H.R. 4306 (103rd): Risk Assessment Improvement Act of 1994

103rd Congress, 1993–1994. Text as of Oct 07, 1994 (Reported by House Committee).

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HR 4306 RH

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.

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