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



104th Congress                                             Rept. 104-33
                        HOUSE OF REPRESENTATIVES

 1st Session                                                     Part 2
_______________________________________________________________________


 
             JOB CREATION AND WAGE ENHANCEMENT ACT OF 1995

                                _______


               February 15, 1995.--Ordered to be printed

_______________________________________________________________________


   Mr. Walker, from the Committee on Science, submitted the following

                              R E P O R T

                             together with

  THE TRANSCRIPT FROM THE LEGISLATIVE MARKUP OF THE SCIENCE COMMITTEE

                                and the

             ADDITIONAL, SUPPLEMENTAL, AND DISSENTING VIEWS

                         [To accompany H.R. 9]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Science, 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.

                                CONTENTS

                                                                   Page
  I. Amendment........................................................1
 II. Background and need for the legislation.........................16
III. Legislative history and committee actions.......................20
 IV. Summary of Hearings.............................................22
  V. Explanation of the bill as reported: Section-by-section analysis 
     and Committee Views.............................................26
 VI. Committee oversight activities..................................42
VII. Oversight findings and recommendations by the Committee on 
     Government Reform and Oversight.................................42
VIII.Budget analysis and projections.................................42

 IX. Cost estimate of Congressional Budget Office....................42
  X. Impact on inflation.............................................46
 XI. Changes in existing law.........................................47
XII. Committee recommendation........................................47
XIII.Proceedings from Full Committee Markup on Title III of H.R. 9...47


    Additional, supplemental, and dissenting views.

                              I. AMENDMENT

    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.
          (6) Although risk assessment is one important method 
        to improve regulatory decision-making, other approaches 
        to secure prompt relief from the burden of unnecessary 
        and overly complex regulations will also be necessary.

             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, or used by, any Federal agency in connection with 
        Federal programs designed to protect human health, 
        safety, and 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 
        included in, or in the administrative record for, each 
        of 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) Any proposed or final regulatory 
                decision relating to decontamination or other 
                clean-up plans for a facility.
                  (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 terms also include 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) The terms ``significant risk assessment 
        document'' and ``significant risk characterization 
        document'' also include such risk assessment and risk 
        characterization documents of agency as--
                  (i) are provided by an agency to the public 
                and are likely to result in an annual effect on 
                the economy of $25,000,000 or more; or
                  (ii) the head of the agency may identify, in 
                consultation with the Director of the Office of 
                Management and Budget.
          (C) Within 15 months after the date of the enactment 
        of this Act, each agency administering programs 
        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 to be considered 
        significant risk assessment documents or significant 
        risk characterization documents for purposes of this 
        subtitle. In establishing such categories, the head of 
        the agency shall consider--
                  (i) the benefits of consistent compliance by 
                documents in the categories concerned with the 
                principles under sections 3104 and 3105;
                  (ii) the administrative burdens of including 
                documents in various categories concerned with 
                the principles under section 3104 and 3105;
                  (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.--(A) This subtitle does not apply to 
        the following:
                  (i) A situation that the head of the agency 
                considers to be an emergency or to be necessary 
                to maintain military readiness.
                  (ii) A screening analysis, where 
                appropriately labeled as such, including a 
                screening analysis for purposes of product 
                regulation, or premanufacturing notices.
                  (iii) 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 agency prior to use.
                  (iv) Any health, safety, or environmental 
                inspections or individual facility permitting 
                actions.
          (B) No analysis shall be treated as a screening 
        analysis for purposes of subparagraph (A) if the 
        results of such analyses are used as the basis for 
        imposing restrictions on substances or activities.
    (c) Savings Provisions.--The provisions of this subtitle 
shall be supplemental to any other provisions of law relating 
to risk assessments and risk characterizations, except that 
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 Federal agency shall 
apply the principles set forth in subsection (b) in order to 
assure that risk assessments 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 and rely, to the 
extent available and practicable, on scientific findings. 
Discussions or explanations required under this section need 
not be repeated in each 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 are as 
follows:
          (1) When discussing human health risks, a significant 
        risk assessment document shall contain a discussion 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 
        include discussion of possible reconciliation of 
        conflicting information, and as appropriate, 
        differences in study designs, comparative physiology, 
        routes of exposure, bioavailability, pharmacokinetics, 
        and any other relevant factor, including the 
        availability of raw data for review. Greatest emphasis 
        shall be placed on data that indicate a biological 
        basis of the resulting harm in humans. Animal data 
        shall be reviewed with regard to its relevancy to 
        humans.
          (2) Where a significant risk assessment document 
        involves selection of any significant assumption, 
        inference, or model, a Federal agency shall--
                  (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 a significant risk assessment document, each Federal 
agency shall assure compliance with each of the following:
          (1) Estimates of risk.--The risk characterization 
        shall describe the populations or natural resources 
        which are the subject of the risk assessment. If a 
        numerical estimate of risk is provided, the agency 
        shall, to extent feasible, 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 department, 
                agency, or instrumentality); and
                  (B) a statement of the reasonable range of 
                scientific uncertainties.
        In addition to such best estimate or estimates, the 
        risk characterization may present plausible upper-bound 
        or conservative estimates in conjunction with plausible 
        lower bounds estimates. Where appropriate, the risk 
        characterization 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 characterization 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 risk 
        characterization 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.--The Federal agency shall provide a 
        statement that places the nature and magnitude of risks 
        to human health, safety, or the environment in context. 
        Such statement shall include appropriate comparisons 
        with estimates of greater and lesser risks that are 
        familiar to and routinely encountered by the general 
        public as well as other risks. The statement shall 
        identify relevant distinctions among categories of risk 
        and limitations to comparisons.
          (4) Substitution risks.--Each significant risk 
        assessment or risk characterization document referred 
        to in section 3103(b) shall include a statement of any 
        significant substitution risks to human health, where 
        information on such risks is available to the agency.
          (5) Summaries of other risk estimates.--If--
                  (A) a Federal agency provides a public 
                comment period with respect to a significant 
                risk assessment document, or a commenter 
                provides a significant risk assessment 
                document, and a summary of results of such risk 
                assessment, and
                  (B) such risk assessment is consistent with 
                the principles and the guidance provided under 
                this subtitle,
        the agency shall present such summary in connection 
        with the presentation of the agency's risk assessment 
        document, risk characterization document, or the 
        regulation. 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, PLAN FOR ASSESSING NEW INFORMATION, AND REPORT.

    (a) Guidelines.--Within 15 months after the date of 
enactment of this subtitle, 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. In addition, such 
guidelines shall include guidance on at least the following 
subjects: criteria for scaling animal studies to assess risks 
to human health; use of different types of dose-response 
models; thresholds; definitions, use, and interpretations of 
the maximum tolerated dose; weighting of evidence with respect 
to extrapolating human health risks from sensitive species; 
evaluation of benign tumors, and evaluation of different human 
health endpoints.
    (b) Plan.--Within 18 months after the date of the enactment 
of this subtitle, each 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 head of the agency 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 final plan shall 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 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.
    (c) Report.--Within 3 years after the enactment of this 
subtitle, each 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).
    (d) Public Comment and Consultation.--The guidelines, plan 
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.
    (e) Review.--The President shall review and, where 
appropriate, revise the guidelines published under this section 
at least every 4 years.

SEC. 3107. RESEARCH AND TRAINING IN RISK ASSESSMENT.

    (a) Evaluation.--The head of each covered agency shall 
regularly and systematically evaluate risk assessment research 
and training needs of the agency, including the following:
          (1) Research to reduce generic data gaps or 
        redundancies, to address modelling needs (including 
        improved model sensitivity), and to validate default 
        options, particularly those common to multiple risk 
        assessments.
          (2) Research leading to improvement of methods to 
        quantify and communicate uncertainty and variability 
        throughout risk assessment and risk assessment 
        reporting methods that clearly distinguish between 
        uncertainty and variability.
          (3) Research to examine the causes and extent of 
        variability within and among individuals, species, 
        populations, and, in the case of ecological risk 
        assessment, ecological communities.
          (4) Emerging and future areas of research, including 
        research on comparative risk analysis, exposure to 
        multiple chemicals and other stressors, noncancer 
        endpoints, biological markers of exposure and effect, 
        mechanisms of action in both mammalian and nonmammalian 
        species, dynamics and probabilities of physiological 
        and ecosystem exposures, and prediction of ecosystem-
        level responses.
          (5) Long-term needs to adequately train individuals 
        in risk assessment and risk assessment application. 
        Evaluations under this paragraph shall include an 
        estimate of the resources needed to provide necessary 
        training and recommendations on appropriate educational 
        risk assessment curricula.
    (b) Strategy and Actions to Meet Identified Needs.--The 
head of each covered agency shall develop a strategy, schedule, 
and delegation of responsibility for carrying out research and 
training to meet the needs identified in subsection (a).
    (c) Report.--Not later than 6 months after the date of the 
enactment of this Act, the head of each covered agency shall 
submit to the Congress a report on the evaluations conducted 
under subsection (a) and the strategy and schedule developed 
under subsection (b). The head of each covered agency shall 
report to the Congress whenever the evaluations, strategy, and 
schedule are updated or modified.
    (d) Covered Agency Defined.--For purposes of this section, 
the term ``covered agency'' means each of the following:
          (1) The Environmental Protection Agency.
          (2) The Consumer Product Safety Commission.
          (3) The Occupational Health and Safety 
        Administration.
          (4) The Department of Labor.
          (5) The Department of Transportation.
          (6) The Department of Energy.
          (7) The Department of Agriculture.
          (8) The Department of the Interior.
          (9) The Food and Drug Administration.

SEC. 3108. STUDY OF COMPARATIVE RISK ANALYSIS.

    (a) In General.--(1) The Director of the Office of Science 
and Technology Policy shall conduct, or provide for the conduct 
of, a study using comparative risk analysis to rank health and 
environmental risks and to provide a common basis for 
evaluating strategies for reducing or preventing those risks. 
The goal of the study shall be to develop and rigorously test 
improved methods of comparative risk analysis.
    (2) Not later than 90 days after the date of the enactment 
of this Act, the Director, in collaboration with the heads of 
appropriate Federal agencies, shall enter into a contract with 
the National Research Council to provide technical guidance on 
approaches to using comparative risk analysis and other 
considerations in setting environmental risk reduction 
priorities.
    (b) Scope of Study.--The study shall have sufficient scope 
and breadth to evaluate comparative risk analysis and to test 
approaches for improving comparative risk analysis and its use 
in setting priorities for environmental risk reduction. The 
study shall compare and evaluate a range of diverse 
environmental risks, both as to risks to and within an 
environmental medium and risks across environmental media.
    (c) Study Participants.--In conducting the study, the 
Director shall provide for the participation of a range of 
individuals with varying backgrounds and expertise, both 
technical and nontechnical, comprising broad representation of 
the public and private sectors.
    (d) Duration.--The study shall begin within 180 days after 
the date of the enactment of this Act and terminate within 2 
years after the date on which it began.
    (e) Recommendations for Improving Comparative Risk Analysis 
and Its Use.--Not later than 90 days after the termination of 
the study, the Director shall submit to the Congress the report 
of the National Research Council with recommendations regarding 
the use of comparative risk analysis and ways to improve the 
use of comparative risk analysis for decision-making in 
appropriate Federal agencies.

SEC. 3109. 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.
          (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.
          (3) Best estimate.--The term ``best estimate'' means 
        an estimate which 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) Federal agency.--As used in this title, the term 
        ``Federal agency'' means an executive department, 
        military department, or independent establishment as 
        defined in part I of title 5 of the United States Code, 
        except that such term also includes the Office of 
        Technology Assessment.
          (6) Document.--The term ``document'' includes 
        material stored in electronic or digital form.
          (7) Prepare.--As used in this title, the term 
        ``prepare'', when referring to risk assessment, risk 
        characterizations, or analyses of risk reduction 
        benefits and costs, includes both the preparation or 
        use of such a document by an agency.

       Subtitle B--Analysis of Risk Reduction Benefits and Costs

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

    (a) In General.--Except as provided in section 3103(b)(3) 
and subsection (d), the President shall require each Federal 
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, an 
        identification (including an analysis of the costs and 
        benefits) of reasonable alternatives for achieving the 
        identified benefits of the proposed or promulgated 
        rule, including alternatives--
                  (A) that require no government action;
                  (B) that will accommodate differences among 
                geographic regions and among persons with 
                different levels of resources with which to 
                comply; and
                  (C) that employ performance or other market-
                based standards that permit the greatest 
                flexibility in achieving the identified 
                benefits of the proposed or promulgated rule 
                and that comply with paragraph (3).
          (3) An assessment of the feasibility of establishing 
        a regulatory program that operates through the 
        application of market-based mechanisms.
          (4) An assessment of the aggregate effect of the rule 
        on small businesses with fewer than 100 employees, 
        including the effect of the net employment effect of 
        the rule.
          (5) An analysis of whether the identified benefits of 
        the proposed or promulgated rule are likely to exceed 
        the identified costs of the proposed or promulgated 
        rule, and an analysis of whether the proposed or 
        promulgated rule will provide greater net benefits to 
        society than any of the alternatives to the proposed or 
        promulgated rule, including alternatives identified in 
        paragraph (2).
          (6) At the time of the publication of the final major 
        rule, a final cost-benefit analysis (to be published in 
        the rulemaking record), including a summary of the 
        analysis in a statement of basis and purpose.
          (7) For each such proposed or promulgated rule, to 
        the extent feasible, a comparison of any human health, 
        safety, or environmental risks addressed by the 
        regulatory alternatives to other greater or lesser 
        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.
          (8) For each final rule, an assessment of the costs 
        and risk reduction or other benefits associated with 
        implementation of, and compliance with, the rule, 
        including, to the maximum extent practicable, a 
        quantitative assessment of the cumulative financial 
        burden that persons producing products that are 
        regulated by the rule will bear in order to comply with 
        the rule and with related existing standards that 
        affect the product or other similar products produced 
        by such persons.
          (9) For each final rule, a certification by the head 
        of the agency of each of the following:
                  (A) A certification that the assessments 
                under subtitle B are 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.
                  (B) A certification that incremental risk 
                reduction or other benefits of any regulatory 
                or non-regulatory option chosen will be likely 
                to justify, and be reasonably related to, the 
                incremental costs incurred by State, local, and 
                tribal governments, the Federal Government, and 
                other public and private entities.
                  (C) A certification that no regulatory or 
                non-regulatory alternative considered by the 
                agency or proposed to the agency during or 
                prior to the public 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 objective of the regulation, 
                along with a brief explanation of why other 
                regulatory or non-regulatory alternatives that 
                were considered by or proposed to the agency 
                were found to be less cost-effective or less 
                flexible.
    (b) Publication.--For each major rule referred to in 
subsection (a) each agency shall publish in a clear and concise 
manner in the Federal Register along with the proposed and 
final regulation, or otherwise make publicly available, the 
information required to be prepared under subsection (a) of 
this section. The agency shall publish in the Federal Register, 
along with the final regulation, the certifications required by 
subsection (a).
    (c) Definitions.--For purposes of this section:
          (1) Costs.--The term ``costs'' includes the direct 
        and indirect costs to the United States Government, to 
        State, local, and tribal governments, and to private-
        sector prices, wage earners, consumers, and the 
        economy, of implementing and complying with a 
        regulatory action.
          (2) Benefit.--The term ``benefit'' means the 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.
    (d) Substances and Products.--This section and section 3301 
do not apply to any action authorizing or approving any 
individual substance or product. No government action shall be 
treated as authorizing or approving any individual substance or 
product for the purposes of this subsection if the results of 
such action are used as the basis of imposing bans, 
cancellations, suspensions, or revocations of any previously 
marketed or approved substance or product.
    (e) Cost/Benefit Analysis Guidance.--Within 15 months after 
the date of the enactment of this title, the Office of 
Management and Budget shall issue regulations for Federal 
agencies, consistent with this title, governing the development 
and preparation of analyses of risk reduction benefits and 
costs.
    (f) Applicability.--
          (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) Substantial evidence.--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.
    (g) Transitional Plan.--Within 180 days after the date of 
the enactment of this title, Federal agencies, with guidance 
from the Office of Management and Budget, shall develop 
transition plans to assist the agencies, the public, and the 
regulated community in the implementation of this title, 
including any new requirements or procedures needed to 
supplement prior agency practice.
    (h) Reports to Congress.--Federal agencies shall report to 
Congress annually whether their implementation of this title 
has created any significant regulatory or program management 
complications resulting from any differences between the 
certification provisions of this title and the decisional 
criteria for rulemaking that otherwise would have been 
applicable under other statute.

                        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 
Federal agency shall develop a systematic program for 
independent and external peer review of risk assessments 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 experts and shall be broadly 
        representative and balanced and to the extent feasible 
        and appropriate, include representatives of industry, 
        universities, agriculture, labor, consumers, 
        conservation organizations, and other public interest 
        groups and organizations;
          (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 Federal agency shall 
provide for peer review of any evaluation under section 
3201(a)(9)(A) or for purposes of any significant risk 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) Contents.--
          (1) In general.--Each peer review under this section 
        shall include a report to the Federal agency concerned 
        with respect to each of the following:
                  (A) An evaluation of the technical, 
                scientific, and economic merit of the data and 
                methods used for the assessment and analysis.
                  (B) A list of any considerations that were 
                not taken into account in the assessment and 
                analysis, but were considered appropriate by a 
                majority of the members of the peer review 
                panel.
                  (C) A discussion of the methodology used for 
                the assessment and analysis.
          (2) Comments and appendix.--Each peer review report 
        under this subsection shall include--
                  (A) all comments supported by a majority of 
                the members of the peer review panel submitting 
                the report; and
                  (B) an appendix which sets forth the 
                dissenting opinions that any peer review panel 
                member wants to express.
          (3) Separation of assessments.--Peer review of human 
        health, safety, environmental, and economic assessments 
        may be separated for purpose of this subtitle.
    (d) Response to Peer Review.--The head of the Federal 
agency shall provide a written response to all significant peer 
review comments.
    (e) 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.
    (f) 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.
    (g) National Panels.--The President shall appoint National 
Peer Review Panels to annually review the risk assessment and 
cost assessment practices of each 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--Other Provisions

SEC. 3401. JUDICIAL REVIEW.

    Compliance with the requirements of this title shall be 
reviewable pursuant to the Administrative Procedure Act.

SEC. 3402. PRIORITIZATION OF THREATS AND RESOURCE USE.

    For any risk assessment, risk characterization, cost-
benefit analysis, or peer review program prepared by, or on 
behalf of, any Federal agency under this title, the head of the 
Federal agency shall--
          (1) prioritize threats to human health, safety, and 
        the environment according to--
                  (A) the seriousness of the risk they pose; 
                and
                  (B) the opportunities available to achieve 
                the greatest overall net reduction in those 
                risks with the public and private resources 
                available; and
          (2) prioritize the use of resources available to the 
        agency under those laws to reduce those risks in 
        accordance with the priorities established under 
        paragraph (1), including applying the priorities to the 
        budget, strategic planning, and research activities of 
        the agency.

              II. BACKGROUND AND NEED FOR THE LEGISLATION

    Title III--Risk Assessment and Cost Benefit Analysis for 
New Regulations was introduced as part of H.R. 9, the ``Job 
Creation and Wage Enhancement Act of 1995'' on January 4, 1995. 
Title III was subsequently referred to the Committee on Science 
and additionally to the Committee on Commerce and to the 
Committee on Government Reform and Oversight.
    The Risk Assessment and Cost/Benefit Analysis legislation 
was developed in response to the need to develop clear and 
consistent guidelines on the conduct of risk assessment and 
cost benefit analysis for programs throughout the Federal 
government which regulate and otherwise manage risks to human 
health, safety and the environment. The legislation seeks to 
ensure that these assessments and analyses are formulated using 
the best science available.
    The cost of regulation runs in the hundreds of billions of 
dollars. The problem 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 hypothetical, 
exaggerated or small.
    The concern with Federal risk assessment practices is that 
Federal risk assessment, characterization and communication is 
biased and based on a series of hypothetical assumptions which 
are designed to overstate the risks. 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 covered. It is generally 
believed that the ``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 
inappropriately collapses 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 be ``best estimates'' or 
estimates of expected value in addition to upper-bound 
estimates to provide a more realistic benchmark.
    Some Federal provisions require consideration of the costs 
and benefits of regulatory alternatives, although the specific 
language authorizing such consideration differs greatly among 
statutes. While these resulting regulatory decisions are 
judicially reviewable, the general standards of review is for 
courts to be deferential to Federal agencies concerning the 
analysis of factual issues. Moreover, 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 
assessments were 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 of Risk Management 
Budgeting in the Fiscal Year 1992 Budget of the United States 
Government which is a summary of some of the assessments 
performed under Executive Order 12291. The chart illustrates 
the 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 even 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.

                         TABLE C-2. RISKS AND COST-EFFECTIVENESS OF SELECTED REGULATIONS                        
----------------------------------------------------------------------------------------------------------------
                                                                                       Baseline      Cost per   
                                                                                      mortality      premature  
                  Regulation \1\                      Year    Health of    Agency      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
Coke Ovens Occupational Exposure Limit \3\........     1976  H           OSHA-H            7,200            63.5
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.                                                                                           

    The explicit purposes of the bill 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 to 
educate federal, state and local decision makers and the 
public.
    2. To provide for full consideration and relevant data and 
potential methodologies used to assess and communicate and 
characterize health, safety, and environmental risk.
    3. To require explanation of significant choices in the 
risk assessment process which will allow for better peer review 
and public understanding.
    4. To improve consistency within the executive branch in 
preparing risk assessments and risk characterizations through, 
among other methods, further research in the risk assessment 
methodology.
    5. To undertake for every major rule designed to protect 
health, safety and the environment an analysis of the costs and 
benefits of that regulatory action.
    6. To establish a certification process by the head of each 
agency promulgating rules designed to protect health, safety 
and the environment that such regulations are based on 
objective and unbiased scientific and economic evaluation, and 
that the incremental risk reduction or other benefits will be 
likely to justify, and be reasonably related to, the 
incremental costs incurred by state, local, tribal governments, 
and the Federal government and other public and private 
entities.
    7. To establish a certification process that no regulatory 
or non-regulatory alternative considered by the agency or 
proposed to the agency would be more likely to achieve a 
substantially equivalent reduction in risk in a more cost-
effective manner.
    8. To establish an independent and external peer review 
program of risk assessments used to formulate those 
regulations.
    9. To clarify that judicial review of this legislation 
shall be pursuant to the Administrative Procedure Act.
    10. To establish that for any risk assessment, risk 
characterization, cost benefit analysis, or peer review program 
prepared by, or on behalf of, any Federal agency that the head 
of each agency shall prioritize threats to human health, safety 
and the environment according to seriousness of the risk and to 
achieve the greatest reduction in risk given the resources 
available to address those risks.

              III LEGISLATIVE HISTORY AND COMMITTEE ACTION

    Title III of H.R. 9 was referred to the Committee on 
Science and, in addition, to the Committees on Commerce and 
Government Reform and Oversight. Markup of Title III, Risk 
Assessment and Cost/Benefit Analysis for new regulations, was 
preceded by two hearings by the Full Committee on January 31, 
1995 and February 3, 1995, respectively. During the first 
hearing the Committee received testimony from private sector 
witnesses, and the second hearing included witnesses from the 
Administration and environmental and other public policy 
entities.
    The issue of risk assessment had been raised many times 
during the 103rd Congress. The Committee on Science, Space, and 
Technology was referred the bill, H.R. 4306. The bill was 
designed to establish a comprehensive risk assessment program 
within the Environmental Protection Agency (EPA). Within the 
Committee on Science, Space, and Technology, the bill was 
referred to the Subcommittee on Technology, Environment and 
Aviation (TEA). After reviewing testimony of witnesses during 
three hearings, the TEA Subcommittee marked up the bill on May 
18, 1994. Following the Subcommittee markup, changes were made 
in an effort to enlist the support of EPA, environmental groups 
and industry groups. The Full Committee was convened to markup 
H.R. 4306 on July 20, 1994. After adoption of an amendment by 
Ranking Republican Member Robert S. Walker (R-PA) containing 
some of the principles now in Title III of H.R. 9, the Risk 
Assessment Improvement Act of 1994 was reported on October 7, 
1994, to the House.
    Other bills of the 103rd Congress, such as the Safe 
Drinking Water Act of 1994, the Superfund Reform Act of 1994, 
the Agriculture Reorganization Act of 1994, the Department of 
Environment Act of 1993 and the Environmental Research, and 
Development and Demonstration Act of 1993 included provisions 
for risk assessment or risk management.

                         Full Committee Markup

    On February 8, 1995, the Science Committee convened to 
markup Title III of H.R. 9. Chairman Walker offered an 
Amendment in the Nature of a Substitute. The substitute 
clarified that risk assessments and risk characterizations in 
Subtitle A are supplemental to, but do not supersede, any other 
provision of law designed to protect health, safety, or the 
environment; made clear the importance of characterizing and 
then communicating the nature of risks to decisionmakers and to 
the public in terms that are clear and understandable; 
elaborated on the concept of substitution risk (past regulatory 
action in trying to ameliorate one type of risk has often 
merely substituted another hazard); clarified that risk 
assessments and characterizations that are undertaken between 
the date of the enactment and the effective date of this 
legislation may be reviewed on the basis of risk assessment 
guidelines and any new information received, if such 
information would significantly alter results; clarified the 
cost/benefit analysis criteria; and assured that the normal 
time-tested judicial review provisions of the Administrative 
Procedure Act apply.
    Of the thirteen (13) amendments offered, nine (9) were 
adopted regarding Subtitle A:
    Mr. Minge offered an amendment to Section 3001 which 
provides for a finding that there should be prompt relief from 
the burden of unnecessary and overly complex regulations. The 
amendment was adopted by voice vote.
    Mr. Davis offered an amendment to Section 3104(a) to 
clarify the use of available scientific data. The amendment was 
adopted by a roll call vote: Yeas--36, Nays--9.
    Mr. Davis offered a second amendment to Section 3104(b)(1) 
which adds for the provision of raw data, and requires that 
data acquired from animal experiments should be reviewed for 
its relevancy. The amendment was adopted by voice vote.
    Mr. Barton offered an amendment to Section 3104(b) 
mandating that agencies cannot adopt the risk recommendations 
of a non-U.S. based entity without performing their own 
independent risk assessment. The amendment was adopted by a 
roll call vote: Yeas--36, Nays--11.
    Mr. Olver offered an amendment in two parts to Section 
3105(3). The first part of the amendment reinstated the words 
``human health, safety, or the environment'' and was adopted by 
voice vote.
    Mr. Roemer offered an amendment which adds a provision for 
Research and Training in Risk Assessment. The amendment was 
adopted by voice vote.
    Mr. Roemer offered a second amendment which adds a 
provision to study Comparative Risk Analysis. The amendment was 
adopted by voice vote.
    Mr. Bartlett offered an amendment which clarifies the 
definition of ``significant risk assessment document.'' The 
amendment was adopted by voice vote.
    Mr. Tanner offered an amendment which clarifies the role of 
the Defense Department by adding the phrase to Section 3103, 
``or to be necessary to maintain military readiness.'' The 
amendment was adopted by voice vote.
    Two (2) of three (3) amendments offered to Subtitle B were 
adopted.
    Mr. Davis offered an amendment to Section 3201(a). The 
amendment applies to major rules to protect human health, 
safety and the environment and requires the considering agency 
to identify reasonable alternatives which would achieve the 
identical benefits of the proposed rule including (1) no 
government action; (2) accommodation of geographic difference; 
(3) use of performance or market-based standards that provide 
flexibility to achieve identified benefits; (4) an assessment 
of the aggregate effects on small business, and (5) a cost/
benefit analysis based on the net benefits to society. The 
amendment was adopted by voice vote.
    Mr. Wamp offered an amendment to Section 3201(a)(3) 
requiring Departments or Agencies to meaningfully quantify, in 
a rule making, the cumulative burden on manufacturers or other 
affected parties, of multiple regulations by the same agency, 
as well as the cumulative effect by different agencies for the 
same product. The amendment was adopted by voice vote.
    One (1) of the two (2) amendments offered under Subtitle C 
was adopted:
    Mr. Boehlert, Mrs. Morella, and Mr. Ehlers offered an en 
bloc amendment which adds Section 3401 that would mandate the 
agencies to prioritize threats to human health and the 
environment; identify opportunities for the most significant 
risk reduction, to direct their resources accordingly in areas 
where they can do the most good for the American people and for 
the environment. This amendment was adopted by voice vote.
    The Committee favorably reported the bill, as amended, by 
voice vote.

                        IV. SUMMARY OF HEARINGS

    The Committee convened two days of hearings on Title III of 
H.R. 9, the ``Job Creation and Wage Enhancement Act of 1995.'' 
Title III would create a system of risk assessment and cost-
benefit analysis for all federal agencies which issue 
regulations designed to protect human health, safety, and 
environment. On January 31, 1995, the Committee heard testimony 
from private sector witnesses. On February 3, 1995, the 
Committee heard testimony from members of Congress, the 
Administration, and from public policy groups. In receiving the 
testimony from the witnesses, the following questions were 
explored by the Committee:
    Does the current system of risk characterization properly 
convey to the American people the environmental, health or 
safety hazards they encounter in their daily lives?
    Do current risk assessments identify real or imaginary 
risks?
    Can risk assessments be used to achieve more efficient 
regulation by prioritizing which risks can be best addressed in 
the most cost-efficient manner?
    What will the administrative burden be on the agencies 
implementing risk assessment?

a. Risk assessment and cost/benefit analysis, January 31, 1995

    This hearing evaluated testimony from witnesses 
representing the private sector.
    The witnesses were:
          Dr. Jerry J. Jasinowski, President, National 
        Association of Manufacturers (NAM), representing the 
        Alliance for Reasonable Regulation;
          Dr. John Graham, Professor of Policy and Decision 
        Sciences, Harvard Center for Risk Analysis;
          Mr. Gordon Garner, Executive Director, Louisville and 
        Jefferson County Metropolitan Sewer District;
          Mr. Sam Kazman, General Counsel, Competitive 
        Enterprise Institute; and
          Mr. Scott Holman, President/CEO, Bay Cast, Inc.
    Mr. Jasinowski testified that federal agencies must develop 
a more rational, risk-based system to evaluate (and set 
priorities for the regulation of) risks to human health, 
safety, and the environment. Agencies must improve their risk 
assessment methodologies and the accuracy and relevance of the 
resulting risk estimates and characterizations. 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. Opportunities 
for public participation in the hazard evaluation and risk 
assessment process should be increased--both prospectively and, 
in appropriate cases, retrospectively as well. The risk 
management decisionmaking process must be improved in a number 
of respects.
    Dr. Graham testified that there is a need to mandate broad-
based rankings of health, safety and environmental risks that 
cut across the jurisdictions of existing agencies. There is a 
need, he said, to make sure that the findings of benefit-cost 
analyses are actually used by federal agencies when making 
specific rulemaking decisions. The capacity of the Executive 
Office of the President to exercise leadership analysis needs 
to be strengthened by legislative authorization and resources. 
More thought needs to be given to whether the universities in 
this country are providing professional scientists with 
appropriate training in risk analysis to meet the demands 
likely to be generated by this legislation.
    Mr. Garner testified that he believes the ``Risk Assessment 
and Communication Act of 1995'' provides a mechanism for better 
priority-setting consistent with efforts being made by state 
and local governments across the country and with efforts 
already being used by some federal agencies, but not required 
by law. The Act is just one piece of the solution to the 
puzzle; it requires that a baseline level of information be 
available when national legislation is being considered. It 
should be supported, and efforts to twist the intent and the 
effect of the legislation should be avoided. Risk assessment, 
he said, must be based on available resources and the best 
information the agencies can find, recognizing that there is an 
element of uncertainty in the risk assessment process. Risk 
assessments should not be inappropriately used to undervalue 
natural systems. Mr. Garner also expressed his concern that 
Title III of H.R. 9 not lead to extensive litigious burden.
    Mr. Kazman testified that Title III of H.R. 9 would 
constitute a major advance of this issue, directing agencies to 
carefully consider a host of factors that are often neglected 
in government contexts. He supported retention of Title III's 
judicial review provision, section 3301(e), to ensure that all 
cost-benefit and risk assessment materials are available to the 
courts in cases challenging agency action. Peer review should 
be the responsibility of an entity whose institutional 
responsibility is to review and restrain agency action. H.R. 9 
should do the opposite--it should modify these and other 
statutes to require that every regulatory action be shown to 
produce a net benefit.
    Mr. Holman testified that small business strongly supports 
the effort to make risk-based decisionmaking a priority for the 
new Congress through passage of Title III of H.R. 9. The 
provisions of Title III would strengthen the use of risk and 
cost-benefit analysis and lead toward the development of 
higher-quality decisions by regulators. Title III would 
increase accountability of federal agencies.

b. Risk assessment and cost/benefit analysis, February 3, 1995

    On February 3, 1995, the Committee on Science held a second 
day of hearings on Risk Assessment and Cost Benefit Analysis, 
Title III of H.R. 9, Job Creation and Wage Enhancement Act of 
1995. Panel One consisted of witnesses from the Executive 
Branch:
          The Honorable Jack Gibbons, Director, Office of 
        Science and Technology Policy, Executive Office of the 
        President;
          Dr. Lynn Goldman, Assistant Administrator, Office of 
        Prevention, Pesticides, and Toxic Substances, U.S. 
        Environmental Protection Agency;
          Mr. Keith Collins, Acting Chief Economist, Department 
        of Agriculture; and,
          Mr. William Schultz, Deputy Commissioner for Policy, 
        Food and Drug Administration.
    Panel Two consisted of witnesses from academia and 
regulatory and public policy institutes:
          Dr. Thomas A. Burke, Associate Professor of Health 
        Policy and Management, Johns Hopkins University School 
        of Hygiene and Public Health;
          Dr. Paul R. Portney, Vice President, Resources for 
        the Future;
          Mr. Thomas O. McGarity, University of Texas School of 
        Law;
          Mr. Terry F. Yosie, Senior Vice President, E. Bruce 
        Harrison Company;
          The Honorable Don Ritter, Chairman, National 
        Environmental Policy Institute; and,
          Mr. Thorne Auchter, Former Assistant Secretary of 
        Labor, Occupational Safety and Health Administration.
    Prior to proceeding with testimony from witnesses on Panels 
One and Two, the Committee heard testimony from Congressman 
John Mica (R-FL) and Congressman Dick Zimmer (R-NJ).
    Both Members testified in support of the legislation. Mr. 
Mica stressed that requiring federal agencies to provide ``best 
estimates'' of risk is critical, and that the language 
requiring an agency to place the risk in context by comparing 
the risk with three other risks that are familiar to the 
general public must be passed. Mr. Zimmer presented testimony 
regarding his support of risk assessment and addressed 
components of H.R. 690, the Risk Assessment Cost-Benefit 
Analysis Act of 1995, a bill which he has introduced.
    Dr. Gibbons testified that the Administration actively 
supports the goal of bringing ``greater scientific and economic 
rationality to the regulation of risks to our health, safety, 
and environment.'' He discussed the Executive Order on 
Regulatory Planning and Review (No. 12866) signed by the 
President September 30, 1993, which required agencies to 
propose or adopt regulations only after determining that their 
benefits justify their costs, and that the rules are developed 
according to sound regulatory principles. Dr. Gibbons expressed 
the Administration's opposition to the legislation, saying, 
that they have reviewed Title III of H.R. 9 carefully, and 
regretted that it is not fair, effective and affordable; nor 
does it live up to its own professed standards or regulatory 
efficiency and cost-effectiveness.
    Dr. Goldman of EPA also expressed strong support for the 
``science of risk assessment and of its appropriate use along 
with cost benefit and other analyses.'' She reiterated Dr. 
Browner's previously stated support for legislation that says 
that risk assessment should provide both decision-makers and 
the public with a clear and meaningful understanding of the 
risks that will be addressed. Dr. Goldman expressed the 
Administration's opposition to the legislation based on the 
concern that Title III of H.R. 9 would create new opportunities 
for litigation, resulting in delay of the rulemaking process, 
and that the cost-benefit requirements of the bill would 
conflict with statutory provisions currently administered by 
EPA.
    Mr. Collins testified that USDA also supported the ``use of 
risk assessment and cost-benefit analysis for the efficiency 
and effectiveness these analytical tools can bring to 
government programs.'' He objected, however, to provisions of 
Title III which he saw as having negative effects on the 
Department's ability to protect human health, safety, and the 
environment, and which would ``create unnecessary red tape and 
bureaucracy.'' Mr. Collins noted that the Department is in the 
process of implementing legislation enacted last year which 
created an Office of Risk Assessment and Cost-Benefit Analysis. 
He expressed concern about the breadth of application of the 
legislation, particularly as it pertains to the nature of the 
USDA's work.
    Mr. Schultz conveyed the FDA's opposition to Title III of 
H.R. 9. Nonetheless, he too called risk assessment a useful 
tool, which the agency has been using for more than 20 years. 
He opposed Title III, however, on the grounds that it adds 
``extensive new procedural and substantive requirements to the 
tens of thousands of decisions involving informal assessment of 
risk that the FDA performs annually.'' He cited additional 
burdens and costs to industry, delay of products reaching the 
marketplace, and delays in the agency's enforcement programs, 
adversely impacting the use of perishable products.
    Dr. Burke also supports efforts to improve the risk 
assessment process, but he stated his concern that Title III of 
H.R. 9 relies on an ``over-dependence upon risk assessment and 
cost-benefit analysis as the primary vehicles for shaping our 
national approach to managing and preventing public health and 
environmental risks.''
    Dr. Portney expressed support for cost-benefit analysis as 
a ``powerful analytical tool that can play a very useful role 
in public policymaking. Benefit-cost analysis can help 
illuminate cases in which regulatory proposals have not been 
carefully thought through.
    Mr. McGarity opposes Title III, on the grounds that it 
would effectively repeal certain statutes.
    Mr. Yosie testified that H.R. 9 ``represents an ambitious 
attempt to codify and restructure certain aspects of the risk 
assessment process. It reflects a frustration that many people 
have concerning the slow pace of improving risk assessment and 
altering regulatory policies.'' He believes that H.R. 9 would 
not substantially change the way risk assessments are currently 
conducted, would make the current process more inefficient and 
expensive. He expressed opposition to the peer review provision 
as especially burdensome.
    Mr. Ritter expressed his strong support for Title III of 
H.R. 9, stating that the legislation ``has the potential to 
help decision-makers and regulators know better where to put 
our energies, our talents, and our dollars.''
    Mr. Auchter expressed strong support for Title III of H.R. 
9, and cited risk assessment as an ``invaluable starting point 
for the consideration of regulatory issues, provided it is 
systematically employed through the adoption of common 
principles.'' He expressed support for a petition process that 
could be then appealed in court.

V. EXPLANATION OF THE BILL AS REPORTED: SECTION-BY-SECTION ANALYSIS AND 
                            COMMITTEE VIEWS

                          Sec. 3001. Findings

    The findings indicate that health, safety and environmental 
regulations have led to dramatic improvements in these areas. 
However, these regulations could be improved based upon a 
greater use of a realistic consideration of risk, risk 
reduction opportunities and costs. These objectives can be 
achieved by a greater reliance on risk assessments based on 
sound science.
    The findings also recognize that resources to accomplish 
reductions in hazards to health, safety and the environment are 
not unlimited and should be allocated so that the greatest 
needs for corrective action should be addressed first.
    The third finding recognizes that these goals can be 
accomplished by employing unbiased risk assessments, 
comparative risk analysis, and risk management choices that are 
grounded in cost-benefit principles.
    The findings also state that despite the fact that risk 
assessment has been a useful analytical tool, further 
improvements need to be made in risk assessment methodology. 
Once a risk assessment has been formulated, however, it must be 
characterized in such a manner so that the nature of the 
assessment can be communicated to decision makers and the 
public in a clear and concise manner. Such transparent 
communication will allow the decision makers and the public to 
better understand the risks that are being addressed by health, 
environmental and safety regulations.
    Finally, finding number six discusses the fact that risk 
assessment is only one analytical tool that needs to be 
employed to secure regulatory relief.

             Subtitle A--Risk Assessment and Communication

  Sec. 3101. Short Title: ``Risk Assessment and Communication Act of 
                                 1995''

                          Sec. 3102. Purposes.

    The purposes of this subtitle are 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; to provide for 
full consideration and discussion of relevant data and 
potential methodologies used in risk assessments and risk 
characterizations; to require explanation of significant 
choices in the risk assessment process which will allow for 
better peer review and public understanding; and to improve 
consistency within the executive branch in preparing risk 
assessments and risk characterizations.

     Sec. 3103. Effective Data; Applicability; Savings Provisions.

    The date upon which Subtitle A becomes effective is 18 
months after the day of its enactment, except as otherwise 
specified.
    This subtitle shall apply to all agencies of the Federal 
government who administer programs designed to protect human 
health, safety and the environment.
    Each agency of the Federal government shall assure 
compliance with the guidelines required by this bill for all 
significant risk assessment and significant risk 
characterization documents used in each of the following:
          1. Any major rule designed to protect human health, 
        safety and the environment which annually increases 
        costs to the Federal, state, local and tribal 
        governments and individuals and the private sector of 
        $25,000,000 or more;
          2. Any proposed or final regulatory decision relating 
        to decontamination or other clean-up plans for a 
        facility;
          3. Any report to Congress which assesses human 
        health, safety, or environmental risks;
          4. Placement of a substance or health effects value 
        on the Integrated Risk Information System (IRIS) 
        Database maintained by the Environmental Protection 
        Agency;
          5. Any regulatory action to place a substance on any 
        official list of carcinogens, toxic or hazardous 
        substances;
          6. Any risk assessment document or risk 
        characterization document, regardless of origin, 
        provided by an agency to the public that is likely to 
        result in an annual effect on the economy of at least 
        $25,000,000; and
          7. Any risk assessment or risk characterizations 
        forming the basis of a final risk assessment protocol 
        of general application.
    Further, this section requires federal agencies to 
promulgate within 15 months of the date of enactment of this 
legislation a rule which lists other risk assessment and risk 
characterization documents deemed to be significant and sets 
forth criteria to be considered when making the rule.
    Federal agencies establish policy on risk assessment and 
risk characterization through many different types of formal 
and informal guidance. Formal guidance usually is in the form 
of regulations. Informal guidance may come through policy 
statements, guidelines, action levels, protocols, speeches, 
congressional testimony, notices, and a wide variety of other 
similar documents. Whether formal or informal, this guidance 
constitutes the vast bulk of federal policy in the area of risk 
assessment and risk characterization.
    Section 3103(b)(2) includes such guidance as a 
``significant risk assessment document'' and ``significant risk 
characterization document'' where it establishes policy of 
general applicability, but not where it is product-specific. 
Thus, a guideline establishing general principles for testing a 
class of products, or for agency review and approval of a type 
of ingredient, is subject to subtitle A, but the application of 
that guideline to a specific ingredient or product is not. A 
regulation establishing new product labeling requirements is 
subject to subtitle A, but the application of those rules to 
individual labels is not. Action levels establishing 
enforcement policy are subject to subtitle A, but their 
application to specific products in individual compliance 
actions are not.
    Finally, there can be no diminution of public health 
protection under this law. Section 3103(b)(3) explicitly 
exempts any situation that the head of an agency considers to 
be an emergency. This assures that immediate action can be 
taken wherever justified.
    This section also provides that this subtitle does not 
apply to emergencies or situations necessary to maintain 
military readiness, screening analysis, or food, drug and 
product labels requiring federal approval prior to their use as 
well as any health, safety or environmental inspections or 
individual facility permitting actions. Military readiness 
should be interpreted to mean training procedures of military 
personnel required to provide for the national security
    The Committee expects that the head of an agency shall 
determine an emergency situation based on ordinary notions of 
urgency. Such factors which may be considered are any 
condition, circumstance, or practice reasonably expected to 
cause death, serious illness, or severe injury to humans, or 
substantial endangerment to private property or the 
environment. Further, in determining whether an emergency 
exists, an agency head should be guided by applicable statutory 
definitions. However, 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.
    The Committee also notes that it has jurisdiction over the 
National Aeronautics and Space Administration (NASA). The 
Committee acknowledges that NASA currently performs stringent 
risk assessments to evaluate safety, mission-success 
probabilities, programmatic cost and scheduling issues. These 
risk assessments are integral to the accomplishment of NASA's 
statutory mandate to improve ``the usefulness, performance, 
speed, safety, and efficiency of aeronautical and space 
vehicles'' [42 U.S.C. 2451(d)(2)]. While the Committee does 
intend for the provisions of Title III of H.R. 9 to apply to 
NASA, the Committee does not believe or intend that these 
requirements impose any unjustifiable new costs or burdens on 
the agency. Since NASA is a leading fundamental science mission 
agency, the Committee expects compliance with scientifically 
objective, unbiased risk guidelines to be fully consistent with 
their mission. It should be noted, however, that Title III of 
H.R. 9 provides for a transitional plan and Congressional 
reporting process.
    Within 180 days after the date of enactment of this title, 
Federal agencies, with guidance from the Office of Management 
and Budget, shall develop transition plans to assist the 
agencies, the public, and the regulated community in the 
implementation of this title, including any new requirements or 
procedures needed to supplement prior agency practices.
    Federal agencies shall report to Congress annually as to 
whether their implementation of this title has created any 
significant regulatory or program management complication 
resulting from any differences between the certification 
provisions of this title and decisional criteria for rule 
making that otherwise would have been applicable under other 
statute.
    This section also 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.

               Sec. 3104. Principles for Risk Assessment

    To assure that risk assessments distinguish scientific 
findings from other considerations and present a complete, 
unbiased description of risk, this section sets forth the 
following principles for the preparation of significant risk 
assessment documents: (1) in documents discussing human health 
risks, a discussion of laboratory and epidemiological data, the 
correlation between health risks and potential toxins and 
activities, and an explanation of conflicts among the data; (2) 
in documents selecting significant assumptions, inferences or 
models, an explanation of alternative assumptions, an 
explanation of choices made between models, identification of 
policy or value judgments, a full description of models used 
and their underlying assumptions, and an indication of 
conflicts between models and empirical data; and (3) a 
prohibition against the automatic adoption or incorporation, 
without opportunity for notice and comment, of any 
recommendation or classification of the health effects value of 
a substance made by a non-United States-based entity. The 
Committee states that the term non-United States-based entity 
means: any foreign nation or government and its agencies; the 
United Nations or any of its subsidiary organizations; other 
international governmental bodies or standards-making 
organizations or any other organization or private entity 
without a place of business located in the United States or its 
territories.
    Risk characterizations currently produced by Federal 
agencies frequently overstate risks and lack key information. 
The bill addresses this problem by requiring Federal agencies 
to assure that significant 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, including animal data which shall be reviewed 
with regard to its relevancy to humans.
    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.
    Federal agencies often use default options when real data 
exist. Default options allow risk assessors to make 
quantitative estimates of risk when available data are 
incomplete. Often agencies choose default options which, given 
the available scientific information, tend to overstate risks 
in the resulting risk estimate. One such default option 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 
assessments to include all relevant data. Subparagraph 
3104(b)(2) will remove the current disincentive for 
organizations to develop data that will increase the accuracy 
of risk assessments.

   Sec. 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 attendant 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 greater than 
they are.
    This section mandates that federal agencies provide, to the 
extent feasible, 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 Subtitle A makes clear that no calculation is 
precluded. Best estimates are defined to be a central estimate, 
which is the most statistically probable level of risk, as well 
as any other methodology designed to provide the most plausible 
level of risk, given the scientific information available to 
the head of the department of agency. Subtitle A does not opine 
on which combination of scientific assumptions or methodology 
are most appropriate and, thus, makes no pronouncement on the 
science itself. The decision should be made under the current 
standards of review. The standard presentation of best 
estimates, however, differs substantially from the current 
system at EPA of simply presenting different forms of upper-
bound or conservative point estimates.
    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 decision makers 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. 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 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 options where the actual information is more 
scientifically plausible than the information underlying the 
default assumption.
    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 risk.
    Paragraph 3105(2) requires agencies to explain the exposure 
scenarios used and provides 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 
handfuls of 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. 
Statements such as ``there is a one in ten thousand additional 
lifetime risk of getting cancer,'' without context, may promote 
confusion and misapprehension. 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. However, simply for illustrative 
purposes, the following chart demonstrates the type of 
comparisons that provide a helpful context for evaluating the 
significance of a statistical risk.

  APPROXIMATE DOSES OF NATURALLY-OCCURRING SUBSTANCES IN FOOD OR DRINK  
 THAT PRODUCE AN UPPER-BOUND, LIFETIME RISK OF CANCER OF ``1 IN 10,000''
        FOR A LIFETIME OF CONSUMPTION, USING EPA METHODOLOGY \1\        
------------------------------------------------------------------------
             Substance                               Dose               
------------------------------------------------------------------------
Ethyl Alcohol......................  One glass of wine every three years
                                      as an adult; or                   
                                     One bottle of beer every two years 
                                      as an adult                       
Caffeic Acid.......................  One head of lettuce every two      
                                      years; or                         
                                     One apple a month; or              
                                     Three stalks of celery a month; or 
                                     Three carrots a month; or          
                                     Five potatoes a month.             
Caffeic Acid and 18 other rodent     Three and one half cups of coffee a
 carcinogens.                         month as an adult.                
8-Methoxypsoralen..................  Five parsnips a year.              
Allyl Isothiocyanate...............  One 3-ounce jar of brown mustard a 
                                      year.                             
Mixture of hydrazines..............  Four mushrooms a year.             
Estragole..........................  Four grams of dried basil a year.  
d-Limonene.........................  Two 6-ounce glasses of orange juice
                                      a month.                          
Aflatoxin..........................  Three peanut butter sandwiches a   
                                      month.                            
------------------------------------------------------------------------
\1\ Converted from data in ``Rodent Carcinogens: Setting Priorities'' by
  Lois Swirsky Gold, Thomas H. Sloane, Bonnie R. Stern, Neela B. Manley,
  Bruce N. Ames (Science, Vol. 258(9). October 1992) in a manner similar
  to current EPA risk assessment guidelines.                            
                                                                        
 Note.--The risk posed by these foods could be as low as zero.          

    Paragraph 3105(4) requires that each significant risk 
assessment or significant risk characterization document 
referred to in section 3103(b) shall include a statement of any 
significant substitution risks to human health, where 
information on such risk is available to the agency. The term 
``substitution risk'' is defined in section 3109 to mean any 
potential risk to human health, safety or the environment 
resulting from a regulatory option designed to decrease other 
risks. Current risk characterization and communication fail to 
provide adequate information about the ``new'' risks that the 
proposed action will pose. Because they are not currently 
assessed, those causal risks are often assumed to be zero. Many 
risk management actions pose their own intended and unintended 
risks.
    This requirement applies to ``significant'' substitution 
risks. The Committee expects agencies to look to the 
substitution risk relative to the risk being addressed by the 
particular regulatory strategy. If a regulatory strategy is 
addressing minor risks, then a minor substitution risk may be 
significant. If the strategy is addressing major risks, then a 
minor substitution risk may not be significant by itself.
    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.

 Sec. 3106. Guidelines, Plan for Assessing New Information, and Report

    This section requires the President to issue guidelines for 
Federal agencies within 15 months of the date of enactment of 
this legislation consistent with sections 3104 and 3105. In 
addition, such guidelines shall include guidance on at least 
the following subjects: criteria for scaling animal studies to 
assess risks to human health; use of different types of dose-
response models; thresholds; definitions, use, and 
interpretations of the maximum tolerated dose; weighing of 
evidence with respect to extrapolating human health risks from 
sensitive species; evaluation of benign tumors, and evaluation 
of different human health endpoints.
    This section also requires that within 18 months after the 
date of enactment of this legislation, each Federal agency 
which conducts risk assessments shall publish a plan to review 
and, where appropriate, revise any significant risk assessment 
document or risk characterization document which was issued 
before the effective date of this legislation. The head of the 
agency determines that the application of the principles set 
forth in sections 3104 and 3105 would likely 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 final plan shall set priorities for 
review, and, where appropriate, for revision of risk assessment 
documents and risk characterization documents based on the 
potential to more efficiently focus national economic resources 
within Federal 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.
    This section also requires agencies to evaluate policy and 
value judgments inherent in their risk assessments and report 
to Congress within 3 years after the date of the enactment of 
this legislation.
    Further, this section requires the President to review and, 
where appropriate, revise the guidelines published under this 
section at least every 4 years. In this manner, advances in 
risk assessment and risk characterization science and 
methodology can be incorporated into each agency's program.
    The guidelines, plan and report under this section are 
subject to public notice and comments.

          Sec. 3107. Research and Training in Risk Assessment

    This section would require that each Federal agency 
regularly and systematically evaluate risk assessment research 
and training needs. Further, each agency head must develop a 
strategy schedule, and delegation of responsibility within the 
agency to meet those needs and report to Congress on the 
progress made to implement this section. Section 3106 would be 
applicable to only the following agencies: the Environmental 
Protection Agency, the Consumer Product Safety Commission, the 
Occupational Health and Safety Administration, the Department 
of Labor, the Department of Transportation, the Department of 
Energy, the Department of Agriculture, the Department of 
Interior, and the Food and Drug Administration.

             Sec. 3108. Study of Comparative Risk Analysis

    This section would require the Director of the Office of 
Science and Technology Policy to conduct or commission a study 
using comparative risk analysis to rank health and 
environmental risks, and to provide a common basis for 
evaluating strategies for reducing or preventing these risks. 
The purpose of this study is to improve and list comparative 
risk methodology.
    This section further directs the Director of OSTP to enter 
into an agreement with the National Research Council to provide 
technical guidance on varying ways in which to prioritize 
environmental risks using comparative risk analysis.
    Paragraph 3108(2)(e) requires the Director of OSTP to 
report to Congress on the findings of the study.

                         Sec. 3109. Definitions

    This section defines certain terms. 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. 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. The term ``best estimate'' means an 
estimate which is based on one of the following: 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; 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. As used in 
this title, the term ``Federal agency'' means an executive 
department, military department, or independent establishment 
as defined in part I of title 5 of the United States Code, 
except that such term also includes the Office of Technology 
Assessment. The term ``document'' includes material stored in 
electronic or digital form. As used in this title, the term 
``prepare,'' when referring to risk assessment, risk 
characterizations, or analyses of risk reduction benefits and 
costs, includes both the preparation or use of such a document 
by an agency.

       Subtitle B--Analysis of Risk Reduction Benefits and Costs

        Sec. 3201. Analysis of Risk Reduction Benefits and Costs

    This section directs the President to require 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; reasonable alternatives for the 
proposed rule including alternatives that require no government 
action, an assessment of the aggregate effect of the rule on 
small businesses with fewer than 100 employees; an analysis of 
whether the identified benefits of the proposed or promulgated 
rule are likely to exceed the identified costs of the proposed 
or promulgated rule, a comparison of any human health, safety, 
or environmental risks addressed by the regulatory alternatives 
to other greater or lesser risks chosen by the head of the 
agency, including at least three (3) other risks regulated by 
the agency and to at least three (3) other risks which the 
public is familiar; a quantitative assessment of the cumulative 
financial burden that persons producing products that are 
regulated by the rule will bear in order to comply with the 
rule and with existing standards that affect the product or 
other similar products produced by such persons; 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. This section prohibits promulgation 
of any final rule subject to this title unless the 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. This section 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 this section are met and supported by 
substantial evidence of the rulemaking record. For each major 
rule, it requires agencies to publish in the Federal Register 
or otherwise make available the information required to be 
prepared under this section. For the purposes of this subtitle, 
``costs'' are defined to include the direct and indirect costs 
of compliance to the federal government, state and local 
governments, and private entities; ``benefits'' are defined to 
include direct and indirect social and economic benefits; 
``major rule'' is defined 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.
    Emergencies as defined in subtitle A of this legislation 
are exempted from these requirements.
    The provisions of 3201(c) make the provisions of this 
section applicable to new regulations promulgated under 
existing federal statutes. The 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 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 this 
section.
    When there is a conflict with or explicit textual language 
in a federal statute prohibiting consideration of the criteria 
as set forth, the provisions of 3201(f) state that the 
decisional criteria in this section 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 this 
section criteria. By this means, the language molds the 
ultimate decisional criteria for rulemaking applied under all 
such statutes to the requirements of this section with as 
little disruption as feasible to the otherwise applicable 
instructions of Congress.
    An illustration chart on the manner in which this would be 
applied to certain existing federal statutes follows:

                             Summary Chart

                IMPACT OF SUBTITLE B ON VARIOUS STATUTES

    Subtitle B includes provisions: (1) elaborating the 
principles for risk assessments, (2) determining when cost/
benefit analyses must be considered, and (3) defining the 
circumstances under which independent peer review will be 
required. This chart presents, in summary form, the primary 
statutes affected by Subtitle B. The assessment of impact is 
based solely on those instances when Subtitle B applies. Thus, 
no excluded agency activities or analyses are affected. These 
exclusions include: health, safety, and environmental 
inspections; individual facility permitting; product/substance 
clearance; screening analyses; and emergency situations. In 
addition, scope limitations apply. Basically, the bill mandates 
risk assessment and cost/benefit analysis requirements for 
major rules with an economic impact of $25 million or more. For 
peer review, the threshold is $100 million or more. As an 
example, section 6 of the Toxic Substances Control Act 
establishes procedures and an unreasonable risk criteria under 
which the Environmental Protection Agency can place 
restrictions on products. The bill does not affect those 
procedures or criteria, except to the extent that it 
supplements the existing risk assessment, cost/befit analysis, 
and peer review requirements.
    As used in the following chart, the term ``SUPPLEMENTS'' 
means that the statute already contains a risk assessment, 
cost/benefit analysis or peer review requirement, and that the 
provisions in the bill will better or more explicitly define 
the agency's obligations. ``ADDS'' refers to statutes that are 
silent as to risk assessment, cost/benefit analyses, or peer 
review. In those cases, the bill adds a new requirement to the 
agency's process. The term ``SUPERSEDES'' is used when existing 
legislation does not permit risk assessment, cost/benefit 
analyses, or peer review. In these instances, Subtitle B would 
now require these principles or procedures to be implemented. 
The term ``N/A'' is used when the provisions of the bill are 
not applicable to particular agency action. This table is 
intended to be exemplary only and is not an exhaustive or 
detailed listing of the impact of Subtitle B.

------------------------------------------------------------------------
                                        Cost benefit                    
      Statute        Risk assessment      analysis         Peer review  
------------------------------------------------------------------------
Occupational        Supplements.....  Adds............  Adds            
 Safety and Health                                                      
 Act.                                                                   
Consumer Product                                                        
 Safety Act:                                                            
    Product         N/A.............  N/A.............  N/A             
     recalls.                                                           
    Product safety  Supplements.....  Supplements.....  Adds            
     standards.                                                         
    Products bans.  Supplements.....  Supplements.....  N/A             
Federal Hazardous   Supplements.....  Supplements.....  Adds            
 Substances Act.                                                        
Poison Prevention   Supplements.....  Supplements.....  Adds            
 Packaging Act.                                                         
Hazardous                                                               
 Materials                                                              
 Transportation                                                         
 Uniform Safety                                                         
 Act:                                                                   
    Designating/    Supplements.....  Supplements.....  Adds            
     defining                                                           
     hazardous                                                          
     materials.                                                         
    Packing,        Adds............  Adds............  Adds            
     labeling,                                                          
     placarding.                                                        
    Shipping        Adds............  Adds............  N/A             
     documentation.                                                     
    Unintended      Adds............  Adds............  N/A             
     release                                                            
     notice.                                                            
    Package/        Adds............  Adds............  Adds            
     container                                                          
     design.                                                            
Clean Air Act.....  Supplements.....  Supersedes......  Supplements     
Resource            Supplements.....  Supersedes......  Supplements     
 Conservation and                                                       
 Recovery Act.                                                          
Clean Water Act...  Adds............  Supplements.....  Supplements     
Toxic Substances    Supplements.....  Supplements.....  Supplements     
 Control Act.                                                           
Comprehensive       Supplements.....  Supersedes......  Adds            
 Environmental                                                          
 Response,                                                              
 Compensation, and                                                      
 Liability Act.                                                         
Safe Drinking       Supplements.....  Supplements.....  Supplements     
 Water Act.                                                             
Federal             Supplements.....  Supersedes......  Supplements     
 Insecticide,                                                           
 Fungicide, and                                                         
 Rodenticide Act.                                                       
Oil Pollution Act.  Adds............  Supplements.....  Adds            
Emergency Planning  Adds............  Adds............  Adds            
 and Community                                                          
 Right-to-Know Act.                                                     
Endangered Species  Supplements.....  Supersedes......  Supplements     
 Act.                                                                   
Clean Water Act     Supplements.....  Supersedes......  Adds            
 Section Sec.  404                                                      
 Wetlands Permit                                                        
 Program.                                                               
Federal Food,       Supplements.....  Supersedes......  Supplements     
 Drug, and                                                              
 Cosmetic Act.                                                          
Federal Trade       Adds............  Adds............  Adds            
 Commission Act.                                                        
Federal Mine        Supplements.....  Adds............  Adds            
 Safety and Health                                                      
 Act.                                                                   
------------------------------------------------------------------------

    Subtitle B establishes a flexible decisionmaking framework 
for Federal agencies that reflects the straightforward, common-
sense way in which real people make real decisions. It requires 
that every Federal agency answer two simple questions before a 
major rule ($25 million impact or more on the economy) is 
promulgated--is this action ``worth it,'' and does this way of 
doing it maximize society's net benefits because the agency has 
chosen the most cost-effective and flexible of the alternatives 
considered by or proposed to it. Section 3201(a) uses neutral 
principles, and creates a level and open playing field for 
public policy decisionmaking, with no effort to skew the 
results up or down in advance. Where risks need to be regulated 
and regulation is justified by its benefits, regulation will go 
forward even if costly or inconvenient to some.
     Section 3201(a) contains both procedural requirements that 
a regulatory impact analysis be conducted, and substantive 
decisional criteria. To be effective, the cost/benefit analysis 
provided for in Section 3201(a) must govern agency decisions. 
The ``certifications'' required by Section 3201(a) are 
substantive decisional criteria, as is made clear by the 
provisions of Sections 3201(f)(1) and (2). In making its 
rulemaking decision, each agency must certify that the 
incremental risk reduction or other benefits of any regulatory 
or non-regulatory option chosen will be likely to justify, and, 
in addition, be reasonably related to, the incremental costs to 
be incurred by the action, and that no regulatory or non-
regulatory alternative considered by or proposed to the agency 
during or prior to the public comment period would be more 
likely to achieve a substantial 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.
     Section 3201(b) provides that the information required by 
Section 3201(a) must be placed in the administrative record, 
and is to be published in a clear and concise manner in the 
Notice of Proposed Rulemaking and the Federal Register notice 
for the final regulation.
     The requirements of Section 3201(a) are also designed to 
ensure that risk assessments and risk comparisons based on good 
science will be provided to aid in reasoned decisionmaking. 
Quantification in cost/benefit analysis and risk assessments is 
required to the extent feasible, 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 reasoned decisionmaking on the matter at 
issue, considering any need for expedition.
     In this regard, it is important to emphasize that both 
risk assessments and cost/benefit analyses can be ``tiered''--
that is, they can be tailor-made to fit the nature of 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 place a ``straitjacket'' on agency decisionmaking, 
nor does it require a ``cookbook'' approach to risk assessment 
or cost/benefit analysis. Rather, it aims at ensuring the 
essential rationality of 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. The Committee anticipates that the 
cost/benefit analysis guidance to be developed by the Office of 
Management and Budget under Section 3201(e) will provide 
agencies with sufficient flexibility so that the basic 
principles of risk assessment and cost/benefit analysis can be 
made workable in the individual circumstances faced by each. 
Further, the legislation is intended to promote agency use of 
the best available science as it conducts its risk assessment.
     In short, Section 3201(a) focuses on decisionmaking, not 
on simply multiplying procedural burdens. Its mandates are 
flexible and goal-oriented--not prescriptive. The risk and 
cost/benefit requirements can be molded to the nature of the 
decisionmaking faced by the agency in question. They do not 
require the impossible, but judicial review will hold 
government decisionmakers clearly accountable for doing the 
possible in good faith.
     Section 3201(a) calls for an assessment of ``incremental'' 
costs and ``incremental'' risk reduction or other benefits 
associated with each significant regulatory alternative. It is 
essential, and this language considering ``incremental'' costs 
and benefits is intended to ensure, that the agencies recognize 
the role of diminishing returns in taking action toward any 
regulatory objective. In many cases, high levels of benefit may 
be obtained by relatively cheap and simple steps; it is the 
intent of the word ``incremental'' that the agencies must apply 
cost/benefit analysis so as to assess the utility of each 
further increment of control or action, as well as ensuring 
that the action level finally chosen has benefits that outweigh 
its costs.
     The cost/benefit and the cost-effectiveness decisional 
criteria embodied in Section 3201(a) are made applicable by 
Section 3201(f) to actions under all other Federal legislation. 
The Section 3201(a) 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 elaborated risk assessment principles and 
procedures, and apply as additional decisional criteria the 
cost/benefit and cost-effectiveness certification requirements 
of Section 3201(a).
     When there is a conflict between the decisional criteria 
in Section 3201(a) and those decisional criteria otherwise 
applicable under the statute pursuant to which the rule is 
promulgated, or where there is explicit textual language in any 
other Federal statute prohibiting the consideration of the 
criteria set out in Section 3201(a), Section 3201(f)(1) 
provides that the decisional criteria in Section 3201(a) shall 
be used in place of those in the statute pursuant to which the 
rule is promulgated. In either case, however, the decisional 
criteria otherwise applicable will continue to apply to the 
extent not inconsistent with the Section 3201(a) criteria. By 
this means, the Committee intends to mold the ultimate 
decisional criteria for rulemaking applied under all such 
statutes to the requirements of Section 3201(a) with as little 
disruption to the otherwise applicable instructions by Congress 
in that statute or statutory program as is feasible. The 
reports to Congress required by Section 3201(h) should 
delineate any difficulties created by the operation of Section 
3201(f)(1), and allow this Committee to focus on any 
legislative changes necessary in existing statutes to allow 
reasoned decisionmaking to prevail more simply and easily in 
all of the Federal regulatory programs covered by this 
legislation.

                        Subtitle C--Peer Review

                    Sec. 3301. Peer Review Program.

     This section requires each 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 protection 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 exempts 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--Other provisions

                       Sec. 3401. Judicial review

     This section clarifies that judicial review shall be 
limited to the provisions of the Administrative Procedure Act. 
The availability of effective judicial review of an agency's 
regulatory impact analysis under Section 3201(a) is important 
if that analysis is to be a genuine element of the agency's 
procedural and substantive decisional process. For purposes of 
efficiency, the judicial review of the risk assessment and 
cost/benefit analyses contained in the regulatory impact 
analysis required under Section 3201(a) should proceed, on the 
basis of the whole record of the rulemaking (which will include 
the actions taken under Section 3201(a)), 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, of course, already 
subject to judicial review under the particular statute 
granting the agency authority to conduct the rulemaking. 
Section 3401 of Subtitle D clarifies that the procedures and 
decisional criteria 3201(a) shall be judicially reviewable, 
pursuant to the Administrative Procedure Act. This review 
should occur at the same time and in the same court that 
reviews agency findings under the statute granting the agency 
authority to conduct the rulemaking. Other than in the case of 
the ``major rule'' determination noted below, it is essential 
that judicial review be ``channeled'' so that the entire 
decision related to a rule, including both the procedures and 
decisional criteria under this legislation and the procedures 
and decisional criteria under the statute granting the agency 
the authority to conduct the rulemaking, be coordinated. For 
example, a ``major'' rule promulgated by EPA under the Clean 
Air Act would be subject to judicial review under Section 3401 
to determine whether the rule satisfied the decisional criteria 
of Section 3201(a), under Section 307(d)(9) of the Clean Air 
Act. Thus, the language of Section 3401 is intended to ensure 
time and effort are not wasted needlessly during judicial 
review because the proper coordination of that review was not 
established during passage of this legislation.
     The conduct of judicial review should, of course, proceed 
under the traditional standards of review established by 
Congress in the Administrative Procedure Act, as interpreted by 
the courts. It is essential, however, that the courts apply 
those standards of review in the way Congress intended, without 
undue deference to agency determinations. When conducting 
judicial review, the reviewing court should use the normal 
standards of review, but apply them carefully, as we note 
below, to assure that undue deference is not given to agency 
decisions.
     The reviewing court should affirm the agency's 
interpretation of the statute granting authority to promulgate 
the rule if, applying traditional principles of statutory 
construction, it finds that the interpretation is clearly the 
interpretation of the statute intended by Congress. If, 
applying traditional principles of statutory construction, the 
court finds that an interpretation other than the 
interpretation applied by the agency is clearly the 
interpretation of the statute intended by Congress, the 
reviewing court should find that the agency's interpretation is 
erroneous and contrary to law.
     If a reviewing court, applying established principles of 
statutory construction, finds that the statute gives the agency 
discretion to choose from among a range of permissible 
statutory constructions, the reviewing court shall apply the 
normal ``arbitrary and capricious'' and ``substantial evidence 
in the record'' standards of review, as appropriate. But, under 
the provisions of Section 3201(f)(2), the certification 
required under Section 3201(a) must be supported by substantial 
evidence in the rulemaking record. Further, the reviewing court 
should affirm the agency's interpretation where the record on 
review establishes that (1) the agency has correctly identified 
the range of permissible statutory constructions, (2) the 
interpretation chosen is one that is within that range, and (3) 
the agency has engaged in reasonable decisonmaking in 
determining that the interpretation it has chosen, rather than 
other permissible constructions of the statute, is reasonable 
because it is the one that maximizes net benefits to society.
    The importance of both the procedural and substantive 
requirements of Section 3201(a) is such that it is the 
intention of this Committee that a reviewing court shall set 
aside agency action that fails to satisfy those procedural 
requirements or decisional criteria.
    For similar reasons, it is essential that courts guard 
vigilantly against agency attempts to evade the requirements of 
Section 3201(a) by the promulgation of guidelines, guidance, 
criteria or general statements of interpretation which are 
declared by the agency not to be binding, and thus not subject 
to Section 3201(a) and to notice and comment rulemaking and 
judicial review at the time they are made public. Where such 
guidelines, guidance, criteria, or general statement of 
interpretation are applied in fact by either the Federal agency 
or by the states in such a way that they constitute ``de 
facto'' rules because they are given substantive effect in 
individual cases or other agency actions, whether they are said 
by the agency to be binding or not, they constitute ``an agency 
statement of general or particular applicability and future 
effect designed to implement, interpret, or prescribe law or 
policy'' under the definition of ``rule'' in Section 551(4) of 
the Administrative Procedure Act, and must be classified by 
courts as rules for all purposes. It is the intent of this 
Committee that agencies not be allowed to avoid the important 
Section 3201(a) requirements for reasoned decisionmaking by 
simple agency declarations that their guidelines, guidance, 
criteria or general statements of interpretation are not 
``binding.''

