[House Report 105-730]
[From the U.S. Government Publishing Office]



105th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES

 2d Session                                                     105-730
_______________________________________________________________________


 
                     SOUND SCIENTIFIC PRACTICES ACT

                                _______
                                

 September 18, 1998.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

_______________________________________________________________________


   Mr. Goodling, from the Committee on Education and the Workforce, 
                        submitted the following

                              R E P O R T

                             together with

                             MINORITY VIEWS

                        [To accompany H.R. 2661]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Education and the Workforce, to whom was 
referred the bill (H.R. 2661) to establish peer review for the 
review of standards promulgated under the Occupational Safety 
and Health Act of 1970, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.
  The amendment is as follows:
  Strike out all after the enacting clause and insert in lieu 
thereof the following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Sound Scientific Practices Act''.

SEC. 2. PEER REVIEW.

  (a) General Rule.--Whenever the Secretary of Labor determines that a 
standard should be promulgated under section 6(b) of the Occupational 
Safety and Health Act of 1970, the Secretary shall, in order to serve 
the objectives of such Act and in lieu of the authority of the 
Secretary to appoint an advisory committee described in section 6(b)(1) 
of such Act, appoint a panel of individuals to review--
          (1) the scientific and economic data which forms the basis 
        for such standard; and
          (2) the relevance of the data to industries and workers which 
        would be affected by such standard.
  (b) Panel.--A panel appointed under subsection (a) shall be balanced 
in terms of the points of view represented and shall consist of persons 
who are able to give independent judgment and who have expertise in 
scientific or economic analysis related to the matter which is the 
subject of the standard. Any individual with a financial interest in 
the outcome of the standard shall be excluded as a member of the panel 
unless such individual fully discloses such interest to the Secretary.
  (c) Reports.--Reports of the panel, including any individual or 
minority reports, shall be published together with any proposed or 
final rule promulgating a standard. The Secretary shall provide a 
written response to all significant comments of the panel and shall 
include such responses with the proposed or final rule to which the 
reports of the panel are attached.
  (d) Negotiated Rulemaking.--The requirement of subsection (a) shall 
not apply when the rule is completed through negotiated rulemaking 
under subchapter III of chapter 5 of title 5, United States Code.

                                PURPOSE

    The purpose of H.R. 2661, the Sound Scientific Practices 
Act, is to require the Occupational Safety and Health 
Administration (OSHA) to conduct peer review of the scientific 
and economic data which serves as the basis for an occupational 
safety and health standard.

                           LEGISLATIVE ACTION

    The Subcommittee on Workforce Protections held a series of 
three hearings in 1997 on the subject of Occupational Safety 
and Health Administration's ``reinvention'' plans.
    The first hearing was held on June 24, 1997, to learn the 
views and perspective of OSHA in its effort to ``reinvent'' the 
agency. The Acting Assistant Secretary for OSHA, Greg Watchman, 
testified at the hearing.
    The second hearing was held on July 23, 1997, to examine 
OSHA's reinvention project, hearing testimony from a variety of 
individuals who have either studied or had recent experiences 
with OSHA. The witnesses included Mr. Ronald D. Schaible, 
Director, Global Safety, AMP Incorporated, Harrisburg, 
Pennsylvania, testifying on behalf of the National Association 
of Manufacturers; Ms. M. Kathleen Winters, Corporate Manager, 
Environmental Health and Safety, Mack Printing Company, Easton, 
Pennsylvania, testifying on behalf of Printing Industries of 
America, Inc.; Dr. Gary Rainwater, President, American Dental 
Association, Dallas, Texas; Mr. James J. Gonzalez, Attorney-at-
Law, Holland & Hart LLP, Denver, Colorado; Mr. Richard S. 
Baldwin, Safety and Health Director, BE & K Engineering and 
Construction Company, Birmingham, Alabama, testifying on behalf 
of Associated Builders and Contractors; Professor John 
Mendeloff, Graduate School of Public and International Affairs, 
University of Pittsburgh, Pittsburgh Pennsylvania; Ms. Lee Anne 
Elliott, Executive Director, Voluntary Protection Programs 
Participants' Association, Falls Church, Virginia; and Mr. 
Michael J. Wright, Director, Health, Safety and Environment, 
United Steelworkers of America, Pittsburgh, Pennsylvania.
    The third hearing was held on September 11, 1997, to hear 
from individuals with a first-hand knowledge of OSHA's 
reinvention program and on changes that should occur as OSHA 
moves into the 21st century. The following witnesses testified: 
Mr. Gerald V. Anderson, President, Anderson Construction 
Company, Inc., Fort Gaines, Georgia, testifying on behalf of 
the Associated General Contractors of America; Mr. James L. 
Abrams, Attorney-at-Law, Denver Colorado; Mr. Frank A. White, 
Vice President, Organization Resources Counselors, Inc., 
Washington, DC; Mr. Michael C. Nichols, Vice President, 
Management Development/Human Resources, SYSCO Corporation, 
Houston, Texas; Mr. Norbert Plassmeyer, Vice President and 
Director of Environmental Affairs, Associated Industries of 
Missouri, Jefferson City, Missouri; and Nicholas A. Ashford, 
Ph.D, J.D., Professor of Technology and Policy, Massachusetts 
Institute of Technology, Cambridge Massachusetts.
    The Subcommittee on Workforce Protections held two 
legislative hearings in 1998 on several bills amending the OSH 
Act, including two bills to require OSHA to conduct peer review 
of scientific and economic data used in rulemakings (H.R. 2871 
and H.R. 2661). The first hearing was held on March 27, 1998, 
and the following witnesses testified: Ms. Claudia Brumm, 
Director, Risk Management, Borg Warner Automotive, Inc., 
Chicago, Illinois, testifying on behalf of the Labor Policy 
Association; Mr. Linwood O. Smith, Vice President, Risk and 
Safety Management, T. A. Loving Company, Goldsboro, North 
Carolina, testifying on behalf of the Associated General 
Contractors of America; Mr. James ``Mike'' McMichael, The 
McMichael Company, Central, South Carolina, testifying on 
behalf of the National Association of Home Builders; Mr. Ronald 
W. Taylor, Attorney-at-Law, Venable, Baetjer & Howard, 
Baltimore, Maryland, testifying on behalf of the United States 
Chamber of Commerce; Mr. Jerry Hartman, President, Reese Press, 
Inc., Baltimore, Maryland, testifying on behalf of the Printing 
Industries of America, Inc.; and Ms. Margaret M. Seminario, 
Director, Occupational Safety and Health Department, American 
Federation of Labor-Congress of Industrial Organizations (AFL-
CIO), Washington, DC.
    The Subcommittee on Workforce Protections held a second 
hearing on April 29, 1998, on pending legislation to amend the 
OSH Act, including H.R. 2871 and H.R. 2661. The following 
witnesses testified at the hearing: Mr. Charles N. Jeffress, 
Assistant Secretary for Occupational Safety and Health, 
Occupational Safety and Health Administration, U.S. Department 
of Labor, Washington, DC; Mr. George R. Salem, Attorney-at-Law/
Partner, Akin, Gump, Strauss, Hauer & Feld, LLP, Washington, 
DC, testifying on behalf of the National Association of 
Manufacturers; Mr. Richard E. Schwartz, Attorney-at-Law/
Partner, Crowell & Moring LLP, Washington, DC, testifying on 
behalf of the American Iron & Steel Institute; Mr. John W. 
Bishop, President, Gurnee Heating & Air Conditioning 
Corporation, Closter, New Jersey, testifying on behalf of 
Associated Builders and Contractors; Mr. David G. Sarvadi, 
Attorney-at-Law, Keller and Heckman, Washington, DC; and Mr. 
Thomas J. Meighen, Safety & Risk Manager and Vice President, 
Stromberg Sheet Metal Works, Inc., Beltsville, Maryland, 
testifying on behalf of the Mechanical Electrical Sheet Metal 
Alliance.
    The Subcommittee on Workforce Protections approved H.R. 
2661, as amended, by a roll call vote of 6-4 on May 14, 1998, 
and ordered the bill favorably reported to the Full Committee. 
The Committee on Education and the Workforce approved H.R. 
2661, as amended, by a roll call vote of 24-15 on June 10, 
1998, and ordered the bill favorably reported to the House of 
Representatives.

