68262 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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.

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 § 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,

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68263

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 workrelated 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 workrelated 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’’ (WorkRelated 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 workrelated MSDs and workplace risk

factors;

II. A 1998 study by the National

Research Council/National

Academy of Sciences on workrelated MSDs;

• A critical review by NIOSH of more

than 600 epidemiological studies

addressing the effects of exposure to

workplace risk factors (1997);

• A 1997 General Accounting Office

report of companies with ergonomics

programs;

I. Other evidence and analyses in the

Health Effects section of the

preamble to the final rule;

II. Hundreds of case studies from

companies with successful

ergonomics programs; and

I. Testimony and evidence submitted to

the record by expert witnesses,

workers, safety and health

professionals, and others, which is

discussed throughout the preamble

to the final rule.

Taken together, this evidence

indicates that:

• High levels of exposure to

ergonomic risk factors on the job lead to

an increased incidence of work-related

MSDs among exposed workers;

• Reducing exposure to physical risk

factors on the job reduces the incidence

and severity of work-related MSDs;

• Many work-related MSDs are

preventable; and

• Ergonomics programs are

demonstrably effective in reducing risk,

decreasing exposure and protecting

workers against work-related MSDs.

As with any scientific field, research

in ergonomics is ongoing. The National

Academy of Sciences is currently

undertaking another review of the

science in order to expand on its 1998

study. OSHA has examined all of the

research results in the record of this

rulemaking in order to ensure that the

final Ergonomics Program standard is

based on the best available and most

current evidence. Although more

research is always desirable, OSHA

finds that more than enough evidence

already exists to demonstrate the need

for a final standard. In the words of the

American College of Occupational and

Environmental Medicine, the world’s

largest occupational medical society,

‘‘there is an adequate scientific

foundation for OSHA to proceed * * *

and, therefore, no reason for OSHA to

delay the rulemaking process * * *.’’

D. Information OSHA Is Providing To

Help Employers Address Ergonomic

Hazards

Much literature and technical

expertise on ergonomics already exists

and is available to employers, both

through OSHA and a variety of other

sources. For example:

• Information is available from

OSHA’s ergonomics Web page, which

can be accessed from OSHA’s World

Wide Web site at http://www.osha.gov

by scrolling down and clicking on

‘‘Ergonomics’’;

• Many publications, informational

materials and training courses, which

are available from OSHA through

Regional Offices, OSHA-sponsored

educational centers, OSHA’s state

consultation programs for small

businesses, and through the Web page;

• Publications on ergonomics

programs, which are available from

NIOSH at 1–800–35–NIOSH. NIOSH’s

Web page is also ‘‘linked’’ to OSHA’s

ergonomics Web page;

• OSHA’s state consultation

programs, which will provide free onsite consultation services to employers

requesting help in implementing their

ergonomics programs; and

• OSHA-developed compliance

assistance materials, which are available

as non-mandatory appendices to the

standard, electronic compliance

assistance training materials (e-cats) on

specific tasks (e.g., lifting) or work

environments (e.g., nursing homes).

OSHA is also making several

publications available on the web, such

as the Easy Ergonomics Booklet, Fact

Sheets, and so on. These materials can

be obtained by accessing OSHA’s

Internet home page at www.OSHA.gov.

II. Events Leading to the Development

of the Final Standard

In this final standard, OSHA has

relied on its own substantial experience

with ergonomics programs, the

68264 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

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

August 10, 2000.

OSHA receives nearly 11,000 comments and 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68265

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

68266 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 fourpronged program including training,

education, and outreach activities; study

and analysis of the work-related hazards

that lead to MSDs; enforcement; and

rulemaking.

1. Training, Education, and Outreach

a. Training. The OSHA ergonomics

web page has been an important part of

the Agency’s education and outreach

effort. Other OSHA efforts in training,

education and outreach include the

following:

• Grants to train workers and

employees about hazards and hazard

abatement.

• Three training courses in

ergonomics through the OSHA Training

Institute available for OSHA compliance

officers, one of which is open to the

public;

• One day training for nursing home

operators, at more than 500 nursing

homes in each of seven targeted states;

• Booklets on ergonomics,

ergonomics programs, and computer

workstations, such as ‘‘Ergonomics

Program Management Guidelines for

Meatpacking Plants’’ and ‘‘Ergonomics:

the Study of Work,’’ both of which are

available on OSHA’s Website.

• Videotapes on ergonomics programs

in general industry and specifically in

nursing homes.

OSHA has awarded almost $3 million

for 25 grants addressing ergonomics,

including lifting hazards in healthcare

facilities and hazards in the red meat

and poultry industries. These grants

have enabled workers and employers to

identify ergonomic hazards and

implement workplace changes to abate

these hazards.

Some grant program highlights follow:

• The United Food and Commercial

Workers International Union (UFCW)

conducted joint labor-management

ergonomics training at a meatpacking plant

that resulted in a major effort at the plant to

combat cumulative trauma disorders. The

program was so successful that management

asked the UFCW to conduct the ergonomics

training and work with management at some

of its other facilities.

• The University of California at Los

Angeles (UCLA) and the Service Employees

International Union (SEIU) both had grants

for preventing lifting injuries in nursing

homes. SEIU developed a training program

that was used by UCLA to train nursing home

workers in California. UCLA also worked

with some national back injury prevention

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68267

programs. At least one of the nursing home

chains has replicated the program in other

states.

• Mercy Hospital in Des Moines, Iowa, had

a grant to prevent lifting injuries in hospitals.

It trained over 3,000 hospital workers in Des

Moines and surrounding counties. It had a

goal of reducing lost work days by 15

percent. The goal was surpassed, and, six

months after the training, none of those

trained experienced a lost workday due to

back injury.

• Hunter College in New York City trains

ergonomics trainers for the United

Paperworkers International Union. The

trainers then return to their locals and

conduct ergonomics training for union

members. As a result of this training, changes

are being made at some workplaces.

Examples include purchasing new

equipment that eliminates or reduces

workers’ need to bend or twist at the

workstation, rotating workers every two

hours with a ten-minute break before each

rotation, and modifying workstations to

reduce worker strain.

b. Education and Outreach. To

provide a forum to discuss ergonomic

programs and to augment information in

the literature with the experience of

companies of different sizes and from a

variety of industries, OSHA and NIOSH

sponsored the first in a series of

conferences that brought industry, labor,

researchers, and consultants together to

discuss what works in reducing MSDs.

The 1997 OSHA and NIOSH conference

was followed by 11 more regional

conferences across the country. OSHA

and NIOSH held the second national

conference on ergonomics in March of

1999. More than 200 presentations were

given at the conferences on how

companies have successfully reduced

MSDs. Presentations were made by

personnel from large and small

companies in many different industries.

Other examples of successful

ergonomics programs have come from

OSHA’s Voluntary Protection Program

(VPP). The VPP program was

established by OSHA to recognize

employers whose organizations have

exemplary workplace safety health

programs. Several sites that have been

accepted into VPP have excellent

ergonomics programs.

In addition to OSHA’s enforcement

efforts, the Agency’s Ergonomics

Program Management Guidelines for

Meatpacking Plants (‘‘Guidelines’’) (Ex.

2–13) are viewed by many as essential

to the implementation of successful

workplace programs addressing

ergonomic hazards. For example, in

contrasting OSHA’s proposal to the

Guidelines, IBP Inc.’s Bob Wing

acknowledged that the Guidelines had

been successful (Ex. 30–4046, p.1).

Similarly, the American Meat Institute

(‘‘AMI’’), the main representative for the

U.S. meat industry, including 276 meat

packers and processors, who operate

559 facilities, acknowledged that the

industry worked with OSHA on the

Guidelines, and has been using them for

nearly ten years (Ex. 30–3677, p.1). The

AMI notes that the Guidelines work and

that the industry has made substantial

progress in addressing ergonomic issues

since development of the Guidelines (id.

at 1–4). The AMI recommended that the

Guidelines be extended throughout

general industry (id. at 4). The utility of

OSHA’s Guidelines also was hailed by

the United Food and Commercial

Workers’ Union, which noted that upon

publication of the Guidelines, industry

began to respond both from the

standpoint of technology as well as

ergonomics programs (Ex. 32–210–2, pp.

25–26). The success of the Guidelines

led to their use and acceptance in other

industries. The poultry industry appears

to have secured substantial reductions

in chronic MSDs from adherence to the

principles in the document (Ex. 30–

3375, p.1.).

2. Ergonomics Best Practices

Conferences

During the period from Sept. 17, 1997

through Sept. 29, 1999, OSHA and its

Regional Education Centers cosponsored 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.

68268 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 industryspecific 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 MSDrelated 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

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

68270 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 § 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 § 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68271

exposure ceased even though the

exposure caused no overt symptoms

while it was occurring. An employee

who is beginning to suffer a workrelated 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

68272 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68273

regulating workplace conditions that are

shown to cause such loss:

The amendment provides that nonoccupationally 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 ‘‘workrelated,’’ ‘‘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

68274 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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).

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

concentrations of work-related MSDs

are reported in a wide variety of

occupations that are found throughout

general industry establishments. BLS

data for 1996 show that general industry

truck drivers, laborers, and janitors,

occupations found widely dispersed

throughout general industry sectors,

experienced more than 48,000, 38,000

and 15,000 lost workday (LWD) MSDs,

respectively. (See Section VII (Risk

Assessment) of this preamble.)

Evidence submitted by rulemaking

participants confirms the broad

distribution of MSDs and MSD hazards

throughout general industry. For

example, the Service Employees

International Union (SEIU) submitted

evidence that union members working

in a variety of health care settings (e.g.,

hospitals, nursing homes, private

homes, pharmacies) have suffered MSDs

(Ex. 32–311–1). These health care

workers include registered nurses,

licensed practical nurses, nurses’ aides,

orderlies, physical therapists, radiology

technicians, housekeepers (maids and

housemen), laundry workers, laundry

machine operators, maintenance

workers, kitchen and food preparation

workers, central supply workers, and

janitors and cleaners. In addition, SEIU

said that other union members such as

janitors and cleaners working in a

variety of other industries, including

hotels/motels, restaurants, offices have

also experienced MSDs (Ex. 32–311–1).

At the rulemaking hearing, many

employees testified that they had

suffered serious work-related MSDs.

Occupations in which these employees

were working when they became

injured include:

• Nurse

• Home health care aide

• Nurses’ aide

• Package delivery

• Package sorting

• Meatpacking and poultry

processing

• Office clerical worker

• Internet publishing

• Machinists

• Sewing machine operator

• Truck driver

• Food warehousing and distribution

• Grocery store cashier

• Physical therapist

• Mail carrier

• Letter sorter

• Teacher

• Teachers’ aide

• Auto assembly

• Molding and casting machine

operator

• Reporter

• Grocery shelf stocker

• Sonographer

• Television film editor

• Electrical workers

(Exs. 30–4200, 32–185–3, 32–210–2, 32–198–

3, 32–311, 500–218, Tr. 4009–10, 4235, 4240,

4234, 6004, 6009, 6319, 6321–22, 6333,

7320–21, 7335–37, 7341–42, 17950).

Doctors and other health care

professionals (HCPs) also testified that

they had treated employees in many

different jobs and industries for workrelated MSDs (Exs. 37–12, 37–28, Tr.

14973, 15045–46, 16819, 16829). Dr.

Robert Harrison testified that, in his

research and practice, he had diagnosed

and treated over 1,000 patients with

work-related MSDs from a wide variety

of industries and occupations, including

(Ex. 37–12):

• Postal workers

• Materials handlers

• Computer operators

• Grocery checkout clerks

• Meat processors

• Assemblers

• Seamstresses

• Telephone operators

• Pipefitters

• Customer service agents

• Machine operators

• Automotive manufacturing workers

• Aircraft manufacturing workers

• Optical scanners

• Graphic artists

• Restaurant workers

• Bakers

• Plumbers

• Letter sorters

68276 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

Dr. Robin Herbert, the medical codirector of the Mt. Sinai Center for

Occupational and Environmental

Medicine, testified that she had treated

or supervised the treatment of more

than 2,000 patients with upper

extremity MSDs in the past 12 years:

My patients have included journalists,

computer graphic artists, health care workers,

technicians for telephone companies,

automobile manufacturing workers, cashiers,

garment workers, meat wrappers, dental

hygienists, secretaries, and chefs. Industries

from which I have seen patients include

publishing, journalism, entertainment,

manufacturing, health care, transportation,

and telecommunications (Ex. 37–28).

Dr. George Piligian, who also works at

the Mount Sinai Center, testified about

finding and treating MSDs in dancers,

musicians, editors, secretaries,

telephone operators, sewing machine

operators and hospital workers (Tr.

7813–20).

Similarly, insurance companies,

employers and trade associations

representing the following industries

testified about the implementation of

ergonomics interventions and programs

because work-related MSDs were

occurring among workers in the

following environments:

• Chemical manufacturing

• Pharmaceutical manufacturing

• Automotive manufacturing

• Automotive repair

• Boat manufacturing

• Textile manufacturing

• Clothing manufacturing

• Printing

• Dental

• Meatpacking

• Electric utility

• Hospitals

• Office workers

• Hotel/motel

• Emergency medical services

• Furniture manufacturing

• Oil and gas drilling

• Moving and storage

• Fabricare

• Nursing homes

• Telephone operation and

installation

• Funeral and cemetery

• Insurance

• Solid waste removal and recycling

• Paint manufacturing

• Poultry processing

• Food warehousing and distribution

• Beverage delivery

• Assembly line

• Grocery store

• Retail clothing

• Foundry

(see, e.g., Tr. 3337–9, Tr. 5104, Tr. 8458–

8480, Tr. 16553–57).

Finally, several of the ergonomists

who appeared as OSHA’s expert

witnesses, including David Alexander

(Ex. 37–7), David Caple (Ex. 37–20),

Dennis Mitchell (Ex. 37–11), Maurice

Oxenburgh (Ex. 37–24), Suzanne

Rodgers (Ex. 37–25), and John

Rosecrance (Ex. 37–26), testified that

employers in the following different

industries had hired them to help

reduce the incidence of work-related

MSDs among employees:

• Newspaper

• Luggage manufacturing

• Meatpacking

• Packaging

• Papermaking

• Plumbing supply

• Route sales and delivery

• Film products manufacturing

• Hospitals

• Heavy appliance manufacturing

• Automobile manufacturing and

subassembly

• Furniture manufacturing

• Paper and pulp products

• Forest products

• Food service

• Clerical

• Electronics

• Clothing and textile manufacturing

• Baking

• Restaurant

• Home and office furniture

manufacturing

• Hospitality—hotel/motel

• Fiber manufacturing

• Logistic and supply warehousing

• Telecommunication

• Textile and apparel manufacturing

• Metal forging and cast metals

• Electronics manufacturing

• Health care

• Petroleum

• Electrical manufacturing

• Airline freight handling

• Steel manufacturing

• Fishing

• Aircraft manufacturing

• Gas and electric utility

• Flooring products

• Computer and computer accessory

manufacturing

• Plumbing fixtures manufacturing

• Food products manufacturing and

processing

• Chemical manufacturing

• Printing

• Waste treatment

• Plastic manufacturing

• Clothing retail

• Power plants

• Research laboratories

• Transportation

• Printing

• Upholstery

• Rubber manufacturing

• Welding

• Mail sorting and delivery

• Transportation

• Electronics

• Medical products manufacturing

All of this evidence supports OSHA’s

decision to provide the protections of

this standard to all general industry

employees. On the other hand, OSHA

recognizes that there may be some

general industry employers with few or

no MSD hazards. Until an MSD is

reported, the employer’s obligation is

limited to distributing the information

in paragraph (d).

B. Application of Requirements

Unlike the proposal, this final

standard does not differentiate among

general industry employers. Under the

proposal, employers of employees

engaged in manufacturing or manual

handling would have been required to

implement some elements of an

ergonomics program whether or not

their employees had suffered any MSDs.

Other general industry employers would

not have had to take any action until a

‘‘covered MSD’’ occurred, and a covered

MSD was defined differently for them

than for manufacturing and manual

handling employers (64 FR 65782–84,

65791). In this final standard all general

industry employers are required, as

specified in paragraph (d), to provide

basic information on ergonomics and

the standard to their employees. The

employer has no further obligation until

the employee reports an MSD or the

signs or symptoms of an MSD (see

paragraph (e)).

OSHA developed its bifurcated

proposal because about 60 percent of all

reported MSDs occurred in

manufacturing and manual handling

jobs, even though those jobs accounted

for less than 30 percent of general

industry employment. Although some

commenters agreed that this might

justify a focus on manufacturing and

manual handling (Ex. 30–4837), very

few expressed satisfaction with the

proposed approach (Exs. 30–400, 31–78,

32–198, 32–210, 32–461, 500–218, Tr.

3224). Many commenters said that

manufacturing and manual handling

jobs should not be singled out because

MSD hazards were present and MSD

rates were high in other jobs and

industries (Exs. 30–626, 30–2208, 31–

156, 500–218). For example,

participants said that there were many

MSD hazards and MSDs in ‘‘any job

involving regular computer use,’’

therefore, programming, journalism,

data entry, system administration,

accounting, analysis, and insurance jobs

should have been included by name

(Exs. 30–49, 30–400, 31–3, 31–12, Tr.

2783, 2932). Likewise, other

commenters argued that custodians and

supermarket employees including

cashiers, bakery personnel, baggers and

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

68278 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 shockabsorbing handles to pliers with soil handles

and spring returns to reduce the stress of

opening them after each use. The use of

portable power tools has increased

dramatically in construction as batteries have

gotten lighter and more powerful. Cordless

screw guns have become commonplace in

construction over the past few years,

reducing the repetitive use of screwdrivers by

hand and the force that had to be used. There

are simple pieces of equipment, like drywall

carrying handles, which I have here, and a

mortar-pan stand to raise the height of the

pan, which cost less than $50 and can make

the work much easier. A D-handle

attachment for a shovel, which I have here,

costs less than $20, and has been shown to

reduce awkward postures during shoveling.

There are simple carts for moving glass or

drywall, vibration-dampened jackhammers

and equipment for moving them on and off

of trucks. (Tr. 15762–63).

These commenters also pointed out that

many of the controls used in general

industry, such as manual handling aids,

were applicable or readily adaptable to

construction, agriculture and maritime

industries (Ex. 31–183). Moreover, tool

and equipment interventions are

becoming more widely available ‘‘as

manufacturers are responding to the

need for better ergonomically designed

tools’’ (Ex. 3–183; see also Tr. 15761–62,

17561).

Finally, several participants were

concerned that OSHA’s stated intent to

promulgate an ergonomics standard for

the excluded industries in the future

would never come to fruition:

OSHA’s standard-setting history during the

past 30 years raises serious doubt that

workers excluded from this standard will

ever have legal protection from MSD hazards.

When OSHA has excluded workers from

coverage under a promulgated standard, only

in two cases has the Agency followed up to

extend coverage to those workers—Hazard

Communication and Construction. But those

actions were as the result of a court decisions

and order (hazard communication) * * * or

legislative mandate by Congress (lead) (Ex.

500–218, p. 132–33).

These participants said that if OSHA

does not cover construction, agriculture

and maritime in the current rulemaking,

the Agency should begin further

rulemaking immediately and even

establish a deadline for completing that

project (Exs. 30–400, 30–576, 30–4837,

31–12, 31–263).

OSHA is aware that there is

significant evidence in the record

indicating that work-related MSDs exist

in operations and employment beyond

general industry (Exs. 31–183, 500–218,

Tr. 7475, 7484–85, 17538–39). Indeed,

the problem appears to exist in virtually

every industry. Nonetheless, for several

reasons OSHA believes its decisions to

regulate MSD hazards through

sequential rulemaking proceedings, and

to limit the first proceeding to general

industry, is appropriate and supported

by the record.

A primary basis for the Agency’s

decision to limit the scope of this

rulemaking to general industry is that

most of the available evidence and data

relating to ergonomic interventions

addresses general industry. For

example, the vast majority of the studies

reviewed in both the NIOSH and NAS

reports pertained to general industry

(Exs. 26–1, 26–37). Similarly, the

majority of case studies on the

effectiveness of ergonomics programs

and control interventions that OSHA

had gathered focused on general

industry (64 FR 65954–75). Although

some participants submitted evidence

on ergonomics programs and controls in

the excluded industries, mostly in

construction (Exs. 32–339–1–25, 32–

3888, 38–65, 38–66, 500–210), most of

the available evidence continues to

pertain to general industry jobs,

operations and workplaces.

If it included construction, agriculture

and maritime within the scope of this

rule, OSHA would have had to delay

issuing the rule for general industry

while it gathered and analyzed the

necessary evidence. Because it is likely

that the rule would have a significant

impact on small employers in

construction, agriculture and maritime,

OSHA would also have had to convene

a small business review panel pursuant

to SBREFA. Further, in order to include

construction, agriculture, and maritime

in its final rule, OSHA, in the interest

of fair notice, would have had to amend

the ergonomics proposal or re-propose

to include these industries and hold

additional hearings. Expanding the rule

to cover agriculture, construction and

maritime would seriously delay

addressing the urgent need for

protection for general industry

employees, who work in the jobs in

which more than 90 percent of MSDs

are reported.

In addition, as the proposal pointed

out, work conditions and factors present

in agricultural, construction and

maritime employment often differ from

those in general industry. OSHA listed

a number of aspects of construction

work to illustrate this statement (64 FR

65787):

• They consist primarily of jobs of

short duration,

• Employees work under a variety of

adverse environmental and workplace

conditions (e.g., cold, heat, confined

spaces, heights),

• At non-fixed workstations or nonfixed work sites,

• On multi-employer work sites,

• They involve the use of ‘‘day

laborers’’ and other short-term

‘‘temporary workers,’

• Involve situations in which

employees provide their own tools and

equipment, and

• Involve employees who may be

trained by unions or other outside

certifying organizations, rather than by

the employer.

OSHA did not mean to imply that the

mere existence of any of these factors,

alone or in combination, would be

enough to justify excluding an entire

industry from the rule. This fact was

apparently not clear to some

commenters, however, who argued that

the presence of some of the listed factors

in their industries meant that they too

should be excluded from the standard

(Exs. 30–297, 30–626, 31–147, 32–234,

32–300). For example, Broccolo Tree

and Lawn Care Inc., pointed out that

landscaping jobs involve short-duration

tasks and no fixed workstations (Ex. 31–

147). The National Solid Waste

Management Association (NSWMA)

said that its employees are also exposed

to adverse environmental conditions

and work at non-fixed work sites (Ex.

32–234, p. 6–7).

In the proposal, OSHA discussed its

discretion to set appropriate rulemaking

priorities, and to promulgate standards

applicable to less than all of American

industry. 64 FR 65786–65788. General

industry accounts for more than 90

percent of the more than 620,000 LWD

MSDs reported each year. By

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68279

1A 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.

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

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

68280 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

companies have safety and health

programs that include addressing

ergonomic hazards on a ‘‘day to day’’

basis indicates that most industry

employers already are taking these steps

(Tr. 18074).

Although NSWMA argued that high

turnover in the industry supports

exemption in the same way that the use

of ‘‘day laborers’’ in the construction

industry does, NSWMA did not provide

any evidence on turnover rates in its

industry, or on how those rates compare

to other industries this rule covers. Nor

did NSWMA explain why high turnover

rates pose the same issues as day

laborers. Other solid waste associations

and employers did not indicate that

high turnover rates are a problem in the

industry. The solid waste industry has

the opportunity to train its workers; in

fact NSWMA and MWMA testified that

their members already provide training

(Tr. 13404–405, 18079). It explained

that this training is the most effective

way to deal with the fact that its

workers are often unsupervised:

MR. BEDERMAN: No, the most important

way to monitor this type of thing is actually

not to monitor it, but * * * actually good

training (Tr. 18079).

The record also does not support

industry claims that solid waste

industry employers have little control

over their employees’ working

conditions. For example, NSWMA said

that, because of municipal ordinances,

its members have no control over the

weight and location of the garbage they

collect and that municipalities were

‘‘very hesitant’’ to make changes (Ex.

32–234–2, Tr. 18041). But 60 percent of

residential collection is privately

controlled (Tr. 18046). For the 40

percent of trash collection that is under

the control of municipalities, as noted

below, the testimony of NSWMA and

MWMA suggest there is not a significant

problem.

NSWMA testified that a majority of

municipalities have already

implemented container requirements

(Tr. 18071; see also Tr. 13402). Both

NSWMA and MWMA testified that the

growing trend is toward requiring

customers to place garbage containers at

the curbside (to eliminate the need for

employees to carry heavy containers)

and limiting container size (to reduce

injury associated with heavy lifting) (Tr.

18070–71, 13402–3; see also Tr. 12019).

Bruce Walker, of Portland’s solid waste

and recycling agency, said that such

weight limits had been positively

received in that city (Tr. 12014–15).

NSWMA, MWMA and Mr. Walker also

said that employers are instructing their

employees not to lift containers that

exceed the weight limits (Tr. 12014,

13404–06, 18073). In addition, container

size and location issues are regularly

addressed as part of contract

negotiations between private collectors

and municipalities (Tr. 18041). All of

this evidence suggests that solid waste

employers should not have difficulties

continuing to negotiate contracts that

will assist them in complying with this

final standard.

And contrary to NSWMA’s argument,

the record contains abundant evidence

on MSD hazards and ergonomic

solutions in this industry (Ex. 32–234–

2). The industry recognizes that lifting

heavy loads creates a hazard for

employees (Tr. 13406, 13413, 18009).

Industry representatives testified that

their workers experience work-related

MSDs, particularly MSDs of the lower

back (Tr. 13379, 13396, 13412, 18009).

In fact, NSWMA submitted a manual of

recommended ergonomic practices

developed by Environmental Industry

Associations (EIA), NSWMA’s parent

organization, that identified lifting

bulky loads and twisting and carrying

loads as risk factors for the industry and

identified back pain, hernias and

strains, sprains and tears as common

MSDs in the industry (Ex. 32–234–2–1).

EIA also recommended that employers

establish ergonomics programs for trash

collection and recycle operations (Ex.

32–234–2–1).

The record also includes evidence on

a wide range of controls that are

successfully in use in the industry. The

EIA manual on ergonomic practices said

the industry ‘‘has many options’’ for

addressing ergonomic hazards,

including weight limits built into

residential contracts, the use of lifting

devices, and training (Ex. 32–234–2–1).

The record indicates that the following

controls are also in use in the industry:

• Mechanical container lifts,

• Limits on container size and weight

and requirements for container handles,

• Carts, dollies and other mechanical

assists for pushing, carrying and lifting

containers,

• Collection trucks designed for use

in narrow alleys and streets to eliminate

carrying containers long distances,

• Changes in municipal collection

regulations to reduce lifting hazards

(e.g., curbside service, container size

and weight limits, reduction in loads

through increases in collections per

week, separate collections for large

bulky items),

• Training in proper lifting

techniques,

• Work practice controls (e.g.,

training not to lift overweight loads),

• Changes in compensation systems

to eliminate incentives for hazardous

work speed and lifting (Tr. 12017,

13402–06, 17969, 18212).

John Legler, of Waste Equipment

Technology Association, added that

garbage trucks are being retrofitted with

mechanical lifts ‘‘quite regularly’’ (Tr.

18012–13). Bruce Walker, of Portland’s

residential solid waste and recycling

agency, testified that enforcing

container weight limits had been

established had led to low MSD rates

(Tr. 11968–70).

This evidence not only does not

support exemption, it is clear evidence

that effective ergonomic programs and

controls are technologically and

economically feasible for the industry as

a whole. OSHA recognizes that some of

the hazards facing waste industry

employees cannot be eliminated

completely. But the standard only

requires employers to control MSD

hazards ‘‘to the extent feasible.’’ It

expects NSWMA’s member companies

to continue to implement the type of

safety programs they are already using,

and to continue improving those

programs as knowledge and technology

advance.

2. Utility Workers

Utility companies asked OSHA to

exempt utility line workers and power

plant maintenance workers from the

standard for two reasons. First, they

pointed out that line workers face some

of the same conditions as construction,

agriculture and maritime (e.g., adverse

environmental conditions). They also

argued that these jobs involve both

general industry and construction

activities because utility line workers

not only maintain and repair utility

lines, a general industry activity, but

also they install, alter, and improve

lines, activities which are governed by

OSHA construction standards (Exs. 30–

3853, 32–300, Tr. 2893–95). Edison

Electric Institute (EEI) testified:

As you know, a line worker working on a

pole may at one moment be engaged in what

is considered to be construction work under

1910.12(b) and under 1926(b) and at the next

moment be engaged in what is considered to

be general industry work under 1910.269.

That is to say that if a person is doing work

for the improvement of the facility, that is

construction as defined by OSHA and the

Review Commission. And if not, then general

maintenance (Tr. 97–98).

EEI also pointed out that it would not

be practical for its employees to be

covered by the standard for only some

of their tasks:

EEI recommends that OSHA clarify that to

perform a job hazard analysis means to

analyze a job, not a task. A job may not

involve only one task, but may involve

multiple tasks depending upon the nature of

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

68282 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 multiemployer 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68283

with any necessary MSD management,

including WRP. OSHA believes that this

is basically how businesses are

currently operating. OSHA expects that

they may pay more attention to these

issues and address them explicitly in

their contracts after the standard is in

effect.

C. United States Postal Service

Questions were also raised as to the

effect of this standard on the United

States Postal Service. In 1998, Congress

amended Section 3(5) of the OSH Act to

include the United States Postal Service

within the Act’s definition of employer.

29 U.S.C. 652(5). Postal Service

Enhancement Act, P.L. 105–241. As a

result, this standard applies to all USPS

operations that are not construction,

agriculture or maritime operations.

D. Municipalities

A number of municipalities asked

whether the standard applies to local

governments. States and their political

subdivisions are not employers under

the OSH Act, and they are not covered

by this final rule or any other federal

OSHA standards. However, the 23

States and 2 Territories with approved

State Plans are required by Section

18(c)(2) of the OSH Act to issue

standards that are ‘‘at least as effective’’

as Federal standards. 29 U.S.C. 667.

Therefore, State Plan States must adopt

ergonomics program standard within six

months of the publication of this

standard. Under Section 18(c)(6), State

Plan States must apply such standards

to State employees and to employee’s of

the State’s political subdivisions. (See

State Plan States section of this

preamble for the list of State plan

States.)

Industries and Jobs This Standard Covers

• Agricultural services

• Soil preparation and crop services,

including crop planting, cultivating and

protecting

• Crop harvesting

• Veterinary services

• Lawn and garden services

• Ornamental shrub and tree service

• Tree trimming

• Landscaping and horticultural services

• Oil and gas drilling/extraction operations

• Health care employees

• Truck driving

• Office workers employed by general

industry establishments

• Office workers employed by agricultural

services establishments

• Utility line operations including

maintenance, repair, installation,

construction, alteration and improvement

operations

• Power plant maintenance operations

including repair, alteration and

improvements

• Boat building and repair

• Airline baggage handlers

• Airline reservation and ticket agents

• Airline maintenance crews

• Railroad equipment building and

rebuilding

• Maintenance of equipment or structures

• Forestry services

• Forestry nurseries and gathering of forest

products

• Commercial fishing

• Fish hatcheries and preserves

• Hunting and trapping

• Game propagation

• State and municipal employees (in State

Plan States) performing general industry

operations

• U.S. Postal Service

• Federal government employees

performing general industry operations

Industries and Jobs This Standard Does Not

Cover

• Construction employment and

operations

• Agriculture employment and operations

• Farm labor and management services

• Livestock and animal specialty services

• Maritime employment and operations

• Ship building and repair

• Longshoring

• Office workers employed by

construction, agriculture or maritime

establishments

• Maintenance workers employed by

construction, agriculture or maritime

establishments

• Work at the employee’s own home

• Railroad work

• Railroad terminal and switching

• Airline attendants

• Airline pilots

Paragraph (c)—How Does This Standard

Apply if I Already Have an Ergonomics

Program in Place When the OSHA

Ergonomics Program Standard Becomes

Effective?

Paragraph (c) of the final standard is

a grandfather clause, which, under

certain conditions, permits an employer

who has already implemented and

evaluated his or her ergonomics

program by the date on which the final

rule becomes effective to continue that

program instead of complying with the

OSHA standard. This paragraph permits

employers to do this only if the

program: is in writing, contains the core

elements of basic ergonomics programs,

and is demonstrably effective. The

criteria for judging whether an

employer’s program adequately

addresses the core elements are

contained in paragraphs (c)(1)(i) through

(v). Examples of criteria for judging the

effectiveness of the program are

contained in paragraph (c)(1)(v).

Paragraph (c)(2) requires that, within 1

year of the standard’s effective date,

grandfathered programs have in place

an MSD management policy that meets

the requirements of paragraphs (p)

through (s) of the final rule. Final

paragraph (c)(3) denies grandfather

status to employers who have policies

or procedures that discourage

employees from participating in the

program or reporting signs or symptoms

of MSDs or the presence of MSD

hazards in the workplace.

In the final rule, OSHA is requiring

that grandfathered programs be in

writing. The final rule’s grandfather

clause requires the employer to

demonstrate program effectiveness and,

like the proposal, to have a program that

includes the core elements of effective

programs. The Agency believes that this

can best be accomplished with a written

program. Further, both OSHA and the

employer will find compliance with the

grandfather clause easier to demonstrate

if the program is written. By ‘‘written,’’

OSHA also intends that the program can

be maintained electronically.

Final paragraph (c)(1) requires

grandfathered programs to include the

core elements of effective ergonomics

programs: management leadership and

employee involvement; job hazard

analysis and control; training; and

program evaluation. This paragraph also

indicates the subelements within each

core element that OSHA believes are

essential to the proper functioning of

that core element. These subelements

are stated broadly. For example, a

subelement of management leadership

(paragraph (c)(1)(i)) that OSHA

considers essential is the establishment

of an effective reporting system that

permits employees to report the signs

and symptoms of MSDs and to receive

prompt responses to their reports. The

employer’s program must include all of

the subelements of the core elements to

qualify for grandfather status.

The following discussion explains the

subelements comprising each of the core

elements. Employers are free to include

additional elements or subelements in

their program, and doing so will not

interfere with the program’s grandfather

status, provided that the program

includes the core elements identified by

paragraphs (c)(1)(i) through (v), and the

subelements associated with them.

The proposed rule would have

required an existing program to meet a

‘‘basic obligation’’ provision for each

core element. Basic obligations, which

were intended to capture the essence of

the more detailed subelements proposed

for each core element, were proposed

for each program element. Table 1

compares the proposed rule’s basic

obligations sections with the

corresponding subelements of the final

rule’s grandfather clause. The following

discussion also explains OSHA’s

68284 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 privatesector 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

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

Proposed basic obligation Corresponding core elements and subelements of the final grandfather

clause

Proposed Management Leadership Obligation Final § 1910.900(c)(1)(i) and (ii) and (c)(3): [Your program must contain

the following elements:]

You must demonstrate management leadership of your

ergonomics program. Employees (and their designated representatives) must have ways to report MSD signs and MSD

symptoms; get responses to reports; and be involved in developing, implementing and evaluating each element of your program. You must not have policies or practices that discourage

employees from participating in the program or from reporting

MSD signs or symptoms.

(c)(1)(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;

(c)(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 under paragraph (c) of this section.

68286 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE 1—COMPARISON OF PROPOSED BASIC OBLIGATIONS WITH FINAL GRANDFATHER CLAUSE PROGRAM ELEMENT

CORE ELEMENTS AND SUBELEMENTS—Continued

Proposed basic obligation Corresponding core elements and subelements of the final grandfather

clause

Proposed Employee Participation Obligation:

You must set up a way for employees to report MSD signs and

symptoms and to get prompt responses. You must evaluate employee reports of MSD signs and symptoms to determine whether a covered MSD has occurred. You must periodically provide

information to employees that explains how to identify and report

MSD signs and symptoms.

(c)(1)(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;

[See also paragraph (c)(1)(iv).]

Proposed Job Hazard Analysis and Control Obligation: Final § 1910.900(c)(1)(iii): [Your program must contain the following

elements:]

You must analyze the problem job to identify the ergonomic risk

factors that result in MSD hazards. You must eliminate the MSD

hazards, reduce them to the extent feasible, or materially reduce

them using the incremental abatement process in this standard.

If you show that the MSD hazards only pose a risk to the employee with the covered MSD, you may limit the job hazard analysis and control to that individual employee’s job.

Job hazard analysis and control, as demonstrated by a process that

identifies, analyzes, and uses feasible engineering and administrative

controls to control MSD hazards or to reduce MSD hazards to the

levels specified in Appendix D 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 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 § 1910.900(c)(1)(iv): [Your program must contain the following

elements:]

You must provide training to employees so they know about MSD

hazards and your ergonomics program and measures for eliminating or materially reducing the hazards. You must provide

training initially, periodically, and at least every 3 years at no

cost to employees.

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.

Proposed MSD Management Obligation: Final § 1910.900(c)(2): [Your program must contain the following elements:]

You must make MSD management available promptly whenever a

covered MSD occurs. You must provide MSD management at

no cost to employees. You must provide employees with the

temporary ‘‘work restrictions’’ and ‘‘work restriction protection

(WRP)’’ this standard requires.

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.

Proposed Program Evaluation Obligation: Final § 1910.900(c)(1)(v): [Your program must contain the following elements:]

You must evaluate your ergonomics program periodically, and at

least every 3 years, to ensure that it is in compliance with this

standard.

Program evaluation, as demonstrated by regular reviews of the elements of the program; regular reviews 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

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

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

68288 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

2UNITE also noted that the proposed quick fix

section had no basic obligation section at all.

would mean that the occurrence of even

a single MSD would require their clients

to implement new engineering controls.

Consequently, they believed that their

clients’ programs would not qualify

under the proposed grandfather clause.

Other commenters also noted that their,

their members’, or their clients’

programs would not meet the proposed

standard’s grandfather clause for similar

reasons (see, e.g., Exs. 30–3344, 30–

3347, 30–3368, 30–3845, 30–4137).

One witness at the hearing, Thomas J.

Durbin of PPG Industries, noted that

since no one would benefit from the

grandfather clause as it was proposed,

OSHA should either put in a true

grandfather clause that recognizes

programs containing the six core

elements or eliminate it altogether (Tr.

3135, Tr. 3147). In questioning, he

stated that he interpreted the proposal

to require the full program as long as

MSDs continued to occur (Tr. 3140).

The Boeing Company argued that the

restrictive nature of the proposal’s

grandfather clause ran counter to the

intent of the OSH Act (Ex. 30–1547). In

support of their position, they pointed

to section 6(d) of the Act, which

provides for a variance procedure to

recognize alternative approaches to

compliance with OSHA standards,

provided that the alternative provides

equivalent employee protections.

Boeing was particularly concerned that

the standard, as proposed, would deny

grandfather status to an employer who

had a program but who had not yet

completed the implementation of all of

the control measures required by the

proposal.

On the other hand, many rulemaking

participants indicated that the proposed

standard’s grandfather clause would

allow ineffective programs to be

grandfathered (see, e.g., Exs. 30–4200,

32–111, 32–182, 32–198, 32–210, 32–

339; Tr. 3477). For example, the United

Steelworkers of America and others

were concerned that employers whose

program evaluations failed to identify

deficiencies simply because the

evaluations were not done properly

could be grandfathered in under the

proposed standard (see, e.g., Exs. 32–

111, 32–182). They recommended that

OSHA develop additional regulatory

text to strengthen the program

evaluation provisions. The Union of

Needletrades, Industrial and Textile

Employees (UNITE) was also very

concerned that the proposed grandfather

clause would inadequately protect

employees (Ex. 32–198), stating:

The acceptability of existing programs

depends largely on the criteria used to

determine acceptability. Therefore, the

correctness of the current criteria—

compliance solely with the ‘‘basic

obligation’’ provisions—is critical to the

protection of workers from OSHA’s approval

of programs which are in fact ineffective. For

the reasons [summarized by OSHA] below,

UNITE does not believe that these criteria

will provide the appropriate level of workers

protection (Ex. 32–198).

Several unions, including UNITE and

the United Food and Commercial

Workers International Union (UFCW),

gave the following reasons why the

proposal’s grandfather clause was

inadequate:

• The detailed provisions

implementing each of the proposed

program elements, which would not be

required for grandfathered programs, are

necessary for adequate protection of

employees. UNITE pointed to OSHA’s

extensive justification for each of these

proposed provisions in the preamble

and indicated that the justification

applied just as well to programs in

existence before the rule becomes

effective as to programs implemented

afterward (Ex. 32–198).

• The proposed basic obligation

sections for the management leadership

and training elements, which would be

the only requirements employers with

grandfathered programs would have to

meet, would allow poorly trained

managers to make determinations that

their program complies with the

standard. The unions noted that training

for managers was not included as part

of the proposed basic obligation for

these elements. They were particularly

concerned that inadequate training of

managers would result in improper

program evaluations (see, e.g., Exs. 30–

4200, 32–198, 32–210, 32–421).

• Job hazard analysis and control and

quick fixes could be performed without

the input of employees because

employee participation is not a part of

the proposed basic obligation of those

provisions.2 The unions argued that,

without feedback from employees, a

provision not addressed in the proposed

basic obligation for the job hazard

analysis section, employers would be

likely to improperly identify risk factors

or select improper hazard controls (see,

e.g., Exs. 30–4200, 32–198, 32–210, 32–

461).

• The proposed MSD management

basic obligation is missing a

requirement for health care

professionals to be provided with

information about the workplace and

the employee’s job (Ex. 32–198).

According to UNITE, which has had

first-hand experience with programs

that do not require such information

sharing, this omission would result in

ill-conceived recommendations from the

health care professional (Ex. 32–198).

• The basic obligation for the

proposed job hazard analysis and

control section omitted requirements

that limited the use of personal

protective equipment and mandated

that employers provide it at no cost to

employees (Ex. 32–210).

• The proposal’s requirements for

program evaluation were inadequate

and would allow employers to overlook

serious program deficiencies (see, e.g.,

Exs. 30–4200, 32–198, 32–210). The

unions believed that, because the rule’s

evaluation provisions are the primary

means for determining the acceptability

of an existing program under the

grandfather clause, these provisions

should be revised in the final rule to

prevent employers from inappropriately

approving unacceptably weak programs

for grandfather status. (Also see the

summary and explanation for paragraph

(u), later in this section of the

preamble.)

The International Brotherhood of

Teamsters (IBT) observed that the

proposed standard would consider any

new ergonomics program coming into

effect to comply with the standard as

deficient if the new program did not

meet one or more of the standard’s

requirements (Exs. 30–4200, 32–461).

The IBT argued that existing programs

should be held to the same standard:

Any program grandfathered under this

proposal would essentially be judged by a

different set of criteria than a program

developed after the effective date. The

grandfathered program would be considered

to be in compliance despite having missing

components, provided that the [proposed]

basic obligations as currently defined, are

met. An identical program, that was

developed after the effective date and was

not grandfathered would not be considered to

be fully in compliance and would be cited by

compliance officers for each component of

the standard that was lacking, despite

meeting the very same basic obligations that

the grandfathered program met. This

weakness can not be used as an argument

that compliance is too difficult to determine,

but rather must be viewed as an argument

that the grandfathering provision, as it

currently stands, has serious flaws and must

be significantly improved such that every

worker is provided the same protections

under this standard (Ex. 32–461).

At the hearing, OSHA stated that the

Agency’s intent in the proposal was to

include a grandfather provision that

recognized existing effective ergonomics

programs:

Other requirements of the proposal that

OSHA has designed to be flexible include a

grandfather clause that permits employers

who have already implemented an

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

68290 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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).

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68291

3This is the overall MSD incidence rate for SIC

283.

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.

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 workrelated 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.

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.

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

68292 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

5Using a rolling average incidence rate would

help smooth out, but would not eliminate the yearto-year variability.

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.

Alternatively, the final rule could

mandate that, to be grandfathered, the

employer’s MSD incidence rates had to

decrease over time, as suggested by

some rulemaking participants (see, for

example, the comments of Unisea, Inc.,

Ex. 500–158, above). Again, the Abbott

Laboratories data in Table 2 show that

this approach would also be

problematic (Ex. 500–153). All three of

Abbott Laboratories’ plants experienced

increasing rates in some years in the

period reported. Although the overall

trend over the full 9-year period is

downward for all of the Abbott plants,

this is not the case for all time periods.

For example, Plant C’s incidence rates

went up over the 4-year period from

1995 to 1998 (see Table 2). In fact,

OSHA’s experience is that, as an

employer’s ergonomics program

matures, incidence rates begin to level

off, albeit at a much lower rate than

before the program was established (see

Chapter IV of the Economic Analysis).

Other ‘‘objective’’ measures of

effectiveness recommended by

rulemaking participants (see e.g., Ex.

30–3813; Tr. 4112) pose similar

problems. Decreases in the rate of

workers’ compensation claims have the

same problems as incidence rates when

they are used as effectiveness measures.

Symptom surveys, although valuable as

an early reporting tool, vary from one

workplace to another and therefore

cannot be used for different sites.

Reductions in employee exposure to

MSD hazards is a good measure of

whether an ergonomics program is

working but, OSHA has no benchmark

that adequately describes the

performance of an effective program.

Without a benchmark, reductions in

employee exposure to MSD hazards

cannot be used as the sole criterion for

grandfathering programs at different

sites.

In addition, OSHA has concluded that

the core elements (management

leadership and employee participation,

hazard identification and assessment,

hazard prevention and control, MSD

management, training, and evaluation)

are essential to a properly functioning

ergonomics program. These elements

are included in the safety and health

programs recommended or used by

many different organizations (the

ergonomics standard uses slightly

different terminology for some of these

elements):

• OSHA’s VPP, SHARP, and

consultation programs;

• The safety and health programs

mandated by 18 states;

• The safety and health programs

recommended by insurance companies

for their insureds (many of which give

premium discounts for companies that

implement these programs or impose

surcharges on those that do not);

• The safety and health programs

recommended by the National

Federation of Independent Business, the

Synthetic Organic Chemical

Manufacturers Association, the

Chemical Manufacturers Association,

the American Society of Safety

Engineers, and many others;

• The strong recommendations of

OSHA’s Advisory Committees

(NACOSH, ACCSH, and MACOSH),

which consider these program elements

essential to effective worker protection

programs.

OSHA also is including WRP, or

equivalent protections against wage

loss, as a requirement for all programs

(both those that are grandfathered and

those complying with the standard)

because, without it, OSHA believes that

many employees will be reluctant to

report their MSDs because they fear

economic loss. There is strong evidence

that such underreporting is currently

taking place, as well as evidence that

protecting workers from wage loss

increases reporting (see the discussion

of underreporting in the summary and

explanation for MSD management).

OSHA’s purpose in including a WRP

provision, both in the grandfather clause

and in the standard, is to ensure

employee participation and free and full

reporting of MSDs and MSD hazards.

Effective ergonomics programs depend

on such reporting, and the standard also

depends on employee reporting for its

effectiveness. Absent such reporting, no

ergonomics program will achieve its

worker protection goals.

For these reasons, OSHA has

concluded that quantitative

effectiveness measures alone cannot be

the sole basis for judging whether an

employer’s program should be

grandfathered. The Agency’s experience

over the last two decades, and that of

private industry and insurance

companies, is that safety and health

programs, and ergonomics programs,

containing the core elements are

effective in lowering injury and illness

rates. These programs work because

they involve everyone in the

organization in finding and fixing

hazards. They also establish two-way

communication in the form of reporting

and response systems. OSHA finds that

the core elements are essential to

effective ergonomics programs, and the

record provides ample evidence of this

(see the discussion below on whether

the core elements are necessary).

Employee participation, for example, is

a prominent component of the programs

of many leading companies (see, e.g.,

Exs. 32–77, 32–185, 32–210; Tr. 4973,

Tr. 5339). The core elements also help

to ensure that employees are reporting

their MSDs, that management is

responding to these reports, that jobs are

being analyzed and fixed, and that the

program is functioning as it should. The

core elements thus help to ensure that

programs are not focusing too heavily

on quantitative measures of

effectiveness, which, as the discussion

above shows, are often misleading.

