[House Report 104-33]
[From the U.S. Government Publishing Office]



104th Congress                                             Rept. 104-33
                        HOUSE OF REPRESENTATIVES

 1st Session                                                     Part 1
_______________________________________________________________________


 
             JOB CREATION AND WAGE ENHANCEMENT ACT OF 1995

                                _______


               February 15, 1995.--Ordered to be printed

_______________________________________________________________________


  Mr. Bliley, from the Committee on Commerce, submitted the following

                              R E P O R T

                             together with

         ADDITIONAL, MINORITY, AND ADDITIONAL DISSENTING VIEWS

                         [To accompany H.R. 9]

      [Including cost estimate of the Congressional Budget Office]
    The Committee on Commerce, to whom was referred title III 
of the bill (H.R. 9) to create jobs, enhance wages, strengthen 
property rights, maintain certain economic liberties, 
decentralize and reduce the power of the Federal Government 
with respect to the States, localities, and citizens of the 
United States, and to increase the accountability of Federal 
officials, 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 title III and insert the following:
     TITLE III--RISK ASSESSMENT AND COST/BENEFIT ANALYSIS FOR NEW 
                              REGULATIONS

SEC. 3001. FINDINGS.

  The Congress finds that:
          (1) Environmental, health, and safety regulations 
        have led to dramatic improvements in the environment 
        and have significantly reduced human health risk; 
        however, the Federal regulations that have led to these 
        improvements have been more costly and less effective 
        than they could have been; too often, regulatory 
        priorities have not been based upon a realistic 
        consideration of risk, risk reduction opportunities, 
        and costs.
          (2) The public and private resources available to 
        address health, safety, and environmental concerns are 
        not unlimited; those resources need to be allocated to 
        address the greatest needs in the most cost-effective 
        manner and so that the incremental costs of regulatory 
        options are reasonably related to the incremental 
        benefits.
          (3) To provide more cost-effective and cost-
        reasonable protection to human health and the 
        environment, regulatory priorities should be based upon 
        realistic consideration of risk; the priority setting 
        process must include scientifically sound, objective, 
        and unbiased risk assessments, comparative risk 
        analysis, and risk management choices that are grounded 
        in cost-benefit principles.
          (4) Risk assessment has proven to be a useful 
        decision making tool; however, improvements are needed 
        in both the quality of assessments and the 
        characterization and communication of findings; 
        scientific and other data must be better collected, 
        organized, and evaluated; most importantly, the 
        critical information resulting from a risk assessment 
        must be effectively communicated in an objective and 
        unbiased manner to decision makers, and from decision 
        makers to the public.
          (5) The public stake holders must be fully involved 
        in the risk-decision making process. They have the 
        right-to-know about the risks addressed by regulation, 
        the amount of risk to be reduced, the quality of the 
        science used to support decisions, and the cost of 
        implementing and complying with regulations. This 
        knowledge will allow for public scrutiny and promote 
        quality, integrity, and responsiveness of agency 
        decisions.

SEC. 3002. DEFINITION OF COVERED FEDERAL AGENCY.

  As used in this title, the term ``covered Federal agency'' 
means each of the following:
          (1) The Environmental Protection Agency.
          (2) The Occupational Safety and Health 
        Administration.
          (3) The Department of Transportation (including the 
        National Highway Transportation Safety Administration).
          (4) The Food and Drug Administration.
          (5) The Department of Energy.
          (6) The Department of the Interior.
          (7) The Department of Agriculture.
          (8) The Consumer Product Safety Commission.
          (9) The National Oceanic and Atmospheric 
        Administration
          (10) The United States Army Corps of Engineers.
          (11) The Mine Safety and Health Administration.

SEC. 3003. COVERAGE OF TITLE.

  This title does not apply to any situation that the head of 
the covered Federal agency concerned considers to be an 
emergency.

             Subtitle A--Risk Assessment and Communication

SEC. 3101. SHORT TITLE.

  This subtitle may be cited as the ``Risk Assessment and 
Communication Act of 1995''.

SEC. 3102. PURPOSES.

  The purposes of this subtitle are--
          (1) to present the public and executive branch with 
        the most scientifically objective and unbiased 
        information concerning the nature and magnitude of 
        health, safety, and environmental risks in order to 
        provide for sound regulatory decisions and public 
        education;
          (2) to provide for full consideration and discussion 
        of relevant data and potential methodologies;
          (3) to require explanation of significant choices in 
        the risk assessment process which will allow for better 
        peer review and public understanding; and
          (4) to improve consistency within the executive 
        branch in preparing risk assessments and risk 
        characterizations.

SEC. 3103. EFFECTIVE DATE; APPLICABILITY; SAVINGS PROVISIONS.

  (a) Effective Date.--Except as otherwise specifically 
provided in this subtitle, the provisions of this subtitle 
shall take effect 18 months after the date of enactment of this 
subtitle.
  (b) Applicability.--
          (1) In general.--Except as provided in paragraph (3), 
        this subtitle applies to all significant risk 
        assessment documents and significant risk 
        characterization documents prepared by, or on behalf 
        of, any covered Federal agency in connection with 
        Federal regulatory programs designed to protect human 
        health, safety, or the environment.
          (2) Significant risk assessment document or 
        significant risk characterization document.--(A) As 
        used in this subtitle, the terms ``significant risk 
        assessment document'' and ``significant risk 
        characterization document'' include, at a minimum, risk 
        assessment documents or risk characterization documents 
        prepared by or on behalf of a covered Federal agency 
        and included by the agency in, or inserted by the 
        agency in the administrative record for, the following:
                  (i) Any major rule, as defined in subtitle B, 
                promulgated as part of any Federal regulatory 
                program designed to protect human health, 
                safety, or the environment.
                  (ii) A proposed or final permit placing 
                restrictions on facility siting or operation, 
                or a proposed or final cleanup plan, or Federal 
                guidelines for the issuance of any such permit 
                or plan, under Federal laws administered by the 
                Environmental Protection Agency or the 
                Department of the Interior.
                  (iii) Any report to Congress.
                  (iv) Placement of a substance or health 
                effects value on the Integrated Risk 
                Information System Database maintained by the 
                Environmental Protection Agency.
                  (v) Any regulatory action to place a 
                substance on any official list of carcinogens 
                or toxic or hazardous substances.
        Such term also includes any risk assessment or risk 
        characterization that forms the basis of a final risk 
        assessment or risk characterization guideline or 
        protocol of general application.
          (B) Within 15 months after the enactment of this Act, 
        each covered Federal agency administering a regulatory 
        program designed to protect human health, safety, or 
        the environment shall promulgate a rule establishing 
        those additional categories, if any, of risk assessment 
        and risk characterization documents the agency will 
        consider significant risk assessment documents or 
        significant risk characterization documents for 
        purposes of this subtitle. In establishing such 
        categories, the agency head shall consider--
                  (i) the benefits of consistent compliance by 
                documents in the categories concerned with the 
                principles under section 3104 and 3105,
                  (ii) the administrative burdens of including 
                documents in various categories,
                  (iii) the need to make expeditious 
                administrative decisions regarding documents in 
                various categories,
                  (iv) the possible use of a risk assessment or 
                risk characterization in any compilation of 
                risk hazards or health or environmental effects 
                prepared by an agency and commonly made 
                available to, or used by, any Federal, State, 
                or local government agency, and
                  (v) such other factors as may be appropriate.
          (3) Exceptions.--This subtitle does not apply to risk 
        assessments or risk characterizations performed with 
        respect to:
                  (A) A situation that the head of the agency 
                considers to be an emergency.
                  (B) A screening analysis, where appropriately 
                labeled as such, including a screening analysis 
                for purposes of product regulation, product 
                reregistration, or premanufacturing notices.
        No analysis shall be treated as a screening analysis 
        for purposes of this subparagraph if the results of 
        such analyses are used as the basis for imposing 
        restrictions on substances or activities.
          (4) Labels.--This subtitle shall not apply to any 
        individual food, drug, or other product label, or to 
        any risk characterization appearing on any such label, 
        if the individual product label is required by law to 
        be approved by a Federal department or agency prior to 
        use.
  (c) Savings Provisions.--The provisions of this subtitle 
shall be supplemental to any other provisions of law relating 
to risk assessments and risk characterizations, but nothing in 
this subtitle shall be construed to modify any statutory 
standard or statutory requirement designed to protect health, 
safety, or the environment. Nothing in this subtitle shall be 
interpreted to preclude the consideration of any data or the 
calculation of any estimate to more fully describe risk or 
provide examples of scientific uncertainty or variability. 
Nothing in this title shall be construed to require the 
disclosure of any trade secret or other confidential 
information.

SEC. 3104. PRINCIPLES FOR RISK ASSESSMENT.

  (a) In General.--The head of each covered Federal agency 
shall apply the principles set forth in subsection (b) when 
preparing any significant risk assessment document in order to 
assure that such risk assessment documents and all of their 
components distinguish scientific findings from other 
considerations and are, to the maximum extent feasible, 
scientifically objective, unbiased, and inclusive of all 
relevant data. Discussions or explanations required under this 
section need not be repeated in each significant risk 
assessment document as long as there is a reference to the 
relevant discussion or explanation in another agency document.
  (b) Principles.--The principles to be applied when preparing 
significant risk assessment documents are as follows:
          (1) When discussing human health risks, a significant 
        risk assessment document shall contain a discussion, to 
        the extent relevant, of both laboratory and 
        epidemiological data of sufficient quality which finds, 
        or fails to find, a correlation between health risks 
        and a potential toxin or activity. Where conflicts 
        among such data appear to exist, or where animal data 
        is used as a basis to assess human health, the 
        significant risk assessment document shall, where 
        feasible or appropriate, include discussion of 
        reconciliation of conflicting information, and as 
        appropriate, differences in study designs, comparative 
        physiology, routes of exposure, bioavailability, 
        pharmacokinetics, and any other relevant factor.
          (2) Where a significant risk assessment document 
        involves selection of any significant assumption, 
        inference, or model, the covered Federal agency 
        preparing the document shall, to the extent feasible--
                  (A) present a representative list and 
                explanation of plausible and alternative 
                assumptions, inferences, or models;
                  (B) explain the basis for any choices;
                  (C) identify any policy or value judgments;
                  (D) fully describe any model used in the risk 
                assessment and make explicit the assumptions 
                incorporated in the model; and
                  (E) indicate the extent to which any 
                significant model has been validated by, or 
                conflicts with, empirical data.
          (3) No covered Federal agency shall automatically 
        incorporate or adopt any recommendation or 
        classification made by a non-United States-based entity 
        concerning the health effects value of a substance 
        without an opportunity for notice and comment, and any 
        risk assessment document or risk characterization 
        document adopted by a covered Federal agency on the 
        basis of such a recommendation or classification shall 
        comply with the provisions of this subtitle.

SEC. 3105. PRINCIPLES FOR RISK CHARACTERIZATION AND COMMUNICATION.

  In each significant risk characterization document, each 
covered Federal agency characterizing the risk shall comply 
with each of the following:
          (1) Estimates of risk.--The head of such agency shall 
        describe the populations or natural resources which are 
        the subject of the risk characterization. If a 
        numerical estimate of risk is provided, the agency 
        shall, to the extent feasible and scientifically 
        appropriate, provide--
                  (A) the best estimate or estimates for the 
                specific populations or natural resources which 
                are the subject of the characterization (based 
                on the information available to the agency); 
                and
                  (B) a statement of the reasonable range of 
                scientific uncertainties.
        In addition to such best estimate or estimates, the 
        covered Federal agency may present plausible upper-
        bound or conservative estimates in conjunction with 
        plausible lower bounds estimates. Where appropriate, 
        the covered Federal agency may present, in lieu of a 
        single best estimate, multiple estimates based on 
        assumptions, inferences, or models which are equally 
        plausible, given current scientific understanding. To 
        the extent practical and appropriate, the covered 
        Federal agency shall provide descriptions of the 
        distribution and probability of risk estimates to 
        reflect differences in exposure variability or 
        sensitivity in populations and uncertainties.
          (2) Exposure scenarios.--Where relevant, the covered 
        Federal agency shall explain the exposure scenarios 
        used in any risk assessment, and, to the extent 
        feasible, provide a statement of the size of the 
        corresponding population at risk and the likelihood of 
        such exposure scenarios.
          (3) Comparisons.--To the extent feasible, the covered 
        Federal agency shall provide a statement that places 
        the nature and magnitude of risks to human health in 
        context. Such statement shall include appropriate 
        comparisons with estimates of risks that are familiar 
        to and routinely encountered by the general public as 
        well as other risks and, where appropriate and 
        meaningful, comparisons of those risks with other 
        similar risks regulated by the Federal agency resulting 
        from comparable activities and exposure pathways. Such 
        comparisons should consider relevant distinctions among 
        risks, such as the voluntary or involuntary nature of 
        risks and the preventability or non preventability of 
        risks.
          (4) Substitution risks.--Each significant risk 
        assessment or significant risk characterization 
        document referred to in clause (i), (ii), or (iii) of 
        section 3103(2)(A) shall include, to the extent 
        feasible, a statement of any significant and clear 
        substitution risks to human health, where information 
        on such risks has been provided to the agency.
          (5) Summaries of other risk estimates.--If--
                  (A) a covered Federal agency provides a 
                public comment period with respect to a 
                significant risk assessment document or a 
                significant risk characterization document,
                  (B) a commenter provides the covered Federal 
                agency with a risk assessment document or a 
                risk characterization document, and a summary 
                thereof, and
                  (C) such risk assessment document or risk 
                characterization document is consistent with 
                the principles and the guidance provided under 
                this subtitle,
        the agency shall, to the extent feasible, present such 
        summary in connection with the presentation of the 
        agency's risk assessment document or risk 
        characterization document. Nothing in this paragraph 
        shall be construed to limit the inclusion of any 
        comments or material supplied by any person to the 
        administrative record of any proceeding.

SEC. 3106. GUIDELINES.

  (a) Guidelines.--Within 15 months after the date of enactment 
of this Act, the President shall issue guidelines for Federal 
agencies consistent with the risk assessment and 
characterization principles set forth in sections 3104 and 3105 
and shall provide a format for summarizing risk assessment 
results.
  (b) Report.--Within 3 years after the enactment of this Act, 
each covered Federal agency shall provide a report to the 
Congress evaluating the categories of policy and value 
judgments identified under subparagraph (C) of section 
3104(b)(2).
  (c) Public Comment and Consultation.--The guidelines and 
report under this section, shall be developed after notice and 
opportunity for public comment, and after consultation with 
representatives of appropriate State agencies and local 
governments, and such other departments and agencies, offices, 
organizations, or persons as may be advisable.
  (d) Review.--The President shall review and, where 
appropriate, revise the guidelines published under this section 
at least every 4 years.

SEC. 3107. JUDICIAL REVIEW OF SECTIONS 3104 AND 3105.

  When a significant risk assessment document or a significant 
risk characterization document subject to this subtitle is part 
of the administrative record in a final agency action, in 
addition to any other matters that the court may consider in 
deciding whether the agency's action was lawful, the court 
shall consider the agency action unlawful if such significant 
risk assessment document or a significant risk characterization 
document does not comply with the requirements of section 3104 
or 3105.

SEC. 3108. DEFINITIONS.

  For purposes of this subtitle:
          (1) Risk assessment document.--The term ``risk 
        assessment document'' means a document containing the 
        explanation of how hazards associated with a substance, 
        activity, or condition have been identified, 
        quantified, and assessed or describing the degree of 
        toxicity, exposure, or other risk they pose for exposed 
        individuals, populations, or resources.
          (2) Risk characterization document.--The term ``risk 
        characterization document'' means a document 
        quantifying or describing the degree of toxicity, 
        exposure, or other risk they pose for exposed 
        individuals, populations, or resources, but such term 
        does not include a food, drug or other product label.
          (3) Best estimate.--The term ``best estimate'' means 
        an estimate which, to the extent feasible and 
        scientifically appropriate, is based on one of the 
        following:
                  (A) Central estimates of risk using the most 
                plausible assumptions.
                  (B) An approach which combines multiple 
                estimates based on different scenarios and 
                weighs the probability of each scenario.
                  (C) Any other methodology designed to provide 
                the most unbiased representation of the most 
                plausible level of risk, given the current 
                scientific information available to the Federal 
                agency concerned.
          (4) Substitution risk.--The term ``substitution 
        risk'' means a potential risk to human health, safety, 
        or the environment from a regulatory option designed to 
        decrease other risks.
          (5) Document.--The term ``document'' includes 
        material stored in electronic or digital form.

       Subtitle B--Analysis of Risk Reduction Benefits and Costs

SEC. 3201. ANALYSIS OF RISK REDUCTION BENEFITS AND COSTS.

  (a) In General.--The President shall require each covered 
agency to prepare the following for each major rule designed to 
protect human health, safety, or the environment that is 
proposed or promulgated by the agency after the date of 
enactment of this Act:
          (1) For each such proposed or promulgated rule, an 
        assessment of incremental costs and incremental risk 
        reduction or other benefits associated with each 
        significant regulatory alternative considered by the 
        agency in connection with the rule or proposed rule. 
        Costs and benefits shall be quantified to the extent 
        feasible and appropriate and may otherwise be 
        qualitatively described.
          (2) For each such proposed or promulgated rule, to 
        the extent feasible, a statement that places the nature 
        and magnitude of the risk in context. The statement 
        shall, to the extent feasible, provide a comparison of 
        any human health, safety, or environmental risks 
        addressed by the regulatory alternatives to other risks 
        chosen by the head of the agency, including at least 3 
        other risks regulated by the agency and to at least 3 
        other risks with which the public is familiar. The 
        statement shall also identify relevant distinctions 
        among categories of risk and limitations to 
        comparisons.
          (3) For each final rule, an assessment of the costs 
        and risk reduction or other benefits associated with 
        implementation of, and compliance with, the rule.
  (b) Decision Criteria.--No final rule subject to the 
provisions of this title shall be promulgated unless the agency 
certifies that--
          (1) The assessment under paragraph (3) of subsection 
        (a) is based on an objective and unbiased scientific 
        and economic evaluation of all significant and relevant 
        information and risk assessments provided to the agency 
        by interested parties relating to the costs, risks, and 
        risk reduction or other benefits addressed by the rule.
          (2) The incremental risk reduction or other benefits 
        of any regulatory or nonregulatory option chosen will 
        be likely to justify, and be reasonably related to, the 
        incremental costs incurred by local and State 
        governments, the Federal Government, and other public 
        and private entities.
          (3) No regulatory or nonregulatory option considered 
        by the agency or proposed during the comment period 
        would be more likely to achieve a substantially 
        equivalent reduction in risk in a more cost-effective 
        manner or would be more likely to provide flexibility 
        to the regulated entities in achieving the objectives 
        of the regulation, along with a brief explanation of 
        why other regulatory or nonregulatory options that were 
        considered by the head of the agency were found to be 
        less cost-effective or less flexible.
  (c) Effect of Requirements.--
          (1) In general.--Notwithstanding any other provision 
        of law, the requirements of this section shall 
        supplement and, to the extent there is a conflict, 
        supersede the decisional criteria for rulemaking 
        otherwise applicable under the statute pursuant to 
        which the rule is promulgated.
          (2) Prohibition.--Notwithstanding any other provision 
        of Federal law, no major rule shall be promulgated by 
        any Federal agency pertaining to the protection of 
        health, safety, or the environment unless the 
        requirements of section 3201 (a) and (b) are met and 
        the certifications required therein are supported by 
        substantial evidence of the rulemaking record.
  (d) Publication.--For each major rule referred to in 
subsection (a) the head of each covered Federal agency shall 
publish in a clear and concise manner in the Federal Register 
along with the proposed or final regulation, or otherwise make 
publicly available, the information required to be prepared 
under subsection (a) and subsection (b) of this section.
  (e) Definitions.--For purposes of this subtitle:
          (1) Costs.--The term ``costs'' includes the 
        reasonably identifiable and significant direct and 
        indirect costs to the United States Government, to 
        State and local governments, and to the private sector 
        prices to wage earners, consumers, and the economy, of 
        implementing and complying with a regulatory action.
          (2) Benefit.--The term ``benefit'' means the 
        reasonably identifiable significant benefits, including 
        social and economic benefits, that are expected to 
        result directly or indirectly from implementation of a 
        rule or an alternative to a rule.
          (3) Major rule.--The term ``major rule'' means any 
        regulation that is likely to result in an annual 
        increase in costs of $25,000,000 or more. Such term 
        does not include any regulation or other action taken 
        by an agency to authorize or approve any individual 
        substance or product.

                        Subtitle C--Peer Review

SEC. 3301. PEER REVIEW PROGRAM.

  (a) Establishment.--For regulatory programs addressing human 
health, safety, or the environment, the head of each covered 
Federal agency shall develop a systematic program for peer 
review of significant risk assessment documents and economic 
assessments used by the agency. Such program shall be 
applicable across the agency and--
          (1) shall provide for the creation of peer review 
        panels consisting of independent and external experts 
        and shall be broadly representative and balanced to the 
        extent feasible;
          (2) may provide for differing levels of peer review 
        depending on the significance or the complexity of the 
        problems or the need for expeditiousness;
          (3) shall not exclude peer reviewers with substantial 
        and relevant expertise merely because they represent 
        entities that may have a potential interest in the 
        outcome, provided that interest is fully disclosed to 
        the agency and in the case of a regulatory decision 
        affecting a single entity no peer reviewer representing 
        such entity may be included on the panel;
          (4) may provide specific and reasonable deadlines for 
        peer review panels to submit reports under subsection 
        (c); and
          (5) shall provide adequate protections for 
        confidential business information and trade secrets, 
        including requiring peer reviewers to enter into 
        confidentiality agreements.
  (b) Requirement for Peer Review.--Each covered Federal agency 
shall provide for peer review of any significant risk 
assessment document or cost assessment prepared in connection 
with any regulation that is likely to result in an annual 
increase in costs of $100,000,000 or more (other than any 
regulation or other action taken by an agency to authorize or 
approve any individual substance or product. In addition, the 
Director of the Office of Management and Budget may order that 
peer review be provided for any major risk assessment or cost 
assessment that is likely to have a significant impact on 
public policy decisions.
  (c) Response to Peer Review.--The head of the covered Federal 
agency shall provide a written response to all significant peer 
review comments.
  (d) Availability to Public.--All peer review comments or 
conclusions and the agency's responses shall be made available 
to the public and shall be made part of the administrative 
record for purposes of judicial review of any final agency 
action.
  (e) Previously Reviewed Data and Analysis.--No peer review 
shall be required under this section for any data or analysis 
which has been previously subjected to peer review or for any 
component of any evaluation or assessment previously subjected 
to peer review.
  (f) National Panels.--The President shall appoint National 
Peer Review Panels to annually review the risk assessment and 
cost assessment practices of each covered Federal agency for 
programs designed to protect human health, safety, or the 
environment. The Panel shall submit a report to the Congress no 
less frequently than annually containing the results of such 
review.

                     Subtitle D--Agency Priorities

SEC. 3401. PETITION PROCESS

  (a) In General.--(1) Within 1 year after the date of 
enactment of this Act the head of each covered agency shall 
establish procedures for accepting and considering petitions 
for--
          (A) reviewing and revising any health or 
        environmental effects value, such as those values in 
        the Integrated Risk Information System (IRIS) database 
        or any other compilation of risk, hazard or health or 
        environmental effects information prepared by the 
        agency that is made commonly available or is used by 
        any Federal department, agency, or instrumentality, the 
        States or local governments as a scientific basis for 
        regulatory action;
          (B) reviewing a risk assessment that supports a major 
        rule, as defined in section 3201(e)(3), and revising it 
        to take into consideration new information or 
        methodologies or to comply with the requirements of 
        subtitle A;
          (C) requiring that a risk assessment that supports a 
        major rule, as defined in section 3201(e)(3), or other 
        agency scientific or technical document supporting a 
        regulatory action be peer reviewed; or
          (D) reviewing any major rule, as defined in section 
        3201(e)(3), promulgated prior to the effective date of 
        this title and revising it to comply with the 
        requirements of this title.
  (2) Such procedures be consistent with each of the following:
          (A) Any person may petition.
          (B) Such petitions shall include adequate supporting 
        documentation, including, where appropriate, new 
        studies or other relevant information that provide the 
        basis for a proposed revision or modified health 
        effects value and where appropriate a summary 
        characterization of the risk complying with the 
        requirements of section 3105 of this title.
  (3) The agency head shall respond to the petition in the 
Federal Register within 90 days from receipt.
  (4) The agency shall accept the petition if the new 
information or methodologies or the application of the 
provisions of this title would significantly alter the result 
of the existing risk assessment, health effects value or 
regulation. If the agency head rejects the petition, the agency 
head shall state the reasons for doing so. If the agency head 
accepts the petition, he shall publish a notice in the Federal 
Register for comment on the substantive issues raised in the 
petition. The agency head shall accept and consider any 
relevant data of sufficient quality submitted in response to 
the notice.
  (b) Final Agency Action.--(1) Within 1 year following the 
submission of a petition under subsection (a), the agency head 
shall take final action either--
          (A) initiating the action requested in the petition; 
        or
          (B) denying the petition by determining that the risk 
        assessment, health effects value or regulation should 
        not be changed, stating in the Federal Register the 
        reasons therefor.
  (2) Rejection or denial of a petition by an agency head shall 
constitute final agency action and be subject to review as 
provided in section 700 and following of title 5 of the United 
States Code (the Administrative Procedures Act). Any person 
whose petition was rejected or denied and who can establish 
that--
          (A) the petition included adequate supporting 
        evidence, and
          (B) the agency failed or refused to comply with this 
        section
may bring an action in the appropriate United State district 
court for judicial review of such rejection or denial.