                            COMMITTEE VIEWS

Background

    Peer review is the critical evaluation of scientific and 
technical work products by independent experts.\1\ Expert 
review of government regulations is not a new topic, but is one 
that has been of considerable interest to many Members of 
Congress and their constituents given the increased presence of 
the federal government in the nation's economic affairs.
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    \1\ U.S., General Accounting Office, Peer Review: EPA's 
Implementation Remains Uneven (GAO/RCED-96-236, September 24, 1996), p. 
1.
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    Peer review has been recommended as a helpful regulatory 
reform by a wide variety of groups that have studied the 
federal government's environmental, health and safety 
rulemaking processes, including the Presidential/Congressional 
Commission on Risk Assessment and Risk Management.\2\ The 
Commission had this to say about peer review in its final 1997 
report: \3\
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    \2\ The Presidential/Congressional Commission on Risk Assessment 
and Risk Management was mandated by Congress in 1990 ``to make a full 
investigation of the policy implications and appropriate uses of risk 
assessment and risk management in regulatory programs under various 
Federal laws to prevent cancer and other chronic human health effects 
which may result from exposure to hazardous substances . . . The 
Commission held hearings across the country and made recommendations 
about the uses and limitations of risk assessment, economic analysis, 
risk management, and regulatory decision-making.'' Final Report, vol. 2 
(1997), pp. 103-105.
    \3\ U.S., The Presidential/Congressional Commission on Risk 
Assessment and Risk Management, Risk Assessment and Risk Management in 
Regulatory Decision-Making, vol. 2 (1997), p. 103.

          Peer review is an important and effective mechanism 
        for evaluating the accuracy or appropriateness of 
        technical data, observations, interpretations, and the 
        scientific and economic aspects of regulatory 
        decisions. . . . Peer review should play a critical 
        role in evaluation of the quality of technical 
        information used in regulatory decision-making. Peer 
        review of economic and social science information 
        should have as high a priority as peer review of 
        health, ecological, and engineering information. The 
        primary criterion for membership on peer review panels 
        should be expertise in the area of concern; however, 
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        financial conflicts must be avoided.

    Not only is peer review important to credible regulatory 
action, but it is also a common and widely accepted aspect of 
credible science generally. As the General Accounting Office 
stated:\4\
---------------------------------------------------------------------------
    \4\ U.S., General Accounting Office, Peer Review: EPA's 
Implementation Remains Uneven (GAO/RCED-96-236, September 24, 1996), p. 
2.

          Peer review is well established as a mechanism for 
        assuring the quality, credibility, and acceptability of 
        individual and institutional work products. This 
        assurance is accomplished by having the products 
        undergo an objective, critical review by independent 
        reviewers. Peer review has long been used by academia, 
---------------------------------------------------------------------------
        professional organizations, industry, and government.

