[Congressional Record Volume 141, Number 107 (Wednesday, June 28, 1995)]
[Senate]
[Pages S9261-S9296]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                  COMPREHENSIVE REGULATORY REFORM ACT

  The PRESIDING OFFICER. The clerk will report the pending business.
  The legislative clerk read as follows:

       A bill (S. 343) to reform the regulatory process, and for 
     other purposes.

  The Senate proceeded to consider the bill which had been reported 
from the Committee on Governmental Affairs to strike out all after the 
enacting clause and inserting in lieu thereof the language shown in 
italic; and from the Committee on the Judiciary with amendments as 
follows:
  (The parts of the bill intended to be stricken are shown in boldface 
brackets, and the parts of the bill intended to be inserted are shown 
in italic.)
     [SECTION 1. SHORT TITLE.

       [This Act may be cited as the ``Comprehensive Regulatory 
     Reform Act of 1995''.

     [SEC. 2. DEFINITIONS.

       [Section 551 of title 5, United States Code, is amended--
       [(1) in paragraph (13), by striking out ``; and'' and 
     inserting in lieu thereof a semicolon;
       [(2) in paragraph (14), by striking out the period and 
     inserting in lieu thereof ``; and''; and
       [(3) by adding at the end thereof the following new 
     paragraph:
       [``(15) `Director' means the Director of the Office of 
     Management and Budget.''.

     [SEC. 3. ANALYSIS OF AGENCY RULES.

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

               [``SUBCHAPTER II--ANALYSIS OF AGENCY RULES

     [``Sec. 621. Definitions

       [``For purposes of this subchapter the definitions under 
     section 551 shall apply and--
       [``(1) the term `benefit' means the reasonably identifiable 
     significant favorable effects, including social, 
     environmental and economic benefits, that are expected to 
     result directly or indirectly from implementation of a rule 
     or an alternative to a rule;
       [``(2) the term `cost' means the reasonably identifiable 
     significant adverse effects, including social, environmental, 
     and economic costs that are expected to result directly or 
     indirectly from implementation of, or compliance with, a rule 
     or an alternative to a rule;
       [``(3) the term `cost-benefit analysis' means an evaluation 
     of the costs and benefits of a rule, quantified to the extent 
     feasible and appropriate and otherwise qualitatively 
     described, that is prepared in accordance with the 
     requirements of this subchapter 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;
       [``(4)(A) the term `major rule' means--
       [``(i) a rule or a group of closely related rules that the 
     agency proposing the rule, the Director, or a designee of the 
     President reasonably determines is likely to have a gross 
     annual effect on the economy of $100,000,000 or more in 
     reasonably quantifiable direct and indirect costs; or
       [``(ii) a rule or a group of closely related rules that is 
     otherwise determined to be a major rule by the agency 
     proposing the rule, the Director, or a designee of 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, local, or tribal government 
     agencies, or geographic regions;
       [``(II) significant adverse effects on wages, economic 
     growth, 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;
       [``(III) a serious inconsistency or interference with an 
     action taken or planned by another agency;
       [``(IV) the material alteration of the budgetary impact of 
     entitlements, grants, user fees, or loan programs, or the 
     rights and obligations of recipients thereof; or
       [``(V) a significant impact on a sector of the economy, or 
     disproportionate costs to a class of persons and relatively 
     severe economic, social, and environmental consequences for 
     the class; and
       [``(B) the term `major rule' shall not include--
       [``(i) a rule that involves the internal revenue laws of 
     the United States;
       [``(ii) a rule or agency action that authorizes the 
     introduction into, or removal from, commerce, or recognizes 
     the marketable status, of a product; or
       [``(iii) a rule exempt from notice and public comment 
     procedure under section 553 of this title;
       [``(5) the term `market-based mechanism' means a regulatory 
     program that--
       [``(A) imposes legal accountability for the achievement of 
     an explicit regulatory objective, including the reduction of 
     environmental pollutants or of risks to human health, safety, 
     or the environment, on each regulated person;
       [``(B) affords maximum flexibility to each regulated person 
     in complying with mandatory regulatory objectives, and such 
     flexibility shall, where feasible and appropriate, include 
     the opportunity to transfer to, or receive from, other 
     persons, including for cash or other legal consideration, 
     increments of compliance responsibility established by the 
     program; and
       [``(C) permits regulated persons to respond at their own 
     discretion in an automatic manner, consistent with 
     subparagraph (B), to changes in general economic conditions 
     and in economic circumstances directly pertinent to the 
     regulatory program without affecting the achievement of the 
     program's explicit regulatory mandates under subparagraph 
     (A);
       [``(6) the term `performance standard' means a requirement 
     that imposes legal accountability for the achievement of an 
     explicit regulatory objective, such as the reduction of 
     environmental pollutants or of risks to human health, safety, 
     or the environment, on each regulated person;
       [``(7) the term `risk assessment' has the same meaning as 
     such term is defined under section 632(5); and
       [``(8) the term `rule' has the same meaning as in section 
     551(4) of this title, and shall not include--
       [``(A) a rule of particular applicability that approves or 
     prescribes for the future rates, wages, prices, services, 
     corporate or financial structures, reorganizations, mergers, 
     acquisitions, accounting practices, or disclosures bearing on 
     any of the foregoing;
       [``(B) a rule relating to monetary policy proposed or 
     promulgated by the Board of Governors of the Federal Reserve 
     System or by the Federal Open Market Committee;
       [``(C) a rule relating to the safety or soundness of 
     federally insured depository institutions or any affiliate of 
     such an institution (as defined in section 2(k) of the Bank 
     Holding Company Act of 1956 (12 U.S.C. 1841(k)); credit 
     unions; the Federal Home Loan Banks; government-sponsored 
     housing enterprises; a Farm Credit System Institution; 
     foreign banks, and their branches, agencies, commercial 
     lending companies or representative offices that operate in 
     the United States and any affiliate of such foreign banks (as 
     those terms are defined in the International Banking Act of 
     1978 (12 U.S.C. 3101)); or a rule relating to the payments 
     system or the protection of deposit insurance funds or Farm 
     Credit Insurance Fund; or
       [``(D) a rule issued by the Federal Election Commission or 
     a rule issued by the Federal Communications Commission 
     pursuant to sections 312(a)(7) and 315 of the Communications 
     Act of 1934.

