[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1022 Engrossed in House (EH)]







104th CONGRESS
  1st Session
                                H. R. 1022

_______________________________________________________________________

                                 AN ACT


 
 To provide regulatory reform and to focus national economic resources 
  on the greatest risks to human health, safety, and the environment 
  through scientifically objective and unbiased risk assessments and 
through the consideration of costs and benefits in major rules, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Risk Assessment and Cost-Benefit Act 
of 1995''.

SEC. 2. 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 alternatives 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.

SEC. 3. COVERAGE OF ACT.

    This Act does not apply to any of the following:
            (1) A situation that the head of an affected Federal agency 
        determines to be an emergency. In such circumstance, the head 
        of the agency shall comply with the provisions of this Act 
        within as reasonable a time as is practical.
            (2) Activities necessary to maintain military readiness.
            (3) Any individual food, drug, or other product label, or 
        to any risk characterization appearing on any such label, if 
        the individual product label is required by law to be approved 
        by a Federal department or agency prior to use.
            (4) Approval of State programs or plans by Federal 
        agencies.

SEC. 4. UNFUNDED MANDATES.

    Nothing in this Act itself shall, without Federal funding and 
further Federal agency action, create any new obligation or burden on 
any State or local government or otherwise impose any financial burden 
on any State or local government in the absence of Federal funding, 
except with respect to routine information requests.

SEC. 5. DEFINITIONS.

    For purposes of this Act:
            (1) Costs.--The term ``costs'' includes the direct and 
        indirect costs to the United States Government, to State, 
        local, and tribal governments, and to the private sector, wage 
        earners, consumers, and the economy, of implementing and 
        complying with a rule or alternative strategy.
            (2) Benefit.--The term ``benefit'' means the reasonably 
        identifiable significant health, safety, environmental, social 
        and economic benefits that are expected to result directly or 
        indirectly from implementation of a rule or alternative 
        strategy.
            (3) Major rule.--The term ``major rule'' means any 
        regulation that is likely to result in an annual increase in 
        costs of $25,000,000 or more. Such term does not include any 
        regulation or other action taken by an agency to authorize or 
        approve any individual substance or product.
            (4) Program designed to protect human health.--The term 
        ``program designed to protect human health'' does not include 
        regulatory programs concerning health insurance, health 
        provider services, or health care diagnostic services.
            (5) Emergency.--As used in this Act, the term ``emergency'' 
        means a situation that is immediately impending and 
        extraordinary in nature, demanding attention due to a 
        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 
        if no action is taken.

SEC. 6. AVAILABILITY OF INFORMATION AMONG FEDERAL AGENCIES.

    Covered Federal agencies shall make existing databases and 
information developed under this Act available to other Federal 
agencies, subject to applicable confidentiality requirements, for the 
purpose of meeting the requirements of this Act. Within 15 months after 
the date of enactment of this Act, the President shall issue guidelines 
for Federal agencies to comply with this section.

               TITLE I--RISK ASSESSMENT AND COMMUNICATION

SEC. 101. SHORT TITLE.

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

SEC. 102. PURPOSES.

    The purposes of this title 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. 103. EFFECTIVE DATE; APPLICABILITY; SAVINGS PROVISIONS.