                            Subtitle E--Plan

SEC. 3501. PLAN FOR ASSESSING NEW INFORMATION.

  (a) Plan.--Within 18 months after the date of enactment of 
this subtitle, each covered Federal agency shall publish a plan 
to review and, where appropriate revise any significant risk 
assessment document or significant risk characterization 
document published prior to the expiration of such 18-month 
period if, based on information available at the time of such 
review, the agency head determines that the application of the 
principles set forth in sections 3104 and 3105 would be likely 
to significantly alter the results of the prior risk assessment 
or risk characterization. The plan shall provide procedures for 
receiving and considering new information and risk assessments 
from the public. The plan may set priorities for review and, 
where appropriate, revision of risk assessment documents and 
risk characterization documents based on the potential to more 
efficiently focus national economic resources within Federal 
regulatory programs designed to protect human health, safety, 
or the environment on the most important priorities and on such 
other factors as such Federal agency considers appropriate.
  (b) Public Comment and Consultation.--The plan under this 
section, shall be developed after notice and opportunity for 
public comment, and after consultation with representatives of 
appropriate State agencies and local governments, and such 
other departments and agencies, offices, organizations, or 
persons as may be advisable.

                         Subtitle F--Priorities

SEC. 3601. PRIORITIZATION.

  (a) Identification of Opportunities.--In order to assist in 
the public policy and regulation of risks to public health, the 
President shall identify opportunities to reflect priorities 
within existing Federal regulatory programs designed to protect 
human health in a cost-effective and cost-reasonable manner. 
The President shall identify each of the following:
          (1) The likelihood and severity of public health 
        risks addressed by current Federal programs.
          (2) The number of individuals affected.
          (3) The incremental costs and risk reduction benefits 
        associated with regulatory or other strategies.
          (4) The cost-effectiveness of regulatory or other 
        strategies to reduce risks to public health.
          (5) Intergovernmental relationships among Federal, 
        State, and local governments among programs designed to 
        protect public health.
          (6) Statutory, regulatory, or administrative 
        obstacles to allocating national economic resources 
        based on the most cost-effective, cost-reasonable 
        priorities considering Federal, State, and local 
        programs.
  (b) Annual Report.--The President shall annually issue a 
report to Congress, after notice and opportunity for public 
comment, to recommend priorities, modifications, elimination, 
or strategies among existing Federal regulatory programs 
designed to protect public health. Within 6 months after the 
issuance of the report, the President shall notify the Congress 
in writing of the recommendations which can be implemented 
without further legislative changes and the agency shall 
consider the priorities set forth in the report when preparing 
a strategic plan for any regulatory program.
                          Purpose and Summary

    Title III of H.R. 9 seeks to improve the Federal risk 
assessment and regulatory decisions in programs designed to 
protect human health and the environment. Subtitle A provides 
for minimum standards of disclosure, objectivity and 
informativeness for the assessment and presentation of risk 
information in significant Federal risk assessment and risk 
characterization documents. Subtitle B requires analysis and 
consideration of costs, benefits, and flexibility among 
regulatory options when promulgating major rules. Subtitle C 
requires independent peer review of certain major risk or 
economic assessments. Subtitle D provides criteria to petition 
Federal agencies to revise risk assessments in light of 
significant new information and under certain circumstances. 
Subtitle E requires covered Federal agencies to provide an 
additional plan outlining any additional processes for 
receiving new information and setting priorities for revising 
prior risk assessments. Finally, Subtitle F requires the 
President to identify and report on priorities among Federal 
regulatory programs to protect human health, consider a number 
of criteria to provide for recommendations to Congress, and to 
incorporate such priorities into strategic planning.

                Background and Need for the Legislation

               i. perceived problems with the status quo

A. General concerns over excess regulatory costs and inappropriate 
        priorities

    The general problem as perceived by many in State and local 
government and in the business community is that Federal 
regulatory costs are too often out of proportion to the 
problems that the regulations are designed to address. The 
concern in the area of health, safety and environmental 
regulations is that the Federal programs require expenditures 
of substantial economic resources on reductions in risk which 
are either too hypothetical, exaggerated or small. The overall 
perception from many quarters is that a significant portion of 
Federal health, safety or environmental regulatory costs 
reflect unwise priorities for national economic resources. 
While estimates vary, many estimates project annual compliance 
costs of environmental regulations alone at well above $185 
billion by the year 2000. Thus, many argue that, while such an 
amount may not be too high, $185 billion is too high to spend 
unwisely.
    As part of the general problem, there is particular concern 
over the Federal practice of risk assessment, characterization 
and communication.\1\ There is also concern that Federal 
agencies do not consider the incremental costs and benefits or 
regulatory alternatives that are, in some instances, not even 
measured and, in other instances, not sufficiently considered. 
These two concerns formed the basis for substantial 
controversies during the 103rd Congress and are the central 
issues addressed in Title III of H.R. 9.
    \1\ There are a number of terms and relationships that are useful 
for understanding the general issues concerning Title III. As related 
to Title III, risk assessment is a science/policy tool to synthesize 
available scientific information on risk to human health, safety or 
natural resources. Risk managers consider information on risks, as well 
as policy, value, and often political judgments, to design and 
implement strategies to address those risks. Risk managers hire risk 
assessors to analyze information and answer questions relevant to the 
risk managers. Risk characterization is the final step in the risk 
assessment process and constitutes the summary of the analysis which 
states the nature and magnitude of the risk. Risk communication is the 
practice of reporting the risks or otherwise placing risks in context.
---------------------------------------------------------------------------

B. Concerns over Federal risk assessment, characterization and 
        communication

    The concern with Federal risk assessment practices is the 
perception among many that Federal risk assessment, 
characterization and communication is biased and based on a 
series of hypothetical assumptions which are designed to 
overstate the risks. Others argue that Federal risk assessments 
fail to consider important factors and, thus, understate risks 
in critical ways. Many on both sides argue that the Federal 
practice of risk assessment, characterization, and 
communication is not sufficiently transparent or informative. 
The concern is greatest in situations where there are the 
fewest facts. Statistics on automobile accidents, for example, 
are generally considered to be reliable from year to year and 
likely to reflect the number of projected automobile accidents 
the next year. Risks to human health from low levels of 
chemicals, however, are much more subtle and difficult to 
measure.
    The uncertainties, themselves, are not the fault of risk 
management or assessment practices--they simply reflect the 
lack of ability to prove or disprove the many assumptions 
needed to fill in the facts for a given risk assessment. 
However, the resulting controversies are difficult to address 
or manage.
    In many contexts, Federal agencies explicitly state that 
their risk assessment process is designed to produce estimates 
that ``err on the side of safety'' because of scientific 
uncertainties and to ensure that the broadest range of the 
public is protected, consistent with Federal statutory intent. 
It is generally believed that these ``upper bound estimates'' 
are highly improbable and differ from the most plausible level 
of risk by many orders of magnitude. Moreover, the practice of 
only calculating upper bound or worst case estimates of risk is 
criticized as inappropriately collapsing scientific findings 
with a preconceived policy judgment or bias. The perceived 
overstatement of risk is a serious concern among the regulated 
community. Many argue there should also be ``best estimates'' 
or estimates of expected value in addition to upper-bound 
estimates to provide a more realistic benchmark.

C. Concerns over the costs and benefits of regulatory programs

    Some Federal provisions require consideration of the costs 
and benefits of regulatory alternatives, although the specific 
language authorizing such consideration differs greatly among 
statutes. The resulting regulatory decisions are judicially 
reviewable. The general standard of review is for courts to be 
deferential to Federal agencies concerning the analysis of 
factual issues, especially where Congress has not specifically 
stated a course of action. On the other hand, many Federal 
statutes prohibit or do not explicitly authorize consideration 
of costs and benefits for determining regulatory requirements.
    The Reagan Administration issued Executive Order 12291 in 
order to encourage agencies to at least try to assess the costs 
and benefits of regulatory options where statutes did not 
otherwise compel such an assessment. As an executive order, the 
assessment was not judicially reviewable. The Clinton 
Administration has replaced Executive Order 12291 with 
Executive Order 12866 which, more or less, continues the 
requirements of 12291.
    Following is a chart from the section on Risk Management 
Budgeting in the Fiscal Year 1992 Budget of the United State 
Government which is a summary of some of the assessments 
performed under Executive Order 12291. The chart illustrates 
the perceived problem. For some regulations, the costs per 
theoretical life saved are in the thousands of dollars. In 
other cases, the costs per theoretical life saved or cancer 
incidence avoided are in the millions or billions. Many of the 
costs associated with the reduction of perceived risks from 
chemicals are also upper bound estimates and, thus, the true 
risk reduction is even less cost-effective--possibly by several 
orders of magnitude. Accordingly, many advocate giving more 
prominence to the consideration of the relationship between 
costs and benefits and setting regulatory priorities to both 
save money and increase protection by focusing resources on the 
greatest risk reduction opportunities.

                              RISKS AND COST-EFFECTIVENESS OF SELECTED REGULATIONS                              
----------------------------------------------------------------------------------------------------------------
                                                                                       Baseline      Cost per   
                                                                                      mortality      premature  
                  Regulation \1\                     Year     Health or    Agents      risk per    death averted
                                                    issued     safety?                 million      ($ millions 
                                                                                       exposed         1990)    
----------------------------------------------------------------------------------------------------------------
Unvented Space Heater Ban........................     1980   S           CPSC              1,890             0.1
Aircraft Cabin Fire Protection Standard..........     1985   S           FAA                   5             0.1
Auto Passive Restraint/Seat Belt Standards.......     1984   S           NHTSA             6,370             0.1
Steering Column Protection Standard \2\..........     1967   S           NHTSA               385             0.1
Underground Construction Standards \3\...........     1989   S           OSHA-S           38,700             0.1
Trihalomethane Drinking Water Standards..........     1979   H           EPA                 420             0.2
Aircraft Seat Cushion Flammability Standard......     1984   S           FAA                  11             0.4
Alcohol and Drug Control Standards \3\...........     1985   H           FRA                  81             0.4
Auto Fuel-System Integrity Standard..............     1975   S           NHTSA               343             0.4
Standards for Servicing Auto Wheel Rims \3\......     1984   S           OSHA-S              630             0.4
Aircraft Floor Emergency Lighting Standard.......     1984   S           FAA                   2             0.6
Concrete & Masonry Construction Standards \3\....     1988   S           OSHA-S              630             0.6
Crane Suspended Personnel Platform Standard \3\..     1988   S           OSHA-S           81,000             0.7
Passive Restraints for Trucks & Buses (Proposed).     1989   S           NHTSA             6,370             0.7
Side-Impact Standards for Autos (Dynamic)........     1990   S           NHTSA                NA             0.8
Children's Sleepwear Flammability Ban \4\........     1973   S           CPSC                 29             0.8
Auto Side Door Support Standards.................     1970   S           NHTSA             2,520             0.8
Low-Altitude Windshear Equipment & Training           1988   S           FAA                  NA             1.3
 Standards.                                                                                                     
Electrical Equipment Standards (Metal Mines).....     1970   S           MSHA                 NA             1.4
Trenching and Excavation Standards \3\...........     1989   S           OSHA-S           14,310             1.5
Traffic Alert and Collision Avoidance (TCAS)          1988   S           FAA                  NA             1.5
 Systems.                                                                                                       
Hazard Communication Standard \4\................     1983   S           OSHA-S            1,800             1.6
Side-Impact Stds for Trucks, Buses and MPVs           1989   S           NHTSA                NA             2.2
 (Proposed).                                                                                                    
Grain Dust Explosion Prevention Standards \3\....     1987   S           OSHA-S            9,450             2.8
Rear Lap/Shoulder Belts for Autos................     1989   S           NHTSA                NA             3.2
Standards for Radionuclides in Uranium Mines \3\.     1984   H           EPA               6,300             3.4
Benzene NESHAP (Original: Fugitive Emissions)....     1984   H           EPA               1,470             3.4
Ethylene Dibromide Drinking Water Standard.......     1991   H           EPA                  NA             5.7
Benzene NESHAP (Revised: Coke By-Products) \3\...     1988   H           EPA                  NA             6.1
Asbestos Occupational Exposure Limit \3\.........     1972   H           OSHA-H            3,015             8.3
Benzene Occupational Exposure Limit \3\..........     1987   H           OSHA-H           39,600             8.9
Electrical Equipment Standards (Coal Mines) \3\..     1970   S           MSHA                 NA             9.2
Arsenic Emission Standards for Glass Plants......     1986   H           EPA               2,660            13.5
Ethylene Oxide Occupational Exposure Limit \3\...     1984   H           OSHA-H            1,980            20.5
Arsenic/Copper NESHAP............................     1986   H           EPA              63,000            23.0
Haz Waste Listing for Petroleum Refining Sludge..     1990   H           EPA                 210            27.6
Cover/Move Uranium Mill Tailings (Inactive Sites)     1983   H           EPA              30,100            31.7
Benzene NESHAP (Revised: Transfer Operations)....     1990   H           EPA                  NA            32.9
Cover/Move Uranium Mill Tailings (Active Sites)..     1983   H           EPA              30,100            45.0
Acrylonitrile Occupational Exposure Limit \3\....     1978   H           OSHA-H           42,300            51.5
Lockout/Tagout \3\...............................     1989   S           OSHA-S                4            70.9
Asbestos Occupational Exposure Limit \3\.........     1986   H           OSHA-H            3,015            74.0
Arsenic Occupational Exposure Limit \3\..........     1978   H           OSHA-H           14,800           106.9
Asbestos Ban.....................................     1989   H           EPA                  NA           110.7
Diethylstilbestrol (DES) Cattlefeed Ban..........     1979   H           FDA                  22           124.8
Benzene NESHAP (Revised: Waste Operations).......     1990   H           EPA                  NA           168.2
1,2-Dichloropropane Drinking Water Standard......     1991   H           EPA                  NA           653.0
Haz Waste Land Disposal Ban (1st 3rd)............     1988   H           EPA                   2         4,190.4
Municipal Solid Waste Landfill Standards              1988   H           EPA                  <1        19,107.0
 (Proposed).                                                                                                    
Formaldehyde Occupational Exposure Limit \3\.....     1987   H           OSHA-H               31        86,201.8
Atrazine/Alachlor Drinking Water Standard........     1991   H           EPA                  NA        92,069.7
Haz Waste Listing for Wood Preserving Chemicals..     1990   H           EPA                  <1     5,700,000.0
----------------------------------------------------------------------------------------------------------------
\1\ 70-year lifetime exposure assumed unless otherwise specified.                                               
\2\ 50-year lifetime exposure.                                                                                  
\3\ 45-year lifetime exposure.                                                                                  
\4\ 12-year exposure period.                                                                                    
NA=Not available.                                                                                               
                                                                                                                
Agency abbreviations.--CPSC: Consumer Product Safety Commission; MSHA: Mine Safety and Health Administration;   
  EPA: Environmental Protection Agency; NHTSA: National Highway Traffic Safety Administration; FAA: Federal     
  Aviation Administration; FRA: Federal Railroad Administration; FDA: Food and Drug Administration; OSHA-H:     
  Occupational Safety and Health Administration, Health Standards; OSHA-S: Occupational Safety and Health       
  Administration, Safety Standards.                                                                             
                                                                                                                
Source: John F. Morrall, III, ``A Review of the Record,'' Regulation, Vol. 10, No. 2 (1986), p. 30. Updated by  
  the Author, et. al.                                                                                           

    Others fear that poorly written cost-benefit provisions 
could (1) create computer-like reliance on information that is 
often highly subjective and difficult to quantify; (2) create 
administrative burdens that would slow the issuance or 
enforcement of regulations necessary to the Nation's commitment 
to protecting health, safety, and the environment; and, (3) 
fail to reflect a value system where some degree of protection 
is a right and not a value to be traded away by regulatory 
decisions.

 II. REPORTED PROBLEMS WITH FEDERAL RISK ASSESSMENT, CHARACTERIZATION, 
                      AND COMMUNICATION PRACTICES

    In 1983 the National Academy of Sciences made 
recommendations concerning risk assessments which included the 
statement that:

          Regulatory agencies should take steps to establish 
        and maintain a clear conceptual distinction between 
        assessments of risks and the consideration of risk 
        management alternatives; that is, scientific findings 
        and policy judgements embodied in risk assessments 
        should be explicitly distinguished from the political, 
        economic, and technical considerations that influence 
        the design and choice of regulatory strategies.

    Despite these recommendations, the practice across most 
Federal agencies has often been simply to analyze and 
communicate a single ``upper-bound,'' conservative, or ``worst 
case'' estimate of risk. Generally, this practice has evolved 
where there is limited actual information and the agencies must 
choose a default assumption to fill the gaps of actual 
information. In many of these situations, the assumption chosen 
is not designed to be the assumption which is the most 
scientifically plausible, given the information available, but 
rather a ``conservative'' assumption which is more likely to 
overstate than understate the actual risk. Because risk 
assessments often involve multiplying the values of assumptions 
and data together, Federal risk assessors often compound the 
conservative assumptions yielding numerical estimates that can 
be improbable and differ by many orders of magnitude from a 
best estimate of the risk. This practice has recently been 
described as ``plausible conservatism.''
    Federal agencies, often see this practice of ``erring on 
the side of safety'' as consistent with their statutory 
missions. Under this practice, Federal agencies sometimes 
ignore relevant data because it may not fit into simple models 
or would require changes in agency analyses. This can result in 
understatement or overstatement of risks and also tends to 
inhibit advancements in scientific analyses. Finally, Federal 
agencies often fail to explain significant choices among 
significant scientific models or assumptions. The result of 
these tendencies is poor information concerning the most likely 
nature and magnitude of the risk; stagnation in development of 
more accurate risk assessments; inconsistency between programs; 
and, ultimately, regulatory policy that fails to address 
serious risks, while requiring the expenditure of billions of 
dollars on hypothetical and very low levels of risk.
    The practices of only presenting upper-bound estimates and 
plausible conservatism have been criticized for the past 15 
years by the Office of Management and Budget, a number of 
scientific organizations, and the regulated community. 
Moreover, risks that regulators set their sites on today are 
increasingly subtle, difficult to document, and entail greater 
costs relative to the incremental benefits. This has 
intensified the concerns over Federal risk assessment, 
characterization and communication practices over the last five 
years. The following reports outline a number of the salient 
criticisms.
    The 1983 Regulatory Policy Guidelines from the Presidential 
Task Force on Regulatory Relief includes the following among 
its statements of principles:

          Regulations that seek to reduce health or safety 
        risks should be based upon scientific risk-assessment 
        procedures, and should address risks that are real and 
        significant rather than hypothetical or remote.

The report included the following discussion about cost-benefit 
analysis and the need for objective, unbiased risk assessments 
based on best estimates rather than hypothetical situations:

        All decisions involving risk--public and private--have 
        costs as well as benefits, and excessive costs in any 
        one area can be counterproductive on the whole, 
        reducing resources or incentives for increased health 
        and safety in other areas. * * * To be useful in 
        determining overall benefits and costs, risk 
        assessments must be scientifically objective and 
        include all relevant information. In particular, risk 
        assessments must be unbiased best estimates, not 
        hypothetical ``worst cases'' or ``best cases.'' Extreme 
        ``best'' or ``worst'' safety or health results should 
        be weighted (along with intermediate results) by the 
        probability of their occurrence to estimate the 
        expected result implied by the available evidence. In 
        addition, the distribution of probabilities for various 
        possible results should be presented separately, so as 
        to allow for an explicit ``margin of safety'' in final 
        decisions.

    The 1987-88 Regulatory Program of the United States made 
similar points, decrying the inefficiency of misallocating 
resources to address hypothetical costs.

          [T]here is a pressing need to improve Federal risk 
        assessment and risk management activities used to 
        assess potential health and safety regulatory actions. 
        Often these risk assessments so overstate risks that 
        the chance that they approximate actual risks is 
        remote. This overstatement--and the uncertainty as to 
        the degree of overstatement--are likely to cause 
        policymakers to overestimate the benefits of regulatory 
        action. As a result, they often select what are, in 
        fact, the wrong targets for reducing risks to society 
        and apply stringent and costly regulatory measures that 
        may actually have little or no risk-reducing benefits, 
        but that may impose significant costs. * * * This 
        nation can ill afford to commit limited resources to 
        the wrong targets. * * * Spending these scarce 
        resources inefficiently will preclude us from pursuing 
        better opportunities to reduce risks and to improve the 
        Nation's standard of living.

The 1990-91 version of this document was even more blunt:

          Unfortunately, risk assessment practices continue to 
        rely on conservative models that effectively 
        intermingle important policy judgements within the 
        scientific assessments of risk. * * * This policy 
        environment makes it difficult to discern serious 
        hazards from trivial ones, and distorts the ordering of 
        the Government's regulatory priorities. In some cases, 
        the distortion of priorities may actually increase 
        health and safety risks.
          These ``upper-bound'' estimates are often useful as a 
        screening device, to exclude from regulatory concern 
        potential hazards that are insignificant even under 
        worst-case conditions. Unfortunately, upper-bound risk 
        estimates are routinely employed for altogether 
        different purposes, such as estimating the likely 
        benefits of regulatory actions.
          To the extent that risk assessments differ in the 
        degree to which they adopt conservative assumptions, it 
        is difficult to determine which activities pose the 
        greatest risks and hard to establish reasonable 
        priorities for regulatory action. Because conservatism 
        in risk assessment is especially severe with respect to 
        carcinogens, it is reasonable to expect that other 
        health and safety risks tend to receive relatively less 
        attention and weight. As a result, society may actually 
        incur greater total risk, because of misordered 
        priorities caused by conservative biases in cancer risk 
        assessment.
          The public and affected parties also benefit from 
        knowing both the expected risk and the margin of safety 
        rather than being given upper-bound estimates that are 
        probably very different from actual risks * * * 
        providing information in this way should help improve 
        public confidence in quantitative risk assessment as 
        the basis for decisionmaking.

    In the case of some agencies, there is evidence that 
institutional factors may pose a barrier to objective risk 
presentation and appropriate regard for basing regulatory 
action on credible science. In a 1992 Report, ``Safeguarding 
the Future: Credible Science, Credible Decisions,'' an EPA-
appointed panel of experts found a ``climate and culture'' 
within the EPA that cast serious doubt on the quality of 
science used by the Agency to justify its programs. Even many 
agency personnel perceived that EPA science was "adjusted to 
fit policy." Among the specific findings are:

        EPA's science activities to support regulatory 
        development * * * do not always have adequate, credible 
        quality assurance, quality control, or peer review. EPA 
        has not always ensured that contrasting, reputable 
        scientific views are well explored and well documented 
        from the beginning to the end of the regulatory 
        processes. Instead, studies are frequently carried out 
        without the benefit of peer review or quality 
        assurance. They sometimes escalate into regulatory 
        proposals with no further science input, leaving EPA 
        initiatives on shaky scientific ground.

    In 1994, the National Research Council's report on the EPA 
entitled, Science and Judgment in Risk Assessment, cited the 
following observations and problems with the failure to 
communicate relevant information by only reporting upper-bound 
point estimates:

          EPA does not adequately communicate to its own 
        decision-makers, to Congress, or to the public the 
        variabilities that are and are not accounted for in any 
        risk assessment and the implications for the 
        conservatism and representativeness of the resulting 
        number.
          EPA often reports only a single point estimate of 
        risk as a final output. * * * Use of a single point 
        estimate suppresses information about sources of error 
        that result from choices of model, data sets, and 
        techniques for estimating values of parameters from 
        data.
          When EPA reports estimates of risks to decisionmakers 
        and the public, it should present not only point 
        estimates of risk, but also the sources and magnitudes 
        of uncertainty associated with those estimates.

The report also cited support for applying uniform risk 
assessment processes and procedures:

          Without uniform guidelines, there is a danger that 
        the models used in risk assessments will be selected on 
        an ad hoc basis, according to whether regulating a 
        substance is thought to be politically feasible or 
        according to other parochial concerns.
          EPA does not always provide a method by which 
        industry, environmental groups, or the general public 
        can raise questions regarding the scientific basis of a 
        decision * * * [and] does not have a procedural 
        mechanism that allows those outside EPA to petition for 
        departures from default options.