       Section 3402: Prioritization of threats and resources use.

    This section establishes a method of prioritizing risks to 
human health, safety, and the environment on the basis of the 
seriousness of the risks addressed and resources available to 
reduce such risks.

Cost of Implementation

    Title III of H.R. 9 does not authorize any additional 
appropriations for agencies to implement the provisions of this 
bill. First, it should be noted, the bill would not require any 
additional risk assessments other than those required by 
current law. Additionally, the following comments by Dr. John 
Graham, Director of the Harvard Center for Risk Analysis, 
regarding a $220 million estimate for EPA implementation during 
the Science Committee's January 31 legislative hearing, are 
additionally instructive:

          $220 million. Let's start, for the sake of argument, 
        and say that is absolutely correct. The Environmental 
        Protection Agency, it's roughly a $5 billion agency in 
        taxpayer costs, yet it imposes, on the private sector 
        of the economy and the states and localities $150 
        billion per year. For every dollar of EPA taxpayer 
        costs, that is $30 in external activity. Even if we 
        were to inadvertently double the size of EPA, if we 
        could reduce by 10% the $150 billion cost of EPA, it 
        would save $15 billion and only cost an extra $5 
        billion. So, when you are talking in millions of 
        dollars, you are in the noise level of this issue. This 
        is a massive regulatory program on the states and 
        localities and the economy of this country. We can 
        afford to do a little risk analysis to figure out how 
        to save some of that $150 billion . . . even if you 
        take the worst case possibility, as the agencies might 
        be inclined to do . . .
          ``. . . I think the idea of getting the Congressional 
        Budget Office for example to make some estimates of 
        this is fine, but with the process of doing that I 
        certainly hope they look at the possibility of actually 
        rearranging some of the existing personnel in EPA, 
        reducing, for example, the number of lawyers of the 
        U.S. Environmental Protection Agency and having a few 
        more of them invested in risk analysis, and maybe we 
        can do this without a substantial increase in the 
        overall size of the Environmental Protection Agency.

    It should also be noted for the record that the 
Congressional Budget Office cost estimate for H.R. 4306, the 
Risk Assessment Improvement Act of 1994, reported by the House 
Science, Space, and Technology Committee just last October, 
estimated the cost to the Federal government at only $15 
million total over five (5) years. That bill, while limited to 
EPA and otherwise less complete, would have required EPA to 
review existing guidelines with specified minimum contents for 
characterizing risks, and respond in the Federal Register to 
peer review comments. H.R. 4306 also included a study of 
comparative risk analysis.
    The Committee believes this legislation easily passes any 
cost/benefit analysis.

                         VI. OVERSIGHT FINDINGS

    Clause 2(l)(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 no 
oversight findings.

    VII. OVERSIGHT FINDINGS AND RECOMMENDATIONS OF THE COMMITTEE ON 
                    GOVERNMENT REFORM AND OVERSIGHT

    Clause 2(l)(3)(D) of rule XI requires each committee report 
to contain a summary of the oversight findings and 
recommendations made by the Government Reform and Oversight 
Committee pursuant to clause 4(c)(2) of rule X, whenever such 
findings have been timely submitted. The Committee on Science 
has received no such findings or recommendations from the 
Committee on Government Reform and Oversight.

                 VIII. BUDGET ANALYSIS AND PROJECTIONS

    This Act provides for no new authorization or budget 
authority or tax expenditures. Consequently, the provisions of 
Section 308(a) of the Congressional Budget Act are not 
applicable.

           IX. COST ESTIMATE AND CONGRESSIONAL BUDGET OFFICE


                                     U.S. Congress,
                               Congressional Budget Office,
                                 Washington, DC, February 15, 1995.
Hon. Robert S. Walker,
Chairman, Committee on Science,
U.S. 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).

               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 Science on February 8, 1995.
    4. Bill purpose: This title applies to all 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 government, or the private sector of at least $25 million 
annually. Subtitle B would apply to agency rules expected to 
have a direct or indirect cost at least $25 million annually, 
regardless of whether or not a risk assessment or 
characterization document is prepared.
    Subtitle A would require all 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.
    5. Estimated cost to the Federal Government: We estimate 
that enactment of this title would increase the cost of issuing 
and reviewing regulations by the major federal regulatory 
agencies by at least $250 million annually. 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 implementing research and training in 
risk assessment, as outlined in section 3107 of the bill. CBO 
has insufficient information at this time to estimate the cost 
impacts of this bill on all federal agencies, however we 
believe the major cost impacts would fall upon the agencies 
discussed below.
    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 on 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 environment, 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 for 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 1998. 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 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. Estimate comparison: On February 15, 1995, CBO prepared 
a cost estimate for Title III of H.R. 9, as ordered reported by 
the House Committee on Commerce on February 8, 1995.
    There are three major differences between the two versions 
of Title III. First, the Science Committee version would apply 
to all federal agencies that prepare risk assessment documents 
in connection with regulatory programs designed to protect 
human health, safety, or the environment; the Commerce 
Committee version would limit the application of Title III of 
the bill to 12 specified agencies. Second, the Science 
Committee version of the bill would not apply to permitting 
activities conducted by the EPA and DOI, while the Commerce 
Committee version would cover these activities. Finally, the 
Science Committee version does not include the petitioning 
process described in subtitle D of the Commerce Committee 
version of the bill. Under subtitle D of the Commerce version 
of Title III, individuals would be able to petition the covered 
agencies to address whether or not existing regulations comply 
with the principles of H.R. 9.
    CBO was not able to estimate the costs of applying Title 
III of H.R. 9 to permits issued by EPA and DOI or implementing 
a petitioning process under subtitle D, as required by the 
Commerce Committee's version of the bill. Such additional costs 
could be significant, but they would not apply to the Science 
Committee's version of the bill.
    By expanding the coverage of Title III of H.R. 9 beyond the 
12 agencies covered in the Commerce Committee version to 
include all federal agencies, the Science Committee version of 
the bill would increase the cost to the federal government of 
implementing this title. CBO does not have sufficient 
information at this time to estimate the cost of including all 
federal agencies under the provisions of Title III; however, we 
believe that most of the costs for complying with Title III 
would be incurred by the 12 agencies specified in the Commerce 
Committee version.
    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.

                         X. IMPACT ON INFLATION

    In accordance with rule XI, clause 2(l)(4) of the Rules of 
the House of Representatives, this legislation is assumed to 
have no inflationary effect on prices and costs in the 
operation of the national economy.

                      XI. CHANGES IN EXISTING LAW

    If enacted, this bill would make no change in existing law.

                     XII. COMMITTEE RECOMMENDATION

    On February 8, 1995, a quorum being present, the Committee 
on Science favorably reported the bill, as amended, by a voice 
vote.

  XIII. PROCEEDINGS FROM FULL COMMITTEE MARKUP OF TITLE III OF H.R. 9

                          Committee on Science

       full committee markup--february 8, 1995--amendment roster

Title III--Risk assessment and cost benefit analysis for new 
        regulations (H.R. 9, the Job Creation and Wage Enhancement Act 
        of 1995)

    Motion to adjourn the markup: Defeated: Y--22; N--25.
    Motion to order the measure reported, as amended: Agreed to 
by voice vote.
    Attendance Record.

------------------------------------------------------------------------
 No.        Sponsor            Description               Results        
------------------------------------------------------------------------
1     Mr. Walker.........  Amendment in the     Adopted.                
                            Nature of a                                 
                            Substitute for                              
                            Title III                                   
                            (Original text to                           
                            be used as the                              
                            markup vehicle).                            
                                                                        
------------------------------------------------------------------------
                               SUBTITLE A                               
                                                                        
------------------------------------------------------------------------
2     Placeholder--Being   Amendment will       Not offered.            
       drafted by LC.       limit application                           
                            of Title III to                             
                            the Environmental                           
                            Protection Agency.                          
3     Placeholder--Being   Amendment will       Not offered.            
       drafted by LC.       exclude USDA as                             
                            one of the federal                          
                            agencies covered                            
                            by the bill.                                
4     Placeholder--Being   Amendment will       Not offered.            
       drafted by LC.       limit application                           
                            of Title III to                             
                            specified covered                           
                            agencies, and a                             
                            definition of                               
                            covered agencies                            
                            to include:                                 
                            Environmental                               
                            Protection Agency,                          
                            Occupational                                
                            Safety and Health                           
                            Administration,                             
                            the Food and Drug                           
                            Administration.                             
5     Ms. McCarthy.......  New Sec. 3002--      Withdrawn.              
                            Savings Clause.                             
5a    Mr. Minge..........  Relief from the      Unanimous consent to    
                            burden of            modify amendment was   
                            unnecessary and      adopted.               
                            overly complex      Modified amendment      
                            regulations.         adopted by voice vote. 
5b    Mr. Brown..........  Sec. 3002--Savings   Defeated by a roll call 
                            Clause.              vote: Y--15; N--18.    
6     ...................  En bloc amendment    Not offered.            
                            page 36, line 11;                           
                            page 45, line 16.                           
6a    Mr. Brown..........  In section           Defeated by voice vote. 
                            3103(b)(1) (page                            
                            4, lines 12 and                             
                            13), strike ``in                            
                            connection with                             
                            Federal regulatory                          
                            programs'' and                              
                            insert ``in                                 
                            connection with                             
                            major rules''.                              
7     ...................  Amends Sec.          Not offered.            
                            3103(b)--Applicabi                          
                            lity.                                       
8     Mr. Davis..........  Amends Sec.          Withdrawn.              
                            3103(c)--Savings                            
                            Provisions.                                 
9     Mr. Davis..........  Clarifying           Adopted by a roll call  
                            amendment--In        vote: Y--36: N--9.     
                            section 3104(a),                            
                            insert ``and rely,                          
                            to the extent                               
                            available and                               
                            practicable, on                             
                            scientific                                  
                            findings'' after                            
                            ``inclusive of all                          
                            relevant data''.                            
10    Mr. Davis..........  Add at the end of    Withdrawn.              
                            Sec. 3104(b) a new                          
                            paragraph (3).                              
11    Mr. Davis..........  Amends Sec.          Adopted by voice vote.  
                            3104(b)(1)--Princi                          
                            ples.                                       
12    Mr. Barton.........  Mandates that        Substitute offered      
                            agencies cannot      instead of amendment   
                            adopt the risk       listed in the roster.  
                            recommendations of  Adopted by a roll call  
                            a non-U.S. based     vote: Y--36; N--11.    
                            entity without                              
                            performing their                            
                            own independent                             
                            risk assessment.                            
13    ...................  Sound Science:       Not offered.            
                            Comparisons.                                
13a   Mr. Olver..........  (Requested           Adopted by voice vote.  
                            unanimous consent                           
                            to break his                                
                            amendment down                              
                            into 2 separate                             
                            amendments.).                               
                           In section 3105(3)                           
                            (page 11, line                              
                            13), insert ``,                             
                            safety, or the                              
                            environment''                               
                            after ``human                               
                            health''                                    
13b   ...................  Amends Sec.          Defeated by voice vote. 
                            3105(3)--Compariso                          
                            ns of Risk.                                 
14    Mr. Barton.........  Establishes a        Withdrawn.              
                            petition process                            
                            with reasonable                             
                            deadlines for                               
                            targeted review                             
                            and revision of                             
                            existing                                    
                            regulations to                              
                            either comply with                          
                            the provisions of                           
                            Title III or                                
                            consider new                                
                            methodologies.                              
15    Mr. Roemer.........  Amends Sec. 3106--   Withdrawn.              
                            Guidelines, Plan                            
                            for Assessing New                           
                            Information, and                            
                            Report--by adding                           
                            a new subsection                            
                            (f).                                        
15a   Mr. Roemer.........  Amends Sec. 3107--   Adopted by voice vote.  
                            Research and                                
                            Training in Risk                            
                            Assessment.                                 
16    ...................  New Sec. 3107--      Not offered.            
                            Research and                                
                            Training in Risk                            
                            Assessment.                                 
17    ...................  Amends Sec. 3107--   Not offered.            
                            Definitions.                                
18    ...................  New Sec. 3108--      Redrafted.              
                            Study of                                    
                            Comparative Risk                            
                            Analysis.                                   
18a   Mr. Roemer.........  Amends Sec. 3107--   Adopted by voice vote.  
                            Study of                                    
                            Comparative Risk                            
                            Analysis.                                   
19    ...................  En bloc amendment    Not offered.            
                            ``Cost-Benefit/                             
                            Certification:                              
                            Substitute''.                               
      Mr. Tanner.........  End of Title III,    Withdrawn.              
                            Subtitle A,                                 
                            Section 3103--                              
                            Language with                               
                            regard to the                               
                            Department of                               
                            Defense.                                    
      Mr. Bartlett.......  Perfecting           Adopted by voice vote.  
                            amendment.                                  
      Mr. Olver..........  Strike pages 15,     Unanimous consent to add
                            lines 9 through 21   2 words to the text--  
                            and insert the       ``agreed to.''         
                            following: (3)      Defeated by voice vote. 
                            Best Estimates.                             
      Mr. Tanner.........  At the end of title  Adopted by voice vote.  
                            III, subtitle A,                            
                            section 3103,                               
                            subsection                                  
                            b(3)(a)(i) (page                            
                            7, at the end of                            
                            line 6, add the                             
                            following phrase:)                          
                            ``or to be                                  
                            necessary to                                
                            maintain military                           
                            readiness.''.                               
      Mr. Minge..........  En bloc amendment--  Defeated by voice vote. 
                            Exempts the U.S.                            
                            Dept. of                                    
                            Agriculture.                                
      Ms. Lofgren........  Risks to Particular  Defeated by voice vote. 
                            Groups.                                     
      Mr. Traficant......  Amendment to define  Withdrawn.              
                            ``non-United                                
                            States-based                                
                            entity''.                                   
------------------------------------------------------------------------
                               SUBTITLE B                               
------------------------------------------------------------------------
20    Mr. Davis..........  In section 3201(a),  Adopted by voice vote.  
                            insert after                                
                            paragraph (1) the                           
                            following new                               
                            paragraphs (2)                              
                            through (6) (and                            
                            redesignate                                 
                            subsequent                                  
                            paragraphs                                  
                            accordingly).                               
21    ...................  At the end of Sec.   Not offered.            
                            3201(a)(1),                                 
                            insert: ``In any                            
                            situation in which                          
                            benefits or costs                           
                            cannot be                                   
                            quantified,                                 
                            qualitative                                 
                            measures should be                          
                            provided''.                                 
22    Mr. Wamp...........  Amends Sec.          Adopted by voice vote.  
                            3201(a)(3).                                 
23    Mr. Davis..........  En bloc amendment--  Withdrawn.              
                            Sec. 3201(b) and                            
                            Sec. 3201(b) new                            
                            subsection (c)--                            
                            Limitation.                                 
24    ...................  Amends Sec. 3201 to  Not offered.            
                            request a ``Report                          
                            to Congress''.                              
25    ...................  Page 48, line 11,    Not offered.            
                            strike ``and                                
                            indirect''.                                 
26    Ms. McCarthy.......  En bloc amendment--  Not offered.            
                            page 48, 52.                                
27    Mr. Barton.........  New Sec. 3202--      Not offered.            
                            Judicial Review                             
                            Provides for                                
                            judicial review of                          
                            the cost-benefit                            
                            analyses mandated                           
                            by Title III. The                           
                            courts would be                             
                            able to declare                             
                            any agency action                           
                            unlawful if it                              
                            does not comply                             
                            with H.R. 9 and                             
                            could grant                                 
                            injunctive relief.                          
      Ms. Jackson Lee....  Further refinement   Withdrawn.              
                            of the definition                           
                            of the words                                
                            ``major rule.''.                            
      Mr. Olver..........  Strike paragraph     Defeated by a roll call 
                            (f)(1) of Sec.       vote; Y--12; N--31.    
                            3201.                                       
------------------------------------------------------------------------
                               SUBTITLE C                               
------------------------------------------------------------------------
28    Mr. Roemer.........  Amends Sec. 3301--   Substitute amendment    
                            Peer Review          offered instead of     
                            Program--(a)         amendment listed in the
                            through (f).         roster--Withdrawn.     
29    Mr. Doggett........  Amends Sec. 3301--   Defeated by a roll call 
                            Peer Review          vote; Y--16; N--26.    
                            Program.                                    
      Mr. Boehlert.......  En bloc amendment--  ........................
                            Establishes.                                
      Mrs. Morella.......  Prioritization of    Adopted by voice vote.  
                            Hazard Reduction.                           
                                                                        
------------------------------------------------------------------------
                               SUBTITLE D                               
                                                                        
------------------------------------------------------------------------
30    Mr. Geren..........  New Subtitle D--     Withdrawn.              
                            Agency Priorities.                          
                            Sec. 3401--Agency                           
                            Program Goals.                              
31    Mr. Roemer.........  New Subtitle D--     Not offered.            
                            Agency Priorities.                          
                            Sec. 3401--Agency                           
                            Program Goals.                              
32    Mr. Tanner.........  New Subtitle D--     Not offered.            
                            Other provisions.                           
                            Sec. 3401--                                 
                            National Security                           
                            Waiver.                                     
33    ...................  New Subtitle D--     Not offered.            
                            General                                     
                            Provisions. Sec.                            
                            3401--Judicial                              
                            Review.                                     
34    Mr. Doggett........  New Subtitle IV--    Defeated by a roll call 
                            Sunset. Sec. 3401--  vote: Y--13; N--29.    
                            Sunset. This title                          
                            shall cease to be                           
                            in effect on                                
                            January 3, 2000.                            
      Mr. Roemer.........  Amends Sec. 3401--   Defeated by a roll call 
                            Judicial Review.     vote: Y--16; N--27.    
      Mr. Barton.........  Subtitle D--Agency   Defeated by a division  
                            Priorities.          vote: Y--15; N-25.     
------------------------------------------------------------------------


                             ATTENDANCE RECORD COMMITTEE MARKUP OF H.R. 9, TITLE III                            
----------------------------------------------------------------------------------------------------------------
                                                                                                           Not  
  Rm.    Phone                          Name                         Present   Absent    Yea      Nay     Voting
----------------------------------------------------------------------------------------------------------------
2369..    52411  Mr. Walker, PA....................................        X                                    
2300..    56161  Mr. Brown, CA.....................................        X                                    
2332..    55101  Mr. Sensenbrenner, WI.............................        X                                    
2236..    56673  Mr. Hall, TX......................................        X                                    
2246..    53665  Mr. Boehlert, NY..................................        X                                    
2446..    55261  Mr. Traficant, OH.................................        X                                    
2159..    53515  Mr. Fawell, IL....................................        X                                    
2432..    52031  Mr. Hayes, LA.....................................        X                                    
106...    55341  Mrs. Morella, MD..................................        X                                    
1127..    54714  Mr. Tanner, TN....................................        X                                    
2452..    52011  Mr. Curt Weldon, PA...............................        X                                    
2448..    55071  Mr. Geren, TX.....................................        X                                    
2338..    52415  Mr. Rohrabacher, CA...............................        X                                    
407...    53915  Mr. Roemer, IN....................................        X                                    
2404..    56316  Mr. Schiff, NM....................................        X                                    
236...    54801  Mr. Cramer, AL....................................  .......        X                           
2264..    52002  Mr. Barton, TX....................................        X                                    
1410..    58171  Mr. Barcia, MI....................................        X                                    
1034..    51986  Mr. Calvert, CA...................................        X                                    
217...    56411  Mr. McHale, PA....................................        X                                    
1724..    51880  Mr. Baker, CA.....................................        X                                    
325...    58220  Ms. Harman, CA....................................        X                                    
322...    52721  Mr. Bartlett, MD..................................        X                                    
1123..    58885  Ms. Johnson, TX...................................        X                                    
1717..    53831  Mr. Ehlers, MI....................................        X                                    
1415..    52331  Mr. Minge, MN.....................................        X                                    
423...    53271  Mr. Wamp, TN......................................        X                                    
1027..    55335  Mr. Olver, MA.....................................        X                                    
216...    53671  Mr. Dave Weldon, FL...............................        X                                    
1039..    51313  Mr. Hastings, FL..................................        X                                    
1429..    55301  Mr. Graham, SC....................................        X                                    
1116..    56261  Ms. Rivers, MI....................................        X                                    
115...    52635  Mr. Salmon, AZ....................................        X                                    
1232..    54535  Ms. McCarthy, MO..................................        X                                    
415...    51492  Mr. Davis, VA.....................................        X                                    
1032..    55401  Mr. Ward, KY......................................        X                                    
417...    56565  Mr. Stockman, TX..................................        X                                    
118...    53072  Ms. Lofgren, CA...................................        X                                    
425...    52472  Mr. Gutknecht, MN.................................        X                                    
126...    54865  Mr. Doggett, TX...................................        X                                    
1216..    53601  Mrs. Seastrand, CA................................        X                                    
1218..    52135  Mr. Doyle, PA.....................................        X                                    
1319..    56216  Mr. Tiahrt, KS....................................        X                                    
1520..    53816  Ms. Jackson=Lee, TX...............................        X                                    
410...    52211  Mr. Largent, OK...................................        X                                    
1419..    52271  Mr. Luther, MN....................................        X                                    
114...    56831  Mr. Hilleary, TN..................................        X                                    
1114..    52311  Mrs. Cubin, WY....................................        X                                    
506...    55792  Mr. Foley, FL.....................................        X                                    
509...    51976  Mrs. Myrick, NC...................................        X                                    
                                                                    ------------------------------------        
                       Total.......................................       49        1                           
----------------------------------------------------------------------------------------------------------------


                                         MOTION TO ADJOURN BY MR. BROWN                                         
----------------------------------------------------------------------------------------------------------------
  Rm.    Phone                         Name                        Present   Absent    Yea      Nay    Notvoting
----------------------------------------------------------------------------------------------------------------
2369..    52411  Mr. Walker, PA..................................  .......  .......  .......        X           
2300..    56161  Mr. Brown, CA...................................  .......  .......        X  .......           
2332..    55101  Mr. Sensenbrenner, WI...........................  .......  .......  .......        X           
2236..    56673  Mr. Hall, TX....................................  .......  .......        X  .......           
2246..    53665  Mr. Boehlert, NY................................  .......  .......  .......  .......           
2446..    55261  Mr. Traficant, OH...............................  .......  .......        X  .......           
2159..    53515  Mr. Fawell, IL..................................  .......  .......  .......        X           
2432..    52031  Mr. Hayes, LA...................................  .......  .......        X  .......           
106...    55341  Mrs. Morella, MD................................  .......  .......  .......        X           
1127..    54714  Mr. Tanner, TN..................................  .......  .......        X  .......           
2452..    52011  Mr. Curt Weldon, PA.............................  .......  .......  .......        X           
2448..    55071  Mr. Geren, TX...................................  .......  .......        X  .......           
2338..    52415  Mr. Rohrabacher, CA.............................  .......  .......  .......        X           
407...    53915  Mr. Roemer, IN..................................  .......  .......        X  .......           
2404..    56316  Mr. Schiff, NM..................................  .......  .......  .......        X           
236...    54801  Mr. Cramer, AL..................................  .......  .......  .......  .......           
2264..    52002  Mr. Barton, TX..................................  .......  .......  .......        X           
1410..    58171  Mr. Barcia, MI..................................  .......  .......        X  .......           
1034..    51986  Mr. Calvert, CA.................................  .......  .......  .......        X           
217...    56411  Mr. McHale, PA..................................  .......  .......        X  .......           
1724..    51880  Mr. Baker, CA...................................  .......  .......  .......        X           
325...    58220  Ms. Harman, CA..................................  .......  .......        X  .......           
322...    52721  Mr. Bartlett, MD................................  .......  .......  .......        X           
1123..    58885  Ms. Johnson, TX.................................  .......  .......        X  .......           
1717..    53831  Mr. Ehlers, MI..................................  .......  .......  .......  .......           
1415..    52331  Mr. Minge, MN...................................  .......  .......        X  .......           
423...    53271  Mr. Wamp, TN....................................  .......  .......  .......        X           
1027..    55335  Mr. Olver, MA...................................  .......  .......        X  .......           
216...    53671  Mr. Dave Weldon, FL.............................  .......  .......  .......        X           
1039..    51313  Mr. Hastings, FL................................  .......  .......        X  .......           
1429..    55301  Mr. Graham, SC..................................  .......  .......  .......        X           
1116..    56261  Ms. Rivers, MI..................................  .......  .......        X  .......           
115...    52635  Mr. Salmon, AZ..................................  .......  .......  .......        X           
1232..    54535  Ms. McCarthy, MO................................  .......  .......        X  .......           
415...    51492  Mr. Davis, VA...................................  .......  .......  .......        X           
1032..    55401  Mr. Ward, KY....................................  .......  .......        X  .......           
417...    56565  Mr. Stockman, TX................................  .......  .......  .......        X           
118...    53072  Ms. Lofgren, CA.................................  .......  .......        X  .......           
425...    52472  Mr. Gutknecht, MN...............................  .......  .......  .......        X           
126...    54865  Mr. Doggett, TX.................................  .......  .......        X  .......           
1216..    53601  Mrs. Seastrand, CA..............................  .......  .......  .......        X           
1218..    52135  Mr. Doyle, PA...................................  .......  .......        X  .......           
1319..    56216  Mr. Tiahrt, KS..................................  .......  .......  .......        X           
1520..    53816  Ms. Jackson-Lee, TX.............................  .......  .......        X  .......           
410...    52211  Mr. Largent, OK.................................  .......  .......  .......        X           
1419..    52271  Mr. Luther, MN..................................  .......  .......        X  .......           
114...    56831  Mr. Hilleary, TN................................  .......  .......  .......        X           
1114..    52311  Mrs. Cubin, WY..................................  .......  .......  .......        X           
506...    55792  Mr. Foley, FL...................................  .......  .......  .......        X           
509...    51976  Mrs. Myrick, NC.................................  .......  .......  .......        X           
                                                                  ------------------------------------          
                       Total.....................................  .......  .......       22       25           
----------------------------------------------------------------------------------------------------------------

                        Original Markup Vehicle

    [H.R. 9, The Job Creation and Wage Enhancement Act of 
1995.--Title III, referred to the Committee on Science and, in 
addition, to the Committees on Commerce and Government Reform 
and Oversight--pages 33-52.]

     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.

             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 (2), 
        this title applies to all risk assessments and risk 
        characterizations prepared by, or on behalf of, any 
        Federal agency in connection with Federal regulatory 
        programs designed to protect human health, safety, or 
        the environment.
          (2) Exceptions.--(A) This title does not apply to 
        risk assessments or risk characterizations performed 
        with respect to either of the following:
                  (i) A situation that the head of the agency 
                considers to be an emergency.
                  (ii) A screening analysis, including a 
                screening analysis for purposes of product 
                regulation, product reregistration, or 
                premanufacturing notices.
          (B) No analysis shall be treated as a screening 
        analysis for purposes of subparagraph (A) if the 
        results of such analyses are used either--
                  (i) as the basis for imposing restrictions on 
                substances or activities, or
                  (ii) to characterize a positive finding of 
                risks from substances or activities in any 
                final agency document made available to the 
                general public.
          (3) Labels.--This title shall not apply to any food, 
        drug, or other product label or to any risk 
        characterization appearing on any such label.
  (c) Savings Provisions.--Nothing in this subtitle shall be 
construed to modify any statutory standard or 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 Federal agency shall apply 
the principles set forth in subsection (b) when preparing risk 
assessments in order to assure that such risk assessments 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 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 
risk assessments are as follows:
          (1) When assessing human health risks, a risk 
        assessment shall consider and discuss 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 assessment shall include discussion of possible 
        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 risk assessment involves selection of any 
        significant assumption, inference, or model, the 
        Federal agency preparing the assessment shall--
                  (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.

SEC. 3105. PRINCIPLES FOR RISK CHARACTERIZATION AND COMMUNICATION.

  In characterizing risk in any risk assessment document, 
regulatory proposal or decision, report to Congress, or other 
document which is made available to the public, each 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 department, 
                agency, or instrumentality); and
                  (B) a statement of the reasonable range of 
                scientific uncertainties.
        In addition to such best estimate or estimates, the 
        Federal agency may present plausible upper-bound or 
        conservative estimates in conjunction with plausible 
        lower bounds estimates. Where appropriate, the 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 Federal agency shall provide 
        descriptions of the distribution and probability of 
        risk estimates to reflect differences in exposure 
        variability in populations and uncertainties.
          (2) Exposure scenarios.--The 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 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. The statement shall identify relevant 
        distinctions among categories of risk and limitations 
        to comparisons.
          (4) Substitution risks.--When a Federal agency 
        provides a risk assessment or risk characterization for 
        a proposed or final regulatory action, such assessment 
        or characterization shall include a statement of any 
        significant 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 Federal agency provides a public 
                comment period with respect to a risk 
                assessment or regulation,
                  (B) a commenter provides a risk assessment, 
                and a summary of results of such risk 
                assessment, and
                  (C) such risk assessment is consistent with 
                the principles and the guidance provided under 
                this subtitle,
        the agency shall present such summary in connection 
        with the presentation of the agency's risk assessment 
        or the regulation.

SEC. 3106. GUIDELINES, PLAN FOR ASSESSING NEW INFORMATION, AND REPORT.

  (a) Guidelines.--Within 15 months after the date of enactment 
of this subtitle, 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. In addition, such guidelines shall include guidance on 
at least the following subjects: criteria for scaling animal 
studies to assess risks to human health; use of different types 
of dose-response models; thresholds; definitions, use, and 
interpretations of the maximum tolerated dose; weighting of 
evidence with respect to extrapolating human health risks from 
sensitive species; evaluation of benign tumors, and evaluation 
of different human health endpoints.
  (b) Plan.--Within 18 months after the date of enactment of 
this subtitle, each Federal agency shall publish a plan to 
review and revise any risk assessment published prior to the 
expiration of such 18-month period if the agency determines 
that significant new information or methodologies are available 
that could significantly alter the results of the prior risk 
assessment. 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 revision of 
risk assessments based on factors such Federal agency considers 
appropriate.
  (c) Report.--Within 3 years after the enactment of this 
subtitle, each 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).
  (d) Public Comment and Consultation.--The guidelines, plan 
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.
  (e) Review.--The President shall review the guidelines 
published under this section at least every 4 years.

SEC. 3107. DEFINITIONS.

  For purposes of this subtitle:
          (1) Risk assessment.--The term ``risk assessment'' 
        means the process of identifying hazards and 
        quantifying or describing the degree of toxicity, 
        exposure, or other risk they pose for exposed 
        individuals, populations, or resources. Such term also 
        refers to the document containing the explanation of 
        how the assessment process has been applied to an 
        individual substance, activity, or condition.
          (2) Risk characterization.--The term ``risk 
        characterization'' means that element of a risk 
        assessment that involves presentation of the degree of 
        risk in any regulatory proposal or decision, report to 
        Congress, or other document which is made available to 
        the public. The term includes discussions of 
        uncertainties, conflicting data, estimates, 
        extrapolations, inferences, and opinions.
          (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 increased risk to human 
        health, safety, or the environment from a regulatory 
        option designed to decrease other risks.
          (5) Federal agency.--The term ``Federal agency'' 
        means an executive department, military department, or 
        independent establishment as defined in part I of title 
        5 of the United States Code, except that such term also 
        includes the Office of Technology Assessment.

       Subtitle B--Analysis of Risk Reduction Benefits and Costs

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

  (a) In General.--Except as provided in subsection (b), the 
President shall require each executive branch 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.
          (2) For each such proposed or promulgated rule, to 
        the extent feasible, 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.
          (3) For each such proposed or promulgated rule, a 
        statement of other human health risks potentially posed 
        by implementing or complying with the regulatory 
        alternatives, including substitution risks.
          (4) For each final rule, an assessment of the costs 
        and risk reduction or other benefits associated with 
        implementation of, and compliance with, the rule.
          (5) For each final rule, a certification by the head 
        of the agency of each of the following:
                  (A) A certification that the assessment under 
                paragraph (4) is based on an objective and 
                unbiased scientific and economic evaluation of 
                all significant and relevant information 
                provided to the agency by interested parties 
                relating to the costs, risks, and risk 
                reduction or other benefits addressed by the 
                rule. Such information shall have been 
                subjected to peer review to the extent required 
                by section 3301.
                  (B) A certification that the rule will 
                substantially advance the purpose of protecting 
                human health or the environment, as applicable, 
                against the risk addressed by the rule.
                  (C) A certification that the rule will 
                produce benefits to human health or the 
                environment that will justify the costs 
                incurred by local and State governments, the 
                Federal Government, and other public and 
                private entities as a result of implementation 
                of and compliance with the rule, as determined 
                under paragraph (1).
                  (D) A certification that there is no 
                regulatory alternative that is allowed by the 
                statute under which the regulation is 
                promulgated that would achieve an equivalent 
                reduction in risk in a more cost-effective 
                manner, along with a brief explanation of why 
                other regulatory alternatives that were 
                considered by the head of the agency were found 
                to be less cost-effective.
  (b) Publication.--For each major rule referred to in 
subsection (a) the head of each 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) of this section.
  (c) Definitions.--For purposes of this section:
          (1) Costs.--The term ``costs'' includes the direct 
        and indirect costs to the United States government, 
        costs to State and local governments, and costs to the 
        private sector, of implementing and complying with a 
        regulatory action.
          (2) Major rule.-- The term ``major rule'' means any 
        regulation that is likely to result in one or more of 
        the following:
                  (A) An annual effect on the economy of 
                $25,000,000 or more.
                  (B) A major increase in costs or prices for 
                consumers, individual industries, Federal, 
                State, or local government agencies, or 
                geographic regions.
                  (C) Significant adverse effects on 
                competition, employment, investment, 
                productivity, innovation, or on the ability of 
                United States-based enterprises to compete with 
                foreign-based enterprises in domestic or export 
                markets.

                        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 Federal 
agency shall develop a systematic program for peer review of 
risk assessments 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 
        who are 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 merely because 
        they represent entities that may have a potential 
        interest in the outcome, provided that interest is 
        fully disclosed to the agency; and
          (4) shall provide open opportunity to become part of 
        a peer review panel at a minimum by soliciting 
        nominations through a Federal Register announcement.
  (b) Requirement for Peer Review.--Each Federal agency shall 
provide for peer review of scientific and economic information 
used for purposes of any evaluation under section 3201(a)(5)(A) 
or for purposes of any significant risk or cost assessment 
prepared in connection with a major rule. In addition, the 
Director of the Office of Management and Budget shall order 
that peer review be provided for any major risk assessment or 
cost assessment that may have a significant impact on public 
policy decisions.
  (c) Contents.--
          (1) In general.--Each peer review under this section 
        shall include a report to the Federal agency concerned 
        with respect to each of the following:
                  (A) An evaluation of the technical, 
                scientific, and economic merit of the data and 
                methods used for the assessment and analysis.
                  (B) A list of any considerations that were 
                not taken into account in the assessment and 
                analysis, but were considered appropriated by a 
                majority of the members of the peer review 
                panel.
                  (C) A discussion of the methodology used for 
                the assessment and analysis.
          (2) Comments and appendix.--Each peer review report 
        under this subsection shall include--
                  (A) all comments supported by a majority of 
                the members of the peer review panel submitting 
                the report; and
                  (B) an appendix which sets forth the 
                dissenting opinions that any peer review panel 
                member wants to express.
          (3) Separation of assessments.--Peer review of human 
        health, safety, environmental, and economic assessments 
        may be separated for purpose of this subtitle.
  (d) Response to Peer Review.--The head of the Federal agency 
shall provide a written response to all significant peer review 
comments.
  (e) 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.
  (f) 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.
  (g) National Panels.--The President shall appoint National 
Peer Review Panels to annually review the risk assessment and 
cost assessment practices of each 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.
  (h) Major Rule Defined.--For purposes of this section, the 
term ``major rule'' has the same meaning as provided by section 
3201(c) except that ``$100,000,000'' shall be substituted for 
``$25,000,000''.

 Amendment in the Nature of a Substitute for Title III Offered By Mr. 
                                 Walker

    Page 33, strike line 6 and all that follows through page 
52, line 13, 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 costreasonable 
        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.

             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, or used by, any Federal agency in connection with 
        Federal programs designed to protect human health, 
        safety, and 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 
        included in, or in the administrative record for, each 
        of 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) Any proposed or final regulatory 
                decision relating to decontamination or other 
                clean-up plans for a facility.
                  (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 terms also include 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) The terms ``significant risk assessment 
        document'' and ``significant risk characterization 
        document'' also include such risk assessment and risk 
        characterization documents of agency as--
                  (i) are provided by an agency to the public 
                and are likely to result in an annual effect on 
                the economy of $25,000,000 or more; or
                  (ii) the head of the agency may identify, in 
                consultation with the Director of the Office of 
                Management and Budget.
          (C) Within 15 months after the date of the enactment 
        of this Act, each agency administering programs 
        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 to be considered 
        significant risk assessment documents or significant 
        risk characterization documents for purposes of this 
        subtitle. In establishing such categories, the head of 
        the agency shall consider--
                  (i) the benefits of consistent compliance by 
                documents in the categories concerned with the 
                principles under sections 3104 and 3105;
                  (ii) the administrative burdens of including 
                documents in various categories concerned with 
                the principles under section 3104 and 3105;
                  (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.--(A) This subtitle does not apply to 
        the following:
                  (i) A situation that the head of the agency 
                considers to be an emergency.
                  (ii) A screening analysis, where 
                appropriately labeled as such, including a 
                screening analysis for purposes of product 
                regulation, or premanufacturing notices.
                  (iii) 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 agency prior to use.
                  (iv) Any health, safety, or environmental 
                inspections or individual facility permitting 
                actions.
          (B) No analysis shall be treated as a screening 
        analysis for purposes of subparagraph (A) if the 
        results of such analyses are used as the basis for 
        imposing restrictions on substances or activities.
    (c) Savings Provisions.--The provisions of this subtitle 
shall be supplemental to any other provisions of law relating 
to risk assessments and risk characterizations, except that 
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 Federal agency shall 
apply the principles set forth in subsection (b) in order to 
assure that risk assessments 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 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 are as 
follows:
          (1) When discussing human health risks, a significant 
        risk assessment document shall contain a discussion 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 
        include discussion of possible 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, a Federal agency shall--
                  (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.

SEC. 3105. PRINCIPLES FOR RISK CHARACTERIZATION AND COMMUNICATION.

    In a significant risk assessment document, each Federal 
agency shall assure compliance with each of the following:
          (1) Estimates of risk.--The risk characterization 
        shall describe the populations or natural resources 
        which are the subject of the risk assessment. If a 
        numerical estimate of risk is provided, the agency 
        shall, to extent feasible, 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 department, 
                agency, or instrumentality); and
                  (B) a statement of the reasonable range of 
                scientific uncertainties.
        In addition to such best estimate or estimates, the 
        risk characterization may present plausible upper-bound 
        or conservative estimates in conjunction with plausible 
        lower bounds estimates. Where appropriate, the risk 
        characterization 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 characterization 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 risk 
        characterization 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.--The 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 
        greater and lesser risks that are familiar to and 
        routinely encountered by the general public as well as 
        other risks. The statement shall identify relevant 
        distinctions among categories of risk and limitations 
        to comparisons.
          (4) Substitution risks.--Each significant risk 
        assessment or risk characterization document referred 
        to in section 3103(b) shall include a statement of any 
        significant substitution risks to human health, where 
        information on such risks is available to the agency.
          (5) Summaries of other risk estimates.--If--
                  (A) a Federal agency provides a public 
                comment period with respect to a significant 
                risk assessment document, or
                  (B) a commenter provides a significant risk 
                assessment document, and a summary of results 
                of such risk assessment, and
                  (C) such risk assessment is consistent with 
                the principles and the guidance provided under 
                this subtitle,
        the agency shall present such summary in connection 
        with the presentation of the agency's risk assessment 
        document, risk characterization document, or the 
        regulation. 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, PLAN FOR ASSESSING NEW INFORMATION, AND REPORT.

    (a) Guidelines.--Within 15 months after the date of 
enactment of this subtitle, 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. In addition, such 
guidelines shall include guidance on at least the following 
subjects: criteria for scaling animal studies to assess risks 
to human health; use of different types of dose-response 
models; thresholds; definitions, use, and interpretations of 
the maximum tolerated dose; weighting of evidence with respect 
to extrapolating human health risks from sensitive species; 
evaluation of benign tumors, and evaluation of different human 
health endpoints.
    (b) Plan.--Within 18 months after the date of the enactment 
of this subtitle, each 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 head of the agency 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 final plan shall 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 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.
    (c) Report.--Within 3 years after the enactment of this 
subtitle, each 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).
    (d) Public Comment and Consultation.--The guidelines, plan 
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.
    (e) Review.--The President shall review and, where 
appropriate, revise the guidelines published under this section 
at least every 4 years.

SEC. 3107. 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.
          (3) Best estimate.--The term ``best estimate'' means 
        an estimate which 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) Federal agency.--As used in this title, the term 
        ``Federal agency'' means an executive department, 
        military department, or independent establishment as 
        defined in part I of title 5 of the United States Code, 
        except that such term also includes the Office of 
        Technology Assessment.
          (6) Document.--The term ``document'' includes 
        material stored in electronic or digital form.
          (7) Prepare.--As used in this title, the term 
        ``prepare'', when referring to risk assessment, risk 
        characterizations, or analyses of risk reduction 
        benefits and costs, includes both the preparation or 
        use of such a document by an agency.

       Subtitle B--Analysis of Risk Reduction Benefits and Costs

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

    (a) In General.--Except as provided in section 3103(b)(3) 
and subsection (d), the President shall require each Federal 
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 comparison of any human health, 
        safety, or environmental risks addressed by the 
        regulatory alternatives to other greater or lesser 
        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.
          (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.
          (4) For each final rule, a certification by the head 
        of the agency of each of the following:
                  (A) A certification that the assessments 
                under subtitle B are 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.
                  (B) A certification that incremental risk 
                reduction or other benefits of any regulatory 
                or non-regulatory option chosen will be likely 
                to justify, and be reasonably related to, the 
                incremental costs incurred by State, local, and 
                tribal governments, the Federal Government, and 
                other public and private entities.
                  (C) A certification that no regulatory or 
                non-regulatory alternative considered by the 
                agency or proposed to the agency during or 
                prior to the public 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 objective of the regulation, 
                along with a brief explanation of why other 
                regulatory or non-regulatory alternatives that 
                were considered by or proposed to the agency 
                were found to be less cost-effective or less 
                flexible.
    (b) Publication.--For each major rule referred to in 
subsection (a) each agency shall publish in a clear and concise 
manner in the Federal Register along with the proposed and 
final regulation, or otherwise make publicly available, the 
information required to be prepared under subsection (a) of 
this section. The agency shall publish in the Federal Register, 
along with the final regulation, the certifications required by 
subsection (a).
    (c) Definitions.--For purposes of this section:
          (1) Costs.--The term ``costs'' includes the direct 
        and indirect costs to the United States Government, to 
        State, local, and tribal governments, and to private-
        sector prices, wage earners, consumers, and the 
        economy, of implementing and complying with a 
        regulatory action.
          (2) Benefit.--The term ``benefit'' means the 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.
    (d) Substances and Products.--This section and section 3301 
do not apply to any action authorizing or approving any 
individual substance or product. No government action shall be 
treated as authorizing or approving any individual substance or 
product for the purposes of this subsection if the results of 
such action are used as the basis of imposing bans, 
cancellations, suspensions, or revocations of any previously 
marketed or approved substance or product.
    (e) Cost/Benefit Analysis Guidance.--Within 15 months after 
the date of the enactment of this title, the Office of 
Management and Budget shall issue regulations for Federal 
agencies, consistent with this title, governing the development 
and preparation of analyses of risk reduction benefits and 
costs.
    (f) Applicability.--
          (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) Substantial evidence.--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) are met and the 
        certifications required therein are supported by 
        substantial evidence of the rulemaking record.
    (g) Transitional Plan.--Within 180 days after the date of 
the enactment of this title, Federal agencies, with guidance 
from the Office of Management and Budget, shall develop 
transition plans to assist the agencies, the public, and the 
regulated community in the implementation of this title, 
including any new requirements or procedures needed to 
supplement prior agency practice.
    (h) Reports to Congress.--Federal agencies shall report to 
Congress annually whether their implementation of this title 
has created any significant regulatory or program management 
complications resulting from any differences between the 
certification provisions of this title and the decisional 
criteria for rulemaking that otherwise would have been 
applicable under other statute.

                        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 
Federal agency shall develop a systematic program for peer 
review of risk assessments 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 Federal agency shall 
provide for peer review of any evaluation under section 
3201(a)(5)(A) or for purposes of any significant risk 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) Contents.--
          (1) In general.--Each peer review under this section 
        shall include a report to the Federal agency concerned 
        with respect to each of the following:
                  (A) An evaluation of the technical, 
                scientific, and economic merit of the data and 
                methods used for the assessment and analysis.
                  (B) A list of any considerations that were 
                not taken into account in the assessment and 
                analysis, but were considered appropriate by a 
                majority of the members of the peer review 
                panel.
                  (C) A discussion of the methodology used for 
                the assessment and analysis.
          (2) Comments and appendix.--Each peer review report 
        under this subsection shall include--
                  (A) all comments supported by a majority of 
                the members of the peer review panel submitting 
                the report; and
                  (B) an appendix which sets forth the 
                dissenting opinions that any peer review panel 
                member wants to express.
          (3) Separation of assessments.--Peer review of human 
        health, safety, environmental, and economic assessments 
        may be separated for purpose of this subtitle.
    (d) Response to Peer Review.--The head of the Federal 
agency shall provide a written response to all significant peer 
review comments.
    (e) 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.
    (f) 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.
    (g) National Panels.--The President shall appoint National 
Peer Review Panels to annually review the risk assessment and 
cost assessment practices of each 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--Other Provisions

SEC. 3401. JUDICIAL REVIEW.

    Compliance with the requirements of this title shall be 
reviewable pursuant to the Administrative Procedures Act.

                          Amendment To H.R. 9

    [Placeholder: Text being drafted by Leg Counsel. Amendment 
will limit applications of Title III to the Environmental 
Protection Agency.]

                Amendment To H.R. 9 Offered by Mr. Minge

    [Placeholder: Text being drafted by Legislative counsel. 
Amendment will exclude USDA as one of the federal agencies 
covered by the bill.]
    [Placeholder: Text being drafted by Leg Counsel. Amendment 
will limit application of Title III to specified covered 
agencies, and a definition of covered agencies to include: 
Environmental Protection Agency, Occupational Safety and Health 
Administration, the Food and Drug Administration, perhaps 
others.]

              Amendment To H.R. 9 Offered By Ms. McCarthy

SEC. 3002. SAVINGS CLAUSE.

    Nothing in this title shall create an obligation or burden 
on any State or local government of change of affect any State 
law or regulatory requirement or otherwise impose any financial 
burden any State or local government.

  Amendment Offered by Mr. Minge To the Amendment in the Nature of a 
             Substitute For Title III Offered by Mr. Walker

    At the end of section 3001 (page 3, after line 4), add the 
following new paragraph:
          (6) Although risk assessment is one important method 
        to improve regulator decision-making, other approaches 
        to secure prompt relief from the burden of unnecessary 
        and overly complex regulations will also be necessary. 
        [The productivity and competitiveness of American 
        businesses will be enhanced by implementing a variety 
        of measures to simplify Federal regulatory requirements 
        and reduce transaction costs.]

 Amendment Offered by Mr. Brown of California To the Amendment in the 
       Nature of a Substitute For Title III Offered By Mr. Walker

    After section 3001 (page 3, after line 4), add the 
following new section:

SEC. 3002. SAVINGS CLAUSE.

    Nothing in this title shall be construed to modify any 
statutory standard or requirement designed to protect health, 
safety, or the environment or to change the factors that an 
agency is authorized to consider in promulgating a regulation 
pursuant to any statute, or shall delay any action required to 
meet a deadline imposed by a statute or a court.

                                   AMENDMENT OFFERED BY MR. BROWN SECTION 3002                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                           Not  
  Rm.    Phone                          Name                         Present   Absent    Yea      Nay     Voting
----------------------------------------------------------------------------------------------------------------
2369..    52411  Mr. Walker, PA....................................  .......  .......  .......        X         
2300..    56161  Mr. Brown, CA.....................................  .......  .......        X  .......         
2332..    55101  Mr. Sensenbrenner, WI.............................  .......  .......  .......  .......         
2236..    56673  Mr. Hall, TX......................................  .......  .......  .......  .......         
2246..    53665  Mr. Boehlert, NY..................................  .......  .......  .......  .......         
2446..    55261  Mr. Traficant, OH.................................  .......  .......        X  .......         
2159..    53515  Mr. Fawell, IL....................................  .......  .......  .......        X         
2432..    52031  Mr. Hayes, LA.....................................  .......  .......  .......  .......         
106...    55341  Mrs. Morella, MD..................................  .......  .......  .......        X         
1127..    54714  Mr. Tanner, TN....................................  .......  .......        X  .......         
2452..    52011  Mr. Curt Weldon, PA...............................  .......  .......  .......        X         
2448..    55071  Mr. Geren, TX.....................................  .......  .......  .......  .......         
2338..    52415  Mr. Rohrabacher, CA...............................  .......  .......  .......        X         
407...    53915  Mr. Roemer, IN....................................  .......  .......        X  .......         
2404..    56316  Mr. Schiff, NM....................................  .......  .......  .......        X         
236...    54801  Mr. Cramer, AL....................................  .......  .......  .......  .......         
2264..    52002  Mr. Barton, TX....................................  .......  .......  .......        X         
1410..    58171  Mr. Barcia, MI....................................  .......  .......  .......  .......         
1034..    51986  Mr. Calvert, CA...................................  .......  .......  .......        X         
217...    56411  Mr. McHale, PA....................................  .......  .......        X  .......         
1724..    51880  Mr. Baker, CA.....................................  .......  .......  .......        X         
325...    58220  Ms. Harman, CA....................................  .......  .......  .......  .......         
322...    52721  Mr. Bartlett, MD..................................  .......  .......  .......        X         
1123..    58885  Ms. Johnson, TX...................................  .......  .......        X  .......         
1717..    53831  Mr. Ehlers, MI....................................  .......  .......  .......        X         
1415..    52331  Mr. Minge, MN.....................................  .......  .......        X  .......         
423...    53271  Mr. Wamp, TN......................................  .......  .......  .......        X         
1027..    55335  Mr. Olver, MA.....................................  .......  .......        X  .......         
216...    53671  Mr. Dave Weldon, FL...............................  .......  .......  .......        X         
1039..    51313  Mr. Hastings, FL..................................  .......  .......  .......  .......         
1429..    55301  Mr. Graham, SC....................................  .......  .......  .......        X         
1116..    56261  Ms. Rivers, MI....................................  .......  .......        X  .......         
115...    52635  Mr. Salmon, AZ....................................  .......  .......  .......        X         
1232..    54535  Ms. McCarthy, MO..................................  .......  .......        X  .......         
415...    51492  Mr. Davis, VA.....................................  .......  .......  .......        X         
1032..    55401  Mr. Ward, KY......................................  .......  .......  .......  .......         
417...    56565  Mr. Stockman, TX..................................  .......  .......  .......  .......         
118...    53072  Ms. Lofgren, CA...................................  .......  .......  .......  .......         
425...    52472  Mr. Gutknecht, MN.................................  .......  .......  .......  .......         
126...    54865  Mr. Doggett, TX...................................  .......  .......        X  .......         
1216..    53601  Mrs. Seastrand, CA................................  .......  .......  .......  .......         
1218..    52135  Mr. Doyle, PA.....................................  .......  .......        X  .......         
1319..    56216  Mr. Tiahrt, KS....................................  .......  .......  .......        X         
1520..    53816  Ms. Jackson-Lee, TX...............................  .......  .......        X  .......         
410...    52211  Mr. Largent, OK...................................  .......  .......  .......        X         
1419..    52271  Mr. Luther, MN....................................  .......  .......        X  .......         
114...    56831  Mr. Hilleary, TN..................................  .......  .......  .......  .......         
1114..    52311  Mrs. Cubin, WY....................................  .......  .......  .......  .......         
506...    55792  Mr. Foley, FL.....................................  .......  .......  .......  .......         
509...    51976  Mrs. Myrick, NC...................................  .......  .......  .......  .......         
                                                                    ------------------------------------        
                       Total.......................................  .......  .......       15       18         
----------------------------------------------------------------------------------------------------------------

                   Amendment To H.R. 9 Offered by   

    Page 36, line 11, strike ``in connection with Federal 
regulatory programs'' and insert in lieu thereof ``in 
connection with major rules.''
    Page 45, line 16, insert at the end of section 3107 the 
following new subsection:
          ``(6) Major rule--The term ``major rule'' means any 
        regulation that is likely to result in an annual effect 
        on the economy of $100,000,000 or more.''

 Amendment Offered by Mr. Brown of California to the Amendment in the 
              Nature of a Substitute Offered by Mr. Walker

    In section 3103(b)(1) (page 4, lines 12 and 13), strike 
``in connection with Federal regulatory programs'' and insert 
``in connection with major rules''.

                 Amendment to H.R. 9 Offered By Mr.   

    In section 3103(b)(2)(i), strike the period and insert ``or 
where the head of the agency determines that compliance with 
this subtitle could endanger human health, safety, or the 
environment,''.

                Amendment To H.R. 9 Offered By Mr. Davis

    In section 3103(c), strike ``Nothing in this subtitle shall 
be construed to modify any statutory standard or requirement 
designed to protect health, safety, or the environment.''.

                Amendment To H.R. 9 Offered By Mr. Davis

    In section 3104(a), insert ``and rely, to the extent 
available and practicable, on scientific findings'' after 
``inclusive of all relevant data''.

                                 AMENDMENT OFFERED BY MR. DAVIS TO SECTION 3104                                 
----------------------------------------------------------------------------------------------------------------
  Rm.    Phone                         Name                        Present   Absent    Yea      Nay    NotVoting
----------------------------------------------------------------------------------------------------------------
2369..    52411  Mr. Walker, PA..................................  .......  .......        X  .......           
2300..    56161  Mr. Brown, CA...................................  .......  .......  .......        X           
2332..    55101  Mr. Sensenbrenner, WI...........................  .......  .......        X  .......           
2236..    56673  Mr. Hall, TX....................................  .......  .......        X  .......           
2246..    53665  Mr. Boehlert, NY................................  .......  .......        X  .......           
2446..    55261  Mr. Traficant, OH...............................  .......  .......        X  .......           
2159..    53515  Mr. Fawell, IL..................................  .......  .......        X  .......           
2432..    52031  Mr. Hayes, LA...................................  .......  .......        X  .......           
106...    55341  Mrs. Morella, MD................................  .......  .......        X  .......           
1127..    54714  Mr. Tanner, TN..................................  .......  .......        X  .......           
2452..    52011  Mr. Curt Weldon, PA.............................  .......  .......        X  .......           
2448..    55071  Mr. Geren, TX...................................  .......  .......  .......  .......           
2338..    52415  Mr. Rohrabacher, CA.............................  .......  .......        X  .......           
407...    53915  Mr. Roemer, IN..................................  .......  .......        X  .......           
2404..    56316  Mr. Schiff, NM..................................  .......  .......        X  .......           
236...    54801  Mr. Cramer, AL..................................  .......  .......  .......  .......           
2264..    52002  Mr. Barton, TX..................................  .......  .......        X  .......           
1410..    58171  Mr. Barcia, MI..................................  .......  .......        X  .......           
1034..    51986  Mr. Calvert, CA.................................  .......  .......  .......  .......           
217...    56411  Mr. McHale, PA..................................  .......  .......        X  .......           
1724..    51880  Mr. Baker, CA...................................  .......  .......        X  .......           
325...    58220  Ms. Harman, CA..................................  .......  .......        X  .......           
322...    52721  Mr. Bartlett, MD................................  .......  .......        X  .......           
1123..    58885  Ms. Johnson, TX.................................  .......  .......  .......        X           
1717..    53831  Mr. Ehlers, MI..................................  .......  .......        X  .......           
1415..    52331  Mr. Minge, MN...................................  .......  .......        X  .......           
423...    53271  Mr. Wamp, TN....................................  .......  .......        X  .......           
1027..    55335  Mr. Olver, MA...................................  .......  .......  .......        X           
216...    53671  Mr. Dave Weldon, FL.............................  .......  .......        X  .......           
1039..    51313  Mr. Hastings, FL................................  .......  .......  .......        X           
1429..    55301  Mr. Graham, SC..................................  .......  .......        X  .......           
1116..    56261  Ms. Rivers, MI..................................  .......  .......  .......        X           
115...    52635  Mr. Salmon, AZ..................................  .......  .......        X  .......           
1232..    54535  Ms. McCarthy, MO................................  .......  .......  .......        X           
415...    51492  Mr. Davis, VA...................................  .......  .......        X  .......           
1032..    55401  Mr. Ward, KY....................................  .......  .......  .......        X           
417...    56565  Mr. Stockman, TX................................  .......  .......        X  .......           
118...    53072  Ms. Lofgren, CA.................................  .......  .......        X  .......           
425...    52472  Mr. Gutknecht, MN...............................  .......  .......        X  .......           
126...    54865  Mr. Doggett, TX.................................  .......  .......  .......        X           
1216..    53601  Mrs. Seastrand, CA..............................  .......  .......        X  .......           
1218..    52135  Mr. Doyle, PA...................................  .......  .......  .......  .......           
1319..    56216  Mr. Tiahrt, KS..................................  .......  .......        X  .......           
1520..    53816  Ms. Jackson Lee, TX.............................  .......  .......  .......        X           
410...    52211  Mr. Largent, OK.................................  .......  .......        X  .......           
1419..    52271  Mr. Luther, MN..................................  .......  .......        X  .......           
114...    56831  Mr. Hilleary, TN................................  .......  .......        X  .......           
1114..    52311  Mrs. Cubin, WY..................................  .......  .......  .......  .......           
506...    55792  Mr. Foley, FL...................................  .......  .......        X  .......           
509...    51976  Mrs. Myrick, NC.................................  .......  .......        X  .......           
                                                                  ------------------------------------          
                       Total.....................................  .......  .......       36        9           
----------------------------------------------------------------------------------------------------------------

                Amendment To H.R. 9 Offered by Mr. Davis

    Add at the end of section 3104(b) the following new 
paragraph:
          (3) A risk assessment shall be prepared at the level 
        of detail appropriate and practicable for reasoned 
        decision-making on the matter involved, taking into 
        consideration the significance and complexity of the 
        decision and any need for expedition.

                Amendment To H.R. 9 Offered by Mr. Davis

    In section 3104(b)(1), insert after ``any other relevant 
factor'' the following:
, including the availability of raw data for review. Greatest 
emphasis shall be placed on data that indicate a biological 
basis of the resulting harm in humans. Animal data shall be 
reviewed with regard to its relevancy to humans.

           Amendment To H.R. 9 Offered by Mr. Barton of Texas

    Page 39, after line 11, (in section 3104(b), after 
paragraph (2)), insert the following:
          (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.

                                         AMENDMENT OFFERED BY MR. BARTON                                        
----------------------------------------------------------------------------------------------------------------
                                                                                                           Not  
  Rm.    Phone                          Name                         Present   Absent    Yea      Nay     Voting
----------------------------------------------------------------------------------------------------------------
2369..    52411  Mr. Walker, PA....................................  .......  .......        X  .......         
2300..    56161  Mr. Brown, CA.....................................  .......  .......  .......        X         
2332..    55101  Mr. Sensenbrenner, WI.............................  .......  .......        X  .......         
2236..    56673  Mr. Hall, TX......................................  .......  .......        X  .......         
2246..    53665  Mr. Boehlert, NY..................................  .......  .......  .......  .......         
2446..    55261  Mr. Traficant, OH.................................  .......  .......        X  .......         
2159..    53515  Mr. Fawell, IL....................................  .......  .......        X  .......         
2432..    52031  Mr. Hayes, LA.....................................  .......  .......        X  .......         
106...    55341  Mrs. Morella, MD..................................  .......  .......        X  .......         
1127..    54714  Mr. Tanner, TN....................................  .......  .......        X  .......         
2452..    52011  Mr. Curt Weldon, PA...............................  .......  .......        X  .......         
2448..    55071  Mr. Geren, TX.....................................  .......  .......        X  .......         
2338..    52415  Mr. Rohrabacher, CA...............................  .......  .......        X  .......         
407...    53915  Mr. Roemer, IN....................................  .......  .......        X  .......         
2404..    56316  Mr. Schiff, NM....................................  .......  .......        X  .......         
236...    54801  Mr. Cramer, AL....................................  .......  .......  .......  .......         
2264..    52002  Mr. Barton, TX....................................  .......  .......        X  .......         
1410..    58171  Mr. Barcia, MI....................................  .......  .......        X  .......         
1034..    51986  Mr. Calvert, CA...................................  .......  .......        X  .......         
217...    56411  Mr. McHale, PA....................................  .......  .......        D  .......         
1724..    51880  Mr. Baker, CA.....................................  .......  .......        X  .......         
325...    58220  Ms. Harman, CA....................................  .......  .......        X  .......         
322...    52721  Mr. Bartlett, MD..................................  .......  .......        X  .......         
1123..    58885  Ms. Johnson, TX...................................  .......  .......  .......        X         
1717..    53831  Mr. Ehlers, MI....................................  .......  .......        X  .......         
1415..    52331  Mr. Minge, MN.....................................  .......  .......        X  .......         
423...    53271  Mr. Wamp, TN......................................  .......  .......        X  .......         
1027..    55335  Mr. Olver, MA.....................................  .......  .......  .......        X         
216...    53671  Mr. Dave Weldon, FL...............................  .......  .......        X  .......         
1039..    51313  Mr. Hastings, FL..................................  .......  .......  .......        X         
1429..    55301  Mr. Graham, SC....................................  .......  .......        X  .......         
1116..    56261  Ms. Rivers, MI....................................  .......  .......  .......        X         
115...    52635  Mr. Salmon, AZ....................................  .......  .......        X  .......         
1232..    54535  Ms. McCarthy, MO..................................  .......  .......  .......        X         
415...    51492  Mr. Davis, VA.....................................  .......  .......        X  .......         
1032..    55401  Mr. Ward, KY......................................  .......  .......  .......        X         
417...    56565  Mr. Stockman, TX..................................  .......  .......        X  .......         
118...    53072  Ms. Lofgren, CA...................................  .......  .......  .......        X         
425...    52472  Mr. Gutknecht, MN.................................  .......  .......        X  .......         
126...    54865  Mr. Doggett, TX...................................  .......  .......  .......        X         
1216..    53601  Mrs. Seastrand, CA................................  .......  .......        X  .......         
1218..    52135  Mr. Doyle, PA.....................................  .......  .......        X  .......         
1319..    56216  Mr. Tiahrt, KS....................................  .......  .......  .......  .......         
1520..    53816  Ms. Jackson Lee, TX...............................  .......  .......  .......        X         
410...    52211  Mr. Largent, OK...................................  .......  .......        X  .......         
1419..    52271  Mr. Luther, MN....................................  .......  .......  .......        X         
114...    56831  Mr. Hilleary, TN..................................  .......  .......        X  .......         
1114..    52311  Mrs. Cubin, WY....................................  .......  .......        X  .......         
506...    55792  Mr. Foley, FL.....................................  .......  .......        X  .......         
509...    51976  Mrs. Myrick, NC...................................  .......  .......        X  .......         
                                                                    ------------------------------------        
                       Total.......................................  .......  .......       36       11         
----------------------------------------------------------------------------------------------------------------

                          Amendment to H.R. 9

                  III. (C) SOUND SCIENCE: COMPARISONS

    On page 41, line 3 following the word ``health'' inset: ``; 
safety, or the environment''
    On page 41, line 4 strike the sentence beginning with, 
``Such statement'' through the end of line 9 and insert:
    ``Where appropriate and meaningful, such a statement shall 
include a comparison of risks relative to other similar risks, 
regulated by that Federal agency or another Federal agency, 
resulting from comparable activities and exposure pathways 
(such comparisons should consider relevant distinctions among 
risks, such as the voluntary and involuntary nature of risks, 
and the preventability and nonpreventability of risks).''

  Amendment Offered By Mr. Olver to the Amendment in the Nature of a 
                    Substitute Offered by Mr. Walker

    13(a) In section 3105(3) (page 11, line 13), insert ``, 
safety, or the environment'' after ``human health''.
    13(b) In section 3105(3) (page 11, lines 13 through 19), 
strike ``Such statement'' and all that follows through the end 
of the paragraph and insert the following:
Where appropriate and meaningful, such a statement shall 
include a comparison of risks relative to other similar risks, 
regulated by that Federal agency or another Federal agency, 
resulting from comparable activities and exposure pathways 
(such comparisons should consider relevant distinctions among 
risks, such as the voluntary and involuntary nature of risks, 
and the preventability and nonpreventability of risks).

           Amendment to H.R. 9 Offered By Mr. Barton of Texas

    Page 42, strike line 23 and all that follows down through 
line 9 on page 43 and insert the following (and redesignate 
subsections (c), (d), and (e) on page 43 accordingly):
    (b) In General.--(1) Within 1 year after the date of 
enactment of this Act the agency head 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 and revising it to 
        take into consideration new information or 
        methodologies or to comply with the requirements of 
        this subtitle;
          (C) requiring that a risk assessment or other agency 
        scientific or technical document supporting a 
        regulatory action be peer reviewed; or
          (D) reviewing any regulation 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 interested member of the public 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.
    (c) Final Agency Action.--(1) Within 1 year following the 
submission of a petition under subsection (b), 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 therefore.
    (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).

               Amendment To H.R. 9 Offered By Mr. Roemer

    At the end of section 3106, add the following new 
subsection:
    (f) Limitation on Judicial Review.--The development, 
issuance, and publication of risk assessment guidelines under 
this subsection shall not be subject to judicial review.

  Amendment Offered By Mr. Roemer to the Amendment in the Nature of a 
                    Substitute Offered by Mr. Walker

    Add after section 3106 the following new section 3107 (and 
redesignate subsequent sections accordingly):

SEC. 3107. RESEARCH AND TRAINING IN RISK ASSESSMENT.

    (a) Evaluation.--The head of each Federal agency shall 
regularly and systematically evaluate risk assessment research 
and training needs of the such agency, including the following 
needs:
          (1) Research to reduce data gaps or redundancies, 
        address modelling needs, and validation of default 
        options, particularly those common to multiple risk 
        assessments.
          (2) Research to examine the causes and extent of 
        variability within and among individuals, species, 
        populations, and, in the case of ecological risk 
        assessment, ecological communities.
          (3) Research leading to the improvement of methods to 
        quantify and communicate uncertainty and variability 
        throughout the risk assessment, and risk assessment 
        reporting methods that clearly distinguish between 
        uncertainty and variability.
          (4) Emerging and future areas of research, including 
        research on comparative risk analysis, exposure to 
        multiple chemicals and other stressors, noncancer 
        endpoints, biological markers, mechanisms of action in 
        both mammalian and nonmammalian species, dynamics and 
        probabilities of physiological and ecosystem exposures, 
        and prediction of ecosystem-level responses.
          (5) Long-term needs to adequately train individuals 
        in risk assessment and risk assessment applications. An 
        evaluation under this paragraph shall include an 
        estimate of the resources needed to provide necessary 
        training and recommendations on appropriate educational 
        risk assessment curricula.
    (b) Development of Strategy.--The head of each Federal 
agency shall develop a strategy, schedule, and delegation of 
responsibility for carrying out research and training to meet 
the needs identified in subsection (a).
    (c) Report.--Not later than 120 days after the date of the 
enactment of this Act, the head of each Federal agency shall 
submit to the Congress a report on the evaluations conducted 
under subsection (a) and the strategy and schedule developed 
under subsection (b). The head of each Federal agency shall 
report to the Congress whenever the evaluations, strategy, and 
schedule are updated or modified.

                          Amendment To H.R. 9

            VI. (A) RESEARCH AND TRAINING IN RISK ASSESSMENT

    On page 43, line 24 insert the following new Section 3107 
and renumber subsequent sections accordingly:

SEC. 3107. RESEARCH AND TRAINING IN RISK ASSESSMENT.

