
estimates that there is at least one unreported MSD for every MSD 
reported to BLS on OSHA logs. However, the final standard creates 
incentives for employees to report MSDs by providing work restriction 
protection to employees. The final standard can also be triggered by 
reports of persistent symptoms. To account for these differences, OSHA 
estimates that MSD incidents will be reported at a rate 50 percent 
higher than current MSD rates based on BLS data.
    Most of the benefits of the final standard will be generated when 
employers fix their problem jobs and thus reduce the number of covered 
MSDs these jobs cause. Hazard information, MSD management and work 
restriction protection will also generate benefits because they will 
ensure that MSDs are identified and treated early in their development, 
thus preventing progression of the MSD to a serious long-term 
disability. However, OSHA has not found ways to calculate the benefits 
of early detection, although the Agency is aware that early reporting 
and medical management have substantial benefits that are similar to 
those associated with preventive medicine in general. For example, 
Oxenburgh et al. (1985) compared two groups of VDU operators (Ex. 26-
1041). In Group A, which did not report early or receive medical 
management early, 22% of cases were at the second or third stage by the 
time they sought medical attention, compared with 8% at these stages in 
Group B, which had been made aware of the need to report early and the 
value of prompt medical management. The mean period of absence for 
Group A workers was 33.9 days; only 25% of this group continued to work 
(i.e., at alternate duty) throughout the period of recuperation. In 
Group B, however, the mean period of absence from work was only 3.4 
days, and fully 80% of this group remained in alternate duty 
throughout. The mean number of alternate duty days was 91 days for 
Group A workers and 31.5 days for those in Group B. The total amount of 
time the average worker in Group A lost, either to days away or 
alternate duty, was 124.9 days; in Group B, this figure decreased by 
72%, to 34.9 days.
    The final standard (and therefore this economic analysis) is 
structured in such a way that the number of jobs fixed in any given 
year depends on the number of MSD incidents reported that involve 
workers in jobs that need to be controlled, and the number of workers 
OSHA estimates hold jobs that involve the same physical work activities 
as the job giving rise to the reported MSD. For purposes of estimating 
the number of jobs that will require control under the final standard, 
OSHA used answers to a Washington state survey indicative of how many 
workers would be above the compliance endpoint given in Appendix D-1 
(Ex. 500-41-3). This survey showed that 37 percent of all workers will 
be exposed at levels that meet the screen, and thus that their jobs 
will require job hazard analysis, medical management and work 
restriction protection. The survey also showed that 33 percent of 
workers will be above the levels indicated by the hazard identification 
tools in Appendix D-1, and thus will require hazard controls.
    Combining this data allowed OSHA to estimate the number of jobs 
that would be controlled and the resulting reduction in the number of 
MSDs projected as a result of the standard. OSHA estimates that 
employers will be required to fix almost 7 million jobs in the first 
year the standard is in place, and a diminishing number every year 
thereafter. Over ten years, approximately 18 million jobs will be 
fixed. OSHA estimates that fixing these jobs will reduce the number of 
MSD incidents caused by these jobs by 50 percent per year (based on the 
effectiveness rate reported in the Risk Assessment section of this 
preamble) for the next ten years (the time horizon of this analysis). 
In the first 10 years, the final standard is therefore projected to 
avert approximately 2.3 million currently reported MSDs and an 
additional 2.3 million MSDs not currently reported, for a total of 4.6 
million MSDs averted. These estimates reflect changes from the 
estimates in the Preliminary Economic Analysis, which are mainly the 
result of the inclusion of the screen and clearly defined compliance 
endpoints in the standard, but are also the result of including 
unreported MSDs in the analysis of benefits. These changes to the 
standard make the rule substantially more cost effective then the 
proposal would have been, because they reduce the number of jobs to be 
fixed by 40 percent.

[[Page 68773]]

    OSHA estimates that the direct cost savings associated with each 
currently reported MSD, including the savings in lost productivity, 
lost tax payments, and administrative costs for workers' compensation 
claims, are $27,700 and $7,000 per MSD not currently reported (1996 
dollars). (The difference in the dollar values assigned to these two 
categories of MSDs is attributable to the fact that OSHA assumes that 
the currently unreported MSDs are much less severe than those being 
reported.) These direct cost savings do not attribute a value or assign 
a monetary cost to the pain and suffering of injured or ill workers, 
losses to their families, or losses of the worker's ability to 
contribute at home, and are thus conservative estimates of these 
savings. Based on this estimate of the direct cost savings associated 
with each reported MSD avoided, the annualized benefits (using a 
discount rate of 7%) accruing in the first ten years the standard is in 
effect are estimated to be $9.1 billion per year.

E. Costs of Compliance (Chapter V)

    This chapter presents OSHA's estimates of the costs employers would 
incur to comply with the ergonomics program rule. The costs reported 
are annualized costs measured in real 1996 dollars over the first 10 
years the rule is in effect. To calculate annualized costs, non-
recurring costs have been annualized using a discount rate of 7 percent 
for an estimated life of 10 years. The cost analysis does not account 
for any changes in the economy over time, or for possible adjustments 
in the demand and supply of goods, changes in production methods, 
investment effects, or macroeconomic effects of the standard. Taking 
account of all of these effects could increase or decrease the cost or 
benefit estimates presented here, although the macroeconomic effects of 
any rule whose costs are less than 0.05 percent of GNP are likely to be 
minimal. OSHA believes that its approach, i.e., of determining the 
benefits and costs of the standard for industry as it is today, is the 
least speculative and least controversial way of presenting the 
benefits and costs of the final standard.
    OSHA relied on responses to a 1993 ergonomics survey (see Chapter V 
of the Final Economic Analysis) of thousands of general industry 
employers to estimate the extent to which establishments within the 
scope of the standard already have implemented ergonomics programs 
involving the control of jobs. This current industry baseline was taken 
into account in calculating industry-by-industry and size-of-
establishment cost estimates, i.e., any costs employers have already 
incurred, and any benefits they have already accrued, to voluntarily 
implement such programs have not been attributed to the final rule.
    Costs were calculated separately at the three-digit SIC code level 
for all industries. These industry-by-industry cost estimates account 
for differences among industries in terms of wage rates, turnover, 
baseline rates of compliance, and the MSD rate for the industry. To 
facilitate analysis of the impacts of the final rule on small 
businesses, costs were calculated separately for each of three size 
classes of establishments. The Final Regulatory Flexibility Analysis 
(Section VIII. H. of this Preamble) provides a detailed summary of 
OSHA's unit cost estimates for each element of the standard.
    OSHA estimates that the annualized costs to society of the final 
standard will be $3.9 billion per year. (All costs are expressed as 
1996 dollars and annualized using a 7 percent discount rate and a 10-
year annualization period.) Table VIII-2 shows the costs of the final 
ergonomics standard, by major provision of the standard. Costs are 
considered in two parts: costs to society and costs to employers. This 
distinction is necessary because the costs associated with the 
standard's work restriction protection provisions represent a cost to 
employers, but not to society as a whole. Table VIII-2 shows that the 
total estimated costs to society for the private sector are $3.4 
billion per year, while estimated costs for all affected parties, 
including state and local governments, are $3.9 billion per year. 
Estimated costs to employers in the private sector as a whole are $4 
billion per year, and to all affected sectors are $4.5 billion per 
year.
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    The programmatic elements of the standard have annualized costs of 
$2.2 billion. In addition, the provision requiring employers to control 
jobs that have been found to have MSD hazards, has costs of $1.3 
billion per year. Four of the industries covered by the standard have 
costs of more than $100 million per year: hospitals (SIC 806); eating 
and drinking places (SIC 581); trucking and courier services (SIC 421) 
and grocery stores (SIC 541).
    Estimates of the costs of job controls are presented as net costs, 
because OSHA has taken the benefits employers often accrue from 
productivity improvements associated with job controls as offsets to 
the costs of job control. OSHA estimates that the labor savings 
(productivity improvements) provided by the job controls the standard 
will require will amount to approximately $700 million per year in 
annualized savings.\2\ OSHA believes that many ergonomic interventions 
improve productivity, either because they reduce employee fatigue and 
relieve muscle pain (which means that the employee will do more work in 
less time), or because they involve automating portions of jobs in ways 
that can be expected to improve productivity. In addition to such 
direct effects on productivity, ergonomic interventions frequently 
offset the employers' cost for controls by :
---------------------------------------------------------------------------

    \2\ OSHA estimated productivity impacts by determining the 
average percentage reduction from gross costs caused by productivity 
in a set of examples of ergonomic interventions. Please see the 
Final Economic Analysis, particularly Tables V-17 through V-19, for 
details.
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    <bullet> Reducing absenteeism because a worker is less likely to 
take time off to recover from muscle soreness, fatigue, etc.;
    <bullet> Reducing turnover, particularly since new hires are more 
likely to find an ergonomically designed job within their physical 
capacity;
    <bullet> Improving product quality because fewer errors are made 
when processes are more mechanized and demand less physical effort.
    These positive productivity impacts are attested to by the 
experience of many employers (see the productivity tables in Chapter V 
of the Final Economic Analysis). OSHA's 1993 ergonomics survey of 
general industry employers found that 30 percent of those employers who 
had implemented ergonomics controls reported that their ergonomics 
programs had had measurable positive impacts on productivity. On 
average, these employers (including the few employers who reported that 
their controls had negative impacts on productivity) reported a 
weighted average productivity improvement of 7 percent per ergonomic 
intervention. The cost estimates presented in this Final Economic 
Analysis differ appreciably from those presented in the Preliminary 
Economic Analysis. These changes are described in greater detail in 
Chapter V of this final analysis, but the most important changes and 
the reasons for them are the following:
    <bullet> The inclusion of a clearly defined action trigger in the 
final standard has served to significantly reduce the costs of the 
standard. In the preliminary economic analysis, OSHA assumed that all 
MSDs in jobs that had not yet been fixed would require job controls and 
other actions as appropriate. Under the final rule (and thus in this 
final analysis), many reports of MSDs will not trigger further action 
because they would not meet the standard's screen. Thus the screen 
serves to significantly reduce the costs of the standard.
    <bullet> In order to ensure that the economic analysis reflects the 
costs associated with implementing ergonomics programs in practice, the 
costs for most program elements have been revised upward to account for 
the extensive comments in the record on the experience of firms that 
have implemented ergonomics programs. On the other hand, the estimated 
costs to general industry employers in establishments that do not have 
MSDs have been reduced, since the final standard, unlike the proposal, 
no longer has a requirement for all establishments with manufacturing 
or manual handling jobs to have a basic program.
    <bullet> Work restriction protection (WRP) costs are substantially 
reduced overall, although the per-case costs have been increased. The 
overall decrease in WRP costs is a result of the reduced length of WRP 
coverage (from 6 to 3 months) and the effects of the screen; WRP will 
only be paid under the final rule to workers in jobs that meet the 
action trigger. In addition, OSHA agrees with comments in the record 
pointing out that OSHA's preliminary WRP cost estimates did not 
accurately reflect the full costs to the employer of WRP wage 
replacement, and the final WRP costs have been adjusted accordingly.
    <bullet> OSHA's cost estimates in the final rule also take account 
of the increase in the number of MSDs the Agency believes will be 
reported to employers as a result of the encouragement to report 
provided by WRP and the inclusion of persistent signs and symptoms in 
the standard's definition of an MSD incident.
    OSHA has not significantly changed its estimates of the unit costs 
of job controls since the proposal. OSHA believes, after a review of 
the comments and cost estimates in the record and an analysis of the 
controls needed to achieve the final rule's endpoint, that its initial 
costs-of-control estimates are reasonable.

F. Economic Feasibility (Chapter VI)

    The OSH Act requires the Agency to set standards that are feasible, 
both technologically and economically. To demonstrate that a standard 
is feasible, the courts have held that OSHA must ``construct a 
reasonable estimate of compliance costs and demonstrate a reasonable 
likelihood that these costs will not threaten the existence or 
competitive structure of an industry'' [United Steelworkers of America, 
AFL-CIO-CLC v. Marshall (the ``Lead'' decision)], 647 F2d 1189 (DC Cir. 
1980).
    OSHA's analysis of economic feasibility was conducted on an 
establishment basis. For each affected industry, estimates of per-
establishment annualized compliance costs were compared with per-
establishment estimates of revenues and per-establishment estimates of 
profits, using two worst-case assumptions about the ability of 
employers to pass the costs of compliance through to their customers: 
The no cost passthrough assumption and the full cost passthrough 
assumption. Based on the results of these comparisons, which define the 
universe of potential impacts of the ergonomics program standard, OSHA 
then assessed the final standard's economic feasibility for 
establishments in all covered industries.
    OSHA assumed that the establishments falling within the scope of 
the final standard had the same average sales and profits as other 
establishments in their industries. This assumption is reasonable 
because there is no evidence suggesting that the financial 
characteristics of those firms whose employees experience MSD incidents 
are different from firms that do not have such incidents among their 
workforce. Absent such evidence, OSHA relied on the best available 
financial data (those from the Bureau of the Census (Ex. 28-6) and 
Robert Morris Associates (Ex. 502-69)), used commonly accepted 
methodology to calculate industry averages, and based its analysis of 
the significance of the projected economic impacts and the feasibility 
of compliance on these data. For this Final Economic Analysis, OSHA 
averaged profit data for the four years 1995 to 1998 rather than using 
a single year's data. Because industry profit can show major year-to-
year variance, this modification assures that

[[Page 68781]]

the results of the analysis will not depend on a single unusually bad 
or good year for an industry,
    The analysis of the potential impacts of the ergonomics program 
standard on before-tax profits and sales shown in Table VIII-3 is 
called a screening analysis because it simply measures costs as a 
percentage of pre-tax profits and sales under the worst-case 
assumptions discussed above, but does not predict impacts on these 
before-tax profits or sales. The screening analysis is used to 
determine whether the compliance costs potentially associated with the 
final standard could lead to significant impacts on all establishments. 
The actual impact of the final standard on the profit and sales of 
establishments in a given industry will depend on the price elasticity 
of demand for the products or services of establishments in that 
industry.
    Table VIII-3 shows that the potential impacts of the final standard 
on average industry profits are small, even under the worst-case 
scenario of no cost passthrough. For all industries as a whole, 
annualized compliance costs are 0.5 percent of profits. Compliance 
costs do not exceed 5 percent of profits in any industry.
    Based on the data for establishments in all industries shown in 
Table VIII-3, OSHA concludes that the ergonomics program standard is 
economically feasible for the establishments covered by the standard. 
OSHA reaches this conclusion based on the fact that, even under the 
worst case scenario of full cost passthrough, impacts on average 
industry revenues are only 0.02 percent and under the worst case 
scenario of no cost passthrough, impacts on average profits are only 
0.5 percent, with no industry having impacts on profit of greater than 
5 percent.
    OSHA's Final Economic Analysis also examined impacts for those 
establishments most likely to be affected by the standard as a result 
of having MSD hazards, and found the standard was feasible for these 
establishments as well. (See Chapter VI of the Final Economic Analysis)
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G. Economic Impacts

    To identify possible economic impacts, OSHA compared annualized 
costs to revenues and profits for all covered establishments, for small 
entities defined as small using Small Business Administration (SBA) 
size criteria, and for all small entities with 1-19 employees (Ex. 28-
3). Costs were annualized over ten years, including the costs of 
controlling all of the MSDs projected to occur in the facility over 
that time period.
    OSHA analyzed the impacts of the final standard's annualized 
compliance costs on small entities in each 3-digit SIC industry. The 
results of this analysis are shown in Tables VIII-4 and VIII-5. OSHA's 
procedures call for the agency to conduct a Final Regulatory 
Flexibility Analysis if, in any affected sector, the impact of the 
annualized compliance costs exceeds 1 percent of revenues or 5 percent 
of profits for a substantial number of small entities. As Table VIII-4 
shows, in no 3-digit industry do the expected costs of compliance 
exceed 1 percent of revenues. However, the impact of the compliance 
costs exceeds 5 percent of profits for 1 industry, SIC 315, leather 
gloves and mittens.
    Focusing on very small establishments, Table VIII-5 shows that no 
3-digit industry has estimated costs that exceed one percent of average 
revenues. The table also shows that in no industry do impacts on 
profits exceed 5 percent.
    However, OSHA analysis in Chapter VII of the Final Economic 
Analysis shows that some small entities and very small entities in the 
most affected class, those finding MSD hazards, would have compliance 
costs exceeding 5 percent of profits.
    OSHA prepared an Initial Regulatory Flexibility Analysis as a 
follow up to convening a Small Business Regulatory Enforcement Fairness 
Act (SBREFA) Panel (the report of the Panel is in the docket of this 
rulemaking as Ex. 23). Based on the finding that in some industries the 
most affected small entities would have compliance costs exceeding 5 
percent of profits, OSHA prepared a Final Regulatory Flexibility 
Analysis, a summary of which is presented in the next section.

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H. Summary of the Final Regulatory Flexibility Analysis

    The Regulatory Flexibility Act, as amended in 1996, requires that a 
Final Regulatory Flexibility Analysis (FRFA) contain the following 
elements: \3\
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    \3\ The Regulatory Flexibility Act states that a Regulatory 
Flexibility Analysis need not contain all of the above elements in 
toto if these elements are presented elsewhere in the documentation 
and analysis of the rule. The Regulatory Flexibility Analysis 
should, however, summarize where these elements can be found 
elsewhere in the rulemaking record.
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    (1) a succinct statement of the need for, and objectives of, the 
rule;
    (2) a summary of significant issues raised by public comments on 
the Initial Regulatory Flexibility Analysis (IRFA), a summary of the 
assessment of the Agency of the issues, and a statement of any changes 
made in the proposal as a result of the comments;
    (3) a description and estimate of the number of small entities 
affected by the final standard, where possible;
    (4) a description of the reporting, recordkeeping, and other 
compliance requirements of the rule, including an estimate of the 
classes of small entities which will be subject to the requirements, 
and the type of professional skills necessary for the preparation of 
the report or record; and
    (5) a description of the steps the Agency has taken to minimize the 
significant economic impact on small entities consistent with the 
stated objectives of the applicable statutes, including a statement of 
the factual, policy, and legal reasons for selecting the alternative 
adopted in the final rule and why each one of the other significant 
alternatives to the rule considered by the Agency which affect the 
impact of the small entities was rejected.
    In addition, a Final Regulatory Flexibility Analysis must contain a 
description of any significant alternatives to the proposed rule that 
accomplish the stated objectives of the applicable statute (in this 
case the OSH Act) and that minimize any significant economic impact of 
the proposed rule on small entities. This section summarizes OSHA's 
Final Regulatory Flexibility Analysis. The full analysis, including 
responses to comments on the IRFA and a discussion of alternatives, is 
provided as part of the Final Economic and Regulatory Flexibility 
Analysis, which is Ex. 900 in the Docket.
    1. Description of the Reasons for Agency Action. OSHA is issuing a 
final Ergonomics Program Standard to address the significant risk of 
employee exposure to ergonomic risk factors in general industry 
workplaces. Exposure to ergonomic risk factors on the job leads to 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 employers, and evidence 
suggests that an even larger number of non-lost worktime MSDs occur 
every year. The purpose of this standard is to reduce the number and 
severity of MSDs caused by exposure to risk factors in the workplace.
    2. Significant issues raised by public comments on the Initial 
Regulatory Flexibility Analysis (IRFA), an assessment of the issues, 
and changes made in the proposal as a result of the comments. 
Relatively few commenters provided comment on the Initial Regulatory 
Flexibility Analysis. However commenters did raise many issues relevant 
to the regulatory flexibility analysis. Some of the principal issues 
raised by public comments that have special relevance to regulatory 
flexibility analysis, and OSHA's responses to them, are summarized in 
the remainder of this section.
    Many commenters referred to an estimate attributed to SBA that the 
costs of complying with the proposal would be 2.5 to 15 times higher 
than the Agency's estimate (see, e.g., Tr. pp. 7767-7768, pp. 5730-
5731, pp. 16005-16006, p. 9975, pp. 15668-15669, 30-2047. 30-3811, 30-
2056, 30-238, 31-326, 31-326, 30-2058). While OSHA does not agree with 
that estimate, OSHA has revised the rule in a variety of ways to make 
it less costly to small businesses. The introduction of a two part 
action trigger will have the effect of significantly decreasing the 
number of jobs small businesses will need to address through a full 
ergonomics program or a quick fix. OSHA has also increased its 
estimates of many of the unit costs for activities required in response 
to comments from businesses of all sizes and SBA.
    Many small businesses were concerned about would be the necessity 
of hiring consultants or ergonomic experts (which the standard does not 
require) (see, e.g., Exs. 30-2993, Tr. p. 15586, Exs. 30-3849, 30-3166, 
30-4334, 30-3167, 30-2993, Tr. pp. 14934, 30-3231, Tr. pp. 16935-
16936). OSHA has increased its estimate of the time that managers will 
need to understand how to implement ergonomics programs, but continues 
to believe that, with adequate training, ergonomic consultants will be 
needed for only 15 percent of all problem jobs.
    Some commenters were concerned about the differing impact of the 
final standard on large and small employers. ``Smaller businesses 
unlike large corporations do not maintain positions for health and 
safety officers * * * many small businesses will be forced to obtain 
consultations and assistance from an outside firm'' (Tr. pp. 9195-
9196). Or that small businesses ``do not have means to hire'' experts 
such as ergonomists, engineers, and doctors (Tr. pp. 9258-9259), a 
statement that was repeated by many commenters from small businesses. 
Many small businesses also stated that the complexity of the standard 
and specialized skills necessary for job hazard analysis or job 
controls would make compliance difficult. ``The vast majority of small 
businesses * * * lack the safety and health expertise necessary to 
interpret the complex standard'' (Ex. 30-4843). Other commenters found 
the standard and ergonomics too technical, too complex, or beyond their 
abilities (e.g., Exs. 30-4334, 30-1545, Tr. pp. 12770-12771, 15564-
15566). OSHA agrees that the standard may have greater impacts on small 
businesses than on large businesses. However, as Chapter VII of the 
final economic analysis demonstrates, the standard is economically 
feasible even for very small businesses and will reduce significant 
risk to small entity employees. Furthermore, in the long run, the 
standard will lead to significant reductions in the costs of workers' 
compensation and other injury related costs for many small employers.
    In terms of the regulatory approach of the proposal, some small 
business commenters urged the Agency to provide a specification type of 
standard. ``Small businesses * * * often cannot deal with that type of 
flexibility [referring to controlling hazards] and so prefer 
certainty'' (Tr. pp. 6202-6206). ``What OSHA failed to do in the 
proposed standard is give the specific steps that a small business 
owner must take to prevent MSDs. The proposed standard only gives small 
businesses a process for how they should develop their own solutions to 
the MSD problem'' (Ex. 30-1897). ``Small businesses prefer certainty 
which rule [sic] unfortunately does not provide'' (Tr. pp. 6202-6206). 
In developing the final rule, OSHA has tried to retain the flexibility 
that will reduce costs to many small employers, while adding clarity to 
many provisions. Particularly the use of the screen as part of the 
action trigger and the optional safe harbors for determining compliance 
should significantly simplify compliance for the small employer.

[[Page 68809]]

    3. An estimate of the number of small entities affected by the 
final standard. OSHA estimates that there are 4.75 million small 
establishments in general industry affected by the rule. The final 
standard covers an estimated 4.2 million very small entities (i.e., 
those employing fewer than 20 employees).
    4. Reporting, recordkeeping, and other compliance requirements of 
the rule, including an estimate of the classes of small entities which 
will be subject to the requirements and the type of professional skills 
necessary for the preparation of the report or record. Table VII-6 
summarizes the compliance requirements of the rule, which types of 
small entities they apply to, the expected burden requirements, and the 
types of professional skills needed.
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    5. Steps the Agency has taken to minimize the significant economic 
impact on small entities. The final standard contains many elements 
that will reduce burden on small entities as compared with the 
proposal. The scope of the standard is simplified. All employers must 
provide basic information to employees, and there are no special 
obligations for employers with employees engaged in manufacturing or 
manual handling operations. Employers will need less time and effort to 
determine how they are affected by the scope of the rule. In the 
appendices to the standard, OSHA has provided material that employers 
can use to meet this requirement, further reducing the burden of the 
rule. The Agency has also kept an MSD trigger mechanism, and has added 
a screen. Employers do not need to do anything beyond provide 
information to employees unless an MSD incident in a job that meets the 
screen. The addition of the screen serves both to simplify 
decisionmaking for small employers and to target the rule toward high 
risk jobs. For employees in jobs meeting the action trigger, employers 
must provide a quick fix or initiate an ergonomics program. In 
addition, the employer need not control the job unless MSD hazards are 
found during the job hazard analysis. Employers may meet their job 
hazard analysis and control obligations in any one of a variety of 
ways. The addition of clearer compliance endpoints will reduce employer 
uncertainty about whether they are in compliance with the rule. 
Finally, an employer can cease having a program at any time the risks 
in the job are lowered so that the job no longer meets the screen.
    Establishments with fewer than 11 employees do not have to keep 
records. Where a job hazard analysis or job controls are necessary, 
employers do not have to hire a professional ergonomic consultant. The 
Agency will also supply compliance guides for small businesses and a 
Web-based expert system to guide employers through the applicability of 
the final standard. The Agency has provided flexibility in choosing 
controls to reduce MSD hazards, including administrative controls along 
with engineering and work-practice controls. Finally, the Agency is 
permitting existing ergonomic programs to be grandfathered and 
considered in compliance with the standard as long as the existing 
program meets the requirements in paragraph (c).
    The principal reasons that the Agency has made its revisions for 
the final standard are to make the final standard less costly, more 
cost-effective, and still achieve the goal of employee protection. 
These revisions will help all employers, including small employers.

Alternatives to the Proposed Standard

    In the Final Regulatory Flexibility Analysis, OSHA considered 
alternatives with respect to voluntary action, alternative scope 
provisions, alternative trigger provisions, alternative work 
restriction protection provisions and other approaches to the rule 
making such as exempting small or low hazard employers. SBA's Office of 
Advocacy (Ex. 601-X-1) urged OSHA to consider exempting low hazard 
industries, and exempting small firms from WRP. OSHA believes that the 
new two part action trigger is a superior means of focusing the rule's 
obligation on high hazard work situations, while maintaining employee 
protection. The action trigger serves to assure that employers do not 
need to try to fix low hazard jobs. Further, this approach does this in 
a way that assures that even small firms in high hazard industries will 
not need to fix their low hazard jobs, while workers in the occasional 
high hazard job in a low hazard industry receive the protection they 
need. Exempting small businesses from WRP would remove needed 
protections for employees in small businesses. The Agency's analysis 
found that those alternatives that significantly alleviated the impact 
on small businesses more than OSHA's final standard did not provide 
adequate protection to worker health and safety. Many of the 
alternatives to specific provisions, such as WRP, are also discussed in 
the Preamble in the sections describing these provisions.

IX. Unfunded Mandates

    OSHA reviewed the final ergonomics program standard in accordance 
with the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et 
seq.). As discussed above in the Summary of the Final Economic Analysis 
(Section VIII of the preamble), OSHA estimates that compliance with the 
final ergonomics program standard will require the expenditure of 
approximately $4.0 billion each year by employers in the private 
sector. Therefore, the final ergonomics program standard establishes a 
federal private sector mandate and is a significant regulatory action, 
within the meaning of Section 202 of UMRA (2 U.S.C. 1532). OSHA has 
included this statement to address the anticipated effects of the final 
ergonomics program standard pursuant to Section 202.
    OSHA standards do not apply to state and local governments, except 
in states that have voluntarily elected to adopt an OSHA State Plan. 
Consequently, the final standard does not meet the definition of a 
``Federal intergovernmental mandate'' (Section 421(5) of UMRA (2 U.S.C. 
658(5)).
    This final rule was proposed under Section 6(b) of the OSH Act. The 
final ergonomic program standard will prevent 4.6 million MSDs over the 
next 10 years. The final ergonomics program standard will lead to $558 
million per year in costs on state, local or tribal governments. OSHA 
pays 50 percent of State plan costs but does not provide funding for 
state, local or tribal governments to comply with its rules.
    OSHA does not anticipate any disproportionate budgetary effects 
upon any particular region of the nation or particular state, local, or 
tribal governments, or urban or rural or other types of communities. 
Chapters V and VI of the economic analysis provide detailed analyses of 
the costs and impacts of the final rule on particular segments of the 
private sector. OSHA has analyzed the economic impacts of the rule on 
the affected industries and found that compliance costs are, on 
average, only 0.05 percent of sales, and that few, if any, facility 
closures or job losses are anticipated in the affected industries. As a 
result, impacts on the national economy would be too small to be 
measurable by economic models.
    The anticipated benefits and costs of this final standard are 
addressed in the Summary of the Final Economic Analysis (Section VIII 
of this preamble), above, and in the Final Economic Analysis (Ex. 900). 
In addition, pursuant to Section 205 of the UMRA (2 U.S.C. 1535), 
having considered a reasonable number of alternatives as outlined in 
this preamble and in the economic analysis (Ex. 900), the Agency has 
concluded that the final standard is the most cost-effective 
alternative for implementation of OSHA's statutory objective of 
substantially reducing or eliminating a significant risk of material 
impairment. This is discussed at length in the economic analysis (Ex. 
900) and in the Summary and Explanation (Section IV of this preamble) 
for the various provisions of the final ergonomics program standard.

X. Environmental Impact Statement

    Pursuant to the National Environmental Policy Act, the Department 
of Labor has issued regulations to determine when an environmental 
impact statement is required in a rulemaking proceeding. Section 29 CFR 
Sec. 11.10(a)(3) states:

    Preparation of an environmental impact statement will always be 
required for

[[Page 68819]]

proposals for promulgation, modification or revocation of health 
standards which will significantly affect air, water, soil quality, 
plant or animal life, the use of land and other aspects of the human 
environment.