OSHA agrees, however, that

effectiveness measures can be useful in

determining the degree to which an

ergonomics program is working.

Employers and authors of effectiveness

studies routinely rely on them as

evidence that an ergonomics program is

having a positive effect. Of the measures

available, incidence and severity rates

are most commonly used and were most

often recommended in the rulemaking

record (see, e.g., Exs. 30–1901, 30–2208,

30–3344, 30–3348, 30–3361). If one of

these measures is used, the employer

must take care to ensure that the

calculated incidence or severity rate

accurately reflects conditions at the

workplace. First, the effectiveness

measure chosen must be appropriate for

the size and nature of the workforce and

the employer’s MSD experience. For

example, as explained earlier, an

employer with few employees will not

find incidence rates useful to measure

effectiveness. Instead, such employers

could examine whether employee

exposure to MSD hazards has been

reduced. Second, the employer must

check to ensure that some MSDs are not

going unreported. If employees are

failing to report MSDs, the employer’s

calculated incidence and severity rates

will not accurately reflect the injury

experience at the workplace. Third, the

employer should check rates over a

variety of periods to ensure an overall

downward trend in the data. Looking at

data over a single period can be

misleading.

OSHA finds, based on the evidence in

the record as a whole, that reliance on

both qualitative (the core elements) and

quantitative (effectiveness measures)

components will best assure that any

program that is grandfathered deserves

this status and will continue to operate

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

68294 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

Equally important, contrary to OSHA’s

contention in the preamble, the ability of an

employer to continue applying an existing

program should not be based on whether the

‘‘basic obligation section of each program

element in this standard’’ is satisfied. OSHA

has provided no objective evidence that the

requirements of the proposed standard will

be any more effective than other programs

already in place. There is certainly no basis

for compelling an employer to rework an

effective program to force it to meet the

specifics even of the proposed basic

obligations (Ex. 30–3813).

Dow, ORC, and others suggested that

OSHA simply require grandfathered

programs to address the six basic

elements of the program instead of

requiring them to meet the proposal’s

full basic obligation for each core

element (see, e.g., Exs. 30–2134, 30–

2725, 30–3171, 30–3765, 30–3813, 32–

77). ORC noted that the proposed work

restriction protection requirements were

particularly troublesome, since

‘‘[v]irtually none of ORC’s member

companies, whose ergonomics programs

are among the most sophisticated and

effective in the country, would meet this

requirement * * *’’ (Ex. 30–3813). Dow

was concerned that the language in the

proposal would not recognize their

program, which is tailored to fit their

management structure. They stated:

The so-called Grandfather clause that

OSHA has proposed is so demanding in its

requirements that companies that have

existing and successful ergonomics programs,

such as Dow, will not be able to take

advantage of this provision to maintain their

current programs. The Grandfather clause is

so limited that already functioning and

successful programs, tailored to the needs of

a particular company, business or workplace,

will not be able to satisfy the requirement.

For example, in Dow’s case, we would not be

able to satisfy the extensive recordkeeping

requirements or elements of the WRP section

(since it goes beyond that required by

Workers’ Compensation laws.) Similarly,

given Dow’s management structure, we

would not satisfy OSHA’s communication

and training requirements wherein they

intend a more archaic management structure,

such as one having ‘‘supervisors’’ and the

like, than what Dow utilizes. So even though

Dow has had a successful ergonomics

program for years and has a lower than

average MSD incidence rate, we would have

to scrap our efforts and use a program which

will not fit our needs or management

structure, just to comply with this standard.

Dow believes this is unacceptable.

Instead, Dow urges OSHA to delete the

proposed Grandfather clause and replace it

with a provision that allows for an

‘‘acceptable’’ or ‘‘appropriate equivalent’’

program. Such a concept is not foreign to

OSHA or the regulated community as other

OSHA standards, such as the Process Safety

Management (‘‘PSM’’) standard, utilize this

concept so that companies that have existing

programs that are functioning successfully

can continue to use them. This concept also

allows companies who may not yet have an

existing program to create one tailored to

their own needs, rather than use a more ‘‘one

size fits all’’ program as envisioned by this

proposal. ‘‘Acceptable (or appropriate)

Equivalence’’ would include those programs

who have the basic elements of a program,

but not all the mandated details or

documentation. Such a concept embodies

‘‘performance-oriented mandates’’ at their

best as they allow an employer to employ

those methods of prevention that best meets

the needs of its particular workforce and/or

workplace. OSHA should only be concerned

with the results (i.e. lower injury rates) rather

than the methodology a particular employer

used to obtain that goal (Ex. 30–3765).

At the hearing and in their notice of

intention to appear at the public

hearing, Dow described their

ergonomics program and detailed how

they believe their program would fall

short of the proposal’s requirements (Ex.

32–77; Tr. 5339). Dow expressed

concern that, although their program

meets the spirit of the proposed

standard, it would not meet the letter of

the law.

In response to Dow’s concern, OSHA

reviewed the perceived discrepancies

between the proposed rule and Dow’s

description of their program. In every

respect except one, Dow’s program

would have satisfied the proposed

grandfather clause; the discrepancies

Dow was concerned about were

apparently the result of

misinterpretation rather than

deficiencies on the part of Dow’s

program. For example, Dow stated that,

in its program, employees report MSDs

using the company’s existing injury and

illness reporting system rather than a

separate system set up just for MSDs;

Dow evidently believed that a separate

system would have been required by the

proposal (Ex. 32–77; Tr. 5340).

However, the proposed standard would

not have required employers to set up

a separate system for reporting MSDs as

long as their existing system included a

system for the reporting of MSDs. On

the other hand, Dow was correct in

stating that their program did not

include the proposed work restriction

protection provisions and would

therefore not have been eligible for

grandfather status under the proposed

rule.

In its post-hearing submission, Edison

Electric Institute argued that the

specificity of the proposal’s basic

obligations is counter to the goal of

flexibility, and the Institute

recommended that the final rule reduce

the detail in the basic obligation

sections to allow employers greater

latitude (Ex. 500–33).

The Mead Corporation suggested that,

if the Agency’s safety and health

program rule was not promulgated

before the ergonomics rule, OSHA

should alter the grandfather clause in

the ergonomics rule in one of two ways:

(1) Make the basic obligations less

prescriptive and detail acceptable

alternatives for prevention-oriented

programs, or (2) permit employers with

effective programs to maintain them

without making sweeping changes (Ex.

30–2216).

On the other hand, the AFL–CIO

argued that the standard should require

employers to meet the proposed basic

obligations for each core element before

being grandfathered in (Ex. 32–339; Tr.

3477). The AFL–CIO pointed out,

however, that the basic obligation

sections for several of the proposed core

elements left out important

requirements that were included under

the core elements:

The AFL–CIO believes that employers with

existing programs should be permitted to

continue with these programs if they are

comprehensive, provide workers and their

representatives full information and rights of

participation, and are effectively reducing

MSDs and exposure to hazards. However, as

proposed, the ‘‘grandfather’’ provisions are

deficient in a number of respects and will

permit employers to continue programs that

do not provide adequate protection.

First, the [proposed] basic obligation

requirements which all programs must meet,

exclude a number of elements that in our

view are essential for an effective program.

For example:

• The [proposed] basic obligation section

for Hazard Information and Reporting * * *

does not [include] any requirement to

provide employees information about MSD

hazards.

• The [proposed] basic obligation on

training * * * excludes any requirement for

training supervisors or individuals

responsible for the ergonomics program, thus

permitting programs to be ‘‘grandfathered’’

even if persons responsible for the program

do not have the necessary training. The basic

obligation for training also fails to provide for

job specific training on MSD hazards and

control measures.

• The [proposed] basic obligation for

Medical Management * * * does not require

that medical evaluations be conducted by a

health care provider.

• The [proposed] basic obligation for

Program Evaluation * * * does not require

consultation with employees in problem jobs

or their designated representatives to

determine their views on the effectiveness of

the program (Ex. 32–339).

As noted earlier, other rulemaking

participants also urged OSHA to

strengthen the proposed basic

obligations sections (see, e.g., Exs. 30–

4200, 32–198, 32–210, 32–461). These

commenters criticized the proposed

rule’s lack of basic obligation

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

68296 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68297

issued soon after promulgation of the

final rule.

5. Alternatives and Revisions to the

Grandfather Clause

Several rulemaking participants

suggested approaches that would permit

alternative programs developed after the

standard is in effect to be followed by

employers in lieu of compliance with

the standard (see, e.g., Exs. 30–2216,

30–3765; 30–3813, 32–339, 500–44; Tr.

3477). Many of these commenters

argued that their recommendations

would address the previously discussed

concerns with the proposed rule’s

grandfather clause—concerns such as

the perceived illusory nature,

vagueness, and subjectivity of the

proposed grandfather clause. The

alternatives or revisions to the proposed

grandfather clause suggested by these

commenters included:

• Revising the clause to allow

programs that are incomplete at the time

of the effective date to be grandfathered

(see, e.g., Ex. 30–3813; Tr. 4111);

• Revising the clause to make clear

that a company whose program had

been grandfathered could extend that

program (and grandfather status) to

establishments newly built or owned, or

acquired through mergers or

acquisitions (see, e.g., Exs. 30–3813, 30–

3922, 32–78; Tr. 5538);

• Revising the clause to allow any

program developed by an employer at

any time, including after the standard

has become effective, to be implemented

without fear of citation for

noncompliance with the OSHA

standard (see, e.g., 30–429, 30–1090; Tr.

15657);

• Revising the clause to specify that

OSHA will certify or approve

employers’ programs as qualified for

grandfather status (see, e.g., Ex. 32–133,

500–139);

• Revising the clause to recognize for

grandfather status any program that

complies with either the Washington

State or the California standard (see,

e.g., Exs. 30–429, 30–434, 30–973, 30–

1090, 30–1547, 30–1671, 30–2835, 30–

3813, 30–4134, 31–337, 32–311);

• Delete the grandfather clause and

substitute instead provisions giving

employers credit for already having

performed some of the required

elements, such as training, before the

effective date (see, e.g., Exs. 30–1547,

32–185, 32–311, 32–339, 32–461, 500–

207; Tr. 6423, 11129, 13092).

For example, ORC made several

suggestions along these lines (Ex. 30–

3813; Tr. 4111). First, they

recommended that OSHA rename this

section ‘‘Alternative Programs

Provision.’’ They also suggested that, as

a stimulus to innovation, OSHA allow

employers who do not now have fully

developed programs to qualify for

grandfather status in the future when

they do have such programs. DuPont

SHE Excellence Center made a similar

recommendation:

[One] improvement in the flexibility would

be to allow whichever elements that have

been put in place to be grandfathered and

those which are not in place to be added. The

grandfather clause should not be an ‘‘all-ornothing’’ 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).

68298 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 industryspecific 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

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

(§ 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.

68300 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

6Even 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.

7However, 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.

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.

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.

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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68301

8An 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.

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.

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).

68302 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

Otherwise, they argued, the standard

would not only upset the performance

of existing programs but would result in

poor allocation of risk control resources.

They gave examples of what they

believed might occur:

[O]ne Forum member, CCE, has spent

millions of dollars researching and

developing methods to reduce injuries

related to various warehousing and delivery

activities, such as improving new order

fulfillment systems. In this respect, CCE is

pioneering achievements that likely will

eventually be adopted throughout its

industry. However, particularly with respect

to employee participation in developing

safety programs, CCE is unlikely to meet the

strict requirements for grandfathering. As a

result, CCE anticipates that many of its

current efforts will be derailed as resources,

especially the time of its highly trained staff,

will have to be diverted to ensuring

compliance with the OSHA standard. Instead

of developing fixes that will prevent injuries,

these resources will be directed towards

‘‘fixing’’ the administrative structure of its

program.

Similarly, many NACS members

(convenience store operators and petroleum

marketers) incorporate MSD prevention and

ergonomics issues into their general worker

safety programs that cover a wide range of

issues, from dealing with slips and falls to

robbery deterrents to customer safety issues.

These programs have been extremely

effective in reducing MSD injuries. If not

grandfathered, implementing OSHA’s

proposed standard would require upsetting

and dramatically changing these already

effective programs (Ex. 30–3845).

Mead Corporation (Ex. 30–2216) made a

similar comment:

Responsible employers would be forced to

alter achieving programs and pursue

measures that we know are not as effective

as what we are already doing. The resources

that are focused on MSD prevention would

be shifted toward less meaningful activities.

A new infusion of MSDs may result at many

workplaces that have effectively controlled

these types of accidents to date because of

the shift in emphasis brought on by

compliance demands.

Consider:

• Many companies utilize periodic risk

assessments to update priorities for

ergonomics projects. Risk assessments

commonly include a survey of the workplace,

discussions with employees about potential

concerns, and analysis of MSDs. Priorities are

established and incorporated into a work

plan for the site’s ergonomics/safety team.

• When ergonomics teams in Mead

conduct analyses of jobs, they are encouraged

to identify as many opportunities for

continuous improvement (potential risk

factors) as possible and then to prioritize

based upon risk. Action plans are developed

for high risk concerns. Lower priorities are

not addressed at the time unless they are low

cost. Teams maintain documentation of these

items and may revisit them in the future once

higher priority items are resolved

In each of these examples, employers

are pursuing activities that should be

recognized as meaningful and exceeding

the level of protection OSHA is

currently seeking for the control of

MSDs. With the proposed standard,

however:

• When persistent symptoms develop at a

job considered to be moderate priority for

continuous improvement, higher priority

changes would be delayed, placing more

employees at higher risk for developing

MSDs;

• Similarly, when partial work aggravation

associated with a low risk task triggers a

manufacturing job, high priority changes

recommended by the ergonomics team based

upon comprehensive analysis will be

delayed; and

• Documentation of MSD prevention

activities will be increasingly scrutinized and

restricted due to concerns over how OSHA

would interpret the information (Ex. 30–

2216).

On the other hand, the American

Society of Safety Engineers stated that

ergonomics programs fit easily into

existing safety and health programs:

The establishment of basic ergonomic

management programs, increasing employee

awareness and involvement on these issues

is not a burden to employers when compared

to other safety and health compliance

requirements.

In fact, most efficient and effective

ergonomic initiatives will usually dovetail

with other existing safety and health

programs (Tr. 11611).

The final rule in general, and the

grandfather clause in particular, will

not, in OSHA’s view, require an

inefficient reallocation of resources. In

fact, because MSDs are the leading

cause of on-the-job injuries and

illnesses, OSHA believes that the final

rule will ensure that resources will be

devoted to areas where significant

improvement in injury and illness rates

can be realized.

OSHA agrees with the American

Society of Safety Engineers that

ergonomics programs fit well as part of

comprehensive workplace safety and

health programs. The final grandfather

clause does not require employers to

divorce ergonomics from their existing

safety and health programs. Thus,

employers who address ergonomics in

existing effective safety and health

programs typically will not need to

reinvent their ergonomics program just

to qualify for the grandfather clause.

In addition, as noted earlier, the final

rule accommodates prioritization of the

implementation of permanent controls,

as Mead Corporation is doing, where the

employer cannot fix all problem jobs at

once. Therefore, OSHA does not believe

that the final rule’s grandfather clause

will be disruptive or result in an

unwarranted reallocation of resources.

Union Carbide recommended that the

standard not require employee

participation in the development of

existing programs that would otherwise

qualify under the grandfather clause

(Ex. 30–3784). ORC also identified

employee participation in the

development of each element of the

program as one area that few of its

member companies could comply with

(Tr. 4135).

OSHA agrees with these rulemaking

participants that employee participation

in the development of ergonomics

programs is not necessary where an

existing program that qualifies for the

grandfather clause is at issue. The

primary purpose of the grandfather

clause is to recognize ergonomics

programs that employers have already

put into place, i.e., that are already well

past the developmental stage. According

to ORC, some of these programs have

not involved employees in the past

development, implementation, or

evaluation of the program. As drafted in

the final rule, employee participation in

these stages of program implementation

is required as appropriate, from this

time forward. In other words, OSHA is

not requiring employee participation in

the past development of a program as a

condition of the grandfather clause; it is

requiring employee participation in the

implementation, evaluation, and future

development of grandfathered programs,

however.

Alcoa, Inc., recommended that, for

existing capital-intensive industries and

equipment, OSHA allow employers

additional time to come into compliance

with the grandfather clause (Ex. 30–

3922). They argued that the

implementation of permanent controls

within 2 years, as proposed, was neither

realistic nor economically feasible for

some employers. The final rule’s

grandfather clause allows an employer

to have a process for identifying,

analyzing, and controlling MSD hazards

in problem jobs and following up to

ensure control effectiveness. Through a

prioritization process, an employer may

choose to temporarily implement

interim controls. Although the employer

is expected to institute permanent

controls as soon as possible, the final

rule does not provide a date when this

must be accomplished. Thus, employers

in all industries with qualifying

programs will be able to prioritize their

jobs for control in a rational manner that

permits them to take advantage of the

capital involvement and replacement

schedules of their industries.

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

68304 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

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

68306 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 hazardbased 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

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

68308 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

impose an undue burden on employers.

As discussed above, most small

manufacturing establishments do not

experience any injuries or illnesses in

any given year (Exs. 30–542, 30–3167,

500–1–128, Tr. 2980, 3073, 3096). In

fact, many establishments do not

experience any injuries or illnesses over

a considerable period. According to a

report prepared for the Small Business

Administration Office of Advocacy, 75

percent of manufacturing

establishments with fewer than 11

employees, 50 percent with 11–50

employees, and 25 percent of those with

50–249 employees would experience

almost no MSD incidents in any given

6-year period. (See also Economic

Analysis, chapters III and IV.) If this

standard were to adopt a multiple MSD

requirement, particularly one requiring

at least two MSDs in the same job

during a single year, injured employees

in many establishments might never be

provided with needed medical

intervention or protection from

additional injuries because it would

take so long for the triggering event to

occur.

The changes in the definition of

‘‘MSD incident,’’ and the new Basic

Screening Tool, both discussed below,

will also help to address the concerns of

some commenters that significant

employer action will be triggered by the

report of ‘‘any ache or pain,’’ whether or

not it is work related (Exs. 30–1722, 30–

2208, 30–3956, 500–52). P.J. Edington,

executive director of the Center for

Office Technology, said:

OSHA assumes any discomfort on the job

is work-related. That leaves all employers in

a continuous and costly cycle of trying to

eliminate all ‘‘signs and symptoms’’ of MSDs

(Ex. 30–2208).

But employers have the right under

this final rule to make reasonable

determinations that particular MSDs are

not work related. And only MSDs severe

enough to require medical treatment or

a job restriction, or signs and symptoms

persistent enough to last for seven

consecutive days, have any triggering

effect. Moreover, the standard’s Basic

Screening Tool establishes specific

thresholds for the duration, magnitude

and frequency of exposure to risk factors

that a job must involve in order for an

MSD incident in that job to be one that

triggers the standard’s program

requirements.

The final rule also takes into account

the concerns of commenters that a

single incident trigger ignores the fact

that an MSD may be related to the

‘‘unique physical characteristics’’ of the

worker (Exs. 30–328, 30–1651, 30–2208,

500–1–27, Tr. 5660–61). For example,

where the employer has reason to

believe that only the injured employee

is exposed to awkward postures because

he or she is very tall or very short, the

employer can limit the response to that

individual employee’s job or

workstation. See paragraph (j), below.

3. Definition of ‘‘MSD Incident’’

In this standard, the term ‘‘MSD

incident’’ means either an MSD that is

work-related and:

• Involves a work restriction, or

• Requires medical treatment beyond

first aid, or

• Involves MSD signs or symptoms

that are work-related and persist for 7 or

more consecutive days after the

employee reports them to the employer.

Work restriction is defined to mean

one or more days away from work, one

or more days of limitations on the work

activities of the employee’s current job

or temporary transfer to alternative

duty. Reducing an employee’s work

requirements in a new job to reduce

muscle soreness from the use of muscle

in an unfamiliar way is not considered

a work restriction under this final rule.

Also, the day an employee first reports

an MSD is not considered a day away

from work or a work restriction even if

the employee is temporarily removed

from work to recover.

Relationship to Recordkeeping Rule.

The proposed rule defined a ‘‘covered

MSD’’ as an OSHA recordable MSD that

occurred in a job in which the physical

work activities and conditions were

reasonably likely to cause or contribute

to that type of MSD, and those activities

and conditions were a core element or

took up a significant amount of the

employee’s worktime. In this final rule

OSHA has changed the term ‘‘covered

MSD’’ to ‘‘MSD incident’’ to dispel any

implication that any such MSD

immediately triggers a full ergonomics

program. Although some participants

found the definition of covered MSD to

be ‘‘relatively clear’’ (Exs. 30–3934, 30–

4837; 31–173, 31–186, 31–205, 31–229,

31–347), many more objected that it

covered too many MSDs, was too vague,

or was improperly linked to OSHA’s

recordkeeping rule (Exs. 30–1364, 30–

1722, 30–2088, 30–3167, 30–3845, 30–

3956, 500–73, 500–104, 32–337–1, Tr.

4366, 8226, 10000, 12797, 15977). The

new definitions of MSD and Action

Trigger in this standard address these

concerns.

OSHA received a great deal of

comment on the proposal’s use of an

OSHA-recordable MSD, i.e., an MSD

required by 29 CFR Part 1904 to be

recorded on the employer’s injury/

illness log, as a trigger for further action.

Many of these comments pointed out

potential problems that could be caused

by linking an employer’s obligations

under this standard to obligations and

interpretations contained in a separate

rule (Exs. 30–3853, 30–4137, 32–77–2,

Tr. 10632). This problem was

highlighted by the facts that OSHA has

proposed to amend its recordkeeping

rule, so that it has not been clear at any

stage of this ergonomics rulemaking

what the definition of an OSHArecordable 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

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

68310 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 workrelated 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

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

68312 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

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

68314 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 exposurebased ‘‘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

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

68316 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

1231, 26–36, 26–1018, 500–41–50, 26–

102, 26–900, 26–58, 500–71–53). For

exposure durations of one-fourth to onehalf 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 nonstatistically 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/s2). OSHA assumes that a moderate

vibration level is approximately 2.5m/

s2. The duration for moderate vibration

level is more than 2 hours total per day.

Assuming that a high vibration level is

approximately 10m/s2 (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,

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

68318 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

mind however, that these are not

intended to imply that a hazard exists

and requires control be instituted. There

is substantial evidence in the record that

supports the agency’s choice of risk

factors and duration levels. As with

‘‘action levels’’’ contained in other

health standards, the duration levels

were set at levels where the risk begins

to rise and additional, simple steps are

necessary.

The purpose of this screen is to focus

on those jobs that are likely to have

caused or contributed to the MSDs that

are reported. In general, activities

causing or contributing to such MSDs

are more likely to be ones that make up

significant amounts of the employee’s

worktime and represent a core element

of the employee’s job. As such, these

activities are likely to be a foreseeable

part of the job that can be reasonably

predicted and thus can be taken into

account when designing an ergonomics

program. These are the types of jobs that

OSHA seeks to capture under the final

standard so that programs can be put in

place to prevent further MSDs from

occurring.

In order to better enable employers to

capture such jobs, OSHA is setting a

minimum frequency for job or task

activities that must occur as a part of the

screening tool. OSHA is setting this

frequency at one day per week or more.

Obviously, there are numerous values

that could be chosen. However, OSHA

believes that this value can reasonably

be used to determine those job or task

activities that are core element of an

employee’s job, and are foreseeable or

reasonably predictable. In addition, a

frequency of once a week or more is

likely to capture many work activities

that are an element of an employee’s job

that occur on a weekly basis (e.g.,

deliveries or maintenance activities). To

meet the screen, a job must ‘‘routinely’’

involve tasks that meet the designated

criterion at least one day a week. This

value will also provide guidance in that

it can be used to rule out job or task

activities that are rare occurrences, that

are not predictable, or that result from

unusual work circumstances.

In conclusion, in response to the

comments received on the proposed

standard, OSHA has developed a

screening tool that will provide

employers with quantitative guidance

for determining work activities and

conditions that are likely to cause or

contribute to MSDs and that are a core

element of a job or make up a significant

amount of the employee’s worktime.

This screening tool includes specific

descriptions of tasks and durations that

will enable employers to evaluate jobs,

quickly and consistently, at their

worksites. To the extent possible, these

descriptions and durations were

developed using to the extent possible

using the best available epidemiological

literature as well as expert opinion from

other groups who have developed very

similar screening tools. This screen is

intended to be used in conjunction with

the event of an MSD incident to identify

work conditions where exposure risks

may exist such that a job analysis must

be conducted to determine whether job

controls are quickly and consistently

necessary.

Paragraph (g)—What Actions Must I

Take if the Employee’s Job Meets the

Action Trigger?

Paragraph (g) of the final rule defines

the actions that employers must take if

an employee with an MSD incident is

employed in a job that meets or exceeds

the action trigger. The paragraph

requires that the employer must either

implement the Quick Fix option in

paragraph (o) of the final rule, or

develop and implement an ergonomics

program that includes the following

elements:

(i) Management leadership as

specified in paragraph (h) of this

section;

(ii) Employee participation as

specified in paragraph (i) of this section;

(iii) MSD management as specified by

paragraphs (p), (q), (r), and (s) of this

section;

(iv) Job hazard analysis as specified

by paragraph (j) of this section;

(v) Hazard reduction and control

measures as specified in paragraphs (k),

(l), and (m) of this section, and

evaluations as specified in paragraph (u)

of this section, if the job hazard analysis

determines that the job presents an MSD

hazard;

(vi) Training as specified in paragraph

(t) of this section.

A few commenters suggested that the

effectiveness of ergonomics programs in

reducing workplace MSD hazards was

not demonstrated for the proposed rule.

For example, the post hearing brief

submitted on behalf of the U.S. Chamber

of Commerce stated:

None of this ‘‘evidence’’ * * * begins to

support the proposition that an Ergonomics

Program Standard such as the one contained

in the Proposed Rule will reduce at all the

incidence of workplace musculoskeletal

complaints. [Ex. 500–188]

In contrast, the use of ergonomics

programs as an effective method for

addressing workplace MSD hazards was

endorsed by the vast majority of

commenters in the rulemaking record

(see, e.g. Exs. 30–3855, 32–185, 500–

209, Tr. 4940, Tr. 1491). For example,

Mr. McCauseland, representing the

American Meat Institute (AMI), testified

during the rulemaking hearing: So what

has happened in the 10 years since the

meat packing guidelines were issued?

Well, a number of things. In our

industry, reduced levels of injuries and

illnesses have been approximately one

third of all incidents. Nearly one-half of

lost time incidents have been reduced as

well. * * * The guidelines have

fostered proactive efforts to eliminate

ergonomic risks and hazards in a wide

ranging number of applications [Tr.

4940].

A complete discussion of the

widespread support for the proposition

that ergonomics programs are effective

is contained in Chapter III of the Final

Economic Analysis for the final rule. In

that chapter, OSHA discusses the

history of successful ergonomics

programs and describes the extensive

use of ergonomic programs throughout

broad sectors of industry. In fact, the

number, longevity, and extensive use of

ergonomic programs that are similar to

those required by OSHA’s final rule

clearly validate the Agency’s regulatory

approach, as well as demonstrating the

inherent feasibility of the standard for

covered employers who establish such

programs.

Many of these programs have most or

all of the program elements required by

paragraph (g) of the final rule. The wide

use of these elements in current

programs is evidence that employers

believe them to be essential, workable

concepts. The program elements

contained in the final rule are

summarized and explained in other

sections of this preamble and therefore

will be discussed only briefly here in

the context of the overall program

requirement.

Paragraph (g) of the final rule

specifies that if an employee’s job

exceeds the action trigger, the employer

may implement a quick fix option for

that job under paragraph (o). An

employer who qualifies for the quick fix

option does not need to establish an

ergonomics program, although he or she

must follow all of the quick fix

procedures. However, if the employer

cannot or does not implement a quick

fix, then the standard requires an

ergonomics program with the following

elements:

• Management leadership,

• Employee participation,

• MSD management,

• Job hazard analysis,

• Hazard reduction and control,

• Training, and

• Evaluation.

Management leadership is critical to

the successful implementation and

operation of ergonomics programs.

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

68320 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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, twoway 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68321

employees are protected. It may

accomplish this objective through others

if it chooses, but the duty to provide the

protection remains the employer’s.’’ If,

for example, an employer has

determined that lifting an 80-pound box

poses an MSD hazard to employees, the

employer can establish a policy of

requiring employees to use a

mechanical lift to raise such a box and

train employees how to do this. The

employer could then hold the employee

accountable for adhering to this policy

in the same manner as other policies or

rules are enforced.

In addition to providing authority,

resources, and information, the

proposed management leadership

section included a requirement to

provide the training necessary to meet

assigned responsibilities. Because

training for those responsible for setting

up and managing the program is

addressed in paragraph (t) of this final

rule, training has been deleted from this

paragraph in order to avoid potential

confusion.

Some commenters expressed the

belief that management leadership is

implicit in an effective ergonomics

program, and an independent

requirement for management leadership

is therefore unwarranted (see, e.g., Exs.

30–3765, 30–1293). Dow Chemical, for

example, while strongly supporting the

need for management leadership in

safety and health activities, expressed

the view that it is not appropriate for

OSHA to attempt to regulate and enforce

leadership. By establishing and

evaluating the effectiveness of an

ergonomics program, Dow argued, the

employer has in effect demonstrated

leadership (Ex. 30–3765).

In a similar vein, some parties argued

that the requirements for management

leadership were largely redundant with

other sections of the proposal. They

pointed out, for example, that

communicating periodically with

employees about the ergonomics

program and their concerns about MSDs

was part of the proposed management

leadership provision, while separate,

specific requirements for

communication with employees were

proposed as part of the provisions

pertaining to quick fix, employee

participation, hazard information and

reporting, job hazard analysis and

control, training, MSD management, and

program evaluation. This ‘‘duplication,’’

it was argued, could subject employers

to being cited twice for a single

violation (see, e.g., Exs. 30–3344, 30–

4674).

OSHA believes that there is little, if

any, overlap with other parts of this

standard. The management leadership

and employee participation elements of

the final rule should be considered the

overall conceptual foundation of an

effective ergonomics program and a vital

part of the organizational framework of

an effective program. By fully

understanding the importance of

management leadership and employee

participation, it is expected that

program managers will determine how

best to apply these concepts in a

particular workplace and how the

individual subelements will work most

efficiently in their environment. Even

where some overlap could be perceived,

it is not OSHA’s policy to issue

duplicate citations for a single violation.

The management leadership element

also includes requirements unique to

this paragraph, such as the requirement

in paragraph (h)(3). That requirement

specifies that the employer must ensure

that their policies and practices

encourage and do not discourage

reporting or participation in the

program. OSHA believes that applying

this provision in an ergonomics program

is a logical component of management’s

effort to direct the ergonomics program

in a manner that will be protective of

employee health.

OSHA’s proposed requirement for

employers to ensure that their existing

policies and practices encourage and do

not discourage reporting and

participation in the ergonomics program

elicited a substantial volume of

comment. As explained in the preamble

of the proposal, this proposed provision

was intended to encourage the early

reporting of MSDs and meaningful

employee participation in the

ergonomics program. OSHA believes

that employees in all workplaces should

be encouraged by their employers to

report injuries, illnesses, and hazards of

all kinds—not just those related to

ergonomic issues—because only full

and frank reporting allows employers to

identify hazards and do something

about them.

Particular attention was paid by

participants regarding the requirement

that employers ensure that their policies

and practices do not discourage

reporting and participation in the

program, and the effect of this provision

on existing employer programs,

including safety incentive programs and

employee drug testing programs.

Policies and practices given in the

preamble to the proposal as examples of

those that may discourage reporting

included:

• Programs that reward or punish

employees on the basis of injury or

illness reports by offering incentives or

awards based on low numbers or rates

of reported MSDs.

• Policies that require every

employee reporting an MSD or MSD

signs and symptoms to submit to a drug

or alcohol test.

• Direct or reasonably perceived

threats of retaliation, including firing or

suspension, withholding overtime work

for anyone who reports MSD signs or

symptoms, (even from jobs that do not

involve exposure to risk factors),

prohibiting the use of sick leave for a

work-related injury; and sending every

employee who reports MSD signs and

symptoms home without pay.

Expressed or implied warnings of

retaliation for reporting MSDs, MSD

signs and symptoms, or MSD hazards

would clearly be considered a practice

that would discourage reporting. If, for

example, a supervisor were to inform

employees working the day shift that

reporting MSD signs and symptoms

would automatically result in transfer to

the night shift, this action could be

reasonably anticipated to suppress

reporting. An example of a situation

similar to this was described by the

UFCW. The union explained that

employees were reluctant to report

injuries in this situation due to the

consequences they would face:

[The company] had established a special

‘‘C’’ shift—the graveyard shift—for

employees suffering from work-related

injuries, many of which were cumulative

trauma disorders. The purported purpose of

the C shift crew was to assist injured workers

with long term medical restrictions in

returning to regular duty. In fact, however, a

number of employees assigned to the crew

were taken off regular duty jobs which they

had been performing successfully with their

restrictions. They were then isolated and

segregated on the C shift and assigned

degrading, demeaning, make-work tasks such

as picking up cigarette butts in the parking

lot at night with flashlights or scraping rust

off of pipes in the rendering department (Ex.

32–210–2).

Some employers have taken this a

step further, pursuing policies that

discipline workers for reporting injuries,

without considering the cause of those

injuries. When rewards or punishment

are linked to the reporting of MSDs or

MSD signs and symptoms, employee

reporting behavior can clearly be

influenced. Punishment for reporting in

the form of wage reductions, loss of

overtime, reprimands, suspensions, or

other means can be expected to

discourage reporting.

An example of this approach is a

system of imposing progressively more

severe penalties when injuries are

reported, such as a written reprimand

for the first incident, followed by

suspension, and finally termination

(see, e.g., Exs. 32–298–2). Another

example is a system that assigns a point

68322 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

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

68324 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 nonreporting (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

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

68326 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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.

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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-x1587, 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

68328 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 nonmandatory 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.

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

68330 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 labormanagement 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.

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

68332 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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).

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

68334 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

4709, p. 6, 500–145, 30–2208). For

example, a five-foot tall employee in a

commercial bakery may report a back or

shoulder MSD related to extended

reaches involved in sorting rolls.

However, other, taller, employees who

have performed the job for several years

do not have (and never have had)

difficulty performing the physical work

activities of the job. In this case, the

employer could conclude, based on the

job hazard analysis, that the problem is

limited to the injured employee. The

employer then may limit the further

action required by the standard (e.g.,

analysis, control, training,

recordkeeping, evaluation) to that

employee’s workstation.

A similar situation could occur where

one employee is much taller than others

in the same job. The tall employee

reports persistent back pain that rises to

the level of an MSD incident, and the

employer observes that having to bend

much further than the other employees

to work at the work surface is likely to

have caused the back problem. Allowing

employers to limit the analysis and

control to a single employee if the

analysis reveals that the problem is

unique to that employee is consistent

with the approach taken by several

commenters who have successful

ergonomics programs (see, e.g., Exs. 30–

1071, 30–3755, 30–3745). As one of

these commenters reported, ‘‘we have

often modified the job to fit that one

individual—however, modification was

not needed for co-workers at similar or

identical duty stations’’ (Ex. 30–1071).

Paragraph (j)(2)

Paragraph (j)(2) of the final rule

describes the steps the employer must

take in performing the job hazard

analysis. Paragraph (j)(2)(i) states that

the employer must talk to the employees

who perform the job, and their

representatives, about tasks that may

relate to the MSD incident. Paragraph

(j)(2)(ii) requires the employer to

observe the employees performing the

job to identify the risk factors and assess

the extent of their exposure (its

magnitude, frequency, and duration) to

those risk factors. The employer must

include all of the employees performing

the job, or a sample of those with the

greatest exposure to risk factors, in this

analysis.

According to the record (see, e.g., Exs.

26–2, 26–5, 26–1370, 37–1, 37–25)

effective job hazard analyses have the

following steps or activities in common:

• Obtaining information about the

specific tasks or actions the job

involves;

• Obtaining information about the job

and problems in it from employees who

perform the job;

• Observing employees performing

the job;

• Identifying specific risk factors in

the job; and

• Evaluating those factors (i.e., their

duration, frequency and magnitude) to

determine whether they are causing or

contributing to the problem.

The job hazard analysis requirements

of the final rule reflect these steps.

Unless the employer qualifies for and

chooses the Quick Fix Option in

paragraph (o), the employer must use

the job hazard analysis process in this

paragraph to determine whether the

physical work activities and job

conditions pose an MSD hazard to

workers in that job. Jobs that pose an

MSD hazard to employees are called

‘‘problem jobs,’’ and must be controlled

in accordance with paragraphs (k)

through (m) of this final rule.

When employers perform a

comprehensive job hazard analysis,

their goal is to identify those ergonomic

risk factors that impose biomechanical

stress on the worker and evaluate

magnitude, frequency, and duration as

required by paragraphs (j)(2)(ii) and

(j)(3). Once the risk factors and their

magnitude, frequency, and duration

have been determined, the employer is

required to assess whether the risk

factors identified pose an MSD hazard

to employees. The standard defines an

MSD hazard as the ‘‘presence of risk

factors in a job at a level of magnitude,

frequency, and/or duration that is

reasonably likely to cause MSDs that

result in work restrictions or medical

treatment beyond first aid.’’ Ergonomic

risk factors are the elements of MSD

hazards, and they often work

synergistically. That is, jobs that have

multiple risk factors pose a greater risk,

all things equal, than a single risk factor.

Paragraph (j)(2)(i)

Paragraph (j)(2)(i) of the final rule

requires employers to talk with

employees and their representatives

about the tasks the employees perform

that may relate to MSDs. Much has been

written about the value of employee

participation in the identification of risk

factors and controls at the hazard

analysis stage (see, e.g., Exs. 3–232, 26–

4, 26–11, 26–15, 26–18, 26–19, 26–21,

26–1370, 26–1420, 32–339–1–42, 38–

32). Studies have shown substantial

improvements in health and safety after

participatory ergonomics programs are

implements (e.g. Ex. 32–38). A comment

from Johnson & Johnson sums up the

opinion of many participants:

Hazards cannot be addressed efficiently

without an accurate evaluation of the

situation. The line employee is one of the

best sources of this information * * * [those

employees are] local process experts (Ex. 3–

232).

The record contains considerable

evidence that many employers talk to

employees to get insight into the job

requirements that only those who work

at the job can provide (see, e.g., Exs. 30–

3755, 30–3748, 500–117, 500–137–1–1,

500–137–6–1, 500–218, 500–220, Tr.

3890, 13808). These commenters stated

that talking with employees is often the

best way to identify the causes of the

problem and to identify the most costeffective 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

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

68336 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

Risk factors—shorter

worker Identified by Risk factors—tallerworker Identified by

Contact Stress ............ Armstrong (TR. 928), Alexander (TR. 2249),

Fernandez (TR. 5384), LeGrande (TR.

9047), Brossard (TR. 13221), Robbins (TR.

1362).

Awkward neck posture Armstrong (TR. 929), Alexander (TR. 2250),

Fernandez (TR. 5380), Brossard (TR.

13228), Rich (TR. 9590).

Static Posture ............. Armstrong (TR. 928), Fernandez (TR. 5384),

LeGrande (TR. 4096), Rich (TR. 9592).

Static posture ............. Fernandez (TR. 5380), Rich (TR. (9592).

Awkward neck posture Alexander (TR. 2250), Fernandez (TR. 5385),

Brossard (TR. 13224).

Awkward wrist posture Rich (TR. 9598).

Awkward back posture LeGrande (TR. 4096), Brossard (TR. 13225),

Rich (TR. 9601).

Awkward back posture Brossard (TR. 13227).

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),

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68337

the final rule gives employers the option

of including only a sample of those

employees in the analysis.

Some commenters asked OSHA to

clarify when jobs are the same (see, e.g.,

Ex. 30–3784). Jobs are the same when

workers perform the same physical

work activities or same job tasks.

Employees perform the same job when

the discrete elements or physical actions

they perform are the same, even if not

every aspect of their jobs is identical.

For example,

• Employees whose jobs involve

picking up packages from one conveyor

and putting them onto another are

performing the same job, even if the

packages contain different products, or

are placed on different conveyors.

• Orderlies whose job tasks involve

lifting and moving patients have the

same job even though some

characteristics of the patients, room

layout and the purpose of the lift or

move may vary each time.

• Garbage collectors who pick up

trash cans and recycle bins, and dump

their contents into the garbage truck,

have the same job even though their

routes are not identical (e.g., variations

in terrain, traffic, distance from

residences).

On the other hand, just because the

workstations, tools and equipment

employees use is the same does not

mean that these employees have the

same job. For example:

• Employees who use VDTs do not

have the same job where one employee’s

job involves steady typing for most of

the workday while the other employee

uses the VDT to read and send

electronic messages for only a few hours

a day.

• Employees in an automotive

assembly plant who use glue guns or

staple guns do not necessarily have the

same job if they are assembling different

aspects of the product (installing seats

versus windshields), particularly if they

use the tools in different ways, with

different force, and in different

positions.

For purposes of this standard, job

titles or classifications do not determine

whether employees are in the same job.

Where employees are performing the

same physical work activities or tasks,

they are in the same job even if they

have different job titles. Often jobs

involving the same physical work

activities may have different job titles if

there are working supervisors, some

kinds of seniority systems, or different

work shifts. For example, a ‘‘Fabricator

II’’ on the third shift may be performing

the same physical work activities as a

‘‘Junior Fabricator II’’ or ‘‘Apprentice

Fabricator’’ on the first shift.

At the same time, just because

employees have the same job title does

not mean that the employer must

include them in the job hazard analysis

if the job tasks are not the same. This

is especially true when employers have

general job classifications, such as office

worker, assembly line workers,

production staff. ‘‘Office workers’’ may

be assigned to tasks as varied as

answering phones, operating copy

machines, filing, or typing. If the MSD

incident affected an office worker typing

documents, the employer would only

need to include in the job hazard

analysis other office workers whose

work task is to type documents.

Likewise, ‘‘lineworkers’’ or ‘‘production

workers’’ in a poultry processing plant

may perform very different tasks.

Sample of Employees

Paragraph (j)(2) also gives employers

the option to include in the job hazard

analysis only a sample of the employees

in the same job. Where the employer

elects to use a sample of employees, the

sample must include those employees

with the greatest exposure to the

‘‘relevant risk factors’’ (i.e., those risk

factors that exceed the levels on the

Basic Screening Tool). The proposed

rule also included a similar option and

many commenters supported it (see e.g.,

Exs. 30–3344, 30–3745, 30–3749).

OSHA believes that this option

should help to reduce burdens for

employers while at the same time

ensuring that the analysis of risk factors

exposure in the job is accurately

characterized and not underestimated.

Some commenters, including AnheuserBusch and United Parcel Service

reported that they had dozens to

hundreds of employees in their

establishments who perform the same

job (Exs. 32–241). This option also

should help establishments employing

telephone operators, customer service

representatives, catalog sales

representatives, data processors, trash

collectors, warehouse selectors, grocery

store cashiers, meatpackers, poultry

processors and others. Including every

employee in these ‘‘same jobs’’ in the

job hazard analysis may be

unnecessarily resource intensive,

especially where the workstation

layouts and tools are identical (Ex. 500–

145). Employers may be able to identify

the problem and possible controls after

analyzing the jobs of only a handful of

employees.

This option will also help in

situations where jobs are of short

duration or do not have fixed

workstations (e.g., visiting nurses, home

health aides, home repairmen, furniture

movers, beverage delivery, package

delivery, utility line workers, trash

collectors) (Exs. 30–339–22, 30-3714,

32–234–2–1, 500–73, 500–147–33, Tr.

14300). Changes in job locations and job

conditions may make it very difficult to

analyze the job of each employee.

However, analyzing the job for a sample

of employees allows employers to

identify the MSD hazards facing all of

the employees.

OSHA is requiring employers to

sample those employees with the

greatest exposure to the relevant risk

factors to ensure that exposure levels in

the job are characterized accurately.

OSHA has used the concept of

‘‘representative sampling’’ for hazard

identification purposes in several of its

standards, such as the asbestos standard

(29 CFR 1910.1001), the formaldehyde

standard (29 CFR 1910.1048), and the

lockout/tagout standard (29 CFR

1910.147). The principle behind this

concept is that, if the job hazard

analysis (or the exposure monitoring, in

the case of chemical exposures) reveals

that the exposures to this group of most

highly exposed workers are not at levels

of concern, it is likely that those of other

lesser exposed workers will also not be

of concern.

A few participants disagreed that the

representative sampling option would

be useful to reduce burdens for

employers:

OSHA concedes that ‘‘conducting a job

hazard analysis that covers all employees in

a problem job may be burdensome’’ * * * It

is not possible for an employer to know of

and account for the multitude of physical

factors that affect the way its employees

work. A sample selected, for instance, could

inadvertently ignore the employee with the

widest fingers, the smallest feet or the most

sensitive hearing, in violation of the

proposed rule. OSHA’s ‘‘shortcut’’ for

performing a job analysis is to us

insignificant and illusory—employers will, in

practice, have to observe virtually every

employee in the problem job—a task that

even OSHA admits can be burdensome (Ex.

500–197).

OSHA does not believe that

employers will have difficulty

identifying the employees in a job who

are most likely to have the greatest

exposure to the risk factors. The specific

criteria in the Basic Screening Tool will

be particularly useful in helping

employers identify, for example, those

employees who:

• Repeat the same motion for the

longest continuous period during the

workshift;

• Lift the heaviest objects or packages

or the most objects per workshift;

• Have the greatest degree of flexion

or extension of their wrists;

• Use vibrating hand tools for the

most time during the workshift; and

68338 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

9Neutral 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.

• 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.

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

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

68340 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68341

approaches, including simple

checklists, more structured assessment

tools, and reliance on expert

consultants.

The United Automobile Workers

(UAW) submitted a number of

checklists that its members use (Exs.

32–185–3–26, 32–185–3–33), and

described several approaches to hazard

identification that employers have used

to identify ergonomic risk factors

effectively (Ex. 500–220). These

approaches include:

• Development of consistent methods

to measure the physical stresses on the

body. Stress is determined by the force

exerted on a body part, the frequency of

the motion and the posture of the joint.

The Force-Frequency-Posture paradigm

is common to both expert and checklist

approach to ergonomics analysis.

• Development of simplified nonexpert approaches to measurement of

risk factors (checklists)

• Formulation of the NIOSH lifting

guide and related biochemical models

which take into account the weight of

an object, distance from the body and

motion of the body in lifting.

• Validation of symptom surveys and

discomfort surveys (psychophysical

measures) as risk factor identification

tools

• Validation of the use of risk factor

checklists and symptom surveys by

workforce personnel to identify high

risk jobs and propose abatement

methods.

Dr. Don Chaffin, founder of the Center

for Ergonomics at the University of

Michigan, testified that the precision of

many tools used to evaluate risk factors

is very high (Tr. 8255–8286). Ms. Lisa

Brooks, corporate ergonomist for

International Paper, commented that

there were many different analysis tools

used throughout the company (Tr.

11427).

The AFL–CIO also commented on the

widespread availability of risk factor

evaluation tools (Ex. 500–218):

Testimony and evidence in the record

demonstrate the job analysis tools such as the

NIOSH Lifting Equation and Snook—Ciriello

Push-Pull Tables are widely utilized by

employers, unions, consultants and others to

evaluate exposure to ergonomic risk factors

throughout a wide range of industries and

businesses. Representatives of International

Paper (Tr. 11425–26), Owens-Corning (Tr.

10856), Conti Group Corp. (Tr. 10788), Coca

Cola (Tr. 14356) and Levi Strauss (Tr. 14710)

testified that they routinely used these tools

in their ergonomic programs to analyze jobs

for ergonomic risk factors. Representatives

from the UAW and UNITE! testified how

these and other tools such as UAW–GM

Check Lists were used by employers and

union representatives to evaluate ergonomic

hazards at Ford (Ex. 32–185–3–42; 46, Tr.

