[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 690 Introduced in House (IH)]







104th CONGRESS
  1st Session
                                H. R. 690

  To improve the use of risk assessment and cost-benefit analysis by 
                           Federal agencies.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 25, 1995

  Mr. Zimmer introduced the following bill; which was referred to the 
 Committee on Government Reform and Oversight and, in addition, to the 
  Committees on Science and Commerce, for a period to be subsequently 
   determined by the Speaker, in each case for consideration of such 
 provisions as fall within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
  To improve the use of risk assessment and cost-benefit analysis by 
                           Federal agencies.

    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 
Analysis Act of 1995''.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) Risk assessment and cost-benefit analysis are useful 
        tools that serve to enhance the information available in 
        developing public health and environmental regulations and 
        programs.
            (2) Risk assessment and cost-benefit analysis can also 
        serve as useful tools in setting priorities and evaluating the 
        success of public health and environmental protection programs.
            (3) Public and private resources available to address 
        health and environmental concerns are limited. Those resources 
        need to be allocated carefully so that the country addresses 
        the greatest needs in the most cost-effective manner.
            (4) To provide more cost-effective protection to human 
        health and the environment regulatory priorities should be 
        based upon risk assessment, comparative risk analysis that 
        incorporates societal values, and risk management choices that 
        consider cost-benefit principles.
            (5) Regulatory priorities have often not been based upon 
        consideration of potential risk nor has the opportunity for 
        risk reduction been fully considered.
            (6) Risk assessment has proved to be a useful scientific 
        decisionmaking tool. However, pertinent scientific data must be 
        better collected, organized, and evaluated by risk assessors 
        and information must be more effectively communicated from risk 
        assessors to decisionmakers and from decisionmakers to the 
        public.
            (7) Research provides the scientific foundation for risk 
        assessment, yet risk assessment research is fragmented within 
        and across Federal agencies, complicating the setting of risk 
        assessment research priorities.
            (8) The risk assessment practices of Federal agencies must 
        be significantly improved if risk assessment is to provide 
        maximum utility to decisionmakers.
            (9) Federal agencies need to improve the degree and 
        timeliness with which they incorporate scientific advances into 
        their risk assessment methods and guidelines.
            (10) The risk assessment activities of Federal agencies are 
        poorly coordinated, such that risk assessment procedures and 
        outcomes within and across Federal agencies are often 
        incompatible.
            (11) The data gaps, variability, and uncertainties inherent 
        in risk assessment are neither adequately communicated by risk 
        assessors nor clearly recognized by decisionmakers and the 
        public.
            (12) Improving the reliability, accuracy, and validity of 
        risk assessments will require additional research to fill data 
        gaps and improve risk assessment methodologies, including 
        comparative risk analysis methodologies.
            (13) Federal agencies require a more effective mechanism to 
        ensure scientific peer review is adequately reported in risk 
        assessments.
            (14) There is a lack of broadly skilled risk assessors and 
        insufficient resources to provide multidisciplinary training 
        and curricula needed for risk assessors and decisionmakers.
            (15) There is no common mechanism for collecting risk data, 
        for disseminating such data to all relevant Federal agencies, 
        and for updating risk assessment methodologies.

SEC. 3. PURPOSES.

    The purposes of this Act are the following:
            (1) To establish an Office of Risk Assessment and Cost-
        Benefit Analysis in each covered agency, that will--
                    (A) oversee the development, periodic revision, and 
                implementation of risk assessment guidelines throughout 
                the covered agency;
                    (B) provide for appropriate scientific peer review 
                of and public comment on risk assessment guidelines and 
                risk assessments throughout the process of development 
                and implementation;
                    (C) identify, prioritize, and recommend to the head 
                of the agency, research needed to advance the science 
                of risk assessment; and
                    (D) develop risk characterization guidance and 
                oversee its implementation in order to communicate a 
                description of the full range of risks and 
                uncertainties.
            (2) To direct the head of each covered agency to prioritize 
        research and regulatory initiatives to achieve the greatest 
        risk reductions by--
                    (A) prioritizing threats to human health and the 
                environment according to 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.
            (3) To direct the head of each covered agency to 
        incorporate risk-based priorities into the budget, strategic 
        planning, and research activities of the agency.

