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

                                                 Union Calendar No. 474

103d CONGRESS

  2d Session

                               H. R. 4306

                          [Report No. 103-857]

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                            October 7, 1994

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed

                                                 Union Calendar No. 474
103d CONGRESS
  2d Session
                                H. R. 4306

                          [Report No. 103-857]

    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

                            October 7, 1994

Additional sponsors: Mr. Minge, Mr. Barca of Wisconsin, Mr. McHale, Mr. 
Hughes, Mr. Beilenson, Ms. Eshoo, Mr. Sanders, Mr. Johnson of Georgia, 
                       Mr. Inslee, and Mr. Porter

                            October 7, 1994

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
 [For text of introduced bill, see copy of bill as introduced on April 
                               28, 1994]

_______________________________________________________________________

                                 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 rigorous and systematic procedure 
        for evaluating and quantifying environmental hazards which may 
        threaten human health and ecological resources and is an 
        important tool for informed policy and decisionmaking.
            (2) While risk assessment is important to the environmental 
        decisionmaking process, risk assessment alone is not a 
        sufficient basis for environmental decisionmaking, which must 
        also ensure the consideration of a full range of political, 
        economic, environmental, and social equity concerns, and 
        societal values.
            (3) 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.
            (4) 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.
            (5) 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.
            (6) 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.
            (7) 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.
            (8) 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.
            (9) The Environmental Protection Agency and other Federal 
        agencies require a more effective mechanism to ensure 
        scientific peer review of risk assessments.
            (10) There is a lack of broadly skilled risk assessors and 
        insufficient resources to provide multidisciplinary training 
        and curricula needed for risk assessors and decisionmakers.
            (11) 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 and public comment on the risk assessment guidelines 
                and risk assessments throughout the process of 
                guideline development and implementation;
                    (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 a 
                scientifically sound, unbiased, and accurate 
                description of the full range of risks and significant 
                uncertainties;
            (2) to establish a study of comparative risk analysis; and
            (3) to direct the Office of Science and Technology Policy, 
        acting through the National Science Technology Council, to 
        establish an interagency coordinating process 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. The Director shall be compensated at the rate 
authorized for level V of the Executive Schedule in section 5316 of 
title 5, United States Code.
    (c) Scientific Peer Review.--
            (1) In general.--The Director shall develop a process to 
        conduct independent scientific peer review, involving qualified 
        individuals from a variety of disciplines and interests, of all 
        risk assessment guidelines developed by the Environmental 
        Protection Agency.
            (2) Response of director.--As part of the peer review 
        process, 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 guidelines, and, the reasons why a 
        comment has not been fully incorporated.
            (3) Selection of peer reviewers.--The Administrator shall 
        provide for the conduct of scientific peer review required by 
        this Act by one or more of the following entities:
                    (A) The Science Advisory Board established under 
                the Environmental Research, Development, and 
                Demonstration Authorization Act of 1978.
                    (B) Any other appropriate science advisory panel of 
                the Environmental Protection Agency.
                    (C) Any other person, agency, or institution. The 
                Director may award a grant to, and enter into a 
                contract, interagency agreement, or cooperative 
                agreement with, such person, agency, or institution for 
                the conduct of such scientific peer review.
            (4) 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 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) Development.--
                    (A) In general.--The Director shall regularly and 
                systematically develop and issue, through publication 
                in the Federal Register, risk assessment guidelines 
                that seek to provide consistency and technical quality 
                and ensure that risk assessments conducted by the 
                Agency shall be scientifically objective and unbiased 
                and that significant uncertainties regarding facts, 
                scientific knowledge, and the validity of analytical 
                techniques, or numerical risk estimates are clearly 
                disclosed in terms readily understandable to the 
                public. The guidelines shall ensure that risk 
                assessments performed by the Agency make use of the 
                best information and the most plausible and unbiased 
                assumptions, given the scientific information available 
                to the Administrator.
                    (B) Deadlines for compliance.--The Director shall 
                ensure that risk assessment guidelines issued by the 
                Environmental Protection Agency are consistent with the 
                requirements of paragraph (3) according to the 
                following schedule:
                            (i) Not later than 3 years after the date 
                        of the enactment of this Act, for guidelines 
                        that were issued by the Environmental 
                        Protection Agency, or are under development, 
                        prior to the date of the enactment of this Act.
                            (ii) On the date of their issuance, for 
                        guidelines that are developed and issued by the 
                        Environmental Protection Agency after the date 
                        of the enactment of this Act.
                    (C) Updates.--The Director shall review the need to 
                update the guidelines referred to in clauses (i) and 
                (ii) of subparagraph (B) not less than once every 3 
                years after the date by which such guidelines are made 
                consistent with the requirements of paragraph (4).
                    (D) Interim guidance.--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 providing for appropriate scientific peer review 