    In the preamble to the proposed rule, the Agency stated that no 
environmental impact statement would be required for this rule because 
it does not meet the criteria set forth in 29 CFR Sec. 11.10(a)(3), as 
stated above. OSHA received one comment disagreeing with this 
determination. The commenter (Ex. 500-221) suggested that employer 
compliance activities associated with the proposed Ergonomics Program 
Standard would have the potential to cause enormous environmental 
impacts. The commenter also suggested that the proposed standard would 
increase the demand for electricity by encouraging workplace 
automation; increase the consumption of natural resources by 
encouraging employers to use greater numbers of smaller product 
containers; and impair air quality by encouraging delivery vehicles to 
remain at idle while employees manually move smaller loads per trip. 
Finally, the commenter asserted that the proposed standard would 
encourage automation of trash collection and waste disposal operations, 
and would discourage recycling.
    OSHA notes that the final standard requires employers to control 
problem jobs by modifying the conditions under which the work is 
performed, including such changes as workstation modification, redesign 
of tools, and job rotation. The final standard also requires employers 
to develop ergonomic programs that involve such elements as assessment 
of problem jobs, modification of jobs to reduce MSD hazards, employee 
training, and MSD management.
    Ergonomics-related job modifications typically result in greater 
production efficiencies without the need for additional natural 
resources or the increased discharge of pollutants. As several 
ergonomists testified at the hearings (David Alexander, Tr. Pp 2142-53, 
2369-72 and Dennis Mitchell, Tr. Pp 2366-68) ergonomic modifications 
typically involve mechanization (e.g. the use of carts, shelves, 
adjustable workstations, etc.) and only rarely involve automation (the 
replacement of people by machines.) Automation is a rarely-used 
approach unless the employer considers that process efficiency will be 
improved. The likelihood is that updated, more energy-efficient 
production equipment will actually lead to a decrease, not an increase, 
in energy consumption. In the trash collection and recycling 
industries, automation and mechanization are increasing because of 
factors that long predate issuance of this final rule. Mechanization 
and automation in those industries are likely to produce greater 
efficiencies and lower costs as well as reducing the risks and costs of 
employee injuries. OSHA disagrees with the commenter's assertion that 
recycling would be abandoned on a large scale as a result of OSHA's 
standard on ergonomics programs; by necessity or law, most local 
jurisdictions in the U.S. have now committed themselves to recycling.
    OSHA believes the claims of adverse environmental effects asserted 
by the commenter are highly speculative, and fail to make a plausible 
case that the final Ergonomics Program Standard will significantly 
affect the human environment. Moreover, none of the impacts predicted 
by the commenter takes into account any of the environmental benefits 
that might result from ergonomics-related job modifications, such as 
productivity increases and waste reduction. Accordingly, OSHA concludes 
that the final rule will not result in significant environmental 
impacts and, therefore, an environmental impact statement is not 
required.

XI. Additional Statutory Issues

1. Fair Notice

    Numerous commenters contend that various terms used in the proposed 
standard are unduly vague and fail to provide fair notice of what the 
standard requires. For example, the American Iron & Steel Institute 
asserts that the proposal ``is not written in language that can 
reasonably be understood by those who must comply with it.'' Ex. 32-
206-1. Morgan, Lewis & Bockius believes that several provisions of the 
proposal ``are unworkably vague in their current state.'' Ex. 30-4467 
at p. 6. Organization Resources Counselors, Inc. (ORC) states that the 
proposal contains an ``excess of complex terms and definitions.'' Ex. 
32-78-1 at p. 5. Similar objections were raised by the Edison Electric 
Institute (Ex. 32-300-1 at p. 6); the Integrated Waste Service 
Association (Ex. 22-337-1 at p. 8); the National Coalition on 
Ergonomics (Ex. 32-368-1 at pp. 126-29); the Chamber of Commerce (Ex. 
30-1722 at pp. 24-25 & Ex. 500-188 at pp. 66-69); the Forum for a 
Responsible Ergonomics Standard (Ex. 30-3845 at pp. 26-29); and 
numerous others. Among the phrases in the proposal the commenters 
assert were overly vague are ``eliminate or materially reduce the MSD 
hazards;'' ``significant amount of the employee's worktime;'' 
``repeated exposure;'' ``core element;'' ``no cost to employee;'' 
``employer commitment;'' ``employee participation;'' ``ergonomic 
hazard;'' ``persistent MSD symptoms;'' ``forceful lifting/lowering;'' 
``problem job;'' ``common sense determination;'' ``ergonomic risk 
factors;'' ``OSHA recordable MSD;'' ``reasonably likely to cause or 
contribute to the type of MSD reported;'' ``cold temperatures;'' 
``dynamic motion;'' ``awkward posture;'' ``static posture;'' and 
``reduce to the extent feasible.'' E.g., Ex. 32-368-1 at p. 126 & Ex. 
500-197 at pp. III-3-18 (NCE); Ex. 32-206-1 at pp. 13-14 (American Iron 
& Steel Institute); Ex. 32-241-4 at pp. 166-80 (Anheuser-Busch and 
United Parcel Service).
    Some of the same commenters, as well as others, object to what they 
characterize as the proposal's ``one size fits all'' approach. E.g., 
Ex. 30-3845 at p. 37 (Forum for a Responsible Ergonomics Standard); Ex. 
32-368-1 at p. 72 (NCE); Ex. 30-3077 at p. 1 (National Tooling and 
Machining Association); Ex. 30-2993 at p. 2 (Small Business Legislative 
Council). They believe it is inadvisable for OSHA to issue a standard 
that applies to a wide variety of different industries because 
conditions pertinent to ergonomics vary widely among industries.
    The reason OSHA included general language, such as the phrases the 
commenters contend are too vague, in the proposed standard was to avoid 
the very ``one size fits all'' approach to which some of the same 
commenters and many others object. Because of the numerous variables 
that can result in work-related MSDs, OSHA drafted the proposed rule in 
flexible, performance-oriented language to enable employers to develop 
ergonomics programs tailored to their workplaces, rather than 
attempting to prescribe, for example, the specific manner in which 
employers should control an MSD hazard. As a result, the proposal used 
a number of general phrases to allow employers the maximum amount of 
flexibility consistent with the standard's goal of reducing MSDs.
    In response to the numerous comments that criticized the proposed 
standard as being unduly vague, OSHA has made a number of changes to 
the final standard that are designed to give additional guidance as to 
what the standard requires of employers. Some of the complaints most 
frequently voiced in the comments--that employer obligations are not 
defined with sufficient clarity--are addressed by (1) changing the 
scope of the standard to no longer require employers to determine 
whether their employees are engaged in ``manual handling'' or 
manufacturing;

[[Page 68820]]

(2) including an objective Action Trigger for determining whether an 
employer must fix a job in which an employee has reported a MSD 
incident; and (3) establishing compliance endpoints that will enable 
employers to tell with certainty whether they have taken sufficient 
steps to fix a problem job. As a result of these changes, certain 
phrases that commenters claimed were too vague, such as ``significant 
amount of the employee's worktime,'' ``core element of the job,'' and 
``forceful lifting/lowering'' are no longer used. The changes to the 
final rule, and the reasons for them, are discussed in the Summary and 
Explanation section of this preamble. Although the final rule contains 
greater specificity than the proposal, OSHA believes that the final 
rule still gives employers sufficient flexibility to develop ergonomics 
programs that are suited to the particular characteristics of their 
workplaces.
    OSHA believes that this final rule provides fair notice to 
employers of their obligations. On its face, it provides persons of 
ordinary intelligence a reasonable opportunity to understand the 
conduct it prohibits or requires. See Hill v. Colorado, 120 S.Ct 2480, 
2498 (2000). Moreover, in addition to the language of the standard and 
the further guidance provided by this preamble, other sources will be 
available to help employers determine their compliance obligations. 
OSHA intends to make compliance assistance conveniently available to 
the public, both through its website (www.osha.gov) and through printed 
publications. Among the compliance assistance materials will be a small 
entity compliance guide, as required by the Small Business Regulatory 
Enforcement Fairness Act of 1996, specifically designed to inform small 
businesses of their obligations under the rule in language that is 
readily understandable. Employers and employees will also be able to 
look to guidelines that have proven successful in averting MSDs in 
specific industries, such as the red meat guidelines. Ex. 2-13. OSHA-
funded consultation services through state agencies will be available 
to qualifying employers who request it. And personnel in OSHA's 
national and field offices will be available to answer questions about 
the standard. OSHA also encourages trade associations and other 
business organizations to disseminate information, such as case studies 
of successful ergonomic interventions by employers in their industries, 
that will help facilitate compliance with the standard by their 
members.

2. OSHA's Past Enforcement Efforts

    In the NPRM, OSHA noted that it had gained experience over the 
years in addressing ergonomic issues through a variety of means, 
including enforcement, consultation, training and education, compliance 
assistance, the Voluntary Protection Programs, and issuance of 
voluntary guidelines. 64 FR at 65774. In the area of enforcement, the 
agency had successfully issued over 550 ergonomics citations under the 
OSH Act's General Duty Clause, section 5(a)(1). Id. Almost all of these 
citations, the agency observed, had led to the implementation of 
ergonomics programs by the cited employers, included some corporate-
wide programs developed pursuant to settlement agreements. Id.
    The Chamber of Commerce criticizes OSHA for not mentioning cases 
where, in the Chamber's words, OSHA's enforcement efforts ``abjectly 
failed.'' Ex. 30-1722 at p. 7. The Chamber states that OSHA lost the 
``only three enforcement actions that were actually tried to 
completion,'' citing Pepperidge Farm, 17 O.S.H. Cas. (BNA) 1993 (Rev. 
Comm'n, 1997); Dayton Tire, Division of Bridgestone/Firestone, Inc., 
1998 WL 99288 (ALJ, 1998); and Beverly Enters., 1994 WL 693958 (ALJ, 
1995), review directed (Nov. 9, 1995), decided by the Commission (Oct. 
27, 2000). Ex. 30-1722 at pp. 7-8. See also Ex. 500-197 at Ex. III-C, 
E. Scalia, OSHA's Ergonomics Litigation Record Three Strikes and It's 
Out, cato inst. No. 391. These cases, the Chamber contends, 
``demonstrate the futility of promulgating a mandatory ergonomics 
program standard, and underscore OSHA's failure to understand the state 
of the scientific evidence and its legal authority.'' Ex. 30-1722 at p. 
10. Similarly, the NCE asserts that litigation of ergonomics citations 
under the general duty clause demonstrates OSHA's inability to garner 
sufficient scientific evidence to support an ergonomics rule. Ex. 32-
368-1 at p. 14.
    Contrary to the Chamber's contentions, OSHA has not ``lost'' the 
only three ergonomics cases tried to completion. In the case of Beverly 
Enters., the ``loss'' to which the Chamber refers was an adverse 
administrative law judge's decision that was under review by the 
Commission when the Chamber submitted its comments. The Commission has 
since, in a decision issued on October 27, 2000, reversed the 
administrative law judge's decision and held that the company's 
practices for lifting patients in its nursing homes exposed its nursing 
assistants to a serious recognized hazard. The Commission decision in 
Pepperidge Farm held that the company's employees were exposed to 
recognized lifting and repetitive motion hazards. In Dayton Tire, OSHA 
received an adverse decision from the administrative law judge and 
decided the case did not present a proper vehicle for appeal. The final 
order in Dayton Tire is therefore an unreviewed administrative law 
judge's decision and lacks precedential value. United States v. Sturm, 
Ruger & Co., 84 F.3d 1, 5 n. 4 (1st Cir.1996); Matter of Establishment 
Inspection of Cerro Copper Prods. Co., 752 F.2d 280, 284 (7th Cir. 
1985); Leone Constr., 3 O.S.H. Cas. (BNA) 1979, 1981 (Rev. Comm'n 
1976).
    The Chamber contends that the ``unfavorable'' decisions in these 
three cases undermine the scientific basis for ergonomics regulation 
and hence for this rule. To the contrary, OSHA believes that the 
decisions in Beverly and Pepperidge Farm support both the need for and 
the scientific basis of this rule. They demonstrate that, even under 
the heavy burden of proof OSHA bears in general duty clause litigation, 
the preponderance of the credible evidence shows that workplace 
exposures cause MSDs, that employers recognize this, and that serious 
injuries result from these exposures.
    The Chamber also cites testimony of OSHA witnesses in these cases, 
along with deposition testimony from Hudson Foods, a case that was 
ultimately settled, to attempt to show that experts engaged by OSHA 
cannot state with certainty the degree of risk caused by exposure to 
different levels of ergonomic stressors (Ex. 30-1722 at pp. 26-27, 47); 
that OSHA compliance officers are unqualified to evaluate the health 
risk from ergonomic stressors (Ex. 30-1722 at pp. 28, 64); that experts 
are unable to define with precision terms such as ``awkward posture,'' 
``high force,'' and ``long periods of standing'' (Ex. 30-1722 at pp. 
64-69); that two OSHA expert witnesses in Dayton Tire did not offer 
consistent definitions of the stressors in certain jobs (Ex. 30-1722 at 
p. 69); and that OSHA experts were unable to testify to the 
effectiveness of abatement measures (Ex. 30-1722 at pp. 72-73).
    The Chamber's reliance on selected testimony in these cases does 
not undermine the scientific basis for this final rule. First, as the 
Commission decisions in Beverly and Pepperidge Farm show, the evidence 
in those cases supports OSHA's decision to address ergonomic hazards in 
this final rule. Second, even if reasonable experts differ over the 
nature of ergonomic risks or cannot precisely quantify those risks, 
OSHA is not precluded from issuing a

[[Page 68821]]

rule. ``OSHA is not required to support its finding that a significant 
risk exists with anything approaching scientific certainty.'' Benzene, 
448 U.S. at 656. As long as its findings are supported by a body of 
reputable scientific thought, OSHA may use conservative assumptions in 
interpreting the evidence and risk error on the side of overprotection 
rather than underprotection. Id. See also American Dental Ass'n v. 
Martin, 984 F.2d 823, 827 (7th Cir.), cert. denied, 510 U.S. 859 (1993) 
(``OSHA was required neither to quantify the risk to workers health nor 
to establish the existence of significant risk to a scientific 
certainty.''). Certainly, the record of this rulemaking contains 
conflicting evidence on the issues the Chamber raises, such as the 
relationship between ergonomic stressors and MSDs. However, given the 
high number of MSDs workers have been suffering and continue to suffer, 
OSHA does not believe that the lack of a consensus among knowledgeable 
experts justifies further delay in the issuance of a rule that is 
needed to protect workers against such ailments. In addition, there is 
a substantial body of scientific evidence to support the promulgation 
of an ergonomics standard.
    Because the Chamber and other rulemaking participants have argued 
that Pepperidge Farm and Beverly undermine the basis for this rule, a 
brief discussion of those cases is appropriate.
Pepperidge Farm
    In Pepperidge Farm, the Commission held that the employer willfully 
violated the OSH Act in requiring its employees to perform hazardous 
lifts, which caused them to suffer high rates of serious MSDs. The 
administrative law judge found that the employer's manual lifting 
tasks, which required the lifting of objects weighing up to 165 pounds, 
were hazardous, that the company recognized the hazard, and that 
feasible means of abating the hazard existed. 17 O.S.H. Cas. (BNA) at 
2003. The employer did not dispute before the Commission the ALJ's 
findings that the lifting tasks were hazardous and that abatement was 
feasible, but argued that it did not recognize the hazard. The 
Commission rejected the argument, finding that Pepperidge Farm 
recognized the hazard based on recommendations by its worker's 
compensation carrier and its own corporate ergonomist. Id. at 2003-07. 
Thus, Pepperidge Farm illustrates, as OSHA has found in this 
rulemaking, that repetitive lifting of heavy objects is hazardous and 
that feasible means that will prevent or materially reduce the hazard 
are available.
    The Commission also agreed with OSHA that repetitive motion 
assembly line tasks posed a recognized hazard. 17 O.S.H. Cas. (BNA) at 
2010. Over a three-year period, 28 employees engaged in repetitive 
motion tasks had undergone 42 separate surgical procedures, including 
32 carpal tunnel releases. Id. at 2015. Based on this evidence and on 
testimony about the rate of carpal tunnel syndrome in the general 
population, the Commission found that the incidence of carpal tunnel 
injury caused by repetitive motions performed at the plant was 
``substantially in excess of that found in other populations, including 
other populations of workers.'' Id. at 2029. The Commission relied on 
expert testimony, evidence of biological plausibility, and 
epidemiological studies, to find that the high rate of MSDs suffered by 
the employees was caused by their work on the assembly line. Id. at 
2028-29. The Commission also held that the employer recognized the 
hazard posed by the repetitive motions because the company's own 
medical staff attributed the cause of employee disorders to the tasks 
performed at the facility. Id. at 2030. And, the Commission held that 
the upper extremity musculoskeletal disorders resulting in surgery, 
disability, and restricted work suffered by employees from their 
assembly line tasks ``clearly involved serious physical harm.'' Id. at 
2032. The actual hazard posed to employees from the highly repetitive 
work, as opposed to a potential hazard, was thus not ``benign,'' as 
claimed by one writer. Ex. 500-197 at p.12.
    Finally, the Commission accepted OSHA's position that Pepperidge 
Farm was required to follow a process of abatement to eliminate or 
materially reduce the hazard. 17 O.S.H. Cas. (BNA) at 2034-35. The 
Commission agreed with OSHA on the core components of such a process--
``accurate record keeping, medical treatment for injured employees, 
workplace analysis to assess the potential hazard and steps to abate 
it, education and training of workers and management, and further 
actions, to the extent feasible, to materially reduce the hazard.'' Id. 
at 2034. Under this process, the employer would determine ``precisely 
what particular mix of engineering and administrative controls most 
efficiently reduces the [hazard].'' Id. at 2033. The Commission found 
that Pepperidge Farm had in fact followed such a process by 
implementing a number of engineering and administrative controls and 
taking the other process steps recommended by OSHA. Id. at 2034-38. The 
Commission concluded that the evidence did not show that the steps 
taken by the company were inadequate and therefore held that Pepperidge 
Farm had fulfilled its duty under the general duty clause with respect 
to the repetitive motion hazards. Id. at 2040-41.
Beverly Enterprises
    In Beverly Enterprises, OSHRC No. 91-3344 et al., (Rev. Comm'n, 
Oct. 27, 2000), the nursing assistants (NA's) the company employed in 
its nursing homes were required to lift patients manually and, in many 
cases, without assistance. Those employees suffered a disproportionate 
number of cases of lower back pain (LBP), 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. Slip. op. at 16. The administrative 
law judge concluded that OSHA had not proven that the cases of LBP were 
caused by Beverly's lifting practices. The ALJ therefore vacated the 
citation for lack of proof of a hazard.
    The Commission reversed the ALJ's decision. The Commission 
extensively examined the evidence showing that the nurses aides were 
exposed to the risk of contracting LBP from their lifting activities. 
The evidence included: (1) The high rate of lost-time cases of LBP 
suffered by Beverly's NA's; (2) evidence of biomechanical modeling, 
which evaluated the compressive force imposed by lifts of various 
weights and body positions on the lower back and calculated the 
percentage of the working population that could safely perform such 
lifts; (3) the NIOSH lifting equation, a formula developed for NIOSH 
for determining a safe level of lift based on data compiled by various 
researchers on the biomechanical, epidemiological, psychophysical, and 
physiological bases for LBP; and (4) epidemiological studies showing a 
correlation between patient lifting and LBP in populations of health 
care workers. The Commission concluded:

    We find on the scientific evidence presented that manual lifting 
of residents is a known and recognized risk factor for LBP. 
Considering also the evidence showing that the frequency and manner 
in which Beverly's NA's performed their assigned tasks exposed them 
to compressive forces in excess of limits well-established and 
accepted in the scientific community, and that Beverly's working 
conditions resulted in numerous lost-time incidents and prevented 
Beverly's NA's from performing their usual daily activities, we 
conclude that the manual lifting of residents was shown on this 
record to be a hazardous work practice and that Beverly controls the 
methods used to perform the lifting.


[[Page 68822]]


Slip op. at 52.
    The Commission further found that Beverly recognized the hazard. 
Among other evidence, the Commission noted that Beverly had adopted a 
``Lift with Care'' program, which referred to the NIOSH limits for safe 
lifting and taught its NA's how to lift patients in a way that would 
reduce the likelihood both of injury to the resident and back injury to 
the NA. Id. at 53, 59-60. In addition, Beverly knew its NA's were 
suffering high rates of LBP from its workers' compensation claims; that 
failure to use correct lifting techniques is one cause of back injury; 
and that its nursing homes did not have enough mechanical hoists to 
ensure that such equipment was available when necessary. Id. at 54-55. 
Finally, the Commission relied on testimony showing that experts 
familiar with the nursing home industry perceive lifts such as those 
performed by Beverly to be hazardous. Id. at 62.
    The Commission found that the hazard was likely to cause serious 
physical harm. ``LBP has a substantial and significant effect on the 
affected employees'' ability to perform their normal activities and 
effectively disables employees for periods of time which are extensive 
in some instances. We conclude that in view of the debilitating effect 
on employees and the potential duration of the disability, LBP is 
properly considered serious physical harm.'' Id. at 68.
    The parties disputed before the Commission whether OSHA had proven 
the feasibility and likely utility of abatement measures. Since the 
administrative law judge had not made factual findings on that issue, 
the Commission remanded the case for such findings. Id. at 72-73.

Settlements of General Duty Clause Citations

    The Chamber of Commerce takes issue with OSHA's claim in the NPRM 
(64 Fed. Reg. at 65774) that the settlement agreements that resolved 
most of the contested General Duty Clause citations showed the success 
of OSHA's enforcement efforts and the efficacy of ergonomics programs. 
Ex. 30-1722 at pp. 10-12. The Chamber says that employers settle 
ergonomic citations to avoid the prospect of expensive litigation, and 
that OSHA therefore cannot conclude that ``those employers ergonomics 
programs will in fact reduce injury in the workplace, and that, in the 
absence of OSHA's interventions, the employees in question would have 
been without protection.'' Id. at 10-11. OSHA continues to believe, 
contrary to the Chamber's assertion, that the settlement agreements are 
highly significant. While avoidance of the time and expense of 
litigation undoubtedly entered into those employers' decisions to 
settle, they nevertheless agreed to put forth substantial efforts to 
reduce or eliminate the hazards for which they had been cited. For 
many, the agreements went far beyond the cited locations to other 
corporate facilities not visited by OSHA and, therefore, far beyond any 
abatement orders OSHA might have obtained in litigation.
    Those agreements and resulting efforts were clearly successful. As 
noted in the proposed rule preamble, OSHA held a workshop in March 
1999, in which ten 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 MSD's since implementing the programs defined in 
their agreements. Ex. 26-1420. Most companies reported lower workers' 
compensation costs, as well as higher productivity and product quality. 
Id. Only five of the 13 companies involved in these agreements 
consistently reported the number of MSD cases or MSD case rates, and 
all five 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.
    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 agreement 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 gave a number 
of examples illustrating the efficacy of these agreements and resulting 
programs. One was that of IBP's Dakota City meatpacking plant, which 
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] worker's compensation costs were reduced 
significantly.'' Id. at 9.
    The Chamber of Commerce asserts that a settlement agreement with 
Hudson Foods is an example of a case that the employer settled despite 
palpable weaknesses in OSHA's evidence. Ex. 30-1722 at pp. 11-12. The 
Chamber suggests that OSHA settled for little to get out of litigation 
that was not going well. In fact, OSHA had developed strong evidence to 
support the citations and was fully prepared to go to trial if 
necessary. See generally OSHA's Reply to Hudson Foods. Inc.'s Motion to 
Exclude Expert Testimony, Secretary v. Hudson Foods, Inc., dated April 
30, 1999 (OSHRC Docket No. 98-0079)(Ex. 502-26). However, OSHA was 
willing to settle because the settlement secured all of its objectives. 
Hudson, which was purchased by Tyson Foods, Inc. after OSHA's 
inspection, but before the settlement, withdrew its notice of contest 
to the ergonomic allegations contained in the citations, paid a total 
penalty of $200,000 for all citations, and, most importantly, agreed to 
implement the comprehensive, existing Tyson Foods ergonomics program 
that the parties anticipated would abate the violations. Ex. 502-42, 
pp. 3-5, Exhibits ``A'' and B''. With this hazard recognition and gain 
in employee safety and health, continued litigation over a larger 
penalty was pointless. The exculpatory language cited by the Chamber 
was acceptable in light of the intervening purchase of Hudson by Tyson 
Foods, which had not caused the cited conditions and had displayed good 
faith through its own implementation of a comprehensive ergonomics 
program. Ex. 30-4137, p. 1.

OSHA's Red Meat Guidelines

    In addition to OSHA's enforcement efforts, many knowledgeable 
witnesses agreed that the agency's Ergonomics Program Management 
Guidelines for Meatpacking Plants (``Red Meat Guidelines'') (Ex. 2-13) 
have resulted in implementation of successful workplace programs 
addressing ergonomic hazards. For example, in contrasting OSHA's 
proposal to the Red Meat 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, 
operating 559 facilities, acknowledged that the industry worked with 
OSHA on the Red Meat Guidelines and has been using them for nearly ten 
years. Ex. 30-3677, p. 1. The AMI notes that the Red Meat Guidelines 
work and that the industry has made substantial progress in addressing 
ergonomic issues since

[[Page 68823]]

development of the Guidelines. Id. at 1-4. The AMI recommends that the 
Guidelines be extended throughout general industry. Id. at 4. The 
utility of OSHA's Red Meat Guidelines was also 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 ergonomic programs. Ex. 32-210-2, pp. 25-26. The 
success of the Guidelines led to use and acceptance in other 
industries. The poultry industry appears to have secured substantial 
reductions in chronic MSD's from adherence to the principles in the 
document (Ex. 30-3375, p. 1).

Enforcement Actions and Compliance Costs

    Some commenters (e.g., Anheuser-Busch and United Parcel Service, 
Ex. 32-241-4 at pp. 259-266 and the National Coalition on Ergonomics et 
al., Ex. 500-197 at pp. II-79-84) contend that OSHA's compliance cost 
estimates ignore the way the agency has enforced ergonomic requirements 
under section 5(a)(1). The commenters assert that OSHA's estimated 
costs of compliance with the ergonomics standard are far lower than the 
costs of the controls OSHA has ``demanded'' in 5(a)(1) enforcement 
actions.
    This argument lacks a factual foundation because it is unsupported 
by any evidence of the abatement costs associated with the section 
5(a)(1) ergonomics citations. In any event, OSHA does not believe those 
costs are extravagant. In many cases, the abatement measures sought by 
OSHA were already being used by similarly-situated employers. In Hudson 
Foods, as discussed above, the settlement agreement simply required 
Hudson to adopt the ergonomics program of its new owner, Tyson Foods. 
In Pepperidge Farm, abatement of the lifting violations found by the 
Commission required the company to do no more than its own corporate 
ergonomist had recommended. 17 O.S.H. Cas. (BNA) at 2004-06. Similarly, 
the process for abating the repetitive motion hazards that Pepperidge 
Farm had already been following was found by the Commission to meet its 
duty to implement a feasible means of abatement. Id. at 2039-41. Thus, 
the citations in Pepperidge Farm did not require the employer to take 
additional steps beyond those it was already taking.
    Moreover, these arguments reflect a fundamental misunderstanding of 
the significance of abatement requirements in 5(a)(1) citations and on 
a mistaken belief that employers who received section 5(a)(1) citations 
are typical of the employers who will have duties under this standard. 
Section 5(a)(1) comes into play when there is a serious recognized 
hazard in an employer's workplace that need not be abated under a 
specific standard. In order to prove an employer violated section 
5(a)(1), OSHA must prove that a recognized hazard that is likely to 
cause death or serious physical harm exists in the employer's 
workplace. Nelson Tree Srvs v. OSHRC, 60 F.3d 1207, 1209 (6th Cir. 
1995). OSHA must also specify a means by which the employer can 
eliminate or materially reduce the hazard and demonstrate the 
feasibility and likely utility of those means. Id. OSHA can not, 
however, ``demand'' that an employer abate a 5(a)(1) violation in any 
particular way. The employer is not limited to using the means listed 
in the citation to eliminate or materially reduce the hazard but is 
free to use any means that accomplishes that goal. See OSHA Field 
Inspection Reference Manual, Ch. A.4.f(2) (``the employer is not 
limited to the abatement methods suggested by OSHA.''); Marshall v. 
B.W. Harrison Lumber Co., 569 F.2d 1303, 1308 (5th Cir. 1978). An 
employer will generally have more detailed knowledge of its operations 
and processes than OSHA will gain during a relatively brief inspection 
of the workplace and may therefore be able to devise methods of 
eliminating ergonomics hazards that are more cost effective than those 
proposed by OSHA. As a result, the costs associated with the means of 
abatement listed in a citation, even if those costs were quantified in 
this record, may well be higher than those the employer will actually 
incur.
    For additional reasons as well, the costs associated with section 
5(a)(1) citations cannot be used to calculate the costs of this 
standard. The employers who have been cited for 5(a)(1) ergonomics 
violations are not representative of the universe of employers who will 
have compliance duties under the standard. As noted above, to sustain a 
5(a)(1) citation, OSHA must be able to prove not only that a hazard is 
present but that the hazard is one that is recognized by the employer 
or its industry and is likely to cause death or serious physical harm. 
Because of this heavy burden of proof, OSHA has only issued 5(a)(1) 
citations for ergonomic violations to a relatively small number of 
employers, and those employers have been cited because their employees 
had been suffering unusually high rates of work-related MSDs. And 
because the employers cited under 5(a)(1) had particularly severe 
ergonomics problems, their compliance costs would not be representative 
of the costs the average employer will incur in complying with the 
standard.
    Moreover, the existence of an ergonomics standard will help reduce 
compliance costs compared to enforcement of ergonomics protection under 
section 5(a)(1). It has frequently been observed that reliance on 
standards is preferable to enforcement under section 5(a)(1) because 
standards spell out employer duties more specifically than does section 
5(a)(1). E.g., St. Joe Minerals Corp. v. OSHRC, 647 F.2d 840, 846 n.13 
(8th Cir. 1981); B & B Insulation, Inc. v. OSHRC, 583 F.2d 1364, 1371 & 
n.12 (5th Cir. 1978). That is true of this final rule. For example, 
unlike section 5(a)(1), this rule establishes safe harbors that will 
enable employers to know with a high degree of certainty when they have 
fulfilled their compliance obligations. By providing better notice of 
employer duties than does section 5(a)(1), the standard will promote 
the efficient use of employer resources and thereby help minimize 
costs.
3. Cost-effectiveness.
    All OSH Act standards must be cost effective. Cotton Dust, 453 U.S. 
at 514 n. 32. 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. Id.; Lockout/Tagout II, 37 F.3d 
at 668.
    OSHA has taken a number of steps to ensure that this final rule is 
cost-effective. First, the rule allows employers with problem jobs to 
use any combination of engineering, administrative, and work practice 
controls to control the MSD hazards. Therefore, from the entire range 
of controls that would be potentially effective in an employer's 
workplace, the employer is able to select those that are the least 
costly.
    The standard also ensures the cost-effective use of employer 
resources by focusing employers' compliance resources where they will 
do the most good: on those jobs that are demonstrably causing MSDs. It 
requires all covered employers to provide basic information about MSDs 
to its employees, but only those employers whose employees experience 
MSD incidents in jobs that meet the standard's Action Trigger have 
additional duties. In this regard, the final standard is more cost-
effective than the proposal, which would have required all employers 
engaged in manufacturing and manual handling to implement ergonomics 
programs.