          (1) Evaluation.--The head of each covered agency 
        shall regularly and systematically evaluate risk 
        assessment research and training needs of the 
        Environmental Protection Agency, including the 
        following needs:
                  (A) Research to reduce data gaps or 
                redundancies, address modelling needs, and 
                validation of default options, particularly 
                those common to multiple risk assessments.
                  (B) Research to examine the causes and extent 
                of variability within and among individuals, 
                species, populations, and, in the case of 
                ecological risk assessment, ecological 
                communities.
                  (C) Research leading to the improvement of 
                methods to quantify and communicate uncertainty 
                and variability throughout the risk assessment, 
                and risk assessment reporting methods that 
                clearly distinguish between uncertainty and 
                variability.
                  (D) Emerging and future areas of research, 
                including research on comparative risk 
                analysis, exposure to multiple chemicals and 
                other stressors, noncancer endpoints, 
                biological markers, mechanisms of action in 
                both mammalian and non-mammalian species, 
                dynamics and probabilities of physiological and 
                ecosystem exposures, and prediction of 
                ecosystem-level responses.
                  (E) Long-term needs to adequately train 
                individuals in risk assessment and risk 
                assessment applications. An evaluation under 
                this paragraph shall include an estimate of the 
                resources needed to provide necessary training 
                and recommendations on appropriate educational 
                risk assessment curricula.
          (2) Development of Strategy.--The head of each 
        covered agency shall develop a strategy, schedule, and 
        delegation of responsibility for carrying out research 
        and training to meet the needs identified in paragraph 
        (1).
          (3) Report.--Not later than 120 days after the date 
        of the enactment of this Act, the head of each covered 
        agency shall submit to the Congress a report on the 
        evaluations conducted under paragraph (1) and the 
        strategy and schedule developed under paragraph (2). 
        The Administrator shall report to the Congress whenever 
        the evaluations, strategy, and schedule are updated or 
        modified.

                  III. (B) SOUND SCIENCE: DEFINITIONS

    On page 44, strike line 1 through line 16 and insert:
                  (1) Risk Assessment.--The term ``risk 
                assessment'' means a systematic process or 
                procedure for organizing and analyzing 
                scientific knowledge identify, characterize, 
                and to the extent practicable quantify the 
                potential adverse health, safety, or ecological 
                effects of exposure of individuals, 
                populations, habitats or ecosystems and (their 
                associated species) to hazardous pollutants, 
                activities, or other stressors.\1\
    \1\ National Research Council, ``Risk Assessment in the Federal 
Government: Managing the Process'', 1983, and National Research 
Council, ``Science and Judgment in Risk Assessment,'' 1994.
---------------------------------------------------------------------------
                  (2) Risk Characterization.--The term ``risk 
                characterization'' means the final component of 
                a risk assessment. Risk characterization 
                involves integration of information from the 
                first three steps of a risk assessment to 
                develop an estimate that qualitatively or 
                quantitatively (or both) describes the 
                magnitude and consequences of that risk in 
                terms of the population exposed to the risk and 
                the types of potential effects of the exposure. 
                Risk characterization should also include a 
                full discussion of the uncertainties associated 
                with the estimate or risk.\2\
    \2\ National Research Council, ``Science and Judgment in Risk 
Assessment, 1994; and Council on Environmental Quality, ``Risk 
Analysis: A Guide to Principles and Methods for Analyzing Health and 
Environmental Risks,'' 1989.
---------------------------------------------------------------------------

               VI. (B) COMPARATIVE RISK ASSESSMENT STUDY

    Insert a new Section 3108 and renumber subsequent sections 
as appropriate.

SEC. 3108. STUDY OF COMPARATIVE RISK ANALYSIS.

    (a) In General.--The Director of the Office of Science and 
Technology Policy shall conduct, or provide for the conduct of, 
a study using comparative risk analysis to rank health and/or 
environmental risks and to provide a common basis for 
evaluating strategies for reducing or preventing those risks. 
The goal of the study shall be to develop and rigorously test 
improved methods of comparative risk analysis.
    Not later than 90 days after the date of enactment of this 
Act, the Director, in collaboration with appropriate federal 
agencies shall enter into a contract with the National Research 
Council to provide technical guidance on approaches to using 
comparative risk analysis and other considerations in setting 
environmental risk reduction priorities.
    (b) Scope of Study.--The study shall have sufficient scope 
and breadth to evaluate comparative risk analysis and to test 
approaches for improving comparative risk analysis and its use 
in setting priorities for environmental risk reduction. The 
study shall compare and evaluate a range of diverse 
environmental risks, both as to risks to and within an 
environmental medium and risks across environmental media.
    (c) Study Participants.--In conducting the study, the 
Director shall provide for the participation of a range of 
individuals with varying backgrounds and expertise, both 
technical and nontechnical, comprising broad representation of 
the public and private sectors.
    (d) Duration.--The study shall begin within 180 days after 
the date of the enactment of this Act and terminate within 2 
years after the date on which it began.
    (e) Recommendations for Improving Comparative Risk Analysis 
and Its Use.--Not later than 90 days after the termination of 
the study, the Director shall submit to the Congress the report 
of the National Research Council with recommendations regarding 
the use of comparative risk analysis and ways to improve the 
use of comparative risk analysis for decisionmaking in 
appropriate federal agencies.

Amendment To Walker Amendment In Nature of a Substitute Offered By Mr. 
                                 Roemer

  Insert after section 3106 (page 14, line) the following new 
section 3107 (and redesignate subsequent sections accordingly):

SEC. 3107. STUDY OF COMPARATIVE RISK ANALYSIS.

  (a) In General.--(1) The Director of the Office of Science 
and Technology Policy shall conduct, or provide for the conduct 
of, a study using comparative risk analysis to rank health and 
environmental risks and to provide a common basis for 
evaluating strategies for reducing or preventing those risks. 
The goal of the study shall be to develop and rigorously test 
improved methods of comparative risk analysis.
  (2) Not later than 90 days after the date of the enactment of 
this Act, the Director, in collaboration with the heads of 
appropriate Federal agencies, shall enter into a contract with 
the National Research Council to provide technical guidance on 
approaches to using comparative risk analysis and other 
considerations in setting environmental risk reduction 
priorities.
  (b) Scope of Study.--The study shall have sufficient scope 
and breadth to evaluate comparative risk analysis and to test 
approaches for improving comparative risk analysis and its use 
in setting priorities for environmental risk reduction. The 
study shall compare and evaluate a range of diverse 
environmental risks, both as to risks to and within an 
environmental medium and risks across environmental media.
  (c) Study Participants.--In conducting the study, the 
Director shall provide for the participation of a range of 
individuals with varying backgrounds and expertise, both 
technical and nontechnical, comprising broad representation of 
the public and private sectors.
  (d) Duration.--The study shall begin within 180 days after 
the date of the enactment of this Act and terminate within 2 
years after the date on which it began.
  (e) Recommendations for Improving Comparative Risk Analysis 
and Its Use.--Not later than 90 days after the termination of 
the study, the Director shall submit to the Congress the report 
of the National Research Council with recommendations regarding 
the use of comparative risk analysis and ways to improve the 
use of comparative risk analysis for decision-making in 
appropriate Federal agencies.

            V. (C) COST-BENEFIT / CERTIFICATION: SUBSTITUTE

    On page 45, line 22 insert the phrase ``regulatory 
analysis'' immediately after the word ``following''.
    On page 46, strike line 1 through page 48 line 2 and insert 
the following:
          (b) Regulatory Analysis.--The head of each Federal 
        agency shall ensure that any regulatory analysis that 
        is conducted under this section includes a risk 
        assessment and cost-benefit analysis that is performed 
        consistently and uses reasonably obtainable and sound 
        scientific, technical, economic, and other data. Such 
        an analysis shall be conducted with as much specificity 
        as practicable, of--
                  (1) the risk, including the effect of the 
                risk, to human health, human safety or the 
                environment, and any combination thereof, 
                addressed by the regulation, including, where 
                applicable and practicable, the health and 
                safety risks to persons who are 
                disproportionately exposed or particularly 
                sensitive;
                  (2) the costs, including the incremental 
                costs, associated with implementation of, and 
                compliance with, the regulation;
                  (3) where appropriate and meaningful, a 
                comparison of that risk relative to other 
                similar risks, regulated by that Federal agency 
                or another 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 and nonpreventability of risks); 
                and
                  (4) the quantitative and qualitative benefits 
                of the regulation, including the reduction of 
                prevention of risk expected from the 
                regulation.
    Where such a regulatory analysis is not practicable because 
of compelling circumstances, the head of each Federal agency 
shall provide an explanation in lieu of conducting an analysis 
under this section.
          (c) Evaluation.--For each final rule, the regulatory 
        analysis referred to in paragraph (b) should also 
        contain a statement that the head of the Federal agency 
        evaluated each of the following:
                  (1) whether the regulation will substantially 
                advance the purpose of protecting against the 
                risk referred to in paragraph (b)(1); and
                  (2) whether the regulation will produce 
                benefits and reduce risks to human health, 
                human safety, or the environment, and any 
                combination thereof, in a cost-effective manner 
                as a result of the implementation of and 
                compliance with the regulation, by local, 
                State, and Federal Government and other public 
                and private entities, as estimated in paragraph 
                (b)(2).
    (2) Major Rule.--As used in this section, the term ``major 
rule'' means any regulation that is likely to have an annual 
impact on the economy of the United States $100,000,000 in 1995 
dollars.

  Amendment Offered By Mr. Tanner To the Amendment in the Nature of A 
                    Substitute Offered By Mr. Walker

    At the end of title III, subtitle A, section 3103, 
subsection (b)(3)(A) (Page 7, after line 18), add the following 
new clause:
    (v) Any situation or circumstance where the Secretary of 
Defense or the Secretary of a military department determines 
that compliance is not consistent with national security 
interests and missions. The Secretary of Defense or the 
Secretary of a military department shall promptly notify 
Congress of any such determinations and the reasons for such 
determinations.

 Amendment Offered by Mr. Barlett To the Amendment in the Nature of a 
                               Substitute

    Page 15, line 1, after ``assessed'' strike all through line 
3 and insert''.''

  Amendment Offered By Mr. Oliver To the Amendment in the Nature of A 
                    Substitute Offered By Mr. Walker

    Strike page 15, lines 9 through 21 and insert the 
following:
          (3) Best estimate.--The term ``best estimate'' means 
        an appropriate statistical representation of the full 
        range of the estimate of risk, given the current 
        scientific information available to the Federal agency 
        concerned, including a discussion and analysis of 
        uncertainties, limitations, and assumptions affecting 
        the risk estimate.

  Amendment Offered By Mr. Tanner To The Amendment in the Nature of A 
                    Substitute Offered By Mr. Walker

    At the end of title III, subtitle A, section 3103, 
subsection (b)(3)(A) i (page 7, at the end of line 6, add the 
following phrase:
          Or to be necessary to maintain military readiness.

  Amendment Offered by Mr. Minge To the Amendment in the Nature of a 
             Substitute For Title III Offered By Mr. Walker

    In section 3107(5) (page 16, line 6), add after the period 
the following: ``Such term does not include the Department of 
Agriculture.''.
    At the end of section 3201(c) (page 19, after line 20), add 
the following new paragraph:
          (4) Executive branch agency.--The term ``Federal 
        agency'' does not include the Department of 
        Agriculture.
    At the end of section 3301 (page 25, after line 5) add the 
following new subsection:
    (h) Federal Agency Defined.--For purposes of this section, 
the term ``Federal agency'' does not include the Department of 
Agriculture.

 Amendment Offered by Ms. Lofgren To the Amendment in the Nature of a 
             Substitute For Title III Offered By Mr. Walker

    Add at the end of section 3105 (page 12, after line 18) the 
following new paragraph 6:
          (6) Risks to particular groups.--Notwithstanding any 
        other provision of this title, risk assessments shall, 
        to the extent feasible and scientifically appropriate, 
        describe risks to particular groups (such as infants, 
        children, the elderly, pregnant women, individuals with 
        atypical diets, and individuals with preexisting 
        illnesses) whose risk is higher than that of the rest 
        of the studied population due to greater exposure or 
        greater susceptibility to adverse effects.

Amendment Offered by Mr. Traficant To the Amendment in the Nature of a 
                    Substitute Offered By Mr. Walker

    On page 16, following line 13, insert the following:
    (8) Non-United States-Based Entity.--As used in this title, 
the term ``non-United States-based entity'' means (a) an entity 
which is not incorporated in the United States, does not have 
its principal place of business in the United States, and does 
not provide a benefit to the United States economy and (b) the 
United Nations or any of its divisions.
    (9) United States.--As used in this title, the term 
``United States'' means the 50 States, the District of 
Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin 
Islands, American Samoa, the Commonwealth of the Northern 
Marianas Islands, and any other territory or possession of the 
United States.

                Amendment To H.R. 9 Offered By Mr. Davis

    In section 3201(a), insert after paragraph (1) the 
following new paragraphs (2) through (6) (and redesignate 
subsequent paragraphs accordingly):
          (2) For each such proposed or promulgated rule, an 
        identification (including an analysis of the costs and 
        benefits) of reasonable alternative for achieving the 
        identified benefits of the proposed or promulgated 
        rule, including alternatives--
                  (A) that require no government action;
                  (B) that will accommodate differences among 
                geographic regions and among persons with 
                different levels of resources with which to 
                comply; and
                  (C) that employ performance or other market-
                based standards that permit the greatest 
                flexibility in achieving the identified 
                benefits of the proposed or promulgated rule 
                and that comply with paragraph (3).
          (3) An assessment of the feasibility of establishing 
        a regulatory program that operates through the 
        application of market-based mechanisms.
          (4) An assessment of the aggregate effect of the rule 
        on small businesses with fewer than 100 employees, 
        including the effect of the net employment effect of 
        the rule.
          (5) An analysis of whether the identified benefits of 
        the proposed or promulgated rule are likely to exceed 
        the identified costs of the proposed or promulgated 
        rule, and an analysis of whether the proposed or 
        promulgated rule will provide greater net benefits to 
        society than any of the alternatives to the proposed or 
        promulgated rule, including alternatives identified in 
        paragraph (2).
          (6) At the time of the publication of the final major 
        rule, a final cost-benefit analysis (to be published in 
        the rulemaking record), including a summary of the 
        analysis in a statement of basis and purpose.

                   Amendment To H.R. 9 Offered By Mr.

    At the end of section 3201(a)(1), insert: ``In any 
situation in which benefits or costs cannot be quantified, 
qualitative measures should be provided''.

                Amendment To H.R. 9 Offered By Mr. Wamp

    In section 3201(a)(3), insert before the period the 
following: ``, including, to the maximum extent practicable, a 
quantitative assessment of the cumulative financial burden that 
persons producing products that are regulated by the rule will 
bear in order to comply with the rule and with related existing 
standards that affect the product or other similar products 
produced by such persons''.

                Amendment To H.R. 9 Offered By Mr. Davis

    In section 3201(b), strike ``proposed or final regulation'' 
and insert ``proposed and final regulation''.
    In section 3201, insert after subsection (b) the following 
new subsection (c) (and redesignate subsequent subsections 
accordingly):
    (c) Limitation.--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 subsections (a) and (b) 
are met and the certification required therein is supported by 
substantial evidence of the rulemaking record.

                   Amendment To H.R. 9 Offered By Mr.

    Insert the following after section 3201(b) and redesignate 
section 3201 (c) as (d):
    (c) Report to Congress.--Whenever an agency head is unable 
to make a certification required by subsection (a) with respect 
to one or more of the matters addressed in subsection (a)(b), 
the agency shall identify those matters for which certification 
cannot be made, and shall include a statement of the reasons 
therefore in the Federal Register along with the rule. Not 
later than March 1 of each year, each agency head shall submit 
a report to Congress identifying those major rules promulgated 
during the previous calendar year for which complete 
certification was not made, and summarizing the reasons 
therefore.
    Page 48, line 11, strike ``and indirect''.

              Amendment To H.R. 9 Offered by Ms. McCarthy

    Page 48, strike line 15 through page 49, line 3, and insert 
in lieu thereof the following:
          ``Major rule--The term ``major rule'' means any 
        regulation that is likely to result in an annual effect 
        on the economy of $100,000,000 or more.''
    Page 52, strike lines 10 through 13.

           Amendment To H.R. 9 Offered By Mr. Barton of Texas

  Page 49, after line 3 insert:

SEC. 3202. JUDICIAL REVIEW.

  (a) In General.--When a rule, order, or other agency action 
that is predicated in whole or in part on a risk assessment or 
risk characterization subject to subtitle A, or a major rule 
that is subject to the requirements of section 3201, is brought 
before a court for judicial review under any other provision of 
law, the risk assessment and risk characterization and any 
material prepared by the agency pursuant to section 3201 shall 
be made a part of the administrative record to be considered by 
the court. In addition to any other matters that the court may 
consider in deciding whether the agency's action was lawful, 
the court shall have the authority to hold unlawful and set 
aside the rule, order, or other agency action being reviewed if 
it finds that--
          (1) in preparing the risk assessment or 
        characterizing the risk, the agency did not apply or 
        comply with the risk assessment principles of section 
        3104 or the risk characterization principles of section 
        3105;
          (2) the agency did not comply with the requirements 
        of section 3201; or
          (3) a certification required to be made under section 
        3201 was arbitrary, capricious, an abuse of discretion, 
        or unsupported by substantial evidence.
  (b) Civil Actions.--(1) Any person who is adversely affected 
by a risk assessment or risk characterization that is prepared 
by an agency and made available to the public independently of 
a rule or other agency action that is subject to judicial 
review may commence a civil action against the agency where it 
is alleged that in preparing the risk assessment or risk 
characterization, the agency did not apply or comply with the 
applicable risk assessment or risk characterization principles 
of sections 3104 and 3105.
  (2) The district courts shall have jurisdiction, without 
regard to the amount in controversy or the citizenship of the 
parties, to hold the risk assessment or risk characterization 
unlawful and grant appropriate injunctive relief in such an 
action if the court finds that the agency failed to apply or 
comply with the applicable risk assessment or risk 
characterization principles of sections 3104 and 3105, without 
limiting the court's discretion, appropriate relief may include 
issuance of an order--
          (A) requiring the agency to prepare and make publicly 
        available a revised risk assessment and/or risk 
        characterization that applies or complies with the risk 
        assessment or risk characterization principles of 
        sections 3104 and 3105;
          (B) requiring the agency to provide the appropriate 
        notice to the public that the challenged risk 
        assessment and/or risk characterization has been found 
        to be unlawful;
          (C) prohibiting the agency from relying on or 
        otherwise using the challenged risk assessment and/or 
        risk characterization as a basis for taking regulatory 
        action; and
          (D) providing for any other injunctive relief that 
        the court finds to be appropriate.

Amendment Offered by Rep. Jackson Lee to the Amendment in the Nature of 
                  a Substitute Offered by Mr. Walker.

    ``On page 19, line 20, after the period add the following 
sentence:
    ``Such term does not include any regulation that the head 
of any Federal agency in connection with Federal programs 
determines is an immediate life threatening situation.' ''

  Amendment To the Amendment in the Nature of a Substitute of H.R. 9, 
                    Title III Offered by Mr. Oliver

    Strike Paragraph (f) (1) of SECTION 3201 and renumber the 
following paragraph as paragraph (f) (1).


                                           AMENDMENT OFFERED BY OLVER                                           
----------------------------------------------------------------------------------------------------------------
                                                                                                           Not  
  Rm.    Phone                          Name                         Present   Absent    Yea      Nay     Voting
----------------------------------------------------------------------------------------------------------------
2369..    52411  Mr. Walker, PA....................................  .......  .......        X  .......         
2300..    56161  Mr. Brown, CA.....................................  .......  .......  .......  .......         
2332..    55101  Mr. Sensenbrenner, WI.............................  .......  .......        X  .......         
2236..    56673  Mr. Hall, TX......................................  .......  .......        X  .......         
2246..    53665  Mr. Boehlert, NY..................................  .......        X  .......  .......         
2446..    55261  Mr. Traficant, OH.................................  .......  .......        X  .......         
2159..    53515  Mr. Fawell, IL....................................  .......  .......        X  .......         
2432..    52031  Mr. Hayes, LA.....................................  .......  .......  .......  .......         
106...    55341  Mrs. Morella, MD..................................  .......        X  .......  .......         
1127..    54714  Mr. Tanner, TN....................................  .......  .......  .......  .......         
2452..    52011  Mr. Curt Weldon, PA...............................  .......  .......        X  .......         
2448..    55071  Mr. Geren, TX.....................................  .......  .......        X  .......         
2338..    52415  Mr. Rohrabacher, CA...............................  .......  .......        X  .......         
407...    53915  Mr. Roemer, IN....................................  .......  .......        X  .......         
2404..    56316  Mr. Schiff, NM....................................  .......  .......        X  .......         
236...    54801  Mr. Cramer, AL....................................  .......  .......  .......  .......         
2264..    52002  Mr. Barton, TX....................................  .......  .......        X  .......         
1410..    58171  Mr. Barcia, MI....................................  .......        X  .......  .......         
1034..    51986  Mr. Calvert, CA...................................  .......  .......        X  .......         
217...    56411  Mr. McHale, PA....................................  .......        X  .......  .......         
1724..    51880  Mr. Baker, CA.....................................  .......  .......        X  .......         
325...    58220  Ms. Harman, CA....................................  .......  .......  .......  .......         
322...    52721  Mr. Bartlett, MD..................................  .......  .......        X  .......         
1123..    58885  Ms. Johnson, TX...................................  .......        X  .......  .......         
1717..    53831  Mr. Ehlers, MI....................................  .......  .......        X  .......         
1415..    52331  Mr. Minge, MN.....................................  .......  .......        X  .......         
423...    53271  Mr. Wamp, TN......................................  .......  .......        X  .......         
1027..    55335  Mr. Olver, MA.....................................  .......        X  .......  .......         
216...    53671  Mr. Dave Weldon, FL...............................  .......  .......        X  .......         
1039..    51313  Mr. Hastings, FL..................................  .......  .......  .......  .......         
1429..    55301  Mr. Graham, SC....................................  .......  .......        X  .......         
1116..    56261  Ms. Rivers, MI....................................  .......        X  .......  .......         
115...    52635  Mr. Salmon, AZ....................................  .......  .......        X  .......         
1232..    54535  Ms. McCarthy, MO..................................  .......  .......  .......  .......         
415...    51492  Mr. Davis, VA.....................................  .......  .......        X  .......         
1032..    55401  Mr. Ward, KY......................................  .......        X  .......  .......         
417...    56565  Mr. Stockman, TX..................................  .......  .......        X  .......         
118...    53072  Ms. Lofgren, CA...................................  .......        X  .......  .......         
425...    52472  Mr. Gutknecht, MN.................................  .......  .......        X  .......         
126...    54865  Mr. Doggett, TX...................................  .......        X  .......  .......         
1216..    53601  Mrs. Seastrand, CA................................  .......  .......        X  .......         
1218..    52135  Mr. Doyle, PA.....................................  .......  .......        X  .......         
1319..    56216  Mr. Tiahrt, KS....................................  .......  .......        X  .......         
1520..    53816  Ms. Jackson-Lee, TX...............................  .......        X  .......  .......         
410...    52211  Mr. Largent, OK...................................  .......  .......        X  .......         
1419..    52271  Mr. Luther, MN....................................  .......        X  .......  .......         
114...    56831  Mr. Hilleary, TN..................................  .......  .......        X  .......         
1114..    52311  Mrs. Cubin, WY....................................  .......  .......        X  .......         
506...    55792  Mr. Foley, FL.....................................  .......  .......  .......        X         
509...    51976  Mrs. Myrick, NC...................................  .......  .......  .......        X         
                                                                    ------------------------------------        
                       Total.......................................  .......  .......       12       31         
----------------------------------------------------------------------------------------------------------------

   Amendment Offered Mr. Roemer to the Amendment in the Nature of a 
                    Substitute Offered by Mr. Walker

    In section 3301(a)(3) (page 22, beginning on line 10), 
strike ``and in the case of'' to the end of the paragraph and 
insert the following: ``and the peer reviewers do not have a 
financial or other interest that will, or may reasonably be 
expected to, create a bias in favor of obtaining an outcome 
that is consistent with such financial or other interest;''.
    Strike section 3301(a)(4) (page 22, line 14 through line 
16) and insert the following:
          (4) shall result in the appointment of peer reviewers 
        who are qualified on the basis of their professional 
        training or expertise as reflected in their record of 
        peer-reviewed publications or equivalent;
    Page 22, line 20, strike the period and insert ``; and''.
    At the end of section 3301(a) (page 22, after line 20), 
insert the following new paragraph:
          (6) may provide specific and reasonable deadlines for 
        peer review panels to submit reports under subsection 
        (c).
    In section 3301(b) (page 23, lines 1 through 7), strike 
``(other than any regulation'' and all that follows through 
``policy decision.'' and insert the following: ``. The Director 
of the Office of Management and Budget may order that peer 
review be provided for any significant risk assessment or cost 
assessment if the agency has failed to do so itself.''.
    At the end of section 3301(b) (page 23, line 7), add the 
following: ``Where such a peer review is not practicable 
because of compelling circumstances, the head of each Federal 
agency shall provide an explanation in lieu of conducting a 
peer review under this subtitle.''.

    After section 3301(g) (page 25, after line 5) insert the 
following:

    (h) Definitions.--For purposes of this subtitle:

          (1) Independent experts.--The term ``independent 
        experts'' means individuals who have not participated 
        in the design, conduct, or analysis of the experiment 
        or data in question.
          (2) External experts.--The term ``external experts'' 
        means experts who are not direct employees of the 
        Federal Government, as well as Federal Government 
        employees who are external to the program which 
        produced the risk assessment or economic assessment 
        being peer reviewed and who did not participate, in a 
        significant way, in the preparation of such assessment 
        or in the key data upon which the assessment depends.
          (3) Major rule.--The term ``major rule'' means any 
        rule (as such term is defined in section 551(4) of 
        title 5, United States Code) that is likely to result 
        in an annual effect on the economy of $100,000,000 or 
        more.

Amendment to the Amendment in the Nature of a Substitute Offered by Mr. 
                     Walker Offered by Mr. Doggett

    Page 22, line 6 through 13. Strike paragraph (3) and insert 
the following:
    Shall exclude peer reviewers who have a potential interest 
in the outcome:

                                        AMENDMENT OFFERED BY MR. DOGGETT                                        
----------------------------------------------------------------------------------------------------------------
                                                                                                           Not  
  Rm.    Phone                          Name                         Present   Absent    Yea      Nay     Voting
----------------------------------------------------------------------------------------------------------------
2369..    52411  Mr. Walker, PA....................................  .......  .......  .......        X         
2300..    56161  Mr. Brown, CA.....................................  .......  .......  .......  .......         
2332..    55101  Mr. Sensenbrenner, WI.............................  .......  .......  .......        X         
2236..    56673  Mr. Hall, TX......................................  .......  .......        X  .......         
2246..    53665  Mr. Boehlert, NY..................................  .......  .......  .......        X         
2446..    55261  Mr. Traficant, OH.................................  .......  .......        X  .......         
2159..    53515  Mr. Fawell, IL....................................  .......  .......  .......        X         
2432..    52031  Mr. Hayes, LA.....................................  .......  .......  .......  .......         
106...    55341  Mrs. Morella, MD..................................  .......  .......  .......        X         
1127..    54714  Mr. Tanner, TN....................................  .......  .......  .......  .......         
2452..    52011  Mr. Curt Weldon, PA...............................  .......  .......  .......        X         
2448..    55071  Mr. Geren, TX.....................................  .......  .......        X  .......         
2338..    52415  Mr. Rohrabacher, CA...............................  .......  .......  .......        X         
407...    53915  Mr. Roemer, IN....................................  .......  .......        X  .......         
2404..    56316  Mr. Schiff, NM....................................  .......  .......  .......        X         
236...    54801  Mr. Cramer, AL....................................  .......  .......  .......  .......         
2264..    52002  Mr. Barton, TX....................................  .......  .......  .......  .......         
1410..    58171  Mr. Barcia, MI....................................  .......  .......        X  .......         
1034..    51986  Mr. Calvert, CA...................................  .......  .......  .......        X         
217...    56411  Mr. McHale, PA....................................  .......  .......        X  .......         
1724..    51880  Mr. Baker, CA.....................................  .......  .......  .......        X         
325...    58220  Ms. Harman, CA....................................  .......  .......  .......  .......         
322...    52721  Mr. Bartlett, MD..................................  .......  .......  .......        X         
1123..    58885  Ms. Johnson, TX...................................  .......  .......        X  .......         
1717..    53831  Mr. Ehlers, MI....................................  .......  .......  .......        X         
1415..    52331  Mr. Minge, MN.....................................  .......  .......        X  .......         
423...    53271  Mr. Wamp, TN......................................  .......  .......  .......        X         
1027..    55335  Mr. Olver, MA.....................................  .......  .......        X  .......         
216...    53671  Mr. Dave Weldon, FL...............................  .......  .......  .......        X         
1039..    51313  Mr. Hastings, FL..................................  .......  .......  .......  .......         
1429..    55301  Mr. Graham, SC....................................  .......  .......  .......        X         
1116..    56261  Ms. Rivers, MI....................................  .......  .......        X  .......         
115...    52635  Mr. Salmon, AZ....................................  .......  .......  .......        X         
1232..    54535  Ms. McCarthy, MO..................................  .......  .......  .......  .......         
415...    51492  Mr. Davis, VA.....................................  .......  .......  .......        X         
1032..    55401  Mr. Ward, KY......................................  .......  .......        X  .......         
417...    56565  Mr. Stockman, TX..................................  .......  .......  .......        X         
118...    53072  Ms. Lofgren, CA...................................  .......  .......        X  .......         
425...    52472  Mr. Gutknecht, MN.................................  .......  .......  .......        X         
126...    54865  Mr. Doggett, TX...................................  .......  .......        X  .......         
1216..    53601  Mrs. Seastrand, CA................................  .......  .......  .......        X         
1218..    52135  Mr. Doyle, PA.....................................  .......  .......        X  .......         
1319..    56216  Mr. Tiahrt, KS....................................  .......  .......  .......        X         
1520..    53816  Ms. Jackson-Lee, TX...............................  .......  .......        X  .......         
410...    52211  Mr. Largent, OK...................................  .......  .......  .......        X         
1419..    52271  Mr. Luther, MN....................................  .......  .......        X  .......         
114...    56831  Mr. Hilleary, TN..................................  .......  .......  .......        X         
1114..    52311  Mrs. Cubin, WY....................................  .......  .......  .......        X         
506...    55792  Mr. Foley, FL.....................................  .......  .......  .......        X         
509...    51976  Mrs. Myrick, NC...................................  .......  .......  .......        X         
                                                                    ------------------------------------        
                       Total.......................................  .......  .......       16       26         
----------------------------------------------------------------------------------------------------------------

 Amendment Offered by Mrs. Morella, Mr. Boehlert, or Mr. Ehlers to the 
     Amendment in the Nature of a Substitute Offered By Mr. Walker

    In section 3301(a) (page 21, line 20), insert ``independent 
and external'' after ``program for''.
    In section 3301(a)(1) (page 21, line 24), strike 
``independent and external''.
    In section 3301(a)(1) (page 22, line 2), strike ``to the 
extent feasible'' and insert the following:
and to the extent feasible and appropriate, include 
representatives of industry, universities, agriculture, labor, 
consumers, conservation organizations, and other public 
interest groups and organizations.
    At the end of the title, add the following:

SEC. 3402. PRIORITIZATION OF THREATS AND RESOURCE USE.

    For any risk assessment, risk characterization, cost-
benefit analysis, or peer review program prepared by, or on 
behalf of, any Federal agency under this title, the head of the 
Federal agency shall--
          (1) prioritize threats to human health, safety, and 
        the environment according to--
                  (A) the seriousness of the risk they pose; 
                and
                  (B) the opportunities available to achieve 
                the greatest overall net reduction in those 
                risks with the public and private resources 
                available; and
          (2) prioritize the use of resources available to the 
        agency under those laws to reduce those risks in 
        accordance with the priorities established under 
        paragraph (1), including applying the priorities to the 
        budget, strategic planning, and research activities of 
        the agency.

SEC. 3403. RESEARCH AND TRAINING IN RISK ASSESSMENT.

    (a) Evaluation.--The head of each covered agency shall 
regularly evaluate risk assessment research and training needs 
of the agency, including the following:
          (1) Research to improve model sensitivity and 
        otherwise reduce generic data gaps, particularly those 
        common to multiple risk assessments.
          (2) Research leading to improvement of methods to 
        quantify and communicate uncertainty and variability 
        throughout risk assessment.
          (3) Emerging and future areas of research, including 
        research on comparative risk analysis, exposure to 
        multiple chemicals, noncancer endpoints, biological 
        makers of exposure and effect, mechanisms of action in 
        both mammalian and nonmammalian species, ecosystem 
        exposures, and prediction of ecosystem-level response.
          (4) Long-term needs to adequately train individuals 
        in risk assessment and risk assessment application. 
        Evaluations under this paragraph shall include an 
        estimate of the resources needed to provide necessary 
        training and recommendations on appropriate educational 
        risk assessment curricula.
    (b) Strategy and Actions to Meet Identified Needs.--The 
head of each covered agency shall develop a strategy, schedule, 
and delegation of responsibility for carrying out research and 
training to meet the needs identified in subsection (a).
    (c) Report.--Not later than 6 months after the date of the 
enactment of this Act, the head of each covered agency shall 
submit to the Congress a report on the evaluations conducted 
under subsection (a) and the strategy and schedule developed 
under subsection (b). The head of each covered agency shall 
report to the Congress whenever the evaluations, strategy, and 
schedule are updated or modified.
    (d) Covered Agency Defined.--For purposes of this section, 
the term ``covered agency'' means each of the following:
          (1) The Environmental Protection Agency.
          (2) The Consumer Product Safety Commission.
          (3) The Occupational Health and Safety 
        Administration.
          (4) The Department of Labor.
          (5) The Department of Transportation.
          (6) The Department of Energy.
          (7) The Department of Agriculture.
          (8) The Department of the Interior.
          (9) The Food and Drug Administration.

           Amendment To H.R. 9 Offered By Mr. Green of Texas

    At the end of title III add the following new subtitle:

                     Subtitle D--Agency Priorities

SEC. 3401. AGENCY PROGRAM GOALS.

    (a) Prioritizing Activities.--In exercising authority under 
the Federal laws to protect human health, safety, and the 
environment within the agency's jurisdiction, the head of each 
Federal agency shall--
          (1) prioritize threats to human health, safety, and 
        the environment according to--
                  (A) the seriousness of the risk they pose; 
                and
                  (B) the opportunities available to achieve 
                the greatest overall net reduction in those 
                risks with the public and private resources 
                available; and
          (2) prioritize the use of resources available to the 
        agency under those laws to reduce those threats in 
        accordance with the priorities established under 
        paragraph (1), including applying the priorities to the 
        agency's budget, strategic planning, and research 
        activities.
    (b) Reports to Congress.--The head of each Federal agency 
shall annually submit to Congress--
          (1) a budget analysis describing--
                  (A) the results of the agency's 
                prioritization under subsection (a)(1);
                  (B) the basis for that prioritization; and
                  (C) explicitly how the funds requested by the 
                agency will be used to address those risks; and
          (2) in March of each year, an analysis of any 
        statutory, regulatory or administrative obstacles to 
        allocating agency resources in accordance with the 
        priorities established under subsection (a)(1) with 
        recommendations--
                  (A) for repealing or modifying existing laws 
                to reduce, eliminate or enhance programs or 
                mandates relating to human health, safety and 
                the environment; and
                  (B) for modifying statutorily or judicially 
                mandated deadlines that would better enable the 
                agency to prioritize its activities to address 
                the threats to human health, safety, and the 
                environment consistent with the priorities 
                established under subsection (a)(1).

SEC. 3402. COMPARATIVE RISK ANALYSIS.

    (a) Requirement.--Within 3 months after the date of the 
enactment of this title, the Director of the Office of 
Management and Budget shall enter into a contract with an 
appropriately qualified organization to conduct a comparative 
risk analysis. The analysis shall compare and rank, to the 
extent feasible, human health, safety, and environmental risks 
potentially regulated across the existing Federal programs to 
protect human health, safety and the environment.
    (b) Criteria.--In arranging for the comparative risk 
analysis referred to in subsection (a), the Director shall 
ensure that--
          (1) the analysis is conducted with sufficient 
        specificity and scope to provide guidance to the 
        President and the heads of Federal agencies in 
        allocating budgetary resources across agencies and 
        among programs to achieve the greatest degree of 
        reduction in risk for the public and private resources 
        expended;
          (2) the analyses is conducted, to the extent feasible 
        and practicable, in a manner consistent with the risk 
        assessment and risk characterization criteria contained 
        in subtitle A of this title;
          (3) the analysis is conducted by individuals with 
        relevant expertise in areas such as toxicology, 
        biology, medicine, industrial hygiene, engineering, and 
        environmental effects;
          (4) the methodologies and principal scientific 
        determinations made in the analysis are subjected to 
        independent and external peer review and that the 
        conclusions of the peer review are made publicly 
        available as part of the final report;
          (5) there is an opportunity for public comment on the 
        results prior to making the results final; and
          (6) the results are presented in a manner that 
        distinguishes between the scientific conclusions and 
        any policy or value judgments embodied in the 
        comparisons.
    (c) Report.--Not later than 3 years after the date of the 
enactment of this Act, the Director shall complete the 
comparative risk analysis referred to in subsection (a) and 
submit to the President and Congress a report that reviews the 
comparative risk analysis. The Director shall review and revise 
the comparative risk analysis every 5 years thereafter for a 
minimum of 15 years following the completion of the first 
analysis. The Director shall arrange for such review and 
revision in the same manner as provided in subsections (a) and 
(b).

               Amendment To H.R. 9 Offered By Mr. Roemer

    At the end of title III add the following new subtitle:

                     Subtitle D--Agency Priorities

SEC. 3401. AGENCY PROGRAM GOALS.

    (a) Prioritizing Activities.--In exercising authority under 
the Federal laws to protect human health, safety, and the 
environment within the agency's jurisdiction, the head of each 
Federal agency shall--
          (1) prioritize threats to human health, safety, and 
        the environment according to--
                  (A) the seriousness of the risk they pose; 
                and
                  (B) the opportunities available to achieve 
                the greatest overall net reduction in those 
                risks with the public and private resources 
                available; and
          (2) prioritize the use of resources available to the 
        agency under those laws to reduce those threats in 
        accordance with the priorities established under 
        paragraph (1), including applying the priorities to the 
        agency's budget, strategic planning, and research 
        activities.
    (b) Reports to Congress.--The head of each Federal agency 
shall annually submit to Congress--
          (1) a budget analysis describing--
                  (A) the results of the agency's 
                prioritization under subsection (a)(1);
                  (B) the basis for that prioritization; and
                  (C) explicitly how the funds requested by the 
                agency will be used to address those risks; and
          (2) in March of each year, an analysis of any 
        statutory, regulatory or administrative obstacles to 
        allocating agency resources in accordance with the 
        priorities established under subsection (a)(1) with 
        recommendations--
                  (A) for repealing or modifying existing laws 
                to reduce, eliminate or enhance programs or 
                mandates relating to human health, safety and 
                the environment; and
                  (B) for modifying statutorily or judicially 
                mandated deadlines that would better enable the 
                agency to prioritize its activities to address 
                the threats to human health, safety, and the 
                environment consistent with the priorities 
                established under subsection (a)(1).

SEC. 3402. COMPARATIVE RISK ANALYSIS.

    (a) Requirement.--Within 3 months after the date of the 
enactment of this title, the Director of the Office of 
Management and Budget shall enter into a contract with an 
appropriately qualified organization to conduct a comparative 
risk analysis. The analysis shall compare and rank, to the 
extent feasible, human health, safety, and environmental risks 
potentially regulated across the existing Federal programs to 
protect human health, safety and the environment.
    (b) Criteria.--In arranging for the comparative risk 
analysis referred to in subsection (a), the Director shall 
ensure that--
          (1) the analysis is conducted with sufficient 
        specificity and scope to provide guidance to the 
        President and the heads of Federal agencies in 
        allocating budgetary resources across agencies and 
        among programs to achieve the greatest degree of 
        reduction in risk for the public and private resources 
        expended;
          (2) the analysis is conducted, to the extent feasible 
        and practicable, in a manner consistent with the risk 
        assessment and risk characterization criteria contained 
        in subtitle A of this title;
          (3) the analysis is conducted by individuals with 
        relevant expertise in areas such as toxicology, 
        biology, medicine, industrial hygiene, engineering, and 
        environmental effects;
          (4) the methodologies and principal scientific 
        determinations made in the analysis are subjected to 
        independent and external peer review and that the 
        conclusions of the peer review are made publicly 
        available as part of the final report;
          (5) there is an opportunity for public comment on the 
        results prior to making the results final; and
          (6) the results are presented in a manner that 
        distinguishes between the scientific conclusions and 
        any policy or value judgments embodied in the 
        comparisons.
    (c) Report.--Not later than 3 years after the date of the 
enactment of this title, the Director shall complete the 
comparative risk analysis referred to in subsection (a) and 
submit to the President and Congress a report that reviews the 
comparative risk analysis. The Director shall review and revise 
the comparative risk analysis every 5 years thereafter for a 
minimum of 15 years following the completion of the first 
analysis. The Director shall arrange for such review and 
revision in the same manner as provided in subsections (a) and 
(b).

               Amendment To H.R. 9 Offered By Mr. Tanner

    At the end of title III (page 52, after line 13), add the 
following new subtitle:

                      Subtitle D--Other Provisions

SEC. 3401. NATIONAL SECURITY WAIVER.

    The Secretary of Defense or the Secretary of a military 
department may waive a provision of this title with respect to 
the Department of Defense or the military department if the 
Secretary concerned--
          (1) determines that such a waiver is necessary in the 
        national security interests of the United States; and
          (2) promptly notifies Congress of the waiver and the 
        reasons for the waiver.

                   Amendment To H.R. 9 Offered By Mr.

    At the end of subtitle C insert:

                     Subtitle D--General Provisions

SEC. 3401. JUDICIAL REVIEW.

    Nothing in this title creates any right to judicial or 
administrative review, nor creates any right or benefit, 
substantive or procedural, enforceable at law of equity by a 
party against the United States, its agencies or 
instrumentalities, its officers or employees, or any other 
person. If an agency action is subject to judicial or 
administrative review under any other provision of law, the 
adequacy of any certification or other document prepared 
pursuant to this title, and any alleged failure to comply with 
this title, may not be used as grounds for affecting or 
invalidating such agency action, but statements and information 
prepared pursuant to this title, including statements contained 
in the certification or document which are otherwise part of 
the record, may be considered as part of the record for the 
judicial or administrative review conducted under such other 
provision of law.

              Amendment To H.R. 9. Offered By Mr. Doggett

    Add at the end of title III the following new subtitle:

                          Subtitle IV--Sunset

SEC. 3401. SUNSET.

    This title shall cease to be in effect on January 3, 2000.

                                        AMENDMENT OFFERED BY MR. DOGGETT                                        
----------------------------------------------------------------------------------------------------------------
                                                                                                           Not  
  Rm.    Phone                          Name                         Present   Absent    Yea      Nay     Voting
----------------------------------------------------------------------------------------------------------------
2369..    52411  Mr. Walker, PA....................................  .......  .......  .......        X         
2300..    56161  Mr. Brown, CA.....................................  .......  .......  .......  .......         
2332..    55101  Mr. Sensenbrenner, WI.............................  .......  .......  .......        X         
2236..    56673  Mr. Hall, TX......................................  .......  .......        X  .......         
2246..    53665  Mr. Boehlert, NY..................................  .......  .......  .......        X         
2446..    55261  Mr. Traficant, OH.................................  .......  .......        X  .......         
2159..    53515  Mr. Fawell, IL....................................  .......  .......  .......        X         
2432..    52031  Mr. Hayes, LA.....................................  .......  .......  .......  .......         
106...    55341  Mrs. Morella, MD..................................  .......  .......  .......        X         
1127..    54714  Mr. Tanner, TN....................................  .......  .......  .......  .......         
2452..    52011  Mr. Curt Weldon, PA...............................  .......  .......  .......        X         
2448..    55071  Mr. Geren, TX.....................................  .......  .......  .......        X         
2338..    52415  Mr. Rohrabacher, CA...............................  .......  .......  .......        X         
407...    53915  Mr. Roemer, IN....................................  .......  .......  .......        X         
2404..    56316  Mr. Schiff, NM....................................  .......  .......  .......        X         
236...    54801  Mr. Cramer, AL....................................  .......  .......  .......  .......         
2264..    52002  Mr. Barton, TX....................................  .......  .......  .......  .......         
1410..    58171  Mr. Barcia, MI....................................  .......  .......  .......        X         
1034..    51986  Mr. Calvert, CA...................................  .......  .......  .......        X         
217...    56411  Mr. McHale, PA....................................  .......  .......        X  .......         
1724..    51880  Mr. Baker, CA.....................................  .......  .......  .......        X         
325...    58220  Ms. Harman, CA....................................  .......  .......  .......  .......         
322...    52721  Mr. Bartlett, MD..................................  .......  .......  .......        X         
1123..    58885  Ms. Johnson, TX...................................  .......  .......        X  .......         
1717..    53831  Mr. Ehlers, MI....................................  .......  .......  .......        X         
1415..    52331  Mr. Minge, MN.....................................  .......  .......        X  .......         
423...    53271  Mr. Wamp, TN......................................  .......  .......  .......        X         
1027..    55335  Mr. Olver, MA.....................................  .......  .......        X  .......         
216...    53671  Mr. Dave Weldon, FL...............................  .......  .......  .......        X         
1039..    51313  Mr. Hastings, FL..................................  .......  .......  .......  .......         
1429..    55301  Mr. Graham, SC....................................  .......  .......  .......        X         
1116..    56261  Ms. Rivers, MI....................................  .......  .......        X  .......         
115...    52635  Mr. Salmon, AZ....................................  .......  .......  .......        X         
1232..    54535  Ms. McCarthy, MO..................................  .......  .......  .......  .......         
415...    51492  Mr. Davis, VA.....................................  .......  .......  .......        X         
1032..    55401  Mr. Ward, KY......................................  .......  .......        X  .......         
417...    56565  Mr. Stockman, TX..................................  .......  .......  .......        X         
118...    53072  Ms. Lofgren, CA...................................  .......  .......        X  .......         
425...    52472  Mr. Gutknecht, MN.................................  .......  .......  .......        X         
126...    54865  Mr. Doggett, TX...................................  .......  .......        X  .......         
1216..    53601  Mrs. Seastrand, CA................................  .......  .......  .......        X         
1218..    52135  Mr. Doyle, PA.....................................  .......  .......        X  .......         
1319..    56216  Mr. Tiahrt, KS....................................  .......  .......  .......        X         
1520..    53816  Ms. Jackson-Lee, TX...............................  .......  .......        X  .......         
410...    52211  Mr. Largent, OK...................................  .......  .......  .......        X         
1419..    52271  Mr. Luther, MN....................................  .......  .......        X  .......         
114...    56831  Mr. Hilleary, TN..................................  .......  .......  .......        X         
1114..    52311  Mrs. Cubin, WY....................................  .......  .......  .......        X         
506...    55792  Mr. Foley, FL.....................................  .......  .......  .......        X         
509...    51976  Mrs. Myrick, NC...................................  .......  .......  .......        X         
                                                                    ------------------------------------        
                       Total.......................................  .......  .......       13       29         
----------------------------------------------------------------------------------------------------------------

  Amendment Offered By Mr. Roemer To the Amendment in the Nature of a 
             Substitute For Title III Offered by Mr. Walker

    Strike section 3401 (page 25, lines 7 through 10) and 
insert the following:

SEC. 3401. JUDICIAL REVIEW.

    Nothing in this title creates any right to judicial or 
administrative review, nor creates any right or benefit, 
substantive or procedural, enforceable at law or equity by a 
party against the United States, its agencies or 
instrumentalities, its officers or employees, or any other 
person. If an agency action is subject to judicial or 
administrative review under any other provision of law, the 
adequacy of any certification or other document prepared 
pursuant to this title, and any alleged failure to comply with 
this title, may not be used as grounds for affecting or 
invalidating such agency action, but statements and information 
prepared pursuant to this title, including statements contained 
in the certification of document which are otherwise part of 
the record, may be considered as part of the record for the 
judicial or administrative review conducted under such other 
provision of law.

                                         AMENDMENT OFFERED BY MR. ROEMER                                        
----------------------------------------------------------------------------------------------------------------
                                                                                                           Not  
  Rm.    Phone                          Name                         Present   Absent    Yea      Nay     Voting
----------------------------------------------------------------------------------------------------------------
2369..    52411  Mr. Walker, PA....................................  .......  .......  .......        X         
2300..    56161  Mr. Brown, CA.....................................  .......  .......  .......  .......         
2332..    55101  Mr. Sensenbrenner, WI.............................  .......  .......  .......        X         
2236..    56673  Mr. Hall, TX......................................  .......  .......        X  .......         
2246..    53665  Mr. Boehlert, NY..................................  .......  .......        X  .......         
2446..    55261  Mr. Traficant, OH.................................  .......  .......        X  .......         
2159..    53515  Mr. Fawell, IL....................................  .......  .......  .......        X         
2432..    52031  Mr. Hayes, LA.....................................  .......  .......  .......  .......         
106...    55341  Mrs. Morella, MD..................................  .......  .......        X  .......         
1127..    54714  Mr. Tanner, TN....................................  .......  .......  .......  .......         
2452..    52011  Mr. Curt Weldon, PA...............................  .......  .......  .......        X         
2448..    55071  Mr. Geren, TX.....................................  .......  .......        X  .......         
2338..    52415  Mr. Rohrabacher, CA...............................  .......  .......  .......        X         
407...    53915  Mr. Roemer, IN....................................  .......  .......        X  .......         
2404..    56316  Mr. Schiff, NM....................................  .......  .......  .......        X         
236...    54801  Mr. Cramer, AL....................................  .......  .......  .......  .......         
2264..    52002  Mr. Barton, TX....................................  .......  .......  .......        X         
1410..    58171  Mr. Barcia, MI....................................  .......  .......        X  .......         
1034..    51986  Mr. Calvert, CA...................................  .......  .......  .......        X         
217...    56411  Mr. McHale, PA....................................  .......  .......        X  .......         
1724..    51880  Mr. Baker, CA.....................................  .......  .......  .......        X         
325...    58220  Ms. Harman, CA....................................  .......  .......  .......  .......         
322...    52721  Mr. Bartlett, MD..................................  .......  .......  .......        X         
1123..    58885  Ms. Johnson, TX...................................  .......  .......  .......        X         
1717..    53831  Mr. Ehlers, MI....................................  .......  .......  .......        X         
1415..    52331  Mr. Minge, MN.....................................  .......  .......        X  .......         
423...    53271  Mr. Wamp, TN......................................  .......  .......  .......        X         
1027..    55335  Mr. Olver, MA.....................................  .......  .......        X  .......         
216...    53671  Mr. Dave Weldon, FL...............................  .......  .......  .......        X         
1039..    51313  Mr. Hastings, FL..................................  .......  .......  .......  .......         
1429..    55301  Mr. Graham, SC....................................  .......  .......  .......        X         
1116..    56261  Ms. Rivers, MI....................................  .......  .......        X  .......         
115...    52635  Mr. Salmon, AZ....................................  .......  .......  .......        X         
1232..    54535  Ms. McCarthy, MO..................................  .......  .......  .......  .......         
415...    51492  Mr. Davis, VA.....................................  .......  .......  .......        X         
1032..    55401  Mr. Ward, KY......................................  .......  .......        X  .......         
417...    56565  Mr. Stockman, TX..................................  .......  .......  .......        X         
118...    53072  Ms. Lofgren, CA...................................  .......  .......        X  .......         
425...    52472  Mr. Gutknecht, MN.................................  .......  .......  .......        X         
126...    54865  Mr. Doggett, TX...................................  .......  .......        X  .......         
1216..    53601  Mrs. Seastrand, CA................................  .......  .......  .......        X         
1218..    52135  Mr. Doyle, PA.....................................  .......  .......        X  .......         
1319..    56216  Mr. Tiahrt, KS....................................  .......  .......  .......        X         
1520..    53816  Ms. Jackson Lee, TX...............................  .......  .......  .......        X         
410...    52211  Mr. Largent, OK...................................  .......  .......  .......        X         
1419..    52271  Mr. Luther, MN....................................  .......  .......        X  .......         
114...    56831  Mr. Hilleary, TN..................................  .......  .......  .......        X         
1114..    52311  Mrs. Cubin, WY....................................  .......  .......  .......        X         
506...    55792  Mr. Foley, FL.....................................  .......  .......  .......        X         
509...    51976  Mrs. Myrick, NC...................................  .......  .......  .......        X         
                                                                    ------------------------------------        
                       Total.......................................  .......  .......       16       27         
----------------------------------------------------------------------------------------------------------------

            H.R. 9 Amendment Offered By Mr. Barton of Texas

    After subtitle C, insert the following new subtitle and 
make the necessary conforming changes:

                     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(c)(2), 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(c)(2), 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(c)(2), 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 persons with a direct financial interest 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 therefore.
    (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) he or she had a direct financial interest in 
        subject of the petition,
          (B) the petition included adequate supporting 
        evidence, and
          (C) 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.


MARK UP ON OVERSIGHT AGENDA CONSIDERATION OF TITLE III RISK ASSESSMENT 
    AND COST/BENEFIT ANALYSIS FOR NEW REGULATIONS OF H.R. 9 THE JOB 
               CREATION AND WAGE ENHANCEMENT ACT OF 1995

                              ----------                              


                      WEDNESDAY, FEBRUARY 8, 1995

                     U.S. House of Representatives,
                                      Committee on Science,
                                                    Washington, DC.
    The Committee met at 10:12 a.m., in Room 2318 of the 
Rayburn House Office Building, the Honorable Robert S. Walker, 
Chairman of the Committee, presiding.
    The Chairman. The Committee will come to order.
    Today, the Committee is convened to conduct several items 
of important business: to adopt its Oversight Agenda, as 
required by the rules of the House; to mark up Risk Assessment; 
and the hydrogen research legislation.
    Although these may on the surface appear to be disparate 
issues, they do have one thing in common--they are focused on 
the future of this Committee and on the future of the country.
    The Oversight Agenda is this Committee's plan of action 
over the next two years. It sets out a blueprint for 
comprehensive examination of the issues under the jurisdiction 
of the Science Committee.
    The Risk Assessment bill, at long last, puts the Federal 
Government role in determining and communicating risk into 
perspective. For too long, the burden of regulation has fallen 
squarely on the backs of the regulated. And ultimately, on 
consumers.
    Title III of H.R. 9 finally puts some balance back into the 
system by requiring regulators to assume the responsibility of 
assuring that the regulations are drafted on the basis of sound 
science.
    In my view, the most important section of this legislation 
is the risk characterization and communications sections. It is 
important that not only decision-makers understand the real 
hazards that are encountered in our daily lives, but that the 
members of the public-at-large also understand the risks which 
face us.
    In the final analysis, each one of us in a free society are 
our own ultimate risk-assessors.
    Finally, the Hydrogen Future Act of 1995 is about doing 
research now on a fuel of the future. Surely, we are better off 
spending scarce dollars in developing a clean, renewable fuel 
than on funding a complex regulatory process.
    I would now yield to the Ranking Minority Member of the 
Committee, Mr. Brown.
    Mr. Brown. Thank you very much, Mr. Chairman.
    I commend you for moving ahead on these important items. I 
think that we are in substantial agreement on the Oversight 
program which has been proposed, and we certainly would like to 
be cooperative in instigating a vigorous oversight program.
    We have shared your concern over hydrogen in the past and I 
think, with a little cooperation, we can work out a suitable 
hydrogen bill. And I offer my full cooperation in attempting to 
do this with the Chairman.
    On the risk bill, Mr. Chairman, I have very, very 
substantial reservations. I ask you if you can engage in a 
flight of fancy. To imagine that we were back in the good old 
days of the last Congress and you were presented with a piece 
of important legislation and told that we had to get that 
through in a time certain.
    You hadn't yet seen the bill. You ask for a postponement in 
order to review it. You did not receive acceptance of that.
    You ask for an opportunity to see the bill at the earliest 
possible date and you still haven't seen the bill.
    What tactics would you use at that point to demonstrate 
that you, as an important member of the Minority, were not 
going to be run over roughshod by an uncaring Majority which 
was bent on ramming through a piece of legislation which had 
not even seen the light of day yet?
    That may be difficult for you to do, but I know that you 
have the ability to do it. I know you can envision precisely 
what tactics you would use. And I would ask you if it would not 
be better if you were to allow the Minority, in this particular 
case, based upon your own previous position on minority rights, 
to have an opportunity to study the bill, to cooperate with the 
Minority in achieving some acceptable amendments, and to 
postpone further efforts to mark this bill up for some 
reasonable period of time.
    Maybe a week. Maybe even 24 hours.
    I know the gentleman is under compulsion to move this bill 
and I ask you to consider very carefully the point that you may 
not be able to keep every bill that you want to keep on 
schedule, on schedule. And that at some point, you're going to 
have to accept the inevitable and ask for an opportunity in 
your own leadership to do a good job, instead of a haphazard 
job and take another few weeks, another month, in order to 
accomplish some of the things that need to be done.
    I ask that with full respect for all the pressures that are 
on you, Mr. Chairman. But the current situation with regard to 
the Risk bill is utterly impossible, from my standpoint, and I 
think most members of the Minority share that view.
    We have not even seen a draft of your en bloc amendments 
until this morning. You have consistently said that you 
expected to receive at least 24 hours' notice, and I presume 
you meant to say that you would give 24 hours' notice of what 
the text of a bill was, or other important action.
    That has not been done in this case and we're not very 
happy with it.
    Now I can elaborate on that. But rather than do so, I'll 
conclude my remarks and ask that I be permitted to extend them 
in the record.
    The Chairman. Without objection.

     OPENING STATEMENT REPRESENTATIVE GEORGE E. BROWN, JR.