    Many government agencies regularly use peer review in 
making scientific and regulatory decisions. Congressionally 
mandated peer review of both grants and research occurs at the 
National Institutes of Health.\5\ At the Consumer Product 
Safety Commission (CPSC), a formal peer review process is 
required before issuance of certain rules related to cancer, 
birth defects, or gene mutations, and the agency employees peer 
review voluntarily in certain cases with scientific 
controversy.\6\ The Environmental Protection Agency and the 
Department of Energy use peer review in their regulatory 
processes.\7\ Several states-including Alaska, Arizona, 
California, Connecticut, Florida, Georgia, Kansas, Louisiana, 
Maine, Michigan, New York, North Dakota, Ohio, Tennessee, and 
Texas-specifically incorporate peer review in various portions 
of their state code.\8\ The General Accounting Office has 
recently recommended that the Office of Management and Budget 
encourage all federal agencies to conduct peer review of 
economic analyses used as the basis for regulatory actions.\9\
---------------------------------------------------------------------------
    \5\ U.S., Congress, House, Committee on Education and the 
Workforce, Subcommittee on Workforce Protections, Review of the 
Occupational Safety And Health Act, 105th Cong., 2nd sess. (April 29, 
1998). Testimony of Mr. Richard E. Schwartz, Attorney-at-Law/Partner, 
Crowell & Moring LLP, Washington, DC, testifying on behalf of the 
American Iron & Steel Institute.
    \6\ U.S., The Presidential/Congressional Commission on Risk 
Assessment and Risk Management, Risk Assessment and Risk Management in 
Regulatory Decision-Making, vol. 2 (1997), p. 104.
    \7\ U.S., Congress, House, Committee on Education and the 
Workforce, Subcommittee on Workforce Protections, Review of the 
Occupational Safety And Health Act, 105th Cong., 2nd sess. (March 27, 
1998). Testimony of Mr. Ronald W. Taylor, Attorney-at-Law, Venable, 
Baetjer & Howard, Baltimore, Maryland, testifying on behalf of the 
United States Chamber of Commerce.
    \8\ Ibid.
    \9\ U.S., General Accounting Office, Regulatory Reform: Agencies 
Could Improve Development Documentation, and Clarity of Regulatory 
Economic Analyses (GAO/RCED-98-142, May 1998), p. 33.
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    In its report on the use of peer review by the 
Environmental Protection Agency (EPA), the General Accounting 
Office described the benefits of peer review not only to the 
quality of regulations but also to the agency: \10\
---------------------------------------------------------------------------
    \10\ U.S., General Accounting Office, Peer Review: EPA's 
Implementation Remains Uneven (GAO/RCED-96-236, September 24, 1996), p. 
1.

          . . . [EPA's] senior leadership has stated that peer 
        review is an important mechanism for enhancing the 
        quality, credibility, and acceptability of products 
        that may ultimately form the basis of regulations and 
        other key decisions by the agency. Properly 
        implemented, peer review can also conserve resources by 
        steering product development along the most efficient, 
        effective course, thereby avoiding costly and time-
        consuming delays. EPA's current policy, issued in June 
        1994, expands on the agency's prior policy and 
        practices. The new policy continues to emphasize that 
        major scientific and technical work products should 
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        normally be peer reviewed.

    Peer review is so widely accepted that the U.S. Supreme 
Court has observed that ``submission to the scrutiny of the 
scientific community is a component of `good science.' '' \11\ 
An article in the New England Journal of Medicine indicated 
that ``when properly used it is a powerful means of protecting 
and improving the quality of what is published. Peer review has 
its limitations, but it is hard to imagine how we could get 
along without it.'' \12\
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    \11\ Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 
593 (1993).
    \12\ Relman and Angell, ``How Good is Peer Review,'' New England 
Journal of Medicine, vol. 321, pp. 827-829 (September 21, 1989), cited 
in testimony of Mr. Richard E. Schwartz, Attorney-at-Law/Partner, 
Crowell & Moring LLP, Washington, DC, testifying on behalf of the 
American Iron & Steel Institute, at a hearing before the House 
Subcommittee on Workforce Protections, April 29, 1998.
---------------------------------------------------------------------------
    Despite the overwhelming body of opinion that peer review 
is essential to credible science and regulatory action, OSHA 
still has failed to incorporate peer review into its regulatory 
process, and only infrequently has submitted data used as the 
basis for a standard to an independent peer review process.\13\ 
The Committee believes that independent peer review is 
essential to ``sound science'' in OSHA rulemaking, just as it 
is for other regulatory agencies and throughout the scientific 
community.
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    \13\ The Department of Labor drafted a peer review policy for OSHA 
in 1991; however it was not formally adopted, and the effort to do so 
was dropped by the Clinton Administration.
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Peer review in OSHA's standard-setting process

    OSHA's standard-setting process is set forth in section 
6(b) of the OSH Act.\14\ Information supporting a proposed 
standard is developed by OSHA and/or submitted by interested 
persons.\15\ OSHA must publish a proposed rule in the Federal 
Register and allow not less than 30 days for interested persons 
to submit comments and/or request a public hearing on the 
proposed rule.\16\ Subsequent to the comment period and 
whatever time for public hearing is provided, OSHA may issue a 
final rule.\17\ In order to satisfy the purposes of notice and 
comment under the OSH Act and the Administrative Procedures 
Act, the final rule must generally follow-be the ``logical 
outgrowth'' of-the agency's proposed rule.\18\ Thus, the 
analysis and technical decisions of the agency prior to the 
publication of the proposed rule dictate to a large extent the 
agency's final regulatory decisions.
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    \14\ 29 U.S.C. Section 655(b). In addition, a number of other 
statutes and executive orders may apply to the process of writing an 
occupational safety and health standard, including the Administrative 
Procedures Act, the Paperwork Reduction Act of 1965, the Small Business 
Regulatory Fairness Enforcement Act, the Negotiated Rulemaking Act, and 
Executive Order No. 12866.
    \15\ 29 U.S.C. Section 655(b)(1).
    \16\ 29 U.S.C. Section 655(b)(2),(3).
    \17\ 29 U.S.C. Section 655 (b)(4).
    \18\ See, e.g., Fertilizer Institute v. EPA, 935 F.2d 1303 (D.C. 
Cir. 1991); Rybacheck v. EPA, 904 F.2d 1276 (9th Cir. 1990)
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    H.R. 2661 requires that independent peer review of the 
scientific and economic data take place ``whenever the 
Secretary of Labor determines that a standard should be 
promulgated.'' The bill thus requires peer review of the 
economic and scientific data before a proposed standard is 
published. Requiring independent peer review of technical data 
early in the rulemaking process, before the proposed rule is 
published, will help ensure that the standard is based on sound 
science and help OSHA avoid misinterpretations and mistakes 
that might otherwise set the agency's standard in an 
``unsound'' direction.