[[Page 68824]]

    The Quick Fix option in the final rule also adds to the rule's 
cost-effectiveness by allowing employers to fix problem jobs without 
incurring the additional costs of setting up an entire ergonomics 
program. The Quick Fix option is available for those jobs that can be 
fixed quickly and completely once the job is identified as a problem 
job.
    The extended compliance dates in the standard will also help 
minimize employers' compliance costs. Employers are given 11 months 
from the date of the standard's publication to provide their employees 
with the basic information the standard requires. Employers will 
thereby have sufficient time to first become familiar with the standard 
themselves and then have time to provide the required information to 
their employees.
    Employers are given up to four years from the standard's effective 
date to complete the implementation of permanent controls for problem 
jobs. This extended time frame will promote cost-effectiveness in 
several ways. First, it will give employers sufficient time to learn 
about the range of available controls, both from the compliance 
assistance OSHA plans to make available and from other sources. Many 
employers will thereby be able to implement ``off-the-shelf'' controls, 
which will be less costly than if the employer needs to develop 
controls on its own or hire an outside expert to recommend controls. 
Second, the extended compliance period will enable an employer to adopt 
an incremental abatement approach that may, in turn, result in less 
expensive controls than if the employer had to commit itself to a 
control strategy immediately. For example, an employer can first try a 
low-cost control and, if it works, would not need to consider higher-
cost controls. Third, the extended time frame will enable employers who 
have more than one problem job to control the highest risk jobs first 
while still giving them sufficient time to control their other problem 
jobs. This will enable such an employer to avert more MSDs at an 
earlier time and thereby minimize its costs for MSD management and 
worker removal protection.
    Finally, OSHA is permitting those employers who already have 
implemented ergonomics programs meeting certain criteria to continue 
those programs rather than establish new programs under this final 
rule. Those employers whose current programs qualify for 
``grandfathering'' will therefore not incur any new costs as a result 
of this final rule.
4. Alleged Conflict With Other Federal Statutes
    A number of commenters contend that portions of the standard 
conflict with other federal laws, in particular the National Labor 
Relations Act (NLRA), 29 U.S.C. 141 et seq., the Americans with 
Disabilities Act (ADA), 42 U.S.C. 12101 et seq., the Family and Medical 
Leave Act (FMLA), 29 U.S.C. 2601 et seq., Title VII of the Civil Rights 
Act of 1964, 42 U.S.C. s 2000e et seq., and the Age Discrimination in 
Employment Act (ADEA), 29 U.S.C. 621 et seq. The preamble to the 
proposed standard discussed in some detail the standard's consistency 
with the NLRA and the ADA, see 64 FR at 65,794-65,795 (NLRA), 66,058-
66,059 (ADA), and, as discussed below, the comments do not alter OSHA's 
conclusion that there is no conflict with those statutes. The proposed 
preamble did not address the FMLA, Title VII, or the ADEA, but there 
too we conclude there is no conflict, as discussed below.
    a. National Labor Relations Act--NLRA's prohibition on employer-
dominated labor organizations in nonunion workplaces. Various 
provisions of the standard require employers to convey information to 
their employees and obtain information from their employees. Paragraph 
(i), governing employee participation, requires that employees: (1) 
Have ways to promptly report MSDs, their signs and symptoms, and MSD 
hazards in the workplace; (2) receive prompt responses to their reports 
of MSD signs and symptoms and MSD hazards; (3) have ready access to the 
standard and to information about MSDs, MSD signs and symptoms, and the 
employer's ergonomics program; and (4) have ways to be involved in 
developing, implementing and evaluating the ergonomics program. 
Paragraph (j) requires an employer analyzing a problem job to talk with 
affected employees and their representatives about the tasks they 
perform that relate to MSDs. Paragraph (m) provides that an employer 
required to control a problem job must ask employees and their 
representatives for recommendations about reducing the MSD hazards and 
consult with employees and their representatives about the 
effectiveness of the controls the employer implements. Paragraph (o) 
provides that an employer who chooses the Quick Fix option must ask 
employees and their representatives for recommendations about reducing 
the MSD hazards. Paragraph (t) requires the employer to train employees 
in the aspects of the ergonomics program that affect them and to give 
the employees the opportunity to ask questions about the ergonomics 
program. Paragraph (u) requires employers to consult with employees and 
their representatives about the effectiveness of the program and any 
problems with it.
    Some commenters contend that the requirement for employee 
participation in an ergonomics program, to the extent it applies in 
nonunion workplaces, would conflict with section 8(a)(2) of the NLRA, 
which prohibits employers from dominating or interfering with a labor 
organization. Ex. 32-368-1 at pp. 124-26 (National Coalition on 
Ergonomics); Ex. 32-234-2 at pp. 29-30 (National Solid Waste Management 
Association); Ex. 30-3845 at p. 36 (Forum for a Responsible Ergonomics 
Standard). The National Coalition on Ergonomics (NCE) states that 
because the standard requires that employers provide ways for employees 
to be involved in developing, implementing, and evaluating ergonomics 
programs, the standard is an ``open invitation'' to violate Section 
8(a)(2). Ex. 32-368-1 at p 126. NCE also asserts that requiring 
employers to respond to employee reports of MSD symptoms would require 
conduct violating Section 8(a)(2). Id.
    These arguments are without merit. Nothing in the standard requires 
creation of any sort of employee organization or committee, let alone 
one that violates the NLRA. Section 8(a)(2) of the NLRA does not 
restrict the ability of nonunion employers to deal with employees as 
individuals, and such employers can comply fully with the standard's 
employee participation provisions by doing so. Contrary to NCE's 
contention, the requirement that employers respond to employee reports 
of MSD symptoms does not violate the NLRA. Even before the passage of 
the OSH Act, it was common for employees to report injuries to 
employers, and for responsible employers to respond to those reports by 
correcting workplace hazards. See Taft Broadcasting Co., Kings Island 
Div., 13 O.S.H. Cas. (BNA) 1137, 1140 (Rev. Comm'n 1987), aff'd, 849 
F.2d 990 (6th Cir. 1988). It has never been suggested that such actions 
violate the NLRA, and they clearly do not.
    Moreover, nonunion employers can use a variety of other means to 
comply with the employee participation provisions of the standard 
without running afoul of section 8(a)(2)'s proscription against 
dominating or interfering with the formation or administration of any 
labor organization. A ``labor organization'' under the NLRA is ``any 
organization of

[[Page 68825]]

any kind, or any agency or employee representation committee or plan, 
in which employees participate and which exists for the purpose, in 
whole or in part, of dealing with employers concerning grievances, 
labor disputes, wages, rates of pay, hours of employment, or conditions 
of work.'' 29 U.S.C. Sec. 152(5). A critical component of this 
definition is that the organization or committee ``deal[] with'' an 
employer. Such ``dealing'' occurs if there is a ``bilateral process'' 
that entails a pattern or practice by which a group of employees makes 
proposals to management and management responds to those proposals by 
acceptance or rejection by word or deed. EFCO Corp., 327 N.L.R.B. No. 
71 (Dec. 31, 1998), aff'd, EFCO Corp. v. NLRB, 2000 WL 623436 (4th Cir. 
2000) (unpublished); Electromation, Inc., 309 N.L.R.B. 990 (1992). 
However, if there are only isolated instances in which a group makes ad 
hoc proposals to management, the element of dealing is lacking. E.I. du 
Pont de Nemours & Co., 311 N.L.R.B. 893, 894 (1993).
    In its preamble to the proposed rule, OSHA carefully explained that 
the requirement that employees have ways of being involved in the 
ergonomics program can be satisfied by measures that fall short of the 
employer-dominated committees and other employee organizations that 
violate Section 8(a)(2). In general, the agency emphasized that the 
``nature, form, and extent of how employers must provide employees with 
opportunities to participate will vary among workplaces,'' depending 
upon a variety of factors, including ``[t]he presence or absence of a 
union.'' 64 FR at 65,800. In particular, it explained that OSHA has 
been careful to structure the ``employee participation requirements so 
that they are entirely consonant with the case law based on the NLRA.'' 
64 FR at 65,795. Thus, the agency explained that the proposed rule does 
not ``mandate any particular method `` such as employee committees `` 
for ensuring employee participation,'' and that this ``leaves employers 
free to involve employees in the program in ways that do not violate 
the NLRA but will further meaningful employee participation.'' Id.
    Moreover, OSHA has already explained that there are various 
permissible ways to meet the requirement that employees be involved in 
developing, implementing, and evaluating ergonomics programs. The 
preamble to the proposed standard pointed to certain methods of 
obtaining employee input through employee group activity--a 
brainstorming group, an information-gathering committee, or a safety 
conference--that is structured so as not to ``deal with'' the employer, 
within the meaning of Section 8(a)(2). See 64 FR at 65,795 (discussing 
Ex. 26-29: May 13, 1999 testimony of Henry L. Solano, Solicitor of 
Labor, to the Subcommittee on Workforce Protections, Committee on 
Education and the Workforce in the House of Representatives). In 
addition, the preamble noted that employers can provide mechanisms for 
individual employees to report problems and make recommendations, or 
can assign safety responsibilities to employees as part of their job 
descriptions, without implicating Section 8(a)(2). Id.
    The NCE questions whether ``brain-storming'' groups or 
``information-gathering'' committees would actually fall outside the 
scope of Sections 2(5) and 8(a)(2). Ex. 32-368-1 at p. 126. These types 
of entities are specifically mentioned in NLRA case law as ones that 
would pass muster. See E.I. du Pont, 311 N.L.R.B. at 894, cited in Ex. 
26-23, pp. 11-12; see also EFCO Corp., 327 N.L.R.B. No. 71, slip op. 5 
(``[a] significant portion of the purposes and functions of the Safety 
Committee, such as the reporting and correction of safety problems, 
would not contribute to a finding that it is a labor organization''); 
id. (employee suggestion screening committee did not ``deal with'' 
employer because it merely reviewed and forwarded suggestions without 
formulating proposals or presenting them to management). Nor does the 
fact that the proposed preamble elsewhere refers to an ``ergonomics 
committee'' or a ``labor-management CTD committee'' as effective 
components of an ergonomics program suggest that the agency is being 
``disingenuous,'' as NCE charges. Ex. 32-368-1 at p. 125 n. 228. The 
general reference to an ``ergonomics committee'' does not suggest that 
OSHA, contrary to its express statements, requires employers to 
institute employee committees that violate Section 8(a)(2), and the 
reference to a joint-labor management committee is consistent with 
OSHA's statement that a permissible mechanism for employee 
participation in unionized workplaces, consistent with the proposed 
standard and the NLRA, is a ``joint labor-management committee 
established in compliance with the NLRA by bargaining between the 
employer and the union representing the employees.'' 64 FR at 65,795.
    Impact on collective bargaining agreements in unionized workplaces. 
As to unionized settings, the Chamber of Commerce contends that the 
proposed rule would force employers to run afoul of the NLRA and the 
Railway Labor Act because it would require employers to make unilateral 
changes in mandatory subjects of bargaining, thereby subjecting them to 
unfair labor practice charges under section 8(a)(5) of the NLRA, labor 
unrest, and possible criminal penalties. Ex. 30-1722 at p. 82. The NCE 
and others say that unionized employers would be forced into direct 
dealing with represented employees and will thereby violate section 
8(a)(5). Ex. 500-197 at pp. III-53-61. Similarly, the Edison Electric 
Institute (EEI) reads the proposed standard as requiring employers to 
deal with individual employees regarding their working conditions and 
contends that this requirement ``creates the seeds of conflict with the 
exclusive bargaining authority of recognized unions under Section 9(a) 
of the [NLRA].'' Ex. 32-300-1 at p. 9. The Integrated Waste Services 
Association (ISWA) makes a similar argument. Ex. 22-7-1 at pp. 16-17. 
EEI and ISWA urge OSHA to make clear in the final rule that where 
employees are represented by a certified bargaining representative, 
employers will satisfy the employee involvement provisions of the 
standard by dealing in good faith with the union. Ex. 32-300-1 at p. 11 
(EEI); Ex. 22-337-1 at p.17 (ISWA).
    As discussed elsewhere in this preamble, employee participation in 
an ergonomics program is a vital component of an effective program. 
OSHA further believes that unions, where they exist, must be involved 
in the program and has therefore provided that ``representatives'' of 
employees be afforded the opportunity to participate in job hazard 
analyses, recommendations for controls, and program evaluation. Cf. 
OSHA Field Inspection Reference Manual, Ch. II, Sec. A.3.f (where 
employees are represented by a recognized union, the highest ranking 
on-site union official or union employee representative designates who 
will represent employees during a walkaround inspection); OSHA 
Instruction CPL 2-2.45A (Sept. 13, 1994), Process Safety Management of 
Highly Hazardous Chemicals--Compliance Guidelines and Enforcement 
Procedures, Appendix B (``employee representative'' under employee 
participation provision of process safety management standard, 29 
C.F.R. 1910.119(c), refers to recognized union). Thus, rather than 
bypassing unions, the standard provides that they play an important 
role.
    For example, the employer must, under paragraph (m), ask the 
``employees and their representatives'' for recommendations about how 
to best eliminate or control MSD hazards. The

[[Page 68826]]

requirement that employers ask ``employees and their representatives'' 
for such recommendations does not mean that a unionized employer must 
deal separately with its represented employees and their union. That 
language is intended to encompass the entire range of workplaces, 
including nonunion workplaces, unionized workplaces in which all of the 
employees in problem jobs are represented by the union, and workplaces 
in which some of the employees in problem jobs are represented by the 
union and some are not. In workplaces in which all employees in a 
problem job are within the bargaining unit, employers may, as EEI and 
ISWA suggest, fulfill their obligations under the provisions that 
require the involvement of ``employees and their representatives'' by 
dealing in good faith with the union. The employer and union may agree 
on any mechanism for employee participation that is consistent with the 
standard.
    Some commenters note that ergonomic provisions have been 
incorporated into collective bargaining agreements and assert that 
employers may be forced to violate these agreements to comply with the 
rule. Ex. 30-1722 at p. 82 (Chamber of Commerce); Ex. 500-197 at p. 
III-62 (National Coalition on Ergonomics and others). The duty to 
bargain with recognized unions over safety and health matters does not 
excuse employers from complying with OSH Act standards. Employers and 
unions cannot bargain away an obligation under the Act. See Trans World 
Airlines v. Hardison, 432 U.S. 63, 79 (1977) (``neither a collective-
bargaining contract nor a seniority system may be employed to violate 
the statute.''); Alexander v. Gardner Denver Co., 415 U.S. 36, 51 
(1974) (notwithstanding contrary provision of collective bargaining 
agreement, employee has right to court hearing on race discrimination 
claim under Title VII). See generally United Steelworkers v. Marshall, 
647 F.2d 1189, 1236 (D.C. Cir. 1980), cert. denied, 453 U.S. 913 (1981) 
(``[i]n passing a massive worker health and safety statute, Congress 
certainly knew it was laying a basis for agency regulations that would 
replace or obviate worker safety provisions of many collective 
bargaining agreements''), cert. denied, 453 U.S. 913 (1981); see also 
Murphy Oil USA, Inc., 286 NLRB 1039, 1042 (1987) (employer can 
unilaterally adopt work rule required by OSHA standard without 
bargaining with union); Louisiana Chem. Ass'n v. Bingham, 550 F. Supp. 
1136, 1144 (W.D. La. 1982), aff'd, 731 F.2d 280 (5th Cir. 1984). Thus, 
if there is an irreconcilable conflict between the standard and a 
collective bargaining agreement, the standard would prevail.
    The possibility that existing collective bargaining agreements 
address ergonomics does not, as the Chamber of Commerce suggests, place 
employers in an untenable position. If such collectively bargained 
programs meet the standard as adopted or qualify under the standard's 
grandfather clause, they will not need to be altered. If they conflict 
with the standard, the employer's statutory obligation to comply with 
the standard takes priority over the agreement. Murphy Oil, 286 NLRB at 
1042 (employer ``was not only within its rights, but also legally bound 
to adopt a rule that complied with Federal law.''); Standard Candy Co., 
147 NLRB 1070, 1073 (1964) (employer was legally obligated to raise 
wages to new federally-mandated minimum wage without bargaining with 
union).
    To the extent the employer has discretion in the means by which it 
achieves compliance, and the means involve a mandatory subject of 
bargaining, the employer would be required to bargain with the union 
regarding the means of compliance. United Steelworkers, 647 F.2d at 
1236 (``[w]hen an issue related to earnings protection not wholly 
covered by OSHA regulation arises between labor and management, it will 
remain a mandatory subject of collective bargaining''); see Watsonville 
Newspapers, LLC, 327 N.L.R.B. No. 160, slip op. 2-3 (Mar. 24, 1999); 
Dickerson-Chapman, Inc., 313 N.L.R.B. 907, 942 (1994) (although 
employer must comply with OSH Act standard requiring daily inspections 
of open excavations by a ``competent person,'' employer must bargain 
with union about who would be so designated); Hanes Corp., 260 N.L.R.B. 
557, 561-562 & n.12 (1982) (where OSHA standard required use of 
respirators but gave employer discretion with respect to choice of 
respirator, employer could require use of respirator without 
bargaining, but could not unilaterally determine which approved 
respirator would be used). Nothing in the ergonomics program standard 
forecloses employers from bargaining with unions about discretionary 
aspects of the standard that are mandatory subjects of bargaining under 
the NLRA. To the contrary, OSHA has repeatedly emphasized the 
importance of involving employee representatives in all aspects of the 
ergonomics program. As the AFL-CIO points out:

    The reality is that since the OSHAct's passage, employers and 
unions have been able to meet both their responsibilities under 
OSHA's standards and their duty to bargain under the NLRA. Unions 
have a strong interest in dealing with employers over safety and 
health matters, and will eagerly deal with employers over 
ergonomics. The record reflects extensive union-management efforts 
to tackle ergonomic hazards. Thus, the notion that the employer's 
bargaining obligation stands in the way of OSHA compliance does not 
reflect reality. Ex. 500-218 at p. 162.

    The National Coalition on Ergonomics argues that imposition of some 
of the controls suggested by OSHA could violate seniority and line of 
progression provisions in collective bargaining agreements. Ex. 32-368-
1 at p. 81. The NCE is apparently referring to the standard's inclusion 
of employee rotation in the definition of ``administrative controls.'' 
The NCE also claims that employees being rotated into other jobs may 
not be qualified to perform those jobs and that job rotation can create 
a greater hazard by subjecting employees to the risk of new MSD risk 
factors they were not exposed to in their prior jobs. Id.
    These objections are unpersuasive. First, many workplaces are not 
covered by collective bargaining agreements that contain seniority or 
line of progression limitations. In those workplaces, the concerns 
raised by NCE are totally absent. Second, the standard does not require 
any employer to use job rotation. To the contrary, it specifically 
states that engineering controls, where feasible, are to be preferred 
over administrative controls, including job rotation. However, to give 
employers maximum flexibility, the standard gives employers the option 
of using administrative controls. As a result, those employers who can 
use job rotation safely and effectively are free to do so, while those 
who believe job rotation would lead to contractual or safety problems 
can address ergonomic hazards in other ways.
    b. Americans with Disabilities Act. The ADA is an anti-
discrimination statute that prohibits discrimination by covered 
employers against ``qualified individual[s] with a disability,'' that 
is, persons ``with a disability who, with or without reasonable 
accommodation, can perform the essential functions of the employment 
position that such individual holds or desires.'' 42 U.S.C. 12111(8), 
12112(a). Under the ADA, employers must reasonably accommodate disabled 
workers. However, if there is no reasonable accommodation that would 
permit a disabled employee to work for the employer, the employer is 
free to discharge the employee under the ADA.

[[Page 68827]]

Commenters argue that the proposed standard improperly requires 
employers to take steps beyond those required by the ADA in that the 
standard's requirement that employers control ergonomics hazards 
requires steps beyond ADA's requirement for reasonable accommodation. 
Ex. 32-368-1 at p. 118 (NCE); Ex. 30-1722 at p. 81 (Chamber of 
Commerce). These comments are fundamentally misguided.
    In the preamble to the proposed rule OSHA explained its authority 
under the OSH Act for promulgating this standard. In order to achieve 
the Act's purpose of assuring ``safe and healthful'' workplaces, 29 
U.S.C. 651(b), the Secretary of Labor is authorized to promulgate 
health and safety standards, id. Sec. 655(b), which may require 
``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.'' Id. 
Sec. 652(8). Pursuant to this authority, see 64 FR at 65,774-65,775, 
OSHA has determined, based on the best available evidence, that the 
various components of the ergonomics standard are reasonably necessary 
and appropriate to provide adequate protection from hazards that are 
reasonably likely to cause or contribute to work-related MSDs. It is on 
the basis of this authority that OSHA is requiring employers to take 
such actions as analyzing jobs to identify MSD hazards, implementing 
measures to control such hazards, and removing a disincentive to 
reporting MSDs by providing economic protection for workers who are 
placed on temporary work restrictions or removed from work because of 
MSDs related to their jobs. See generally 64 FR at 65,838-65,861. 
Nothing in the ADA limits OSHA's authority under the OSH Act to issue 
standards that are reasonably necessary and appropriate to protect 
worker health and safety.
    The ADA's definition of disability is not keyed to impairments that 
are occupational in origin, but more generally encompasses impairments 
(whatever their origin) that substantially limit (or are regarded as 
limiting) an individual's major life activities. 42 U.S.C. 
Secs. 12111(10), 12112(b)(5)(A). Reasonable accommodations to such 
impairments may include ``job restructuring, part-time or modified work 
schedules, reassignment to a vacant position, acquisition or 
modification of equipment or devices'' and other similar 
accommodations. Id. Sec. 12111(9)(B). Employers are not required, 
however, to provide accommodations that would pose undue business 
hardship, which is defined as ``an action requiring significant 
difficulty or expense, when considered in light of'' certain statutory 
factors. Id. Secs. 12111(10), 12112(b)(5)(A).
    As OSHA explained in the preamble to the proposed standard, the 
ergonomics standard and the ADA are complementary in purpose. 64 FR at 
66,058-66,059. The standard implements measures in problem jobs that 
would reduce the likelihood of those jobs causing or aggravating MSDs 
(a category that includes impairments that may be disabilities under 
the ADA, although it also includes impairments that do not rise to the 
level of an ADA-covered disability). These measures will not only 
prevent MSDs within the meaning of the ergonomics standard, but also 
make it easier for persons with existing impairments (including ADA-
covered disabilities) to work in those jobs. Accordingly, the standard 
comports well with the ADA's goal of reducing barriers to the 
employment of individuals with disabilities.
    Notwithstanding this complementary purpose, the NCE and the Chamber 
of Commerce argue that the standard impermissibly conflicts with the 
ADA because it may require employers to make changes to jobs it is not 
required to make under the ADA. Ex. 32-368-1 at p. 118 (NCE); Ex. 30-
1722 at p. 81 (Chamber). This contention is meritless. As noted, the 
ergonomics standard is squarely based on OSHA's authority to promulgate 
health and safety standards. Moreover, although the NCE and the Chamber 
suggest that the ADA prohibits OSHA from requiring changes to jobs 
beyond the reasonable accommodations required under the ADA, nothing in 
the ADA even remotely supports this proposition. 29 C.F.R. pt. 1630 
app. at 354 (``nothing in [EEOC ADA regulations] prohibits employers * 
* * from providing accommodations beyond those required by th[e]'' 
regulations).
    Similarly, nothing in the ergonomics standard conflicts with the 
ADA. The standard does not purport to authorize discrimination that is 
prohibited by the ADA; nor does it purport to eliminate any defenses 
that an employer may have to an ADA action. NCE's charge that OSHA is 
attempting to eliminate defenses under the ADA is based on a 
misunderstanding of the thrust of the pertinent agency statements in 
the preamble to the proposed standard. Ex. 32-368-1 at p. 121; see 64 
FR at 66,059-66,060. OSHA explained that the ergonomics standard, by 
requiring employers to control problem jobs, ultimately should make it 
easier for employers to hire persons with MSD-related disabilities and 
should lessen the incidence of MSDs. The standard should therefore 
lessen the number of occasions on which employers would need to raise 
defenses under the ADA, such as that the accommodation involves an 
undue hardship or that the disabled person is a direct threat, see 42 
U.S.C. 12113(b), to the health or safety of others that cannot be 
eliminated by the reasonable accommodation. 64 FR at 66,060. This 
salutary effect does not establish a conflict with the ADA and provides 
no ADA-based reason for not implementing the standard.
    NCE argues that a provision in the proposal (proposed section 
1910.132(a)(2)) conflicts with the ADA by requiring employers to keep 
confidential certain information pertaining to an employee's medical 
condition that the employer could, under limited circumstances, release 
under the ADA. Ex. 32-368-1 at pp.119-20. The proposed provision would 
have required confidentiality ``to the extent permitted and required by 
law,'' avoiding any possible conflict with another statute's disclosure 
requirement. The provision has been deleted from the final standard 
because, as NCE notes, it is superfluous. Ex. 32-368-1 at p.120.
    NCE also objects to a provision in the proposed standard providing 
that the employer instruct the health care provider (HCP) that 
diagnoses unrelated to workplace exposure to MSD must remain 
confidential and must not be included in the opinion communicated to 
the employer. Ex. 32-368-1 at p.119. This provision has been carried 
over into the final standard (with the addition of an exception as 
discussed below). Although NCE appears to contend that this provision 
also conflicts with the ADA's confidentiality exceptions, it offers no 
cogent reason why this is so. OSHA continues to believe, as it 
explained in the preamble to the proposed standard, that a provision 
protecting the confidentiality of medical conditions that are not 
workplace-related is needed to protect employees' privacy and, for that 
reason, has been a routine feature of OSHA health standards for many 
years. 64 FR at 65,844. Such a confidentiality provision is reasonably 
necessary to encourage employee reporting of MSD hazards because 
employees could be deterred from such reporting if they knew 
information about their medical condition would be improperly 
disclosed. Thus, the agency clearly has the authority to adopt such a 
provision. Moreover, OSHA has added language to the provision 
clarifying that it is subject to an exception: the information may be

[[Page 68828]]

communicated where authorized by federal or state law.
    Finally, the NCE contends that compliance with the proposed 
standard could subject employers to discrimination claims under the 
ADA. NCE argues that because the ergonomics standard may require 
employers to alter jobs to a greater extent than does the ADA's 
reasonable accommodation requirement, persons with non-MSD disabilities 
may claim that the employer has engaged in disparate treatment by 
providing more extensive accommodations for MSD disabilities than non-
MSD disabilities. Ex. 32-368-1 at p. 119. Even assuming that 
allegations of differing degrees of accommodation for different 
disabilities states a viable claim of disparate treatment under the 
ADA, the employer would have a defense to such a claim. EEOC 
regulation, 29 CFR 1630.15(e), recognizes that ``[i]t may be a defense 
to a charge of discrimination under this part that a challenged action 
is required or necessitated by another Federal law or regulation.'' The 
employer's obligation to comply with the ergonomics standard would 
constitute a legitimate, nondiscriminatory reason explaining the 
difference between its treatment of disabilities also covered under the 
ergonomics standard and its treatment of other disabilities. See 
generally id. pt. 1630, app. at 369 (necessity of compliance with 
federal law or regulation a defense, where not a pretext for 
discrimination).
    OSHA emphasizes that this final standard does not limit an 
employer's obligation to comply with the ADA. If an HCP advises the 
employer, pursuant to paragraph (r)(2)(ii) of the standard, that an 
employee with a MSD can never resume his or her former work activities, 
any obligations the employer has toward that employee under the ADA 
would remain in effect.
    c. Family and Medical Leave Act. Under the FMLA, an ``eligible 
employee'' is entitled to take up to a total of 12 work weeks of unpaid 
leave for the birth of a child and to care for such child, for the 
placement of a child for adoption or foster care, to care for a spouse 
or an immediate family member with a serious health condition, or when 
he or she is unable to work because of a serious health condition. See 
29 U.S.C. 2612(a)(1). In response to the proposed standard, the Chamber 
of Commerce and the NCE pointed out that, while the FMLA only requires 
employers to provide 12 weeks of unpaid leave to employees with serious 
health conditions, the proposed standard's provisions for work 
restriction protection provided that an employee unable to continue in 
his or her current job due to a work-related MSD may be placed on leave 
for up to 6 months [90 days in the final rule] with 90% of pay. The 
Chamber states that the agency has not explained how ``it acquired the 
authority to enact a regulation that would make Congressional policies 
embodied in the FMLA irrelevant for OSHA's preferred class of 
employees,'' Ex. 30-1722 at p. 82. The NCE similarly contends that 
``OSHA cannot supersede the requirements of another federal statute 
without express statutory authority,'' Ex. 32-368-1 at p. 124. Similar 
arguments are made by the National Solid Wastes Management Association 
(Ex. 32-234-2 at p. 28); and Paul, Hastings, Janofsky & Walker LLP (Ex. 
32-211-1 at pp. 10-11);
    As with the ADA, there is nothing in the FMLA or its implementing 
regulations that suggests any restriction on OSHA's authority to 
regulate workplace safety and health. Nor is there anything in the 
ergonomics standard that would cause an employer to violate the FMLA. 
There is thus no FMLA-based obstacle to adoption of the standard. 
Moreover, the FMLA requires employers to accommodate employees' need 
for time off to care for their own or their family's health. The 
ergonomics rule will prevent many incipient MSDs from progressing to 
the type of serious health conditions that might justify leave under 
the FMLA and will thereby reduce the need for employees to invoke the 
FMLA's protections. Thus, as with the ADA, the ergonomics standard 
works in concert with, not against, the purposes of the FMLA.
    The NCE raises some questions about the interplay between the FMLA 
and the standard's work restriction protection (WRP) provisions. Ex. 
32-368-1 at p. 123. NCE asks, for example, whether an employee could 
receive six months of WRP payments while removed from work and then 
obtain an additional 12 weeks of unpaid leave under the FMLA. FMLA 
regulations provide that an employer may in specified circumstances 
designate paid leave as FMLA leave. 29 CFR 825.208. Nothing in the 
ergonomics standard precludes an employer from designating WRP-leave as 
FMLA leave if the limited circumstances under which paid leave may be 
designated as FMLA leave are met.
    NCE also contends that the ergonomic standard's provisions 
regarding opinions of health care providers (HCPs) conflict with FMLA 
regulations regarding medical certifications for the existence of a 
serious health condition. Ex. 32-368-1 at p. 123; citing 29 U.S.C. 
2613. See also 29 CFR 825.305-825.308. The ergonomics standard does not 
preclude employers from making use of the FMLA medical certification 
provisions when questions arise as to the application of the FMLA to an 
employee with an MSD-based condition. We note, however, that in the 
scenario with which NCE seems most concerned--the employee who is on 
paid WRP-leave--it is highly unlikely that there will be a bona fide 
dispute about whether the employee has a serious health condition that 
has rendered him or her unable to perform the functions of the job. See 
29 CFR 825.114(a)(2) (serious health condition includes condition that 
causes more than three consecutive calendar days of incapacity and 
involves either two visits to a HCP or one visit followed by a regimen 
of continuing treatment under the HCP's supervision), 825.115. In other 
words, it is implausible that an employee on paid WRP-leave would 
resist the employer's designation of the leave as FMLA-leave on the 
ground that he or she does not have a serious health condition.
    NCE also contends that compliance with the proposed standard could 
subject employers to discrimination claims under the FMLA because 
workers covered by the standard may receive WRP consisting of paid 
leave, while other workers with serious health conditions who are 
unable to perform their job are entitled only to unpaid leave under the 
FMLA. NCE 123-124. The FMLA's anti-discrimination provision, however, 
does not sweep so broadly. It prohibits interference with the exercise 
of rights under that statute, 29 U.S.C. 2615(a)(1), and proscribes 
discrimination against an individual for having engaged in activity 
such as opposing unlawful practices under the statute, filing charges, 
or giving information or testifying in connection with FMLA proceedings 
or inquiries. 29 U.S.C. 2615(a)(2), (b). An employer who has placed 
employees on paid WRP-leave under the ergonomics standard has not, by 
that action, interfered with other employees' FMLA rights. Nor would 
its reason for not giving similar paid leave to those other employees--
that the employees were outside the scope of the WRP provisions of the 
ergonomics standard--constitute a basis of prohibited discrimination 
under the FMLA (such as retaliation for protected activities).
    d. Title VII of the Civil Rights Act of 1964 and the ADEA. Title 
VII prohibits employment practices and devices that discriminate on the 
basis of race, color, religion, sex, or national origin. The ADEA 
prohibits employment discrimination on the basis of age. The

[[Page 68829]]

Forum for a Responsible Ergonomics Standard contends that women and 
older workers are more susceptible to MSDs than younger persons and 
that the ergonomics standard will therefore encourage employers to 
violate these statutes by hiring a young, male-dominated workforce. Ex. 
30-3845 at pp. 36-37.
    These anti-discrimination statutes were adopted to combat the 
attitudes prevalent among many employers that older workers, or female 
workers, or minority workers, were not as qualified to do a job as well 
as young, white males. Through their enactment, Congress prohibited 
employers from relying on such outdated stereotypes rather than making 
hiring decisions on the basis of a worker's individual capabilities. 
See Hazen Paper Co. v. Biggins, 507 U.S. 604, 610 (1993) (``Congress 
promulgation of the ADEA was prompted by its concern that older workers 
were being deprived of employment on the basis of inaccurate and 
stigmatizing stereotypes.''); Los Angeles Dept. of Water & Power v. 
Manhart, 435 U.S. 702, 707 n. 13 (1978) (``In forbidding employers to 
discriminate against individuals because of their sex, Congress 
intended to strike at the entire spectrum of disparate treatment of men 
and women resulting from sex stereotypes.'').
    In particular, these statutes preclude discriminatory hiring 
decisions based on perceived gender or age-based susceptibility to a 
safety or health risk inherent in the job. In UAW v. Johnson Controls, 
Inc., 499 U.S. 187 (1991), the Supreme Court held that an employer's 
``fetal protection policy'' violated Title VII. Under that policy, the 
employer refused to assign women to jobs involving lead exposure unless 
the women could show they were unable to become pregnant. The employer 
claimed that this policy was justified because lead in a pregnant 
woman's bloodstream could potentially harm the fetus. The Supreme Court 
held that the employer's concern that women who were or might become 
pregnant would be particularly susceptible to a health risk from lead 
exposure was not a valid reason to allow them to exclude such women 
from jobs for which they were qualified.
    The rulemaking record shows that workers of both sexes and all ages 
suffer MSDs when exposed to high levels of the risk factors addressed 
by this standard. OSHA therefore does not believe that the rulemaking 
record supports the commenters' claim that this standard will provide 
any incentive to employers to violate Title VII and the ADEA. However, 
even if some employers believe they can gain some benefit by hiring 
only young, male workers, Title VII and the ADEA prohibit them from 
doing so on the basis that it will make compliance with the standard 
easier.

