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[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2910 Introduced in House (IH)]

103d CONGRESS
  1st Session
                                H. R. 2910

   To more fully and accurately inform the public concerning health, 
    safety, and environmental risks, to improve consistency in the 
 presentation of scientific information, and to enhance the scientific 
credibility of the regulatory decisions of the Environmental Protection 
                                Agency.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             August 6, 1993

  Mr. Moorhead (for himself, Mr. Brown of California, Mr. Bliley, Mr. 
 Oxley, Mr. Hayes, Mrs. Lloyd, Mr. Walker, and  Mr. Zimmer) introduced 
  the following bill; which was referred jointly to the Committees on 
         Science, Space, and Technology and Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
   To more fully and accurately inform the public concerning health, 
    safety, and environmental risks, to improve consistency in the 
 presentation of scientific information, and to enhance the scientific 
credibility of the regulatory decisions of the Environmental Protection 
                                Agency.

    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 Communication Act of 1993''.

SEC. 2. PURPOSES.

    The purposes of this Act are--
            (1) to present the public and Environmental Protection 
        Agency officials with the most scientifically objective 
        information concerning the nature and magnitude of health, 
        safety, and environmental risks in order to provide for sound 
        regulatory decisions and public education;
            (2) to provide for full consideration and discussion of 
        relevant data and potential methodologies;
            (3) to require explanation of significant choices in the 
        risk assessment process which will allow for better peer review 
        and public understanding; and
            (4) to improve consistency within the Environmental 
        Protection Agency in preparing risk assessments and risk 
        characterizations.

SEC. 3. EFFECTIVE DATE; APPLICABILITY; SAVINGS PROVISIONS.

    (a) Effective Date.--Except as otherwise specifically provided in 
this Act, the provisions of this Act shall take effect 2 years after 
the date of enactment of this Act.
    (b) Applicability.--(1) Except as provided in paragraph (2), this 
Act applies to all risk assessments and risk characterizations prepared 
by or on behalf of the Environmental Protection Agency in connection 
with health, safety, and environmental risks.
    (2) This Act does not apply to risk assessments or risk 
characterizations performed with respect to a situation that the 
Administrator considers to be an emergency.
    (c) Savings Provisions.--Nothing in this Act shall be construed to 
modify any statutory standard or requirement designed to protect 
health, safety, or the environment.

SEC. 4. PRINCIPLES FOR RISK ASSESSMENT.

    (a) In General.--The Administrator of the Environmental Protection 
Agency shall apply the principles set forth in subsection (b) when 
preparing risk assessments in order to assure that such risk 
assessments and all of their components are, to the maximum extent 
possible, scientifically objective and inclusive of all relevant data. 
Discussions or explanations required under this section need not be 
repeated in each risk assessment document as long as there is a 
reference to the relevant discussion or explanation in another agency 
document.
    (b) Principles.--The principles to be applied when preparing risk 
assessments are the following:
            (1) The Administrator shall explicitly distinguish 
        scientific findings in risk assessments from other 
        considerations affecting the design and choice of regulatory 
        strategies.
            (2) The Administrator shall consider and discuss both 
        negative and positive laboratory or epidemiological data of 
        sufficient quality when presenting assessments of human health 
        risks. Where conflicts among such data appear to exist, the 
        assessment shall include discussion of possible reconciliation 
        of conflicting information, which may include differences in 
        study designs, comparative physiology, routes of exposure, 
        bioavailability, pharmacokinetics, and any other relevant 
        factor.
            (3) Where the risk assessment process involves selection of 
        any significant assumption, inference, or model the 
        Administrator shall (A) present a representative list and 
        explanation of plausible and alternative assumptions, 
        inferences, or models; (B) explain the basis for any choices; 
        and (C) identify any policy or value judgments. The 
        Administrator shall also indicate the extent to which any 
        significant model has been validated by or conflicts with 
        empirical data.

SEC. 5. PRINCIPLES FOR RISK CHARACTERIZATION.