    (a) Effective Date.--Except as otherwise specifically provided in 
this title, the provisions of this title shall take effect 18 months 
after the date of enactment of this title.
    (b) Applicability.--
            (1) In general.--Except as provided in paragraph (3), this 
        title applies to all significant risk assessment documents and 
        significant risk characterization documents, as defined in 
        paragraph (2).
            (2) Significant risk assessment document or significant 
        risk characterization document.--(A) As used in this title, the 
        terms ``significant risk assessment document'' and 
        ``significant risk characterization document'' include, at a 
minimum, risk assessment documents or risk characterization documents 
prepared by or on behalf of a covered Federal agency in the 
implementation of a regulatory program designed to protect human 
health, safety, or the environment, used as a basis for one of the 
items referred to in subparagraph (B), and--
                    (i) included by the agency in that item; or
                    (ii) inserted by the agency in the administrative 
                record for that item.
            (B) The items referred to in subparagraph (A) are the 
        following:
                    (i) Any proposed or final major rule, including any 
                analysis or certification under title II, promulgated 
                as part of any Federal regulatory program designed to 
                protect human health, safety, or the environment.
                    (ii) Any proposed or final environmental clean-up 
                plan for a facility or Federal guidelines for the 
                issuance of any such plan. As used in this clause, the 
                term ``environmental clean-up'' means a corrective 
                action under the Solid Waste Disposal Act, a removal or 
                remedial action under the Comprehensive Environmental 
                Response, Compensation, and Liability Act of 1980, and 
                any other environmental restoration and waste 
                management carried out by or on behalf of a covered 
                Federal agency with respect to any substance other than 
                municipal waste.
                    (iii) Any proposed or final permit condition 
                placing a restriction on facility siting or operation 
                under Federal laws administered by the Environmental 
                Protection Agency or the Department of the Interior. 
                Nothing in this section (iii) shall apply to the 
                requirements of section 404 of the Clean Water Act.
                    (iv) Any report to Congress.
                    (v) Any regulatory action to place a substance on 
                any official list of carcinogens or toxic or hazardous 
                substances or to place a new health effects value on 
                such list, including the Integrated Risk Information 
                System Database maintained by the Environmental 
                Protection Agency.
                    (vi) Any guidance, including protocols of general 
                applicability, establishing policy regarding risk 
                assessment or risk characterization.
            (C) The terms ``significant risk assessment document'' and 
        ``significant risk characterization document'' shall also 
        include the following:
                    (i) Any such risk assessment and risk 
                characterization documents provided by a covered 
                Federal agency to the public and which are likely to 
                result in an annual increase in costs of $25,000,000 or 
                more.
                    (ii) Environmental restoration and waste management 
                carried out by or on behalf of the Department of 
                Defense with respect to any substance other than 
                municipal waste.
            (D) Within 15 months after the date of the enactment of 
        this Act, each covered Federal agency administering a 
        regulatory program designed to protect human health, safety, or 
        the environment shall promulgate a rule establishing those 
        additional categories, if any, of risk assessment and risk 
        characterization documents prepared by or on behalf of the 
        covered Federal agency that the agency will consider 
        significant risk assessment documents or significant risk 
        characterization documents for purposes of this title. In 
        establishing such categories, the head of the agency shall 
        consider each of the following:
                    (i) The benefits of consistent compliance by 
                documents of the covered Federal agency in the 
                categories.
                    (ii) The administrative burdens of including 
                documents in the categories.
                    (iii) The need to make expeditious administrative 
                decisions regarding documents in the 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.
                    (v) Such other factors as may be appropriate.
            (E)(i) Not later than 18 months after the date of the 
        enactment of this Act, the President, acting through the 
        Director of the Office of Management and Budget, shall 
        determine whether any other Federal agencies should be 
        considered covered Federal agencies for purposes of this title. 
        Such determination, with respect to a particular Federal 
        agency, shall be based on the impact of risk assessment 
        documents and risk characterization documents on--
                    (I) regulatory programs administered by that 
                agency; and
                    (II) the communication of risk information by that 
                agency to the public.
        The effective date of such a determination shall be no later 
        than 6 months after the date of the determination.
            (ii) Not later than 15 months after the President, acting 
        through the Director of the Office of Management and Budget, 
        determines pursuant to clause (i) that a Federal agency should 
        be considered a covered Federal agency for purposes of this 
        title, the head of that agency shall promulgate a rule pursuant 
        to subparagraph (D) to establish additional categories of risk 
        assessment and risk characterization documents described in 
        that subparagraph.
            (3) Exceptions.--(A) This title does not apply to risk 
        assessment or risk characterization documents containing risk 
        assessments or risk characterizations performed with respect to 
        the following:
                    (i) A screening analysis, where appropriately 
                labeled as such, including a screening analysis for 
                purposes of product regulation or premanufacturing 
                notices.
                    (ii) Any health, safety, or environmental 
                inspections.
                    (iii) The sale or lease of Federal resources or 
                regulatory activities that directly result in the 
                collection of Federal receipts.
            (B) No analysis shall be treated as a screening analysis 
        for purposes of subparagraph (A) if the results of such 
        analysis are used as the basis for imposing restrictions on 
        substances or activities.
            (C) The risk assessment principle set forth in section 
        104(b)(1) need not apply to any risk assessment or risk 
        characterization document described in clause (iii) of 
        paragraph (2)(B). The risk characterization and communication 
        principle set forth in section 105(4) need not apply to any 
        risk assessment or risk characterization document described in 
        clause (v) or (vi) of paragraph (2)(B).
    (c) Savings Provisions.--The provisions of this title shall be 
supplemental to any other provisions of law relating to risk 
assessments and risk characterizations, except that nothing in this 
title shall be construed to modify any statutory standard or statutory 
requirement designed to protect health, safety, or the environment. 
Nothing in this title 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. 104. PRINCIPLES FOR RISK ASSESSMENT.