              III. COMMITTEE HEARINGS IN THE 103D CONGRESS

    On November 17, 1993, the Subcommittee on Transportation 
and Hazardous Materials held a hearing on Federal risk 
assessment practices and review of risk legislation, including 
H.R. 2910, The Risk Communication Act of 1993. While the scope 
of Title III of H.R. 9, the Job Creation and Wage Enhancement 
Act, is broader than in the last Congress, the principles of 
disclosure providing best estimates and comparisons from H.R. 
2910 form the basis for Subtitle A of Title III.
    Testimony relevant to Federal risk assessment, 
characterization, and communication practices and H.R. 2910 is 
highlighted below:

A. Excerpts from the testimony of the Honorable Thomas Grumbly, 
        Assistant Secretary for Environmental Restoration and Waste 
        Management, Department of Energy

          [Y]ou want to be sure that as you are going forward 
        to clean up, to spend large sums of money, that the 
        regulators * * * aren't letting their policy choices 
        about what we think we ought to do * * * influence the 
        actual assessments of risk * * * I think that frankly 
        is something I think our colleagues in all of the 
        regulatory agencies in the land need to keep a little 
        more paramount in their consideration.
          EPA contractors come in, turn the crank, use a lot of 
        assumptions that * * * tends to cascade conservative 
        assumption upon conservative assumption, and then hit a 
        particular hazardous waste site with a risk, an 
        estimated risk that simply doesn't bear any 
        relationship to what anybody who is knowledgeable 
        actually thinks is a real risk at the site.
          [O]ne of your former colleagues used to say $1 
        billion here, $1 billion there, pretty soon it is real 
        money. We are going to spend $14 billion next year 
        cleaning up hazardous waste in this country. And I 
        think that often there are large questions in a lot of 
        people's mind whether we are getting the benefits for 
        that. The only way to really assess the benefits better 
        is to make some investments in assessing the risks. * * 
        * I think we really need to grapple with this and make 
        sure they have the resources that are necessary, 
        because the costs to society if not is really 
        tremendous.

B. Excerpts from the testimony of Dr. Lynn Goldman, Assistant 
        Administrator for Prevention, Pesticides and Toxic Substances, 
        U.S. Environmental Protection Agency

          I don't think that overall the system is slanted 
        [toward only answering the question of the upper bound 
        risk level as opposed to the most plausible level of 
        risk. I do think that there are differences in the 
        different statutes we use in terms of whether we are 
        instructed to look at upper bounds -- or upper bound 
        risk level -- as opposed to the most plausible level of 
        risk] but I don't think that the current practice or 
        policies for doing risk assessment * * * I would not 
        call them slanted.
          I do think, though, there is a lot of concern that 
        assumptions may build on each other and that you may 
        end up with impossible assumptions.

C. Excerpts from the testimony of Dr. Michael Gough, Program Manager, 
        Biology and Behavioral Sciences Program, Office of Technology 
        Assessment

          Better risk communication among researchers, 
        assessors, and managers will inform the rest of 
        government, industry, and citizens about the process, 
        the problems, and the opportunities. It will make 
        little difference if the process works to the 
        satisfaction of experts and the decision-makers, and 
        leaves the public uneasy and wary.
          I think that it is fair [to ask for a best estimate]. 
        I think also it fits in with what the OTA report says 
        that it would be directing people--direct research in 
        those directions.

D. Excerpts from the testimony of Dr. John Graham, senior scientist, 
        Center for Risk Analysis, Harvard School of Public Health

          We have done at the Harvard Center for Risk Analysis 
        a systematic study of the way EPA does risk assessment. 
        And here is the news: The various EPA program and 
        regional offices do not report risk estimates in a 
        consistent fashion * * * usually only one number is 
        reported. Some of these numbers are worst-case figures. 
        Some are conservative yet plausible numbers. Some are 
        central estimates. And some are simply impossible to 
        interpret how conservative the number is. So as Dr. 
        Goldman told you, risk assessors don't always do worst-
        case estimates. The problem is we are doing different 
        things in different places. Few programs report the 
        desired lower-bound estimate, central estimate, and 
        upper-bound estimate that would be helpful.
          There are many decisionmakers outside of EPA--States 
        and localities, environmental advocacy groups, industry 
        groups and international bodies, that do not appreciate 
        the single risk number that EPA is generally reporting. 
        Yet they use this number oftentimes in making their 
        decisions about risk assessment and risk management.
          Practices have emerged in different parts of the 
        agencies and different fiefdoms based upon influences, 
        people, history, and institutional history and the laws 
        per se, while they regulate risk management, do not 
        regulate risk assessment in any particularly strong 
        way.
          While EPA is making efforts to correct this problem, 
        I would characterize the progress as slow and there are 
        clear institutional reasons why particular program 
        offices and particular regions won't necessarily 
        benefit from a more consistent way of reporting risks, 
        and they are going to put up institutional barriers to 
        making this process move forward.
          H.R. 2910, the Risk Communication Act, is a very 
        unique initiative at fostering more accurate, complete, 
        and consistent reporting of risk estimates.
          It is a widely misunderstood point among people who 
        think they are advocating on behalf of public health 
        and the environment that in fact the worst-case 
        estimate of risk will not do the most with our scarce 
        resources for environmental and public health 
        protection.
          I am having conversations with EPA scientists and 
        risk managers about the bills that we are talking about 
        today. It is interesting, the kind of reactions you 
        get. On the one hand, you hear the argument that we are 
        already doing all these things, why are you requiring 
        us to do what we are already doing? On the other hand, 
        they will argue to you that these things add enormous 
        layers of extra expensive analytical requirements, they 
        are going to drag out decisions for two or three years.

E. Excerpts from the testimony of Dr. John Moore, president, Institute 
        for Evaluating Health Risks, former Assistant Administrator, 
        Office of Pesticides and Toxic Substances

          Well, if you make a cascading series of default 
        assumptions in trying to put together a risk 
        assessment, you can end up with an outcome that when 
        you step back and take a hard look at it, it almost 
        doesn't pass the laugh test. I guess what bothers me is 
        that when a risk assessment is brought to a decision-
        maker that is replete with these cascading assumptions, 
        that the fact that those cascading assumptions have 
        been used is not made apparent to the decision-maker, I 
        think is wrong.
          I think H.R. 2910 comes close to achieving the 
        positive results that we all maybe would like to see, 
        without creating undue administrative burdens. I think 
        it remains focused on the main issue which is the 
        systematic development and communication of the 
        scientific basis for identifying and characterizing 
        health risks. I don't think it is proscriptive in 
        detailing how it is to be done.

F. Excerpts from the testimony of Mr. Ben Maiden, vice president, 
        Battelle Operations [accompanying Greg Lashutka, mayor of 
        Columbus, Ohio]

          I think one of the major policy issues that the 
        committee must look at is the full disclosure provision 
        which is a key element of the Risk Communication Act, 
        as I understand it, and I tend to endorse the testimony 
        of previous individuals, including Dr. Graham, who 
        indicated that not only will the Nation save 
        considerable money and have a better set of results for 
        limited dollar investments, looking at the best-
        estimate case rather than the worst case. It is a win-
        win situation all around when it comes to that.
          But focusing on the central estimates of risk rather 
        than on the worst case while disclosing the worst case, 
        in my judgment, would substantially reduce the unfunded 
        mandate problem and improve the performance of the 
        results, the return on our investment.

 IV. REPORTED PROBLEMS WITH FAILURE OF FEDERAL REGULATORY PROGRAMS TO 
  PROVIDE A REASONABLE RELATIONSHIP OF COSTS AND BENEFITS, SUFFICIENT 
          FLEXIBILITY, AND REALISTIC RISK REDUCTION PRIORITIES

A. General Problems

    In a 1992 article, the New York Times summed up the 
prevailing criticism of Congress' and the Environmental 
Protection Agency's choice of priorities:

          In the last 15 years, environmental policy has too 
        often evolved largely in reaction to popular panics, 
        not in response to sound scientific analysis of which 
        environmental hazards present the greatest risks. As a 
        result * * * billions of dollars are wasted each year 
        in battling problems that are no longer considered 
        especially dangerous, leaving little money for others 
        that cause far more harm.

    A 1990 report by EPA's Science Advisory Board, ``Reducing 
Risk: Setting Priorities and Strategies for Environmental 
Protection,'' agrees with this general analysis and states: 
``There are heavy costs involved if society fails to set 
environmental priorities.'' The Center for Resource Economics 
in a report released May 1992 points out that this failure is 
currently affecting EPA programs and estimates that EPA spends 
just 20% of its own budget on the most serious risks.
    While estimates do vary, many of the estimates place 
Federal regulatory costs at over $540 billion per year--a 
figure that will grow through the year 2000 even without any 
additional legislative mandates. In the area of health, safety, 
and the environment, regulation is particularly expensive. 
Federal environmental mandates drained over $115 billion of 
national economic resources in 1993 alone.
    The health and environmental benefits of Federal 
environmental programs vary dramatically in terms of the cost-
effectiveness of reducing health and environmental risks. The 
previous chart from the FY 1992 Budget document which described 
the cost efficiency of several recent regulations is indicative 
of the wide range in cost-effectiveness.
    The Committee specifically began to address these concerns 
in the context of Superfund and Safe Drinking Water Act 
legislation in the 103rd Congress.

B. EPA, States, municipalities, and the General Accounting Office call 
        for more realistic priorities for the expenditure of limited 
        national economic resources for reducing risks to human health, 
        safety, and the environment.

            1. EPA
    In 1990, former EPA Administrator Bill Reilly released a 
statement entitled, ``Aiming Before We Shoot: The `Quiet 
Revolution' in Environmental Policy.'' Mr. Reilly stated that 
``we have to find a better way of setting environmental 
priorities * * * Risk is a common metric that lets us 
distinguish the environmental heart attacks from broken bones 
or indigestion or bruises.'' These principles lead to a report 
from EPA's Science Advisory Board titled ``Reducing Risk: 
Setting Priorities and Strategies for Environmental 
Protection.'' The first recommendation in the report is that 
EPA should target its environmental protection efforts on the 
basis of opportunities for greatest risk reduction.
            2. National Governors Association
    In two major policy statements on the cumulative impact of 
environmental regulations, the National Governors Association 
noted:

          Under funded and inflexible environmental regulations 
        often exceed the financial and technical capabilities 
        of the governing agencies * * * Resources are finite, 
        but current regulatory practices--which may not include 
        the flexibility to adapt to distinctive, specific 
        characteristics of individual areas--often preclude the 
        intelligent application of resources to problems * * * 
        As recommended by the Science Advisory Board of the 
        Environmental Protection Agency (EPA), EPA should set 
        risk-based priorities for environmental protection. EPA 
        should target its efforts to reducing the most serious 
        remaining risks to the environment and public health. 
        Risk identification and resulting environmental 
        regulation should be the product of scientific study.
          National Governor's Association Policy, NR-8 
        Environmental Priorities and Unfunded Mandates.
          8.2.1 Federal environmental laws and regulations must 
        recognize the need to set priorities and focus on the 
        most important environmental objectives at the 
        national, State, and local levels. In order to promote 
        risk-based priority setting, environmental requirements 
        should be based upon sound science and risk-reduction 
        principles, including the appropriate use of cost-
        benefit analysis that considers both quantifiable and 
        qualitative measures. Such analyses will ensure that 
        funds expended on environmental protection and 
        conservation address the greatest risks first and 
        provide the greatest possible return on investment.
            3. Mayors of cities and municipalities
    A bipartisan group of 114 mayors from towns and cities 
across the United States sent a letter to President Clinton 
warning of an ``impending fiscal crisis'' in trying to pay for 
the costs of unfunded Federal environmental mandates. The 
letter also urges Congress to assure that environmental 
protection investments are made where they accomplish the 
greatest good.
    The report accompanying the letter entitled, ``Paying for 
Federal Environmental Mandates: a Looming Crisis for Cities and 
Counties,'' found major shortcomings in the way Congress and 
Federal agencies make decisions on environmental protection. 
These include:

          Environmental issues are addressed in a vacuum 
        without examining the impacts new mandates have on 
        local government costs, personal incomes, private 
        property rights, and the economy.
          Mandates sometimes are not scientifically justified, 
        and respond to preconceived rather than real risks.
            4. National League of Cities
    The National League of Cities has adopted a resolution 
calling on Congress and the Administration to ``review, 
evaluate, and calculate the total burden unfunded mandates 
place on State and local governments * * * and to authorize and 
fund significant efforts to assess real and scientifically 
verifiable risk prior to requiring any action.'' The League 
also called on Congress and the Administration to ``develop 
guidelines based on the results of scientifically verifiable 
risk assessment which would authorize regional authorities, 
states, and local governments to prioritize the implementation 
of national environmental mandates based on the actual 
regional, State and/or local environmental problems.''
    5. General Accounting Office
    In a June 1991 report titled, ``Environmental Protection: 
Meeting Public Expectations with Limited Resources,'' the 
General Accounting Office recommended that the Administrator of 
EPA work with Congress to shift resources from problems of less 
severe risk to problems whose risks are greater and to educate 
the public about relative environmental risks. The report 
further stated that in authorizing and appropriating funds the 
Congress should take into account EPA's effort to reorder 
budget priorities so they incorporate the concept of relative 
risks to human health and the environment, including the costs 
and feasibility of reducing these risks.

            V. LEGISLATIVE BACKGROUND ON TITLE III OF H.R. 9

A. Efforts in the 103rd Congress

            1. Legislation related to subtitles A--risk assessment and 
                    communication
    Proposals for risk assessment reform and cost-benefit were 
a dominant part of the legislative agenda of the 103rd 
Congress. Subtitle A of Title III is largely based on H.R. 
2910, the Risk Communication Act of 1993, which was introduced 
by Representatives Moorhead, Brown, Bliley, Oxley, Hayes, 
Lloyd, Walker, and Zimmer. The most significant difference 
between H.R. 2910 and Title III is that H.R. 2910 applies only 
to the Environmental Protection Agency whereas Title III as 
reported by the Committee on Commerce applies to a broader list 
of covered Federal agencies to the extent they have regulatory 
programs designed to protect human health, safety or the 
environment. An oversight hearing related to H.R. 2910 was 
conducted by the Subcommittee on Hazardous Materials and 
Transportation on November 17, 1993, but there was no 
subsequent legislative action. Nonetheless, H.R. 2910 attracted 
a significant amount of support and created political pressure 
for related legislation and amendments.
    The Science Committee held a number of hearings on related 
issues and reported H.R. 4306, the Risk Assessment Improvement 
Act. H.R. 4306 also only applied to EPA and contained 
provisions designed to address the same perceived problems with 
Federal risk assessment and characterization practices. H.R. 
4306 was not brought up for a vote on the floor. Representative 
Walker, now Chairman of the Science Committee, did offer a 
subset of H.R. 4306 as an amendment to H.R. 3870, the 
Environmental Technologies Act of 1994. The Walker amendment 
was approved 286 to 139.
    During the 103rd Congress, the Energy and Commerce 
Committee adopted several Republican amendments requiring 
unbiased presentation of risk information during markups of 
H.R. 3800, The Superfund Reform Act of 1994; H.R. 3392, the 
Safe Drinking Water Act Amendments of 1994; H.R. 2448, The 
Radon Awareness and Disclosure Act, and H.R. 2919, the Indoor 
Air Act of 1994. The Safe Drinking Water and Radon legislation 
were both approved on the House floor but did not become law. 
These provisions reflected requirements for transparency and 
objectivity similar to those in Subtitle A. H.R. 3800, the 
Superfund bill, also contained provisions for a National Risk 
Protocol designed, in part, to address the perceived problems 
of unrealistic and probably exaggerated risk estimates in the 
Superfund program.
            2. Legislation Related to Subtitle B--Cost-Benefit Analysis
    Based on concerns over both risk assessments at EPA and the 
perceived failure of EPA regulations to reflect costs and 
benefits, the Senate also approved risk and cost-benefit 
language in the Johnston amendment by a vote of 95-3 during 
floor consideration of legislation to elevate EPA to Cabinet 
status in early 1993. A less demanding version of the Johnston 
amendment was also attached to legislation reauthorizing the 
Safe Drinking Water Act in the Senate. The Johnston amendment 
basically required: (1) cost-benefit analysis for major rules; 
(2) comparative risk analysis to place the risk reduction into 
perspective; and (3) certifications that the science used the 
best reasonably available scientific information and that the 
benefits of the rule justified the costs.
    Subtitle B of Title III is patterned after the Johnston 
amendment with at least three substantial modifications. First, 
Subtitle B applies to health, safety or environmental 
regulations regardless of the Federal agency, whereas the 
Senate versions of the Johnston amendment applied only to EPA. 
Second, Subtitle B applies requirements to all rules whose 
projected annual compliance cost exceeds $25 million dollars, 
whereas the Johnston amendment defined major rules at $100 
million dollars annual compliance cost. Finally, the Johnston 
amendment contained explicit exclusions from judicial review, 
whereas Subtitle B does not.
    Despite the lopsided votes in the Senate, the amendment 
sparked controversy--with both the Administration and 
environmental groups expressing concerns. The then chairmen of 
four House committees and one Subcommittee, in a letter to 
President Clinton, stated that the Johnston amendment would 
overturn ``carefully considered judgements which Congress 
designed to fit the specifics of the problems in question'' and 
complained that the amendment imposed ``insidious and 
burdensome new mandates designed to undermine [EPA's] efforts 
to protect our nation's health and environment.'' Environmental 
groups, in letters to President Clinton dated May 20, 1993, 
stated that the Johnston amendment:

          * * * intrudes into the carefully crafted analyses 
        already mandated by numerous substantive environmental 
        laws. In doing so it clearly treads upon the expertise 
        and jurisdiction of committees that have, over the past 
        two decades, fine tuned EPA's numerous statutory duties 
        * * *

    The environmental groups also stated that the amendment:

          * * * fails to explain whether the life of a person 
        with a low income or an elderly person should be worth 
        less than someone with a high income who is young. It 
        does not resolve whether a risk imposed on someone 
        involuntarily and unnecessarily by a polluter is 
        different from an avoidable risk a person has 
        voluntarily and knowingly accepted. In other words, the 
        Johnston Amendment requires the agency to give detailed 
        answers to essentially unanswerable questions before 
        the agency acts * * *

    On the other hand, Dr. John Graham, Director of Harvard's 
Center for Risk Analysis has said:

          [The Johnston Amendment] is necessary and appropriate 
        because bureaucratic politics does not naturally 
        produce scientific candor about the extent of various 
        risks and the costs of achieving varying amounts of 
        risk reduction. By injecting such information into 
        environmental rulemaking, this bill will raise the 
        level of public debate about the proper course of 
        environmental policy.

    Based on this controversy, the Democratic leadership in the 
House sought to avoid votes on analogues to the Johnston 
amendment through a combination of germaneness rules and by 
proposing a restricted rule for consideration on the House 
floor. The proposed restrictive rule was defeated by a vote of 
227 to 191, and the House version of EPA Cabinet legislation, 
H.R. 3425, was never taken up on the House floor. A less 
demanding version of the Johnston amendment, however, was 
adopted as part of H.R. 3171, the Department of Agriculture 
Reauthorization bill. Mr. Tauzin also introduced H.R. 3395 
which was referred to the Committee on Energy and Commerce and 
essentially matched the Johnston amendment.
    In the Committee on Energy and Commerce, the major cost-
benefit issues were considered in the context of specific 
statutes. For example, in reathorization of both H.R. 3800, The 
Superfund Reform Act, and H.R. 3392, The Safe Drinking Water 
bill, the Committee modified statutory cleanup and drinking 
water standards to include consideration of incremental costs 
and benefits in more situations. When costs and benefits are 
part of standard setting, there is generally no dollar 
threshold for applicability, and there is judicial review of 
the administrative decisions.
            3. Legislation Related to Subtitle E--Setting Priorities
    Mr. Zimmer and Mr. Slattery introduced H.R. 3111, the Risk 
Reduction Act of 1993. The bill is essentially the analogue to 
S. 110 introduced by Senator Moynihan. The bill creates three 
advisory committees: one, to identify and rank the relative 
environmental risks; the second, to quantify the benefits of 
reducing risks; and the third, to develop and implement 
strategies for communicating risk information to the public. 
All of these advisory committees would provide reports to 
Congress by 1995 and every two years thereafter. Section 6 of 
the bill requires EPA to provide general risk assessment 
guidelines. Section 7 sets out areas for further research. 
Section 9 would establish an Interagency Panel on Risk 
Assessment and Reduction. Finally, section 10 sets out a 
biennial Report to Congress which sets priorities for health 
and environmental risks, provides options for addressing these 
risks and corresponding estimates of costs and benefits. The 
bill was not marked up, although a version of the bill was 
adopted as part of Safe Drinking Water legislation on the 
Senate Floor.

B. History of Title III of the Job Creation and Wage Enhancement Act 
        and ``Contract With America"

    The Job Creation and Wage Enhancement Act generally 
embodies the principles addressed in ``Contract with America.'' 
The Contract is a political and policy document, intended to 
serve as a blueprint for legislative action in the House of 
Representatives during the first 100 days of the first session. 
The political commitment of the Contract with respect to Title 
III is to bring risk assessment reform and cost-benefit 
legislation for a vote on the House floor in the first 100 
days. This commitment does not freeze legislative language in 
place and fully encompasses the need to modify and improve the 
policy positions and workability in the Title and to gain 
greater political consensus where possible.
    As discussed previously, Subtitle A of Title III, as 
introduced, is patterned after H.R. 2910, the Risk 
Communication Act of 1993. The major difference is an expansion 
of the applicability of Title III to more Federal agencies than 
the Environmental Protection Agency.
    As discussed above Subtitle B, as introduced, is patterned 
after the Johnston amendment with at least three substantial 
modifications. First, Subtitle B applies to health, safety or 
environmental regulations across a number of agencies, not just 
the EPA. Second, Subtitle B applies requirements to all rules 
whose projected annual compliance cost exceeds $25 million 
dollars, whereas the Johnston amendment defined major rules at 
$100 million annual compliance cost. Finally, Subtitle B does 
not contain explicit exclusions from judicial review as did the 
Johnston amendment.
    Draft copies of the Job Creation and Wage Enhancement Act 
were publicly available in September and October of 1994. After 
the November 1994 election, the draft became subject to public 
scrutiny and discourse. On this basis a number of changes were 
made between the September 1994 draft of Title III and the bill 
as introduced on January 4, 1995, to improve the workability of 
the Title and, in part, to address a number of concerns from 
the Administration. These included (1) reducing the scope of 
the bill from all Federal agencies to regulatory programs 
addressing health, safety and the environment; (2) changing the 
numerical threshold for applicability of Subtitle B from rules 
imposing $1 million in annual compliance cost to $25 million; 
(3) reducing the prescriptiveness of Subtitle C generally; (4) 
changing the numerical threshold peer review requirements to 
rules imposing annual compliance costs of $100 million; (5) 
eliminating the provision affording peer review panels an 
effective veto in the rulemaking process and (6) eliminating a 
citizen suit provision which would have added a number of new 
causes of action.

             vi. committee hearings on title iii of h.r. 9

    On February 1 and 2, 1995, the Subcommittee on Commerce, 
Trade and Hazardous Materials and the Subcommittee on Health 
and Environment held joint hearings on Title III of H.R. 9.
    As a general matter, many groups representing State and 
local governments and a wide range of businesses appear to 
support statutory risk assessment reform and provisions for 
elevating the status and consideration of costs and benefits in 
Federal regulatory programs. The Administration stated a 
willingness to work on such legislation, but has a number of 
concerns with Title III specifically and H.R. 9 generally. A 
number of environmental or public interest groups have also 
taken issue with H.R. 9 generally. A cross-section of these 
parties was represented at the hearing along with a number of 
scientists and professional organizations with expertise on 
risk assessment.
    The regulated community generally considers Title III, as 
drafted, to be a modest ``down payment'' on regulatory reform. 
While these groups appear willing to support modifications to 
improve the workability of Title III, many have expressed 
concerns that the title contains too many loopholes. Several in 
the business community also discussed more far reaching 
amendments. There was strong support among the regulated 
community for maintaining requirements which are enforceable 
against the Federal agencies in court.
    The Administration has expressed a desire to craft 
appropriate risk legislation which is ``fair, effective, and 
affordable'' but believes Title III as drafted does not meet 
these tests. Moreover, the Administration notes that Title III 
is interrelated to other provisions in H.R. 9, such as Title 
V's paper work reduction requirements and Title VI and VII's 
requirements for regulatory impact analyses. Thus, the 
Administration argues that the cumulative impact on Federal 
agencies is too broad, too prescriptive, too costly, and 
creates too many avenues for excessive review and opportunities 
for legal challenge.
    The issue of scope is of great concern and was one of the 
important topics during the hearing. By expanding the 
applicability of these provisions beyond EPA, the 
Administration argued that there are a potentially greater 
number of unintended consequences and areas which, one could 
argue, are not part of the political or policy problems. The 
hearing also highlighted the need to redefine terms in Subtitle 
A to avoid application of new requirements for risk 
characterization to reports or documents stemming from minor 
inspection activities such as food inspections or other actions 
which (1) are unlikely to affect actions to impose further 
regulatory costs and (2) unlikely to affect public 
understanding or discourse on risk issues the way major Federal 
reports might.
    Many of the witnesses stated that the general provisions of 
Title III would provide substantial benefits in terms of 
greater public confidence in the Federal risk information 
system; consistency; consideration of costs and benefits; and 
more informed decisionmaking. Administration witnesses, the 
Environmental Defense Fund, OMB Watch, and a representative 
from the United Auto Workers generally expressed concerns over 
greater administrative burdens on Federal agencies, potential 
delays in rulemakings, and the negative consequences of adding 
new areas of law for parties challenging administrative actions 
to litigate.
    All of the testimony from the hearing helped shape the 
legislation reported out of Committee. The following excerpts 
highlight a number of significant points of witnesses that 
encouraged the Committee to report comprehensive risk 
assessment and cost-benefit legislation.