                and opportunity for public participation, shall provide 
                interim guidance on the use of the guidelines and the 
                conduct of the risk assessments. The Director shall 
                make available to the public any interim guidance 
                provided, the results of any scientific peer review 
                conducted, and any public comment received, under this 
                paragraph. The Director shall issue the interim 
                guidance in accordance with paragraph (2) and, as 
                appropriate, shall incorporate the interim guidance 
                into the guideline when the Director next reviews the 
                need to update that guideline under subparagraph (C).
            (2) Process for guideline development.--When developing or 
        revising a risk assessment guideline or interim guidance, the 
        Director shall publish in the Federal Register a declaration of 
        the intent to issue the guideline or interim guidance, together 
        with the text of the proposed guideline or interim guidance, 
        and shall provide an opportunity for public notice and comment 
        on the proposal. After the close of the comment period and any 
        informal hearing that may be held, the Director shall prepare 
        and place in the public record a response to the comments that 
        were submitted on the proposal and shall issue the new or 
        revised guideline or interim guidance by publishing the 
        document in the Federal Register along with a summary of the 
        Director's response to comments.
            (3) Scope and applicability of guidelines.--The guidelines 
        shall address issues relevant to human and ecological risk 
        assessments and to fundamental aspects of risk assessment 
        procedures and practices. The Administrator shall conduct risk 
        assessments in accordance with all appropriate guidelines. 
        Discussions or explanations required under paragraph (4) need 
        not be repeated in each risk assessment as long as there is 
        reference to the relevant discussion or explanation in another 
        Agency document. Exercises conducted by the Environmental 
        Protection Agency which serve an internal planning function, 
        and which do not support a final Agency action or rule, may be 
        determined by the Director not to be subject to the provisions 
        of this Act. Screening analyses where the results of such 
        analyses are not used as the basis for imposing restrictions on 
        substances or activities and the results of the analyses are 
        not used to characterize a positive finding of risks from 
        substances or activities in any final Agency document made 
        available to the general public shall be excluded from the 
        provisions of this Act. A risk assessment which departs from a 
        guideline and which is conducted in support of an emergency 
        action, an expedited formal adjudication, emergency rule, or 
        emergency order which does not permit adequate time for 
        adherence to the procedures set forth in section 4(g)(2), shall 
        be exempt from the provisions of section 4(g)(2).
            (4) Contents.--The risk assessment guidelines shall, at a 
        minimum, include each of 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.
                    (C) A complete description of any mathematical 
                models or other assumptions likely to be used in the 
                risk assessment, including a discussion of their 
                plausibility.
                    (D) A description of the default options, the 
                justification and validation for the default options, 
                and an explicit statement of the rationale for 
                selecting a particular default option, in the absence 
                of adequate data, based on explicitly stated science 
                policy choices and consideration of relevant scientific 
                information.
                    (E) The technical justification for, and a 
                description of the degree of, conservatism each default 
                option imposes upon the risk assessment.
                    (F) Criteria for using iterative or tiered 
                approaches to risk assessment, with varying levels of 
                effort and data requirements in the conduct of risk 
                assessment based on the need for accuracy of the risk 
                estimate.
                    (G) Criteria for conducting uncertainty analysis 
                during the course of the risk assessment, and an 
                explanation of the data needs for such analysis.
                    (H) Guidance for risk characterization developed, 
                issued, and updated under subsection (h).
                    (I) Effective methods for reporting risk 
                assessment, to ensure that the results are reasonably 
                understandable by interested persons, including formats 
                which clearly identify and distinguish sources of 
                uncertainty and variability in the risk assessment.
                    (J) Criteria for identification and use of the most 
                plausible and unbiased methodologies and assumptions, 
                given the scientific information available to the 
                Administrator.
            (5) Report.--Not later than 180 days after the date of the 
        enactment of this Act, the Administrator shall submit to the 
        Congress a report that describes (A) the status of all risk 
        assessment guidelines issued before such date with respect to 
        the extent to which such guidelines are consistent with the 
        requirements of paragraph (4) and a schedule for making such 
        guidelines consistent with such requirements; (B) a schedule 
        for issuing any risk assessment guidelines which are being 
        developed by the Environmental Protection Agency on such date, 
        including a plan for making such guidelines consistent with the 
        requirements of paragraph (4); and (C) a plan for identifying 
        and developing future risk assessment guidelines consistent 
        with the requirements of paragraph (4). The Administrator shall 
        annually thereafter submit to the Congress an update of the 
        schedule referred to in subparagraph (B) and the plans referred 
        to in subparagraphs (B) and (C).
    (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 (A) interim guidance is provided by the 
        Director under subsection (f)(1) which permits that departure; 
        or (B) that departure is for a specific risk assessment and is 
        approved in writing by the Director. The Director shall seek 
        appropriate scientific peer review of any such departure. Any 
        such departure shall seek to ensure the consistency referred to 
        in subsection (g)(1) and shall be included in any public record 
        of the specific risk assessment for which the departure was 
        made together with the justification for why that departure was 
        made.
    (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 all 
        such risk characterizations are as complete as practicable to 
        make apparent the distinction between data and policy 
        assumptions and to facilitate accurate interpretation and 