5827, 5828), GM (Tr. 5831), Maytag (Tr.

8062), VF Corp. (Tr. 7074), Owens-Corning

(Tr. 10858), Levi Strauss (Tr. 14710), Coca

Cola (Tr. 14356), PPG Industries (Tr. 3131).

OSHA has included several of these

tools in Appendix D–1.

Paragraph (j)(3)(i)

Paragraph (j)(3)(i) of the final rule

allows the employer to evaluate

ergonomic risk factors using one or

more of the hazard identification tools

listed in Appendix D–1 of this section.

Appendix D–1 list eight hazard

identification tools: (1) The Job Strain

Index (Ex. 26–883), (2) the NIOSH

lifting equation (Ex. 26–572), (3) the

UAW–GM checklist (Ex. 32–185–3–26),

(4) the applicable ACGIH threshold

limit values for physical agents (Exs. DC

389, 500–166–1, 502–273), (5) the Rapid

Entire Body Assessment (REBA) (Ex.

500–121–26), (6) the Rapid Upper Limb

Assessment (RULA) (Ex. 26–1421), (7)

Appendix B to the final Washington

State ergonomics standard (WAC 296–

05174) (Ex. 32–210–2–99), (8) the Snook

Push/Pull Hazard Table (Ex. 26–1008).

Tools selected must be relevant to the

risk factors being addressed. This

means, for example, that an employer

could not use the NIOSH Lifting

Equation, which is appropriate for

employees exposed to certain types of

force, to analyze a job involving

repetition and awkward posture.

A number of participants submitted

evaluation tools to the record (see, e.g.,

Exs. 26–2, 26–5, 32–77–2–1, 502–67,

26–883, IL–162–Q, 32–185–3–31, 500–

142–12, OR–348–1, 32–185–3–26, 500–

121–61, 38–260, IL–218, IL–228, 32–

339–1–82, DC 417–6, 500–121–21, 38–

93, 500–121–28, 32–111–1, 32–198–4–

27–1), while others (see, e.g., Exs. 500–

220, 500–218, Tr. 5567) suggested that

the final rule include tools, such as the

Snook tables and the OSHA

Meatpacking Guidelines (Ex. 30–2387).

Still other participants merely asked the

Agency to provide more guidance in the

final rule for companies to identify

ergonomics risk factors (see, e.g., Exs.

30–276, 30–3818, 30–4290, 500–197,

500–218, 30–3864, Tr. 11601, Tr. 9070,

Tr. 17419), and many commenters

suggested that OSHA provide nonmandatory 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

68342 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 welldesigned for: manual handling tasks

involving objects weighing more than 10

pounds; forceful lifting tasks in

production and assembly work; package

sorting, handling, delivery and pickup.

ACGIH TLV Hand/Arm (Segmental)

Vibration TLV

The ACGIH Hand/Arm (Segmental)

Vibration TLV describes how to

measure hand tool vibration and

provides threshold limit values for

exposure.

Areas of the body addressed: Hands,

Arms/Shoulders.

Risk factors evaluated: Vibration.

Examples of jobs that the Hand/Arm

(Segmental) Vibration TLV is applicable

to or well-designed for: Jobs involving

use of powered and vibrating hand tools

(e.g., grinding, sanding furniture,

sawing, jigsawing, chain saws).

GM–UAW Checklist

The UAW–GM checklist was

developed to evaluate a range of risk

factors in production jobs. The checklist

uses checks (√) and stars (*) to indicate

whether the certain activities and

conditions are present for less than or

more than one-third of the production

cycle or workday. The number of checks

and stars, in conjunction with the report

of an MSD, is used to determine if the

job requires further investigation or

control action.

Areas of the body addressed: Hand/

wrists, Forearms/elbows, Shoulders,

Neck, Back/Trunk, Legs/knees.

Risk factors evaluated: Force

(including manual handling),

Repetition, Awkward Postures

(including Static Postures), Vibration,

Contact stress

Examples of jobs that the GM–UAW

checklist is applicable to or welldesigned for: cyclical production and

assembly work jobs.

RULA

The Rapid Upper Limb Assessment

(RULA) was developed to evaluate

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

68344 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 factorbased 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 ergonomistconsultants 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,

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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°F, ambient air 45°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

68346 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

three options. Employers are in

compliance with this paragraph when

the controls they have implemented:

• Control the MSD hazards to the

extent that they are no longer reasonably

likely to cause MSDs that result in work

restrictions or medical treatment beyond

first aid,

• Reduce MSD hazards in accordance

with or to levels below those in the

hazard identification tools in Appendix

D that the employer used to conduct the

job hazard analysis, or

• Reduce MSD hazards to the extent

feasible.

As described in the Risk Assessment

and Economic Analysis sections of this

preamble, much evidence in the record

demonstrates that employers with

existing programs are able to

successfully control the MSD hazards in

problem jobs to a level where an MSD

is reasonably unlikely to occur.

Paragraph (k) of the final rule does not

require employers to eliminate all

MSDs. OSHA recognizes that, in a

number of jobs, workplaces, and

physical work activities it may not be

possible to eliminate MSDs. OSHA is

also aware that employers who have an

effective ergonomics program may still

receive reports of MSDs. The goal of the

final rule is to assure that employers

take effective action to control MSD

hazards, and paragraph (k) tells

employers how far they must go in

implementing controls.

Paragraph (k)(1)(i)

An employer is in compliance with

paragraph (k)(l)(i) when it reduces MSD

hazards to the extent that they are no

longer reasonably likely to cause MSDs

that result in work restrictions or

medical treatment beyond first aid. The

hazard analysis conducted under

paragraph (j) will have identified the

risk factors of concern. To control the

MSD hazard, the employer must reduce

the magnitude, duration, or frequency of

the risk factors to the level where they

are reasonably unlikely to cause such

MSDs. There are several ways an

employer can achieve this goal.

First, the employer can reduce

ergonomic risk factors below the levels

in the Basic Screening Tool. The final

standard recognizes that risk factors

below the levels in the screening tool

are not reasonably likely to cause MSDs,

and allows an employer to discontinue

his or her ergonomics program if it has

reached those levels.

Second, the employer can otherwise

control the hazards such that they are

reasonably unlikely to cause MSDs. In

some cases, the needed controls may be

obvious or readily discoverable by

reference to compliance assistance

materials. In other cases, judgment may

be required. In any event, the employer

may refer to the method it used under

paragraph (j) to determine whether the

job presents a hazard. For example, the

employer may use a professional trained

in ergonomics to conduct the analysis

and determine whether job conditions

present a hazard and to recommend

measures to control the hazard. The

employer can also make use of its own

knowledge and experience gained under

its program.

The employer may also use hazard

identification tools. As described above

in the explanation of paragraph (j), the

employer may choose from a variety of

such tools. Appendix D lists a number

of specific tools that provide safe

harbors for compliance under paragraph

(k)(1)(ii); however, the employer may

also consider other tools that are

effective in identifying hazardous levels

of exposure in determining what

controls to implement.

These examples are not intended to be

exhaustive. They are intended to

illustrate means employers may use to

‘‘control MSD hazards.’’

Several points bear noting. First, the

obligation is not to reach a level of

absolute safety or to assure that no

further MSDs will occur: it is to reduce

the hazard so that work activities are not

reasonably likely to cause MSDs.

Second, the hazard reduction is targeted

to MSDs that result in work restrictions

(including days away from work) or

medical treatment beyond first aid.

These are serious conditions by any

measure. Finally, the standard allows

the employer to take up to two years to

implement permanent controls. This

extended period should be sufficient to

allow for situations in which

installation of effective controls requires

a period of adjustment.

Paragraph (k)(1)(ii)

The second option is to reduce MSD

hazards in accordance with or to levels

below those in the hazard identification

tools in Appendix D that the employer

used to conduct the job hazard analysis.

This appendix is intended to give

employers specific guidance to help

them determine whether or not they

have gone far enough in controlling

MSD hazards. As discussed more fully

below, many rulemaking participants

felt that the proposed rule was vague

and shifted the burden of determining

how far to control MSD hazards to

employers (see, e.g., Exs. 30–1722; 30–

3956, 35–106; Tr. 4110, 15648–15649)

or suggested that OSHA provide, in the

final rule, more guidance on how to

make that determination (see, e.g., Exs.

30–1557, 30–2987, 30–3748, 30–3765,

32–133, 32–300). OSHA has responded

to these comments by allowing

employers the option of controlling

MSD hazards to the specific levels set

out in Appendix D.

Paragraph (k)(1)(iii)

Paragraph (k)(1)(iii) of the final rule

states that employers are in compliance

with the endpoint if they have reduced

the hazard to the extent feasible. This

paragraph applies when it is not feasible

for employers to reach one of the

endpoints in paragraphs (k)(1)(i) and

(ii). It is included because OSHA has no

authority to require employers to do

what is not feasible or ‘‘capable of being

done.’’ American Textile Mfrs. Institute

v. Donovan (Cotton Dust), 452 U.S. 490,

509, 513 n. 31, 540 (1981). A control

that will reduce a hazard in a job is

feasible if it is achievable within the

limits of current technology and

knowledge and the employer’s financial

resources. An employer’s inability to

afford controls will not establish

infeasibility if its level of compliance

lags significantly behind the rest of its

industry. See Section IV–A.6.a(4)(a) and

(b) of OSHA’s Field Inspection

Reference Manual (CPL 2.103). See also,

United Steelworkers v. Marshall, 647

F.2d 1189, 1269 (D.C. Cir. 1980).

OSHA is also requiring that

employers who meet the compliance

endpoint by being at the limits of

feasibility, but have not fully controlled

MSD hazards, periodically check to see

whether new technology has been

developed and is available. These

checks must be carried out at least once

every 3 years. When additional feasible

controls are identified, the final rule

requires employers to implement them

until one of the compliance endpoints

given in paragraph (k)(1)(i) or (k)(1)(ii)

is reached. Requiring employers to look

for and implement new control

methodology ensures that an employer

who has not fully controlled ergonomic

hazards is not relying on obsolete

control measures.

What Happens When a New MSD Is

Reported After Controls Have Been

Implemented?

Paragraph (k)(2) of the final rule tells

employers what to do if an employee

reports an MSD in a job in which the

employer has implemented MSD hazard

controls. If an employee makes such a

report, the employer must check to see

if the controls are still in place and are

functioning and being used properly.

The employer must also check to see if

any new hazards exist that were not

present when the job hazard analysis

was conducted. The employer need not

conduct another full job hazard analysis

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68347

but may undertake a review of the

previous job hazard analysis to

determine if it is adequate.

Sometimes, after ergonomic control

measures have been implemented in a

problem job, another employee will

experience and report an MSD. The

injury could be a sign that the controls

are not functioning correctly or that new

hazards have arisen. For example, an

employer might have, among other

things, installed adjustable keyboard

trays at each VDT station and trained

employees in their use. If one of the

keyboard trays gets out of adjustment,

the operator using that tray might

experience and report tendinitis in his

or her wrists. An employer following

paragraph (k)(2) of the final rule would

check to ensure that the keyboard tray

is still present and is adjusted properly.

Note to Paragraph (k)

A clarifying note at the end of

paragraph (k) explains that the

occurrence of an MSD in a problem job

is not in itself a violation of the

standard. This note emphasizes that the

focus of the final rule’s compliance

endpoint is on the control of MSD

hazards and not on the elimination of

MSDs from the workplace. OSHA

recognizes that, for a number of jobs,

workplaces, and physical work

activities, it may not be possible to

eliminate MSDs. OSHA is also aware

that employers who have effective

ergonomics programs may still receive

reports of MSDs. The goal of the final

rule is to have employers put a good

working system into place so that they

can take effective action to control MSD

hazards.

The Proposed Rule

The proposed rule would have

required employers to meet one of three

compliance endpoints:

• Materially reduce MSD hazards in

the problem job using the incremental

abatement process;

• Reduce MSD hazards in the

problem job to the extent feasible; or

• Eliminate MSD hazards in the

problem job.

OSHA explained the first endpoint

with a definition of ‘‘materially reduce

MSD hazards.’’ The definition, which

was repeated in a note following

proposed § 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

§ 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]

68348 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 longstanding 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–

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

68350 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

10The 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.

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]

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 openended 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

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

68352 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

11With 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]

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).

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. § 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

§§ 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

§§ 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68353

12As noted elsewhere in this preamble, the

Coalition has mischaracterized the proposal’s use of

the term ‘‘covered MSD’’ as ‘‘complaints.’’

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:

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 posthearing 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

68354 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 openended requirement to use all feasible

control methods until the risk of an

MSD reaches zero conflicts with wellestablished 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 shortterm 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 costeffective, 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.

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

68356 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

[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

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

68358 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 (§ 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

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

68360 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 postinjury devices used to speed

rehabilitation, are not considered PPE

for the purposes of this standard.

Paragraph (l)(i)—Feasible Controls

Paragraph (l)(i) of the final standard

mandates the use of feasible controls

(engineering, work practice, and

administrative controls) or any

combination of them to control or

reduce MSD hazards in problems jobs.

This paragraph also states that

engineering controls, where feasible, are

the preferred method of control. This

paragraph of the final rule is essentially

unchanged from the proposal. OSHA is

allowing employers this flexibility in

the choice of controls because the

Agency’s experience and information in

the rulemaking record indicates that

these control approaches have been

effective in contributing to reductions in

the number and severity of workplace

MSDs. In addition, OSHA believes that

the broad range of jobs to which the

standard will apply, and the great

variation in workplace conditions

covered, make compliance flexibility

essential.

The final standard defines

engineering controls as controls that

physically change the job in a way that

controls or reduces MSD hazards.

Examples of engineering controls that

are used to address ergonomic hazards

are workstation modifications, changes

to the tools or equipment used to do the

job, facility redesigns, altering

production processes, and/or changing

or modifying the materials used.

Engineering controls range from very

simple to complex: from putting blocks

under a desk to raise the work surface

for a taller-than-average worker to

providing a lumbar support pillow or

rolled-up towel to a video display unit

(VDU) operator, to redesigning an entire

facility to enhance productivity, reduce

product defects, and reduce workplace

MSDs.

When choosing an engineering

control to address a particular

ergonomic problem, employers often

have many choices, depending on how

much they wish to spend, how

permanent a solution they seek, how

extensive a production process change

they need, and employee acceptance

and preference (see the discussion of

control approaches in the summary and

explanation for paragraph (m)). For

example, as MacLeod (Ex. 26–1425)

points out, an employer whose VDU

operators are experiencing neck and

shoulder problems has many options

available, including the following:

• Raising the height of the monitor by

putting it on phone books, building a

monitor stand, buying an adjustable

monitor stand, buying an adjustable

wall-mounted monitor stand, or buying

an adjustable desk-mounted monitor

stand;

• Putting the desk on blocks; or

• Providing an adjustable-height desk

or workstation.

Work practice controls involve

changes in the way an employee does

the job. They are defined by the

standard as changes in the way an

employee performs the physical work

activities of a job that reduce exposure

to MSD hazards. Work practice controls

involve procedures and methods for safe

work. Examples of work practices that

reduce the potential for exposure to

ergonomic risk factors are the use of

neutral positions or postures to perform

tasks (keeping wrists straight, lifting

close to the body), use of two-person

lifts when mechanical lifts are not

available, and the observance of microbreaks 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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, § 1910.1001;

benzene, § 1910.1047; cadmium,

§ 1910.1027; and methylene chloride,

§ 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, vibrationattenuation gloves, and gloves worn to

protect against cold temperatures.

The hierarchy of controls, which, as

discussed above, is widely endorsed by

ergonomists, occupational safety and

health specialists, and health care

professionals, accords last place to PPE

because:

• Its efficacy in practice depends on

human behavior (the manager’s,

supervisor’s and worker’s),

• Studies have shown that the

effectiveness of PPE is highly variable

and inconsistent from one worker to the

next,

• The protection provided cannot be

measured reliably,

• PPE must be maintained and

replaced frequently to maintain its

effectiveness,

• It is burdensome for employees to

wear, because it decreases mobility and

is often uncomfortable,

• It may pose hazards of its own (e.g.,

the use of vibration-reduction gloves

may also force workers to increase their

grip strength).

One author (Ex. 26–1408) notes that:

‘‘ * * * in most cases, the use of PPE

focuses attention upon worker

responses and not the causes of

ergonomic hazards.* * * PPE does not

eliminate ergonomic hazards * * *

[and] must be considered as the last line

of defense against ergonomic hazard

exposure.’’ Thus, although the final

standard permits PPE to be used as a

supplemental control, it cannot be

relied on as a permanent solution to

MSD hazards unless other feasible

controls are unavailable.

In the proposal, OSHA included a

note to the proposed section on the

hierarchy of controls that stated that

back belts/braces and wrist braces/

splints were not to be considered PPE

for purposes of the standard. This note

was added to alert employers to the fact

that back belts and wrist braces, which

are widely used in U.S. workplaces,

were not to be considered a control to

reduce ergonomic hazards under the

proposed standard. OSHA pointed out

that these devices were being marketed

as equipment that could prevent MSDs,

although the evidence to support these

claims was inconclusive.

A number of commenters and studies

in the record (see, e.g., 32–30–1–15, 32–

30–1–6, 32–30–1–7, 32–30–1–29, 32–

30–1–14) suggest that OSHA should

allow the use of back belts as PPE on the

grounds that these devices have been

shown to reduce workplace injuries. For

68362 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 § 1910.919,

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68363

although they have been revised in the

final rule to reflect the Action Trigger

and to state what employers must do if

the controls they have implemented are

not effectively reducing MSD hazards.

The steps specified in paragraph (m) are

widely recognized as basic procedures

in effective control selection and

problem-solving. For example, the

NIOSH publication, Elements of

Ergonomic Programs, describes a similar

process (Ex. 26–2). Paragraph (m) also

sets the deadlines for the

implementation of initial and

permanent controls to reduce MSD

hazards. OSHA received very few

comments on the proposed control steps

provision.

The corresponding provision in the

proposal also contained a requirement

that employers identify and evaluate

MSD hazards when they changed,

designed, or purchased equipment or

processes in problem jobs. The final rule

contains no similar requirement.

OSHA does not believe that a separate

provision is necessary, because the final

rule includes a ‘‘feedback’’ loop

between paragraph (m)(4) of the rule

and paragraphs (m)(1) and (m)(2). OSHA

received only one comment on this

proposed provision (Ex. 32–300–1). This

commenter asked whether OSHA

intended this provision to be similar to

the management of change provision in

the Process Safety Management

standard (29 CFR 1910.119). Since this

proposed provision has not been carried

forward in the final rule, the issue

raised by this commenter is moot.

Paragraph (m)(1)—Ask Employees

This paragraph requires employers

who have determined that they have a

problem job to ask the employees in the

problem job, and employee

representatives, to recommend measures

to reduce the MSD hazard in the job.

This provision is essentially unchanged

from the proposal, except that employee

representatives are mentioned

specifically in the regulatory text, which

reflects OSHA’s decision to add this

language to provisions of the regulatory

text where the involvement of employee

representatives is particularly

important. Several commenters (see,

e.g., Exs. 32–339–1, 32–182–1) urged

OSHA to include employee

representatives in this step of the hazard

identification and control process

because of the contribution they could

make. OSHA agrees and has revised the

text accordingly.

Asking employees and their

representatives for recommendations of

controls that will reduce MSD hazards

is an effective and efficient way of

solving ergonomic problems. Many

commenters (see, e.g., Exs. 3–112, 3–

164, 30–3765, 30–3748, 500–137, 500–

220) reported that the employees who

are doing the job are usually the best

source of information on the tasks

causing the hazard and ways of solving

the problem. For example, the American

Health Care Association stated:

Employers and employees who work in the

industry are in the best possible position to

identify risk factors in their workplace and to

develop prevention methods that concentrate

on the significant problems unique to their

particular industry’s environment (Ex. 3–

112).

In many problem jobs, employees and

their representatives will be able to

pinpoint the problem quickly and to

suggest easily adopted controls. In many

cases, the solution will become obvious

at the job hazard analysis stage; many

problems also can be addressed with

simple, off-the-shelf controls. Examples

are:

• Eliminating awkward postures

(such as bending when leaning across

the workstation to reach a tool) by

putting blocks under a work bench to

raise the work surface height.

• Eliminating awkward postures of

the neck and reducing stress on the back

by putting packages of copy paper under

a VDT monitor to raise it or taking the

VDT off the CPU to lower it.

• Reducing awkward postures of the

neck by moving the light source or

removing the light bulbs that were

causing glare on the VDT monitor

screen.

• Reducing force by cleaning thread

from the wheels of a cart that has been

hard to push. (Many of these controls

would qualify for the Quick Fix option

(see paragraph (o).)

Some commenters (see, e.g., Tr.

63354, 9038, 12647), however, were

concerned that consulting with

employees and their representatives

could lead to disagreements about the

controls selected. OSHA’s experience,

and comments to the record (see, e.g.,

Exs. 3–112, 26–5, 30–3765, 30–3748,

500–137, 500–220, 500–218), do not

suggest that this is a problem. Instead,

these commenters point to the value of

employee input. OSHA expects,

however, that employers will use their

management experience and judgment

to resolve any disagreement that may

arise. As is the case for all OSHA

standards, the employer is clearly

responsible for selecting controls and

evaluating their effectiveness.

Another commenter (Ex. 32–300–1)

argued against involving employees in

the problem-solving and control

identification process on the grounds

that doing so might disappoint the

employees if their suggestions were not

taken. OSHA’s experience suggests just

the opposite, i.e., that nothing

disappoints employees more than not

being part of a process that affects their

working conditions so directly. Some

employers also report that they bring

their in-house resources (ergonomics

committee members, safety and health

professionals, ergonomists) into the

process at this stage (see, e.g., Exs. 26–

1370, 502–17).

Paragraph (m)(2)—Initial Controls

This provision requires employers to

identify and implement initial controls

(referred to as ‘‘interim’’ controls in the

proposal) to reduce MSD hazards within

90 days of the time the employer

determines that the job is a problem job.

Because the final rule allows employers

to choose from engineering controls,

administrative controls, work practice

controls, and—as a supplement to these

controls—personal protective

equipment, OSHA believes that

employers will be able to meet this

timetable, which is essential to the

protection of employees in problem

jobs. OSHA anticipates that many

employers, particularly those whose

jobs can be controlled with off-the-shelf

controls, will simply implement

permanent controls within 90 days and

be done with it. Others, however, will

develop a plan and timetable for

permanent control implementation and

may need the full 4 years (2 years after

the standard has been in effect for some

time) to reach the control levels

specified in paragraphs (k)(1) or (k)(2) of

the final rule.

For these employers, the

implementation of initial controls will

generally mean a greater reliance on

administrative controls, work practices,

and, in those situations where personal

protective equipment is effective, on

PPE, in the period between the 90-day

deadline in paragraph (m)(2) and the

permanent control compliance deadline

in paragraph (m)(3). OSHA recognizes

that initial controls may not, in all

cases, reach the control levels required

by paragraph (k)(1) or (k)(2) for

permanent controls; nevertheless,

employers are required to make good

faith efforts to address problem jobs

promptly to protect the employees in

them.

OSHA expects employers to

implement initial controls that will

substantially reduce employee exposure

to the risk factors that are contributing

to the MSD hazard. For example,

employers might provide employees

required to manually carry loads from

one point to another with a cart or a

hand dolly as an initial control, or they

might reduce the weight of the object

68364 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

being carried while waiting to install a

permanent conveyor system. In other

cases, an employer might decide to

implement a system of employee

rotation while waiting to install new

power tools throughout the plant. Other

examples of controls employers often

implement initially and then replace

with more permanent controls later are

the provision of tools with longer

handles when excessive reaching is

involved, anti-fatigue mats and sit-stand

stools when excessive standing is the

problem, and vibration-reduction gloves

while waiting for new power tools with

lower vibration levels to be installed. By

substantial reduction, OSHA means that

the initial controls must reduce the

MSD hazard materially by decreasing

the magnitude, frequency or duration of

the employee’s exposure to the relevant

risk factors. Examples of controls that

would not meet the employer’s

obligations under paragraph (m)(2)

would be decreasing the weight of a

package that is manually lifted from 90

to 85 pounds (because both weights

substantially exceed the weight an

employee should lift alone) or rotating

employees into a second job that has the

same risk factors (because this would

not reduce the magnitude or duration of

exposure).

The purpose of paragraph (m)(2) is to

ensure that the employer takes steps

quickly (i.e., no more than 90 days after

the job is identified as a problem job) to

reduce the exposures of at-risk

employees (i.e., those in jobs that have

identified MSD hazards). Waiting until

permanent controls are installed, which

may take as long as 4 years, would leave

these employees unprotected and

increase the likelihood that another

MSD incident will occur. The concept

of initial controls (interim controls) is a

well-established principle of worker

safety and health protection and is

incorporated in many OSHA standards,

as one commenter noted (Ex. 26–1370).

Paragraph (m)(3)—Permanent Controls

This paragraph requires employers to

identify and implement permanent

controls that will achieve the hazard

reductions required by paragraphs (k)(1)

and (k)(2) of the standard. This

provision is essentially unchanged from

the proposal, except that it has been

revised to reflect the final rule’s

objective compliance endpoints and the

function of the action trigger.

There are many ways employers can

identify permanent controls in addition

to asking employees and their

representatives for control ideas. These

include:

• Asking other establishments in the

company how they have solved a

similar problem; many companies with

OSHA corporate-wide settlements have

found this approach useful (see, e.g., Ex.

32–185–3).

• Asking the industry trade

associations for suggestions (the food

retail industry, for example, worked as

a group to reduce package weights (Tr.

4948).

• Attending ergonomics conferences

and trade shows.

• Talking to the company’s insurance

agent about solutions that have worked

for other companies.

• Reviewing equipment catalogs (one

commenter reported using this approach

to identify mechanical alternatives to

drum handling (Tr. 6981)).

Several commenters stated that

employers are best positioned to choose

their own sources of control information

and ideas (see, e.g., Exs. 30–434, 30–

240, 30–133, 30–3122, 30–3284, 32–

300–1), and OSHA agrees, except that

employees in the problem job and their

representatives must also be involved in

the process, as required by paragraph

(m)(1).

Employers have many control

strategies to choose from when

identifying permanent controls. The

controls selected may be any one, or any

combination of, engineering, work

practice, or administrative controls.

These controls may be supplemented by

PPE, but PPE may not be used alone

unless other feasible controls are not

available (see paragraph (l) of the

standard). Among the factors employers

consider when selecting controls are:

• Which control achieves the greatest

reduction in employee exposure to the

MSD hazard

• Which is likely to be accepted and

used by employees

• Which takes the least amount of

time to implement

• Which achieves a substantial

reduction in exposure at the lowest cost.

These criteria are included as

examples only; the standard does not

require employers to use these criteria

because OSHA recognizes that

employers will choose those factors to

consider that are most appropriate to

their workplace. The following chart

lists many controls that may be

appropriate to reduce employee

exposure to the risk factors that are

responsible for MSD hazards, depending

on the circumstances of a particular

workplace. This list is illustrative only;

it is not exhaustive but is provided

merely to show that there are often

many different control approaches that

will reduce the magnitude, duration, or

frequency of risk factor exposure.

Ergonomic risk factors that may be

present Examples of controls

Force (Exertions) ............................ Use powered tools

Change pinch to power grip

Use longer handle

Use appropriate size handle

Use powered lift assist

Counterbalance the weight

Use lift tables

Reduce the weight of the object

Ensure that the center of gravity of the tool is over the hand

Use a fixture, clamp or jig

Provide periodic tool or equipment maintenance

Force (Manual Handling) ................ Lighten the load

Use lift assist

Use lift table

Place package in larger containers that are then mechanically handled

Use two-person lift team

Rely on gravity to move the object

Reduce friction when objects must be pushed or pulled

Reposition object closer to the employee

Provide pallet or table that can be rotated

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68365

Ergonomic risk factors that may be

present Examples of controls

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

68366 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

were to do if their controls were not

working as planned.

OSHA believes that this paragraph is

essential, for several reasons. First,

unless employers follow up on their

control efforts, they will not know

whether they are protecting their

employees and are in compliance with

paragraphs (k)(1) or (k)(2) of the rule.

Second, in establishments with many

problem jobs and a job prioritization

plan in place, ascertaining the

effectiveness of controls is important to

ensuring that the employer’s abatement

strategy is an effective one. Third,

control effectiveness is the basis of any

effective program, and thus plays a

critical role in evaluating the elements

of the program. For example, an

evaluation of work practice controls is

an excellent way of determining

whether training in these controls has

been effective.

This step of the control monitoring

process requires employers to consult

with employees in the problem job and

their representatives to ensure that the

controls have been effective in reducing

the physical difficulties employees

associated with the job. The standard

does not require employers to use

quantitative or qualitative measures to

evaluate control effectiveness, but many

employers use such methods. Examples

of before-and-after approaches used over

a longer (i.e., 6-month) period include:

• Reductions in severity (measured as

fewer days away from work)

• Reductions in the number of

symptoms reported in a symptoms

survey

• Reductions in workers’

compensation costs

• Reductions in MSD incidence rates.

Methods used in shorter-term

evaluations, i.e., those conducted within

30 days, include talking with employees

and their representatives and symptoms

surveys. NIOSH (Ex. 26–2) recommends

that employers wait at least 2 to 4 weeks

after control implementation to assess

the effectiveness of controls, because

this period of time is often enough to

allow employees to tell whether the

situation has improved.

OSHA believes that the process of

hazard identification, control selection,

and control evaluation has been greatly

facilitated by the fact that the final rule

identifies objective criteria against

which employers can measure the

extent of the risk factors present and the

effectiveness of their efforts to control or

reduce the hazard. Employers are not

required to use the hazard identification

tools referenced in Appendix D–1 or

provided in Appendix D–2, but they are

free to do so. OSHA believes that

employers will generally find that the

greater certainty that results from the

appropriate use of these tools enhances

their ability to protect their employees

and increase the employer’s confidence

that the standard’s control endpoints are

being met.

Paragraph (o)—May I Use a Quick Fix

Instead of Setting up a Full Program?

Paragraph (o) of the final rule sets out

alternative provisions that employers

may follow in lieu of setting up a full

ergonomics program. These alternative

provisions are referred to as the Quick

Fix approach. The Quick Fix option

allows employers to control an MSD

hazard quickly and more informally

without, for example, conducting a

complete job hazard analysis, setting up

a training program or a periodic

program evaluation process.

OSHA has included a Quick Fix

option in this standard to provide

compliance flexibility for those

employers who have:

• Only a few isolated MSD hazards

(that is, they have had one prior MSD

incident in any job in which an MSD

incident is reported after the effective

date and only 2 prior MSD incidents in

the workplace during the 18 months

before the new MSD incident is

reported), and

• MSD hazards that can be identified

easily and addressed quickly (that is,

they can fix the job within 90 days after

the MSD incident is determined to meet

the Action Trigger).

OSHA believes that the Quick Fix

option is an efficient mechanism for

providing ergonomic protection for

employees, while at the same time

reducing regulatory burdens for those

employers who have only a few isolated

problems.

The proposed rule also included a

Quick Fix provision, which a number of

commenters supported (e.g., Exs. 30–

3813, 30–3436, 32–210–1, 30–294, OR

326, 500–218, Tr. 2134, 13642). For

example, one commenter stated, ‘‘I

think that the Quick Fix is an

outstanding idea that will reduce the

burden of this standard for many

companies’’ (Ex. 30–3436). Portland

General Electric Company agreed:

We believe that the Quick Fix option is

extremely valuable. We operate on a system

of early reporting and effective individual

case management, to the benefit of both the

employee and the company (Ex. OR 326).

Some employers said that they had

implemented types of Quick Fix

approaches in their workplaces (see,

e.g., Exs. OR 326, Tr. 14715–16).

A number of commenters maintained

that the Quick Fix would not be helpful

or would not work. For instance,

Integrated Waste Services Association

said: ‘‘While the ‘‘quick fix’’ idea

sounds reasonable, quickly ‘fixing a

problem job’ is unrealistic and illusory’’

(Ex. 30–3853). Some of these

commenters said the Quick Fix

approach would not reduce regulatory

burdens for employers (see, e.g., Exs.

30–3853, 30–2988, 30–3815). And the

National Association of Manufacturers

(Ex. 30–3815) said that the Quick Fix ‘‘is

next to meaningless for an

establishment of any size.’’

Other commenters were more

optimistic about the Quick Fix concept,

but said that changes were needed to

make it more useful for employers.

Kaiser Permanente, for instance,

supported the Quick Fix idea as a

‘‘practical and cost effective idea’’ in

principle, but argued that the proposed

provision was too limited and too vague

to be workable (Ex. 30–3934). Others

said the proposed Quick Fix offered an

‘‘inappropriately narrow opportunity’’

and urged OSHA to allow more

abatement time and allow more than

one Quick Fix in any one job (Ex. 30–

2988, 500–145). Some commenters,

however, argued that allowing more

than one Quick Fix in a job was not

protective enough (see, e.g., Ex. 30–

2825, 32–182–1). In addition, AFSCME

opposed extending the Quick Fix option

this way because it would be

‘‘encouraging a piecemeal and

disjointed approach to ergonomics’’ (Ex.

32–182–1).

On the other hand, some commenters

were concerned that the proposed Quick

Fix was not adequately targeted to those

workplaces where such an approach

would be appropriate. The AFL–CIO

said:

In our view, the quick fix provisions

proposed by OSHA are more properly suited

to those workplaces where the number of

jobs with MSD hazards is limited and where

there are few MSDs. In those situations,

focused efforts to identify and correct

hazards quickly may be the best solutions,

and a full ergonomics program may not be

needed (Ex. 32–339–1).

The AFL–CIO and others also

identified specific high hazard

workplaces in which the Quick Fix

would not be appropriate, such as

nursing homes, warehouses, automotive

assembly plants, and meatpacking and

poultry processing plants (Exs. 32–339–

1).

OSHA has made a number of changes

to the Quick Fix provision in this final

standard to address these concerns.

These changes include:

• Focusing the Quick Fix more

carefully on those employers with

limited MSD problems by specifying

that it applies where there have been

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68367

only 2 prior MSDs in the workplace in

the past 18 months,

• Providing clearer criteria for hazard

identification and control (i.e., the Basic

Screening Tool) and compliance

‘‘endpoint’’ (i.e., the levels in Appendix

D),

• Ensuring that employees receive

training in using the implemented

controls so that the Quick Fix is more

likely to be successful, and

• Simplifying the criteria for

determining whether a Quick Fix has

been successful or has failed.

Paragraph (o)(1)

Paragraph (o)(1) defines which

employers may avail themselves of the

Quick Fix approach instead of

implementing a complete ergonomics

program. Employers may use the Quick

Fix approach if, within the last 18

months:

• No more than 1 prior MSD incident

has occurred in the job in which another

MSD incident is reported, and

• There have been no more than 2

prior MSD incidents in the workplace as

a whole.

This represents a change from the

proposed rule, which would have

allowed employers to use Quick Fix

option in every job in the workplace,

but only for the first MSD incident in

that job.

OSHA believes that the changes in the

final rule provide more compliance

flexibility, and thus will allow more

employers to take advantage of the

Quick Fix option. First, changing the

Quick Fix provision to allow employers

to use it 2 times in the same job makes

the option available for more jobs.

Allowing 2 Quick Fixes in one job

recognizes, as Kaiser Permanente

pointed out, that the occurrence of a

second MSD in the same job may not

necessarily mean that a previous control

measure has not worked, but rather that

a different combination of risk factors

may be present (Ex. 30–3934):

[T]he conclusion in the proposed rule that

the ‘‘Quick Fix does not work’’ if another

MSD is reported in the same job within 36

months * * * wrongly assumes that the

same fix should work for the same physical

work activities and conditions. The fix that

works for one employee’s condition may not

work for another because of that employee’s

physical characteristics or non-work related

contributing factors. A second or third MSD

in the same job does not mean the initial

quick fix did not work, and employers

should have the option to apply a quick fix

to newly reported MSDs (Ex. 30–3934; see

also Exs. 30–2088, 500–215).

Second, not restricting the 2 MSD

incidents to ones caused by different

risk factors, as the proposed rule would

have done, will also make the Quick Fix

option available to more jobs.

Eliminating this restriction on the

second MSD incident also addresses

commenters’ concerns that this

provision was not clear enough to be

workable (see, e.g., Exs. 30–1349, 30–

358, 30–595, 30–538, 30–323, 30–1022,

30–1551, 30–3745, 30–3723).

Third, halving the Quick Fix time

frame to 18 months should make the

Quick Fix option available to more

employers because MSDs that occurred

several years ago would not disqualify

employers from using the Quick Fix

option. In addition, it makes the Quick

Fix option more attractive, as Kaiser

Permanente noted:

[F]or large employers, tracking MSDs to

determine whether another covered MSD is

reported in the same job within 36 months

would be cumbersome (Ex. 30–3934).

Organization Resources Counselors, Inc.

(ORC), agreed:

The proposed requirement that the

employer establish a full ergonomics program

if another similar MSD occurs in the job

within 36 months is too rigid because the

occurrence of MSDs is so closely related to

individual worker characteristics. If the

employer determines that additional feasible

controls will eliminate the significant risk

from that job for that worker, another quick

fix should be permitted (Ex. 30–3812).

OSHA estimates that these changes

should allow a large percentage of jobs,

as high as 25 percent of all jobs meeting

the Action Trigger, to be controlled

using a Quick Fix. (See Chapter V of the

Final Economic Analysis).

At the same time, limiting the Quick

Fix option to employers who have only

2 MSDs in their workplace during the

prior year and a half also helps to target

more precisely the provision to those

workplaces that have only isolated MSD

problems. OSHA agrees with

commenters that where only a few

MSDs are occurring, employers may be

able to address the problems effectively

in an informal way, but that the

occurrence of several MSDs in a

workplace in just over a year ‘‘may be

indicative of a bigger problem’’ that

requires a more systematic approach to

adequately address (Ex. 32–210–2).

Although OSHA believes that

targeting the Quick Fix to workplaces

with few isolated MSD hazards will

likely make the option most useful to

small businesses, larger employers may

also find the Quick Fix a useful

mechanism. For example, large

employers who have ergonomics

programs in some jobs would be free to

use the Quick Fix option if an MSD

hazard were identified in another job.

Paragraph (o)(2)

Paragraph (o)(2) of the final rule sets

up the process that employers using the

Quick Fix option must follow.

Employers must use this process to fix

the injured employee’s job and all

‘‘same jobs’’ in the establishment.

Although this process is informal and

flexible, it nonetheless includes those

basic steps that employers who have

Quick Fix or ‘‘quick response’’

processes use (Ex. 32–198–4–27–1).

This process includes:

• Providing prompt MSD

management to the injured employee

(paragraph (o)(2)(i));

• Talking with employees to identify

those tasks they associate with the MSD

incident (paragraph (o)(2)(ii));

• Observing employees performing

the job to identify the risk factors likely

to have caused the MSD incident

(paragraph (o)(2)(iii));

• Asking employees for their ideas for

reducing exposure to the MSD hazards

(paragraph (o)(2)(iv));

• Implementing measures within 90

days to control or reduce the MSD

hazards (paragraph (o)(2)(v));

• Training employees in using the

controls implemented (paragraph

(o)(2)(vi)); and

• Keeping records of the Quick Fix

(paragraph (o)(2)(vii)).

These provisions of the final rule are

similar to steps in the proposed Quick

Fix, although they have been revised in

some respects to respond to comments

received.

Same Jobs

Also similar to the proposed rule,

those employers who qualify for and

select the Quick Fix option must fix not

only the injured employee’s job but also

all other ‘‘same jobs’’ in the

establishment. This requirement applies

both to employers using the Quick Fix

and to those who must implement

ergonomics programs. Several

commenters objected to requiring

employers to apply the Quick Fix

beyond the injured employee’s

individual job (see, e.g., Exs. 30–2208,

30–2725, 30–3745, Tr. 9183). Some said

having to fix all same jobs was not

necessary and would impose excessive

cost. For example, the Center for Office

Technology (Ex. 30–2208) stated:

The Quick Fix section is worded so that if

one office worker is experiencing discomfort

and his workstation is changed—the example

given is purchasing an adjustable workstation

for a VDT operator—all the ‘‘same job’’

employees at that worksite would also have

to get an adjustable workstation when in fact

no other employees may need them.

OSHA believes this requirement is

necessary because it helps to ensure that

68368 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

other employees performing the same

physical work activities and exposed to

the same MSD hazards are provided

with protection before they too get hurt.

In this sense, the ‘‘same job’’

requirement helps to make the final rule

more proactive and preventive. OSHA

believes that controlling other same jobs

will also be cost-effective for employers

because it is only a matter of time, in

jobs meeting the Action Trigger, until

another MSD incident occurs.

For several reasons, OSHA does not

believe that the ‘‘same job’’ requirement

will impose an undue burden on

employers. First, OSHA believes that

the number of ‘‘same jobs’’ in the

establishments likely to use the Quick

Fix option will be small, because OSHA

believes that many qualifying employers

will generally be small businesses.

Second, the final rule allow employers

to limit the Quick Fix to the injured

employee’s job where the employer has

reason to believe that the risk factors in

the job only pose a problem to the

injured employee. (See note to

paragraph (j).) Thus, if the case referred

to by COT (Ex. 30–2208) meets the

requirements described in the note to

paragraph (j), the employer would only

be required to fix that employee’s job.

This provision was included in the

proposed rule, and a number of

commenters supported it, saying that

such an exception was needed because

the individual characteristics of one

worker may require controls that don’t

work for or are not needed by other

workers (see, e.g., Exs. 30–3745, 30–

358).

Finally, even where there are ‘‘same

jobs’’ that also must be Quick Fixed,

OSHA does not believe that the Quick

Fix process will be burdensome for

employers. The Quick Fix process is

very informal and thus provides

employers with great flexibility in

complying with each step in the Quick

Fix process. In addition, the final rule

allows employers to include a sample of

employees, rather than all employees in

the same jobs, in the hazard

identification and solution consultation

process. OSHA agrees with commenters

that allowing employers to rely on a

sample of the employees who are likely

to have the greatest risk factor exposure

in the job should help reduce burdens

for large employers and for employers

with many employees in the same job

(Ex. 30–2208).

1. Provide MSD Management

Like employers who must implement

an ergonomics program, employers who

select the Quick Fix option must

provide the injured employee with

prompt MSD management after they

have determined that an MSD incident

has occurred and the job meets the

Action Trigger. This includes providing

the injured employee with access to an

HCP and work restrictions during the

recovery period, if necessary. Where

work restrictions are needed, employers

who select the Quick Fix option also

must provide the work restriction

protection (WRP) that this standard

requires. (For further discussion of MSD

management requirements, see

summary and explanation for

paragraphs (p), (q), (r), and (s) below.)

2. Talk With Employees

Paragraph (o)(2)(ii) requires that, as

part of the process of identifying the

MSD hazards, employers using the

Quick Fix option must at least to talk

with the employees in the job (and their

representatives). The purpose of this

consultation is to ensure that employers

ask those who know the most about the

job-those that perform it-for their help

in identifying the physical work

activities and job conditions that they

believe are mostly likely to be

associated with the MSD incident.

OSHA believes that including this step

in the Quick Fix process will help

employers more quickly and fully

identify the problem so they will have

the chance to fix the problem within the

Quick Fix deadline.

Many commenters agreed with the

importance of including employees in

the hazard identification process (see,

e.g., Exs. 500–200, 500–215, 30–1100,

Tr. 3565). The record consistently

shows that employers with effective

ergonomics programs consult with their

employees because employees know

what tasks are contributing to their MSD

signs and symptoms and because they

often have the best and least expensive

ideas for solutions (Exs. 30–1100, 500–

200, 500–215, Tr. 14903, Tr. 3062).

Talking to other employees who

perform the same job as the injured

employee also provides employers with

an opportunity to identify the problems

with the job more fully, and this, in

turn, will help ensure that the right

solutions will be found to address the

problem.

3. Observe the Job

Paragraph (o)(2)(iii) specifies that

employers must observe employees

performing the job to identify the MSD

hazards that caused the MSD incident.

This step helps to ensure that nothing

has been overlooked in the discussion

with employees. In addition, as several

commenters have pointed out, often

problems in jobs become readily

apparent as soon as the person

responding to the report has an

opportunity to watch employees

performing the job (Exs. 30–3436, 26–2,

Tr. 1038).

To provide employers with maximum

flexibility in complying with this step,

paragraph (o)(2)(iii) allows employers to

select the method of job observation that

works best for the conditions in their

workplace. For example, employers may

simply watch employees perform the

job; videotape the job; or use a simple

checklist, such as the VDT checklist in

Appendix D–2 or checklists similar to

the one developed by the Dow Chemical

Company (Ex. 32–77–2–1 ). In addition,

employers are free to determine in what

order they want to conduct the steps of

the Quick Fix process. Some

commenters said that they observe the

job first as a way to better focus their

discussions with employees.

4. Ask Employees for Solutions

Paragraph (o)(2)(iv) specifies that

employers using the Quick Fix option

must ask employees in the problem job

for their ideas to fix the job. OSHA has

included this step in the Quick Fix

process because time and again

employers have said that their

employees often come up with the best

and least expensive solutions to

problems (Tr. 8725, 1160, 9508). For

example, PPG stated that:

We [management] do not have to look over

their shoulders to make sure that they are

implementing every—dotting every I. And it

is a successful program. Essentially, the

workers run it (Tr. 3062).

This step also was included in the

proposed Quick Fix. Some commenters

asked OSHA to clarify whether

employers were obligated to implement

the recommendations that employees

make (Ex. 30–595). The requirement

that employers ask employees for their

recommendations does not limit them to

implementing only those solutions

recommended by employees. OSHA

expects employers to use their judgment

when responding to employee

suggestions and to select controls that

will achieve the reduction in MSD

hazards mandated by the rule. OSHA

notes that the records shows that

employee suggestions for ergonomic

improvements are often both practical

and effective.

5. Implement Controls Within 90 Days

Paragraph (o)(2)(v) of the final rule

requires employers, within 90 days, to

implement measures that either:

• Control the MSD hazards (i.e.,

reduce hazards to the extent that they

are no longer reasonably likely to cause

MSDs requiring days away, work

restrictions or medical treatment), or

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68369

• Reduce the hazards to the levels

indicated in the appropriate hazard

identification tool in Appendix D.

Employers must put controls into

place within 90 days of the time the

employer determines that the job meets

the Action Trigger. Employers are free to

use any combination of engineering,

work practice or administrative controls

to fix the job. As part of the Quick Fix,

employers must also train employees

how to use the controls that have been

implemented.

Implement Controls

The proposal would have allowed

employers to use the Quick Fix option

only where they could ‘‘eliminate MSD

hazards,’’ which was defined as

controlling physical work activities and

conditions to the extent that an MSD

was not reasonably likely to occur,

which was a higher level of control than

for employers who were implementing

full ergonomics programs. Several

commenters opposed the proposed

Quick Fix control endpoint, generally

saying that it was either too vague to be

workable or impossible to attain (see,

e.g., Exs. 30–4290, 30–3812, 30–2208,

Tr. 2998, 8394, 9182). The comment of

ORC was typical of this opposition:

One fundamental change that must be

made to this provision is the revision of the

proposed requirement to eliminate MSD

hazards; the formulation is problematic and

may be legally impermissible. It is well

established that employers may only be

required to take technologically and

economically feasible abatement measures.

The second problem is that employers cannot

be required to establish a risk-free

environment, so that to the extent that the

terms ‘‘eliminate MSD hazards and eliminate

employee exposure’’ suggest that an

employer must go beyond reducing the

significant risk of harm in a particular

instance, these terms must be revised and

clarified (Ex. 30–3812).

OSHA believes that the changes in

this provision address the commenters’

concerns. The final rule’s Action Trigger

helps to ensure that employers will only

have to take action in higher-risk jobs.