     [``Sec. 622. Rulemaking cost-benefit analysis

       [``(a) Before publishing notice of a proposed rulemaking 
     for any rule (or, in the case of a notice of a proposed 
     rulemaking that has been published on or before the effective 
     date of this subchapter, no later than 30 days after such 
     date), each agency shall determine whether the rule is or is 
     not a major rule within the meaning of section 621(4)(A)(i) 
     and, if it is not, determine whether it is a major rule under 
     section 621(4)(A)(ii). For the purpose of any such 
     determination, a group of closely related rules shall be 
     considered as one rule.
       [``(b)(1) If an agency has determined that a rule is not a 
     major rule, the Director or a designee of the President may, 
     as appropriate, determine that the rule is a major rule no 
     later than 30 days after the publication of the notice of 
     proposed rulemaking for the rule (or, in the case of a notice 
     of proposed rulemaking that has been published on or before 
     the effective date of this subchapter, no later than 60 days 
     after such date).
       [``(2) Such determination shall be published in the Federal 
     Register, together with a succinct statement of the basis for 
     the determination.
       [``(c)(1)(A) When the agency publishes a notice of proposed 
     rulemaking for a major rule, the agency shall issue and place 
     in the rulemaking file an initial cost-benefit analysis, and 
     shall include a summary of such analysis in the notice of 
     proposed rulemaking.
       [``(B)(i) When the Director or a designee of the President 
     has published a determination that a rule is a major rule 
     after the publication of the notice of proposed rulemaking 
     for the rule, the agency shall promptly issue and 