        appropriate use of the assessment by decisionmakers and 
        interested persons. The Director shall oversee the use of such 
        guidance within the Agency to ensure that all such risk 
        characterizations distinguish human health risks from 
        ecological and other risks. The Environmental Protection Agency 
        shall consider and incorporate, as appropriate, the 
        recommendations from the study of the Committee on Risk 
        Characterization of the National Academy of Sciences on risk 
        characterization and report to the Congress on the inclusion of 
        such recommendations in the risk characterization guidance.
            (2) Deadlines.--The Director shall ensure that initial risk 
        characterization guidance is issued, through publication in the 
        Federal Register, within 2 years after the date of the 
        enactment of this Act.
            (3) Contents.--At a minimum, the guidance shall require 
        that any risk characterization contain the following:
                    (A) Relevant information on data and assessment 
                methods that significantly influence the risk estimate.
                    (B) A statement of the limitations, assumptions, 
                and default options included in the assessment and a 
                statement of 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 range and distribution of exposures derived 
                from exposure scenarios used in a risk assessment, 
                including, for example, upper-bound and central 
                estimate(s) and their qualitative, or where possible 
                quantitative, likelihood, and, when available and 
                appropriate, the identification of highly susceptible 
                groups, species, individuals, and subpopulations whose 
                exposure exceeds that of the general population.
                    (E) The use of both quantitative and qualitative 
                descriptors, when available and appropriate, to present 
                a comprehensive range of risks which are or may be 
                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 appropriate statistical 
                expressions of the range and variability of the risk 
                estimate, including the population or populations 
                addressed by any risk estimate(s), central estimates of 
                the risk for the specific population, any appropriate 
                upper-bound and lower-bound estimates, and the 
                reasonable range or other description of uncertainties 
                in the assessment process.
                    (G) When providing estimates of risk to public 
                health, appropriate comparisons with estimates of other 
                risks to health, including those that are familiar to 
                and routinely encountered by the general public, and 
                relevant substitution risks, where information on such 
                risks is made available to the Administrator. In 
                stating comparisons, the Administrator shall identify 
                relevant distinctions among categories or risks and 
                limitations to comparisons.
            (4) 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 institute a program to 
promote open dialogue among scientists, decisionmakers, and the public 
in order to improve the understanding of risk assessments by 
decisionmakers and to accurately 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 or 
                redundancies, modelling needs, and validation of 
                default options, particularly those common to multiple 
                risk assessments.
                    (B) Research to examine the causes and extent of 
                variability within and among individuals, species, 
                populations, and, in the case of ecological risk 
                assessment, ecological communities.
                    (C) Research leading to the improvement of methods 
                to quantify and communicate uncertainty and variability 
                throughout the risk assessment, and risk assessment 
                reporting methods that clearly distinguish between 
                uncertainty and variability.
                    (D) Emerging and future areas of research, 
                including research on comparative risk analysis, 
                exposure to multiple chemicals and other stressors, 
                noncancer endpoints, biological markers, mechanisms of 
                action in both mammalian and non-mammalian species, 
                dynamics and probabilities of physiological and 
                ecosystem exposures, and prediction of ecosystem-level 
                responses.
                    (E) Long-term needs to adequately train individuals 
                in risk assessment and risk assessment applications. An 
                evaluation under this paragraph shall include an 
                estimate of the resources needed to provide necessary 
                training and recommendations on appropriate educational 
                risk assessment curricula.
            (2) Development of strategy.--The 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.
    (k) Review of Risk Characterizations.--
            (1) Provision for independent review.--On an annual basis 
        for a period of three years following the date of issuance of 
        risk characterization guidance by the Environmental Protection 
        Agency under the provisions of this Act, and every three years 
        thereafter, the Director shall provide for review of the 
        conformance of the Agency's risk characterizations with its 
        risk characterization guidance. The review shall be conducted 
        by an independent body composed of individuals from outside the 
        Agency who are technically qualified in risk characterization. 
        By publication in the Federal Register of the intent to convene 
        each review and of a period for public comment, the public will 
        be provided an opportunity for comment to the independent body 
        on the Agency's conformance with the guidance.
            (2) Annual report.--Not later than December 1 each year, 
        the independent body shall provide to the Congress, through the 
        Administrator, a report that evaluates the degree to which the 
        risk characterization issued by the Environmental Protection 
        Agency during the preceding calendar year conform to the risk 
        characterization guidance issued under subsection (h). The 
        report shall include an identification of those risk 
        characterizations, if any, that the independent body finds 
        failed to conform in a significant respect with applicable risk 
        characterization guidance.
            (3) Response to report.--Within 12 months of receiving a 
        report pursuant to paragraph (2), the Administrator shall 
        prepare and issue revised versions of any risk characterization 
        that the independent body identified as failing to conform in a 
        significant respect with applicable risk characterization 
        guidance. Such revised risk characterizations shall conform to 
        the applicable risk characterization guidance or include an 
        explanation of why the Administrator considers such conformance 
        to be inappropriate.

