[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4306 Introduced in House (IH)]

103d CONGRESS
  2d Session
                                H. R. 4306

    To establish a comprehensive risk assessment program within the 
        Environmental Protection Agency, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 28, 1994

   Mr. Klein (for himself, Mr. Zimmer, Mr. Brown of California, Mr. 
   Studds, Mrs. Lloyd, Mr. Synar, Mr. Stenholm, Mr. Valentine, Mrs. 
   Morella, Mr. Pallone, Mr. Roemer, Mr. Swett, Mr. Deal, Ms. Eddie 
 Bernice Johnson of Texas, Mrs. Thurman, and Mr. Boehlert) introduced 
  the following bill; which was referred to the Committee on Science, 
                         Space, and Technology

_______________________________________________________________________

                                 A BILL


 
    To establish a comprehensive risk assessment program within the 
        Environmental Protection Agency, 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 Improvement Act of 
1994''.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) Risk assessment is a scientific procedure for 
        evaluating and quantifying the magnitude and severity of 
        environmental hazards which may threaten human health and 
        ecological resources and is an important tool for informed 
        policy and decisionmaking.
            (2) Research provides the scientific foundation for risk 
        assessment, yet risk assessment research is fragmented within 
        and across the Environmental Protection Agency and the Federal 
        agencies, complicating the setting of risk assessment research 
        priorities.
            (3) The risk assessment practices of the Environmental 
        Protection Agency and other Federal agencies must be 
        significantly improved if risk assessment is to provide maximum 
        utility to decisionmakers.
            (4) The Environmental Protection Agency and other Federal 
        agencies need to improve the degree and timeliness with which 
        they incorporate scientific advances into their risk assessment 
        methods and guidelines.
            (5) The risk assessment activities of the Environmental 
        Protection Agency and other Federal agencies are poorly 
        coordinated, such that risk assessment procedures and outcomes 
        within and across Federal agencies are often incompatible.
            (6) The data gaps, variability, and uncertainties inherent 
        in risk assessments are neither adequately communicated by risk 
        assessors nor clearly recognized by decisionmakers and the 
        public.
            (7) Improving the reliability, accuracy, and validity of 
        risk assessments will require additional research to fill data 
        gaps and to improve risk assessment methodologies, including 
        comparative risk analysis methodologies.
            (8) The Environmental Protection Agency and other Federal 
        agencies require a more effective mechanism to ensure 
        scientific peer review of risk assessments.
            (9) There is a lack of broadly skilled risk assessors and 
        insufficient resources to provide multidisciplinary training 
        and curricula needed for risk assessors and decisionmakers.
            (10) 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.

    It is the purpose of this Act--
            (1) to establish a Risk Assessment Program in the 
        Environmental Protection Agency that--
                    (A) develops and periodically revises risk 
                assessment guidelines within the Environmental 
                Protection Agency which reflect scientific advances;
                    (B) oversees the implementation of the guidelines 
                and ensures consistent application of the guidelines 
                throughout the Agency;
                    (C) provides for appropriate scientific peer review 
                of the risk assessment guidelines and risk assessments;
                    (D) identifies and conducts research needed to 
                advance the science of risk assessment; and
                    (E) develops risk characterization guidance and 
                oversees its implementation in order to communicate the 
                full range of risks and uncertainties;
            (2) to establish a pilot program on comparative risk 
        analysis; and
            (3) to establish an interagency coordinating process within 
        the Office of Science and Technology Policy, acting through the 
        National Science Technology Council, to promote more compatible 
        risk assessment procedures across Federal agencies.

SEC. 4. ESTABLISHMENT OF RISK ASSESSMENT PROGRAM.