[[Page S9262]]
     place in the rulemaking file an initial cost-benefit analysis for the 
     rule and shall publish in the Federal Register a summary of 
     such analysis.
       [``(ii) Following the issuance of an initial cost-benefit 
     analysis under clause (i), the agency shall give interested 
     persons an opportunity to comment pursuant to section 553 in 
     the same manner as if the draft cost-benefit analysis had 
     been issued with the notice of proposed rulemaking.
       [``(2) Each initial cost-benefit analysis shall contain--
       [``(A) an analysis of the benefits of the proposed rule, 
     including any benefits that cannot be quantified, and an 
     explanation of how the agency anticipates that such benefits 
     will be achieved by the proposed rule, including a 
     description of the persons or classes of persons likely to 
     receive such benefits;
       [``(B) an analysis of the costs of the proposed rule, 
     including any costs that cannot be quantified, and an 
     explanation of how the agency anticipates that such costs 
     will result from the proposed rule, including a description 
     of the persons or classes of persons likely to bear such 
     costs;
       [``(C) an identification (including an analysis of costs 
     and benefits) of an appropriate number of reasonable 
     alternatives allowed under the statute granting the 
     rulemaking authority for achieving the identified benefits of 
     the proposed rule, including alternatives that--
       [``(i) require no government action;
       [``(ii) will accommodate differences among geographic 
     regions and among persons with differing levels of resources 
     with which to comply; and
       [``(iii) employ voluntary programs, performance standards, 
     or market-based mechanisms that permit greater flexibility in 
     achieving the identified benefits of the proposed rule and 
     that comply with the requirements of subparagraph (D);
       [``(D) an assessment of the feasibility of establishing a 
     regulatory program that operates through the application of 
     market-based mechanisms;
       [``(E) an explanation of the extent to which the proposed 
     rule--
       [``(i) will accommodate differences among geographic 
     regions and among persons with differing levels of resources 
     with which to comply; and
       [``(ii) employs voluntary programs, performance standards, 
     or market-based mechanisms that permit greater flexibility in 
     achieving the identified benefits of the proposed rule;
       [``(F) a description of the quality, reliability, and 
     relevance of scientific or economic evaluations or 
     information in accordance with the cost-benefit analysis and 
     risk assessment requirements of this chapter;
       [``(G) if not expressly or implicitly inconsistent with the 
     statute under which the agency is proposing the rule, an 
     explanation of the extent to which the identified benefits of 
     the proposed rule justify the identified costs of the 
     proposed rule, and an explanation of how the proposed rule is 
     likely to substantially achieve the rulemaking objectives in 
     a more cost-effective manner than the alternatives to the 
     proposed rule, including alternatives identified in 
     accordance with subparagraph (C); and
       [``(H) if a major rule subject to subchapter III addresses 
     risks to human health, safety, or the environment--
       [``(i) a risk assessment in accordance with this chapter; 
     and
       [``(ii) for each such proposed or final rule, an assessment 
     of incremental risk reduction or other benefits associated 
     with each significant regulatory alternative considered by 
     the agency in connection with the rule or proposed rule.
       [``(d)(1) When the agency publishes a final major rule, the 
     agency shall also issue and place in the rulemaking file a 
     final cost-benefit analysis, and shall include a summary of 
     the analysis in the statement of basis and purpose.
       [``(2) Each final cost-benefit analysis shall contain--
       [``(A) a description and comparison of the benefits and 
     costs of the rule and of the reasonable alternatives to the 
     rule described in the rulemaking, including the market-based 
     mechanisms identified under subsection (c)(2)(C)(iii); and
       [``(B) if not expressly or implicitly inconsistent with the 
     statute under which the agency is acting, a reasonable 
     determination, based upon the rulemaking file considered as a 
     whole, whether--
       [``(i) the benefits of the rule justify the costs of the 
     rule; and
       [``(ii) the rule will achieve the rulemaking objectives in 
     a more cost-effective manner than the alternatives described 
     in the rulemaking, including the market-based mechanisms 
     identified under subsection (c)(2)(C)(iii).
       [``(e)(1) The analysis of the benefits and costs of a 
     proposed and a final rule required under this section shall 
     include, to the extent feasible, a quantification or 
     numerical estimate of the quantifiable benefits and costs. 
     Such quantification or numerical estimate shall be made in 
     the most appropriate units of measurement, using comparable 
     assumptions, including time periods, shall specify the ranges 
     of predictions, and shall explain the margins of error 
     involved in the quantification methods and in the estimates 
     used. An agency shall describe the nature and extent of the 
     nonquantifiable benefits and costs of a final rule pursuant 
     to this section in as precise and succinct a manner as 
     possible. An agency shall not be required to make such 
     evaluation primarily on a mathematical or numerical basis.
       [``(2)(A) In evaluating and comparing costs and benefits 
     and in evaluating the risk assessment information developed 
     under subchapter III, the agency shall not rely on cost, 
     benefit, or risk assessment information that is not 
     accompanied by data, analysis, or other supporting materials 
     that would enable the agency and other persons interested in 
     the rulemaking to assess the accuracy, reliability, and 
     uncertainty factors applicable to such information.
       [``(B) The agency evaluations of the relationships of the 
     benefits of a proposed and final rule to its costs shall be 
     clearly articulated in accordance with this section.
       [``(f) As part of the promulgation of each major rule that 
     addresses risks to human health, safety, or the environment, 
     the head of the agency or the President shall make a 
     determination that--
       [``(1) the risk assessment and the analysis under 
     subsection (c)(2)(H) are based on a scientific evaluation of 
     the risk addressed by the major rule and that the conclusions 
     of such evaluation are supported by the available 
     information; and
       [``(2) the regulatory alternative chosen will reduce risk 
     in a cost-effective and, to the extent feasible, flexible 
     manner, taking into consideration any of the alternatives 
     identified under subsection (c)(2) (C) and (D).
       [``(g) The preparation of the initial or final cost-benefit 
     analysis required by this section shall only be performed 
     under the direction of an officer or employee of the agency. 
     The preceding sentence shall not preclude a person outside 
     the agency from gathering data or information to be used by 
     the agency in preparing any such cost-benefit analysis or 
     from providing an explanation sufficient to permit the agency 
     to analyze such data or information. If any such data or 
     information is gathered or explained by a person outside the 
     agency, the agency shall specifically identify in the initial 
     or final cost-benefit analysis the data or information 
     gathered or explained and the person who gathered or 
     explained it, and shall describe the arrangement by which the 
     information was procured by the agency, including the total 
     amount of funds expended for such procurement.
       [``(h) The requirements of this subchapter shall not alter 
     the criteria for rulemaking otherwise applicable under other 
     statutes.