SEC. 5. STUDY OF COMPARATIVE RISK ANALYSIS.

    (a) In General.--As part of the Program, the Director shall 
conduct, or provide for the conduct of, a study 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 study shall be to develop and rigorously test methods 
of comparative risk analysis. The Director shall consult with the 
Director of the Office of Science and Technology Policy regarding the 
scope of the study. Not later than 90 days after the date of the 
enactment of this Act, the Administrator, in collaboration with other 
appropriate Federal agencies, shall enter into a contract with the 
National Research Council to provide technical guidance on approaches 
to using comparative risk analysis and other considerations in setting 
environmental priorities.
    (b) Scope of Study.--The study shall have sufficient scope and 
breadth to evaluate comparative risk analysis and to test approaches 
for improving comparative risk analysis and its use in setting 
priorities for environmental risk reduction. The study shall compare 
and evaluate a range of diverse environmental risks, both as to risks 
to and within an environmental medium and risks across environmental 
media.
    (c) Study Participants.--In conducting the study, the Director 
shall provide for the participation of a range of individuals with 
varying backgrounds and expertise, both technical and nontechnical, 
comprising broad representation of the public and private sectors.
    (d) Duration.--The study shall begin within 180 days after the date 
of the enactment of this Act and terminate within 2 years after the 
date on which it began.
    (e) Recommendations for Improving Comparative Risk Analysis and Its 
Use.--Not later than 90 days after the termination of the study, the 
Director shall submit to the Administrator a report that evaluates the 
results of the study 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 a final report to the 
Congress with the results of the scientific peer review and 
recommendations regarding the use of comparative risk analysis and ways 
to improve the use of comparative risk analysis for decisionmaking in 
the Environmental Protection Agency.
    (f) Savings.--Nothing in this section shall be construed to 
prohibit or discourage the performance after the date of the enactment 
of this Act of any comparative risk analysis.