    (a) Establishment.--There is established a Risk Assessment Program 
in the Environmental Protection Agency.
    (b) Director; Conduct of Program.--The Administrator shall appoint 
a Director of the Program, who has appropriate expertise in risk 
assessment, and acting through the Director, shall conduct the 
activities of the Environmental Protection Agency under the Program as 
provided in this Act.
    (c) Scientific Peer Review.--The Director shall develop a process 
to conduct scientific peer review of all risk assessment guidelines 
developed by the Environmental Protection Agency. The Director shall 
ensure that the guidelines provide for an independent scientific peer 
review process for risk assessment activities that contributes to the 
quality and objectivity of risk assessment. The Director may award 
grants and enter into contracts for the conduct of scientific peer 
review. Not later than 120 days after the date of the enactment of this 
Act, the Administrator shall submit to the Congress a report on a plan 
for conducting scientific peer review described in this subsection. The 
Administrator shall report to the Congress whenever significant 
modifications are made to the plan.
    (d) Advice to the Administrator.--The Director shall regularly 
provide to the Administrator advice and recommendations on the conduct 
of risk assessment, research needs, and the development of risk 
assessment guidelines within the Environmental Protection Agency.
    (e) Use of Services; Consultation.--In conducting activities under 
the Program, the Director may use the services of consultants, 
establish advisory boards, and, to the extent practicable, consult with 
the Science Advisory Board established under the Environmental 
Research, Development, and Demonstration Authorization Act of 1978, 
State and local government agencies, appropriate professional groups, 
and such representatives (with expertise in risk assessment) of 
industry, universities, agriculture, labor, consumers, conservation 
organizations, and other public interest groups, organizations, and 
individuals as appropriate.
    (f) Guideline Development.--
            (1) In general.--The Director shall regularly and 
        systematically develop, issue, and, not less than every 3 years 
        for each guideline, review the need to update risk assessment 
        guidelines consistent with the requirements of paragraph (2) 
        that establish methods for conducting scientifically sound risk 
        assessments. Whenever the Director determines that there has 
        been a significant scientific advancement which warrants the 
        updating of a guideline or that a specific risk assessment need 
        has arisen which is not addressed by a guideline, the Director, 
        after appropriate scientific peer review, shall provide interim 
        guidance on the use of the guidelines and the conduct of the 
        risk assessments.
            (2) Contents.--The risk assessment guidelines shall include 
        the following:
                    (A) An explanation of the scope and applicability 
                of the guidelines, including appropriate limitations or 
                restrictions on their use, and an identification of 
                appropriate Offices at the Environmental Protection 
                Agency to contact for further information on risk 
                assessment.
                    (B) Criteria for accepting and evaluating data, and 
                a complete description of any mathematical models or 
                other assumptions used in the risk assessment.
                    (C) Criteria for selecting default options based 
                upon explicitly stated science policy choices and 
                consideration of relevant scientific information. The 
                guidelines should set forth the justification and 
                validation for the default options, and provide 
                criteria for departing from or substituting any such 
                default option.
                    (D) An evaluation of the technical justification 
                and the degree of conservatism each default option 
                imposes upon the risk assessment.
                    (E) Criteria for using iterative or tiered 
                approaches to the risk assessment, with increasing 
                levels of effort and data requirements based on the 
                need for accuracy of the risk estimate.
                    (F) Criteria for conducting formal uncertainty 
                analysis during the course of the risk assessment, and 
                an explanation of the data needs for such analysis.
                    (G) Criteria for risk characterization in order to 
                facilitate accurate interpretation and appropriate use 
                of the assessment by decisionmakers.
                    (H) Effective methods for reporting risk 
                assessment, including formats which clearly identify 
                and distinguish sources of uncertainty and variability 
                in the risk assessment.
            (3) Report.--Not later than 180 days after the date of the 
        enactment of this Act, the Administrator shall submit to the 
        Congress a report on risk assessment guidelines which the 
        Environmental Protection Agency has developed, issued, and 
        updated and on the schedule within the Environmental Protection 
        Agency for reviewing the guidelines. The Administrator shall 
        report to the Congress whenever the guidelines are updated.
    (g) Use of Guidelines.--
            (1) In general.--The Director shall oversee the use of risk 
        assessment guidelines by the Program and Regional Offices of 
        the Environmental Protection Agency in the conduct of any risk 
        assessments that may be conducted by the Environmental 
        Protection Agency. The Director shall seek to ensure 
        consistency in the use of such guidelines, to the extent such 
        consistency is appropriate in application to various 
        environmental media or environmental hazards. The Director 
        shall supervise the use of such guidelines within the 
        Environmental Protection Agency to ensure that risk assessment 
        is, to the extent permitted by law, conducted, applied, and 
        practiced throughout the Offices of the Agency in accordance 
        with the guidelines and that advances made in one area of risk 
        assessment are applied as appropriate within the Agency to 
        other areas of risk assessment.
            (2) Departures from guidelines.--A Program or Regional 
        Office of the Environmental Protection Agency may not depart 
        from a guideline unless the departure is consistent with 
        guidance provided by the Director under subsection (f)(1). Any 
        interested person may petition the Director for review of a 
        decision by a Program or Regional Office to depart from a 
        guideline. Within 120 days after receiving the petition, the 
        Director shall, using appropriate scientific peer review, 
        review the decision to determine whether the departure was 
        warranted and whether to issue interim guidance under 
        subsection (f)(1).
    (h) Risk Characterization.--
            (1) In general.--The Director shall regularly and 
        systematically develop, issue, and update guidance within the 
        Environmental Protection Agency for any risk characterizations 
        that may be conducted by the Agency. The Director shall oversee 
        the use of such guidance within the Agency to ensure that any 
        such risk characterizations are complete and provide for 
        informed evaluation and use of risk assessment.
            (2) Contents.--The guidance shall include guidance on the 
        following:
                    (A) Relevant information on data and assessment 
                methods that significantly influence the risk estimate.
                    (B) Limitations, assumptions, and default options 
                included in the assessment and the rationale and extent 
                of scientific consensus with respect to their use.
                    (C) A statement that identifies major uncertainties 
                and their influence upon the assessment. The statement 
                shall characterize uncertainties associated with 
                experimental measurement errors and uncertainties 
                associated with the choice of specific models and 
                default options.
                    (D) The ranges of exposures derived from exposure 
                scenarios, their estimated probabilities.
                    (E) The use of both quantitative and qualitative 
                descriptors to present the full range of risks 
                encountered by the various populations and individuals 
                in a human health risk assessment, or by the various 
                species and ecological communities in an ecological 
                risk assessment, exposed to the environmental hazard 
                being evaluated in the risk assessment.
                    (F) A description of all appropriate statistical 
                expressions of the range and variability of the risk 
                estimate.
            (3) Report.--Not later than 180 days after the date of the 
        enactment of this Act, the Administrator shall submit to the 
        Congress a report on risk characterization guidance developed, 
        issued, and updated under this subsection. The Administrator 
        shall report to the Congress whenever risk characterization 
        guidance under this subsection is updated.
    (i) Risk Communication.--The Director shall promote open dialogue 
among scientists, decisionmakers, and the public in order to improve 
the use of risk assessments by decisionmakers and to accurately, 
objectively, and clearly communicate risk characterizations.
    (j) Research and Training in Risk Assessment.--
            (1) Evaluation.--The Director shall regularly and 
        systematically evaluate risk assessment research and training 
        needs of the Environmental Protection Agency, including the 
        following needs:
                    (A) Research with respect to data gaps, modeling 
                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, mechanisms of action in both 
                mammalian and non-mammalian species, 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 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 Administrator 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.