     [``Sec. 623. Judicial review

       [``(a) Compliance or noncompliance by an agency with the 
     provisions of this subchapter and subchapter III shall not be 
     subject to judicial review except in connection with review 
     of a final agency rule and according to the provisions of 
     this section.
       [``(b) Any determination by a designee of the President or 
     the Director that a rule is, or is not, a major rule shall 
     not be subject to judicial review in any manner.
       [``(c) The determination by an agency that a rule is, or is 
     not, a major rule under section 621(4)(A)(i) shall be set 
     aside by a reviewing court only upon a clear and convincing 
     showing that the determination is erroneous in light of the 
     information available to the agency at the time the agency 
     made the determination. Any determination by an agency that a 
     rule is, or is not, a major rule under section 621(4)(A)(ii) 
     shall not be subject to judicial review in any manner.
       [``(d) If the cost-benefit analysis or risk assessment 
     required under this chapter has been wholly omitted for any 
     major rule, a court shall vacate the rule and remand the case 
     for further consideration. If an analysis or assessment has 
     been performed, the court shall not review to determine 
     whether the analysis or assessment conformed to the 
     particular requirements of this chapter.
       [``(e) Any cost-benefit analysis or risk assessment 
     prepared under this chapter shall not be subject to judicial 
     consideration separate or apart from review of the agency 
     action to which it relates. When an action for judicial 
     review of an agency action is instituted, any regulatory 
     analysis for such agency action shall constitute part of the 
     whole administrative record of agency action for the purpose 
     of judicial review of the agency action, and shall, to the 
     extent relevant, be considered by a court in determining the 
     legality of the agency action.

     [``Sec. 624. Deadlines for rulemaking

       [``(a) All deadlines in statutes that require agencies to 
     propose or promulgate any rule subject to section 622 or 
     subchapter III during the 2-year period beginning on the 
     effective date of this section shall be suspended until the 
     earlier of--
       [``(1) the date on which the requirements of section 622 or 
     subchapter III are satisfied; or
       [``(2) the date occurring 6 months after the date of the 
     applicable deadline.
       [``(b) All deadlines imposed by any court of the United 
     States that would require an agency to propose or promulgate 
     a rule subject to section 622 or subchapter III during the 2-
     year period beginning on the effective date of this section 
     shall be suspended until the earlier of--
       [``(1) the date on which the requirements of section 622 or 
     subchapter III are satisfied; or
       [``(2) the date occurring 6 months after the date of the 
     applicable deadline.
       [``(c) In any case in which the failure to promulgate a 
     rule by a deadline occurring during the 2-year period 
     beginning on the effective date of this section would create 
     an obligation to regulate through individual adjudications, 
     the deadline shall be suspended until the earlier of--

[[Page S9263]]

       [``(1) the date on which the requirements of section 622 or 
     subchapter III are satisfied; or
       [``(2) the date occurring 6 months after the date of the 
     applicable deadline.