The need for expert review of OSHA standards

    For years, the Committee has heard testimony that OSHA's 
safety and health standards are burdensome and excessively 
costly and ineffective in improving safety and health.\19\ 
Despite promises by the Clinton Administration to ``reinvent'' 
OSHA and deliver ``common sense'' regulations, concerns about 
OSHA rulemakings remain strong.
---------------------------------------------------------------------------
    \19\ U.S., Congress, House, Committee on Economic and Educational 
Opportunities, Subcommittee on Oversight and Investigations, Hearing on 
the Need for Regulatory Reform: The Case of OSHA and NIOSH, 104th 
Cong., 1st sess., ser. 104-11 (February 16, 1995).
---------------------------------------------------------------------------
    These concerns were expressed during Subcommittee on 
Workforce Protection hearings. Mr. Ronald D. Schaible, Director 
of Global Safety for AMP, Inc. in Harrisburg, Pennsylvania 
testified that ``OSHA continues to pursue promulgation of 
standards that would amount to super-regulation of the 
workplace, resisting calls for peer review and independent 
studies . . . AMP [remains] concerned . . . [about] OSHA's 
over-regulation of the workplace.'' \20\
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    \20\ U.S., Congress, House, Committee on Education and the 
Workforce, Subcommittee on Workforce Protections, Hearing to Examine 
the Occupational Safety and Health Administration's Reinvention 
Project, 105th Cong., 1st sess. (September 11, 1997). Testimony of Mr. 
Ronald D. Schaible, AMP, Inc., Harrisburg, Pennsylvania.
---------------------------------------------------------------------------
    Mr. Jerry Anderson, President of Anderson Construction 
Company in Ft. Gaines, Georgia testified--\21\
---------------------------------------------------------------------------
    \21\ Ibid. Testimony of Mr. Jerry Anderson, Anderson Construction 
Company, Fort Gaines, Georgia.

          While the ``Reinvent OSHA'' was a recognition by OSHA 
        that its traditional approach to enforcement was no 
        longer relevant, it falls short in one crucial respect. 
        None of the changes proposed in ``Reinvent OSHA'' are 
        permanent. There are no guarantees that the next OSHA 
        administrator will maintain the policies set forth in 
        the ``Reinvent OSHA'' initiative. The question facing 
        Congress is how to make both the changes within OSHA 
        and the positive safety and health achievements 
---------------------------------------------------------------------------
        occurring in the private sector permanent.

    Mr. Anderson then went on to testify in support of OSHA 
safety and health standards based on sound science. He stated 
that most OSHA safety and health standards are broadly written 
standards that end up imposing huge compliance costs on 
contractors.\22\ ``Moreover, OSHA's safety and health standards 
do not have to be based on peer-reviewed sound science. . . . 
By requiring OSHA safety and health standards to be based on 
sound science, the agency will be forced to focus its 
regulatory efforts on those hazards that harm the most workers. 
It will also keep OSHA from enforcing safety and health 
standards that do little to enhance workplace safety.'' \23\
---------------------------------------------------------------------------
    \22\ Ibid.
    \23\ Ibid.
---------------------------------------------------------------------------
    Mr. Michael C. Nichols, Vice President for Management 
Development and Human Resources for SYSCO Corporation also 
testified about problems with OSHA's standard-setting process: 
\24\
---------------------------------------------------------------------------
    \24\ Ibid. Testimony of Mr. Michael C. Nichols, SYSCO Corporation, 
Houston, Texas.

          . . . we are skeptical of such initiatives [like 
        OSHA's safety and health program standard, its indoor 
        air pollution rule, and its desire for an ergonomics 
        program] because they are supported by inadequate 
        science, are likely to be vague in critical respects 
        (raising daunting compliance challenges), and seek to 
        superimpose Federal government `solutions' to problems 
        and safety challenges that many employers successfully 
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        handle on their own.

    As these and other witnesses have testified, the history of 
OSHA's standards demonstrates a need to improve OSHA's 
regulatory process. But even if OSHA's regulatory record were 
better, peer review should be a part of the agency's rulemaking 
process. Promulgating sound safety and health standards is a 
difficult challenge. As one expert on the process stated before 
the Subcommittee on Workforce Protections: \25\
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    \25\ U.S., Congress, House, Committee on Education and the 
Workforce, Subcommittee on Workforce Protections, Review of the 
Occupational Safety And Health Act, 105th Cong., 2nd sess. (April 29, 
1998). Testimony of Mr. David Sarvadi, Washington, DC.

          Regarding peer review, the scientific decisions being 
        made by agencies today are complex and difficult, often 
        at the cutting edge of scientific knowledge. Given the 
        changing nature of this knowledge, it seems 
        unquestionable that it would be advantageous to have 
        outside review of agency scientists' work. Indeed, in 
        all other endeavors, an individual's efforts are 
        subject to the kind of critical review that we think of 
        when we use the words, peer review.
          A second reason for supporting peer review is that 
        the agency staff cannot possibly have expertise in all 
        of the areas that a regulation needs to address. It 
        must of necessity consult outside experts. In this 
        sense, the peer review bill simply requires OSHA to 
        formalize what should already be a part of its process. 
        And it offers the benefit of giving greater stature and 
        prestige to the decisions which are now made solely by 
        those on the inside.