XII. Procedural Issues

I. Introduction

    OSHA began seeking public participation in this rulemaking when it 
published an Advance Notice of Proposed Rulemaking (ANPR) in August 
1992. The Agency received more than 250 comments in direct response to 
that notice. See Comments in Ex. 3. The next year OSHA conducted an 
extensive survey of employers to obtain information on the extent of 
existing ergonomics programs and practices in general industry. In 
1994-1995, and again in 1998 and 1999, OSHA held a series of 
``stakeholder meetings'' across the country where interested members of 
the public discussed with representatives of OSHA their experiences and 
opinions relating to ergonomics and ergonomic programs. See Ex. 26-
1370. In some cases, OSHA even shared early drafts of regulatory text 
under consideration with participants in these meetings.
    In developing the proposed standard, OSHA took account of all the 
information it had obtained during this period: the ANPR comments; the 
survey responses; and the stakeholders' views and experience, as well 
as its own enforcement experience and information gleaned from a 
comprehensive review of the relevant literature. In response to this 
input, OSHA revised its regulatory approach substantially from that 
reflected in its early drafts of a standard. In February 1999, as part 
of the review process required by the Small Business Regulatory 
Enforcement Fairness Act (SBREFA), 5 U.S.C. Sec. 601 et seq., OSHA 
released to the public a draft proposed Ergonomics Program standard 
(SBREFA draft) that reflected much of the regulatory approach of the 
proposal. The SBREFA draft was also made available on OSHA's website. 
OSHA received a large amount of feedback on this draft from the small 
entity representatives participating in the SBREFA process, and OSHA 
made a number of alterations to the draft based on that feedback. See 
Ex. 23.
    As described in detail below, OSHA's official Notice of Proposed 
Rulemaking provided the public with additional opportunities to 
participate in the rulemaking. Specifically, OSHA established a 70 day 
pre-hearing comment period (later extended to 100 days), during which 
the public could comment and submit evidence on all aspects of the 
proposed standard. OSHA also scheduled a nine week informal public 
hearing, for interested parties to testify on the proposed standard. 
Finally, OSHA established a 90 day post-hearing comment period. The 
post-hearing comment period gave hearing participants 45 additional 
days to submit data and evidence, and 90 additional days to submit 
comments for consideration by OSHA. In sum, those individuals who 
participated in the informal public hearing had 216 days (more than 
seven months) after publication of the proposed rule to submit data and 
evidence to the rulemaking record for OSHA's consideration, and 261 
days (nearly nine months) after publication of the proposed rule to 
submit briefs and arguments to the rulemaking record.
    Although these procedures exceed the legal requirements for OSHA 
rulemaking and are consistent with the procedures used in past Agency 
rulemakings, a number of participants, primarily employer groups, have 
attacked them as inadequate. A major theme of these attacks is that the 
issues in this rulemaking are unprecedentedly complex, and that OSHA 
therefore should have provided extraordinary comment periods and other 
opportunities to challenge its preliminary conclusions. OSHA recognizes 
that the size of the record on some issues could have posed challenges, 
although by no means insurmountable ones, to rulemaking participants. 
OSHA responded to these challenges by making adjustments to the 
rulemaking schedule and to the procedures used in earlier rulemakings 
in order to provide interested parties with easier access to rulemaking 
materials (including extending Docket Office hours), and to ensure that 
the rulemaking proceeded in a fair and orderly manner.

II. The Adequacy of the Rulemaking Process

A. Length of the Pre-Hearing Comment Period

    OSHA published its proposed Ergonomics Program standard on November 
23, 1999. 64 FR 65768 (Nov. 23, 1999); see also 64 FR 73448 (Dec. 30, 
1999) (publication of corrections notice). In the Federal Register 
notice, OSHA established a 70 day pre-hearing comment period to submit 
written comments and evidence on the proposed standard. Id. These 
materials were required to be postmarked by February 1, 2000. Id.

[[Page 68830]]

    OSHA received a number of requests to extend the pre-hearing 
comment period and delay the informal public hearing. See e.g., Letters 
in Ex. 33. In response to these requests, OSHA extended the pre-hearing 
comment period an additional 30 days, until March 2, 2000, and delayed 
the start of the informal public hearing by 20 days, until March 13, 
2000. 65 FR 4795 (Feb. 1, 2000). This schedule gave interested parties 
a total of 100 days to submit pre-hearing comments on the proposed 
standard. OSHA also notified participants of a number of innovations in 
its filing and docket access procedures, so that parties would have as 
little difficulty as possible in reviewing the record and filing 
comments in the time allowed. See Ex. DC-423. For example, OSHA placed 
copies of the proposed rule, the full Health Effects section, and the 
full Preliminary Economic Analysis on its webpage and on CD-ROM. OSHA 
mailed a CD-ROM free of charge to all individuals who had participated 
in earlier stakeholder meetings and to any other interested party upon 
request.
    The 100-day pre-hearing comment period was more than three times as 
long as that required by the OSH Act. The OSH Act only requires OSHA to 
give interested parties 30 days to comment on a proposed standard. 29 
U.S.C. 655(2). OSHA's procedural regulations also state that a proposed 
rule must provide interested persons with 30 days in which to submit 
``written data, views, and arguments, which shall be available for 
public inspection and copying.'' 29 CFR 1911.11(b)(3). See also 
Executive Order 12866, 58 FR 51735 (Sept. 30, 1993) (encouraging 
administrative agencies to provide a minimum 60 day pre-hearing comment 
period). The 100 day pre-hearing comment period provided here was more 
than adequate to meet all of these requirements.
    This comment period is also consistent with past OSHA practice in 
rulemakings of this magnitude. In the Air Contaminants Rulemaking, OSHA 
proposed to lower the permissible exposure limits for over 400 
hazardous substances, 54 FR 2332 (Jan. 19, 1989), an enormous 
undertaking by any measure. The Eleventh Circuit subsequently rejected 
a challenge to the 47 day pre-hearing comment period OSHA afforded in 
that rulemaking. AFL-CIO v. OSHA, 965 F.2d 962, 969 n.8 (11th Cir. 
1992) (Air Contaminants) (``[W]e are unpersuaded that the time period 
allowed in this rulemaking was so insufficient as to prevent interested 
parties from commenting on the proposed rule.'').
    Numerous other OSHA rulemakings have also included pre-hearing 
comment periods of similar length. For example:
    <bullet> Tuberculosis--123 day pre-hearing comment period. 63 FR 
5905 (Feb. 5, 1998).
    <bullet> Butadiene--91 day pre-hearing comment period. 55 FR 42406 
(Oct. 19, 1990).
    <bullet> Bloodborne Pathogens--76 day pre-hearing comment period. 
54 FR 23042 (May 30, 1989).
    <bullet> Hazard Communication--60 day pre-hearing comment period. 
48 FR 53280 (Nov. 25, 1983).
    Most significantly, it is clear that the 100 day comment period 
provided the public with an adequate opportunity to comment on the 
proposed rule. The comprehensive and detailed nature of many of the 
pre-hearing comments OSHA received is itself compelling evidence of 
this fact. For example:
    <bullet> The National Coalition on Ergonomics (NCE) submitted a 156 
page comment, as well as attachments of 321 pages. Ex. 30-3956.
    <bullet> The U.S. Chamber of Commerce (Chamber) submitted a 95 page 
comment, as well as attachments of 524 pages. Ex. 30-1722.
    <bullet> Anheuser-Busch, Inc. and United Parcel Service, Inc. (UPS) 
submitted a 299 page comment, as well as attachments of 2007 pages. 
These attachments consisted of additional comment and evidence prepared 
by 23 expert witnesses. Ex. 32-241.
    <bullet> The Union of Needletrades and Industrial Textile Employees 
(UNITE) submitted a 70 page comment, as well as attachments of 1078 
pages. Ex. 32-198-4.
    <bullet> The United Food and Commercial Workers Union (UFCW) 
submitted a 179 page comment, as well as attachments of 2218 pages. Ex. 
32-210-2.
    Although some of these submissions came from parties complaining 
that the comment period was inadequate, the comments listed above, as 
well as many others, demonstrated a thorough mastery of the proposal 
and preamble, as well as extensive familiarity with OSHA's Preliminary 
Economic Analysis, its Health Effects discussion, and much of the 
material in the record. See e.g., Exs. 30-1722; 30-3956; 32-241. And a 
number of comments were submitted early, including the Chamber's 619 
page comment, which was submitted on February 16, 2000, a full two 
weeks before the due date. See Ex. 30-1722.
    Moreover, the pre-hearing comment period represented only one 
aspect of the public participation opportunities in this rulemaking. 
OSHA also scheduled nine weeks of informal public hearings and a 90 day 
post-hearing comment period on the proposed rule. Thus, those parties 
who filed Notices of Intent to Appear at the hearing had a total of 261 
days (nearly nine months) from the date the proposal was issued to the 
end of the post-hearing comment period to comment on the proposed rule. 
OSHA believes that this period of time was more than adequate to allow 
interested parties an opportunity to review the record and submit 
meaningful comments.
    In addition, OSHA's procedures typically provide that only parties 
who participated in an OSHA rulemaking hearing may file post-hearing 
submissions. But in this rule OSHA permitted trade associations or 
other groups who were eligible to file such comments to attach to their 
own submissions comments from their members who were not eligible to 
file on their own. Many interested parties (e.g., members of the 
National Association of Manufacturers) who did not file a Notice of 
Intent to Appear, therefore, were able to submit post-hearing 
submissions through their trade association or other group. See e.g., 
Letters in Ex. 500-1.
    Moreover, many interested parties were familiar with the overall 
structure of the proposed rule before it was published on November 23, 
1999. OSHA posted the SBREFA draft, which was similar to the proposed 
rule in many respects, on its website in February, 1999. Many 
interested parties, including small business owners, commented on the 
draft rule. See Ex. 23. In addition, OSHA had engaged interested 
parties in discussions on ergonomics issues for quite some time before 
publication of the proposed rule. See Discussion in Part II above. Many 
parties who commented on the proposed rule and participated in the 
informal public hearing were very familiar with the issues relevant to 
the rulemaking long before the pre-hearing comment period began.
    For these reasons, OSHA does not agree with those commenters who 
complained that 100 days was an inadequate amount of time to analyze 
the rulemaking record fully and to submit meaningful comments on the 
proposal. A couple of commenters went so far as to claim that the 100 
day pre-hearing comment period violated parties' due process rights. 
Ex. 30-3956, p. 141; 30-3865, pp. 33-4. The American Iron and Steel 
Institute (AISI) suggested that the OSH Act required OSHA to give a 30 
day pre-hearing comment period for each hazard at issue in the 
rulemaking (i.e., force, repetition,

[[Page 68831]]

awkward posture, static posture, contact stress, cold temperatures, and 
vibration); thus, AISI argued that OSHA was obligated to set a 210 day 
pre-hearing comment period. Ex. 500-223, p. 94. Many commenters noted 
as well that a number of holidays occurred during the pre-hearing 
comment period, and that these, as well as Year 2000 computer issues, 
made review and preparation of comments particularly difficult. See 
e.g., Ex. 30-3865, p. 34; Letters in Exhibit 33. Finally, a number of 
commenters stated that OSHA's grant of a 30 day extension of time from 
70 days to 100 days was not meaningful because it was not granted until 
January 27, 2000, a few days before pre-hearing comments were 
originally scheduled to be filed. See e.g., Exs. 500-188, p. 6 n.3; 
500-109; 30-3956, p. 142.
    No party's due process rights were violated by the 100 day pre-
hearing comment period. As shown above, the comment period was more 
than adequate for interested parties to review the record and submit 
pre-hearing comments. Nor does the OSH Act require OSHA to provide a 30 
day pre-hearing comment period for each risk factor at issue. As 
explained above, the OSH Act provides for a minimum 30 day comment 
period for each ``proposed rule promulgating * * * an occupational 
safety or health standard.'' 29 U.S.C. 655(b)(2) (emphasis added). The 
OSH Act does not place a requirement upon OSHA to provide additional 
time for comment depending upon the number or types of hazards being 
regulated. See Air Contaminants, 965 F.2d at 969 n.8.
    Furthermore, the occurrence of holidays during the pre-hearing 
comment period did not substantially affect the ability of parties to 
review the record and comment on the proposed rule. In fact, holidays 
accounted for only five days of the pre-hearing comment period. 
Similarly, OSHA does not believe that Year 2000 computer conversion 
issues substantially affected stakeholders' ability to comment on the 
proposed standard. Employers and other parties always devote resources 
to different areas of their enterprises at different times of the year. 
For example, when industry and labor are engaged in collective 
bargaining negotiations, employers and labor unions (including safety 
and health representatives) must devote additional resources (including 
time and money) to the negotiations. The time and resources devoted to 
these negotiations certainly ``conflict'' with other priorities of both 
parties. Yet both parties to the negotiations are able to continue to 
function during this period and to carry out their other 
responsibilities. These types of conflicts do not prevent interested 
parties from submitting meaningful comments on any particular proposed 
rule.
    Finally, the extension of the pre-hearing comment period was not 
granted too late. OSHA originally believed that the 70 day pre-hearing 
comment period established in the proposal was sufficient to allow 
interested parties to comment meaningfully on the proposed standard. 
(The 70 day period was more than twice as long as that required by the 
OSH Act, and longer than the 60 day minimum period recommended by 
Executive Order 12866). OSHA seriously considered the requests it 
received to extend the initial 70 day pre-hearing comment period, 
however, and ultimately decided to grant the 30 day extension.
    OSHA granted the extension on January 27, 2000, a few days before 
written comments were originally scheduled to be filed. In addition to 
publishing notice of the extension in the Federal Register on February 
1, 2000, 65 FR 4795 (Feb. 1, 2000), OSHA issued a press release to 
inform the public that the comment period had been extended and placed 
the press release on its web-page. See http://www.osha.gov/media/oshnews/jan00/national-20000127.html. Some commenters thanked OSHA for 
granting the extension. See Exs. 32-21-1, p.9; 500-1-26; 30-4496, p. 1. 
The 30 day extension was useful in allowing interested parties 
additional time to review the record and comment on the proposed rule.
    In fact, OSHA often grants extensions of comment periods near the 
end of the original period. For example, in the Butadiene rulemaking, 
OSHA granted an extension on the final day of the original pre-hearing 
comment period. 55 FR 42406 (Oct. 19, 1990). Similarly, in the 
tuberculosis rulemaking, OSHA granted an extension a mere 12 days 
before the close of the original pre-hearing comment period. 63 FR 5905 
(Feb. 5, 1998). Indeed, often it is only toward the end of any filing 
period that a need to extend becomes clear. It would hardly be logical 
to permit Agencies to respond to this need only if they did so several 
weeks before the close of the original comment period.

B. There Was Adequate Opportunity for Participants To Prepare for and 
Participate in the Informal Public Hearing

1. The Hearing Procedures and the Hearing Schedule
    In the November 23, 1999 Federal Register notice, OSHA also 
scheduled an informal public hearing to provide interested parties 
another opportunity to comment on the proposed standard. 64 FR 65768 
(Nov. 23, 1999). Participants in the hearing could present testimony 
and ask questions of OSHA and other public witnesses. OSHA scheduled 
the informal public hearing for three cities: Washington, DC; Portland, 
OR; and Chicago, IL. Id. at 65769. The hearing was originally scheduled 
to begin on February 22, 2000, and OSHA required participants to file 
Notices of Intent to Appear by January 24, 2000. Id. at 65768. When 
OSHA extended the pre-hearing comment period, it also delayed the start 
of the hearing until March 13, 2000, 11 days after the close of the 
pre-hearing written comment period. 65 FR 4795 (Feb. 1, 2000). In 
addition, because it received more than 400 Notices of Intent to Appear 
at the hearing, OSHA added an additional 7 days to the hearing in 
Washington, DC and Portland, OR, in order to accommodate all members of 
the public who sought to testify. See 65 FR 11948 (Mar. 7, 2000); 65 FR 
19702 (Apr. 12, 2000).
    On February 25, 2000, the Assistant Secretary issued special 
hearing procedures to ensure that the hearing proceeded in a fair, 
orderly, and timely manner. 65 FR 11948 (Mar. 7, 2000). In doing so, 
the Assistant Secretary acted pursuant to Section 1911.4 of OSHA's 
procedural regulations governing informal public hearings, which allows 
the Assistant Secretary, upon reasonable notice, to specify additional 
or alternative hearing procedures for good cause. 29 CFR 1911.4. OSHA 
published the Hearing Procedures in the Federal Register, mailed them 
to every hearing participant, and placed them on its web-page. The 
Assistant Secretary and the Chief Administrative Law Judge also met 
with interested members of the public to describe and answer questions 
about the conduct of the hearing. Representatives of the U.S. Chamber 
of Commerce, United Parcel Service, Inc., the National Coalition on 
Ergonomics, and the AFL-CIO attended this meeting.
    The Hearing Procedures described the nature of the informal public 
hearing, as well as the procedural rules governing the hearing. Id. The 
Hearing Procedures gave the locations and scheduled times for the 
different hearing sites; they also permitted the presiding 
Administrative Law Judge to extend the hearing past the scheduled 
closing time for any particular day ``to assure orderly development of 
the record.'' Id.
    The Hearing Procedures emphasized that the hearing was a 
legislative-type hearing, not an adjudicative one. Id. Thus, neither 
the rules of evidence nor other procedural rules governing

[[Page 68832]]

adjudications applied. Id. The hearing was intended to provide an 
opportunity for persons who filed a Notice of Intent to Appear to 
testify and question witnesses. Id. Such participation, however, was 
designed to ``facilitate the development of a clear, accurate and 
complete record, while assuring fairness and due process.'' Id. ``The 
intent is to provide an opportunity for effective oral presentation by 
interested persons, and to avoid procedures which might unduly impede 
or protract the rulemaking process * * * '' Id. at 11947-48.
    The Procedures also described the conduct of the rulemaking 
hearing. First, a panel of OSHA representatives would be available to 
answer questions on the proposed standard for two full days, on March 
13 and 14, 2000. Id. at 11948. The Hearing Procedures explained the 
process for handling the questioning of the OSHA panel, to assure that 
the questioning time was distributed in a fair and equitable manner. 
Id. They also prescribed the manner of questioning of OSHA's expert 
witnesses and a panel of witnesses from the National Institute of 
Occupational Safety and Health (NIOSH). Id.
    The Hearing Procedures directed public participants to use their 
oral presentations to summarize and clarify their written submissions 
rather than to read those submissions into the record. Id. The 
Procedures provided that the Administrative Law Judge should allocate 
time for questioning of public witnesses as appropriate; however, the 
procedures required that the ``testimony and questioning of all 
witnesses scheduled for each day [be] completed that day.'' Id. The 
Procedures further encouraged participants having similar interests to 
``designate one representative [to] conduct the questioning on their 
behalf.'' Id.
    Finally, the Hearing Procedures established a 45 day post-hearing 
period in which participants could submit additional information and 
data to the record, and a 90-day post-hearing period in which they 
could submit briefs and arguments on the proposed standard. Id.
    Along with the Hearing Procedures, OSHA distributed a schedule for 
witness testimony at the informal public hearing. See Ex. 502-476. OSHA 
sent the initial schedule for the Washington, DC and Chicago, IL 
locations to hearing participants on February 26, 2000 (with the 
Hearing Procedures), and posted it on the OSHA web page. OSHA sent the 
schedule for the Portland, OR location to the Portland participants on 
March 8, 2000, and also posted it on the OSHA web page. The schedules 
listed the dates and times for the testimony of the expert witnesses 
who were to testify on behalf of OSHA, the panel of experts from NIOSH, 
and each public witness who had filed a Notice of Intent to Appear. Id.
    The schedule organized the public witnesses into panels, and 
allotted each witness an amount of time to testify based upon the time 
the witness had requested. Id. The Hearing Procedures established the 
following format for questioning of the public witnesses: each public 
witness on a panel would present testimony; after all of the witnesses 
on the panel presented, the panel as a group would answer questions 
from members of the public and OSHA. 65 FR 11948-49 (Mar. 7, 2000). The 
Hearing Procedures, however, also gave the presiding Administrative Law 
Judge authority to allocate the time for questioning of witnesses in a 
different manner, as he deemed appropriate. Id. at 11949. This provided 
a fair and orderly process for questioning the public witnesses while 
allowing flexibility to accommodate participants' desire for more or 
less questioning of certain witnesses. See e.g., Tr. pp. 9043; 9378-79; 
13345.
    After OSHA published the initial schedule, a substantial number of 
participants requested that OSHA alter the hearing schedule. OSHA 
accommodated these individuals to the extent possible. Some examples of 
the accommodations made for various hearing participants included:
    <bullet> American College of Occupational and Environmental 
Medicine --Rescheduled from 4/13/2000 to 5/11/2000.
    <bullet> American Iron and Steel Institute--Rescheduled from 4/07/
2000 to 4/18/2000.
    <bullet> American Society of Safety Engineers--Rescheduled from 5/
09/2000 to 4/21/2000.
    <bullet> International Order of the Golden Rule--Rescheduled from 
4/07/2000 to 4/12/2000.
    <bullet> Levi-Strauss--Rescheduled from 4/18/2000 to 5/04/2000.
    <bullet> National Automobile Dealers Association--Rescheduled from 
4/13/2000 to 4/14/2000.
    <bullet> Association for Suppliers of Printing, Publishing, and 
Converting Technologies--Rescheduled from 3/31/2000 to 5/09/2000.
    <bullet> Screenprinting and Graphic Imaging Association 
International--Rescheduled from 3/22/2000 to 4/12/2000.
    <bullet> UniSea Inc.--Rescheduled from 4/27/2000 to 5/02/2000.
    <bullet> Three UPS expert witnesses--Rescheduled from 4/2000 to 5/
10/2000.
    See Ex. 502-476. Throughout the informal public hearing, OSHA 
continued to work with hearing participants to try to accommodate their 
schedules. As OSHA made changes to the hearing schedule, OSHA posted 
the changes on its web page and often announced them at the beginning 
or end of a hearing day. See e.g., Tr. pp. 7161; 7567; 13121; 13531.
    The informal public hearing began on March 13, 2000 in Washington, 
DC and ended on May 15, 2000. OSHA's Director of the Safety Standards 
Program Directorate (Director) made a short statement at the beginning 
of the hearing. For the rest of the first two days of the hearing, a 
panel of representatives from OSHA and the Solicitor of Labor (OSHA 
panel), headed by the Director, answered questions on ergonomics 
generally and on the proposed standard specifically. In total, the OSHA 
panel answered questions for approximately 16 hours. See Tr. pp. 1-5-
819.
    As established in the Hearing Procedures, OSHA allowed each member 
of the public who filed a Notice of Intent to Appear to question the 
OSHA panel. In order to accommodate the large number of individuals who 
wished to question the OSHA panel, the Hearing Procedures provided that 
the questioning occur in ``rounds.'' In total, there were four rounds 
of questioning of the OSHA panel; thus, questioners were able to 
question at four different times over the two days. The amount of time 
allotted for questioners in each round was the following:
    <bullet> Round 1-- Ten minutes per questioner. Tr. p. 1-27.
    <bullet> Round 2-- 20 minutes per questioner. Tr. p. 1-244.
    <bullet> Round 3-- 20 minutes per questioner. Tr. p. 615.
    <bullet> Round 4-- 15 minutes per questioner. Tr. p. 771.
    Thus, each member of the public had up to one hour and five minutes 
to question the OSHA panel.
    After the first two days of the hearing, 28 OSHA expert witnesses 
testified about various aspects of ergonomics, MSDs, and other issues 
raised by the proposed rule. Ex. 502-476. A panel of representatives 
from NIOSH also testified about the causes and prevention of ergonomic 
injuries. Id.
    The OSHA expert witnesses were grouped into subject-matter panels. 
Generally, each expert provided affirmative testimony for about 15 
minutes (45 minutes per panel), and the panel answered questions for 
about two hours. In some instances, panels answered questions for 
approximately three hours. See e.g., Ex. 502-476,

[[Page 68833]]

Testimony of Wednesday, March 15, 2000; March 20, 2000; March 21, 2000.
    During the first two days of testimony by OSHA's experts, the 
questioning followed the same format as the questioning of the OSHA 
panel. After the first two days of testimony, however, the 
Administrative Law Judge altered the allocation of time so that 
employer representatives collectively, and labor representatives 
collectively, were each given approximately 40% of the time to ask 
questions, and OSHA was assigned approximately the remaining 20%. 
Questioners who did not represent either employers or labor were 
allotted proportional amounts of time from industry and labor's time. 
Tr. pp. 1774-75; 1780-1790.
    OSHA's expert witnesses testified from Wednesday, March 15, 2000, 
through Tuesday morning, March 21, 2000. See Ex. 502-476. In order to 
maximize the public's time to question these experts, OSHA encouraged 
the witnesses to shorten their affirmative presentations, and ceded 
some of its own time for questioning to industry and labor. See Tr. pp. 
1791; 1816; 2087; 2496; 2287-88.
    A panel of NIOSH experts also testified during the first week of 
the hearing, on Friday, March 17, 2000. See Ex. 502-476. NIOSH was 
scheduled to appear for 4\1/2\ hours, and the public questioners, 
including both labor and industry representatives, had been allocated 
3\1/2\ hours for questioning. See Ex. 502-476. However, the questioners 
used only 2 hours and forty-five minutes of this time. See Tr. p. 2125.
    Public witnesses testified during the remainder of the nine weeks 
of the informal public hearing. After a panel of public witnesses 
presented testimony, the witnesses were available for questioning by 
members of the public and OSHA. See Ex. 502-476. The Administrative Law 
Judge presiding over the hearing on any particular day exercised 
discretion in terms of how the testimony and questioning of the public 
witnesses would proceed. On a few occasions the presiding 
Administrative Law Judge admitted into the rulemaking record evidence 
and testimony that were not submitted in accordance with the hearing 
procedures. See Tr. pp. 1095-97; 7168-73. Such allowances by the 
Presiding Officer were appropriate under the hearing procedures in 
order to ensure a clear, complete, and accurate rulemaking record. With 
respect to the allocation of time for questioning of the public 
witnesses, in the vast majority of instances the questioning proceeded 
in a similar format to that established during the questioning of 
OSHA's expert witnesses (i.e., dividing the allotted time among 
industry, labor, and OSHA).
    OSHA scheduled appearance times for all of the more than 400 
parties who filed Notices of Intent to Appear at the hearing. Id. More 
than 100 of these parties, however, canceled their scheduled testimony. 
Many of these parties did not notify OSHA of their cancellations, or 
did so at the last minute, so that OSHA was often not able to adjust 
the schedule to allow more time for other witnesses. See e.g., Tr. pp. 
3138; 9379; 12036-12041.
2. Adequacy of the Procedures
    A number of participants complained that the 11 days between the 
end of the comment period and the beginning of the hearing was too 
short to allow them to participate meaningfully in the rulemaking. See 
Exs. 500-188, p. 6; 500-197, p. IV-5; 30-3956, p. 142. OSHA disagrees. 
There is no statutory requirement that OSHA allow any particular amount 
of time between the close of the comment period and the public hearing. 
OSHA's own procedural regulations, however, require a 10 day period 
between the close of the pre-hearing comment period and the hearing. 29 
CFR 1911.11(b)(4). The 11-day period OSHA provided in this rulemaking 
was consistent with those regulations.
    During this period, OSHA made unprecedented efforts to assist 
participants in preparing for the hearing. OSHA extended its Docket 
Office hours and established a separate ergonomics reading room. See 
Ex. DC-423. It also made Docket Office staff available to help 
individuals locate materials quickly and efficiently. Interested 
parties were able to review the materials submitted to the rulemaking 
record as soon as they were received by OSHA.
    After the schedule for the Washington, DC and Chicago, IL hearing 
locations was issued on February 26, hearing participants could use it 
to utilize their own preparation period most effectively. And hearing 
participants had no need to read each others' comments to prepare for 
their own questioning of the OSHA panel. Parties had more than 100 days 
to prepare for this process. In addition, many hearing participants 
were already familiar with the NIOSH and OSHA expert witnesses and with 
the substance of their testimony. One of the participants who 
complained repeatedly that there was inadequate time to prepare for the 
public hearing had, in fact, cross-examined some of the expert 
witnesses on similar issues in earlier OSHA enforcement litigation. See 
Attachments to Ex. 30-1722. OSHA therefore disagrees with those 
commenters who stated that 11 days was insufficient to review the 
comments and testimony submitted, or to prepare for questioning of all 
of the witnesses who were scheduled to appear over the nine weeks of 
hearings. See Exs. 500-188, p. 6; 500-197, p. IV-5; 30-3956, p. 142.
    The conduct of the hearing was also consistent with the OSH Act and 
OSHA's procedural regulations. Although this legislative type hearing 
is informal, OSHA's procedural regulations provide for more than the 
bare essentials of informal rulemaking and include: (1) An ALJ to 
preside at the hearing; (2) ``an opportunity for cross-examination on 
crucial issues,'' and (3) a verbatim transcript of the hearing. 29 CFR 
1911.15(b) (emphasis added). Indeed, OSHA rulemakings differ from the 
rulemakings of other federal agencies in that members of the public can 
question OSHA's expert witnesses and each other. The procedural 
regulations also permit the Assistant Secretary for OSHA, upon 
reasonable notice, to ``prescribe additional or alternative procedural 
requirements:
    <bullet> In order to expedite the conduct of the proceeding;
    <bullet> In order to provide greater protection to interested 
persons whenever it is found necessary or appropriate to do so; or
    <bullet> For any other good cause which may be consistent with the 
applicable laws.''
See 29 CFR 1911.4.
    Here, as it frequently does, OSHA scheduled the informal public 
hearing when it published the proposed rule on November 23, 1999. The 
informal public hearing complied with OSHA's procedural regulations: 
(1) An Administrative Law Judge presided over it; (2) interested 
parties were given an opportunity to cross-examine witnesses on crucial 
issues; (3) OSHA provided transcripts of the proceedings; and (4) OSHA 
designed procedures that effectuated the stated intent of OSHA informal 
hearings, i.e., ``to provide an opportunity for effective oral 
presentation by interested persons which can be carried out with 
expedition. * * *'' 29 CFR 1911.15(a)(3).
    Due to the large number of individuals who filed Notices of Intent 
to Appear, the Assistant Secretary also had ``good cause'' to issue 
special hearing procedures to ensure that the hearing proceeded in a 
fair and orderly manner. The Assistant Secretary issued the Hearing 
Procedures on February 25, 2000, giving hearing participants