    (a) In General.--The head of each covered Federal agency shall 
apply the principles set forth in subsection (b) in order to assure 
that significant risk assessment documents and all of their components 
distinguish scientific findings from other considerations and are, to 
the 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 which is available to the public.
    (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 relevant 
        laboratory and relevant 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, to the extent feasible and 
        appropriate, include discussion of possible reconciliation of 
        conflicting information, and as relevant, differences in study 
        designs, comparative physiology, routes of exposure, 
        bioavailability, pharmacokinetics, and any other relevant 
        factor, including the sufficiency of basic data for review. The 
        discussion of possible reconciliation should indicate whether 
        there is a biological basis to assume a 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, 
        the document shall, to the extent feasible--
                    (A) present a representative list and explanation 
                of plausible and alternative assumptions, inferences, 
                or models;
                    (B) explain the basis for any choices;
                    (C) identify any policy or value judgments;
                    (D) fully describe any model used in the risk 
                assessment and make explicit the assumptions 
                incorporated in the model; and
                    (E) indicate the extent to which any significant 
                model has been validated by, or conflicts with, 
                empirical data.

SEC. 105. PRINCIPLES FOR RISK CHARACTERIZATION AND COMMUNICATION.

    Each significant risk characterization document shall meet each of 
the following requirements:
            (1) Estimates of risk.--The risk characterization 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, 
        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 Federal agency); and
                    (B) a statement of the reasonable range of 
                scientific uncertainties.
        In addition to such best estimate or estimates, the risk 
        characterization document may present plausible upper-bound or 
        conservative estimates in conjunction with plausible lower 
        bounds estimates. Where appropriate, the risk characterization 
        document may present, in lieu of a single best estimate, 
        multiple best estimates based on assumptions, inferences, or 
        models which are equally plausible, given current scientific 
        understanding. To the extent practical and appropriate, the 
        document shall provide descriptions of the distribution and 
        probability of risk estimates to reflect differences in 
        exposure variability or sensitivity in populations and 
        attendant uncertainties. Sensitive subpopulations or highly 
        exposed subpopulations include, where relevant and appropriate, 
        children, the elderly, pregnant women, and disabled persons.
            (2) Exposure scenarios.--The risk characterization document 
        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 document shall contain a statement 
        that places the nature and magnitude of risks to human health, 
        safety, or the environment in context. Such statement shall, to 
        the extent feasible, provide comparisons with estimates of 
        greater, lesser, and substantially equivalent risks that are 
        familiar to and routinely encountered by the general public as 
        well as other risks, and, where appropriate and meaningful, 
        comparisons of those risks with other similar risks regulated 
        by the Federal agency resulting from comparable activities and 
        exposure pathways. Such comparisons should consider relevant 
        distinctions among risks, such as the voluntary or involuntary 
        nature of risks and the preventability or nonpreventability of 
        risks.
            (4) Substitution risks.--Each significant risk assessment 
        or risk characterization document 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 commenter provides a covered Federal agency 
                with a relevant risk assessment document or a risk 
                characterization document, and a summary thereof, 
                during a public comment provided by the agency for a 
                significant risk assessment document or a significant 
                risk characterization document, or, where no comment 
                period is provided but a commenter provides the covered 
                Federal agency with the relevant risk assessment 
                document or risk characterization document, and a 
                summary thereof, in a timely fashion, and
                    (B) the risk assessment document or risk 
                characterization document is consistent with the 
                principles and the guidance provided under this title,
        the agency shall, to the extent feasible, present such summary 
        in connection with the presentation of the agency's significant 
        risk assessment document or significant risk characterization 
        document. Nothing in this paragraph shall be construed to limit 
        the inclusion of any comments or material supplied by any 
        person to the administrative record of any proceeding.
A document may satisfy the requirements of paragraph (3), (4) or (5) by 
reference to information or material otherwise available to the public 
if the document provides a brief summary of such information or 
material.