As mentioned in the summary and

explanation for paragraph (f), jobs that

meet the Action Trigger (i.e., exceed the

exposure levels in the Basic Screening

Tool) are ones that generally pose a risk

of MSDs that is three times higher than

those that do not. Second, the control

endpoints employers must meet under

the Quick Fix option do not require the

elimination of all risk. For example,

employers will be considered in

compliance with the Quick Fix control

requirement if they reduce exposure

levels to below those in Appendix B of

Washington State’s ergonomics rule.

The acceptable exposure levels in the

Appendix B are almost twice as high as

those in the Basic Screening Tool. Thus,

the standard does not require employers

to achieve a ‘‘risk-free environment.’’

Third, the Quick Fix now contains more

specific criteria for identifying and

controlling hazards so that employers

more clearly understand when a hazard

is present and when they have done

enough to fix the job. Thus, the final

rule is not requiring employers to take

‘‘technologically or economically’’

infeasible abatement measures.

90-day Control Time Line

The final rule continues the proposed

90-day time line for implementing

Quick Fix controls, but now specifies

that the time begins to run only after the

employer has determined that the job in

which the MSD incident occurred meets

the Action Trigger. Comments on the

proposed 90-day time line were mixed.

Some commenters testified that many

MSD hazards can be controlled quickly

(see, e.g., Exs. 30–3813, 30–3436, 32–

210–2, 30–294, Tr. 13642, Tr. 2134),

while others said that controls,

especially engineering controls, could

not be implemented in 90 days (see, e.g.,

Exs. 30–3815, 30–240, 31–307, Tr. 4628,

30–3853, 30–1091, 30–1048). As a

result, some commenters requested that

OSHA provide extended abatement time

for employers who could not implement

Quick Fix within the allotted time frame

(Ex. 30–3853).

For several reasons, OSHA believes

that the Quick Fix deadline should not

be extended. First, OSHA believes that

extending the deadline negates the

principle underlying the Quick Fix

concept. Second, OSHA believes that

controls that take longer than 90 days to

implement indicate that the problem

may be more complex than originally

anticipated, and therefore, may more

appropriately be addressed in the

context of a comprehensive ergonomics

program.

Third, OSHA does not believe that

extending the 90-day Quick Fix

deadline is necessary, because the

record shows that there are many

controls that can be implemented

quickly to control or reduce MSD

hazards. Many of these are obvious and

low-cost fixes that can be made to

workstations (e.g., raising or lowering

work surface or chair, placing

equipment directly in front of an

employee to eliminate extended reaches

or awkward postures, providing a

platform or box to stand on as a way to

eliminate overhead reaching, putting

reams of copy paper under a monitor as

a way to eliminate awkward neck

postures), tools or equipment (e.g.,

servicing of powered hand tools,

changing the way bags move on a

conveyor), and work schedules (e.g., rest

breaks, job rotation, job enlargement)

(see, e.g., Tr. 2147, 6510). One

participant discussed the effectiveness

of these types of Quick Fix adjustments

in office environments:

If you’re looking, say, at the office

environment, the quick fix situation is very

often the one that’s there in any case, because

you’re looking at people who need

improvements to their posture and so on and

so forth. And very often, the whole work

environment is already there to be adjusted.

It just needs a quick-fix, which in this case

is often training and showing people how

they should be adjusting their workstation for

their particular tasks. So very often, in the

office environment, the quick fix is the only

way to do it. (Tr. 2707)

The record also includes information

on a wide variety of inexpensive ‘‘offthe-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.

68370 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 workrelatedness 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) onetime 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68371

years is absurd. [Dow] * * * suggests 45

days or until the ‘‘quick fix’’ is implemented

and results validated.

OSHA believes that records are

necessary where employers substitute

one-time action for a comprehensive

approach to controlling MSD hazards.

First, the Quick Fix option does not

include the ‘‘checks and balances’’ of a

comprehensive program (i.e.,

management leadership, employee

training, and program evaluation).

Second, employers who use this option

will need these records to demonstrate

that the Quick Fix process has been

successful in controlling the hazards. In

addition, employers themselves need

records to be able to demonstrate that

they continue to qualify for using the

Quick Fix option. Finally, OSHA

believes that keeping the Quick Fix

records for just 3 years will not pose a

burden for employers, especially since

these employers will not have to put

resources into keeping the other records

that employers who have full

ergonomics programs must maintain.

Paragraphs (o)(3) and (o)(4)

The last two provisions of the Quick

Fix process provide that employers are

not required to take additional action as

long as the job hazards remain

controlled or exposures do not exceed

the levels in Appendix D. As long as

these control levels are maintained,

employers need only provide training in

the use of the controls to new

employees who are assigned to Quick

Fixed jobs. If, however, hazards cannot

be reduced to those levels within the

Quick Fix time frame, or be maintained

at those levels, employers must

implement an ergonomics program in

that job, i.e., if more than one MSD

incident has already occurred in the job.

However, if this is the first Quick Fix in

that job, the employer would be free to

repeat the Quick Fix to see if a second

effort might be more successful.

The proposed rule, on the other hand,

would have adopted a ‘‘wait and see’’

approach, requiring employers to

implement a full ergonomics program if

it turned out that the controls did not

eliminate the hazards with the deadline

or if another MSD occurred in the job

sometime during the following 36

months. The proposed rule would have

provided one exception to moving onto

a full ergonomics program in those cases

where the second MSD incident in the

job was caused by different risk factors.

Several participants commented on

this proposed provision (see, e.g., Exs.

30–3813, 30–3815, 30–710, 30–1107,

30–494, 30–4540, Tr. 14985). Most

commenters (see, e.g., Exs. 30–3813, 30–

3815) argued that the 36-month ‘‘wait

and see’’ period was too long. OSHA has

responded by reducing the ‘‘wait and

see’’ period to 18 months. This means

that employers continue to qualify to

use the Quick Fix option if no more

than 2 MSD incidents have occurred in

the past 18 months. MSD incidents that

occurred more than 18 months

previously would not be considered in

determining whether the employer

could continue to use the Quick Fix

option in that workplace.

MSD Management and Work Restriction

Protection

Paragraphs (p), (q), (r), and (s) of the

final rule set forth the final rule’s

requirements for MSD management and

work restriction protection (WRP).

These provisions require employers to

set up a process to manage MSD

incidents when they occur. OSHA’s

final rule requires that employers make

MSD management available promptly to

workers in jobs that meet the action

trigger whenever an MSD incident

occurs; provide this MSD management

at no cost to the employee; provide

temporary work restrictions and ‘‘work

restriction protection’’, and provide a

mechanism for multiple health care

professional (HCP) review when health

care providers disagree about the proper

course of action the employer should

take. The discussion of these sections is

divided into two parts; the first section

discusses MSD management, and the

second, worker restriction protection

and multiple HCP review.

MSD Management

Under the final rule, employers would

be required to make MSD management

available promptly whenever an MSD

incident occurs; provide this MSD

management at no cost to the employee;

and evaluate, manage, and follow-up on

the MSD incident. Specifically,

employers are required by the final rule

to:

• promptly provide effective MSD

management at no cost to the employee,

• provide employees with access to a

health care provider (HCP),

• provide work restrictions the

employer or the HCP find necessary,

• provide the HCP with information

about MSD management and the

employee’s job,

• obtain a written opinion from the

HCP about the MSD,

• provide the employee with the

HCP’s opinion, and

• evaluate, manage and follow-up on

the MSD incident.

The final rule’s MSD management

provisions are quite similar to the

provisions in the proposed rule. The

final rule differs from the proposed rule

section in the following ways:

• MSD management is provided

under different circumstances (only

when a worker has an MSD incident

and the job rises above the action

trigger),

• MSD management is no longer

described as being for the purpose of ‘‘to

prevent their (the employee’s) condition

from getting worse’’,

• the employer is not required to

determine the need for work restrictions

or other actions before consultation with

a health care provider,

• the employer must provide slightly

different information to the health care

provider,

• the health care provider is not

afforded a right to walk through the

employers workplace,

• minor editorial changes to the

numbering, language and sequence of

the requirements to simplify the

sections and reduce duplication, and

• changes to the work restriction

protection (WRP) requirements reducing

WRP payments from 6 months to 3

months, and allowing the use of sick

leave during the WRP period.

These changes reflect OSHA’s review

and analysis of the many comments and

other evidence in the record pertaining

to MSD management, which are

discussed below. OSHA also asked for

input on several specific issues in

Section XIV of the proposal, Issues on

Which OSHA Seeks Comment. The

comments provided in response to those

questions are included in the discussion

of the relevant issues below.

Is MSD Management Needed?

OSHA received many comments on

the proposed MSD management section.

Many commenters generally supported

the inclusion of MSD management

provisions in the standard (see, e.g., Exs.

30–626, 30–651, 30–2387, 30–3033, 30–

3034, 30–3035, 30–3258, 30–3259, 30–

3686, 30–3813, 30–3826, 30–4538, 30–

3934, 30–4159, 30–4468, 30–4536, 30–

4538, 30–4547, 30–4549, 30–4562, 30–

4627, 30–4776, 30–4777, 30–4800, 31–

23, 31–31, 31–43, 31–71, 31–92, 31–105,

31–113, 31–150, 31–156, 31–160, 31–

161, 31–163, 31–186, 31–229, 31–243,

31–259, 31–301, 31–309, 31–342, 31–

345, 31–347, 32–182–1, 32–210–2, 32–

339–1, 32–85–3, 32–111–4, 32–133–1,

32–450–1, 30–4468, DC 75, 30–1104, L–

30–4860, 37–12, 37–28).

Several commenters stated that MSD

management is an essential component

of an ergonomics program. For example,

Lieutenant Colonel Mary Lopez, of the

Department of Defense, reported at the

hearing that healthcare management

(i.e., MSD management) is a critical

68372 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

element in any ergonomics program (Tr.

3221, Ex. 30–3826–14, 500–218). The

3M Company stated that ‘‘The need for

effective MSD management is

universally accepted’’ (Ex. 30–3185). Dr.

Robert Harrison stated that ‘‘The

medical and scientific literature and my

own clinical experience confirm that

MSD management is an essential part of

an ergonomics program’’ (Ex. 37–12).

Evidence in the record shows that

many companies, through early

intervention and the effective

management of MSDs, have achieved

substantial reductions in the number

and severity of MSDs, which have in

turn, translated into less lost-work time,

fewer lost-workdays, lower costs per

case, and fewer workers’ compensation

claims (see, e.g., Exs. 3–56; 3–59; 3–73;

3–95; 3–113; 3–118; 3–147; 3–175; 3–

217; 26–23, 26–24, 26–25, 26–26, 30–

3185, 500–20–3, 500–71–84, Tr. 14357,

Tr. 14721, Tr. 17431). Representative of

these comments, Dr. Colin Baigel of the

Bristol Myers Squibb Company reported

at the hearing that ‘‘[o]ne of our keys is

early medical intervention with any

sorts [of] symptoms or signs of physical

illness’’ (Tr. 10516). He commented

further that, in his company’s program,

they see and evaluate employees early,

modify the workplace, and institute

aggressive conservative treatment if

necessary (Tr. 10516).

North Carolina State University

discussed the consequences of not

providing prompt MSD management,

stating that ‘‘I know of employees who

were ordered by a non-medical

supervisor to get back to work after an

injury—in each case the lack of

immediate medical care exacerbated

their conditions’’ (Ex. 31–163)

Several commenters recommended

that OSHA strengthen the provisions of

this section to achieve early detection

and a more proactive approach to MSD

management (see, e.g., Exs. 30–626, 30–

2387, 30–4583, 32–182–1, 32–339–1, L–

30–4860, 500–71–86, 500–218). Many

suggested that MSD management should

be triggered when an employee reports

the signs and/or symptoms of MSDs

(see, e.g., Exs. 30–3686, 30–4538, 32–

111–4, 32–182–1, 32–339–1, 32–210–2,

32–461–1, 32–85–3, L–30–4860). For

example, the American Public Health

Association stated that MSD

management should be required for all

MSDs reported to the employer

including symptoms of MSDs (Ex. 30–

626). The AFL–CIO (Ex. 32–339–1)

argued that, as proposed, the MSD

management provided by the proposed

standard would not achieve the goal of

early detection and urged OSHA to rely

on employee reports of persistent signs

and symptoms to trigger MSD

management for all jobs, rather than

relying on covered MSDs to trigger

action in some jobs, as the proposal did.

Others recommended using an even

more proactive, risk-based approach to

trigger MSD management, instead of

waiting for an employee report of an

MSD (see, e.g., Exs. 30–626, 30–2387,

30–3686).

Several commenters supported the

proposed MSD management provisions

with reservations/concerns (Ex. 30–

3185, 30–3188, 30–4777). For example,

the American Occupational Therapy

Association urged OSHA to ‘‘[p]rovide

guidance about the difference between

treatment of a disorder and the

management of early symptoms’’ (Ex.

30–4777).

Other commenters opposed the

approach to MSD management taken in

the proposal (see, e.g., Exs. 30–276, 30–

400, 30–1090, 30–1294, 30–1350, 30–

1357, 30–1370, 30–1722, 30–1727, 30–

1989, 30–2037, 30–2208, 30–2216, 30–

2435, 30–3032, 30–3167, 30–3200, 30–

3284, 30–3344, 30–3368, 30–3392, 30–

3677, 30–3765, 30–3845, 30–3853, 30–

3867, 30–3956, 30–4040, 3–4046, 30–

4185, 30–4470, 30–4499, 30–4564, 30–

4567, 30–4837, 30–4839, 30–4843, 31–

27, 31–77, 31–78, 31–79, 31–125, 31–

135, 31–172, 31–180, 31–202, 31–220,

31–225, 31–227, 31–245, 31–246, 31–

247, 31–248, 31–252, 31–253, 31–265,

31–280, 31–283, 31–286, 31–307, 31–

319, 31–321, 31–337, 32–120–1, 32–

300–1, 500–1–127, 500–177–2, 500–

208). In a representative comment, PPG

industries recommended that OSHA

Remove these sections completely. These

are very onerous requirements and the cost

estimates of OSHA for these issues do not

begin to approximate the real costs to

industry to comply with these provisions.

Further, they do nothing to achieve improved

ergonomics in the workplace (Ex. 500–177–

2).

Some of these commenters objected to

the proposed MSD management section

because it included provisions

protecting the wages and benefits of

injured workers (see, e.g., Exs. 30–240,

30–3813, 30–3765, 30–3845, 601–x–1).

These comments are discussed in detail

below in conjunction with the

comments received on the proposed

rule’s provisions on work restriction

protection. Other commenters objected

for the following reasons:

• The proposed provisions exceed

OSHA’s legal authority (see, e.g., Exs.

30–710, 30–1350, 30–3956, 30–1722,

30–2208, 30–3765, 30–3845, 30–3956,

30–4499, 31–319, 32–241–4);

• The proposed provisions are

unnecessary (Exs. 30–3677, 30–3765,

30–4185, 500–177–2); employers

already have systems in place for

medical management of all injuries (Exs.

30–3677, 30–3765, 30–4185, 31–79, 31–

321, 500–177–2);

• Medical management is addressed

in other OSHA standards (1910.151

Medical services and first aid.) (Exs. 30–

3765);

• The proposed provisions add

burden on employers (see, e.g., Exs. 30–

1294, 30–3765, 30–4040, 30–4499, 30–

4564, 500–177–2), the cost for medical

assessment of illnesses is too high (see,

e.g., 30–1026, 30–1302, 30–0295, 30–

1362, 30–0070, 30–0262, 30–0586, 30–

0280, 30–3760), and the proposed

requirements are too prescriptive (Ex.

30–400, 30–1294, 500–177–2);

• The proposed provisions are

unclear about what the employer is

supposed to do (Ex. 30–3344), fails to

tell an employer when to provide access

to an HCP (Ex. 32–120–1), or uses vague

terms (see, e.g., Exs. 30–2987, 30–3364,

30–3677);

• The proposed provisions conflict

with workers’ compensation laws (see,

e.g., Exs. 30–300–1, 30–710, 30–1350,

30–1722, 30–2435, 30–2987, 30–3284,

30–3745, 30–3765, 30–3845, 30–4026,

30–4564, 30–3677, 30–4499, 31–172,

31–180, 31–220, 31–252, 32–206–1);

• The proposed provisions create a

preferential system for MSDs and

enforces the notion that ergonomics

injuries are more important than other

injuries (see, e.g., Exs. 30–1294, 30–

3765, 30–4470, 30–4843, 31–280, 500–

177);

• The proposed provisions would

interfere with existing collective

bargaining agreements (see, e.g., Exs.

30–3284, 30–3765, 32–266–1);

• The proposed provisions would

address a problem that was, in the

opinion of these commenters, largely or

exclusively non-occupational in origin

(see, e.g., Exs. 30–240, 32–241–4, 30–

3167, 30–3956, 30–3956, 30–4046, 30–

4713, 32–241–4); and

• The proposed provisions change the

traditional relationship between

doctors, patients and employers (Exs.

30–4470) or inappropriately inject the

employer into the employee-patient

relationship (Ex. 30–4567).

In a representative comment, the Dow

Chemical Company (Ex. 30–3765) stated

that (1) a management system for workrelated 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68373

workplace activity’’ i.e., on the workrelated 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.

68374 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 nonoccupational MSD cases are excluded.

The final rule does not require the

employer to take any action for nonwork-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

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

68376 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 nonphysicians 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.

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

68378 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 COHNS (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 workrelated 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. Followup of injured employees is essential to

ensure that MSDs are resolving. Followup 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 § 1910.931(b) be

deleted. Additionally, the phrase ‘‘temporary

work restrictions’’ should be replaced with

‘‘physical limitations’’ in § 1910.932(b). This

would then require only that the HCP

provide a written recommendation of

physical limitations. Additionally, the

wording of § 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

68380 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

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

68382 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 workrelated (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 decisionmaking. 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 nonoccupational 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

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

68384 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

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

68386 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 workrelated 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:

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

68388 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

13The audits show that approximately 10% or

more of injuries and illnesses reported by

employees are not recorded in the logs.

‘‘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 nonworkplace 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 nonworkplace 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.

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.

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

68390 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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. Nonsection 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–

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 § 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, NonRegulatory 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 McCarranFerguson 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. § 1012(b). Congress passed the

McCarran-Ferguson Act in reaction to

68392 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 McCarranFerguson 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 coauthored numerous articles on workers’

compensation, see Ex. 37–14,

Curriculum Vitae of Emily A. Spieler,

including:

• Spieler E. Is Workers’

Compensation the Only Legal Remedy

for Workers Who Are Injured at Work?

In Occupational Health: Recognition

and Prevention of Work-Related Disease

and Injury (4th ed. (Lippincott,

Williams & Wilkins, Levy BS, Wegman,

DW, eds., 2000).

• Spieler E. Dispute Resolution in

Workers’ Compensation Managed Care.

Report prepared for Robert Wood

Johnson funded project, A Guide to

Evaluating the Effectiveness of Managed

Care Programs in Workers’

Compensation.

• Spieler E. Perpetuating Risk?

Workers’ Compensation and the

Persistence of Occupational Injuries, 31

Houston Law Rev. 119–264 (1994).

• Spieler E. Injured Workers,

Workers’ Compensation, and Work, 95

W.Va. Law Rev. 333–467 (1992–93).

Professor Spieler stated that WRP

would not alter or affect the legal

scheme of state workers’ compensation

systems; nor would it ‘‘supersede’’ those

systems. Specifically, she stated:

(1) WRP would in no way change the

eligibility criteria for obtaining workers’

compensation benefits in the state workers’

compensation systems. In fact, she noted that

the eligibility criteria for WRP and the

eligibility criteria for state workers’

compensation were substantially different.

(2) WRP would in no way change the filing

requirements for state workers’ compensation

claims. Thus, an employee report of an MSD

under the standard would not constitute the

filing of a workers’ compensation claim.

Every state has its own procedures for filing

workers’ compensation claims; these would

remain unchanged by WRP.

(3) WRP would in no way change the

benefit payments paid through workers’

compensation systems. Workers’

compensation benefits are set by state statute;

WRP would not affect the payment of those

benefits.

(4) WRP would in no way change the

review and adjudication process governing

workers’ compensation claims. ‘‘Because of

the no-fault principle of the workers’

compensation program[], the level of hazard

in the workplace and the general treatment

of the injured worker is irrelevant to workers’

compensation proceedings. In fact, OSHA

rules have largely remained outside of

workers’ compensation discussions and

proof. The existence of an ergonomics

standard will not change that.’’

(5) WRP would not cause an increase in

workers’ compensation premiums or change

the calculation of workers’ compensation

premium rates.

Id. at 15–18; Ex. 500–140, pp. 1–2.

In summary, Professor Spieler stated

that ‘‘the proposed ergonomics standard

[including WRP would] not interfere

with, undermine, or federalize workers’

compensation systems or illegally or

inappropriately undermine the

exclusivity doctrine.’’ Id. at 18. See also

Ex. 500–26 (Lynn Marie-Crider).

The Attorney General of New York

State, Eliot Spitzer, echoed these same

points with respect to the New York

State workers’ compensation system.

General Spitzer stated that WRP would

leave New York’s workers’

compensation system ‘‘wholly intact as

a legal matter.’’ Ex. DC 75, p. 3.

Specifically, WRP would not affect

workers’ compensation eligibility

criteria in New York. Id. at 5. Neither

would employers in New York State be

effectively admitting liability under the

state system by making certain

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

68394 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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-towork’’ 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-towork’’ 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 returnto-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

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

68396 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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.

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

68398 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 nonmonetary 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 nonmonetary 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 nonmonetary 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 sixmonth 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

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

68400 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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.

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

68402 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 OSHArequired 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

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

However, if these time periods belong to

employees, i.e., are not periods that are

on the clock, they cannot be used for the

training required by this standard.

Who Should be Trained?

OSHA proposed that employees in

‘‘problem’’ jobs (defined in the proposal

as those jobs in which an employee had

experienced a covered MSD and

performed activities involving exposure

to risk factors for a substantial amount

(or as a ‘‘core element’’ of the work

shift), their supervisors, and persons

involved in the ergonomics program

(except for outside consultants) be

trained initially, periodically as needed,

and at least every three years. The final

rule, at paragraph (t)(1), includes similar

requirements, although the final rule’s

initial and follow-up training

requirements apply only to jobs that

meet the Action Trigger, rather than to

‘‘problem jobs,’’ as proposed. In

addition, while the final rule requires

initial and 3-year follow-up training, it

does not require ‘‘refresher’’ training at

other intervals. The specified initial and

follow-up training requirements are

well-suited to the revised format of the

standard and the Action Trigger

concept.

OSHA’s reasoning in including these

requirements in the final rule is that,

once employees in jobs meeting the

action trigger have been trained, they

will be able to report MSD hazards and

problems early enough to prevent

problems from becoming worse and to

protect other employees in the same job

from incurring a similar MSD. Early

reporting informs employers of the need

to address MSD hazards and provide

MSD management. Trained employees

can also participate more effectively in

the program and thus better protect

themselves by working safely. OSHA

also believes that the supervisors (or

team leaders or lead employees) of

employees in these jobs must be trained

because they are the personnel to whom

employees report their symptoms and

the presence of MSD hazards.

Supervisors are in a position to ensure

that employees in such jobs understand

the conditions that may lead to MSDs

and use the work practices and

procedures established by the employer

to control MSD hazards. Also, in many

cases, supervisors are in a position to

observe MSD hazards first hand and to

recognize when MSDs are developing in

the workers they supervise.

OSHA also believes that training is

critical for those individuals who

establish, administer, and implement

the employer’s ergonomics program.

Because these managers represent the

employer, it is in the employer’s best

interest that program administrators and

others responsible for implementing the

program be as knowledgeable as

possible. Also, as these managers

become more knowledgeable, they will

provide better training to their

employees in the ergonomics program.

Of course, as the proposal noted,

outside consultants do not have to have

employer-provided training because

consultants are responsible for

preparing themselves to perform their

professional duties.

The question of who should be

trained was a significant issue in the

rulemaking. Commenters offered

opinions on a variety of issues and

represented conflicting viewpoints. The

major issues with respect to who should

be trained under the ergonomics rule

were:

• The scope of the training provision,

• The number of employees to be

trained,

• Whether supervisory employees

should be trained, and

• The training and qualifications of

trainers.

Some commenters urged OSHA to be

more inclusive in the employees

required to be trained. They stated that

all workers, or all general industry

employees (see, e.g., Exs. 30–3826, 30–

297, 30–4538), or all workers in the

industry (see, e.g., Ex. 30–3686) should

be trained. Some stated that, although

all employees should receive training,

employers should conduct more

extensive training specifically for those

in problem jobs (see, e.g., Ex. 30–4538).

The thrust of these comments, in

general, was that the training required

by the standard should be expanded

beyond employees in problem jobs (see,

e.g., Exs. 30–3826, 30–3686, 32–182–1,

30–3765, 32–198–4, 30–297, 30–4538).

For example, Dow Chemical stated,

Employees having an active role in the

prevention of MSD injuries and information

on how best to recognize and control MSD

hazards is a necessary component of a

successful program. In fact, Dow encourages

such training for employees, beyond whether

they are in a ‘‘problem job’’ or not. All work

activities involve some bodily movement and

therefore MSD risks are always present. Dow

supports internally a more pro-active sharing

of this type of information rather than

waiting for an MSD to present itself (Exhibit

30–3765).

Expanding the scope of the required

training to include more employees, and

to include employees who have not

experienced an MSD, would clearly

make this program element more

proactive, as many commenters urged

(see, e.g., Exs. 30–3826, 32–111–4, 30–

3686, 32–182–1). Some participants

argued that the full program, including

training, should be implemented

without waiting for workers to report

injuries (see, e.g., Ex. 32–198–4). Others

suggested that training be part of new

employee orientation (see, e.g., Ex. 500–

180–51) be provided when workers are

transferred (Ex. 32–182–1), or be given

when the ergonomics program is first

implemented or new employees are

hired (see, e.g., Ex. 32–198–4). One

commenter stated that the training

requirements of the proposed rule,

unlike the case in other OSHA rules, do

not apply to workers who are only

potentially exposed but instead apply

only to workers who are actually

exposed (Ex. 32–339–1).

Given the central role of the workers in an

effective ergonomics program (e.g., reporting

symptoms and hazards and making

recommendations about controls), we believe

that more regular training is warranted (Ex.

32–339–1).

Another comment addressed the

effect that training only some employees

might have on employee morale. This

commenter noted that, in some

ergonomics pilot training programs,

68404 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 workrelated 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 firstlevel 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 labormanagement, 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

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

(1) When a problem job is

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 managing the

ergonomics

program.

(1) When they are initially

assigned to setting up and

managing the ergonomics

program;

(2) Periodically as needed

(e.g., when evaluation reveals significant deficiencies in the program,

when significant changes

are made in the

ergonomics program); and

(3) At least every 3 years.

In the final rule, OSHA has revised

the timetable for initial training to

reflect the addition of the Action Trigger

to the standard, and to allow time for

the employer to conduct the job

screening process and implement the

ergonomic program. Accordingly,

paragraph (t)(4) provides the fillowing

timeframes for initial training: When the

employer determines that an employee’s

job meets the Action Trigger, the

employer has 45 days from that time to

train employees involved in setting up

and managing the program, and 90 days

from that time to train each current

employee in that job and their

supervisor and team leader. Also, if the

employer assigns a new or current

employee to a job that the employer has

already determined meets the Action

Trigger, that employee must be trained

prior to starting the job.

Paragraph (t)(1) of the final rule also

requires follow-up training, every three

years, for employees whose jobs meet

the Action Trigger. This requirement

differs from the corresponding proposed

provision, which did not rely upon the

Action Trigger concept.

Several commenters (see, e.g., Exs.

32–198–4, 32–198–1/42, 30–3686, 32–

339–1, 30–2116, 30–2825, 30–2847, 30–

3001, 30–3033, 30–3034, 30–3035, 30–

3258, 30–3332, 30–4159–30–4536, 30–

4546, 30–4547) urged OSHA to require

refresher training more frequently than

once every three years.

Some of the reasons cited by these

commenters for more frequent training

included:

• Many workers experience problems

in less than a year (Ex. 32–198–4–1/42).

• Training should be required

annually and whenever jobs or

conditions change (Ex. 30–3686).

• Employers should train every two

years at a minimum because many

employers are already providing

training on an annual basis (Ex. 32–198–

4).

Other commenters requested that

OSHA require training less often or

require training less often in some

situations (see, e.g., Exs. 32–300–1, 30–

3813, 30–3765, 30–327, 30–710, 30–

2725, 30–3284, 30–4046). Some specific

reasons given for less frequent retraining

were:

• There should not be a minimum

three year retraining provision for

employees where the reported MSD has

resolved within the three years and no

other MSDs (affecting the same part of

the body) have been reported in that job

(Ex. 30–3813).

• Employees will retain knowledge

about their job’s core functions, like

how to use controls and work practices

properly, even without training (Exs.

32–300–1, 30–3284).

• OSHA should allow employees and

supervisors to demonstrate knowledge

retention so that they can be exempt

from the three year retraining

requirement (see, e.g., Exs. 32–300-1,

30–327, 30–1671, 30–328).

• Program administrators should be

allowed to bypass portions of initial and

refresher training if they already possess

background training. This group could

include health and safety personnel,

medically trained personnel, and

ergonomists (see, e.g., 32–300–1, 30–

327, 30–1671, 30–3284).

OSHA responds to these comments on

the appropriate frequency of training as

follows. First, OSHA believes that

refresher training every three years for

those in higher-risk jobs is appropriate,

given the very broad range and diverse

nature of businesses covered by this

standard. For example, the number of

employees in the average business

covered by this standard is 16; such a

business is likely to experience not

more than one or two MSDs in a given

year, at most, which means that one or

two employees will receive initial

training every year and one or two will

need refresher training (once the

standard has been in effect for a few

years). In a business such as this,

ergonomics awareness is likely to be

quite high, both because of the amount

of training going on and because of the

job hazard anlysis and control activities

being conducted. In other words, the

initial training and 3-year follow-up

training requirements will virtually

ensure that ergonomics training will be

a regular part of the program for many

employers. In response to those

commenters who argued that refresher

training every three years was

unnecessary or burdensome, OSHA

notes that the standard allows

employers considerable flexibility in the

form that training must take. For

example, although all of the required

topics must be addressed in the

refresher training, trainers who observe

that trainees ‘‘know the basics’’ are free

to spend more of the training time on

such workplace-specific topics as

changes to workstations that have taken

place since the last training.

Some commenters argued that many

workplaces are static rather than

dynamic in nature and therefore that

workers in them do not need refresher

training (see, e.g., Exs. 30–2835, 30–

3356). OSHA disagrees. MSDs occur in

workplaces with fixed workstations, in

service industry jobs, and in office

settings; indeed, one of the striking

characteristics of MSDs is that they

occur in all general industry sectors (see

the risk assessment section of this

preamble, Section V). Whenever MSDs

occur in jobs that meet the action

trigger, OSHA believes that workers in

these jobs should be trained initially,

and that they should also receive

follow-up training at least every three

years. This approach ensures that those

workers who are clearly at risk have the

knowledge and skills they need to work

as safely in those jobs as possible. The

approach taken in the final rule—to

require refresher training only for

employees, and the supervisors of

employees, in jobs that meet the Action

Trigger—is also responsive to those

commenters who argued that no such

training should be required if the

problem has gone away (see, e.g., Ex.

30–3813). OSHA is unsympathetic to

those who believe that employees do

not need refresher training because they

will remember what they need to know

about the ‘‘core functions’’ of their job

(see, e.g., Exs. 32–300–1, 30–3284). This

is not OSHA’s experience, and the

thousands of fatal and disabling injuries

that occur in U.S. workplaces every year

confirm the fact that workers and their

supervisors often do not remember the

safe operating procedures in which they

were trained.

68406 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 selfemployed 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-thejob 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-thetrainer and employee training credits

the program with reducing lost-time

injuries by 64% within the first year

(Ex. 500–71–61). The record thus

demonstrates that persons with a wide

range of credentials, skills, and

experience can effectively train

employees, supervisors, and managers,

provided that they themselves have

been well-trained.

Topics for Training. Paragraph (t)(2)

of the final rule requires that the

employees identified in paragraph (t)(1)

be trained in the following topics (as

appropriate to their responsibilities in

the ergonomics program):

• The employer’s ergonomics

program and their role in it;

• The signs and symptoms of MSDs

and ways of reporting them;

• The risk factors and MSD hazards

present in the employee’s job, as

identified by the Basic Screening Tool

and the job hazard analysis;

• The employer’s plan and timetable

for addressing the risk factors and

hazards identified;

• How to use engineering, work

practice, and administrative controls, or

any PPE, that will be used in the job;

and

• How to evaluate the effectiveness of

the control approach adopted to reduce

the risk factors and MSD hazards.

With two exceptions, these are the same

training topics (with minor editorial

changes) that OSHA proposed. The two

exceptions are specific training in the

requirements of the standard and in the

importance of early reporting of MSD

signs and symptoms. OSHA has not

included these topics in the list of

training topics in the final rule because

the hazard information provided to

employees under paragraph (d) of this

standard already includes this

information. Thus all employers

covered by the standard will have

access to a summary of the standard and

will be aware of the importance of early

reporting.

OSHA believes that training in the

topics listed in paragraph (t)(2) is an

important way to ensure that employees

at all levels of the organization have the

information and skills they need to

participate effectively in the ergonomics

program. Only workers trained to

recognize MSD hazards and MSD signs

and symptoms, to use the controls

implemented to reduce these hazards,

and to evaluate the effectiveness of

these controls, can make the program

work in terms of reducing work-related

MSDs.

There was substantial disagreement

among those commenters who

addressed the content of the proposed

training requirements. Several felt that

the list of training topics should be

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68407

expanded, while others argued that

some requirements should be deleted. In

addition, many commenters submitted

data and information showing that

training programs can achieve

significant results in reducing

workplace MSD hazards and associated

MSDs.

Examples of some of the suggestions

commenters had for revising the

proposed training topics included:

• OSHA should specifically require

that employers provide training on the

requirements for medical management,

Work Restriction Protection, and the

standard’s prohibition against

discouraging workers reports (Exs. 32–

111–4, 32–339–1).

• Work Restriction Protection should

be explained during the initial training

(Exs. 30–4538, 32–339–1).

• First-line supervisors as well as the

program manager should have hazard

analysis training (Ex. 30–3826).

• Training should include

discussions of medical records

confidentiality, job hazard analysis

(including ergonomic assessment of

work stations) and disease and

disability related to ergonomic injuries

(Ex. 30–3686).

• OSHA should include both detailed

and more general topics in initial

training, and job-specific training for

employees in problem jobs and their

supervisors (Ex. 32–198–4).

• Training should cover the

importance of height differences among

employees, the training of lift team

members, and the importance of

labeling packages with their weights

(Exs. 32–461–1, 30–115, 30–4538).

Other commenters recommended that

certain subjects be deleted from the

required training topics. For example,

several commenters suggested that

training on the specific requirements of

the standard be deleted from the list

(see, e.g., Exs. 30–3765, 32–300–1, 30–

240, 30–3284). These commenters were

of the opinion that there is no need to

provide in-depth training on the

standard itself, but that the training

should instead focus on elements of the

standard only as they specifically apply

to the company’s program. Further,

these commenters believed that

employees have ample access and

opportunity to familiarize themselves

with OSHA standards, including access

to OSHA’s internet homepage (see, e.g.,

Ex. 330–3765).

OSHA agrees that the specific

suggestions for additional training

content made by commenters would be

useful to employees. However, the

Agency has decided to require only that

employees be trained in those basic

topics that are essential to worker

protection. The required topics are

general, in order to allow the flexibility

needed in different workplace

situations. This approach is consistent

with the training content requirements

of other OSHA standards (see, e.g., 29

CFR 1910.1018 and 29 CFR 1910.147).

The final rule requires training in the

employer’s ergonomics program and

each employee’s role in it; the signs and

symptoms of MSDs and ways of

reporting them; the risk factors and

MSD hazards present in the employee’s

job, as identified by the Basic Screening

Tool and the job hazard analysis; the

employer’s plan for addressing

identified hazards, including the

employer’s timetable to abate the

hazards identified; training in how to

use the controls in the job, including

any personal protective equipment; and

how to evaluate the effectiveness of the

control approach used.

OSHA believes that the required

topics constitute a minimal training

program and recognizes that many

employers may choose to administer

more extensive training. OSHA

anticipates that many employers will

cover such topics in their training

programs as OSHA’s discrimination

regulations (Section 11(c) of the Act),

Work Restriction Protection, MSD

management, and multiple HCP review.

Several of these topics are briefly

addressed in the information on the

standard employees receive in response

to the requirements of paragraph (d).

OSHA believes that training under

paragraph (t) should concentrate

primarily on MSDs and MSD hazards

that are specific to the employee’s job.

OSHA has also not included the more

detailed topics—package weight

labeling, the importance of height

differences among employees, lift team

training, and so forth—suggested by

commenters (see, e.g., Exs. 32–461–1,

30–115, 30–4538). Such topics are

workplace-specific and thus not

appropriate to include in general

training requirements that will apply to

all workplaces covered by the standard.

Some commenters recommended that

OSHA expand its training activities by

developing outreach training programs

and other compliance assistance

materials (see, e.g., Exs. 30–3686, 30–

4538, 32–198–4, 30–3826, 30–614, 30–

1037, 30–2806). Some specific

suggestions were that OSHA develop a

sample curriculum, including

audiovisuals (Ex. 30–4538), or that

OSHA provide a curriculum, instructor

materials (and translations), and

training videos at minimal cost (Ex. 32–

198–4). Other comments urged OSHA to

establish an ‘‘advice line’’ for program

managers (those setting up and

implementing the program) and urged

employers to work closely with health

care professionals. These commenters

were concerned that, without such

assistance, managers would be tempted

to buy expensive but ineffective

ergonomic fixes and purchase products

that do not address the root cause of the

problem (Exs. 30–614–, 30–898, 30–

4139).

Other stakeholders suggested that

OSHA train its compliance officers to

have, at a minimum, the same level of

knowledge as consultants advising

employers in ergonomics programs (see,

e.g., Exs. 30–1037, 30–3922). These

commenters urged the OSHA training

centers to make ergonomic certification

programs and other courses available to

the public or at least to make employers

aware of sample programs that already

exist (see, e.g., Exs. 30–1037, 30–3123,

30–3128).

OSHA does have programs in place to

help employers with their ergonomics

programs. The Agency offers free

consultation services through the states.

The OSHA consultation program is

specifically designed for small- and

medium-size organizations (i.e.,

employers with 250 employees or fewer

per site or 500 per organization). These

services are confidential, and

consultants will not issue citations or

propose penalties. OSHA also offers offsite 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

68408 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

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

68410 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

training session is over (see, e.g., Exs.

30–2116, 30–2809, 30–2825, 30–2847,

30–3001, 30–3033, 30–3034, 30–3035,

30–3258, 30–3332, 30–4159, 30–4536,

30–4546, 30–4547).

Some commenters suggested that

specific training techniques to be

included in the rule. Suggestions

included:

• Allow the use of electronic media,

telephone reviews, and videos (see, e.g.,

Exs. 30–3826, 30–3765, 30–434, 30–

3392).

• Require that training be provided in

a supportive atmosphere that

encourages discussion of concerns with

respect to MSD-related working

conditions and encourages

opportunities for questions (Ex. 30–

3686).

• Require training to be administered

‘‘live’’; prohibit written training (Ex. 32–

198–4).

A commenter argued for the need for

live training as follows:

Employers often do not know at what level

their employees are reading and

comprehending. Workers are generally

reluctant to share information about their

literacy limitation (Sarmiento and Kay,

‘‘Workers Centered Learning,’’ 1990). It is

estimated that between 45%–50% of adults

in America struggle due to some limitations

in their literacy and/or language proficiency

(which result in limitation of

‘‘understanding’’ or ‘‘reasoning’’), according

to ‘‘Adult Literacy in America’’ in

publications of the U.S. Department of

Education (1993). In addition, many of those

functioning at a limited literacy level don’t

see themselves as having these limitations

(Ex. 32–198–4).

The same commenter recommended

methods such as visual aids, discussion

and problem solving, and small group

‘‘hands-on’’ sessions, and noted that

workers are more likely to trust the

employers’ programs and develop

confidence if these more oral training

methodologies are implemented (Ex.

32–198–4).

In response to these comments, OSHA

restates the position it has taken

consistently in other standards: OSHA’s

objectives are to require employers to

provide basic training in ergonomics, to

ensure that all trained employees

understand the training, and to permit

employees to ask questions if they need

further information. The Agency does

not dictate the methods that employers

choose to achieve compliance with

these requirements. Properly trained

employees will be sufficiently informed

to recognize the signs and symptoms of

MSDs and the value of reporting them

early, to identify MSD hazards in their

jobs, to know how to use and evaluate

the control measures that the employer

implements to reduce those hazards,

and to work in ways that will reduce the

risks in their jobs. The standard also

does not state how long the training

must last and when the question and

answer periods must occur; instead,

OSHA is leaving such things to the

employer’s discretion.

Paragraph (u)—What Must I Do To

Make Sure My Ergonomics Program Is

Effective?

The intent of the provisions of the

Program Evaluation paragraph of the

final Ergonomics Program standard is to

require employers to evaluate their

ergonomics program to ensure that it is

effective. Good management, as well as

common sense, suggest that periodic

review of a program’s effectiveness is

necessary to ensure that the resources

being expended on the program are, in

fact, achieving the desired result and

that the program is doing so in an

efficient way. Program evaluation is a

tool that can be used to ensure that an

ergonomics program is appropriate for

the specific MSD hazards in the

employer’s problem jobs and that the

program is achieving desired results.

OSHA has long considered program

evaluation to be an integral component

of programs implemented to address

health and safety issues in the

workplace. For example, the

Ergonomics Program Management

Guidelines for Meatpacking Plants

(‘‘Meatpacking Guidelines’’) recommend

regular program review and evaluation

(Ex. 2–13). These guidelines suggest that

procedures and mechanisms be

developed to evaluate the ergonomics

program and to monitor progress

accomplished. Program evaluation is

described in the Meatpacking

Guidelines as a program component

whose use reflects both management

commitment and employee

involvement. OSHA’s 1989 voluntary

Safety and Health Program Management

Guidelines also recommend regular

program evaluation as an integral

program component (Ex. 2–12). Further,

OSHA’s Voluntary Protection Programs

(V.P.P.) and Consultation Program

require periodic evaluations of an

employer’s safety and health program,

including that portion of the program

addressing ergonomic issues.

The proposal contained a ‘‘basic

obligation’’ section that merely

summarized the proposed program

evaluation provisions. The proposed

basic obligation section also stated that

employers were to evaluate their

ergonomics program periodically, and at

least every 3 years, ‘‘to ensure that it is

in compliance with this standard.’’

Because the basic obligation sections of

the proposed standard led to confusion

and were not helpful, OSHA has not

included them in the final rule. Since

the basic obligation section only

summarized the proposed program

evaluation requirements, comments on

that section are discussed below, in

connection with the proposed

requirement to which they refer.

The proposed rule contained

provisions requiring employers with

programs to review them periodically to

ensure their effectiveness; identified the

procedures employers were required to

follow when conducting evaluations;

proposed that evaluations be conducted

as often as needed and at least every 3

years; and proposed that program

deficiencies identified during the

evaluation be corrected promptly. The

final rule’s program evaluation

provisions have been revised to reflect

comments received, but are generally

similar to those proposed.

Paragraph (u)(1) of the final rule

provides for the frequency of required

program evaluations. The methods and

procedures employers are required to

use in such evaluations are included in

paragraph (u)(1)(i) through (iv).

Provision is made for other events that

may trigger program evaluations at more

frequent intervals in paragraph (u)(2). In

addition, the prompt correction of any

deficiencies identified during the

evaluation is covered in final rule

paragraph (u)(3). The following

discussion presents OSHA’s reasons for

including revised program evaluation

provisions in the final rule, and

summarizes the comments the Agency

received on the proposed program

evaluation requirements.

Paragraph (u)(1)—Frequency of Program

Evaluations

OSHA received many comments (see,

e.g., Exs. 30–240; 30–1671; 30–3860;

500–71–86; 500–137; 30–3686; 32–210–

2; 32–85; Tr. 8982; 30–2116; 30–2809;

30–2825; 30–2847; 30–3258; 30–3035;

30–3001; 30–3033; 30–3034; 30–4159;

30–4534; 30–4536; 30–4800; 30–4776;

30–4546; 30–4547; 30–4548; 30–4549;

30–4562; 30–4627; 30–3332; 30–3259;

30–4801; 30–3898; 30–4270; 30–4498;

30–3813 ; 500–33; 30–3745; 30–3765;

30–3368; 30–4713; 30–4046; 30–4247)

on the proposed frequency of ergonomic

program evaluations, as well as on the

events that should trigger them. A few

commenters (see, e.g. Exs. 30–240, 30–

1671, 30–3860, 500–137) agreed with

OSHA’s proposed 3 year time frame,

while others stated that they believed a

3-year interval was too long and that

program evaluations should take place

periodically and at least annually (see,

e.g., Exs. 30–3686; 32–210–2; 32–85;

and Tr. 8982).

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

68412 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

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

68414 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

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

68416 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 noncompliance.’’ 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

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

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.

68418 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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.

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

68420 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68421

unnecessary. For example, The Eastman

Kodak Company (Ex. 30–429, p. 8)

remarked that

This creates significant difficulties in that

the prior health histories of such workers are

unknown to the contracting employers and

initial health checks are usually not

conducted. Personnel service workers could

have pre-existing conditions that could

become aggravated without MSD factors

being present in their workplaces.

OSHA’s rationale for including these

employees is that it is the number of

employees, not the duration or kind of

employment relationship they have

with the employer, that necessitates the

keeping of records. The size of the

workforce is the factor that makes layers

of management and more formal

methods of communication (and

therefore recordkeeping) necessary. In

fact, supervising part-time or leased

employees often adds considerable

complexity to management planning,

oversight, and recordkeeping. Thus, the

final rule uses a workforce of more

than10 employees on any day of the

previous calendar year as the size

threshold that triggers compliance with

the rule’s recordkeeping requirements.

Applicability to federal facilities. In a

comment unique to federal agencies, the

U. S. Department of Navy (Ex. 30–3818,

p. 2) recommended that OSHA

‘‘acknowledge the different

recordkeeping requirements for federal

agencies and rewrite * * * [the

standard] to include provisions for the

federal facilities recordkeeping program

of 29 CFR 1960.’’ OSHA has considered

this request, but has decided that a

separate provision stating the

applicability of the rule to federal

facility recordkeeping programs is

unnecessary because this matter is

better addressed in a compliance

directive for affected federal agencies.

Paragraph (v) of the final rule, which

corresponds to section 1910.940 of the

proposed rule, establishes the final

rule’s requirements for keeping the

records required by the standard. It

specifies which records employers must

keep and how long they must keep

them. OSHA proposed that employers

required by the standard to keep records

maintain the following:

• Employee reports of MSDs and the

employer’s responses to these reports,

II The results of job hazard analyses and

Quick Fixes,

II The controls implemented to reduce

or eliminate MSD hazards,

II The MSD management process, and

II The results of ergonomics program

evaluations.

OSHA also proposed that most

ergonomic program records be retained

by the employer for 3 years or until

replaced by an updated record, and the

final rule mandates the same retention

periods. The final rule, like the

proposal, makes an exception to the 3-

year retention period for MSD

management records. These records are

required to be maintained for the length

of the injured employee’s employment

plus 3 years, a retention period

considerably shorter than that required

for other OSHA-mandated medical

records. OSHA health standards, for

example, generally require exposure

records to be kept for 30 years and

medical surveillance records to be kept

for the duration of employment plus 30

years, as required by 29 CFR 1910.1020,

OSHA’s access to employee exposure

and medical records standard. These

lengthy retention periods are

appropriate for many toxic substances

and harmful physical agent standards

because of the long latency between

exposure on the job and the onset of

disease. However, since the latency

period for most musculoskeletal

disorders is shorter than is the case for

many of the chronic conditions and

illnesses covered by other OSHA rules,

the Agency believes that a shorter

retention period is appropriate for the

ergonomics rule. Also, changes in the

workplace, such as equipment or

process changes, often make older

ergonomics records irrelevant to current

jobs and the present workplace

environment. Employers’ ergonomics

programs continue to evolve, with

records of the most recent aspects of

that evolution being the most relevant

for employee protection.