[[Page 68834]]

reasonable notice. OSHA mailed the Hearing Procedures the very next day 
to all individuals who had filed Notices of Intent to Appear, published 
them in the Federal Register, and posted them on the OSHA web page. In 
addition, the Assistant Secretary and the Chief Administrative Law 
Judge held a meeting with interested parties on March 7, 2000, in order 
to discuss the procedures and answer any questions from the 
participants.
    The conduct of the informal hearing was also consistent with that 
of other OSHA rulemakings. For example, in the Tuberculosis rulemaking, 
the Pre-hearing Guidelines signed by the Administrative Law Judge laid 
out the following similar parameters:
    <bullet> The purpose of the hearing was for information gathering 
and clarification; the hearing was not an adjudicative one but rather 
an informal administrative proceeding.
    <bullet> Each hearing day would end when the scheduled testimony 
and questions for the day had been completed.
    <bullet> Because written submissions were made a part of the 
rulemaking record, public witnesses ``should'' use their oral testimony 
to summarize and clarify their written submissions.
    <bullet> Questioning of public witnesses should be limited to 15 
minutes, but the presiding Administrative Law Judge could alter the 
schedule as appropriate to allow more time for questioning of a 
particular witness.
    <bullet> If the hearing were to fall significantly behind schedule, 
the presiding Administrative Law Judge could further restrict the 
questioning or order further consolidation of the questioning.
    <bullet> Participants having similar interests should, if possible, 
designate one representative to conduct the questioning on their 
behalf.
    <bullet> If an organization were represented by more than one 
questioner, only one person should question a witness on a particular 
topic area.
    <bullet> Questions should be brief and should be designed to 
clarify a presentation or elicit information within the competence or 
expertise of the witness.
    <bullet> A tentative 120 day post-hearing comment period was 
established.
Docket H-371, Ex. 24; See also Pre-hearing Guidelines for Hearing on 
Employer Payment for Personal Protective Equipment, Docket S-042, Ex. 
17 (including same); Mintz, OSHA: History, Law, and Policy 66-7 (BNA 
1984). As is clear from the above, OSHA did not deviate meaningfully in 
the ergonomics rulemaking hearing from the hearing procedures used in 
past OSHA rulemakings.
    For these reasons, OSHA does not agree with those commenters who 
stated that the informal public hearing was not adequate to provide 
interested parties an opportunity to present additional evidence, and 
to cross-examine public witnesses and OSHA on crucial issues. See Exs. 
500-188, pp. 6-10; 500-197, pp. IV-11-14. On the contrary, OSHA 
believes that the process struck an appropriate balance: it gave 
interested parties the opportunity to present testimony, to question 
OSHA, and to question other members of the public, while ensuring that 
the proceedings would proceed in an orderly manner.
    Specific objections included the complaints of some participants 
that they did not have enough time to question the OSHA panel and that 
OSHA did not disclose who would be representing it on the panel until 
the day the informal public hearing began. See e.g., Tr. pp. 1-42-43. A 
few of these commenters, United Parcel Service, Inc., the National 
Coalition on Ergonomics, and the U.S. Chamber of Commerce, requested 
that the OSHA panel return for additional questioning at the end of the 
informal public hearing. Ex. DC-424. Before the Assistant Secretary 
could respond to that request, however, it was modified (and presumably 
withdrawn) on April 11, 2000. Id.; see also Tr. pp. 17956-58.
    In any event, OSHA believes that the hearing participants had more 
than an adequate opportunity to question the OSHA panel on the proposed 
rule. The OSHA panel answered questions for approximately 16 hours; 
those participants who questioned the panel for each round had over one 
hour to question the panel.
    Like other administrative agencies, OSHA explains its reasons for 
issuing a proposed rule in the preamble to the proposal and other 
supporting documentation. OSHA is not required by any law or regulation 
to explain its rationale further at the informal public hearing. OSHA, 
however, generally spends some time at the beginning of rulemaking 
hearings answering a few questions from participants. In the past, OSHA 
usually made a panel available for a few hours at the beginning of the 
hearing. For example, in both the Tuberculosis and Access to Employee 
Exposure to Medical Records hearings, the OSHA panel answered questions 
for a couple of hours at the beginning of the hearings. See Docket H-
022B, Ex. 171A; Docket H-371, Ex. 25A. Recognizing that there were a 
number of parties who wished to question the Agency more extensively in 
this case, however, OSHA deviated from its past practice and set aside 
two full days for the panel to answer questions on the proposal. See 
Ex. 502-476.
    Furthermore, in order to ensure that the questioning was evenly 
distributed among the participants, OSHA set up a format for the 
questioning. OSHA established several ``rounds'' of questioning. 
Although there were a large number of individuals who wished to 
question OSHA during the first two rounds, only a few had remaining 
questions in rounds three and four. In fact, by the final round of 
questioning only three questioners (representing Boral Bricks, NCE, and 
the Chamber) asked questions of OSHA. Tr. pp. 771-819. Those parties 
who utilized their full time in every round had over one hour total to 
question OSHA. OSHA believes that this schedule provided adequate time 
for interested parties to question the Agency, while not unduly 
protracting the rulemaking process.
    Finally, OSHA did not prejudice any member of the public by waiting 
until the day of the hearing to disclose the members of the OSHA panel. 
The purpose of the first two days of the informal public hearing was to 
allow interested parties an opportunity to question OSHA about its 
proposed rule; the purpose was not to provide an opportunity to 
question individuals about their views of the proposed rule. The panel 
members were made available to answer questions about the proposed rule 
on behalf of OSHA. They did not appear to express personal opinions 
about ergonomics or the proposed standard. Thus, there is no validity 
to the implication that questioners should have had additional time to 
prepare for the kind of credibility-based cross examination that would 
be appropriate in adversarial litigation. See e.g., Tr. pp. 539-41.
    Some participants also objected during the hearing that there was 
not enough time to question the government's expert witnesses. Tr. pp. 
936-941; 1438-1444. The Chamber, for example, complained that OSHA only 
gave ``industry as a whole under two hours of cross-examination'' to 
question the NIOSH panel. Ex. 500-188, p. 7 (emphasis in original).
    Once again, OSHA believes that the amount of time allotted for 
questioning its expert witnesses was reasonable and provided interested 
parties adequate time to ask questions, clarify presentations, and 
elicit new information, while not unduly protracting the rulemaking 
process. Each panel was available for questioning for over two hours 
(and on many occasions for over three hours).

[[Page 68835]]

See Ex. 502-476. This amount of time was longer than that provided for 
questioning of most other members of the public, and OSHA believes it 
was sufficient to allow members of the public to question the experts 
on ``crucial issues.''
    OSHA also encouraged its expert witnesses to provide only brief 
oral presentations. Some of them gave only short opening statements. 
See e.g., Tr. pp. 2361-65, 2366-69, 2369-72; see also Tr. pp. 1816 
(Industry questioner thanking panel of OSHA expert witnesses for 
abbreviating testimony). On other occasions, OSHA ceded the Agency's 
time to the public for questioning. See e.g., Tr. pp. 2087; 2496; 2287-
88. Contrary to the arguments of UPS and NCE that the procedures were 
somehow designed to ``minimize time available for industry 
questioning,'' Ex. 500-197. p. IV-13, OSHA's efforts in fact increased 
the amount of time for public questioning of the expert witnesses.
    Third, the Administrative Law Judge changed the questioning format 
after the second day of testimony by the government experts in order to 
allow questioning to proceed more efficiently. To ensure an even 
distribution of questioning, the Administrative Law Judge divided the 
time available for questioning among the three broad categories of 
questioners--labor, industry, and OSHA. The Hearing Procedures issued 
by the Assistant Secretary gave the Administrative Law Judge this 
authority; in fact, the Procedures envisioned the exercise of this 
authority in just such a situation. See 65 FR 11948 (Mar. 7, 2000). 
OSHA believes that this revision in format allowed all interested 
participants an even greater opportunity to question OSHA's expert 
witnesses.
    Finally, OSHA finds completely unfounded the allegation made 
repeatedly by some commenters (including the Chamber) that there was 
insufficient time to question the NIOSH panel. See e.g., Ex. 500-188, 
p. 7. OSHA allotted an entire afternoon, 3\1/2\ hours, for questioning 
of the NIOSH panel. (In total, OSHA scheduled NIOSH for a 4\1/2\ hour 
block of time to present its testimony and respond to questions.) In 
fact, the hearing was recessed early on that day because there were no 
questions left for the NIOSH panel to answer. See Tr. p. 2125. The time 
allotted for questioning of the NIOSH panel was more than adequate; if 
anything, OSHA scheduled too much time for the questioning of this 
panel.
    OSHA also believes that all interested parties had an adequate 
opportunity to present their affirmative testimony. See e.g., Tr. pp. 
16851-52. First, as OSHA stated in its Hearing Procedures, public 
witnesses were asked to summarize their written submissions. See 65 FR 
11948-49 (Mar. 7, 2000). Because written submissions were already part 
of the rulemaking record and available for all to review beforehand, 
there was no reason for participants also to read those submissions 
into the record.
    Second, OSHA established the amount of time for public testimony 
based on the amount of time witnesses requested in their Notices of 
Intent to Appear. Witnesses who requested only 10 minutes to testify 
were typically scheduled for the entire amount of time they requested 
in their Notice. If individuals requested 15 minutes, OSHA typically 
scheduled them for 10 minutes of affirmative testimony. If they 
requested 20 minutes, OSHA typically scheduled them for 15 minutes. For 
witnesses who requested longer periods of time, OSHA scheduled time for 
affirmative testimony based upon the number of topics to be addressed 
by a hearing participant. Thus, UPS filed Notices of Intent to Appear 
for over 20 individuals and requested varying amounts of time to cover 
a wide range of subject areas. Ex. 32-241-1. OSHA allotted these 
witnesses 2\1/2\ days (22 hours and forty-five minutes), a significant 
amount of time by any measure, to present their testimony and respond 
to questions. Ex. 502-476. OSHA believes that the amount of time given 
the public witnesses to testify met the goal of allowing interested 
parties to summarize their main points, while not ``unduly 
protracting'' the rulemaking process.
    Nonetheless, some participants objected throughout the hearing that 
there was not enough time to question public witnesses. See Tr. pp. 
8265; 3500; 6062. NCE et al., for example, stated that OSHA improperly 
``suspended the rules that allow for [cross-examination]'' and asked 
leading questions of certain witnesses in a manner that did not develop 
the rulemaking record. Ex. 500-197, p. IV-11, 15-16.
    OSHA did not suspend any rules allowing for cross-examination. In 
fact, as described in detail above, the hearing procedures expressly 
provided for cross-examination. The hearing was not a trial, however, 
and no OSHA procedural regulation gives the public unlimited time to 
question witnesses. The public's desire to question witnesses must be 
balanced against the primary function of the hearing: to assist OSHA in 
gathering evidence that will help the Agency determine whether and how 
to regulate. Those parties who complained that their ability to 
``cross-examine'' certain witnesses was improperly curtailed 
misunderstood the nature and purpose of OSHA's informal rulemaking 
hearings.
    It is clear that the public witnesses had adequate time to question 
each other. The schedule typically allowed a panel of witnesses to be 
questioned for one hour. In other words, for every hour of testimony, 
OSHA allowed an hour of questioning. Consistent with its decision to 
allow much more time for questioning of the government expert 
witnesses, OSHA also allowed for greater questioning of public 
witnesses who were particularly well-known in the field of ergonomics.

    <bullet> Dr. Don Chaffin, a Professor of Industrial Engineering 
at the University of Michigan, former Director of its Center for 
Ergonomic Studies, and author of numerous articles on ergonomics 
(See Ex. 500-5), appeared on a panel by himself and had only a short 
affirmative presentation; OSHA ceded its own questioning time to 
allow for more questions from the public. Tr. p. 8264.
    <bullet> Dr. Gary Franklin, a physician who treats patients with 
MSDs and has written extensively on ergonomics and MSDs, appeared on 
a panel by himself and only gave a short affirmative presentation; 
the amount of time available for questioning by industry 
representative was significantly increased by the presiding 
Administrative Law Judge. See Tr. pp. 13340-13415.
    <bullet> Dr. Barbara Silverstein, Director of the Safety and 
Health Assessment and Research Program in Washington State and 
author of numerous articles on ergonomics and MSDs, appeared on a 
panel with one other individual and had only a short affirmative 
presentation; members of the public had one hour to question the two 
witnesses. See Ex. 502-476.

    Second, OSHA repeatedly ceded to the public its own questioning 
time to allow for more questioning by public participants. See e.g., 
Tr. pp. 8264; 10546; 17602-03. The Administrative Law Judges also often 
adjusted the schedule to allow more time for questioning of witnesses 
when interested members of the public had remaining questions. See 
e.g., Tr. pp. 8263-66; 13345; 13366; 13380; 13415.
    The time available for questioning could have been substantially 
increased had more scheduled witnesses notified OSHA in advance of 
their intent not to appear. As stated above, over 100 witnesses 
canceled their appearances (amounting to approximately one week of 
scheduled hearing time), often with no advance notice. This included 
many of the same parties who objected most vigorously to the length of 
the questioning time and would have been expected to be most anxious to 
assist OSHA in increasing that time. See e.g., Tr. pp. 3138; 12036-
12041. For

[[Page 68836]]

example, UPS and its expert witnesses requested over 20 hours to 
present affirmative testimony. OSHA scheduled almost 23 hours for UPS 
testimony and questioning. UPS, however, canceled all but six of those 
witnesses. OSHA was unable to fill that time; this resulted in 
approximately two days during the hearing where no testimony or 
questioning occurred. See Ex. 502-476. Similarly:
    <bullet> Keller & Heckman LLP requested 40 minutes to testify and 
canceled its appearance. See Exs. 32-215; 32-215-1.
    <bullet> Fed Ex Corporation and its subsidiaries requested 100 
minutes to testify and canceled their appearances. See Exs. 32-203; 32-
205; 32-208; 32-209; 32-208-2.
    <bullet> NCE's economic task force requested 130 minutes to testify 
and canceled its appearance. See Ex. 32-375; Tr. pp. 12036-41.

    <bullet> The Rubber Manufacturers Association requested 45 minutes 
to testify and canceled its appearance. See Ex. 32-242; Tr. p. 3138.
All of these entities, or representatives of these entities, objected 
to the amount of time allotted for cross-examination of witnesses. See 
Ex. 500-197 section IV; Tr. p. 2303.
    NCE et al.contended that OSHA further reduced the time for the 
public questioning of witnesses by using its own questioning time 
ineffectively. Ex. 500-197, IV-14-15. But many participants in the 
hearing complained that others asked irrelevant questions, wasted time, 
and otherwise failed to develop the record efficiently. The AFL-CIO 
pointed to an exchange in which a UPS lawyer spent several transcript 
pages attempting, unsuccessfully, to elicit a particular response from 
an AFL-CIO witness. Ex. 500-218, pp. 168-170. But this merely 
highlights that one participant in a rulemaking may believe that 
certain questions are of relevance, while another participant may think 
precisely the opposite. OSHA designed the informal public hearing to 
give both itself and the hearing participants the opportunity to 
question members of the public in a manner each believed would best 
develop the rulemaking record. OSHA believes that it did this 
effectively throughout the informal hearing.
    The same participants also complained that ``OSHA withheld the 
hearing transcript from the rulemaking's participants'' and that the 
``transcripts were not provided until the hearings were ended.'' Ex. 
500-197, p. IV-17; see also Ex. 500-109. However, OSHA did not withhold 
the transcripts from the hearing participants; nor did OSHA wait until 
the end of the proceedings to make the transcripts available. First, 
during the initial week of the hearing, OSHA informed participants that 
they could contact the reporter directly to receive copies of the 
hearing transcripts. Tr. p. 936. Second, on May 3, 2000, OSHA placed on 
its web page unofficial copies of the hearing transcripts. Third, on 
May 30, 2000, OSHA made the official transcripts available on its web-
page. OSHA placed paper copies of the official transcripts in the 
Docket Office a few days later.
    There is no statutory, regulatory, or other authority requiring 
that OSHA go to such lengths to provide copies of the transcripts to 
the public. OSHA's procedural regulations state only that transcripts 
``shall be available to any interested person upon such terms as the 
presiding officer may provide.'' See 29 CFR 1911.15(b)(3). OSHA's 
efforts to make the transcripts available certainly exceeded what is 
required by its procedural regulations and was more than adequate to 
allow parties to review transcripts of the proceedings promptly and in 
a meaningful way.

C. Availability of Record Material in the Docket

    When it issued the proposal, OSHA placed in the rulemaking docket a 
large amount of material and evidence. Throughout the rulemaking, OSHA 
received additional evidence, both from rulemaking participants and 
through its own efforts. This entire body of evidence forms the basis 
for the issuance of this final standard, and OSHA took unprecedented 
steps to ensure that all of it was available for public inspection.
    The OSHA Docket Office (Docket Office) provides a number of ways to 
review and access materials submitted. First and foremost, the Docket 
Office maintains hard copies of all documents submitted to the 
rulemaking record and places them on a central shelf in the Docket 
Office reading room. Any interested party can view and copy these 
documents, consistent with applicable copyright laws. Docket Office 
staff are always available to help interested parties find and obtain 
rulemaking materials. Until recently, this method was the only way to 
access an OSHA rulemaking docket.
    Recently, however, OSHA has been exploring methods of using 
technology to make access to its dockets even more convenient. For 
example, OSHA began a process of scanning all materials into an 
electronic database. This permits interested parties to view documents 
in the database, search for documents submitted, and print copies of 
the documents. OSHA intends this system to provide an easier means to 
view materials submitted to its rulemaking records.
    Because OSHA anticipated that there would be a large amount of 
material submitted to the docket during this rulemaking, the Agency 
implemented special procedures to ensure timely and convenient access 
to the docket. For example, OSHA made the proposed rule and preamble, 
the Preliminary Economic Analysis, and the full Health Effects sections 
available on its web page and on CD-ROM. In fact, OSHA mailed a CD-ROM 
containing this information free of charge to all parties who 
participated in the stakeholder meetings OSHA held before issuance of 
the proposed rule and to any other interested party upon request.
    OSHA also extended its Docket Office hours by 3 hours a day, and 
designated an area in the Docket Office as an ``ergonomics reading 
room,'' where parties could review docket submissions as soon as they 
were received by the Agency. Ex. DC-423. In addition, OSHA moved people 
from other positions in the Agency to process public comments and scan 
the material into the computer database as quickly as possible. These 
steps, which exceeded any legal obligations and went far beyond OSHA's 
own past practice, were more than adequate to ensure interested parties 
a meaningful opportunity to comment on the proposed rule.
    Although an administrative agency engaged in rulemaking must make 
``critical factual material * * * used to support the agency's 
position'' available to the public for review in a rulemaking 
proceeding, Air Transport Ass'n. v. FAA, 169 F.3d 1, 7 (D.C. Cir. 
1999), agencies generally are not required to make the material 
``available'' in any particular format, so long as the public has an 
opportunity to review the material during the rulemaking.
    There can be no question that OSHA made the material ``available'' 
here within the meaning of this requirement. With only a few 
exceptions, OSHA placed all documents cited in the preamble to the 
Proposal in the Docket Office by November 23, 1999--the date the 
proposal was published. OSHA also scanned the documents into a computer 
database to allow interested parties to view, search, and print copies 
of the documents more efficiently. Docket Office staff were available 
to help interested parties in searching the computer database and 
locating particular documents. See Ex. 30-3956, p. 133 (``[T]he Docket 
Office staff were extraordinarily helpful in attempting to

[[Page 68837]]

assist us in gaining access to OSHA's data, even to the extent of 
allowing us a dedicated work station in the docket office (subject, of 
course, to use by OSHA staff in carrying out their projects).''). But 
OSHA did not design the database to serve as the primary mechanism for 
reviewing the rulemaking record; it is an additional convenience for 
the public.
    In fact the computer database for viewing, searching, and printing 
the record is relatively new technology in the context of OSHA's 
rulemakings. Similarly, OSHA has not previously made documents 
available on CD-ROM and the web page. Extending the hours the Docket 
Office was open to allow the public greater access to the rulemaking 
record was also not commonplace in earlier rulemakings; the Agency also 
does not typically dedicate a special area of the Docket Office to 
serve as a reading room. Thus, in numerous earlier rulemakings, 
interested parties reviewed and copied (as necessary) the paper copies 
of documents submitted to the record of a particular rulemaking. The 
extraordinary efforts made in this case not only exceeded any 
applicable legal requirements, they were an appropriate response to the 
comments of some parties that the number of issues involved in the 
rulemaking required additional accommodations. See e.g., Ex. 500-223, 
p. 94.
    For these reasons, OSHA does not agree with those commenters who 
contended that underlying record material was not available to 
interested parties for their review. NCE, for example, alleged that 
``numerous documents were missing or unavailable because they had been 
sent out for photocopying, including the 1100 page Preliminary Economic 
and Regulatory Flexibility analysis and approximately 500 pages of 
associated materials offered in support of the Agency's conclusions,'' 
Ex. 30-3956, p. 133, and that Exhibits 28-3, 28-4, 28-5, and 28-6 were 
not available for review on November 23, 1999. Ex. 30-3956, Appendix 
IV. NCE also made a number of other attacks on the integrity of the 
record and on OSHA's provision of access to it:
    <bullet> OSHA generally relied upon additional underlying data that 
it did not make available to the public.
    <bullet> There was only one high speed printer for use in the OSHA 
docket office, and that printer takes approximately two hours to print 
800 pages.
    <bullet> The Docket Office only stays open for 6 hours a day.
    <bullet> The computer systems and printers were not operating 
perfectly--there were occasional computer and printer failures.
    <bullet> OSHA rejected a request for electronic copies of the 
entire docket on disk or zip drive, even though the docket was 
available to OSHA staff through its intranet.
    <bullet> The copying fee of 15 cents a page was excessive.
    <bullet> OSHA relied on a NIOSH review of 2000 studies in 
supporting the proposed rule; ``the 2000 studies were not'' in the 
docket.
    <bullet> One economic document appeared to be named differently in 
the Preliminary Economic Analysis than in the preamble.
    <bullet> The Docket Index was incomplete at certain times during 
the pre-hearing comment period.
    <bullet> Only the cover pages of some documents were in the docket, 
as compared to the entire document.

Ex. 30-3956, pp. 134-37.
    Many of these allegations are not accurate, and those that are 
represent the minor and harmless complications of managing any large 
record. It is not true that ``numerous'' documents, including the 
Preliminary Economic Analysis, were not available for public inspection 
by November 23, 1999. The Preliminary Economic Analysis was stamped as 
received in the Docket Office at 9:55 a.m. on November 23, 1999. As 
such, it was available for inspection and copying at that time. To the 
extent interested parties had difficulty locating or obtaining the 
Preliminary Economic Analysis, Docket Office staff were available to 
assist them.
    OSHA also disputes the allegation that Exhibits 28-3, 28-4, and 28-
5 were missing on November 23, 1999. In fact, the record indicates that 
Exhibits 28-3 and 28-4 were entered into the computer database on 
November 23, 1999 and thus were certainly available for viewing at that 
time. Exhibit 28-5 is a number without an exhibit; there is no such 
document and ``Exhibit 28-5'' was not cited or relied upon by OSHA in 
the preamble to the proposed rule, or in the Preliminary Economic 
Analysis.
    OSHA does not know which other documents NCE and other commenters, 
see 30-3815, p. 4; 30-3956, pp. 133, 135; 30-3819, p. 3, claim were 
``unavailable.'' After the proposed rule was published, however, OSHA 
discovered that a few documents cited in the proposed rule had been 
inadvertently omitted from the material placed in the docket by 
November 23, 1999. These documents included the following:

    <bullet> Firm Size Data Provided by the Bureau of the Census 
(Exhibit 28-6)--These data provide estimates of the number of firms, 
number of establishments, employment, annual payroll and estimated 
receipts for employment size of firm categories by SIC code. It is 
available to the public from the Small Business Administration web 
page. OSHA used this information to estimate the economic impact of 
the proposed rule on various industries, as well as small 
businesses. When OSHA recognized that these data had inadvertently 
not been placed in the docket, it immediately placed in the docket a 
hard copy of the web page where interested parties could access the 
material (on December 23, 1999). On February 1, 2000, OSHA placed 
hard copies of the data (127 pages) in the docket. See Ex. 28-6-1.
    <bullet> RMA data--These data provide net return on sales 
information by industry SIC code and are available in many public 
libraries. OSHA used this information to estimate the economic 
impact of the proposed rule on various industries. Due to copyright 
concerns, OSHA originally did not place this information in the 
docket. OSHA later obtained permission to include these data in the 
docket; once it obtained this permission, OSHA placed the 
information in the docket (on February 18, 2000). See Ex. 28-10.
    <bullet> IRS data--These data also provide net return on sales 
information by industry and are available on the IRS web page. OSHA 
only used these data for a handful of industry sectors for which the 
RMA data were not available. When OSHA recognized that these data 
had inadvertently not been placed in the docket, it immediately 
placed the material in the docket (on January 31, 2000). See Ex. 28-
9.

    OSHA also did not rely upon data that it did not place in the 
rulemaking record. The commenters who raised this issue did not 
identify precisely what data they were referring to, see Exs. 30-3716, 
p.5; 30-3736, p. 10, but it may have been the same material that was 
requested in a number of Freedom of Information Act (FOIA) requests 
filed by some hearing participants. See e.g., Ex. 503. Some of these 
requests were for information that was in the rulemaking docket, and 
others were for information that was not part of the rulemaking record, 
because OSHA had not relied on it in the proposed rule.
    OSHA responded to the requests for information in a timely manner. 
See Ex. 500-23-1, p. 8. To the extent the information was available, 
OSHA provided it to the requesters, and, as appropriate, placed the 
FOIA requests and responses in the docket. See Ex. 503. OSHA is not, 
however, aware of any information it relied upon that it did not place 
in the docket. To be sure, OSHA receives data and information from a 
number of different sources when preparing a proposed rule. But all 
data that were relevant to the promulgation of the proposed rule and 
were relied upon by OSHA in the rulemaking were placed in the record.