SEC. 106. RECOMMENDATIONS OR CLASSIFICATIONS BY A NON-UNITED STATES-
              BASED ENTITY.

    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 title. For the purposes of this section, the 
term ``non-United States-based entity'' means--
            (1) any foreign government and its agencies;
            (2) the United Nations or any of its subsidiary 
        organizations;
            (3) any other international governmental body or 
        international standards-making organization; or
            (4) any other organization or private entity without a 
        place of business located in the United States or its 
        territories.

SEC. 107. GUIDELINES AND REPORT.

    (a) Guidelines.--Within 15 months after the date of enactment of 
this title, the President shall issue guidelines for Federal agencies 
consistent with the risk assessment and characterization principles set 
forth in sections 104 and 105 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) Report.--Within 3 years after the enactment of this title, each 
covered Federal agency shall provide a report to the Congress 
evaluating the categories of policy and value judgments identified 
under subparagraph (C) of section 104(b)(2).
    (c) Public Comment and Consultation.--The guidelines and report 
under this section, shall be developed after notice and opportunity for 
public comment, and after consultation with representatives of 
appropriate State, local, and tribal governments, and such other 
departments and agencies, offices, organizations, or persons as may be 
advisable.
    (d) Review.--The President shall review and, where appropriate, 
revise the guidelines published under this section at least every 4 
years.

SEC. 108. 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, where relevant and appropriate, the 
following:
            (1) Research to reduce generic data gaps, 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 among individuals, 
        species, populations, and, in the case of ecological risk 
        assessment, ecological communities.
            (3) 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.
            (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.
    (b) Strategy and Actions To Meet Identified Needs.--The head of 
each covered agency shall develop a strategy and schedule 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 periodically on the 
evaluations, strategy, and schedule.

SEC. 109. STUDY OF COMPARATIVE RISK ANALYSIS.

    (a) In General.--(1) The Director of the Office of Management and 
Budget, in consultation with the Office of Science and Technology 
Policy, shall conduct, or provide for the conduct of, a study using 
comparative risk analysis to rank health, safety, 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 
improve 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 health, 
safety, and 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 health, safety, and environmental risk reduction. The 
study shall compare and evaluate a range of diverse health, safety, and 
environmental risks.
    (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. 110. DEFINITIONS.

    For purposes of this title:
            (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. The term also 
        includes a written statement accepting the findings of any such 
        document.
            (2) Risk characterization document.--The term ``risk 
        characterization document'' means a document quantifying or 
        describing the degree of toxicity, exposure, or other risk 
        posed by hazards associated with a substance, activity, or 
        condition to which individuals, populations, or resources are 
        exposed. The term also includes a written statement accepting 
        the findings of any such document.
            (3) Best estimate.--The term ``best estimate'' means a 
        scientifically appropriate estimate which is based, to the 
        extent feasible, 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 alternative designed to decrease 
        other risks.
            (5) Covered federal agency.--The term ``covered Federal 
        agency'' means each of the following:
                    (A) The Environmental Protection Agency.
                    (B) The Occupational Safety and Health 
                Administration.
                    (C) The Department of Transportation (including the 
                National Highway Transportation Safety Administration).
                    (D) The Food and Drug Administration.
                    (E) The Department of Energy.
                    (F) The Department of the Interior.
                    (G) The Department of Agriculture.
                    (H) The Consumer Product Safety Commission.
                    (I) The National Oceanic and Atmospheric 
                Administration
                    (J) The United States Army Corps of Engineers.
                    (K) The Mine Safety and Health Administration.
                    (L) The Nuclear Regulatory Commission.
                    (M) Any other Federal agency considered a covered 
                Federal agency pursuant to section 103(b)(2)(E).
            (6) 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.
            (7) Document.--The term ``document'' includes material 
        stored in electronic or digital form.

        TITLE II--ANALYSIS OF RISK REDUCTION BENEFITS AND COSTS

SEC. 201. ANALYSIS OF RISK REDUCTION BENEFITS AND COSTS.