    Mr. Chairman, I realize that this is the first mark-up that 
you have presided over in this Congress. I hope that the 
process that we have followed in consideration of this bill is 
not representative of the way that we will proceed in the 
future.
    Mr. Chairman, this is an important bill. It proposes 
serious changes in the way that we have passed regulations over 
the last twenty years to protect the environment, consumers, 
and workers. It deserves thoughtful scrutiny and honest and 
open debate. Unfortunately, that has not happened. Although we 
were assured that this legislation was going to be thoroughly 
examined before we proceeded to mark-up, the fact is that this 
bill is being rushed through the Committee without a serious 
opportunity to consider it or to negotiate our differences.
    Let me point out that the hearing record on this bill is 
still open, and we have not even had time to receive responses 
to my requests for information from more than half of the 
agencies who will be required to implement this legislation. I 
don't think that any of us can truthfully say that we fully 
understand the implications of this legislation. While it is 
true that we had hearings in prior Congresses, this bill--and 
the Walker amendment--go far beyond anything the Committee has 
previously considered. Further, about half of this Committee is 
new to this Congress and have not had the benefit of our past 
debates.
    Indeed, this bill has far more to do with economic and 
financial analyses than with scientific ones. I am particularly 
disappointed by the latter characterization. I have always 
thought of science as a tool to be used to educate and inform 
us and to improve our quality of life. In this bill, science is 
relegated to the role of a deregulatory handmaiden.
    I will again state my sincere belief that we should work to 
improve the regulatory process. I believe that scientific and 
economic information, and analyses such as risk assessment and 
cost-benefit analyses are useful tools that can assist us in 
designing a regulatory system that is cheaper, better, and 
faster. I regret that we have not had an opportunity during the 
development of this bill to pursue this important goal.
    The minority have never been consulted about this bill, 
despite our assurances of willingness to work together. The 
Administration has never been consulted about this bill, 
despite its willingness, expressed at last Friday's hearing, to 
work with you in developing a legislative vehicle. We were 
anticipated the receipt of a copy of the mark-up vehicle and 
amendments to be offered by Majority members on Monday evening. 
However, our staff did not see ``draft'' amendments until 6 
p.m. last night; other amendments we have seen for the first 
time this morning. It is disappointing that the Walker 
amendments introduce at the very last hour major changes, 
including wholesale revisions of definitions, back-door repeals 
of laws that have been written by Congress over the last 20 
years to protect consumers, workers, and the environment, and 
fundamental changes in the standards under which courts review 
agency actions.
    We expect to be here for quite a while this afternoon 
because we have a great number of questions about the 
amendments. The cursory examination of the amendments that time 
permitted me, left me wondering where in the hearing record are 
the bases for these proposals? I hope that we will be able to 
clarify the intent of these suggested changes as we move along 
today.
    I realize that many of the majority Members promised to 
complete the Contract legislation within the first 100 days of 
this Congress. I made no such promise, nor would I have. If 
this bill is enacted in close to its present form, I doubt our 
constituents will be consoled by the fact that we did not use 
any additional time to produce it. It is easy enough to make 
mistakes even when legislation is well thought out and fully 
debated, as many have pointed out in regard to our regulatory 
statutes. A fast-track process such as we have experienced with 
this bill is certain to result in more unintended than intended 
consequences.
    By treating Committee business in such cavalier fashion 
Members are abdicating their legislative responsibilities. 
Hearings and mark-ups at the subcommittee and full committee 
levels all serve as important points at which we gather 
information, hear views of those who will be impacted by the 
legislation under consideration. They provide an opportunity 
for all Members to exchange their thoughts and perspectives 
with each other so that areas of common concern and consensus 
for action can be identified. We lose much more than time when 
we do not take advantage of the opportunities that Committee 
activities provide.
    The past operating procedure of the Committee was that the 
Minority received the bill the night before. My understanding 
is that it was delivered to your staff yesterday at 6:00, and 
that this is exactly the same pattern that we operated under in 
the past, and that we will proceed ahead with this.
    We are, in fact, because we showed it to you early and 
understood that you would object to the handling of the en 
block amendments, we are in the process of redrafting into a 
substitute to satisfy the concern of the Minority.
    We will recess the Committee at an appropriate time here in 
order to give members an opportunity to look at the substitute. 
It would in fact incorporate the en bloc amendments, which have 
been available since last night.
    So we are going to try to give people an opportunity to 
digest this. But we are proceeding in exactly the same manner 
that the previous majority proceeded on these kinds of issues.
    With that----
    Mr. Brown. Would the gentleman allow me just a brief 
rebuttal?
    The Chairman. Sure. I'd be happy to.
    Mr. Brown. We could quibble over whether we received the 
documents last night at 6 o'clock. I don't think the 
Legislative Council finished drafting them until midnight.
    But, nevertheless, what the gentleman proposed to do was to 
offer about 50 amendments in the form of en bloc amendments 
covering 16 pages, in violation of the rules of the Committee.
    We indicated that we would object to this, and now the 
gentleman proposes to redraft them in a proper form and submit 
them to us. Obviously, we haven't seen the redraft. We assume 
that it will include what he has in the en block amendments.
    But let me say that there have been so many changes in the 
en bloc amendments, I can't accept anything as being for sure 
until I actually see the document in proper form.
    The Chairman. Well, I thank the gentleman for that. It is 
the indication of the Chair to assure members that what was in 
the en bloc amendments is in fact what is being redrafted into 
the bill.
    But because of the gentleman's suspicion and his 
unwillingness to accept the Chair's word on that, we are in 
fact, as I say, going to redraft the bill and make it available 
so that members can assure themselves that that is precisely 
what the Committee intends to do.
    I don't want to have anybody feel as though they don't have 
an opportunity to see the legislation. And so that is the way 
in which we proceed.
    As to the gentleman's point that we never submitted to the 
wishes of leadership when the other majority was in place, I 
remember well debating issues like proxy voting, where the 
gentleman would assure me over and over again that he was in 
fact in favor of getting rid of proxy voting, but his 
leadership simply wouldn't let the Committee move in that 
direction.
    In my case, the leadership has a schedule that they wish to 
keep and it is important to us to maintain that schedule.
    I think that we have an obligation, as the Majority here, 
to do that, and are prepared to move head.
    We obviously would like to have the cooperation of all 
members in moving forward because I think that these are 
important issues to address. But it is our intention to move 
ahead and to move forward.
    With that, I would proceed on to adoption of the Oversight 
Agenda, which is before the Committee. Members have before them 
the proposed Oversight Agenda for the 104th Congress.
    This is the first time that we have done this kind of 
setting of an Oversight Agenda. It reflects the rules change 
that was made to highlight the importance of the Committee's 
oversight activities.
    We have solicited input for this agenda from all members on 
both sides and have incorporated, I think, virtually all the 
suggestions that were given to us by members in a timely manner 
into the document.
    This will be submitted to the Committees on House Oversight 
and Government Reform as an indication of the ways in which we 
intend to proceed.
    The agenda is a plan for reviewing those programs under the 
Committee's jurisdiction. The oversight will be conducted in a 
number of ways. And I want the members to understand this 
point.
    It will include, but will not be limited to, hearings, 
briefings, correspondence, and information requests. This 
Oversight Agenda is not just a schedule for hearings that will 
be held by the Committee. There are a number of different ways 
in which the Committee pursues its Oversight Agenda, and this 
document indicates the topics that will be a part of the 
overall oversight work of the Committee.
    This is not all-inclusive, nor is it final. Additional 
crisis-oriented or emerging topics will be identified as they 
are appropriate to this Committee's work.
    I would yield to Mr. Brown for further discussion, and then 
to any other members that might wish to be recognized.
    Mr. Brown. Mr. Chairman. I understand that there has been 
staff cooperation in the compiling of this list and that the 
items that we thought could be added were not objectionable to 
the people, the staff members on your side.
    I know that there's no particular magic in listing these 
items. They can either be pursued aggressively or not 
aggressively, as we have the opportunity and the motivation.
    But I would like to offer the amendments to the Oversight 
Agenda which I understand were discussed and agreed to on your 
side.
    The Chairman. Well, I would say to the gentleman, I've 
opened the matter for discussion at the present time on kind of 
the overall issue.
    We will move to the amendment process in a timely manner. 
At that point, I will certainly be glad to consider the 
amendments, and those that we've agreed to, we would certainly 
be willing to consider en bloc.
    Mr. Brown. Let me just in brief say that we concur with 
your desire to proceed with an aggressive oversight plan. We 
will do everything we can to assist. And we look forward to the 
strong cooperation between both sides on this aggressive 
agenda.
    The Chairman. I thank the gentleman for that.
    Mr. Sensenbrenner.
    Mr. Barton. Mr. Chairman.
    The Chairman. Mr. Barton.
    Mr. Barton. I'd just like to commend you for putting this 
agenda together. I'm the subcommittee chairman on oversight and 
investigation on the Energy and Commerce Committee and I can 
tell you it's a different task to try to determine the schedule 
and the subjects that should be reviewed.
    I think you and your staff, in conjunction with the 
Minority staff, have done an outstanding job of clarifying and 
codifying what this Committee's oversight role is going to be. 
And I just want to commend you on that.
    The Chairman. I thank the gentleman.
    Mr. Traficant.
    Mr. Traficant. From what I understand, there's no 
contentious points on any of these amendments, save for one 
that I have brought. And mine deals with the fruits of American 
research trickling down to American firms. And I understand the 
Chair has a concern about the definition of what those U.S. 
firms really are.
    It is not my intention to exclude those corporations that 
do business in America and hire Americans. And I am open to 
accommodate those types of changes to the thrust.
    But I'd just like to say before we get into this matter, 
this may be the only contentious matter. And my concern is that 
we pay an awful lot of money through federal research for our 
gains in technology. And much of that then trickles down to the 
benefit of foreign companies and foreign nations that enjoy 
great surpluses with us.
    The thrust of my language is simply to try and focus as 
much as possible for that trickle-down to benefit American 
firms.
    So I am not opposed to those corporations, foreign firms 
that are doing business in America and hiring American workers. 
And I would be willing to consider those changes.
    But I just wanted to make that point and I wanted to say, 
Mr. Chairman, that, overall, I wanted to commend you, as Mr. 
Barton did, for your position here on oversight and hope that 
there can be some medium of approveability to that concern that 
I have.
    The Chairman. Well, I thank the gentleman. He does help 
clarify the matter.
    The Chair would ask for just as a purpose, that when we 
give members an opportunity to work with us in advance, that it 
would be helpful to have these issues come before us so that we 
can have these kinds of discussions and resolve these kinds of 
questions.
    If the gentleman is assuring me that there is no attempt 
here to try back us out of participation in the global 
marketplace, that it's simply an assurance that our R&D is in 
fact benefiting firms that do business in this country, I see 
no particular problem with that in this sense.
    I do want to make certain that those things that we do 
recognize that research and development, as well as business 
these days, is in fact a global enterprise and that science 
always has been something which the data has been generally 
shared across the world and has not been nationalized.
    And so, I just want to make certain that anything that 
we're doing here does not get in the way of kind of long-
standing traditions, and certainly the opening of the global 
economy.
    Mr. Traficant. Would the Chairman yield?
    The Chairman. Sure. I'd be happy to yield.
    Mr. Traficant. Certainly, no intention to the contrary to 
anything that you've spoken. But I would like to say that we 
come up with billions of dollars of research and many times 
that technology is used against us, and we're at a major trade 
deficit in this world economy.
    And I would just like to see some emphasis being placed on 
a reasonable approach to having some of that research 
investment trickle down to the benefit of America and our 
ability to compete in that global marketplace.
    So it is a bona fide intention not to obstruct, and I would 
welcome any supportive language that you could fashion and 
would welcome it.
    The Chairman. I would say to the gentleman, all we're doing 
is adopting an Oversight Agenda here, and with his assurance 
that that Oversight Agenda is in fact a broad one on this 
topic.
    Obviously, the work of this Committee is aimed at assuring 
that the science that we develop in this country is used 
insofar as possible to the benefit of this country. And that is 
the overall mission of the Committee.
    It sound to me as though the gentleman's language fits in 
with that very well, and so we can probably include that as a 
part of the en bloc.
    Mr. Hayes. Would the gentleman yield?
    The Chairman. Sure, I'll be happy to yield to the gentleman 
from Louisiana.
    Mr. Hayes. Mr. Walker, is it not correct that with your 
approval as Chair, that if Mr. Barton and Mr. Traficant were to 
get together on the subject nature of a hearing on this, that 
you could in fact approve that with or without its inclusion 
today in the Oversight Agenda, as the substance of a hearing to 
be chaired by Mr. Barton?
    Would you not have that authority?
    The Chairman. I think Mr. Barton is making the point that 
he in fact has jurisdiction on some of these matters at the 
Commerce Committee, rather than here.
    But the fact is, as I stated earlier, that this is not an 
inclusive list. This is strictly a list of items that we are 
committing ourselves to at this point.
    But just because some item is not on this list doesn't mean 
that the Committee may not have an opportunity to deal with it 
in the future.
    Ms. Harman.
    Ms. Harman. Mr. Chairman, I would like to state my 
enthusiasm for this Oversight Agenda. I'm sure Mr. Brown's 
additions will be good, too.
    But this line of approach I think finally fulfills much of 
the promise of this Committee. Our legislative jurisdiction is 
not vast, but our oversight jurisdiction and our ability to 
discuss these critical issues that will be central in the 21st 
century, which is only five years off, is vast.
    And so, I commend you for putting this together this way 
and I hope that we will proceed in this direction.
    The Chairman. I thank the gentlelady.
    Mr. Weldon.
    Mr. Weldon of Pennsylvania. Thank you, Mr. Chairman.
    I too want to applaud you for this agenda. It's aggressive, 
but I think it's certainly timely and fitting for the 
jurisdictional responsibilities of this Committee.
    I just want to note for the record that as the current 
chairman of the Research and Technology Subcommittee of the 
National Security Committee, that I have offered--and I 
understand that we have at least some general agreement on 
conducting joint hearings on areas where the jurisdiction of 
this Committee overlaps, or in fact interconnects with the 
jurisdiction of the Research and Technology Subcommittee of the 
National Security Committee.
    So, hopefully, we can have that joint effort throughout the 
next two years on issues that in fact are under the DoD budget, 
but certainly have science and technology implications.
    The Chairman. I thank the gentleman for his remarks.
    If there is no further general discussion, the Chair would 
open the Oversight Agenda to amendment at this point, and would 
welcome the Ranking Minority Member taking those items that he 
wishes to and putting them en bloc, and then, again, we can 
have discussion on the various items, if that's the will of the 
Committee.
    I would recognize the gentleman from California.
    Mr. Brown. The distinguished Chairman is not trying to trap 
me into offering a long series of complicated amendments en 
bloc in order to set a precedent for what he's trying to do on 
another bill.
    The Chairman. The gentleman is entirely too suspicious. 
[Laughter.]
    Mr. Brown. Mr. Chairman, I offer the four items listed on 
the package in front of you as additional items for oversight 
by the Committee.
    The Chairman. Is there any discussion on the amendment en 
bloc offered by the gentleman from California?
    [No response.]
    Hearing none, I would entertain a unanimous consent request 
that the amendment en bloc be approved.
    Mr. Traficant. Mr. Chairman, I ask unanimous consent the 
amendment en bloc be approved.
    The Chairman. Without objection--well, let me ask whether 
or not we have any other amendments to the oversight----
    Mr. Brown. I was just going to say that I understand one of 
our members may have an additional item.
    Ms. Jackson. Mr. Chairman, I wanted to inquire whether or 
not we could have by unanimous consent to add to those 
utilization of women and minorities in science-related 
businesses.
    The Chairman. Well, we have just approved the women and 
minorities in science amendment as a part of the en bloc 
amendment.
    Ms. Jackson. And that's why I was adding in science-related 
businesses.
    The Chairman. Understanding that this is a general 
oversight agenda, that particular item would certainly be 
included under Amendment No. 4 listed on the roster.
    Ms. Jackson. That's all I would ask, is that you'd have 
your commitment that we could look at those issues.
    The Chairman. Sure.
    Ms. Jackson. Thank you.
    The Chairman. That would be included in that overall.
    Ms. Jackson. Thank you.
    The Chairman. Are there any other amendments to the 
oversight agenda to come before the Committee?
    [No response.]
    If not, I would turn to the gentleman from California for a 
motion.
    Mr. Brown. Mr. Chairman, I move that the Oversight Agenda 
for the Committee on Science for the 104th Congress be adopted 
as amended, that the staff be instructed to make the necessary 
technical and conforming changes, and that the agenda be 
forwarded to the Committees on House Oversight and Government 
Reform in accordance with House Rule X2D1.
    The Chairman. The motion has been heard. All of those in 
favor, say aye.
    [A chorus of ayes.]
    Those opposed, no.
    [No response.]
    The ayes have it. A quorum being present, the Oversight 
Agenda is approved.
    I am informed by staff that the Legislative Council is in 
the process of delivering the substitute amendment on Risk 
Assessment at the present time.
    It is the intention of the Chair to recess the Committee 
for a period of time so that members do have an opportunity to 
look at that particular amendment and have time to digest it.
    So, therefore, we hope to have that in hand and hope to 
have it reviewed by 11:00 o'clock. It is the Chair's intention 
to give members then two hours to have an opportunity to review 
it before we go into a marathon session to consider other 
amendments that may come before the body.
    And so----
    Mr. Brown. Mr. Chairman.
    The Chairman. I yield to the gentleman from California.
    Mr. Brown. Mr. Chairman, I hope that the Chair understands, 
and I want the members to understand, that our request for time 
to review this is not something that is engaged in or put 
forward for the purpose of creating delay or obfuscating the 
basic situation that we're in.
    The fact is that it is very difficult to amend the en bloc 
amendment, and that's why the rules require unanimous consent 
to do that.
    We have a series of what we think are constructive 
amendments on our side. They can be offered much more readily 
to the substitute, and that's what we propose to do.
    But we need now to redraft our amendments to conform to the 
language of the substitute which we have not yet seen. So we 
need an opportunity to review it and then to redraft our 
amendments.
    That is the purpose lying behind our request for an 
adequate amount of time.
    Now, we do not know at this point whether a delay which may 
or may not be up to as much as two hours will allow us to go 
through this fairly complicated process. Our amendments are 
drafted, but they all have to be conformed to the new language.
    We would prefer 24 hours. As you know, the Committee on 
Commerce delayed their mark-up from Tuesday until today because 
of similar reasons.
    But if you feel that two hours is the most you can give, I 
want it fully understood that we may not be able to do the kind 
of workmanlike job that we think ought to be done on this bill.
    And I'm putting that to you for your consideration.
    The Chairman. Well, the reason why the Chair decided to go 
the en bloc route was so that we could share all of these items 
with the Minority in advance.
    I understand that that does require unanimous consent and 
that you were well within your rights to suggest that that was 
not something that you were willing to proceed with.
    That is the reason why the Chair has gone back and drafted 
a substitute.
    I repeat again that the substitute will reflect that which 
was in the en bloc amendments, so the subject matter should be 
familiar with you from last night's discussion, last night's 
material.
    With regard to the business of making certain that the page 
numbers and line numbers are right, the Chair is not going to 
be picayune about those kinds of questions. It is subject 
matters and we'll see to it that they're plugged in at the 
right point. And if we have to have corrections made as the 
amendments are being distributed to members to put the right 
page numbers and so on in, we are certainly going to permit 
that to take place.
    So that I would hope that in a timely manner, we can 
proceed ahead.
    But it is the Chair's intention to proceed ahead with the 
mark-up on the bill. We have attempted to accommodate the 
Minority with regard to hearings. We did schedule an extra set 
of hearings at your request. I think it was a valuable 
addition. We learned a lot and we've incorporated some of that 
into the substitute.
    So we will continue to try to cooperate insofar as we can, 
but we do have obligations that we have to meet and it is the 
Chair's intention to meet those obligations.
    I'd be happy to yield to the gentleman.
    Mr. Brown. The gentleman knows the high regard I have for 
him and his sense of fairness, and we will try and observe that 
at all times.
    I would point out to the gentleman that we pointed out the 
difficulties to him on Friday of this process and asked and 
informed him that we would ask him to abide by the rules in 
this matter. And we still didn't get the fruits. We didn't get, 
for example, an affirmation that you would follow the route 
which the rules require until right today, as a matter of fact.
    The Chair was of course correct in stating that we received 
an additional day of hearings. I might point out that that, 
too, is required by the rules.
    What I'm saying to the gentleman is he's been meticulous in 
making sure that we got what the rules require we get, but not 
one iota more.
    Now he may think that that is an example of outreach and 
cooperation. We think that it is good judgment on his part to 
observe the rules.
    The Chairman. I thank the gentleman for that and I assure 
him that we have in fact followed the rules and will continue 
to do so, so that all members, both Majority and Minority, are 
appropriately protected.
    Mr. Rohrbacher. Mr. Chairman?
    The Chairman. I'd be happy to yield to the gentleman from 
California.
    Mr. Rohrbacher. I think it's important for us to note at 
this time and juncture of the discussion that the Chairman is, 
number one, being very scrupulous in his going by the rules and 
making sure all the rules are being met.
    But also, he's being very diligent in making sure we move 
forward this piece of legislation.
    As the Minority, as well as the Majority, realizes, we have 
set a deadline in this first 100 days of accomplishing certain 
things in Congress. And after this 100 days, when we have 
accomplished that legislative agenda, I'm sure that the 
Chairman will be much more inclined towards giving the Minority 
even more time than is legally required for them to get.
    But in this case, the Chairman is absolutely right, that 
the Majority has to be diligent. We have made an agreement with 
the people. We said this during the last election, we would 
accomplish certain legislative items within a certain period of 
time.
    The Chair is abiding by the rules, but being very diligent 
and moving the legislation along is appreciated.
    Mr. Brown.  Would the gentleman yield briefly?
    Mr. Rohrbacher. I yield to my former chairman, Mr. Brown, 
sure.
    Mr. Brown. I understand what the gentleman has stated. And 
while I think that's wrong, I'm not anxious to delay this. I'm 
offering to cooperate in every way possible.
    Our effort would be to have as good a product for you as 
possible. And I'll tell you very frankly, that in many cases, 
in strategy debates within the Democratic side, we have debated 
whether or not we ought to screw you up by letting you go ahead 
and do what you're doing. [Laughter.]
    But the point that I would like to make with regard to your 
comment that at the end of the 100 days you're going to give us 
more time, at the end of the 100 days, you're going to rest.
    this is the biblical way. [Laughter.]
    The Chairman. I would only say to that, I hope so. 
[Laughter.]
    But let me also comment to the gentleman that the problem, 
of course, that we face is that the rules also require things 
after the process finishes here.
    We are going to be meticulous in giving everyone their 
chance for three days on the report and a number of other 
items, which means that even after the bill leaves the 
Committee, there are about ten days before you can possibly 
bring it to the floor.
    On the schedule that we are proceeding under, that does 
compress our time fairly substantially and means that we do 
have to accomplish some of these things in a timely manner, so 
that we can be assured that we can be on the floor at the time 
that we have been assigned by the leadership.
    Let me go to Mr. Roemer, and then come back to a couple of 
other members.
    Mr. Roemer. Mr. Chairman, let me just preface my remarks by 
saying that I certainly recognize your timeframe and the need 
to move in a quick fashion, given what the Contract for America 
says.
    Let me also preface my remarks by saying, I come from a 
position on both these bills as strong supporters of both Risk 
Assessment and the Hydrogen bill.
    Risk Assessment--many of us on this side fought rules put 
together by our own party last year because they did not 
consider the opportunity for us to attach Risk Assessment to 
the elevation of EPA as a new Cabinet-level agency.
    We believe strongly in this legislation.
    But that does not, I would hope, preclude us from the 
possibility of reading the legislation and amending it. I am 
not suggesting any kind of dilatory tactics here.
    Much was made last year by people on both sides of the 
aisle about crime bills that would come to us with six hours of 
preparation on the floor of the House and we couldn't read it, 
we couldn't amend it. We'd have to vote on it a couple of hours 
later.
    A similar fashion I think might be repeated today if we 
only get the legislation a few hours before we are seriously 
supposed to consider it, intellectually amend it, improve it, 
modify, it. And again, I am coming at this as a supporter, as 
somebody that will probably vote for final passage of both 
bills.
    We just had hearings on both these bills in the last couple 
of weeks. For instance, on Hydrogen, I intend to offer a couple 
of amendments based upon the hearings and suggestions in the 
hearings last week. I'm hopeful that you will agree to those 
amendments, and they won't even be controversial.
    But on Risk Assessment, I think that we can work together 
to improve it as well.
    And I think that Mr. Brown is not saying we want to wait 
two weeks. I think we just want to have time to read it.
    Maybe a suggestion would be that we bring up Hydrogen first 
and get to Risk Assessment later today or first thing in the 
morning.
    But in no way am I trying to delay either your first 100 
days or this legislation. I am just trying to make the point 
that I think that there are some bipartisan things that we can 
do in a committee process to try to improve both bills.
    The Chairman. Well, I thank the gentleman for his 
statement. I don't think the Chair has indicated in any way 
that he believes that anybody is engaging in dilatory tactics 
here.
    I am not reviewing the amendments that the Minority has put 
forward. I agree with some of them. I don't agree with others 
of them.
    I think we need to have that debate.
    But in all cases, the amendments that I have seen thus far 
have been valuable additions to the debate and I think will 
help us better understand the bill.
    I don't see any need based upon the fact that the Minority 
has been able to put together a series of what I think are 
fairly substantive amendments, to delay the consideration and 
the debate on those amendments because, in most instances, 
these are exactly the same issues that we debated in the last 
Congress before we reported legislation. There may be 
difference in detail in some elements of the bill, but, again, 
that's the reason why we want members to have some time to 
understand it here, and we are prepared to give you a couple of 
hours to do that.
    But there is obviously a good enough understanding that 
some very reasonable amendments and valuable amendments have 
been put together.
    As I say, I may not agree with all of those, but the fact 
is I think they are going to inspire very useful debate about 
the nature and content of this bill.
    I don't see any particular reason to delay moving forward 
with that debate.
    Mr. Baker. Mr. Chairman.
    Mr. Baker of California.
    Mr. Baker. Is it the Chairman's intention, then, to 
reconvene in two hours and accept the Minority's amendments as 
written for debate, without renumbering, repaging, all of the 
tedious work that needs to be done?
    The Chairman. Yes. It's the Chair's view that the Minority 
amendments in fact go to the policy within the bill that the 
substitute is going to have those policies.
    And I would urge the members of the Majority not to get 
into any kind of technicality debate here on whether or not 
it's properly numbered.
    In other words, to facilitate the debate, I'm going to 
allow the numbers and so on to be changed in terms of page 
numbers and that sort of thing without engaging in some 
argument over technicalities.
    Mr. Baker. All right. And as the Chair who worked with the 
former chairman on these two bills last year, both of which, I 
believe, got on the floor and out of this Committee, would it 
be your intention to review the status as we go along to see if 
there's any areas of misunderstanding that need more time?
    The Chairman. Well, I think we've tried to do that. That's 
the reason why we did try to get the information to the 
Minority last evening.
    In all honesty, I did not have a chance to go over some of 
the negotiations that have taken place with the Commerce 
Committee until about 5:00 o'clock last evening myself.
    Mr. Baker. Right. But since this issue----
    The Chairman. And soon, as soon after that, that I got my 
chance to review the final nature of the language, that it was 
shared with the Minority as well.
    Mr. Baker. But since this issue has been before us for two 
years, some members notwithstanding, and the details are pretty 
well beaten out, it's your intention to start the debate and 
see how we go as we move along.
    Is that right?
    The Chairman. That is my intention. And my intention is to 
go today until we have completed action on the bill.
    Mr. Barton.
    Mr. Barton. Mr. Chairman, I want to make all the members 
aware of something that they may already be aware of. But the 
identical bill with almost identical amendments in many 
sections is being marked up today in the Energy and Commerce 
Committee, and apparently is going to be done simultaneously, 
since we're going to take this break.
    Now I have two questions. Number one, what would happen if 
for some reason we didn't finish our mark-up? Would we go 
with--assuming that the other committee finishes their mark-up, 
is that the document that goes to the Rules Committee?
    And number two, if we do intend to finish it, do you intend 
to finish it today, even if we're here until midnight?
    The Chairman. Well, I would say to the gentleman that it is 
my intention of finishing the bill today.
    We are the primary committee of jurisdiction on this 
legislation. If we report a bill, our bill will be the primary 
bill taken before the Rules Committee. The Commerce Committee's 
bill will be a part of that consideration as well.
    If in fact we did not report a bill from this Committee, we 
would lose our jurisdiction, our primary jurisdiction, and at 
that point, the Commerce Committee's bill would become the 
operative bill.
    Mr. Barton. So it is important that we have a work product.
    The Chairman. Well, insofar as we want to be the lead 
committee on the floor with the bill, it seems to me that we do 
want to complete our work and move it forward, yes.
    Mr. Barton. Thank you.
    Mr. Brown. Would the gentleman yield briefly to me?
    The Chairman. Certainly, I'd be glad to yield to the 
gentleman.
    Mr. Brown. I understand the parliamentary situation to be 
that no bill can go forward unless we report a bill or we are 
discharged from the consideration of that bill.
    I agree completely with the gentleman that it's in our best 
interest to move forward with a bill, even though it may be 
substantially equivalent to the Commerce Committee bill.
    I understand also the difficulties in the liaison between 
the two committees. I will say that my understanding is that 
the Commerce Committee members had the substance of the 
substitute that the gentleman is proposing last Friday and, 
nevertheless, postponed their Tuesday mark-up until today.
    We sense that there is a certain confusion here. We do not 
blame anybody for it. We would like to help alleviate it, as a 
matter of fact, and go forward with a good bill from our 
Committee that can be the vehicle for action on the floor.
    I have at no time assumed that the Chairman was 
deliberately trying to obfuscate this process. I have too much 
respect for him to think that. Just as he recognizes that we 
have made a good-faith effort to draft sound amendments to the 
bill.
    But, nevertheless, it has been a rather hectic process and 
we would like to see that improve.
    It is not quite correct to say that we have substantially 
addressed the substance of this bill in prior Congresses. For 
one thing, a third of the members of this Committee are new and 
have never had an opportunity to address this bill. For another 
thing, two-thirds of the provisions of Title III are new and do 
not include what we discussed, which is Part A of Title III, in 
the last Congress.
    But despite that, there are large overlaps. The subject 
matter has not only been addressed in the last session, but 
occasionally, over the last 15 years, and has been 
controversial during all that period of time.
    I think it's only fair to point out that new members and 
those who never really understood the issue before really ought 
to have a little time, if it can be arranged within the 
constraints of the schedule that the Chairman is compelled to 
follow.
    Mr. Barton. Would the gentleman from California yield on 
that point?
    Mr. Brown. The Chairman has the time.
    The Chairman. Well, let me just point out to the gentleman, 
and then I will come to the gentleman from Texas, that I 
believe that we have followed exactly the same process that the 
Commerce Committee followed on this matter. The Commerce 
Committee, though, had a day earlier schedule.
    The fact is that there were briefings of LAs and so on the 
end of last week on the mark-up vehicle that was going to be 
before this Committee.
    That has been changed somewhat. It is my understanding that 
the Commerce Committee was shared a draft of the amendments or 
the substitute two days ago. But since that was revised again, 
it was then given to them last night at the same time that this 
Committee got it.
    Now, we did not do the intermediate step of the Monday 
situation because we believe that we did not have a final 
vehicle in hand at that point.
    But a soon as we had a final draft, that is when we shared 
it with the Minority. And that was the draft as of last night, 
and it's my understanding that the Commerce Committee got it 
the same time that we did as of last night.
    So we are trying to proceed along the same grounds, and 
they are marking up on the same schedule that we are, given the 
nature of the drafting process that went forward.
    I am in fact trying to provide the members with some time 
that would then provide similar time as to what is available to 
the Commerce Committee to review the bill before we move 
forward.
    The gentleman from Texas?
    Mr. Barton. Mr. Chairman, I think I have a solution. I 
believe I'm the only member of either party that are on both 
committees.
    If we could ask unanimous consent to let me just take 
control of the entire bill, I'll go to John Dingell and Tom 
Bliley and get their unanimous consent and everybody else can 
take the rest of the day off, and I guarantee you we'll have a 
bill out of here by 2:00 o'clock this afternoon [Laughter.]
    The Chairman. Yes. I think you've got objection from our 
side on that. [Laughter.]
    The gentleman from Tennessee?
    Mr. Tanner. I don't want to belabor the point, Mr. 
Chairman, but I want to echo that Mr. Roemer said.
    We have some ideas and we'd like to participate. I know 
when you all were in the Minority, you wanted the same 
consideration.
    But the position we sometimes see or feel ourselves in 
today is now, not only are we rushing against an arbitrary 100-
day deadline, now we're in the position of racing other 
committees within the House.
    We just want to ask that we be given consideration to 
participate fully, thoughtfully, and in a constructive way. And 
when we're placed in the position of not only racing against a 
deadline of 100 days, but now racing against another committee 
to the floor, this is not the best approach, Mr. Chairman.
    The Chairman. Well, I would say to the genetleman----
    Mr. Tanner. And we're for the legislation.
    The Chairman. I don't think there's any race with the 
Commerce Committee with regard to this. It doesn't matter 
whether we report it our first or not.
    There's no race involved on it. It's simply a matter that 
in both cases, the committees are bound by the rules of the 
House which require certain period of lay-over and so on before 
we can go to the Rules Committee and before we can report it to 
the floor.
    And given our schedule, and we, while I understand that 
there may be some in the Minority who feel that the 100-day 
mandate is in fact an arbitrary mandate, I assure you that on 
our side of the aisle, we do not regard it as arbitrary. We 
regard it as a true mandate upon us to move ahead, and we do 
intend to stick to that schedule.
    So the arbitrary nature of that is, I think, in the eyes of 
the beholder.
    We are in fact, though, intent upon doing our work at this 
Committee and hopefully including all members who wish to 
participate.
    Mr. Rohrbacher. Mr. Chairman?
    The Chairman. It is the Chair's intention to allow any 
member that has something to contribute to the process, to make 
that contribution in the course of this, and depending on how 
many members want to make their contribution along the line, we 
could be here quite a long time doing that.
    But we will do so.
    Mr. Rohrbacher. Mr. Chairman, we've been discussing this 
about a half-hour now. Those folks could have been reading the 
bill and doing their work all this half-hour.
    The Chairman. Well, I'm kind of watching the time. I was 
told it would probably be available about 11:00. So I was 
perfectly willing to have a discussion here until the time that 
I knew it would be available.
    My staff tells me it's now available, so we've done our 
work very well here. It's been very efficient use of the time.
    We do in fact have this available for members to review.
    The Chair would declare a recess until 1:00.
    [Whereupon, at 11:00 a.m., the Committee recessed, to 
reconvene at 1:00 p.m. of the same day.]
    The Chairman. The Committee will come to order.
    It is the intention of the Chair to proceed at this time 
with the markup of Title III of H.R. 9 which is the Risk 
Assessment and Cost/Benefit Analysis For New Regulations.
    It is further the intent of the Chair to put on the table 
for amendment, a substitute that has grown out of the hearings 
that were held last week.
    In my view, those hearings brought to light a number of 
issues which demanded some clarification and, it seemed to me, 
demanded some changes in the original text of H.R. 9.
    There is now before the members a copy of the Substitute. 
What the Substitute does is incorporates the en bloc amendments 
that were developed over the last couple of days and were made 
available last night.
    As I said earlier, I assured the Committee that what is 
included in this Substitute is the same as what was in those en 
bloc amendments, so that there has been a period of review.
    Let me clarify just what we have here so that you'll 
understand the nature of the changes that were made.
    Under the Substitute, only regulations of major import, 
which are based upon risk assessment and risk 
characterizations, are included within the scope of the 
Substitute.
    These include any regulatory effect on the economy of $25 
million or more, any proposed final regulatory decision to 
decontaminate or clean up facilities, any report to Congress, 
placement of a substance or health effects value on the 
Integrated Risk Information System Database, any regulatory 
action to place a substance on any official list of carcinogens 
or toxic or hazardous substances, and any risk assessment or 
risk characterization guideline or protocol of general 
application.
    In consideration of the ministerial functions of the 
Government on which we receive testimony, the Substitute also 
exempts certain categories of Government activities, such as 
emergencies, screening analyses, food, drug or other product 
labels, health and safety or environmental inspection or 
individual facility permitting action.
    The Substitute would give direction to agencies to 
establish additional risk assessment and characterization 
criteria.
    These include consistence compliance throughout the Federal 
Government, administrative burden, impact on Federal, State and 
local governments.
    The Substitute also clarifies that risk assessments and 
risk characterizations are supplemental to, but do not 
supersede, any other provision of law designed to protect 
health, safety, or the environment.
    The Substitute also makes clear the importance of 
characterizing and then communicating the nature of risks to 
decisionmakers and to the public in terms that are clear and 
understandable.
    The characterization shall include a description of the 
impact of risks on specific and sensitive populations or 
natural resources.
    The Substitute further elaborates on the concept of 
substitution risk, past regulatory action in trying to 
ameliorate one type of risk has often merely substituted 
another hazard.
    The Substitute clarifies that risk assessments and 
characterizations that are undertaken between the date of 
enactment and the effective date of this legislation may be 
reviewed on the basis of risk assessment guidelines and any new 
information received, if such information would significantly 
alter the results.
    Subtitle B of the Bill deals with the analysis of risk 
reduction benefits and costs. Amendments to the Subtitle 
attempt to put into perspective the benefits as well as the 
costs of the Environmental Health and Safety Regulations.
    The amendments ask for certification from the affected 
agency that benefits will justify the cost of Federal, State, 
and local governments and private entities, and that there will 
be no regulatory or non-regulatory alternative more likely to 
achieve substantially equivalent reduction in risk in a more 
cost effective manner.
    The Substitute also clarifies that the cost benefit 
analysis shall supplement existing law. However, to the extent 
that there is a conflict with existing law, the criteria for 
rulemaking for rulemaking the criteria in this section shall 
supersede existing law.
    However, to ameliorate those conflicts of law, the Office 
of Management and Budget shall develop transition plans to meet 
the new criteria.
    Further, so that the Congress may consider changing these 
laws in conflict, the Federal agency shall report any 
differences between the certification provisions of this Title 
and the decisional criteria for rulemaking that would have 
otherwise been applicable under other statute.
    Subtitle C of the Bill is a section which formalizes a peer 
review process amongst agencies. My amendment to this section 
attempts to resolve concerns expressed at the hearing about the 
potential conflict of interest of the reviewers by proposing 
that no peer reviewer may be excluded because the reviewer 
represents an interest that may have a potential stake in the 
outcome, provided that interest is fully disclosed.
    In the case of a regulatory decision affecting a single 
entity, no peer reviewer representing such an entity may be 
included on the panel.
    To exclude an individual with requisite knowledge base in a 
given field would be impractical. My language, however, would 
assure that full disclosure of the reviewer's interests is 
made.
    Now that covers the major items that are included in the 
Substitute that were not in the original Bill. And the Chair is 
of course prepared to discuss a variety.
    There's one thing that I also want to point out to the 
Committee. That under this provision, we also do retain 
judicial review, and that's largely to ensure that agencies do 
what we tell them to do in the Bill.
    However, there's been concern expressed that we need to 
make certain that there are appropriate limitations on that 
judicial review, and that we don't end up with every scientific 
decision going to court.
    So what we've done, under the Substitute, is to assure that 
the normal time-tested judicial review provisions of the 
Administrative Procedures Act apply.
    So that we have done as a typical process under the 
Administrative Procedures Act is going to apply in this case.
    Under our judicial review provision, a risk assessment, 
cost benefit certification, or peer review requirement could 
only be subject to judicial review when associated with a final 
agency action, like a rule, because they would be a part of the 
administrative record.
    Mr. Brown. Would the gentleman yield to me on that point?
    The Chairman. I'd be happy to.
    Mr. Brown. I haven't had the benefit of discussion this 
with counsel but its my off-the-cuff opinion that this 
clarification of the judicial review is helpful and desirable.
    We were deeply concerned that there would be an indefinite 
number of opportunities for judicial review before, and this 
makes that much more clear.
    I am constrained to point out, however, that this was added 
between 6:00 o'clock last night and this morning, when we got 
this final text, along with several other, some minor, some not 
so minor changes, and this illustrates to me, and I hope to 
you, the need for the opportunity to review these points.
    Now some of our amendments were aimed at this judicial 
review provision. They are no longer necessary. They may be 
necessary, I'm advised.
    But in any event--you can never depend on counsel to back 
you up in this game, you know. [Laughter.]
    Mr. Brown. In any event, this is a constructive move 
forward, and we would hope that we could have some additional 
movement of a similar nature.
    The Chairman. Well, thank you.
    And I think the nature of the amendment process is going to 
be that we probably will be able to proceed in a constructive 
way.
    The gentleman is correct that this is an addition. It was 
done primarily at the instruction of the Chairman who had an 
evening to think about what he had heard about the Bill 
yesterday, and decided that I did want to clarify what I've 
always believed the intent of the Bill was, and asked staff to 
do that this morning. And so----
    Mr. Hastings. Would the Chairman yield?
    The Chairman. That is a different position. That is 
virtually the only thing in the substitute which is a change 
from what the amendments en bloc that was provided last 
evening.
    The gentleman from Florida.
    Mr. Hastings. I thank the Chair, and I'd like to put a 
question to the Chairman.
    I'm not completely clear that this is going to minimize the 
opportunities for persons to litigate. And I'm curious as to 
how it works.
    If it's applicable, if the law itself is applicable to the 
Administrative Procedures Act, then I assume that all things 
that the Act allows for will allow for an individual to 
litigate it appropriately.
    So how is it that some so-called judicial limitation is 
going to stop folk from litigating matters of consequence that 
appear in the Bill itself?
    The Chairman. Well, as I explained earlier in my comments, 
the Administrative Procedures Act is applicable to those things 
which are involved in the regulatory process.
    And so this would limit judicial review to those things 
that become a part of the administrative record. And it would 
mean then that every little instance out there where there's 
regulatory action being taken would not necessarily be subject 
to judicial review. It would mean that the major rulemaking 
authority that is in the agencies, subject to the other 
exemptions, would be the things that would be brought under 
judicial review.
    Mr. Hastings. I thank the Chair.
    Mr. Roemer. Mr. Chairman, just a simple statement.
    I have an amendment on judicial review that I would still 
like to offer and discuss.
    The Chairman. Nothing in the substitute precludes anybody 
from offering any amendments.
    In fact, you know, we now have a vote on the floor. You 
know, it is my intention to come back, open the floor to 
discussion on the Bill and on the Substitute. And then proceed 
into the amendment process.
    What we're trying to do in this Substitute is handle some 
of the questions that have arisen, but it is not meant in any 
way to preclude any member from offering amendments that they 
think help clarify or help improve the Bill.
    Mr. Roemer. And that's where I would like to work with the 
Chairman on this clarification, moving from being silent on 
this issue of judicial review to clarifying where we want to 
go.
    The Chairman. Well, I would say to the gentleman that my 
concern was that the Bill was silent on the issue. I don't 
believe that the language that I have developed changes the 
Bill in any substantive way. However, I thought it was 
important to have language in the Bill that clarified directly 
what it was we intended to have be the process for judicial 
review.
    If the gentleman wants to further clarify that, we'll 
certainly consider his amendments. I'm not positive that I am 
prepared to take amendments that go further than this 
particular provision, but we certainly want to have those kinds 
of discussions.
    Mr. Roemer. I like your direction, Mr. Chairman, and just 
want to provide further clarification.
    The Chairman. I thank the gentleman.
    Mr. Roemer. Thank you, Mr. Chairman.
    The Chairman. With that, the Committee will recess to go 
vote, and then we'll proceed immediately following the vote.
    [Recess.]
    The Chairman. The Chair would call the Committee to order.
    The Chair has explained the Substitute that has been laid 
before the Committee, would now open the Committee for purposes 
of general discussion of the measure, of the Substitute, before 
actually laying the Substitute before the Committee for 
amendment.
    And so the Chair would recognize those members who wish to 
engage in discussion of the Substitute and the Bill.
    Mr. Brown. Mr. Chairman?
    The Chairman. The gentleman from California?
    Mr. Brown. I think the Chair, himself, has gone through an 
done a reasonably good job in explaining the main thrust, but 
sometimes the devil is in the details.
    And I wonder if the counsel could provide for the members 
of the Committee a brief discussion, starting with any 
differences that may exist between the version that we received 
this morning and the version that we had a couple days ago.
    Now staff on our side has gone through and identified 
possibly a couple dozen relatively minor changes, plus the 
addition of the judicial review provision.
    And I would just like to have Committee counsel confirm 
those changes that have been made, if he's had a chance to 
review it in sufficient detail.
    The Chairman. Would counsel specify those areas where there 
have been changes between the measure put before the members 
last evening as a draft and the version of the Substitute that 
is now before us?
    Mr. Brown. I might say that we recognize that the process 
of improving language goes on continuously, particularly with 
the legislative counsel, and we're not objecting to this. We 
just want to make sure we've identified all the changes.
    Mr. Beringer. Mr. Brown, the major changes you've already 
pointed our was in the addition of the judicial review section. 
It was our intention that the rest of the changes, for 
instance, there were several misspellings, just the word 
``likely'' would be merely clarifying or technical changes.
    I know of no others that are of substance other than the 
judicial review section.
    Mr. Brown. May I call the counsel's attention to a couple 
of instances here.
    For example, on page 10 of the version that was presented 
to us this afternoon, and this is more or less picked at 
random, it says ``In a significant risk assessment document . . 
.'' whereas the earlier version had ``In a significant risk 
characterization document.''
    Is that intended to represent a difference or a 
clarification or what?
    Mr. Beringer. It's supposed to read ``characterization'' 
being in that Title.
    Mr. Brown. It is supposed to read ``characterization'' 
which is the way it originally was?
    Mr. Beringer. That's my understanding.
    The Chairman. It is my understanding that that, that it is 
as it was presented last night.
    Mr. Brown. Yes, but the document before us says risk 
assessment.
    [Pause.]
    Mr. Beringer. The bill's supposed to read 
``characterization.''
    [Pause.]
    The Chairman. It is my understanding that the way the 
language is now drafted indicates that a risk characterization 
is in fact a portion of a risk assessment, and it is the same 
as was presented, the language, as was presented in the 
amendment provided last night.
    Now this is different from language that was given to you 
three days ago. And that is in fact changed. It's one of the 
series of changes that we went though before finalizing some of 
this last night.
    But this language that you have before you is the language 
that was provided to the Committee last evening.
    Mr. Brown. Well, I'm not sure that I understand the 
significance of the difference between assessment and 
characterization.
    I think the Committee wants to know what is the language 
that is currently before us and how it differs from any 
previous language that was offered.
    The Chairman. And the language before you indicates that in 
a significant risk assessment document.
    Mr. Brown. Yes.
    The Chairman. And we are talking about the risk assessment 
document and we are talking about--later on we are talking 
about risk characterizations being a part of that risk 
assessment document.
    And so what we have in the language----
    [Pause.]
    Mr. Brown. We found about 20 instances of this kind of 
minor changes, and I'm not at all attempting to sow confusion 
in your ranks here, but----
    The Chairman. Well, there is no confusion in our ranks. The 
fact is that risk characterization is a part of a risk 
assessment document, and that is exactly what the legislation 
now says. So there is no confusion about this in any way, 
shape, or form.
    I'm sorry that it's confusing people otherwise, but I don't 
believe that we feel that there's any confusion at all, and 
that the language now conforms with what legislative counsel 
has told us is the appropriate way to make certain that we are 
addressing those things that we wanted to get addressed.
    Mr. Brown. All right. You're sure then that what you want 
is risk assessment, not risk characterization, in the language 
on line 3?
    The Chairman. Line 3 simply refers to the fact that as you 
see, we are talking about principles for risk characterization 
and communication, so we are defining where that would take 
place. It would take place in a risk assessment document, risk 
characterization being a part of risk assessment.
    And so we have placed language in the law that assures that 
we are characterizing risk in the appropriate documents.
    Mr. Brown. Well, you recognize that you have in the Bill 
provisions for both risk assessment documents and risk 
characterization documents?
    The Chairman. I understand that, and they are--we are 
trying to assure that we have clarified exactly what it is we 
want at particular points in the Bill. That's what we thought 
we were doing.
    Mr. Brown. Well, I'm happy if the gentleman feels that it's 
clarified. I'm not at all clear as to what it means and I'm 
worried about some poor bureaucrat reading this and wondering 
what the risk assessment document means in a paragraph on 
principles of risk characterization, and what the different 
uses of the different documents are intended to be.
    The Chairman. Well, if the gentleman would go back to the 
original language that was before the Committee in H.R. 9, we 
said there, ``in characterizing risk in any risk assessment 
document.'' We have changed that to ``in a significant risk 
assessment document.''
    So what we have attempted to do is be more clear than what 
you had before. We have attempted to say, first of all, that 
this is not in any risk assessment document, it's in a 
significant risk assessment document and that in fact, since we 
are defining characterization anyhow, we didn't think we had to 
use the word, characterizing, in the earlier language.
    Now I realize that all of this gets very confusing but, you 
know, I don't think we're confused at all about what it is we 
accomplished.
    Mr. Brown. You made the decision last night then to change 
the document which said ``risk characterization document.''
    The Chairman. No. No. We did not make the decision last 
night. It was handed to you last night in this form.
    Mr. Brown. It was handed to us in the form of a risk 
characterization document last night, and then changed this 
morning to a risk assessment document.
    The Chairman. Everything that we have before, I mean, I 
have the documents here that were handed to you last night.
    Mr. Minge. Mr. Chairman, perhaps I could shed some light on 
this?
    If you would look at pages 4, lines 17, 18, 19, and 20, the 
two phrases are used interchangeably.
    Mr. Brown. Page 4.
    Mr. Minge. And I think the confusion may arise from the 
fact that we have two phrases that are very similar and the 
question is, are these phrases used in different contexts in 
different places in the Bill, and what is the significance of 
the difference?
    Because the provision on page 4 between lines 15 through 
some place in the middle of page 5, well, through the end of 
that page and on to page 5, that is new language in this draft 
of the Bill.
    So what I think has happened--I wonder if this isn't tied 
to the judicial review provision because there's an attempt to 
talk about final agency action or decisions and so on at this 
point.
    And I would just ask if the counsel for the Committee could 
explain why we have two different parallel phrases and the 
function of this new section or this new language in the Bill 
so that we know how it relates to other language in the Bill.
    Mr. Beringer. The risk assessment documents are the--first 
of all the document part attempts to define what is the scope 
of the coverage of the Bill. Only significant documents that 
are in the purview of the Bill.
    The characterization section goes to the way in which risk 
is described to the decisionmakers and the general public.
    And so there is a difference between risk assessment and 
risk characterization. However, risk characterization comes as 
a result of the risk assessment.
    Mr. Minge. Would we minimize confusion if we used the same 
phrase consistently in the Bill, rather than having two 
separate phrases?
    Mr. Beringer. Well, no, because they are two separate 
concepts. The characterization is the way in which the 
scientist or the people conducting the risk assessment so 
indicate what they think the risk is. For instance, what is the 
exposure of certain populations to a certain risk. Sometimes 
it's determined in qualitative form, sometimes it's in 
quantitative form.
    For instance, we heard discussion the other day about the 
population exposure of ten to the minus sixth. That would mean 
one extra cancer risk for every millionth person. That's a risk 
characterization.
    So there is a difference.
    Mr. Minge. Is there a place in the Bill where those two 
phrases are defined?
    Mr. Beringer. Yes. Yes, they are.
    Mr. Minge. At what point are they defined?
    [Pause.]
    Mr. Brown. Mr. Chairman, may I continue with another 
question or two?
    The Chairman. Certainly.
    Mr. Beringer. Page 14 and 15.
    [Pause.]
    Mr. Minge. If I may say?
    Mr. Beringer. Yes, sir?
    Mr. Minge. I think those of us here that have worked with 
administrative agencies find this a fairly illusive 
distinction, and I'm afraid that those in the public trying to 
deal with it, or even those in the agencies will find some 
confusion.
    And I'm wondering if there's any way that we could clarify 
that to minimize the confusion that's apt to arise?
    The Chairman. Well, the gentlemen is certainly able to 
offer an amendment at the appropriate time if he thinks other 
clarification is necessary.
    Mr. Berigner. The assessment is the basic science. The 
characterization is the way in which that science is 
interpreted.
    [Pause.]
    The Chairman. The gentleman from California.
    Mr. Brown. Mr. Chairman, I note that on page 16, line 6. 
specific reference is made to the Office of Technology 
Assessment.
    I would like to inquire of counsel if an OTA report 
requested by Congress on hazardous waste, for example, be a 
risk assessment document under the definition of risk 
assessment document contained in this Bill, and thus trigger 
the kinds of procedural activities that are required here?
    Mr. Beringer. That would be the way that would be 
interpreted.
    What we're trying to get at, Mr. Brown, seven though 
that's, as you point out, is a mandate on the Congress itself, 
but it's a certain area of the Congress, the OTA, that rather 
than putting out, if you will, a free floating assessment 
without any review, that they have to undertake some of the 
other things that people are required to do under the Act.
    Mr. Brown. Well, I'm inclined to feel that this is 
inappropriate in this sense. That OTA does not make risk 
assessments per se. It does technology assessments and these 
are peer reviewed by stakeholders throughout the country and 
agreed to through a consensus process by those stakeholders.
    It would seem to me highly undesirable and inappropriate to 
consider these to be formal risk assessments in the sense that 
the legislation is intended to address, and may stem from a 
misunderstanding of what the role of OTA is.
    May I ask if that factor was considered in including the 
OTA in this language?
    Mr. Beringer. What was considered, Mr. Brown, was the fact 
that they do hazard evaluation and we felt that it should be 
under the same stringencies as the other agencies of the 
Government.
    I understand the point you're making, but it was 
considered.
    Mr. Brown. Well, the point is this entire legislation is 
aimed at reducing the impact of Federal regulations based upon 
a better form of risk assessment.
    The OTA engages in no regulation, has in no way any impact 
upon the public except in the fact that they can read the 
reports.
    Mr. Beringer. Well, I'd also say that since they are not 
rulemaking that by and large they would not have to undertake 
this. But there might be some cases where they put out a 
warning, so to speak, about some hazard that may not be 
sufficiently reviewed.
    The Chairman. Let me ask counsel, doesn't it also--isn't it 
also further limited because it would fall under page 4, 
Section (b)(1) in which it would have to be anything relating 
to protection of human health, safety and environment.
    And so that that limitation means that it's not all reports 
at OTA. It is simply those in that narrow category included as 
coverage in the Bill.
    Is that not correct?
    Mr. Beringer. That's correct, Mr. Chairman.
    Mr. Brown. But the language of the Bill on page 5, line 4, 
says ``Any report to Congress.''
    and I've just asked if that included the OTA report, and in 
fact it specifically says OTA reports.
    The Chairman. But it's also limited, if you will look 
further up under ``Applicability,'' it's limited by the fact 
that any Federal agency in connection with Federal programs 
designed to protect human health, safety, and the environment.
    So you've got to look at the totality of it, not just 
individual lines along the way.
    And in totality, once again, there is no confusion. It says 
specifically what we mean.
    Mr. Brown. Mr. Chairman, if you will allow me, the OTA does 
not engage in any of the things that you have mentioned here. 
It does not have any programs that in any way, shape or form, 
are designed to protect human health, safety, and the 
environment, which is the thrust of the Bill.
    Now why do you even include OTA there?
    The Chairman., As counsel has explained, they have in fact 
issued reports, from time to time, hat do deal with hazards of 
one kind or another that in fact may have the impact.
    It was felt that the nature of those reports to Congress 
could in fact influence regulatory authority and so, therefore, 
should include a risk analysis. But they are only in that very 
narrow category.
    Mr. Brown. Mr. Chairman, I appreciate the effort that you 
have made to reassure me.
    May I assure you that I'm not reassured, that I think that 
this was a mischaracterization in the Bill, and that it should 
never have been included.
    I will agree with you that it might have trivial impact 
because most people with common sense, understanding that OTA 
does not engage in any regulatory activity, are not going to 
worry about it too much. But I don't think this is good 
legislative draftsmanship.
    The Chairman. Well, I thank the gentleman. He speaks as a 
true member of the Board of OTA.
    Mr. Brown. One who was trying to recruit you, as a matter 
of fact.
    Mr. Chairman. Yes, Ms. McCarthy?
    Mr. McCarthy. Thank you, Mr. Chairman.
     would like some clarification, while we're on general 
discussion, on the standard for major rules.
    I understand there are three different triggers in Section 
A, B, and C.
    Could you review those for me and then give some 
explanation of why the amounts differ?
    The Chairman. Counsel?
    Mr. Beringer. The standards in Subtitle A are $25 million, 
and in Subtitle B also $25 million, and in Subtitle C $100 
million.
    The reason is trying to limit the burden on agencies for a 
full-blown review process.
    We were trying to get at regulations or economic impacts of 
$100 million, which was approximately 4 to 8 percent of rules 
that are issued on health, safety and the environment by the 
agencies, according to our analyses from CRS.
    Twenty-five million was designed to try to capture a 
greater percentage of the rules and make them subject to the 
requirements of this Act.
    Ms. McCarthy. How do you get a risk assessment without a 
peer review?
    Mr. Beringer. This doesn't preclude doing a risk assessment 
without peer review for the higher level. It just merely--this 
merely says that for those risk assessments in the $100 million 
category, you shall peer review.
    As we heard in testimony, many times the agencies do peer 
reviews on many risk assessments, even ones that would be 
considered minor. The second panel on the second day testified 
to that.
    Ms. McCarthy. Would you look with me on page 5, lines 1, 2, 
and 3 at the top. It's a subheading (ii).
    Mr. Beringer. Yes, ma'am.
    Ms. McCarthy. On line 3, what type of facility are we 
talking about here? Is it a state or a Federal facility?
    Mr. Beringer. It would be any facility that would come 
under the purview of Federal law.
    Ms. McCarthy. So it we're doing a $75 million rule with 
regard to this, does that trigger risk assessment or peer 
review?
    Mr. Beringer. Yes, ma'am.
    Ms. McCarthy. One or both?
    Mr. Beringer. It would trigger risk assessment and 
characterization, but it would not, not not, if I may use a 
double negative, bring in peer review.
    In other words, they could do a peer review and they 
probably would, but we were trying to limit the scope on 
mandatory peer review to the $100 million category.
    Ms. McCarthy. Even if it's a RCRA facility, you think 
there's complete discretion there on whether to do the peer 
review or not at $75 million?
    Mr. Beringer. Yes.
    Ms. McCarthy. By lowering from 100 to 25 the risk 
assessment in cost benefit levels, contrary to the witnesses, 
every witness that we heard, how many more risk assessments 
will we be doing?
    Mr. Beringer. I asked CRS for figures on that, and they did 
not have them. So there is no definitive answer.
    Ms. McCarthy. The $100 million threshold which was first 
used in the Ford Administration for regulatory review, and has 
also been used in the Reagan, Bush, and Clinton Executive 
Orders, those figures are available. OMB estimated those 
figures.
    Do you happen to have those for the Committee?
    Mr. Beringer. We provided them for the record in the 
Committee the other day.
    Ms. McCarthy. Do you recall what those were?
    Mr. Beringer. If you would allow me to refer to the 
document, we could give that to you.
    Ms. McCarthy. I would appreciate that.
    While he's doing that, Mr. Chairman, I would like to ask 
you a question, because in my earlier questioning of witnesses 
I raised my concern about what this measure is going to cost 
the American taxpayers.
    And my concern is that the standards that we've set for the 
major rule are going to trigger additional costs. In fact, EPA 
estimates a considerable amount of costs for its department in 
preparing these new, following these new guidelines.
    So I would like staff to address the costs as well because 
I think that's something that needs to be considered as we 
review these different standards, especially in light of the 
fact that every witness that came before us recommended a 
threshold higher than $25 million.
    Mr. Jasonowski, on January 31st, at your very own 
questioning, Mr. Chairman, said to you, ``the coalition we are 
testifying on behalf of, Mr. Chairman, suggests and recommends 
$50 million.''
    And there was no other witnesses that came forward that 
recommended the 25, so I'd like an explanation as to why the 25 
is in the final version that's before us, a sense of the costs 
to the American public?
    The Chairman. Well, further review of Mr. Jasonowski's 
remarks indicated that he may have been speaking for a lot of 
his people in big business, but there were a lot of people in 
small business that did not agree with that higher threshold.
    And it was our belief that perhaps small businessmen and 
individuals ought to be taken into account, as well as the big 
corporate entities.
    And so that was the main reason why we retained the figure.
    I would say to the gentlelady, with regard to the numbers 
here, the Congressional Research Service says that there were 
82 rules issued at the $100 million level in 1990.
    It's interesting to note that in the six months beginning 
October 1st of 1993, the Administration issued 67 rules of such 
magnitude, putting it on tract to issue over 130 rules in 1993-
94, an increase over 60 percent in rules with an impact of $100 
million.
    So, indeed, to some extent, this will be a case of how much 
rulemaking the Administration wants to do.
    Now, in my view, one of the ways that you can mitigate the 
expense of this is to do less rulemaking. In all honesty, one 
of the things that many of us think is probably worthwhile is 
to have the Federal Government doing less rulemaking and higher 
quality rulemaking. And that this process will in fact lead not 
to additional expense but to less expense because we won't have 
as many rules that we have to comply with.
    Ms. McCarthy. Well, Mr. Chairman, I appreciate that 
particular point of view, and certainly those of us that have 
labored out in the states under Federal rulemaking appreciate 
it as well.
    But I think when you're speaking to the American public, 
and particularly on some of the issues with regard to the 
environment, there is a genuine concern that it is the 
responsibility of the Federal Government to step up to the 
plate and address these issues.
    And that's why I was concerned about the language on page 
5, and about the differing amounts and the burden that might be 
placed on anyone trying to assess the standard and comply with 
it.
    May I go back to staff, please, for an answer to my 
question that was addressed to you?
    Mr. Beringer. First of all, we're getting the document for 
you right at this moment.
    But the main concern was that $25 million would indeed 
capture a large segment of the small business community that 
has been adversely impacted by regulations; for instance, the 
dry cleaning industry, the local gas stations, people such as 
that.
    So there is an expression of concern to us that the 
threshold not be raised so high that these people aren't 
included in the analysis of risk and benefit.
    The Chairman. The Chair is attempting to be generous with 
time here, so that there can be an explanation of the things 
that the members are concerned with.
    I will say to the membership, however, that it is the 
intention of the Chair to complete this Bill today or tonight 
or tomorrow morning or wherever it happens to come down.
    And so, you know, while we want to be generous with the 
time in terms of asking questions and so on, I have not held 
people to the five-minute rule, but it is our intention to 
proceed.
    Ms. McCarthy. Thank you, Mr. Chairman.
    The Chairman. The gentleman from Florida, Mr. Weldon.
    Mr. Dave Weldon. In an effort to expedite the operation, 
I'll withhold my question, Mr. Chairman.
    The Chairman. I thank the gentleman.
    Mr. Bartlett. Mr. Chairman.
    The Chairman. Mr. Bartlett.
    Mr. Bartlett. Thank you very much, Mr. Chairman.
    I'd like to return, for just a moment, to a question that 
was raised by Mr. Brown and by Mr. Minge, and that is the 
definition of risk assessment and risk characterization.
    And if you could turn to page 15, I think that we might do 
a relatively simple thing that would help clarify this.
    Let me first read, on page 14, what a risk assessment 
document is, the first part of that definition.
    ``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 . . .''
    And I think that that's pretty much what you said it was.
    If you'll now look at the language that follows that, after 
the ``or'', lines 1, 2, and 3, you will find that that is 
exactly identical language with lines 6, 7, and 8, beginning 
with the word ``describing.''
    And obviously you can't describe two documents which are 
different using exactly the same language to describe them.
    And I would wonder if we couldn't just strike the ``or'' 
and everything after it on lines 1, 2, and 3, so as it would 
now make the risk assessment document different than the risk 
characterization document.
    The Chairman. Let me say to the gentleman, as I said to Mr. 
Minge, if in fact the gentleman has a clarifying amendment that 
he wishes to offer at the appropriate place in the process, we 
would certainly be willing to consider it at that time.
    Mr. Bartlett. We will do that sir, and thank you very much.
    Mr. Minge. I've marked mine in the identical fashion. I'll 
join with Mr. Bartlett.
    Mr. Barton. Mr. Chairman?
    The Chairman. The gentleman from Texas.
    Mr. Barton. I just have a parliamentary inquiry.
    Have you offered your en bloc amendment for discussion yet?
    The Chairman. Well, we are in fact discussing both the 
Substitute and kind of the general subject at the present time. 
As soon as members have had a chance to do this, it is my 
intention at that point to offer the Substitute and open it for 
amendment.
    Mr. Barton. And following up on that, when amendments are 
in order to be offered, are you going to go in the sequence in 
which they've been printed in you agenda, or are you going to 
allow that members that have multiple duties on the same bill 
in two different places to perhaps go out of order?
    The Chairman. Well, it is my intention to go in the order 
in which they were on the agenda, and then, as we complete each 
Subtitle, to close the Subtitle so that if there are amendments 
that are not reflected on the agenda to that particular 
Subtitle, they would have to be offered at the end of the 
Subtitle before we closed out that Subtitle.
    Mr. Barton. Thank you.
    Mr. Brown. Mr. Chairman?
    The Chairman. Mr. Brown?
    Mr. Brown. Just to kind of pick up a couple of loose ends.
    First of all, the amendment process is going to have to be 
fairly flexible because our original amendment, which is the 
basis of the agenda, were addressed to the earlier version of 
your legislation, not to the text that we have before us at the 
present time.
    And with a little leniency on you part, I think we can 
adapt to that.
    The Chairman. The Chair has already indicated that as long 
as we are addressing the same subject matters that are there, 
that we are going to attempt to deal with any kind of 
technicalities in a very flexible way to assure the amendment 
is properly in order.
    Mr. Brown. Now, in connection with the previous discussion 
of the $25 million designation for a significant risk 
assessment document, there was some parts of the discussion, 
and in fact you contributed to this by indicating that you 
wanted to cover small businesses--this figure has nothing to do 
with the size of the business, it has to do with the national 
economic impact.
    Now that could occur as the impact on one very large 
corporation or on a thousand very small corporations. And we 
need to look at that with a factual understanding of what that 
limit means.
    And the implication that you gave, and perhaps 
unintentionally, was that you wanted to include a lot more 
small businesses. I don't think this has any relevance to 
including additional small businesses.
    The Chairman. Well, it's sector specific and insofar as it 
deals with a sector of the economy, we want to make certain 
that that sector of the economy is in fact a $25 million 
impact.
    When you begin to raise that overall limitation, you 
eliminate certain sectors of the economy, most of them 
involving small business. So it is small businesses who are 
most concerned about maintaining that figure because it 
broadens the applicability to sectors of the economy.
    The fact is that big businesses are more likely to have a 
broader impact, and so anything which affects them is likely to 
have broader impacts of $50 million is perfectly appropriate 
for them. Fifty million dollars isn't much to General Motors. 
It's quite a bit to the dry cleaning industry.
    Mr. Brown. Mr. Chairman, may I respond briefly?
    And I don't want to belabor this point at all.
    First of all, I would like, since you indicated you made a 
command decision in order to protect small business to leave 
the figure at $25 million, would you be able to point to 
anything in the record or any documentation that small business 
in any way supported this, or that it would make a difference 
in the way it impacts them?
    And secondly, could we make it clear that this has nothing 
to do with the size of the business but it relates to the 
impact of say an air regulation, and this is particularly true 
in Southern California.
    It impacts dry cleaners, paint shops, all kinds of small 
business, and has a cumulative effect of $100 million or more, 
and it's irrelevant to the size of the business.
    And most of the big businesses, as a matter of fact, have 
already made the necessary corrections. The major power plants, 
for example, the big industries probably wouldn't be concerned, 
but you're going to distort this thing, it seems to me, in a 
fashion that will probably achieve your goal of reducing the 
amount of regulation, just because you're now going to require 
when it has an impact nationally on any sector of $25 million.
    If that's your goal to preclude additional regulation, you 
will well achieve it by this.
    The Chairman. Well, I thank the gentleman.
    I can only say that the feedback that we got from testimony 
before the Committee from groups such as the Chamber of 
Commerce, indicated that they were not satisfied with the $50 
million figure, that they were in fact looking at the $25 
million figure, which was the figure I believe that was in the 
original Bill as being important.
    We are going to have amendments offered here to lower that 
figure even further. It is the Chair's intention not to be in 
favor of those particular amendments despite the fact I 
understand the legitimacy of what they're doing.
    Those are being primarily offered at the behest of small 
businesses who believe that the impact is as I've described it. 
And, you know, I do believe that there are people who view this 
in different ways, depending upon the size of their impact on 
the totality of the economy.
    And we are simply trying to assure that people who may have 
interests in this particular legislation feel as though we have 
treated a number of sectors of the economy, including the 
biggest sectors, in a fair and equitable way.
    Ms. Jackson-Lee. Mr. Chairman.
    The Chairman. Ms. Jackson-Lee.
    Ms. Jackson-Lee. Thank you very much, Mr. Chairman.
    I wanted to pursue a line of questioning with staff just to 
further understand the definition as used on the major rule.
    And I note that the new section on page 4, and I guess in 
section (a) then refers to the definition of major rule. On 
page 19 section (b), and I think the line of questioning 
preceding mine follows the same line of thought.
    I noted in the testimony that we had, there was some 
comment, and I don't have an exact recollection, but there was 
some comment as to decisions made under the Reagan 
Administration about lead content in gasoline.
    And that there was a determination that it was such an 
important issue that they would move forward as quickly as they 
possibly could.
    My question is, is there anywhere in here in reading the 
issue or reading the definition of major rule, that gives some 
further refinement if the matter is life-threatening?
    I use lead in gasoline, but then I can also refer to lead 
paint as it impacted children in inner cities, and whether or 
not there is a way that we would be able to further refine that 
that if it is a life-threatening matter, that this definition 
of a major rule would be further refined by putting some 
exceptions or some breaks, if you will, as to whether we need 
to do this because of the life-threatening situation.
    Mr. Beringer. The Bill throughout has exemptions for 
emergencies but that doesn't exactly answer the question of the 
gentlelady.
    There could be further refinements and language that would 
make that clear. However, the overall thrust of the Bill would 
try to do risk assessments in all these general areas because 
in the case, for instance, of life-threatening asbestos in 
schools, it was later discovered that the one threat of removal 
was probably greater than the threat of having them remain in 
the school.
    So there is a balancing test. It's up to the members of the 
Committee to determine what that test should be.
    Ms. Jackson-Lee. And I appreciate that the give and take 
will be amongst the Committees, recognizing that those of us 
who've come from communities outside of Washington, we've 
certainly heard the debate on risk assessment and its overall 
impact.
    I would say to you that, and staff, that I'd like to 
suggest and be able to work, Mr. Chairman, with further 
refinement as it relates to the life-threatening issues. I find 
that distinctive, and you cite the asbestos problem in our 
schools throughout the nation and in fact in old buildings.
    And there have been situations where it was an emergency to 
do it, and other situations where it was the wise thing to 
leave it alone.
    But I think we can further refine this language to narrowly 
capture what all of us could agree to would be life-threatening 
situations where you would not want to be inhibited by what was 
interpreted here, and further refine the words ``major rule.''
    The Chairman. I thank you.
    All right. With that, the Chair will put before the 
Committee the Substitute of the Chair, and open the Substitute 
to amendment.
    The first amendment listed is the en bloc amendment which 
is no longer needed because of the Substitute. There is an 
amendment that would limit application of Title III to the 
Environmental Protection Agency that's listed next that was a 
placeholder amendment.
    Is that being offered?
    Mr. Brown. No, that's not being offered, Mr. Chairman.
    The Chairman. The next amendment would exclude USDA as a 
placeholder amendment.
    Is that going to be offered?
    Mr. Brown. I'm informed that that amendment will be offered 
but it's at a different location in the Bill, Mr. Chairman.
    The Chairman. Fine. We'll get to it at the appropriate 
place then.
    There is an amendment to limit application of Title III to 
specifically covered agencies.
    Is that going to be offered?
    Mr. Brown. That will not be offered, Mr. Chairman.
    The Chairman. All right, then.
    Ms. McCarthy would have an amendment, a new Section 3002.
    Mr. Brown. Mr. Chairman, if I may be permitted, I have a 
savings clause amendment which occurs at Section 3002, which we 
would like to--
    The Chairman. Is this in lieu of Ms. McCarthy's amendment?
    Mr. Brown. No, this is a different amendment.
    The Chairman. What I'd hoped to do, and I mean, I'm subject 
to change on this, but what I'd hoped to do is go down through 
the ones that we had put on the schedule and then come back and 
pick up any others in that particular section, in Section A.
    Mr. Brown. Mr. Chairman, I appreciate the need for an 
orderly procedure, which the Chair can keep on top of, and you 
are doing a reasonable thing.
    The Chairman. Okay, very good.
    So I will recognize Ms. McCarthy.
    Ms. McCarthy. Thank you, Mr. Chairman.
    My amendment that I offer would be inserted on page 3, 
after line 4. And it addresses the nature of unfunded mandates.
    ``Nothing in this title shall create an obligation or 
burden on any state or local government or change or affect any 
state law or regulatory requirement or otherwise impose any 
financial burden on any state or local government.''
    My concern, and I raised this during the testifying of the 
witnesses and during general discussion, is that I have a 
genuine concern about the costs, and particularly with regard 
to permitting which is done in many ways by the states. The 
states administer much of this nation's health and safety 
programs and often they face demands for cleanup of Federal 
environmental facilities.
    I don't want them to have to undertake risk assessment, Mr. 
Chairman, and so I offer this amendment genuinely to make sure 
we are carrying through with our intent in this Congress, which 
is to not further unfunded mandates onto any state or local 
government.
    Mr. Brown. Would the gentlelady yield briefly to me?
    Ms. McCarthy. Absolutely.