[[Page 68838]]

    The allegation that ``2000 studies'' relied upon by NIOSH in its 
literature review were not in the docket on November 23, 1999 is also 
factually inaccurate and of questionable relevance. NIOSH did not rely 
on 2000 studies in its literature review. As described more fully in 
Section V above, NIOSH originally examined 2000 studies in preparing 
its literature review but chose to use only about one-third of them, 
based on certain methodological criteria NIOSH established for the 
study. Ultimately, NIOSH included about 600 studies in its literature 
review. Many of these studies were in the rulemaking docket. For 
example, a quick check by OSHA located the following studies in the 
rulemaking record:
    <bullet> Aaras A. [1994]. Relationship between trapezius load and 
the incidence of musculoskeletal illness in the neck and shoulder. Int. 
J. Ind. Ergonomics 14(4):341-348. Ex. 26-892.
    <bullet> Armstrong T. et al. [1987a]. Ergonomic considerations in 
hand and wrist tendinitis. J. Hand. Sur. 12A(5):830-837. Ex. 26-48.
    <bullet> Bigos S. et al. [1986b]. Back injuries in industry: a 
retrospective study. III. Employee-related factors. Spine 11:252-256. 
Ex. 26-871.
    <bullet> Dehlin O. [1977]. Back symptoms and psychological 
perception of work: a study among nursing aides in a geriatric 
hospital. Scand. J. Rehabil. Med. 9:61-65. Ex. 26-820.
    Even though a few of the studies examined by NIOSH may not have 
been in the docket, however, the public would not have been deprived of 
an adequate opportunity to review the information OSHA relied upon in 
the proposed rule, because OSHA relied upon the NIOSH literature review 
in discussing the epidemiological evidence supporting the proposed 
standard. The NIOSH literature review was in the docket and available 
for review by November 23, 1999. Ex. 26-1. OSHA's use of, and reliance 
upon, its research arm in this manner was expressly contemplated by 
Congress when it created NIOSH in the OSH Act. See 29 U.S.C. Sec. 671. 
Furthermore, OSHA is not obligated to place in the docket every 
underlying study used by any researcher in reviewing the scientific 
literature about any particular subject. Cf. Cable & Wireless P.L.C. v. 
FCC, 166 F.3d 1224, 1234 (D.C. Cir. 1999) (FCC did not unreasonably 
rely upon published study even though underlying data for the study was 
not available to the FCC or the public).
    It is also not true that printer failures and other computer 
problems prevented interested parties from reviewing and commenting 
meaningfully on any material in the docket. As stated earlier, OSHA is 
required to make critical material available for public inspection 
during the rulemaking proceeding. OSHA is generally not required to 
make such material available in any particular form or manner. In this 
case, OSHA made the relevant material available in hard copy format for 
review and copying (as appropriate) in the Docket Office reading room. 
OSHA is aware of no commenter who has suggested that any of the 
material in the docket was not available in hard copy form or that any 
of the copying machines were not functioning during the comment period. 
Indeed, one commenter expressly noted that there were ``no particular 
difficulties'' in requesting, reviewing, and copying documents in the 
rulemaking record. Ex. 500-218, p. 165.
    And as explained, OSHA never intended its computer database to 
serve as the sole method for interested parties to use to review the 
record. OSHA intended the database to be an additional tool to 
facilitate this review, for those participants who prefer electronic 
access. OSHA does not believe that the occasional technical failure of 
this additional tool deprived any party of an opportunity to review 
relevant material.
    Similarly, interested parties were not denied meaningful review 
because OSHA did not produce the entire docket electronically or on a 
zip file. First, as described above, OSHA provided a number of 
documents to interested parties on its web page and on CD-ROM, 
including the full Health Effects section as well as the entire 
Preliminary Economic Analysis. Second, OSHA made the information in the 
docket available electronically on its computer database. Providing the 
entire docket on a zip file would have been administratively difficult, 
expensive, and time consuming, particularly since the docket was 
constantly growing, with new submissions being received by Docket 
Office staff daily.
    Third, providing the record in such a way would raise copyright 
issues for some of the material in the record. Finally, and as 
mentioned previously, OSHA is not required to provide the material in 
the record as an electronic or zip file. OSHA is, of course, 
continually investigating new ways to provide interested members of the 
public with access to the rulemaking record. However, there is surely 
no due process requirement that OSHA provide access to the document in 
any particular form, and OSHA's decision not to provide an additional 
form of electronic access did not violate due process or impede 
participants' ability to view the material in the rulemaking.
    The fact that the Docket Office was open for 6 hours a day during 
the prehearing comment period also did not deny any party an adequate 
opportunity to review the record. Particularly with the technological 
assistance described above, OSHA believes that interested parties could 
adequately review the record and comment on the proposed rule in the 
time allotted. And as also discussed above, the quality and 
comprehensiveness of the pre-hearing submissions, including NCE's own 
156 page submission, belie any suggestion that the parties were impeded 
in their ability to comment. Even so, when the hearing began OSHA 
extended the Docket Office hours to allow the public even more time to 
review the comments and evidence received into the rulemaking record. 
Docket Office hours were extended on March 13, 2000; the Docket Office 
continued these extended hours until September 1, 2000, well after the 
rulemaking record closed.
    Certainly, the $0.15 a page fee the Docket Office charges for 
copying and printing did not deny interested parties an opportunity to 
review the record. OSHA is authorized to charge this nominal fee in 
order to recoup some of the costs of paper and toner, etc. See 29 CFR 
70.40(d)(2). But OSHA does not charge any fee for interested parties to 
enter the Docket Office and review documents submitted to the record, 
so the fee did not prevent any interested party from viewing any 
document.
    The fact that one particular economic document was improperly named 
in the Preliminary Economic Analysis also did not deprive parties of an 
adequate review of the record. Certainly, OSHA took pains to ensure 
that all documents were accurately cited in the preamble to the 
proposed rule, as well as in the computer database. It is precisely 
because human error may occur from time to time, however, that Docket 
Office staff are available to answer questions from interested parties, 
as well as to make inquiries of OSHA if parties are having difficulty 
locating certain documents. The specific document referred to by NCE, 
Exhibit 28-7--Tabulations from OSHA's 1993 Ergonomics Survey, was 
inadvertently titled Description of Cost Estimates of Ergonomic 
Controls Under Draft OSHA Ergonomics Standard in both the Preliminary 
Economic Analysis and the Summary of the Preliminary Economic Analysis 
(Summary) in the Preamble. OSHA corrected the error in the Summary in a 
corrections notice published December 30, 1999. See 64 FR 73448-58 
(Dec. 30, 1999). OSHA,

[[Page 68839]]

however, did not place any new material--material that would have 
required additional analysis--into Exhibit 28-7 after correcting the 
title to the document. OSHA thus does not believe that this inaccurate 
citation deprived the public of an opportunity to review and comment 
upon the material in the Exhibit.
    OSHA also believes that the Docket Index was never ``incomplete.'' 
By its very nature, the Docket Index is an unfinished and ever-growing 
document. Interested parties are continually sending documents to OSHA 
to place in the record. When the Docket Office receives a document, it 
is processed and placed into the record. Part of the processing 
involves entering the document into the computer database and 
generating the Docket Index. Thus, the Docket Index is constantly 
growing as new information is submitted to the record. This does not 
mean, however, that the Docket Index is ``incomplete'' at any 
particular time.
    Docket Office staff processed rulemaking documents as soon as 
possible upon receipt. Indeed, OSHA moved people from other positions 
within the agency to expedite this process. OSHA does not believe that 
its processing of documents into the record and onto a Docket Index 
deprived any interested party an adequate opportunity to review the 
record or to comment meaningfully on the proposed standard.
    Finally, in a few cases, due to copyright concerns, OSHA placed 
only the cover pages and tables of contents of published documents into 
the docket. These documents were generally available to interested 
parties upon request; they were also often publicly available. See 
e.g., Tr. p. 2640 (Hearing participant complaining that only cover page 
of book in the record, but admitting he was able to obtain copy of the 
book). Once again, Docket Office staff were available to answer any 
questions from interested parties and to help locate materials that 
might otherwise be difficult to find. OSHA does not believe that this 
practice deprived interested parties of their right to review the 
record.
    As the above discussion demonstrates, OSHA undertook extraordinary 
measures to provide interested members of the public access to the 
rulemaking record. These efforts ensured that all participants had an 
opportunity to examine the underlying information and comment 
meaningfully on the proposed rule.

D. OSHA's Use of Expert Witnesses

    Consistent with its past practice, see Mintz, OSHA: History, Law, 
and Policy 64-5 (BNA 1984), OSHA contracted with a number of experts to 
testify at the hearing and to provide other assistance in the 
rulemaking process. Twenty-eight experts prepared pre-hearing comments, 
testified during the informal public hearing, answered questions at the 
hearing, and submitted post-hearing comments and data. These experts 
testified on a wide range of issues including the work-relatedness of 
MSDs, the diagnosis of MSDs, the implementation of engineering controls 
in workplaces, and the costs of ergonomic programs. See Testimony in 
Ex. 37. OSHA's use of expert witnesses in this way is expressly 
authorized by the OSH Act, is consistent with past practice, and is 
consistent with the practice of other administrative agencies.
    Section 7(c)(2) of the OSH Act states: ``In carrying out his 
responsibilities under this Act, the Secretary [of Labor] is authorized 
to * * * (2) employ experts and consultants or organizations thereof as 
authorized by Section 3109 of Title 5.'' 29 U.S.C. Sec. 656(2). The OSH 
Act does not limit the purposes for which OSHA may obtain expert 
assistance, and assuring that it has appropriate expertise during 
rulemaking proceedings falls squarely within this authorization. In 
United Steelworkers of America v. Marshall (Lead), 647 F.2d 1189 (D.C. 
Cir. 1980), the U.S. Court of Appeals for the District of Columbia 
Circuit upheld OSHA's authority under the OSH Act to employ experts to 
prepare written comments, submit relevant data, and present testimony 
during rulemaking proceedings. The court stated: ``The OSH[] Act 
empowers the agency to employ expert consultants * * * and OSHA might 
have possessed that power even without express statutory authority * * 
* .'' Id. at 1217. The court also noted that it would be absurd to 
require OSHA and other agencies to ``hire enormous regular staffs 
versed in all conceivable technological issues, rather than use their 
appropriations to hire specific consultants for specific problems.'' 
Id.
    OSHA has historically used experts to testify at public hearings 
about parts of proposed rules that fall within their areas of 
expertise. Some earlier OSHA rulemakings that involved OSHA expert 
witnesses included: the Lead rulemaking (1980); the Hazard 
Communication rulemaking (1983); the Ethylene Oxide rulemaking (1984); 
the Benzene rulemaking (1987); and the Methylene Chloride rulemaking 
(1997). Other federal agencies also use expert witnesses in ways 
similar to OSHA's. The Environmental Protection Agency, the Food and 
Drug Administration, and the Department of Transportation, for example, 
make extensive use of consultants in their rulemaking activities. See 
e.g., BASF Wyandotte Corp. v. Costle, 598 F.2d 637, 640-41 (1st Cir. 
1979) (EPA retained outside consultants to analyze pesticide industry 
in preparation of regulation); cf. National Small Shipments Traffic 
Conf., Inc. v. I.C.C., 725 F.2d 1442, 1449 (D.C. Cir. 1984) (ICC 
retained consultant to evaluate various methodological criticisms of 
rulemaking record). As explained in A Guide to Federal Agency 
Rulemaking published by the ABA:

    Agencies sometimes use the services of outside consultants in 
developing rules or supporting analyses, particularly in rulemakings 
involving questions of science or technology as to which the agency 
needs added expertise. The tasks consultants are asked to perform 
vary, but they include testifying as witnesses, conducting research, 
summarizing and evaluating data in the record, and helping draft 
portions of the final rule and its rationale. Lubbers, A Guide to 
Federal Agency Rulemaking 243 (ABA 1998).

    Clearly, therefore, those commenters who claimed that it was 
improper, per se, for OSHA to contract with expert witnesses to 
participate in the rulemaking process were wrong. See e.g., Exs. 500-
43, pp. 1-2; 500-201, p. 2. OSHA has also considered the more specific 
objections that: (1) OSHA did not disclose to the public that it had 
contracted with the expert witnesses to participate in the rulemaking 
proceedings; (2) the expert witnesses had a financial interest in the 
rulemaking and therefore their testimony was tainted; (3) OSHA coached 
the witnesses; (4) the expert witnesses provided additional detailed 
critiques of other public commenters that were not placed in the 
rulemaking record; and (5) OSHA improperly used the expert witnesses to 
review and analyze the public comments and hearing testimony. See Exs. 
500-188, pp. 7-10; 500-197, pp. IV-1925.
    First, the rulemaking record is replete with evidence that OSHA's 
use of expert witnesses and consultants was disclosed to the public and 
was clearly known to the parties who cross-examined OSHA's experts at 
the public hearings. OSHA notified interested members of the public of 
its expert witnesses in several ways: (1) OSHA clearly listed its 
expert witnesses as ``OSHA Witnesses'' on the hearing schedule that was 
sent to hearing participants and placed on the OSHA webpage, see Ex. 
502-476; (2) OSHA placed the witnesses' testimony

[[Page 68840]]

under a separate Exhibit number in the Docket Office labeled ``OSHA 
Expert Witnesses'', see Ex. 37; and (3) OSHA referred to its expert 
witnesses when responding to questions from members of the public 
during the first two days of the hearing. See Tr. pp. 1-142; 1-189; 1-
205; 1-206; 1-229; 1-230; 719. Indeed, it was clear to the parties who 
cross-examined OSHA's experts that OSHA's experts were paid witnesses. 
For example, when an attorney representing UPS questioned OSHA witness 
Maurice Oxenburgh, he referenced the ``Expert Witness Cont[r]act for 
Dr. Maurice Oxenburgh.'' Tr. pp. 2637; see also Tr. p. 1440.
    Second, OSHA's expert witnesses had no financial interest, and 
therefore no conflict of interest, in the outcome of the ergonomics 
rulemaking. The basis for this objection, raised by NCE et al., appears 
to be that, because many of the expert witnesses were well-known 
ergonomics experts, they would benefit financially from an ergonomics 
standard, presumably because they would be hired more often to address 
ergonomic issues. According to this theory, the witnesses testified 
that there was a need for a standard on ergonomics in order to receive 
this future, speculative economic benefit. See e.g., Ex. 500-197, p. 
IV-19.
    In fact, however, OSHA hired these witnesses precisely because 
their experience with ergonomics provided them with relevant expertise. 
And their testimony shows clearly why most of them supported 
promulgation of this standard: they have participated in the 
implementation of ergonomics programs similar to those required by this 
standard, and have observed the success of those programs in reducing 
MSD rates, increasing productivity and efficiency, and decreasing 
workers' compensation costs. In other words, they believe that a 
program standard is necessary because they have seen programs work to 
reduce injuries among workers and save money for their employers. See 
e.g., Exs. 37-7; 37-25; 37-20.
    Third, there is no basis for the claim that OSHA improperly 
``coached'' the expert witnesses. One of the witnesses'' functions was 
to help the public understand the scientific and technical research on 
which OSHA based its proposal. OSHA worked with its experts to be sure 
that they were prepared to explain clearly and succinctly, the 
reasoning and assumptions on which OSHA relied in developing the 
proposed standard. Indeed, OSHA believes that it had a responsibility 
to prepare its expert witnesses to present the scientific and technical 
assumptions that underlay the proposal. This preparation, however, does 
not represent improper ``coaching'' the witnesses. See Lead, 647 F.2d 
at 1211-16. None of the expert witnesses testified to anything they did 
not believe; in fact, some criticized aspects of the proposed rule with 
which they disagreed. See e.g., Testimony of Les Boden, Tr. pp. 1683-34 
(``Even though I happen to be here at the request of OSHA, I think it's 
clear that OSHA should reword the language that describes WRP so that 
people like myself, when they first read it, won't think that it means 
that the worker is supposed to be paid 90 percent of their after tax 
earnings * * * .''); Testimony of Laura Punnett, Tr. p. 1011 (``I would 
prefer to see a standard which is based on exposure levels * * * and 
which does not require the occurrence of disorders before a program 
goes into place.'').
    Fourth, OSHA's expert witnesses did not prepare any detailed 
written critiques of public witnesses during the rulemaking process 
that OSHA could have, but did not place in the rulemaking record. The 
commenter who made this allegation, the Chamber, gave no support for 
it, but rather summarily stated: ``the Chamber understands that many of 
these supposed experts have apparently prepared detailed critiques of 
the public comments the Agency received, which have never been released 
to the public, much less subjected to rebuttal or cross-examination.'' 
Ex. 500-188, p. 8 (emphasis added). This allegation is not true. As 
detailed above, OSHA placed in the docket all of the information it 
relied upon in promulgating the standard.
    Fifth and finally, OSHA did not improperly involve expert witnesses 
in the preparation of the proposed and final rule, and in the review 
and analysis of the public comments and hearing transcripts. It is true 
that OSHA hired some experts to help in preparing the proposed and 
final rule and in evaluating the rulemaking record; however, such use 
of experts is not improper. As described above, it is expressly 
authorized by the OSH Act and has been upheld by the D.C. Circuit Court 
of Appeals. Lead, 647 F.2d at 1216 (OSHA properly hired experts ``to 
summarize and evaluate data in the record, prepare record data for 
computer processing, and help draft portions of the Preamble and the 
final standard.''). In the end, OSHA must weigh the evidence and 
determine whether a standard is appropriate and how that standard 
should be designed to substantially reduce a significant risk of 
material harm. After examining all of the evidence in the rulemaking 
record--evidence that was subject to notice and comment--OSHA has made 
the determination that this standard is reasonably necessary and 
appropriate to reduce the significant risk of MSDs. OSHA's use of 
experts in helping to make that determination was not improper or 
inappropriate.

E. Supplemental Hearing on the Economic Impact of the Proposed Standard 
on the United States Postal Service, State and Local Governments, and 
Railroads

    After OSHA published the proposed standard on November 23, 1999, it 
realized that it had failed to include in its Preliminary Economic 
Analysis and Initial Regulatory Flexibility Analysis an assessment of 
the economic impact of the proposed standard on the United States 
Postal Service, State and local governments, and railroads. Once OSHA 
recognized the omission, it conducted a supplemental analysis of the 
economic impact of the proposed standard on these groups (supplemental 
analysis) and published the analysis in the Federal Register. See 65 FR 
33263 (May 23, 2000).
    In order to allow interested parties an opportunity to comment on 
the supplemental analysis, which consisted only of 2 Federal Register 
pages (with a 10 page Technical Appendix), OSHA established a 30 day 
pre-hearing comment period, scheduled an informal public hearing on the 
supplemental analysis, and established a 34 day post-hearing comment 
period. 65 FR 33263 (May 23, 2000). The post-hearing comment period for 
the supplemental analysis closed the same day as the post-hearing 
comment period for the rest of the proposed standard. Id.
    The hearing took place on July 7, 2000 in Atlanta, GA, and 8 
parties filed Notices of Intent to Appear. See Exs. 701; 702. The 
hearing was scheduled to begin at 9:00 a.m. and conclude by the end of 
the day. 65 FR 37322, 37323 (June 14, 2000). An OSHA panel was 
available for questioning on the supplemental analysis from 9:15 a.m. 
until 12:00 p.m. A representative of UPS questioned the panel for more 
than two hours, and the presiding Administrative Law Judge permitted 
one person who had not filed a Notice of Intent to Appear to question 
OSHA for about 10 minutes. See Tr. pp. 18153-55; 18218. A 
representative of the railroad industry was the only party to present 
testimony at the afternoon session--the others having canceled their 
appearances--and the hearing concluded early. See Tr. pp. 18217-81.

[[Page 68841]]

    OSHA's issuance of the supplemental analysis and procedures for 
comment on the analysis were consistent with applicable law. As 
described in detail above, the OSH Act and OSHA's procedural 
regulations require that OSHA provide at least 30 days for interested 
parties to comment on a proposed rule. 29 U.S.C. 655(2); 29 CFR 
1911.11(b)(3). OSHA gave interested parties such an amount of time to 
submit pre-hearing comments on the supplemental analysis.
    OSHA's procedures for seeking comment were also adequate to allow 
interested parties an opportunity to meaningfully comment on the 
supplemental analysis. The supplemental analysis was based in large 
measure on the original Preliminary Economic Analysis published on 
November 23, 1999. Id. at 33264. Interested parties, therefore, were 
familiar with the methodology employed by OSHA in the supplemental 
analysis before it was published on May 23, 2000. Indeed, virtually all 
of the parties who filed a Notice of Intent to Appear at the informal 
public hearing on the supplemental analysis (or who submitted written 
comments on the supplemental analysis) also filed written comments on 
the November 23, 1999 proposal. See e.g., Comments of the United States 
Postal Service, Ex. 35-106; Comments of the Association of American 
Railroads, Ex. 30-3750; Comments of UPS, Ex. 32-241-4.
    Because it was based on the earlier Preliminary Economic Analysis, 
the supplemental analysis was not a large, complicated document. See 
e.g., Ex. 28-15 (Technical Appendix). Interested parties did not need 
to review numerous additional documents to prepare written comments. In 
addition, the industries analyzed in the supplemental analysis 
represented only a small fraction of the total industries affected by 
the proposed rule.
    OSHA therefore disagrees with those commenters who contended that, 
by setting a 30 day pre-hearing comment period and by failing to 
provide a bifurcated post-hearing comment period (i.e., the first part 
of the period for submission of additional data and evidence and the 
second part for post-hearing briefs and argument), OSHA did not provide 
for adequate comment on the supplemental analysis. OSHA gave interested 
parties more than 60 days to comment on the supplemental analysis 
(including the pre-hearing and post-hearing comment period); OSHA 
believes this period of time was more than adequate to allow interested 
parties to review the relevant record material, submit written comments 
and data, and prepare for the informal public hearing. In fact, the 
information supplied by the railroad industry was largely responsible 
for OSHA's decision to reserve for possible future rulemaking the issue 
of the applicability of the final rule to the railroad industry. See 
Discussion in Part IV, Paragraph (b) above.

F. The Post-Hearing Comment Period

    As stated above, the Hearing Procedures established a 90 day post-
hearing comment period for the rulemaking. 65 FR 11948, 11949 (Mar. 7, 
2000). During the first 45 days of the period (until June 26, 2000), 
hearing participants could submit additional data and evidence to the 
rulemaking record. Id. Hearing participants had until August 10, 2000 
to submit post-hearing briefs and arguments. Furthermore, trade 
associations or other groups who filed Notices of Intent to Appear were 
permitted to attach to their post-hearing submissions comments from 
their members who had not participated in the informal public hearing. 
See e.g., Ex. 500-1. Numerous hearing participants availed themselves 
of the post-hearing comment period. For example:
    <bullet> NCE et al. submitted 906 pages of new information and data 
and submitted a 565 page brief. See Exs. 500-118; 500-197.
    <bullet> The Chamber submitted 22 pages of new information and data 
and submitted a 107 page brief. See Exs. 500-109; 500-188.
    <bullet> The AFL-CIO submitted 2072 pages of new information and 
data and submitted a 178 page brief. See Exs. 500-71; 500-97; 500-218.
    <bullet> The American Iron and Steel Institute submitted 186 pages 
of new information and data and submitted a 129 page brief. See Exs. 
500-168; 500-223.
    OSHA and its expert witnesses also participated in the post-hearing 
comment period. OSHA submitted new evidence and data it had obtained 
since publication of the proposal to the docket by June 26, 2000. See 
Ex. 502. Some of OSHA's expert witnesses also submitted new data, 
information, and argument at this time. See e.g., 500-38; 500-134; 500-
84. A few expert witnesses also submitted argument after June 26, 2000. 
See e.g., 500-167. These arguments were postmarked on or before August 
10, 2000, in accordance with the Hearing Procedures. 65 FR 11948, 11949 
(Mar. 7, 2000).
    The 90 day post-hearing comment period and OSHA's participation in 
it were consistent with Agency practice in past OSHA rulemakings, and 
did not deprive any member of the public the opportunity to comment on 
relevant evidence. Past OSHA rulemakings have included post-hearing 
comment periods of similar length. For example:
    <bullet> Powered Industrial Trucks--90 day post-hearing comment 
period. 63 FR 66237 (Dec. 1, 1998).
    <bullet> Cadmium--90 day post-hearing comment period. 57 FR 42101 
(Sept. 14, 1992).
    <bullet> Process Safety Management--90 day post-hearing comment 
period. 57 FR 6356 (Feb. 24, 1992).
    <bullet> Hazard Communication--93 day post-hearing comment period. 
48 FR 53280 (Nov. 25, 1983).
    Indeed, in the Air Contaminants rulemaking the Secretary of Labor 
established a 77 day post-hearing comment period, a shorter period than 
that provided here. 53 FR 34708 (Sept. 7, 1988). As described in more 
detail above, the time allotted for comment in that rulemaking was 
challenged in the 11th Circuit Court of Appeals, which held that those 
comment periods did not deprive individuals of the opportunity to 
comment meaningfully. Air Contaminants, 965 F.2d at 969 n.8.
    Here, too, OSHA believes that the 90 day post-hearing comment 
period was more than adequate to allow interested parties an 
opportunity to submit additional data and argument on the proposed 
rule. As stated above, parties who participated in the informal public 
hearing had 216 days, including the 90 day post-hearing comment period, 
from the date OSHA published the proposed rule to submit data and 
evidence to the rulemaking record for OSHA's consideration. They had 
261 days from the date OSHA published the proposed rule to submit 
briefs and arguments to the rulemaking record. OSHA believes that this 
gave interested parties more than enough time to review the record, 
comment on the evidence submitted, and comment on the proposed rule.
    In addition, the participation of OSHA and its expert witnesses in 
the post-hearing comment period was not improper. See Ex. 803-2. First, 
the Hearing Procedures did not preclude OSHA and its expert witnesses 
from participating in the post-hearing comment period. See 803-2. In 
past rulemakings, OSHA and its expert witnesses have participated fully 
in post-hearing comment periods by submitting data, evidence, and 
argument. See e.g., Docket S775 (Steel Erection); Docket H225 
(Formaldehyde); Docket S048 (Logging); Docket H049 (Respiratory 
Protection). For OSHA and its expert witnesses not to submit additional 
data and information it becomes aware of in the post-hearing

[[Page 68842]]

comment period would be negligent, given OSHA's mandate to consider the 
``best available evidence'' in promulgating a standard. It would also 
give rise to the charge that OSHA was relying in the final standard on 
non-record evidence.
    Second, in accordance with the Hearing Procedures, OSHA and its 
expert witnesses submitted all new data and evidence by June 26, 2000. 
Although some of the material was not scanned into the computer 
database until later, all of the information was available after June 
26, 2000, in hard copy form in the Docket Office. OSHA even prepared a 
finding aid to help interested members of the public locate and review 
the information submitted. Thus, interested members of the public had 
an opportunity to review and comment on all new data and evidence 
submitted by OSHA and its expert witnesses. OSHA admits that a handful 
of its expert witnesses, like many other Hearing Participants, 
submitted post-hearing argument on August 10, 2000. See e.g., Exs. 500-
167; 500-187; 500-173. As explained above, this was permitted under the 
Hearing Procedures. 65 FR 11948, 11949 (Mar. 7, 2000). OSHA does not 
believe that these submissions constituted new information or data, as 
some commenters suggested. See 803-2. Rather, these submissions 
interpreted and analyzed evidence and data that were already a part of 
the rulemaking record. In any events, OSHA has not relied in the final 
standard on comments from its expert witnesses submitted after June 26, 
2000.
    OSHA acknowledges that NIOSH submitted a handful of new studies to 
the rulemaking record after the June 26, 2000 deadline. Because of 
this, OSHA has not relied upon these studies in promulgating this final 
rule; OSHA has also not relied upon the conclusions NIOSH reached in 
its post-hearing brief as evidence in the final standard, even though 
OSHA believes that NIOSH's post-hearing brief represents argument, not 
new data and evidence. OSHA has considered, however, the numerous 
studies NIOSH submitted in accordance with the Hearing Procedures on 
June 26, 2000. See Ex. 500-121. In short, OSHA is not relying in this 
standard on any information that interested parties did not have an 
opportunity to comment upon.
    Finally, OSHA notes that some Hearing Participants submitted new 
evidence and data to the rulemaking record on August 10, 2000. See 
e.g., Ex. 500-219. This new data and evidence was not submitted in 
accordance with the Hearing Procedures and other hearing participants 
did not have an opportunity to comment upon it during the post-hearing 
comment period. See 65 FR 11948, 11949 (Mar. 7, 2000). OSHA is thus 
under no obligation to consider it in promulgating the final rule. Even 
so, OSHA has examined the information and data carefully and given it 
appropriate consideration (consistent with the fact that it has not 
been subject to rebuttal by other hearing participants).
    For these reasons, OSHA does not agree with those commenters who 
have implied that the post-hearing comment period was too brief or that 
OSHA and its expert witnesses improperly participated in the post-
hearing comment period. See e.g., Exs. 803-2; 500-197, p. IV-9.

XIII. Federalism

    OSHA has reviewed the final ergonomics program rule in accordance 
with the Executive Order on Federalism (Executive Order 13132, 64 FR 
43255, August 10, 1999). This Order requires that agencies, to the 
extent possible, refrain from limiting state policy options, consult 
with States prior to taking any actions that would restrict state 
policy options, and take such actions only when there is clear 
constitutional authority and the presence of a problem of national 
scope. The Order provides for preemption of State law only if there is 
a clear Congressional intent for the agency to do so. Any such 
preemption is to be limited to the extent possible.
    Section 18 of the Occupational Safety and Health Act (OSH Act) 
expresses Congress' clear intent to preempt State laws with respect to 
which Federal OSHA has promulgated occupational safety or health 
standards. Under the OSH Act a State can avoid preemption only if it 
submits, and obtains Federal approval of, a plan for the development of 
such standards and their enforcement. Occupational safety and health 
standards developed by such State Plan States must, among other things, 
be at least as effective as the Federal standards in providing safe and 
healthful employment and places of employment.
    Since many work-related MSDs are reported every year in every State 
and since MSD hazards are present in workplaces in every state of the 
Union, the risk of work-related MSD disorders is clearly a national 
problem. The Federal final ergonomics program standard is written so 
that employees in every State would be protected by the standard. To 
the extent that there are any State or regional peculiarities, States 
with occupational safety and health plans approved under Section 18 of 
the OSH Act would be able to develop their own comparable State 
standards to deal with any special problems.
    In short, there is a clear national problem related to occupational 
safety and health for employees exposed to MSD hazards in the 
workplace. Any rule pertaining to ergonomics developed by States that 
have elected to participate under Section 18 of the OSH Act would not 
be preempted by this final rule if the State rule is determined by 
Federal OSHA to be ``at least as effective'' as the Federal rule. 
California has already promulgated a final ergonomics standard, and so 
has Washington. The State of North Carolina has proposed one. Because 
the ergonomics program standard may preempt State rules that are not 
``at least as effective'' as the Federal rule, OSHA has determined that 
it has ``federalism implications'' as defined in Executive Order 13132. 
The order requires consultation with State and local governments for 
regulations that have federalism implications.
    In the course of OSHA's development of this final standard for 
ergonomics, OSHA solicited and received a great deal of participation 
from representatives of state, county and municipal governments. Some 
representatives participated by attending one or more stakeholder 
meetings held by OSHA in the early stages of the rulemaking effort. 
Others participated by submitting written comment or testifying at the 
public hearing. Below is a listing of those who participated in the 
rulemaking process.
    Representatives of the following state, county, and municipal 
entities attended one or more of the OSHA-sponsored stakeholder 
meetings addressing the Ergonomic Program Standard:

    The City of Greensboro, N.C.; the Virginia State Department of 
Labor and Industry; the State of Hawaii Department of Labor; the 
Washington State Department of Labor and Industries; Iowa OSHA; the 
Maryland Occupational Safety and Health Administration; the New York 
State Department of Labor; the North Carolina Safety and Health 
Program, and Utah OSHA.

    Representatives of the following state, county, and municipal 
entities were invited to attend one or more of the OSHA-sponsored 
stakeholder meetings addressing the Ergonomic Program Standard, but 
elected not to send a representative:

    Cal/OSHA Consultation Services; California OSHA; the City of 
Casper, Wyoming; The City of Mt. Airy, North Carolina; the City of 
Portland, Oregon, Bureau of Risk Management; the North Carolina 
Department of Labor; the North

[[Page 68843]]

Carolina League of Municipalities; the Ohio Bureau of Workers' 
Compensation; Oregon OSHA; the State of Kansas Consultation Program, 
and the Texas Workers Compensation Insurance Fund.