SEC. 4. REQUIREMENT FOR COVERED AGENCIES.

    In exercising authority under any Federal law to protect human 
health and the environment, the head of each covered agency shall--
            (1) conduct risk assessment and cost-benefit analysis for 
        all major rules protecting human health and the environment;
            (2) demonstrate that for all major rules the benefits to 
        human health or the environment justify the costs;
            (3) publish with each final rule an identification of the 
        most flexible and cost effective regulatory option and, if 
        those options are not employed, an explanation justifying why 
        they are not employed;
            (4) 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;
            (5) prioritize the use of resources available to the agency 
        under those laws to reduce those risks in accordance with the 
        priorities established under paragraph (4), including applying 
        the priorities to the budget, strategic planning, and research 
        activities of the agency; and
            (6) apply peer review to each risk assessment and each 
        cost-benefit analysis that may have a significant impact on 
        that exercise of authority.

SEC. 5. ESTABLISHMENT OF OFFICE OF RISK ASSESSMENT AND COST BENEFIT 
              ANALYSIS IN EACH COVERED AGENCY.

    (a) Establishment.--There is established in each covered agency an 
Office of Risk Assessment and Cost-Benefit Analysis.
    (b) Director, Generally.--There shall be at the head of the Office 
of each covered agency a Deputy Assistant Secretary or Deputy Assistant 
Administrator (as specified by the head of the covered agency), who 
shall be appointed by the head of the covered agency from among 
individuals having appropriate expertise in risk assessment.
    (c) Functions of the Director.--The head of each covered agency, 
acting through the Director for the agency, shall ensure that all risk 
assessments and cost benefit analyses conducted by the agency under 
section 4(2) are performed in accordance with risk assessment 
guidelines issued by the Director under subsection (f) and use 
relevant, reliable, and reasonably obtainable data.
    (d) Scientific Peer Review.--
            (1) In general.--The head of each covered agency, acting 
        through the Director, shall develop and apply a process to 
        conduct external and independent scientific peer review, 
        involving qualified individuals from a variety of disciplines 
        and a balanced representation of all interested persons, of all 
        risk assessment guidelines and risk assessments and cost-
        benefit analyses required by this Act.
            (2) Response of director.--As part of the peer review 
        process, the head of a covered agency, acting through the 
        Director, shall provide a written response to comments made by 
        the persons conducting the peer review. The response shall 
        indicate that the Director explicitly considered the comments, 
        the degree to which such comments have been incorporated into 
        the risk assessment guidelines or risk assessment, as 
        applicable, and the reason why a comment has not been 
        incorporated.
            (3) Selection of peer reviewers.--The head of each covered 
        agency, acting through the Director, shall provide for the 
        conduct of scientific peer review required by this Act by one 
        or more of the following entities:
                    (A) Science advisory boards or panels established 
                under other existing laws.
                    (B) Any other person determined by the Director to 
                be appropriate.
            (4) Grants, contracts, and agreements.--The head of a 
        covered agency, acting through the Director and subject to the 
        availability of appropriations, may enter into grants, 
        contracts, and interagency or other cooperative agreements for 
        the conduct of peer review under this Act.
            (5) Reports.--Not later than 180 days after the date of the 
        enactment of this Act, the head of each covered agency, acting 
        through the Director, shall submit to the Congress a report on 
        a plan for conducting scientific peer review under this Act, 
        and shall also report to the Congress whenever significant 
        modifications are made to the plan.
    (e) Use of Services; Consultation.--In conducting activities under 
this Act, the Director of a covered agency may--
            (1) use services of consultants,
            (2) establish advisory boards, and
            (3) to the extent practicable consult with--
                    (A) science advisory boards and panels established 
                under other laws,
                    (B) State and local government agencies,
                    (C) appropriate professional groups,
                    (D) appropriate representatives of industry, 
                universities, agriculture, labor, consumers, 
                conservation organizations, other public interest 
                groups and organizations, and
                    (E) individuals.
    (f) Issuance of Risk Assessment Guidelines.--
            (1) In general.--The Director of each covered agency shall 
        develop, issue, and publish risk assessment guidelines that 
        provide consistency and technical quality among risk 
        assessments performed by the agency.
            (2) Notice and comment.--Before issuing guidelines under 