The proposed recordkeeping

provisions elicited several comments.

Commenters addressed the following

issues: the potential burden imposed by

the recordkeeping requirements; the

kinds of records employers should keep;

the appropriate retention period for

program-related records; the need to

permit employees and designated

representatives to access the records;

and electronic recordkeeping. The

paragraphs below discuss the

comments; OSHA’s responses to the

comments follow this discussion.

Several rulemaking participants

agreed with OSHA’s proposed

recordkeeping requirements (see, e.g.,

Exs. 32–339–1, 182–1; Ex. 500–206; Tr.

3488). Typical of the views of these

commenters was the comment of the

AFL–CIO (Tr. 3488) ‘‘The recordkeeping

provisions of the rule * * * are

necessary for the effective

implementation of the program.’’

Recordkeeping requirements are

burdensome. A number of rulemaking

participants (see, e.g., Exs. 30–74, 294,

429, 526, 544, 546, 652, 653, 710, 1070,

1090, 2428, 2433, 2807, 2991, 3284,

3336, 3367, 3557, 3593, 3723, 3745,

3765, 3770, 3781, 4134, 4184, 4185,

4628, 4839; Exs. 32–77–2, 300–1; Exs.

500–7, 16, 113, 130, 145, 163; Tr. 3136–

37, Tr. 5039, Tr. 5334–35, Tr. 5493, Tr.

5638, Tr. 9207–9209, Tr. 12198–99, Tr.

12770, Tr. 12860, Tr. 16486–87, Tr.

16491, Ex. 500–163) argued that the

proposed recordkeeping requirements

were excessive, burdensome and

unnecessary. For example, a commenter

for Owens Corning (Ex. 500–163, p. 7)

stated that

The recordkeeping requirements in the

proposed standard are excessive and poorly

defined. In addition, the implied

documentation requirements of the proposed

standard are inconsistent with the

requirements of * * * [the proposed

rulemaking section], i.e., the real

recordkeeping requirements are much more

extensive than those specifically required by

this section.

OSHA also received numerous preand 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,

68422 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 hazardspecific 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

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

68424 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

§ 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

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

68426 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 phasedin 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 twotiered 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

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

§ 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 § 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

§ 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 § 1910.943

or how it would work (see, e.g., Exs. 30–

2116, 30–2809, 30–2825, 30–2847, 30–

68428 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

§ 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 § 1910.943 than was

proposed for initial compliance in

§ 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 performancebased replacement for the ‘one MSD in

three years’ criterion.’’ OSHA has

considered this suggestion but has

determined that such a performancebased 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,

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

68430 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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, employerdesignated 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] § 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 selfexplanatory; 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 ‘‘followup’’ 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).

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

68432 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

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

68434 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 crossreference 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 corporatewide obligations on businesses that

have multiple establishments. Instead,

the standard is job-based in the first

instance, i.e., employers are only

required to implement the ergonomics

program in those jobs identified as

problem jobs. It is establishment-based

in the second instance, i.e., employers

are only required to include in their

program the problem job (and the

workers in them) within the

establishment to which the problem job

is ‘‘attached.’’ This means that, where

the workforce is mobile, the

establishment to which the injured

employee reports would be considered

the establishment, for the purposes of

the standard. Since the standard

requires employers to extend the

standard’s protections to all employees

in the same job, the employer is

required to ‘‘fix’’ the MSD hazards in

the workstations or work environments

of all employees in the same job who are

located in, or report to, the same

establishment.

For the purposes of the standard,

OSHA defines an establishment as a

single physical location where business

is conducted or where services or

industrial operations are performed. For

activities where employees do not work

at a single physical location, such as

construction; transportation;

communications, electric, gas and

sanitary services; and similar

operations, the establishment is

represented by main or branch offices,

terminals, stations, etc., that either

supervise such activities or are the base

from which personnel carry out these

activities.

One commenter (Exs. 30–2825 and

30–3332) suggested that OSHA add a

definition of repetitive motion jobs to

the final rule. OSHA does not believe

such a definition is necessary because

the final rule contains clear definitions

of each of the risk factors (see the Basic

Screening Tool in Table 1).

Several commenters asked OSHA to

clarify the definitions of industries

covered and exempted from the final

rule (see, e.g., Exs. 30–1897, 30–3818

and 30–4716). For example, the

Honorable James Talent, Chairman of

the U.S. House of Representatives

Committee on Small Business (Ex. 30–

1897), noted that the proposed rule did

not apply to agriculture, construction, or

maritime operations, but did not clarify

each of these terms. Paragraph (b) of the

final rule provides clear definitions of

the standard’s scope and explicitly

states that it does not apply to maritime,

agricultural, railroad, or construction

employment.

Finally, some commenters suggested

that OSHA define the term recovery

period, which was used in the definition

of work restriction protection (WRP)

(see, e.g., Exs. 30–3749 and 30–3344).

OSHA has not done so because this term

is used in the final rule in its everyday

sense, and is therefore clear on its face.

V. Health Effects

In this section, OSHA presents the

evidence contained in the rulemaking

record that addresses the causal

relationship between exposure to

biomechanical risk factors at work and

an increased risk of developing

musculoskeletal disorders (MSDs). This

evidence consists of epidemiological

studies of exposed workers in diverse

occupational settings, biomechanical

studies describing the relationships

between exposure to risk factors and

associated forces imposed on

musculoskeletal tissue, studies of tissue

pathology describing the kinds of tissue

alterations that have been seen to result

from such forces, and medical and

diagnostic information relating to MSDs.

In making its findings from this

evidence, OSHA is relying in part on the

extensive scientific evidence presented

in the detailed Health Effects

Appendices to the proposal (64 FR

65865–65926) (Ex. 27–1), located on

OSHA’s webpage at http://

www.osha.gov and summarized in this

section. In addition, OSHA’s analysis

includes results from several other

studies placed into the rulemaking

record after publication of the proposed

rule, as well as comment and testimony

from many distinguished scientific

experts.

This section is divided into the

following seven parts:

• Part A, Description of Biomechanical

Risk Factors;

• Part B, Overview of the Health Effects

Evidence;

• Part C, Evidence on Neck and Shoulder

Disorders;

• Part D, Evidence on Upper Extremity

Disorders;

• Part E, Evidence on Back Disorders;

• Part F, Evidence on Lower Extremity

Disorders; and

• Part G, OSHA’s Response to Issues

Raised in the Rulemaking.

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68435

A. Biomechanical Risk Factors

Biomechanical risk factors are the

aspects of a job or task that impose a

physical stress on tissues of the

musculoskeletal system, such as

muscles, nerves, tendons, ligaments,

joints, cartilage, spinal discs, or (in the

case of hand-arm vibration syndrome)

blood vessels of the upper extremities.

To accomplish motion and work,

muscle, nerves, connective tissue, and

skeleton are affected by a number of

external and internal physical demands

causing metabolic and compensatory

tissue reactions. External demands can

include direct pressure on tissues or

tissue friction. Internal responses can

include inflammatory responses to

tissue injury, neurochemical changes,

and altered metabolism. The

consequences of these external and

internal demands associated with work

activities can include a spectrum of

symptoms or clinical findings. Although

some types of tissue, like skeletal

muscle, have the ability to recover after

an injury that does not physically

disrupt the tissue, exceeding tissue

limits may result in permanent damage

to a tissue. However, skeletal muscle is

just one type of tissue that can be

affected; other tissues like tendon,

ligament, nerve, and cartilage can also

be damaged by exposure to excessive

physical task factors. These tissues,

unlike skeletal muscle, do not have the

same capacity for recover and repair

after injury. (Each part of this Health

Effects section briefly summarizes the

pathogenesis of MSDs; OSHA’s Health

Effects Appendices (Ex. 27–1),

developed for the proposed rule,

contains detailed discussions of the

scientific literature describing the

pathogenesis of MSDs).

The biomechanical risk factors

addressed by this final rule are

repetition, force, awkward postures,

vibration to the upper extremity (i.e.,

segmental vibration), and contact stress.

In occupations where an increased

prevalence or incidence of MSDs has

been observed, these risk factors

frequently occur in combination; the

level of risk associated with exposure

depends on the intensity and duration

of exposure as well as the amount of

recovery time available to the strained

tissues for repair. Soft tissues of the

musculoskeletal system will develop

tolerance to physical loading if

sufficient recovery time is provided.

Without adequate recovery time,

affected tissues can accumulate damage

or become more prone to failure. The

need for adequate recovery time

between exposure events means that the

pattern of exposure also has an

important influence on risk. The

biomechanical risk factors covered in

the final rule are force, repetition,

awkward postures, contact stress, and

segmental vibration; the basic screening

tool in the final rule describes criteria

for each of these risk factors that

identifies those jobs where there is a

potential risk of MSDs. Each of these

risk factors is described below.

Force

Force refers to the amount of physical

effort that is required to accomplish a

task or motion. Force also refers to the

degree of loading to muscles and other

tissues as a result of applying force to

perform work. Tasks or motions that

require application of higher force place

higher mechanical loads on muscles,

tendons, ligaments, and joints (Ex. 26–

2). The force required to complete a

movement increases when other risk

factors are also involved. For example,

more physical effort may be needed to

perform tasks when the speed or

acceleration of motions increases, when

vibration is present, or when the task

also requires awkward postures. Hand

tools that require use of pinch grips

require more forceful exertions to

manipulate the tool than do those that

permit use of power grips.

Relationships among external loads,

internal tissue loads, and mechanical

and physiological responses have also

been studied extensively, using

simulation, direct instrumentation,

indirect instrumentation, and

epidemiological studies. In a report on

the Research Base of Work-Related

Musculoskeletal Disorders prepared by

the National Research Council (NRC) in

response to a request from the National

Institutes of Health (NIH) (Ex. 26–37),

the steering committee provides some

rationale for evaluating and controlling

biomechanical risk factors, specifically

force:

• The concept of force can be generalized

to encompass numerous ways of measuring

and characterizing external loads. For

example, force can be measured in terms of

the weight of parts, tool reaction force,

perceived exertion, muscle electrical activity,

or observer ratings.

• Internal loads can be estimated by using

external loads. For example, a worker must

bend or stoop to lift something from the floor;

a worker will exert more force on a stiff

keyboard than a light touch keyboard.

Understanding these relationships allows

prediction of internal loads.

• Predicted internal loads generally agree

with measured internal and external loads.

For example, measurements of muscle loads

during activity using electromyography

generally agree with predicted values.

Force can be assessed qualitatively or

quantitatively. Quantitative measures

include strain gauges, spring scales, and

electromyography to measure muscle

activity. A qualitative assessment of

force is based on direct observation of

the amount of physical exertion

required to complete a task, and is

usually graded on an ordinal scale (i.e.,

low, medium, high).

Repetition

Repetition refers to the frequency

with which a task or series of motions

are repeated with little variation in

movement. Although force and/or

awkward postures can combine with

repetition to increase the risk of MSDs

over that of repetition alone,

acceleration and velocity of repetitive

movement are also important

considerations in that they may ‘‘cause

damage that would not be predicted by

muscle forces or joint angles alone’’

(Washington State CES, p.20, Ex. 500–

71–93).

Repetitive motions occur frequently

in manufacturing operations where

production and assembly processes

have been broken down into small

sequential steps, each performed by

different workers. However, it also

applies to many manual handling

operations, such as warehouse

operations and baggage handling.

Repetition is typically assessed by direct

observation or videotaping of job tasks.

The intensity of exposure is usually

expressed as a frequency of motion or as

a percent of task cycle time, where a

cycle is a pattern of motions.

Awkward Postures

Awkward postures refer to positions

of the body (e.g., limbs, joints, back) that

deviate significantly from the neutral

position while job tasks are being

performed. For example, when a

person’s arm is hanging straight down

(i.e., perpendicular to the ground) with

the elbow close to the body, the

shoulder is said to be in a neutral

position. However, when employees are

performing overhead work (e.g.,

installing or repairing equipment,

grasping objects from a high shelf) their

shoulders are far from the neutral

position. Other examples include wrists

bent while typing, bending over to grasp

or lift an object, twisting the back and

torso while moving heavy objects, and

squatting. Awkward postures often are

significant contributors to MSDs

because they increase the exertion and

the muscle force that is required to

accomplish the task, and compress soft

tissues like nerves, tendons, and blood

vessels. As used in the final rule’s basic

screening tool, awkward postures may

be either static postures held for

68436 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 handarm 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 wholebody 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

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

Report, Workshop Summary, and

Workshop Papers (1999; Ex. 26–37).

NIOSH’s review focused on repetition,

force, posture, and vibration when

evaluating epidemiologic evidence for

the neck, shoulder, elbow, and hand/

wrist. For the low-back, the authors

looked at the evidence for heavy

physical work, lifting and forceful

movements, bending and twisting

(awkward postures), whole body

vibration and static work postures. The

‘‘work factors’’ identified by the NRC in

their report on Work-Related

Musculoskeletal Disorders are the same

as the ‘‘biomechanical risk factors’’

identified by OSHA. Although terms

may differ depending upon the part of

the body being described, it is easy to

see the relationship between heavy

physical work and lifting and the

concept of force/exertion to the back, for

example .

The Steering Committee Report for

the NRC workshop on ‘‘Examining the

Research Base (for Work-Related

MSDs)’’, participants agreed there is

‘‘enough scientific evidence to confirm that

strain on musculoskeletal tissue increases

when humans perform activities that involve

forceful manual exertions, awkward postures,

repetitive or prolonged exertions, exposure to

vibrations and exposure to cold

temperatures.’’

However, in a separate paper

prepared for the NRC/NAS workshop,

Radwin and Lavender also discuss

‘‘workplace layout,’’ ‘‘interactions with

objects,’work scheduling’’ and other

‘‘workplace design factors,’’ as factors

that these authors, as well as others,

have studied in relation to MSDs.

Although there is strong agreement on

biomechanical factors associated with

MSDs, the science is still evolving with

regard to other types of factors. Thus,

when sources refer to biomechanical

risk factors, all literature reviewed from

the rulemaking record identified the

same basic risk factors, all essentially

related to force/exertion, repetition,

posture and vibration.

Literature reviews published in the

scientific literature also evaluate these

same risk factors. Literature reviews of

this type use selection criteria to capture

the best-designed studies with a

particular focus, usually risk factors

associated with a specific type of

disorder, for analysis. Burdorf and

Sorock reviewed 35 articles that

evaluated risk factors for back disorders

and concluded that lifting or carrying

loads (force), whole-body vibration and

frequent bending and twisting (awkward

postures) were consistently related to

work-related low-back disorders (1997;

Ex. 500–71–24). In a systematic review

of 31 studies, Hoogendoorn et al (1997;

Ex. 500–71–32) found strong evidence

exists for manual materials handling,

bending and twisting (awkward

posture), and whole-body vibration as

risk factors for back pain, and moderate

evidence exists for patient handling and

physical work.

In their review of the literature on the

role of physical load factors in carpal

tunnel syndrome, Viikari-Juntura and

Silverstein found an association with

carpal tunnel syndrome and forceful,

repetitive work, extreme wrist postures

and vibration (1999; Ex. 32–339–1–56).

Other authors (Ariens et al., 2000; Ex.

500–71–23) found a relationship

between neck pain and neck flexion,

arm force, arm posture, duration of

sitting, twisting or bending of the trunk,

hand-arm vibration, and workplace

design.

In both written submissions to the

record, and in oral testimony, numerous

scientific experts confirmed and

substantiated OSHA’s position that

sufficient scientific evidence exists, and

is contained in the record, to conclude

that workplace exposure to the

biomechanical risk factors described

above increase the risk for work-related

MSDs (Exs. 37–1; 37–2; 37–3; 37–6; 37–

8; 38–9; 37–10; 37–13; 37–15; 37–16;

37–17; 37–18; 37–21; 37–27; 37–28; 26–

37). Scientists who testified at the

hearings also confirmed that each of

these risk factors are linked to an

increased risk of developing an MSD in

exposed workers (Dr. Don Chaffin,

University of Michigan, Tr 8254; Dr.

Nicholas Warren, University of

Connecticut Health Center, Tr.1084–85;

Dr. Martin Cherniak, Ergonomics

Technology Center of Connecticut, Tr.

1128; Dr. Richard Wells, University of

Waterloo, Tr. 1353–54; Dr. Robert

Harrison, Tr. 1648; Dr. Amadio, Mayo

Clinic, Tr. 9815, 98; Dr. Eckardt

Johanning, Eastern New York

Occupational and Environmental Health

Center, Tr. 16831–33; Dr. Jim

McGlothlin, Purdue University, Dr.

Malcolm Pope, Tr. 16808; Dr. Margit

Bleeker, Tr. 16826). This written and

oral testimony from scientific experts

provides a compelling case establishing

the link between exposure to

biomechanical risk factors and an

increased risk of MSD incidence.

OSHA heard from a number of

scientists and physicians during it’s

hearing with comments along the lines

of that by Dr. Robert Harrison, from the

University of California (Tr. 1649–50):

The jobs and tasks my patients are

performing are the ones the literature has

identified as high-risk jobs with exposure to

many of the same physical risk factors. In

fact, my patients are exposed to the identical

physical work activities and conditions that

have been identified by OSHA as causing

excessive exposure to force, frequent

repetition, awkward posture, contact stress,

vibration and cold temperatures.

The record contains many US and

international regulations and guidelines

that reflect the same biomechanical risk

factors addressed in the final rule; some

are listed below:

• National Research Council. (1999)

Work-Related Musculoskeletal

Disorders: Report, Workshop Summary,

and Workshop Papers. National

Academy Press. (Ex. 26–37);

• National Institute for Occupational

Safety and Health. (1997)

Musculoskeletal Disorders and

Workplace Factors. Centers for Disease

Control and Prevention (Ex. 26–1);

• National Institute for Occupational

Safety and Health. (1998) Elements of

Ergonomics Programs, A Primer Based

on Workplace Evaluations of

Musculoskeletal Disorders. (Ex. 26–2);

• European Agency for Safety and

Health at Work. Work-related neck and

upper limb musculoskeletal disorders

(1999). (Ex.500–71–28);

• Department of Labor and Industries,

Washington State. (5/25/00) Concise

Explanatory Statement, WAC 296–62–

051, Ergonomics (Ex. 500–71–93);

• Ergonomics for the Prevention of

Musculoskeletal Disorders, Swedish

National Board of Occupational Safety

and Health on Ergonomics for the

Prevention of Musculoskeletal

Disorders. AFS 1998:1; (Ex. 500–71–14);

• National Codes of Practice for the

Prevention of Occupational Overuse

Syndrome-Worksafe Australia

[NOHSC:2013(1994)], (Ex. 500–71–2);

• National Standard for Manual

Handling and National Code of Practice

for Manual Handling, Worksafe

Australia. 1990 (Ex. 500–71–4);

• Occupational Overuse Syndrome:

Guidelines for Prevention and

Management, Occupational Safety and

Health Services, Department of Labor,

New Zealand (Ex. 500–71–12);

• Ergonomics (MSI) Requirements,

British Columbia, Canada (Ex. 32–339–

1–6);

68438 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

• Regulations and Code of Practice,

(Manual Handling) Occupational Health

and Safety Regulations 1988. Victoria,

Canada. (Ex. 500–71–17);

• European Communities Council

Directive on Manual Handling (Ex. 32–

339–1–12);

• American Conference of

Governmental Industrial Hygienists,

Threshold Limit Value (TLV)

Committee, Nov. 13, 1999. Notice of

Intent to Establish a Threshold Limit

Value, Hand Activity Level (Ex. 32–

339–1–63);

• American Conference of

Governmental Industrial Hygienists.

1987. Ergonomic Interventions to

Prevent Musculoskeletal Injuries in

Industry (Ex. DC–386, Tr. 16291–335);

• American Industrial Hygiene

Association. 1994. Ergonomic Guide

Series (Ex. 32–133–1);

• American National Standards

Institute (ANSI) draft Ergonomic

Standard, Z–365 (1998) (Ex.26–1264).

Furthermore, the vast majority of the

many job evaluation tools found in the

record and reviewed by the Agency

collectively address these same risk

factors covered under the final rule (Exs.

26–521, 26–1421, 26–1008, 26–883, 26–

500–71–92). Also, studies using specific

interventions to reduce biomechanical

load address these same risk factors (see

section VI, Risk Assessment).

B. Overview of Evidence of Health

Effects for Work-Related

Musculoskeletal Disorders

A substantial body of scientific

evidence supports OSHA’s effort to

provide workers with ergonomic

protection (see the Health Effects

Appendix of the proposal preamble, and

the Health Effects Summary, Risk

Assessment, and Significance of Risk

sections of this preamble, below). This

evidence strongly supports two basic

conclusions: (1) there is a positive

relationship between exposure to

biomechanical risk factors and

development of work-related

musculoskeletal disorders and (2)

ergonomics programs and specific

ergonomic interventions can reduce

these risks. Although it is recognized

that many individual and nonbiomechanical 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 WorkRelated 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 workrelated 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, casecontrol studies, cross-sectional studies,

longitudinal cohort studies, and case

series were included.

The first step in the analytical process

was to classify the epidemiologic

studies by the following criteria:

• The participation rate was ≥ 70%. This

criterion limits the degree of selection bias in

the study.

• The health outcome was defined by

symptoms and physical examination. This

criterion reflects the preference of most

reviewers to have health outcomes that are

defined by objective criteria.

• The investigators were blinded to health

or exposure status when assessing health or

exposure status. This criterion limits

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68439

observed bias in classifying exposure or

disease.

• The joint (part of body) under discussion

was subjected to an independent exposure

assessment, with characterization of the

independent variable of interest (such as

repetition or repetitive work). Studies that

used either direct observation or actual

measurements of exposure were considered

to have a more accurate exposure

classification scheme, whereas studies that

exclusively used job title, interviews, or

questionnaire information were assumed to

have less accurate exposure information.

During review of the studies, the

greatest qualitative weight was given to

studies that had objective exposure

assessments, high participation rates,

physical examinations, and blinded

assessment of health and exposure

status.

The second step of the analytical

process was to divide the studies into

those with statistically significant

associations between exposures and

health outcomes and those without

statistically significant associations. The

associations were then examined to

determine whether they were likely to

be substantially influenced by

confounding or other selection bias

(such as survivor bias or other

epidemiologic pitfalls that might have a

major influence on the interpretation of

the findings). These include the absence

of nonrespondent bias and

comparability of study and comparison

groups.

The third step of the analytical

process was to review and summarize

studies with regard to the epidemiologic

criteria for causality: strength of

association, consistency in association,

temporal association, and exposureresponse 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 workrelatedness, 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 longduration 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 welldefined, explicit criteria determined

before the study. Studies whose primary

outcomes were clinically relevant

diagnostic entities, generally had less

misclassification and were likely to

involve more severe cases. Studies

whose primary outcomes were the

reporting of symptoms generally had

more misclassification of health status

and a wider spectrum of severity.

Care should be taken when

interpreting some study results

regarding individual workplace factors

of repetition, force, extreme or static

postures, and vibration. As Kilbom

(1994; Ex. 26–1352) stated, these factors

occur simultaneously or during

alternating tasks within the same work,

and their effects concur and interact. A

single odds ratio (OR) for an individual

risk factor may not accurately reflect the

actual association, as not all of the

studies derive ORs for simultaneously

occurring factors. Thus these studies

were not only viewed individually

(taking into account good epidemiologic

principles) but together for making

broader interpretations about

epidemiologic causality. Many

investigators did not examine each risk

factor separately but selected study and

comparison groups based on

combinations of risk factors (such as

workers in jobs involving high force and

repetition compared with workers

having no exposure to high force and

repetition.)

Based on the epidemiologic criteria

described above, NIOSH made the

following findings:

Strong evidence of work-relatedness

exists for the following associations:

• High levels of static contraction,

prolonged static loads, extreme working

postures involving the neck/shoulder

muscles and an increased risk for neck/

shoulder MSDs;

• Exposure to a combination of risk

factors (e.g., force and repetition, force

and posture) and CTS;

• Job tasks that require a combination

of risk factors (e.g., highly repetitious,

forceful hand/wrist exertions) and

hand/wrist tendinitis;

• High level exposure to hand-arm

vibration and vascular symptoms of

hand-arm vibration syndrome;

• Work-related lifting and forceful

movements;

• Exposure to whole-body vibration

and low-back disorder.

2. Evidence exists for the following

associations:

• Highly repetitive work and neck

and neck/shoulder MSDs, considering

both repetitive neck movements (using

frequency and duration of movements)

and repetitive work involving

continuous arm or hand movements;

• Forceful exertion and neck MSDs,

with ‘‘forceful work’’ involving forceful

arm or hand movements, which

generate loads to the neck/shoulder

area;

• Highly repetitive work and

shoulder MSDs;

• Repeated or sustained shoulder

postures with greater than 60 degree of

flexion or abduction and shoulder

MSDs;

• Highly repetitive work, both alone

and in combination with other factors

and carpal tunnel syndrome;

• Work involving hand/wrist

vibration and CTS;

• Any single factor (repetition, force

and posture) and hand/wrist tendinitis;

• Work-related awkward postures and

low-back disorders.

3. Insufficient evidence of workrelatedness exists for the following

associations:

• Vibration and neck disorders;

• Force and shoulder MSDs;

• Extreme posture and CTS.

The NIOSH review (Bernard, 1997;

Ex. 26–1) is an authoritative, systematic,

critical review of the epidemiologic

evidence regarding work-related risk

68440 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

factors and their relationship to MSDs of

the neck, shoulder, elbow, hand/wrist,

and low back. In considering its

purpose, the authors state:

This review of the epidemiologic literature

may assist national and international

authorities, academics, and policy makers in

assessing risk and formulating decisions

about future research or necessary preventive

measures.

In 1998, the National Institutes of

Health asked the National Academy of

Sciences/National Research Council

(NRC) to assemble a group of experts to

examine the scientific literature relevant

to the work-related musculoskeletal

disorders of the lower back, neck and

upper extremities. A steering committee

was convened to design a workshop, to

identify leading researchers on the topic

to participate, and to prepare a report

based on the workshop discussions and

their own expertise. Additionally, the

steering committee was asked to

address, to the extent possible, a set of

seven questions posed by Congress on

the topic of musculoskeletal disorders.

The steering committee includes experts

in orthopedic surgery, occupational

medicine, epidemiology, ergonomics,

human factors, statistics, and risk

analysis (NRC, 1999; Ex. 26–37). Note:

The steering committee’s report was

published in 1998, and was referred to

in OSHA’s proposal as Ex. 26–37. In the

final rule, Ex. 26–37 refers to the final

report, (Work-Related Musculoskeletal

Disorders: Report, Workshop Summary,

and Workshop Papers, National

Research Council, 1999; Ex. 26–37),

which includes the steering committee’s

report, a summary of the proceedings of

the 2-day workshop (Work-Related

Musculoskeletal Injuries: The Research

Base), and the workshop papers.

The charge to the steering committee,

reflected in the focus of the workshop,

was to examine the current state of the

scientific research base relevant to the

problem of work-related

musculoskeletal disorders, including

factors that can contribute to such

disorders, and strategies for intervention

to ameliorate or prevent them. The

NAS/NRC organized their examination

of the evidence of factors that

potentially contribute to

musculoskeletal disorders:

(1) Biological responses of tissues to

biomechanical stressors;

(2) Biomechanics of work stressors,

considering both work and individual

factors, as well as internal loads;

(3) Epidemiologic perspectives on the

contribution of physical

(biomechanical) factors;

(4) Non-biomechanical (e.g.,

psychological, organizational, social)

factors; and

(5) Interventions to prevent or

mitigate musculoskeletal disorders.

For four of these topics, discussions at

the workshop centered on a paper (or

papers) commissioned for the

workshop, followed by the comments of

invited discussants. For the

epidemiology of physical factors, the

steering committee used a panel format

to take advantage of a recent review of

this literature, the NIOSH review,

published in 1997, and previously

discussed here.

Use of this broad approach provided

for the examination of evidence from

both basic and applied science and a

wide variety of methodologies, and

considered sources of evidence that

extend well beyond the epidemiologic

literature alone. In determining whether

scientific evidence supports a causal

claim for risk factors and work-related

musculoskeletal disorders, the NAS/

NRC steering committee considered the

following five criteria:

• Temporal ordering requires that the

cause be present before the effect is

observed.

• Cause and effect covary. For

example, when no force is applied to a

tendon, it remains in a relaxed state; in

the presence of the cause (a force), the

tendon responds.

• Absence of other plausible

explanations for the observed effect.

Adequate controlling of confounding

factors by the design of the experiment

or observation makes other explanations

for the observed effect less likely.

• Temporal contiguity, amplifies the

first (temporal ordering). To the extent

that the effect follows the cause closely

in time, the plausibility that other

factors are operative is reduced.

• Congruity between the cause and

effect, that is the size of the cause is

related to the size or magnitude of the

effect.

In its report, the NRC noted that in

addressing complex research questions,

such as relationships between risk

factors and work-related

musculoskeletal disorders, single

studies rarely, if ever, provide

conclusiveness of a causal relationship.

Replication and synthesis of evidence

across studies, preferably with studies

that use a variety of methods (each with

different strengths and weaknesses)

strengthens causal associations. In

performing such synthesis, studies that

most completely satisfy the five criteria

specified above should be given greatest

weight. Inferential strength is gained by

examining the evidence from a variety

of theoretical perspectives, as well as a

variety of research methods. A major

strength of the NRC/NAS review is that

it takes this broad approach toward

evaluating the relevant scientific

evidence.

In evaluating the epidemiologic

literature and NIOSH’s review of that

literature, the NRC/NAS steering

committee identified the following

limitations in the epidemiologic

evidence:

• Temporal contiguity between the

stressors and onset of effects, as well as

amelioration after reduction of stressors,

could not always be established, nor could

the clinical course of the observed effects;

• Methods used for the assessment of

exposures and health outcomes vary,

rendering the task or merging and combining

evidence more challenging than in some

other areas of occupational risk assessment;

• Lack of baseline prevalence and

incidence data for the general population.

Despite these limitations, the steering

committee reached the following conclusions

regarding the epidemiologic evidence:

• Restricting our focus to those studies

involving the highest levels of exposure to

biomechanical stressor of the upper

extremity, neck, and back and those with the

sharpest contrast in exposure among the

study groups, the positive relationship

between the occurrence of musculoskeletal

disorders and the conduct of work is clear.

* * * (T)hose associations identified by the

NIOSH review (NIOSH, 1997; Ex 26–1) as

having strong evidence are well supported by

competent research on heavily exposed

populations.

• There is compelling evidence from

numerous studies that as the amount of

biomechanical stress is reduced, the

prevalence of musculoskeletal disorders at

the affected body region is likewise reduced.

This evidence provides further support for

the relationship between these work

activities and the occurrence of

musculoskeletal disorders.

• Evidence of a role for biomechanical

stress in the occurrence of musculoskeletal

disorders among populations exposed to low

levels of biomechanical stressors remains less

definitive, though there are some highquality 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68441

discussions with invited workshop

participants.

and, as a result concluded (in

summary):

• There is a higher incidence of reported

pain, injury, loss of work, and disability

among individuals who are employed in

occupations where there is a high level of

exposure to physical loading than for those

employed in occupations with lower levels of

exposure.

• There is a strong biological plausibility

on the relationship between the incidence of

musculoskeletal disorders and the causative

exposure factors in high-exposure

occupational settings.

• Research clearly demonstrates that

specific interventions can reduce the

reported rate of musculoskeletal disorders for

workers who perform high-risk tasks.

• Research can (1) provide a better

understanding of the mechanisms that

underlie the established relationships

between causal factors and outcomes; (2)

consider the influence of multiple factors

(mechanical, work, social, etc.) on symptoms,

injury, reporting, and disability; (3) provide

more information about the relationship

between incremental change in load and

incremental biological response as a basis for

defining the most efficient interventions; (4)

improve the caliber of measurements for risk

factors, outcome variables, and injury data

collection systems; and (5) provide better

understanding of the clinical course of these

disorders.

The relevant scientific literature has

been thoroughly and systematically

evaluated by two highly-reputable and

independent scientific bodies and their

experts, who used different approaches

to evaluate the literature from different

scientific disciplines (while allowing for

some overlap), using causality criteria

from two related but different

frameworks. The NIOSH and NRC/NAS

reviews offer two distinct but consistent

sets of conclusions that can be drawn

from the literature on work-related

musculoskeletal disorders. Generally,

both reviews agree that the scientific

evidence provides compelling support

for a higher risk of work-related

musculoskeletal disorders and the loss

of work, and disability among

individuals who are employed in

occupations where there is a high level

of exposure to physical loading

(biomechanical factors), and that

evidence clearly demonstrates that

specific interventions can reduce the

reported rate of musculoskeletal

disorders for workers who perform highrisk tasks.

In the face of overwhelming evidence

that biomechanical/physical risk factors

in the workplace cause MSDs, some

critics, such as UPS argue that there is

not even one study which demonstrates

that repetitive motion causes injury (Ex.

32–241–4). When asked at the hearing

whether he agreed with this UPS

position, Dr. Robert McCunney,

representing the American College of

Occupational and Environmental

Medicine replied ‘‘I find this statement

incredulous’’ (Tr. 7662). Dr. McCunney

then continued in his testimony to state

that there is sufficient scientific

literature showing that repetitive motion

activities can lead to MSDs. According

to Dr. Barbara Silverstein, of the

Washington State Department of Labor

and Industries, scientific researchers

who hold to the UPS view that there is

no evidence that repetitive movements

causes injury ‘‘are in a minority’’ (Tr.

17415). Likewise, in response to the

same question regarding the UPS

contention, Dr. Thomas Armstrong

(University of Michigan) defended the

scientific evidence that repetitive

movements can result in injury, by

replying:

There are physiological studies looking at

repetitive work as it contributes to muscle

fatigue and changes in histology of muscle

tissue. There are epidemiological studies that

have looked at the relationship between

various exposures to repetition and a variety

of musculoskeletal types of disorders. These

studies from different disciplines all come

together and support the same conclusion.

Professional and scientific

organizations supporting OSHA’s

determinations regarding the scientific

basis underlying the standard include:

• American Association of

Occupational Health Nurses (Ex. 30–

2387)

• American College of Occupational

and Environmental Medicine (Ex. 30–

4468, Tr. 7637–7690)

• American Conference of

Governmental Industrial Hygienists (Ex.

DC–386, Tr. 16291–335)

• American Industrial Hygiene

Association (Ex. 32–133–1, Tr. 16464–

72, Tr. 16518–27)

• American Nurses Association (Ex.

30–3686, Tr. 15875–95)

• American Occupational Therapy

Association (Ex. 30–4777, Tr. 18095–

18121)

• American Public Health

Association (Ex. 30–626, Tr. 17649–

17704)

• American Society of Safety

Engineers (Ex. 32–21–1–2; Tr. 11612)

• Human Factors and Ergonomics

Society (Ex. 502–472)

• National Association of Orthopedic

Nurses (Tr. 10578–10588)

• The American Society of Plastic

and Reconstructive Surgery (Ex. DC–46,

Tr. 1534)

OSHA finds no merit to assertions

that there is insufficient science on

which to base its proposal and

subsequent final rule. Rather, the

Agency finds that the body of scientific

evidence on which OSHA based this

rule is vast and conclusive. This

position was supported by many

witnesses and multiple pages of hearing

testimony, and added to the substantial

base of scientific literature that OSHA

relied on for the publication of it’s

proposal. And, although there have been

critics to OSHA’s actions, they are in

fact, in the vast minority. The science

overwhelmingly supports reducing

biomechanical risk factors in the

workplace as an effective approach to

reducing work-related musculoskeletal

disorders.

When asked ‘‘whether ACOEM

believes that detection and elimination

of these ergonomic risk factors at work

can result in a reduction in the number

of these disorders’’ during the hearing,

Dr. McCunney replied ‘‘Very much so’’

(Tr. 7663).

The following parts of this section

discuss the evidence for the workrelatedness 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

68442 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 welldefined 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 workrelated 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

(Aara ̊s 1994a, Ex. 26–892; Aara ̊s 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 selfreported 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 Zline 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 lumbarsacral 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 selfVerDate 11<MAY>2000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00183 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2
68444 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 ........

body posture ......

physical exam .... OR=9.9 *

(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 ........

cycle time ...........

physical exam .... OR=3.6 *

(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 ........

EMG ...................

physical exam .... OR=3.8 *

(2.1–6.6)

Norander (1999) Ex. 38–408 ...................................... fish processing ... R/P observation ........

cycle time ...........

physical exam .... OR=3.0 *

(1.5–5.9)

Kukkonen (1983) Ex. 26–1138 ................................... data entry ........... R?/P posture ...............

observation ........

physical exam .... OR=2.3 *

(1.1–4.6)

Bjelle (1981) Ex. 26–1519 .......................................... industrial plant .... F/R/P flexion .................

EMG ...................

physical exam .... NR *

Jonsson (1988) Ex. 26–969; Kilbom (1986) Ex. 500–

41–75.

electronics manufacture.F/R/P flexor MVC .........

flexion .................

physical exam .... NR *

Dimberg (1989) Ex. 26–1211 ..................................... automotive ......... F/R/P observation ........ physical exam .... NR*

(p<0.1)

Sakakibara (1995) Ex. 26–800 ................................... fruit bagging ....... F?/R?/P observation ........

arm elevation .....

physical exam .... OR=1.5

(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)

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68445

TABLE V–1.—SUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING NECK AND UPPER BACK MUSCULOSKELETAL

DISORDERS—Continued

Study Job type studies Physical

factors Exposure basis Diagnosis Risk Measure(95% CI) 1

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 ...................

muscle load ........

symptoms only ... NR *

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 processing.F?/R/P questionnaire ..... symptoms only ... OR=7.5

(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 ........

cycle time ...........

symptoms only ... PRR=1.6 *

(1.1–2.3)

Viikari-Juntura (2000) Ex. 500–41–50 ........................ forest industry .... P/R? questionnaire ..... symptoms only ... OR=1.4

Botha (1998) Ex. 500–212–10 .................................... nurses ................ P/F observation ........ symptoms only ... NR *

Bjo ̈rk Cste ́n (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;

*=p<0.05

1 95% confidence interval expressed for the upper end of the risk measure range

68446 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 crosssectional 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 doseresponse 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 crosssectional 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

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

Ta ̈tigkeitsanalyse) along with the

NIOSH lifting equation. Each work task

classified according to three factors:

weight of the materials handled (<1,

1<5, 5<10, 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

68448 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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.

Aaraa ̊s (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 vibrationspecific 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 vibrationinduced 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 endproduct 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

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

68450 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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.

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68451

TABLE V–2.—SUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING MUSCULOSKELETAL DISORDERS OF THE SHOULDER

Study Job type studied Physical

factors Exposure basis Physicalexam

Risk measure

(95% CI) 1

Hughes (1997) Ex. 26–907 .......................................... Aluminum smelter .... F/R?/P Checklist .................. Yes ......... OR=46 *

(3–550)

Herberts (1981) Ex. 26–51; (1984) Ex. 26–960 .......... Shipyard welding ..... F/R?/P Observation EMG .... Yes ......... PRR=15–18 *

(14–22)

Bjelle (1979) Ex. 26–1112 ........................................... Industry case control F?/R/P Observation ............. Yes ......... OR=10.6 *

(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 cycle

time.

Yes ......... OR=1.1–6.0 *

(3.0–12.2)

Ohlsson (1995) Ex. 26–868 ......................................... Assembly line .......... F?/R/P Flexion cycle time .... Yes ......... OR=4.2 *

(1.4–13.2)

Baron (1991) Ex. 26–967 ............................................ Grocery checking ..... F/R/P Job titles .................. Yes ......... OR=3.9 *

(1.4–11.0)

Ohlsson (1994) Ex. 26–1189 ....................................... Fish processing ....... F/R/P Observation freq./angles.Yes ........ OR=3.5 *

(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 case/

control.

F/R/P Cycle/flexionlift load Yes ........ OR=1.1–4.0 *

(1.7–9.4)

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; Jonsson (1988) Ex. 26–

833.

Electronics manufacture.F/R/P MVC, flexion cycle

time.

Yes ......... NR *

Bjelle (1981) Ex. 26–1519 ........................................... Industrial plant ......... F/R/P Flexion EMG ............ Yes ......... NR *

Sakakibara (1995) Ex. 26–800 .................................... Fruit bagging ............ F?/R?/P Observation arm elevation.Yes ......... NR *

Zetterberg (1997) Ex. 26–899 ..................................... Auto assembly ......... F/P Cycle time tool

weight.

Yes ........ NR

English (1995) Ex. 26–848 .......................................... Patients case/ control.F/R/P Question- naire ........ Yes ........ OR=2.3 *

(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; (1993) Ex. 26–1459 ...... Rockblasting bricklaying.V/F/R? Questionaire ............ Yes ......... OR=0.4–4.0 *

(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 aceleration ....... No .......... OR=1.5 *

(NR)

Bergenudd (1988) Ex. 26–1342 .................................. Multiple industries .... F/R?/P? Questionnaire .......... No .......... NR

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 production F?/R?/P? Job title .................... No .......... OR=2.2 *

(1.4–4.4)

Hales (1989) Ex. DC–139–D ....................................... Poultry processing ... F/R Job title .................... Yes ......... OR=0.9–3.8 *

(0.6–22.8)

Hales (1994) Ex. 26–131 ............................................. Telecommunication .. R/P Questionnaire .......... Yes ........ NR

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 processing ... F/R/P? Job title .................... Yes ......... OR=1.6–4.0

(0.6–29)

Kvarnstrom (1983) Ex. 26–1201 .................................. Factory/office ........... F/R/P? Questionnaire .......... Yes ........ RR=2.2–5.4

(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 operation R/P Questionnaire .......... No .......... OR=2.5–4.8 *

(1.6–17.2)

Sweeney (1994) Cited Ex. 26–1 .................................. Sign language interpreter.R/P? Questionnaire .......... Yes ......... OR=2.5

(0.8–8.2)

De Zwart (1997) Ex. 26–617 ....................................... Various occupations F/R?/P? Questionnaire .......... No .......... OR=1.25–2.5 *

(p<0.001)

68452 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE V–2.—SUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING MUSCULOSKELETAL DISORDERS OF THE SHOULDER—

Continued

Study Job type studied Physical

factors Exposure basis Physicalexam

Risk measure

(95% CI) 1

LeMasters (1998) Ex. 500–121–44; Bhattacharya

(1997) Ex. 500–121–7; Booth-Jones (1998) Ex.

500–121–9.

Carpenters ............... F/R/P Observation, measurement.Only

small

subset.

OR=2.3–3.2 *

(1.1–8.9)

Pope (1997) Ex. 32–137–1–4 ...................................... Various occupations F/R?/P Questionnaire .......... No .......... OR=2.1–5.5 *

(1.8–17.4)

Botha (1998) Ex. 500–121–10 ..................................... Nurses ..................... F/R?/P Questionnaire, observation.No .......... NR

De Joode (1997) Ex. 500–121–72 .............................. Ship maintenance .... F/R?/P Strain gauge ............ No .......... RI=1.7–3.9

(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.

* p<0.05.

1 95% confidence interval expressed for the upper end of the risk measure range.

The NIOSH noted several wellconducted 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

(p<0.05) 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

(p<0.05) 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 (p<0.05)

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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 shoulderneck region in a laboratory study of 20

subjects (10 male, 10 female). Surface

electrodes measured EMG activity in the

right trapezius muscle while subjects

abducted the arm to a 90 degree angle.

Subjects reported fatigue using the Borg

10-point scale. Each subject was tested

under two conditions: a 5-minute test

with no load in the hand and a 2.5

minute test with a 2-kg load in the hand.

At the no-load level, there was no

change in EMG MPF over the course of

the trial; however, subjective fatigue

increased. With the 2-kg. load, there was

a small linear decrease in MPF over the

trial and there was a negative

correlation between MPF and the Borg

rating  = 0.46). The authors concluded

that MPF was not a good proxy for

perceived fatigue during low-intensity

static exertions of the shoulder.

Using EMG, several investigators have

demonstrated that the supraspinatus

muscle is activated throughout most of

the range of motion of the shoulder.

Herberts and Kadefors (1976, Ex. 26–

470) and Herberts et al.(1984), Ex. 26–

960 postulated that the level of tension

in the supraspinatus muscle during arm

elevation (with or without holding an

object in the hands) was sufficiently

high to increase intramuscular pressure

to a point sufficient to compromise

intramuscular circulation. As reported

by Edwards, Hill, and McDonell (1999;

Ex. 26–1232), intramuscular pressures

of 20 mm Hg may be sufficient to

prevent muscular perfusion. Since many

of the blood vessels within the tendon

are longitudinal extensions of the blood

vessels in the muscle belly, reduced

perfusion of the intramuscular blood

vessels implies reduced perfusion of the

intratendinous blood vessels. If this

reduced perfusion is sustained for

sufficient durations of time, the

tenocytes or other tendon components

are susceptible to ischemic injury. In

terms of biomechanical task variables,

experimental data suggest that overhead

work may cause intramuscular

pressures capable of reducing

intramuscular perfusion. Lifting

combined with arm elevation (shoulder

load) also contributes to the magnitude

of supraspinatus muscle activation.

From a temporal perspective, this

proposed model is more related to the

duration of the intramuscular pressure

than to its frequency.

After reviewing the scientific

literature, Winkel and Westgaard

(1992a, Ex. 26–1163) recommended less

than 4 hours of work requiring overhead

or extended reach postures. For

continuous work, they recommended

exposure times of one hour or less,

particularly if the work involved highly

repetitive tasks, low worker control, or

a lack of alternating tasks. When large

forces are also exerted, they

recommended that the exposure time

should be even less.

Wiker, Chaffin and Langolf (1999; Ex.

26–1028) used psychophysical methods

to investigate the relationship between

strength capacity of the shoulder

complex and fatigue/discomfort

induced by sustained awkward arm

postures in simulated light assembly

work. Awkward shoulder postures

(arms above shoulder level) produced

severe discomfort at less than 10% MVC

within one hour and were unrelated to

subject strength. These authors

recommended elimination of overhead

work even in light-weight manual

assembly environments, irrespective of

individual worker strength or

anthropometry.

Conclusion

The 1997 NIOSH report made the

following statement with regard to the

epidemiological evidence that links

physical work factors and shoulder

tendinitis:

The evidence for specific shoulder

postures is strongest where there is combined

exposure to several physical factors like

holding a tool while overhead. The strength

of the association was positive and consistent

in six studies that used diagnosed cases of

shoulder tendinitis or a combination of

symptoms and physical findings consistent

with tendinitis as the health outcome (Ex.

26–1).

68454 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 reinjury:

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, handarm 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 muscletendon 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 bonetendon 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

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

Study Job type studied Physical

factors Exposure basis Physicalexam

Risk Measure

(95% CI) 1

Hughes (1997) Ex. 26–907 ................................................ Aluminum smelter F/R?/P Checklist ............... Yes ......... OR=37*

(3–470)

Roquelaure (1996) Ex. 500–41–111 .................................. Manufacturing ....... F/R/P Checklist ............... Yes ......... OR=7.7–18.0*

(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 processing F/R/P? Measurement ........ Yes ......... NR*

(p<0.002)

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 checking F/R/P Measurement ........ Yes ........ OR=2.3

(0.5–11)

Viikari-Juntura (1991) Ex. 26–1197 .................................... Meat processing ... F/R/P? Observation .......... Yes ......... OR=0.88

(0.3–2.8)

68456 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE V–3.—SUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING EPICONDYLITIS—Continued

Study Job type studied Physical

factors Exposure basis Physicalexam

Risk Measure

(95% CI) 1

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.

