```

[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 333 Amendment Ordered to be Printed Senate (AS)]

                           Amendment No. 230

                                 S. 333
                                                                   IIIA
<bullet>S 333 AS
  
AMENDMENT NO. 230
Purpose: To add additional provisions relating to risk assessments

       IN THE SENATE OF THE UNITED STATES--104th Cong., 1st Sess.

                                 S. 333

 To direct the Secretary of Energy to institute certain procedures in 
 the performance of risk assessments in connection with environmental 
            restoration activities, and for other purposes.

             February 3 (legislative day, January 30), 1995

 Referred to the Committee on Energy and Natural Resources and ordered 
                             to be printed

Amendment intended to be proposed by Mr. Murkowski (for himself and Mr. 
        Lott)
Viz:
    At the end of the bill add the following:

SEC. 11. AMENDMENT OF TITLE 5, UNITED STATES CODE.

    (a) In General.--Chapter 6 of title 5, United States Code, is 
amended by adding at the end the following:

                   ``SUBCHAPTER II--RISK ASSESSMENTS

``Sec. 621. Definitions
    ``In this subchapter--
            ``(1) Agency.--The term `agency' has the meaning stated in 
        section 551(1).
            ``(2) Benefit.--The term `benefit' means the reasonably 
        identifiable significant benefits, including social and 
        economic benefits, that are expected to result directly or 
        indirectly from implementation of a rule or an alternative to a 
        rule.
            ``(3) Best estimate.--The term `best estimate' means an 
        estimate that, to the extent feasible and scientifically 
        appropriate, is based on one or more of the following:
                    ``(A) Central estimates of risk using the most 
                plausible assumptions.
                    ``(B) An approach that combines multiple estimates 
                based on different scenarios and weighs the probability 
                of each scenario.
                    ``(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 agency concerned.
            ``(4) Cost.--The term `cost' means the reasonably 
        identifiable significant costs and adverse effects, including 
        social and economic costs, reduced consumer choice, 
        substitution effects, and impeded technological advancement, 
        that are expected to result directly or indirectly from 
        implementation of, or compliance with, a rule or an alternative 
        to a rule.
            ``(5) Emergency.--The term `emergency' means a clearly 
        imminent and substantial endangerment to public health, safety, 
        or natural resources.
            ``(6) Major rule.--The term `major rule'--
                    ``(A) means--
                            ``(i) a rule or a group of closely related 
                        rules that the agency proposing the rule or the 
                        President reasonably determines is likely to 
                        have a gross annual effect on the economy of 
                        $50,000,000 or more in reasonably quantifiable 
                        increased direct and indirect costs, or has a 
                        significant impact on a sector of the economy; 
                        or
                            ``(ii) a rule or a group of closely related 
                        rules that is otherwise designated a major rule 
                        by the agency proposing the rule, or by the 
                        President on the ground that the rule is likely 
                        to result in--
                                    ``(I) a substantial increase in 
                                costs or prices for wage earners, 
                                consumers, individual industries, 
                                nonprofit organizations, Federal, 
                                State, or local government agencies, or 
                                geographic regions; or
                                    ``(II) significant adverse effects 
                                on competition, employment, investment, 
                                productivity, innovation, the 
                                environment, public health or safety, 
                                or the ability of enterprises whose 
                                principal places of business are in the 
                                United States to compete in domestic or 
                                export markets; but
                    ``(B) does not include--
                            ``(i) a rule that involves the internal 
                        revenue laws of the United States; or
                            ``(ii) a rule that authorizes the 
                        introduction into commerce, or recognizes the 
                        marketable status, of a product;.
            ``(7) Person.--The term `person' has the meaning stated in 
        section 551(2).
            ``(8) Plausible.--The term `plausible' means realistic and 
        scientifically probable.
            ``(9) Risk assessment.--The term `risk assessment' means--
                    ``(A) the process of identifying hazards, and 
                quantifying (to the extent practicable) or describing 
                the degree of toxicity, exposure, or other risk the 
                hazards pose for exposed individuals, populations, or 
                resources; and
                    ``(B) the document containing the explanation of 
                how the assessment process has been applied to an 
                individual substance, activity, or condition.