     [``Sec. 625. Agency review of rules

       [``(a)(1)(A) No later than 9 months after the effective 
     date of this section, each agency shall prepare and publish 
     in the Federal Register a proposed schedule for the review, 
     in accordance with this section, of--
       [``(i) each rule of the agency that is in effect on such 
     effective date and which, if adopted on such effective date, 
     would be a major rule; and
       [``(ii) each rule of the agency in effect on the effective 
     date of this section (in addition to the rules described in 
     clause (i)) that the agency has selected for review.
       [``(B) Each proposed schedule required under subparagraph 
     (A) shall be developed in consultation with--
       [``(i) the Administrator of the Office of Information and 
     Regulatory Affairs; and
       [``(ii) the classes of persons affected by the rules, 
     including members from the regulated industries, small 
     businesses, State and local governments, and organizations 
     representing the interested public.
       [``(C) Each proposed schedule required under subparagraph 
     (A) shall establish priorities for the review of rules that, 
     in the joint determination of the Administrator of the Office 
     of Information and Regulatory Affairs and the agency, most 
     likely can be amended or eliminated to--
       [``(i) provide the same or greater benefits at 
     substantially lower costs;
       [``(ii) achieve substantially greater benefits at the same 
     or lower costs; or
       [``(iii) replace command-and-control regulatory 
     requirements with market mechanisms or performance standards 
     that achieve substantially equivalent benefits at lower costs 
     or with greater flexibility.
       [``(D) Each proposed schedule required by subparagraph (A) 
     shall include--
       [``(i) a brief explanation of the reasons the agency 
     considers each rule on the schedule to be a major rule, or 
     the reasons why the agency selected the rule for review;
       [``(ii) a date set by the agency, in accordance with 
     subsection (b), for the completion of the review of each such 
     rule; and
       [``(iii) a statement that the agency requests comments from 
     the public on the proposed schedule.
       [``(E) The agency shall set a date to initiate review of 
     each rule on the schedule in a manner that will ensure the 
     simultaneous review of related items and that will achieve a 
     reasonable distribution of reviews over the period of time 
     covered by the schedule.
       [``(2) No later than 90 days before publishing in the 
     Federal Register the proposed schedule required under 
     paragraph (1), each agency shall make the proposed schedule 
     available to the Director or a designee of the President. The 
     President or that officer may select for review in accordance 
     with this section any additional rule.
       [``(3) No later than 1 year after the effective date of 
     this section, each agency shall publish in the Federal 
     Register a final schedule for the review of the rules 
     referred to in paragraphs (1) and (2). Each agency shall 
     publish with the final schedule the response of the agency to 
     comments received concerning the proposed schedule.
       [``(b)(1) Except as explicitly provided otherwise by 
     statute, the agency shall, pursuant to subsections (c) 
     through (e), review--
       [``(A) each rule on the schedule promulgated pursuant to 
     subsection (a);
       [``(B) each major rule promulgated, amended, or otherwise 
     continued by an agency after the effective date of this 
     section; and
       [``(C) each rule promulgated after the effective date of 
     this section that the President or the officer designated by 
     the President selects for review pursuant to subsection 
     (a)(2).
       [``(2) Except as provided pursuant to subsection (f), the 
     review of a rule required by this section shall be completed 
     no later than the later of--
       [``(A) 10 years after the effective date of this section; 
     or
       [``(B) 10 years after the date on which the rule is--
       [``(i) promulgated; or
       [``(ii) amended or continued under this section.
       [``(c) An agency shall publish in the Federal Register a 
     notice of its proposed action under this section with respect 
     to a rule being reviewed. The notice shall include--
       [``(1) an identification of the specific statutory 
     authority under which the rule was promulgated and an 
     explanation of whether the agency's interpretation of the 
     statute is expressly required by the current text of that 
     statute or, if not, whether it is within the range of 
     permissible interpretations of the statute;
       [``(2) an analysis of the benefits and costs of the rule 
     during the period in which it has been in effect;
       [``(3) an explanation of the proposed agency action with 
     respect to the rule, including action to repeal or amend the 
     rule to resolve inconsistencies or conflicts with any other 
     obligation or requirement established by any Federal statute, 
     rule, or other agency statement, interpretation, or action 
     that has the force of law; and
       [``(4) a statement that the agency seeks proposals from the 
     public for modifications or alternatives to the rule which 
     may accomplish the objectives of the rule in a more effective 
     or less burdensome manner.
       [``(d) If an agency proposes to repeal or amend a rule 
     under review pursuant to this section, the agency shall, 
     after issuing the notice required by subsection (c), comply 
     with the provisions of this chapter, chapter 5, and any other 
     applicable law. The requirements of such provisions and 
     related requirements shall apply to the same extent and in 
     the same manner as in the case of a proposed agency action to 
     repeal or amend a rule that is not taken pursuant to the 
     review required by this section.
       [``(e) If an agency proposes to continue without amendment 
     a rule under review pursuant to this section, the agency 
     shall--
       [``(1) give interested persons no less than 60 days after 
     the publication of the notice required by subsection (c) to 
     comment on the proposed continuation; and
       [``(2) publish in the Federal Register notice of the 
     continuation of such rule.
       [``(f) Any agency, which for good cause finds that 
     compliance with this section with respect to a particular 
     rule during the period provided in subsection (b) of this 
     section is contrary to an important public interest may 
     request the President, or the officer designated by the 
     President pursuant to subsection (a)(2), to establish a 
     period longer than 10 years for the completion of the review 
     of such rule. The President or that officer may extend the 
     period for review of a rule to a total period of no more than 
     15 years. Such extension shall be published in the Federal 
     Register with an explanation of the reasons therefor.
       [``(g) If the agency fails to comply with the requirements 
     of subsection (b)(2), the rule for which rulemaking 
     proceedings have not been completed shall cease to be 
     enforceable against any person.
       [``(h) Nothing in this section shall relieve any agency 
     from its obligation to respond to a petition to issue, amend, 
     or repeal a rule, for an interpretation regarding the meaning 
     of a rule, or for a variance or exemption from the terms of a 
     rule, submitted pursuant to any other provision of law.