*=p<0.05.

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 workrelated 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 nonstrenuous 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

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

68458 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 workrelated 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 muscletendon 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]

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 selfreports or general knowledge of job

tasks.

TABLE V–4.—SUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING HAND/WRIST TENDINITIS

Study Job type studied Physical

factors Exposure basis Physicalexam

Risk measure

(95% 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.

F/R?P Observation .......... Yes ......... PRR=7.0*

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,

cycle time.

Yes ......... OR=3.2*

(1.3–8.3)

Bystrom (1995) Ex. 26–897 ............................................... Auto assembly ...... F/R/P Forearm load, wrist

flex.

Yes ......... PRR=2.5*

(1.0–6.2)

Kuorinka (1979) Ex. 26–639 .............................................. Scissor production F?/R/P Cycle time, wrist

flex.

Yes ........ PRR=1.4

(0.8–2.5)

Amano (1988) Cited in Ex. 26–1 ........................................ Shoe assembly ..... F?/R/P Job title ................. Yes ......... PRR=3.7–6.2*

(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;

*=p<0.05.

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/lowrepetition group and low-force/highrepetition 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 highforce/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

68460 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 nonstrenuous 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 (p<0.01) 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 crosssectional 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 exposureresponse 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 (p<0.05) in

a multiple logistic model that included

age, gender, plant site and years on the

job. The corresponding OR for highforce jobs, irrespective of repetitiveness,

was 2.9 (p>0.05) but the OR for

combined exposures to high repetition

and force was 15.5 (p<0.05).

TABLE V–5.—SUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING CARPAL TUNNEL SYNDROME

Study Job type studied Physical factors Exposure basis Diagnosis Risk measure

(95% 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)

68462 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE V–5.—SUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING CARPAL TUNNEL SYNDROME—Continued

Study Job type studied Physical factors Exposure basis Diagnosis Risk measure

(95% CI)1

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.

*=p<0.05.

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

(p<0.05) 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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; p<0.002) 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 preexisting 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–

68464 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

66–5; Homan et al.1999, Ex. 38–172;

Olafsdotti et al. 2000, Ex 38–288.

One of the above studies is among

several papers published by Dr. Peter

Nathan and colleagues, which were

based on two group of workers whom

they have followed prospectively (Ex.

26–990; Ex. 26–988; Ex. 26–989; Ex. 26–

1294; Ex. 26–517; Ex. 38–437; Ex. 38–

13; Ex. 351–14). Because of the

importance of these studies to the

ergonomics rulemaking, they are

addressed in detail here. In one of the

earlier studies (Nathan et al.1988, Ex.

26–990), nerve conduction was assessed

on 471 randomly chosen individuals

from four industries (steel mill, meat/

food packaging, electronics, and plastics

manufacturing). The group was divided

into the following exposure categories:

• Group 1, very low force, low

repetition;

• Group 2, low force, very high

repetition;

• Group 3, moderate force, moderate

repetition;

• Group 4, high force, moderate

repetition; and

• Group 5, high force, high repetition.

No significant difference in median

nerve sensory latency values was found

between Group 1 and Group 2, which

differed primarily by the amount of

repetition exposure. There was a

statistically significantly higher number

of subjects with median nerve slowing

in Group 5 compared to Group 1, but

not when compared to Groups 2, 3, or

4. When individual hands were used to

base calculations rather than number of

individuals, only Group 3 showed a

significantly higher prevalence of

median nerve conduction slowing.

When prevalence ratios were calculated,

Groups 3, 4, and 5 had significantly

higher PRs compared to Group 1.

This same group of workers was

followed up for five years in a 1992

study (Ex. 26–988) and eleven years in

a 1998 study (Ex. 38–13). The study

used hands, rather than individuals, as

the basis for analysis. The authors stated

that they found no significant difference

in the prevalence of median nerve

slowing among any of the exposure

groups. The authors claimed to have

confirmed this finding in a second

combined cohort of Japanese and

American industrial workers (Ex. 38–

437) as well as validated their exposure

categories (Ex. 26–1294). They went on

to show that slowing of nerve

conduction was significantly associated

with obesity (Ex. 26–989), body mass

index (Ex. 26–517), wrist depth/width

and a number of other non-occupational

risk factors (Ex. 351–14).

However, their research has a number

of flaws in the study design, analysis

and interpretation of the results, which

call their conclusions into doubt. Chief

among these is the failure to adequately

justify and validate their grouping and

rank order of occupational hand use.

This provides multiple opportunities for

exposure misclassification and will tend

to underestimate the association of

exposure with health outcome. This

aspect of the study has been criticized

by several experts (Ex. 26–1010; Ex. 26–

952; Tr. 1000). Despite this potential for

misclassification, there was a significant

increase in prevalence between the

lowest (Group I) and higher exposure

groups combined (Groups III, IV, and V)

in the cross-sectional study (Ex. 26–

990). Others have also concluded that,

methodological shortcomings aside, the

articles by Nathan et al.demonstrate a

positive exposure-response relationship

between ‘‘occupational hand activity’’

and slowed conduction of the median

nerve (Tr. 1519–1522; Tr. 9862). Others

have testified that alternative exposure

grouping of the data resulting in less

exposure misclassification would result

in a clear exposure-response

relationship between job group and

median nerve latency (Punnett

testimony, Ex. 37–2; Gerr testimony, 27–

2). Some who testified at OSHA’s

informal hearing have also stated that

Dr. Nathan’s articles use statistical

presentation and analysis methods that

obscure the evidence, and that not

enough data are presented for the reader

to independently evaluate whether the

authors’ conclusions are justified (Tr.

1521; Tr. 7850.). Low participation

rates, unusual and inconsistent case

definition, and inappropriate statistical

analysis may also have limited the

ability to detect increases in CTS

prevalence over time in these studies

with respect to work-related

biomechanical factors. For example, the

authors reported in the baseline study

that they randomly selected the study

participants (Ex. 26–990). However,

they did not report the proportion of

those who were selected and invited

that actually participated. Since the 471

subjects represented only 26 percent of

the total workforce of the participating

companies, the representativeness of the

sample is unknown, the ability to

generalize from the data is highly

limited, and the potential for selection

bias is substantial. There is no

comparative information on participants

and non-participants with respect to

demographics, occupational history or

exposure, or medical history. The lack

of clarifying information is particularly

problematic because the direction of the

selection bias could be either toward or

away from the null value. This problem

affects not only the 1988 baseline study

but all future follow-up studies of the

same cohort. Because of these

criticisms, OSHA finds that the Nathan

studies do not convincingly

demonstrate a lack of association

between workplace exposure to

biomechanical risk factors and CTS.

In his written testimony, Dr. Peter

Nathan calls into question the case

definition for CTS relied upon by OSHA

in their evaluation of the

epidemiological studies (Ex. 32–241–3–

13). He testifies that ‘‘there is general

agreement among experts that classic

symptoms associated with positive

electrodiagnostic findings for the

median nerve are necessary for a

diagnosis of CTS’’ but that ‘‘there is no

general agreement that symptoms, in the

presence of negative electrodiagnostic

findings is equivalent to CTS.’’ (Id., pg

4). Dr. Nathan then goes on to criticize

OSHA and NIOSH, in their 1997 review,

for accepting studies that use CTS case

definitions without electrodiagnostic

confirmation. He argues that

longitudinal studies are the only study

design of value for determining

causation and concludes ‘‘if one

required electrodiagnostic studies for a

valid case definition of CTS, and a

longitudinal design for establishing

temporal relationships, then only one

[his own] of the 31 studies analyzed by

NIOSH would have met standard

criteria for establishing causation.’’ (Id.,

pg 11).

OSHA accepts that specific symptoms

determined during clinical exam in

combination with objective evidence of

median nerve dysfunction through

electrodiagnostic tests is the most

definitive case definition for CTS at the

present time. This has been supported

by expert testimony not only from Dr.

Nathan but Dr. Frederick Gerr (Ex. 37–

2) and Dr. Gary Franklin (Tr. 13363).

OSHA also does not dispute lack of

agreement among experts on CTS

diagnosis when symptoms exist in the

presence of normal median nerve

conduction. However, the relevant issue

is whether clinical symptoms and signs

in the absence of electrodiagnostic

testing are an invalid CTS case

ascertainment for the purposes of

evaluating epidemiological evidence to

determine if work-related physical

factors are associated with the disorder.

NIOSH addressed the issue in its 1997

review and cited studies that found

satisfactory correlations between CTS

diagnosed by nerve conduction and the

disorder diagnosed by symptom

questionnaire and physical examination

(Ex. 26–1501; Ex. 26–439). It was also

reported that clinical examination for

CTS diagnosis without the benefit of

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

68466 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 crosssectional 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 selfreported questionnaires. Standard and

relatively uniform diagnostic criteria

were used in defining HAVS cases. This

generally included episodes of coldprovoked, well-demarcated blanching of

the fingers, occurrence of vibration

white finger attacks after employment

and following use of power tools, and

abnormal digital artery response to cold

provocation. All studies used the

Stockholm Taylor-Palmear scale to

grade and stage symptoms. The five

investigations included vibration

measurements of exposure on tools used

by the study subjects combined with

information on exposure time obtained

by direct interview.

The four cross-sectional studies found

statistically significant positive

relationship between exposure to

vibration and prevalence of HAVS. The

strength of this association was high

with reported ORs ranging from 6 to 85.

The one prospective study showed

significant decreases in HAVS

prevalence with decreasing exposure to

vibration over time. All five

investigations contributed evidence of

exposure-response relationships

between HAVS and vibration

acceleration or duration of exposure.

One study also documented a

relationship between exposure and

symptom severity.

TABLE V–6.—SUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING HAND-ARM VIBRATION

Study Job type studied Physical

Factors Exposure basis Diagnosis Risk measure(95% CI)1

Nilsson (1989) Ex. 26–1148 ....................................... Pulp mill machining.V Tool acceleration Physical exam .... OR=14–85 *

(15–486)

Bovenzi (1995) Ex. 26–354 ........................................ Forestry .............. V Chain saw acceleration.Cold provocation OR=6.2–32 *

(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 acceleration.Symptoms ischemia.NR

Koskimies (1992) Ex. 26–1490 ................................... Forestry .............. V Chain saw acceleration.Physical exam .... NR

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 acceleration.Physical exam .... NR

Mirbod (1997) Ex. 500–121–49 .................................. Motorcyclists ...... V Handlebar acceleration.Questionnarie ..... NR *

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 acceleration.Physical exam

cold test.

OR=2.2–2.6*

(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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68467

TABLE V–6.—SUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING HAND-ARM VIBRATION—Continued

Study Job type studied Physical

Factors Exposure basis Diagnosis Risk measure(95% CI)1

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.

* =p<0.05.

1 95% confidence interval expressed for the upper end of the risk measure range.

Bovenzi et al.found a significantly

greater prevalence of HAVS in a group

of 222 active forestry workers engaged

in chain saw work as compared to

randomly chosen shipyard workers

unexposed to hand vibration (Bovenzi et

al.1995, Ex. 26–354). The reported OR

was 11.8 (95% CI 4.5–31.1) for all

forestry workers and 6.3 (95% CI 2.3–

17.1) for workers only using ‘‘antivibration’’ 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 doseresponse 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 crosssectional studies over time (Koskimies

et al.1992, Ex. 26–1490). Their analysis

showed a monotonic decrease in

prevalence from 40 percent in 1972 to

6 percent in 1990. In a subcohort of 57

workers followed prospectively, HAVS

cases decreased from 35 percent in 1975

to 6 percent in 1986. Over the same time

period, modifications in chain saws

used by the workers resulted in a

reduction vibration acceleration from 14

m/s2 to 2 m/s2. While it is likely that the

decline in HAVS is due to changes in

the vibration acceleration, exposures

and outcomes were never linked for

individual workers.

The 1989 NIOSH criteria document

(Ex. 26–392) provides some

epidemiological evidence for an

exposure-response relationship and

temporal association between HAVS

and vibration exposure. NIOSH

analyzed HAV acceleration levels and

prevalence of HAV-related vascular

symptoms from 23 cross-sectional

studies and found the two variables

linearly correlated (R=0.67; p<0.01).

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 selfreported.

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 handarm vibration syndrome (HAVS). These

studies are of workers with high levels of

exposures such as forestry workers, stone

cutters or carvers, shipyard workers, or

platers. These workers were typically

exposed to HAV acceleration levels of 5 to 36

m/s2 * * * There is substantial evidence that

as intensity and duration of exposure to

vibrating tools increase, the risk of

developing HAVS increases. [Ex. 27–1,

Emphasis in original]

OSHA agrees with the NIOSH

statements that intensity and duration of

exposure to vibrating tools is linked to

the risk of developing HAVS. Most of

the epidemiological studies show a

strong and consistent association

between high-level exposure to HAV

and HAVS symptomatology. The data

indicate there are strong exposureresponse 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 longterm use of hand held power tools, are

68468 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

at increased risk of developing handarm 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 highfrequency 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 (p<0.02) 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 handheld 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 lowback 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

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

68470 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 noninnervated, 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 workrelatedness 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.

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

measurement.

Yes ........ OR=2.2–8.1*

(1.4–4.4)

Astrand, 1987 Ex. 26–527 .............................................. Pulp mill ............... HPW Questionnaire job

title.

Yes ........ OR=2.3*

Bigos, 1991 Ex. 26–1242 ................................................ Aircraft assembly HPW Observation questionnaire.No .......... NR*

Burdorf, 1991 Ex. 26–454 ............................................... Concrete fabrication.HPW/BT

LFM

Observation

measurement.

No .......... OR=2.8*

(1.3–6.0)

Clemmer, 1991 Ex. 26–1345 .......................................... Offshore drilling ... HPW Questionnaire job

title.

No .......... OR=2.2–4.3*

Hildebrandt, 1995 Ex. 26–1516 ...................................... Population based HPW Questionnaire job

title.

No .......... OR=1.2*

(1.33–1.55)

Heliovaara, 1991 Ex. 26–959 .......................................... Population based HPW/LFM Questionnaire job

title.

Yes ........ OR=1.9–2.5*

(1.4–4.7)

Hildebrandt, 1996 Ex. 26–770 ........................................ Steel maintenance HPW Questionnaire job

title.

No .......... NR

Johansson, 1994 Ex. 26–1132 ....................................... Metal workers ...... HPW/BT

LFM

Questionnaire job

title.

No .......... PRR=1.76

(1.25–2.47)

Leigh, 1989 Ex. 26–750 .................................................. Population based HPW Questionnaire job

title.

No .......... OR=1.5*

(1.1–2.2)

Masset, 1994 Ex. 26–1470 ............................................. Steel workers ...... HPW/BT Questionnaire job

title.

No .......... NR

Partridge, 1968 Ex. 26–1, pg. 6–81 ................................ Dock workers ...... HPW Questionnaire job

title.

Yes ........ OR=1.2

Riihimaki, 1989 Ex. 26–998 ............................................ Concrete workers HPW/BT Questionnaire job

title.

No .......... OR/1.0–1.5*

Riihimaki, 1994 Ex. 26–1188 .......................................... Heavy equipment

operators.

BT Questionnaire job

title.

No .......... NR

Ryden, 1989 Ex. 26–809 ................................................ Hospital employees.HPW/BT Questionnaire job

title.

No .......... OR=2.2*

(1.25–4.15)

Svensson, 1989 Ex. 26–732 ........................................... Population based HPW/BT

LFM

Questionnaire job

title.

No .......... OR=1.2*

Videman, 1990 Ex. 26–1023 ........................................... Hospital patients .. HPW/SWP

LFM

Questionnaire job

title.

autopsy .. OR=2.8–24.6*

(1.5–409)

Bergenudd, 1988 Ex. 26–1342 ....................................... Population based HPW Questionnaire job

title.

No. ......... OR=1.8*

(1.2–2.7)

Burdorf, 1990 Ex. 26–1518 ............................................. Crane operators .. HPW/SWP

LFM

Questionnaire job

title.

No .......... OR=0.5–4.0

(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

title.

Yes ......... OR=1.3* for BT

(1.1–1.5)

Huang, 1988 Ex. 26–1204 .............................................. School lunch

workers.

LFM Observation

measurement.

No .......... NR

Kelsey, 1975 Ex. 26–1134 .............................................. Case/control herniated lumbar

disc.

LFM/SWP Questionnaire job

title.

No .......... NR

Kelsey, 1984 Ex. 26–752 ................................................ Case/control

prolapsed lumbar disc.

LFM/BT Questionnaire job

title.

Yes ........ OR=3.1*

(1.3–7.5)

Knibbe, 1996 Ex. 26–766 ................................................ Nurses ................. LFM Questionnaire job

title.

No .......... OR=1.3

Magora, 1972, 1973 Ex. 26–1513 .................................. 8 occupations ...... LFM/BT Observation

measurement.

No .......... OR=1.0–1.7*

(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

measurement.

No .......... OR=10.7*

(4.9–23.6)

Toroptsova, 1995 Ex. 26–1, pg. 6–92 ............................ Machine builders LFM/BT/

SWP

Questionnaire job

title.

Yes ......... OR=1.4*–1.7*

Undeutsch, 1982 Ex. 26–731 .......................................... Airport baggage

handlers.

LFM Questionnaire job

title.

Yes ......... NR

Walsh, 1989 Ex. 26–1437 ............................................... Population based LFM/SWP Questionnaire job

title.

No .......... OR=1.5–2.0*

(1.1–3.7)

Skov, 1996 Ex. 26–674 ................................................... Saleworkers ......... SWP Questionnaire job

title.

No .......... OR=2.5*

(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 2500 medical exams.

HPW Questionnaire ...... Yes ......... OR=1.4*

(1.0–2.0)

68472 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE V–7.—SUMMARY OF EPIDEMIOLOGY STUDIES EXAMINING MUSCULOSKELETAL DISORDERS OF THE BACK—

Continued

Study/exhibit number Job type studied Physical factors Exposure basis Physical

exam.

Risk measure

(95% CI)1

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

title.

No .......... OR=1.7–4.3*

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,

LPNs, attendants.

LFM Questionnaire ...... No .......... OR=1.0–2.7*

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

workers.

HPW Questionnaire

records.

Yes ......... OR=3.04*

(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

measurement.

No .......... OR=2.45*

(1.29–4.85)

Wang, 1998 Ex. 500–41–52 ........................................... Manual handling .. LFM Measurement ...... No .......... Significant correlation

p<0.01

Van Poppel, 1998 Ex. 500–121–71 ................................ Airline baggage

handlers.

HPW Questionnaire ...... No .......... NR

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. 500–71–39, (38) ................... Not by identifiable risk factor but

by title—office carpenter machine driver

Job title ................ Yes ......... OR=2.0–8.1*

(2.4–21.1)

SHARP, 1993 Ex. 30–7 .................................................. Data entry ............ SWP Questionnaire ...... No .......... NR*

(p<0.05)

Larese, 1994 Ex. 38–130 ................................................ Hospital nurses ... LFM Measurement ...... Yes ......... OR=1.9–2.4*

Myers, 1999 Ex. 500–119–10 ......................................... Case/control municipal workers.HPW/BT/

LFM

Questionnaire

measurement

job title.

No .......... OR=1.6–2.0*

(1.13–3.67) for

BT

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; *=p<0.05

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 casecontrol (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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68473

Injuries and Illnesses as well as other

health interview surveys have found

elevated LBP rates and MSDs in typical

HPW associated occupations, (female)

nursing aides, orderlies and attendants;

personal care; and air transportation

workers (see the risk assessment in

section VI of this preamble). While

survey statistics may not be definitive in

themselves, they show a pattern of

consistency with the results from the

epidemiology studies discussed above.

OSHA notes that these types of

population-based studies can be less

reliable than other epidemiology

designs due to generally less knowledge

about individual exposures.

Since OSHA’s Ergonomics proposal

was published, several other studies on

HPW and LBP have been put into the

record. Several are discussed below:

The Vingard et al., 2000 (Ex. 500–41–

114) population-based case-referent

study suggests that prolonged exposure

to many years of heavy work and

forward bending (cumulative exposure)

increases the risk of LBP. The Latza et

al., 2000 (Ex. 38–424) prospective study,

after adjusting for trade, found

exposure-response relationships for

hours per shift laying sandstone

(PR=1.8, 95% C.I. 0.7—4.7, for 0 to <2

hours; PR=2.6, 95% C.I. 1.1—6.5, for ≥

2 hours; trend test p=0.03), and stone

load (PR=1.8, 95% C.I. 0.4—9.5, for

intermediate level; PR=4.0, 95% C.I.

0.8—19.8 for high level; trend test

p=0.03). The Krause et al. 1998 study

(Ex. 38–272) found that cable car crews

performing the heaviest physical labor

had a three-fold increased risk of spinal

injury compared with bus driver

(OR=3.04, 95% C.I. 1.85—5.00). This

five year prospective study of 1,871

transit vehicle operation also found both

physical workload and psychosocial job

factors independently predict spinal

injury in transit vehicle operators.

OSHA has also considered three other

studies available since the proposal on

HPW. Two of these three studies found

at least one statistically significant

association between LBP and HPW

while the third suffered from

methodological problems. Myers et al.

(1999, Ex. 500–119–10) carried out a

case-control study of 274 workers with

symptoms and signs of low back pain

from four municipal departments (a

73% participation rate). The stated

purpose was to identify factors, both

physical work characteristics and

psychosocial factors, associated with

acute low back injury. Two randomly

selected controls were chosen, one

matched according to work tasks, which

the authors stated ‘‘could be used to

examine importance of non-ergonomic

factors’’ and one matched by

department. Cases were defined from

reports from the city Occupational

Medicine Clinic, and were those who

had been assigned restricted work or

had lost work time due to back injury.

Further information was gathered from

questionnaire about work history, work

characteristics, work injuries, back pain,

psychosocial behaviors, and

demographics. Exposure was assessed

by questionnaire and measurement; the

strenuousness of each worker’s job

classified as light, medium, or heavy

according to weight capacity, frequency

and duration of sitting-standingwalking. 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 whitecollar 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/m2 (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

68474 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 casecontrol designs. Only the one casecontrol 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 crosssectional 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 exposureresponse 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 (p<0.01)

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

68476 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 WorkRelated 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 crosssectional 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 workrelated risk factors to the incidence of

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

68478 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 cotwin 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 matchedcontrol 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 agespecific 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 workrelated 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 workVerDate 11<MAY>2000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00219 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2
68480 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 lowback 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 lowback 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 workrelated low-back disorders.

Static Loading

In evaluating the pathogenesis of softtissue 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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-ofmotion parameters commonly used to

quantify impairment had poor ability to

discriminate normal vs. chronic lowback 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 ThreeJoint 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

68482 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 loadbearing 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 lowback 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.

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

68484 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

Other MSDs of the lower extremity

that may be caused by physical workrelated 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≥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≥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 exposureresponse 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

Study Job type studied Physical

factors Exposure basis Diagnosis/bodypart Other attributes

Risk measure (95%

CI)1

Kivimaki (1992) Ex. 500–41–

78.

carpet laying; floor

laying.

F/R/P observation questionnaire.questionnaire

ultrasound/knee.

NR*

Jensen (1997) Ex. 500–41–69 carpet laying; carpentry.F/R/P questionnaire observation.questionnaire radiology/knee.exposure response OR=1.5–6.4*

(3.2–8.9)

Tanaka (1986) Ex. 502–317 .. floor laying; tile

setting.

F/R/P questionnaire ........ questionnaire knee exposure response PRR=1.1–

5.0*

(3.2–7.8)

Sandmark (2000) Ex. 500–

41–114.

prosthetic knee patients.F/R/P questionnaire ........ surgery/knee ......... exposure response OR=0.7–3.2*

(2.0–5.2)

Cooper (1994) Ex. 26–460 .... general population F/R/P questionnaire ........ questionnaire Xray/knee.OR=0.8–6.9*

(1.8–26.4)

Anderson (1988) Ex. 26–926 general population F?/R/P job title questionnaire.questionnaire Xray/knee.OR=0.8–3.5*

(1.2–10.5)

Vingard (1991) Ex. 26–1400 .. various occupations.F/R?/P? job title .................. hospitalization

knee or hip.

RR=0.6–3.8*

(1,2–12.1)

Coggon (1998) Ex. 26–1285 patients case/control.F/R/P? questionnaire ........ hip replacement .... OR=1.0–2.1*

(1.1–3.9)

Croft (1992) Ex. 26–1503 ...... patients case/control.F/R?/P? questionnaire job

title.

joint measurement/

hip.

OR=0.8–2.5

(1.1–5.7)

Vingard (1997) Ex. 26–1617 .. patients case/control.F/R/P? questionnaire ........ hip replacement .... RR=0.8–2.3*

(1.5–3.6)

De Zwart (1997) Ex. 500–

121–18.

Various occupations.F/R/P job title .................. questionnaire

lower limbs.

temporal relationship.NR*

F=forceful exertions; R=repetitive motion; P=awkward posture; ?=presence of risk factor unclear;

RR=relative risk; OR=odds ratio; PRR=prevalence rate ratio

*=p<0.05

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

68486 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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°, while normal daily

activities involve less flexion (e.g.,

sitting, 87°; tying shoe laces, 74°;

walking upstairs, 97°). 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 workrelated 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

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

68488 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 workrelated 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 workrelated 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 workrelated 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: ‘‘Nonbiomechanical 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68489

extremity, neck, and back and those with the

sharpest contrast in exposure among the

study groups, the positive relationship

between the occurrence of musculoskeletal

disorders and the conduct of work is clear.

The relevant studies have not precisely

determined the causal mechanical factors

involved nor the full clinical spectrum of the

reported MSDs (which are often lumped

together nonspecifically as MSDs of a body

region); nonetheless, those associations

identified by the NIOSH review as having

strong evidence are well supported by

competent research on heavily exposed

populations (Ex. 26–37, pg 15–16).

There is compelling evidence from

numerous studies that as the amount of

biomechanical stress is reduced, the

prevalence of musculoskeletal disorders at

the affected body region is likewise reduced.

This evidence provides further support for

the relationship between these work

activities and the occurrence of

musculoskeletal disorders (Ex. 26–37. p 16).

OSHA believes these NAS

conclusions are not ‘‘inconclusive at

best’’ but as the commenters claims,

instead clearly support those

associations between work-related

biomechanical factors and MSDs

identified in the NIOSH review where

evidence is strong, namely

combinations of forceful exertions,

repetitive motions, awkward postures,

vibration and heavy lifting. The above

biomechanical exposures are the same

ones that the OSHA standard seeks to

reduce.

The NAS Steering Committee did

point out some limitations to the

epidemiological evidence, particularly

that ‘‘it was difficult to make strong

causal inferences on the basis of

evidence from any individual study.’’

(Ex. 26–37, p. 15; emphasis added).

They acknowledged that ‘‘the

occurrence of MSDs among populations

exposed to low levels of biomechanical

stressors was less definite. * * * In case

of low levels of biomechanical stress,

the possible contribution of other factors

to MSDs is important to consider.’’ (Ex.

26–37, p. 16). OSHA agrees with these

statements and has not ignored the

contribution of individual,

organizational, and psychosocial factors

in the etiology of MSDs. The Health

Effects section of the rule emphasizes

the multifactorial nature of MSDs.

Substantial evidence in the rulemaking

record, however, demonstrates that

biomechanical risk factor show strong

associations with elevated MSD risk

when other non-work-related factors are

controlled for. Thus, OSHA does not

believe that the existence of other risk

factors should prevent actions that

reduce exposures to those work-related

biomechanical stressors.

OSHA agrees that the majority of the

NAS participants supported the

ergonomic hypothesis that OSHA is

espousing. This is not because the NAS

selection process excluded those with

other views, as implied by the

commenters. The NAS prides itself on

and is regarded world-wide as an

organization that renders impartial and

unbiased expert judgment on scientific

issues. The reason for the NAS

participants’ support is simply that most

ergonomic experts around the world

agree there is clear evidence that

biomechanical work factors increase the

risk of MSDs.

OSHA is aware that one member of

the six person panel addressing physical

factors and epidemiology, Dr. Howard

Sandler, was critical of NIOSH’s

methodology and findings. OSHA does

not agree with Dr. Sandler’s statements,

and neither did the majority of the other

panel members. In the NAS workshop

summary, the consensus of the panel

was that NIOSH had not overlooked any

important body of epidemiological

evidence. The panelists generally agreed

that the NIOSH analysis resulted in the

review on of high quality studies. With

the exception of Dr. Sandler, the

panelists unanimously agreed that a

reassessment of the epidemiological

literature would not alter the

conclusions drawn by NIOSH regarding

the work-relatedness of MSDs.

Finally, it is important to note that in

evaluating all the evidence, not just the

epidemiology, the NAS Steering

Committee made the following

conclusions:

Thus, while there are many points about

which we would like to know more, there is

little to shake our confidence in the thrust of

our conclusions, which draw on converging

results from many disciplines, using many

methods:

• There is a higher incidence of reported

pain, injury, loss of work, and disability

among individuals who are employed in

occupations where there is a high exposure

to physical loading than for those employed

in occupations with lower level of exposure.

• There is a strong biological plausibility

between the incidence of MSDs and the

causative exposure factors in high exposure

occupational settings.

• Research clearly demonstrates that

specific interventions can reduce the

reported rate of MSDs for workers who

perform high risk tasks. No single

intervention is universally effective.

Successful interventions require attention to

individual, organizational, and job

characteristics, tailoring the corrective

actions to those characteristics (Ex. 26–37)

OSHA believes the above NAS

conclusions support, not undermine,

the premise that there is convincing

evidence that exposure to work-related

physical factors increases the risk of

MSDs. There is a higher incidence of

MSDs in exposed individuals; there is

strong biological plausibility that relates

these disorders to biomechanical risk

factors; and interventions that reduce

exposure to those factors have been

demonstrated to reduce the incidence of

the MSDs.

In summary, the methodology used by

NIOSH to arrive at its findings that there

is evidence of an association between a

number of work-related physical risk

factors and MSDs of the neck, upper

extremity, and back is not a flawed

‘‘black box,’’ but a scientifically sound

approach based on well-accepted

epidemiological principles. By NIOSH’s

own testimony, OSHA’s conclusions

regarding biomechanical factors and the

risk of MSDs in the workplace reinforce

and do not misrepresent the 1997

NIOSH findings. Finally, the

conclusions in the 1999 NAS report are

supportive of both the NIOSH analysis

and the OSHA position. In addition, to

the NIOSH and NAS, the European

Agency for Safety and Health at Work

(Ex. 500–71–28) and Washington State

(Ex. 500–71–93) have evaluated the

scientific evidence and also reached

similar conclusions regarding the

evidence linking work-related

biomechanical factors with the

development of MSDs.

2. Issues Relating to Causal Inference in

Epidemiology

Several commenters to the Proposal

argued that OSHA had failed to show

causality between exposure to

workplace factors and MSDs; one group

of comments emphasized that the types

of studies used by NIOSH and OSHA to

evaluate causality of the various MSD

risk factors were inadequate for that

purpose because of the studies design

(see, e.g., Ex. 32–241–4, pg 86–91).

Specific comments were:

Only repeated longitudinal prospective

studies can establish causation; OSHA relies

instead on methodologies prone to error and

bias. * * * Cross-sectional studies, upon

which OSHA heavily relies, are incapable of

providing evidence of cause and effect,

because correlation does not establish

causation (Id. pg. 86). Case-control studies

are highly prone to bias. Prospective cohort

studies are the best method of studying

etiology, * * * retrospective studies [are

prone to] the hazards of * * * ‘‘recall bias.’’

(Id. pg. 87). * * * In the case of

musculoskeletal pain, which OSHA [has]

linked to ‘‘awkward postures’’ and other

biomechanical exposures, recall bias [in any

retrospective design] can be extreme. * * *

Cross-sectional studies are necessarily

retrospective and prone to recall bias. (Id. pg.

87). [Cross-sectional studies] are useful for

observing patterns and correlations, but can

only generate hypotheses. A review seeking

evidence of causation must exclude all crossVerDate 11<MAY>2000 21:17 Nov 13, 2000 Jkt 194001 PO 00000 Frm 00229 Fmt 4701 Sfmt 4700 E:\FR\FM\14NOR2.SGM pfrm08 PsN: 14NOR2
68490 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 metaanalysis 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-ofevidence 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 crosssectional 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 peerreviewed 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 crosssectional 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 crosssectional 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 metaanalysis 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-ofevidence 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 metaanalysis, 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 metaanalysis. Neither Dr. Fisher nor anyone

else has provided any specific evidence

to support his contention that a metaanalysis 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

68492 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 workrelated 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 wellestablished 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 workrelated physical factors and

epicondylitis (Ex. 26–1, pg 4–1 to 4–48).

It should be noted that these OSHA and

NIOSH conclusions do not, in fact,

speak of causation as purported by

Gibson, Dunn & Crutcher; both OSHA’s

and NIOSH’s conclusions are careful to

conform to the language of the Manual.

In Section V on health effects, OSHA

evaluates the epidemiological evidence

for MSDs of the upper extremity,

shoulder, neck, back, and lower

extremity, be focusing primarily on the

most reliable studies. This usually

means studies where exposures to

physical work factors are directly

observed or measured, not assumed

based on job title, and the MSDs have

been confirmed by a combination of

symptoms, physical exam, and medical

tests as appropriate. In addition to the

evidence for epicondylitis cited above:

• Thirteen studies examined neck

and neck/shoulder MSDs using physical

exam and direct observation of

exposure. All but one found significant

associations between biomechanical risk

factors and health outcome. At least

three studies reported odds ratios

greater than five (see Table V–1).

• Seventeen studies examined

shoulder MSDs (mostly tendinitis) using

physical exam and direct observation of

exposure. All but one found significant

associations between biomechanical risk

factors and health outcome. At least six

studies reported odds ratios greater than

five (see Table V–2).

• Seven studies examined hand/wrist

tendinitis using physical exam and

direct observation of exposure. All but

one found significant associations

between biomechanical risk factors and

health outcome. At least four studies

reported odds ratios greater than five

(Table V–4).

• Seventeen studies examined carpal

tunnel syndrome using physical exam

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68493

and/or nerve conduction and direct

observation of exposure. Thirteen found

significant associations between

biomechanical risk factors and health

outcome. At least five studies reported

odds ratios greater than five.

• Six studies examined hand/arm

vibration syndrome using physical exam

and vibration measurements. Four

found significant associations between

vibration and health outcome; all of

which reported odds ratios greater than

five.

OSHA has carefully evaluated the

collective data base of studies for each

MSD category using the criteria for

causality cited in the Manual (pg. 374–

378). OSHA used the epidemiological

data, biomechanical research studies,

and information addressing biological

plausibility to draw its overall

conclusions with regard to the evidence

that the work-related biomechanical

factors were responsible for the

observed increase in the risk of health

impairment. OSHA finds this evidence

compelling and points to the need to

take action to provide workers with

necessary protection. OSHA does not

believe that it is appropriate to wait for

‘‘proof of causation’’ since scientific

evidence cannot ever establish

causation beyond any doubt. As Sir

Bradford Hill wrote over 35 years ago:

All scientific work is incomplete—whether

it is observational or experimental. All

scientific work is liable to be upset or

modified by advancing knowledge. That does

not confer upon us a freedom to ignore the

knowledge we already have or to postpone

the action that it appears to demand at a give

time (Ex. 26–726).

3. Evidence for Exposure Response

Relationships

Several submissions, such as those

submitted by the U.S. Chamber of

Commerce and experts testifying on

behalf of United Parcel Service (Exs. 30–

1722, 32–241–3–19, 32–241–3–13, 30–

4184, 30–1552), claimed that there is no

epidemiologic evidence of exposureresponse (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 exposureresponse 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 exposureresponse 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

68494 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 (unit) Health outcome/body region

affected Measure of effect Reference

Neck and Shoulder

Years sewing machine operator (4

categories).

Neck/Shoulder .............................. Odds Ratio [unadj]

0 (control: 1.0

0–7: 2.3 (0.5–11.0)

8–15: 6.8 (1.6–28.5)

>15: 16.7 (4.1–67.5)

Andersen et al.(1993: Ex. 26–

1451).

Years sewing machine operator (4

categories).

Chronic neck pain ........................ Odds Ratio [adj]

0 (control): 1.0

0–7: 1.9 (1.3–2.9)

8–15: 3.8 (2.3–6.4)

>15: 5.0 (2.9–8.7)

Andersen et al.(1993: Ex. 26–

1502).

Years sewing machine operator (4

categories).

Chronic should pain ..................... Odds Ratio [adj]

0 (control): 1.0

0–7: 1.4 (0.9–2.4)

8–15: 3.9 (2.3–6.5)

>15: 10.3 (5.9–17.9)

Andersen et al.(1993: Ex. 26–

1502).

Years sewing machine operator (4

categories).

Chronic neck and/or shoulder

pain.

Odds Ratio [adj]

0 (control): 1.0

0–7: 1.8 (1.2–2.6)

8–15: 4.3 (2.6–6.9)

>15: 8.0 (4.7–13.8)

Andersen et al.(1993: Ex. 26–

1502).

Data entry at video display unit

(hours/week).

Neck (cervical diagnoses) ............ Odds Ratio [adj]

5–20 hr/wk: 1.2 (0.4–4.3)

≥20 hr/wk: 1.7 (0.7–4.3)

Bergqvist et al.(1995: Ex. 26–

1195, 500–165–25).

Data entry at video display unit ...... Neck/shoulder .............................. Odds Ratio [adj]

Data entry: 1.4 (0.7–2.9)

Data entry plus limited rest

breaks: 4.8 (1.3–18.1)

Bergqvist et al.(1995: Ex. 26–

1195, 500–165–25).

Typing speed ................................... Neck ............................................. Prevalence [unadj] (test of trend):

Slow: 10%

Moderate: 14%

Fast: 25% (p<0.001)

Burt et al.(1990: Ex. 26–698).

Percentage of time typing ............... Neck ............................................. Odds Ratio [adj]

<20: 1.0

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)

Burt et al.(1990: Ex. 26–698).

Typing speed ................................... Shoulder ....................................... Odds Ratio [adj]

Slow: 1.0

Moderate: 2.6(1.1–5.9)

Fast: 4.1 (1.8–9.4))

Burt et al.(1990: Ex. 26–698).

Percentage of time typing ............... Shoulder ....................................... Prevalence [unadj] (test of trend):

0–19: 6%

20–39: 10%

40–59: 13%

60–79: 11%

80–100: 15% (p=.10)

Burt et al.(1990: Ex. 26–698).

Repetitive precision movements

(hours/day) (3 categories).

Neck/Shoulder .............................. Odds Ratio [adj]

Low: 1.0

Medium: 3.8 (0.7–20)

High: 15.6 (2.2–113)

Ekberg et al.(1994: Ex. 26–1238).

Work pace (3 categories) ................ Neck/Shoulder .............................. Odds Ratio [adj]

Low: 1.0

Medium: 7.6 (1.6–36)

Rushed: 10.7 (2.2–52)

Ekberg et al.(1994: Ex. 26–1238)

Hour per day of video display terminal (VDT) use.Neck, shoulder, upper back

(‘‘upper torso’’).

Odds Ratio [unadj] per hour 1.4

(1.0–2.0)

Faucett et al.(1994: Ex. 38–256)

Monotonous working movements

(duration of repetitive movements, static stress and sitting).

Neck (in white collar workers) ...... Partial correlation coefficient [adj]

0.38 (p < 0.05)

Johansson et al.(1994: Ex. 26–

1331)

Monotonous working movements

(duration of repetitive movements, static stress and sitting).

Shoulder (in white collar workers) Partial correlation coefficient [adj]

0.32 (p < 0.05)

Johansson et al.(1994: Ex. 26–

1331)

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68495

TABLE V–9.—EVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS WITH EXPOSURE

TO REPETITIVE MANUAL WORK—Continued

Measure of repetitiveness (unit) Health outcome/body region

affected Measure of effect Reference

Monotonous working movements

(duration of precision movements, repetitive movements,

and static and stress).

Shoulder (in blue collar workers) Partial correlation coefficient [adj]

0.15 (p < 0.05)

Johansson et al.(1994: Ex. 26–

1331)

Years employed in repetitive assembly work.Neck ............................................. Increasing odds (graphical presentation only)Ohlsson et al.(1989: Ex. 25–

1290)

Shoulder ....................................... Increasing odds (p=0.03); below

35 years of age, p=0.01

Work pace (items/hour) (4 categories).Shoulder ....................................... Odds Ratio [adj]

< 100: 1.0

100–199: est 8.0 (p=0.0006)

200–700: est 9.0 (p=0.0006)

> 700: est 2.0 (p-value not

given)

Ohlsson et al. (1989: Ex. 26–

1290)

Hours per day of VDT use (4 categories).Neck ............................................. Prevalence [unadj] (test of trend):

0 hr: 7%

0.5–3 hr: 7%

4–6 hr: 12%

≥7 hr: 19% (p<0.00001)

Rossignol et al.(1987: Ex. 26–

804)

Odds Ratio [adj]

0 hr: 1.0

0.5–3 hr: 1.8 (0.5–6.8)

4–6 hr: 4.0 (1.1–14.8)

≥7 hr: 4.6 (1.7–13.2)

Hours per day of VDT use (4 categories).Shoulder ....................................... Prevalence [unadj] (test of trend):

0 hr: 6%

0.5–3 hr: 5%

4–6 hr: 10%

≥7 hr: 16% (p=< 0.00001)

Rossignol et al.(1987: Ex. 26–

804)

Odds Ratio [adj]

0 hr: 1.0

0.5–3 hr: 2.5 (0.7–10.8)

4–6 hr: 4.0 (1.0–16.9)

≥7 hr: 4.8 (1.6–17.2)

Sewing machine operation (years of

employment).

Neck ............................................. Odds Ratio [unadj]

< 8 yrs: 1.0

8–14 yrs: 1.1 (0.4–2.6)

≥15 yrs: 2.1 (0.8–5.6

Schibye et al.(1995: Ex. 26–1463)

Shoulder ....................................... < 8 yrs: 1.0

8–14 yrs: 1.3 (0.5–3.4)

≥

15 yrs: 4.3 (1.5–12.5)

Arm and Elbow

Data entry at video display unit

(hours/week).

Arm/hand ...................................... Odds Ratio [unadj]

5–20 hr/wk: 1.6 (0.6–4.5)

≥ 20 hr/wk: 1.8 (0.8–3.9)

Bergqvist et al.(1995: Exs. 26–

1195, 500–165–25)

Percentage of time typing ............... Elbow/forearm .............................. Odds Ratio [adj]

20–39%: 1.2 (0.6–22.5)

40–59%: 1.7 (0.8–3.5)

60–79%: 1.9 (0.9–4.3)

80–100%: 2.8 (1.4–5.7)

Burt et al.(1990: Ex. 26–698)

Typing speed ................................... Elbow/forearm .............................. Prevalence [unadj] (test of trend):

Slow: 7%

Moderate: 11%

Fast: 13% (p=0.02)

Burt et al.(1990: Ex. 26–698)

Hours per day of VDT use .............. Arm ............................................... Prevelance [unadj] (test of trend):

0 hr: 4%

0.5–3 hr: 2%

4–6 hr: 4%

≥7 hr: 7% (p=0.01)

Rossignol et al.(1987: Ex. 26–

804)

68496 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE V–9.—EVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS WITH EXPOSURE

TO REPETITIVE MANUAL WORK—Continued

Measure of repetitiveness (unit) Health outcome/body region

affected Measure of effect Reference

Hand and Wrist

Typing at video display unit (hours/

day).

Hand/wrist .................................... Odds Ratio [adj]

0–<2 hr: 1.0

2–<4 hr: 1.3 (0.6–1.8)

4–<6 hr: 1.3 (0.8–2.2)

6–≥8 hr: 2.1 (1.3–3.6)

 ́8 hr: 3.3 (1.2–8.9)

Bernard et al.(1994: Ex. 500–

165–21)

Typing speed ................................... Hand/wrist .................................... Odds Ratio [adj]

Slow: 0.9 (0.3–2.3)

Moderate: 1.3 (0.6–3.1)

Fast: 2.5 (1.0–5.6)

Burt et al.(1990: Ex. 26–698)

Percentage of time typing ............... Hand/wrist .................................... Prevalence [unadj] (test of trend):

0–19: 13%

20–39: 23%

40–59: 27%

60–79: 30%

80–100: 24% (p<0.01)

Burt et al.(1990: Ex. 26–698)

Hours per day of video display terminal (VDT) use.Hand and arm .............................. Odds Ratio [unadj] per hour

1.5 (1.1–2.0)

Faucett et al.(1994: Ex. 38–256)

Repetition rating (1 unit on 0–10

scale).

Odds Ratio [adj]: Latko et al.(1999: Ex. 38–171)

Dominant wrist/hand/fingers ......... 1.17 (1.06–1.29)

Tendinitis (distal upper extremity) 1.23 (1.04–1.46)

Carpal tunnel syndrome ............... 1.16 (1.00–1.34)

Cycle length (seconds), in work

performed 4–8 hours per day.

Carpal tunnel syndrome ............... Odds Ratio [adj]

≥1 min: 1.0

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)

Leclerc et al.(1998: Ex. 500–205–

11)

Years employed in repetitive assembly work.Hand ............................................. Increasing odds (p=0.002) Ohlsson et al.(1989:Ex. 26–1290)

Repetitive wrist motions (years of

exposure).

Carpal tunnel syndrome ............... Odds Ratio [unadj]

<1 yr: 1.0

1–20 yrs: 2.3 (0.7–7.9)

>20 yrs: 9.6 (2.8–33.0)

Wieslander et al.(1989: Ex. 26–

1027)

Multiple Body Regions

Piece-rate wage system (years of

employment).

Musculo- skeletal diseases .......... Odds Ratio [adj]

0–4 yrs: 1.0

5–9 yrs: 4.3 (0.5–35.9)

10–14 yrs: 10.0(1.0–79.3)

15–19 yrs. 8.0 (0.8–76.8)

≥20 yrs: 11.4 (0.9–137.1)

Brisson et al.(1989: Ex. 26–937)

Hours per week of video display

terminal use.

Upper extremity and back ............ Mean hours per week [unadj]

30 in cases, 27 in non-cases

(p<0.05)

Knave et al.(1985: Ex. 26–753)

Percentage of recovery time per

work cycle.

Upper extremity ............................ Linear regression coefficient

[unadj]:

Ln(% recovery): 0.6 (r2=0.49,

p<0.001)

Moore et al.(1994: Ex. 26–1033)

Hours per day at keyboard ............. Hand, wrist, forearm and/or elbow Prevalence [unadj] (test of trend):

3 hr: 21%

4 hr: 24%

6 hr: 45%

6 hr: 50%

>6 hr: 86%(p<0.00001)

Oxenburgh (1987: Ex. 26–1367)

Keyboarding speed ......................... Upper extremity ............................ Prevalence [unadj] (test of trend):

<40 wpm: 17%

40–60 wp,: 22%

>60 wpm: 29% (p=0.025)

Polanyi et al.(1997): Ex. 500–41–

106)

Daily time keyboarding (hours per

day).

Upper extremity ............................ Means (test of difference) [unadj]:

Cases 3.9 hours/day, controls 3.2

hours/day

(p<0.001)

Polanyi et al.(1997: Ex. 500–41–

106)

Note: adj = adjusted for other covariate(s)

unadj = not adjusted for other covariates

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68497

TABLE V–10.—EVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS WITH

EXPOSURE TO FORCEFUL MANUAL EXERTION

Measure of manual force (unit) Health outcome/body region affected Measure of effect Reference

Neck and Shoulder

Grocery checking: hours per week

of checking work.

Shoulder ....................................... Odds Ration [unadj]

<20: 1

20–25: 1

>25: 3.6 (p<0.05)

Baron et al.(1991: Ex. 26–697)

Forearm rotation while exerting very

high forces (Frequency of exposure * Years of exposure).