            ``(10) Risk characterization.--The term `risk 
        characterization'--
                    ``(A) means the element of a risk assessment that 
                involves presentation of the degree of risk to 
                individuals and populations expected to be protected, 
                as presented in any regulatory proposal or decision, 
                report to Congress, or other document that is made 
                available to the public; and
                    ``(B) includes discussions of uncertainties, 
                conflicting data, estimates, extrapolations, 
                inferences, and opinions.
            ``(11) Rule.--The term `rule' has the meaning stated in 
        section 551(4).
            ``(12) Substitution risk.--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.
``Sec. 622. Applicability
    ``(a) Except as provided in subsection (b), this subchapter shall 
apply to all risk assessments and risk characterizations prepared by, 
or on behalf of, or prepared by others and adopted by, any agency in 
connection with health, safety, and risk to natural resources.
    ``(b)(1) This subchapter shall not apply to risk assessments or 
risk characterizations performed with respect to--
            ``(A) a situation that the head of the agency considers to 
        be an emergency;
            ``(B) a rule that authorizes the introduction into 
        commerce, or recognizes the marketable status of a product; or
            ``(C) a screening analysis.
    ``(2)(A) An analysis shall not be treated as screening analysis for 
the purposes of paragraph (1)(B) if the result of the analysis is 
used--
            ``(i) as the basis for imposing a restriction on a 
        substance or activity; or
            ``(ii) to characterize a positive finding of risks from a 
        substance or activity in any agency document or other 
        communication made available to the public, the media, or 
        Congress.
    ``(B) Among the analyses that may be treated as a screening 
analyses for the purposes of paragraph (1)(B) are product 
registrations, reregistrations, tolerance settings, and reviews of 
premanufacture notices and existing chemicals under the Federal 
Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.) and 
the Toxic Substances Control Act (15 U.S.C. 2601 et seq.).
    ``(3) This subchapter shall not apply to any food, drug, or other 
product label or to any risk characterization appearing on any such 
label.
``Sec. 623. Rule of construction
    ``Nothing in this subchapter shall be construed to--
            ``(1) preclude the consideration of any data or the 
        calculation of any estimate to more fully describe risk or 
        provide examples of scientific uncertainty or variability; or
            ``(2) require the disclosure of any trade secret or other 
        confidential information.
``Sec. 624. Requirement to prepare risk assessments
    ``(a) Except as provided in section 622, the head of each agency 
shall prepare for each major rule relating to human health, safety, or 
natural resources that is proposed by the agency after the date of 
enactment of this subchapter, is pending on the date of enactment of 
this subchapter, or is subject to a granted petition for review 
pursuant to section 627--
            ``(1) a risk assessment in accordance with this subchapter;
            ``(2) for each such proposed or final rule, an assessment, 
        quantified to the extent feasible, of incremental risk 
        reduction or other benefits associated with each significant 
        regulatory alternative to the rule or proposed rule; and
            ``(3) for each such proposed or final rule, quantified to 
        the extent feasible, a comparison of any human health, safety, 
        or natural resource risks addressed by the regulatory 
        alternatives to other relevant risks chosen by the head of the 
        agency, including at least 3 other risks regulated by the 
        agency and to at least 3 other risks with which the public is 
        familiar.
    ``(b) A risk assessment prepared pursuant to this subchapter shall 
be a component of and used to develop the cost-benefit analysis 
required by subchapter II, and shall be made part of the administrative 
record for judicial review of any final agency action.
``Sec. 625. Principles for risk assessment
    ``(a)(1) The head of each agency shall apply the principles set 
forth in subsection (b) when preparing any risk assessment, whether or 
not required by section 624, to ensure that the risk assessment and all 
of its components--
            ``(A) distinguish scientific findings and best estimates of 
        risk from other considerations;
            ``(B) are, to the maximum extent practicable scientifically 
        objective, unbiased and inclusive of all relevant data; and
            ``(C) rely, to the extent available and practicable, on 
        scientific findings.