    (a) In General.--The President shall require each Federal agency to 
prepare the following for each major rule within a program 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) An identification of reasonable alternative strategies, 
        including strategies that--
                    (A) require no government action;
                    (B) will accommodate differences among geographic 
                regions and among persons with different levels of 
                resources with which to comply; and
                    (C) employ performance or other market-based 
                mechanisms that permit the greatest flexibility in 
                achieving the identified benefits of the rule.
        The agency shall consider reasonable alternative strategies 
        proposed during the comment period.
            (2) An analysis of the incremental costs and incremental 
        risk reduction or other benefits associated with each 
        alternative strategy identified or considered by the agency. 
        Costs and benefits shall be quantified to the extent feasible 
        and appropriate and may otherwise be qualitatively described.
            (3) A statement that places in context the nature and 
        magnitude of the risks to be addressed and the residual risks 
        likely to remain for each alternative strategy identified or 
        considered by the agency. Such statement shall, to the extent 
        feasible, provide comparisons with estimates of greater, 
        lesser, and substantially equivalent risks that are familiar to 
        and routinely encountered by the general public as well as 
        other risks, and, where appropriate and meaningful, comparisons 
        of those risks with other similar risks regulated by the 
        Federal agency resulting from comparable activities and 
        exposure pathways. Such comparisons should consider relevant 
        distinctions among risks, such as the voluntary or involuntary 
        nature of risks and the preventability or nonpreventability of 
        risks.
            (4) For each final rule, an analysis of whether the 
        identified benefits of the rule are likely to exceed the 
        identified costs of the rule.
            (5) An analysis of the effect of the rule--
                    (A) on small businesses with fewer than 100 
                employees;
                    (B) on net employment; and
                    (C) to the extent practicable, on the cumulative 
                financial burden of compliance with the rule and other 
                existing regulations on persons producing products.
    (b) Publication.--For each major rule referred to in subsection (a) 
each Federal 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).

SEC. 202. DECISION CRITERIA.

    (a) In General.--No final rule subject to the provisions of this 
title shall be promulgated unless the agency certifies the following:
            (1) That the analyses under section 201 are based on 
        objective and unbiased scientific and economic evaluations of 
        all significant and relevant information and risk assessments 
        provided to the agency by interested parties relating to the 
        costs, risks, and risk reduction and other benefits addressed 
        by the rule.
            (2) That the incremental risk reduction or other benefits 
        of any strategy 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.
            (3) That other alternative strategies identified or 
        considered by the agency were found either (A) to be less cost-
        effective at achieving a substantially equivalent reduction in 
        risk, or (B) to provide less flexibility to State, local, or 
        tribal governments or regulated entities in achieving the 
        otherwise applicable objectives of the regulation, along with a 
        brief explanation of why alternative strategies that were 
        identified or considered by the agency were found to be less 
        cost-effective or less flexible.
    (b) Effect of Decision Criteria.--
            (1) In general.--Notwithstanding any other provision of 
        Federal law, the decision criteria of subsection (a) shall 
        supplement and, to the extent there is a conflict, supersede 
        the decision 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 
        201 and subsection (a) are met and the certifications required 
        therein are supported by substantial evidence of the rulemaking 
        record.
    (c) Publication.--The agency shall publish in the Federal Register, 
along with the final regulation, the certifications required by 
subsection (a).
    (d) Notice.--Where the agency finds a conflict between the decision 
criteria of this section and the decision criteria of an otherwise 
applicable statute, the agency shall so notify the Congress in writing.

SEC. 203. OFFICE OF MANAGEMENT AND THE BUDGET GUIDANCE.

    The Office of Management and Budget shall issue guidance consistent 
with this title--
            (1) 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; and
            (2) governing the development and preparation of analyses 
        of risk reduction benefits and costs.

SEC. 204. ENVIRONMENTAL CLEAN-UP.

    For purposes of this title, any determination by a Federal agency 
to approve or reject any proposed or final environmental clean-up plan 
for a facility the costs of which are likely to exceed $5,000,000 shall 
be treated as major rule subject to the provisions of this title (other 
than the provisions of section 201(a)(5)). As used in this section, the 
term ``environmental clean-up'' means a corrective action under the 
Solid Waste Disposal Act, a remedial action under the Comprehensive 
Environmental Response, Compensation, and Liability Act of 1980, and 
any other environmental restoration and waste management carried out by 
or on behalf of a Federal agency with respect to any substance other 
than municipal waste.