        this subsection, the Director of a covered agency shall--
                    (A) publish all proposed guidelines for the purpose 
                of seeking public comment; and
                    (B) publish notice of the intent to revise existing 
                guidelines or to develop new guidelines and a list of 
                the issues the Director intends to address and upon 
                which the Director seeks public comment.
            (3) Review and updates.--The Director of a covered agency 
        shall review and, as necessary, update guidelines issued under 
        this subsection every 3 years.
            (4) Procedures for review of risk assessments.--Within 1 
        year after the date of the enactment of this Act, the head of 
        each covered agency shall develop and publish procedures for 
        the review and revision of any risk assessment performed by the 
        agency. The procedures shall provide for receiving and 
        considering new information from the public and criteria for 
        appropriate use of peer review and public comment in evaluating 
        new information.
            (5) Limitation on judicial review.--The development, 
        issuance, and publication of risk assessment guidelines under 
        this subsection shall not be subject to judicial review.
    (g) Use of Guidelines.--The Director of each covered agency shall 
oversee the use of risk assessment guidelines and the conduct of risk 
assessments by the agency. The Director shall seek to ensure 
consistency in the use of such guidelines to the extent such 
consistency is appropriate.
    (h) Use of Cost-Benefit Analysis.--The head of each covered agency 
acting through the Director shall conduct a cost-benefit analysis 
before issuing any major rule. The analysis shall include an assessment 
of incremental costs and incremental risk reduction or other benefits 
associated with significant regulatory alternatives considered in 
connection with the rule or proposed rule.
    (i) Research and Training in Risk Assessment.--
            (1) Evaluation.--The Director of each covered agency shall 
        regularly evaluate risk assessment research and training needs 
        of the agency, including the following:
                    (A) Research to improve model sensitivity and 
                otherwise reduce generic data gaps, particularly those 
                common to multiple risk assessments.
                    (B) Research leading to improvement of methods to 
                quantify and communicate uncertainty and variability 
                throughout risk assessment.
                    (C) 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.
                    (D) 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.
            (2) Strategy and actions to meet identified needs.--The 
        Director 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 evaluations conducted under 
        paragraph (1) and the strategy and schedule developed under 
        paragraph (2). The head of each covered agency shall report to 
        the Congress whenever the evaluations, strategy, and schedule 
        are updated or modified.

SEC. 6. RISK CHARACTERIZATION.

    (a) In General.--The head of each covered agency, acting through 
the Director, shall ensure that all risk characterizations make 
apparent the distinction between data and policy assumptions to 
facilitate interpretation and appropriate use of the characterization 
by decisionmakers.
    (b) Contents.--
            (1) In general.--At a minimum, risk characterizations shall 
        contain the following:
                    (A) Relevant information on data selection and 
                rejection in the risk assessment, including a specific 
                rationale justifying the basis for the selection.
                    (B) Identification of limitations and assumptions, 
                and the rationale and extent of scientific support with 
                respect to their use.
                    (C) A discussion of major uncertainties and their 
                influence upon the risk assessment.
                    (D) Identification of key data gaps and the likely 
                impact of additional data on the risk assessment.
            (2) Requirements regarding quantitative estimates of 
        risk.--At a minimum, a risk characterization that includes 
        quantitative estimates of risk shall contain the following:
                    (A) When scientifically feasible, the range and 
                distribution of exposures derived from exposure 
                scenarios used in the risk assessment of which the risk 
                characterization is a component, including upper bound 
                estimates and central estimates and, when appropriate 
                and practicable, the identification of susceptible 
                groups, species, and subpopulations whose exposure 
                exceeds the general population.
                    (B) When scientifically feasible, a description of 
                appropriate statistical expressions of the range and 
                variability of the risk estimate, including the 
                population or populations addressed by any risk 
                estimates, central estimates of risk for each such 
                specific population, any appropriate upper bound 
                estimates, the reasonable range, or other description 
                of uncertainties in the risk assessment of which the 
                risk characterization is a component.