    Mr. Brown. I merely want to ascertain that each member has 
the current draft of the gentlelady's amendment before them. I 
understood that there was an original and then a revised draft.
    Mr. McCarthy. Excuse me, gentlemen.
    I was under the impression the Committee would print up and 
distribute the amendments. I did turn it in in a timely fashion 
as per the request of the Chairman.
    Due to the nature of a new draft this morning, the title--
the actual directions would have to change, not the language 
itself, which would be a new section, Section 3002, a Savings 
Clause, but it would have to be inserted after Section 3001 now 
on page 3, not page 35, and after line 4.
    And I'm not sure if the Committee has received the new 
amendment, gentlemen, because that I left to the Committee's 
staff.
    [Pause.]
    Mr. Brown. Well, I have the gentlelady's revised version. I 
just wanted to make sure that the other members of the 
Committee did.
    The Chairman. It is my understanding that what the members 
have before them is what was in the package. If the gentlelady 
has changed the amendment since the package was put together, 
then we do need to have distributed to the members the full 
text of her amendment.
    Ms. McCarthy. I appreciate that, Mr. Chairman.
    The only thing that has changed is because we received a 
substitute late this morning, the page number has changed. If 
you would prefer that I withdraw it and offer it at another 
time, I would----
    The Chairman. I'm not worried about page numbers, but if 
there has been change in the language in any way----
    Ms. McCarthy. No, Mr. Chairman, there has not.
    The Chairman. So the language then that is being offered by 
the gentlelady reads. ``Nothing in this Title shall create an 
obligation or burden on any state or local government or change 
or affect any state law or regulatory requirement or otherwise 
impose any financial burden on any state or local government.''
    Is that correct?
    Ms. McCarthy. That's correct, Mr. Chairman.
    The Chairman. That's fine.
    Is there discussion?
    Mr. Baker.
    Mr. Baker. The purpose as stated on page 1 of this draft 
that states that Federal funds are not unending and that when 
we regulate, we have to carefully target out regulations so 
that they're effective against the highest and worst risks.
    That's generally called risk assessment, and it's going to 
take a few dollars and a few minutes for the agencies to step 
back and review the regulations to see are we indeed going 
after something worth going after.
    And obviously if this amendment passes, we won't include 
risk assessment, we'll just include regulations.
    But don't forget the regulations impose a tremendous burden 
on the private sector without regard to risk assessment.
    So what we're saying is don't curtail big Government, don't 
inconvenience them by looking before they leap, just go out and 
do it.
    An example would be the EPA. In California, we license 
under strict licensure, the automobile emissions, and private 
sector checks the automobiles, regulated by the State of 
California.
    EPA went out and said the heck with all that. The State 
should set up a system of licensure and checking of 
automobiles, period, putting all of those companies out of 
business.
    No one looked at that. No risk assessment, no mandates, no 
problem, just wipe out an industry in California, and 
substitute for it a big, bureaucratic Government agency to 
which, like in Washington, D.C., you can spend four hours in 
line with you auto running polluting the air and wait a half a 
day and lose that pay, and then get up and pay the Government 
instead of some of you friendly neighbors at a gas station or a 
licensed clinic the fee.
    So all we're saying here is look before you leap. It's 
obviously going to cost a few cents more, but perhaps we could 
save billions on the private sector by determining that was not 
a very smart thing to do.
    This morning in Transportation Committee, the Assistant 
Director of CalTrans was there bemoaning the fact that EPA 
tried to mandate this on the State of California, and they're 
going to try and undo that in the 1st legislation.
    Mr. Doggett. Will the gentleman yield?
    Mr. Baker. Yes, I certainly will.
    Mr. Doggett. I can't tell if you're for or against the 
amendment.
    Mr. Baker. I'm against the amendment because it is a none-
too-subtle way of trying to kill the process of risk 
assessment.
    Mr. Doggett. So how do you see this Bill intersecting with 
the unfunded mandates legislation? Is it your desire to--
    Mr. Baker. I think what you're going to end up with is a 
lot less regulation and a lot less cost in the private sector.
    Mr. Doggett. But you're opposed to the idea of this not 
being an unfunded mandates requirement?
    Mr. Baker. If I had my way, there'd be half as much 
regulation and a lot less Government expense. I see the cute 
point to this trick, and I'm happy to joust with you, but I 
think the cost of the regulation is far worse than the risk 
assessment being added to the regulation.
    Ms. McCarthy. Would the gentleman yield?
    Mr. Chairman, I'm having difficulty understanding the 
thrust of the gentleman's point in order to respond.
    Mr. Baker. Even if they had to type one sheet, there'd be a 
cost. Even if they had to type up a sheet saying there's no 
major risk and therefore no assessment is needed, there would 
be a cost.
    The Chairman. I think what the gentleman is saying is that 
the amendment is so broad that virtually any expense incurred 
by state or local government, even to respond that they have no 
liability in this, would in fact be covered under the 
gentlelady's amendment and would make it impossible for 
agencies to even determine the appropriate nature of potential 
risk assessment.
    Ms. McCarthy. Mr. Chairman, I appreciate that 
clarification. I thought that's why we put thresholds in the 
Bill and we'd had a lengthy discussion on the nature of those 
lower thresholds at $25 million just moments ago, a discussion 
which I instigated.
    The Chairman. But your amendment contains no thresholds. 
Your amendment is in a Section of the Bill long before the 
thresholds, and so therefore says that absolutely no costs can 
be incurred, even if it's 32 cents for a stamp.
    Ms. McCarthy. Mr. Chairman, putting it in the context of 
the bill, there would be no rule made, correct, at those 
particular threshold levels until we reached them? That was, I 
thought, the reason to have them.
    The Chairman. Well, the gentlelady I think misunderstands. 
The threshold level is $25 million of impact on the totality of 
the economy. That might have a fairly minimal impact on any 
state and local government, but if the agency writes them and 
asks them whether or not there's any minimal impact, and they 
write back and say no, there is no impact, they have in fact 
expended money at that point for 32 cents for a stamp, and that 
would be in violation of the gentlelady's amendment.
    Ms. McCarthy. Well, that is not the intent of the 
amendment. It is to work hand in hand with the unfunded 
mandates law which this House has spoken to and then quite 
strongly.
    The Chairman. Well, I'm sure that that is the intent, but 
the practical applicability of the amendment is such that it 
means that they could not expend any money in any way. And we 
have passed an Unfunded Mandates Bill that will certainly be 
directly related to this because this applies only to Federal 
agencies.
    It doesn't apply to imposing costs on state and local 
governments anyhow. If you'll look at the language in the bill, 
it applies to the work being done by Federal agencies. And if 
Federal agencies are in fact incurring costs for state and 
local governments, then the unfunded mandate legislation, 
assuming that it becomes law, would in fact be applicable.
    Mr. Minge. Would the gentlelady yield for a moment?
    Ms. McCarthy. Yes, certainly.
    Mr. Minge. I doubt we're working at cross purposes here. I 
don't think that your intent is to essentially repeal this 
legislation by inserting a provision that's inconsistent with 
the rest of it, but instead to try to avoid this legislation 
having an unexpected effect on state and local governments.
    And with the leave of the Committee Chair, I would suggest 
that perhaps withdrawing the amendment at this time, with the 
understanding that you could submit it later in the day with 
any corrective language, would be a way to achieve your intent 
without running afoul of the unintended consequence that's 
being identified by some of the other members of the Committee.
    The Chairman. Well, we will certainly be willing to 
consider it again as a part of Section A if a redrafted 
amendment is brought forward.
    Mr. Minge. Would that be a way to achieve your goal, which 
I think is really one that almost everybody in this Committee 
would support?
    Ms. McCarthy. Yes. I thank you gentlemen, and as you were 
drawing those conclusions, I was thinking that this should be 
redrawn to make it parallel the unfunded mandates provisions 
that have passed this House so that we are not contrary to the 
purposes of the House.
    So, Mr. Chairman, with the understanding it could be 
reoffered if redrafted properly, I would like to withdraw the 
amendment at this time.
    The Chairman. So long as we are in Section A. Once we close 
out Section A of the Bill,----
    Ms. McCarthy. Well, I believe I'm the only amendment in 
this section.
    Mr. Minge. Well, I have one that I'll offer.
    Ms. McCarthy. Oh, good. Thank you.
    The Chairman. Okay, we know of two others. So as long as we 
are in this Section of the Bill, I would certainly entertain 
the amendments, but I don't think that we can start a process 
where everybody, once they find out they've got a problem, 
comes back later on and does amendments.
    So we're going to accept the amendments and hope that 
they're in good form at the beginning, but since this is the 
first one, we will attempt to accommodate the gentlelady.
    Mr. Minge. Mr. Chairman?
    The Chairman. This amendment, having been withdrawn by 
unanimous consent, if I hear no objection?
    [No response.]
    The Chairman. And none is heard.
    The next amendment on my list is an en bloc amendment on 
page 36.
    Do you have an amendment before we get to Section A, Mr. 
Minge?
    Mr. Minge. Yes, I have an amendment to Section 3001 and I 
believe that this amendment has been presented to the Chair, 
and it hold be with the counsel for the Committee.
    The Chairman. We would ask that the amendment be 
distributed.
    Mr. Beringer. We don't have copies of it and have not seen 
the amendment.
    [Pause.]
    Mr. Minge. Mr. Chairman, just so I use the Committee's time 
while you're waiting, I don't expect this amendment would be 
controversial. It is designed to complement the purpose of the 
Bill and to emphasize that while we recognize that there are 
new regulatory measures that are being considered by agencies 
and rules that are being or will be promulgated in the future, 
we have a grave need in American industry, commerce and 
industry, for relief from regulations which are currently 
unnecessary or overly complex. And that, at the same time that 
we're pursuing this goal of relief from unnecessary regulation 
or overly burdensome regulation in the future, we should be 
looking at ways to deal with the bulk of the regulatory 
framework that burdens American commerce and industry.
    And it's simply a statement to that effect. It does not 
impose any requirement on Congress or any other agency to take 
any steps, it's simply a recognition.
    The Chairman. Well, I thank the gentleman.
    I don't have any problem with the statement, but I would 
ask counsel whether or not this has in any way a broadening 
effect to the Bill that might cause us jurisdictional problems?
    Mr. Beringer. Mr. Chairman, that is my opinion that it 
might be beyond the scope of this particular Bill, and we may 
be getting into the Judiciary Committee's territory here.
    The Chairman. That would be my one concern is that it has 
the effect of broadening the scope and moves us outside our 
particular jurisdiction as the gentleman would understand.
    I mean, we've had to draft very carefully to stay within 
what is the jurisdiction of this particular Committee. and 
while I am sensitive to the need to look at a host of other 
things, and we're going to do that in a series of hearings in 
this Committee, when we actually go to legislating, we do have 
some restrictions on our ability.
    It seems to me that if the gentleman would eliminate the 
final sentence, that we probably then don't have a problem. If 
he simply makes the statement that there are other ways, there 
are other overly complex regulations that are necessary, but 
doesn't get into the questions of productivity and 
competitiveness and simplifying and a lot of that, we probably 
don't have a particular problem with it.
    Would the gentleman be willing to modify it?
    Mr. Minge. I'm willing to withdraw the final sentence of 
the amendment as offered in order to avoid the problems that 
the Chair is concerned about.
    The Chairman. If that's, without objection, the amendment--
--
    Mr. Hastings. Reserving the right to object, Mr. Chairman, 
and I would not object. but I would like to ask counsel how it 
is that this puts us outside the scope, since you assert that 
it does.
    I have difficulty understanding how that last sentence--as 
a matter of fact, Mr. Chairman, what I have proposed would be 
to take the first sentence out and leave the last sentence.
    How is it that it does something outside the scope of the 
jurisdiction of this Committee?
    And I thank the Chair, and I will not object.
    Mr. Beringer. Congressman, I think it has to do more with 
the word ``implementing'' probably than anything else. Because 
that's implementing regulatory decisions, and there are a 
number of things that are being considered by the Judiciary 
Committee which would deal with that right now.
    So that's my opinion without actually having conferred with 
the Judiciary Committee.
    The Chairman. Well, if the gentleman, by unanimous 
consent--if there is no objection to the gentleman modifying 
his amendment, the Chair is prepared to accept the amendment as 
modified.
    Mr. Minge. Well, to begin with, I would agree with my 
colleague from Florida that this amendment should not impinge 
on the jurisdiction of the Judiciary Committee. However, I do 
not wish to make an issue of the language of the amendment.
    The amendment is simply something that allows our Committee 
to recognize that with our limited jurisdiction, we're trying 
to do what we can. But we, as a Committee know, and we want the 
rest of the world to know that we're aware that many other 
things need to be done.
    That's the long and short of it.
    The Chairman. The gentleman, with his modified amendment, 
has helped us make that point. I appreciate it.
    Gentlelady Ms. Rivers?
    Ms. Rivers. Thank you, Mr. Chairman.
    That raises a question for me as we're talking about 
implementing in this Bill. In another section, and I didn't get 
a chance to ask this earlier, but it falls right into this.
    On page 18, there's new language put in that creates two 
new concepts, and one of the concepts that's put into place is 
the idea that the agency involved must examine non-regulatory 
as well as regulatory alternatives.
    And since we're talking about jurisdiction, what 
jurisdiction do agencies have to implement non-regulatory 
alternatives?
    Mr. Beringer. This would propose an examination of those.
    Ms. Rivers. And then?
    Mr. Beringer. They don't have the--unless Congress gives 
them specific jurisdiction, they don't have the authority to 
implement them.
    Ms. Rivers. So if they have no authority, why are we asking 
them to consider them?
    Mr. Beringer. We are asking them to--well, Congress may 
have given them the authority, so we are--it's another one of 
the examinations that we feel should go forward in the Bill.
    Ms. Rivers. What would it look like? What is an example of 
a non-regulatory alternative that a regulatory agency would be 
putting in place?
    The Chairman. Well, we don't want to go into it at this 
point, but for instance, the adoption of hydrogen fuel would 
allow us to get rid of a bunch of regulations that now affect 
other kinds of fuels.
    So I mean there are in fact ways of developing new ideas 
and new things.
    Tax policy that would encourage people to do things might 
be used in place of mandates, command and control mandates, 
that force people to do things.
    I mean, there are a variety of non-regulatory approaches 
that we might want to have examined toward possible legislation 
in the future.
    Ms. Rivers. But those would be normally the ones you are 
pointing to would be Congressional initiatives as opposed to 
agency initiatives, and these appear to be an obligation that 
the agency incurs as a part of this whole process.
    The Chairman. I would love to have some agencies to 
recommend to us some non-regulatory approaches.
    Mr. Traficant. Mr. Chairman.
    The Chairman. Mr. Traficiant.
    Mr. Traficant. I'm not going to make an issue of the 
amendment that was offered by Mr. Minge.
    But I do want to make an issue for the sake of precedent 
because I do not believe, as the gentleman from Florida, that 
that last sentence would throw this into a consequential 
referral.
    The language did not say that productivity and 
competitiveness of American businesses will be enhanced by 
implementing the following measures. It is a vague, general 
statement that just basically says that productivity and 
competitiveness in American businesses would be enhanced by 
implementing a variety of measures of which we do not mandate, 
of which we do not cover here with any legislative authority.
    So I'm not going to make a further issue over this, but I 
think that if we're going to do this, and if we're going to be 
constantly worried about consequential referral, I think that's 
going to have to come over specific issues that may in fact 
violate or push us into a referral to another committee.
    I'm not so sure this one did.
    The Chairman. Well, I thank the gentleman for his point, 
and of course it would have been easier to evaluate this had we 
had the amendment further in advance. And I understand that 
there are a variety of reasons why that couldn't be done.
    I just want to make certain that we don't have the 
problems. The gentleman has agreed to modify his amendment. I 
think it still makes his statement, and without objection, the 
amendment is adopted.
    Is there objection?
    [No response.]
    The Chairman. The Chair hears none. The amendment's 
adopted.
    We will not go on to--do we have another amendment to the 
findings?
    Does anybody else have an amendment to findings?
    Mr. Brown. Mr. Chairman, I have an amendment that goes to 
the findings. It's amendment I have labeled number two.
    The Chairman. Do we have that before us?
    Mr. Brown. Which I would like to have the Clerk distribute.
    The Chairman. The Clerk will distribute the amendment.
    Mr. Brown. And it adds Section 3002 on page 3 after line 4.
    [The amendment is distributed.]
    [Pause]
    The Chairman. The gentleman is recognized to describe his 
amendment.
    Mr. Brown. Mr. Chairman, this is essentially the same kind 
of savings clause language that already exists in the Bill on 
page 8, but only applying to that Subtitle.
    What my amendment seeks to do is to apply this same savings 
clause language to the entire Title.
    There may be some good reason why the Chair, in his wisdom, 
was willing to put a savings clause in with respect to the 
Subtitle, and I'm sure he'll explain that, but not willing to 
put it in for the entire Title.
    Now, one of the things that has aroused considerable 
anxiety on the part of many people around the country is that 
this Bill is really intended to override existing law on a 
large scale.
    That it is intended in effect to negate a lot of the 
environmental, health, and safety and other laws, perhaps the 
Safe Drinking Water Act, the Clean Air Act, and they would be 
much more reassured and willing to accept the thrust of this, 
which is improving the regulatory process, if they were 
reassured by an amendment of the sort that I'm offering, which, 
as I've said, merely repeats language that applies to one 
portion of this Title and applies it to the entire Title, and 
makes it clear that this is not designed to modify any 
statutory standard or requirement that currently exists or 
delay any action required to meet a deadline imposed by a 
statute or a court.
    I think it would be an amendment which would make this Bill 
far more acceptable, and it would garner much support for it 
from the public and other Members of Congress.
    The Chairman. Well, I thank the gentleman.
    I think that the Chair is concerned about some of the 
language in this particular section and applying it to the 
whole Title, because when you state that nothing in the Title 
shall change the factors that the agency is authorized to 
consider in promulgating a regulation pursuant to any statute, 
that means that not only present statutes but statutes in the 
future, no agency would be able to change the factors that it's 
authorized to consider.
    This whole Bill is aimed at attempting to change some of 
the factors that they use in promulgating regulations, and so 
the gentleman, in this particular finding, has essentially 
gutted what we are attempting to achieve in the whole risk 
assessment process.
    And so that particular language, I think, would cause the 
Chair to have some considerable degree of problem with the 
proposal.
    Mr. Traficant. Mr. Chairman.
    The Chairman. The gentleman from Ohio.
    Mr. Traficant. I'm not so sure that I share the same 
anxieties you have with this language. I think that your 
language in the Bill, in your Substitute, certainly speaks to 
salient points that are also covered by this amendment and in 
tandem might even clarify the long range issues that the 
amendment portends to address.
    And as I see it, on page 8, all of that of the substitute 
from line 1 through line 9, I think that it amplifies upon, and 
even strengthens, the language that the Chairman has in his 
substitute.
    The Chairman. Mr. Weldon.
    Mr. Dave Weldon. Well, I would disagree with the gentleman 
and I would assert that the language in this amendment would 
seriously go to weaken the provisions in the Bill as proposed, 
and the intent of the legislation is to make the regulatory 
process a more difficult one for Federal agencies and to 
provide some regulatory relief to industry--and acknowledging 
the fact that the American marketplace is being overly 
regulated by the Federal Government.
    Also, I believe this legislation is intended to bring some 
sanity to the regulatory process. And this amendment would 
seriously undermine the intent of the legislation.
    And I would oppose this amendment.
    The Chairman. I thank the gentleman.
    The Chair will put the question on the amendment.
    Those in favor of the amendment say aye?
    [Chorus of ayes.]
    Mrs. Morella. Mr. Chairman.
    The Chairman. Mrs. Morella.
    Mr. Morella. Thank you, Mr. Chairman.
    I want to ask you how this amendment that's being offered 
correlates or connects with, on page 20, the applicability 
which deals with the fact that no major rule shall be 
promulgated by any Federal agency, number 2, and then number 1 
also.
    I mean, does it----
    The Chairman. That was the point that the Chair made a few 
minutes ago. It conflicts with that particular section.
    Mrs. Morella. Yes. I think it does conflict with it.
    The Chairman. Yes. Yes. And that's one of the Chair's 
problems with the language, that this offers a conflicting 
standard.
    Mr. Traficant. Mr. Chairman, rather than have a vote on 
this, I think that the members are not quite sure on this 
thing.
    The Chairman. Well, we're going to find out.
    Mr. Traficant. If it be the will of the membership here, 
maybe we should wait until we get back. We've got a vote 
underway on the floor.
    The Chairman. I appreciate the gentleman, but the facts is 
the Committee has not recessed, and the Chair intends to put 
the question, and does put the question, on the amendment. 
Those in favor, say aye.
    [Chorus of ayes.]
    The Chairman. Those opposed, no.
    [Chorus of nays.]
    The Chairman. In the opinion of the Chair, the noes have 
it.
    Mr. Brown. Mr Chairman, I'd like to request a roll call 
vote on this.
    The Chairman. The Clerk will call the roll.
    The Clerk. Mr. Walker?
    The Chairman. No.
    The Clerk. Mr. Walker, no.
    Mr. Brown?
    Mr. Brown. Aye.
    The Clerk. Mr. Brown, aye.
    Mr. Sensenbrenner?
    [No response.]
    The Clerk.  Mr. Hall?
    [No response.]
    The Clerk. Mr. Boehlert?
    [No response.]
    The Clerk. Mr. Traficant?
    Mr. Traficant. Aye.
    The Clerk. Mr. Traficant, aye.
    Mr. Fawell?
    Mr. Fawell. No.
    The Clerk. Mr. Fawell, no.
    Mr. Hayes?
    [No response.]
    The Clerk. Mrs. Morella?
    Mrs. Morella. Mrs. Morella passes.
    The Clerk. Mr. Tanner?
    Mr. Tanner. Aye.
    The Clerk. Mr. Tanner votes aye.
    Mr. Weldon of Pennsylvania?
    [No response.]
    The Clerk. Mr. Geren?
    [No response.]
    The Clerk. Mr. Rohrabacher?
    Mr. Rohrabacher. No.
    The Clerk. Mr. Rohrabacher votes no.
    Mr. Roemer?
    Mr. Roemer. Aye.
    The Clerk. Mr. Roemer votes aye.
    Mr. Schiff?
    Mr. Schiff. No.
    The Clerk. Mr. Schiff votes no.
    Mr. Cramer?
    [No response.]
    The Clerk. Mr. Barton?
    Mr. Barton. No.
    The Clerk. Mr. Barton votes no.
    Mr. Barcia?
    [No response.]
    The Clerk. Mr. Calvert?
    Mr. Calvert. No.
    The Clerk. Mr. Calvert votes no.
    Mr. McHale?
    [No response.]
    The Clerk. Mr. Baker?
    Mr. Baker. No.
    The Clerk. Mr. Baker votes no.
    Ms. Harman?
    [No response.]
    The Clerk. Mr. Bartlett?
    Mr. Bartlett. No.
    The Clerk. Mr. Bartlett votes no.
    Ms. Johnson?
    Ms. Johnson. Aye.
    The Clerk. Ms. Johnson votes aye.
    Mr. Ehlers?
    Mr. Ehlers. No.
    The Clerk. Mr. Ehlers votes no.
    Mr. Minge?
    Mr. Minge. Aye.
    The Clerk. Mr. Minge votes aye.
    Mr. Wamp?
    Mr. Wamp. No.
    The Clerk. Mr. Wamp votes no.
    Mr. Olver?
    Mr. Olver. Yes.
    The Clerk. Mr. Olver votes aye.
    Mr. Weldon of Florida?
    Mr. Dave Weldon. No.
    The Clerk. Mr. Weldon votes no.
    Mr. Hastings?
    [No response.]
    The Clerk. Mr. Graham?
    Mr. Graham. No.
    The Clerk. Mr. Graham votes no.
    Ms. Rivers?
    Ms. Rivers. Aye.
    The Clerk. Ms. Rivers votes aye.
    Mr. Salmon?
    Mr. Salmon. No.
    The Clerk. Mr. Salmon votes no.
    Ms. McCarthy?
    Ms. McCarthy. Aye.
    The Clerk. Ms. McCarthy votes aye.
    Mr. Davis?
    Mr. Davis. No.
    The Clerk. Mr. Davis votes no.
    Mr. Ward?
    [No response.]
    The Clerk. Mr. Stockman?
    [No response.]
    The Clerk. Ms. Lofgren?
    [No response.]
    The Clerk. Mr. Gutknecht?
    [No response.]
    The Clerk. Mr. Doggett?
    Mr. Doggett. Aye.
    The Clerk. Mr. Doggett votes aye.
    Mrs. Seastrand?
    [No response.]
    The Clerk. Mr. Doyle?
    Mr. Doyle. Aye.
    The Clerk. Mr. Doyle votes aye.
    Mr. Tiahrt?
    Mr. Tiahrt. No.
    The Clerk. Mr. Tiahrt votes no.
    Ms. Jackson-Lee?
    Ms. Jackson-Lee. Aye.
    The Clerk. Ms. Jackson-Lee votes aye.
    Mr. Largent?
    Mr. Largent. No.
    The Clerk. Mr. Largent votes no.
    Mr. Luther?
    Mr. Luther. Aye.
    The Clerk. Mr. Luther votes aye.
    Mr. Hilleary?
    [No response.]
    The Clerk. Mrs. Cubin?
    [No response.]
    The Clerk. Mr. Foley?
    [No response.]
    The Clerk. Mrs. Myrick?
    [No response.]
    The Chairman. The Clerk will report.
    How is Mr. McHale recorded?
    The Clerk. Mr. McHale is not recorded.
    Mr. McHale. I'd like to be recorded as aye.
    The Clerk. Mr. McHale votes aye.
    The Chairman. Mr. Weldon of Pennsylvania?
    The Clerk. Mr. Weldon of Pennsylvania is not recorded.
    Mr. Curt Weldon. No.
    The Clerk. Mr. Weldon votes no.
    The Chairman. The Clerk will report.
    Mrs. Morella, how is she recorded?
    Mrs. Morella. Mrs. Morella is going to change the pass to 
no on the basis of what the Chairman has said about the fact 
that it is not parallel with the other sections.
    The Chairman. Mrs. Morella votes no.
    The Clerk. Mrs. Morella votes no.
    Mr. Chairman, I have 15 yeas, 18 nays.
    The Chairman. The amendment is defeated. The Committee 
stands in recess to go vote.
    [Recess.]
    The Chairman. The Committee will come to order.
    Mr. Hastings. Mr. Chairman, I have a point of parliamentary 
inquiry.
    The Chairman. The gentleman will state it.
    Mr. Hastings. Mr. Chairman, is it proper for the Chair to 
call a roll call vote at the same time that a record vote is 
called? And I cite for you the background on what just 
transpired.
    My understanding is that the bell had gone off. Several 
members, including myself, left to go and vote on a recorded 
vote, and you called a roll call vote.
    I understand the ruling from the House, from the Speaker, 
but I'm curious as to how you're going to operate this 
Committee and how it is that I'm supposed to be able to vote 
here and there at the same time?
    The Chairman. Well, I thank the gentleman for his inquiry. 
The recorded vote was requested. The Committee had not gone 
into recess at that point. While the Committee is meeting there 
is a potential for recorded votes, and members need to be 
advised of that.
    I am aware that for some members, it's created a hardship 
that they were at other Committees and so on. That is one of 
the difficulties that we have under a system where we're trying 
to do a lot of business very fast, and I wish that all members 
could have been here for the vote.
    On both sides of the aisle, there were members who missed 
the vote because of other obligations.
    But I will say I don't believe that there was anybody who 
was in the room who participated in the recorded vote who 
missed the vote in the House. I think virtually everybody was 
able to get to the House in time to make the vote.
    Mr. Hastings. Will the Chair yield?
    The Chairman. And so, you know, it was the discretion of 
the Chair of course that when a recorded vote as asked for, to 
move ahead with the recorded vote with the members who were in 
the room at that time. And at the time that the vote was over, 
we did declare a recess so that members could go and vote.
    Mr. Hastings. All right. I'll take the matter up with the 
Chair, but I'd have you to understand that all of us may not 
have the physical wherewithal. I had heart surgery last year, 
and the doctor told me when the bill rings, leave. And I've 
learned to do that, and somehow or another my life means a 
little more to me than the recorded vote, but I'll take it up 
with you, Mr. Chairman.
    Ms. Lofgren. Mr. Chairman, I would like to, if I may, 
concur in Mr. Hastings' comments. I think that I'm a new 
member, but I've never, in my years in local government and 
observing here seen something like this happen. I think it's 
highly discourteous to the members, and I don't think when the 
bells ring and members go over to fulfill their obligations on 
the floor that it is reasonable to call a recorded vote in this 
Committee, and I would like to register my objection in 
defense.
    The Chairman. Well, it seems to me that the Chair has a 
duty to respond to the member who's asking for a recorded vote. 
It is in fact the right of every member to ask for a recorded 
vote on their amendment, and that was in fact what the Chair 
did, and so that the Chair was responding to the request of the 
member for a recorded vote.
    The Chair would prefer that we could avoid recorded votes, 
but that is the circumstance that does arise.
    I would say--the gentleman from Wisconsin?
    Mr. Sensenbrenner. Mr. Chairman, I would point out that the 
House Rules specifically state that the Chair does not have the 
power to declare a recess once the Chair puts the question on a 
voice vote, and after the Chair announces his decision on which 
side had it, should a member ask for a recorded vote, the Chair 
is obligated to direct the Clerk to call the roll and does not 
have the power, under House Rules, to declare a recess.
    So what the Chair did was entirely within the scope of 
House rules. I was one who missed the vote because I heard the 
bell ring and I went over to vote. I guess that's the breaks of 
the game.
    The Chairman. I thank the gentleman, because I think that 
is a reflection of the rules.
    Mr. Foley. Mr. Chairman?
    The Chairman. The gentleman from Florida.
    Mr. Foley. Yes Mr. Chairman. I don't want to belabor the 
point, but there would be an opportunity to at least inform our 
fellow colleagues if one of the members will be demanding a 
recorded vote in that interim. I was here in the room when the 
bells went off and did in fact go to the floor to vote.
    So I think in fairness, our colleagues should at least 
alert us if you are going to call a vote or ask the Chair to 
call a vote.
    The Chairman. The Chair would indicate that he thinks that 
that would be desirable. On the other hand, most members don't 
know whether or not they're going to get a recorded vote until 
they see how the voice votes come out or how a division vote 
comes out, so it's kind of hard for them at times to inform the 
members.
    But the Chair would appreciate also knowing. It would in 
fact help us to assure members of their status.
    Mr. Doggett. Mr. Chairman, for the parliamentary inquiry on 
that subject then, do I understand that under the Rules of the 
House then, once a matter is put to a voice vote, that you 
cannot declare a recess for a vote of the House thereafter?
    The Chairman. After the vote has begun and is underway, at 
that point it is not open to the discretion of the Chair to 
halt that process.
    Mr. Doggett. Was not the last vote of this Committee 
initiated after the bell had rung?
    The Chairman. That's correct.
    Mr. Doggett. And do the Rules of the House contemplate 
casting votes in Committee after the bell has rung?
    The Chairman. Well, the Rules of the House are such that as 
long as members can get there within the 15 minute time, that 
only until the Committee has declared a recess are the members 
free to leave.
    Mr. Doggett. Would a rule of this Committee that prohibited 
the taking of votes during the time, during the 15-minute 
period, be out of order or inconsistent with the Rules of the 
House?
    The Chairman. They are not a part of the Rules of the 
Committee.
    Mr. Doggett. Would such a rule, if it were adopted, be a 
part--would be in conflict?
    The Chairman. It would be in conflict with the House if in 
fact the recess would occur in the midst of attempting to deal 
with a matter before the Committee that has been put to a vote.
    Mr. Doggett. The recess requirement wouldn't apply if the 
vote weren't put during the 15-minute period?
    The Chairman. Well, again, I mean--
    Mr. Doggett. Are our Committee rules subject to--is it 
proper under the Rules of the Committee to advance further 
amendments to the rules after they've been adopted during the 
course of this session in Congress?
    The Chairman. Well, that would be an unusual circumstance 
and I would say to the gentleman that my guess is that that 
would have to be something to be taken up at a separate session 
of the Committee.
    Mr. Doggett. Thank you.
    Mr. Hastings. Mr. Chairman, I have a request. And my 
request is, had I been present at the last roll call vote that 
was called during a recorded vote, then I would have voted yes.
    The Chairman. The gentleman's statement will be recorded.
    Ms. Lofgren. Mr. Chairman, I have a unanimous consent 
request to the same effect as Mr. Hastings. I would have voted 
yes.
    The Chairman. The gentlelady's vote mentioned will be 
recorded.
    The gentleman from Wisconsin?
    Unknown Member. Mr. Chairman, I make the same request. Had 
I been present, I would have voted yes to the amendment.
    The Chairman. The gentleman from Florida?
    Mr. Dave Weldon. The same request for a recorded yes vote.
    Unknown Member. The same request for a no vote.
    The Chairman. The gentleman from Texas.
    The Chairman. The gentleman from Florida wishes to be 
record as?
    Mr. Foley. No vote.
    The Chairman. No, okay.
    These will not be reflected, you understand, in the vote 
itself. They will simply be reflected in the record.
    Ms. Cubin. Mr. Chairman, the same request with a recorded 
no vote.
    The Chairman. The gentlewoman's will be noted.
    The gentlewoman from North Carolina? The same request for a 
no vote.
    Mr. Tanner. The same request, Mr. Chairman, for a no vote.
    The Chairman. No vote, OK.
    Mr. Hayes. Mr. Chairman, I would make the same request for 
a yes vote.
    The Chairman. The gentleman from Louisiana makes the same 
request for a yes vote.
    All right. We will proceed onward now to the next amendment 
listed on the markup amendment roster as Amendment Number 6, en 
bloc amendment to page 36 and page 45 that raises the dollar 
limit.
    Who will be offering this amendment? We don't have a--
    Mr. Brown. Mr. Chairman, I'm informed that I have this 
amendment but that I have to offer a substitute for the one 
that's listed in your record, and that I would need to ask the 
Clerk to distribute the substitute.
    The Chairman. The Clerk will distribute the substitute.
    [The substitute is distributed.]
    Mr. Brown. I assume that the content is the same--Because 
of the numbering problem, sequencing.
    Mr. Chairman, while the Clerk is distributing this, it's a 
very simple amendment, and if you will turn to your substitute, 
Mr. Walker's substitute on page 4, line 12, there would be a 
substitution of about four or five words there.
    The word ``in connection with Federal programs'' would be 
stricken, and instead it would insert ``in connection with 
major rules.''
    Now, this is intended to reflect an emphasis in this Bill 
on the rulemaking procedure, not on a function of trying to 
change Federal law with regard to programs.
    This entire thrust of this Bill has to do with the 
regulatory process, as implemented through the rulemaking 
procedures, and we are suggesting that this would be better 
reflected if we would just substitute actually the two words 
``major rules'' for ``Federal programs.''
    And I would ask support for this modest change, which I 
think better reflects what the thrust of the legislation should 
be.
    Ms. Lofgren. Mr. Brown? Mr. Brown, would you yield for a 
question?
    Mr. Brown. I'd be happy to yield to the lady.
    Ms. Lofgren. Some of the questions that I have gotten over 
on the floor from Judiciary Committee members are in the nature 
of whether this Bill would in fact cover the Bureau of Prisons, 
the FBI, law enforcement agencies who are charged with the 
protection of the safety of people.
    And there are a number of lawyers on that Committee who 
feel that this Bill would in fact cover rulemaking in the 
Bureau of Prisons and elsewhere which, from the hearings and 
the discussion here, I don't think was really what most members 
had in mind as needing reform, unless I'm misunderstanding the 
nature of the testimony I heard.
    Would your amendment cure that defect, do you think? My 
sense is it would not, but I'm anxious to address that.
    Mr. Brown. Without intending to be facetious, I doubt if 
any simple amendment will cure the defects in this Bill, but 
the fact is that it moves the Bill in the direction of 
restricting it to an area which is more sensible and more 
proper in terms of approving the risk assessment process.
    Now the way the Bill is currently drafted, it is extremely 
broad in scope, and I think some of the Chairman's amendments 
have served to narrow that scope somewhat. But it still has 
overly broad language in a number of areas.
    For example, just at the bottom of that same page, page 4, 
``any major,'' it refers to significant documents and says, 
``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.''
    That would include Federal prisons, for example, or other 
Federal agencies which definitely enact rules that are aimed at 
protecting human health, safety and the environment, but which 
I think should not be within the scope of this Bill which 
intended to apply to a different category of problems than 
would be included in the Federal prisons.
    Ms. Lofgren. Thank you.
    The Chairman. Is there further discussion on the amendment?
    [No response.]
    The Chairman. If there's no further discussion, the Chair 
would indicate that the gentleman from California's described 
his amendment correctly. It is an amendment which has very, 
very severe limits in it.
    By characterizing only major rules, rather than regulatory 
programs, it means only the regulations would be covered under 
the Act.
    this would mean that potentially this would not cover the 
cleanup and decontamination of facilities, it would not cover 
things such as anything that an agency or OMB identifies as a 
potential problem, it would not cover reports to the Congress, 
it would not cover documents with over a $25 million effect.
    Let me give you one thing that it would not have covered 
that I think most of us agree is a problem. The Alar 
controversy where an agency literally almost ruined an entire 
food product industry in this country would not be covered 
under this kind of provision.
    It is exactly that kind of problem that we seek to resolve 
with this legislation. And so this would have an extremely 
detrimental effect on solving some of the problems that we 
believe are very real in this society.
    I don't want to approve a piece of legislation that would 
not have covered the Alar controversy. In this particular case, 
this amendment would cause that problem.
    Mrs. Morella. Mr. Chairman?
    The Chairman. The gentlelady from Maryland.
    Mrs. Morella. Thank you.
    Just an inquiry. I'm just wondering if this Bill and the 
amendment being offered would cover the Centers for Disease 
Control?
    The Chairman. Does counsel wish to comment?
    Mr. Beringer. In certain cases, it probably would. However, 
most of the things that the Centers for Disease Control do are 
responding to emergencies or sometimes in response to health, 
safety, or environmental types of--even though they don't do 
the inspections themselves, they promote those inspections, so 
I think those two things taken together could be fairly 
represented to exempt that agency.
    Mrs. Morella. So your feeling is that by and large it is 
excluded by virtue of the fact that, although it doesn't say, 
emergency when they do preventive programs, they are geared 
toward disease prevention?
    Mr. Beringer. Right.
    The Chairman. Thank the gentleman.
    Mr. Bartlett?
    Mr. Bartlett. Mr. Chairman, do we have a problem with being 
concerned that the cure not be worse than the disease no matter 
where it occurs in our society?
    The Chairman. I think that that's one of the things we're 
trying to deal with.
    I thank the gentleman.
    If there's no further comment, the Chair will put the 
question on the amendment.
    All those in favor of the amendment by Mr. Brown will say 
aye.
    [Chorus of ayes.]
    The Chairman. Those opposed will say no.
    [Chorus of nays.]
    The Chairman. In the opinion of the Chair, the noes have 
it.
    The next amendment will be Amendment Number 7 on the list.
    Mr. Brown. I understand we're withdrawing that amendment.
    The Chairman. It's my understanding that that amendment 
then is withdrawn.
    Next on the list was an amendment by Mr. Davis, Number 8, 
which he is not going to offer, but he is going to offer his 
Amendment Number 9.
    The gentleman will describe the amendment.
    Mr. Davis. This simply adds, if you can look at the 
appropriate section, 3104(a), the amendment adds, ``and rely, 
to the extent available and practicable, on scientific 
findings.''
    I think it's a clarifying amendment, and I would offer it 
for that reason.
    The Chairman. This is an amendment that is in the packet, 
and I would say to the gentleman that this is an amendment that 
the Chair did have an opportunity to examine, and is prepared 
to accept.
    I don't know if there's additional comment on the amendment 
or not?
    Anybody else have additional comment?
    Mr. Brown. Mr. Chairman? I'm having difficulty in 
understanding the amendment.
    Although it appears to be fairly simple, it uses the term 
``to the extent available and practicable on scientific 
findings.''
    I wonder if the author would be able to indicate what his 
intentions were in connection with this amendment?
    Mr. Davis. I think it's clarifying. It comes out of the 
Senate Bill which parallels this. It makes them read congruent. 
It's congruent to that, and I think it speaks for itself.
    Mr. Brown. Well, the gentleman may feel that it does, but I 
can assure him that it doesn't speak to me. [Laughter.]
    Mr. Davis. I don't think much of these do.
    Mr. Brown. And I have not found it always practicable to 
rely on Senate language in the past.
    Now there's some of the amendment that we were intending to 
pose that would incorporate Senate language, but I had a 
feeling that that was not sufficient to justify us offering the 
amendments, and we haven't done so.
    Mr. Davis. Well, the purpose here is that when the head of 
an agency will apply the principles that are set forth in 
subsection B when preparing risk assessments, in order to 
assure that the risk assessment and all the other components 
distinguished scientific findings from other considerations are 
to the maximum extent feasible scientifically objective, 
unbiased and inclusive of all relevant data.
    This reinforces the idea that the focus, when preparing a 
risk, should be on scientific findings.
    The Chairman. And the Chair, when he examined this 
amendment, felt that also it adds a little bit of additional 
discretion for the head of the agency as well because it does 
use the language ``to the extent available practicable,'' it 
does give a little----
    Mr. Davis. A little wiggle room.
    The Chairman [continuing]. Additional room for the agency 
heads to deal with the matter.
    Mr. Davis. Does that clarify the gentleman's concern or?
    Okay.
    The Chairman. Well, is there any further discussion on the 
amendment?
    [No response.]
    The Chairman. All those in favor of the amendment will say 
aye.
    [Chorus of ayes.]
    The Chairman. Those oppose will say no.
    [Chorus of nays.]
    The Chairman. In the opinion of the Chair, the ayes have 
it. The amendment is approved.
    Mr. Hayes. Mr. Chairman, on that I ask for a vote, since I 
missed some, I'm going to get some back. [Laughter.]
    The Chairman. The gentleman from Louisiana has requested a 
recorded vote.
    Those in favor will be recorded as aye, those opposed will 
be no.
    The Clerk will call the roll.
    The Clerk. Mr. Walker?
    The Chairman. Aye.
    The Clerk. Mr. Walker votes aye.
    Mr. Brown?
    Mr. Brown. No.
    The Clerk. Mr. Brown votes no.
    Mr. Sensenbrenner?
    Mr. Sensenbrenner. Aye.
    The Clerk. Mr. Sensenbrenner votes aye.
    Mr. Hall?
    Mr. Hall. Pass.
    The Clerk. Mr. Hall votes present.
    Mr. Bochlert?
    Mr. Boehlert. Aye.
    The Clerk. Mr. Boehlert votes Aye.
    Mr. Traficant?
    Mr. Traficant. Aye.
    The Clerk. Mr. Traficant votes aye.
    Mr. Fawell?
    Mr. Fawell. Aye.
    The Clerk. Mr. Fawell votes aye.
    Mr. Hayes?
    Mr. Hayes. Aye.
    The Clerk. Mr. Hayes votes aye.
    Mrs. Morella?
    Mrs. Morella. Aye.
    The Clerk. Mrs. Morella votes aye.
    Mr. Tanner?
    Mr. Tanner. Aye.
    The Clerk. Mr. Tanner votes aye.
    Mr. Weldon of Pennsylvania?
    Mr. Curt Weldon. Aye.
    The Clerk. Mr. Weldon votes aye.
    Mr. Geren?
    [No response.]
    The Clerk. Mr. Rohrabacher?
    Mr. Rohrabacher. I give an aye.
    The Clerk. Mr. Rohrabacher votes aye.
    Mr. Roemer?
    [No response.]
    The Clerk. Mr. Schiff?
    Mr. Schiff. Aye.
    The Clerk. Mr. Schiff votes aye.
    Mr. Cramer?
    [No response.]
    The Clerk. Mr. Barton?
    Mr. Barton. Yes.
    The Clerk. Mr. Barton votes aye.
    Mr. Barcia?
    Mr. Barcia. Aye.
    The Clerk. Mr. Barcia votes aye.
    Mr. Calvert?
    [No response.]
    The Clerk. Mr. McHale?
    Mr. McHale. Aye.
    The Clerk. Mr. McHale votes aye.
    Mr. Baker?
    Mr. Baker. Aye.
    The Clerk. Mr. Baker votes aye.
    Ms. Harman?
    Ms. Harman. Aye.
    The Clerk. Ms. Harman votes aye.
    Mr. Bartlett?
    Mr. Bartlett. Aye.
    The Clerk. Mr. Bartlett votes aye.
    Ms. Johnson?
    Ms. Johnson. No.
    The Clerk. Ms. Johnson votes no.
    Mr. Ehlers?
    Mr. Ehlers. Aye.
    The Clerk. Mr. Ehlers votes aye.
    Mr. Minge?
    Mr. Minge. Aye.
    The Clerk. Mr. Minge votes aye.
    Mr. Wamp?
    Mr. Wamp. Aye.
    The Clerk. Mr. Wamp votes aye.
    Mr. Olver?
    Mr. Olver. No.
    The Clerk. Mr. Olver votes no.
    Mr. Weldon of Florida?
    Mr. Dave Weldon. Aye.
    The Clerk. Mr. Weldon votes aye.
    Mr. Hastings?
    Mr. Hastings. Nay.
    The Clerk. Mr. Hastings votes nay.
    Mr. Graham?
    Mr. Graham. Aye.
    The Clerk. Mr. Graham votes aye.
    Ms. Rivers?
    Ms. Rivers. No.
    The Clerk. Ms. Rivers votes no.
    Mr. Salmon?
    Mr. Salmon. Aye.
    The Clerk. Mr. Salmon votes aye.
    Ms. McCarthy?
    Ms. McCarthy. No.
    The Clerk. Ms. McCarthy votes no.
    Mr. Davis?
    Mr. Davis. Aye.
    The Clerk. Mr. Davis votes aye.
    Mr. Ward?
    Mr. Ward. No.
    The Clerk. Mr. Ward votes no.
    Mr. Stockman?
    Mr. Stockman. Yes.
    The Clerk. Mr. Stockman votes Aye.
    Ms. Lofgren?
    Ms. Lofgren. Aye.
    The Clerk. Ms. Lofgren votes aye.
    Mr. Gutknecht?
    Mr. Gutknecht. Aye.
    The Clerk. Mr. Gutknecht votes aye.
    Mr. Doggett?
    Mr. Doggett. Nay.
    The Clerk. Mr. Doggett votes no.
    Mrs. Seastrand?
    Mrs. Seastrand. Aye.
    The Clerk. Mrs. Seastrand votes aye.
    Mr. Doyle?
    [No response.]
    The Clerk. Mr. Tiahrt?
    Mr. Tiahrt. Aye.
    The Clerk. Mr. Tiahrt votes aye.
    Ms. Jackson-Lee?
    Ms. Jackson-Lee. No.
    The Clerk. Ms. Jackson-Lee votes no.
    Mr. Largent?
    Mr. Largent. Aye.
    The Clerk. Mr. Largent votes aye.
    Mr. Luther?
    Mr. Luther. Aye.
    The Clerk. Mr. Luther votes aye.
    Mr. Hilleary?
    Mr. Hilleary. Aye.
    The Clerk. Mr. Hilleary votes aye
    Mrs. Cubin?
    [No response.]
    The Clerk. Mr. Foley?
    Mr. Foley. Aye.
    The Clerk. Mr. Foley votes aye.
    Mrs. Myrick?
    Ms. Myrick. Aye.
    The Clerk. Mrs. Myrick votes aye.
    Mr. Roemer. Mr. Chairman, how am I recorded?
    The Chairman. The gentleman from Indiana, how is he 
recorded?
    The Clerk. Mr. Roemer is not recorded.
    Mr. Roemer. Aye.
    The Clerk. Mr. Roemer votes aye.
    Mr. Hall. Mr. Chairman, how am I recorded?
    The Chairman. How is Mr. Hall recorded?
    The Clerk. Mr. Hall is not recorded.
    Mr. Hall. I vote aye.
    The Clerk. Mr. Hall votes aye.
    The Chairman. Mr. Hall votes aye.
    Is there anybody else in the room that is not certain how 
they've been recorded?
    [No response.]
    The Chairman. Then all members have been recorded.
    The Clerk will report.
    The Clerk. Mr. Chairman, I count 36 yeas, 9 nays.
    The Chairman. Thirty-six yeas, 9 nays, the amendment is 
agreed to.
    The next amendment on the list is also an amendment by Mr. 
Davis of Virginia.
    Mr. Davis. This is Amendment 11. We're not going to offer 
10 but Amendment 11.
    This Section 3104(b) deals with risk assessment of human 
health risks. It addresses the types of data one should 
consider and discuss when conducting a risk assessment. The 
base document includes laboratory and epidemiological data and 
other relevant data.
    This amendment adds raw data, such as may be acquired from 
animal experiments, to the data to be considered.
    When reviewing this, the amendment asks that one consider 
the effects on human health and so on. The inclusion of raw 
data is important and may provide vital and necessary 
information, and under this amendment is specified as opposed 
to raw data being classified as any other relevant data.
    I think this clarifies again, and once again I've shared 
this with the staff, and I hope the Chairman's in agreement.
    The Chairman. Well, the Chair has reviewed this amendment 
and is prepared to accept the amendment.
    Is there any further discussion?
    [No response.]
    Mr. Brown. Mr. Chairman, I have reviewed this language 
myself and, as with the last amendment, I find that it does not 
convey to me any really significant indication of what it 
means.
    It sounds innocuous enough, but I am afraid that the 
ordinary person, including the ordinary bureaucrat who will be 
called upon to carry out the intent of this law, is not going 
to be able to discern exactly what the authors intended.
    Now I will admit that this is a personal opinion, but it 
comes from reading a lot of law with regard to what scientists 
should do, and I am not convinced at all that it provides any 
constructive guidance.
    The Chairman. Is there any further discussion?
    Mr. Olver. Mr. Chairman.
    The Chairman. The gentleman from Massachusetts.
    Mr. Olver. Mr. Chairman, the last sentence here on ``animal 
data should be reviewed with regard to its relevancy to 
humans,'' that at least is already addressed in this section--I 
think. I am having difficulty, I must say. It takes awhile to 
find.
    Mr. Chairman, I always thought this process was on the 
level, and I never realized that we did this to you when we 
were in the majority. [Laughter.]
    Mr. Olver. But I am having a difficult time reading 
through, once a whole lot more words in this area have been 
added, what the meaning can possibly be--which I think is about 
the same problem that the Ranking Member is having.
    Could the Member, the colleague offering this amendment, 
please explain to me again why this is needed, in addition to 
the language that is already there?
    Mr. Davis. The language that is there is so general, this 
calls specifically the attention of raw data for review, and 
then goes on to note that ``the greatest emphasis would be 
placed on data that indicated a biological basis of the 
resulting harm in humans.''
    I think it is clarification when you say--right now it says 
``any other relevant data''; the ``raw data'' could be a key 
ingredient. I think it gives the ``bureaucrats,'' as Mr. Brown 
describes them, the flexibility to go back after--and look at 
the raw data, the underlying--it may not be a published study, 
but the raw data itself, and use that as a basis. So I think it 
gives them flexibility.
    Mr. Olver. Well, the very last sentence, which says that 
``Animal data shall be reviewed with regard to its relevancy to 
humans,'' above, in the very same section, there is the 
language ``where animal data is used as a basis, the document 
shall include discussion of the possible reconciliation of 
conflicting information.''
    I don't know what, then, the language that is in the 
amendment does to clarify or add to what is already there.
    Mr. Davis. What it adds is the raw data. It emphasizes raw 
data as opposed to the current language that just says ``any 
other relevant data.'' It just gives that flexibility, should 
there be any hesitancy on the part of someone putting out the 
rule or regulation.
    I don't think it does--I think it is a clarification. It 
just gives the flexibility to the rulemaker.
    The Chairman. The Chair would say to the gentleman from 
Massachusetts I think he raises a relevant point. The fact is 
that, while the language is duplicative, in one case it refers 
to conflicts, and in the other cases it is definitional to the 
raw data and therefore the repeating of the language does not 
seem to do any harm, and certainly does not contradict that 
which was there earlier in the section.
    Is there any further discussion on the amendment?
    [No response.]
    The Chairman. If not, those in favor of the amendment will 
say aye.
    [Chorus of ayes.]
    The Chairman. Those opposed, no.
    [Chorus of nays.]
    The Chairman. In the opinion of the Chair the ayes have it. 
The ayes have it, and the amendment is agreed to.
    The next amendment is listed on the sheet as No. 12, Mr. 
Barton's amendment.
    The gentleman is recognized.
    Mr. Barton. Thank you, Mr. Chairman.
    [The bells ring.]
    Mr. Barton. Is the Committee in recess?
    [Several Members shout ``aye.''] [Laughter.]
    Mr. Barton. Mr. Chairman, I would ask unanimous consent 
that my amendment be considered and adopted by voice vote 
immediately. [Laughter.]
    The Chairman. The gentleman may be a bit hasty. In light of 
the bells ringing and the past controversy, the Chair would 
call an immediate recess and we will take up Mr. Barton's 
amendment when we come back.
    [Brief recess.]
    The Chairman. The Committee will come to order.
    The next amendment is an amendment offered by Mr. Barton. 
The gentleman is recognized.
    Mr. Barton. I thank you, Mr. Chairman.
    Let me give a report from the other Committee that is 
marking the bill up simultaneously. We are ahead. We are on 
Amendment 12. They are on Amendment No. 3. So I don't know if 
that's good or bad, but we are moving more expeditiously.
    Mr. Chairman, I have two versions of the same amendment at 
the desk and I would like to offer the second version, which is 
marked ``Barton 004''.
    The Chairman. Has the amendment been distributed?
    Mr. Barton. The amendment is in the process of being 
distributed.
    The Chairman. The amendment needs to be distributed.
    Mr. Hayes. Mr. Chairman, I ask that the amendment be read.
    Mr. Barton. Do you want me to read it, or the Clerk to read 
it?
    The Chairman. The Clerk will report the amendment.
    The Clerk. Amendment offered by Mr. Barton of Texas:
    ``Page 39, after line 11, (in section 3104(b)), after 
paragraph (2), insert the following:
    (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.''
    Mr. Barton. Mr. Chairman, what this amendment does is 
eliminate a past practice of some Federal agencies that have 
accepted verbatim regulations that were proposed and 
promulgated overseas and not studied in any independent way by 
a Federal agency in this country.
    The amendment would say a Federal agency could take under 
advisement a regulation that has been adopted overseas, but 
before it could actually accept it it would have to conduct an 
independent assessment of that regulation.
    Ms. Rivers. Mr. Chairman.
    The Chairman. Is there discussion?
    Ms. Rivers.
    Ms. Rivers. Thank you, Mr. Chair.
    I have a couple of questions. I was a little confused when 
I saw this because my recollection was, when we had hearings 
last week, people roundly criticized the FDA for not using data 
that were developed in other parts of the world. And that was 
shown as a flaw in the FDA's procedures.
    So I am surprised now that we are seeing this.
    But, more importantly, I am confused as to how this would 
work. If, for example, we have evidence in other countries that 
certain kinds of drugs are indeed injurious to the health of 
citizens in that country, are we required under this procedure 
to have Americans die or become ill in order to demonstrate 
that the data from the other country is acceptable?
    There is no specificity as to what makes data acceptable 
under this provision.
    Mr. Barton. It is my understanding that the Act that is 
before us specifically excludes the Food and Drug 
Administration, so that question wouldn't be germane.
    Ms. Rivers. Well, in any other situation----
    The Chairman. That is not true.
    Ms. Rivers. Yes. It's not true.
    The Chairman. The gentleman has been misinformed. The Drug 
Administration is included.
    Mr. Barton. Well, if the FDA is included in this, the 
general point that the gentlelady was making, the purpose of 
this amendment, it doesn't preclude the acceptance of a 
regulation that's formulated overseas; it simply says, before 
it's actually adopted there has to be an independent risk 
assessment of that regulation.
    Ms. Rivers. And that's what I am asking is what that looks 
like. Does that mean we have to wait for independent evidence 
in this country? I mean, what does that mean? Are we 
essentially saying you can't----
    Mr. Barton. It does not mean that you have to go back and 
reinvent the wheel. It does mean that someone in a Federal 
agency in the United States Government has to do a study of the 
documentation and the risk assessment of the regulation that 
was promulgated overseas.
    It doesn't mean that it has to be--the entire data trail 
has to be recreated. It simply means there has to be a study by 
a Federal agency of the studies that led to that regulation.
    Ms. Rivers. So would in effect this be an endorsement of 
the procedures that the FDA is now employing in their approval 
of drugs in this country?
    Mr. Barton. No, it's not an endorsement, nor is it a 
condemnation. It simply says that you have to conduct, at the 
Federal agency level in this country, an independent assessment 
of any regulation before it's also adopted.
    So in some cases that could be fairly quick. In other cases 
it might take some time.
    Ms. Rivers. Thank you.
    Mrs. Morella. Mr. Chairman.
    Ms. Lofgren. Mr. Chairman.
    Mr. Brown. Mr. Chairman.
    Mrs. Morella. Mr. Chairman.
    The Chairman. Mrs. Morella.
    Mrs. Morella. Thank you, very much. Thank you, Mr. 
Chairman.
    I wanted to ask the gentleman who offered the amendment, 
Mr. Barton, whether or not this would include international 
agreements like the Montreal Protocol which deals with the 
environment, and a number of others that we have on ocean 
dumping, and whatever, where nations have come together and 
have signed a treaty but you may not have individual 
experimentation or certification, or whatever, in your 
amendment for it.
    So I just wondered if it would apply to those?
    Mr. Barton. If the gentlelady would yield?
    Mrs. Morella. Yes.
    Mr. Barton. This deals with risk assessments and simply 
requires that there be a verification by Federal agency of the 
regulation before it's adopted in this Nation.
    The key word is in the first sentence where it says: ``No 
covered Federal agency shall automatically incorporate``--
''automatically incorporate''.
    Mrs. Morella. Well, if it--would they automatically 
incorporate? What would be an instance where they would 
automatically incorporate?
    Mr. Barton. Well, there have been cases in the past where--
and the one that is the most current is with the chemical 
compound styrene where a regulation was adopted in Europe and 
was automatically adopted in this country without any kind of 
independent review by the review by the Federal agency at all.
    Mrs. Morella. Okay. Thank you.
    Ms. Lofgren. Mr. Chairman.
    The Chairman. The gentlelady from California.
    Ms. Lofgren. I think I understand what the gentleman's 
goals are in offering the amendment, but I am concerned that 
the impact might invoke the law of unintended consequences.
    I am thinking about, and I mentioned during the hearing, 
Clozapine, which is a very successful medication utilized with 
schizophrenics, for some section of schizophrenics that affects 
almost a miraculous recovery.
    It was used successfully in Europe with thousands of 
schizophrenics for over ten years, and the impacts were well 
known beyond any trial that could possibly have been engaged in 
the United States.
    The concern I have is I don't understand how this might or 
might not preclude utilizing not trails but an entire continent 
of people taking this medication to good effect, and 
incorporating that.
    Another example that's currently being studied, and I 
frankly don't understand why, is an herbal tea in China that 
has been found to be effective in the treatment of alcoholism 
that has been used by 3 billion Chinese, and that we would have 
to study it here in the United States.
    I am not sure how much additional study would be required, 
and I wondered if the gentleman could give us an idea in terms 
of months or years.
    And the second question has to do----
    The Chairman. If the gentlelady would yield to me----
    Ms. Lofgren. Certainly.
    The Chairman. I think what you need to do is read the 
gentleman's amendment in light of the other provisions of the 
bill.
    Ms. Lofgren. Yes.
    The Chairman. If you go to the Exceptions section, you will 
see that those things exempt from the bill include ``A 
screening analysis, where appropriately labeled as such, 
including a screening analysis for purposes of product 
regulation, or premanufacturing notices.''
    Then if you go down to subsection (B)--I am on page 7:
    ``(B) No analysis shall be treated as a screening analysis 
for purposes of subparagraph (A) if the results of such 
analyses are used as the basis for imposing restrictions on 
substances or activities.''
    Ms. Lofgren. Okay, so----
    The Chairman. So in other words, if what we are doing--this 
would not apply where we are trying to get approval of things 
that had been approved in other countries.
    However, if we were using data from other countries to stop 
approval in this country, that would be covered by the 
gentleman's amendment. So the kinds of things you are citing, 
FDA could go ahead and approve based upon foreign data, but 
they could not stop an approval based upon foreign data under 
the gentleman's amendment.
    Ms. Lofgren. So if the foreign data says we will approve 
use of a substance and we're going to accept the foreign data, 
but if it's going to preclude use, if there's an alleged 
danger, we won't accept the data?
    The Chairman. Then at that point you have to apply the 
guidelines specified in the gentleman's amendment. It doesn't 
mean that it couldn't happen. It simply means that at that 
point you would have to go out for notice and comment and do 
the things which are covered by the gentleman's amendment.
    Ms. Lofgren. Now would this include pesticides? I know a 
lot of pesticide companies, including some that are not owned 
wholly by U.S. interests, test in Latin America because of the 
reversal of seasons.
    If they did their testing in the Southern Hemisphere in the 
growing season, would we be able or unable to use their results 
under this amendment?
    The Chairman. Well again, if you look it is by non-United 
States-based entity.
    Ms. Lofgren. Right.
    The Chairman. If it is our companies doing the testing, 
they are a U.S.-based entity.
    Ms. Lofgren. But my hypothetical is a multinational that 
could not be fairly ranked as a U.S.-based company--or is 
``U.S.-based company'' defined in this Act?
    Mr. Barton. We are not doing risk assessment for private 
individuals or private organizations. This is for rules and 
regulations that, under the scope of the bill, this simply says 
that we can't automatically adopt something that has been 
adopted overseas without at least an opportunity for a comment 
period and a risk assessment study in this Nation.
    It is actually pretty straight-forward.
    Ms. Lofgren. Well if I could, further, it says ``non-U.S.-
based entity''. It doesn't say ``private entity''. It doesn't 
say ``governmental entity''; it just says--it could be a 
university. It could be a company--or is that defined somewhere 
and I've missed it?
    The Chairman. No, you have to read up--it's ``no covered 
Federal agency shall automatically incorporate'' and then you--
    Ms. Lofgren. I am looking on line 3, though, is the 
question I had.
    The Chairman. But that refers back to the first line. This 
regulation is applying to ``the Federal agency'' not to ``the 
U.S.-based entity''.
    Mr. Barton. Right. We are simply giving an opportunity 
before a--if a Federal agency under its jurisdiction--we're not 
changing jurisdictions--if a Federal agency is contemplating 
adoption of a rule or regulation that has been adopted 
overseas, it can't automatically adopt it without giving an 
opportunity for public comment and notice, and review of any of 
the pertinent risk assessment documentation that was used 
overseas.
    I mean, there is no Machiavellian intent in this amendment. 
It is simply to give our Federal agencies, which we have 
granted by Act of Congress, the right to issue rules and 
regulations for the public health and safety the requirement 
that they don't automatically adopt something that's been 
adopted overseas.
    I mean, I've said that ten times, but that is the intent, 
Mr. Chairman.
    Ms. Lofgren. I am not trying to say there is a 
Machiavellian intent, and I hope the gentleman would understand 
that. I do think, though, it is drafted in such a way that it 
is subject to significant misinterpretation.
    Mr. Barcia. Mr. Chairman.
    The Chairman. Mr. Barcia.
    Mr. Barcia. Mr. Chairman, I want to lend my support to Mr. 
Barton's amendment for the simple reasons, the concepts of 
sound science and greater accountability are compromised by the 
continued use of non-U.S.-based risk assessments. These 
assessments, however beneficial as a source of information, 
should be used as just that: background information.
    In fact I urge the use of such outside entities for 
background research, and I don't believe any of my colleagues 
would want available information suppressed when determining 
appropriate levels of regulation.
    However, I don't believe nonregulatory agencies like the 
International Agency for Research on Cancer, even if the U.S. 
funds a major part of their operation, should be relied on for 
one-third of the input when determining OSHA's Hazardous 
Communications standard, or EPA's Toxic Release Inventory.
    What is important to note is the degree to which IARC is 
relied on, not the fact that IARC assessment was used. Mr. 
Barton's amendment does not simply replace nongovernment 
entities like IARC with some other singular agency, but asks 
that Federal action not base itself solely on the 
recommendation of a singular non-U.S.-based entity.
    Moreover, no agency action shall take such recommendations 
as gospel and automatically adopt them in their regulatory 
process. Ultimately this amendment simply encourages the use of 
non-U.S. recommendations as support for agency risk assessments 
rather than sole determinants of risk.
    Mr. Chairman, it is my view that the mediocrity and 
complacency go hand in hand. If we become complacent with 
selective sources of information, we are subverting the very 
intention of this bill: to use sound science and the most 
reasonable data to best estimate risk.
    Thanks.
    The Chairman. I thank the gentleman.
    Mr. Traficant.
    Mr. Traficant. Mr. Chairman, I support the amendment. I 
think it is straightforward and it is a good safeguard that 
serves this section of the bill very well. I think Mr. Barton 
has explained it very thoroughly and it is quite evident, if 
you read it, that the safeguards are also evident.
    I yield back my time.
    Mr. Brown. Mr. Chairman.
    The Chairman. Thank you. Mr. Brown, Mr. Olver was seeking 
recognition.
    Mr. Brown. Go ahead.
    Mr. Olver. Thank you, Mr. Chairman.
    I would just like to comment that there is a great volume 
of very solid science and research that is available from other 
places, and I really do not understand why, if--and there are 
good organizations doing good risk analysis in some of our 
partners around the world, and I don't understand why there 
would be any need for this kind of language if the definitions 
of ``risk analysis'' are followed in the process of such 
evaluation in those other places.
    What I am particularly concerned about here is that what 
this language does is put in a closed procedure. I am really 
puzzled by the language, the ``No covered Federal agency shall 
automatically incorporate'', but they could incorporate without 
automatically incorporating without this opportunity for notice 
and comment, and so forth, and following the procedures of the 
legislation on risk assessment.
    In essence we are in a situation when very good scientific 
input could come from places that are working on this, on 
developing a cure for AIDS, or whatever, and find that, because 
of this language, we had to go through some question of what 
were the scientific findings with all of the raw data by 
previous amendments that have been offered, along with 
independent studies and risk assessments and so forth, all 
because this language says one has to go through this, even 
though we have excellent evidence that there is good scientific 
research done in other places with good risk analyses being 
done.
    I think that this really puts a straightjacket around an 
area where we should be looking for ways of using the most 
effective data available in competent places elsewhere to help 
us get around this sort of thing.
    I find this very problematical language.
    Mr. Barton. If the gentleman would yield? If the gentleman 
would yield to the author of the amendment?
    Mr. Olver. I am happy to yield.
    Mr. Barton. The point is, it is not the intent of this 
amendment to preclude regulations that have been scientifically 
adopted and validated overseas in this country. That is not the 
intent at all.
    The fact of the matter is that the standard are different 
overseas. Not all regulatory agencies overseas have the same 
criteria that we have in this country, and this amendment 
simply says that before we automatically adopt without even a 
public comment period, we at least have a public comment period 
and let those that have an interest comment on the proposed 
regulation.
    It does not require that there be an actual reconstitution 
of the data base. It does say that there needs to be an 
assessment of the data base that was used to promulgate the 
regulation overseas.
    In the cases that the gentleman has just referred to in a 
hypothetical sense, if in fact the regulation actually is based 
on sound scientific evidence and it has been properly research 
and developed, it will in all probability be adopted after a 
very cursory public comment period.
    But it can't be done automatically. That is the intent of 
the regulation--of the amendment, excuse me.
    I yield back to the distinguished gentleman.
    Mr. Brown. Mr. Chairman.
    The Chairman. Mr. Brown.
    Mr. Brown. Mr. Chairman, I frankly am not on top, frankly, 
of what the impact of this amendment would be. In such 
situations I am inclined to want to go slowly with regard to 
something of this sort.
    I know of nothing in the record of the hearings that dealt 
with this particular subject. I know of no testimony or 
requests from any of the Federal agencies for any of this. If 
the author of the amendment can make reference to the testimony 
of any witness or a request from any source for this language, 
I would certainly appreciate it. It would help me to evaluate 
it.
    I am just--I am not an expert in this subject, either--
recalling examples of Federal regulatory action over the past 
generation or two, I can recall when, for example, when the 
European manufacturer, or even the American manufacturer of a 
product called Thalidomide sought to get it adopted in the 
United States, and it was initially offered in Europe.
    The FDA was extremely leery about doing that, including 
accepting the data from the European company, and apparently 
that is what the gentleman is recommending in this amendment, 
that we be leery of such non-U.S.-based entities' claims with 
regard to something.
    If what he is suggesting is what we are already doing, then 
I question why we need to repeat it in this legislation.
    I would also point out that an increasing amount of health 
effects' studies in every area from pharmaceuticals to 
chemicals, to large-scale things like evaluating the impact of 
global warming, is being done on an international basis today 
and is being done under the auspices of international 
organizations.
    While I don't believe that we should give any more 
credibility to this because of its international sponsorship, I 
certainly don't want to include a presumption that they are not 
engaged in the development of assessments and other 
documentation that is inferior to the United States, and this 
might tend to give that impression.
    I am unclear as to what would happen, for example, when the 
global warming program decides that there is a risk associated 
with the use of freon and that we ought to withdraw that from 
the market.
    Would this require that we not accept the finding?
    Or would it in someway prejudice our ability to act to 
remove the threat of global warming?
    I say this without knowing the answer, and hoping that the 
gentleman can enlighten me on some of these things so that I 
can be absolutely clear that this is the great piece of 
legislation that I know the proponent thinks it is.
    Mr. Barton. Well, I have the--if the distinguished former 
chairman would yield, I will be happy to attempt a probably 
nonsatisfactory response to his eloquent statement and 
question.
    I guess I should have titled this ``The All-America Review 
Amendment,'' taking a page out of Mr. Traficant's book. All we 
are attempting to do is give the appropriate Federal agency in 
this Nation the opportunity to review, and those in this 
country that are concerned about overseas' regulations, a 
public comment period.
    In the cases that the work has been done satisfactorily 
according to standards that we find acceptable, this will not 
be a dilatory process.
    In those cases where perhaps the work was not done 
satisfactorily, it might be a decision made to conduct some 
independent studies of our own before we adopt them.
    I guess an analogy would be what's happening right now, 
today. We've got this bill being marked up simultaneously in 
two separate committees.
    If you use this amendment as an analogy, it simply says we 
want the Science Committee to have an opportunity to take a 
look at what the Commerce Committee does before we accept it.
    Now that is what we are attempting to do here. There is not 
anything other than that involved. I can assure the 
distinguished former chairman that if he will vote with me on 
this, he will someday come and pat me on the back and say, 
Congressman Barton, I'm glad that I accepted your analysis and 
went with you, because it will not backfire on you; I assure 
you.
    Mr. Brown. Would the gentleman yield?
    Mr. Barton. It is your time, so I yield back to the 
distinguished gentleman.
    Mr. Brown. I really would very much like to have the 
gentleman pat me on the back and say that I had done something 
right for a change.
    Mr. Barton. Well the gentleman has done many things right. 
So this wouldn't be the first occasion.
    Mr. Brown. But I still would like a response to the first 
part of my question.
    Can the gentleman refer to any request, any testimony, any 
indication of where the impetus for this amendment can from, 
other than the inspiration that he draws from on High?
    Mr. Barton. Well, actually the inspiration didn't come from 
on High, it came from several organizations that did not 
testify in the public comment period but had a concern based 
on, primarily on practices of the EPA in the past of adopting 
certain regulations without a comment period here in this 
country. But it was not a part of the record developed in the 
testimony before this Committee.
    Mr. Brown. Well that certainly clarified the genesis of the 
amendment and I appreciate it very much.
    Mr. Chairman. Is there further discussion on the amendment?
    Mr. Traficant. Mr. Chairman, I've got an amendment to this 
amendment.
    The Chairman. An amendment to this amendment would be a 
third-degree amendment, which would not be in order.
    Mr. Traficant. I ask unanimous consent that I be allowed to 
offer an amendment to this amendment that was heretofore ruled 
not in order for the sake of defining what a ``U.S.-based 
company'' is.
    Mr. Sensenbrenner. Reserving the right to object, I think 
we would like to see the amendment before waiving our rights.
    Mr. Barton. It doesn't say--if the gentleman from Ohio 
would yield--my amendment says non----
    Mr. Chairman. The gentleman from Wisconsin controls the 
time under a reservation.
    Mr. Sensenbrenner. I would just like to see what the 
amendment is.
    Mr. Traficant. I believe the amendment is at the desk. 
Could they distribute the amendment?
    The Chairman. Does the Clerk have the amendment?
    The Clerk. No.
    The Chairman. There is no amendment at the desk.
    Mr. Sensenbrenner. Well, Mr. Chairman, I object.
    The Chairman. Objection is heard from the gentleman from 
Wisconsin.
    Mr. Barton. Mr. Chairman, if there is no further debate on 
my amendment, I would respectfully move the previous question. 
I don't want to limit debate on it, but if there are no other 
Members wishing----
    The Chairman. Is there further debate on the amendment?
    [No response.]
    The Chairman. If not, the Chair will put the question.
    All those in favor of the amendment of the gentleman from 
Texas will say, aye.
    [Chorus of ayes.]
    The Chairman. Those opposed will say, no.
    [Chorus of nays.]
    The Chairman. In the opinion of the Chair, the ayes have 
it. The ayes have it, the amendment is adopted.
    Ms. Lofgren. Are we having a roll call vote? I would like a 
roll call vote.
    The Chairman. The gentlewoman from California requests a 
roll call vote. The Clerk will call the roll.
    The Clerk. Mr. Walker?
    The Chairman. Aye.
    The Clerk. Mr. Walker votes aye.
    Mr. Brown?
    [No response.]
    The Clerk. Mr. Sensenbrenner?
    Mr. Sensenbrenner. Aye.
    The Clerk. Mr. Sensenbrenner votes aye.
    Mr. Hall?
    Mr. Hall. Aye.
    The Clerk. Mr. Hall votes aye.
    Mr. Boehlert?
    [No response.]
    The Clerk. Mr. Traficant?
    Mr. Traficant. Aye.
    The Clerk. Mr. Traficant votes aye.
    Mr. Fawell?
    Mr. Fawell. Aye.
    The Clerk. Mr. Fawell votes aye.
    Mr. Hayes?
    Mr. Hayes. Aye.
    The Clerk. Mr. Hayes votes aye.
    Mrs. Morella?
    Ms. Morella. Aye.
    The Clerk. Mrs. Morella votes aye.
    Mr. Tanner?
    Mr. Tanner. Aye.
    The Clerk. Mr. Tanner votes aye.
    Mr. Weldon of Pennsylvania?
    Mr. Curt Weldon. Aye.
    The Clerk. Mr. Weldon votes aye.
    Mr. Geren?
    Mr. Geren. Aye.
    The Clerk. Mr. Geren votes aye.
    Mr. Rohrabacher?
    Mr. Rohrabacher. Aye.
    The Clerk. Mr. Rohrabacher votes aye.
    Mr. Roemer?
    Mr. Roemer. Aye.
    The Clerk. Mr. Roemer votes aye.
    Mr. Schiff?
    Mr. Schiff. Aye.
    The Clerk. Mr. Schiff votes aye.
    Mr. Cramer?
    [No response.]
    The Clerk. Mr. Barton?
    Mr. Barton. Aye.
    The Clerk. Mr. Barton votes aye.
    Mr. Barcia?
    Mr. Barcia. Aye.
    The Clerk. Mr. Barcia votes aye.
    Mr. Calvert?
    Mr. Calvert. Aye.
    The Clerk. Mr. Calvert votes aye.
    Mr. McHale?
    Mr. McHale. Aye.
    The Clerk. Mr. McHale votes aye.
    Mr. Baker?
    Mr. Baker. Aye.
    The Clerk. Mr. Baker votes aye.
    Ms. Harman?
    Ms. Harman. Aye.
    The Clerk. Ms. Harman votes aye.
    Mr. Bartlett?
    Mr. Bartlett. Aye.
    The Clerk. Mr. Bartlett votes aye.
    Ms. Johnson?
    Ms. Johnson. Aye.
    The Clerk. Ms. Johnson votes aye.
    Mr. Ehlers?
    Mr. Ehlers. Aye.
    The Clerk. Mr. Ehlers votes aye.
    Mr. Minge?
    Mr. Minge. Aye.
    The Clerk. Mr. Minge votes aye.
    Mr. Wamp?
    Mr. Wamp. Aye.
    The Clerk. Mr. Wamp votes aye.
    Mr. Olver?
    Mr. Olver. No.
    The Clerk. Mr. Olver votes no.
    Mr. Weldon of Florida?
    Mr. Dave Weldon. Aye.
    The Clerk. Mr. Weldon votes aye.
    Mr. Hastings?
    Mr. Hastings. No.
    The Clerk. Mr. Hastings votes no.
    Mr. Graham?
    Mr. Graham. Aye.
    The Clerk. Mr. Graham votes aye.
    Ms. Rivers?
    Ms. Rivers. No.
    The Clerk. Ms. Rivers votes no.
    Mr. Salmon?
    Mr. Salmon. Aye.
    The Clerk. Mr. Salmon votes aye.
    Ms. McCarthy?
    Ms. McCarthy. No.
    The Clerk. Ms. McCarthy votes no.
    Mr. Davis?
    Mr. Davis. Aye.
    The Clerk. Mr. Davis votes aye.
    Mr. Ward?
    Mr. Ward. No.
    The Clerk. Mr. Ward votes no.
    Mr. Stockman?
    Mr. Stockman. Yes.
    The Clerk. Mr. Stockman votes aye.
    Ms. Lofgren?
    Ms. Lofgren. No.
    The Clerk. Ms. Lofgren votes no.
    Mr. Gutknecht?
    Mr. Gutknecht. Aye.
    The Clerk. Mr. Gutknecht votes aye.
    Mr. Doggett?
    Mr. Doggett. No.
    The Clerk. Mr. Doggett votes no.
    Mrs. Seastrand?
    Mrs. Seastrand. Aye.
    The Clerk. Mrs. Seastrand votes aye.
    Mr. Doyle?
    Mr. Doyle. Aye.
    The Clerk. Mr. Doyle votes aye.
    Mr. Tiahrt?
    [No response.]
    The Clerk. Ms. Jackson-Lee?
    Ms. Jackson-Lee. No.
    The Clerk. Ms. Jackson-Lee votes no.
    Mr. Largent?
    Mr. Largent. Aye.
    The Clerk. Mr. Largent votes aye.
    Mr. Luther?
    Mr. Luther. No.
    The Clerk. Mr. Luther votes no.
    Mr. Hilleary?
    Mr. Hilleary. Aye.
    The Clerk. Mr. Hilleary votes aye.
    Mrs. Cubin?
    Mrs. Cubin. Aye.
    The Clerk. Mrs. Cubin votes aye.
    Mr. Foley?
    Mr. Foley. Aye.
    The Clerk. Mr. Foley votes aye.
    Mrs. Myrick?
    Mrs. Myrick. Aye.
    The Clerk. Mrs. Myrick votes aye.
    Mr. Brown. Mr. Chairman, how am I recorded?
    The Chairman. How is Mr. Brown recorded?
    The Clerk. Mr. Brown is not recorded.
    Mr. Brown. Mr. Brown votes no.
    The Clerk. Mr. Brown votes no.
    The Chairman. Any further--Ms. Johnson?
    Ms. Johnson. How am I recorded?
    The Clerk. Ms. Johnson is recorded ``aye.''
    Ms. Johnson. I would like to change that to no.
    The Clerk. Ms. Johnson votes no.
    The Chairman. Anyone else in the room who has not been 
recorded?
    [No response.]
    The Chairman. If not, the Clerk will report.
    The Clerk. Mr. Chairman, I count 36 yeas, 11 nays.
    The Chairman. 36 yeas, 11 nays; the amendment is adopted.
    The next amendment is by Mr. Olver. It is number 13 on the 
sheet that deals with comparability--``comparison,'' I should 
say.
    Mr. Olver. Mr. Chairman, are we--point of parliamentary 
inquiry here. Are we obliged to follow the order on the list? I 
mean, we are not moving into Section 3105, and I had two 
amendments in 3105, one earlier than the one that is listed as 
No. 13.
    What is my obligation in this?
    The Chairman. Well, the Chair intends to move through the 
amendments as reflected on the roster before the Members, and 
then any additional amendments to the particular section we 
will take up after we have completed those items on the roster, 
in the subtitle, I should say.
    Mr. Olver. Thank you very much for the clarification, Mr. 
Chairman.
    I have an amendment which I think then has been circulated. 
It is an amendment in two parts.
    The Chairman. This amendment we understand has not been 
circulated. If the Clerk has the amendment, would the Clerk 
distribute the amendment?
    Is it amendment 13, which is in the package----
    Mr. Olver. Yes.
    The Chairman. Or a different version?
    Mr. Olver. Yes, it is amendment 13 as it is in the package.
    The Chairman. We are being told by counsel on both sides 
that that is not the case; that it has been changed since the 
package was prepared.
    [Pause.]
    Mr. Olver. Mr. Chairman, if in fact the amendment is 
different from what was circulated, then I should wait until 
the Clerk has circulated the amendment.
    The Chairman. The Clerk will distribute the amendment.
    [The amendment is distributed.]
    The Chairman. As I understand it, this is Amendment No. 8 
in the supplementary minority package.
    Mr. Olver. That, I believe, is correct.
    Mr. Barton. Mr. Chairman?
    The Chairman. Who seeks recognition? The gentleman from 
Texas.
    Mr. Barton. Mr. Chairman, I am the next amendment, 
Amendment No. 14, and I would be willing to go ahead with that 
amendment while we are clarifying this amendment, if that would 
be helpful. I am not trying to----
    The Chairman. I think we now have it to distribute, so I 
thank the gentleman for his attempt to cooperate here, but I 
think we now have it coming around.
    I recognize the gentleman from Massachusetts to discuss his 
amendment.
    Mr. Olver. Thank you, Mr. Chairman.
    This amendment is in two parts. It reads in Section 3105(3) 
the addition of the words ``, safety, or the environment'' 
after the words ``human health''.
    And, if I may, I would like to separate the two parts and 
deal with them separately.
    The Chairman. The gentleman can do as he wishes. We will 
take up, then, his amendment to page 11, line 13 first. Is 
that----
    Mr. Olver. That's correct.
    The Chairman. The gentleman is recognized.
    Mr. Olver. I would note that in the language as it came 
out, the words ``, safety, or the environment'' were removed 
there from an earlier version. And I would just call the 
attention of the Members of the Committee that the first 
finding on page 1 of the bill has to do with ``environmental 
health and safety regulations have led to dramatic improvements 
in the environment and have significantly reduced human health 
risk,'' and point out that on page 4 we, in our applicability 
section on page 4, under Applicability, Part B, that the words 
``designed to protect human health, safety, and the 
environment'' are what is involved there.
    So that I would urge the adoption of the reinstatement of 
the words ``human health, safety, or the environment'' in 
context in the point that we're discussing.
    The Chairman. Well the language had been removed in order 
to make this a less cumbersome kind of burden, but the Chair 
has no particular problems with including that language and 
would be willing to accept the amendment.
    Mr. Olver. If there is no discussion, then I would call for 
a vote on that.
    The Chairman. The gentleman moves the previous question.
    Those in favor of the amendment will say, aye.
    [Chorus of ayes.]
    The Chairman. Those opposed will say, no.
    [No response.]
    The Chairman. The ayes have it. The amendment is adopted.
    Mr. Olver. Thank you, Mr. Chairman.
    If I may then go on to the second, which now--since that 
was simple, people may have had a chance to look at the second 
one which I've obviously prejudiced myself, I suppose, by 
allowing that time; but in the second instance, the rest of 
that statement has to do with comparisons of risks that should 
be considered under the risk assessment program.
    The purpose of the amendment, as I have offered it, is to 
make certain that we are comparing risks that are of a similar 
nature and, in order to preclude the possibility that we will 
be dealing with risks that relate to cancer and a variety, say, 
of cancer researches that have been done and the risk 
assessments that may have been done there, from a comparison 
with something that may be a driving risk, or a risk of falling 
on the ice outside today.
    Because we have had a good deal of evidence from people 
before this Committee. Several of the people testifying have 
indicated that this kind of comparison ought to be made among 
similar kinds of risks for reasons, for instance, that if you 
look at voluntary and involuntary risks, or natural and 