    ``(2) 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) The principles to be applied when preparing risk assessments 
are as follows:
            ``(1)(A) When assessing human health risks, a risk 
        assessment shall be based on the most reliable laboratory, 
        epidemiological, and exposure assessment data that finds, or 
        fails to find, a correlation between a health risk and a 
        potential toxin or activity. Other relevant data may be 
        summarized.
            ``(B) When conflicts among such data appear to exist, or 
        when animal data are used as a basis to assess human health, 
        the assessment shall include discussion of possible 
        reconciliation of conflicting information, and, as appropriate, 
        differences in study designs, comparative physiology, routes of 
        exposure, bioavailability, pharmacokinetics, and any other 
        relevant factor, including the availability of raw data for 
        review. Greatest emphasis shall be placed on data that 
        indicates a biological basis of the resulting harm in humans. 
        Animal data shall be reviewed with regard to relevancy to 
        humans.
            ``(2) When a risk assessment involves selection of any 
        significant assumption, inference, or model, the agency shall--
                    ``(A) describe the plausible and alternative 
                assumptions, inferences, or models;
                    ``(B) explain the basis for any choices among such 
                assumptions, inferences, or models;
                    ``(C) identify any policy or value judgments 
                involved in choosing from among such alternative 
                assumptions, inferences, or models;
                    ``(D) fully describe any model used in the risk 
                assessment and make explicit the assumptions 
                incorporated in the model; and
                    ``(E) indicate the extent to which any significant 
                model has been validated by, or conflicts with, 
                empirical data.
            ``(3) A risk assessment shall be prepared at the level of 
        detail appropriate and practicable for reasoned decisionmaking 
        on the matter involved, taking into consideration the 
significance and complexity of the decision and any need for 
expedition.
``Sec. 626. Principles for risk characterization and communication
    ``In characterizing risk in any risk assessment document, 
regulatory proposal or decision, report to Congress, or other document 
that is made available to the public, each agency characterizing the 
risk shall comply with each of the following:
            ``(1)(A) The head of the agency shall describe the 
        populations or natural resources that are the subject of the 
        risk characterization.
            ``(B) If a numerical estimate of risk is provided, the head 
        of the agency, to the extent feasible and scientifically 
        appropriate--
                    ``(i) shall provide--
                            ``(I) the best estimate or estimates for 
                        the specific populations or natural resources 
                        which are the subject of the characterization 
                        (based on the information available to the 
                        department, agency, or instrumentality) or, in 
                        lieu of a single best estimate, an array of 
                        multiple estimates (showing the distribution of 
                        estimates and the best estimate) based on 
                        assumptions, inferences, or models which are 
                        equally plausible, given current scientific 
                        understanding;
                            ``(II) a statement of the reasonable range 
                        of scientific uncertainties; and
                            ``(III) to the extent practicable and 
                        appropriate, descriptions of the distribution 
                        and probability of risk estimates to reflect 
                        differences in exposure variability in 
                        populations and uncertainties;
                    ``(ii) in addition to a best estimate or estimates, 
                may present plausible upper-bound or conservative 
                estimates, but only in conjunction with equally 
                plausible lower-bound estimates; and
                    ``(iii) shall ensure that, where a safety factor, 
                as distinguished from inherent quantitative or 
                qualitative uncertainties, is used, such factor shall 
                be similar in degree to safety factors used to ensure 
                safety in human activities.
            ``(2) The head of the agency shall explain the exposure 
        scenarios used in any risk assessment, and, to the extent 
        feasible, provide a statement of the size of the corresponding 
        population or natural resource at risk and the likelihood of 
        such exposure scenarios.
            ``(3)(A) To the extent feasible, the head of the agency 
        shall provide a statement that places the nature and magnitude 
        of individual and population risks to human health in context.
            ``(B) A statement under subparagraph (A) shall--
                    ``(i) include appropriate comparisons with 
                estimates of risks that are familiar to and routinely 
                encountered by the general public as well as other 
                risks; and
                    ``(ii) identify relevant distinctions among 
                categories of risk and limitations to comparisons.