                      State and Local Governments

A. Excerpts from the testimony of Governor Benjamin Nelson, State of 
        Nebraska

          The science of risk assessment may never be perfect, 
        but the time has come to fully incorporate 
        consideration of risks, priorities, public health 
        benefits, and cost-effectiveness into Federal 
        decisionmaking.
          Governors strongly support risk reduction principles 
        in the development of environmental regulations and 
        commend your pursuit of this legislation. However, we 
        believe it is essential that such analyses focus on 
        cost effectiveness by requiring agencies to identify 
        the least costly regulatory alternatives that achieve 
        risk reductions.
          Requirements established under existing laws and 
        regulations are increasingly burdensome, less that 
        cost-effective, and imbalanced in terms of addressing 
        priority problems first. The governors believe that the 
        days when we could afford to "do it all" have long 
        gone, if they ever existed. Today we have to set 
        priorities, choose among many competing demands for our 
        resources, and spend the public's money--or use 
        regulations to make the public spend its own money--
        more carefully.
          Investments on priority needs will optimize the 
        amount of environmental protection "bought" with the 
        finite resources available by promoting adoption of 
        regulatory alternatives that effectively reduce risks 
        at the least cost. A comprehensive perspective based 
        upon the best obtainable scientific, technical, 
        economic, and other information will better enable 
        Federal and State policymakers to determine how much, 
        if any, new regulation is appropriate for environmental 
        programs.

B. Excerpts from the testimony of Randy Johnson, county commissioner, 
        Hennepin County, Minnesota

          We spend a great deal of our taxpayers money solving 
        problems that, if left to our own decisions, would be 
        placed much lower on the priority list. We divert 
        resources and attention from serious local health 
        threats to comply with Federal laws and regulations 
        that are stapled together and called national 
        environmental policies.
          The National Association of Counties believes that 
        Congress should adopt legislation which requires 
        Federal agencies to provide fair, scientifically sound, 
        and consistent assessments of purported health, safety, 
        or environmental risks prior to the imposition of new 
        regulations. It is just plain wrong to regulate without 
        at least an attempt to make a scientifically-based 
        assessment of the risk that is sought to be abated, its 
        relationship to other risks, and the costs involved.
          At a minimum, all regulations imposing costs on local 
        governments should be peer-reviewed. Risk assessments 
        should be scientifically objective and should include 
        data that argues against the need to regulate as well 
        as for it.
          Risks should also be compared with those that people 
        understand and to which they can readily relate. It is 
        also important to give us the tools to explain to our 
        citizens why some of these regulations are necessary.

C. Excerpts from the testimony of Barbara Wheeler, the National School 
        Boards Association

          The formulation of public policy on the asbestos 
        issue was ahead of the scientific evidence to establish 
        an accurate risk assessment; the result was that 
        millions of scarce educational dollars were wasted. 
        Schools cannot afford to abate questionable 
        environmental hazards, abate them in an unnecessary 
        way, or abate them down to a level that is beyond a 
        meaningful risk.
          Inaccurate risk assessment on asbestos has diverted 
        billions of dollars from schools.
          Developing a firm scientific basis for knowing that 
        we have an environmental hazard and the degree to which 
        it should be abated are critical to ensuring that 
        educational dollars are spent wisely--either to protect 
        the health of children or to educate them.
          On asbestos, the public policy was made ahead of the 
        scientific evidence. The result was that billions of 
        scarce educational dollars were wasted.

D. Excerpts from the testimony of Donald Schregardus, Director, Ohio 
        Environmental Protection Agency, Columbus, Ohio

          As the larger sources of pollution have been 
        controlled, environmental laws have shifted to focus on 
        smaller and more numerous pollution sources and minute 
        quantities of natural and man-made chemicals in the 
        environment. As this occurs, the cost of meeting and 
        administering environmental laws has skyrocketed * * * 
        compliance costs are growing exponentially as the law 
        of diminishing returns takes over.
          In Ohio, for example, Ohio EPA found that of the 52 
        synthetic organic chemical pesticides that US EPA 
        requires water systems to test for, only 9 were used in 
        the State in quantities that might be detected. The 
        State and communities were forced to spend thousands of 
        dollars and significant time providing to US EPA that 
        those pesticides were not a problem instead of using 
        resources to solve real drinking water concerns.
          The provisions in HR 9 will help to ensure that the 
        Federal Superfund program sets priorities according to 
        the risks posed by individual sites and the cost 
        effectiveness of the solutions.
          Federal law must include the flexibility to recognize 
        State and local risk-based priorities because the 
        critical environmental problems in one area may be of 
        little risk in another area.

            Experts in Risk Assessment and Management Policy

A. Excerpts from the testimony of Lester B. Lave, university professor, 
        Carnegie Mellon University

          Congress should instruct regulatory agencies to use 
        the best scientific knowledge, not ``conservative'' 
        decision rules. Agencies should explore all plausible 
        alternative scientific theories and explain why they 
        chose a particular theory and data set as the basis of 
        the risk estimates it is relying on. They should take 
        care to spell out the uncertainties in the analysis.
          There have been far too many instances in which a 
        plausible sounding regulation was adopted and later 
        discovered to have excess costs, give little or no 
        reduction in risks, or to be ineffective. Far too often 
        the attention of regulators and Congress is focused on 
        what turn out to be minor issues, diverting attention 
        from major problems.
          Title III is good in pressing regulators to use the 
        best scientific understanding and to estimate risks 
        based on this understanding. A major contribution to 
        risk analysis policy and providing decision-makers and 
        the public with information is this insistence on using 
        best scientific understanding and not simply 
        calculating conservative estimates.
          Title III mandates benefit-cost analysis as well as 
        risk analysis. I support this requirement based on the 
        same reason: good decisions require good information.
          I stress again that these [benefit-cost] value 
        judgements should not be made by bureaucrats and hidden 
        in the analysis; the analyses ought to be open and 
        permit others to supply the value judgments that they 
        deem appropriate.

B. Excerpts from the testimony of Dr. Gilbert S. Ommen, Chair, 
        Commission on Risk Assessment and Risk Management

          The Commission supports the flexibility that Section 
        3105, Principles for Risk Characterization and 
        Communication, provides * * * Section 3105(1) provides 
        enough flexibility to avoid being prescriptive and 
        enough guidance to be useful in the treatment of 
        numerical estimates; however, this section misses a 
        critical element of risk characterization, namely a 
        qualitative assessment of the nature of the adverse 
        effects and the strength of the evidence. * * *
          The Commission supports the provision of Section 
        3104, Principles for Risk Assessment, that would 
        distinguish scientific findings from other 
        considerations. This provision would make risk 
        assessments clearer and more relevant both to risk 
        managers and to stakeholders.
          Using of risk comparisons in partnership with the 
        public and all levels of government is consistent with 
        the current legislative goal of achieving the maximal 
        reduction of overall health and environmental risks 
        with whatever expenditures are made. * * * we invoke 
        the Committee to consider encouraging more widespread 
        priority setting exercises and implementation of the 
        results of those exercises to improve environmental 
        health in this era of decreasing public funds.

C. Excerpts from the testimony of John A. Moore, president, Institute 
        for Evaluating Health Risks, Washington, D.C.

          The preoccupation with theoretical cancer risk that 
        has dominated regulatory activity, diverted attention 
        from other adverse effects that may be of equal or 
        greater public health importance.
          The greatest impediment to the development of a 
        strong base of support for risk assessment within the 
        scientific community has been the procedures many 
        Federal agencies use to derive quantitative estimates 
        of cancer risk. The risk characterization language in 
        HR 9, including estimates of risk and the requirement 
        to discuss other plausible alternate assumptions, will 
        result in a more balanced presentation of information 
        and foster reconciliation of current differences.
          Throughout my career peer review, when properly used, 
        has consistently demonstrated its value. Peer review 
        can provide a dispassionate analysis as to the quality 
        and balance of the risk assessment and economic 
        assessment that are key components of risk management 
        decisions.

D. Excerpts from the testimony of Dr. John D. Graham, Harvard Center 
        for Risk Analysis

          New legislation can help in numerous ways but the two 
        most urgent needs are (1) a statutory requirement that 
        Federal agencies report realistic estimates of risk 
        based on the best available science, and (2) a 
        statutory requirement that regulators explain how their 
        decisions reflect a reasonable balance between the 
        benefits of reducing risk and the costs ( and 
        unintended risks) of regulation.
          In fact, the choice of regulatory priorities is 
        rarely informed by formal analysis. EPA, for example, 
        now openly acknowledges that its budgetary priorities 
        are not in synch with the seriousness of risks and only 
        modest reallocations from overblown (e.g., pesticides 
        residues) to neglected (e.g., indoor air pollution) 
        dangers have occurred since EPA acknowledged this 
        perversity in 1987. Former EPA Administrator William 
        Reilly commented in a recent speech at Harvard that the 
        fraction of EPA's budget devoted to ``high-risk'' 
        threats increased from 15% to 30% during his four-year 
        tenure at EPA.
          When scientific information about risk is uncertain, 
        some agencies are inclined to publish ``worst-case'' 
        estimates of risk without providing any realistic 
        indication of what the actual risk is likely to be.
          The important practice of subjecting agency analyses 
        to independent peer review by qualified experts is 
        sporadic in some agencies and absent entirely in other 
        agencies.

E. Excerpts from the testimony of Dr. Roger O McClellan, president, 
        Chemical Industry Institute of Toxicology, Research Triangle 
        Park, N.C.

          Risk assessments must make maximum use of available 
        scientific data, with default options utilized only in 
        the absence of specific scientific information. The use 
        of default options in the risk assessment process 
        should be clearly documented and the scientific 
        rationale provided for their use.
          Scientifically sound risk characterizations should be 
        used to compare and prioritize risks for subsequent 
        action and to assure consistency across legislative and 
        agency boundaries.
          Provision must be make for public comment and 
        external peer review of risk assessments. The principal 
        criteria for selection of peer reviewers must be their 
        scientific competence and knowledge of the risk 
        assessment process. All peer review comments, including 
        minority views, should be documented and forwarded to 
        the risk manager.

F. Excerpts from the testimony of Jeremiah Lynch, president, American 
        Industrial Hygiene Association

          To the extent practical and appropriate, agencies 
        should provide descriptions of the distribution and 
        probability of risk estimates to reflect differences in 
        exposure variability in populations and uncertainties. 
        The priority setting process must include 
        scientifically sound, objective, and unbiased risk 
        assessments.
          AIHA has reviewed the proposed requirements for risk 
        assessment found in HR 9. AIHA supports the use of 
        human health risk assessment techniques in regulatory 
        decision making, in the making of public health policy, 
        and in the allocation of government resources to 
        environmental issues. AIHA believes risk assessment 
        should be conducted with the best available scientific 
        data. In the absence of scientific data, AIHA supports 
        the use of health protective but reasonable default 
        values which are selected using well-defined 
        principles.

G. Excerpts from the testimony of Don Ritter, chairman, National 
        Environmental Policy Institute

          We have also wasted vast media-sensitive resources 
        chasing down infinitesimally small amounts of high 
        profile substances; resources that might have been used 
        more effectively or used to boost jobs and American 
        competitiveness here and abroad, when applied to other 
        environmental problems and opportunities.
          Risk assessment that is open, transparent, rigorously 
        peer reviewed, democratized and demystified can go a 
        long way to changing a broken system.
          One of the main policy conclusions of our work is 
        that the risk assessment process should be transparent 
        and peer-reviewed so that Congress, policy makers in 
        agencies, and the public can easily understand the 
        risks we are protecting against.

                        The Regulated Community
A. Excerpts from the testimony of Kenneth W. Farber, Food Industry 
        Environmental Council

          Federal agencies should be required to use sound risk 
        assessment methodologies, including appropriate best 
        estimate analyses, when conducting and reviewing risk 
        assessments. Whenever possible, policy and value 
        considerations should be separated from scientific 
        analyses and should be articulated clearly. Subtitle A 
        of Title III of H.R. 9 accomplishes these objectives.
          The Federal Government treats risk inconsistently 
        within and across agencies. Agencies do not always base 
        policy decisions on sound science, and in some 
        instances, they blur the underlying science with other 
        policy and value considerations in making regulatory 
        decisions.
          In many government decisions, policy and value 
        considerations are left vague or are mixed 
        inappropriately with the scientific rationale of a 
        decision. This bill will help to ensure the scientific 
        basis for risk-based decisions is founded on current 
        and reliable scientific principles and assumptions, and 
        that policy and value considerations are articulated 
        clearly.
          EPA's means of addressing risk should be consistent 
        with that of FDA and the U.S. Department of 
        Agriculture. This is not necessarily the case today. 
        Specifically, the way EPA may make a ``weight of the 
        evidence'' determination is not consistent in many 
        cases with FDA's approach.

B. Excerpts from the testimony of Jerry J. Jasinowski, Alliance for 
        Reasonable Regulation

          Risk assessments, when they are conducted at all, 
        tend to be unrealistic, overly conservative, and 
        reflective of unstated policy choices or default 
        assumptions which, if they must be included in the risk 
        assessment at all, should be explicitly acknowledged 
        and fully explained.
          In most cases, health and environmental risks are 
        inadequately characterized and communicated to 
        decisionmakers and interested members of the public.
          In most cases, the scientific and technical 
        assessments on which regulations are based are not 
        subjected to independent external peer review. As a 
        result, the scientific and technical underpinnings of 
        agency actions that may have enormous consequences 
        often are not adequately tested.
          Environmental regulations sometimes are set at a 
        level of stringency that imposes exceedingly large 
        costs but achieves little, if any, incremental 
        environmental or public health benefit.
          The economic and other adverse impacts of agency 
        rules (including the creation of what H.R. 9 refers to 
        as ``substitution risks'') frequently are not evaluated 
        adequately or are not factored into the ultimate 
        regulatory decision.
          Agency rules tend to be relatively inflexible, 
        reflecting a penchant for command-and-control 
        specification, rather than a performance-based 
        orientation. This results in regulations that are far 
        less cost-effective than they could be, and it 
        frequently precludes the adoption of environmental 
        management practices that would actually be more 
        protective and less costly than the actions required 
        under the rule.
          Alternatives to proposed regulatory actions (whether 
        they be non-regulatory, voluntary, market-based, or 
        regulatory in nature) frequently do not receive the 
        attention they deserve.
          In order to ensure that risk-based decisions have a 
        sound scientific and technical underpinning, any risk 
        assessment that may potentially serve as the basis for 
        a major rule should be subjected to independent, 
        external peer review.

                        Committee Consideration

    On February 8, 1995, the Committee on Commerce met in open 
session and ordered reported the bill H.R. 9 with an amendment 
by a recorded vote of 27 to 16, a quorum being present.

                            Roll Call Votes

    Pursuant to clause 2(l)(2)(B) of rule XI of the Rules of 
the House of Representatives, following are listed the recorded 
votes on the motion to report H.R. 9 and on amendments offered 
to the measure, including the names of those Members voting for 
and against.
                           roll call vote #3

    Bill: Title III, Risk Assessment and Cost/Benefit Analysis 
of New Regulations, of H.R. 9, the Job Creation and Wage 
Enhancement Act.
    Amendment: Amendment to the Oxley-Bilirakis Amendment in 
the Nature of a Substitute by Mr. Markey re: level of 
protection.
    Disposition: Not agreed to, by a roll call vote of 16 ayes 
to 30 nays.

----------------------------------------------------------------------------------------------------------------
         Representative            Aye    Nay   Present           Representative            Aye    Nay   Present
----------------------------------------------------------------------------------------------------------------
Mr. Bliley......................  .....     X   .......  Mr. Dingell.....................     X   .....  .......
Mr. Moorhead....................  .....     X   .......  Mr. Waxman......................     X   .....  .......
Mr. Fields......................  .....     X   .......  Mr. Markey......................     X   .....  .......
Mr. Oxley.......................  .....     X   .......  Mr. Tauzin......................  .....     X   .......
Mr. Bilirakis...................  .....     X   .......  Mr. Wyden.......................     X   .....  .......
Mr. Schaefer....................  .....     X   .......  Mr. Hall........................  .....     X   .......
Mr. Barton......................  .....     X   .......  Mr. Bryant......................     X   .....  .......
Mr. Hastert.....................  .....     X   .......  Mr. Boucher.....................     X   .....  .......
Mr. Upton.......................  .....     X   .......  Mr. Manton......................     X   .....  .......
Mr. Stearns.....................  .....     X   .......  Mr. Towns.......................     X   .....  .......
Mr. Paxon.......................  .....     X   .......  Mr. Studds......................     X   .....  .......
Mr. Gillmor.....................  .....     X   .......  Mr. Pallone.....................     X   .....  .......
Mr. Klug........................  .....     X   .......  Mr. Brown.......................     X   .....  .......
Mr. Franks......................  .....     X   .......  Mrs. Lincoln....................  .....     X   .......
Mr. Greenwood...................  .....     X   .......  Mr. Gordon......................  .....     X   .......
Mr. Crapo.......................  .....     X   .......  Ms. Furse.......................     X   .....  .......
Mr. Cox.........................  .....     X   .......  Mr. Deutsch.....................  .....     X   .......
Mr. Burr........................  .....     X   .......  Mr. Rush........................     X   .....  .......
Mr. Bilbray.....................  .....     X   .......  Ms. Eshoo.......................     X   .....  .......
Mr. Whitfield...................  .....     X   .......  Mr. Klink.......................     X   .....  .......
Mr. Ganske......................  .....     X   .......  Mr. Stupak......................     X   .....  .......
Mr. Frisa.......................  .....     X   .......  ................................  .....  .....  .......
Mr. Norwood.....................  .....     X   .......  ................................  .....  .....  .......
Mr. White.......................  .....     X   .......  ................................  .....  .....  .......
Mr. Coburn......................  .....     X   .......  ................................  .....  .....  .......
----------------------------------------------------------------------------------------------------------------

                           ROLL CALL VOTE #4

    Bill: Title III, Risk Assessment and Cost/Benefit Analysis 
of New Regulations, of H.R. 9, the Job Creation and Wage 
Enhancement Act.
    Motion: Motion by Mr. Stearns to move the previous question 
on the Amendment to the Oxley-Bilirakis Amendment in the Nature 
of a Substitute by Mr. Brown re: exceptions for ``imminent 
endangerment.''
    Disposition: Agreed to, by a roll call vote of 24 ayes to 
21 nays.

----------------------------------------------------------------------------------------------------------------
         Representative            Aye    Nay   Present           Representative            Aye    Nay   Present
----------------------------------------------------------------------------------------------------------------
Mr. Bliley......................     X   .....  .......  Mr. Dingell.....................  .....     X          
Mr. Moorhead....................     X   .....  .......  Mr. Waxman......................  .....     X          
Mr. Fields......................     X   .....  .......  Mr. Markey......................  .....     X          
Mr. Oxley.......................     X   .....  .......  Mr. Tauzin......................  .....     X          
Mr. Bilirakis...................     X   .....  .......  Mr. Wyden.......................  .....     X          
Mr. Schaefer....................     X   .....  .......  Mr. Hall........................  .....     X          
Mr. Barton......................     X   .....  .......  Mr. Bryant......................  .....     X          
Mr. Hastert.....................     X   .....  .......  Mr. Boucher.....................  .....     X          
Mr. Upton.......................     X   .....  .......  Mr. Manton......................  .....     X          
Mr. Stearns.....................     X   .....  .......  Mr. Towns.......................  .....     X          
Mr. Paxon.......................     X   .....  .......  Mr. Studds......................  .....     X          
Mr. Gillmor.....................     X   .....  .......  Mr. Pallone.....................  .....     X          
Mr. Klug........................     X   .....  .......  Mr. Brown.......................  .....     X          
Mr. Franks......................     X   .....  .......  Mrs. Lincoln....................  .....     X          
Mr. Greenwood...................     X   .....  .......  Mr. Gordon......................  .....     X          
Mr. Crapo.......................     X   .....  .......  Ms. Furse.......................  .....     X          
Mr. Cox.........................     X   .....  .......  Mr. Deutsch.....................  .....     X          
Mr. Burr........................     X   .....  .......  Mr. Rush........................  .....     X          
Mr. Bilbray.....................     X   .....  .......  Ms. Eshoo.......................  .....     X          
Mr. Whitfield...................     X   .....  .......  Mr. Klink.......................  .....     X          
Mr. Ganske......................     X   .....  .......  Mr. Stupak......................  .....     X          
Mr. Frisa.......................     X                                                                          
Mr. Norwood.....................     X                                                                          
Mr. White.......................                                                                                
Mr. Coburn......................     X                                                                          
----------------------------------------------------------------------------------------------------------------

                           ROLL CALL VOTE #5

    Bill: Title III, Risk Assessment and Cost/Benefit Analysis 
of New Regulations, of H.R. 9, the Job Creation and Wage 
Enhancement Act.
    Amendment: Amendment to the Oxley-Bilirakis Amendment in 
the Nature of a Substitute by Mr. Brown re: exceptions for 
``imminent endangerment''.
    Disposition: Not agreed to, by a roll call vote of 20 ayes 
to 25 nays.

----------------------------------------------------------------------------------------------------------------
         Representative            Aye    Nay   Present           Representative            Aye    Nay   Present
----------------------------------------------------------------------------------------------------------------
Mr. Bliley......................  .....     X   .......  Mr. Dingell.....................     X   .....  .......
Mr. Moorhead....................  .....     X   .......  Mr. Waxman......................     X   .....  .......
Mr. Fields......................  .....     X   .......  Mr. Markey......................     X   .....  .......
Mr. Oxley.......................  .....     X   .......  Mr. Tauzin......................  .....     X   .......
Mr. Bilirakis...................  .....     X   .......  Mr. Wyden.......................     X   .....  .......
Mr. Schaefer....................  .....     X   .......  Mr. Hall........................     X   .....  .......
Mr. Barton......................  .....     X   .......  Mr. Bryant......................     X   .....  .......
Mr. Hastert.....................  .....     X   .......  Mr. Boucher.....................     X   .....  .......
Mr. Upton.......................  .....     X   .......  Mr. Manton......................     X   .....  .......
Mr. Stearns.....................  .....     X   .......  Mr. Towns.......................     X   .....  .......
Mr. Paxon.......................  .....     X   .......  Mr. Studds......................     X   .....  .......
Mr. Gillmor.....................  .....     X   .......  Mr. Pallone.....................     X   .....  .......
Mr. Klug........................  .....     X   .......  Mr. Brown.......................     X   .....  .......
Mr. Franks......................  .....     X   .......  Mr. Lincoln.....................     X   .....  .......
Mr. Greenwood...................  .....     X   .......  Mr. Gordon......................     X   .....  .......
Mr. Crapo.......................  .....     X   .......  Ms. Furse.......................     X   .....  .......
Mr. Cox.........................  .....     X   .......  Mr. Deutsch.....................     X   .....  .......
Mr. Burr........................  .....     X   .......  Mr. Rush........................     X   .....  .......
Mr. Bilbray.....................  .....     X   .......  Ms. Eshoo.......................     X   .....  .......
Mr. Whitfield...................  .....     X   .......  Mr. Klink.......................     X   .....  .......
Mr. Ganske......................  .....     X   .......  Mr. Stupak......................     X   .....  .......
Mr. Frisa.......................  .....     X   .......  ................................  .....  .....  .......
Mr. Norwood.....................  .....     X   .......  ................................  .....  .....  .......
Mr. White.......................  .....  .....  .......  ................................  .....  .....  .......
Mr. Coburn......................  .....     X   .......  ................................  .....  .....  .......
----------------------------------------------------------------------------------------------------------------

                           ROLL CALL VOTE #6

    Bill: Title III, Risk Assessment and Cost/Benefit Analysis 
of New Regulations, of H.R. 9, the Job Creation and Wage 
Enhancement Act
    Amendment: Amendment to the Oxley-Bilirakis Amendment in 
the Nature of a Substitute by Mr. Bryant re: exceptions for 
product/substance approvals, certifications, and for 
enforcement
    Disposition: Not agreed to, by a roll call vote of 19 ayes 
to 27 nays.

----------------------------------------------------------------------------------------------------------------
         Representative            Aye    Nay   Present           Representative            Aye    Nay   Present
----------------------------------------------------------------------------------------------------------------
Mr. Bliley......................  .....     X   .......  Mr. Dingell.....................     X   .....         
Mr. Moorhead....................  .....     X   .......  Mr. Waxman......................     X   .....         
Mr. Fields......................  .....     X   .......  Mr. Markey......................     X   .....         
Mr. Oxley.......................  .....     X   .......  Mr. Tauzin......................  .....     X          
Mr. Bilirakis...................  .....     X   .......  Mr. Wyden.......................     X   .....         
Mr. Schaefer....................  .....     X   .......  Mr. Hall........................  .....     X          
Mr. Barton......................  .....     X   .......  Mr. Bryant......................     X                 
Mr. Hastert.....................  .....     X   .......  Mr. Boucher.....................     X                 
Mr. Upton.......................  .....     X   .......  Mr. Manton......................     X                 
Mr. Stearns.....................  .....     X   .......  Mr. Towns.......................     X                 
Mr. Paxon.......................  .....     X   .......  Mr. Studds......................     X                 
Mr. Gillmor.....................  .....     X   .......  Mr. Pallone.....................     X                 
Mr. Klung.......................  .....     X   .......  Mr. Brown.......................     X                 
Mr. Franks......................  .....     X   .......  Mrs. Lincoln....................     X                 
Mr. Greenwood...................  .....     X   .......  Mr. Gordon......................     X                 
Mr. Crapo.......................  .....     X   .......  Ms. Furse.......................     X                 
Mr. Cox.........................  .....     X   .......  Mr. Deutsch.....................     X                 
Mr. Burr........................  .....     X   .......  Mr. Rush........................     X                 
Mr. Bilbray.....................  .....     X   .......  Ms. Eshoo.......................     X                 
Mr. Whitfield...................  .....     X   .......  Mr. Klink.......................     X                 
Mr. Ganske......................  .....     X   .......  Mr. Stupak......................     X                 
Mr. Frisa.......................  .....     X                                                                   
Mr. Norwood.....................  .....     X                                                                   
Mr. White.......................  .....     X                                                                   
Mr. Coburn......................  .....     X                                                                   
----------------------------------------------------------------------------------------------------------------

                           roll call vote #7

    Bill: Title III, Risk Assessment and Cost/Benefit Analysis 
of New Regulations, of H.R. 9, the Job Creation and Wage 
Enhancement Act.
    Amendment: Amendment to the Oxley-Bilirakis Amendment in 
the Nature of a Substitute by Ms. Eshoo re: level of protection 
relative to women's health issues.
    Disposition: Not agreed to, by a roll call vote of 14 ayes 
to 24 nays.