    Representatives of the following state, county, and municipal 
entities provided comments to the public rulemaking docket for the 
proposed Ergonomic Program Standard (Docket S-777):

    Butler Rural Elec Cooperative Inc. (Exs. 30-182 and 30-239); 
North Park Public Water District (Ex. 30-212); City of Garner (Ex. 
30-219); Colchester Public Works (Ex. 30-247); Appomattox River 
Water Authority (Ex. 30-248); South Island Public Services District 
(Exs. 30-252; 30-281; and 30-354); Des Moines Water Works (Exs. 30-
254 and 30-279); Mishawaka Utilities (Exs. 30-255 and 30-278); 
Public Works Department (Ex. 30-257); Saginaw Midland Municipal 
Water Supply Corp (Ex. 30-258); Board of Public Utilities (Ex. 30-
261); City of Nashville (Ex. 30-270); Stroudsburg Municipal 
Authority (Ex. 30-271); City of Laurel (Ex. 30-272); City of Drain 
(Ex. 30-273); McCormick Comm of Public Works (Ex. 30-274); Ilion 
Water Comm Municipal Building (Ex. 30-275); Rural Lorain County 
Water Authority (Ex. 30-285); Winchester Municipal Utilities (Ex. 
30-286); Ohio Rural Elec Cooperatives Inc. (Ex. 30-297); St. Louis 
County Water Co (Ex. 30-302); City of East Jordan (Ex. 30-304); 
Clarksdale Public Utilities (Ex. 30-305); Westmont Water Department 
(Ex. 30-342); Bucks County Water and Sewer Authority (Ex. 30-343); 
Town of Hillsborough (Ex. 30-347); Department of Water Supply (Ex. 
30-356); the City of Portsmouth (Ex. 30-357); Cedar Rapids Water 
Department (Ex. 30-366); State of Maine Comm on Labor (Ex. 30-376); 
City of Elko (Ex. 30-377); Arizona School Alliance (Ex. 30-382); New 
Jersey AM Water Co (Ex. 30-402); Fayette County Hospital (Ex. 30-
420); Mohave Union High School District Number 30 (Ex. 30-433); 
Cartwright School District Number 83 (Ex. 30-439); City of 
Murfreesboro (Ex. 30-440); Gurnee Public Works (Ex. 30-450); City of 
David City (Ex. 30-482); Cartwright School District Number 83 (Ex. 
30-492); Tualatin Valley Water District (Ex. 30-495); United Water 
Conservation District (Ex. 30-500); Shoshone Municipal Pipeline (Ex. 
30-501); South Fulton (Ex. 30-504); City of Hood River (Ex. 30-505); 
Municipal Authority of the Township of Robinson (Ex. 30-507); City 
of Petersburg (Ex. 30-508); Town of Greensboro (Ex. 30-510); 
Thermalito Irrigation District (Ex. 30-512); McCloud Comm Services 
District (Ex. 30-513); State of Kansas Department of Human Resources 
(Ex. 30-522); Salt River Project (Ex. 30-526); HI Desert District 
Water (Ex. 30-549); Clear Creek Comm Services District (Ex. 30-553); 
Cucamonga County Water District (Ex. 30-558); Ramona Municipal Water 
District (Ex. 30-578); Clackamas River Water (Ex. 30-579); State 
University of New York (Ex. 30-584); Kyrene School District (Ex. 30-
590); Arizona School Alliance (Ex. 30-591); Pennsylvania State 
Representative (Ex. 30-599); The Arlington Chamber (Ex. 30-600); 
Anchorage Water and Wastewater Utility (Ex. 30-622); Multnomah 
County Oregon (Exs. 30-637 and 500-18); Gilbert Public Schools (Ex. 
30-691); Elsinore Valley Municipal Water District (Ex. 30-693); 
District of Columbia Water and Sewer Authority (Ex. 30-702); 
Bullhead City Schools (Ex. 30-704); Mukilteo Water District (Exs. 
30-714 and 30-982); City of Tampa Water Department (Ex. 30-869); the 
Industrial Commission of Arizona (Ex. 30-877); Valley County Water 
District (Ex. 30-880); Plainview Water District (Ex. 30-900); Lake 
Hemet Municipal Water District (Ex. 30-902); Jordan Valley Water 
Conservancy District (Ex. 30-916); City of David City and David City 
Utilities (Ex. 30-1002); Bellevue Department of Public Works (Ex. 
30-1003); City of Nooksack (Ex. 30-1009); Multnomah County 
Department of Support Services (Ex. 30-1018); Kentucky Labor Cabinet 
(Ex. 30-1024); Olivehain Municipal Water District (Ex. 30-1039); 
Oregon Department of Consumer and Business Services (Ex. 30-1110); 
North Park Public Water District (Ex. 30-1114); Board of Public 
Utilities (Ex. 30-1116); Village of Morrisville Water and Light 
Department (Ex. 30-1118); Pennsylvania Farm Bur (Exs. 30-1121; 30-
1202; and 30-1204); Owatonna Public Utilities (Ex. 30-1124); City of 
Monona (Ex. 30-1125); Consumers Pennsylvania Water Co (Ex. 30-1127); 
Rock Rapids Utilities (Ex. 30-1128); Warminster Municipal Authority 
(Ex. 30-1130); June Lake Public Utility District (Ex. 30-1140); City 
Hall, City of Canyonville (Ex. 30-1206); Central New York Water 
Authority (Ex. 30-1212); Sanitary District No. 4 Town of Brookfield 
(Ex. 30-1247); Nevada Irrigation District (Ex. 30-1262); City of 
Boerne (Ex. 30-1265); Blacksburg Christainsburg VPI Water Authority 
(Ex. 30-1272); Casitas Municipal Water District (Ex. 30-1275); 
Jennings North West Regional Utilities (Ex. 30-1310); Ypsilanti Comm 
Utilities Authority (Ex. 30-1329); Mammoth Comm Water District (Ex. 
30-1376); City of Elko City Hall (Ex. 30-1413); Charter Township of 
Independence (Ex. 30-1415); Town of Oyster Bay, N.Y. (Ex. 30-1447); 
Clear Creek Community Services District (Ex. 30-1471); Washington 
Suburban Sanitary Commission (Ex. 30-1508); Contra Costa Water 
District (Ex. 30-1526); Bona Vista Water Improvement District (Ex. 
30-1527); Stanislaus County (Ex. 30-1531); Alaska Municipal League 
(Ex. 30-1536); Long Beach Public Transportation Co. (Ex. 30-1539); 
Municipal Association of South Carolina (Ex. 30-1583); Salem County 
Utilities Authority (Ex. 30-1714); Texas Department of Criminal 
Justice (Ex. 30-1847); Western Governors Association (Ex. 30-2036); 
State of Kansas Department of Human Resources (Ex. 30-2041); Public 
Hospital District No. 1 of Pend Oreille County (Exs. 30-2731 and 30-
4103); Oregon Department of Consumer and Business Services (Ex. 30-
3022); Point Lookout Village (Ex. 30-3073); Oswego County Ambulance 
(Ex. 30-3186); Louisville Water Company (Ex. 30-3187); Richmond 
Ambulance Authority (Ex. 30-3311); New York Department of Labor (Ex. 
30-3731); Elizabethtown Water Company (Ex. 30-3739); PIMA County 
Risk Management Department (Ex. 30-3968); New York State Thruway 
Authority (Ex. 30-4057); Montana State Fund (Ex. 30-4847); 
Commonwealth of Pennsylvania Department of Labor and Industry (Ex. 
L-30-4932); Attorney General of Missouri (Ex. L-30-5216); Nevada 
City School District (Ex. 31-23); City of Ridgecrest (Ex. 31-135); 
City of De Pere (Ex. 31-137); Sonoma County Water Agency (Ex. 31-
146); Denver Public Schools (Ex. 31-180); Porter Hills Presbyterian 
Village (Exs. 31-209 and 30-220); Stark County Department of Human 
Services (Ex. 31-213); San Diego City Schools (Ex. 31-234); Fairfax 
County Government Risk Management Division (Ex. 31-306); Lewis 
County Public Health (Ex. 31-308); Washington State Farm Bureau (Ex. 
31-312); Indiana Association of Cities and Towns, for Richmond 
Indiana (Ex. 31-328); State of New Mexico Workers Compensation Admin 
(Exs. 500-13-1 thru 500-13-5); Washington Department of Labor and 
Industry (Exs. 500-20-1 thru 500-20-8); Oregon Department of 
Consumer and Business Services (Ex. 500-28-1); Washington State 
Department of Labor and Industry (Exs. 500-41-1 thru 500-41-120); 
State of Oregon Department of Consumer and Business Services (Ex. 
500-71-22); Washington State Department of Labor and Industry (Ex. 
500-86); Oregon Department of Insurance and Finance (Ex. 500-141-1); 
Oregon Workers Compensation Department (Ex. 500-141-2); Oregon 
Department of Insurance and Finance (Ex. 500-141-3); New Mexico 
Workers Compensation Administration (Ex. 500-184-1); City of 
Portland Environmental Services (Ex. 501-4); Washington State (Ex. 
502-67); Alaska Department of Labor (Ex. 502-98); California 
Department of Labor (Ex. 502-104); California Office of Occupational 
Safety and Health (Ex. 502-106); California Department of Industrial 
Relations (Ex. 502-220); Pittsburgh County Memorial Hospital (Ex. 
502-285); Allouez Water Department (Ex. 600-X-15); Goshen Water and 
Sewer Plant (Ex. 600-X-16); Stevens Point Water and Sewage Treatment 
Department (Ex. 600-X-18); City of George West (Ex. 600-X-19); 
Pennsylvania AM Water Company (Ex. 600-X-20); City of Cuyahoga Falls 
(Ex. 600-X-21); Water and Light Department (Ex. 600-X-22); Mars Hill 
Utility District (Ex. 600-X-23); Marshall County Board of Public 
Utilities (Ex. 600-X-24); The City of North Myrtle Beach (Ex. 600-X-
25); Niagara County Water District (Ex. 600-X-26); Old Hickory 
Utility District of Davidson County (Ex. 600-X-27); Bella Vista 
Water District (Ex. 600-X-28); Columbus Water Works (Ex. 600-X-29); 
Dept of Engineering and Public Works (Exs. 600-X-31 and 600-X-67); 
North Carolina General Assembly (Ex. 601-X-391); New Jersey State 
League of Municipalities (Ex. 601-X-444); the Commonwealth of 
Massachusetts (Ex. 601-X-630); Florida House of Representatives 
(Exs. 601-X-712 and 601-X-838); Texas House of Representatives (Ex. 
601-X-946); State of Tennessee (Ex. 601-X-980); Utah State Senate 
(Ex. 601-X-1013); West Virginia Municipal League (Ex. 601-X-1125); 
Rhode Island League of Cities and Towns (Ex. 601-X-1133); New Jersey 
State League of Municipalities (Ex. 601-X-1134); and the City of 
Portland Oregon (Ex. 601-X-1494).
    In addition, representatives of the following state, county, and 
municipal

[[Page 68844]]

entities gave oral testimony at the informal public hearings on the 
proposed Ergonomic Program Standard:

    The New York State Attorney General; the National League of 
Cities; the Montgomery County (Ohio) Administration; the State of 
New Mexico Worker's Compensation Administration; the State of 
California Department of Health and Human Services; the City of 
Portland, Oregon; the Multnomah County, Oregon Government; the 
Oregon Workers' Compensation Division and the State of Washington 
Department of Labor and Industries.

    Representatives of the following state, county, and municipal 
entities provided written comments at the informal public hearing on 
the proposed Ergonomic Program Standard:

    The Wisconsin Department of Industry and Labor (Ex. DC-78); the 
New Jersey Department of Health and Senior Services (Ex. DC-109A); 
Montgomery County, Ohio (Ex. Il-169); the New Mexico Workers' 
Compensation Administration (Ex. Il-222); the City of Portland, 
Oregon (Ex. Or-324); the Oregon Department of Consumer and Business 
Services (Ex. Or-350-1); the State of Oregon Board of Dentistry (Ex 
OR-351-9); the National League of Cities (Ex. DC-371) and the 
Washington State Department of Labor and Industry (Exs. DC 417, 417-
1 and 417-2).

    OSHA's ergonomics rulemaking process has thus involved hundreds of 
representatives from every level of government. Many State governments 
(e.g., Maine, Washington, Oregon, Kansas, Arizona. Kentucky, 
Pennsylvania, New York, Nevada, Texas, Montana, Missouri, New Mexico, 
Alaska, California, Indiana, North Caroline, Massachusetts, Florida, 
Tennessee, Utah and local and municipal governments (e.g., Nashville, 
TN; Portsmouth, VA; Petersburg, AK; Greensboro, NC; Multnomah County, 
OR; District of Columbia, Blackburn-Christainsburg, VA; Ypsilanti, MI; 
Long Beach, CA; Denver, CO; Richmond, IN; Montgomery County, OH) 
participated either by appearing in person at the hearings or 
submitting written comments. Municipal and State entities represented 
included, water districts, school districts, electrical utilities, 
public works departments, municipal authorities, hospitals and long-
term care facilities, labor commissions, human resource departments, 
universities, legislative bodies, industrial commissions, workers' 
compensation administrations, public transportation systems, emergency 
medical services, public highway authorities, emergency medical 
services, public highway authorities, state insurance funds, public 
health departments, and environmental services.
    Representation by governmental entities has been greater for this 
rule than for any other OSHA rule. OSHA has benefitted from the 
information and data provided by these representatives at stakeholder 
meetings held during the years the standard was under development, and 
the Agency has carefully reviewed and considered the oral testimony and 
written submissions of the participants. Many of their comments are 
addressed throughout the preamble to the final rule, others are 
discussed below.
    An examination of the comments revealed that many commenters shared 
similar concerns and views on how to remedy those concerns. OSHA 
received hundreds of comments, for example, expressing concern that the 
proposed standard lacked clarity. Over 80 of these comments were 
identical, raising concerns about coverage, costs and how to comply. 
For example, many commenters said:

    * * * The lack of specificity throws OSHA's estimates of range 
of impact and cost to employers into serious question. It also 
leaves employers attempting to comply in good faith at risk of non-
compliance. Based on these concerns, I therefore, request that OSHA 
review its proposed ergonomics standard and provide clarification 
about both what kind of work and what types of workers are covered 
by it.

    Commenters asked that OSHA clarify its exemption of construction 
work. OSHA has responded in depth to these concerns in the summary and 
explanation of the rule (see the discussion for paragraph (b), Does 
this standard apply to me?) Other commenters asked for clarification as 
to the application of the rule to the agricultural industry, inmates in 
penal institutions, the manufacturing industry, the ambulance industry, 
and the solid waste management industry. These issues are also 
addressed in the summary and explanation for paragraph (b). Some of the 
specific comments are discussed in greater detail below.
    Some commenters complained the proposal was too long; the comment 
period too short and then questioned the science used by OSHA, 
suggesting that OSHA table its work until the National Academy of 
Sciences completes its second literature review. (Exs.30-1018; 30-1536; 
and 30-1847). Comments addressing procedural issues are discussed in 
the Procedural Issues section of the preamble; those on the science 
supporting this rule are reviewed in the Health Effects section 
(Section V).
    The Des Moines Water Works, the Oregon Department of Consumer and 
Business Services, the Alaska Municipal League, and the Long Beach 
Public Transportation Company (See, e.g., Exs. 30-254; 30-1110; 30-
1536; 30-1539;), among many others, expressed concerns regarding the 
effect of the rule on Workers' Compensation Systems and suggested that 
workers' comp is an area best left to the states to address. Some 
commenters questioned whether OSHA had the authority to address issues 
related to workers' compensation systems and questioned whether OSHA's 
cost estimates included the cost to be expended by ``every company in 
the nation in renegotiate their workers compensation premium costs with 
insurance companies for these WRP payments?'' (Ex. 30-254). Issues 
raised by commenters about workers' compensation and its relation, or 
lack of it, to OSHA's work restriction protections, are responded to in 
the summary and explanation for paragraph (r).
    The Pennsylvania Farm Bureau (Ex. 30-1121) said the proposal raised 
concerns for farm employers even though OSHA did not propose to apply 
the rule to agriculture. One concern cited by this commenter was that 
farmers would be affected by higher costs passed on to them by 
suppliers and others directly impacted by the rule. Another concern 
expressed by the Bureau was the extent to which agricultural operations 
were exempt from the rule. The Bureau cited various OSHA 
interpretations and language used to clarify when general industry and 
agricultural standards applied as the reason for their concern. The 
Pennsylvania Farm Bureau stated that OSHA should exclude agriculture 
from the coverage of the proposed standard. Similar concerns on this 
issue were raised by the Pennsylvania Farm Bureau, the New York Farm 
Bureau, the North Carolina Farm Bureau Federation, and others (See 
e.g., Ex. 30-1201; 30-1418; 30-1421) as well as individual farmers (See 
e.g., Ex. 30-1202 and 30-1204). OSHA notes that the final Ergonomic 
Program Standard does not apply to agricultural operations. A full and 
complete discussion of this issue can be found in the summary and 
explanation for paragraph (b), Does this standard apply to me?
    Some commenters (Exs. 30-1536 and 30-1583) who are members of the 
National League of Cities (NLC) noted that the NLC does not support the 
application of the federal ergonomics standards to municipal 
governments. They cited their inability to obtain funding and their 
lack of technical resources to put an ergonomic program together as 
reasons for the objection. OSHA will provide considerable

[[Page 68845]]

compliance assistance to the regulated community that may help NLC 
members reduce expenditures and develop solutions. These materials will 
be listed on OSHA's website at www.osha.gov.
    The Salem County Utilities Authority (Ex. 30-1714) registered their 
support for the position of the National Solid Wastes Management 
Association's (NSWMA) request that the solid waste management industry 
be exempt from the ergonomic program standard. This commenter listed a 
number of reasons similar to those set out by OSHA in the proposed rule 
as the basis for the exemption of the construction, maritime and 
agricultural industries. OSHA's response to NSWMA's concerns are 
addressed in connection with paragraph (b) of the summary and 
explanation.
    The Texas Department of Criminal Justice (TDCJ) (Ex. 30-1847) 
requested an exemption for correctional worker positions and asked for 
clarification of the applicability of the rule to prisoners assigned to 
manufacturing positions. Like other commenters, TDCJ expressed concern 
about the number of new staff that would be needed, in their view, to 
comply with the ergonomics program standard.
    The Butler Rural Electric Cooperative, Inc. (Ex. 30-182) 
acknowledged the importance of an ergonomics program and provided 
details on the work already done by Butler; however, they believe that 
the OSHA ergonomics program standard is not necessary because OSHA 
could continue to rely on the General Duty Clause to do the job. In 
addition, Butler raised some concerns about the Work Restriction 
Protection provisions of the proposal, which they believe will 
encourage fraud. Again, these are areas of concern that have been 
raised by other commenters and are discussed at length in the summary 
and explanation section for paragraph (r).
    The Stanislaus County (CA) Risk Management Division (Ex. 30-1531) 
suggested that more specific guidance was needed to help employers 
comply with the standard. They supported the grandfather clause, 
stating that ``Stanislaus County has saved millions of dollars over the 
last six years with the implementation of our injury and loss 
prevention program. One of these programs includes ergonomics.'' They 
support the grandfather clause because they believe ``There should be 
some incentive for those employers who are already making a good faith 
effort, with programs in place, to be rewarded, and we would encourage 
you to keep the grandfather clause.'' In response, OSHA notes that the 
final rule contains a grandfather clause (see paragraph (c)).
    The Long Beach Public Transportation Company (Ex. 30-1539) stated 
their agreement with the fundamental concepts proposed by OSHA, but 
expressed some opposition regarding the classification of MSDs and the 
standard's potential impact on workers compensation laws. Long Beach 
Transportation encouraged OSHA ``to provide education to promote even 
more voluntary employer ergonomic programs to address the issues of 
MSDs.'' The concluding comment of this entity was that ``The Standard, 
as proposed, however would place an economic and regulatory burden on 
employers, would treat injured employees inequitably and would 
jeopardize voluntary systems already in place to address this issue.'' 
This view was also expressed by many commenters from state, county and 
municipal governments. In response, OSHA notes that employers and 
entities covered by the rule can anticipate to reap substantial 
benefits from their programs (see the discussion of the results 
achieved by others in the final economic analysis).
    The Richmond Ambulance Authority (RAA) (Ex. 30-3311) stated that 
they ``applaud and support OSHA's effort to address ergonomic concerns 
in the workplace.'' This commenter then listed a few areas of concern 
and noted that the exemption criteria for industries with special 
compliance issues clearly apply to the ambulance industry. The RAA said 
that ``compliance efforts by members of the ambulance industry would be 
extremely costly'' and urged OSHA to exclude back pain from the kinds 
of MSDs covered.
    OSHA is grateful to the many state, local, municipal, other 
government entities who have participated actively in this rulemaking. 
All the concerns raised by these commenters have been considered, and 
many changes to the rule have been made based on the comments and 
suggestions provided by these participants.

XIV. State Plans States

    The 23 states and 2 territories which operate their own Federally-
approved occupational safety and health plans must adopt a comparable 
standard within six months of the publication date of a final standard. 
These States include: Alaska, Arizona, California, Connecticut (for 
State and local government employees only), Hawaii, Indiana, Iowa, 
Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, New York 
(for State and local government employees only), North Carolina, 
Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, 
Virginia, Virgin Islands, Washington, Wyoming. Until such time as a 
state or territorial standard is promulgated, Federal OSHA will provide 
interim enforcement assistance, as appropriate.

XV. OMB Review Under the Paperwork Reduction Act of 1995

    This final ergonomics program standard contains collections of 
information (paperwork) that are subject to review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(PRA'95), 44 U.S.C. 3501 et seq. and its regulation at 5 CFR Sec. 1320. 
PRA'95 defines collection of information to mean, ``the obtaining, 
causing to be obtained, soliciting, or requiring the disclosure to 
third parties or the public of facts or opinions by or for an agency 
regardless of form or format.'' [44 U.S.C. Sec. 3502(3)(A)]. OSHA 
submitted an Information Collection Request (ICR) for OMB approval when 
the proposed rule for the ergonomic program standard was published on 
November 23, 1999. OMB did not approve the ergonomic program's 
information collection provisions at that time, but instructed the 
Agency that future ICR submissions should use the OMB control number 
1218-0245. OSHA has submitted a final ICR estimating the paperwork 
burden hours and costs, to OMB as required by 5 CFR Sec. 1320.11(h) for 
approval. Public comments regarding paperwork issues are addressed in 
the Summary and Explanation, and Cost and Benefit chapters of the final 
standard.
    The following section provides information on the collections of 
information contained in the final ergonomics program standard, as 
required by 5 CFR Sec. 1320.5(a)(1)(iv) and Sec. 1320.8(d)(2) . It 
describes the collections of information, the need for and proposed use 
of the information, and the covered employers who will be required to 
collect and maintain information under the standard. The section also 
discusses the required time periods for collecting and maintaining this 
information, and provides an estimate of the annual cost and reporting 
burden. (Reporting burden includes the time for reviewing instructions, 
gathering and maintaining the data needed, and completing and reviewing 
the collection of information.)
    Title: The ergonomics program standard, 29 CFR Sec. 1910.900.
    Description: The final ergonomics program standard addresses the 
significant risk of work-related MSDs confronting employees in various 
jobs in general industry workplaces. The standard's information 
collection requirements are essential components

[[Page 68846]]

that will help employers and employees to recognize work-related MSDs 
and to determine what must be done to address these MSDs and MSD 
hazards in the workplace. OSHA compliance officers will use some of the 
information in their enforcement of the standard.
    Summary of the Collections of Information: The final ergonomics 
standard requires employers to do the following: familiarize themselves 
with the final standard; provide basic ergonomic information to their 
employees; receive employees' reports of musculoskeletal disorders 
(MSDs) or MSD signs or symptoms; and determine if a reported MSD is 
work-related and if the employee's job meets the standard's Action 
Trigger. If an employee's job meets the standard's Action Trigger, the 
employer will incur additional paperwork requirements in complying with 
the ergonomics program requirement or the quick fix option.
    MSD management is triggered when the employee experiences a work-
related MSD that meets the Action Trigger and requires medical 
treatment beyond first aid, or involves MSD signs or MSD symptoms that 
last for 7 or more consecutive days after the employee first reports 
them to the employer. The employer must provide that employee with 
access to a health care professional (HCP). When the employee consults 
with an HCP, the employer must obtain a written opinion from the HCP 
and provide a copy of that opinion to the employee. The employer must 
provide the HCP with a description of the employee's job and 
information about the physical work activities, risk factors, and MSD 
hazards in the job; a copy of this standard; and a list of items that 
the HCP's written opinion must contain, including temporary work 
restrictions, if necessary.
    Paperwork requirements for employers to develop and implement the 
ergonomic program include: management leadership, employee 
participation in the employer's ergonomic program, job hazard analysis, 
hazard control measures, and evaluation of the ergonomic program.
    Employers with 10 or more employees, including part-time employees, 
must keep written or electronic records of the following: (i) Employee 
reports of MSDs, their signs and symptoms and MSD hazards, (ii) 
Employer's response to employee reports; (iii) Job Hazard Analysis; 
(iv) Hazard control measures, (v) Quick fix process, (vi) Ergonomics 
program evaluations, and (vii) Records of work restrictions and the HCP 
written opinions. Employers must keep all records, except the HCP 
written opinion, for 3 years or until replaced by updated records, 
whichever comes first. The HCP written opinion must be kept for the 
duration of the employee's employment plus 3 years.
    Employers must provide employees, their representatives, OSHA, and 
NIOSH access to the above records, except the HCP opinions, for 
examination and copying in accordance with the procedures and time 
periods provided in 29 CFR 1910.1020(e)(1), (e)(2)(ii), (e)(3) and (f). 
Employers must provide the HCP opinion to employees, to anyone having 
the specific written consent of the employee, to OSHA, and to NIOSH 
upon request for examination and copying in accordance with the 
procedures and time periods provided in 29 CFR 1910.1020(e)(1), 
(e)(2)(ii), (e)(3) and (f).
    Respondents: Employers in general industry. The standard does not 
apply to employment covered by the following OSHA standards, or to 
employment such as office management and support services directly 
related to that employment: (i) OSHA construction standards in Part 
1926; (ii) OSHA's maritime standards in Part 1915, 1917, or 1918; or 
OSHA's agriculture standards in Part 1928. The standard also does not 
apply to railroad operations or to employment such as office management 
and support services directly related to the operation of a railroad.
    Frequency of Response: All employers must provide basic ergonomic 
information to current and new employees. The frequency of other 
paperwork requirements is determined by whether the employer has an 
employee who has experienced an MSD incident, and whether the 
employee's job meets the standard's Action Trigger.
    Average Time Per Response: Time per response varies, from minimal 
recordkeeping requirements for a quick fix situation, to establishing 
and implementing a complete ergonomics program.
    Total Burden Hours: Approximately 36.5 million hours.
    Estimated Costs (Operating and Maintenance): $61 million 
(purchasing services).

XVI. Authority and Signature

    This document was prepared under the direction of Charles N. 
Jeffress, Assistant Secretary of Labor for Occupational Safety and 
Health, U.S. Department of Labor for Occupational Safety and Health, 
U.S. Department of Labor, 200 Constitution Avenue, NW, Washington, DC 
20210.
    This final standard is issued pursuant to sections 4, 6, and 8 
Occupational Safety and Health Act, 29 U.S.C. 653, 655, 657, Secretary 
of Labor's Order No. 3-2000 (65 FR 50017) and 29 CFR Part 1911.

List of Subjects in 29 CFR Part 1910

    Ergonomics program, Health, Musculoskeletal disorders, Occupational 
safety and health, reporting and recordkeeping requirements.

    Signed at Washington, DC, this 6th day of November 2000.
Charles N. Jeffress,
Assistant Secretary of Labor for Occupational Safety and Health.

XVII. The Standard

    The Occupational Safety and Health Administration is amending Part 
1910 of title 29 of the Code of Federal Regulations as follows:

PART 1910--[AMENDED]

    New Subpart W of 29 CFR Part 1910 is added to read as follows:
Subpart W--Program Standards
Sec.
1910.900   Ergonomics program standard.

Subpart W--Program Standards

    Authority: Secs. 4, 6, and 8, Occupational Safety and Health 
Act, 29 U.S.C. 653, 655, 657, Secretary of Labor's Order No. 3-2000 
(65 FR 50017); and 29 CFR Part 1911.


Sec. 1910.900  Ergonomics Program Standard.

    (a) What is the purpose of this standard? The purpose of this 
standard is to reduce the number and severity of musculoskeletal 
disorders (MSDs) caused by exposure to risk factors in the workplace. 
This standard does not address injuries caused by slips, trips, falls, 
vehicle accidents, or similar accidents.

    Note to paragraph (a): Definitions of terms used in this 
standard are in paragraph (z) of this section.

    (b) Does this standard apply to all employers? This standard covers 
all employers covered by the Act with the following exceptions:
    This standard does not apply to employment covered by the following 
OSHA standards, or to employment such as office management and support 
services directly related to that employment:
    (i) OSHA's construction standards in Part 1926 of this chapter;
    (ii) OSHA's maritime standards in Part 1915, 1917, or 1918 of this 
chapter; or
    (iii) OSHA's agriculture standards in Part 1928 of this chapter.

[[Page 68847]]

    (2) This standard does not apply to railroad operations or to 
employment such as office management and support services directly 
related to the operation of a railroad.
    (c) How does this standard apply if I already have an ergonomics 
program in place when the OSHA ergonomics program standard becomes 
effective? 
    (1) You may continue to implement your program instead of complying 
with paragraphs (d) through (y) of this section, provided that your 
program is written, complies with the requirements of paragraph (c) of 
this section, has been implemented before November 14, 2000, and 
contains the following program elements:
    (i) Management leadership, as demonstrated by an effective MSD 
reporting system and prompt responses to reports, clear program 
responsibilities, and regular communication with employees about the 
program;
    (ii) Employee participation, as demonstrated by the early reporting 
of MSDs and active involvement by employees and their representatives 
in the implementation, evaluation, and future development of your 
program;
    (iii) Job hazard analysis and control, as demonstrated by a process 
that identifies, analyzes, and uses feasible engineering, work 
practice, and administrative controls to control MSD hazards or to 
reduce MSD hazards to the levels below those in the hazard 
identification tools in Appendix D to this section or to the extent 
feasible, and evaluates controls to assure that they are effective;

    Note to paragraph (c)(1)(iii): Personal protective equipment 
(PPE) may be used to supplement engineering, work practice, 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.