     [``Sec. 626. Public participation and accountability

       [``In order to maximize accountability for, and public 
     participation in, the development and review of regulatory 
     actions each agency shall, consistent with chapter 5 and 
     other applicable law, provide the public with opportunities 
     for meaningful participation in the development of regulatory 
     actions, including--
       [``(1) seeking the involvement, where practicable and 
     appropriate, of those who are intended to benefit from and 
     those who are expected to be burdened by any regulatory 
     action;
       [``(2) providing in any proposed or final rulemaking notice 
     published in the Federal Register--
       [``(A) a certification of compliance with the requirements 
     of this chapter, or an explanation why such certification 
     cannot be made;
       [``(B) a summary of any regulatory analysis required under 
     this chapter, or under any other legal requirement, and 
     notice of the availability of the regulatory analysis;
       [``(C) a certification that the rule will produce benefits 
     that will justify the cost to the Government and to the 
     public of implementation of, and compliance with, the rule, 
     or an explanation why such certification cannot be made; and
       [``(D) a summary of the results of any regulatory review 
     and the agency's response to such review, including an 
     explanation of any significant changes made to such 
     regulatory action as a consequence of regulatory review;
       [``(3) identifying, upon request, a regulatory action and 
     the date upon which such action was submitted to the 
     designated officer to whom authority was delegated under 
     section 644 for review;
       [``(4) disclosure to the public, consistent with section 
     634(3), of any information created or collected in performing 
     a regulatory analysis required under this chapter, or under 
     any other legal requirement; and
       [``(5) placing in the appropriate rulemaking record all 
     written communications received from the Director, other 
     designated officer, or other individual or entity relating to 
     regulatory review.

                  [``SUBCHAPTER III--RISK ASSESSMENTS

     [``Sec. 631. Findings and purposes

       [``(a) The Congress finds that:
       [``(1) Environmental, health, and safety regulations have 
     lead to dramatic improvements in the environment and have 
     significantly reduced risks to human health; except--
       [``(A) many regulations have been more costly and less 
     effective than necessary; and
       [``(B) too often, regulatory priorities have not been based 
     upon a realistic consideration of risk, risk reduction 
     opportunities, and costs.
       [``(2) The public and private resources available to 
     address health, safety, and environmental risks are not 
     unlimited. Those resources should be allocated to address the 
     greatest needs in the most cost-effective manner and to 
     ensure that the incremental costs of regulatory options are 
     reasonably related to the incremental benefits.
       [``(3) To provide more cost-effective protection to human 
     health, safety, and the environment, regulatory priorities 
     should be supported by realistic and plausible scientific 
     risk assessments and risk management choices that are 
     grounded in cost-benefit principles. 

[[Page S9264]]

       [``(4) Risk assessment has proved to be a useful 
     decisionmaking tool, except--
       [``(A) improvements are needed in both the quality of 
     assessments and the characterization and communication of 
     findings;
       [``(B) scientific and other data must be better collected, 
     organized, and evaluated; and
       [``(C) the critical information resulting from a risk 
     assessment must be effectively communicated in an objective 
     and unbiased manner to decision makers, and from decision 
     makers to the public.
       [``(5) The public stakeholders should be involved in the 
     decisionmaking process for regulating risks. The public has 
     the right to know about the risks addressed by regulation, 
     the amount of risk reduced, the quality of the science used 
     to support decisions, and the cost of implementing and 
     complying with regulations. Such knowledge will allow for 
     public scrutiny and will promote the quality, integrity, and 
     responsiveness of agency decisions.
       [``(b) The purposes of this subchapter are to--
       [``(1) present the public and executive branch with the 
     most realistic and plausible information concerning the 
     nature and magnitude of health, safety, and environmental 
     risks to promote sound regulatory decisions and public 
     education;
       [``(2) provide for full consideration and discussion of 
     relevant data and potential methodologies;
       [``(3) require explanation of significant choices in the 
     risk assessment process that will allow for better public 
     understanding; and
       [``(4) improve consistency within the executive branch in 
     preparing risk assessments and risk characterizations.