Peer review will improve the standard-setting process

    Even though the Department of Labor claims that peer review 
is unnecessary,\26\ other witnesses before the Subcommittee on 
Workforce Protections have described how peer review would 
improve OSHA's standard-setting process. For example, Mr. 
Richard Schwartz described past mistakes that could have been 
avoided: \27\
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    \26\ Ibid. Testimony of Mr. Charles N. Jeffress, Assistant 
Secretary for Occupational Safety and Health, Occupational Safety and 
Health Administration, U.S. Department of Labor, Washington, DC.
    \27\ Ibid. Testimony of Mr. Richard E. Schwartz, Attorney-at-Law/
Partner, Crowell & Moring LLP, Washington, DC, testifying on behalf of 
the American Iron & Steel Institute.

          OSHA has made some major mistakes that could have 
        been prevented by peer review. For example, AISI 
        objected to OSHA's 1989 air contaminants rulemaking-
        which involved 428 substances simultaneously-because 
        AISI believed that OSHA was not using good science. 
        Unions also challenged the standards on the grounds 
        that OSHA had not properly used the scientific data. 
        Eventually, the U.S. Court of Appeals agreed with us 
        and vacated the standards-but only after OSHA had 
        wasted an immense amount of time on them, and AISI had 
        expended considerable resources on litigation. The 
        court pointed out that 'in most cases, OSHA cited a few 
        studies and then established a [Permissible Exposure 
        Limits] PEL without explaining why the studies mandated 
        the particular PEL chosen.' The court also faulted OSHA 
        for relying on assumptions that had no basis in 
        reputable scientific evidence. These sorts of errors 
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        are likely to be spotted by a peer review panel.

    Errors such as the one described in the preceding paragraph 
result in years of wasted effort and costs by both the 
Department of Labor and by the parties who would be affected by 
the standard. Indeed, the GAO's study of EPA's implementation 
of peer review made precisely the same point: not conducting 
peer review can be more costly to the agency in time and 
resources than conducting peer review because it can help avoid 
mistakes that later take years to correct.\28\
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    \28\ U.S., General Accounting Office, Peer Review: EPA's 
Implementation Remains Uneven (GAO/RCED-96-236, September 24, 1996), p. 
4.
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Explanation of the Sound Scientific Practices Act (H.R. 2661)

    The Sound Scientific Practices Act was introduced by 
Representative Scott McInnis with bipartisan cosponsorship. It 
is similar to legislation (H.R. 2871) introduced by 
Representative Cass Ballenger. H.R. 2661 requires independent 
peer review of standards promulgated under the Occupational 
Safety and Health Act of 1970. During markup by the 
Subcommittee on Workforce Protections, Representative Cass 
Ballenger offered an amendment in the nature of a substitute 
which was accepted by voice vote. The amendment to H.R. 2661 
makes three changes to the bill as it was introduced by 
Representative McInnis.
    The first change is similar to a provision in a ``peer 
review'' bill (H.R. 2871) introduced by Representative 
Ballenger. This provision requires that if OSHA adopts a rule 
as a result of negotiated rulemaking, then a separate peer 
review of the scientific and economic basis for the standard is 
not required (though OSHA is not prohibited from conducting 
peer review). Mr. Ronald Taylor, a witness before the 
Subcommittee, clearly stated the rationale for this change: 
\29\
---------------------------------------------------------------------------
    \29\ U.S., Congress, House, Committee on Education and the 
Workforce, Subcommittee on Workforce Protections, Review of the 
Occupational Safety And Health Act, 105th Cong., 2nd sess. (March 27, 
1998). Testimony of Mr. Ronald W. Taylor, Attorney-at-Law, Venable, 
Baetjer & Howard, Baltimore, Maryland, testifying on behalf of the 
United States Chamber of Commerce.

          Peer review expands on and will complement the 
        success of negotiated rulemaking. It shares the same 
        benefits that negotiated rulemaking affords the 
        standards-setting process-critical review by diverse 
        parties, yielding sounder, more widely accepted 
---------------------------------------------------------------------------
        standards and the prospect of decreased litigation.

    The second change made by the Ballenger amendment is to 
strengthen the requirement that the peer review panel be 
independent of the agency. The amendment specifically added 
that the ``panel appointed under subsection (a) shall be 
balanced in terms of the points of view represented and shall 
consist of persons who are able to give independent judgement 
and who have expertise in scientific or economic analysis 
related to the matter which is the subject of the standard.'' 
Peer review is successful only if the members are viewed as not 
being influenced by the agency. The Presidential/Congressional 
Commission on Risk Assessment and Risk Management stated that: 
\30\
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    \30\ U.S., The Presidential/Congressional Commission on Risk 
Assessment and Risk Management, Risk Assessment and Risk Management in 
Regulatory Decision-Making, vol. 2 (1997), p. 104.

          Peer review should provide balanced, independent 
        views. When used well, peer review can serve as a 
        system of checks and balances for the technical aspects 
---------------------------------------------------------------------------
        of the regulatory process.