                         TITLE III--PEER REVIEW

SEC. 301. PEER REVIEW PROGRAM.

    (a) Establishment.--For regulatory programs designed to protect 
human health, safety, or the environment, the head of each Federal 
agency shall develop a systematic program for independent and external 
peer review required by subsection (b). 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 relevant and appropriate, may 
        include representatives of State, local, and tribal 
        governments, small businesses, other representatives of 
        industry, universities, agriculture, labor, consumers, 
        conservation organizations, or other public interest groups and 
        organizations;
            (2) may provide for differing levels of peer review and 
        differing numbers of experts on peer review panels, 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.--In connection with any rule that 
is likely to result in an annual increase in costs of $100,000,000 or 
more (other than any rule or other action taken by an agency to 
authorize or approve any individual substance or product), each Federal 
agency shall provide for peer review in accordance with this section of 
any risk assessment or cost analysis which forms the basis for such 
rule or of any analysis under section 201(a). 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.--Each peer review under this section shall include a 
report to the Federal agency concerned with respect to the scientific 
and economic merit of data and methods used for the assessments and 
analyses.
    (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.
    (f) Previously Reviewed Data and Analysis.--No peer review shall be 
required under this section for any data or method which has been 
previously subjected to peer review or for any component of any 
analysis 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.

                       TITLE IV--JUDICIAL REVIEW

SEC. 401. JUDICIAL REVIEW.

    Compliance or noncompliance by a Federal agency with the 
requirements of this Act shall be reviewable pursuant to the statute 
granting the agency authority to act or, as applicable, that statute 
and the Administrative Procedure Act. The court with jurisdiction to 
review final agency action under the statute granting the agency 
authority to act shall have jurisdiction to review, at the same time, 
the agency's compliance with the requirements of this Act. When a 
significant risk assessment document or risk characterization document 
subject to title I is part of the administrative record in a final 
agency action, in addition to any other matters that the court may 
consider in deciding whether the agency's action was lawful, the court 
shall consider the agency action unlawful if such significant risk 
assessment document or significant risk characterization document does 
not substantially comply with the requirements of sections 104 and 105.

                             TITLE V--PLAN

SEC. 501. PLAN FOR ASSESSING NEW INFORMATION.

    (a) Plan.--Within 18 months after the date of enactment of this 
Act, each covered Federal agency (as defined in title I) shall publish 
a plan to review and, where appropriate revise any significant risk 
assessment document or significant risk characterization document 
published prior to the expiration of such 18-month period if, based on 
information available at the time of such review, the agency head 
determines that the application of the principles set forth in sections 
104 and 105 would be likely to significantly alter the results of the 
prior risk assessment or risk characterization. The plan shall provide 
procedures for receiving and considering new information and risk 
assessments from the public. The plan may set priorities and procedures 
for review and, where appropriate, revision of such risk assessment 
documents and risk characterization documents and of health or 
environmental effects values. The plan may also set priorities and 
procedures for review, and, where appropriate, revision or repeal of 
major rules promulgated prior to the expiration of such period. Such 
priorities and procedures shall be based on the potential to more 
efficiently focus national economic resources within Federal regulatory 
programs designed to protect human health, safety, or the environment 
on the most important priorities and on such other factors as such 
Federal agency considers appropriate.
    (b) Public Comment and Consultation.--The plan under this section, 
shall be developed after notice and opportunity for public comment, and 
after consultation with representatives of appropriate State, local, 
and tribal governments, and such other departments and agencies, 
offices, organizations, or persons as may be advisable.

                          TITLE VI--PRIORITIES

SEC. 601. PRIORITIES.

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

            Passed the House of Representatives February 28, 1995.

            Attest:

                                                                 Clerk.
                                     







104th CONGRESS

  1st Session

                               H. R. 1022

_______________________________________________________________________

                                 AN ACT

 To provide regulatory reform and to focus national economic resources 
  on the greatest risks to human health, safety, and the environment 
  through scientifically objective and unbiased risk assessments and 
through the consideration of costs and benefits in major rules, and for 
                            other purposes.