----------------------------------------------------------------------------------------------------------------
         Representative            Aye    Nay   Present           Representative            Aye    Nay   Present
----------------------------------------------------------------------------------------------------------------
Mr. Bliley......................            X     .....  Mr. Dingell.....................     X                 
Mr. Moorhead....................            X     .....  Mr. Waxman......................     X                 
Mr. Fields......................            X     .....  Mr. Markey......................     X                 
Mr. Oxley.......................            X     .....  Mr. Tauzin......................                       
Mr. Bilirakis...................            X     .....  Mr. Wyden.......................     X                 
Mr. Schaefer....................            X     .....  Mr. Hall........................                       
Mr. Barton......................            X     .....  Mr. Bryant......................                       
Mr. Hastert.....................            X     .....  Mr. Boucher.....................                       
Mr. Upton.......................            X     .....  Mr. Manton......................     X                 
Mr. Stearns.....................            X     .....  Mr. Towns.......................     X                 
Mr. Paxon.......................            X     .....  Mr. Studds......................                       
Mr. Gillmor.....................            X     .....  Mr. Pallone.....................     X                 
Mr. Klug........................            X     .....  Mr. Brown.......................     X                 
Mr. Franks......................            X     .....  Mrs. Lincoln....................                       
Mr. Greenwood...................            X     .....  Mr. Gordon......................     X                 
Mr. Crapo.......................            X     .....  Ms. Furse.......................                       
Mr. Cox.........................                  .....  Mr. Deutsch.....................     X                 
Mr. Burr........................            X     .....  Mr. Rush........................     X                 
Mr. Bilbray.....................            X     .....  Ms. Eshoo.......................     X                 
Mr. Whitfield...................            X     .....  Mr. Klink.......................     X                 
Mr. Ganske......................            X     .....  Mr. Stupak......................     X                 
Mr. Frisa.......................            X   .......                                                         
Mr. Norwood.....................            X   .......                                                         
Mr. White.......................            X   .......                                                         
Mr. Coburn......................            X   .......                                                         
----------------------------------------------------------------------------------------------------------------

                           roll call vote #8

    Bill: Title III, Risk Assessment and Cost/Benefit Analysis 
of New Regulations, of H.R. 9, the Job Creation and Wage 
Enhancement Act.
    Amendment: Amendment to the Oxley-Bilirakis Amendment in 
the Nature of a Substitute by Mr. Markey re: peer review.
    Disposition: Not agreed to, by a roll call vote of 17 ayes 
to 25 nays.

----------------------------------------------------------------------------------------------------------------
         Representative            Aye    Nay   Present           Representative            Aye    Nay   Present
----------------------------------------------------------------------------------------------------------------
Mr. Bliley......................  .....     X   .......  Mr. Dingell.....................     X                 
Mr. Moorhead....................  .....     X   .......  Mr. Waxman......................                       
Mr. Fields......................  .....     X   .......  Mr. Markey......................     X                 
Mr. Oxley.......................  .....     X   .......  Mr. Tauzin......................  .....     X          
Mr. Bilirakis...................  .....     X   .......  Mr. Wyden.......................     X                 
Mr. Schaefer....................  .....     X   .......  Mr. Hall........................                       
Mr. Barton......................  .....     X   .......  Mr. Bryant......................     X                 
Mr. Hastert.....................  .....     X   .......  Mr. Boucher.....................     X                 
Mr. Upton.......................  .....     X   .......  Mr. Manton......................     X                 
Mr. Stearns.....................  .....     X   .......  Mr. Towns.......................     X                 
Mr. Paxon.......................  .....  .....  .......  Mr. Studds......................                       
Mr. Gillmor.....................  .....     X   .......  Mr. Pallone.....................     X                 
Mr. Klug........................  .....     X   .......  Mr. Brown.......................     X                 
Mr. Franks......................  .....     X   .......  Mrs. Lincoln....................     X                 
Mr. Greenwood...................  .....     X   .......  Mr. Gordon......................     X                 
Mr. Crapo.......................  .....     X   .......  Ms. Furse.......................     X                 
Mr. Cox.........................  .....     X   .......  Mr. Deutsch.....................     X                 
Mr. Burr........................  .....     X   .......  Mr. Rush........................     X                 
Mr. Bilbray.....................  .....     X   .......  Ms. Eshoo.......................     X                 
Mr. Whitfield...................  .....     X   .......  Mr. Klink.......................     X                 
Mr. Ganske......................  .....     X   .......  Mr. Stupak......................     X                 
Mr. Frisa.......................  .....     X                                                                   
Mr. Norwood.....................  .....     X                                                                   
Mr. White.......................  .....     X                                                                   
Mr. Coburn......................  .....     X                                                                   
----------------------------------------------------------------------------------------------------------------

                           ROLL CALL VOTE #9

    Bill: Title III, Risk Assessment and Cost/Benefit Analysis 
of New Regulations, of H.R. 9, the Job Creation and Wage 
Enhancement Act.
    Amendment: Amendment to the Oxley-Bilirakis Amendment in 
the Nature of a Substitute by Mrs. Lincoln re: relationship of 
Title III requirements to small business.
    Disposition: Not agreed to, by a roll call vote of 21 ayes 
to 22 nays.

----------------------------------------------------------------------------------------------------------------
          Representtive            Aye    Nay   Present           Representative            Aye    Nay   Present
----------------------------------------------------------------------------------------------------------------
Mr. Bliley......................  .....     X   .......  Mr. Dingell.....................     X   .....  .......
Mr. Moorhead....................  .....     X   .......  Mr. Waxman......................  .....  .....  .......
Mr. Fields......................  .....     X   .......  Mr. Markey......................     X   .....  .......
Mr. Oxley.......................  .....     X   .......  Mr. Tauzin......................     X   .....  .......
Mr. Bilirakis...................     X   .....  .......  Mr. Wyden.......................     X   .....  .......
Mr. Schaefer....................     X   .....  .......  Mr. Hall........................     X   .....  .......
Mr. Barton......................     X   .....  .......  Mr. Byrant......................     X   .....  .......
Mr. Hastert.....................  .....     X   .......  Mr. Boucher.....................     X   .....  .......
Mr. Upton.......................  .....     X   .......  Mr. Manton......................     X   .....  .......
Mr. Stearns.....................  .....     X   .......  Mr. Towns.......................  .....  .....  .......
Mr. Paxon.......................  .....     X   .......  Mr. Studds......................  .....  .....  .......
Mr. Gillmor.....................  .....     X   .......  Mr. Pallone.....................     X   .....  .......
Mr. Klug........................  .....     X   .......  Mr. Brown.......................     X   .....  .......
Mr. Franks......................  .....     X   .......  Mrs. Lincoln....................     X   .....  .......
Mr. Greenwood...................  .....     X   .......  Mr. Gordon......................     X   .....  .......
Mr. Crapo.......................  .....     X   .......  Ms. Furse.......................     X   .....  .......
Mr. Cox.........................  .....     X   .......  Mr. Deutsch.....................     X   .....  .......
Mr. Burr........................  .....     X   .......  Mr. Rush........................     X   .....  .......
Mr. Bilbray.....................  .....     X   .......  Ms. Eshoo.......................     X   .....  .......
Mr. Whitfield...................  .....     X   .......  Mr. Klink.......................     X   .....  .......
Mr. Ganske......................  .....     X   .......  Mr. Stupak......................     X   .....  .......
Mr. Frisa.......................  .....     X   .......  ................................  .....  .....  .......
Mr. Norwood.....................  .....     X   .......  ................................  .....  .....  .......
Mr. White.......................  .....     X   .......  ................................  .....  .....  .......
Mr. Coburn......................  .....     X   .......  ................................  .....  .....  .......
----------------------------------------------------------------------------------------------------------------

                           roll call vote #10

    Bill: Title III, Risk Assessment and Cost/Benefit Analysis 
of New Regulations, of H.R. 9, the Job Creation and Wage 
Enhancement Act.
    Amendment: Amendment to the Oxley-Bilirakis Amendment in 
the Nature of a Substitute by Mrs. Lincoln re: unfunded 
mandates and State laws.
    Disposition: Not agreed to, by a roll call vote of 17 ayes 
to 27 nays.

----------------------------------------------------------------------------------------------------------------
         Representative            Aye    Nay   Present           Representative            Aye    Nay   Present
----------------------------------------------------------------------------------------------------------------
Mr. Bliley......................  .....     X   .......  Mr. Dingell.....................     X   .....  .......
Mr. Moorhead....................  .....     X   .......  Mr. Waxman......................  .....  .....  .......
Mr. Fields......................  .....     X   .......  Mr. Markey......................     X   .....  .......
Mr. Oxley.......................  .....     X   .......  Mr. Tauzin......................  .....     X   .......
Mr. Bililrakis..................  .....     X   .......  Mr. Wyden.......................     X   .....  .......
Mr. Schaefer....................  .....     X   .......  Mr. Hall........................  .....     X   .......
Mr. Barton......................  .....     X   .......  Mr. Bryant......................     X   .....  .......
Mr. Hastert.....................  .....     X   .......  Mr. Boucher.....................     X   .....  .......
Mr. Upton.......................  .....     X   .......  Mr. Manton......................     X   .....  .......
Mr. Stearns.....................  .....     X   .......  Mr. Towns.......................     X   .....  .......
Mr. Paxon.......................  .....     X   .......  Mr. Studds......................  .....  .....  .......
Mr. Gillmor.....................  .....     X   .......  Mr. Pallone.....................     X   .....  .......
Mr. Klug........................  .....     X   .......  Mr. Brown.......................     X   .....  .......
Mr. Franks......................  .....     X   .......  Mrs. Lincoln....................     X   .....  .......
Mr. Greenwood...................  .....     X   .......  Mr. Gordon......................     X   .....  .......
Mr. Crapo.......................  .....     X   .......  Ms. Fuse........................     X   .....  .......
Mr. Cox.........................  .....     X   .......  Mr. Deutsch.....................     X   .....  .......
Mr. Burr........................  .....     X   .......  Mr. Rush........................     X   .....  .......
Mr. Bilbray.....................  .....     X   .......  Ms. Eshoo.......................     X   .....  .......
Mr. Whitfield...................  .....     X   .......  Mr. Klink.......................     X   .....  .......
Mr. Ganske......................  .....     X   .......  Mr. Stupak......................     X   .....  .......
Mr. Frisa.......................  .....     X   .......  ................................  .....  .....  .......
Mr. Norwood.....................  .....     X   .......  ................................  .....  .....  .......
Mr. White.......................  .....     X   .......  ................................  .....  .....  .......
Mr. Coburn......................  .....     X   .......  ................................  .....  .....  .......
----------------------------------------------------------------------------------------------------------------

                           ROLL CALL VOTE #11

    Bill: Title III, Risk Assessment and Cost/Benefit Analysis 
of New Regulations, of H.R. 9, the Job Creation and Wage 
Enhancement Act.
    Amendment: Substitute Amendment to the Oxley-Bilirakis 
Amendment in the Nature of a Substitute by Mr. Brown.
    Disposition: Not agreed to, by a roll call vote of 16 ayes 
to 26 nays.

----------------------------------------------------------------------------------------------------------------
         Representative            Aye    Nay   Present           Representative            Aye    Nay   Present
----------------------------------------------------------------------------------------------------------------
Mr. Bliley......................  .....     X   .......  Mr. Dingell.....................     X   .....  .......
Mr. Moorhead....................  .....     X   .......  Mr. Waxman......................  .....  .....  .......
Mr. Fields......................  .....     X   .......  Mr. Markey......................     X   .....  .......
Mr. Oxley.......................  .....     X   .......  Mr. Tauzin......................  .....     X   .......
Mr. Bilirakis...................  .....     X   .......  Mr. Wyden.......................     X   .....  .......
Mr. Schaefer....................  .....     X   .......  Mr. Hall........................  .....     X   .......
Mr. Barton......................  .....     X   .......  Mr. Bryant......................     X   .....  .......
Mr. Hastert.....................  .....     X   .......  Mr. Boucher.....................     X   .....  .......
Mr. Upton.......................  .....     X   .......  Mr. Manton......................     X   .....  .......
Mr. Stearns.....................  .....     X   .......  Mr. Towns.......................     X   .....  .......
Mr. Paxon.......................  .....     X   .......  Mr. Studds......................  .....  .....  .......
Mr. Gillmor.....................  .....     X   .......  Mr. Pallone.....................     X   .....  .......
Mr. Klug........................  .....     X   .......  Mr. Brown.......................     X   .....  .......
Mr. Franks......................  .....     X   .......  Mrs. Lincoln....................  .....  .....  .......
Mr. Greenwood...................  .....     X   .......  Mr. Gordon......................     X   .....  .......
Mr. Crapo.......................  .....     X   .......  Ms. Furse.......................     X   .....  .......
Mr. Cox.........................  .....     X   .......  Mr. Deutsch.....................     X   .....  .......
Mr. Burr........................  .....     X   .......  Mr. Rush........................     X   .....  .......
Mr. Bilbray.....................  .....     X   .......  Ms. Eshoo.......................     X   .....  .......
Mr. Whitfield...................  .....     X   .......  Mr. Klink.......................     X   .....  .......
Mr. Ganske......................  .....     X   .......  Mr. Stupak......................     X   .....  .......
Mr. Frisa.......................  .....     X   .......  ................................  .....  .....  .......
Mr. Norwood.....................  .....     X   .......  ................................  .....  .....  .......
Mr. White.......................  .....     X   .......  ................................  .....  .....  .......
Mr. Coburn......................  .....     X   .......  ................................  .....  .....  .......
----------------------------------------------------------------------------------------------------------------

                           ROLL CALL VOTE #12

    Bill: Title III, Risk Assessment and Cost/Benefit Analysis 
of New Regulations, of H.R. 9, the Job Creation and Wage 
Enhancement Act.
    Amendment: Amendment in the Nature of a Substitute by Mr. 
Oxley and Mr. Bilirakis for Title III.
    Disposition: Agreed to, as amended, by a roll call vote of 
26 ayes to 16 nays.

----------------------------------------------------------------------------------------------------------------
         Representative            Aye    Nay   Present           Representative            Aye    Nay   Present
----------------------------------------------------------------------------------------------------------------
Mr. Bliley......................     X   .....  .......  Mr. Dingell.....................  .....     X   .......
Mr. Moorhead....................     X   .....  .......  Mr. Waxman......................  .....  .....  .......
Mr. Fields......................     X   .....  .......  Mr. Markey......................  .....     X   .......
Mr. Oxley.......................     X   .....  .......  Mr. Tauzin......................     X   .....  .......
Mr. Bilirakis...................     X   .....  .......  Mr. Wyden.......................  .....     X   .......
Mr. Schaefer....................     X   .....  .......  Mr. Hall........................     X   .....  .......
Mr. Barton......................     X   .....  .......  Mr. Bryant......................  .....     X   .......
Mr. Hastert.....................     X   .....  .......  Mr. Boucher.....................  .....     X   .......
Mr. Upton.......................     X   .....  .......  Mr. Manton......................  .....     X   .......
Mr. Stearns.....................     X   .....  .......  Mr. Towns.......................  .....     X   .......
Mr. Paxon.......................     X   .....  .......  Mr. Studds......................  .....  .....  .......
Mr. Gillmor.....................     X   .....  .......  Mr. Pallone.....................  .....     X   .......
Mr. Klug........................     X   .....  .......  Mr. Brown.......................  .....     X   .......
Mr. Franks......................     X   .....  .......  Mrs. Lincoln....................  .....  .....  .......
Mr. Greenwood...................     X   .....  .......  Mr. Gordon......................  .....     X   .......
Mr. Crapo.......................     X   .....  .......  Ms. Furse.......................  .....     X   .......
Mr. Cox.........................     X   .....  .......  Mr. Deutsch.....................  .....     X   .......
Mr. Burr........................     X   .....  .......  Mr. Rush........................  .....     X   .......
Mr. Bilbray.....................     X   .....  .......  Ms. Eshoo.......................  .....     X   .......
Mr. Whitfield...................     X   .....  .......  Mr. Klink.......................  .....     X   .......
Mr. Ganske......................     X   .....  .......  Mr. Stupak......................  .....     X   .......
Mr. Frisa.......................     X   .....  .......  ................................  .....  .....  .......
Mr. Norwood.....................     X   .....  .......  ................................  .....  .....  .......
Mr. White.......................     X   .....  .......  ................................  .....  .....  .......
Mr. Coburn......................     X   .....  .......  ................................  .....  .....  .......
----------------------------------------------------------------------------------------------------------------

                           roll call vote #13

    Bill: Title III, Risk Assessment and Cost/Benefit Analysis 
of New Regulations, of H.R. 9, the Job Creation and Wage 
Enhancement Act.
    Motion: Motion by Mr. Oxley to order H.R. 9 reported to the 
House, as amended.
    Disposition: Agree to, by a roll call vote of 27 ayes to 16 
nays.

----------------------------------------------------------------------------------------------------------------
         Representative            Aye    Nay   Present           Representative            Aye    Nay   Present
----------------------------------------------------------------------------------------------------------------
Mr. Bliley......................     X   .....  .......  Mr. Dingell.....................  .....     X   .......
Mr. Moorhead....................     X   .....  .......  Mr. Waxman......................  .....  .....  .......
Mr. Fields......................     X   .....  .......  Mr. Markey......................  .....     X   .......
Mr. Oxley.......................     X   .....  .......  Mr. Tauzin......................     X   .....  .......
Mr. Bilirakis...................     X   .....  .......  Mr. Wyden.......................  .....     X   .......
Mr. Schaefer....................     X   .....  .......  Mr. Hall........................     X   .....  .......
Mr. Barton......................     X   .....  .......  Mr. Byrant......................  .....     X   .......
Mr. Hastert.....................     X   .....  .......  Mr. Boucher.....................  .....     X   .......
Mr. Upton.......................     X   .....  .......  Mr. Manton......................  .....     X   .......
Mr. Stearns.....................     X   .....  .......  Mr. Towns.......................  .....     X   .......
Mr. Paxon.......................     X   .....  .......  Mr. Studds......................  .....  .....  .......
Mr. Gillmor.....................     X   .....  .......  Mr. Pallone.....................  .....     X   .......
Mr. Klug........................     X   .....  .......  Mr. Brown.......................  .....     X   .......
Mr. Franks......................     X   .....  .......  Mrs. Lincoln....................  .....  .....  .......
Mr. Greenwood...................     X   .....  .......  Mr. Gordon......................  .....     X   .......
Mr. Crapo.......................     X   .....  .......  Ms. Furse.......................  .....     X   .......
Mr. Cox.........................     X   .....  .......  Mr. Deutsch.....................  .....     X   .......
Mr. Burr........................     X   .....  .......  Mr. Rush........................  .....     X   .......
Mr. Bilbray.....................     X   .....  .......  Ms. Eshoo.......................  .....     X   .......
Mr. Whitfield...................     X   .....  .......  Mr. Klink.......................  .....     X   .......
Mr. Ganske......................     X   .....  .......  Mr. Stupak......................  .....     X   .......
Mr. Frisa.......................     X   .....  .......  ................................  .....  .....  .......
Mr. Norwood.....................     X   .....  .......  ................................  .....  .....  .......
Mr. White.......................     X   .....  .......  ................................  .....  .....  .......
Mr. Coburn......................     X   .....  .......  ................................  .....  .....  .......
----------------------------------------------------------------------------------------------------------------

                              VOICE VOTES

    Bill: Title III, Risk Assessment and Cost/Benefit Analysis 
of New Regulations, of H.R. 9, the Job Creation and Wage 
Enhancement Act.
    Amendment: Amendment to the Oxley-Bilirakis Amendment in 
the Nature of a Substitute by Mr. Fields re: definition of 
covered Federal agencies.
    Disposition: Agreed to, by a voice vote.
    Amendment: Amendment to the Oxley-Bilirakis Amendment in 
the Nature of a Substitute by Mr. Barton re: principles for 
risk assessment.
    Disposition: Agreed to, by a voice vote.
    Amendment: Amendment to the Oxley-Bilirakis Amendment in 
the Nature of a Substitute by Mr. Rush re: judicial review.
    Disposition: Not Agreed to, by a voice vote.
    Amendment: Amendment to the Oxley-Bilirakis Amendment in 
the Nature of a Substitute by Mr. Barton re: judicial review of 
Sections 3104 and 3105.
    Disposition: Agreed to, by a voice vote.
    Amendment: Amendment to the Oxley-Bilirakis Amendment in 
the Nature of a Substitute by Mr. Stupak re: risk comparison.
    Disposition: Agreed to, by a voice vote.
    Amendment: Amendment to the Oxley-Bilirakis Amendment in 
the Nature of a Substitute by Mr. Barton re: petition process.
    Disposition: Agreed to, by a voice vote.

                      Committee Oversight Findings

    Clause 2(1)(3)(A) of Rule XI requires each committee report 
to contain oversight findings and recommendations required 
pursuant to Clause 2(b)(1) of Rule X. The committee has had 
several hearings on the subject matter of Title III of H.R. 9, 
including a hearing on November 17, 1993, in the Subcommittee 
on Transportation and Hazardous Materials. The findings of 
these hearings are reflected in the committee report.

              Committee on Government Oversight and Reform
     Pursuant to clause 2(l)(3)(D) of rule XI of the Rules of 
the House of Representatives, no oversight findings have been 
submitted to the Committee by the Committee on Government 
Oversight and Reform.

                        Committee Cost Estimate

     Pursuant to clause 7(a) of rule XIII of the rules of the 
House of Representatives, the Committee is required to estimate 
the costs that would be incurred in carrying out Title III of 
H.R. 9. The Committee adopts as its own the cost estimate 
prepared by the Director of the Congressional Budget Office, 
pursuant to section 403 of the Congressional Budget Act of 
1974, with the following concerns.
    First, Title III is drafted to provide covered Federal 
agencies with flexibility in complying with the requirements of 
the Title. Specifically, the legislation provides that 
``[c]osts and benefits shall be quantified to the extent 
feasible and appropriate and may otherwise be qualitatively 
described.'' Section 3201(a)(1). This language provides Federal 
agencies with flexibility in complying with the requirements of 
the legislation. It is not apparent that this flexibility has 
been taken into account in the information provided by the 
Federal agencies to the Congressional Budget Office for the 
purpose of its estimate.
    Second, it is not apparent that the Congressional Budget 
Office cost estimates take into account the savings to the 
Federal government resulting from this legislation. For 
example, pursuant to Section 3201(b) and (c), this legislation 
could result in savings in hazardous waste cleanup programs, 
some of which would accrue to the Federal government.
    Finally, the Congressional Budget Office estimate does not 
purport to identify savings to Federal, state and local 
governments and the national economy that are expected to occur 
as a result of improved risk assessment and cost-benefit 
legislation. The Committee believes it is important to consider 
these savings when evaluating estimates of costs.