Appointing peer review panels which are balanced, expert, and 
independent is the most important aspect of effective peer 
review. The obligation to do so under H.R. 2661 is on the 
Secretary of Labor.
    The third provision of the Ballenger amendment provides 
that the peer review panels required by H.R. 2661 are in lieu 
of ``standards advisory committees'' currently authorized by 
section 6(b)(1) of the OSH Act. The amendment replaces OSHA's 
current standards advisory committees, which do not have a 
clear purpose in the statute, with peer review panels, which do 
have a clear purpose and are a well-established aspect of 
credible regulatory proceedings.
    Section (2)(b) of H.R. 2661 requires that any individual 
appointed to the peer review panel must fully disclose any 
financial interests in the outcome of a standard to the 
Secretary of Labor or the individual will be excluded from the 
panel. This provision ensures those individuals with the 
knowledge and expertise needed to provide peer review of 
complex and difficult OSHA standards are able to do so while 
also bringing any potential conflicts of interest out into the 
open.\31\
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    \31\ General ``conflict of interest'' provisions in other laws, 
such as 18 U.S.C. Section 208, would also apply to peer review panels.
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    Section (2) (c) of the bill requires that reports of the 
panel will be published with any proposed or final rule 
promulgating a standard and that the Secretary of Labor shall 
provide a written response to all significant comments of the 
panel and includes copies of these responses with the proposed 
or final rule. This provision ensures that the public remains 
informed of the decisions reached by the peer review panel and 
the necessary action taken by the Department of Labor in 
response to these views.
    In testimony before the Subcommittee on Workforce 
Protections, the Assistant Secretary of Labor for Occupational 
Safety and Health gave four reasons for the Department of 
Labor's opposition to H.R. 2661: (1) peer review is unnecessary 
because the OSH Act requires notice, comment, and opportunity 
for public hearing; (2) peer review will delay the time 
required to issue standards; (3) peer review will ``provide 
[peer review panel members] an additional closed-door 
opportunity to influence rulemaking after the public process is 
complete''; and (4) H.R. 2661 would create an additional 
statutory committee.
    The Assistant Secretary's arguments do not reflect the bill 
as passed by the Committee. First, as described above, peer 
review of the economic and scientific data would be required in 
the ``pre-proposed rule'' stage, before the major decisions 
about the direction and parameters of the standard are set. 
Under the OSH Act, notice and comment on standards are at a 
later point in the rulemaking process, and serve a different 
purpose than does peer review.\32\
---------------------------------------------------------------------------
    \32\ U.S., General Accounting Office, Peer Review: EPA's 
Implementation Remains Uneven (GAO/RCED-96-236, September 24, 1996), p. 
3.
---------------------------------------------------------------------------
    Second, there is simply no evidence to support the 
Assistant Secretary's claim that peer review delays rules. In 
fact, the Chairman of the Subcommittee on Workforce Protections 
has repeatedly asked witnesses, including the Assistant 
Secretary, for evidence to back up that claim, and none was 
submitted. As mentioned earlier, the only evidence on this 
point is to the contrary: EPA has found that not doing peer 
review can delay standards.
    Third, peer review is not a ``closed door process'' that 
would give unfair advantage to panelists. The bill requires 
that the full report, including minority views, of the panel be 
published with the proposed rule. In addition, the Federal 
Advisory Committee Act \33\ applies to the appointment and 
conduct of the peer review panels. That law requires that all 
panel member meetings shall be open to the public and records 
of meetings be available to the public.\34\
---------------------------------------------------------------------------
    \33\ U.S.C. Appendix 2, Sections 1-15.
    \34\ U.S.C. Appendix 2, Section 9.
---------------------------------------------------------------------------
    Fourth, H.R. 2661 does not add any new ``statutory 
committee.'' While requiring OSHA to use peer review panels, it 
repeals the current authority for advisory committees whose 
function and purpose is less defined.
    Finally, peer review would not impose a substantial 
financial burden on OSHA. In responding to questions from the 
House Committee on Appropriations, the Assistant Secretary for 
OSHA indicated that the anticipated cost for a peer review 
panel would range from $36,000 to $54,000 for each panel 
convened. Over its 28-year history, OSHA has averaged between 2 
and 3 completed rulemakings per year. Thus, the cost of peer 
review is not a substantial amount, but will help ensure that 
the standards which OSHA does complete are based on sound and 
acceptable use of technical data and information.

Conclusion

    The Sound Scientific Practices Act is one of several steps 
needed to bring about reform in OSHA. It is reasonable 
legislation that helps bring increased accountability to the 
federal regulatory process. As the sponsor of H.R. 2661, 
Representative Scott McInnis said: \35\
---------------------------------------------------------------------------
    \35\ U.S., Congress, House, Committee on Education and the 
Workforce, Subcommittee on Workforce Protections, Review of the 
Occupational Safety And Health Act, 105th Cong., 2nd sess. (March 27, 
1998). Statement of the Honorable Scott McInnis, Member of Congress, 
March 27, 1998.

          This legislation would put common sense back into the 
        regulatory process. I believe that it is important to 
        consult with individuals who are experts in the 
        affected field, and the government will have greater 
        access to this expertise if a peer review system is 
        implemented. This is logical and rational legislation; 
        rather than creating regulations in a vacuum, OSHA will 
        be forced to consider testimony from sources outside 
        the federal government.

                                summary

    The Sound Scientific Practices Act establishes peer review 
of standards promulgated under the OSH Act. It requires OSHA to 
appoint an independent panel of scientific experts to provide 
peer review of the scientific and economic data on which a 
proposed OSHA standard is based.

                      section-by-section analysis

Section 1. Short title

    The title of the bill is the ``Sound Scientific Practices 
Act.''

Section 2. Peer review

    This section of the bill subjects standards promulgated 
under section 6(b) of the Occupational Safety and Health Act of 
1970 to independent scientific peer review by a panel of 
experts who will review the scientific and economic data 
underlying OSHA standards and the relevance to industries and 
workers affected by a standard. OSHA's current advisory 
committees are repealed and replaced by the peer review panels. 
This section also states that if a rule is adopted as a result 
of negotiated rulemaking, a separate peer review of the 
scientific and economic basis for the standard is not required.

                 statement of constitutional authority

    H.R. 2661 requires that standards promulgated under the OSH 
Act be subject to independent peer review and thus falls within 
the scope of Congressional powers under Article I, Section 8, 
Clause 3 of the Constitution of the United States to the same 
extent as does the OSH Act.

                       explanation of amendments

    The Amendment in the Nature of a Substitute is explained in 
the body of this report.