Shoulder ....................................... Odds Ration [adj] per unit: Hughes et al.(1997: Ex. 26–907)

Interview ....................................... 92 (7.3–±)

Examination .................................. 46 (3.8–550)

Light materials handling [factor

formed from frequency and duration of materials handling 0.5–<1

kg and 1–5 kg].

Shoulder (in white collar workers) Partial correlation coefficient [adj]

0.18 (p < 0.05)

Johansson et al.(1994: Ex. 26–

1331)

Years of carpentry work (<10, 10 to

<20, 20+ years).

Shoulder ....................................... Odds Ration [adj]

10–<20 yr: 2.3 (1.0–5.4)

20+ yr: 3.2 (1.1–8.9)

Lemasters et al.(1998: Ex. 500–

121–44)

Load lifted (cumulative exposure, in

3 categories: 0–709; 710–25,999;

and >25,999 kg).

Shoulder: acromio-clavicular osteoarthritis.Odds Ratio [adj] (per category)

Right side: 1.55 (1.03–2.34)

Left side: 2.55 (1.50–4.35)

Stenlund et al.(1992: Ex. 26–733)

Load lifted (cumulative exposure, in

3 categories: 0–709; 710–25,999;

and >25,999 kg).

Shoulder tendinitis ........................ Odds Ratio [adj] (per category)

Right side: 1.02 (0.59–1.76)

Left side: 1.81 (0.95–3.44)

Stenlund et al.(1993: Ex. 502–

462

Arm and Elbow

Grocery checking: hours per week

of checking work.

Elbow ............................................ Elbows Odds Ratio [unadj]

<20: 1

20–25: 1.4

>25: 2.8 (p<0.05)

Baron et al.(1991: Ex. 26–697)

Forearm rotation while exerting very

high forces (Frequency of exposure * Years of exposure).

Elbow/forearm: .............................

Interview .......................................

Examination ..................................

Odds Ratio [adj] per unit:

4 (0.2–4)

37.0 (3.0–470)

Huges et al.(1997: Ex. 26–907)

Strenuous exertions (years of high

exposure).

Epicondylitis ................................. Odds Ratio [adj]

0 yr: 1.0

1–14 yr: 1.8(0.6–5.9)

15–38 yr: 3.3 (0.9–12.5)

Ritz (1995: Ex. 26–1473)

Hand and Wrist

Hand forces (finger flexor muscles

on electromyography).

Carpal tunnel syndrome ............... Average force (test of difference

in means):

Cases: 4.3 ′′ 3.5 kp

Noncases: 3.8 ′′ 3.2 kp (p<0.05)

Armstrong et al.(1979: Ex. 500–

41–8)

Grocery checking (years of exposure).Hand/wrist .................................... Odds Ratio [adj]

0–5: 1

5–10: 2

10+: 6 (p<0.05)

Baron et al.(1991: Ex. 26–697)

Grocery checking (years of exposure).Carpal tunnel syndrome ............... Odds Ratio [adj]

0–5: 1

5–10: 4

10+: 15 (p<0.05)

Baron et al.(1991: Ex. 26–697)

Grocery checking (hours per week

of exposure).

Carpal tunnel syndrome ............... Odds Ratio [adj]

<20: 1

20–25: 2.3

>25: 4.8 (p<0.05)

Baron et al.(1991: Ex. 26–697)

Forearm rotation while exerting very

high forces (Frequency of exposure * Years of exposure).

Hand/wrist: ...................................

Interview .......................................

Examination ..................................

Odds Ratio [adj] per unit

17.0 (2.9–106)

9.3 (1.0–90)

Hughes et al.(1997: Ex. 26–907)

Years of carpentry work (<10, 10 to

<20, 20+ years).

Hand and wrist ............................. Odds Ratio [adj]

10¥lt;20 yr: 2.4(1.1–5.3)

20+yr: 3.1(1.1–8.4)

Lemasters et al.(1998: Ex. 500–

121–44)

Biomechanical index from direct

measurements of force and posture.

Carpal tunnel syndrome ............... Linear regression [unadj]

Flexion 0.017(r=0.62)

Extension: 0.035(r=0.26)

Loslever et al.(1993: Ex. 26–161)

68498 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE V–10.—EVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS WITH

EXPOSURE TO FORCEFUL MANUAL EXERTION—Continued

Measure of manual force (unit) Health outcome/body region affected Measure of effect Reference

Mean relative finger flexor force (by

EMG)/45–90 minute work sampling period.

Wrist ............................................. Linear regression coefficient [adj]:

Mean relative deviation angle

(p<0.05)

Mean relative EMG signal

(p<0.05)

Seniority (years employed)

(p<0.05)

Malchaire et al.(1996: Ex. 26–

1473)

Manual force (as % MVC, in 5 categories).Upper extremity ............................ Linear regression [unadj]:

Ln (Force: 2.0 (r2=0.49,

p<0.001)

Moore et al.(1994: Ex. 26–1033)

Forceful wrist motions (3 categories: low, medium, high).Carpal tunnel syndrome By history.Prevalence [unadj] (test of trend)

Low: 0%

Medium: 10%

High: 63% (p=0.00006)

Osorio et al.(1994: Ex. 26–807)

By nerve conduction velocity ....... Low: 0%

Medium: 7%

High: 33% (p=0.02)

Forceful wrist motions (years exposed).Carpal tunnel syndrome ............... Linear regression [adj], p<0.05

for:

Right median nerve conduction

velocity

Osorio et al.(1994: Ex. 26–807)

Grip >6 lb. per hand (3 categories

of frequency).

Hand/wrist .................................... Prevalence [unadj] (test of trend)

None: 41%

Some: 40%

Frequent: 65% (p=0.30)

Stetson et al.(1993: Ex. 26–1221)

High load on wrist (years of exposure).Carpal tunnel syndrome ............... Odds Ratio [unadj]

<1 yr: 1.0

1–20 yr: 2.1 (0.8–5.2)

>20 yr: 6.6 (1.4–14.7)

Wieslander et al.(1989: Ex. 26–

1027)

Back

Frequency of lifting per shift ........... Low back ...................................... Prevalence [unadj]

0/shift: 29%

1–5/shift: 33%

6–10/shift: 49%

11–20/shift: 55%

>20/shift: 54%

Arad et al.(1986: Ex. 500–41–7)

Frequency of lifting >11.3 kg (times

per day).

Prolapsed lumbar disc ................. Odds Ratio [adj] (test of trend):

0: 1.0

<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)

Kelsey et al.(1984: Ex. 500–41–

73)

Frequency of lifting >11.3 kg (times

per day).

Prolapsed lumbar disc ................. Odds Ratio [adj] (test of trend):

0: 1.0

<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)

Kelsey et al.(1984: Ex. 500–41–

73)

Frequency of carrying 11.3 kg

(times per day).

Prolapsed lumbar disc ................. Odds Ratio [adj] (test of trend):

0: 1.0

<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)

Kelsey et al.(1984: Ex. 500–41–

73)

Lifting 11.3 kg while twisting ........... Prolapsed lumbar disc ................. Odds Ratio [adj] (test of trend):

Never or rare: 1.0

Moderate: 2.5 (0.9–6.8)

Often: 3.1 (1.3–7.5) (p=0.002)

Kelsey et al.(1984: Ex. 500–41–

73)

Load on spine (12 continuous biomechanical variables: peak and

daily integraetd load).

Low back ...................................... Odds Ratio [adj] for inter-quartile

spreads:

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)

Kerr et al.(2000: Ex. 500–41–74)

Index of stone load (weight*hours/

day).

Low back ...................................... Odds Ratio [adj]:

None: 1.0

Intermediate: 1.8 (0.3–9.3)

High: 4.0 (0.8–19.8)

Latza et al.(2000: Ex. 500–19–6)

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68499

TABLE V–10.—EVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS WITH

EXPOSURE TO FORCEFUL MANUAL EXERTION—Continued

Measure of manual force (unit) Health outcome/body region affected Measure of effect Reference

Lifting demands index (‘‘Job Severity Index’’).Back ............................................. Injury incidence rate, disabling injury incidence, and severity rate

increased with JSI (graphical

presentations)

Liles et al.(1984: Exs. 26–33,

500–41–88)

Dynamic trunk motions (31 continuous biomechanical.Low back ...................................... Odds Ratio [adj] for combined

weighted means of 5 variables:

10.7 (4.9–23.6)

Marras et al.(1993: Ex. 500–41–

94)

Load on spine (12 continuous biomechanical variables: peak and

daily integrated load).

Low back ...................................... Higher load in cases vs controls,

by each variable (all p-values

<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)

Norman et al.(1998: Ex. 38–84)

Transfer a patient on canvas and

poles (frequency/average working

shift).

Low back ...................................... Odds Ratio [adj]

0: 1.0

1–4: 1.0 (0.8–1.3)

≥5: 1.3 (0.8–2.1)

Smedley et al.(1995: Ex. 500–41–

40)

Manually transfer patient between

bed and chair (frequency/shift).

Low back ...................................... Odds Ratio [adj]

0: 1.0

1–4: 1.4 (1.1–1.9)

5–9: 1.8 (1.3–2.5)

≥10: 1.5 (1.1–2.1)

Smedley et al.(1995: Ex. 500–41–

40)

Manually move patient around on

bed (frequency/shift).

Low back ...................................... Odds Ratio [adj]

0: 1.0

1–4: 1.2 (0.8–1.7)

5–9: 1.6 (1.1–2.3)

≥10: 1.7 (1.2–2.4)

Smedley et al.(1995: Ex. 500–41–

40)

Manually transfer patient between

bed and chair (frequency/shift).

Low back ...................................... Odds Ratio [adj]

0: 1.0

1–4: 1.3 (0.9–1.7)

5–9: 1.6 (1.1–2.3)

≥10: 1.6 (1.1–2.3)

Smedley et al.(1997: Ex. 500–

205–25)

Transfer patient between bed and

chair with hoist (frequency/shift).

Low back ...................................... Odds Ratio [adj]

0: 1.0

1–4: 1.5 (1.0–2.0)

≥5: 1.6 (0.8–3.0)

Smedley et al.(1997: Ex. 500–

205–25)

Manually move patient around on

bed (frequency/shift).

Low back ...................................... Odds Ratio [adj]

0: 1.0

1–4: 1.3 (0.8–1.9)

5–9: 1.5 (1.0–2.3)

≥10: 1.7 (1.1–2.5)

Smedley et al.(1997: Ex. 500–

205–25)

Lift patient in or out of bath with

hoist (frequency/shift).

Low back ...................................... Odds Ratio [adj]

0: 1.0

1–4: 1.4 (1.0–1.9)

≥5: 2.1 (1.2–3.6)

Smedley et al.(1997: Ex. 500–

205–25)

Frequent vs. infrequent lifting in patient care.Back ............................................. Length of time at work without

back injury longer for those

with infrequent lifting demands

(p<0.01 in survival analysis)

Stobbe et al.(1988: Ex. 500–41–

45)

Lifting frequency (4 categories of

hospital service area, from 1, lifting most, to IV, lifting least).

Back ............................................. Odds Ratio [adj]

Area IV: 1.0

Area III: 1.26 (p>0.05)

Area II: 1.73 (p>0.05)

Area I: 4.26 (p<0.01)

Venning et al.(1987: Ex. 500–41–

49)

68500 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE V–10.—EVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS WITH

EXPOSURE TO FORCEFUL MANUAL EXERTION—Continued

Measure of manual force (unit) Health outcome/body region affected Measure of effect Reference

NIOSH Lifting Equation Lifting

Index (LI) (4 categories).

Low back (severity rating, range

0–5).

Mean severity (standard deviation):

LI:<1: 0.18 (0.15)

1≤LI ≤3: 3.57 (0.86)

LI>3: 4.07 (0.73)

RWL*=0: 3.86 (0.75)

ANOVA (α=0.05)

*Recommended Weight Limit

Wang et al.1998 (1998: Ex. 500–

41–52)

NIOSH Lifting Equation Lifting

Index (LI).

Low back ...................................... Odds Ratio [unadj]

0: 1.0

0<LI ≤1: 1.1 (0.2–5.3)

1<LI ≤2: 1.5 (0.6–3.8)

2<LI ≤3: 2.5 (1.3–4.9)

LI ≥3: 1.6 (0.7–4.0)

Waters et al.(1999: Ex. 500–121–

76)

Strenuous physical activity at work

(hours per day).

Back ............................................. Odds Ratio [unadj]

0–<2 hr: 1.0

2–<4 hr: 4.2

4–<6 hr: 6.4

6–<8 hr: 5.6

≥8 hr: 6.8

Odds Ratio [adj] per hour of

strenuous work: 1.14

(1.11–1.17)

Wild (Ex. 26–1104; 26–1107)

Physically hard work ....................... Low back ...................................... Odds Ratio [unadj] (test of trend):

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 (p<0.001)

Xu et al.(1997: Ex. 500–71–53)

Lower Extremity or Multiple Body Regions

Strength demand of job (3 categories: none, some, much).Knee (radiographic osteoarthritis) Odds Ratio [adj]

Men, ages 55–64: 1.9 (0.9–4.0)

Women, ages 55–64: 3.1 (1.0–

9.4)

Anderson et al.(1988: Ex. 26–

926)

Kneeling, squatting or stair-climbing, with and without heavy lifting.Knee osteoarthritis ....................... Odds Ratio [adj]

Neither kneeling nor lifting: 1.0

Kneeling/squatting: 2.5 (1.1–5.5)

Kneeling and lifting: 5.4 (1.4–

21.0)

Cooper et al.(1994: Ex. 500–41–

27)

Maximum compressive force (lb.)

on L5/S1 lumbar disc.

‘‘Overexertion incidents’’ by clinic

visit.

Incidence rate (per 200,000

hours):

<1000 lb: 65

1000–1500 lb: 150

>1500 lb: 208

Herrin et al.(1986: Ex. 26–961)

Index of physically strenuous load .. Overall MSD morbidity: ............

Symptoms ....................................

Findings ........................................

Linear regression coefficient [adj]:

0.127 (p=0.002)

0.091 (p=0.026)

Leino et al.(1995: Ex. 32–241–3–

54)

Years of carpentry work (<10, 10 to

<20, 20+ years).

Knee ............................................. Odds Ratio [adj]

10–<20 yr: 1.9 (0.9–4.1)

≥20 yr: 3.5 (1.3–9.2)

Lemasters et al.(1998: Ex. 500–

121–44)

Lifting at work (kilograms per day) Knee .............................................

Men: .............................................

Women: ........................................

Odds Ratio [adj]

Medium: 2.5 (1.5–4.4)

High: 3.0 (1.6–5.5)

Medium: 1.2 (0.7–1.9)

High: 1.7 (1.0–2.9)

Sandmark et al.(2000: Ex. 500–

41–114)

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68501

TABLE V–11.—EVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS OF THE NECK

AND SHOULDERS WITH EXPOSURE TO NON-NEUTRAL POSTURE

Measure of posture Health outcome/body region affected Measure of effect Reference

Neck and Shoulder

Height of video display unit keyboard relative to elbow height

(centimeters).

Neck/shoulder .............................. Linear regression coefficient

[unadj] 0.18 (¥0.03, 0.40)

Bergqvist et al.(1995: Ex. 500–

165–24)

Duration of shoulder flexion or abduction >60 degrees (hours/day).Shoulder/neck .............................. Ratio for cases vs. controls:

Right: 2.0 (p <0.005)

Left: 2.4 (p <0.025)

Bjelle et al.(1981: Ex. 26–1519)

Frequency of shoulder flexion or

abduction >60 degrees (times/

day).

Shoulder/neck .............................. Ratio for cases vs. controls:

Right: 2.0 (p <0.001)

Left: 2.2 (p <0.005)

Bjelle et al.(1981: Ex. 26–1519)

Arms lifted (hours per day, 3 categories).Neck/shoulder .............................. Odds Ratio [adj]

Low: 1.0

Medium: 2.4 (0.8–7.1)

High: 4.8 (1.3–18)

Ekberg et al.(1994: Ex. 26–1238)

Elbow flexed >1 time/minute (per

hour/day).

Shoulder ....................................... Odds Ratio [adj]

1.10 (0.98–1.23)

English et al.(1995: Ex. 26–848)

Head rotation ................................... Neck, shoulder, upper back

(‘‘upper torso’’).

R-squared [adj]

Pain: 0.11 (p<0.01)

Stiffness: 0.18 (p<0.01)

Faucett et al.(1994: Ex. 38–256)

Keyboard height relative to elbow .. Neck, shoulder, upper back

(‘‘upper torso’’).

R-squared [adj]

Pain: 0.05 (p<0.05)

Stiffness: 0.06 (p<0.05)

Faucett et al.(1994: Ex. 38–256)

Years of exposure to repetitive

shoulder flexion (angle ≥30 degrees, 600 times/hour) with high

forces.

Shoulder impingement syndrome Increasing prevalence ratio [adj]

with cumulative exposure nonlinear trend, p=0.002 for quadratic term

Frost et al.(1999: Ex. 38–97)

Hands above shoulder level (hours

per day).

Neck/shoulder pain with impairment.Prevalence Ratio [adj]

<1 Hr. 1.1 (0.8–1.5)

1–4 hr. 1.5 (1.2–1.9)

>4 hr. 2.0 (1.4–2.7)

Holmstro ̈m et al (1992: Ex. 500–

41–64)

Stooping (hours per day) ................ Neck/shoulder pain with impairment.Prevalence Ratio [adj]

<1 Hr. 1.0 (0.8–1.3)

1–4 hr. 1.4 (1.1–1.8)

>4 hr. 1.5 (1.1–2.1)

Holmstro ̈m et al (1992: Ex. 500–

41–64)

Bent work postures [factor=duration

of precision movements and

head bent foward; frequency and

duration of trunk forward flexion

(20°–60°)].

Neck (in white collar workers) ...... Partial correlation coefficient [adj]

0.20 (p<0.05)

Johansson et al.(1994: Ex. 26–

1331)

Twisted work postures

[factor=duration of trunk rotation

(>45°) and head rotation (>45°)].

Neck (in white collar workers) ...... Partial correlation coefficient [adj]

0.23 (p<0.05)

Johansson et al.(1994: Ex. 26–

1331)

Extreme work postures

[factor=frequency and duration of

trunk forward flexion (>60°); frequency of trunk forward flexion

(20°–60°); and duration of head

rotation (>45°), trunk rotation

(>45°), and work with hands

above shoulders].

Shoulder (in blue collar workers) Partial correlation coefficient [adj]

0.14 (p<0.05)

Johansson et al.(1994: Ex. 26–

1331)

Twisted work postures

[factor=duration of trunk rotation

(>45°) and head rotation (>45°)].

Shoulder (in white collar workers) Partial correlation coefficient [adj]

0.16 (p<0.05)

Johansson et al.(1994: Ex. 26–

1331)

Percentage of work cycle with

shoulder elevated.

Cervicobrachial (neck to hand) .... Odds Ratio [adj]

1.04 (p<0.05)

Jonsson et al.(1988: Ex. 26–969)

Neck flexion (percentage of work

cycle).

Neck ............................................. Regression coefficient p-value

[adj]

p<0.01

Kilbom et al.(1986: Ex. 500–41–

75)

Shoulder elevated (percentage of

work cycle).

Regression coefficient p-value

[adj]

Kilbom et al.(1986: Ex. 500–41–

75)

Neck ............................................. p<0.05

Shoulder ....................................... p<0.05

Neck flexion (movements per hour) Neck/shoulder .............................. Ratio of median for cases vs.

controls [unadj]

Total movements: 1.3 (p=0.008)

Flexions ≥30°: 1.3 (p=0.02)

Ohlsson et al.(1995: Ex. 26–868)

68502 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE V–11.—EVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS OF THE NECK

AND SHOULDERS WITH EXPOSURE TO NON-NEUTRAL POSTURE—Continued

Measure of posture Health outcome/body region affected Measure of effect Reference

Frequency of shoulder flexion or

abduction.

Neck/shoulder .............................. Median elevation >30° (% of time)

[unadj]:

Cases=16, controls=9 (p=0.05)

Median elevation >30° (movements per hour) [unadj]:

Cases=60, controls=9 (p=0.004)

Median abduction ≥60° (% of

time) [unadj]:

Cases=1, controls=0 (p=0.04)

Median elevation ≥60° (movements per hour) [unadj]:

Cases=47, controls=0 (p=0.04)

Ohlsson et al.(1995: Ex. 26–868)

Shoulder flexion or abduction >90

degrees (duration, as percentage

of work cycle).

Left shoulder ................................

Right shoulder ..............................

Either shoulder .............................

Odds Ratio [unadj] (test of trend)

>0%–<10%: 2.5

≥10%: 5.1 (p=0.0001)

>0%–<10%: 1.7

≥10%: 2.8 (p=0.002)

Ratio of mean duration in cases

vs. controls [unadj]: 2.6

(p=0.003)

Odds Ratio (95% CI) per 10% increment [adj]: 1.4 (1.1–1.8)

Punnett et al.(2000: Ex. 500–41–

109

Twisted or bent postures (4 categories).Neck/shoulder .............................. Odds Ratio [adj]

Little: 1.0

Moderate: 1.2 (1.0–1.5)

Rather much: 1.6 (1.4–1.9)

Very much: 1.8 (1.5–2.2)

Tola et al.(1988: Ex 26–1018)

Twisting of trunk (hours/day) (4 categories).Neck ............................................. Odds Ratio [adj]:

Not at all: 1.0

Little: 1.3 (0.7–2.4)

Moderately: 1.9 (1.1–3.5)

Much: 2.3 (1.2–4.3)

Viikari-Juntura et al.(2000: Ex.

500–41–50)

Working with hand above shoulder

level (hours/day) (3 categories).

Neck ............................................. Odds Ratio [adj]:

<0.5 1.0

0.5–1: 1.2 (1.0–1.3)

>1: 1.4 (1.3–1.6)

Viikari-Juntura et al.(2000: Ex.

500–41–50)

Twisting or bending of trunk at work

(3 categories).

Neck ............................................. Odds Ratio [unadj]:

Very or rather little: 1.0

Moderate: 1.7 (0.9–9–3.2)

Rather or very much: 1.9 (1.2–

3.2)

Viikari-Juntura et al.(1994: Ex.

26–873)

Hand and Wrist

Wrist bending or twisting (per 2

hours/day).

Carpal tunnel syndrome ............... Odds Ratio [unadj]

1.5 (1.2–1.7)

Blanc at al. (1996); Ex. 26–42

500–41–16)

Wrist flexion (hours/week) (hours

truncated at 40).

Carpal tunnel syndrome ............... Odds Ratio [unadj]

0: 1.0

1–7: 1.5 (1.3–1.9)

8–19: 3.0 (1.8–4.9)

20–40: 8.7 (3.1–24.1)

De Krom et al.(1990: Ex. 26–102)

Wrist extension (hours/week) (hours

truncated at 40).

Carpal tunnel syndrome ............... Odds Ratio [unadj]

0: 1.0

1–7: 1.4 (1.0–1.9)

8–19: 2.3 (1.0–5.2)

20–40: 5.4 (1.1–27.4)

De Krom et al.(1990: Ex. 26–102)

Shoulder rotation with arm elevated, >1 time/minute (per hour/

day).

Odds Ratio [adj] English et al.(1995: Ex. 26–848)

Wrist/forearm ................................ 1.6 (1.2–2.3)

Carpal tunnel syndrome ............... 1.8 (1.2–2.8)

Shoulder rotation with elbow flexed,

>1 time/minute (per hour/day).

Finger ........................................... Odds Ratio [adj]

5.1 (2.0–12.8)

English et al.(1995: Ex. 26–848)

Wrist flexion or extension (per 20

repetitions/min).

Thumb .......................................... Odds Ratio [adj]

1.4 (1.1–1.8)

English et al.(1995: Ex. 26–848)

Ulnar abduction (degrees of ‘‘typical’’ work posture).Forearm ........................................ Increasing percentage of operators w/medical findings vs.

angle of ulnar abudction

(graphical presentation only)

Hu ̈nting et al.(1981: Ex. 26–1276)

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68503

TABLE V–11.—EVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS OF THE NECK

AND SHOULDERS WITH EXPOSURE TO NON-NEUTRAL POSTURE—Continued

Measure of posture Health outcome/body region affected Measure of effect Reference

Relative angle of wrist ulnar or radial deviation/45–90 minute work

sampling period.

Wrist ............................................. Linear regression coefficient [adj]:

Mean relative deviation angle

(p<0.05)

Mean relative EMG signal

(p<0.05)

Seniority (years employed)

(p<0.05)

Malchaire et al.(1996: Ex. 26–

1473)

Wrist bending or twisting (mean

hours/day) (5 categories).

Carpal tunnel syndrome ............... Odds Ratio [adj]

0: 1.0

0.25–1.75: 1.34(0.64–2.80)

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

Nordstrom et al.(1997: Ex. 26–

900)

Wrist deviation (3 categories of frequency).Hand/wrist .................................... Prevalence [unadj] (test of trend)

None: 35%

Some: 43%

Frequent: 45% (p=0.43)

Stetson et al.(1993: Ex. 26–1221)

Back

Postural load (index of frequency

and/or duration of 4 postures, in

4 categories).

Low back pain .............................. Odds Ratio [adj] (test for trend) Bovenzi et al.(1994: Ex. 26–774)

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 (hours

per day).

Low back (severe pain with impairment).Prevalence Ratio [adj]:

<1 hr: 1.1 0.8–1.5)

1–4: 1.5 (1.2–2.0)

>4 hr: 1.6 (1.0–2.6)

Holmstro ̈m et al.(1992: Ex. 500–

41–65)

Stopping (hours per day) ................ Low back (severe pain with impairment).Prevalence Ratio [adj]:

<1 hr: 1.3 (0.9–1.8)

1–4 hr: 1.9 (1.4–2.6)

>4 hr: 2.6 (1.7–3.8)

Holmstro ̈m et al.(1992: Ex. 500–

41–65)

Kneeling (hours per day) ................ Low back (severe pain with impairment).Prevalence Ratio [adj]:

<1 hr: 2.4 (1.7–3.3)

1–4 hr: 2.6 (1.9–3.5)

>4 hr: 3.5 (2.4–4.9)

Holmstro ̈m et al.(1992: Ex. 500–

41–65)

Extreme work postures [factor

formed from frequency and duration of trunk forward flexionn

(>60°); frequency of trunk forward

flexion (20°–60°); and duration of

head rotation (>45°), trunk rotation (>45°), and work with hands

above shoulders].

Low back (in blue collar workers) Partial correlation coefficient [adj]

0.16 (p<0.05)

Johansson et al.(1994: Ex. 26–

1331)

Monotonuous working movements

[factor formed from duration of

repetitive movements, static

stress, and sitting].

Low back (in white collar workers Partial correlation coefficient [adj]

0.22 (p<0.05)

Johansson et al.(1994: Ex. 26–

1331)

Driving (hours/week) ....................... Low back ...................................... Odds Ratio [adj] for prevalence:

<10: 1.0

10–14: 1.5 (1.0–2.4)

15–19: 1.2 (0.8–1.9)

20–24: 2.0 (1.3–3.1)

≥ 25 2.1 (1.3–3.4)

Pietri et al.(1992: Ex. 29–309)

68504 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE V–11.—EVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS OF THE NECK

AND SHOULDERS WITH EXPOSURE TO NON-NEUTRAL POSTURE—Continued

Measure of posture Health outcome/body region affected Measure of effect Reference

Driving (hours/week) ....................... Low back ...................................... Odds Ratio [adj] for 1 year cumulative incidence:

<10: 1.0

10–14: 4.0 (1.1–14.3)

15–19: 4.8 (1.4.8–16.4)

20–24: 3.3 (0.9–12.0)

≥ 25 3.7 (0.9–14.0)

Pietri et al.(1992: Ex. 38–309)

Percentage of work cycle in trunk

flexion (3 categories).

Low back ...................................... Odds Ratio [unadj] (test of trend)

Mild flexion:

0%: 1.0

1–10%: 4.2

≥10%: 6.1 (p=0.014)

Severe flexion:

0%: 1.0

0–10%: 4.4

≥10%: 8.9 (p=0.003)

Punnett et al.(1991: Ex. 26–1289)

Percentage of work cycle in nonneutral trunk posture (mild flexion, severe flexion, twist or lateral

bend).

Back ............................................. Odds Ratio [adj]

8.09 (1.5–44.0)

Punnett et al.(1991: Ex. 26–1289)

Twisted or bent postures (4 categories).Low back ...................................... Odds Ratio [adj]

Rather or very little: 1.0

Moderate: 1.3 (1.0–1.7)

Rather much: 1.5 (1.2–1.9)

Very much: 1.5 (1.2–1.9)

Riihima ̊ki et al. (1989: Ex. 26–58)

Forward bending (minutes per day) Low back ...................................... Odds Ratio [adj]:

Men

1–59 min: 1.6 (1.1–2.5)

≥60 min: 1.8 (1.1–3.1)

Women

1–59 min: 1.1 (0.8–1.6)

≥60 min: 1.2 (0.7–1.8)

Vinga ̊rd et al.(2000: Ex. 500–41–

51)

Repeated bending, twisting, and

reaching at work (hours per day.

Back ............................................. Odds Ratio [unadj]

0 hr: 1.0

>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)

Wild (Ex. 26–1106; 26–1107)

Frequent twisting or bending .......... Low back ...................................... Odds Ratio [unadj] (test of trend):

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 (p<0.001)

Xu et al.(1997: Ex. 500–71–53)

Lower Extremity

Knee-bending demand of job (3

categories: none, some, much).

Knee: radiographic osteoarthritis Odds Ratio [adj]

Men, ages 55–64: 2.5 (1.2–5.0)

Women, ages 55–64: 3.5 (1.2–

10.5)

Anderson et al.(1988: Ex. 26–

926)

Kneeling and/or squatting (Floorand carpetlayers 56%, carpenters

25%, compositors 0% of working

time).

Knee ............................................. Odds Ratio [unadj]

Compositors: 1.0

Carpenters: 3.9 (2.7–5.5)

Floor- and carpetlayers: 6.4

(4.0–10.1)

Kirkeskov Jensen et al.[Jensen,

1977#1975]

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 (number

per day).

Knee ............................................. Odds Ratio [adj] Sandmark et al.(2000: Ex. 500–

41–114)

Men .............................................. Medium: 1.3 (0.8–2.2)

High: 2.9 (1.7–4.9)

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68505

TABLE V–11.—EVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIPS FOR MUSCULOSKELETAL DISORDERS OF THE NECK

AND SHOULDERS WITH EXPOSURE TO NON-NEUTRAL POSTURE—Continued

Measure of posture Health outcome/body region affected Measure of effect Reference

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] Vinga ̊rd 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]

Medium: 1.3 (0.8–2.0)

High: 2.1 (1.2–3.6)

Vinga ̊rd et al.(1997: Ex. 26–1616)

TABLE V–12.—EVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIP FOR MUSCULOSKELETAL DISORDERS WITH EXPOSURE

TO SEGMENTAL VIBRATION, BY BODY REGION AFFECTED.

Measure of vibration exposure (unit) Health outcome/body region affected Measure of effect Reference

Vibration exposure (energy equivalent frequency-weighted acceleration) for 4 hours/day.Upper extremity ............................... Odds Ratio [adj]

<7.5 m/sec 2 2.7

>7.5 m/sec 2 14.1

(p<0.005)

Bovenzi et al.(1991: Ex. 500–41–

18)

Daily vibration exposure (energy

equivalent frequency-weighted acceleration).

Upper extremity ............................... Odds Ratio [adj] per unit

1.29 (p<0.5)

Bovenzi et al.(1991: Ex. 500–41–

18)

Daily vibration exposure (energy

equivalent frequency-weighted acceleration).

Upper extremity muscle-tendon syndrome.Odds Ratio [adj] per unit

1.42 (p<0.5)

Bovenzi et al.(1991: Ex. 500–41–

18)

Daily vibration exposure (energy

equivalent frequency-weighted acceleration).

Carpal tunnel syndrome .................. Odds Ratio [adj] per unit

1.73 (p<0.5)

Bovenzi et al.(1991: Ex. 500–41–

18)

Lifetime dose (5 categories of acceleration 2 years).Hand-arm vibration syndrome ......... Odds Ratio [adj] per unit

0: 1.0

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)

Bovenzi et al.(1991: Ex. 500–41–

17)

Riveting (years) .................................. Wrist ................................................. Odds Ratio [adj] per year

1.12 (p<0.05)

Burdorf et al.(1991: Ex. 500–41–21)

Riveting (years) .................................. Hand-arm vibration syndrome ......... Odds Ratio [adj] per year

1.07 (p<0.05)

Burdorf et al.(1991: Ex. 500–41–21)

Power tool usage ............................... Forearm-hand (right) ........................ Median values for

workstations with high vs.

low symptom prevalence

[unadj]

Holding time: 12 sec. vs 6

secs. (p<0.05)

Total duration: 21 sec. vs

15 secs. (p<0.05)

Fransson Hall et al.(1996: Ex. 500–

41–56)

Years of exposure to vibration (chain

saw use).

Vibration-induced white finger ......... Positive association with

duration of exposure

Higher prevalence and earlier onset of symptoms

with earlier first exposure

(higher acceleration levels) (all data presented

graphically)

Futatsuka et al.(1985: Ex. 26–1430)

68506 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE V–12.—EVIDENCE OF EXPOSURE-RESPONSE RELATIONSHIP FOR MUSCULOSKELETAL DISORDERS WITH EXPOSURE

TO SEGMENTAL VIBRATION, BY BODY REGION AFFECTED.—Continued

Measure of vibration exposure (unit) Health outcome/body region affected Measure of effect Reference

Cumulative hours of exposure to vibration.Median and ulnar motor and sensory nerve function.Correlation coefficient

[unadj]

R median motor NCV:

0.274 (p=0.01)

L median motor NCV:

0.123 (p>0.05)

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

Koskimies et al.[Koskimies, 1990

#1983]

Cumulative exposure to vibration (log

hours).

Hand-arm vibration syndrome: ........ Odds Ratio [adj] per common log unitLetz et al.(1992: Ex. 26–384)

Vascular ........................................... 2.9 (1.7–5.0)

Sensorineural ................................... 1.8 (1.2–2.9)

Tool use (years) ................................. Hand-arm vibration syndrome

(Stockholm workshop scales):.

Odds ratio [adj] per year McGeoch et al.(2000: Ex. 500–41–

96)

Neurological stage ≥ 1 ..................... 1.09 (p<0.05)

Vascular stage ≥ 1 ........................... 1.10 (p<0.05)

Years of exposure to vibration ........... Hand-arm vibration syndrome ......... Odds ratio [adj] per year

1.11 (1.05–1.17)

Nilsson et al. (1989: Ex. 26–1148)

Years of exposure to vibration ........... Median nerve latency at carpal tunnel.Odds ratio [adj] per year

Right: 1.12 (1.02–1.23)

Left: 1.09 (1.00–1.20)

Nilsson et al.(1994: Ex. 26–1190)

Cumulative vibration exposure (3 categories: 0–8999; 9000–255,199;

and >255,199 energy-weighted

hours).

Shoulder: osteoarthritis of the

acromioclavicular joint.

Odds Ratio [adj] (per category)

Right side: 1.3 (0.9–1.8)

Left side: 1.8 (1.2–2.6)

Stenlund et al.(1992: Ex. 26–733)

Cumulative vibration exposure (3 categories: 0–8999; 9000–255,199;

and >255,199 energy-weighted

hours).

Shoulder tendinitis ........................... Odds Ratio [adj] (per category)

Right side: 1.7 (1.1–2.6)

Left side: 1.8 (1.1–3.1)

Stenlund et al.(1993: Ex. 502–462)

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.

Exposure factors Health outcome/body region affected Measure of effect Reference

Index of physical stress at work

(sum of 6 items).

Neck ............................................. Odds Ratio [adj]

Age 30–64 years: 1.26 (1.18–

1.33)

Age ≥ 65 years: 1.12 (1.00–

1.26)

Ma ̈kela ̈ et al.(1991: Ex. 26–980)

Index of mechanical workload (sum

of 6 items).

Elbow: epicondylitis ...................... Odds ratio [adj]:

Model 2: 1.5 (1.0–2.3)

Model 3: 1.7 (1.2–2.6)

Ono et al.(1998: Ex. 500–66–4)

Repetition; force (4 categories: LF

= low force; LR = low repetition;

HF = high force; HR = high repetition.

Hand/wrist: tendinitis .................... Prevalence Rate Ratio [unadj]

LF LR: 1.0

HF LR: 4.8 (0.6–39.7)

LF HR: 5.5 (0.7–46.3)

HF HR: 17.0 (2.3–126.2)

Armstrong et al.(1987: Ex. 26–48)

Work at video display unit, with and

without specific job features.

Arm/hand ...................................... Odds Ratio [adj]

Data entry: 1.5 (0.7–3.4)

Data entry plus keyboard too low:

2.8 (0.9–8.6)

≥ 20 hr/week: 0.5 (0.2–1.4)

≥ 20 hr/week plus limited rest

breaks, no lower arm support:

4.6 (1.2–17.9)

Bergqvist et al.(1995: Ex. 26–

1195 500–165–25)

Work at video display unit, with and

without specific job features.

Arm/hand ...................................... Odds Ratio [adj]

Limited rest breaks, plus no lower

arm support, vs. one or neither:

10.1 (2.4–43.2)

Bergqvist et al.(1995: Ex. 500–

165–24)

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68507

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.—Continued

Exposure factors Health outcome/body region affected Measure of effect Reference

Force and repetition of hand activities (5 classes, from very light/

low to very heavy/high).

Hand: Median nerve sensory conduction velocity.Test of positive linear trend:

p < 0.01

Nathan et al.(1988: Ex. 26–990)

Force and repetition of hand activities (5 classes, from very light/

low to very heavy/high).

Hand: Median nerve sensory conduction velocity.Linear regression coefficient [adj]:

Class of hand activity: 0.011 (p <

0.05)

Nathan et al.(1992: Ex. 26–988)

Index of physical risk factors (sum

of 3 items: force; 1 kg, cycle time

< 30 sec, static hand work).

Hand: Radial tunnel syndrome .... P <0.001, test for trend Roquelaure et al.(1996: Ex. 500–

41–111)

Index of physical risk factors (sum

of 5 occupational items plus parity ≥ 3).

Hand: Carpal tunnel syndrome .... Odds ratio [adj]

≤ 2 factors: 1.0

3 factors: 5.6 (1.6–24.5)

4 factors: 93.7 (13.4–93.8)

≥ 5 factors: 90.0 (8.0–366.5)

Roquelaure et al.(1997: Ex. 38–

396)

Repetition; force (4 categories: LF

= low force; LR = low repetition;

HF = high force; HR = high repetition).

Hand/wrist .................................... Odds Ratio [adj]

LF LR: 1.0

HF LR: 5.2

LF HR: 3.3

HF HR: 29.1 (p < 0.05)

Silverstein et al.(1986: Ex. 26–

1404)

Repetition; force (4 categories: LF

= low force; LR = low repetition;

HF = high force; HR = high repetition).

Hand: Carpal tunnel syndrome .... Odds Ratio [adj]

LF LR: 1.0

HF LR: 1.8

LF HR: 2.7

HF HR: 15.5 (p < 0.001)

Silverstein et al.(1987: Ex. 26–34)

Repetitiveness and forceful exertions of the upper limbs (Group I

= neither, Group II = either,

Group III = both).

Test of positive linear trend: Chiang et al.(1993: Ex. 26–1117)

Neck symptoms ............................ p = 0.04

Shoulder symptoms ..................... p = 0.000

Shoulder girdle diagnosis ............. p = 0.000

Elbow symptoms .......................... p = 0.11

Epicondylitis ................................. p = 0.14

Wrist symptoms ............................ p = 0.03

Hand symptoms ........................... p = 0.04

Carpal tunnel syndrome ............... p = 0.02

Index of ergonomic stressors (sum

of 9 items, range 0–25).

Upper extremity (neck, shoulder/

upper arm, elbow/forearm, and/

or hand/wrist).

Prevalence ratio [adj]

0–6: 1.0

7–12: 2.0 (1.2–3.4)

13–18: 2.6 (1.6–4.3)

19–25: 2.8 (1.6–4.8)

Punnett (1998: Ex. 26–38)

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

stress (sum of 5 items, range 0–

5).

Low back ...................................... Odds Ratio [adj]:

0: 1.0

1: 1.2 (0.9–1.6)

2: 1.7 (1.3–2.1)

3: 2.1 (1.6–2.7)

4: 3.2 (2.3–4.5)

5: 2.5 (1.4–4.7)

Helio ̈vaara et al.(1991: Ex. 26–

959)

Lifting >11.3 kg while twisting

Low back: Prolapsed 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 twisting ........ Low back: Prolapsed 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)

Physical exposure index (sum of 3

items, range 0–3.

Low back ...................................... Odds Ratio [adj]:

0: 1.0

1: 1.41 (1.02–1.94)

2: 2.45 (1.63–3.68)

3: 3.18 (1.72–5.81)

Liira et al.(1996: Ex. 26–748)

Forward bending and manual materials handling (MMH) (highly exposed now, 5 and 10 years ago).Low back ...................................... Odds Ratio [adj]: Vinga ̊rd et al.(2000: Ex. 500–41–

51)

68508 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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.—Continued

Exposure factors Health outcome/body region affected Measure of effect Reference

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-climbing, with and without heavy lifting.Knee osteoarthritis ....................... Odds Ratio [adj]:

Neither kneeling nor lifting: 1.0

Kneeling/squatting: 2.5 (1.1–5.5)

Kneeling and lifting: 5.4 (1.4–

21.0)

Cooper et al.(1994: Ex. 500–41–

27)

Kneeling, with (floor layers) and

without (tile/terrazzo setters) use

of knee kicker.

Knee: bursitis ............................... Prevalence ratio [adj]:

Floor layers: 3.2 (1.9–5.4)

Tile setters: 1.8 (0.8–3.9)

Thun et al.(1987: Ex. 26–60)

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 exposureresponse 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

(p<<0.001); rotator cuff syndrome

(p<0.01); and cervical syndrome

(p<0.001). The probability of having no

MSD symptoms showed a negative

trend with years of exposure (p<0.001).

These findings are compatible with

those of Brisson et al., (Brisson et al.,

1989: Ex. 26–937), who examined longterm 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 (ViikariJuntura 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 bioinstrumentation measures and/or

combined into indices. The volume of

evidence is extremely impressive and

demonstrates that such exposureresponse 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, nonneutral 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°

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 exposureresponse 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 (Hu ̈nting 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 exposureresponse relationships with trunk

forward flexion, lateral bending, and

rotation. These studies address nonneutral 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

68510 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 exposureresponse relationships’’ for standardsetting (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 exposureresponse 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; ViikariJuntura 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 nonlinear 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68511

adverse health effects occur, a point

advanced by several in their testimony

to the docket (e.g., United Parcel

Service, Ex. 500–197, pp. I–68; Vender

attachment to UPS post-hearing

comments, Ex. 500–118, page 17). Dr.

Hadler opined that ‘‘whenever a

relationship between exposure and

effect is not linear (not monotonic), you

can be sure there are confounders,

* * *.’’ (Hadler attachment to UPS

post-hearing comments, Ex. 500–118,

page 4). He offered no evidence in

support of this assertion, and in fact

there is no requirement in epidemiology

that the relationship must either be

linear or monotonic. OSHA has relied

on non-linear dose-response

relationships in other health standard

rulemakings (see Formaldehyde, 54

FR46168, Cadmium 57 FR 42101).

Second, most exposure-response

relationships do not indicate a single

exposure level that unambiguously

differentiates risk from no risk. This is

especially true if exposure is treated as

continuous and the relationship fits a

straight line through the origin, in

which case each small increment in

exposure increases the probability of an

adverse health outcome and,

extrapolated downward, there may be

no discernable point without excess risk

above the zero exposure level. Note that

in this regard U.P.S. criticized OSHA for

the assumption that, in fact, UPS had

made: ‘‘OSHA has falsely assumed that

any increment of human muscle usage

is harmful, * * *.’’ (United Parcel

Service, Ex. 500–197, pp. I–68).

On the other hand, when exposures

have been categorized and are ordinally

associated with risk of disease, it can be

argued that the first exposure level

where an elevated risk is observed

above baseline represents an

appropriate point for a permissible

exposure level (at least until subsequent

studies clarify whether there is still

excess morbidity occurring below that

level). This type of approach was taken

recently by the American Conference of

Governmental Industrial Hygienists

(2000), which used essentially the same

epidemiologic evidence available to

OSHA—with its variety of exposure

metrics—to determine the proposed

new Threshold Limit Value for

occupational hand activity level (see

Exs. 38–162, DC–387).

Several authors have called attention

to the complexity of the process of

utilizing exposure-response data for

quantitative risk assessment in the

multi-dimensional domain of physical

ergonomics (e.g., Armstrong et al., 1993:

Ex. 26–1110; Burdorf et al., 1997: Ex.

500–121–13; Frank et al., 1996: Ex. 502–

407; Kilbom, 1999: Ex. 38–406; ViikariJuntura 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 nondifferential 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-exposureresponse 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 casecontrol 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

68512 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

these comparison showed that the

assembly-line packers had a highly

statistically significant (p<0.001)

increased prevalence of (1) syndromes

found in the neck, shoulders and

elbows; and (2) muscle-tendon

syndromes in the hands (p<0.001). 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 assemblyline packers, but only 14% in the shopassistants (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 ‘‘nonpositive’’ 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 muscletendon 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

(p<0.001) 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 repetitivenessstressed 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

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

68514 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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; BieringSorensen 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 WorkRelated 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; BieringSorenson 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

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

68516 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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) strengthtested 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 linearregression 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 averagesized 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 workrelated 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

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

68518 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 covariation 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

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

68520 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 workrelated 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 workrelated 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

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

68522 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 crosssectional studies showing an association

between carpal tunnel syndrome and

physical workplace factors strongly

indicate that exposure to these

workplace factors causes disease. This

conclusion arises in part because it is

illogical to postulate that the presence of

CTS would cause exposure to physical

factors (i.e., workers select themselves

into physically harmful jobs on the basis

of disease status). Dr Gerr testified that

this would be ‘‘like saying cancer causes

smoking. It’s as wrong as it is silly to

hear’’ (Tr. 1525). However, for

psychosocial factors such as poor job

satisfaction or low supervisory support,

it is more difficult to logically infer or

exclude a temporal relationship

between a psychosocial factor and an

MSD; this was described by Dr. Punnett

in her testimony (Tr. 869). That is, it

cannot be known whether having poor

job satisfaction preceded development

of the MSD or whether the presence of

the MSD is causing a worker to become

less satisfied with their job. Thus, in

evaluating the causal nature of

psychosocial factors, the use of a

prospective study design that follows

groups of workers over time becomes

particularly important to evaluate the

temporal relationships between

exposure to biomechanical risk factors,

psychosocial factors, development of

MSDs.

In addition, as was the case with the

biomechanical literature reviewed in

earlier parts of the Health Effects

section, determination of exposure and

health outcome by objective means,

such as direct observation or

measurement of exposure and medical

assessment of health status, is preferable

over sole reliance on worker self-reports

because objective measures rule out the

possibility of reporting bias (e.g., the

possibility that a worker’s disease status

might influence the self-report of

exposure). This design consideration

points to another difficulty in studying

the role of psychosocial factors in that

they can only be assessed by

administering questionnaires or

interviews.

Simultaneous assessment. It is

obvious that to accurately assess the

relative contribution of biomechanical

and psychosocial risk factors to MSD

causation and exacerbation, both classes

of exposure must be measured.

Address collinearity. Levels of both

biomechanical and psychosocial risk

factors are in large part the result of the

way work is organized, the technology

and sector of the company, and the

organizational policies and culture that

drive work organization. Thus the two

classes of stressor are generally highly

correlated in a workplace (Tr. 868–869,

1264, 5942–5943). Concurrent analysis

of exposure-outcome associations must

be very careful to avoid modeling

problems that arise from collinearity.