     [``Sec. 632. Definitions

       [``For purposes of this subchapter, the definitions under 
     sections 551 and 621 shall apply and:
       [``(1) The term `covered agency' means each of the 
     following:
       [``(A) The Environmental Protection Agency.
       [``(B) The Department of Labor.
       [``(C) The Department of Transportation.
       [``(D) The Food and Drug Administration.
       [``(E) The Department of Energy.
       [``(F) The Department of the Interior.
       [``(G) The Department of Agriculture.
       [``(H) The Consumer Product Safety Commission.
       [``(I) The National Oceanic and Atmospheric Administration.
       [``(J) The United States Army Corps of Engineers.
       [``(K) The Nuclear Regulatory Commission.
       [``(L) Any other Federal agency considered a covered agency 
     under section 633(b).
       [``(2) The term `emergency' means a situation that is 
     immediately impending and extraordinary in nature, demanding 
     attention due to a condition, circumstance or practice 
     reasonably expected to cause death, serious illness or severe 
     injury to humans, or substantial endangerment to private 
     property or the environment if no action is taken.
       [``(3) The term `estimates of risk' means numerical 
     representations of the potential magnitude of harm to 
     populations or the probability of harm to individuals, 
     including, as appropriate, those derived by considering the 
     range and distribution of estimates of dose-response 
     (potency) and exposure, including appropriate statistical 
     representation of the range and most likely exposure levels, 
     and the identification of the populations or subpopulations 
     addressed. When appropriate and practicable, a description of 
     any populations or subpopulations that are likely to 
     experience exposures at the upper end of the distribution 
     should be included.
       [``(4) The term `hazard identification' means 
     identification of a substance, activity, or condition as 
     potentially causing harm to human health, safety, or the 
     environment.
       [``(5) The term `risk assessment' means--
       [``(A) identifying, quantifying to the extent feasible and 
     appropriate, and characterizing hazards and exposures to 
     those hazards in order to provide structured information on 
     the nature of threats to human health, safety, or the 
     environment; and
       [``(B) the document containing the explanation of how the 
     assessment process has been applied to an individual 
     substance, activity, or condition.
       [``(6) The term `risk characterization' means the 
     integration, synthesis, and organization of hazard 
     identification, dose-response and exposure information that 
     addresses the needs of decision makers and interested 
     parties. The term includes both the process and specific 
     outputs, including--
       [``(A) the 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 that is 
     made available to the public; and
       [``(B) discussions of uncertainties, conflicting data, 
     estimates of risk, extrapolations, inferences, and opinions.
       [``(7) The term `screening analysis' means an analysis that 
     arrives at a qualitative estimate or a bounding estimate of 
     risk that permits the risk manager to accept or reject some 
     management options, or permits establishing priorities for 
     agency action. Such term includes an assessment performed by 
     a regulated party and submitted to an agency under a 
     regulatory requirement.
       [``(8) The term `substitution risk' means a reasonably 
     likely increased risk to human health, safety, or the 
     environment from a regulatory option designed to decrease 
     other risks.

     [``Sec. 633. Applicability

       [``(a) Except as provided in subsection (c), 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 covered agency in connection 
     with a major rule addressing health, safety, and 
     environmental risks.
       [``(b)(1) No later than 18 months after the effective date 
     of this section, the President, acting through the Director 
     of the Office of Management and Budget, shall determine 
     whether other Federal agencies should be considered covered 
     agencies for the purposes of this subchapter. Such 
     determination, with respect to a particular Federal agency, 
     shall be based on the impact of risk assessment documents and 
     risk characterization documents on--
       [``(A) regulatory programs administered by that agency; and
       [``(B) the communication of risk information by that agency 
     to the public.
       [``(2) If the President makes a determination under 
     paragraph (1), the provisions of this subchapter shall apply 
     to any affected agency beginning on a date set by the 
     President. Such date may be no later than 6 months after the 
     date of such determination.
       [``(c)(1) This subchapter shall not apply to risk 
     assessments or risk characterizations performed with respect 
     to--
       [``(A) an emergency determined by the head of an agency;
       [``(B) a health, safety, or environmental inspection or 
     individual facility permitting action; or
       [``(C) a screening analysis.
       [``(2) This subchapter shall not apply to any food, drug, 
     or other product label, or to any risk characterization 
     appearing on any such label.

     [``Sec. 634. Savings provisions

       [``Nothing in this subchapter shall be construed to--
       [``(1) modify any statutory standard or requirement 
     designed to protect human health, safety, or the environment;
       [``(2) 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
       [``(3) require the disclosure of any trade secret or other 
     confidential information.

     [``Sec. 635. Principles for risk assessment

       [``(a) The head of each covered agency shall ensure that 
     risk assessments and all of the components of such 
     assessments--
       [``(1) provide for a systematic means to structure 
     information useful to decision makers;
       [``(2) provide, to the maximum extent practicable, that 
     policy-driven default assumptions be used only in the absence 
     of relevant available information;
       [``(3) promote involvement from all stakeholders;
       [``(4) provide an opportunity for public input throughout 
     the regulatory process; and
       [``(5) are designed so that the degree of specificity and 
     rigor employed is commensurate with the consequences of the 
     decision to be made.
       [``(b) A risk assessment shall, to the maximum extent 
     practicable, clearly delineate hazard identification from 
     dose-response and exposure assessment and make clear the 
     relationship between the level of risk and the level of 
     exposure to a hazard.