    In characterizing risk in any risk assessment document, regulatory 
proposal or decision, report to Congress, or other document which is 
made available to the public, the Administrator shall comply with each 
of the following:
            (1) The Administrator shall characterize the populations or 
        natural resources at risk. If a numerical estimate of risk is 
        provided, the departments and agencies shall, to the extent 
        feasible, provide the best estimate or estimates for the 
        populations or natural resources at risk, given the information 
        available to the Administrator, along with a statement of the 
        reasonable range of scientific uncertainty. In addition to the 
        best estimate, the Administrator may present plausible upper-
        bound or conservative estimates in conjunction with plausible 
        lower bounds estimates. Where appropriate, the Administrator 
        may present, in lieu of a single best estimate, multiple 
        estimates based on assumptions, inferences, or models which are 
        equally plausible, given current scientific understanding.
            (2) The Administrator shall explain the range of exposure 
        scenarios used in any risk assessment, and, to the extent 
        feasible, provide a statement of the size of the corresponding 
        population at risk and the likelihood of such exposure 
        scenarios.
            (3) To the extent feasible, the Administrator shall provide 
        appropriate comparisons with estimates of other risks, 
        including those that are familiar to and routinely encountered 
        by the general public.
            (4) When the Administrator provides a risk assessment or 
        risk characterization for proposed and final regulatory 
        actions, such assessment or characterization shall include a 
        statement of any known and significant substitution risks.
            (5) In any case in which the Administrator provides a 
        public comment period with respect to a risk assessment or 
        regulation, and a commenter provides a risk assessment and 
        summary of results that is consistent with the principles and 
        the guidance provided under this Act, the Administrator shall 
        present the summary of results of such risk assessment in 
        connection with the presentation of the Environmental 
        Protection Agency's risk assessment (if any) or regulation.

SEC. 6. GUIDANCE, PLAN FOR ASSESSING NEW INFORMATION, AND REPORT.

    (a) Guidance.--Within 18 months after the date of enactment of this 
Act, the Administrator shall issue guidance consistent with the risk 
assessment and characterization principles stated in sections 4 and 5 
and shall provide a format for summarizing risk assessment results.
    (b) Additional Subjects Addressed.--In addition to including the 
principles set forth in sections 4 and 5, the guidance issued under 
this section shall include guidance on at least the following subjects: 
interspecies scaling factors; use of different types of dose-response 
models; thresholds; definitions, use, and interpretations of the 
maximum tolerated dose; weighting of positive and negative findings 
from sensitive species; evaluation of benign tumors, and evaluation of 
different health endpoints.
    (c) Plan.--Within 2 years after the date of enactment of this Act, 
the Administrator shall publish a plan to review and revise any risk 
assessment with respect to which the Environmental Protection Agency 
determines there is significant new information or methodologies 
available that could significantly alter the prior results of the risk 
assessment. The plan shall provide procedures for receiving and 
considering new information and risk assessments from the public. The 
plan may set priorities for review and revision of risk assessments 
based on factors the Administrator considers appropriate.
    (d) Report.--Within 3 years after the enactment of this Act, the 
Administrator shall provide a report to the Congress evaluating the 
policy and value judgments of the type identified under paragraph (3) 
of section 4 which are made by the Administrator in risk assessments 
performed for programs under the Toxic Substances Control Act and the 
effect these judgments have on the regulatory decisions of such 
programs.
    (e) Public Comment and Consultation.--The guidance, plan and report 
under this section, shall be developed after notice and opportunity for 
public comment and in consultation with the EPA Science Advisory Board, 
representatives of appropriate State agencies, and such other 
departments and agencies, offices, organizations, or persons as the 
Administrator considers advisable.
    (f) Review.--Guidance promulgated under this section shall be 
reviewed by the Administrator at least every 4 years in accordance with 
subsection (d).

SEC. 7. DEFINITIONS.

    For purposes of this Act:
            (1) The term ``risk assessment'' means the process of 
        identifying hazards and quantifying or describing the degree of 
        risk they pose for exposed individuals, populations, or 
        resources. It also refers to the document containing the 
        explanation of how the assessment process has been applied to 
        an individual substance, activity, or condition.
            (2) The term ``risk characterization'' means that element 
        of a risk assessment that involves presentation of the degree 
        of risk in any regulatory proposal or decision, report to 
        Congress, or other document which is made available to the 
        public. The term includes discussions of uncertainties, 
        conflicting data, estimates, extrapolations, inferences, and 
        opinions.
            (3) The term ``best estimate'' means an estimate based on 
        (A) central estimates of risk using the most unbiased 
        assumptions and models, (B) an approach which combines multiple 
        estimates based on different scenarios and weighs the 
        probability of each scenario or (C) any other methodology 
        designed to provide the most unbiased representation of the 
        most plausible level of risk, given the current scientific 
        information available to the Administrator.
            (4) The term ``negative data'' means data indicating that 
        under certain conditions a given substance or activity did not 
        induce an adverse effect.
            (5) The term ``substitution risk'' means a potential 
        increased risk to human health, safety, or the environment from 
        a regulatory option designed to decrease other risks.

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