                  Congressional Budget Office Estimate

    Pursuant to clause 2(l)(3)(C) of rule XI of the rules of 
the House of Representatives, following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
403 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                 Washington, DC, February 15, 1995.
Hon. Thomas J. Bliley, Jr.,
Chairman, Committee on Commerce, House of Representatives, Washington, 
        DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for Title III of H.R. 9, 
the Job Creation and Wage Enhancement Act of 1995.
    Enactment of Title III of H.R. 9 could affect direct 
spending or receipts. Therefore, pay-as-you-go procedures would 
apply to the bill.
    If you wish further details on this estimate, we will be 
pleased to provide them.
            Sincerely,
                                              James L. Blum
                              (For Robert D. Reischauer, Director).
               congressional budget office cost estimate

    1. Bill number: Title III of H.R. 9.
    2. Bill title: Job Creation and Wage Enhancement Act of 
1995.
    3. Bill status: As ordered reported by the House Committee 
on Commerce on February 8, 1995.
    4. Bill purpose: This title applies to 12 federal agencies 
with regulatory programs designed to protect human health, 
safety, or the environment. The provisions of subtitle A would 
apply to any risk assessment or risk characterization document 
prepared in connection with a rule that is expected to have 
direct or indirect costs to the federal government, state or 
local governments, or the private sector of at least $25 
million annually. Subtitle A also would apply to permits issued 
by the Environmental Protection Agency (EPA) and the Department 
of the Interior (DOI). Subtitle B would apply to agency rules 
expected to have a direct or indirect cost of at least $25 
million annually, regardless of whether or not a risk 
assessment or characterization document is prepared.
    Subtitle A would require these 12 agencies to apply 
specified principles when preparing risk assessments in 
connection with their regulatory programs. The bill would 
establish a list of components that agencies must include in 
risk characterization documents. Within 15 months following 
enactment, the President is to issue guidelines to agencies 
that are consistent with the risk assessment and risk 
characterization principles described in the bill.
    Subtitle B would require these agencies to assess the 
incremental costs and incremental risk reduction or other 
benefits associated with proposed or promulgated rules designed 
to protect human health, safety, or the environment. The bill 
also would require a review and analysis of other regulatory or 
nonregulatory options considered by the agency. In addition, 
this subtitle would prohibit the promulgation of any final rule 
unless the agency certifies that the incremental risk reduction 
or other benefits of the regulation will be likely to justify, 
and be reasonably related to, the incremental costs.
    Subtitle C would require the specified agencies to 
establish peer review procedures for risk assessments and 
economic assessments associated with rules expected to have 
annual costs to the economy exceeding $100 million. Subtitle D 
would require these agencies to establish procedures for 
considering petitions by individuals for reviewing existing 
rules and revising them to comply with the provisions of this 
bill.
    5. Estimated cost to the Federal Government: We estimate 
that enactment of this title would increase the cost of issuing 
and reviewing regulations by affected federal agencies by at 
least $250 million annually, if the number of federal 
regulations is not affected by the bill. The title may also 
lead to additional legal challenges of proposed federal 
regulatory activities; federal agencies and the courts would 
incur additional costs to defend and process these cases, but 
CBO is unable to estimate the increase in the number of legal 
proceedings or the amount of additional costs. Enacting Title 
III of H.R. 9 could lead to the delay or loss of federal 
receipts expected under current law; therefore, pay-as-you-go 
procedures would apply to the bill. CBO is working with federal 
agencies to determine the amount of the loss in receipts but 
cannot now provide an estimate.
    Few of the agencies that would be affected by this bill 
have had time to systematically study the additional costs that 
its implementation would impose. The risk analysis work, the 
cost/benefit comparisons, and the peer review provisions are 
similar to the work most agencies now conduct for some 
regulations expected to have an economic impact greater than 
$100 million annually. This estimate assumes that agencies will 
try to adhere to their current schedules for implementing new 
regulations and revising existing rules. This estimate does not 
include any costs for analyzing permits issued by EPA and DOI, 
nor does it include any funds for carrying out subtitle D of 
the bill, because we currently have no basis for estimating 
such impacts. None of the agencies we contacted could predict 
the number of petitions that they might receive for reviewing 
and revising current regulations. Several agencies noted, 
however, that the petition process outlined in the bill could 
potentially result in significant costs for additional risk 
assessments and analysis and for increased litigation.
    EPA currently spends about $120 million annually on risk 
assessment and cost/benefit assessments to support rule making 
efforts for regulations expected to have an economic impact 
greater than $100 million annually. Based on information from 
the agency, we estimate that the volume of work that would be 
added by Title III would double the agency's cost for these 
studies. Based on its current regulatory workload, the agency 
estimates that lowering the threshold for detailed risk 
assessments and cost/benefit analysis from regulations with 
economic impacts of $100 million annually to $25 million 
annually would triple the number of regulatory actions 
requiring detailed study. Because it is not clear how the 
provisions of the bill would be applied to the permits issued 
by the agency, this estimate does not include any additional 
costs for risk assessments and cost/benefit analysis of 
permits. The agency handles hundreds of permit applications and 
modifications each year.
    The Department of Agriculture (USDA) currently prepares 
regulatory impact assessments, environmental impact statements, 
and risk analyses for all regulatory actions affecting human 
health, safety, or the environment that are expected to result 
in annual costs to the economy of more than $100 million. Based 
on information from USDA, we estimate that lowering the 
threshold for these analyses would increase the number of risk 
assessments and cost/benefit studies by about 200 each year. 
The additional costs associated with such assessments and 
studies range from less than $100,000 for a relatively routine 
rule to several million dollars for a major regulatory change. 
CBO estimates that most of the additional work would cost 
$150,000 to $250,000 per analysis, or an additional $30 million 
to $50 million annually for the department.
    The cost to the Department of Transportation (DOT) of 
implementing Title III of H.R. 9 also could be large. The 
agency currently spends about $300 million annually on formal 
rule-making proceedings. We cannot estimate the additional 
costs the bill would impose on DOT because the agency is 
currently unclear about how to implement the legislation. The 
type of risk assessments and characterizations conducted by DOT 
are generally quite different from the type defined in Title 
III.
    Based on information from the Food and Drug Administration 
(FDA), CBO estimates that the requirements in Title III of the 
bill would add about $20 million annually to the agency's 
current spending of pre-market regulatory activities. The 
agency estimates that the additional analysis required by the 
bill would add an average of about $700,000 to an additional 25 
rules each year.
    The Department of Energy (DOE) also would incur additional 
costs to implement Title III of H.R. 9. CBO has been unable to 
quantify the impact, but we expect that the incremental cost of 
risk assessment on both the environmental, safety, and health 
program and the environmental management program would be 
significant, perhaps hundreds of millions of dollars.
    The Department of the Interior (DOI) currently spends about 
$50 million per year for regulatory analysis. This work is 
carried out primarily by the Office of Surface Mining, the 
Minerals Management Service, and the Bureau of Land Management 
as part of their overall regulatory enforcement activities. DOI 
estimates that lowering the threshold for regulatory analyses 
from $100 million to $25 million would significantly increase 
the number of analyses these agencies would have to prepare, 
resulting in additional annual costs of about $20 million.
    Requirements in H.R. 9 also would increase costs of the 
Occupational Safety and Health Administration (OSHA), the Mine 
Safety and Health Administration (MSHA), and the Consumer 
Product Safety Commission (CPSC). Based on information from 
these agencies, CBO estimates that Title III would result in 
total additional costs of less than $20 million per year for 
these agencies.
    6. Comparison with spending under current law: CBO 
estimates enactment of this title would add at least $250 
million annually to the cost of issuing regulations.
    7. Pay-as-you-go considerations: Section 252 of the 
Balanced Budget and Emergency Deficit Control Act of 1985 sets 
up pay-as-you-go procedures for legislation affecting direct 
spending or receipts through 1988. Enactment of Title III of 
H.R. 9 could affect receipts; therefore, pay-as-you-go 
procedures would apply to the bill.
    It is possible, depending on how the provisions of Title 
III are interpreted and implemented, that enactment of this 
title could result in a loss of receipts to the federal 
government, such as those from commercial activities on public 
lands. CBO estimates that DOI and USDA collect about $1 billion 
annually from new sales of federal resources that could be 
affected by Title III. If the leasing and sale activities of 
these agencies were significantly delayed, some of these 
receipts would also be delayed.
    If provisions of the title are interpreted to apply to 
agency actions governing the sale of federal resources such as 
oil, gas, and timber, then additional time would be needed to 
prepare cost/benefit analyses and environmental impact 
statements associated with these activities. These additional 
tasks would probably delay some sales. It is also possible that 
the requirements of Title III could be the basis for lawsuits 
against an agency's leasing or sale program, thus delaying some 
sales and associated receipts to the federal Treasury. At this 
time, CBO cannot estimate the loss of receipts that could occur 
if these activities are delayed by enactment of this bill.
    8. Estimated cost to State and local governments: How 
enactment of Title III would affect the budgets of state and 
local governments is unclear. If regulations that would impose 
additional requirements on state and local governments are 
either delayed or precluded by the enactment of these 
provisions, then costs to these entities would be less. It is 
also possible, however, that some regulatory actions that would 
otherwise provide relief to state and local governments could 
be delayed or precluded, thereby increasing their costs for 
various activities. CBO has no basis for predicting the 
direction, magnitude, or timing of such impacts.
    9. Estimated comparison: None.
    10. Previous CBO estimate: None.
    11. Estimate prepared by: Kim Cawley and Connie Takata.
    12. Estimate approved by: Paul N. Van de Water, Assistant 
Director for Budget Analysis.
                     Inflationary Impact Statement

    Clause 2(l)(4) of Rule XI of the Rules of the House of 
Representatives to include an analytical statement describing 
what impact enactment of the measure would have on prices and 
costs in the operation of the national economy. The Committee 
has determined that Title III of H.R. 9 has no inflationary 
impact on the nation's economy, because the bill will make 
Federal regulations more cost-effective and insure that Federal 
and national resources are used to address the most serious 
risks to public health and the environment.

                      Section-By-Section Analysis

Section 3001. Findings

    Under this section, Congress finds that environmental, 
health and safety regulations have dramatically improved the 
environment and significantly reduced risks to human health, 
but that those regulations have been more costly and less 
effective than they could have been. Too frequently, they have 
not been based on a realistic consideration of risk. This 
section further finds that public and private resources are not 
unlimited, and that resources need to be allocated to address 
the greatest needs in the most cost-effective manner, and so 
that incremental regulatory costs are reasonably related to 
incremental benefits. This section further finds that 
regulatory priorities should be based upon realistic 
consideration of risk and sound, objective, and unbiased risk 
assessments. Risk assessments should be based on better science 
and must be communicated more effectively and objectively to 
decision makers and the public. Public stakeholders must be 
fully involved in the risk decisionmaking process.

Section 3002. Definition of covered Federal agency

    This section defines the term ``covered Federal agencies'' 
to include the following agencies: the Environmental Protection 
Agency; the Occupational Safety and Health Administration; the 
Department of Transportation (including the National Highway 
Traffic Safety Administration); the Food and Drug 
Administration; the Department of Energy; the Department of the 
Interior; the Department of Agriculture; the Consumer Product 
Safety Commission; the National Oceanic and Atmospheric 
Administration; the United States Army Corps of Engineers; and 
the Mine Safety and Health Administration.

Section 3003. Coverage of title

    This section provides that the title does not apply to any 
situation that the head of the covered Federal agency concerned 
considers to be an emergency.
    In determining whether an emergency exists, an agency head 
should be guided by applicable statutory definitions and, 
unless otherwise prohibited, ordinary notions of urgency and 
necessity constituting an emergency. The mere existence of the 
usual kind and level of risk which any statute subject to this 
title is designed to regulate does not constitute an emergency. 
[Moreover, there are situations where the Federal agency can 
and should comply with the provisions of the Title after the 
period of time which constitutes the emergency].

             subtitle a--risk assessment and communication

Section 3101. Short title
    This section sets forth the short title of Subtitle A, the 
``Risk Assessment and Communication Act of 1995.''

Section 3102. Purposes

    This section sets forth the following purposes of the 
subtitle: (1) to present the public and the executive branch 
with the most scientifically objective and unbiased information 
about the nature and magnitude of health, safety and 
environmental risks to provide for sound regulatory decisions 
and public education; (2) to provide for full consideration and 
discussion of data and methodologies; (3) to require 
explanation of significant choices in the risk assessment 
process; and (4) to improve consistency in Federal risk 
assessments and risk characterizations.

Section 3103. Effective date, applicability, savings provisions

    This section provides that the subtitle shall take effect 
18 months after the date of enactment, except as otherwise 
specified. This section specifies that Subtitle A applies to 
all significant risk assessment and significant risk 
characterization documents prepared by covered Federal 
agencies. It defines ``significant risk assessment document'' 
and ``significant risk characterization document'' to include 
the following risk documents prepared by or on behalf of a 
covered Federal agency: (1) any major rule designed to protect 
human health, safety or the environment; (2) proposed or final 
permits restricting facility siting or operation, or proposed 
or final cleanup plans, or guidelines for the issuance of such 
permits and plans, under laws administered by the Environmental 
Protection Agency or the Department of the Interior; (3) 
reports to Congress; (4) inclusion of substances on the 
Integrated Risk Information System database; (5) regulatory 
actions placing substances on official lists of carcinogens or 
toxic or hazardous substances; and (6) any risk assessment or 
risk characterization forming the basis of a final risk 
assessment or risk characterization guideline or protocol of 
general application. The term ``regulatory program designed to 
protect human health, safety or the environment'' does not 
include internal personnel matters or programs regulating the 
provision of health care services.
    Subsection 3103(b) recognizes that agency policy relating 
to risk assessment and risk management is established not just 
in formal regulations, but also in final guidances and 
protocols. All of these forms of documents that are intended to 
have general application, rather than to be limited to an 
individual substance, product, or permit, are required to 
comply with the principles established in subtitle A. Second, 
Section 3103(b) is intended to exclude any action where an 
individual substance, product, or permit or its labeling, is 
reviewed and authorized or approved by an agency for some type 
of use. For example, FDA licensing of individual new drugs, 
devices or biologics would be excluded as would EPA approvals 
for individual pesticides or items under the Toxic Substances 
Control Act.
    The guidance documents or protocols on which such a review 
is conducted will be subject to subtitle A, but the individual 
review or individual compliance actions are not themselves 
actions subject to subtitle A unless otherwise specified in 
paragraph 3103(b).
    Paragraph 3103(b)(2) further requires covered Federal 
agencies to promulgate a rule within 15 months of the date of 
enactment listing other risk assessment and risk 
characterization documents deemed to be significant, and sets 
forth criteria to be considered in promulgating the rule. It 
provides that the subtitle does not apply to emergencies, 
screening analyses, or food, drug and product labels requiring 
Federal approval prior to their use. It clarifies that the 
provisions of the subtitle do not modify and are supplemental 
to existing Federal health, safety and environmental standards. 
It further clarifies that nothing in the title requires 
disclosure of trade secrets or confidential information.
    In promulgating regulations under section 3103(b)(2)(B), 
the Committee expects the head of each covered Federal agency 
to place substantial value on the consistent application of the 
principles in sections 3104 and 3105 to provide for sound 
decisionmaking and public discourse. The Committee expects that 
the more likely a category of documents is to affect 
significant regulatory decisions or public discourse, the 
higher the presumption for inclusion.
    Decisions under 3103(b)(2)(B) and the minimum documents 
described in 3103(b)(2)(A) work in conjunction with the several 
rules of reason, such as the phrases ``to the extent feasible'' 
or ``where relevant'' in sections 3104 and 3105. Moreover, 
section 3104 states that discussions or explanations required 
under that section need not be repeated in each significant 
risk assessment document as long as there is a reference to the 
relevant discussion in another agency document. Thus, each 
document category may have somewhat different requirements. 
However, the phrase ``to the extent feasible'' means that where 
it is feasible to comply with one component of a requirement 
and not another, there must be compliance with the component of 
the requirement which is feasible.

Section 3104. Principles for risk assessment

    Subsection 3104(b) provides principles that describe a 
scientifically objective and unbiased risk assessment. These 
principles will make risk assessment processes more 
transparent, allowing risk managers and the public to 
understand the evaluation and selection of data, models, and 
assumptions in a risk assessment.
    Paragraph 3104(b)(1) requires that significant risk 
assessment documents contain discussion of certain data where 
relevant. Federal agencies often use default assumptions when 
actual data exist. Default assumptions allow risk assessors to 
make quantitative estimates of risk when available data are 
incomplete. Often agencies choose default assumptions which, 
given the available scientific information, tend to overstate 
risks in the resulting risk estimate. One such default 
assumption concerning risks to human health is to simply base 
risk estimates on studies which find a positive correlation. 
Agencies often persist in using these defaults, even when 
chemical- or situation-specific data are available. The bill 
addresses this problem by requiring significant risk assessment 
documents to include discussions of relevant data. Subparagraph 
3104(b)(2) will remove the current disincentive for 
organizations to develop data that will increase the accuracy 
of risk assessments.
    Paragraph 3104(b)(2) requires that significant risk 
documents provide or refer to an explanation for certain 
significant choices made by the agency. The paragraph further 
requires that the document provides or refers to a description 
of any significant model and the extent to which such model has 
been validated by, or conflicts with, empirical data.
    Paragraph 3104(b)(3) states that no covered Federal agency 
shall automatically incorporate or adopt any recommendation or 
classification made by a non-United States-based entity 
concerning the health effects value of a substance without an 
opportunity for notice and comment on such incorporation or 
adoption.

Section 3105. Principles for risk characterization and communication

    This section provides for a description in significant risk 
documents of the populations or natural resources subject to 
risk characterization, a best estimate and other risk estimates 
and an explanation of uncertainties in risk assumptions, an 
explanation of exposure scenarios, comparisons to routinely 
encountered risks that place the federally addressed risks in 
context, a statement of significant and clear substitution 
risks, and a summary of other risk estimates to the extent 
feasible.
    Federal agencies generally do not provide complete 
characterizations of risk, but rather provide only single-
point, upper-bound estimates of risk. This forces risk managers 
to make decisions with incomplete information and misleads the 
public into believing that some risks are much larger than they 
are. This section requires the agency to include several pieces 
of information in significant risk characterization documents.
    Paragraph 3105(1) requires covered Federal agencies to 
provide, to the extent feasible and scientifically appropriate, 
the best estimate or estimates for the given populations or 
natural resources, along with the reasonable range of 
scientific uncertainty. The agency may present plausible upper 
bound or conservative estimates in conjunction with plausible 
lower bound estimates. Indeed, the savings clause in section 
3103 makes clear that no calculation is precluded. Best 
estimates are defined flexibly to include any methodology 
designed to provide the most plausible level of risk, given the 
scientific information available to the Administrator. Subtitle 
A does not opine on which combination of scientific assumptions 
or methodology are appropriate and, thus, makes no 
pronouncement on the science itself. Rather, the best estimate 
requirement is simply a question for the risk assessors to 
answer. The scientific debate about the answer continues under 
the current standards of review.
    Best estimates will: (1) help provide a more realistic 
picture of the nature and magnitude of the risks; (2) make the 
impact of conservative assumptions in an upper-bound estimate 
clearer to decisionmakers and the public; (3) separate 
scientific findings from considerations affecting regulatory 
strategies; (4) provide for more realistic comparisons between 
risks; and (5) move scientific debate forward by requiring 
consideration of new, more plausible models and assumptions.
    The provision prohibits agencies from simply ignoring more 
scientifically plausible assumptions and methodologies when 
they are available. The requirement does not require papering 
over legitimate scientific disagreements by averaging 
incompatible estimates. Under such situations, the agency 
merely needs to state why it is not scientifically appropriate 
for the given component of the risk assessment. Nor would 
agencies need to perform new evaluations which are excessively 
burdensome. This is, however, a narrow exception and the agency 
would need to explain why a given approach is not ``feasible.'' 
Moreover, under the language ``to the extent feasible,'' 
agencies would be required to try to get as close to a best 
estimate as feasible. For example, it may be feasible to use 
the most plausible assumptions for some components of a best 
estimate calculation but not others. Finally, what is feasible 
and scientifically appropriate will change over time. 
Certainly, where public comment provides a scientifically sound 
means of getting a risk estimate which is closer to a best 
estimate, the agency should utilize this approach. This 
specifically means that actual information should be used in 
lieu of default assumptions where the actual information is 
more scientifically plausible than the information underlying 
the default assumption.
    Paragraph 3105(l) further requires that, where practical, 
agencies should provide probability distributions for risk 
estimates that reflect both variability and uncertainty. 
Presenting the full distribution of risk provides risk managers 
and the public with the most complete picture of what is and 
what is not known about the risk.
    Paragraph 3105(2) requires agencies to explain the exposure 
scenarios used and provide a statement of the size of the 
population and likelihood that an exposure will occur. This 
information will help assure that the public understands the 
precise basis of the given risk assessment. Moreover, the 
requirement will help separate more likely exposure scenarios 
from unlikely exposure scenarios, such as a child eating dirt 
from a fenced-in industrial site.
    Paragraph 3105(3) requires agencies to provide a statement 
placing the nature and magnitude of risks in context. 
Additional information will assist the public in understanding 
how the risk affects them, and how it relates to other risks 
with which they are more familiar. This section acknowledges 
the difficulty in making useful and meaningful risk comparisons 
by including references to relevant distinctions among 
categories of risk and limitations to comparisons.
    Paragraph 3105(4) requires that each significant risk 
assessment or significant risk characterization document 
referred to in Clause(i), (ii) or (iii) of section 3103(2)(A) 
shall include, to the extent feasible, a statement of any 
significant and clear substitution risks to human health, where 
information on such risk has been provided to the agency. The 
term ``substitution risk'' is defined in section 3108 to mean 
potential risks to human health, safety or the environment that 
arise from a regulatory option designed to decrease other 
risks. Current risk characterization and communication fail to 
provide adequate information about the risks that the proposed 
action will pose. Because they are not currently assessed, 
those risks are often assumed to be zero. Many risk management 
actions pose their own risks. The Committee has provided a 
number of qualifications to this requirement.
    First, the requirement only applies to ``significant'' 
substitution risks. The Committee expects agencies to look to 
the magnitude of the substitution risk relative to the risk 
being addressed by the particular regulatory strategy. If a 
regulatory strategy is addressing minor risks, then minor 
substitution risks may be significant. If the strategy is 
addressing major risks, then minor substitution risks would not 
be significant.
    Second, the requirement only applies to ``clear'' 
substitution risks. This language is designed to preclude 
requiring statements more indirect or hypothetical statements 
of substitution risks. Indirect risks resulting from loss of 
economic resources or the inability to direct such resources to 
other health or safety requirements would not meet the 
requirement for a ``clear'' substitution risk. However, as 
stated in the savings clause, nothing in the Title prevents 
agencies from providing information beyond the minimum 
requirements.
    Third, the requirement applies only ``where information on 
such risks has been provided to the agency. Thus, the provision 
does not require the agencies necessarily to look at all 
possible consequences, for example, restricting a product or 
chemical. However, where specific information is provided and 
reasonably summarized in a comment period, the agencies should 
make feasible efforts to highlight this information.
    Finally, nothing requires the statement to include a 
numerical measure. Statements should be as informative as the 
information available but may be quantitative or qualitative. 
The statement may also be brief with a cross-reference to more 
extensive discussion in another document.
    Paragraph 3105(5) requires agencies to present summaries of 
other risk estimates if they meet certain requirements. Because 
risk assessments often require many subjective judgments, risk 
characterizations conducted by different organizations can vary 
greatly. Inclusion of other risk estimates, provided that they 
meet the standards set forth in the amendment, will provide a 
fuller characterization of risk. The terms ``in connection with 
the presentation of the agency's risk assessment document or 
risk characterization document'' allows for brief summaries 
along with cross references to other documents.

Section 3106. Guidelines

    This section requires the President to issue guidelines for 
Federal agencies consistent with Sections 3104 and 3105 within 
15 months of the date of enactment. It requires agencies to 
evaluate policy and value judgments inherent in their risk 
assessments and report to Congress within three years. It 
provides for public comment and consultation with State and 
local governments and other agencies in the preparation of the 
guidelines and the reports. It requires the President to review 
and, where appropriate, revise the guidelines every four years.
    The section includes the guidelines requirement to ensure 
that the bill's principles are implemented consistently 
throughout the covered Federal agencies and to facilitate 
comparisons of risks assessed by various Federal agencies. Risk 
assessment and characterization guidelines should allow for 
incorporation of new scientific advances and better methods of 
risk characterization and communication.

Section 3107. Judicial Review of Sections 3104 and 3105

    This section requires courts to consider unlawful any 
agency action in which a final agency action does not comply 
with the requirements of sections 3104 or 3105. When a 
significant risk assessment document or a significant risk 
characterization document is prepared in connection with a 
final agency action (e.g., a final rule), that document will be 
part of the administrative record that can be considered by the 
court, if the final agency action is brought before a court for 
review. Under the provisions that govern judicial review of 
most agency actions, such as those codified in Section 10 of 
the Administrative Procedure Act, 5 U.S.C., Section 706, 
reviewing courts are directed to hold unlawful and set aside 
agency action that, among other things, is found to be without 
observance of procedure required by law or otherwise not in 
accordance with law. In making these determinations, the APA 
directs that ``due account shall be taken of the rule of 
prejudicial error.''
    In the absence of a provision like Section 3107, it may not 
be fully clear how a court would evaluate an agency's failure 
to comply with the requirements of sections 3104 and 3105 when 
it reviews a final agency action in connection with the 
preparation of a significant risk assessment or risk 
characterization document.
    For example, without section 3107, courts might declare the 
failure to provide a best estimate under section 3105 a 
harmless error based on the agency's assertion that the 
omission did not influence the final rule. Under the language 
of section 3107, however, courts would consider the final 
agency action unlawful where the action does not comply with 
section 3104 or 3105 because the failure to characterize risk 
in the manner outlined would leave out elements Congress 
considers critical to the rulemaking process. This ensures the 
requirements of 3104 or 3105 supplement otherwise applicable 
statutory requirements and must be followed.
    Courts may continue to gauge whether a given violation of 
sections 3104 or 3105 is de minimus in nature in determining 
whether to set aside agency actions. Moreover, sections 3104 
and 3105 simply require that certain discussions be made a part 
of documents supporting the final agency actions. Judicial 
review of the quality of those discussions remains subject to 
otherwise applicable standards of judicial review.