              APPLICATION OF LAW TO THE LEGISLATIVE BRANCH

    Section 102(b)(3) of Public Law 104-1 requires a 
description of the application of this bill to the legislative 
branch. This bill, the Sound Scientific Practices Act, requires 
the Occupational Safety and Health Administration (OSHA) to 
conduct peer review of the scientific and economic data which 
serves as the basis for an occupational safety and health 
standard. The bill does not prevent legislative branch 
employees from receiving the benefits of this legislation.

                       UNFUNDED MANDATE STATEMENT

    Section 423 of the Congressional Budget and Impoundment 
Control Act requires a statement of whether the provisions of 
the reported bill include unfunded mandates. This bill, the 
Sound Scientific Practices Act, requires the Occupational 
Safety and Health Administration (OSHA) to conduct peer review 
of the scientific and economic data which serves as the basis 
for an occupational safety and health standard. As such, the 
bill does not contain any unfunded mandates.

  STATEMENT OF OVERSIGHT FINDINGS AND RECOMMENDATIONS OF THE COMMITTEE

    In compliance with clause 2(l)(3)(A) of rule XI and clause 
2(b)(1) of rule X of the Rules of the House of Representatives, 
the Committee's oversight findings and recommendations are 
reflected in the body of this report.

 STATEMENT OF OVERSIGHT FINDINGS OF THE COMMITTEE ON GOVERNMENT REFORM 
                             AND OVERSIGHT

    With respect to the requirement of clause 2(l)(3)(D) of 
rule XI of the Rules of the House of Representatives, the 
Committee has received no report of oversight findings and 
recommendations from the Committee on Government Reform and 
Oversight on the subject of H.R. 2661.

                           COMMITTEE ESTIMATE

    Clause 7 of rule XIII of the Rules of the House of 
Representatives requires an estimate and a comparison by the 
Committee of the costs that would be incurred in carrying out 
H.R. 2661. However, clause 7(d) of that rule provides that this 
requirement does not apply when the Committee has included in 
its report a timely submitted cost estimate of the bill 
prepared by the Director of the Congressional Budget Office 
under section 403 of the Congressional Budget Act.

     BUDGET AUTHORITY AND CONGRESSIONAL BUDGET OFFICE COST ESTIMATE

    With respect to the requirements of clause 2(l)(3)(B) of 
rule XI of the House of Representatives and section 308(a) of 
the Congressional Budget Act of 1974 and with respect to 
requirements of 2(l)(3)(C) of rule XI of the House of 
Representatives and section 403 of the Congressional Budget Act 
of 1974, the Committee has received the following cost estimate 
for H.R. 2661 from the Director of the Congressional Budget 
Act:

                                     U.S. Congress,
                               Congressional Budget Office,
                                     Washington, DC, July 14, 1998.
Hon. William F. Goodling,
Chairman, Committee on Education and the Workforce, U.S. House of 
        Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 2661, the Sound 
Scientific Practices Act.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Cyndi 
Dudzinski.
            Sincerely,
                                         June E. O'Neill, Director.
    Enclosure.

H.R. 2661--Sound Scientific Practices Act

    Summary: H.R. 2661 would require the Secretary of Labor to 
appoint an advisory panel when promulgating an occupational 
safety and health standard. Under current law the Secretary 
may, at her discretion, appoint an advisory committee in such 
situations. Since such an advisory body is not now convened 
every time the Secretary promulgates a rule, passage of the 
bill would increase the time and resources spent on the 
rulemaking process. The Occupational Health and Safety 
Administration (OSHA), which enforces occupational safety and 
health regulations has an authorization of such sums as 
necessary. If appropriations are made in the full amount of the 
additional resources required to fulfill the requirements of 
this legislation, CBO estimates that enacting H.R. 2661 would 
result in additional discretionary spending of $3 million over 
the 1999-2003 period.
    H.R. 2661 would not affect direct spending or receipts; 
therefore pay-as-you-go procedures would not apply. The 
legislation also does not contain any intergovernmental or 
private-sector mandates as defined in the Unfunded Mandates 
Reform Act and would not affect the budgets of state, local, or 
tribal governments.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 2661 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health). For the purposes of this estimate, CBO assumes that 
appropriations would be made to pay for the additional 
resources that would be used by OSHA to fulfill the 
requirements of this legislation. CBO also assumed that such 
appropriations would be made by the start of each fiscal year 
and that outlays would follow the historical spending patterns 
for OSHA.

                                    [By fiscal year, in millions of dollars]
----------------------------------------------------------------------------------------------------------------
                                                                   1998    1999    2000    2001    2002    2003
----------------------------------------------------------------------------------------------------------------
                                        SPENDING SUBJECT TO APPROPRIATION
Spending Under Current Law:
  Budget Authority \1\..........................................     336     348     360     372     384     396
  Estimated Outlays.............................................     335     347     358     370     382     394
Proposed Changes:
  Authorization Level...........................................       0       1       1       1       1       1
  Estimated Outlays.............................................       0   (\2\)       1       1       1       1
Spending Under H.R. 2661:
  Authorization Level...........................................     336     349     361     373     385     397
  Estimated Outlays.............................................     335     347     359     371     383     395
----------------------------------------------------------------------------------------------------------------
\1\ The 1998 level is the amount appropriated for that year.
\2\ Less than $0.5 million.