technological risks, that people value those in quite different 
kinds of ways.
    And if you take a voluntary risk that might come from 
something like a skiing accident, say, that to compare it, 
while the number that you might come up with, or the range of 
numbers might be somewhat similar, it is a very different thing 
in people's understanding from what might come from the risks 
of a natural earthquake, or some things which are Acts of God 
or something that might be from a technological act of man, the 
addition of additives to foods, or whatever.
    The point here is that in order to be meaningful, that risk 
comparisons really should be done within what would be an 
appropriate decision making sphere. The contexts of the risks 
as they are considered ought to be in the same mode as has been 
indicated by a number of people who have testified in 
scientific evidence given to us, and the position taken by even 
groups like the National Research Council.
    The Chairman. I thank the gentleman for his explanation.
    Mr. Bartlett.
    Mr. Bartlett. Mr. Chairman, I think that limiting these 
comparisons to activities that are regulated by that Federal 
agency or other Federal agency denies the opportunity to 
provide really appropriate comparisons.
    For instance, some risks may be no greater than the risk of 
being struck by lightning. If that in fact is the risk, I think 
the people have a right to understand that that is the level of 
the risk.
    Comparing it with some arcane language in another 
government regulation may convey nothing relative to the real 
risk that the population is exposed to.
    The Chairman. Any other discussion?
    Mr. Olver. If I may respond to that, I think the whole 
purpose of the risk assessment program is to help us as 
decision-makers, and to help the public understand the nature 
of the comparisons and of the risks that are involved and put 
them in a context that is an appropriate context.
    And the gentleman who just spoke himself used the language 
that the comparisons ought to be appropriate comparisons, which 
is the very point of this; that the comparisons, if one crosses 
lines among in a general way those kinds of topics that I 
mentioned of voluntary and involuntary risks and natural or 
technological ones, that you have really crossed the boundaries 
of appropriate comparison for helping to educate and clarify 
for people the nature of the risks involved.
    The Chairman. Is there further discussion on the amendment?
    Mr. Hastings. Mr. Chairman.
    The Chairman. The gentleman from Florida.
    Mr. Hastings. I thank the Chair.
    Following the discussion--and I strongly support the 
amendment--I would like to know what constitutes an 
``appropriate comparison'' for placing the nature and the 
magnitude of risks to human health in context.
    I am new to this Committee, and all of this is in some 
respects a bit confusing. In the base bill, there is a 
statement regarding categories of risk.
    Well, what are the ``categories of risk''?
    And if I am reading the base bill, how do I know that? And 
what constitutes a ``relevant distinction among categories of 
risk''?
    It is very confusing. If counsel or someone can help me to 
understand that, I would appreciate it.
    The Chairman. Counsel.
    Mr. Beringer. Excuse me, Mr. Hastings, were you referring 
to the amendment, or to the----
    Mr. Hastings. The amendment and the base bill. Okay
    Mr. Beringer. Okay.
    Mr. Hastings. The language as put forward in the bill is: 
``The statement shall identify relevant distinctions among 
categories of risk and limitations to comparisons''.
    If I read that, you know, I am a lawyer, and if that ain't 
gobbledygook, grits ain't groceries. [Laughter.]
    I have a serious problem understanding how anybody will 
understand that other than agency types and people who deal 
with this on a regular basis.
    The Chairman. The Chair is having trouble understanding 
where the gentleman is in the bill. We are on page 11 under the 
Comparison section. The amendment goes to that particular 
section.
    Mr. Hastings. Exactly.
    The Chairman. And the gentleman is quoting from a section 
of the bill that is not there.
    Mr. Hastings. I am on page 11, Mr. Chairman, under 
``Comparisons''. Page 11, Mr. Chairman, lines 16 through 19.
    The Chairman. Oh, so the gentleman is referring to the 
statement ``shall identify relevant distinctions among 
categories of risks and limitations to comparisons''? Is that 
the language?
    Mr. Hastings. Yes, sir. And I don't mean to be facetious, 
Mr. Chairman, but I don't know what the ``categories or risk'' 
are, if I read this. I think that we need to be very clear in 
this regard.
    And I certainly have some serious questions as to what an 
``appropriate comparison'' is, as I've indicated earlier.
    The Chairman. I thank the gentleman.
    The gentleman from Pennsylvania, Mr. Weldon.
    Mr. Curt Weldon. Mr. Chairman, I worked in the insurance 
industry for ten years, and worked in risk management, and we 
used to simply characterize it as ``frequency'' and 
``severity.''
    When you look at the potential for loss, they are the two 
basic characteristics you are looking at. What is the frequency 
of the incident that would occur? And what is the potential 
severity? Then, to assess it based on those two factors.
    I think that is what we are talking about here, if I am not 
mistaken.
    Mr. Hastings. Is that counsel's assessment of this?
    The Chairman. The Chair would recognize the counsel.
    Mr. Beringer. Thank you, Mr. Chairman.
    Mr. Weldon is correct. What the amendment is trying also to 
get at is say relevant distinctions among different categories 
of risks.
    In other words, trying to compare risks that are relevant 
to each other by trying to categorize them in a meaningful way 
to the general public in ways in which they'll understand.
    That is the relevancy test that I believe this is trying to 
get to.
    Mr. Hastings. Well I thank the Chair, and I have no further 
questions, Mr. Chairman, but I urge you to be mindful that what 
we are doing here is likely to cause a very litigious society 
to become even more litigious, and it is akin to the kinds of 
things that we've tried to avoid.
    I suggest to you that we are creating a legal morass.
    The Chairman. Again I thank the gentleman.
    Is there further discussion on the amendment?
    Mr. Olver. Mr. Chairman, may I make one last comment here? 
The language in the first sentence of the comparison section 
reads ``placing the magnitude of risks in context''.
    The whole purpose of my amendment is to establish that 
``context'' as risks which are comparable in their nature of 
people's consideration of them so that this is a section which 
helps us to clarify the way we are assessing these risks and to 
help to educate the public.
    The Chairman. The Chair again thanks the gentleman.
    The Chair feels as though this amendment does strike some 
very important language in the bill. One of the things that we 
have attempted to do in doing comparisons is to give the public 
some idea of what a standard is that is a greater risk, and 
then a lesser risk to that which is being proposed.
    The gentleman strikes that section and instead has us rely 
upon the same kind of information now being developed by 
regulators which tends to be Federal gobbledygook that nobody 
can understand.
    It is the Chair's understanding that that is the way 
Federal regulators and many who approve of these regulations 
want to keep the situation so that there is plenty of 
gobbledygook out there that gives a lot of latitude to lawyers.
    We are hoping that, because the public would have some 
better understanding of the relative degree of risks compared 
to things that they understand in their everyday lives, that 
that would in fact reduce the amount of litigation that would 
be needed to move forward.
    So the language in the original bill is in fact aimed at 
giving the public a more in depth understanding, thereby 
reducing the need for litigation, rather than having mounds and 
mounds of Federal agency gobbledygook that no one understands.
    So the Chair would oppose this particular amendment.
    Is there further discussion?
    [No response.]
    The Chairman. If not, the Chair calls the question.
    Those in favor of the amendment will say, aye.
    [Chorus of ayes.]
    The Chairman. Those opposed will say, no.
    [Chorus of nays.]
    The Chairman. In the opinion of the Chair the noes have it. 
The noes have it, the amendment is not agreed to.
    Mr. Brown. Mr. Chairman?
    The Chairman. Mr. Brown.
    Mr. Brown. May I raise a procedural question? The Chair has 
announced that he intends to move forward with this bill until 
it is completed.
    I have sought to ascertain whether or not that is a 
practical goal, and I am informed that there may be as many as 
25 or 30 additional amendments to yet come before us, which at 
the rate we are going would keep us here until about midnight.
    Does the Chair have anything more optimistic to conclude 
about our procedures for the rest of the evening?
    The Chairman. Well, the Chair would say to the gentleman 
that insofar as people want to breed bills, or breed 
amendments, that will in fact lengthen the amount of time that 
the Committee will have to meet.
    But it is my intention to move ahead. And we would hope 
that we could get done before midnight, but if midnight is the 
goal then we would have to do that.
    Mr. Brown. Mr. Chairman, if I might comment further, this 
matter of ``breeding amendments,'' which has a slightly 
derogatory tone to it, is something that Members of this 
Committee have learned from long experience on this Committee 
from a master who is sitting in the Chair now.
    [Several voices: Amen.] [Laughter.]
    Mr. Brown. I do not wish to be contentious about this 
matter, but I do have a feeling that most of the Members might 
like to consider the possibility of having dinner this evening, 
perhaps seeing their families--since we are in a ``family-
friendly'' atmosphere--[Laughter.]
    Mr. Brown. And, Mr. Chairman, I would like to move that we 
adjourn at this point.
    The Chairman. The motion is in order. The gentleman from 
California moves that the Committee do now adjourn. The 
question is on the motion.
    Those in favor will say, aye.
    [Chorus of ayes.]
    The Chairman. Those opposed will say, no.
    [Chorus of nays.]
    The Chairman. The noes have it.
    Mr. Brown. Mr. Chairman, I ask for a roll call.
    The Chairman. The Clerk will call the roll.
    The Clerk. Mr. Walker?
    The Chairman. No.
    The Clerk. Mr. Walker votes no.
    Mr. Brown?
    Mr. Brown. Aye.
    The Clerk. Mr. Brown votes aye.
    Mr. Sensenbrenner?
    Mr. Sensenbrenner. No.
    The Clerk. Mr. Sensenbrenner votes no.
    Mr. Hall?
    [No response.]
    The Clerk. Mr. Boehlert?
    [No response.]
    The Clerk. Mr. Traficant?
    Mr. Traficant. Aye.
    The Clerk. Mr. Traficant votes aye.
    Mr. Fawell?
    Mr. Fawell. No.
    The Clerk. Mr. Fawell votes no.
    Mr. Hayes?
    Mr. Hayes. Aye.
    The Clerk. Mr. Hayes votes aye.
    Mrs. Morella?
    Ms. Morella. No.
    The Clerk. Mrs. Morella votes no.
    Mr. Tanner?
    Mr. Tanner. Aye.
    The Clerk. Mr. Tanner votes aye.
    Mr. Weldon of Pennsylvania?
    Mr. Curt Weldon. No.
    The Clerk. Mr. Weldon votes no.
    Mr. Geren?
    Mr. Geren. Mr. Chairman, my wife inquired whether or not 
she'd have a chance to vote on this one. [Laughter.]
    I vote aye.
    The Clerk. Mr. Geren votes aye.
    Mr. Rohrabacher?
    Mr. Rohrabacher. No.
    The Clerk. Mr. Rohrabacher votes no.
    Mr. Roemer?
    Mr. Roemer. Aye.
    The Clerk. Mr. Roemer votes aye.
    Mr. Schiff?
    Mr. Schiff. No.
    The Clerk. Mr. Schiff votes no.
    Mr. Cramer?
    [No response.]
    The Clerk. Mr. Barton?
    Mr. Barton. No.
    The Clerk. Mr. Barton votes no.
    Mr. Barcia?
    Mr. Barcia. Yes.
    The Clerk. Mr. Barcia votes yes.
    Mr. Calvert?
    Mr. Calvert. No.
    The Clerk. Mr. Calvert votes no.
    Mr. McHale?
    Mr. McHale. Aye.
    The Clerk. Mr. McHale votes aye.
    Mr. Baker?
    Mr. Baker. No.
    The Clerk. Mr. Baker votes no.
    Ms. Harman?
    Ms. Harman. Aye.
    The Clerk. Ms. Harman votes aye.
    Mr. Bartlett?
    Mr. Bartlett. No.
    The Clerk. Mr. Bartlett votes no.
    Ms. Johnson?
    Ms. Johnson. Aye.
    The Clerk. Ms. Johnson votes aye.
    Mr. Ehlers?
    [No response.]
    The Clerk. Mr. Minge?
    Mr. Minge. Aye.
    The Clerk. Mr. Minge votes aye.
    Mr. Wamp?
    Mr. Wamp. Not.
    The Clerk. Mr. Wamp votes no.
    Mr. Olver?
    Mr. Olver. Yes.
    The Clerk. Mr. Olver votes aye.
    Mr. Weldon of Florida?
    Mr. Dave Weldon. No.
    The Clerk. Mr. Weldon votes no.
    Mr. Hastings?
    Mr. Hastings. Yes.
    The Clerk. Mr. Hastings votes aye.
    Mr. Graham?
    Mr. Graham. No.
    The Clerk. Mr. Graham votes aye.
    Ms. Rivers?
    Ms. Rivers. Aye.
    The Clerk. Ms. Rivers votes aye.
    Mr. Salmon?
    Mr. Salmon. The spirit is willing--I vote no.
    The Clerk. Mr. Salmon votes no.
    Ms. McCarthy?
    Ms. McCarthy. Aye.
    The Clerk. Ms. McCarthy votes aye.
    Mr. Davis?
    Mr. Davis. No.
    The Clerk. Mr. Davis votes no.
    Mr. Ward?
    Mr. Ward. Aye.
    The Clerk. Mr. Ward votes aye.
    Mr. Stockman?
    Mr. Stockman. No.
    The Clerk. Mr. Stockman votes no.
    Ms. Lofgren?
    Ms. Lofgren. Yes.
    The Clerk. Ms. Lofgren votes aye.
    Mr. Gutknecht?
    Mr. Gutknecht. No.
    The Clerk. Mr. Gutknecht votes no.
    Mr. Doggett?
    Mr. Doggett. Aye.
    The Clerk. Mr. Doggett votes aye.
    Mrs. Seastrand?
    Ms. Seastrand. No.
    The Clerk. Mrs. Seastrand votes no.
    Mr. Doyle?
    Mr. Doyle. Aye.
    The Clerk. Mr. Doyle votes aye.
    Mr. Tiahrt?
    Mr. Tiahrt. No.
    The Clerk. Mr. Tiahrt votes no.
    Ms. Jackson Lee?
    Ms. Jackson Lee. Aye.
    The Clerk. Ms. Jackson Lee votes aye.
    Mr. Largent?
    Mr. Largent. No.
    The Clerk. Mr. Largent votes no.
    Mr. Luther?
    Mr. Luther. Aye.
    The Clerk. Mr. Luther votes aye.
    Mr. Hilleary?
    Mr. Hilleary. No.
    The Clerk. Mr. Hilleary votes no.
    Mrs. Cubin?
    Mrs. Cubin. No.
    The Clerk. Mrs. Cubin votes no.
    Mr. Foley?
    Mr. Foley. No.
    The Clerk. Mr. Foley votes no.
    Mrs. Myrick?
    Ms. Myrick. No.
    The Clerk. Mrs. Myrick votes no.
    Mr. Brown. Mr. Chairman, Mr. Hall wants to know how he is 
recorded.
    Mr. Hall. Yes, I do.
    The Clerk. Mr. Hall is not recorded.
    Mr. Hall. I vote aye.
    The Clerk. Mr. Hall votes aye.
    The Chairman. The Clerk will report.
    The Clerk. Mr. Chairman, I count 22 yeas, 25 nays.
    The Chairman. The motion is not agreed to.
    The Chair appreciates those Members who indicated by their 
vote that they are willing to have the Committee continue to 
meet and do its business.
    It is disappointing that, despite the fact that the House 
will be in until at least 8:30 tonight, that other Members did 
not care to continue with Committee business; but I do thank 
those Members that want to proceed ahead.
    We will move ahead now with Amendment No. 14.
    Mr. Barton. Mr. Chairman, I have an amendment at the desk.
    The Chairman. Mr. Barton.
    Mr. Barton. Mr. Chairman, I would ask unanimous consent 
that the amendment be considered as read.
    The Chairman. Has the amendment been distributed to the 
Members?
    Mr. Barton. Yes, sir--it's certainly been at the desk and 
been available to all Members with the notification that we had 
to have it in by I think noon yesterday.
    The Chairman. It is in the packet, so the gentleman may 
proceed.
    Mr. Barton. I thank the Chairman.
    I think that this is one of the, at least it is the most 
important amendment that I will offer to the pending bill.
    We want the Clerk to utilize the new amendment. I didn't 
realize there were differences. I only thought I had one, but 
apparently there are----
    Ms. Lofgren. Do we have----
    The Chairman. The gentleman has provided assurance to the 
Members that that was the one in their pack.
    Mr. Barton. Yes, sir.
    The Chairman. Is that not the case?
    If so, the amendment must be distributed before we can 
proceed.
    Mr. Barton. It was my understanding it was the amendment 
that was in the packet. I am not--but my staff seems to think 
maybe it is not.
    The Clerk. It is not. I don't have it.
    Mr. Barton. Mr. Chairman, the so-called ``new amendment'' 
has been narrowed in scope as to who has jurisdiction to 
petition. The original amendment said any person could 
petition.
    The new amendment indicates that they have to have a direct 
financial interest in order to petition.
    I believe that is the substantive change.
    So the so-called ``new amendment'' is actually a more 
narrowly drawn amendment.
    That is the difference. The one in the packet is a broader 
amendment, apparently. I am offering the more narrowly--and I 
can't say that--narrow amendment.
    Let me explain the amendment and then if we need to read 
it, I'll be happy to have the change read, because it----
    Mr. Minge. Mr. Chairman, could we defer this until we have 
the amendment?
    The Chairman. Can the gentleman tell us whether or not the 
amendment has been distributed to the Members in the form in 
which he wishes to offer it?
    If not, it is not fair to all the Members.
    Mr. Barton. In all honesty--I understand, and I didn't know 
that it had not been----
    Mr. Beringer. It is being distributed now, Mr. Chairman.
    Mr. Barton. I would defer until it has been distributed.
    I can explain it as it is being distributed, if that is the 
will of the Chairman.
    The Chairman. Let's get it down to the Members, first.
    [The amendment is distributed.]
    The Chairman. This amendment would not be in order at this 
point.
    The gentleman has now redrafted his bill as a new subtitle 
at the end of the bill. We are only considering those items in 
Subtitle A, so I would ask the gentleman to withdraw his 
amendment at this point because it would not be in order to be 
considered at this juncture.
    Mr. Barton. I would ask unanimous consent to do that.
    The Chairman. I thank the gentleman.
    As I understand it, Amendment No. 15 by Mr. Roemer has been 
withdrawn, or is going to be withdrawn?
    Mr. Roemer. No, Mr. Chairman.
    The Chairman. The gentleman wishes to offer that amendment?
    Mr. Roemer. The amendment on research and training and risk 
assessment? Is that the one you were referring to?
    The Chairman. No, it is No. 15 on your sheet, the Guideline 
Plan for Assessing New Information.
    Mr. Roemer. No. 15 has been withdrawn; that's correct, Mr. 
Chairman.
    The Chairman. It has been.
    And the gentleman now wishes to offer a new Section 3107 on 
Research and Training and Risk Assessment?
    Mr. Roemer. That's correct.
    The Chairman. The gentleman is recognized.
    Mr. Roemer. Thank you, Mr. Chairman.
    Mr. Chairman, my amendment is a very simple and 
straightforward one.
    As a strong proponent----
    The Chairman. Is the amendment in the package? Let me ask 
the gentleman.
    Mr. Roemer. Yes, it is.
    The Chairman. I thank the gentleman.
    Mr. Roemer. As a strong supporter and proponent of this 
legislation on risk assessment, I come at this particular 
amendment, Mr. Chairman--and having heard the witnesses and 
attended the hearings on risk assessment, one thing that has 
been very, very much in agreement has been that we have needed 
to make sure that we reduce the uncertainty in estimating the 
risk.
    In addition, the need for more people trained in the art of 
risk assessment was clearly identified. Yet the bill before us 
has no research and training requirements.
    As you recall, the Office of Technology Assessment and the 
National Academy of Sciences both testified that this was 
indeed an important part for us to consider and for the bill to 
include.
    This amendment simply establishes research and training 
activity in each Federal agency that is asked to conduct a risk 
assessment under this Act.
    The Chairman. If the gentleman would withhold, we 
understand that there is new language that is now being 
submitted to the Members, the same thing I had a problem with 
Mr. Barton on.
    These amendments are being drafted, and this is not the 
language that was in the package.
    So if the gentleman would withhold for a moment until we 
have an opportunity to look at the language, the Chair would be 
appreciative.
    Mr. Roemer. I would be happy to stop and wait.
    Mr. Chairman, all this does, this section is almost 
identical to a similar, very noncontroversial section that was 
contained in H.R. 4306, the risk assessment bill that was moved 
by this same Committee in the last Congress.
    If we are going to increase our reliance on risk assessment 
as a keystone in the regulatory decisionmaking process, then it 
seems only reasonable that we support needed development in 
this field.
    This amendment supports efficiency, better knowledge and 
true science in terms of developing better research and 
training in risk assessment.
    Just as our businesses are so good at providing training in 
terms of total quality management, all this amendment says is 
our Federal agency should get up to speed as quickly as 
possible and provide the needed skills and requisite 
requirements for these people to perform these tasks, their 
tasks in the different agencies that will be performing this 
much-needed goal in terms of the legislation.
    I would urge the Chairman to support the legislation.
    The Chairman. Would the gentleman yield to the Chairman for 
a moment?
    Mr. Roemer. I would be happy to yield.
    The Chairman. Did I understand the gentleman to say that 
the language he proposes is exactly the same as the language 
that was in H.R. 4306 that passed out of the Committee last 
year?
    Mr. Roemer. That's correct.
    The Chairman. I thank the gentleman.
    That being the case, the Chair is prepared to accept this 
amendment. I think it does add to the bill, and I am prepared 
to be supportive of the amendment.
    Mr. Roemer. I thank the Chairman.
    Mr. Rohrabacher. Mr. Chairman, is there a budgetary effect 
of this amendment? What do we expect this is going to cost?
    The Chairman. Does the gentleman from Indiana have an 
answer to the gentleman from California?
    Mr. Roemer. We do not see any type of budgetary effect from 
this amendment. As the gentleman knows, they already have these 
kinds of training and evaluation teams at the Federal agencies.
    They would just be taking on a different skill to train 
their employees, and we see that this will have negligible, if 
not neutral, budgetary effect.
    Mr. Rohrabacker. So the purpose of this amendment is not 
to----
    Mr. Roemer. It is not to set up a new office.
    It is not to set up new personnel or new bureaucrats.
    In fact, the purpose of the legislation, as the gentleman 
from California knows, is intended to draw down on precisely 
those things.
    Mr. Rohrabacher. I just wanted to make sure that was in the 
record, and thank you very much, Mr. Chairman.
    The Chairman. I thank the gentleman from California.
    Is there any further discussion on the amendment by the 
gentleman from Indiana?
    [No response.]
    The Chairman. If not, the Chair will put the question. 
Those in favor of the amendment will say, aye.
    [Chorus of ayes.]
    The Chairman. Those opposed, will say no.
    [Chorus of nays.]
    The Chairman. The ayes have it. The amendment is adopted.
    Mr. Roemer. I thank the Chairman.
    The Chairman. Amendment No. 17 on the roster would be next.
    [Pause.]
    Has that one been withdrawn? Okay. It has been withdrawn.
    We go now to Amendment No. 18 on the roster.
    [Pause.]
    The Chair would appreciate knowing who was going to offer 
Amendment No. 18, if indeed it is going to be offered.
    Mr. Roemer. Mr. Chairman, I am going to offer that 
amendment.
    The Chairman. Mr. Roemer is offering the amendment.
    Is the amendment available to be distributed?
    Mr. Roemer. It is available, and I would ask for its 
immediate distribution.
    It is in the packet.
    [The amendment is distributed.]
    Mr. Roemer. Mr. Chairman, it is listed as No. 18 in the 
packet.
    The Chairman. The amendment that is being distributed on 
behalf of the gentleman is different from the amendment that is 
in the packet.
    Now which one are we to----
    Mr. Roemer. All we have done is conform it to your 
substitute.
    The Chairman. That's fine. All right. Then the gentleman is 
recognized.
    Mr. Roemer. Mr. Chairman, just as the last amendment in 
terms of training the personnel to perform risk assessment was 
noncontroversial, this amendment is also noncontroversial.
    It was endorsed in testimony by the Western Center for 
Comparative Risk Analysis and by the Northeastern Center for 
Comparative Risk Analysis.
    One of the clear messages from the hearings this year, and 
even last year, is that comparative risk analysis is a tool 
that is still developing and, while that can be used today, 
more should not be expected of it than it can provide.
    In addition, efforts to improve the tool are needed.
    What this amendment does is calls upon the Director of OSTP 
to create a study of comparative risk assessment with the goal 
of providing recommendations regarding the use of comparative 
risk analysis and ways to improve the use of comparative risk 
analysis for decision making.
    This section is almost identical to a similar section, a 
very noncontroversial section that was contained again in H.R. 
4306 last year, the risk assessment bill moved by this 
Committee.
    If we are going to increase our reliance on comparative 
risk analysis to enhance the efficiency and cost effectiveness 
of the regulatory decisionmaking process, then it only seems 
reasonable that we invest in advancing the development of the 
tool.
    If we are going to invest in the people, we need to also 
invest in the analysis and the tool, and I would encourage the 
Chairman to support this amendment, as well.
    Mr. Brown. Regular order.
    The Chairman. Any other discussion on the gentleman's 
amendment?
    [No response.]
    The Chairman. The Chair has examined the amendment. The 
gentleman has proposed an amendment that the Chair sees no 
problem with and is prepared to accept it.
    Mr. Roemer. I thank the Chair.
    The Chairman. With that, the Chair will put the question.
    All those in favor of the amendment will say, aye.
    [Chorus of ayes.]
    The Chairman. Those opposed will say, no.
    [No response.]
    The Chairman. The ayes have it. The amendment is agreed to.
    We have now completed everything that was in the original 
roster with regard to Subtitle A.
    Mr. Luther. Mr. Chairman?
    The Chairman. I am now prepared to accept additional 
amendments--excuse me.
    The gentleman, Mr. Luther, had wanted to raise a couple of 
questions with regard to Section 3106. Let me recognize him to 
do that before we go to additional amendments that were not 
reflected on the roster.
    The gentleman is recognized.
    Mr. Luther. Thank you very much, Mr. Chairman.
    The questions that I have with respect to Section A would 
be on page 13.
    It would be beginning with Line 10, ``(b) PLAN.'' As I 
understand it--and I would address the question to either the 
Chairman or to staff so that I could get a little better handle 
on what is being proposed here, but as I understand this 
section, this is the section that would require the agencies to 
go back and look at what has happened in the past.
    The period covered presumably would be 18 months. The point 
in time would be 18 months after the effective date of this, 
and then beginning at that point in the future then everything 
that has been promulgated in the past would presumably be 
covered by this section, as I understand it, if I am reading it 
correctly.
    My question--I guess my first question here is: How many 
documents would be involved in this kind of an assessment? 
Because as you know, my concern here is that we not get all 
kinds of bureaucracy involved in spending a lot of taxpayers' 
money on things that do not need to be reviewed.
    So I guess my first question would be: What are we talking 
about here? What is the scope of this? What would have to be 
reviewed if we would enact this in the form that it is in?
    The Chairman. The Chair recognizes counsel to respond to 
the gentleman.
    Mr. Beringer. Thank you.
    The primary emphasis, Mr. Luther, is that within the 18-
month period between the time of enactment and the time of the 
effective date of the Act, why there may be a number of risk 
assessments that are done that have not been done under the 
guidelines which would be promulgated under this particular 
Act.
    The primary emphasis is on those risk assessments that are 
done in the interim period.
    However, on past risk assessments, those that would be 
significantly altered by the guidelines would also be 
reviewable, especially on the basis of new information that 
came in that would change or significantly alter the previous 
risk assessment.
    To answer your last question: There is no quantification 
that we have to know how many this would entail.
    Mr. Luther. Then, Mr. Chairman, if I understand your 
response, the intention here is to only cover the 18 months 
beginning on the date of passage of the Act, rather than to go 
back prior to today, for example?
    The way I read it, the plain language would seem to 
indicate that you would go back prior to today, and perhaps 
some clarification in the language would be needed.
    I am looking at the language now on lines 14 and 15 of page 
13. That says every ``document published prior to the 
expiration of'' the ``18-month period''.
    Now that would seem to go back prior to today, for example.
    Mr. Beringer. No, I actually believe that is the intent to 
go back to prior risk assessments.
    As I say, the main emphasis is on the ones that are here 
within the interim period.
    Mr. Luther. Well, Mr. Chairman, perhaps I could understand 
your intent here, as well. Because I would think we would be 
talking about literally thousands and thousands of documents.
    What concerned me in particular is, if this plan of review 
would only include final decisions, then I can see it being 
perhaps somewhat more of a finite number of items that would 
have to be in the plan of review.
    But if literally every agency would be required to put 
together a plan of review that would cover every document that 
would fit in this category, I am wondering if that is really 
what is being proposed here.
    And, if not, if we could just clarify this to try to focus 
on some kind of a process that would be more workable?
    The Chairman. Well, I think the gentleman needs to look 
further down. If you look further down, it says ``The final 
plan shall 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 programs designed to 
protect'', and so on.
    In other words, the ``where appropriate'' certainly gives 
latitude on this.
    I would also say to the gentleman, all that is being 
required here is an update of the science, where appropriate.
    We are attempting to update the science that is involved in 
all of this.
    I don't think we are creating a massive invasion here, 
because the final plan simply sets priorities, where 
appropriate.
    Mr. Luther. Well, Mr. Chairman, I think that clarification 
is helpful.
    What you are then saying is that when you refer to ``plan 
to review'' on line 12, you are not suggesting that each agency 
would go back and be required to conduct, or even plan to 
conduct a review of every documents that would fit in this 
category since the inception of the agency? Because that is 
what one could easily read into this.
    The Chairman. Only if it ``significantly alters the result 
of the prior risk assessment''. If it is likely to do that.
    That is the only--that is the standard.
    Mr. Luther. Mr. Chairman, how would an agency make that 
determination? How would they determine if something would be 
``significantly altered''?
    The Chairman. We are asking the agency for a plan to 
specifically do that; and that the final plan should set 
priorities for the review.
    Mr. Luther. Well, Mr. Chairman, if I understand it, you're 
not suggesting that an agency would have to look at every 
document that fits in this category that they've produced?
    The Chairman. They would be the judgment of whether or not 
it is likely to significantly alter the results. So, the answer 
to the gentleman's question is: No, it would not require 
review, but it would require them to come forward with a plan 
that fits with the criteria as specified here, and the criteria 
are on significantly altering the results.
    Mr. Luther. And, Mr. Chairman, if I can follow up on that, 
you are suggesting that the way they would do that is by 
looking at current science and where in their judgment, the 
agency's judgment, they felt that current science would 
significantly alter the result of some prior document, that 
then their review would be limited to those documents?
    The Chairman. Well, it also relates back to the principles 
set forth in Sections 3104 and 3105.
    So I mean they would have to reference the principles in 
those sections.
    Mr. Luther. Yes.
    But it would be that approach that agencies would use?
    The Chairman. That is my understanding.
    Mr. Luther. Okay. That's helpful.
    The Chairman. I thank the gentleman.
    We have now completed the work in Subtitle A with regard to 
the amendments that were prepared in advance in the roster, the 
process by which, I would say to the Committee, that the 
gentleman from Pennsylvania most often followed when he was in 
a similar position, was preparing the amendments in advance so 
that it was there; but I do understand we now have a number of 
other amendments and I would recognize the people who want to 
offer those.
    Mr. Tanner. Mr. Chairman?
    The Chairman. The gentleman from Tennessee.
    Mr. Tanner. Thank you, Mr. Chairman.
    I want to make a parliamentary inquiry before I offer this 
amendment on Subtitle A.
    I have an amendment that is listed that would come at the 
end of the evening's proceedings that would encompass, I think, 
the amendment that I feel compelled to offer now that would be 
a national security waiver for the Department of Defense.
    Just by way of parliamentary inquiry, if we could adopt out 
of order the waiver at the end, I don't know that we need this 
one that I would otherwise attempt to offer now.
    But if you want to go ahead and do this----
    The Chairman. Well, I think we out to go ahead.
    I mean, I don't want to skip down to the end of the bill.
    We have a series of other people that would like to do the 
same thing. So I think we ought to go ahead with what the 
gentleman has prepared.
    Mr. Tanner. All right, sir. Thank you, Mr. Chairman.
    Mr. Chairman, has our amendment been circulated?
    [The amendment is distributed.]
    Mr. Tanner. It is listed as No. 6 in some package of paper 
I have. When we can't see over the paper, maybe we can adjourn.
    The Chairman. The gentleman is recognized.
    Mr. Tanner. Thank you, Mr. Chairman.
    Mr. Chairman, at the end of Title III, Subtitle A, Section 
3103, I would propose that we add the language that has been 
circulated here with regard to the Defense Department.
    After a thorough reading of the bill, this will just wreck 
absolute havoc with the ongoing BRAC process, with procurement 
reform, the prior amendment last year; there is even some 
question of what it would do with National Guard Summer Camp 
across the country; military aircraft; even routine training 
flights might be subject to this; not to mention what happens 
wit the peer review.
    So this amendment that I offer would just say that when the 
Secretary of Defense or a Secretary of the Army, Navy, Air 
Force, determines that it is not consistent with national 
security interests or missions to comply, they will notify us 
of that determination and the reasons for same.
    I would urge its adoption.
    Mr. Doggett. Mr. Chairman, will the gentleman yield?
    Mr. Tanner. Yes.
    Mr. Doggett. Naturally I am concerned that the Chair would 
offer an amendment that could wreck absolute havoc with all of 
those programs, to use your words, and I am wondering if the 
proposal will wreck absolute havoc with any other parts of the 
government like the Bureau of Prisons.
    We were asked earlier about the Center for Disease Control.
    Should any of these other programs also be included in this 
what appears to be a very necessary exemption?
    Mr. Tanner. Well, I don't know how you voted on some of 
these other matters, but insofar as this amendment is 
concerned----
    Mr. Doggett. I don't suppose that makes any difference. If 
this one has merit, I would want to vote for it, and I would 
want to exclude from absolute havoc any of the other vital 
agencies important to our national security such as certainly 
securing our neighborhoods from criminals at the Bureau of 
Prisons and things like the Center for Disease Control, and I 
am just wondering if the gentleman has considered the kind of 
havoc--as concerned as I am about not disrupting our important 
function of the National Guard--there may be other things that 
are equally important to our safety and that we would not want 
to wreck havoc, to use your words, there either.
    Mr. Tanner. Well, Mr. Doggett, may I simply say, my 
amendment deals with the Department of Defense. We can take up 
your concerns on the other matters in a different amendment.
    Mr. Doggett. I thank the gentleman.
    The Chairman. Is there discussion on the amendment?
    Ms. Harman. Mr. Chairman?
    The Chairman. The gentlelady from California.
    Ms. Harman. I would like to speak for the amendment, as a 
Member of the Committee on National Security, which was the 
reason I missed the vote earlier today. I feel very strongly 
that we do not want to interfere, especially now, with the work 
of the Department of Defense.
    I think this is a valid amendment. I know that another one 
will be offered later in the process, and I intend or hope to 
add NASA to that.
    I think we need to be very careful with the technical 
implications of this bill. The thrust is right. Risk assessment 
is a good idea. But there are some--or I believe there will be 
some unintended or maybe intended consequences here which we 
must guard against, and I strongly support the amendment.
    The Chairman. Mr. Ehlers.
    Mr. Ehlers. Thank you, Mr. Chairman.
    Let me register a little concern about this in view of the 
history of the Department of Defense with regard to 
environmental compliance. This dates back many years back when 
I lived in California.
    I recall very serious pollution problems in the Bay Area 
created by a very careless use of fuel and so forth. And in 
every case the claim was this was a concern of national 
security, and we had to have these--they simply could not put 
the money into containing a fuel, the fuel depots and things of 
that sort.
    We all are aware of that. We've spent billions of dollars 
trying to clean up some of these sites, and we are still far 
behind where the private sector is in many cases.
    I am a little concerned about giving carte blanche to any 
department without some sort of oversight. Without this, this 
just basically says they can do it, and all they have to do is 
let us know.
    I would like to see some independent review of it if we are 
going to do something like this.
    Thank you.
    The Chairman. I thank the gentleman.
    Mr. Tanner. May I respond, Mr. Chairman?
    The Department of Defense already has probably as stringent 
or possibly more so stringent requirements on them on their 
environmental cleanup.
    Just when I have been looking at this matter, this bill is 
supplemental to and in addition to all of the environmental 
cleanups that are ongoing now at the Department of Defense.
    I am told that the peer review requirements just for the 
environmental cleanup in the DOD would amount to a delay of at 
least six months and cost anywhere from $35- to $70 million a 
year at a time when we are cutting defense; at a time when we 
need every dollar we can have for readiness; and at a time when 
the Department of Defense's environmental regulations that you 
refer to are as strong as they are anywhere in the government. 
That seems to me to add another layer of bureaucracy and risk 
assessment supplemental to and in addition to what the 
Department of Defense already has on it and is questionable.
    Mr. Tanner. Mr. Chairman, would the gentleman yield?
    The Chairman. Well, the gentleman from Michigan had the 
time. The gentleman from Tennessee was explaining--
    Mr. Ehlers. Thank you, Mr. Chairman.
    I just would like to respond. I guess you could use the 
same argument for putting these regulations on business, or any 
other sector and say, well, you can argue why should we put a 
$75 million or a $100 million expense on a business.
    The point is, once you start making assumptions for any 
reason, then you have really created a situation where it is 
hard to defend applying it to the others who still are subject 
to the regulations.
    I am not necessarily opposed to this, but I am certainly 
raising a question about it, whether or not this is necessary; 
and, if it is necessary for them, then why isn't it necessary 
for a great many others?
    The Chairman. I thank the gentleman.
    Mr. Weldon.
    Mr. Curt Weldon. Thank you, Mr. Chairman.
    I understand the concerns of my good friend, Mr. Tanner, 
and my understanding is that the legislation currently provides 
for an emergency process. Because I share the concerns relative 
to the military. I would not want to see us get in a position 
where you have to do a risk assessment every time you want to 
do a fly-over or a military exercise.
    My understanding, Mr. Chairman, is that you have taken care 
of that. Is that correct?
    The Chairman. The gentleman is correct that there are 
emergency procedures that would certainly deal with national 
security interests in the bill as drafted.
    The Chair's concern is that the amendment goes much further 
than that and suggests missions. One of the missions of the 
military is the Corps of Engineers. The Corps of Engineers does 
the work that has dramatic impact on the public, and certainly 
should be subjected to the kind of processes that are within 
this particular bill.
    To exempt the Corps of Engineers I think would create a 
major environmental loophole in the bill and would certainly be 
the case under the gentleman's amendment.
    So the Chair has a very strong concern that that exemption 
goes much too far. Some of the national defense facilities that 
are in the process of being cleaned up may have an impact on 
the public at large around those. They should certainly be 
subjected to some of this review, as well, particularly those 
that we intend to do in the future.
    So the Chair is concerned that this amendment does have 
some implications beyond simply the national security mission.
    Mr. Tanner. Will the gentleman yield?
    Mr. Curt Weldon. Sure.
    Mr. Tanner. Mr. Chairman, if you read the language, we 
limit this to ``consistent with national security interests and 
missions.''
    Now I hardly think the Corps of Engineers is engaged in 
matters that affect national security interests. I respect the 
gentleman's opinion, but that is not at all the intent of the 
legislation offered.
    The Chairman. But certainly the Corps of Engineers, which 
is one of the largest parts of the United States Army, is a 
``mission,'' and it is something that would obviously be 
covered under this amendment.
    I would simply say to the gentleman that that is a major 
loophole that we would be opening with this amendment.
    Mr. Brown. Mr. Chairman?
    The Chairman. The gentleman from California.
    Mr. Brown. Mr. Chairman, I am going to support the 
amendment here, although I recognize the validity of the points 
that are made. I particularly applaud Mr. Ehler's principles in 
not wanting to exempt a major activity of this sort.
    But I would like to point out that probably if you 
calculate all of the money being spent on environmental 
remediation anywhere in the United States, the Department of 
Defense is probably spending most of it--more than half of it--
and it amounts to quite a few billions of dollars.
    I will say that, since it is a department of the 
government, it is doing so under the direct direction of the 
President and his staff, and they are doing it in accordance 
with very high standards which have been promulgated by the 
Defense Department over the years.
    I have had to deal with some of the military departments in 
connection with cleanup activities, and I will say that they 
have generally been above and beyond the call of duty. They 
have accepted their responsibilities and are carrying it out 
with great diligence.
    Now it was my original bias in connection with this that 
the efforts being made by the author of this bill are spreading 
too wide a net. The bill here being considered is being 
compared to last year's bill, and I think we all know that last 
years' bill was focused very narrowly at the activities of the 
EPA in terms of environmental cleanup.
    This seeks to go to every department of the government to 
encompass activities never before considered in connection with 
this.
    And while I applaud the effort to develop standards for 
risk assessment that are applicable on a broader basis, I think 
that in including national defense agencies, national security 
agencies, that we are biting off far more than we are likely to 
be able to chew in connection with this bill.
    I know that there is no Member here who would like to feel 
that this legislation in any way, shape, or form hampered the 
military in carrying out their security mission or required 
resources, as Mr. Tanner has pointed out, that are badly needed 
to meet the readiness needs of the services.
    So for these various reasons, I am going to urge that this 
amendment be supported and I hope that it will be supported.
    Mr. Doggett. Would you be willing to yield on that, Mr. 
Brown, for a question?
    Mr. Brown. Yes.
    Mr. Doggett. Because I am sure that Mr. Tanner's objective 
in covering the amendment, now that I have read it, it would 
include the Defense Intelligence Agency, which I would think we 
would certainly want to exempt, but I do not believe the 
amendment includes the Central Intelligence Agency.
    What impact might the kind of wholesale change in the law 
here have on our national security interest as it relates to 
the Central Intelligence Agency?
    Mr. Brown. The gentleman raises a good question, and I 
don't know whether the author intended to include that agency 
or not.
    Mr. Tanner. None other than I think the focal point of the 
discussion here is that this bill as drafted is supplemental to 
and in addition to other laws relating to risk assessment 
particularly with regard to the Corps of Engineers who have--we 
certainly want to bring them in, but in order--and I did not 
mean to give them some sort of blanket exemption.
    What we are talking about is national security interests 
and the fact that this is supplemental and in addition to all 
of the other rules and regulations that the Department of 
Defense undertakes.
    This amendment relates to the Secretary of Defense and the 
Secretaries of the Services only. So in that regard, I doubt 
that the Central Intelligence Agency is included at all.
    Mr. Hastings. Mr. Chairman.
    The Chairman. Mr. Hastings.
    Mr. Hastings. May I ask the author of the amendment if 
there is some way that language can be added that would 
demonstrate what would happen upon notification by a military 
department?
    My point that I raise to my good friend from Tennessee is 
that it does not say that anything will happen. Let me give you 
a ``for example.''
    The Secretary of the Army determines the day before an 
event that may very well require compliance with the base bill, 
makes a determination and notifies Congress that day. Well, 
what is Congress to do?
    Fine?
    Thank you very much for the notification?
    Goodbye?
    Assume for the moment that some harm does occur. There is 
no way that we are dealing with that. Or, is there oversight 
somewhere else in the government that would cover it? And if 
that is satisfactory, then I have no hesitancy in supporting 
it.
    Do you understand what I am saying?
    Mr. Tanner. The gentleman makes a good point. I don't know 
how you can craft language to that effect. I mean, if you have 
a surprise raid on Khadafi again, I don't know how you do a 
risk assessment on something of that nature. Maybe you can; I 
don't know how you do a peer review on some of the weapons that 
we are developing here.
    I mean, are we going to ask the Russians if they think 
these are a good idea?
    What I am saying is, there are rules and regulations. As 
our Ranking Member, Mr. Brown, said, this is a very, very broad 
bill. It is supplemental and in addition to all other laws.
    I just think the Committee ought to realize and know what 
we are doing, particularly as it affects some of the activities 
that are carried on on the part of Defense to which this just 
does not make common sense.
    Mr. Hastings. Reclaiming my time, the gentleman makes the 
point that I wish to make. Not only is it broad, it is over-
reaching and it is vague. And that is going to cause additional 
problems--not just our amendment, but the base bill.
    Your amendment is definitely vague on its face. In that 
sense, I don't think it accomplishes all that we should as 
sound legislators.
    However, I would be very hesitant to not support something 
that was going to give added favor to national security 
interests and missions, but your amendment is flawed.
    The Chairman. I thank the gentleman.
    The debate on the Minority side has eaten into the time to 
get over to vote, so we don't want to continue any further.
    The Committee will stand in recess.
    [Recess.]
    The Chairman. The Committee will come to order.
    Mr. Tanner. Mr. Chairman?
    The Chairman. The Committee will come to order.
    The gentleman from Tennessee.
    Mr. Tanner. Thank you, Mr. Chairman.
    I think I want to withdraw this amendment, but before I do, 
Mr. Chairman, I am going to have another one at the end of the 
proceedings here this evening dealing only with military 
readiness that I hope everybody can support.
    But I want to ask the counsel, if I may, what is the effect 
on non-emergency situations arising in the Department of 
Defense with respect to some of the matters they have to 
undertake in terms of training and readiness?
    The Chairman. Counsel?
    Mr. Beringer. Yes, Mr. Tanner, first of all the bill is 
limited to health, safety, and environmental concerns. So first 
of all, that would be the first parameter.
    But second of all, yes, they do do risk assessments. For 
instance, in their environmental cleanup efforts, 
decontamination, Mr. Williamson advises me that they do this 
for ocean dumping and things of that nature.
    I think some of the things that were mentioned earlier such 
as military readiness would come under the emergency exemption. 
But by and large, they are already required to do, by their own 
regulations, a great deal of risk assessment and 
characterization, and this would be fairly much in line with 
what they already do.
    So I don't think it would add that much of an 
administrative burden to them.
    Ms. Lofgren. Mr. Tanner?
    Mr. Tanner. Well may I say, I think you make the point that 
this common sense would dictate that there ought to be some 
waiver on what is happening with military readiness. I just 
hope that when we get to the end of the evening we could reach 
an agreement on that.
    The Chairman. If the gentleman would yield to the Chairman, 
it seems to me that the gentleman has raised a valuable and 
interesting point. The only interpretation that would make this 
at all a matter of concern is if you get a broad interpretation 
of the words ``safety'' that would include ``national 
security'' matters.
    The way, it seems to me, of dealing with this matter is to 
simply say that the term ``safety'' would not relate to 
national security and military readiness types of matters.
    That would assure, then, that the environmental issues that 
I raised with regard to the Corps of Engineers and so on could 
continue to be covered, which I--you know, when----
    Mr. Tanner. I have no problem with that. That was not the 
intent.
    The Chairman. I understand that. So what I am suggesting to 
the gentleman is that we can either deal with it in report 
language in a way that assures that it is clear that the word 
``safety'' does not include military readiness or national 
security matters; or, if the gentleman feels that you want to 
do an amendment in that nature, it seems to me that that is one 
way of allowing us to assure that that does not.
    But I looked at the gentleman's amendment in the nature of 
a substitute coming at the end of the bill and that still does 
not get us to the question, because the Secretary could still 
under that waiver perhaps exempt Corps of Engineers' activity. 
I do not thank that is the gentleman's intent, but it is my 
concern that the language is broad enough that it could do 
that.
    I would be willing to accept an amendment that says that 
``safety'' as defined in the bill does not include matters 
relating to national security or military readiness.
    We would clarify that in report language. At the end of the 
bill, if the gentleman wants to offer such an amendment, I 
would be prepared to accept an amendment that assures that 
safety is not interpreted in that way.
    Mr. Tanner. We will work on it during the evening.
    The Chairman. I thank the gentleman.
    Mr. Curt Weldon. Mr. Chairman.
    Ms. Lofgren. Mr. Chairman.
    The Chairman. The gentleman from Pennsylvania.
    Mr. Curt Weldon. I thank the Chairman.
    I want to applaud our colleague from Tennessee who takes a 
back seat to no one in support of our military. I agree with 
the tone of the conversation that just occurred.
    Let me say that I think in the end this legislation may 
help us, John, face what has become the largest single 
increasing cost in the defense budget, which is basically 
environmental cleanup.
    For those of you who serve, as we do, on the National 
Security Committee, we know that we are spending $13 billion 
this year on cleaning up sites which on one day are okay for 
our military families to live on and kids to play at, and the 
next day when they are closed they all of a sudden become major 
environmental sites that we have to spend billions of dollars 
on.
    Perhaps this risk assessment process, John, will in the end 
help us control some of those costs and have a positive impact 
on defense spending.
    Mrs. Morella. Mr. Chairman.
    Ms. Lofgren. Mr. Chairman.
    The Chairman. The gentlewoman from California--
    Mrs. Harman. I just have a question in connection with what 
you have just suggested, which I strongly support. Maybe this 
would save us time.
    As you know, later I will be offering an amendment about 
NASA which also engages in safety and related exercises, and 
which I think might be unfortunately swept up in overbroad 
coverage here.
    I just wonder if you are considering some language to 
exempt functions that were not intended to be covered, whether 
NASA and its safety and mission success functions might be 
considered as well?
    The Chairman. Well----
    Ms. Lofgren. Mr. Chairman.
    The Chairman [continuing]. I have not fully considered that 
issue, but insofar as it related to national security certainly 
that would be covered under the language that I have suggested 
that we draft up in that regard.
    The gentlelady from California.
    Ms. Lofgren. Mr. Chairman, along those same lines I wonder 
if there is language that is going to be put in the report, or 
added into the bill later, whether we should not also include 
law enforcement?
    I think the issue about the FBI, the Bureau of Alcohol, 
Tobacco, and Firearms, potentially even the FBI, I mean those 
are important law enforcement functions that I don't think are 
really the object of the authors of this bill, but could be 
swept up into it and ought to be addressed.
    The Chairman. Well, once again I think we may want to look 
at whether or not appropriate report language is a way of 
defining some of those kinds of things, but I don't think that 
we want to complete exempt Department of Justice activities and 
some of those kinds of things that may be involved.
    So I think we need to be a little careful here just how far 
we extend that issue. But we will certainly consider matters as 
they are appropriate to be brought before the Committee.
    Did Mr. Tanner withdraw his amendment? Is that my 
understanding?
    By unanimous consent the amendment is withdrawn.
    Any other amendments to Section A, Subtitle A?
    Mr. Bartlett. Mr. Chairman, I have an amendment at the 
table.
    The Chairman. Mr. Bartlett.
    The amendment of the gentleman needs to be distributed.
    [The amendment is distributed.]
    The Chairman. Okay. The amendment is being distributed. The 
gentleman will explain his amendment.
    Mr. Bartlett. Thank you very much.
    Mr. Chairman, this is a very simple perfecting amendment. 
If you will turn to page 14 of the amendment in the nature of a 
substitute where we have definitions, there are two definitions 
there.
    One of them is ``risk assessment document'' and the second 
one, found on page 15, is the ``risk characterization 
document.''
    The definition of the risk assessment document has 
alternative definitions. The first one I think was the general 
intent of what the risk assessment document should be:
    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''.
    If you now look at the rest of the language there starting 
with line 1 and going through line 3, you will see that this is 
the alternative definition, ``or describing the degree of 
toxicity'' and so forth.
    You will see that that is identical with the language that 
describes the risk characterization document. I would think 
that it would be clarifying if we simply, as my amendment 
indicates, strike from ``assessed'' on and just left the 
definition of the ``risk assessment document'' with the first 
of those two alternative definitions.
    It is difficult to have two documents which are supposed to 
be different and have them defined with precisely the same 
language.
    The Chairman. The gentleman I think has made a contribution 
to the Committee. I am told that there was mistaken language 
included here. The gentleman has discovered that and provides 
the correction that I think is a very valuable addition, and 
the Chair is prepared to accept the amendment.
    Is there further discussion on the amendment?
    [No response.]
    The Chairman. If not, all those in favor of the amendment 
will say aye.
    [Chorus of ayes.]
    The Chairman. Those opposed will say no.
    [No response.]
    The Chairman. The ayes have it. The amendment is adopted.
    Any other amendments to Subtitle A?
    Mr. Olver. Mr. Chairman.
    The Chairman. Mr. Oliver.
    Mr. Olver. Thank you, Mr. Chairman.
    I think I have discovered something very important. I too 
have a very simple perfecting amendment. It is in Section 3107 
under the definition of ``best estimate'' that I think needs to 
be distributed.
    The Chairman. Has the amendment of the gentleman been 
distributed?
    Mr. Olver. I have two that are being distributed, I 
believe.
    The Chairman. Is this an amendment on page 10, or page 15?
    Mr. Olver. Page 15.
    The Chairman. Page 15.
    Mr. Olver. In Section 3107 under the definition section 
under ``best estimate.''
    [The amendment is distributed.]
    Mr. Olver. I would ask unanimous consent to add two words 
to this. In line 5 of the amendment after the word 
``discussion'' to add the words ``and analysis of 
uncertainties, limitations, and assumptions affecting the risk 
estimate''.
    The Chairman. Without objection.
    Mr. Olver. Thank you, Mr. Chairman.
    This amendment has to do with the definition of the ``best 
estimate'' here. The problem that I see in the definition is 
that the bill calls for basically best estimates and puts 
emphasis on ``central estimates'', ``central estimates'' being 
estimates which place the emphasis on the center of a 
distribution; whereas, in proper risk analysis we have in 
almost any population, we have people or segments of that 
population which are at particular risk.
    The Chairman. If the gentleman would suspend, it seems to 
me what we ought to do is allow the gentleman to make his 
explanation at a time when Members are not kind of trying to 
move out of the room to go vote.
    Why don't we go vote and we'll come back and I will 
immediately recognize the gentleman for an explanation of his 
amendment.
    Mr. Olver. Thank you.
    The Chairman. The Committee stands in recess for voting.
    [Recess.]
    The Chairman. The Committee will come to order.
    When the Committee recessed we were in the process of 
considering an amendment from the gentleman from Massachusetts, 
Mr. Olver, numbered 13 on ``best estimate.'' The gentleman was 
in the process of explaining his amendment when I suspended the 
hearing.
    I want to go back to the gentleman to allow him to explain 
his amendment and move forward from there.
    The gentleman is recognized.
    Mr. Olver. Thank you, Mr. Chairman, for your recognition.
    I was a young man when I started explaining this amendment. 
[Laughter.]
    This amendment is short. To me it represents a single and 
comprehensive and encompassing statement of what a best 
estimate for risk analysis ought to be.
    To the degree that it is possible these days in science, it 
is probably something that could be an encompassing amendment 
and statement of what best estimate ought to be some years from 
now as well as just now, and as such it seems to me to get away 
from a couple of serious problems with the language that is in 
legislation in the Substitute that is the markup document.
    Namely the two items that are the problem here is this 
language of mine avoids the use of a point estimate, a single 
point estimate. That is to say, a central estimate. Which is, 
whether it is upper bound central or lower bound, that kind of 
a point estimate is inconsistent with the recommendations of 
the National Research Council and the Risk Assessment and Risk 
Management Commission who attest that those kinds of point 
estimates are just not very reliable or very defensible.
    Secondly, that the amendment in its same point, really 
avoids the central estimate of risk where a central estimate of 
risk ends up being a single estimate in the body of all 
possible persons, say, who might be involved in a hazardous 
situation, whereas it does not then properly reflect what is 
the experience for persons who may be at special risk; the 
individuals who are not average in some ways due to differences 
in genetics, susceptibility, or whatever, or susceptibility to 
disease, really are not likely to be covered by that central 
average estimate over the whole population, but allows then for 
an avoidance for the use of that central estimate and allows 
one to put emphasis on those who are really at risk and 
endangered under whatever is the problem, environmentally, or 
public safety, or public health.
    So I think it avoids several considerable problems with the 
language and is a better living definition, and one that one 
could expect to stand some test of time at least.
    The Chairman. I appreciate the gentleman's explanation. The 
Chair would simply say that the concept of central estimates is 
a definition which is a hallmark of this bill. We don't limit 
ourself to any issue of best estimates to only central 
estimates, but it is something which we think needs to be an 
option.
    Central estimates in this case means the most likely 
probability based upon the science. We think that that is one 
measurement that ought to be available to the agencies.
    But if you will look at the language in the substitute, we 
also give two other options. One is an approach which combined 
multiple estimates based upon different scenarios and weighted 
the probability of each scenario.
    And we also give another option, which is any other 
methodology designed to provide the most unbiased 
representation and the most plausible level of risk given the 
current scientific information available to the Federal agency 
concerned.
    So there are options available under this, but the idea 
that you can use at some point an estimate that comes to the 
most likely probability is fundamental to what we are trying to 
achieve in the bill. So, therefore, I would say that the 
gentleman's amendment goes to the heart of what we are 
attempting to accomplish here and is unacceptable to the Chair.
    Mr. Olver. Without wanting to extend this discussion a 
great deal, I would like to just merely respond to that. Every 
one of the alternatives is designed around a central estimate 
and really in the process of doing so it eliminates the proper 
evaluation of risk for those people who are the most seriously 
and severely at risk from an activity and a regulation process 
in any of the areas that we are trying to provide some benefit 
to people at risk.
    I think that that is the central problem with the language 
of the best estimate definition.
    The Chairman. I would simply say to the gentleman that the 
Chair does not agree with that characterization, when Part C 
says ``any other methodology designed to provide the most 
unbiased representation of the most plausible level of risk.''
    That opens the door to virtually any other methodology, 
whether it involves central risk or not, or central estimates 
or not.
    So it is far from being as the gentleman has characterized 
it, but we think what we have put in the bill is important.
    Is there any other discussion on the amendment?
    [No response.]
    The Chairman. If not, the Chair will put the question. 
Those in favor of the amendment will respond by saying aye.
    [Chorus of ayes.]
    The Chairman. Those opposed will say no.
    [Chorus of nays.]
    The Chairman. In the opinion of the Chair the noes have it. 
The noes have it. The amendment is not agreed to.
    The gentleman had--are there any other amendment to--I had 
said I would recognize the gentleman, Mr. Tanner, next.
    Mr. Tanner. Thank you, Mr. Chairman.
    I had an old professor in law school who said that anything 
that could be said could be said better in a few words.
    Our amendment now reads ``or to be necessary to maintain 
military readiness''.
    The Chairman. It is an excellent amendment which the Chair 
is prepared to take.
    Mr. Tanner. Thank you, sir.
    Unidentified Member: Move its adoption.
    The Chairman. Is there any other discussion on the 
amendment?
    [No response.]
    The Chairman. If not, the Chair will put the question.
    [Chorus of ayes.]
    The Chairman. We should have had the amendment distributed. 
That is the fault of the Chair. But let me read it.
    The gentleman has characterized it. What he says is: We add 
another item to the exceptions already in the bill to say ``or 
be necessary to maintain military readiness''.
    So that it does provide an exception for the Secretary for 
purposes of military readiness. We believe that this is 
something which does no harm to the bill at all and further 
defines the exceptions clause.
    With that, I would put the--the gentleman from Minnesota, 
or Michigan, I'm sorry.
    Mr. Ehlers. I may be West, but not that far.
    The Chairman. Yes.
    Mr. Ehlers. I just----
    The Chairman. They are all ``Ms'' up there to me. 
[Laughter.]
    Mr. Ehlers. Do we still have a notification from them? The 
previous amendment said that for any such variation they would 
notify Congress of such determinations and the reasons for such 
determinations.
    Is that still going to be part of it?
    The Chairman. Well, we intend to define ``military 
readiness'' in the amendment, or in the report language in a 
way that would assure that these are items that are done in 
terms of training and true readiness procedures.
    Since we do not deal with the environment and some of the 
other things in this particular language, we believe that there 
the Corps of Engineers and a lot of other things would still be 
covered.
    But it was not the intent, as I read the language of the 
bill and participated in drafting the bill, to have military 
readiness impacted by what we were doing here. This simply 
clarifies that language.
    Mr. Ehlers. Well, Mr. Chairman, I still register my concern 
and just point out that one great issue with the American 
public which we just resolved was exempting Congress from the 
laws which we pass. I am very concerned about exempting any 
branch of the Federal Government.
    The Chairman. We are not exempting the Defense Department 
in any way, shape, or form here. We are simply exempting those 
activities in the Defense Department that are clearly questions 
of military readiness.
    The Defense Department will still have to comply with the 
bill. We are not exempting the Defense Department with this 
language.
    Mr. Ehlers. All right, I will conclude with one statement.
    I think at some point in the future I will offer an 
amendment on another bill exempting Members of Congress who are 
worried about their political readiness. [Laughter.]
    So thank you very much.
    The Chairman. I thank the gentleman.
    The Chair will now put the question. All those in favor of 
the amendment will say aye.
    [Chorus of ayes.]
    The Chairman. Those opposed will say no.
    [Chorus of nays.]
    The Chairman. The ayes appear to have it. The amendment is 
agreed to.
    Are there any other amendments to Section A, or Subtitle A?
    Mr. Minge. Mr. Chairman?
    The Chairman. The gentleman from Minnesota.
    Mr. Minge. I have an amendment that is at the table and I 
believe that it is also in the package you may have listed as 
No. 14.
    The Chairman. The Clerk will distribute the amendment.
    [The amendment is distributed.]
    Mr. Minge. To save time, I could quickly state what it is.
    The Chairman. The gentleman is recognized.
    Mr. Minge. This amendment builds on the experience that we 
had in 1994 in the 103rd Congress when we decided that the 
United States Department of Agriculture, as a part of its 
reorganization, should be subject to a mandate to engage in 
risk assessment.
    The purpose of this amendment is to exclude the U.S. 
Department of Agriculture from the bill that is under 
consideration.
    The reason for this is that we should allow the U.S. 
Department of Agriculture to proceed with the risk assessment 
procedures that it currently is constructing and use that as a 
basis for determining whether the policy that we established in 
that legislation works better than the policy that we are 
establishing in this.
    It is somewhat like saying that we have 50 States. It is an 
opportunity to experiment. We have within our Federal agencies 
a vast array of departments and operations. This is a chance 
for us to experiment.
    I also believe that it is awkward for us to in one session 
of Congress establish a mandate for an agency or a department, 
and then in the next session of Congress we pull their--we jerk 
their chain and say, all right, start all over again, we're 
going to do it a different way. That is essentially what we are 
doing with USDA with respect to risk assessment.
    The Chairman. Well, I thank the gentleman for his 
explanation.
    We did have in mind some of the problems that were related 
to us that USDA would have in coming up with some of the 
exceptions that are on page 7, including food labeling, health 
and safety environmental inspections, and so on.
    I think that we have attempted to deal with the problems 
that--in terms of the operation of the department.
    The gentleman makes a legitimate point about the questions 
of the laws that were just passed recently and now would be 
subject to this change. It is a legitimate point.
    However, the Chair would be reluctant to begin exempting 
whole departments from the coverage of this bill. It seems to 
me that we open the door to virtually everyone else coming up 
with some reason why they ought to be an exception on the bill.
    In my view we have adopted much of what has previously been 
done on risk assessment in this particular approach, and I 
don't believe it should place an undue burden on the 
department. For that reason, I would oppose the amendment.
    Are there other statements on this particular----
    Mr. Schiff. Would the Chair yield to a question?
    The Chairman. I certainly would.
    Mr. Schiff. Very briefly, Mr. Chairman, I guess we just 
last year passed a similar bill for the Department of 
Agriculture. I wondered, did we do that for any other agency 
that could make the same argument that this Chair knows of for 
an exception?
    The Chairman. I would say to the gentleman that there was 
nothing that cleared the Congress. We did in fact adopt some 
similar language with regard to the Green Technologies bill on 
the Floor, but that of course did not make it through the 
Senate.
    So that is the case. But I would also say to the gentleman 
that I am not so certain that we want a host of different types 
of risk assessment going on around the Government.
    If in fact what we are trying to do is establish a set of 
principles here, it seems to me that the set of principles 
ought to be standard.
    I do not believe the Department of Agriculture is that far 
into their application of this that the new principles could 
not be applied to what they do.
    Mr. Schiff. I thank the Chairman.
    Mr. Minge. The only other comment I would make on that is 
that the bill last time was adopted, I'm not sure if it was by 
a voice vote, but it was an overwhelming bipartisan vote, and 
that the process set up in that bill allows the agency a little 
more discretion in designing its risk assessment procedure.
    I think that there is a real benefit in experimentation 
within our Federal system to try to develop the most effective 
risk assessment process, and this allows for some of that 
experimentation.
    The Chairman. If there is no further discussion, the Chair 
will put the question.
    Those in favor of the amendment will say aye.
    [Chorus of ayes.]
    The Chairman. Those opposed will say no.
    [Chorus of nays.]
    The Chairman. In the opinion of the Chair the noes have it. 
The noes have it, and the amendment is not agreed to.
    Any other amendments to Subtitle A?
    Ms. Lofgren. Mr. Chairman?
    The Chairman. The gentlewoman from California.
    Ms. Lofgren. I have an amendment at the desk, I think.
    The Chairman. The Chair does not have a copy of this 
amendment, so the Chair would want to have it distributed 
before we move forward.
    [The amendment is distributed.]
    The Chairman. The gentlewoman is recognized to describe her 
amendment.
    Ms. Lofgren. Thank you, Mr. Chairman.
    The proposed amendment specifies that where feasible and 
scientifically appropriate a risk assessment will identify risk 
to highly exposed groups.
    The bill calls for risk assessments that use best 
estimates, as we discussed just a few minutes ago, using most 
plausible assumption and unbiased information.
    I think these terms could be interpreted as excluding 
consideration for subsets of the population such as children 
who may be more highly exposed or more vulnerable than average 
adults because these subgroups have exposure and susceptibility 
patterns that are different from most members of the 
population.
    Whereas I think arguable those estimates under Section B 
could in fact touch those groups. They are not required to 
assess the risk for those groups, and I think it is important 
that, in addition to the language that is currently in the 
bill, that we direct that highly sensitive groups such as 
children also be identified, and that that information be 
provided.
    One example of the reason for the necessity for this would 
be lead. As we know, exposure of lead to children is much 
different than the exposure of lead to adults. Lead absorption 
in the stomach, from the stomach to blood in children is about 
50 percent, whereas it is about 15 percent for adults, and 
clearly behavior of children--I have two--when they are little, 
in terms of ingesting dust and dirt, is considerably different 
than most adults.
    So I think that this is well in order and will help in the 
assessment of actual risk to those who are most important to 
the future of our country, our children.
    Thank you.
    The Chairman. I appreciate the gentlewoman's explanation.
    If the Chair can turn the Member's attention to pages 10 
and 11 of the Substitute, you will find there that we say in 
the Substitute: ``To the extent practical and appropriate'' and 
the bottom of page 10, and then going onto page 11, ``the 
characterization shall provide descriptions of the distribution 
probability of risk estimates to reflect differences in 
exposure variability or sensitivity in populations and 
uncertainties.
    That is a very broad way of saying much the same thing that 
the gentlewoman is saying in her amendment, and I think it 
gives broader coverage to assure that there is sensitivity to 
population groups.
    The reason why I would say that that is important is, I 
look at the gentlewoman's amendment and one group that I do not 
see covered under her amendment is, for instance, HIV-positive 
persons in the population.
    It seems to me that in some instances we would want to have 
that as a particular population that we are concerned about.
    She excludes that from her amendment. Under the language 
which is in the bill, that would in fact be included. So----
    Ms. Lofgren. If I may, reclaiming my time, Mr. Chairman, in 
the amendment----
    The Chairman. The time of the gentlewoman had expired.
    Ms. Lofgren. Oh? Had it expired? Pardon me.
    The Chairman. I would be happy to yield to the gentlewoman.
    Ms. Lofgren. I appreciate that very much.
    The parentheses is not meant to be an exhaustive list. I am 
sure we can note the ``such as infants''. It is meant to be 
examples, but not to be an exhaustive list of all those who 
might be vulnerable, if I could just clarify that.
    The Chairman. I thank the gentlewoman, but by singling out 
groups in her particular language, that is in fact a preference 
group that she is singling out.
    What I am suggesting is that in the language that is in the 
substitute, we allow judgments to be made about particular 
groups that we may not know about at the present time.
    This may be a situation where we would have particular 
groups that we want to have a particular sensitivity to at some 
time in the future that we don't even know how to describe at 
the present time.
    So therefore it seems to me that the language that is in 
the bill right now gives broader applicability to sensitive 
groups than singling them out in this particular amendment.
    Ms. Lofgren. Mr. Chairman, I wonder if we could, just 
looking at the language that you have pointed out, 
``sensitivity in populations and subpopulations'' might achieve 
what you and I are both talking about more directly.
    The Chairman. Well, I am told by counsel that that is not 
necessarily needed here; that the sensitivity in populations is 
in fact a subpopulation as well. I mean, that that is a 
description that again simply narrows it and takes away from 
the discretion of the agency to do the kinds of things that I 
think the gentlewoman is seeking to do.
    Ms. Lofgren. Well, I don't want to go on at too great a 
length. I don't agree. Going back to when I took statistics, 
and Mr. Olver's earlier comments, I think that clearly the way 
the bill is drafted--and I am not disagreeing that we ought to 
look at what is the impact on most people in the center of it--
but I think using that statistical analysis we will miss some 
groups. Which is why I have proposed this.
    But I think there is disagreement, so perhaps we can just 
vote.
    Mr. Olver. Mr. Chairman?
    The Chairman. The gentleman from Massachusetts.
    Mr. Olver. Mr. Chairman, on this amendment could counsel--
maybe it is just late at night, but I really don't understand 
what ``uncertainties'' are and what their relationship are to 
the ``variability or sensitivity in populations''.
    The Chairman. Counsel would reply.
    Mr. Beringer. The Chairman is quite correct. When this was 
drafted it was intending to be an all-encompassing amendment 
which would include many of the things that the gentlelady was 
referring to earlier.
    The uncertainty part is one of the words that were used in 
this drafting to try to explain that, as has been stated many 
times throughout the day, that this is not necessarily pure 
science, but there are variables, and there are things that we 
are not certain about.
    So what this is trying to do is give to the risk 
characterizes the broadest discretion possible to try to 
include, but yet at the same time note that everything may not 
be covered.
    Mr. Olver. If I may reclaim my time, the structure of that 
sentence leads one to think of ``populations and 
uncertainties'' being something that ought to be related to 
each other.
    I wonder, is the ``uncertainties'' meant to be something 
somewhere else in this paragraph? It seems to be hanging in the 
wrong place.
    Should it be reading ``Should provide descriptions of 
distributions and probabilities and uncertainties of risk 
estimates to reflect differences in exposure, variability, or 
sensitivity in populations''?
    Mr. Beringer. Mr. Williamson is pointing out to me that to 
further refine what I had previously said, uncertainty means 
the quantifiable and unquantifiable potential error in the 
estimation of risk that is caused by the quality or absence of 
data or the assumptions used in risk estimation.
    So it is, as I said, it is meant to be a qualifier. Perhaps 
it is not in the right place, but that is what it means.
    The Chairman. We can in fact at a time, if in fact counsel 
agrees with the gentleman from Massachusetts, we can in fact in 
technical corrections work the sentence, and so on. But it is--
--
    Mr. Curt Weldon. Would the Chairman yield? Mr. Chairman?
    The Chairman. The gentleman from Pennsylvania.
    Mr. Curt Weldon. Mr. Chairman, I thank you for yielding.
    Can't we take care of much of this in report language?
    The Chairman. Precisely.
    Mr. Curt Weldon. I mean, working it out--not that I am 
trying to downplay the importance of these things, but I think 
we are getting into technical details which really could be 
worked out in report language to the satisfaction of both 
sides.
    The Chairman. The gentleman is correct. I thank the 
gentleman.
    The vote occurs on the amendment of the gentlewoman from 
California. Those in favor will say, aye.
    [Chorus of ayes.]
    The Chairman. Those opposed, no.
    [Chorus of nays.]
    The Chairman. In the opinion of the Chair, the noes have 
it. The noes have it, the amendment is not agreed to.
    Are there any other amendments in Subtitle A?
    Mr. Traficant Mr. Chairman, I have an amendment.
    The Chairman. The gentleman--has the amendment been 
distributed?
    Mr. Traficant. I believe that----
    The Chairman. The Clerk will distribute the amendment.
    [The amendment is distributed.]
    Mr. Traficant. While they are distributing it, it was 
brought up during the Barton amendment where it was alluded to, 
a ``non-United States-based entity''. I believe that the Barton 
amendment as passed is rather shallow without a definition.
    This is an attempt to define ``non-United States-based 
entity.''
    While you are reading, I will just briefly say: Under my 
definition an entity which is not incorporated in the United 
States, does not have as its principal place of business the 
United States, does not provide a benefit to the United States 
economy, and the United Nations or any of its divisions.
    It further clarifies, as it does in paragraph 9 there, that 
which is considered to be the United States. Now there has been 
a lot of discussion on this.
    I think that the Barton amendment that I have supported is 
strengthened and it clarifies what in fact a non-United States-
based entity is.
    I would ask that the Committee, in lieu of this, support 
the amendment. I believe it makes sense, and it at least sets 
the legislative history that could at some point become 
important in the analysis of any of the fine line of the Barton 
amendment or any other aspect of the bill, alluding to such 
non-United States-based entity.
    The Chairman. Would the gentleman----
    Mr. Traficant. I yield to the Chairman.
    The Chairman. I thank the gentleman for his explanation.
    Has the gentleman, since this does modify Mr. Barton's 
amendment, has the gentleman checked with Mr. Barton?
    Mr. Traficant. I have not been able to talk with Mr. Barton 
on that, but I do not see, after looking at Mr. Barton's, why 
there should be a tremendous rush to oppose this amendment.
    I believe, if anything, the Barton amendment leaves open 
certain areas that could be questioned and perhaps reduce the 
effectiveness of the language that has been passed.
    The Chairman. Well the gentleman makes a point, and there 
was in fact no definition in the Barton amendment.
    As I explained to the gentleman earlier, I am not certain 
that I am wise enough off the cuff to be able to draft 
something that defines a ``non-United States-based entity'' in 
a way that meets all the various tests that the gentleman and 
Mr. Barton might have in mind, or that the lawyers might find 
as being acceptable.
    What I would prefer to do, I would say to the gentleman, I 
think he has pointed out something that should be done. I would 
prefer to handle this in the report, as well. I think it would 
make more sense to define what we mean as a part of the report 
language.
    If that is not satisfactory to the gentleman as we define 
it in the report, and if the report language is something that 
he wants to enter into the bill, then it seems to me that on 
the floor we might be able to take an amendment at that point, 
if that is still needed.
    But at this point, I would be reluctant to adopt language 
that I am not certain that I know the full implications of, and 
I am not certain that we have had enough legal advice from both 
outside and inside this institution to know whether or not this 
is an appropriate definition for a non-United States-based 
entity.
    Mr. Traficant. In furtherance of my time, what would be the 
legal status of that report language and its impact on the 
Barton amendment and any other language in the bill?
    The Chairman. Well, I would say to the gentleman that 
report language is in fact definitional of the things which are 
done by the Committee.
    So insofar as the gentleman is concerned that we have not 
appropriately defined language in the bill, we can do that as a 
part of the report language.
    My point to the gentleman is, if at the point we go to the 
Floor the gentleman does not think that that is strong enough, 
I would certainly support his right to offer an amendment on 
the Floor that takes the report language and puts it into the 
bill.
    But I am just reluctant to say that I know that what has 
been drafted here is in fact the appropriate description of a 
``non-United States-based entity'' at the present time.
    Mr. Traficant. With that, Mr. Chairman, I would like to ask 
a question of counsel, then.
    Would the Barton amendment, as it stands, what would be the 
status of some shell structure under an umbrella of the United 
Nations that could in fact operate within the scope of that 
amendment that is located in the United States?
    The Chairman. Counsel is recognized.
    Mr. Beringer It is my understanding, Mr. Traficant, that 
the United Nations entities within the United States 
territorially are not really part of the United States. But 
this just points out the difficulty of this is an off-the-cuff 
opinion, and this just points out the difficulty of trying to 
do this right at the moment.
    Mr. Traficant. I am not going to belabor this, but they are 
an entity that operates in this country and there is the 
potential for abuse and a shell game could come about, which is 
a concern that everybody has with that amendment.
    So without belaboring it any longer, I want to yield to my 
chairman here, Chairman Hall.
    Mr. Hall. I thank the gentleman for yielding.
    I have of course looked at this, and the language appears 
enforceable and seems to enhance the bill, and I think it is 
supportive of the Barton amendment.
    Actually, as Chairman Walker has suggested, also I think 
the gentleman from Ohio has the best of all worlds because we 
do have the word means an entity, and that's what report 
language is for, and shows what it does provide and what it 
does not provide, and it might be enlarged with report 
language.
    But I think it enhances the bill. As a co-author of the 
bill, I intend to vote for it, if a vote is called.
    Mr. Schiff. Mr. Chairman?
    The Chairman. Who is seeking recognition? Mr. Schiff.
    Mr. Schiff. Mr. Chairman, I sympathize with where the 
gentleman from Ohio is trying to go, but as I read this I am 
not entirely clear whether a non-United States entity under 
this language means an entity in which all three of these 
things exist.
    In other words, an entity which is not incorporated in the 
United States; does not have its principal place of business; 
and does not provide a benefit to the United States' economy.
    According to this, if one of the provisions does not exist, 
would this be a United States entity or not?
    In other words, suppose that a business were incorporated 
in another country. Its principal place of business were in 
another country. But it provides a benefit to the United States 
economy such as having a branch in the United States that 
employs Americans.
    Would that be a United States entity, or would that not be 
a United States' entity.
    I would offer to yield to the gentleman from Ohio.
    Mr. Traficant. Yes. It would not be U.S.-based. They would 
not be based in America, even though it provides a benefit that 
accrues to our economy.
    Mr. Schiff. So the gentleman is saying that is or is not a 
United States' entity in the example I gave?
    Mr. Traficant. If it is not based in here, no.
    Mr. Schiff. What if it has a factory in the United States?
    Mr. Traficant. Then if that factory is incorporated as a 
subsidiary and it meets the other requirements, it would be 
considered as a United States' entity.
    Mr. Schiff. Well, in other words----
    Mr. Traficant. Let me further say this. I am not going to 
belabor this tonight--and I want to say this to the Chair--