Assess both stressor categories with

equal precision. Some studies assess

both categories of exposure, but assess

one with more precision or detail than

the other. The category characterized in

more detail presents fewer opportunities

for non-differential exposure

misclassification (which biases results

towards a lower effect) and will thus

show artificially elevated relative

associations with outcome. Dr. Wells

stated that a factor measured with poor

precision in an epidemiological study

will often not appear as a risk factor in

statistical modeling (Tr. 1355).

Ensure adequate variance in all

measures. Studies that assess both

categories of exposure, but with little

variance between exposure groups in

one or the other category of exposure

will generally not find effects associated

with that category or measure.

Regression analysis (a standard

modeling method in many studies)

cannot assess the contribution of an

exposure if its magnitude or intensity is

essentially the same in all study

participants.

Assess both stressor categories at the

same individual or group level. Studies

that assess both categories of exposure,

but at different levels of analysis (i.e.,

the level of the individual worker versus

groups of workers), will generally not

find an effect for the variables measured

at a higher (group) level of aggregation;

this was addressed by Dr. Frank in his

testimony (Tr. 1364–1365). For example,

the Boeing study (Bigos, et al., 1991a, b,

Exs. 26–1241, 26–1242, 1992 Ex. 26–

1393) assessed psychological and

emotional variables at the individual

level and biomechanical variables at the

group level. This error also reflects

violation of the preceding two criteria

since measurement at the group level

reduces both precision in the

biomechanical exposure measure

(compared to measuring exposure at the

individual level) and variance in

biomechanical exposure between

groups. When one variable is aggregated

or represented at the group level, as in

the Bigos measurement of

biomechanical risk, the variations in

exposure within each group are lost;

internal variance within each group is

reduced to zero.

The studies summarized below relied

on assessment of both biomechanical

and psychosocial factors in the

workplace. Thus, in accordance with

the second criteria described above,

studies were excluded if they did not

assess one class of stressor or did not

include both classes in multivariate

analysis. Such studies are useless for the

exploration of combined biomechanical

and psychosocial effects.

The majority of the studies below

demonstrate at least equal, and often

stronger, associations with

biomechanical stressors than with

psychosocial. This fact, combined with

the independent effects of both stressor

classes, as discussed above, is sufficient

to support OSHA’s focus on

biomechanical risk factors in the final

rule. However, relative magnitude of the

associations for biomechanical and

psychosocial risk factors should only be

seen as a qualitative indicator of relative

strength of association with MSD

prevalence or incidence. Actual

quantitative effect sizes may not be

comparable within or between studies

for a number of reasons, including:

• Use of different measurement

scales;

• Use of different analytical strategies

to categorize risk levels; and

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68523

• Use of different outcome measures

in different studies.

Table V–14. summarizes the key

features of the design of each study as

well as the range of measures of

association for biomechanical and

psychosocial factors.

Wickstro ̈m & 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 selfreported 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

Reference Number of

subjects

Study

type

Exposure

measure

Outcome

measure

Study

design Results: outcome and effect

Association with Biomechanical Factors Stronger than with Psychosocial Factors (or effect size not reported)

Wickstro ̈m & 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 & Vanga ̊rd,

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).

Thorbjo ̈rnsson 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.

Vinga ̊rd 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.

68524 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE V–14.—STUDIES ASSESSING BOTH BIOMECHANICAL AND PHYSICAL RISK FACTORS—Continued

Reference Number of

subjects

Study

type

Exposure

measure

Outcome

measure

Study

design Results: outcome and effect

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 β: 0.06–0.16;

Psychosocial β: 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 β: 0.16–0.21;

Psychosocial β: 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 & Ha ̈nninen

(1995).

902 3 1 ............... 1, 3 .......... b, c Back/limb symp. & MD Dx; Physical β: n.s.;

Psychosocial β: .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 (p<0.05)

Key:

Study Type:

1—Cross sectional

2—Case-control/Referent

3—Cohort/Prospective

Exposure Measure:

1—Worker self-report

2—Observation of job

3—Instrumentation

Outcome Measure:

1—Worker self-report

2—Observation/record

3—Clinical findings

Study Design

a—Biomechanical and psychosocial factors studies with equal precision

b—Biomechanical and psychosocial factors assessed at same individual or group level

c—Adequate variance between groups in all measures

* case 2140 con.

** retro. outcome

Bergqvist, Wolgast, Nilsson, Voss 1995

(Ex. 26–1195). hese investigators found

a number of upper extremity diagnoses

to be consistently associated with

standard biomechanical risk factors

(especially postural stressors, ORs 2.2–

4.4, and lack of rest breaks, ORs 2.7–

7.4); some personal factors (especially

age and presence of children at home),

task flexibility (OR 3.2) and quality of

peer contacts (ORs 2.1–4.5) had

independent associations. Although the

study was cross-sectional, confidence in

study findings is improved by the

detailed physical examination used to

determine outcome and the broad array

of exposure measures (including

individual factors, non-work risks, work

organizational factors and

biomechanical factors). Muscle

problems in each body location showed

a different pattern of personal,

psychosocial and biomechanical

stressor associations.

Faucett and Rempel 1994 (Ex. 38–67).

his study of 150 newspaper editorial

work found that upper extremity pain

and numbness symptoms in VDT

workers were related primarily to

postural variables (R2 changes 0.11–

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68525

0.15), with smaller additions to model

R2s from psychological demands,

decision latitude, and employee

relationship with the supervisor (R2

changes 0.03–0.12). The effects of

postural variables on upper torso pain

and stiffness were greater than those for

pain and numbness (R2 changes 0.19–

0.32), while psychosocial effects were

reduced (R2 changes 0.01–0.08).

Interaction terms between keyboard

height and psychosocial variables added

to the model R2s (R2 changes 0.04–0.15),

suggesting that the effect of

biomechanical variables can be

modified by psychosocial variables. In

this study, biomechanical stressors were

clearly the dominant factor, but the size

of the effect for interaction terms may

have meaning for the mechanism of

psychosocial action as being an effect

modifier.

NIOSH Health Hazard Evaluations

(Exs. 26–439, 26–842, 26–725). Three

cross-sectional NIOSH studies, at the

L.A. Times (Bernard, Sauter, Petersen,

Fine, & Hales, 1992, Ex. 500–165–20,

1994, Ex. 26–439), Newsday (Burt, et al.,

1990, Ex. 26–842) and two Social

Security Administration teleservice

centers (Hoekstra et al., 1994, Ex. 26–

725) found associations of

biomechanical risk factors (in particular,

duration of VDU work) with MSD

symptoms, while also finding

independent associations of these

symptoms with several psychosocial

factors. Another NIOSH HHE at U.S.

West Communications (Hales et al. 1992

(Ex. 26–727), 1994 (Ex. 26–131) did not

find associations between symptoms

and physical workplace characteristics

other than use of bifocal glasses (OR

3.8), because the standardized

workstations presented virtually no

variance in biomechanical measures.

Thus, psychosocial factors were

dominant in the models, although work

pressure (OR 1.1–1.2), workload surges

(OR 1.2) and information processing

demands (OR 1.2) probably represent a

combination of physical and

psychosocial exposures. See Table V–

14. for strength of association estimated

by multivariate logistic regression

models in all these studies.

Kerr, et al.2000 (Ex. 38–82).

Researchers at the Institute of Work and

Health (IWH) have carried out several

well-designed studies measuring both

biomechanical and psychosocial

stressor levels in detail. These studies

demonstrate the independent

contributions of biomechanical,

psychosocial and organizational factors

to models explaining back injury and

accidents (Shannon et al., 1996, 1997,

Exs. 26–1368, 26–1369). The most

recent IWH study (Kerr, et al., 2000, Ex.

38–82), performed in concert with the

Ontario Universities Back Pain Study

(OUBPS) group, is a case-control study

reviewed in detail by John Frank (Ex.

37–27). Subjects reported levels of

physical demands (including perceived

exertion) as well as psychosocial factors.

In addition, videotape analysis and

biomechanical modeling provided

quantifiable estimates of actual spinal

loading. These biomechanical measures

acted independently to substantially

increase risk of workers reporting new

cases of LBP, after controlling for

individual and psychosocial factors. In

final models, the biomechanical risk

factors demonstrated ORs of 1.7–3.0,

while psychosocial risks were

associated with ORs of 1.6–2.6. This

study improved on earlier study designs

by directly measuring forces on back

during job performance. The casecontrol 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 selfreported 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 nondisabling 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-weekdriven 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

68526 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 exposureresponse 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 crosssectional 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 randomdigit-dialing study design. This crosssectional 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 physiciandiagnosed 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-intime 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.

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68527

The work organization variable of justin-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.

Vinga ̊rd 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).

Thorbjo ̈rnsson 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

68528 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 noone 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 nonstandard 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 Ha ̈nninen 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 crosssectional 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 workrelated back disorders. Unlike some

other studies (e.g., Leino & Ha ̈nninen,

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

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

Lagerstro ̈m 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 crosssectional, 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 lowback problems.’’ They do acknowledge

the importance of these factors in the

‘‘consequence and maintenance’’ of lowback 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 workrelated 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 longterm 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

& Ha ̈nninen, 1995, Ex. 38–76, ViikariJuntura 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.

68530 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 Va ̈lfors 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). Va ̈lfors 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,

Va ̈lfors 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, nonoccupational 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

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

68532 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 evidencebased 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 evidencebased 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

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

68534 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

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

68536 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

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

68538 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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; p<0.01))

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-ExposureResponse.

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

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

68540 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 workrelatedness 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 workrelated 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

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

68542 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68543

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,

68544 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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:

• ‘‘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;

• ‘‘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

• 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:

• 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

• 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.

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68545

68546 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 nonimpact, 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 posthearing brief, stated that

68548 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

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

68550 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE VI–3.—ESTIMATES OF THE NUMBER OF LOST WORKDAY MUSCULOSKELETAL DISORDERS (MSDS) IN 1996, BY

NATURE OF INJURY AND TYPE OF WORKPLACE EXPOSURE

Nature of injury BLS Code

Type of workplace exposure

Total for all

exposures Overexertion Repetition Subtotal(O and R)

Bodily

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

system diseases

and disorders .... 17 35,238 7,761 18,278 26,039 1,211 27,250

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 (‘‘LostWorktime 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.

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68551

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

68552 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

and cause, for each 2-digit SIC. As

explained above, the BLS-calculated

incidence estimates are based on the

incidence among all employees (fulltime 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).

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68553

68554 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68555

68556 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

1OSHA used two simplifying assumptions when

calculating the probability of experiencing no workrelated 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 workrelated MSD.

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.

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),45

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)45, 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).

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.

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

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

68558 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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.

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 nonwork-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 workrelated 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 workrelated 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 lesserexposed 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., lesserrisk) 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 higherrisk workers. This background risk

represents MSDs that are not workrelated 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 lesserrisk 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

68560 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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.

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68562 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68563

each industry sector by the following

formula:

MSDInc

Pct Pct RR

tot

E E − − [ ] ( ) 1 /

where:

MSDInctot is the MSD incidence among

all workers in the industry sector;

PctE 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

neck/

shoulder

Only

shoulder Elbow Carpal tunnelsyndrome

Hand/wrist

tendinitis

Hand/arm

vibration Back Lowerextremity

Number of Studies Included .. 42 32 18 30 10 12 44 9

Risk Ratios a

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 b

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

a Risk ratios include odds ratios, prevalence rate ratios, and incidence ratios.

bProportion 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 higherrisk 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

P P

P

d −

−

0

0 1

where Pd is the probability of injury or

illness among workers exposed to a

hazard and P0 is the background risk

that occurs among persons who are not

exposed to the hazard. In this case, P0

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.

68564 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68565

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.

68566 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 × 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 workrelated 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 workrelatedness 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 workrelated 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 nonworkplace 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 § 1920.902 of the

proposal. In the final ergonomics

program rule, OSHA has modified its

screening criteria from the performanceoriented 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

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

• The cases reported are only those

that employers have agreed are workrelated,

• The cases reported are only those

that were serious enough to involve at

least one day away from work,

• 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

• 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 underreporting 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 lostwork-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 severalfold 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-theart 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

68568 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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-timeequivalent 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,

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

68570 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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:

• A clearly described intervention,

• Measurable exposure or health

effects endpoints

• Acceptable statistical methods, and

• 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

Study Population Intervention Analytic method Exposure outcome Health effects outcome

Aaras (1994) Ex. 502–

252; Westgaard

(1985) Ex. 26–787;

Westgaard (1984)

Ex. 26–1026.

420 female telecommunication assembly workers.Reduce postural load:

individual adjustment of workstation

height and angle,

increased legroom,

suspending hand

tools, arm supports,

limit vertical dimensions; Design work

to reduce postural

fixity.

Longitudinal survival

analysis (1967–

1984). Exposure

evaluated by

trapezius static

load via EMG, postural angles Outcome: signs &

symptoms, sick

leave due to loadrelated MSDs. Survival analysis.

Decreased postural

load intensity and

duration on

trapezius, reduce

load in hand, reduced shoulder angles.

Reduction in mean

sick leave from 22

days to 1.8 days,

Reduced turnover

from 30.1% to

7.6%, Increased

productivity.

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68571

TABLE VI–11.—SUMMARY OF SCIENTIFIC STUDIES DESIGNED TO ASSESS THE EFFECTIVENESS OF ERGONOMIC

INTERVENTIONS—Continued

Study Population Intervention Analytic method Exposure outcome Health effects outcome

Aaras (1997) Ex. 26–

63.

20 VDU workers ....... Forearm support,

screen sight angle

change.

Laboratory study

using open, randomized GraecoLatin squared trial

with five test conditions using keyboard and then

using mouse,

measurements included descending

m. trapezius and

erector spinae

lumbalis at L3 EMG

and inclinometer.

Trapezius load significantly lower with

forearm support

(both duration and

intensity) with both

sitting and standing. No significant

differences with 15

versus 30 degrees

sightline.

Aaras (1998) Ex. 26–

597.

Male VDU workers,

50 per group.

1 new lighting .........

2 new workplace

design to support

forearms.

3 optical exams and

corrections.

Serial interventions in

2 intervention

groups, 1 control

group, Load measured via EMG and

observation, controlled for psychosocial factors at

work and home.

Reduced trapezius

load in intervention

groups after forearm support and

optometric corrections, Reduced

glare problems in

intervention groups.

Reduced trapezius

pain, in intervention

groups, no change

in forearm pain (appeared to be associated with increased mouse

use, no change in

back 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,

1992–1998.

Implementation of a

program with early

diagnosis and treatment, ergonomic

assessment and

correction: wrist

supports, document

holders, foot rests,

headsets, alternate

keyboards, glare

screens, chairs, etc.

Longitudinal follow-up

of employees reporting to the medical department

after policy to include medical

workup and ergonomic assessments

for UEMSDs starting in 1992. OSHA

200 logs.

Ergonomic assessments (2041), initially with those

with UEMSDs for

job modifications.

By 1994, significantly more assessments on jobs

believed to be risky

prior to injury.

Incidence rate decreased 80% (6.5

in 1992 to 1.3/1000

in 1998), surgery

trend also decreased.

Bohr (1997) Ex. 38–64 600 employees in

three departments

in a large metropolitan medical

center.

Used participatory

worker-management ergonomics

teams to identify

risks and control

strategies.

One year longitudinal

evaluation of the

ability of ergonomic

teams to identify

problems and design solutions.

14 problems identified

and potential solutions considered or

identified.

not assessed.

Brission 1999 Ex. 38–

92.

627 university employees working 5

or more hours per

week with a video

display unit.

Ergonomic training to

identify postural

stressors and make

changes in equipment and work activities.

Six month longitudinal

comparison of postural stressors and

injury statistics in

randomly assigned

experimental

(n=284) and control

(n=343) groups.

Greater decreases in

the prevalence of

three postural

stressors in the experimental group

than the control

group.

Greater decrease in

the prevalence of

musculoskelatal

disorders by both

questionnaire and

physical exam in

experimental group

subjects under 40

years of age than

in the control

group.

68572 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE VI–11.—SUMMARY OF SCIENTIFIC STUDIES DESIGNED TO ASSESS THE EFFECTIVENESS OF ERGONOMIC

INTERVENTIONS—Continued

Study Population Intervention Analytic method Exposure outcome Health effects outcome

Cook (1999) Ex. 38–

205.

20 meatpackers ........ Clamp rather than

hand to hold hog

head while chiseling. Modified handle and tool balance for ham trimming, Air knife to

cut casings rather

than pulling casings

by hand.

RMS EMG measurements if biceps, extrinsic finger and

wrist flexor muscles

after calibration.

Workers randomized order of trials

between old and

new method by

each worker for 30

minutes (multiple

A–B–A–B research

design).

Left wrist and finger

flexor muscle effort

was significantly reduced in chiseling

operation (hand

holding eliminated).

Right wrist and finger flexor muscle

effort significantly

reduced in ham

trimming. Casing

pulling task showed

no significant reduction in muscle

effort.

Drury & Wick (1984)

Ex. 26–1244; Wick

(1987) Ex. 26–1058.

Shoe manufacturing

workers.

Ergonomics program

including employee

training and involvement in developing controls, systematic process of

task analysis, design, testing, implementation and

measurement. Tilted work surfaces,

arm & foot rests,

adjustable chair,

pneumatic pedal,

pallet leveller.

Pre-post study design. Observational

analysis of posture,

force, frequency

every half hour for

week pre and post

intervention, postural discomfort

survey, performance measures

Data for 5 jobs presented.

Prototype implementation showed productivity increased

or remained unchanged, awkward

wrist motions decreased, postural

stress ratings decreased.

Body area discomfort

eliminated (except

forearm). Two year

follow-up of ornament job (Wick)

showed no additional injuries reported.

Evanoff (1999) Ex.

38–32.

100–110 orderlies in

a 1,200 bed urban

hospital.

Used a participatory

worker-management ergonomics

committee to design and implement

changes in training

and work practices

for lifting.

Two year longitudinal

evaluation of pre

and post intervention injury rates and

self reports of

symptoms.

Not reported .............. Decreased OSHA recordable injury and

lost workday rates

(relative risk = 0.64

for all injuries and

0.4 for 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

and one hospital,

employing 57–136

nursing personnel

each.

Used Participatory

employee-management advisory

teams to implement

‘‘zero-lift programs’’.

One year longitudinal

comparison of pre

and post intervention injury statistics.

Not reported .............. For injuries from patient transfers: 62%

decrease in the

number of injuries,

86% decrease in

lost workdays, 64%

decrease in restricted workdays,

84% decrease in

workers’ compensation costs.

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68573

TABLE VI–11.—SUMMARY OF SCIENTIFIC STUDIES DESIGNED TO ASSESS THE EFFECTIVENESS OF ERGONOMIC

INTERVENTIONS—Continued

Study Population Intervention Analytic method Exposure outcome Health effects outcome

Garg & Owen (1992)

Ex.–1093 (1994) Ex.

502–481; Owen &

Garg (1994) Ex. 26–

1415.

57 nursing assistants

in 2 nursing home

units.

Walking belts and

mechanical hoists,

shower chairs.

Pre-post study design: observed

transfer techniques,

rate of perceived

exertion, OSHA

200 logs 4 years

prior to intervention

and 4 months post

intervention.

Significant reduced

perceived exertion

with mechanical

and belt transfers

compared to manual transfers. Mechanical lifts with

scales and shower

chairs reduced the

number of transfers

required per patient.

Back injury incidence

rate decreased

from 83 to 42 per

100 FTEs, Severity

rate decreased

from 634 days to 0

days per 100 FTEs

[Note: short followup time reduces

strength of the

study. There was

an increased in 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

board assembly

workers.

Suspended arms support to reduce neck

and shoulder muscle static loading.

Pre-post intervention

design. Symptoms

(VAS) 12 months

and one week prior

to intervention, and

3 months (n=31)

and monthly ratings

for 1.5 years post

intervention (n=71).

Not reported .............. 31 subjects per-3

months post shoulder symptoms decreased from 62%

to 45%, for neck

decreased from

57% to 55%. Mean

end of shift VAS in

1.5 year follow-up

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 poultry processing plants.

Comprehensive corporate-wide

ergonomics program, including

management commitment, ergonomic

committees, risk

factor checklists,

job analysis, medical management,

education and

training, and job

modification.

Five year longitudinal

evaluation of workers’ compensation

rates and costs and

overall program assessment scores..

Not reported .............. 46% and 20% decrease in UEMSD

incidence rate and

severity rate, respectively. 50%

and 36% decrease

in lifting claims incidence rate and severity rate respectively.

Kadefors (1996) ......... Auto assembly workers in the assembly

versus parallel assembly.

Increase task variability, increase

cycle time, increase

standing upright.

Comparsion of factories with and

without parallel assembly and tilting

car capacity using

observational analysis and EMG.

Reduced time in awkward postures in

each assembly

step when using

tilting device, lower

muscle load with tilt

assembly, reduced

discomfort.

Not described; small

sample size in prefull production

phase limits conclusions.

Loisel, (1997) Ex. 38–

28.

130 employees from

various workplaces,

absent from work

for more than four

weeks with back

pain.

Either occupational

(including ergonomic) or clinical

intervention, separately and in combination.

Population based randomized clinical

trail with three

intervention groups

and one control

group.

Not reported .............. The occupational and

the combined intervention groups returned to regular

work 1.5 and 2.4

times faster than

those in the usual

care intervention

group or the clinical

intervention group.

68574 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE VI–11.—SUMMARY OF SCIENTIFIC STUDIES DESIGNED TO ASSESS THE EFFECTIVENESS OF ERGONOMIC

INTERVENTIONS—Continued

Study Population Intervention Analytic method Exposure outcome Health effects outcome

Marklin & Wilzbacker

(1999).

Electric utility warehouse workers.(a) Raise location of

heavy objects from

below knee to thigh

height.

(b) Replace heavy

oak gate with lighter pine gate.

(c) Modify tool with

extension and better drill bit.

(d) Maintenance of

pulling system.

(e) Height adjustable

lift table for handling meter readers.

(f) Semiautomated

pallet wrap machine.

(g) Power tool for

opening line

clamps.

Pre-post intervention

assessment of exposure in jobs with

historically high injury rates using

NIOSH lifting equation, 3D Static

Strength Prediction

Program, Lumbar

Motion Monitor and

Perceived Exertion.

Reduced lifting index

(a&b), Increased

percentage of population capable (c

& d), Reduction in

probability of back

injury reduced (e &

f), Reduction in

perceived exertion

(g).

Not reported.

McKenzie (1985) ........ 6,600 Telecommunications manufacturing workers.Ergonomics program

with taskforce,

training for engineers and supervisors, improved

workstation and

tools, medical management of restricted workers.

Pre-post program design using OSHA

200 logs for repetitive trauma disorder cases, lost

and restricted days.

Program was implemented in 1981.

Not reported .............. Dramatic decrease in

number of cases,

lost and restricted

days. Authors attribute much of the

improvement in lost

and restricted days

to better medical

management.

Melhorn (1996) Ex.

38–19.

212 rivet gun employees.Random assignment

to various combinations of posture

training, exercise

training and rivet

gun types.

Longitudinal evaluation of risk factors

among eight exposure groups compared with controls.

Decreased risk associated with ergonomic posture

training. Vibration

dampening rivet

guns associated

with decreased risk

among new hires

and increased risk

among previous

hires.

Not assessed.

Melhorn (1999) Ex.

38–131.

3152 newly hired

sheet metal mechanics.

Comprehensive program of education,

job placement,

modifications and

medical management designed for

employees based

on individualized

risk assessments.

Prospective cohort

evaluation with pre

and post intervention comparisons.

Not reported. ............. Increased recordable

case incident rate

and hours worked

per employee. Decreased lost time

case incident rate,

lost time severity

rate, and workers’

compensation costs

per employee. Benefit to cost ratio of

16.5/1.0.

Meyers et al.(1999) .... 194 Wine grape harvest workers in 3

vineyards.

Substitute smaller

tubs to lower

weight to below 50

pounds.

Participatory

ergonomics 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.

Reduced tub weight

from 57 to 47

pounds.

Results not reported.

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68575

TABLE VI–11.—SUMMARY OF SCIENTIFIC STUDIES DESIGNED TO ASSESS THE EFFECTIVENESS OF ERGONOMIC

INTERVENTIONS—Continued

Study Population Intervention Analytic method Exposure outcome Health effects outcome

Miller (1971) Ex. 26–

1250.

Surgeons and scrub

nurses.

Added larger surface

area to handle of

surgical forceps to

increase stability

and decrease load

on fingers.

Pre-post testing of

extensors and

flexors with EMG

over 35 procedures

by six surgeons.

Reduced fatigue and

required recovery

time.

Not applicable.

Moore (1994) Ex. 38–

339–1–35.

5 engine assembly

workers.

Participatory

ergonomics approach: eliminate

carrying 11.6–14.7

kg parts, eliminate

high impact use of

brass head hammers.

Pre-post case study

of one job. OSHA

200 log incidence

data (39 months

pre, 30 months

post), Borg scale,

satisfaction, psychological demands.

Carrying tasks not full

eliminated, manual

hammering eliminated Reduction in

RPE.

UECTD Incidence

rate decreased

78%, 82% decrease in restricted

or lost day rates.

Moore & Garg, (1996)

Ex. 38–24; Moore &

Garg, (1997) Ex.

26–21.

930 pork slaughtering

plant employees.

Two departmental

ergonomics teams

used to analyze

jobs and develop

ergonomics interventions.

Quasi-experimental

design, using post

intervention comparisons of nonequivalent groups.

Exertions per minute,

hand/wrist posture

and strain index

scores improved for

leaf lard pulling job.

Biomechanical

stresses to the lowback, 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.

Not assessed.

Parenmark (1993) ...... Tool and Equipment

manufacturing.

Engineering and organizational improvements in design of new factory:

adjustable work

heights, work technique training, job

enlargement, work

pace decrease

25%, work organization, flexible work

hours, wage system, rehabilitation.

Pre-post design. Follow-up 18 months

after production

started in new factory, emg biofeedback to keep

load below 15–20%

MVC. Sick leave

and turnover rate

were outcome

measures.

Not reported. ............. Sick leave decreased

5%.

Turnover decreased

25%.

Rooney et al.(1992)

Ex. 26–1056.

400 shoe and canvas

luggage manufacturing employees.

Total quality management program,

using an

ergonomics team

‘‘to closely follow

the proposed

OSHA ergonomics

guidelines’’.

Pre and post intervention job analysis.373 job modifications,

85 of which

achieved more than

25% reduction in

force, repetition or

postural stress.

Annual lost time incident rate reduced

from 14.9 to 3.3

per 200,000 hours

during four-year

study period. Not

analyzed for specific associations

with job modifications.

Rosecrance & Cook

(2000) Ex. 38–253.

455 Newspaper employees.Continuous improvement process,

using an

ergonomics committee to manage a

five step problem

solving method.

Pre and post intervention questionnaires and nonstructured interviews.At least one intervention completed in

eleven of twelve office and production

areas, including engineering and administrative

changes to problem

jobs with static postures, repetitive

tasks and non-adjustable

workstations.

Not assessed at 4–6

months post intervention.

68576 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE VI–11.—SUMMARY OF SCIENTIFIC STUDIES DESIGNED TO ASSESS THE EFFECTIVENESS OF ERGONOMIC

INTERVENTIONS—Continued

Study Population Intervention Analytic method Exposure outcome Health effects outcome

St. Vincent (1998) Ex.

500–71–64.

2 electrical product

manufacturing

plants.

Participatory

ergonomics process: 7 jobs with 50

solutions implemented: improving

material feed, repositioning of materials, change in

work station dimensions, change in

product jigs, tool

changes, job enlargement, handling

aids.

Pre-post design.

Video analysis of

posture, force, duration, frequency,

impacts.

78% of solutions reduced risk factors

(postural load,

forces applied),

14% had no observable effect, 8%

could not be evaluated.

Not reported.

Shi (1993) Ex. 26–

1099.

County government

workers.

One year Back injury

prevention program: Individual

health risk assessment at year 1 and

year 2 in intervention group (fitness,

job demands, satisfaction, demographics), training,

ergonomic improvements (lifting devices, gait belts,

improved seating,

minimizing transport).

Pre-post randomized

intervention groups

(n=4, 77% participation) and control

groups (2) with

similar demographics. Measures: Satisfaction,

HRA scores, symptoms prevalence,

workers compensation rates.

Not reported .............. Nonsignificant frequent back pain

prevalence decreased in intervention groups whereas overall prevalence significantly

decreased. Significant increase in job

satisfaction. Significant decrease in

HRA risk status

(not recorded for

control groups).

WC 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

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

68578 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

1Note 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 NB and NA might contain background

MSD cases).

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 ‘‘quasiexperimental’’ 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

( ) NB AB − N N/

where NB represents the number or

incidence of MSD cases prior to

implementation of the ergonomic

intervention, and NA represents the

number or incidence after the

intervention 1.

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

• 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;

• The necessity of conducting

randomized controlled trials to

determine whether ergonomics

programs will, in fact, be effective;

• OSHA’s reliance on the

epidemiological data in making

inferences about the effectiveness of

ergonomics programs; and

• 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, privatesector 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 materialshandling 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, workrelated 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:

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

• ‘‘Is there ‘reasonable cause’ * * *

to believe that exposure to the putative

hazard truly does lead to measurable

adverse health effects?’’;

• ‘‘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

• ‘‘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, nonneutral 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

68580 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 exposureresponse 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 AnheuserBusch 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.

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

68582 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 workrelated 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

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

68584 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 minibreaks) 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

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

68586 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 plantwide 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 nonwork 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

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

68588 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 postimplementation (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)

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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 upperlimb 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 upperlimb 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 * * * preintervention 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

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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 corporatewide 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 coauthored 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

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engage in the type of individual causeand-effect analysis that would be

necessary to link the observed reduction

in reported MSD cases to the sit-stand

workstation as opposed to other nonergonomic 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:

• 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).

• Although Seton has investigated

incidents of MSD symptoms, the

company has no one trained to do a job

hazard analysis (Tr. 3066).

• 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)

68592 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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.

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68638 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68640 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68642 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68644 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68646 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68648 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68650 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68652 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68654 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68656 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68658 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68660 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68662 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68664 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68666 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68668 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68670 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68672 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68674 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68676 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68678 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68680 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68682 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68684 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68686 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68688 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68690 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68692 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68694 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68696 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68698 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68700 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68702 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68708 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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68710 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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BILLING CODE 4510–26–C

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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 lostworkday 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; Vinga ̊rd 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

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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 workrelated 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 upperextremity 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

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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 nonsection 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 workrelated 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 workrelated 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68755

Health Effects sections of the preamble

demonstrate that the risk of workrelated 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 threefold 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 workrelated 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.

68756 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

TABLE VII–I.—SUMMARY OF UNDERREPORTING STUDIES

Study Measure of underreporting Extent of underreporting observed Additional detail

McCurdy, Schenker, and Samuels,

Am. J. Public Health. 81:85

(1991) Ex. 2–2.

Percentage of cases meeting

OSHA reporting criteria not recorded on OSHA Log.

40% of all reportable cases not

recorded; for illnesses, 56% not

recorded.

10 manufacturing facilities in 6

states from semiconductor industry with approx. 50,000 employees; 24% cases met OSHA

recording criteria.

NIOSH. Health Hazard Evaluation

Report, HETA 93–0233–2498,

(1995) Ex. 26–1255.

Failure to report lost workdays

and restricted work on OSHA

200 Log.

Not quantified; ‘‘several’’ employees had surgeries for WMSDs

in 5-year period and 1⁄3 of employee were on restricted work,

but no LWDIs reported on Log

over 5-year period.

Winding and taping department of

an instrument transformer manufacturer; 27 employees in department.

NIOSH. Health Hazard Evaluation

Report, HETA 93–0860–2438,

(1994) Ex. 26–1256.

Percent of medically confirmed

WMSD cases not recorded on

OSHA Log or not reported to

employer.

5 employees reported to NIOSH

that they had been diagnoses

with carpal tunnel syndrome

(CTS); of these, 2 did not report their illness to the employer. 1 of the 5 reported

cases were not reported on log.

News department of large metropolitan TV-news station; video

tape editor and other employees.

Silverstein, Stetson, Keyserling,

and Fine Am. J. Ind. Med. 31:600

(1997) Ex. 26–28.

Incidence (per 100 workers

years) of work-related MSDs,

reported on OSHA 200 logs

compared with cases that received medical treatment, as

identified by self-administered

questionnaire.

Plant/year; OSHA 200 Log; Selfreport:

Plant 1: .....................................

1986: 1.0; 30.9 ......................

1987; 2.7; ..............................

1988; 6.9; ..............................

Four automobile manufacturing

plants. 713 out of 948 workers

selected for the study completed the 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, Anderson, and Sugano, JOM. 28:674

(1986) Ex. 26–920.

Incidence (per 100 worker-years)

of upper-extremity MSDs reported on OSHA 200 logs compared with workers’ compensation (WC), medical absence

records (MAR) and medical

case records (MCR).

Plant; 200; OSHA WC, MAR,

MCR:

B; 0.03; 0.29; 3.04; 2.03 ...........

C: 0.15; 0.45; 1.85; 13.98 ........

Data from two large automobile

manufacturing plants (total employment not reported).

Pransky, Snyder, Dembe, and

Himmelstein, Ergonomics. 42:171

(1999) Ex. 26–922.

Percent of workers reporting musculoskeletal symptoms caused

or aggravated by work, compared to OSHA Log entries.

Work-related Symptom; % reporting; % on Log:.

Hand/Wrist; 86%; 6%

Arm; 33%; 1%

Neck; 21%; 0

Back/legs; 28%; 2%

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 lightduty work arranged by co-workers..

Questionnaire administered to

110 packers, of whom 98 responded. Plant produces variety of childrens’ products.

Park, Krebs, and Mirer JOEM.

38:1111 (1996) Ex. 26–1261.

Number of claims made in a sickness and accident (S&A) disability (sick leave) system compared to lost-work-day (LWD)

injuries and illnesses recorded

in OSHA log.

Only 7 of an estimated 47 (15%)

S&A upper extremity LWD

cases in 1992 were recorded

on the OSHA Log. For LWD

back injuries, 27 of an estimated 36 (75%) S&A cases

were recorded.

Study of an automotive assembly

and stamping complex employing 10,000 workers.

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68757

TABLE VII–I.—SUMMARY OF UNDERREPORTING STUDIES—Continued

Study Measure of underreporting Extent of underreporting observed Additional detail

Park, Nelson, Silverstein, and

Mirer, JOM. 34:731. (1992) Ex.

26–1259.

Medical insurance claims linked

to work histories compared to

OSHA logs.

From 1984 to 1987, OSHA logs

failed to record between 20 and

80 percent of occupational

MSDs..

Conclusion based on authors’

own unpublished data from insurance records of five automotive manufacturing plants.

These records identified 11,577

MSD health claims made by

3,204 workers.

Nelson, Park, Silverstein, and

Mirer, Am. J. Public Health.

82:1550 (1992) Ex. 26–1260.

Medical insurance claims linked

to work histories compared to

OSHA logs..

From 1985 through 1986, OSHA

logs identified 59 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

Report, HETA 88–344–2092

(1991) Ex. 32–450–1.

Percentage of workers with workrelated (W–R) upper extremity

(UE) MSDs not seeking medical care. W–R UE MSD cases

defined by NIOSH standardized

symptom questionnaires and

positive physical findings from

physician-conducted physical

examinations.

40% of supermarket checkers

with WR UE MSD did not seek

medical care.

W–R MSD’s not brought to the

attention of a health care professional (HSP) will not be recorded on the OSHA 200 logs.

NIOSH Health Hazard Evaluation

Report, HETA 90–273–2130

(1991) Ex. 32–450–1–13.

Percentage of workers with W–R

UE MSD not seeking medical

care and whether they were recorded on the OSHA 200 logs.

W–R UE MSD defined by

NIOSH standardized symptom

questionnaires.

85% of employees with W–R UE

MSD symptoms were not evaluated by a HSP.

A small fraction of those with W–

R UE MSD were recorded on

the OSHA logs.

Jewelry manufacturing employees

exposed to repetitive, forceful,

and awkward postures during

job tasks (MSD hazards).

NIOSH Health Hazard Evaluation

Report, HETA 92–331 (close-out

letter) (1993) Ex. 32–450–1.

Evaluation to determine compliance with OSHA corporate settlement agreement. Review of

plant’s health clinic algorithm to

evaluate and treat symptomatic

workers.

Large numbers of symptomatic

workers evaluated by HAPS

and prescribed a temporary job

transfer. HSP deemed these as

‘‘preventive’’ job transfers and

did not record these on the

OSHA 200 logs.

Red meatpacking plant employees exposed to MSD hazards.

BLS requires cases involving

employees with W–R symptoms assigned a job transfer to

be record onto the logs.

NIOSH Health Hazard Evaluation

Report, HETA 95–0294–2594

(1996) Ex. 32–450–1–22.

Percentage of workers with W–R

UE MSD not seeking medical

care and whether they wer recorded on the OSHA 200 logs.

W–R UE MSD defined by

NIOSH standardized symptom

questionnaires.

75% of employees with W–R UE

MSD did not seek medical care.

A small fraction of those with W–

R UE MSD were recorded onto

the OSHA 200 logs.

Research technicians conducting

pipetting operations with MSD

hazards.

NIOSH Health Hazard Evaluation

Report, HETA 96–0101–2476

(1997) Ex. 32–450–1–26.

Employee health records and employee interviews compared

with the plant’s OSHA 200 logs.

23% of employees with W–R UE

MSD not recorded onto the

OSHA 200 logs.

Truck frame assumably employees exposed to MSD hazards.

Same method used to determined

the accuracy of the number of

lost and restricted workdays recorded.

The number of actual lost or restricted work days significantly

under-reported.

Under-reporting the lost or restricted workdays gives the impression of a less serious disorder.

NIOSH Health Hazard Evaluation

Report, HETA 97–0276–2724

(1999) Ex. 32–450–1–2.

Clinic employee report of injury illness forms compared with the

plant’s OSHA 200 logs.

Employee health records compared with the plant’s OSHA

200 logs..

Many entries listed on the Clinic

Employee Report of Injury/Illness forms and many cases

from individual employee health

records were not recorded on

the OSHA 200 logs.

Fiberglass manufacturing plant

employees exposed to MSD

hazards.

NIOSH Health Hazard Evaluation

Report, HETA 98–0085–2715

(1998) Ex. 32–450–1–10.

Comparison of workers reporting

MS symptoms on a body map

diagram with the OSHA 200

logs.

Several discrepancies between

these two lists. Employees

probably not reporting all W–R

symptoms to employer.

Casket manufacturing employees

exposed to MSD hazards.

68758 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 workrelated 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 workrelated 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 onethird 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,

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 crosssectional and 6 case control studies of

carpal tunnel syndrome, Hagberg et

al.(1992, Ex. 26–50) estimated the workattributable 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). Exposureresponse 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 twodigit 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:

• Repetitive motion: This category

reflects the risk factor of repetition;

however, such exposure is often

combined with force and/or posture.

• Overexertion: This category reflects

the risk factor of force; however, such

exposure is often combined with

repetition and/or posture.

• 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

68760 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 workrelated 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 workrelated 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 lowerextremities; 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 crosssectional, 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 workrelated 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 workrelated MSD even in a single year of

work in their job.

68762 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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:

• Identify the establishments and

industries potentially affected by the

rule;

• 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;

• 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;

• Assess the economic feasibility of

the rule for affected industries;

• Evaluate the principal regulatory

and non-regulatory alternatives to the

final rule that OSHA has considered;

• Present the Final Regulatory

Flexibility analysis for the ergonomics

program rule; and

• 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 NonRegulatory 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68763

1Employers 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.

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:

• 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 establishmentspecific details;

• 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;

• 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;

• 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;

• A provision permitting employers

to use a variety of methods to conduct

job hazard analysis;

• A provision permitting employers

to demonstrate that they have met their

hazard control obligations in any one of

a variety of ways;

• 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;

• 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.

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:

• 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

• 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

• 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

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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:

• An HCP determines that the

employee can never return to the former

job;

• The employee is able to return to

the former job without endangering his

or her recovery; or

• 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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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:

• 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.

• 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.

• 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.

• 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.

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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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2OSHA 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.

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 :

• Reducing absenteeism because a

worker is less likely to take time off to

recover from muscle soreness, fatigue,

etc.;

• Reducing turnover, particularly

since new hires are more likely to find

an ergonomically designed job within

their physical capacity;

• 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:

• 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.

• 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.

• 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.

• 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 perestablishment 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

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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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3The 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.

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

(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.

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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 § 11.10(a)(3) states:

Preparation of an environmental impact

statement will always be required for

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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 § 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 (AnheuserBusch 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, performanceoriented 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;

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(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

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

68822 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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

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

68824 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 employerdominated 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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. § 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 employerdominated 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 ‘‘brainstorming’’ groups or ‘‘informationgathering’’ 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

68826 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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.

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

§ 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.

§§ 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 ADAcovered 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 ADAcovered 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 MSDrelated 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

68828 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 WRPleave 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

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

68830 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 prehearing 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 prehearing 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:

• Tuberculosis—123 day pre-hearing

comment period. 63 FR 5905 (Feb. 5,

1998).

• Butadiene—91 day pre-hearing

comment period. 55 FR 42406 (Oct. 19,

1990).

• Bloodborne Pathogens—76 day prehearing comment period. 54 FR 23042

(May 30, 1989).

• 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:

• The National Coalition on

Ergonomics (NCE) submitted a 156 page

comment, as well as attachments of 321

pages. Ex. 30–3956.

• The U.S. Chamber of Commerce

(Chamber) submitted a 95 page

comment, as well as attachments of 524

pages. Ex. 30–1722.

• 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.

• 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.

• 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 posthearing 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 prehearing 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,

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 68831

awkward posture, static posture, contact

stress, cold temperatures, and

vibration); thus, AISI argued that OSHA

was obligated to set a 210 day prehearing 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 prehearing 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 prehearing 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 webpage. 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 prehearing 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 prehearing comment period, it also delayed

the start of the hearing until March 13,

2000, 11 days after the close of the prehearing 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 webpage. 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

68832 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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:

• American College of Occupational

and Environmental Medicine

—Rescheduled from 4/13/2000 to 5/11/

2000.

• American Iron and Steel Institute—

Rescheduled from 4/07/2000 to 4/18/

2000.

• American Society of Safety

Engineers—Rescheduled from 5/09/

2000 to 4/21/2000.

• International Order of the Golden

Rule—Rescheduled from 4/07/2000 to

4/12/2000.

• Levi-Strauss—Rescheduled from 4/

18/2000 to 5/04/2000.

• National Automobile Dealers

Association—Rescheduled from 4/13/

2000 to 4/14/2000.

• Association for Suppliers of

Printing, Publishing, and Converting

Technologies—Rescheduled from 3/31/

2000 to 5/09/2000.

• Screenprinting and Graphic

Imaging Association International—

Rescheduled from 3/22/2000 to 4/12/

2000.

• UniSea Inc.—Rescheduled from 4/

27/2000 to 5/02/2000.

• 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:

• Round 1— Ten minutes per

questioner. Tr. p. 1–27.

• Round 2— 20 minutes per

questioner. Tr. p. 1–244.

• Round 3— 20 minutes per

questioner. Tr. p. 615.

• 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,

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 41⁄2 hours, and the public

questioners, including both labor and

industry representatives, had been

allocated 31⁄2 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 prehearing 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 crossexamination 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:

• In order to expedite the conduct of

the proceeding;

• In order to provide greater

protection to interested persons

whenever it is found necessary or

appropriate to do so; or

• 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

68834 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 Prehearing Guidelines signed by the

Administrative Law Judge laid out the

following similar parameters:

• The purpose of the hearing was for

information gathering and clarification;

the hearing was not an adjudicative one

but rather an informal administrative

proceeding.

• Each hearing day would end when

the scheduled testimony and questions

for the day had been completed.

• 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.

• 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.

• 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.

• Participants having similar interests

should, if possible, designate one

representative to conduct the

questioning on their behalf.

• If an organization were represented

by more than one questioner, only one

person should question a witness on a

particular topic area.

• Questions should be brief and

should be designed to clarify a

presentation or elicit information within

the competence or expertise of the

witness.

• A tentative 120 day post-hearing

comment period was established.

Docket H–371, Ex. 24; See also Prehearing 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).

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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, 31⁄2 hours,

for questioning of the NIOSH panel. (In

total, OSHA scheduled NIOSH for a 41⁄2

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 21⁄2 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 crossexamination. 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.

• 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.

• 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.

• 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

68836 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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:

• Keller & Heckman LLP requested 40

minutes to testify and canceled its

appearance. See Exs. 32–215; 32–215–1.

• 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.

• NCE’s economic task force

requested 130 minutes to testify and

canceled its appearance. See Ex. 32–

375; Tr. pp. 12036–41.

• 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

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

• OSHA generally relied upon

additional underlying data that it did

not make available to the public.

• 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.

• The Docket Office only stays open

for 6 hours a day.

• The computer systems and printers

were not operating perfectly—there

were occasional computer and printer

failures.

• 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.

• The copying fee of 15 cents a page

was excessive.

• OSHA relied on a NIOSH review of

2000 studies in supporting the proposed

rule; ‘‘the 2000 studies were not’’ in the

docket.

• One economic document appeared

to be named differently in the

Preliminary Economic Analysis than in

the preamble.

• The Docket Index was incomplete

at certain times during the pre-hearing

comment period.

• 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:

• 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.

• 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.

• 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.

68838 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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:

• 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.

• Armstrong T. et al. [1987a].

Ergonomic considerations in hand and

wrist tendinitis. J. Hand. Sur.

12A(5):830–837. Ex. 26–48.

• Bigos S. et al. [1986b]. Back injuries

in industry: a retrospective study. III.

Employee-related factors. Spine 11:252–

256. Ex. 26–871.

• 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. § 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,

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

68840 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 crossexamination.’’ 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 posthearing 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.

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

• NCE et al. submitted 906 pages of

new information and data and

submitted a 565 page brief. See Exs.

500–118; 500–197.

• The Chamber submitted 22 pages of

new information and data and

submitted a 107 page brief. See Exs.

500–109; 500–188.

• 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.

• 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:

• Powered Industrial Trucks—90 day

post-hearing comment period. 63 FR

66237 (Dec. 1, 1998).

• Cadmium—90 day post-hearing

comment period. 57 FR 42101 (Sept. 14,

1992).

• Process Safety Management—90

day post-hearing comment period. 57

FR 6356 (Feb. 24, 1992).

• 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

68842 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 nonrecord 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 posthearing 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

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

68844 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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, BlackburnChristainsburg, 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

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 § 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. § 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 § 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 § 1320.5(a)(1)(iv) and

§ 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 § 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

68846 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 workrelated 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.

§ 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.

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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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BILLING CODE 4510–26–C

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(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

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

68852 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations

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 § 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

§ 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.

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Rules and Regulations 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 Employee Participation.Initiate within 30 calendar days after you determine that a job meets

the Action Trigger.

Paragraph (t)(4)(i): Train Employees involved in setting up and managing your ergonomics program.Within 45 calendar days after you determine that a job 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, supervisors or team leaders.Within 90 calendar days after you determine that the 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 § 1910.900

Non-Mandatory Appendix A to § 1910.900:

What You Need To Know About

Musculoskeletal Disorders (MSDs)

Non-Mandatory Appendix B to § 1910.900:

Summary of the OSHA Ergonomics

Program Standard

Appendix C to § 1910.900 [Reserved]

Appendix D to § 1910.900: Hazard

Identification Tools

Appendix D–1 to § 1910.900: Ergonomics Job

Hazard Analysis Tools (Mandatory)

Appendix D–2 to § 1910.900: VDT

Workstation Checklist

Appendix E: Ergonomics Rule Flow Chart

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Non-Mandatory Appendix B to § 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 § 1910.900 [Reserved]

Appendix D to § 1910.900: Hazard

Identification Tools

Appendix D to § 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 § 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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