Section 3108. Definitions

    This section defines certain terms. The term ``risk 
assessment document'' means a document explaining how hazards 
associated with a substance, activity or condition have been 
identified, quantified and assessed or describing the degree of 
toxicity, exposure or other risk they pose for exposed 
individuals, populations or resources. The term ``risk 
characterization document'' means a document quantifying or 
describing the degree of toxicity, exposure, or other risk they 
pose for exposed individuals, populations, or resources, but 
such term does not include a food, drug or other product label. 
The term ``best estimate'' means an estimate which, to the 
extent feasible and scientifically appropriate, is based on 
central estimates of risk using the most plausible assumptions; 
an approach which combines multiple estimates based on 
different scenarios and weighs the probability of each 
scenario; or any other methodology designed to provide the most 
unbiased representation of the most plausible level of risk, 
given the current scientific information available to the 
Federal agency concerned. The term ``substitution risk'' means 
a potential risk to human health, safety or the environment 
from a regulatory option designed to decrease other risks. The 
term ``document'' includes material stored in electronic or 
digital form.
       SUBTITLE B--ANALYSIS OF RISK REDUCTION BENEFITS AND COSTS

Section 3201. Analysis of risk reduction benefits and costs

    Paragraph 3201(a) directs the President to require covered 
Federal agencies to prepare the following for major rules 
proposed or promulgated after the date of enactment and 
designed to protect human health, safety or the environment: an 
assessment of incremental costs and incremental benefits for 
each significant regulatory alternative; a statement placing 
the nature and magnitude of the risks in context; and for each 
final rule, an assessment of the costs and benefits of 
compliance with the rule.
    Quantification in cost-benefit analysis and risks 
assessments is only required to the extent feasible and 
appropriate, and other factors relevant to the decisionmaking 
may be qualitatively described. The methodology and level of 
detail for both risk assessments and cost-benefit analyses 
should be appropriate to the significance and complexity of 
decisionmaking on the matter at issue, considering any need for 
expedition.
    Both risk assessments and cost-benefit analyses can be 
tiered or tailored to fit the decisionmaking process and the 
decision confronting a particular agency, as long as the basic 
elements of reasoned decisionmaking and the logic of the cost-
benefit and risk assessment methodology are respected. This 
legislation does not intend to disregard or minimize the 
application of agency expertise in the decisionmaking process, 
nor does it mandate a strict recipe for risk assessment or 
cost-benefit analysis. Rather, it aims to ensure rationality in 
both the decisionmaking process and the ultimate decisions by 
Federal agencies, recognizing the wide variance in the types of 
decisions and types of situations faced by agency officials.
    Paragraph 3201(b) prohibits promulgation of any final rule 
subject to this title unless the final rule cost-benefit 
assessment is based on an objective, unbiased scientific and 
economic information; incremental benefits are reasonably 
related to and justify the incremental costs; and no other 
proposed or considered options would be more likely to achieve 
a substantially equivalent risk reduction in a more flexible or 
cost-effective manner.
    The language requiring consideration of ``incremental'' 
costs and benefits will ensure that the agencies recognize the 
role of diminishing returns in addressing regulatory 
objectives. In many cases, great benefits may be obtained by 
relatively inexpensive and simple steps. The word 
``incremental'' is used to clarify that the agencies must apply 
cost-benefit analysis to assess the utility of increments of 
risk reduction. Existing regulatory statutes may provide 
criteria by which agencies choose among various cost-benefit 
justified options providing varying levels of costs and 
benefits.
    Paragraph 3201(c) provides that notwithstanding other 
provisions of law, the requirements of the bill supplement, and 
to the extent of any conflict, supersede the decisional 
criteria of underlying statutes. It prohibits promulgation of 
any major rule unless the requirements of 3201(a) and 3201(b) 
are met and supported by substantial evidence of the rulemaking 
record.
    The provisions of 3201(c) make the provisions of 3201(a) 
and 3201(b) applicable to new regulations promulgated under 
existing Federal statutes. The Section 3201(b) decisional 
criteria supplement, and to the extent there is a conflict, 
supersede the decisional criteria for rulemaking otherwise 
applicable under the statute pursuant to which a rule is 
promulgated.
    In effect, agencies will continue to follow the 
instructions provided by Congress in past and future Federal 
legislation, but shall, in addition, follow the risk assessment 
principles and procedures, and apply as additional decisional 
criteria the cost-benefit and cost-effectiveness certification 
requirements of Section 3201(b). When there is a conflict with 
or explicit textual language in a Federal statute prohibiting 
consideration of the criteria set forth in 3201(b), the 
provisions of 3201(c) state that the decisional criteria in 
Section 3201(b) shall supersede those in the statute pursuant 
to which the rule is promulgated, but only to the extent there 
is a conflict. The decisional criteria otherwise applicable 
under other statutory authority will continue to apply to the 
extent not inconsistent with the section 3201(b) criteria. By 
this means, the language molds the ultimate decisional criteria 
for rulemaking applied under all such statutes to the 
requirements of Section 3201(b) with as little disruption as 
feasible to the otherwise applicable instructions by Congress.
    The provisions of paragraphs 3201 (a)-(c) use principles 
which are not designed to predetermine particular policy or 
regulatory approaches. For example, where risks need to be 
regulated and regulation is justified by its benefits, 
regulation will go forward even if costly or inconvenient to 
some.
    Paragraph 3201(d), for each major rule, requires agencies 
to publish in the Federal Register or otherwise make available 
the information required to be prepared under 3201(a) and 
3201(b). For the purposes of this subtitle, it defines 
``costs'' to include the direct and indirect costs of 
compliance to the Federal Government, State and local 
governments, and private entities; it defines ``benefits'' to 
include direct and indirect social and economic benefits; and 
it defines ``major rule'' to mean any regulation, other than a 
regulation or other action to authorize or approve any 
individual substance or product, that is likely to result in an 
annual increase in costs of $25 million or more.
    For purposes of efficiency, the judicial review of the risk 
assessment and cost/benefit analyses contained in the 
regulatory impact analysis required under 3201(a) and (b) 
should proceed, on the basis of the whole record of the 
rulemaking (which will include the actions taken under 3201(a) 
and (b), in conjunction with review of the rule under the 
statute granting the agency authority to conduct the 
rulemaking.
    The promulgation of rules by agencies, whether major rules 
under this legislation or not, are already subject to judicial 
review under the particular statute granting the agency 
authority to conduct the rulemaking. The language intends that 
the procedures and decisional criteria of 3201(a) and (b) shall 
be judicially reviewable, pursuant to the Administrative 
Procedure Act (APA) or the statute granting the agency 
authority to conduct the rulemaking. This review should occur 
at the same time and in the same court that review agency 
findings under the statute granting the agency authority to 
conduct the rulemaking.
    Under the provisions of 3201(c)(2), the certifications 
required under 3201(b) must be supported by substantial 
evidence in the rulemaking record. All other aspects of the 
rule will be subject to otherwise applicable standards of 
review.

                        subtitle c--peer review

Section 3301. Peer review program

    This section requires each covered Federal agency to 
develop a systematic peer review program for significant risk 
assessment documents and economic assessments for regulatory 
programs addressing human health, safety or the environment. 
The program shall provide for peer review panels of independent 
and external experts and shall be broadly representative and 
balanced to the extent feasible; may provide for differing 
levels of peer review depending on the significance or 
complexity of the problems and the need for expeditiousness; 
shall not exclude peer reviewers merely because they represent 
entities with a potential interest in the outcome, provided 
that the interest is fully disclosed, but for regulatory 
decisions affecting a single entity no person representing that 
entity may be included on the panel; may provide specific and 
reasonable deadlines for peer review panels to submit reports; 
and shall provide adequate protections for confidential 
business information and trade secrets. It requires peer review 
for any significant risk assessment document or cost assessment 
prepared for any regulation likely to increase costs by $100 
million or more annually (other than actions to approve 
individual substances or products). It requires covered Federal 
agencies to respond in writing to significant peer review 
comments. It requires that all peer review comments and agency 
responses be made available to the public and part of the 
administrative record. It excepts from peer review data and 
analysis which has been previously peer reviewed. It requires 
the President to appoint peer review panels to annually review 
the risk and cost assessment practices of each covered Federal 
agency and requires those panels to report annually to 
Congress.

                     subtitle d--agency priorities

Section 3401. Petition process

    This section requires each Federal agency to establish 
procedures within one year for accepting and considering 
petitions for reviewing and revising any health or 
environmental effects value, such as those in the Integrated 
Risk Information System database; reviewing risk assessments 
supporting major rules and revising them to take into account 
new information or methodologies or comply with subtitle A; 
requiring peer review; and reviewing and revising any major 
rule promulgated prior to the effective date of this title. It 
requires that the procedures allow any person to petition upon 
adequate information to demonstrate that a revision is 
justified. It requires the agency to respond to petitions in 
the Federal Register within 90 days. It requires the agency to 
accept petitions if the information on which they are based 
would significantly alter an existing risk assessment, and 
requires the agency to explain the reasons for rejecting any 
petition. The section requires initiation or denial of the 
action requested in any petition within one year and deems 
rejection or denial of a petition to be final agency action, 
thereby subjecting it to judicial review under the 
Administrative Procedures Act.
    Section 3401 was added to create a petition process that, 
under certain circumstances, will allow an interested party to 
revise significant risk assessments connected with existing 
regulations, certain other risk assessments, and any major rule 
as defined in section 3201(e)(3).
    The petition process empowers ordinary Americans to help 
find and improve prior risk assessments and, where appropriate, 
correct past regulatory mistakes, while erecting sufficient 
safeguards to prevent a flood of meritless petitions. To ensure 
that the petition process does not place an undue burden on 
covered agencies, Section 3401 requires the petitioner to 
include adequate supporting documentation, including, where 
appropriate, new studies or other information that provides the 
basis for the change requested in the petition. Where the 
petition describes a risk, it should include a summary risk 
characterization that is consistent with the requirements of 
Title III. Petitioner further carries the burden to document 
that a rule is a major rule as defined in section 3201(e)(3).
    Under 3401(b), the rejection or denial of a petition is 
deemed to be a final agency action under the Administrative 
Procedures Act. This provision allows an unsuccessful 
petitioner to seek judicial review of an agency's refusal to 
take the action requested by the petitioner. Under this 
provision, the reviewing court will compel the agency to take 
the requested action if the petitioner can show that the 
petition included adequate evidence to support the requested 
action and that the agency's refusal or denial of the petition 
is inconsistent with the standards of Section 3401. 
Subparagraph 3401(b) sets a requirement to either initiate the 
requested action or deny the petition. There is no requirement 
concerning the timing to complete the actions. Such time period 
should be reasonable given the particular task but not so long 
as to provide a means to escape the purpose of this section.

                            subtitle e--plan

Section 3501. PLAN for assessing new information

    This section requires each covered agency to publish a plan 
to review and, where appropriate, revise significant risk 
assessment documents and risk characterization documents with 
18 months of the date of enactment if the agency determines 
that the principles in sections 3104 and 3105 would likely 
significantly alter the prior results of those documents. It 
provides that each plan must provide procedures for considering 
public comment, and may establish priorities for review and 
revision based on whether economic resources can be more 
effectively focused. It requires that each plan be developed 
after notice and an opportunity for public comment, and in 
consultation with State and local governments and other Federal 
agencies. The plan must go through public notice and comment 
and, thus, provide a clear and open set of procedures to 
supplement the petition process in Subtitle D.

                         subtitle f--priorities

Section 3601. Prioritization

    This section requires the President to identify 
opportunities for regulatory agencies to reflect public health 
priorities within their programs. The President must identify 
the likelihood and severity of the public health risks 
addressed; the number of persons affected; the incremental 
costs and benefits; the cost-effectiveness of risk reduction 
strategies; intergovernmental relationships within regulatory 
programs; and obstacles to allocating resources cost 
effectively to serve public health priorities. The President 
must annually report public health regulatory priorities to 
Congress.
    Too often Federal health risks are not prioritized. Rather 
than following an established procedure, agencies respond 
haphazardly, with the result being an overregulation of some 
risks, under-regulation of others, and reduction of agency 
effectiveness and credibility. An effective priority setting 
process incorporates scientifically sound risk assessments, 
comparative risk analysis based on generally accepted societal 
values, and risk management choices grounded in cost-benefit 
principles.
        ADDITIONAL VIEWS OF MESSRS. BLILEY, OXLEY, AND BILIRAKIS

    We provide these additional views to state our support for 
this legislation, which provides a strong measure of regulatory 
reform, and to comment on some of the proposed amendments that 
we could not support.
    Congress shares responsibility with the Executive Branch, 
and State and local governments for hundreds of billions of 
dollars in regulatory costs. At this time, the legislative 
record of the 103d and 104th Congresses shows that a 
substantial portion of State and local governments, businesses 
and the scientific community have lost confidence in Federal 
risk assessment and characterization processes which form the 
basis of much of these regulatory costs. These groups, with 
sufficient reason, believe that too many Federal programs 
commit national economic resources to reduce risks that are 
excessively hypothetical or very small. These requirements 
constitute ``unfounded'' mandates that drain resources from 
other priorities at the Federal, State and local level.
    Many outside the Washington D.C. beltway further believe, 
with sufficient reason, that Federal regulatory decisions fail 
to consider whether the incremental costs of specific 
regulatory options are justified and reasonably related to the 
purported risk reduction benefits. The record also reflects 
that Federal regulatory decisions create inflexible 
requirements that are not cost-effective in addressing a given 
level of risk reduction. The Executive Branch, however, can 
legitimately complain that existing statutory provisions 
actually restrict it from issuing regulations that are 
reasonable with respect to the above concerns.
    Many Members of the 103d Congress sought to take 
significant steps to address these concerns. Unfortunately, the 
Democratic leadership of the 103d Congress and the Clinton 
Administration opposed these steps. In a number of instances, 
the Democratic leadership simply would not allow a vote on the 
floor for fear that significant legislation that would address 
risk assessment reform and require consideration of costs and 
benefits would in fact pass. If this Congress does not take 
enforceable steps to restore the credibility of the regulatory 
process concerning risk assessments and the costs and benefits 
of regulations, then there will be an even bigger freshman 
class elected in 1996 than in 1994. This legislation was 
reported from the Committee by a recorded vote of 27 to 16. At 
this time, Republicans on the Committee, along with a small 
number of like-minded Democrats, again find themselves alone in 
this effort.
    This legislation is a strong first step. We fully support 
changes to make the bill more effective, eliminate unintended 
consequences, and minimize unnecessary administrative burdens. 
However, to follow the mantra of the Administration, the 
framework of this bill is fair, effective and affordable. We 
simply disagree, however, with the Clinton Administration and 
the minority on what these terms mean.
    Title III as reported out of the Committee is fair because 
it requires that significant Federal risk assessment and risk 
characterization documents present information in an objective, 
unbiased and informative manner. The principles of Subtitle A 
require disclosure that will further promote fairness and 
greater public understanding. The record clearly shows that the 
current Federal practice in this area is both misleading and 
unfair. The legislation is also fair because it requires 
consideration of both costs and benefits and does not require 
any particular outcome from the regulatory process. The 
legislation simply requires careful and objective consideration 
of alternatives, costs and benefits in individual contexts. On 
balance, these principles will both save money and focus 
resources on the most significant risks.
    Title III is also effective because the requirements are 
enforceable. As discussed below, the Executive Branch should 
abide by the law, subject to judicial review, just as States, 
local governments and businesses must. There should be no 
double standard.
    Finally, Title III as passed out of the Committee is 
affordable because careful consideration and objective 
information will help ensure that hundreds of billions of 
dollars in annual economic costs are focused on real and 
substantial risk reduction. We cannot afford to continue to 
regulate without the information and factors set out in this 
bill. Informed decisionmaking--doing it right or, as a former 
Administrator of the Environmental Protection Agency states, 
aiming before we shoot--carries administrative burdens. The 
initial estimates of this burden are high but they specifically 
fail to account for the flexibility provided in the legislation 
and the boilerplate nature of much of the analyses.
    For example, the legislation simply asks that rules which 
are likely to impose $25 million in annual costs be called 
major rules subject to Subtitle B. Under Subtitle B, costs and 
benefits are to be quantified ``to the extent feasible and 
appropriate and may otherwise be qualitatively described.'' 
Nothing requires a ``Cadillac'' analysis. Perhaps the 
legislation should. Twenty-five million dollars in annual costs 
is not a small sum of money. Home buyers and car buyers 
certainly make an effort to acquire objective information and 
carefully consider alternatives before purchasing. Businesses 
must do the same before making major investments. State and 
local governments have been forced to make painful choices 
concerning education and crime prevention because of unfunded 
and ``unfounded'' Federal mandates. Why shouldn't Federal 
regulatory programs be subject to the same constraints?
    During the markup of Title III of H.R. 9, a number of 
amendments were offered and rejected. We would like to outline 
our concerns with some of these amendments.
    Mr. Rush offered an amendment that would have explicitly 
prohibited courts from reviewing whether the covered Federal 
agency had complied with the requirements of Title III. The 
exact language of the Rush amendment was, in part, as follows:

          Nothing in this title creates any right to judicial 
        review or administrative review, nor creates any right 
        or benefit substantive or procedural, enforceable at 
        law or equity by any party against the United States, 
        its agencies or instrumentalities, its officers or 
        employees, or any other person.

    We voted against this amendment because it would have 
rendered Title III unenforceable. If the requirements of Title 
III are not subject to some form of judicial review, the Title 
stands as little more than a non-binding resolution of mere 
congressional preference concerning risk assessment practices. 
Judicial review of the requirements of Title III is essential 
to ensure that risk management decisions are based on objective 
and unbiased information.
    Mr. Markey also offered an amendment that would have 
altered the fundamental effect of the legislation. While 
attractive at first glance, it would have vitiated Title III by 
preventing Federal agencies from revising their risk assessment 
and risk management practices to improve the Federal 
government's overall efficiency in addressing risks and improve 
cost-effectiveness. Mr. Markey's amendment provided that 
``[n]othing in this title shall be implemented in a manner that 
reduces the degree or level of protection of human health or 
safety or the environment otherwise provided by law.''
    The Markey amendment fails to recognize the balance between 
incremental costs and benefits. Title III, as reported out of 
Committee, is designed to influence change in Federal 
regulatory programs in a fair and effective manner. The 
construct of the bill is to provide information to regulators 
and the public to make wise use of resources. In some 
instances, this will mean a greater investment of economic 
resources; in others, it will mean avoiding the expenditure of 
large amounts of economic resources for marginal and, often, 
hypothetical levels of risk reduction benefits. The Markey 
amendment would have eliminated the central construct of the 
legislation.
    Mr. Markey also offered an amendment that would have 
prohibited individuals with a financial interest in the outcome 
of a peer review from participating in such peer review unless 
the financial interest is disclosed to the agency and the 
agency determines that such interest will not reasonably be 
expected to create a bias in favor of obtaining an outcome that 
is consistent with such interest. We opposed this amendment for 
the following reasons.
    First, Mr. Markey's amendment takes a naive and rather 
unrealistic view of the peer review process. In many instances, 
few people may be qualified to review the underlying science of 
Federal regulatory decisions, which are typically very 
complicated. Many of the people most likely to be qualified 
with the appropriate expertise are those who have received 
grant money from a company interested in the outcome. Second, 
one of the basic ideas behind the bill is to allow for full 
public participation. To cut off the productive sector from 
participating in risk assessments, despite provisions in the 
bill to ensure the disclosure of financial interests, is 
directly contrary to the open process the Committee is trying 
to foster.
    We also had concerns about two amendments offered by Mrs. 
Lincoln which may have sounded good on initial review, but 
ultimately seemed based on a misapprehension of the bill's 
effects. These amendments stated that nothing in the bill shall 
force changes in State regulations or require businesses with 
fewer than 100 employees to conduct more tests. The bill has no 
application to State regulations except insofar as State laws 
tie their scope and standards to Federally adopted standards. 
Nor does the bill have any requirement that businesses must 
perform risk assessments. We note that the National Federation 
of Independent Businesses has stated its support for Title III.
    In the case of both amendments, we believe that overall 
Title III will dramatically lessen Federal regulatory burdens 
on State and local governments and businesses of all sizes by 
requiring that Federal regulations be based on sound science 
and cost-justified. As a result of Title III, individual 
changes in Federal regulatory programs may increase or decrease 
regulatory burdens based on context. Title III does not 
predetermine outcomes, but it does require application of a 
process which overall will scientifically and economically 
justify Federal efforts.
    Finally, Mr. Brown offered a substitute amendment that 
rolled together several of these amendments, and added other 
language that would have prevented the bill from having its 
intended effect. One provision stated that any agency action 
taken without conforming to this bill would not be considered a 
prohibited regulatory action. Another provision would have 
allowed any agency to avoid the requirements of the legislation 
any time the agency head deemed the agency was unable to meet 
them. In essence, such language makes compliance with the bill 
optional, as the agency head sees fit. We feel that such 
language demonstrates the basic opposition of the minority to 
the idea of fir, objective risk assessments and cost-
justification of regulatory actions.
    Title III is a strong effort toward better Federal 
regulation. We fully support changes that will make the bill 
more effective, eliminate unintended consequences and minimize 
unnecessary administrative burdens. However, we have a strong 
disagreement with many of the steps the minority proposed in an 
effort they contend was designed to improve the bill.
    Congress must help ensure an effective and workable system 
of accountability, disclosure, peer-review, and careful 
analysis of alternatives. In the end, we must ensure that the 
Federal government can stand behind and justify regulations 
based on the facts. Title III is the right down payment toward 
this result.

                                   Thomas J. Bliley, Jr.
                                   Michael G. Oxley.
                                   Michael Bilirakis.
                            ADDITIONAL VIEWS

    The enthusiasm for risk assessment legislation is not new 
to the 104th Congress. Nor is it limited specifically to the 
Committee on Commerce or its predecessor the Energy and 
Commerce Committee. In the last Congress, I was a sponsor of 
H.R. 2910, the 1993 Risk Communication Act, which set some 
critical objectives and requirements for our system of 
communicating risks. H.R. 2910 was meant as a first step to 
ensure that we could compare and understand information from 
program to program.
    The Committee on Science, Space and Technology also was 
interested in risk assessments and their use. The Science, 
Space and Technology subcommittee on Investigations and 
Oversight held hearings in 1994 on unfunded environmental 
mandates and their effects on State and local governments. 
Speaking before the committee, on behalf of the National 
Association of Counties (NACo) was the Honorable Tom Davis, 
Chairman of the Fairfax County, Virginia, Board of Supervisors. 
Mr. Davis stated:

          One of the biggest problems we have is the 
        environmental regulations and standards we are required 
        to meet most often are not based on scientifically 
        sound assessments of purported health, safety or 
        environmental risk. Before requiring State and local 
        governments to spend billions of dollars, we need to be 
        sure that the standards we're required to meet will 
        significantly reduce the risks. That's why NACo fully 
        supports the Risk Communications Act (H.R. 2910) and we 
        commend you and Chairman George Brown and other Members 
        for sponsoring this legislation. If enacted, it will 
        help promote risk assessment in developing future 
        regulations.

While H.R. 2910 was never passed, Title III does incorporate 
the language regarding risk assessments.
    EPA's Science Advisory Board, The National Governors 
Association, representatives of local governments and 
businesses are all asking for simple accountability for Federal 
regulatory programs. They want to make sure we are spending 
money based on assessments of real risks, not on assessments of 
excessively hypothetical and exaggerated risks. Assessing risks 
is the cornerstone of environmental decisionmaking and is 
important in other Federal agencies as well.
    Everyday human activity produces many risks. For instance, 
driving 50 miles in a car creates approximately a one-in-a-
million risk of a fatality. Similarly, how do we know whether 
naturally occurring radon gas poses a risk in homes or whether 
alar on apples or asbestos in schools are really a risk to our 
children? Almost half a billion dollars was lost on the alar 
scare along with almost $27 billion dollars on asbestos 
removal, much of which was not necessary.
    These examples are only a few of the reasons that Title III 
and its language are needed. An unrealistic understanding of 
the nature and magnitude of risks produces unrealistic 
expectations, priorities, and programs which themselves cause 
needless administrative burdens on Federal agencies along with 
very costly burdens for local governments and businesses.
    Unnecessary spending for programs that do little to protect 
human health and safety must be curbed. Title III sets some 
critical objectives and requirements for our system of 
communicating risks. It is a first step to ensure that we can 
compare and understand information from program to program and 
agency to agency. Title III will help ensure that each 
subsequent risk manager and the public shares the same 
information on risks. This is an important investment and worth 
the burden of changing to a new set of minimum requirements.

                                                Carlos J. Moorhead.
 ADDITIONAL VIEWS ON TITLE III, H.R. 9 BY MR. BARTON, MR. TAUZIN, MR. 
                                 CRAPO

   section 3401--petition process to review existing rules and risk 
                              assessments

    We believe the Committee took a very important step toward 
reform of outdated and mistaken existing regulations when it 
adopted by a voice vote the ``petition process'' amendment we 
sponsored. It is a vital part of Title III and should be 
included in the bill sent to the President.
    The amendment establishes a process whereby interested 
parties can seek changes in existing regulations and other 
significant agency documents that are not consistent with the 
principles of Title III. Title III of H.R. 9 is designed to 
ensure that federal regulations are based on realistic and 
understandable estimates of health, safety, and environmental 
risks, and that federal agencies do not impose significant 
costs on American businesses and consumers in order to address 
risks that are trivial compared to the risks of daily life. As 
originally drafted, the provisions of Title III would have 
applied only to future regulatory actions.
    Members of the Committee were concerned that it did not 
address existing regulations and other agency documents that 
support regulatory decisions. Many existing risk assessments 
supporting major rules should be updated to reflect current 
science. Therefore, we proposed that Section 3401 be added. We 
believe that full regulatory reform, which certainly must 
include a review of existing major rules, will not occur 
without a provision like the petition process in Section 3401.