before I offer a unanimous consent to withdraw, I want to work 
with the leaders on both sides. I believe it is imperative and 
important that this entity, non-U.S.-based entity, be defined.
    I would be willing to accept the judgment and work out 
language, and if necessary offer that on the Floor, or for 
whatever other remedy can be obtained.
    Rather than going into it at this hour, I ask unanimous 
consent that my amendment be withdrawn and be given 
consideration for the conference.
    The Chairman. Without objection.
    Let me say to the gentleman that he has my assurance that 
we will work with him.
    As I said, either we can do report language on this that 
does provide the definition--he has raised a legitimate point. 
I hope I made that clear. I think it is a legitimate issue.
    Since this is not--I checked with counsel earlier to find 
out whether or not there was a definition of such entities in 
the U.S. Code.
    I am told that there is not.
    So, therefore, we probably do need to do a definition here.
    The gentleman has been most helpful in withdrawing so that 
we can be sure that the definition that we work out is the 
right definition.
    I assure him we will work with him to see to it that we 
come up with that right definition.
    All right, are there further amendments to Subtitle A?
    [No response.)
    The Chairman. Hearing none, I will close out Subtitle A and 
we will go to Subtitle B.
    Are there amendments to Subtitle B?
    The gentleman from Virginia, Mr. Davis.
    Mr. Davis. I have Amendment No. 20 that is in front of 
everyone.
    It is fairly lengthy. I will try to explain it briefly.
    Simultaneous Voices. Aye. [Laughter.]
    Mr. Davis. This applies to major rules to protect human 
health, safety, environment. The amendment forces the 
considering agency to identify reasonable alternatives which 
would achieve the identified benefits of the proposed rule.
    It offers alternatives that take into account, alternatives 
that may require no Government action that would look at 
geographic differences, that would employ performance or 
market-based standards, and provide flexibility to achieve 
identified benefits, an assessment of the aggregate effects on 
small business, and a cost benefit analysis based on the net 
benefits to society.
    I think the key is that the amendment expands on the 
alternatives identified in the base text. I think it's very 
pro-small business, recognizes many times we're getting $50 
solutions to five dollar problems.
    And I hope the Committee will approve it.
    The Chairman. The gentleman does elaborate on the types of 
alternatives that should be considered during rulemaking. I see 
no problem with the items that he adds to those alternatives, 
and the Chair is prepared to accept the amendment.
    If there further discussion on the amendment?
    Mr. Olver. Mr. Chairman.
    The Chairman. The gentleman from Massachusetts.
    Mr. Olver. Just for clarification, are we talking about 
Amendment 20?
    The Chairman. Amendment 20.
    Mr. Olver. The regular order?
    The Chairman. The gentleman's correct.
    If there's no further discussion, the Chair will put the 
question on the amendment.
    Those in favor will say aye.
    [Chorus of ayes.]
    The Chairman. those opposed, no?
    [No response.]
    The Chairman. The ayes have it. The amendment's agreed to.
    The next amendment in the package is an amendment by Mr. 
Wamp.
    Mr. Wamp. Thank you, Mr. Chairman.
    Actually, it's 3201(a)(3) and not 3201(a)(4) I think, as it 
says on the chart, which would pick the language up there at 
the end of the period (.), and say ``including, to the maximum 
extent practicable, a quantitative assessment of the cumulative 
financial burden that persons producing products that are 
regulated by the rule will bear in order to comply with the 
rule and with related existing standards that affect the 
product or other similar products produced by such persons.''
    It should be in your packet.
    Mr. Chairman, regulatory reform should require departments 
and agencies to meaningfully quantify, in a rulemaking, the 
cumulative burden on manufacturers or other affected parties, 
of multiple regulations by the same agency on different 
products or subjects affecting the same manufacturer or party.
    Further, departments and agencies should meaningfully 
quantify in a rulemaking the cumulative burden on manufacturers 
or other affected parties of related regulations by different 
agencies on the same product or subject.
    Let me give you an example.
    Full line appliance manufacturers are subject to Department 
of Energy energy efficiency standards for up to seven 
individual product standards. DOE undertakes no consideration 
of the cumulative financial or technical resource burden of 
continuously redesigning seven major products.
    At the same time, under the Clean Air Act, EPA is 
regulating industry's use of vital chemicals for refrigerator 
and room air conditioners which are critical to meeting the DOE 
standards, yet neither EPA nor DOE coordinate with one another 
or fully take into account the problems of meeting separate 
standards at the same time.
    EPA and DOE standards are often technically at cross 
purposes, which only serves to add to the burden of compliance.
    Currently, Mr. Chairman, full line manufacturers are each 
investing hundreds of millions of dollars in new equipment and 
designs to meet energy standards for six major product 
categories, and this drain on corporate research and 
development funds and human resources impedes product 
innovation and is exacerbated by Clean Air Act requirements 
relating to ozone depleting substances and other Federal 
requirements.
    And I move for approval.
    The Chairman. The Chair's examined the gentleman's 
amendment. What the amendment does is tries to shed light on 
whether or not the impact reaches the $25 million threshold. I 
think it's an excellent amendment. It strengthens the bill, and 
I'm prepared to accept the amendment.
    Is there further discussion on the amendment?
    [No response.]
    The Chairman. If not, the Chair will put the question.
    Those in favor of the amendment will say aye.
    [Chorus of ayes.]
    The Chairman. Those opposed will say no.
    [Chorus of nays.]
    The Chairman. The ayes appear to have it. The amendment is 
agreed to.
    Any other amendments to Subsection B?
    Mr. Davis. Mr. Chairman? I'm not going to offer number 23 
because I think that your substitute basically takes care of 
those concerns, but I would note on page 20 of your substitute 
on line 22, just in reading it, if members would want to turn 
to that, line 22 on page 20, you have ``or the environment 
unless the requirements of section 3201(a) are met . . .''
    Trying to move this back to what I had in amendment number 
22, wouldn't you want to say 3201(a) and (b).
    I might just offer that as a technical change for the staff 
to consider to just make it comply. I would think that might 
have been the intent of that.
    The Chairman. Well, let me say to the gentleman, we'll 
examine that and make certain. I don't want to talk off the 
cuff.
    Mr. Davis. And that's fine.
    The Chairman. Let me check with counsel.
    Mr. Davis. That's fine. I throw that out just for 
everybody's consideration.
    Mr. Beringer. I believe that's correct, but we will check 
that out further.
    The Chairman. Yes, we'll check that out as a technical 
change.
    Mr. Davis. I have nothing else to offer.
    The Chairman. Okay. Any other amendments in Subtitle B?
    [No response.]
    The Chairman. If there are no further amendments----
    Ms. Jackson-Lee. I have.
    The Chairman. Ms. Jackson-Lee?
    Ms. Jackson-Lee. Yes, Mr. Chairman. I have an amendment at 
the desk, I believe.
    [Pause.]
    The Chairman. The gentlelady is recognized. I apologize to 
her.
    Ms. Jackson-Lee. That's all right, Mr. Chairman. Thank you 
very much.
    We had this discussion earlier when I inquired of counsel 
the further refinement or my thought on seeing the need for 
further refinement of the definition of the words ``major 
rule.''
    And in inquiring to counsel, I think we established that a 
further refinement certainly might be welcomed. I would hope 
the Chairman would welcome this further refinement as it 
relates to life-threatening situations.
    Many Federal regulatory reviews reveal high risk situations 
in the midst of a risk assessment or other regulatory 
proceeding.
    In recent years, for example, many regulatory reviews have 
been made of chemicals, drugs and other regulated products that 
were grandfathered in as more rigorous regulatory standards 
have been passed.
    When regulatory agencies have undertaken reviews to update 
their toxic and other effects data as a part of a full risk 
assessment, they have discovered previously unknown risks of a 
very significant nature.
    This has frequently triggered the need for an agency to 
take immediate action on a chemical or drug in advance of a 
complete risk assessment.
    We need to continue, I believe, giving agencies this 
flexibility. This is complementary. This is a clarifying which 
in life threatening situations. For example, the situation with 
ethylene dibromide, EDB, which was suspended in the mid-1980s, 
I think clearly because it seemed to cause cancer in a major 
way, that this and the effort and direction that we're trying 
to go, complements and provides leeway for life-threatening 
situations.
    This does not, I think, get answered in the provision 
dealing with emergencies. This is directly what I'm speaking 
of, life-threatening situations.
    I mentioned earlier the issue of lead paint as it impacts 
children, and there are a variety of other situations, 
pesticides, particularly under review by EPA, which would 
warrant the further explanation that an agency could take 
immediate action in life-threatening situations.
    And I would ask for support of this refinement of ``major 
rule.''
    The Chairman. I thank the gentlelady for her explanation.
    I would point out to the gentlelady and to the members of 
the Committee that at the beginning of Subtitle A, the 
emergency provisions of the rest of the bill do apply. And so 
we do in fact have the emergency section of the bill that would 
be applicable to the major rulemaking.
    The emergency situation, in my opinion, is something where 
there is a longstanding belief that it would certainly include 
life-threatening situations.
    However, because the gentlelady has raised the point, it 
seems to me that this is something that we could cover in 
report language to make absolutely certain that it's clear that 
emergency, for the purpose of the bill, does include any kind 
of life-threatening situation.
    I think to put an exception in the part of the bill where 
she is intending to do so does in fact complicate our ability 
to deal with the bill in a responsible way.
    We have exceptions in the other sections of the bill. So I 
would simply say that I agree with the gentlelady that she has 
made an important contribution. It is covered under the 
emergencies, but we want to clarify that.
    And I am prepared to clarify that, using her terminology in 
terms of life-threatening situations in report language.
    Ms. Jackson-Lee. Mr. Chairman, we probably would disagree 
somewhat in terms of the necessity or validity of having an 
exception.
    I'm willing to work with the Chairman in terms of having 
that language specifically clarified with the language 
emergency.
    I would argue somewhat differently that the emergency does 
not necessarily go to the highest level of life-threatening, 
speaking clearly as it relates to human impact.
    But I would welcome that clarification and ask that I be 
allowed to work with staff and the Chair to make that 
clarification in the report.
    The Chairman. We will certainly clear any language that we 
would put into the report language with the gentlelady to make 
certain that it fits with her intent.
    Yet, I'm hoping that we can make clear that if in fact she 
has some concerns that emergency does not properly cover the 
kind of life-threatening situations that she is referring to, 
that we make it clear that for the purposes of this bill, it's 
going to.
    Ms. Jackson-Lee. All right, thank you.
    I will then ask unanimous consent, Mr. Chairman, to 
withdraw this amendment at this time.
    The Chairman. I thank the gentlelady.
    Any other amendments to Subtitle B?
    Mr. Doggett. Mr. Chairman, I had another amendment but it 
may well be, rather than lay it out, that a quick question to 
counsel can resolve it, and it could be handled with report 
language.
    That was with regard to Subsection (f)(1) that refers to 
``not withstanding any other provision of law.''
    Would it be possible for you to simply identify, either 
here or in the report, which public laws you anticipate 
supplementing or superseding by this legislation?
    [Pause.]
    The Chairman. The Chair recognizes counsel.
    Mr. Beringer. I think it would be a difficult task to do it 
with exactness in a short amount of time.
    Mr. Doggett. Do you know which ones you're superseding? Do 
you know any of them?
    Mr. Beringer. Yes, we do. We have an illustrative chart 
which----
    Mr. Doggett. Could you perhaps just attach that as an 
illustrative chart that is not an exclusive list but an example 
of what you're superseding?
    Mr. Beringer. Yes, we could, sir.
    Mr. Doggett. I think that'd be fine.
    Mr. Beringer. OK, thank you.
    The Chairman. I thank the gentleman.
    Mr. Olver. Mr. Chairman.
    The Chairman. Who seeks recognition?
    Mr. Olver.
    Mr. Olver. Mr. Chairman, I would like to explore the same 
area just a little bit further. I would like to know if counsel 
can tell me what is the intent of that?
    Does that have to do with the future or does that have to 
do with going back into law which we, as members of Congress, 
may have passed in the past where there were not risk 
assessments as are defined under this Act, and carefully laid 
forward as to procedures and definitions and such?
    Would this mean that if we, as a Congress, had passed 
legislation, the Clear Air Act, for instance, and defined what 
had to be done without really doing or ordering risk assessment 
as defined by this Act, would that mean that now all those 
things that hadn't been done and in keeping consistent could 
not be continued, or is this meant to be prospective for the 
possibility that Congress would again pass legislation without 
reflecting in the legislation the risk assessment procedures 
herein, and which we've done from time to time, as the Chairman 
knows?
    What is the intent here?
    And I think it goes really not just to (f)(1) but also 
(f)(2), but (f)(1) is a little bit, one can at least, that's a 
little bit more limited in its language and, therefore, I think 
easier to try to understand here under the circumstances.
    The Chairman. Counsel.
    Mr. Beringer. This is meant to be prospective in nature, 
Mr. Olver.
    Mr. Olver. Is there anything in the language that, I mean, 
we have done things which related to the NRC and transportation 
or storage of wastes and management of dangerous materials of 
other sorts, and the Clean Air, Clean Water, things of that 
sort.
    Mr. Beringer. This is meant to be prospective in nature, 
Mr. Olver.
    Mr. Olver. Is there anything in the language that, I mean, 
we have done things which related to the NRC and transportation 
or storage of wastes and management of dangerous materials of 
other sorts, and the Clean Air, Clean Water, things of that 
sort.
    What is there here to assure us that this does not affect 
retrospectively laws that have already been passed?
    Mr. Beringer. Well, in general, the applicability of the 
effective date of the legislation is 18 months from the date of 
enactment.
    Now what this applies to prospectively is new rules under 
old acts. So it, for instance, it would say that if you did a 
new assessment under the Clean Air Act, then in the 
applicability section in (f)(1), it would be supplemental.
    Or in other cases where they are specifically required to 
do risk assessments, it should be supplemental.
    But to the extent that there is no conflict, it would 
supersede decisional criteria for rulemaking, but again that's 
prospective rules, that's not the rules that are currently on 
the books.
    Mr. Olver. So then all rules that are currently on the 
books--how would I see that in the language that is here? How 
would I, as a lay person, non-lawyer, in essence see that in 
this language of the proposed law to know that the rules 
presently promulgated are not affected by this, but yet that 
those that might be promulgated in the future under the same 
laws that are in effect would be affected under this?
    How would I see that?
    Mr. Beringer. The only thing that I could reply on that is 
the effective date of the Act, sir.
    Ms. Morella. Mr. Chairman?
    The Chairman. The gentlelady from Maryland.
    Ms. Morella. Thank you, Mr. Chairman.
    On that point, reflecting on the response that Mr. Olver 
got, if in fact it would be applicable to new rules of old 
laws, and because of the fact that you have many facets of the 
Clean Air Act, the Safe Drinking Water Act that have not yet 
been promulgated, then this would apply.
    Is that correct, this would apply to those new rules to 
laws in existence?
    Mr. Beringer. Yes, that is correct.
    Legislative counsel, however, also has pointed out to me 
that unless otherwise stated, that all laws are prospective in 
nature rather than retrospective. So--but your interpretation 
is correct, Ms. Morella.
    Ms. Morella. Because there are a lot of rules that have not 
yet been promulgated?
    Mr. Beringer. That is correct.
    Mr. Olver. Would the gentlelady yield? Do you yield on that 
point?
    So if I'm understanding what now is clarified, it's often 
easier to clarify when questions to another member are being 
answered, rather than directly here.
    That if there are rules yet to be promulgated under law 
already passed, where we, as Congress, have set standards, 
which may or may not, which didn't have risk assessment as 
promulgated in this, that this Act would supersede the act of 
Congress at prior times and in setting those standards?
    Mr. Beringer. Yes, sir.
    Mr. Olver. Yes. The answer to that is yes? Oh, my.
    The Chairman. Well, the Chair would simply state that what 
we are assuring here is that any new rules promulgated even 
under old Acts would in fact require good science to be 
utilized.
    I know that that disturbs some people but it is in fact 
something that we think that, even under old law, that if 
you're promulgating new rules under old law, that the best 
science ought to be used as a part of that process.
    Ms. Morella. Thank you.
    On that same point, actually, I guess a concern I have is 
not so much that they would be reviewed, but the cost benefit 
test, would that apply?
    That's quite different.
    Mr. Beringer. Yes, ma'am.
    Ms. Morella. It would. Thank you.
    The Chairman. If there are no further--are there further 
amendments to Subtitle B?
    [No response.]
    The Chairman. If not, I'm closing Sub--does the gentleman 
have an amendment?
    Mr. Luther. Mr. Chairman, if I could just ask a follow-up 
question on that point that relates to subpart B.
    The Chairman. Well, the Chair will allow the question to go 
on. The Chair's been very lenient with regard to time and, you 
know, has not imposed the five-minute rule here, but if we're 
going to continue to explore this, the Chair will begin to 
suggest that the Rules of the House in regard to the five-
minute rule should apply to these matters. But I do recognize 
the gentleman.
    Mr. Luther. Excuse me. I will be brief, Mr. Chairman.
    I wonder if counsel could indicate on the record why, when 
we're talking about the risk assessment, we talk about these 
requirements being supplemental, and yet when we get into the 
cost benefit part of the bill, we talk about them not just 
being supplemental but also superseding.
    If you could just explain why there is that difference in 
the two parts?
    Mr. Beringer. It is the intention of the drafters that on 
risk assessment, that there are currently requirements in the 
law to do risk assessment. There are not many requirements in 
the law to do cost benefit analysis, and it is somewhat of a 
departure.
    So therefore it is making explicit that this is a new law.
    Mr. Luther. Mr. Chairman, then I think, if I could just 
follow up on Mr. Doggett's request, I think in those instances 
where there potentially could be a requirement that's 
supersede, I think if we could have a specific list attached or 
whatever, I think that would be extremely helpful.
    Mr. Beringer. We will clarify that to the best of our 
ability, sir.
    Mr. Olver. Mr. Chairman, I have an amendment.
    The Chairman. Mr. Olver, is it in writing?
    Mr. Olver. It is in writing. It is under a different name, 
but it is to strike paragraph (f)(1) of the Section 3201 and 
renumber the remaining paragraphs appropriately. It is at the 
desk.
    But I think after the discussion that we've had, I think it 
need not be distributed.
    I must say, I am----
    The Chairman. The gentleman's recognized for five minutes.
    Mr. Olver [continuing]. Mr. Chairman, I do not mind the 
application of this Act to future Acts as a decision that we 
make as a Congress.
    What I think has come out from the discussion back and 
forth here by myself and the gentlewoman from New Jersey--
Maryland, excuse me, sorry about that--that this in fact, where 
Congress itself may have set standards, and I'm a believer in 
the best science being used in these risk assessments and 
everything, a complete believer in proper use of risk 
assessments in this process, that where we have specifically 
made a determination of what standards should be, that this 
language precludes decisions by the Congress, direct decisions 
by the Congress.
    I would hope that in the future, we would not set standards 
and allow risk assessment, proper risk assessment to take 
proper science in that process to take over in deciding what 
should be the standards in the rule.
    But we have done things in the past which set specific 
standards and which have gone forward in all parts of the 
country to a degree, and now to supersede those, at this point, 
I think would be incorrect.
    And the unfortunate thing is, I don't know how, right at 
this time, to write the language which I would prefer to do, to 
make this prospective rather than retrospective on legislation 
which has already passed the Congress.
    So, I'm offering instead the striking of the paragraph.
    The Chairman. I thank the gentleman for his explanation.
    This of course goes to the core of what we're attempting to 
achieve in this bill.
    The fact is that the old structure has gone bad. That the 
regulatory climate that has been created under old laws has in 
fact created a terrible burden on businesses, on communities, 
and on a variety of phases of our economic life.
    It is that correction that we are attempting to make here. 
We are not attempting to go back and reach back to laws that 
are presently in place and presently providing regulations.
    However, as we proceed ahead with new rulemaking, even 
under old laws, we are attempting to assure that the best 
available information be utilized in that process.
    To strike this section would in fact prevent us from 
getting rid of some of the bad practices that have crept into 
the system.
    Again, the Chair is aware that there are some who believe 
that the regulatory climate that we have created has in fact 
been a positive for the country. In some instances it has been 
and in some instances it needs correction.
    This is the bill that is attempting to do the correction, 
and we are hoping with this bill that we can make the proper 
judgments.
    That means that some of the old standards set by Congress 
are in fact things that need to be changed in a positive way. 
And we are attempting to do that in this bill.
    To strike this section will prevent that kind of positive 
rulemaking from going forward.
    Is there further discussion?
    Mr. Olver. Mr. Chairman, in answer to the Chairman's 
comments, I believe I heard the Chairman say, in what you have 
just said, that you're not attempting to supersede what is 
already in law, but that seems to me to contradict what the 
counsel had said earlier, that in fact it did supersede.
    The Chairman. There's no contradiction. There's no 
contradiction, I would say to the gentleman. Present law, as 
the regulations are laid down, is not affected by paragraph (f) 
in any way.
    However, new rulemaking under the old law would in fact be 
affected.
    And so all we're dealing with here is new rulemaking under 
previously passed law. If there are, in fact, rules to be 
promulgated under certain laws that are not on the books that 
are not now there, they would in fact be affected by this law.
    Rules that are presently there would not be affected.
    And so, you know, that's the only point that the gentleman 
is making.
    Mr. Olver. But that does involve superseding direct action 
by the Congress in setting standards for those laws.
    The Chairman. It does mean that the 104th Congress is 
reviewing some of the Acts of previous Congresses and deciding 
that there may be in fact some things that were done in 
previous Congresses that we now want to change a little.
    Ms. Lofgren. Could I ask, I don't want to belabor this any 
more, but could I ask just one quick question to make sure I 
understand this?
    If we now have controlled substances that are primarily 
narcotics, but additional illegal drugs can be added as they 
are designed, so that if a new psychedelic drug is cooked up in 
a lab in Berkeley, that would be subject to (f), whereas heroin 
would not be?
    Is that right?
    [Pause.]
    Ms. Lofgren. That's to counsel.
    Mr. Beringer. I believe that that would fall under the 
emergency exemption.
    [Pause.]
    The Chairman. Is there further discussion on the amendment 
by the gentleman from Massachusetts?
    [No response.]
    Mr. Olver. Mr. Chairman, I move the previous question.
    The Chairman. The gentleman moves the previous question on 
his amendment.
    The Chair will put the question.
    All those in favor of the gentleman's amendment will say 
aye.
    [Chorus of ayes.]
    The Chairman. Those opposed will say nay.
    [Chorus of nays.]
    The Chairman. In the opinion of the Chair, the nays have 
it.
    Mr. Olver. Mr. Chairman, I would like a roll call vote on 
the question.
    The Chairman. The gentleman requests a roll call vote.
    The Clerk will call the roll.
    The Clerk. Mr. Walker?
    The Chairman. No.
    The Clerk. Mr. Walker votes no.
    Mr Brown?
    [No response.]
    The Clerk. Mr. Sensenbrenner?
    Mr. Sensenbrenner. No.
    The Clerk. Mr. Sensenbrenner votes no.
    Mr. Hall?
    Mr. Hall. No.
    The Clerk. Mr. Hall votes no.
    Mr. Boehlert?
    [No response.]
    The Clerk. Mr. Traficant?
    Mr. Traficant. No.
    The Clerk. Mr. Traficant votes no.
    Mr. Fawell?
    Mr. Fawell. No.
    The Clerk. Mr. Fawell votes no.
    Mr. Hayes?
    [No response.]
    The Clerk. Mrs. Morella?
    Mrs. Morella. Aye.
    The Clerk. Mrs. Morella votes aye.
    Mr. Tanner?
    [No response.]
    The Clerk. Mr. Weldon of Pennsylvania?
    Mr. Curt Weldon. No.
    The Clerk. Mr. Weldon votes no.
    Mr. Geren?
    Mr. Geren. No.
    The Clerk. Mr. Geren votes no.
    Mr. Rohrabacher?
    Mr. Rohrabacher. No.
    The Clerk. Mr. Rohrabacher votes no.
    Mr. Roemer?
    Mr. Roemer. No.
    The Clerk. Mr. Roemer votes no.
    Mr. Schiff?
    Mr. Schiff. No.
    The Clerk. Mr. Schiff votes no.
    Mr. Cramer?
    [No response.]
    The Clerk. Mr. Barton?
    [No response.]
    The Clerk. Mr. Barcia?
    Mr. Barcia. Aye.
    The Clerk.  Mr. Barcia votes aye.
    Mr. Calvert?
    Mr. Calvert. No.
    The Clerk. Mr. Calvert votes no.
    Mr. McHale?
    Mr. McHale. Aye.
    The Chairman. Mr. McHale votes aye.
    Mr. Baker?
    Mr. Baker. No.
    The Clerk. Mr. Baker votes no.
    Ms. Harman?
    [No response.]
    The Clerk. Mr. Bartlett?
    Mr. Bartlett. No.
    The Clerk. Mr. Bartlett votes no.
    Ms. Johnson?
    Ms. Johnson. Aye.
    The Clerk. Ms. Johnson votes aye.
    Mr. Ehlers?
    Mr. Ehlers. No.
    The Clerk. Mr. Ehlers votes no.
    Mr. Minge?
    Mr. Minge. No.
    The Clerk. Mr. Minge votes no.
    Mr. Wamp?
    Mr. Wamp. No.
    The Clerk. Mr. Wamp votes no.
    Mr. Olver?
    Mr. Olver. Yes.
    The Clerk. Mr. Olver votes yes.
    Mr. Weldon of Florida?
    Mr. Dave Weldon. No.
    The Clerk. Mr. Weldon votes no.
    Mr. Hastings?
    [No response.]
    The Clerk. Mr. Graham?
    Mr. Graham. No.
    The Clerk. Mr. Graham votes no.
    Ms. Rivers?
    Ms. Rivers. Aye.
    The Clerk. Ms. Rivers votes aye.
    Mr. Salmon?
    Mr. Salmon. No.
    The Clerk. Mr. Salmon votes no.
    Ms. McCarthy?
    [No response.]
    The Clerk. Mr. Davis?
    Mr. Davis. No.
    The Clerk. Mr. Davis votes no.
    Mr. Ward?
    Mr. Ward. Yes.
    The Clerk. Mr. Ward votes aye.
    Mr. Stockman?
    Mr. Stockman. No.
    The Clerk. Mr. Stockman votes no.
    Ms. Lofgren?
    Ms. Lofgren. Aye.
    The Clerk. Ms. Lofgren votes aye.
    Mr. Gutknecht?
    Mr. Gutknecht. No.
    The Clerk. Mr. Gutknecht votes no.
    Mr. Doggett?
    Mr. Doggett. Aye.
    The Clerk. Mr. Doggett votes aye.
    Mrs. Seastrand?
    Mrs. Seastrand. No.
    The Clerk. Mrs. Seastrand votes no.
    Mr. Doyle?
    Mr. Doyle. No.
    The Clerk. Mr. Doyle votes no.
    Mr. Tiahrt?
    Mr. Tiahrt. No.
    The Clerk. Mr. Tiahrt votes no.
    Ms. Jackson-Lee?
    Ms. Jackson-Lee. Aye.
    The Clerk. Ms. Jackson-Lee votes aye.
    Mr. Largent?
    Mr. Largent. No.
    The Clerk. Mr. Largent votes no.
    Mr. Luther?
    Mr. Luther. Aye.
    The Clerk. Mr. Luther votes aye.
    Mr. Hilleary?
    Mr. Hilleary. No.
    The Clerk. Mr. Hilleary votes no.
    Mrs. Cubin?
    Mrs. Cubin. No.
    The Clerk. Mrs. Cubin votes no.
    Mr. Foley?
    Mr. Foley. No.
    The Clerk. Mr. Foley votes no.
    Mrs. Myrick?
    Mrs. Myrick. No.
    The Clerk. Mrs. Myrick votes no.
    Mr. Barton. Mr. Chairman?
    The Chairman. Mr. Barton?
    Mr. Barton. How am I recorded.
    The Chairman. How's Mr. Barton recorded?
    The Clerk. Mr. Barton is not recorded.
    Mr. Barton. I would like to be recorded as no in person.
    The Clerk. Mr. Barton votes no.
    The Chairman. That's the only way you can be recorded these 
days.
    Mr. Barton. That's true.
    The Chairman. The gentleman from New York.
    Mr. Boehlert. How am I recorded?
    The Clerk. Mr. Boehlert is not recorded.
    Mr. Boehlert. Aye.
    The Chairman. Mr. Boehlert votes aye.
    The Clerk will report.
    The Clerk. Mr. Chairman, I count 12 yeas and 31 nays.
    The Chairman. The amendment is not agreed to.
    Any other amendments to Section B?
    Mr. Ward wanted to be recognized to explain----
    Mr. Ward. I just would ask unanimous consent that I be not 
recorded but show, reflect that I was not here for the vote on 
Mr. Brown's amendment for Section 3002, the savings clause. Had 
I been here, I would have voted yes, and I would like the 
record to reflect that.
    The Charman. The record will reflect it. We thank the 
gentleman.
    Are there further amendments to Subsection B, Subtitle B?
    Mr. Hall. Mr. Chairman?
    The Chairman. The gentleman from Texas.
    Mr. Hall. Mrs. Harman had an amendment to Subtitle D and it 
involved the National Aeronautics and Space Administration, and 
I will not offer it but I would----
    The Chairman. That's the new Title D, I would say.
    Mr. Hall. Yes, it's to add a title.
    The Chairman. Yes, it's to add a title.
    Mr. Hall. But we're not requesting that. I just want to be 
assured that we can put something in the report language to 
show whether or not this applies to NASA and the space program.
    The Chairman. Okay. We're not there yet, but I can assure 
the gentleman that we can put in report language the situation 
as it applies to NASA.
    Mr. Hall. I thank the Chair.
    The Chairman. Any further amendments to Subtitle B?
    [No response.]
    The Chairman. If not, the Chair moves now to Subtitle C. 
Amendments to Subtitle C?
    Mr. Roemer. Mr. Chairman?
    The Chairman. Mr. Roemer?
    Mr. Roemer. Mr. Chairman, I have an amendment but before I, 
or as I'm asking the Clerk to distribute the amendment drafted 
to the Walker Amendment in the nature of a substitute, I would 
make a unanimous consent proposal that we begin to apply the 
five-minute rule.
    It's after 10:00 o'clock at night. You've been exceedingly 
fair in allowing members to talk at length for the last few 
hours.
    We've been here since 10:00 o'clock this morning, and I 
will live under the five-minute rule.
    The Chairman. I'm delighted to be able to accommodate that 
unanimous consent request.
    Is there objection?
    [No response.]
    The Chairman. Without objection, we will apply the five 
minute rule.
    Mr. Roemer. Mr. Chairman, first of all, my amendment deals 
with peer review, which is a very important section, especially 
to people such as myself that support this bill.
    And I would like to compliment you on what you've done to 
strengthen the peer review process. It begins on page 22 and 
goes through page 25.
    In particular, I'm supportive of your response to peer 
review, your availability to the public where you insist that 
all peer review comments or conclusions and the agencies' 
responses shall be made available to the public in addition to 
Section (f) on line 19 on page 24, 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.
    I think these are all helpful in putting together a strong 
peer review process.
    My amendment would do three things to further strengthen 
this provision.
    One, it would make sure that peer review is used in a very 
focused and targeted manner, and not one where we waste 
taxpayers' resources, or scientists' resources, so that the 
trigger is at a level whereby we're not going after superfluous 
things.
    Secondly, that when we put these peer review panels 
together, that the participants be professionally qualified and 
that the scientists not have any conflict of interest that 
would bias their outcome.
    Thirdly, that we establish a time line with deadlines in 
this process so that they cannot use dilatory tactics to delay 
this process from happening. That we don't have unnecessary 
bureaucratic delay.
    That is what my amendment accomplishes, Mr. Chairman, I 
would encourage my colleagues to support it.
    All done under five minutes, Mr. Chairman.
    The Chairman. I thank the gentleman for doing that.
    The Chair is having some problem because this is a 
different language than what the gentleman had submitted 
earlier as part of the package. And it appears now to be a 
total rewrite of the peer review process that's included in the 
bill.
    My concern about that is that what we had included in the 
bill was very much related to that which we heard in testimony 
with regard to peer review.
    In dealing with conflict of interest questions and so on, 
we heard questions raised by the Committee and then responded 
to by the witnesses, questioning, you know, who could 
participate in peer review, and got a fairly substantial record 
in the Committee that peer review should, in fact, include 
people who have some knowledge in the areas in which they're 
acting.
    And it is not clear to me that the gentleman's attempt here 
to change the language with regard to conflict of interest 
isn't in conflict with the testimony we received before the 
Committee.
    So I am concerned at this point in a Section that we 
thought we got pretty well in hand based upon what we heard in 
testimony is not being substantially rewritten without a clear 
reference to the record that was before the Committee.
    Mr. Roemer. Well, I would say to the Chairman's questions 
that what my amendment does, and I will read directly from the 
amendment:
    ``It shall result in the appointment of peer reviewers who 
are qualified on the basis of their professional training or 
expertise as reflected in the record of peer reviewed 
publications or equivalent.''
    I don't think that there's anything too controversial about 
a conflict of interest there.
    Secondly, it says, and I will read from the amendment:
    ``May provide specific and reasonable deadlines for peer 
review panels to submit reports under subsection'' so that they 
can't go at length.
    I don't think that those are controversial. And while I 
cannot site somebody specifically at hearings saying that we 
should put deadlines in for this process or that we should make 
sure that they don't have ethical conflicts, I would think that 
these would make sense.
    The Chairman. Well, I would say to the gentleman that in 
the bill already in the way it's written, we have the specific 
and reasonable deadlines for peer review panels. That's already 
in the bill.
    By limiting, in the way he does, who may be selected for 
peer review panels to only those people who have published, I 
would say that the qualifications for people to be engaged in 
peer review panels go well beyond that criteria, and 
traditionally have.
    And so the gentleman is, in what he has read to the 
Committee, providing a very, very severe limitation. And I'm 
not so certain that we are prepared, at this point, to accept a 
limitation that severe for who may be a part of a peer review 
panel.
    Mr. Roemer. Mr. Chairman, what about the language in the 
first paragraph of my amendment that says simply ``and the peer 
reviewers do not have a financial or other interest that will 
or may reasonably be expected to create a bias in favor of 
retaining an outcome that is consistent with such financial or 
other interests''?
    [Pause.]
    The Chairman. What we have in the bill as it's written is 
on page 22, ``shall not exclude peer reviewers with a 
substantial or relevant expertise merely because they represent 
entities that may have a potential interest in the outcome, 
providing the interest is fully disclosed to the agency, and in 
a case of regulatory decision affecting a single entity, no 
peer reviewer representing such agency may be included on the 
panel.''
    So we have in fact excluded people who would be directly 
involved, and required full disclosure for all others.
    Again, based upon the testimony that we received, that 
appeared to be the right way to assure that potential conflict 
of interests were dealt with.
    Mr. Roemer. Mr. Chairman, since you were so gracious to me 
in accepting my first two amendments, I would certainly like to 
work with you in terms of clarifying both the financial 
interest and the deadlines, and I will withdraw the amendment.
    The Chairman. Well, I thank the gentleman. We would 
certainly be glad to work with him to clarify in the report any 
questions that he might have with regard to the language we 
have here. If he doesn't feel that goes far enough, this would 
certainly be an amendment I think that could be taken to the 
floor at the appropriate time.
    Mr. Roemer. I thank the Chairman.
    The Chairman. I think the gentleman, and the gentleman, 
with unanimous consent, withdraws the amendment.
    Any other amendments in Subtitle C?
    Mr. Doggett. Yes. Mr. Chairman.
    I have an amendment dealing with the same subsection at the 
desk that I can explain as it's being distributed because it 
simply revises the subsection you were just reviewing with Mr. 
Roemer.
    I have the same concern that he expressed and slightly 
different language in doing it.
    But just to make it clear that there shall not be peer 
reviewers participating in these studies who have a potential 
interest in the outcome, rather than depending on them to 
recuse themselves, this would make it clear that peer reviewers 
are not to be participating. That it's not sufficient to simply 
have disclosure.
    [Pause.]
    The Chairman. Well, I thank the gentleman, and it's the 
discussion that we just had.
    Again, the testimony before the Committee indicated that to 
ensure that we have the best minds involved in reviewing the 
quality of risk assessments, we can't afford to ignore talented 
and qualified individuals, regardless of where they come from, 
so long as any perceived or real interest in the outcome is 
fully disclosed. And that is what we're attempting to do in our 
amendment.
    The gentleman would substantially narrow the numbers of 
people that could be brought into the process and in fact 
because of the broad nature of the language that he gives us, 
could assure that practically no one would be qualified to 
review anything that was actually in their field.
    And it seems to me that that reduces the quality of the 
peer review process in ways that would be harmful. At least 
again that follows the testimony that we had before the 
Committee in that regard.
    Mr. Doggett. Respecting the Chairman's view, I think it's 
important to have a strong conflict of interest provision in 
this statute and assure we don't have, as peer reviewers, 
people who have an axe to grind who are basically getting paid 
by the very folks who have a stake in what is occurring here, 
and that we don't have a situation of the peer reviewer being 
the fox guarding the henhouse.
    And so I'd move adoption of the amendment.
    The Chairman. Well, I thank the gentleman for his further 
explanation.
    As I say, I think we have to have some trust that Federal 
officials do in fact exercise good judgment in these regards in 
picking the peer review panels.
    And secondly, we in fact do, under our process, require 
full disclosure, and the gentleman obviously disagrees with the 
concept of full disclosure on that.
    The gentleman has moved his amendment.
    Those in favor of the amendment will say aye.
    [Chorus of ayes.]
    The Chairman. Those opposed will say no.
    [Chorus of nays.]
    The Chairman. In the opinion of the Chair, the noes have 
it.
    Mr. Roemer. Mr. Chairman, I would like a record vote on 
this because conflict of interest is an important provision.
    The Chairman. The Clerk will call the roll.
    The Clerk. Mr. Walker?
    The Chairman. No.
    The Clerk. Mr. Walker votes no.
    Mr. Brown?
    [No response.]
    The Clerk. Mr. Sensenbrenner?
    Mr. Sensenbrenner. No.
    The Clerk. Mr. Sensenbrenner votes no.
    Mr. Hall?
    Mr. Hall. Aye.
    The Clerk. Mr. Hall votes aye.
    Mr. Boehlert?
    Mr. Boehlert. No.
    The Clerk. Mr. Boehlert votes no.
    Mr. Traficant?
    Mr. Traficant. Aye.
    The Clerk. Mr. Traficant votes aye.
    Mr. Fawell?
    Mr. Fawell. No.
    The Clerk. Mr. Fawell votes no.
    Mr. Hayes?
    [No response.]
    The Clerk. Mrs. Morella?
    Ms. Morella. No.
    The Clerk. Mrs. Morella votes no.
    Mr. Tanner?
    [No response.]
    The Clerk. Mr. Weldon of Pennsylvania?
    Mr. Curt Weldon. No.
    The Clerk. Mr. Weldon votes no.
    Mr. Geren?
    Mr. Geren. Aye.
    The Clerk. Mr. Geren votes aye.
    Mr. Rohrabacher?
    Mr. Rohrabacher. No.
    The Clerk. Mr. Rohrabacher votes no.
    Mr. Roemer?
    [No response.]
    The Clerk. Mr. Schiff?
    Mr. Schiff. No.
    The Clerk. Mr. Schiff votes no.
    Mr. Cramer?
    Mr. Roemer. Mr. Chairman, how am I recorded?
    The Clerk. Mr. Roemer, you're not recorded.
    Mr. Roemer. Yes.
    The Clerk. Mr. Roemer votes yes.
    The Clerk. Mr. Cramer?
    [No response.]
    The Clerk. Mr. Barton?
    [No response.]
    The Clerk. Mr. Barcia?
    Mr. Barcia. Yes.
    The Clerk. Mr. Barcia votes aye.
    Mr. Calvert?
    Mr. Calvert. No.
    The Clerk. Mr. Calvert votes no.
    Mr. McHale?
    Mr. McHale. Aye.
    The Clerk. Mr. McHale votes aye.
    Mr. Baker?
    Mr. Baker. No.
    The Clerk. Mr. Baker votes no.
    Ms. Harman?
    [No response.]
    The Clerk. Mr. Bartlett?
    Mr. Bartlett. No.
    The Clerk. Mr. Bartlett votes no.
    Ms. Johnson?
    Ms. Johnson. Aye.
    The Clerk. Ms. Johnson votes aye.
    Mr. Ehlers?
    Mr. Ehlers. No.
    The Clerk. Mr. Ehlers votes no.
    Mr. Minge?
    Mr. Minge. Aye.
    The Clerk. Mr. Minge votes aye.
    Mr. Wamp?
    Mr. Wamp. No.
    The Clerk. Mr. Wamp votes no.
    Mr. Olver?
    Mr. Olver. Yes.
    The Clerk. Mr. Olver votes aye.
    Mr. Weldon of Florida?
    Mr. Dave Weldon. No.
    The Clerk. Mr. Weldon votes no.
    Mr. Hastings?
    [No response.]
    The Clerk. Mr. Graham?
    Mr. Graham. No.
    The Clerk. Mr. Graham votes no.
    Ms. Rivers?
    Ms. Rivers. Aye.
    The Clerk. Ms. Rivers votes aye.
    Mr. Salmon?
    Mr. Salmon. No.
    The Clerk. Mr. Salmon votes no.
    Ms. McCarthy?
    [No response.]
    The Clerk. Mr. Davis?
    Mr. Davis. No.
    The Clerk. Mr. Davis votes no.
    Mr. Ward?
    Mr. Ward. Aye.
    The Clerk. Mr. Ward votes aye.
    Mr. Stockman?
    Mr. Stockman. No.
    The Clerk. Mr. Stockman votes no.
    Ms. Lofgren?
    Ms. Lofgren. Aye.
    The Clerk. Ms. Lofgren votes aye.
    Mr. Gutknecht?
    Mr. Gutknecht. No.
    The Clerk. Mr. Gutknecht votes no.
    Mr. Doggett?
    [No response.]
    The Clerk. Mrs. Seastrand?
    Ms. Seastrand. No.
    The Clerk. Mrs. Seastrand votes no.
    Mr. Doyle?
    Mr. Doyle. Aye.
    The Clerk. Mr. Doyle votes aye.
    Mr. Tiahrt?
    Mr. Tiahrt. No.
    The Clerk. Mr. Tiahrt votes no.
    Ms. Jackson Lee?
    Ms. Jackson Lee. Aye.
    The Clerk. Ms. Jackson Lee votes aye.
    Mr. Largent?
    Mr. Largent. No.
    The Clerk. Mr. Largent votes no.
    Mr. Luther?
    Mr. Luther. Aye.
    The Clerk. Mr. Luther votes aye.
    Mr. Hilleary?
    Mr. Hilleary. No.
    The Clerk. Mr. Hilleary votes no.
    Mrs. Cubin?
    Ms. Cubin. No.
    The Clerk. Ms. Cubin votes no.
    Mr. Foley?
    Mr. Foley. No.
    The Clerk. Mr. Foley votes no.
    Mrs. Myrick?
    Ms. Myrick. No.
    The Clerk. Mrs. Myrick votes no.
    Mr. Doggett. Mr. Chairman, I'm not sure I heard my name 
repeated. Since I sponsored the amendment, I'd like to be sure 
I'm recorded in favor of it.
    The Clerk. Mr. Doggett votes aye.
    The Chairman. Are there any further members wishing to 
vote?
    [No response.]
    The Chairman. If not, the Clerk will report.
    [Pause.]
    The Clerk. Mr. Chairman, I count 16 yeas, 26 nays.
    The Chairman. The amendment is not agreed to.
    Any other amendments to Subtitle C?
    Mr. Boehlert. Mr. Chairman, I ask unanimous consent to 
consider my amendment en bloc, and I think it's been passed out 
already.
    The Chairman. Without objection.
    It needs to be distributed.
    [Pause.]
    Mr. Boehlert. It's titled. This is a troika. Morella, 
Boehlert, Ehlers. What a team that is.
    The Chairman. The Clerk will distribute the amendment.
    Mr. Boehlert. Mr. Chairman, would you like me to start?
    The Chairman. Yes, the gentleman's recognized for five 
minutes.
    Mr. Boehlert. Mr. Chairman, this amendment would improve 
the bill, and I think facilitate its implementation.
    This amendment reflects concerns which were raised by both 
industry and the environmental organizations and by various 
members of this Committee, Republicans and Democrats alike.
    In the area of risk prioritization, specifically we propose 
a new Subtitle IV, page 2 in the bill, containing--
    The Chairman. The gentleman will suspend. We will be in 
order so that the gentleman from New York has a chance to 
present his amendment.
    Mr. Boehlert. Well, they were so excited about it, Mr. 
Chairman, the enthusiasm.
    The Chairman. It didn't sound like cheers to me. 
[Laughter.]
    So I wanted to get the Committee in order. [Laughter.]
    Mr. Boehlert. I move that the Chairman get an examination, 
hearing.
    First, in the new Section 3401, we would mandate the 
agencies to prioritize threats to human health and the 
environment.
    Two, to identify opportunities for the most significant 
risk reductions; and
    Three, to direct their resources accordingly.
    I would point out that Title III, like other bills before 
the Congress, would erect new and potentially costly procedural 
hurdles to agency rulemaking.
    This section would ensure that the agencies direct their 
relatively scarce resources in areas where they can do the most 
good for the American people and for the environment.
    Another new section, Section 3402 in Subtitle IV would fill 
an important void in the original draft of Title III.
    Although most of us would profess a belief in the 
usefulness of risk assessment techniques, I don't think any of 
us can really claim that risk assessment is a highly reliable 
or test science at this point. Further research is essential if 
risk assessments are to evolve into a mainstay of public policy 
decisionmaking.
    Moreover, we do not know how many truly competent 
practitioners of risk assessment there are in this country. 
Clearly, HR 9 would place significant new demands on this 
professional group, both for assessments and for conducting 
peer reviews.
    The new section 3402, formulated with help from our 
distinguished former colleague, Mr. Zimmer, would require 
regulatory agency heads to report regularly on risk research 
needs within the agencies. They would also have to assess needs 
for training individuals competent in risk assessment.
    Agencies would have to develop strategies to address these 
needs and report regularly to Congress on their progress.
    The research would address a variety of important unknowns 
in the risk field including the effect of multiple chemical 
exposures, the effect of toxins on ecological health, and the 
magnitude of non-cancer risks posed by pollutants.
    Finally, on page 1 and 2 of the amendment, we offer several 
technical and clarifying changes to the bill.
    These changes would include improvements to the language on 
peer review, ensuring that these panels are broadly based and 
fully representative of the range of scientific opinion.
    This amendment would streamline and strengthen Title III.
    Let me add, in urging adoption of these changes, that I 
have other broad concerns remaining about the bill. I won't go 
into them, Mr. Chairman, but I think what we would like to see 
right now is these en bloc amendments, which are significant 
improvements to the original bill and also to the Chairman's 
part, be embraced.
    Thank you, Mr. Chairman.
    The Chairman. Thank the gentleman.
    The Chair is prepared to accept this amendment.
    I would point out that in accepting an amendment earlier of 
Mr. Roemer's, we accepted language very similar to this, to 
some of the final sections in the bill.
    It is almost exactly the same. In accepting this amendment, 
I want to assure the gentleman from Indiana and the authors of 
this amendment, that what we will do is work out whatever small 
points of difference there are, but I don't believe that 
there's really anything here that is in major conflict.
    But I don't want to lend confusion here. Both are on the 
same path, and I think we can work it out.
    Mr. Boehlert. I appreciate the Chair's enlightened approach 
to this
    The Chairman. Okay.
    Mr. Roemer. Mr. Chairman, I'd be happy to work with the 
gentleman from New York on this. I offered mine in Subtitle A, 
Section 3106, and as you said, they are very similar in terms 
of the research and training in risk assessment, and I've 
offered amendments where we don't want to be duplicative 
either, and I would want to make sure that we're not doing that 
here, and look forward to working with him.
    Mr. Boehlert. The gentlelady from Maryland authored this 
language on our side and I would recognize her.
    Ms. Morella. Mr. Chairman, I just simply want to say I look 
forward to working with the other members of the Committee.
    The Chairman. I thank the gentlelady.
    Mr. Geren. Mr. Chairman.
    The Chairman. Mr. Geren.
    Mr. Geren. Mr. Chairman, I had planned to offer an 
amendment very similar to Mr. Boehlert's. In fact, the first 
part of it would be identical, and add some additional 
provisions which I discussed with your staff.
    And I would like to just mention it briefly. I intend to 
withdraw the amendment, but I think that we need to go further 
than Mr. Boehlert has gone, and my amendment would add to the 
end of the risk prioritization section of the amendment. It 
would require each covered agency or department to submit a 
report to Congress on how it's implementing the program.
    These reports would be a notification to Congress of any 
constraints that would impede each agency's ability to achieve 
cost effective reduction.
    Additionally, this amendment would help set priorities 
across agencies or departments by requiring OMB to contract 
with an appropriate qualified organization to rank those risks 
to human health, safety, or the environment.
    I feel like this would be an important addition to Mr. 
Boehlert's amendment, and I had prepared this amendment to 
offer tonight.
    It's 31 in the packet, but at this time, Mr. Chairman, with 
your agreement to work with us on some of these issues, I'd 
like unanimous consent to withdraw the amendment.
    The Chairman. Well, I thank the gentleman for that. I 
appreciate his not going ahead and offering the amendment. 
Obviously what he's doing has merit, and what we want to do is 
work with him. I will ask the staff to work with your staff and 
with the gentleman from New York and his colleagues, to see if 
we can't come up with an agreed upon solution as we move toward 
Rules Committee.
    If we can do that, I'm certainly prepared then to accept an 
amendment on the floor that everyone has worked out.
    Mr. Geren. Thank you, Mr. Chairman.
    With that, I'll ask unanimous consent to withdraw my 
amendment.
    The Chairman. I thank the gentleman.
    Mr. Roemer. Mr. Chairman, could I just add, I think that 
this is a very important part of the section, as well, too, and 
Mr. Geren and I would very much like to work with the 
gentlelady from Maryland and the gentleman from New York on 
this.
    In clarifying it, I think we do need to go a little bit 
further. As these agencies come up with risk assessments, there 
are limited resources as to how to implement those risk 
assessments. They should, therefore, prioritize those risk 
assessments, given the diminishing resources that we have to 
implement them.
    That only makes sense if we're going to go through this 
exercise.
    So I think we do need to strengthen the last part of this 
language and I think we do need to work on making sure the 
first part isn't repetitive.
    And I would thank the Chair.
    The Chairman. Thank the gentleman.
    The gentleman from New York moves his amendment.
    Those in favor will say aye.
    [Chorus of ayes.]
    The Chairman. Those opposed, say no.
    [No response.]
    The Chairman. The ayes have it. The amendment is carried.
    Further amendments to Subtitle C?
    [No response.]
    The Chairman. Hearing none, Subtitle C is closed.
    We will not accept amendments coming at the end of the bill 
that would be in Subtitle D.
    Mr. Doggett. Mr. Chairman, I have one at the desk.
    The Chairman. The gentleman from Texas has an amendment at 
the desk.
    Mr. Doggett. It's a very short amendment, one sentence, an 
amendment that I understand has been put on a number of bills 
that have come out of this Committee in the past. It is a 
sunset amendment.
    I think that many of the problems that particularly the 
members of the majority have emphasized in the course of the 
debate of this bill would have been avoided, had there been 
sunset provisions on some of these regulatory programs.
    I favor those. But I also favor them on other well-
intentioned initiatives of which this is one.
    And I think putting a limit on the life of this initiative 
and forcing the Committee and the Congress to look at it again 
would be healthy.
    And so this places a five-year life on this legislation. 
That's all it does. One sentence.
    The Chairman. Well, I thank the gentleman.
    We are in fact attempting to deal with this across a broad 
base, and since what we are attempting to do here is acquire 
good science, I would suggest that maybe we ought not sunset 
good science as of the year 2000 and go back to bad science.
    So the Chair would oppose this amendment as being something 
which does not further the aims of bringing about the reforms 
that this bill attempts to put into place.
    Mr. Doggett. Thanking the Chairman.
    There rarely have been legislators in any legislative body 
who've introduced legislation that was bad legislation for bad 
science or bad anything else; it's always good. But sometimes 
good intentions go astray and the only way to assure they don't 
is to force the legislative body for bills you support and 
bills you don't support to have to review it again.
    And that's all this amendment does, and I would move its 
adoption.
    The Chairman. Well, I would say to the gentleman that when 
you sunset provisions, what you do is you end their life. You 
don't force review. And in this particular case, I have a 
feeling that what we're doing here will be subject to much 
review in the Congress.
    I would prefer to have that review aimed at either 
modifying or extending the program, not aimed at having a sure 
kill of the program at a particular time, and so would continue 
to say to the gentleman that I oppose the amendment.
    Further discussion on the amendment?
    [No response.]
    The Chairman. If not, the Chair will put the question.
    Those in favor of the amendment will say aye.
    [Chorus of ayes.]
    The Chairman. Those opposed, say no.
    [Chorus of nays.]
    The Chairman. In the opinion of the Chair, the noes have 
it.
    Mr. Doggett. Mr. Chairman, I need a record vote on that 
one.
    The Chairman. The gentleman likes record votes and is 
entitled to one.
    And the Clerk will call the roll.
    Mr. Boehlert. Mr. Chairman, can we do it by a show of 
hands?
    The Chairman. The gentleman asked for a record vote. He's 
entitled to a record vote. He wants to have the names I think 
recorded.
    Mr. Boehlert. Will the gentleman accept a division vote? 
You just want to see if you got the numbers?
    Mr. Doggett. If our rules will permit the recording of the 
names of all the people who raise their hands, that's fine.
    The Chairman. No. [Laughter.]
    Mr. Doggett. Just as long as it's reflected in the report, 
I don't care how you record.
    The Chairman. The Clerk will call the roll.
    The Clerk. Mr. Walker?
    The Chairman. No.
    The Clerk. Mr. Walker votes no.
    Mr. Brown?
    [No response.]
    The Clerk. Mr. Sensenbrenner?
    Mr. Sensenbrenner. No.
    The Clerk. Mr. Sensenbrenner votes no.
    Mr. Hall?
    Mr. Hall. Aye.
    The Clerk. Mr. Hall votes aye.
    Mr. Boehlert?
    Mr. Boehlert. No.
    The Clerk. Mr. Boehlert votes no.
    Mr. Traficant?
    Mr. Traficant. Aye.
    The Clerk. Mr. Traficant votes aye.
    Mr. Fawell?
    Mr. Fawell. No.
    The Clerk. Mr. Fawell votes no.
    Mr. Hayes?
    [No response.]
    The Clerk. Mrs. Morella?
    Mrs. Morella. No.
    The Clerk. Mrs. Morella votes no.
    Mr. Tanner?
    [No response.]
    The Clerk. Mr. Weldon of Penssylvania?
    Mr. Curt Weldon. No.
    The Clerk. Mr. Weldon votes no.
    Mr. Geren?
    Mr. Geren. No.
    The Clerk. Mr. Geren votes no.
    Mr. Rohrabacher?
    Mr. Rohrabacher. No.
    The Clerk. Mr. Rohrabacher votes no.
    Mr. Roemer?
    Mr. Roemer. No.
    The Clerk. Mr. Roemer votes no.
    Mr. Schiff?
    Mr. Schiff. No.
    The Clerk. Mr. Schiff votes no.
    Mr. Cramer?
    [No response.]
    The Clerk. Mr. Barton?
    [No response.]
    The Clerk. Mr. Barcia?
    Mr. Barcia. No.
    The Clerk. Mr. Barcia votes no.
    Mr. Calvert?
    Mr. Calvert. No.
    The Clerk. Mr. Calvert votes no.
    Mr. McHale?
    Mr. McHale. Aye.
    The Clerk. Mr. McHale votes aye.
    Mr. Baker?
    Mr. Baker. No.
    The Clerk. Mr. Baker votes no.
    Ms. Harman?
    [No response.]
    The Clerk. Mr. Bartlett?
    Mr. Bartlett. No.
    The Clerk. Mr. Bartlett votes no.
    Ms. Johnson?
    Ms. Johnson. Aye.
    The Clerk. Ms. Johnson votes aye.
    Mr. Ehlers?
    Mr. Ehlers. No.
    The Clerk. Mr. Ehlers votes no.
    Mr. Minge?
    Mr. Minge. Aye.
    The Clerk. Mr. Minge votes aye.
    Mr. Wamp?
    Mr. Wamp. No.
    The Clerk. Mr. Wamp votes no.
    Mr. Olver?
    Mr. Olver. Yes.
    The Clerk. Mr. Olver votes aye.
    Mr. Weldon of Florida?
    Mr. Dave Weldon. No.
    The Clerk. Mr. Weldon votes no.
    Mr. Hastings?
    [No response.]
    The Clerk. Mr. Graham?
    Mr. Graham. No.
    The Clerk. Mr. Graham votes no.
    Ms. Rivers
    Ms. Rivers. Aye.
    The Clerk. Ms. Rivers votes aye.
    Mr. Salmon?
    Mr. Salmon. No.
    The Clerk. Mr. Salmon votes no.
    Ms. McCarthy?
    [No response.]
    The Clerk. Mr. Davis?
    Mr. Davis. No.
    The Clerk. Mr. Davis votes no.
    Mr. Ward?
    Mr. Ward. Aye.
    The Clerk. Mr. Ward votes aye.
    Mr. Stockman?
    Mr. Stockman. No.
    The Clerk. Mr. Stockman votes no.
    Ms. Lofgren?
    Ms. Lofgren. Aye.
    The Clerk. Ms. Lofgren votes aye.
    Mr. Gutknecht?
    Mr. Gutknecht. No.
    The Clerk. Mr. Gutknecht votes no.
    Mr. Doggett?
    Mr. Doggett. Aye.
    The Clerk. Mr. Doggett votes aye.
    Mrs. Seastrand?
    Mrs. Seastrand. No.
    The Clerk. Mrs. Seastrant votes no.
    Mr. Doyle?
    Mr. Doyle. Aye.
    The Clerk. Mr. Doyle votes aye.
    Mr. Tiahrt?
    Mr. Tiahrt. No.
    The Clerk. Mr. Tiahrt votes no.
    Ms. Jackson-Lee?
    Ms. Jackson-Lee. Aye.
    The Clerk. Ms. Jackson-Lee votes aye.
    Mr. Largent?
    Mr. Largent. No.
    The Clerk. Mr. Largent votes no.
    Mr. Luther?
    Mr. Luther. Aye.
    The Clerk. Mr. Luther votes aye.
    Mr. Hilleary?
    Mr. Hilleary. No.
    The Clerk. Mr. Hilleary votes no.
    Mrs. Cubin?
    Mrs. Cubin. No.
    The Clerk. Mrs. Cubin votes no.
    Mr. Foley?
    Mr. Foley. No.
    The Clerk. Mr. Foley votes no.
    Mrs. Myrick?
    Mrs. Myrick. No.
    The Clerk. Mrs. Myrick votes no.
    Mr. Chairman, I count 13 yeas, 29 nays.
    The Chairman. The amendment is not agreed to.
    Any other amendments to Subtitle D?
    Mr. Roemer. Mr. Chairman.
    The Chairman. Mr. Roemer.
    Mr. Roemer. I happily offer the last amendment of the 
night, I hope, on a serious topic on judicial review, and I 
will be very brief in explaining this.
    The Chairman. The faster you do it, the more we are assured 
that there won't be more amendments.
    Mr. Roemer. The move votes I get.
    That aren't bred in the process.
    I'm offering this amendment again to strength this bill Mr. 
Chairman, and many of us are concerned with the original bill 
which was silent, and I believe that now, with your Substitute, 
it is still vague with respect to judicial review and 
particularly interim judicial review.
    The whole purpose of moving this legislation forward is to 
make sure that lawyers don't get more of a license to litigate, 
and they don't make money on this law.
    This judicial review amendment clarifies that the money 
will go to implement risk assessment rather than to feed at the 
lawyers' troughs for them to litigate at every step of the way 
of trying to implement this new law.
    So while this language in your new substitute I think is 
better than the original language, I think it is still vague.
    Secondly, while I am not an attorney, in counsel, in 
drafting this amendment, I think it is very important for us to 
consider, what is in front of the court if they do try to 
litigate in this.
    We want to make sure this law is implemented and exercised 
and not stopped and not delayed and bureaucrats at the 
different Federal agencies don't throw monkey wrenches into the 
works to try to stop a good law from going through.
    That's what this amendment would try to do.
    Finally, I think you could call this the one-bite-out-of-
the-apple amendment. This will ensure that whether you are an 
interest group, an industry, environmental, public interest or 
business competitor, that you get one bite out of the apple and 
not a bunch of different bites out of the apple to try to stop 
this risk assessment law from being implemented, once it 
reaches the agency.
    So I would encourage my colleagues to support this 
legislation, this amendment, and I think this seriously 
improves the rather vague language in your legislation as it 
reads now.
    The Chairman. The gentleman from California wishes to be 
recognized.
    Mr. Baker. We described, during the hearings, and I'm 
sympathetic to what you're trying to do, but we described 
during the hearings, the case where the Corps of Engineers 
moves in on our project, that the city and the locality wants 
and the person building the project wants, finds three weeds 
that are indigenous to a wetlands and ties up your project.
    You have not right of review, you have no time limit, 
there's no way to get your project out from under this cloud.
    So when you say in the first paragraph, nothing in this 
Title creates any right to judicial or administrative review, 
you're leaving the law the way it is.
    And we want the victims out there that are being squashed 
by the bureaucracies to have, when they feel they're not 
getting heard or in a timely manner, they have to have a right 
to somewhere in the court is that right.
    So I think you're undoing judicial review where we want 
that safeguard there. None of this wants to turn this into a 
full employment act for lawyers, but you have almost said, in 
your first paragraph, you don't have the right to review.
    Mr. Roemer. If the gentleman would yield.
    What this legislation says is nothing like that at all. It 
just says that you have one final actions. You cannot litigate 
at every step of the way as that agency tries to promulgate 
this risk assessment forward, you get one bite of the apple and 
that is once we have finally promulgated the risk assessment.
    Mr. Minge. Will the gentleman yield?
    Mr. Roemer. I'd be happy to yield.
    Mr. Minge. I don't claim a continuing expertise in this, 
but for seven years I taught administrative law in a law school
    And the section that we have here that's been offered is an 
attempt to use language which is consistent with the 
Administrative Procedures Act. I've not had a chance to look at 
that, but it uses language which bears some resemblance to 
what's in the Administrative Procedures Act, and it really is 
designed to ensure that there is review of final agency action, 
meaning the rule itself.
    And I think the ambiguity that's created by the language on 
page 25 is that the risk assessment process may be an 
independent basis for review and review may become available 
during that process.
    Now I think it's a stretch to find that judicial review or 
that extra review feedbag for lawyers in the proposal, but 
arguably it's there somewhere and it'll take several years to 
shake this out with numerous appeals in the courts.
    I think that the concern that you have, that you've 
expressed that you want people who are under the heel of a 
Federal agency to have the opportunity to get out from under 
that heel, is not forwarded by the legislation that we're 
considering in terms of quick judicial review, and it's not 
defeated by the amendment being offered.
    We're talking essentially about apples and oranges, and if 
you want judicial review in that context, I think that it will 
take a section different than what's in the Walker Substitute.
    So I'm not saying that the Roemer amendment is the best 
thing since sliced bread here. I don't want to imply that. But 
I do think it takes us one step further, one step beyond what's 
in the Walker Substitute, and makes it clear that we are not 
creating a feedbag for lawyers, if you want to characterize 
this problem in those terms.
    Mr. Roemer. I thank the gentleman from Minnesota for that 
pseudo-endorsement. [Laughter.]
    Mr. Hall. Will the gentleman yield.
    The Chairman. The gentleman from Pennsylvania, Mr. McHale 
is recognized.
    Mr. McHale. Thank you, Mr. Chairman.
    Mr. Chairman. I support Mr. Roemer's amendment. I listened 
carefully the other day as Professor McGarrity from the 
University of Texas Law School compared the content of the 
original draft of the legislative to the extensive litigation 
that has occurred regarding environmental impact statements 
under the National Environmental Policy Act.
    Under NEPA, going back 20 years, we have had a whole body 
of case law develop interpreting the timing, the scope, and the 
adequacy of environmental impact statements.
    It has been one of the most prolific areas of litigation in 
the last two decades.
    Professor McGarrity said, and I think correctly, that if we 
enact this legislation without the Roemer amendment, in my 
opinion, we will see analogous legislation or analogous 
litigation over the next several decades, testing the validity, 
the scope, the adequacy, the timing of each and every risk 
assessment that occurs pursuant to the litigation.
    I guarantee you Professor McGarrity is correct. If we don't 
accept the Roemer amendment, we're looking at a whole new field 
of litigation where individuals of a wide range of ideology 
will repeatedly, at great expense, over a long period of time, 
test the validity of individual risk assessments.
    I don't think that's the intent of this legislation. I 
think the Roemer amendment is fully consistent with greater 
efficiency, better science and a limitation on litigation.
    I urge its support.
    Mr. Schiff. Mr. Chairman, I wonder if I could ask the 
sponsor of the amendment, so that I can follow this, is the 
sponsor saying that judicial review still exists but it's at 
the end of the process?
    Is that the substance of the gentleman's amendment?
    Mr. Roemer. That's correct, and that's the way it exists in 
current law. So what we're saying to the gentleman from New 
Mexico is that if you are a drug company and you are competing 
with somebody else, and that drug company is two years ahead in 
terms of developing research for a new product, instead of 
waiting for the final rule to be issued and promulgated, they 
can try to make up for that two-year hiatus or delay by trying 
to litigate all along through this process, and unfairly catch 
up in that two-year period through litigation, rather than 
through competition.
    That is how this loophole could be used to create a cottage 
industry for lawyers, and to really circumvent the intent of 
this law.
    The intent of this law is to have the money go for risk 
assessment, not to lawyers for litigation.
    Mr. Schiff. My only concern is when we say we don't want 
the money to go to litigation, we want the ability to litigate 
it at some point.
    Mr. Roemer. At one final point, once the rule has been 
issued, not all through every step of the process.
    Mr. Schiff. All right. Let me just conclude by saying--I've 
obviously not had a lot of time to study this amendment--but it 
seems to me, from what I'm hearing, that the gentleman came up 
with the same compromise we came up with in the unfunded 
mandate legislation, which is to not allow interim stays and so 
forth.
    Mr. Roemer. That's correct.
    Mr. Schiff. All right. I yield back, Mr. Chairman. Thank 
you.
    The Chairman. Thank the gentleman.
    Mr. Hall. Mr. Chairman?
    The Chairman. Mr. Hall.
    Mr. Hall. Strike the requisite number of words.
    This seems to me, and I might ask the author, I think the 
amendment makes it clear that it doesn't expand the right to 
judicial review and Professor Minge, I took administrative law 
at Southern Methodist University, and I didn't have as good a 
professor as you probably were, but I did make the highest 
grade of all who failed that course. [Laughter.]
    It seems to me that this does not spawn any new rights. It 
simply codifies existing rights.
    Is that what you intend for it to do?
    Mr. Roemer. If the gentleman will yield, it doesn't expand, 
it simply preserves what the very esteemed and intelligent 
gentleman is talking about, despite his grades.
    Mr. Hall. I yield back my time.
    The Chairman. Thank the gentleman.
    The Chair is concerned about this amendment because, while 
the gentleman says it tracks the Administrative Procedures Act, 
it is, in fact, new language beyond the Administrative 
Procedures Act.
    If you want to stick with the Administrative Procedures 
Act, where we have a longstanding history of what the 
litigation is likely to do, that's exactly what we do in the 
language which is in the bill.
    The language in the bill requires compliance. That in fact 
gets the one bite at the apple that the gentleman claims to be 
for.
    Because under the Administrative Procedures Act, when you 
arrive at the end of the process, that's when judicial review 
is possible for those people affected by the rulemaking.
    And so it seems to me that if we want to reduce the amount 
of potential litigation, what we do is stick with that which 
has at least some history, and we do not create new language 
that then can be newly interpreted by lawyers and giving them 
additional rights beyond the Administrative Procedures Act.
    In my view, judicial review is essential and I am concerned 
that some of the language in this particular amendment seems to 
obviate judicial review, at least the initial parts of it.
    We need some judicial review to assure that the Federal 
agencies are going to do what we tell them to do under this 
Act. We need to use a normal, time-tested judicial review 
procedure. That's what we do by referencing the Administrative 
Procedures Act.
    Under our judicial review provision, a risk assessment, 
cost benefit certification, or peer review requirement could 
only be subject to judicial review when associated with a final 
agency action, like a rule, because that would be part of the 
Administrative record.
    It seems to me that it is that kind of narrow 
administrative action that we want to encourage without 
expanding this into all kinds of litigation.
    I think by expanding the language in the bill that we in 
fact are creating a situation where you are in fact making it 
more of a heyday for lawyers and I would be opposed to the 
amendment as offered by the gentleman.
    Mr. Roemer. If the gentleman would yield.
    I don't think we're expanding the language at all. I think 
we are narrowing the language so that these smart lawyers in 
Washington, D.C. cannot drive a truck through this and exploit 
it.
    And I would disagree with the Chairman's interpretation.
    The Chairman. So what the gentleman is doing is narrowing 
the Administrative Procedures Act?
    Mr. Roemer. What I'm trying to do is clarify what we're 
doing here by this language, and----
    The Chairman. I would simply say to the gentleman that by 
adding additional language, that tends not to clarify, it tends 
to obviate, and that the clearest language that we can have is 
simply to stick with where we are in the Administrative 
Procedures Act.
    Mr. Minge. Will the gentleman yield?
    What we've created is a fairly significant overlay on the 
rulemaking process as it's set up in the Administrative 
Procedures Act.
    And the question that will come up, and this will come up 
not just from, let's say, the industry side, but also from the 
environmental side. Has an agency complied with each provision 
along the step of the way, and is there a right to a 
restraining order to try to prevent agency action as it's 
proceeding.
    And it's that litigation which I think Mr. McHale and Mr. 
Roemer are referring to, and it's that type of litigation that 
this language is designed to avoid.
    So it's a two-edged sword that we face here. And there are 
several industry groups that have visited with me that have 
emphasized they recognize that the litigation risk is maybe not 
so much the agency being sued by regulated industry as the 
agency being sued by an environmental group that is hostile to 
what we're going through here.
    So this is intended to be neutral, and I would support Mr. 
Roemer's efforts.
    I'm not saying his language couldn't be improved upon; 
maybe it could.
    The Chairman. The gentleman has made clear his position. I 
hope the Chair has made clear his position.
    Mr. Roemer. Mr. Chairman, I would move approval of my 
amendment.
    The Chairman. With that, the Chair would call for the vote.
    Those in favor will say aye.
    [Chorus of ayes.]
    The Chairman. Those opposed no, no?
    [Chorus of nays.]
    The Chairman. In the opinion of the Chair, the noes have 
it.
    Mr. Roemer. Mr. Chairman, I'd ask for a recorded vote.
    The Chairman. On that, the gentleman asks for a recorded 
vote.
    The Clerk will call the roll.
    The Clerk. Mr. Walker?
    The Chairman. No.
    The Clerk. Mr. Walker votes no.
    Mr. Brown?
    [No response.]
    The Clerk. Mr. Sensenbrenner?
    Mr. Sensenbrenner. No.
    The Clerk. Mr. Sensenbrenner votes no.
    Mr. Hall?
    Mr. Hall. Aye.
    The Clerk. Mr. Hall votes aye.
    Mr. Boehlert?
    Mr. Boehlert. Aye.
    The Clerk. Mr. Boehlert votes aye.
    Mr. Traficant?
    Mr. Traficant. Aye.
    The Clerk. Mr. Traficant votes aye.
    Mr. Fawell?
    Mr. Fawell. No.
    The Clerk. Mr. Fawell votes no.
    Mr. Hayes?
    [No response.]
    The Clerk. Mrs. Morella?
    Ms. Morella. Aye.
    The Clerk. Mrs. Morella votes aye.
    Mr. Tanner?
    [No response.]
    The Clerk. Mr. Weldon of Pennsylvania?
    Mr. Curt Weldon. No.
    The Clerk. Mr. Weldon votes no.
    Mr. Geren?
    [No response.]
    The Clerk. Mr. Rohrabacher?
    Mr. Rohrabacher. No.
    The Clerk. Mr. Rohrabacher votes no.
    Mr. Roemer?
    Mr. Roemer. Aye.
    The Clerk. Mr. Roemer votes aye.
    Mr. Schiff?
    Mr. Schiff. No.
    The Clerk. Mr. Schiff votes no.
    Mr. Cramer?
    [No response.]
    The Clerk. Mr. Barton?
    Mr. Barton. No.
    The Clerk. Mr. Barton votes no.
    Mr. Barcia?
    Mr. Barcia. Aye.
    The Clerk. Mr. Barcia votes aye.
    Mr. Calvert?
    Mr. Calvert. No.
    The Clerk. Mr. Calvert votes no.
    Mr. McHale?
    Mr. McHale. Aye.
    The Clerk. Mr. McHale votes aye.
    Mr. Baker?
    Mr. Baker. No.
    The Clerk. Mr. Baker votes no.
    Ms. Harman?
    [No response.]
    The Clerk. Mr. Bartlett?
    Mr. Bartlett. No.
    The Clerk. Mr. Bartlett votes no.
    Ms. Johnson?
    Ms. Johnson. No.
    The Clerk. Ms. Johnson votes no.
    Mr. Ehlers?
    Mr. Ehlers. No.
    The Clerk. Mr. Ehlers votes no.
    Mr. Minge?
    Mr. Minge. Aye.
    The Clerk. Mr. Minge votes aye.
    Mr. Wamp?
    Mr. Wamp. No.
    The Clerk. Mr. Wamp votes no.
    Mr. Olver?
    Mr. Olver. Yes.
    The Clerk. Mr. Olver votes aye.
    Mr. Weldon of Florida?
    Mr. Dave Weldon. No.
    The Clerk. Mr. Weldon votes no.
    Mr. Hastings?
    [No response.]
    The Clerk. Mr. Graham?
    Mr. Graham. No.
    The Clerk. Mr. Graham votes no.
    Ms. Rivers?
    Ms. Rivers. Aye.
    The Clerk. Ms. Rivers votes aye.
    Mr. Salmon?
    Mr. Salmon. No.
    The Clerk. Mr. Salmon votes no.
    Ms. McCarthy?
    [No response.]
    The Clerk. Mr. Davis?
    Mr. Davis. No.
    The Clerk. Mr. Davis votes no.
    Mr. Ward?
    Mr. Ward. Aye.
    The Clerk. Mr. Ward votes aye.
    Mr. Stockman?
    Mr. Stockman. No.
    The Clerk. Mr. Stockman votes no.
    Ms. Lofgren?
    Ms. Lofgren. Yes.
    The Clerk. Ms. Lofgren votes aye.
    Mr. Gutknecht?
    Mr. Gutknecht. No.
    The Clerk. Mr. Gutknecht votes no.
    Mr. Doggett?
    Mr. Doggett. Aye.
    The Clerk. Mr. Doggett votes aye.
    Mrs. Seastrand?
    Mrs. Seastrand. No.
    The Clerk. Mrs. Seastrand votes no.
    Mr. Doyle?
    Mr. Doyle. Aye.
    The Clerk. Mr. Doyle votes aye.
    Mr. Tiahrt?
    Mr. Tiahrt. No.
    The Clerk. Mr. Tiahrt votes no.
    Ms. Jackson Lee?
    Ms. Jackson Lee. No.
    The Clerk. Ms. Jackson Lee votes no.
    Mr. Largent?
    Mr. Largent. No.
    The Clerk. Mr. Largent votes no.
    Mr. Luther?
    Mr. Luther. Aye.
    The Clerk. Mr. Luther votes aye.
    Mr. Hilleary?
    Mr. Hilleary. No.
    The Clerk. Mr. Hilleary votes no.
    Mrs. Cubin?
    Ms. Cubin. No.
    The Clerk. Ms.Cubin votes no.
    Mr. Foley?
    Mr. Foley. No.
    The Clerk. Mr. Foley votes no.
    Mrs. Myrick?
    Ms. Myrick. No.
    The Clerk. Mrs. Myrick votes no.
    Mr. Geren. Mr. Chairman, may I ask how I'm recorded?
    The Chairman.  How's Mr. Geren recorded?
    The Clerk. Mr. Geren is not recorded.
    Mr. Geren. Mr. Chairman, I'd ask to be recorded as aye.
    The Clerk. Mr. Geren votes aye.
    The Chairman. The Clerk will report.
    The Clerk. Mr. Chairman, I count 16 yeas, 27 nays.
    The Chairman. The amendment is not agreed to.
    Are there further amendments to Section D?
    Mr. Barton. Mr. Chairman?
    Mr. Chairman. The gentleman from Texas?
    Mr. Barton. Mr. Chairman, I have an amendment at the desk.
    The Chairman. The Clerk will distribute the amendment.
    Mr. Barton. Barton 13.
    [Pause.]
    Mr. Barton. It's the last one.
    The Chairman. I hope this is the last one.
    Voices. No, no. [Laughter.]
    Mr. Barton. I would ask unanimous consent that the 
amendment be considered as read, and that will save some time.
    The Chairman. Without objection.
    Mr. Barton. You want me to start explaining? Okay. Mr. 
Chairman, may I begin to explain the amendment as it's being 
circulated?
    The Chairman. The gentleman can explain the amendment.
    Mr. Barton. I thank the Chairman.
    Mr. Chairman, this amendment would be a substitute for 
Subtitle D. Under the bill as currently drafted, there is an 
18-month period during which the affected Federal agencies can 
review existing rules and regulations.
    And if it is the agency determination that there is new 
information or new methodology that would render the existing 
rule and regulation obsolete, then they can make a self-imposed 
decision to review the existing rules and regulations.
    My amendment would substitute a petition process where 
outside parties that have a direct financial interest in the 
existing rules and regulations could petition that those rules 
and regulations be reviewed.
    The Federal agency that receives the petition has a 90-day 
time period during which they can determine whether they 
believe that the petitioned rule or regulation should be 
reviewed.
    If they accept the petition, there is a one-year time 
period where there is a public comment, and they go, they 
accept the additional information, and then make a final 
decision.
    If, on the other hand, they decide the petition does not 
have validity, they have to publish in the Federal Register the 
reasons that they believe the petition is not valid.
    If the party that rendered the petition feels that the 
rendering of the Federal agency is inappropriate, they can go 
then, under the existing law, into court and ask that the 
existing rule and regulation be reviewed.
    Basically, what this amendment does is substitute an 
internal review by the Federal agency with an external petition 
process that has specific time periods.
    The Energy and Commerce Committee adopted this amendment 
that's been circulated, with one change; they deleted the 
provision that limited the petition to people with a direct 
financial interest.
    Congressman Markey of Massachusetts wanted to delete that, 
and so as passed by the Energy and Commerce Committee, this 
amendment allows any person to instigate petition.
    So this is the case that gives us the ability to look at 
existing rules and regulations by allowing outside parties that 
have a direct financial interest to instigate or initiate the 
petition.
    If you think the existing rules and regulations need to be 
reviewed and don't trust the existing Federal agencies to 
automatically review some of these rules and regulations, you 
should support this amendment.
    Mr. Doggett. Will the gentleman yield?
    Mr. Barton. I'll be happy to yield.
    Mr. Doggett. Do I understand then that you are offering it 
in the form that the Commerce Committee approved it, or are you 
offering it in the form that has been circulated?
    Mr. Barton. No, I'm offering it in the form that it's being 
circulated because I didn't want to confuse the Committee, but 
it was passed with a broadening amendment. But I'm offering it 
in its existing form because that's the form that was at the 
desk, and earlier this evening, we had a mixup where I had two 
different amendments, and I didn't want to embarrass the 
Committee again with that purpose.
    But I want to tell the Committee that it has been adopted 
with that perfecting amendment in the Energy and Commerce 
Committee.
    Mr. Doggett. Well, would you be--an amendment to your 
amendment would be out of order, I assume.
    The Chairman. That would be an amendment in third degree 
and would be out of order.
    Mr. Doggett. Right.
    Mr. Barton. It would require unanimous consent of the 
members present in this Committee to change the amendment, 
that's correct.
    Mr. Boehlert. I would like to know what the Chairman thinks 
of the amendment?
    The Chairman. Well, the Chair will comment on the 
amendment.
    Do we have further discussion of the amendment?
    Mr. Barton. Not at this time.
    The Chairman. The Chair is going to oppose the amendment. I 
think it has some merit to it, but the Chair has two problems 
with this particular amendment.
    I believe that this would result in additional litigation 
and we have attempted, insofar as I have been involved in this 
process, to reduce the amount of litigation insofar as we can, 
I believe, to some of those questions.
    And I do believe that this does provide a substantial 
reachback beyond that which has been included in the bill, and 
so, therefore, I am not disposed toward approving this 
amendment at this time.
    Mr. Geren.
    Mr. Geren. Mr. Chairman, I'd like to speak in support of 
Mr. Barton's amendment.
    The Chairman. The gentleman's recognized.
    Mr. Geren. I beg your pardon?
    The Chairman. The gentleman is recognized.
    Mr. Geren. Oh, excuse me.
    I think that it is a good middle ground that will give the 
citizens of the country an opportunity to review existing law, 
and we wouldn't be considering this bill that we have in front 
of us today if it weren't for some abuses that we have had to 
live with in the past.
    And I think this is a good middle ground. It does give an 
opportunity on a case by case basis for citizens and other 
entities to petition our Government and seek review of these 
provisions.
    Mr. Barton. Would the gentleman yield?
    Mr. Geren. Yes, I'll be glad to yield.
    Mr. Barton. If the distinguished gentleman from Texas would 
yield, I want to say that I gratefully accept his support. And 
this did pass in the Commerce Committee with bipartisan 
support.
    I hope we can also pass it here.
    I would also like to comment on the distinguished 
Chairman's opposition. He and I have discussed this amendment 
and we certainly understand each other.
    My position is that we should not automatically trust the 
existing Federal agencies during the 18-month period it's in 
the bill is drafted, to go out and review many of these 
existing rules and regulations.
    In some ways, that's like allowing the fox to guard the 
henhouse.
    What this amendment does, if passed, is allow outside 
parties to petition those agencies that there should be a 
review. So it gives grassroots America the opportunity to come 
in and require specific rules and regulations to be reviewed.
    It is the only way that we automatically guarantee that 
some of the existing rules and regulations will be reviewed.
    And that is a key difference in this amendment and the 
Committee print.
    And I yield back to the gentleman from Texas.
    Mr. Doggett. Mr. Chairman, I again just express my support 
for this amendment and yield back the balance of my time.
    The Chairman. Is there further discussion?
    [No response.]
    The Chairman. If not, the question occurs on the amendment 
by the gentleman from Texas.
    Those in favor will say aye.
    [Chorus of ayes.]
    The Chairman. Those opposed will say no.
    [Chorus of nays.]
    The Chairman. In the opinion of the Chair, the noes have 
it.
    Mr. Barton. Mr. Chairman, could I have a show of hands?
    The Chairman. The gentleman asks for a division. A division 
is requested.
    Those in favor of the amendment will raise their hand.
    [Show of hands.]
    The Chairman. Does the Clerk have them all?
    Those opposed will raise their hands.
    [Show of hands.] [Laughter.]
    [Pause.]
    The Chairman. The Clerk will report.
    The Clerk. Mr. Chairman, I count 15 yeas, 25 nays.
    The Chairman. On the division, the amendment is not agreed 
to.
    It was nice here on the last vote to see kind of a 
bipartisan split on these things. It shows that we got more 
honest as we went.
    Are there further amendments to Section D, Subtitle D?
    [No response.]
    The Chairman. If not, Subtitle D is closed.
    Any other amendments to the Substitute?
    [No response.]
    The Chairman. If not, the Chair moves the Substitute as 
amended.
    All those in favor will say aye.
    [Chorus of ayes.]
    The Chairman. Those opposed say no.
    [Chorus of nays.]
    The Chairman. In the opinion of the Chair, the ayes have 
it.
    The Chair now moves the--oh, the gentleman from Texas, Mr. 
Hall.
    Mr. Hall. Mr. Chairman, I would move that the Committee 
report on the bill HR 9 to the House as amended, with the 
recommendation that it pass.
    Furthermore, I instruct the staff to prepare the 
legislative report and to make technical and conforming 
changes.
    The Chairman. The Committee has heard the motion.
    Those in favor of the motion will respond by saying aye.
    [Chorus of ayes.]
    The Chairman. Those opposed, no?
    [Chorus of nays.]
    The Chairman. The motion is agreed to, and the bill is 
reported.
    Mr. Hall. Mr. Chairman?
    The Chairman. The gentleman from Texas has some additional.
    Mr. Hall. Mr. Chairman, under the Rules, I request three 
days within which members can file separate, additional and 
dissenting views.
    The Chairman. Without objection.
    Mr. Hall. Mr. Chairman, I also ask unanimous consent to 
allow members to include statements in the record.
    The Chairman. Without objection.
    Mr. Boehlert?
    Mr. Boehlert. Mr. Chairman, I want to say that we've been 
at this since 10:00 o'clock this morning, and I want to commend 
the Chair for the fairness in which you've presided over this 
hearing.
    Everyone had the opportunity to speak their piece and it 
was a darn good hearing, and I'm proud to serve on this 
Committee.
    The Chairman. I thank the gentleman.
    I want to say thank you to all the members on both sides. 
We did stick through a long period of time here, and I do 
appreciate the members participating in this.
    Hopefully, we participated in a good, open discussion.
    The Chair would also make the point that the Hydrogen Bill 
that was on the schedule is going to be postponed.
    The Chair will recess the Committee at the call of the 
Chair and will reschedule in the near future to come back to do 
the Hydrogen Bill.
    With that, the Committee stands in recess at the call of 
the Chair.
    Thank you very much.
    [Whereupon, at 11:20 p.m., Wednesday, February 8, 1995, the 
Committee was adjourned, subject to call of the Chair.]

