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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