    Basis of estimate: Under current law OSHA has the authority 
to convene an advisory committee when promulgating a rule. 
However, OSHA rarely exercises this option. Therefore, by 
requiring OSHA to convene an advisory panel and conduct a peer 
review every time a rule is promulgated, H.R. 2661 would 
increase the resources and time put into the rulemaking 
process. Based on information from OSHA, CBO estimates that it 
would cost approximately $45,000 to pay for the expenses of a 
peer review panel and $35,000 in contract funds and about one 
additional full-time employee to respond to the peer review 
comments. OSHA promulgates about 5 regulations per year. As a 
result, CBO estimates that implementing the proposal under H.R. 
2661 would increase OSHA's costs by $0.7 million in fiscal year 
1999. If appropriations are made in the full amount of these 
costs, federal discretionary spending would increase by $0.1 
million in fiscal year 1999 and $3 million over the 1999-2003 
period.
    Pay-as-you-go considerations: None.
    Intergovernmental and private-sector impact: H.R. 2661 
contains no intergovernmental or private sector mandates as 
defined in the Unfunded Mandates Reform Act and would not 
affect the budgets of state, local, or tribal governments.
    Estimate prepared by: Federal Costs: Cyndi Dudzinski, 
impact on State, Local, and Tribal Governments: Marc Nicole, 
impact on the Private Sector: Kathryn Rarick.
    Estimate approved by: Paul N. Van de Water, Assistant 
Director for Budget Analysis.


                             Roll Call Vote




              MINORITY VIEWS--H.R. 2661 SEPTEMBER 18, 1998

    We strongly oppose H.R. 2661 as reported by Committee. If 
enacted, this legislation will place significant and 
unreasonable burdens on the ability of the Occupational Safety 
and Health Administration (OSHA) to ensure the safety and 
health of workers. This legislation does not enhance or improve 
the process by which health and safety standards are developed. 
Rather, H.R. 2661 appears to be intended to afford special 
business interests a further opportunity to influence the 
rulemaking process; to delay by months, and perhaps years, the 
time it takes for OSHA to issue standards; and to invite 
unnecessary and time-consuming litigation challenging such 
standards as are issued. H.R. 2661 will not improve the way 
standards are developed, nor will it lessen litigation.
    Under OSHA's current procedures, proposed standards and the 
underlying scientific and economic data and analyses are 
subject to extensive public review. Written comments are 
solicited and public hearings are conducted where OSHA presents 
its analyses and is subject to cross examination by all 
interested parties. OSHA's current procedures ensure full 
public review of the standard and the underlying data 
supporting the standard.
    Creating a closed process involving panels that include 
representatives with a direct interest in the outcome of the 
rulemaking will not improve the scientific basis for the 
standard. Normal practice for scientific peer review panels is 
to exclude anyone with a direct economic interest in the 
outcome. H.R. 2661, as introduced, permitted people who 
represented entitled that had a potential conflict of interest 
to serve on panels so long as that information was disclosed. 
The bill, as introduced, also provided that where a standard 
affected a single entity, no peer reviewer representing that 
entity may be included on the review panel.
    As reported by Committee, the bill is significantly worse. 
Only those with a direct financial interest in the outcome of 
the standard have an obligation to publicly disclose what is 
clearly a conflict of interest. Where a panel member works for 
an entity that has an interest in the outcome of standard, but 
does not have a personal financial interest in the standard, no 
public disclosure is required under the chairman's amendment. 
In addition, the language prohibiting reviewers who represent 
an entity from serving on panels considering a standard that 
solely affects that entity was dropped in Committee. In effect, 
the legislation now not only invites those who have a direct 
conflict of interest to judge the scientific basis for a 
proposed OSHA standard, but it allows those individuals to hide 
that conflict of interest from the public.
    Proponents of the bill contend that it will promote 
consensus and serve to limit litigation challenging OSHA 
standards. In fact, the legislation appears to be drafted to 
produce exactly the opposite effect. H.R. 2661 requires the so 
called ``peer review''panels to issue reports that must be 
published with any proposed or final rule promulgating a standard. Such 
reports are to include individual and minority reports and the 
Secretary of Labor is required to respond in writing to ``all 
significant comments of the panel.'' Far from promoting consensus, the 
requirement that panel reports include minority and individual views 
not only guarantees divergence, but those views will inevitably serve 
to inspire litigation challenging implementation of new standards.
    H.R. 2661 will further prolong a standard setting process 
that, in the view of many, is already seriously flawed. Recent 
OSHA standards on respiratory protection, methylene chloride, 
and 1,3-butadiene each took 12 to 16 years to develop. During 
the years those standards wound their way through the 
promulgation process, thousands of workers were unnecessarily 
exposed to dangerous levels of toxic substances. H.R. 2661 
ensures that the ability of OSHA to generate new standards will 
be further delayed in the future by imposing a review process 
that is at best redundant and more likely counter-productive. 
As a consequence, it ensures that more workers will be exposed 
for a greater period of time to significant risks to their 
health and safety. H.R. 2661 does not simply embody flawed 
policy, it promotes a dangerous policy that invites further 
needless injury and death for American workers.

                                   William L. Clay.
                                   Dale E. Kildee.
                                   Major R. Owens.
                                   Patsy T. Mink.
                                   Lynn Woolsey.
                                   Chaka Fattah.
                                   Carolyn McCarthy.
                                   Ron Kind.
                                   Harold E. Ford, Jr.
                                   George Miller.
                                   Matthew G. Martinez.
                                   Donald M. Payne.
                                   Robert E. Andrews.
                                   Robert C. Scott.
                                   Carlos Romero-Barcelo.
                                   Ruben Hinojosa.
                                   John F. Tierney.
                                   Loretta Sanchez.
                                   Dennis J. Kucinich.

                                
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