    (iv) Training of managers, supervisors, and employees (at no cost 
to these employees) in your ergonomics program and their role in it; 
the recognition of MSD signs and symptoms; the importance of early 
reporting; the identification of MSD hazards in jobs in your workplace; 
and the methods you are taking to control them; and
    (v) Program evaluation, as demonstrated by regular reviews of the 
elements of the program and of 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 MSD 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 January 16, 2001.
    (2) By January 16, 2002, you must have implemented a policy that 
provides MSD management as specified in paragraphs (p), (q), (r), and 
(s) of this section.
    (3) An employer who has policies or procedures that discourage 
employees 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 under paragraph (c) of this section.
    (d) If the standard applies to me, what initial action must I take?
    (1) You must provide each current and each new employee basic 
information about:
    (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 your 
workplace;
    (iv) The kinds of risk factors, jobs and work activities associated 
with MSD hazards; and
    (v) A short description of the requirements of OSHA's ergonomics 
program standard.
    (2) You must make available to the employee a summary of the 
requirements of this standard.
    (3) You must provide the information in written form or, if all 
employees have access, in electronic form. You must provide the 
information to new employees within 14 days of hiring. You must post 
the information in a conspicuous place in the workplace (e.g., employee 
bulletin board or, if all employees have access, electronic posting).

    Note to paragraph (d): You may use the information sheet in non-
mandatory Appendix A to this section to comply with paragraphs 
(d)(1) of this section and the summary sheet in non-mandatory 
Appendix B to this section to comply with paragraph (d)(2) of this 
section.

    (e) What must I do when an employee reports an MSD or the signs or 
symptoms of an MSD?
    (1) You must promptly determine whether the reported MSD or MSD 
signs or symptoms qualify as an MSD incident. You may request the 
assistance of a Health Care Professional (HCP) in making this 
determination. A report is considered to be an MSD incident in the 
following two cases:
    (i) The MSD is work-related and requires days away from work, 
restricted work, or medical treatment beyond first aid; or
    (ii) The MSD signs or symptoms are work-related and last for 7 
consecutive days after the employee reports them to you.
    (2) If the employee has experienced an MSD incident, you must 
determine whether the job meets the standard's Action Trigger. See 
paragraph (f) of this section.
    (3) If the employee has not experienced an MSD incident, you do not 
need to take further action.
    (f) How do I determine whether the employee's job meets the Action 
Trigger?
    (1) A job meets the Action Trigger if:
    (i) An MSD incident has occurred in that job; and
    (ii) The employee's job routinely involves, on one or more days a 
week, exposure to one or more relevant risk factors at the levels 
described in the Basic Screening Tool in Table W-1.
    (2) If the employee's job does not meet the Action Trigger, you do 
not need to take further action.
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[[Page 68850]]

    (g) What actions must I take if the employee's job meets the Action 
Trigger? For the employee's job and all jobs in the establishment that 
are the same as that job, you must either:
    (1) Comply with the Quick Fix option in paragraph (o) of this 
section, or
    (2) 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.
    (h) What must I do to demonstrate management leadership? You must:
    (1) Assign and communicate responsibilities for setting up and 
managing the ergonomics program;
    (2) Provide designated persons with the authority, resources, and 
information necessary to meet their responsibilities;
    (3) Ensure that your policies and practices encourage and do not 
discourage:
    (i) The early reporting of MSDs, their signs and symptoms, and MSD 
hazards; and
    (ii) Employee participation in the ergonomics program;
    (4) Communicate periodically with employees about the ergonomics 
program and their concerns about MSDs.
    (i) What must I do to ensure employee participation in my program? 
You must ensure that employees and their representatives:
    (1) Have ways to promptly report MSDs, MSD signs and symptoms, and 
MSD hazards in your workplace;
    (2) Receive prompt responses to their reports of MSDs, MSD signs 
and symptoms, and MSD hazards;
    (3) Are provided with a summary of the requirements of this 
standard, as specified in paragraph (d)(2) of this section, and have 
ready access to a copy of this standard and to information about MSDs, 
MSD signs and symptoms, MSD hazards, and your ergonomics program; and
    (4) Have ways to be involved in the development, implementation, 
and evaluation of your ergonomics program.
    (j) What must I do to determine whether a job that meets the Action 
Trigger poses an MSD hazard to employees in that job?
    (1) You must conduct a job hazard analysis for that job. You may 
rely on an analysis previously conducted in accordance with this 
section to the extent it is still relevant.
    (2) Your job hazard analysis must include all employees who perform 
the same job, or a sample of employees in that job who have the 
greatest exposure to the relevant risk factors, and include the 
following steps:
    (i) Talk with those employees and their representatives about the 
tasks the employees perform that may relate to MSDs; and
    (ii) 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 those risk factors.
    (3) You must use one or more of the following methods or tools to 
conduct this analysis:
    (i) One or more of the hazard identification tools listed in 
Appendix D-1 to this section, if the tools are relevant to the risk 
factors being addressed;
    (ii) The occupation-specific hazard identification tool in Appendix 
D-2 to this section;
    (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.
    (4) If you determine that there is an MSD hazard in the job, the 
job will be termed a ``problem job.''

    Note to paragraph (j): If you determine that the MSD hazards 
pose a risk only to the employee who reported the MSD, you may limit 
your job controls, training and evaluation to that individual 
employee's job.

    (k) What is my obligation to reduce MSD hazards in a problem job?
    (1) You must:
    (i) Control MSD hazards; or
    (ii) Reduce MSD hazards in accordance with or to levels below those 
in the hazard identification tools in Appendix D to this section; or
    (iii) If you cannot reduce MSD hazards in accordance with 
paragraphs (k)(1)(i) or (k)(1)(ii) of this section, you must do the 
following:
    (A) Reduce MSD hazards to the extent feasible;
    (B) At least every 3 years, assess the job and determine whether 
there are additional feasible controls that would control or reduce MSD 
hazards; and
    (C) If such controls exist, implement them until you have reduced 
the MSD hazards in accordance with paragraphs (k)(1)(i) or (k)(1)(ii) 
of this section.
    (2) If a work-related MSD occurs in a job whose hazard(s) you have 
reduced to the levels specified in paragraph (k)(1) of this section, 
you must:
    (i) Ensure that appropriate controls are still in place, are 
functioning, and are being used properly, and
    (ii) Determine whether new MSD hazards exist and, if so, take steps 
to reduce the hazards as specified in paragraph (m) of this section.

    Note to paragraph (k): The occurrence of an MSD in a problem job 
is not in itself a violation of this standard.

    (l) What kinds of controls must I use to reduce MSD hazards?
    (1) For each problem job, you must use feasible engineering, work 
practice or administrative controls, or any combination of them, to 
reduce MSD hazards in the job. Where feasible, engineering controls are 
the preferred method of control.
    (2) You may use personal protective equipment (PPE) to supplement 
engineering, work practice or administrative controls, but you may use 
PPE alone only where other controls are not feasible. Where you use 
PPE, you must provide it at no cost to employees.
    (m) What steps must I take to reduce MSD hazards? You must:
    (1) Ask employees in the problem job and their representatives to 
recommend measures to reduce MSD hazards;
    (2) Identify and implement initial controls within 90 days after 
you determine that the job meets the Action Trigger. Initial controls 
mean controls that substantially reduce the exposures even if they do 
not reach the levels specified in paragraph (k)(1) of this section.
    (3) Identify and implement permanent controls that meet the levels 
specified in paragraph (k)(1) of this section within 2 years after you 
determine that a job meets the Action Trigger, except that initial 
compliance can take up to January 18, 2005 whichever is later.
    (4) Track your progress and ensure that your controls are working 
as intended and have not created new MSD hazards. This includes 
consulting with employees in problem jobs and their representatives. If 
the controls are not effective or have created new MSD hazards, you 
must use the process in paragraphs (m)(1) and (m)(2) of this section to 
identify additional control measures that are appropriate and

[[Page 68851]]

implement any such measures identified.
    (n) [Reserved].
    (o) May I use a Quick Fix instead of setting up a full ergonomics 
program?
    (1) You may use a Quick Fix for a job if your employees have 
experienced no more than one MSD incident in that job, and there have 
been no more than two MSD incidents in your establishment, in the 
preceding 18 months.
    (2) To use a Quick Fix, you must:
    (i) Provide the MSD management required by paragraphs (p), (q), 
(r), and (s) of this section, as appropriate, to the employee promptly 
after you determine that the employee's job meets the Action Trigger;
    (ii) Talk with employees in the job and their representatives about 
the tasks the employees perform that may relate to the MSD incident; 
and
    (iii) Observe employees performing the job to identify which risk 
factors are likely to have caused the MSD incident;
    (iv) Ask the employee(s) performing the job and their 
representatives to recommend measures to reduce exposure to the MSD 
hazards identified;
    (v) Within 90 days of your determination that the job meets the 
Action Trigger in paragraph (e) of this section, implement controls in 
the job in accordance with paragraph (l) of this section that control 
the MSD hazards or reduce MSD hazards in accordance with or to levels 
below those in the hazard identification tools in Appendix D to this 
section, and train the employee(s) in the use of these controls;
    (vi) Within 30 days after you implement the controls, review the 
job to determine whether you have reduced the MSD hazards to the levels 
specified in paragraph (o)(2)(v) of this section; and
    (vii) Keep a record of the Quick Fix process for each job to which 
it is applied. You must keep the record for 3 years.
    (3) If you determine that you have reduced the MSD hazards to the 
levels specified in paragraph (o)(2)(v) of this section, you need take 
no further action except to maintain controls, the training related to 
those controls, and recordkeeping.
    (4) If you have not reduced MSD hazards to the levels specified in 
paragraph (o)(2)(v) of this section, you must implement an ergonomics 
program, as specified in paragraph (g) of this section.
    (p) What MSD management process must I implement for an employee 
who experiences an MSD incident in a job that meets the Action Trigger?
    (1) You must provide the employee with prompt and effective MSD 
management at no cost to the employee. MSD management must include:
    (i) Access to a Health Care Professional (HCP);
    (ii) Any necessary work restrictions, including time off work to 
recover;
    (iii) Work restriction protection; and
    (iv) Evaluation and follow-up of the MSD incident.
    (2) You must obtain a written opinion from the HCP for each 
evaluation conducted under this standard, and provide a copy to the 
employee. You must instruct the HCP that the opinion may not include 
any findings or information that is not related to workplace exposure 
to risk factors, and that the HCP may not communicate such information 
to the employer, except when authorized to do so by State or Federal 
law.
    (3) Whenever an employee consults an HCP for MSD management, you 
must provide the HCP with the following:
    (i) A description of the employee's job and information about the 
physical work activities, risk factors and MSD hazards in the job;
    (ii) A copy of this standard; and
    (iii) A list of information that the HCP's opinion must contain.

    Note to paragraph (p): MSD management under this standard does 
not include medical treatment, emergency or post-treatment 
procedures.

    (q) What information must the HCP's opinion contain? The HCP's 
opinion must contain:
    (1) The HCP's assessment of the employee's medical condition as 
related to the physical work activities, risk factors and MSD hazards 
in the employee's job;
    (2) Any recommended work restrictions, including, if necessary, 
time off work to recover, 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 exposure to 
physical work activities, risk factors and MSD hazards in the 
employee's job; and
    (4) A statement that the HCP has informed the employee about work-
related or other activities that could impede recovery from the injury.
    (r) What must I do if temporary work restrictions are needed?
    (1) If an employee experiences an MSD incident in a job that meets 
the Action Trigger, you must provide the employee with any temporary 
work restrictions or time off work that the HCP determines to be 
necessary, or if no HCP was consulted, that you determine to be 
necessary.
    (2) Whenever you place limitations on the work activities of the 
employee in his or her current job or transfer the employee to a 
temporary alternative duty job in accordance with paragraph (r)(1) of 
this section, you must provide that employee with Work Restriction 
Protection, which maintains the employee's employment rights and 
benefits, and 100% of his or her earnings, until the earliest of the 
following three events 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 determination review 
provisions in paragraph (s) of this section, that the employee can 
never resume his or her former work activities; or
    (iii) 90 calendar days have passed.
    (3) Whenever an employee must take time off from work in accordance 
with paragraph (r)(1) of this section, you must provide that employee 
with Work Restriction Protection, which maintains the employee's 
employment rights and benefits and at least 90% of his or her earnings 
until the earliest of the following three events occurs:
    (i) The employee is able to return to the former job without 
endangering his or her recovery;
    (ii) An HCP determines, subject to the determination review 
provisions in paragraph (s) of this section, that the employee can 
never return to the former job; or
    (iii) 90 calendar days have passed.
    (4) You may condition the provision of WRP on the employee's 
participation in the MSD management that this standard requires.
    (5) Your obligation to provide WRP benefits to a temporarily 
restricted or removed employee is reduced to the extent that the 
employee receives compensation for earnings lost during the work 
restriction period from either a publicly or an employer-funded 
compensation or insurance program, or receives income from employment 
made possible by virtue of the employee's work restriction.

    Note to paragraph (r): The employer may fulfill the obligation 
to provide work restriction protection benefits for employees 
temporarily removed from work by allowing the employees to take sick 
leave or other similar paid leave (e.g., short-term disability 
leave), provided that such leave maintains the worker's benefits and 
employment rights and provides at least 90% of the employee's 
earnings.

    (s) What must I do if the employee consults his or her own HCP?
    (1) If you select an HCP to make a determination about temporary 
work restrictions or work removal, the

[[Page 68852]]

employee may select a second HCP to review the first HCP's finding at 
no cost to the employee. If the employee has previously seen an HCP on 
his or her own, at his or her own expense, and received a different 
recommendation, he or she may rely upon that as the second opinion;
    (2) If your HCP and the employee's HCP disagree, you must, within 5 
business days after receipt of the second HCP's opinion, take 
reasonable steps to arrange for the two HCPs to discuss and resolve 
their disagreement;
    (3) If the two HCPs are unable to resolve their disagreement 
quickly, you and the employee, through your respective HCPs, must, 
within 5 business days after receipt of the second HCP's opinion, 
designate a third HCP to review the determinations of the two HCPs, at 
no cost to the employee;
    (4) You must act consistently with the determination of the third 
HCP, unless you and the employee reach an agreement that is consistent 
with the determination of at least one of the HCPs;
    (5) You and the employee or the employee's representative may agree 
on the use of any expeditious alternative dispute resolution mechanism 
that is at least as protective of the employee as the review procedures 
in paragraph (s) of this section.
    (t) What training must I provide to employees in my establishment?
    (1) You must provide initial training, and follow-up training every 
3 years, for:
    (i) Each employee in a job that meets the Action Trigger;
    (ii) Each of their supervisors or team leaders; and
    (iii) Other employees involved in setting up and managing your 
ergonomics program.
    (2) The training required for each employee and each of their 
supervisors or team leaders must address the following topics, as 
appropriate:
    (i) The requirements of the standard;
    (ii) Your ergonomics program and the employee's role in it;
    (iii) The signs and symptoms of MSDs and ways of reporting them;
    (iv) The risk factors and any MSD hazards in the employee's job, as 
identified by the Basic Screening Tool in Table W-1 and the job hazard 
analysis;
    (v) Your plan and timetable for addressing the MSD hazards 
identified;
    (vi) The controls used to address MSD hazards; and
    (vii) Their role in evaluating the effectiveness of controls .
    (3) The training for each employee involved in setting up and 
managing the ergonomics program must address the following:
    (i) Relevant topics in paragraph (t)(2) of this section;
    (ii) How to set up, manage, and evaluate an ergonomics program;
    (iii) How to identify and analyze MSD hazards and select and 
evaluate measures to reduce the hazards.
    (4) You must provide initial training to:
    (i) Each employee involved in setting up and managing your 
ergonomics program within 45 days after you have determined that the 
employee's job meets the Action Trigger;
    (ii) Each current employee, supervisor and team leader within 90 
days after you determine that the employee's job meets the Action 
Trigger;
    (iii) Each new employee or current employee prior to starting a job 
that you have already determined meets the Action Trigger;
    (5) You do not have to provide initial training in a topic that 
this standard requires to an employee who has received training in that 
topic within the previous 3 years.
    (6) You must provide the training required by paragraph (t) of this 
section in language that the employee understands. You must also give 
the employee an opportunity to ask questions about your ergonomics 
program and the content of the training and receive answers to those 
questions.
    (u) What must I do to make sure my ergonomics program is effective?
    (1) You must evaluate your ergonomics program at least every 3 
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 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.
    (2) You must also evaluate your program, or a relevant part of it, 
when you have reason to believe that the program is not functioning 
properly.
    (3) If your evaluation reveals deficiencies in your program, you 
must promptly correct the deficiencies.

    Note to paragraph (u): The occurrence of an MSD incident in a 
problem job does not in itself mean that the program is ineffective.

    (v) What is my recordkeeping obligation?
    (1) If you have 11 or more employees, including part-time or 
temporary employees, you must keep written or electronic records of the 
following:
    (i) Employee reports of MSDs, MSD signs and symptoms, and MSD 
hazards,
    (ii) Your response to such reports,
    (iii) Job hazard analyses,
    (iv) Hazard control measures,
    (v) Quick fix process,
    (vi) Ergonomics program evaluations, and
    (vii) Work restrictions, time off of work, and HCP opinions.
    (2) You must provide all records required by this standard, other 
than the HCP opinions, upon request, for examination and copying, to 
employees, their representatives, the Assistant Secretary and the 
Director in accordance with the procedures and time periods provided in 
Sec. 1910.1020(e)(1), (e)(2)(i), (e)(3), and (f).
    (3) You must provide the HCP opinion required by this standard, 
upon request, for examination and copying, to the employee who is the 
subject of the opinion, to anyone having the specific written consent 
of the employee, and to the Assistant Secretary and the Director in 
accordance with the procedures and time periods provided in 
Sec. 1910.1020(e)(1), (e)(2)(ii), (e)(3), and (f).
    (4) You must keep all records for 3 years or until replaced by 
updated records, whichever comes first, except the HCP's opinion, which 
you must keep for the duration of the employee's employment plus 3 
years.
    (5) You do not have to retain the HCP opinion beyond the term of an 
employee's employment if the employee has worked for less than one year 
and if you provide the employee with the records at the end of his or 
her employment.
    (w) When does this standard become effective? This standard becomes 
effective January 16, 2001.
    (x) When must I comply with the provisions of the standard?
    (1) You must provide the information in paragraph (d) of this 
section to your employees by October 15, 2001. After that date you must 
respond to employee reports of MSDs and signs and symptoms of MSDs.
    (2) You must meet the time frames shown in Table W-2 for the other 
requirements of this section, when you have determined that an employee 
has experienced an MSD incident, in accordance with paragraph (e) of 
this section.

[[Page 68853]]



                                       Table W-2.--Compliance Time Frames
----------------------------------------------------------------------------------------------------------------
         Requirements and related recordkeeping                                Time frames
----------------------------------------------------------------------------------------------------------------
Paragraph (e), (f): Determination of Action Trigger....  Within 7 calendar days after you determine that the
                                                          employee has experienced an MSD incident.
----------------------------------------------------------------------------------------------------------------
Paragraphs (p), (q), (r), (s): MSD Management..........  Initiate within 7 calendar days after you determine
                                                          that a job meets the Action Trigger.
----------------------------------------------------------------------------------------------------------------
Paragraphs (h) & (i): Management Leadership and          Initiate within 30 calendar days after you determine
 Employee Participation.                                  that a job meets the Action Trigger.
----------------------------------------------------------------------------------------------------------------
Paragraph (t)(4)(i): Train Employees involved in         Within 45 calendar days after you determine that a job
 setting up and managing your ergonomics program.         meets the Action Trigger.
----------------------------------------------------------------------------------------------------------------
Paragraph (j): Job Hazard Analysis.....................  Initiate within 60 calendar days after you determine
                                                          that a job meets the Action Trigger.
----------------------------------------------------------------------------------------------------------------
Paragraph (m)(2): Implement Initial Controls...........  Within 90 calendar days after you determine that a job
                                                          meets the Action Trigger
----------------------------------------------------------------------------------------------------------------
Paragraph (t)(5)(ii): Train current employees,           Within 90 calendar days after you determine that the
 supervisors or team leaders.                             employee's job meets the Action Trigger.
----------------------------------------------------------------------------------------------------------------
Paragraph (m)(3): Implement Permanent Controls.........  Within 2 years after you determine that a job meets the
                                                          Action Trigger, except that initial compliance can
                                                          take up to January 18, 2005 whichever is later.
----------------------------------------------------------------------------------------------------------------
Paragraph (u): Program Evaluation......................  Within 3 years after you determine that a job meets the
                                                          Action Trigger.
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------


    Note to paragraph (x): Refer to paragraph (o) of this section 
for Quick Fix timeframes.

    (y) When may I discontinue my ergonomics program for a job? You may 
discontinue your ergonomics program for a job, except for maintaining 
controls and training related to those controls, if you have reduced 
exposure to the risk factors in that job to levels below those 
described in the Basic Screening Tool in Table W-1.
    (z) Definitions. The following definitions apply to this standard:
    Administrative controls are 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 for MSD hazards include:
    (1) Employee rotation;
    (2) Job task enlargement;
    (3) Alternative tasks;
    (4) Employer-authorized changes in work pace.
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, or designated representative.
    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.
    Director means the Director of the National Institute for 
Occupational Safety and Health, U.S. Department of Health and Human 
Services, or designated representative.
    Employee representative means, where appropriate, a recognized or 
certified collective bargaining agent.
    Engineering controls are physical changes to a job that reduce MSD 
hazards. Examples of engineering controls include changing or 
redesigning workstations, tools, facilities, equipment, materials, or 
processes.
    Follow-up means the process or protocol an employer or HCP uses to 
check on the condition of an employee after a work restriction is 
imposed on that employee.
    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 to be delegated the responsibility to carry out some 
or all of the MSD management requirements of this standard.
    Job means the physical work activities or tasks that an employee 
performs. This standard considers jobs to be the same if they involve 
the same physical work activities or tasks, even if the jobs have 
different titles or classifications.
    Musculoskeletal disorder (MSD) is 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 considered MSDs for the purposes of this 
standard.
    MSD hazard means the presence of risk factors in the job that occur 
at a magnitude, duration, or frequency that is reasonably likely to 
cause MSDs that result in work restrictions or medical treatment beyond 
first aid.
    MSD incident means an MSD that is work-related, and requires 
medical treatment beyond first aid, or MSD signs or MSD symptoms that 
last for 7 or more consecutive days after the employee reports them to 
you.
    MSD signs are objective physical findings that an employee may be 
developing an MSD. Examples of MSD signs are:
    (1) Decreased range of motion;
    (2) Deformity;

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    (3) Decreased grip strength; and
    (4) Loss of muscle function.
    MSD symptoms are physical indications that an employee may be 
developing an MSD. For purposes of this Standard, MSD symptoms do not 
include discomfort. Examples of MSD symptoms are:
    (1) Pain;
    (2) Numbness;
    (3) Tingling;
    (4) Burning;
    (5) Cramping; and
    (6) Stiffness.
    Personal protective equipment (PPE) is 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.
    Problem job means a job that the employer has determined poses an 
MSD hazard to employees in that job.
    Risk factor means, for the purpose of this standard: force, awkward 
posture, repetition, vibration, and contact stress.
    Work practice controls are changes in the way an employee performs 
the physical work activities of a job that reduce or control exposure 
to MSD hazards. Work practice controls involve procedures and methods 
for safe work. Examples of work practice controls for MSD hazards 
include:
    (1) Use of neutral postures to perform tasks (straight wrists, 
lifting close to the body);
    (2) Use of two-person lift teams;
    (3) Observance of micro-breaks.
    Work-related means that an exposure in the workplace caused or 
contributed to an MSD or significantly aggravated a pre-existing MSD.
    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 and 
participation in insurance programs, retirement benefits and savings 
plans.
    Work restrictions are 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 temporary 
removal from the workplace to recover. For the purposes of this 
standard, temporarily reducing an employee's work requirements in a new 
job in order to reduce muscle soreness resulting from the use of 
muscles in an unfamiliar way is not a work restriction. The day an 
employee first reports an MSD is not considered a day away from work, 
or a day of work restriction, even if the employee is removed from his 
or her regular duties for part of the day.
    You means the employer as defined by the Occupational Safety and 
Health Act of 1970 (29 U.S.C. 651 et seq.)

Appendices to Sec. 1910.900

Non-Mandatory Appendix A to Sec. 1910.900: What You Need To Know 
About Musculoskeletal Disorders (MSDs)
Non-Mandatory Appendix B to Sec. 1910.900: Summary of the OSHA 
Ergonomics Program Standard
Appendix C to Sec. 1910.900 [Reserved]
Appendix D to Sec. 1910.900: Hazard Identification Tools
Appendix D-1 to Sec. 1910.900: Ergonomics Job Hazard Analysis Tools 
(Mandatory)
Appendix D-2 to Sec. 1910.900: VDT Workstation Checklist
Appendix E: Ergonomics Rule Flow Chart


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Non-Mandatory Appendix B to Sec. 1910. 900: Summary of the OSHA 
Ergonomics Program Standard

    1. Why did OSHA issue an Ergonomics Program Standard?
    OSHA has issued an ergonomics standard to reduce musculoskeletal 
disorders (MSDs) developed by workers whose jobs involve repetitive 
motions, force, awkward postures, contact stress and vibration. The 
principle behind ergonomics is that by fitting the job to the worker 
through adjusting a workstation, rotating between jobs or using 
mechanical assists, MSDs can be reduced and ultimately eliminated.
    2. Who is covered by the standard?
    All general industry employers are required to abide by the rule. 
The standard does not apply to employers whose primary operations are 
covered by OSHA's construction, maritime or agricultural standards, or 
employers who operate a railroad.
    3. What does the rule require employers to do?
    The rule requires employers to inform workers about common MSDs, 
MSD signs and symptoms and the importance of early reporting. When a 
worker reports signs or symptoms of an MSD, the employer must determine 
whether the injury meets the definition of an MSD incident--a work-
related MSD that requires medical treatment beyond first aid, 
assignment to a light duty job or temporary removal from work to 
recover, or work-related MSD signs or MSD symptoms that last for seven 
or more consecutive days.
    If it is an MSD Incident, the employer must check the job, using a 
Basic Screening Tool to determine whether the job exposes the worker to 
risk factors that could trigger MSD problems. The rule provides a Basic 
Screening Tool that identifies risk factors that could lead to MSD 
hazards. If the risk factors on the job meet the levels of exposure in 
the Basic Screening Tool, then the job will have met the standard's 
Action Trigger.
    4. What happens when the worker's job meets the standard's Action 
Trigger?
    If the job meets the Action Trigger, the employer must implement 
the following program elements:
    A. Management Leadership and Employee Participation: The employer 
must set up an MSD reporting and response system and an ergonomics 
program and provide supervisors with the responsibility and resources 
to run the program. The employer must also assure that policies 
encourage and do not discourage employee participation in the program, 
or the reporting of MSDs, MSD signs and symptoms, and MSD hazards.
    Employees and their representatives must have ways to report MSDs, 
MSD signs and symptoms and MSD hazards in the workplace, and receive 
prompt responses to those reports. Employees must also be given the 
opportunity to participate in the development, implementation, and 
evaluation of the ergonomics program.
    B. Job Hazard Analysis and Control: If a job meets the Action 
Trigger, the employer must conduct a job hazard analysis to determine 
whether MSD hazards exist in the job. If hazards are found, the 
employer must implement control measures to reduce the hazards. 
Employees must be involved in the identification and control of 
hazards.
    C. Training: The employer must provide training to employees in 
jobs that meet the Action Trigger, their supervisors or team leaders 
and other employees involved in setting up and managing your ergonomics 
program.
    D. MSD Management: Employees must be provided, at no cost, with 
prompt access to a Health Care Professional (HCP), evaluation and 
follow-up of an MSD incident, and any temporary work restrictions that 
the employer or the HCP determine to be necessary. Temporary work 
restrictions include limitations on the work activities of the employee 
in his or her current job, transfer of the employee to a temporary 
alternative duty job, or temporary removal from work.
    E. Work Restriction Protection: Employers must provide Work 
Restriction Protection (WRP) to employees who receive temporary work 
restrictions. This means maintaining 100% of earnings and full benefits 
for employees who receive limitations on the work activities in their 
current job or transfer to a temporary alternative duty job, and 90% of 
earnings and full benefits to employees who are removed from work. WRP 
is good for 90 days, or until the employee is able to safely return to 
the job, or until an HCP determines that the employee is too disabled 
to ever return to the job, whichever comes first.
    F. Second Opinion: The standard also contains a process permitting 
the employee to use his or her own HCP as well as the employer's HCP to 
determine whether work restrictions are required. A third HCP may be 
chosen by the employee and the employer if the first two disagree.
    G. Program Evaluation: The employer must evaluate the ergonomics 
program to make sure it is effective. The employer must ask employees 
what they think of it, check to see if hazards are being addressed, and 
make any necessary changes.
    H. Recordkeeping: Employers with 11 or more employees, including 
part-time employees, must keep written or electronic records of 
employee reports of MSDs, MSD signs and symptoms and MSD hazards, 
responses to such reports, job hazard analyses, hazard control 
measures, ergonomics program evaluations, and records of work 
restrictions and the HCP's written opinions. Employees and their 
representatives must be provided access to these records.
    I. Dates: Employers must begin to distribute information, and 
receive and respond to employee reports by October 15, 2001. Employers 
must implement permanent controls by November 14, 2004 or two years 
following determination that a job meets the Action Trigger, whichever 
comes later. Initial controls must be implemented within 90 days after 
the employer determines that the job meets the Action Trigger. Other 
obligations are triggered by the employer's determination that the job 
has met the Action Trigger.
    5. Flexibility features of the Ergonomics Program Standard:
    A. Employers whose workers have experienced a few isolated MSDs may 
be able to use the ``Quick Fix'' option to reduce hazards and avoid 
implementing many parts of the program.
    B. Employers who already have ergonomics programs may be able to 
``grandfather'' existing programs.
    C. The employer may discontinue parts of the program under certain 
conditions.
    The full OSHA Ergonomics Standard can be found at http://www.osha.gov.

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Appendix C to Sec. 1910.900 [Reserved]

Appendix D to Sec. 1910.900: Hazard Identification Tools

    Appendix D to Sec. 1910.900 contains hazard identification tools. 
This appendix consists of Appendix D-1, Ergonomics Job Hazard Analysis 
Tools, and Appendix D-2, VDT Workstation Checklist.

Appendix D-1 to Sec. 1910.900: Ergonomics Job Hazard Analysis Tools 
(Mandatory)

    Paragraph (j)(3)(i) of the OSHA Ergonomics Program Standard allows 
employers to use any of the job hazard analysis tools in this appendix, 
where appropriate to the risk factors in the job, to fulfill their 
obligations to conduct a job hazard analysis (paragraph (j)(3)) and 
reduce MSD hazards (paragraphs (k) and (m)). This mandatory appendix 
contains important information about these tools. A description of each 
of these tools is also contained in the Summary and Explanation of 
paragraph (j) in the preamble to this standard.
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[FR Doc. 00-28854 Filed 11-13-00; 8:45 am]
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