                                   Joe Barton.
                                   Mike Crapo.
                                   Billy Tauzin.
                        MINORITY VIEWS ON H.R. 9

    We strongly support the goal of improving federal 
regulatory programs through greater use of risk assessment, 
cost-benefit analysis, and peer review. These analytical tools 
can help agencies do their jobs better, limit burdens on 
private industry, and reduce government waste. We also believe 
federal agencies must be held to high standards in terms of 
getting the biggest ``bang'' for every dollar spent on laws to 
safeguard health and the environment. The Nation cannot 
tolerate excessive industry regulation, or excuse sloppy or 
biased regulatory programs.
    We feel just as firmly, however, that environmental, 
health, and safety laws, which Congress adopted after careful 
consideration, are on the books for good reasons. While 
legislation to improve regulatory analysis is desirable, it 
must not swallow up the larger purpose of protecting health, 
safety, and the environment. The question is not whether 
regulatory reform is important--but rather how to achieve it in 
the most cost-effective and responsible manner.
    The bill reported by the Committee is deeply flawed and 
will undermine important statutory protections. Rather than 
directing agencies to perform useful analyses as adjuncts to 
better policy, the bill treats analysis as a goal unto itself. 
In fact, H.R. 9 as reported will create many new layers of 
bureaucracy, clog the regulatory process, invite litigation, 
and impose substantial new costs on the federal treasury while 
doing little to improve the efficiency of our regulatory 
agencies.

                       the democratic alternative

    During the Committee markup, Mr. Brown of Ohio offered a 
Democratic alternative that requires covered agencies to 
conduct risk assessment and cost-benefit analysis for all major 
rules. It also requires agencies, consistent with other 
applicable law, to demonstrate that the benefits justify the 
costs of major rules and to identify the most cost-effective 
options for carrying out regulatory responsibilities. The 
amendment directs agencies to develop standards for how and 
when to conduct scientific peer review. The amendment also 
requires agencies to establish regulatory priorities based on 
the seriousness of risk and risk reduction opportunities, 
taking into account available public and private resources. The 
amendment, however, does not permit analytical tools to become 
the masters of the statutes they should serve or to erect a 
monumental bureaucracy that undermines the goal of protecting 
public health, safety, and the environment.
    We are surprised that, only a few days after the House of 
Representatives approved a balanced budget amendment to the 
U.S. Constitution, the Committee is reporting legislation that 
will dramatically increase the size and staffing needs of the 
federal government. Under the leadership of Vice-President 
Gore's ``Reinventing Government'' initiative, the 
Administration is making real progress in streamlining and 
downsizing government. Since the start of the Clinton 
Administration the federal government has been reduced by 
102,000 employees. By the end of the next fiscal year, it will 
have been reduced by approximately 170,000.
    This bill will reverse that trend. It will demand a much 
bigger federal government, staffed by more agency employees to 
carry out its requirements. A Majority of the Committee 
approved this bill with no consideration of the cost or impact 
on the size of government. By contrast, the Democratic 
alternative provides a much less costly, less bureaucratic, and 
less complicated way to ensure that government regulatory 
actions are based on sound science.

      overriding existing health, safety, and environment statutes

    Over many years, Republican and Democratic Presidents alike 
have proposed, and Congress has enacted, specific laws to 
protect the American people from identifiable threats to human 
health, safety, and the environment. These statutes cover a 
wide range of concerns--protecting women from breast cancer, 
protecting children from unsafe toys, regulating emissions of 
hazardous air pollutants, providing for worker safety, and 
providing for clean rivers and safe food and drinking water, 
among others. The standards for protection differ from statute 
to statute. Each was carefully worked out for a particular set 
of reasons, based on particular circumstances posed by a 
particular threat.
    With little review and no analysis of consequences based on 
the record, the Majority at the last minute added a provision 
to H.R. 9 (section 3201(c)) that supplants the standards and 
decisionmaking criteria of all existing health, safety, and 
environmental statutes. The bill as reported applies the same 
decisionmaking criteria to all statutes without regard to the 
implications for each of the individual threats to our health 
or safety.
    This strict adherence to uniformity is badly misdirected. 
Indeed, completely contrary to the Majority complaints about 
``one-size-fits-all'' mandates, this bill establishes a ``one-
size-fits-all'' criteria for risk assessment and health and 
safety standards. We expect, at the outset, protracted 
litigation over whether the decisionmaking criteria of the 
cost-benefit subtitle conflict with standards and criteria of 
current law. No one knows what competitive impacts will result 
for companies and industries that have undertaken significant 
investments in new technology or processes to comply with 
existing legal standards. Delay of ongoing and necessary 
government actions to protect public health and safety 
inevitably will occur. There are many examples, but a few will 
suffice to illustrate the point:
    1. Mammography Quality. Over 50,000 women each year die 
from breast cancer. Many of these deaths can be prevented 
through early detection and treatment. Providing women access 
to quality mammography services is a key to early detection of 
breast cancer. The Mammography Quality Standards Act of 1992 
required the Secretary, who is acting through the Food and Drug 
Administration (FDA), to ensure that quality through the 
regulation of facilities delivering mammography services.
    The statute requires that all mammography facilities be 
accredited and certified and establishes quality standards for 
accreditation. Under these standards, for example, 1) a medical 
physicist must survey mammography equipment and oversee quality 
assurance practices at each facility and 2) mammography 
facilities must maintain each patient's mammogram in the 
patient's permanent medical records for a specified period of 
time.
    The statute specifies these requirements. There are no 
subjective decisional criteria to be applied. Because such 
regulations likely would exceed the $25 million threshold for 
application of H.R. 9, however, and because section 3002 of 
H.R. 9 states clearly that FDA is one of the agencies covered 
by the bill, the agency will in the future be expected in 
issuing regulations to implement the mammography statute to 
incorporate the requirements of H.R. 9 and elaborate on their 
application.
    Under H.R. 9, the survey and record retention regulations 
would need to be justified by the agency as both the most cost-
effective and the most flexible for the industry. It is unclear 
whether the agency could adopt the most cost-effective approach 
if it were not also the most flexible. It is also unclear what 
type of information, if any, would be available to the agency 
to make such determinations. Were it unable to develop either 
justification, it could not promulgate the regulation. 
Moreover, even if the agency were able to develop the necessary 
justification, that justification could be challenged in court. 
Thus, the effect of H.R. 9 is to create two opportunities, one 
for the agency and one for the courts, to overturn the clear 
statutory mandate of mammography facility quality standards.
    2. Inspection & Maintenance (CAA). The enhanced motor 
vehicle inspection and maintenance program under the Clean Air 
Act of 1990 is required only in the most heavily polluted 
areas. According to recent testimony from the EPA 
Administration, this program is by far the most cost-effective 
air pollution control means, achieving reduction in emissions 
of volatile organic compounds at a cost of just over $500 per 
ton compared to $2,000 to $10,000 per ton for controls at 
stationary services. Applying the cost-effectiveness and 
flexibility decisionmaking mandates of section 3201 may well 
require the adoption by EPA of a nationwide enhanced inspection 
and maintenance program. This would transfer emission reduction 
burden from major industries to the average citizen--contrary 
to the Congressional determination in 1990.
    3. Hazardous Air Pollutants. Title III would supersede the 
current technology-based approach for regulating hazardous air 
pollutants under section 112 of the Clean Air Act. Instead it 
would likely force the EPA to return to a process of analyzing 
risks and sources of individual pollutants similar to that 
employed by the agency from 1970 to 1990. Over those 20 years, 
EPA managed to set standards for only seven hazardous air 
pollutants. EPA was mired in endless debates over risk 
assessment and cost-benefit analyses for cancer risks and other 
risks (birth defects, reproductive effects, etc.) that are 
difficult or impossible to quantify. This process requires 
years of analysis for each pollutant and each source of 
pollution.
    In 1990, Congress acknowledged the failure of the risk-
based approach to protect public health and replaced it with a 
technology-based system. The emissions standards for hazardous 
air pollutants ``shall require the maximum degree of reduction 
in emissions of hazardous air pollutants . . . that the 
Administrator, taking into consideration the cost of achieving 
such emissions reduction, and any non-air quality health and 
environmental impacts and energy requirements, determines is 
achievable for new or existing sources'' in the subject 
category (Maximum Achievable Control Technology or MACT). A 
list of 189 pollutants was specified in the new law, and EPA 
was required to promulgate standards for major sources of these 
pollutants over a 10-year period.
    Since 1990, EPA has been able to address 58 types of 
industrial toxic emitters, ranging from chemical plants to coke 
ovens. These actions will likely eliminate more than one 
billion pounds of toxic emissions annually.
    Enactment of Title III, with its complex risk assessment 
and cost-benefit decisionmaking criteria, will confuse and 
undermine issuance of any further air toxics standards. It 
could reverse the gains already made by opening the door to 
petitions to revisit standards already in place.
    4. Hunting Season--Closed Before It Opens. The sweeping 
approach of H.R. 9 will require the Fish and Wildlife Service 
to make various certifications, including that a cost-benefit 
assessment has been performed considering all risk assessments 
provided to the agency by any party, before it issues its 
annual regulations opening the waterfowl hunting season 
pursuant to the Migratory Bird Treaty. Tens of thousands of 
dollars will be wasted meeting irrelevant requirements. 
According to the Fish and Wildlife Service, under a best-case 
scenario, meeting the rulemaking certification requirements of 
H.R. 9 virtually will eliminate the 1995 hunting season in the 
United States.

              Increased Bureaucracy and Bigger Government

    The myriad complex requirements of H.R. 9, according to 
every responsible prediction and estimate, will create more 
paperwork and increase the number of bureaucrats who must be 
involved in decisionmaking and litigation. As Sally Katzen, 
Administrator of the Office of Information and Regulatory 
Affairs in the Office of Management and Budget (OMB), 
testified:

          The effect of the requirements of Title III, whether 
        taken alone or in conjunction with Title VII, is not to 
        bring sound science to bear on regulation, but to load 
        on the regulatory system so much that it cannot move 
        forward, retarding substantially our ability to take 
        sensible steps to protect human health and human safety 
        and the environment while creating more bureaucracy, 
        more paperwork, and less efficiency in government.

    The extensive and prescriptive risk assessment requirements 
in subtitle A of Title III cover everything from major 
regulations, permits, and reports to Congress to the ambiguous 
category of ``guidelines or protocols of general application.'' 
The drafters of the bill have insisted that it is not intended 
to provide a source of legal relief for manufacturers who 
produce unsafe, contaminated, or filthy products. Yet, many 
factory inspections are based on guidelines or protocols of 
general application. This legislation thus aids companies who 
are determined to thwart the application of health or safety 
standards by creating a bureaucratic and legal maze for every 
guideline designed to ensure adherence to such standards--
standards on which every American relies. Indeed, we were 
surprised by the Majority's refusal to expand the bill's narrow 
emergency exception even to accommodate ``imminent'' threats to 
human health, safety, or the environment, as Mr. Brown proposed 
in amendments at markup.
    Although OMB reports that 96% of the total costs of 
government regulation occur as a result of regulations with an 
economic impact of $100 million or more, the risk assessment, 
cost-benefit analysis, and peer review requirements of Title 
III extend to additional regulations with a national economic 
impact of $25 million. In a $7 trillion economy, this means 
that hundreds of government employees would be hired to 
scrutinize regulations that could have a financial impact of as 
little, on average, as $500,000 per state. We note that 
President Reagan (Executive Order 12291) selected $100,000,000 
as the appropriate rulemaking threshold for requiring cost-
benefit analyses and every subsequent President has followed 
suit.
    H.R. 9 creates a complicated labyrinth of decisionmaking, 
requiring agencies to: engage in analyses and re-analyses; 
perform specific types of comparisons (whether relevant or 
not); provide detailed explanations, calculations, estimations, 
representations, and recapitulations; and ``certify'' to a 
series of complex decisionmaking criteria. It requires at least 
one level of peer review, and more in cases where the decision 
may have a ``significant'' policy impact. It requires peer 
review not only of scientific matters but of economic analyses 
as well. While couching these requirements in the murky fuzz of 
``if feasible or appropriate,'' the bill actually limits the 
agency's ability to determine what is or is not appropriate, 
and will lead to endless debates over whether a particular 
action is feasible.
    The petition process added by amendment during Committee 
markup requires agencies to establish a mechanism whereby any 
citizen may ask the agency retroactively to review--and 
potentially revise--any risk assessment associated with a major 
rule and ``any health or environmental effects value . . . in . 
. . any compilation . . . used . . . as a scientific basis for 
regulatory action'' at the local, state, or federal level. The 
agency is required to respond to each petition within 90 days 
and, within one year, either to deny the petition and provide 
reasons for doing so or to initiate the ``action requested in 
the petition.''
    Thousands of such petitions may be envisioned under this 
process, challenging virtually every environmental, health, or 
safety rule on the books today. The agency's denial of any such 
petition, or its failure to act in accord with these 
requirements (including failure to meet preposterously short 
time frames), is specifically subject to legal challenge. 
Today, without this incredibly burdensome petition requirement, 
citizens have the right to--and do--petition regulatory 
agencies in a logical time frame through a well-defined 
process. Such agencies will be required to increase their 
staffing manyfold to deal with the flood of petitions that may 
well result from enacting this provision.

                  dragging science through the courts

    The petition process will not be the only source of 
litigation generated by H.R. 9. The bill as reported is nothing 
short of a lawyer's relief act. It invites litigation 
concerning virtually every significant agency decision 
assessing risks and determining cost-benefit relationships. 
These legal challenges will not necessarily be limited to the 
agency's substantive decisions, or even to the procedural 
lapses that are the traditional province of the courts under 
the Administrative Procedure Act. Instead, they will render 
every hypertechnical step in the entire process vulnerable to 
judicial second-guessing.
    Wholly apart from the vague, duplicative, and inconsistent 
provisions that set Title III of H.R. 9 at war with other 
titles, Title III itself will spawn ceaseless, circular battles 
over matters that lawyers and unelected federal judges are 
peculiarly unsuited to resolve. Such cases will revolve around 
issues of science on which more often than not the scientists 
themselves disagree and around data which are highly 
susceptible to subtle manipulation and subjective 
interpretation. We know from experience that the evidentiary 
tools and equitable remedies available to a federal judge are 
rather blunt and unsatisfactory instruments for the resolution 
of complex scientific disputes.
    Both the introduced version of the bill and the Republican 
substitute offered in the Committee left somewhat unsettled the 
question of whether and to what extent judicial review of 
agency risk assessments and risk-characterization analyses 
would be available. Those doubts, however, were settled upon 
the adoption of the Barton amendment, which makes clear that a 
reviewing court ``shall consider the agency action unlawful'' 
if a significant risk assessment or characterization document 
``does not comply with the requirements of section 3104 or 
3105.''
    These two sections purport to set forth ``principles'' for 
risk assessment, characterization, and communication. Their 
evolution--and their interaction with the Barton amendment--are 
a telling example of how the bill's proponents, when criticized 
for trying to cripple outright the federal government's ability 
to respond to health, safety, and environmental threats, have 
sought to accomplish the same end by clever indirection. The 
Administration's testimony criticized the bill in general, and 
sections 3104 and 3105 in particular, for imposing a highly 
prescriptive, one-size-fits-all regime on every statute, 
program, agency, and major regulation dealing with health, 
safety, and the environment. The Administration sought the 
introduction into those sections of a greater rule of reason to 
guide agency decisionmaking.
    The Republican substitute responded to those concerns by 
adding phrases like ``to the maximum extent feasible,'' ``to 
the extent relevant,'' ``to the extent feasible,'' ``to the 
extent feasible and scientifically appropriate,'' ``to the 
extent practical and appropriate,'' and so forth. In the 
absence of judicial review, these phrases would have been a 
helpful guide to the agencies and--together with an element of 
``reasonableness'' still missing from the legislation--would 
have provided some commonsense flexibility in the prescriptive 
nature of these two sections. With the adoption of the Barton 
amendment, however, every of these phrases becomes fodder for a 
lawsuit, each word susceptible to the subjective and elastic 
interpretations for which thousands of lawyer-hours will be 
billed. If H.R. 9 is exacted with these provisions intact, we 
would not be surprised to see risk assessment and cost-benefit 
lawsuits become the biggest growth market for the American bar, 
as law firms all over the country tap into this litigation gold 
mine. Sadly, their clients and ultimately all taxpayers will 
foot the bill for this folly.
    Many in American business who support this legislation in 
its current form genuinely believe it will be advantageous to 
them, but creating new causes of action can be a two-edged 
sword. We cannot (and should not try to) create these rights 
only for industry. When we allow our government's decisions to 
be challenged, our courts must be open to any and all aggrieved 
parties. Yet the Barton amendment and this bill as reported 
will put a powerful new tool in the hands of environmental 
groups, public interest organizations, consumer advocates, 
local community associations, and others who will be able to 
sue agencies by arguing that the risks and costs of any new 
agency decision in favor of business (such s decisions in favor 
of siting or permitting facilities, or even renewing existing 
permits) were not appropriately considered.
    All of these groups, like business and industry, have 
available to them under current law a whole panoply of remedies 
that allow agency decisions to be challenged. If an agency 
violates a substantive statute, or makes a decision that is not 
supported by the record, or takes an action that is arbitrary 
and capricious, aggrieved parties may take their case to court. 
Under an amendment offered by Mr. Rush and unfortunately 
rejected by the Committee, whatever rights any person may now 
have to sue--whether under the APA or under the actual 
substantive statutes themselves--would have been preserved. But 
the Rush amendment also would have ensured that this 
legislation itself would spawn no new litigation.
    In cases where parties aggrieved by agency action must 
resort to the courts for relief, the disagreements at issue 
generally revolve around disputed questions of law, which the 
courts are uniquely well-suited to decide, or around disputed 
but relatively narrow issues of fact, rooted in a carefully 
constructed administrative record, which can be remanded if 
necessary to an expert agency for further resolution. The 
courts, however, are most certainly not the best place in which 
to resolve complex disputes over risk, cost-benefit ratios, and 
other highly technical scientific and statistical questions--as 
to which there is often no consensus even within the relevant 
scientific community. In reporting this legislation, the 
majority has elected to encourage frivolous litigation and to 
anoint lawyers and judges as the arbiters of scientific 
disputes.

                       why the rush to judgment?

    This sweeping legislation was introduced on January 4, 
1995, and in spite of its massive implications for the whole 
fabric of American health, safety, environmental, and 
administrative law, only two days of hearings were held on it 
in our Committee on February 1 and 2. The three subcommittees 
to which the bill was referred were not permitted time to mark 
up the bill, and following one morning of opening statements on 
February 7, the legislation was pushed through a full Committee 
markup in a single ensuing day. The Oxley-Bilirakis Substitute, 
which essentially served as the markup vehicle, was not 
provided to the Members of the Committee until they arrived at 
the markup to deliver their opening statements, and it was not 
provided to the Minority staff for analysis until after 10 p.m. 
the night before.
    Haste in the processing of legislation can be a useful but 
dangerous tool. It can be employed to hide controversial or 
obscure special interest provisions; it can be used to deny the 
Minority time to discover and publicize a bill's faults; and it 
can be to utilized to prevent an organization of effort in 
opposition to the legislation. But such a rush to judgment can 
have embarrassing and unintended consequences as well, since it 
denies even the bill's supporters an opportunity to learn of 
and correct its faults and weaknesses.
    A single example will suffice to make the point. The 
Republican substitute offered at the markup purported to narrow 
the scope of Title III to a list of eight specific agencies. 
One of them is ``The Department of Transportation (including 
the National Transportation Safety Administration).'' We have 
searched diligently through the United States Government Manual 
and have been unable to find the National Transportation Safety 
Administration, either within DOT or elsewhere. Do the authors 
of the legislation mean the National Highway Traffic Safety 
Administration, which is one of DOT's modal agencies? Or do 
they mean the National Transportation Safety Board, which is 
not within DOT at all but rather an independent agency with no 
rulemaking authority but only the power to analyze the causes 
of accidents and make safety recommendations? [We wonder 
whether our Republican colleagues are even aware of this error. 
If so, they made no effort to correct it at the markup.] Like 
the mammography example in footnote 1 above, perhaps more time 
would have permitted more careful and deliberate consideration.
    In this case, the rush to judgment seems to have been 
driven not by a desire to do what is right or even what is 
popular, but by a schedule for floor consideration fixed 
arbitrarily by the Republican leadership without any regard for 
the need to address the defects in this bill. We regret that in 
the service of this arbitrary deadline, the Majority has 
elected to depart from the tradition of careful and precise 
legislating for which this Committee has been traditionally and 
justly proud. We can only wonder what other errors, perhaps 
even more serious, lie embedded in the text we have had so 
little time to review and consider.

                               conclusion

    As this legislation advances toward the floor of the House, 
we will continue to support the imposition on our federal 
bureaucracy of a strong and credible program of risk 
assessment, cost-benefit analysis, and peer review to guide 
regulatory action. However, in order to earn our votes, such 
legislation must be rational, reasonable, carefully drafted, 
and well-tailored to the ills it seeks to address. The version 
of H.R. 9 reported by the Committee fails every one of these 
tests. We hope that our Republican colleagues will abandon 
their taste for the straitjacket and the blunderbuss. Perhaps 
they might consider instead working cooperatively with us to 
craft a precise, finely tuned, and responsible piece of 
legislation that will accomplish the goals we all share--and to 
do so without undermining the fundamental protections of public 
health, safety, and the environment that have so dramatically 
improved American life in the last several decades.
                                   John D. Dingell.
                                   Henry A. Waxman.
                                   Edward J. Markey.
                                   Ron Wyden.
                                   John Bryant.
                                   Rick Boucher.
                                   Thomas J. Manton.
                                   Eldolphus Towns.
                                   Gerry E. Studds.
                                   Frank Pallone, Jr.
                                   Sherrod Brown.
                                   Blanche Lambert Lincoln.
                                   Bart Gordon.
                                   Elizabeth Furse.
                                   Peter Deutsch.
                                   Bobby L. Rush.
                                   Anna G. Eshoo.
                                   Ron Klink.
                                   Bart Stupak.
               ADDITIONAL DISSENTING VIEWS OF MR. MARKEY

    H.R. 9, as introduced, allows corporate insiders and 
lobbyists to serve on the peer review panels considering 
regulations that might have a direct economic impact on a 
particular corporation or industry. The bill provides that such 
peer review panels ``shall not exclude peer reviewers merely 
because they represent entities that may have a potential 
interest in the outcome, provided that interest is fully 
disclosed to the agency.''
    The Republican majority's substitute took some partial 
steps towards alleviating the deficiencies of this provision. 
For example, the substitute provides that peer reviewers should 
be required to sign confidentiality agreements so that they 
would be barred from disclosing confidential trade secrets. I 
am pleased that our Republican colleagues moved to respond to 
this important problem, which I raised during the hearing 
process.
    However, the Republican substitute fails to address the 
underlying problem in H.R. 9 of peer reviewers with potential 
financial conflicts-of-interest. The Republican substitute 
merely provides that ``in the case of a regulatory decision 
affecting a single entity no peer reviewer representing such 
entity may be included on the panel'' (italic added). 
Apparently my Republican colleagues were willing to concede 
that there are some circumstances under which a peer reviewer 
should be excluded because of a financial conflict-of-interest. 
However, since their exclusion is limited to rules that affect 
only one company, it would not be available in the vast 
majority of instances where a peer review panel would be 
convened--inasmuch as a proposed rule under consideration by 
the peer review panel might affect two, three, a dozen, or even 
a hundred companies. Under the Republican substitute, peer 
reviewers from each of the affected companies would be free to 
serve on the panel, despite the fact that they were employed by 
entities with a direct financial stake in the outcome of the 
agency rulemaking. This is exactly the opposite of what we 
should be trying to do with the scientific peer review process. 
It degrades the credibility of peer reviews and it calls into 
question the fundamental scientific and technical credibility 
of the entire peer review process.
    Under an amendment I offered--which was unfortunately 
rejected by the Committee--peer reviewers would have been 
excluded when they are associated with entities that may have a 
financial interest in the outcome, unless such interest is 
disclosed to the agency and the agency has determined that such 
interest will not reasonably be expected to create a bias in 
favor of obtaining an outcome that is consistent with such 
interest. This amendment would have given the agencies the 
ability they need to receive both full disclosure regarding any 
potential conflicts-of-interest that could potentially lead a 
peer reviewer to have bias, and the authority for such agencies 
to exclude reviewers whose associations may give rise to such a 
conflict. The opposition of the Republican Majority to this 
common sense provision is inexplicable, and raises serious 
concerns about whether the peer review process established 
under H.R. 9 will operate effectively to assure that agency 
rules have a strong scientific or economic basis, or whether it 
will merely be exploited by parties with an interest in the 
outcome of agency rules to generate additional litigation.


                                                  Edward J. Markey.