SEC. 7. INTERAGENCY COORDINATION.

    To promote the conduct, application, and practice of risk 
assessment in a consistent manner under Federal law and with respect to 
different environmental media, and to identify risk assessment data and 
research needs common to more than one Federal agency, the Director of 
the Office of Science and Technology Policy shall--
            (1) periodically survey the manner in which each Federal 
        agency involved in risk assessment is conducting such risk 
        assessment to determine the scope and adequacy of risk 
assessment practices in use by the Federal Government;
            (2) provide advice and recommendations to the President and 
        the Congress based on the surveys conducted and determinations 
        made under paragraph (1);
            (3) establish appropriate interagency mechanisms to promote 
        coordination among Federal agencies conducting risk assessment 
        with respect to the conduct, application, and practice of risk 
        assessment and to promote the use of state-of-the-art risk 
        assessment practices throughout the Federal Government;
            (4) establish appropriate mechanisms between Federal and 
        State agencies to communicate state-of-the-art risk assessment 
        practices; and
            (5) periodically convene meetings with State government 
        representatives and Federal and other leaders to assess the 
        effectiveness of Federal-State cooperation in the development 
        and application of risk assessment.

SEC. 8. ANNUAL ENVIRONMENTAL QUALITY REPORT.

    (a) In General.--Section 201 of the National Environmental Policy 
Act of 1969 (42 U.S.C. 4341), requiring the President to transmit an 
annual Environmental Quality Report, is amended by striking ``The 
President'' and inserting ``The Director of the Office of Science and 
Technology''.
    (b) Conforming Amendments.--
            (1) Section 204 of such Act (42 U.S.C. 4344) is amended by 
        repealing paragraph (1).
            (2) Section 11(d) of the Federal Nonnuclear Energy Research 
        and Development Act of 1974 is amended--
                    (A) in the first sentence by inserting ``the 
                Director of the Office of Science and Technology,'' 
                after ``the Secretary,''; and
                    (B) in the second sentence by striking ``The 
                President'' and inserting ``The Director of the Office 
                of Science and Technology''.

SEC. 9. SAVINGS PROVISION.

    Nothing in this Act shall be construed to modify any requirement or 
standard provided for in another provision of law that provides for 
risk assessment or is designed to protect health, safety, or the 
environment.

SEC. 10. DEFINITIONS.

    For the purposes of this Act:
            (1) The term ``major rule'' means any rule (as that 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 
        $25,000,000 or more.
            (2) The term ``risk assessment'' means a process that uses 
        a factual base to--
                    (A) identify, characterize, and to the extent 
                practicable quantify the potential adverse effects of 
                exposure of individuals, populations, habitats, 
                ecosystems, or materials to hazardous pollutants or 
                other stressors; and
                    (B) to the extent practicable, identify and 
                characterize identifiable important uncertainties.
            (3) The term ``risk characterization'' means the final 
        component of a risk assessment, 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 exposure.
            (4) The term ``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.
            (5) The term ``Director'' means the Director of an Office.
            (6) The term ``Office'' means the Office of Risk Assessment 
        and Cost-Benefit Analysis of a covered agency.
            (7) The term ``covered agency'' means each of the 
        following:
                    (A) The Environmental Protection Agency.
                    (B) The Consumer Product Safety Commission.
                    (C) The Occupational Health and Safety 
                Administration.
                    (D) The Department of Labor.
                    (E) The Department of Transportation.
                    (F) The Department of Energy.
                    (G) The Department of Agriculture.
                    (H) The Department of the Interior.
                    (I) The Nuclear Regulatory Commission.
                                 <all>
HR 690 IH----2