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, acting through the 
National Science Technology Council, 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) disseminate to all relevant Federal agencies the 
        results of the study referred to in section 5 and any activity 
        of the National Research Council that is complementary to the 
        study and, as appropriate, coordinate the implementation of 
        such results by all such agencies;
            (5) establish appropriate mechanisms between Federal and 
        State agencies to communicate state-of-the-art risk assessment 
        practices; and
            (6) 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. 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. RISK ASSESSMENT RESEARCH PRIORITIES.

    (a) Identification of Priority Risk Assessment Research Issues.--
            (1) Report.--Within six months after the date of the 
        enactment of this Act, the Administrator shall submit to the 
        Congress a report that identifies at least 10 environmental 
        research issues--
                    (A) correlating to the environmental hazards which 
                the Administrator estimates to be in the category of 
                highest risk;
                    (B) regarding which there are, as determined by the 
                Administrator, significant scientific uncertainties 
                with respect to the assessment of such environmental 
                risks; and
                    (C) with respect to which such uncertainties could 
                be significantly reduced through research.
            (2) Contents of report.--In addition to the identification 
        required by paragraph (1), the report referred to in such 
        paragraph shall include--
                    (A) an assessment of the research that has been, or 
                is being, conducted by the Environmental Protection 
                Agency with respect to each issue identified under such 
                paragraph;
                    (B) an identification, with respect to each such 
                issue, of the significant scientific uncertainties that 
                exist with respect to the assessment of the 
                environmental risks posed by the issue;
                    (C) an identification of the research that needs to 
                be conducted by the Environmental Protection Agency to 
                reduce significantly such scientific uncertainties, the 
                amount of time necessary to conduct such research, and 
                the cost of such research; and
                    (D) a list that identifies such issues in order of 
                the priority in which such research should be conducted 
                and includes the reasons for that priority.
    (b) Research Program.--The Administrator shall carry out a research 
program within the Office of Research and Development to reduce the 
scientific uncertainties with respect to the assessment of the 
environmental risks posed by the issues identified under subsection 
(a). In conducting the research, the Administrator shall consider the 
priority list referred to in subsection (a)(2)(D).
    (c) Budget Coordination.--In the first budget submitted by the 
President to the Congress immediately following the submission required 
by subsection (a), and in the next four budgets submitted immediately 
after such budget, the Administrator shall include a report that 
identifies the research conducted by the Administrator in accordance 
with the priority list referred to in subsection (a)(2)(D).

SEC. 9. 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 estimate, compare, and rank the size and 
        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 on the basis of available 
        data and prevailing theory.
            (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 the process or 
        procedure by which the potential adverse health or ecological 
        effects of exposure of human or nonhuman species to 
        environmental hazards is characterized.
            (8) The term ``risk assessment guideline'' means a document 
        of a Federal agency that contains principles pertaining to the 
        practice or application of risk assessment.
            (9) 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 the exposure.
            (10) The term ``scientific peer review'' means the process 
        of rigorously 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 is unclear, 
        including measurement errors, the lack of fundamental knowledge 
        needed to choose among alternative hypotheses, and assumptions, 
        or experimental models.
            (12) The term ``central estimates'' means estimates of 
        central tendencies or expected risk based, to the extent 
        feasible, on the most plausible and unbiased assumptions, given 
        the scientific information available to the Administrator.
            (13) The term ``substitution risk'' means a potential 
        increase in certain types of risk from a strategy designed to 
        decrease other risks.
HR 4306 RH----2
HR 4306 RH----3
```