SEC. 5. PILOT PROJECT ON COMPARATIVE RISK ANALYSIS.

    (a) In General.--As part of the Program, the Director shall 
conduct, or provide for the conduct of, a pilot project using 
comparative risk analysis to rank dissimilar environmental risks and to 
provide a common basis for evaluating strategies for reducing or 
preventing those risks. The goal of the pilot project shall be to 
develop and test methods of comparative risk analysis which produce 
results that are replicable, testable, and objective.
    (b) Scope of Project.--The pilot project shall have sufficient 
scope and breadth to rigorously and scientifically test the feasibility 
and utility of employing comparative risk analysis. The pilot project 
shall compare and rank a range of diverse environmental risks, both as 
to risks to and within an environmental medium and risks across 
environmental media. The project shall draw on appropriate social 
science literature in formulating methods of comparative risk analysis.
    (c) Project Participants.--In conducting the pilot project, 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 pilot project 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) Evaluation of Use of Comparative Risk Analysis.--Not later than 
90 days after the termination of the pilot project, the Director shall 
submit to the Administrator a report that evaluates the results of the 
pilot project and that has been subject to scientific peer review. Not 
later than 30 days after receiving the report from the Director, the 
Administrator shall forward the report to the Congress with the results 
of the scientific peer review and recommendations regarding the 
advantages, disadvantages, and practical utility of using comparative 
risk analysis for decisionmaking in the Environmental Protection 
Agency.

SEC. 6. 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 
        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; and
            (4) establish appropriate mechanisms between Federal and 
        State agencies to communicate state-of-the-art risk assessment 
        practices.

SEC. 7. 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. Nothing in this Act shall be construed to require the 
conduct of a risk assessment or a risk characterization by the 
Environmental Protection Agency that is not required by law.

SEC. 8. DEFINITIONS.

    For purposes of this Act:
            (1) The term ``Administrator'' means the Administrator of 
        the Environmental Protection Agency.
            (2) The term ``comparative risk analysis'' means a process 
        to systematically measure, compare, and rank the severity of 
        environmental risks in order to provide a common basis for 
        evaluating strategies for reducing or preventing those risks.
            (3) The term ``default option'' means a condition, 
        assumption, or fact that is presumed unless information is 
        available which justifies an alternative.
            (4) The term ``Director'' means the Director of the Risk 
        Assessment Program established in section 4.
            (5) The term ``environmental hazard'' means any physical, 
        chemical, or biological agent, or a situation or circumstance 
        presented through an environmental medium, which may impose an 
        adverse effect upon human health or ecological resources.
            (6) The term ``environmental medium'' means the natural 
        occurrence of air, water, soil, or biologically-derived 
        material, or any combination or process thereof.
            (7) The term ``risk assessment'' means a rigorous and 
        systematic characterization of the potential adverse health or 
        ecological effects of exposure of human or nonhuman species to 
        environmental hazards.
            (8) The term ``risk assessment guideline'' means a peer-
        reviewed document of a Federal agency that contains 
        methodological recommendations pertaining to the practice or 
        application of risk assessment.
            (9) The term ``risk characterization'' means the 
        characterization of a risk, based on a risk assessment, that 
        quantitatively and qualitatively describes the probability and 
        severity of that risk in terms of the population exposed to the 
        risk and the types of potential effects of the exposure and 
        that explicitly states the range, variability, and attendant 
        uncertainty of that risk.
            (10) The term ``scientific peer review'' means the process 
        of objectively evaluating the technical accuracy, validity, and 
        clarity of a risk assessment by an impartial group of 
        technically qualified individuals.
            (11) The term ``uncertainty analysis'' means the systematic 
        process of identifying that which is not known or defined, 
        including measurement errors, as well as the lack of 
        fundamental knowledge needed to choose among alternative 
        hypotheses, assumptions, or experimental models.

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HR 4306 IH----2