                  STATEMENT OF KAREN McCARTHY

    I would like to point out concerns I have with this section 
of the bill as it is currently written. However, before I 
enumerate these concerns, let me make a few remarks about risk 
assessment in general.
    I do believe we can adopt legislation that allows agencies 
to conduct sound risk assessments. I support legislative 
efforts to develop risk assessment legislation that has the 
goal of providing more open and scientifically based risk 
assessments. No one can deny the need for agencies to make 
quantitative and qualitative regulatory decisions about the 
classification of health or environmental hazards based on 
sound regulatory decisions.
    However, it is my belief that the bill the Science 
Committee has under consideration does not promote sound risk 
analysis and in fact creates greater regulatory burdens for 
federal agencies and thus greater costs for consumers and 
businesses. Therefore, I do feel obligated to state my concerns 
with Title III of H.R. 9, as currently written.
    First, we have heard from agency heads about their specific 
concerns with the language. For instance, Deputy Commissioner 
for Policy at the Food and Drug Administration, William 
Schultz, stated before the committee that ``the additional 
requirements of the bill would add layers of bureaucracy to the 
agency's decisionmaking process, increasing the cost of agency 
regulation, without any benefit to the consuming public or the 
regulated industry.'' It concerns me greatly to hear agencies 
talking about increasing bureaucracy when one of my goals is to 
reduce bureaucracy. I cannot see how I can support legislation 
that will have the effect of increasing the burdens caused by 
unnecessary new layers of government.
    Second, the definition of a ``major rule,'' set at $25 
million, is too narrow and needs to be broadened. My fear is 
that the threshold for any regulation that is likely to result 
in an annual effect on economy of $25 million or more would 
include almost all federal regulations. Resources devoted to 
regulatory analysis should be commensurate with the 
significance of the regulatory decision. I would support 
raising the threshold to prevent the need for risk assessments 
and cost-benefit analysis for every regulation promulgated by 
agencies.
    Third, of additional concern is the effect this legislation 
will have on state and local jurisdictions. Unless I have 
guarantees that stipulations in this bill will not require 
states and localities to comply with the risk assessment and 
cost-benefit provisions, then I have to withhold my support for 
the bill.
    Finally, let me say something about the process used to 
consider this bill. I think it is difficult to consider health, 
safety and environmental legislation under the expedited 
procedures that have been employed by the Science Committee. 
While I understand the need to meet deadlines, prudence and 
common sense would dictate that this committee take the time to 
fully evaluate provisions in the bill. We have held only two 
hearings on this bill. The last hearing occurred only three 
legislative days prior to the committee mark up of the bill. 
This is not enough time to analyze the comments and weigh the 
concerns of the witnesses who appeared at the hearing. Many of 
the agencies that would be affected by this legislation voiced 
serious concerns with the legislation. For example, the 
Department of Health and Human Services expressed this concern: 
``Rather than eliminating obstacles to more streamlined, cost-
effective regulatory actions, Title III would add numerous 
burdensome and unproductive procedural requirements that would 
greatly increase the costs and delays of the regulatory 
process.'' We have given scant discussion to the fiscal 
implications of Title III to the federal budget.
    Let me conclude by saying that I want to support risk 
assessment legislation. However, in light of the manner by 
which this legislation was rushed through the Science Committee 
and the concerns expressed by groups affected by Title III, I 
cannot support the bill in its current form.

          ADDITIONAL VIEWS OFFERED BY MS. JACKSON LEE OF TEXAS

    Although understanding that certain difficulties arise for 
businesses and industry when over-restrictive regulations are 
placed upon them, we cannot disregard the positive impact that 
many environmental regulations have had on the safety of women, 
children, and minorities in our inner-cities. Many of our 
inner-city dwellers face added environmental risks by living 
near or working in sectors of our manufacturing industries. I 
believe we can and we should assure their public health and 
safety, and at the same time, strike a balance so as not to 
unfairly burden our nation's businesses. We must be careful to 
ensure that the present legislation does that.

                                                Sheila Jackson Lee.

        ADDITIONAL VIEWS, SUBMITTED BY REPRESENTATIVE TIM ROEMER

    Risk Assessment legislation is an important and necessary 
part of restructuring our government to be more effective, 
efficient and less expensive. We must use modern and scientific 
knowledge to help us establish intelligent policy. This will 
allow us to establish those regulations that are concise and 
reasonable, and avoid or eliminate unworkable and unneeded 
regulation.
    We support this bill, but it needs improvement. Of 
particular importance are the provisions dealing with 
``judicial review.'' While judicial review is an important 
element of the regulatory process, it can be used in 
mischievous or even dilatory ways if not crafted carefully.
    The bill, as drafted, is vague on potential new judicial 
review requirements, and may permit court challenges to a 
regulation before it has even been issued. This form of interim 
judicial review is not, in my estimation, an intention of this 
legislation.
    It is not wise to allow interest groups--industry, 
environmental, public interest, business competitors, perhaps 
even other agencies--to protest a regulation in court before it 
has ever been finalized. Basing legal arguments on anticipated 
outcomes can be a hazard. There are other interim remedies, 
including the gathering of public testimony and public comment 
periods, to address concerns about potential rules without 
disrupting the rulemaking process. The complexity of the 
process created by this bill should not be underestimated. 
Without addressing the judicial review question, we risk 
eroding the solutions created by the bill.
    We supported the Roemer amendment to remedy this flaw. 
Without this amendment, we are opening up an entire new area 
for legal action where none existed before, and it is almost 
certain that lawyers will create a new cottage industry in this 
field. The government cannot afford this litigation explosion: 
we must avoid committing scarce resources into this non-
productive activity.
    The Roemer amendment would clarify that judicial review is 
only available as a remedy to a final agency action. We should 
not surrender our responsibility for conducting scientific and 
technical debates to lawyers and judges. This amendment is 
virtually the same language as was adopted by the Senate last 
year on a large bipartisan basis during consideration of the 
Safe Drinking Water Act.
    We have pledged to work with the Chairman and Ranking 
Member to improve language for floor consideration that would 
correct the vague language in this bill as adopted. We look 
forward to making these needed improvements to this necessary 
legislation during consideration by the full House.

                                   Tim Roemer.
                                   David Minge.
                                   Mike Doyle.

                           SUPPLEMENTAL VIEWS

    We agree with the majority on the need to address risk 
assessment and cost-benefit analysis. However, we do have 
reservations about Title III of the Job Creation and Wage 
Enhancement Act, and we respectfully submit our supplemental 
views regarding judicial review, the major rule threshold, and 
preemptive law.
    Under existing law, final agency rules and orders are 
judicially reviewable under the Administration Procedures Act. 
Without clarification in Title III of the Job Creation and Wage 
Enhancement Act, courts may hold that risk assessment 
guidelines themselves are reviewable, which is sure to lead to 
excessive litigation.
    We believe that risk assessment guidelines should not be 
reviewable. Additionally, we believe that compliance with Title 
III requirements should be reviewable only in the context of a 
challenge to a final agency rule or order. Without such a 
provision, this legislation may exacerbate existing litigation 
problems and stifle efforts to resolve conflicts within a 
federal agency.
    Title III requires federal agencies to conduct resource-
intensive, formal risk assessments and cost-benefit analysis. 
Compliance would be required when an agency proposes a ``major 
rule,'' a regulation that would have an annual impact on the 
economy of $25 million or more. This figure is equal to .0004% 
of the U.S. Gross Domestic Product.
    The $25 million threshold is unreasonably low given Title 
III's analytic requirements. Doing meaningful cost-benefit 
analyses requires substantial time, data, and expertise. If 
these analyses are done poorly they are worse than useless, 
since the resulting ``answers'' have a spurious air of 
reliability that misleads the public and decisionmakers alike.
    EPA estimates that the cost of preparing cost-benefits 
analyses ranges from just over $200,000 to more than 
$2,300,000, averaging $675,000. A $25 million threshold would 
require cost-benefit analyses to be prepared for several 
hundred major rules developed by federal agencies that regulate 
health, safety, and the environment. The annual cost to 
taxpayers is likely to be in the hundreds of millions of 
dollars.
    In addition, Title III will apply to rules that implement 
statutes enacted prior to enactment of Title III, in effect 
amending specific provisions of those laws. The Committee was 
unable to identify which provisions would be affected, much 
less in what fashion. We believe that Title III should apply to 
prospective laws. Otherwise, Title III may undermine landmark 
laws that were enacted only after years of work and discussion 
to create a delicate balance of interested and affected 
parties--laws that range from protection of food and drinking 
water quality, to aviation safety, to hazardous waste 
management, and preservation of wildlife.
    For these reasons, we submit supplemental views on various 
provisions of Title III of the Job Creation and Wage 
Enhancement Act.

                                   Connie Morella.
                                   Sherwood Boehlert.
                                   Vernon J. Ehlers.

                            DISSENTING VIEWS

                              introduction

    In reporting H.R. 9, the Committee is missing an 
opportunity to report thoughtful, well-considered legislation 
to reform the regulatory agencies' risk assessment and cost-
benefit procedures. Risk assessment and cost-benefit analysis 
are important, albeit limited, tools that can help agencies 
regulate in a more reasoned and cost-effective manner. We all 
support efforts to make the rulemaking process faster, cheaper, 
and more rational.
    Instead of targeting specific areas needed for improvement, 
however, H.R. 9 sweeps across a wide range of activities of all 
agencies, guaranteeing dividends on the law of unintended 
consequences. It imposes strict new ``one-size-fits-all'' risk 
assessment procedures which are scientifically unsound. It sets 
up a cumbersome and costly procedural maze which is much more 
likely to lead to gridlock and costly new bureaucracy rather 
than to faster and more rational rulemaking. It gives any 
lawyer who wants to delay a regulation--whether representing 
industry, public interest groups, or competitors--a powerful 
new tool to prolong agency actions through diversionary and 
nonproductive litigation. It will impose costly new information 
requirements on industry.
    As introduced, Title III of H.R. 9 was a modestly flawed 
bill that could have been improved with an opportunity for 
debate and thoughtful consideration. As reported, it is an even 
worse bill that will make the legitimate protection of our 
nation's health, safety, and the environment much more 
difficult, if not impossible. H.R. 9 now proposes to sweep away 
the substantive laws that have been debated and enacted by 
Congress over the last thirty years. If those laws need 
amending, we should do so directly, not through the back-door 
procedural requirements of H.R. 9.
    We believe the bill, as reported, has the following major 
flaws:
          It requires new and more extensive procedures for 
        risk assessment and cost-benefit analysis, overriding 
        existing substantive law on an indiscriminate basis;
          It encourages additional litigation through expanded 
        and confusing language on judicial review;
          It failed to follow procedural safeguards in 
        Committee to insure full and deliberate consideration 
        of complex issues;
          It purports to define and prescribe now scientists 
        should do science;
          It establishes a confusing and non-scientific process 
        of ``Comparative Risk Analysis'' as a component of Risk 
        Assessment and Cost-Benefit Analysis;
          It permits peer review panels to be dominated by 
        industry scientists with financial conflicts of 
        interest; and
          It imposes an inflexible and unrealistic requirement 
        that agencies ``certify'' that benefits outweigh costs 
        as a prerequisite to issuing final rules
    These objections are set forth in greater detail below.

                        overriding existing laws

    As introduced, there was some question whether Title III of 
H.R. 9 would override existing, substantive law through its 
procedural requirements. The Walker amendment adopted by the 
majority erases any doubts: its clear and express intent is to 
override any health, safety, or environmental law that would 
conflict with the bill. The effect of this amendment, taken 
together with the expanded right of judicial review established 
by the bill, cannot be overstated: it will now be much more 
difficult for any agency to protect public health, safety, or 
the environment under any of the laws that Congress has passed 
over the last quarter of a century.
    Section 3201(f) expressly states that the requirements of 
subtitle (b) ``supersede the decisional criteria for rulemaking 
otherwise applicable under the statute pursuant to which the 
rule is promulgated.'' (While the bill purports not to override 
existing statutes or risk assessment, this provision is mooted 
by the much broader requirements of subtitle (b) which 
effectively require every agency to conduct risk assessments 
for virtually every rule.) More significantly, the bill 
prohibits any agency from acting to protect health, safety or 
the environment under its existing lawful authority unless it 
also complies with the bill's new requirements--including the 
requirement that the agency prove through detailed assessments 
that benefits will justify the costs.
    With one broad stroke, H.R. 9 now overturns dozens of laws 
that were carefully considered by Congress and signed by 
Presidents (many of them Republican) after years of public 
debate on the best way to protect American workers, consumers, 
and the environment. In many case, Congress decides that laws 
requiring strict cost-benefit analyses would not provide the 
desired levels of protection, recognizing that costs and 
benefits can be very difficult to quantify and endlessly 
debated. After years of inaction by the EPA, for example, 
Congress set standards and deadlines for EPA to follow in 
setting criteria for safe drinking water and required the use 
of best available technologies to clean up hazardous air 
pollutants. Recognizing the difficulty of setting prices on 
wilderness, open spaces, and biological diversity, Congress in 
the Endangered Species Act and other acts set out clear 
standards for protecting natural areas and threatened species. 
Numerous health, safety and environmental laws are based on 
factors other than, or in addition to, costs and benefits.
    Now these and many other unidentified laws will be swept 
away. Indeed, it is difficult even to know the potential scope 
and implications of this repeal. When asked at the markup, 
neither the Chairman nor the Committee Counsel could identify 
the laws being repealed. Given the fact that the bill applies 
to all agencies and virtually all regulations which could 
impact health, safety, or the environment, it is plain that 
this repeal will have widespread unintended effects. Will it 
apply to regulations relating to childhood immunization 
programs? Regulations by USDA relating to soil conservation 
programs or pest importation programs? Regulations by the 
Immigration and Naturalization Service relating to the 
immigration of persons with contagious diseases? Regulations by 
the Bureau of Prisons relating to the safety and health of 
federal prisoners?
    It may well be that the environmental, health, and safety 
laws should be re-examined and amended in light of the current 
concerns about costly over regulation. Certainly every Member 
has heard the regulatory horror stories; everyone acknowledges 
that Superfund needs to be overhauled. But we should address 
those changes directly by debating and amending the underlying 
statutes, not by a back-door repeal that adds yet another layer 
of bureaucracy and litigation on top of an already costly and 
cumbersome regulatory process.
Litigation explosion
    H.R. 9 could well be subtitled the ``Full Employment for 
Lawyers Act.'' The Act directly expands the scope of judicial 
review for virtually every agency rule that protects the 
environment, health, or safety. The result will be a litigation 
explosion similar to the one experienced after the enactment of 
a similar `` procedural'' statute: The National Environmental 
Policy Act (NEPA). Litigation just drives up costs, creates 
legal uncertainty, delays regulations, and diverts scarce 
public and private resources into nonproductive activity. The 
expanded judicial review afforded by H.R. 9 provides a blunt 
weapon to any party interested in delaying a regulatory 
proceeding--whether an environmental group, industry, or even 
competitors.
    Under the Administrative Procedures Act, any affected party 
already has the right to seek judicial review of final agency 
actions. If a court finds the agency's action to be arbitrary 
or capricious, it will overturn the agency action. The court 
will look at the agency's rulemaking record, which will include 
any risk, cost, or benefit assessments.
    This existing right of judicial review is apparently not 
sufficient for the sponsors of H.R. 9. First, section 
3201(f)(2) changes the standards by which a court reviews an 
agency rule from the existing ``arbitrary and capricious'' 
standard to the higher ``substantial evidence'' standard. 
Second, by adding numerous mandatory procedures, H.R. 9 changes 
the scope of judicial review. Instead of reviewing the agency's 
record as a while to determine whether the agency's action is 
arbitrary and capricious, the court will be able to overturn an 
agency's action solely on the basis that the agency failed to 
follow the exact procedures and certifications set out in the 
bill. For example, courts will have to review the agency's 
certification that the cost and risk assessments were based on 
``objective and unbiased scientific and economic information of 
all significant and relevant information.'' This inquiry will 
inevitably mire the courts in complex scientific and technical 
debates, a role that judges themselves, including Justice 
Stephen J. Breyer, have said is inappropriate.
    The Walker amendment provision that judicial review is to 
be under the Administrative Procedures Act is apparently 
intended to preclude premature interim judicial reviews being 
sought while an agency rulemaking is in progress. But this 
provision fixes only a part of the problem and in any event 
conflicts with section 3201(f)(2). In contrast, the Roemer 
amendment offered at markup would not enlarge judicial review 
by ensuring that the failure to follow the exact procedures of 
the bill would not in and of itself be a basis for overturning 
a rule. The Roemer amendment was identical to language offered 
by Senator Johnston and adopted twice by the Senate on large 
bipartisan margins in the last Congress.
    Some have argued that expanded judicial review is necessary 
to ensure that agencies follow the new mandatory procedural 
requirements. The fact is that there are plenty of incentives 
to ensure the agencies's compliance. First, the agencies' 
compliance will be subject to Congressional oversight. Second, 
new requirements for public participation, transparency, and 
peer review should ensure the quality of the agency's work as 
well as its adherence to the bill's requirements. Third, the 
bill requires an independent National Peer Review panel to 
oversee the agency's compliance, as well as providing for 
separate reviews by the Office of Management and Budget (OMB). 
Finally, as a practical matter, agencies are likely to be at 
higher risk of having their rules reversed on judicial review 
if they fail substantially to follow the procedural 
requirements.

                         the rush to judgement

    In an effort to meet the arbitrary 100-day deadline of the 
Contract with America, the Committee abdicated its 
responsibility to fully consider this bill. Members had little, 
if any, time to consider the bill or amendments. The result is 
a poorly-drafted, ill-considered piece of legislation that will 
have widespread unintended consequences and make legitimate 
regulation to protect public health, safety, and the 
environment much more difficult. By sending this bill to the 
House floor without the benefit of this Committee's expertise, 
we are doing little more than sending a shell bill over to the 
Senate which will end up writing the real legislation.
    Many of the Democratic Members of this Committee have been 
active participants in efforts to promote risk assessment 
legislation and sensible regulatory reform. In the last 
Congress, the Committee held four subcommittee hearings on risk 
assessment and worked on a risk assessment bill for many months 
before bringing it to markup. That bill was subject to 
extensive outside review and many negotiating sessions that 
were open to all Members of the Committee.
    Yet that bill was far less complex and sweeping than the 
legislation before us now, which was developed behind closed 
doors and without any input from any Democratic Member despite 
repeated requests. Notice was provided to be as minimal as 
possible and still comply with the rules. Subcommittee hearings 
and markups were dispensed with. Initially, the Chairman 
proposed a single day of hearings, to be composed of a single 
panel of witnesses sympathetic to the bill, and rejected the 
Administration's requests to testify. We were forced to ask for 
a second day of hearings to even ensure that the Administration 
had an opportunity to present its views to the Committee. We 
also requested written information from the Cabinet Departments 
and several independent agencies to ensure that Members had 
some information about the impacts of this wide-ranging bill.
    The full committee markup commenced on February 8, the 
morning of the third day after the conclusion of testimony. The 
Committee had yet to receive many agency responses analyzing 
the impact of the bill or responses to questions requested from 
witnesses. Despite the Chairman's announced intention that all 
amendments should be submitted 24 hours in advance of the 
markup, the Chairman's own extensive amendments were not 
distributed to Members until the beginning of the markup. (A 
copy marked ``draft'' was provided to the Democratic staff at 
6:15 p.m. the evening before, but it was clear that it was not 
a final draft and was not being provided for circulation. The 
final version, which contained several significant differences, 
was time-stamped 11:36 p.m. from Legislative Counsel's office 
but no copy was made available to the Democratic staff or 
Members until the morning of the markup). No other Republican 
amendments were made available until the morning of the markup.
    The Chairman's amendments, presented to the Members for the 
first time at the mark-up, were extensive; they fundamentally 
changed the scope and application of the bill, added provisions 
on judicial review, and for the first time, clearly overrode 
existing laws. In addition, they were prepared as nearly 5 en 
bloc ``cut and bite'' amendments, a format to which we had 
previously indicated to the Republican staff that we would 
object. After objection, the amendments were redrafted as an 
amendment in the nature of a substitute, and the Chairman 
recessed the markup for two hours to permit Members to review 
it and to redraft amendments to it. The markup raised a number 
of unanswered questions about the bill's provisions.

                  telling scientists how to do science

    As reported, this bill tells scientists how to do risk and 
cost-benefit assessments. The very prescriptive language in the 
bill reflects the belief that Members of Congress know better 
than scientists how to do risk and cost-benefit assessments.
    Scientists are instructed to use the ``most scientifically 
objective and unbiased information'', and the ``most plausible 
assumptions'' to calculate ``best estimates'' (defined 
elsewhere as ``central'' estimates) of risk. While these terms 
sound innocuous and even appealing, they mean different things 
to scientists than they do to lay people. At best, they create 
enormous confusion: there is no consensus within the scientific 
community as to what is ``most plausible'', nor is there any 
way to judge this before the fact. At worst, they overrule by 
legislative fiat the considered judgement of the scientific 
community regarding risk assessment. Given the widespread 
confusion about these terms, and their potential for mischief, 
it is worth explaining these concerns in more detail.
    1. ``Most Plausible Assumptions.''
    In many cases, risk assessors are faced with an absence of 
good, quality data. In such cases, they must make assumptions, 
or use ``default options.'' Obviously, the choice of those 
assumptions can affect the magnitude of the estimated risk. The 
National Research Council, in its 1994 report ``Science and 
Judgement In Risk Assessment,'' described default options used 
in the Agency's risk assessment guidelines as:

          Options used in the absence of convincing scientific 
        knowledge on which of several competing models and 
        theories is correct. The options are not rules that 
        bind the Agency; rather, they constitute guidelines 
        from which the Agency may depart when evaluating the 
        risks posed by a specific substance.

    The National Research Council recommended that principles 
be developed for choosing default options and for judging when 
and how to depart from them. In formulating such principles, 
the following criteria were identified: protecting the public 
health, ensuring scientific validity, minimizing serious errors 
in estimating risks, maximizing incentives for research, 
creating an orderly and predictable process, and fostering 
openness and trustworthiness. These principles inevitably 
exceed the domain of science and involve policy choices on how 
to balance such criteria.
    The bill tells scientists to use the ``most plausible 
assumption,'' but if scientists knew what the ``most 
plausible'' assumptions was, they wouldn't need to make an 
assumption in the first place; it is precisely because there is 
doubt about what is the most predictive ``model'' to use that 
assumptions must be made. Scientists don't know what ``most 
plausible'' means in any scientific or statistical sense. The 
phrase is simply meaningless.
    Indeed, a standard that is based on ``best estimates'' 
(including use of ``most plausible'' assumptions) and 
``unbiased'' information could lead an Agency to seriously 
underestimate the risks to those segments of the population 
most at-risk. These terms could be interpreted as excluding 
consideration of subsets of the population--such as children, 
the elderly, diabetics, asthmatics, and others who may be more 
highly exposed or more vulnerable that the average adults--
simply because these subgroups have exposure or more vulnerable 
that the average adults--simply because these subgroups have 
exposure or susceptibility patterns that are different from 
most members of the population. In many cases, the greatest 
risk is often felt by the highly implausible combination of 
exposure and susceptibility, i.e., a highly exposed individual 
with greater than normal susceptibility to the hazard. Using a 
``most plausible'' standard--whatever it means--might lead an 
Agency to ignore such cases in its risk estimate.
    Lead poisoning is a good example of why the use of language 
such as ``most plausible,'' while perhaps well intentioned, can 
have disastrous effects. Young children have both far higher 
exposure to lead, and far greater susceptibility to its adverse 
effects. Their exposure is greater because young children have 
a high rate of what doctors call hand-to-mouth behavior--
meaning that toddlers go through the stage of putting their 
toys and other objects in their mouth as part of exploring 
their world. As a result, young children ingest far more dust 
and soil than do adults, dust and soil that is often 
contaminated with lead. Doing a risk assessment that makes the 
most plausible assumption about dust and soil ingestion could 
well be based on adult levels of dust ingestion since there are 
many more adults than children in the overall population, but 
it would grossly underestimate risks to children.
    Similarly, the best estimate of absorption of lead from the 
stomach into the blood is about 15% for adults, but close to 
50% for children; thus, use of an ``unbiased'' or ``most 
plausible'' value for the overall population will fail to 
reflect serious risks to important subgroups.
    The term ``bias'' and its converse ``unbiased'' are 
technical terms in mathematical modeling with a statistically 
exact meaning. Both the conventional linear, multi-stage cancer 
model and its maximum likelihood estimate are intentionally 
biased in their estimates of potency. Statistically unbiased 
estimates simply do not exist for the models that are generally 
employed in cancer risk assessment, making this provision 
technically infeasible. Further, as noted above by the National 
Research Council, all assumptions have inherent biases. What 
this language would appear to do is to prevent scientists from 
using assumptions and models which err on the side of 
protecting public health--a default option which is widely 
accepted throughout the scientific community as appropriate in 
many cases.
    2. ``Best Estimates,'' Uncertainty and Variability in Risk 
Assessment.
    Section 3105 sets forth detailed prescriptive language for 
risk communications, particularly given the way the term ``best 
estimates'' is later defined in section 3109 to be a 
``central'' estimate. The emphasis on ``best estimate(s)'' is 
contradictory to the recommendations of the National Research 
Council, which stresses the importance of providing a range of 
estimates and discussion of uncertainty of all estimates, 
rather than focusing on a single, best estimate. A sound risk 
characterization should present the full range of exposures, 
effects and risks, including but not limited to any single-
point estimate such as the ``best estimate'' proposed here. In 
this context, the range of risk estimates should reflect both 
actual variability in people's exposures and their own 
physiologic susceptibility, as well as uncertainties resulting 
from difficulties in measuring these variables and from lack of 
understanding of how to extrapolate from available data.
    Gaps in scientific knowledge lead to inevitable 
uncertainties in risk assessment. Some uncertainties dealing 
with measurement precision can be empirically quantified, while 
others, such as those related to the relevance of models for 
particular applications, cannot. For example, most single point 
estimates of risk do not convey the degree of uncertainty (and 
likewise the degree of conservatism) in the estimate. 
Similarly, variabilities within and among individuals, 
populations and species, variability in exposure and in 
susceptibility to a hazard related to age, lifestyle or 
habitat, genetic background, sex ethnicity as well as other 
factors, make it difficult, if not impossible, to accurately 
convey an environmental risk by a single point estimate.
    For those reasons, the amendment offered by Mr. Olver would 
have required the risk characterization to communicate the 
``full range of risks.'' This requirement was intended to 
convey the comprehensive distribution of risks of all types to 
all segments of the population, including highly exposed and 
highly susceptible individuals or subpopulations. In order to 
accurately convey this breadth, a probability distribution of 
risks would typically be favored over any single, statistical 
point estimate (i.e., the ``best estimate'') representing a 
particular segment of the exposed population or exposed 
species. A single estimate of risk in probabilistic terms 
conveys a level of certainty and a relevance to the public at 
large that is rarely if ever justified.
    The Olver amendment was consistent with the recommendations 
of the National Research Council that the entire risk range 
should be estimated and communicated in a risk 
characterization. This recommendation from the National 
Research Council was endorsed in a December 15, 1994 letter 
from the congressionally-mandated and Presidentially-appointed 
Commission on Risk Assessment and Risk Management to the 
authors of this legislation.
    Nevertheless, Subtitle A requires the use of ``best 
estimates of risk'' defined as a ``central estimate.'' This 
standard is not only misleading, but would fail to protect the 
half the population with slightly greater than average risk to 
an environmentally hazard.

               potentially misleading comparisons of Risk

    Subtitle A, Section 3105 and Subtitle B, Section 3201, call 
for risk comparisons that, at best, will confuse decisionmakers 
and the public and, at worst, will frighten and not educate 
them with respect to the seriousness of the risk in question. 
Few things have been as completely misunderstood as comparative 
risk analysis. The term has been widely misused and has clearly 
meant different things to different people.
    As used in this bill, comparative risk analysis is used to 
mean a tool to communicate the significance of a particular 
environmental risk to the public by comparing it to 
``everyday'' risks. But comparing the avoidable, involuntary 
risk of a toxic substance in drinking water to the risks of 
lightning or automobile travel is like trying to compare 
baseball statistics like RBIs and ERAs to determine who is a 
better baseball player. The risks are entirely dissimilar. The 
public may well be willing to take voluntary risks of equal 
magnitude with the risks that they want prevented by 
regulation.
    In an August 19, 1994 letter to Mr. Brown, then Chairman of 
the Committee on Science, Space, and Technology, three past 
presidents of the Society for Risk Analysis, state that, ``* * 
* comparative risk exercises conducted over the past decade 
have shown us that drawing quantitative comparisons among 
different kinds of risks * * * is almost impossible, and not 
credible if tried. The difficulty arises from our lack of 
understanding of how people value different kinds of losses * * 
*.'' They further note that not all comparisons communicate the 
risk in an equally relevant and meaningful way, and then go on 
to say, ``For instance, saying that sky-diving is (for example) 
ten thousand times more risky than living in a house with 10 
picocuries per liter of radon in the basement doesn't 
communicate very much. It is much more meaningful to know that 
having ten picocuries in your basement leads to as much extra 
radiation exposure as, say, ten airplane trips from New York to 
Los Angeles every year (or something of this sort.)''
    To be meaningful, risk comparisons should be done within an 
appropriate decisionmaking sphere. The language in this bill 
will not ensure that risk comparisons are done within an 
appropriate decisionmaking sphere and does not require that key 
determinants of acceptability of risk, such as whether the risk 
is voluntary or involuntary, preventable or not preventable, 
catastrophic or chronic, are included in the comparison.
    Knowing that a particular environmental risk is lesser or 
greater than some familiar risk does not change the regulator's 
responsibility to carry out environmental statutes. For an 
individual citizen, knowing that breathing the air in his or 
her town is less risky than driving a car doesn't give the 
individual any information relevant to any decisions--such as 
how to reduce that risk. While Agencies need to do more to 
communicate the significance of environmental risks, 
inappropriate risk comparisons such as these are simply more 
likely to mislead rather than inform the public.
    The most concise statement of problems with the type of 
comparative risk approach taken in the bill is contained in the 
following quotes from a February, 1995 editorial in Bioscience 
by Dr. Kristin Shrader-Frechette, a member of the National 
Academy of Sciences Board on Environmental Studies and 
Toxicology:

          Perhaps the biggest problem with comparative risk 
        assessment is that it mixes radically different types 
        of risk in a concession to bureaucratic number 
        crunching. If one hazard (such as a chemical dump) is 
        involuntarily imposed on citizens, whereas another 
        (such as eating fatty foods) is voluntarily accepted or 
        rejected by each individual, then the two risks may not 
        be comparable on the basis of probability alone. 
        Voluntariness or consent may trump probability. Also, 
        the first example of risk is societal; it imposes costs 
        on the public but awards benefits to the chemical 
        company. The risk can be reduced by government 
        regulation. The second example of risk is individual; 
        it imposes costs and benefits on the same person and 
        can be reduced by individual choices. Yet, proponents 
        of comparative risk assessment, by considering only the 
        probabilities, would say that the two risks are 
        comparable. They would stop us from reducing 
        preventable environmental risks simple because other 
        risks have higher probabilities.
          Reducing decision making to comparative risk 
        assessment presupposes that quantitative factors are 
        more important than ethical values such as equity. Yet 
        quantitative comparisons ignore questions such as who 
        performs the assessment, how the risk figures are 
        averaged, who is put at risk, why they are at risk, who 
        pays to reduce the risk, who benefits from the risk, 
        and who consents to the risk. No scientific technique 
        can justify imposing hazards on a community without 
        answering such questions. Scientific techniques such as 
        comparative risk assessment are necessary but not 
        sufficient for sound environmental policy. To assume 
        they are sufficient is to confuse facts with values, 
        technocracy with democracy.

           peer review and avoidance of conflicts of interest

    Subtitle C of the bill would establish extensive new 
requirements for peer review, many of which seem to conflict 
with existing standards. Under the bill as reported, peer 
review is likely to be carried out on a large number of 
relatively routine matters, wasting the resources of taxpayers 
and the scientific community alike. Scientists with serious 
conflicts of interest would be allowed to participate and 
apparently even to form a majority of the panel as long as 
their interests are disclosed to the agency.
    As a result, one of the most critical elements of peer 
review--namely balance--will be rendered virtually impossible. 
It is regrettable that the language in the bill does not call 
for members of peer review panels to be free from serious 
conflicts of interest and to comply with existing ethical 
standards, consistent with the Federal Advisory Committee Act.
    The bill provides for no definition of the word 
``external'' when used with respect to experts in this 
subtitle. It is perfectly logical, therefore, to expect that 
agencies in implementing this provision will exclude all 
Federal Agency scientists from participating in the peer 
review, thereby excluding the people who may have the greatest 
expertise from serving. At the same time, industry scientists 
need only reveal their conflict of interest in order to be 
allowed to serve on the panel and are only precluded from 
serving as a member of a peer review panel, when that review is 
directed at a decision that only affects the company for which 
the expert works.
    Specifically, the bill creates a peer review process with 
no protection from producing panels that are primarily composed 
of industry employees and consultants, and few or no truly 
independent scientists. This would occur because (i) the bill 
contains only extremely weak language calling for peer review 
panels to be balanced ``to the extent feasible''; (ii) the bill 
forbids exclusion of individuals on the ground of conflict-of-
interest, except in the most extreme case; and (iii) the 
language requiring the use of ``external'' experts, as noted 
above, could be interpreted as barring the participation of 
federal scientists from other agencies. (A practice allowed 
under current law.) This is a case of inviting the fox to guard 
the chicken coop.
    In light of the linkage of the peer review process in 
Subtitle C with the ``certification'' requirements of Subtitle 
B, it is critical that the peer review process established by 
this bill be, in fact, a neutral forum for discussion, where 
the best experts come together to review agency risk and cost-
benefit assessments. Unfortunately, the language in this bill 
will not ensure that such peer reviews are ``scientifically 
objective and unbiased'', a criterion which is emphasized in 
earlier parts of the bill.

                    cost-benefit analysis revisited

    Section 3201 of the bill would require the head of an 
agency to carry out extensive cost-benefit analyses and certify 
that ``no regulatory alternative'' would achieve a 
substantially equivalent risk reduction (1) more cost-
effectively or (2) more flexibly for regulated entities.
    The effort to reform the regulatory process is partly 
driven by a concern that the current rulemaking is not 
scientific enough. However, the cost-benefit process required 
in the bill obviously pushes beyond the state of the art in 
doing cost-benefit analysis. The answer the bill's sponsors 
offer up for questionable epidemiological studies will be 
questionable cost-benefit studies.
    Cost-benefit analysis is notoriously difficult to do well. 
As experts testified before the committee, it is impossible to 
anticipate all benefits or costs; many human health and 
ecological benefits are difficult to estimate and cost-benefit 
analysis of environmental programs usually undercount benefits 
relative to costs; scientific understanding is often 
insufficient to support a particular valuation of benefits; and 
the bill's inclusion of ``indirect costs and benefits'' leads 
to additional ambiguities. For example, Prof. John Graham of 
Harvard University testified that ``* * * both the scientific 
models and economic models often suffer from the same problem, 
which is that we are not able to validate, know for sure 
whether or not the prediction of the model in fact proved to be 
correct.'' Commenting on the same point, Dr. J. Clarence Davies 
III, former Assistant Administrator for Policy, Planning, and 
Evaluation at EPA during the Bush Administration, wrote, ``* * 
* the economic analysis necessary for each individual 
regulation would be greatly increased and would involve the use 
of economic models that will make risk assessment models look 
like scientific perfection in comparison.''
    While cost-benefit analysis is an important decision-making 
tool that should be encouraged, requiring an agency head to 
``certify'' that benefits will justify costs as a prerequisite 
for any regulation asks for a level of certainty and precision 
that cost-benefit analysis simply cannot offer. As Dr. Paul 
Portney of Resources for the Future testified, ``If the word 
certification is construed to mean some kind of proof, then I 
am afraid that this provision is unworkable and my concern 
about that is by overloading too much on benefit cost analysis 
and expecting it to deliver something that I think it is 
inherently incapable of delivering, I am afraid we are going to 
lose not only the baby, but also the bassinet with the bath 
water here.''
    Further, H.R. 9 would make such a certification judicially 
reviewable, creating endless opportunities for litigating the 
myriad difficulties of conducting cost-benefit analysis. To 
make matters worse, H.R. 9 also requires the agency head to 
certify that the regulatory approach proposed is superior to 
the universe of other alternative fixes that may have been 
pursued--and makes such a certification also judicially 
reviewable.
    In sum, H.R. 9 turns what is a laudable goal--encouraging 
better cost-benefit analysis--into an inflexible and 
unobtainable prerequisite for any regulation. As in the case 
with risk assessments, the result will not be faster, smarter, 
and cheaper regulation, but regulatory gridlock and a 
litigation explosion.

                                   George E. Brown, Jr. (CA).
                                   James A. Traficant, Jr. (OH).
                                   Jane Harman (CA).
                                   Eddie Bernice Johnson (TX).
                                   John W. Olver (MA).
                                   Alcee L. Hastings (FL).
                                   Lynn N. Rivers (MI).
                                   Karen McCarthy (MO).
                                   Mike Ward (KY).
                                   Zoe Lofgren (CA).
                                   Lloyd Doggett (TX).
                                   Sheila Jackson-Lee (TX).

                                
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