            ``(4) When an agency provides a risk assessment or risk 
        characterization for a proposed or final regulatory action, 
        such assessment or characterization shall include a statement 
        of any significant substitution risks to human health 
        identified by the agency or contained in information provided 
        to the agency by a commenter.
            ``(5) If--
                    ``(A) an agency provides a public comment period 
                with respect to a risk assessment or regulation;
                    ``(B) a commenter provides a risk assessment, and a 
                summary of results of such risk assessment; and
                    ``(C) such risk assessment is reasonably consistent 
                with the principles and the guidance provided under 
                this subtitle,
        the agency shall present such summary in connection with the 
        presentation of the agency's risk assessment or the regulation.
``Sec. 627. Regulations; plan for assessing new information
    ``(a)(1) Not later than 1 year after the date of enactment of this 
subchapter, the President shall issue a final regulation that has been 
subject to notice and comment under section 553 for agencies to 
implement the risk assessment and characterization principles set forth 
in sections 625 and 626 and shall provide a format for summarizing risk 
assessment results.
    ``(2) The regulation under paragraph (1) shall be sufficiently 
specific to ensure that risk assessments are conducted consistently by 
the various agencies.
    ``(b)(1) Review of the risk assessment for any major rule shall be 
conducted by the head of the agency on the written petition of a person 
showing a reasonable likelihood that--
            ``(A) the risk assessment is inconsistent with the 
        principles set forth in section 625 and 626;
            ``(B) the risk assessment produces substantially different 
        results;
            ``(C) the risk assessment is inconsistent with a rule 
        issued under subsection (a); or
            ``(D) the risk assessment does not take into account 
        material significant new scientific data or scientific 
        understanding.
    ``(2) Not later than 90 days after receiving a petition under 
paragraph (1), the head of the agency shall respond to the petition by 
agreeing or declining to review the risk assessment referred to in the 
petition, and shall state the basis for the decision.
    ``(3) If the head of the agency agrees to review the petition, the 
agency shall complete its review within 180 days, unless the Director 
of the Office of Management and Budget agrees in writing with an agency 
determination that an extension is necessary in view of limitations on 
agency resources.
    ``(4) Denial of a petition by the agency head shall be subject to 
judicial review in accordance with chapter 7 of title 5, United States 
Code.
    ``(c) The regulations under this section shall be developed after 
notice and opportunity for public comment, and after consultation with 
representatives of appropriate State agencies and local governments, 
and such other departments and agencies, offices, organizations, or 
persons as may be advisable.
    ``(d) At least every 4 years, the President shall review, and when 
appropriate, revise the regulations published under this section.
``Sec. 628. Decisional criteria
    ``For each major rule subject to this subchapter, the head of the 
agency, subject to review by the President, shall make a determination 
that--
            ``(1) the risk assessment under section 624 is based on a 
        scientific and unbiased evaluation, reflecting realistic 
        exposure scenarios, of the risk addressed by the major rule and 
        is supported by the best available scientific data, as 
        determined by a peer review panel in accordance with section 
        640; and
            ``(2) there is no alternative that is allowed by the 
        statute under which the major rule is promulgated that would 
        provide greater net benefits or that would achieve an 
        equivalent reduction in risk in a more cost-effective and 
        flexible manner.
``Sec. 629. Regulatory priorities
    ``(a) In exercising authority under any laws protecting human 
health and safety or the environment, the head of an agency shall 
prioritize the use of the resources available under such laws to 
address the risks to human health, safety, and natural resources that--
            ``(1) the agency determines are the most serious; and
            ``(2) can be addressed in a cost-effective manner, with the 
        goal of achieving the greatest overall net reduction in risks 
        with the public and private sector resources to be expended.
    ``(b) In identifying the sources of the most serious risks under 
subsection (a), the head of the agency shall consider, at a minimum--
            ``(1) the plausible likelihood and severity of the effect; 
        and
            ``(2) the plausible number and groups of individuals 
        potentially affected.
