[Congressional Record Volume 141, Number 21 (Thursday, February 2, 1995)]
[Senate]
[Pages S2068-S2069]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


                          AMENDMENTS SUBMITTED

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            THE COMPREHENSIVE REGULATORY REFORM ACT OF 1995

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                  DOLE (AND OTHERS) AMENDMENT NO. 229

  (Ordered referred to the Committee on the Judiciary.)
  Mr. DOLE (for himself, Mr. Nickles, Mr. Bond, Mrs. Hutchison, Mr. 
Murkowski, Mr. Lott, Mr. Cochran, Mr. Hatch, Mr. Domenici, Mrs. 
Kassebaum, Mr. Coats, Mr. Abraham, Mr. Inhofe, Mr. Smith, Mr. Santorum, 
Mr. Thompson, Mr. Warner, Mr. Kyl) submitted an amendment intended to 
be proposed by them to the bill (S. 343) to reform the regulatory 
process, and for other purposes; as follows:

       At the appropriate place add the following:

                   ``SUBCHAPTER III--RISK ASSESSMENTS

     ``Sec. 631. Definitions

       ``For purposes of this subchapter:
       ``(1) 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.
       ``(2) The term `emergency' means a clearly imminent and 
     substantial endangerment to public health, safety, or natural 
     resources.
       ``(3) The term `hazard identification' means identification 
     of a substance, activity, or condition as potentially posing 
     a risk to human health or safety or natural resources based 
     on empirical data, measurements, testing, or scientifically 
     acceptable methods showing that it has caused significant 
     adverse effects at some levels of dose or exposure not 
     necessarily relevant to level of dose or exposure that are 
     normally expected to occur.
       ``(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 `plausible' means realistic and 
     scientifically probable.
       ``(6) 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.
       ``(7) 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.
       ``(8) 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. 632. 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. 633. 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. 634. Requirement to prepare risk assessments

       ``(a) Except as provided in section 632, 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 cost-benefit analysis 
     pursuant to section 625 or petition for review pursuant to 
     section 637--
       ``(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. 635. 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 634, 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. 636. 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:
     [[Page S2069]]   ``(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. 637. 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 of this title for agencies to implement the risk 
     assessment and characterization principles set forth in 
     sections 635 and 636 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 635 and 636;
       ``(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.
       ``(5) A risk assessment completed pursuant to a petition 
     may be the basis for initiating a regulatory review pursuant 
     to section 625.
       ``(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. 638. 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 634 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. 639. 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. 640. 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.
       ``(d) The proceedings of peer review panels under this 
     section shall be subject to the applicable provisions of the 
     Federal Advisory Committee Act (5 U.S.C. App.).
     

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