    ``(c) The head of the agency shall incorporate the priorities 
identified in subsection (a) into the budget, strategic planning, and 
research activities of the agency by, in the agency's annual budget 
request to Congress--
            ``(1) identifying which risks the agency has determined are 
        the most serious and can be addressed in a cost-effective 
        manner under subsection (a), and the basis for that 
        determination;
            ``(2) explicitly identifying how the agency's requested 
        funds will be used to address those risks;
            ``(3) identifying any statutory, regulatory, or 
        administrative obstacles to allocating agency resources in 
        accordance with the priorities established under subsection 
        (a); and
            ``(4) explicitly considering the requirements of subsection 
        (a) when preparing the agency's regulatory agenda or other 
        strategic plan, and providing an explanation of how the agenda 
        or plan reflects those requirements and the comparative risk 
        analysis when publishing any such agenda or strategic plan.
    ``(d) In March of each year, the head of each agency shall submit 
to Congress specific recommendations for repealing or modifying laws 
that would better enable the agency to prioritize its activities to 
address the risks to human health, safety, and the environment that are 
the most serious and can be addressed in a cost-effective manner 
consistent with the requirements of subsection (a).
``Sec. 630. Establishment of program
    ``(a) The President shall develop a systematic program for the peer 
review of work products covered by subsection (c), which program shall 
be used uniformly across the agencies.
    ``(b) The program under subsection (a)--
            ``(1) shall provide for the creation of peer review panels 
        consisting of independent and external experts who are broadly 
        representative and balanced to the extent feasible;
            ``(2) shall not exclude peer reviewers merely because they 
        represent entities that may have a potential interest in the 
        outcome, if that interest is fully disclosed;
            ``(3) shall exclude, to the maximum extent practicable, any 
        peer reviewer who has been involved in any previous analysis of 
        the tests and evidence presented for certification by the peer 
        review panel; and
            ``(4) shall provide for a timely completed peer review, 
        meeting agency deadlines, which contains a balanced 
        presentation of all considerations, including minority reports 
        and an agency response to all significant peer review comments.
    ``(c) The peer review and the agency's responses shall be made 
available to the public and shall be made part of the administrative 
record for purposes of judicial review of any final agency action.''.
    (b) Conforming Amendment and Technical Corrections.--
            (1) Conforming amendments.--Part I of title 5, United 
        States Code, is amended by striking the chapter analysis for 
        chapter 6 and inserting the following:

           ``CHAPTER 6--THE ANALYSIS OF REGULATORY FUNCTIONS

                  ``SUBCHAPTER I--REGULATORY ANALYSIS

``Sec.
``601.  Definitions.
``602.  Regulatory agenda.
``603.  Initial regulatory flexibility analysis.
``604.  Final regulatory flexibility analysis.
``605.  Avoidance of duplicative or unnecessary analyses.
``606.  Effect on other law.
``607.  Preparation of analyses.
``608.  Procedure for waiver or delay of completion.
``609.  Procedures for gathering comments.
``610.  Periodic review of rules.
``611.  Judicial review.
``612.  Reports and intervention rights.
                   ``SUBCHAPTER II--RISK ASSESSMENTS

``621.  Definitions.
``622.  Applicability.
``623.  Rule of construction.
``624.  Requirement to prepare risk assessments.
``625.  Principles for risk assessment.
``626.  Principles for risk characterization and communication.
``627.  Regulations; plan for assessing new information.
``628.  Decisional criteria.
``629.  Regulatory priorities.
``640.  Establishment of program.

                 ``SUBCHAPTER I--REGULATORY ANALYSIS''.

            (2) Technical corrections.--The part analysis for part I of 
        title 5, United States Code, is amended--
                    (A) in the item relating to chapter 5 by striking 
                ``501'' and inserting ``500''; and
                    (B) by inserting after the item relating to chapter 
                5 the following:

``6. The Analysis of Regulatory Functions...................     601''.
S 333 AS----2
```