     [``Sec. 636. Principles for risk characterization

       [``In characterizing risk in any risk assessment document, 
     regulatory proposal, or decision, each covered agency shall 
     include in the risk characterization, as appropriate, each of 
     the following:
       [``(1)(A) A description of the exposure scenarios used, the 
     natural resources or subpopulations being exposed, and the 
     likelihood of those exposure scenarios.
       [``(B) When a risk assessment involves a choice of any 
     significant assumption, inference, or model, the covered 
     agency or instrumentality preparing the risk assessment 
     shall--
       [``(i) identify the assumptions, inferences, and models 
     that materially affect the outcome;
       [``(ii) explain the basis for any choices;
       [``(iii) identify any policy decisions or policy-based 
     default assumptions;
       [``(iv) indicate the extent to which any significant model 
     has been validated by, or conflicts with, empirical data; and
       [``(v) describe the impact of alternative choices of 
     assumptions, default options or mathematical models.
       [``(C) The major sources of uncertainties in the hazard 
     identification, dose-response and exposure assessment phases 
     of the risk assessment.
       [``(D) To the extent feasible, the range and distribution 
     of exposures and risks derived from the risk assessment 
     should be included as a component of the risk 
     characterization.
       [``(2) When a covered 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, when 
     information on such risks has been made available to the 
     agency.

     [``Sec. 637. Peer review

       [``(a) The head of each covered agency shall develop a 
     systematic program for independent and external peer review 
     required under subsection (b). Such program shall be 
     applicable throughout each covered agency and--

[[Page S9265]]

       [``(1) shall provide for the creation of peer review panels 
     that--
       [``(A) consist of members with expertise relevant to the 
     sciences involved in regulatory decisions and who are 
     independent of the covered agency; and
       [``(B) are broadly representative and balanced and, to the 
     extent relevant and appropriate, may include persons 
     affiliated with Federal, State, local, or tribal governments, 
     small businesses, other representatives of industry, 
     universities, agriculture, labor consumers, conservation 
     organizations, or other public interest groups and 
     organizations;
       [``(2) shall not exclude any person with substantial and 
     relevant expertise as a panel member on the basis that such 
     person represents an entity that may have a potential 
     interest in the outcome, if such interest is fully disclosed 
     to the agency, and in the case of a regulatory decision 
     affecting a single entity, no peer reviewer representing such 
     entity may be included on the panel;
       [``(3) shall provide for a timely completed peer review, 
     meeting agency deadlines, that contains a balanced 
     presentation of all considerations, including minority 
     reports and an agency response to all significant peer review 
     comments; and
       [``(4) shall provide adequate protections for confidential 
     business information and trade secrets, including requiring 
     panel members to enter into confidentiality agreements.
       [``(b)(1)(A) Except as provided under subparagraph (B), 
     each covered agency shall provide for peer review in 
     accordance with this section of any risk assessment or cost-
     benefit analysis that forms the basis of any major rule that 
     addresses risks to the environment, health, or safety.
       [``(B) Subparagraph (A) shall not apply to a rule or other 
     action taken by an agency to authorize or approve any 
     individual substance or product.
       [``(2) The Director of the Office of Management and Budget 
     may order that peer review be provided for any risk 
     assessment or cost-benefit analysis that is likely to have a 
     significant impact on public policy decisions or would 
     establish an important precedent.
       [``(c) Each peer review under this section shall include a 
     report to the Federal agency concerned with respect to the 
     scientific and technical merit of data and methods used for 
     the risk assessments or cost-benefit analyses.
       [``(d) The head of the covered agency shall provide a 
     written response to all significant peer review comments.
       [``(e) All peer review comments or conclusions 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.
       [``(f) No peer review shall be required under this section 
     for any data, method, document, or assessment, or any 
     component thereof, which has been previously subjected to 
     peer review.

     [``Sec. 638. Guidelines, plan for assessing new information, 
       and report

       [``(a)(1)(A) As soon as practicable and scientifically 
     feasible, each covered agency shall adopt, after notification 
     and opportunity for public comment, guidelines to implement 
     the risk assessment and risk characterization principles 
     under sections 635 and 636, as well as the cost-benefit 
     analysis requirements under section 622, and shall provide a 
     format for summarizing risk assessment results.
       [``(B) No later than 12 months after the effective date of 
     this section, the head of each covered agency shall issue a 
     report on the status of such guidelines to the Congress.
       [``(2) The guidelines under paragraph (1) shall--
       [``(A) include guidance on use of specific technical 
     methodologies and standards for acceptable quality of 
     specific kinds of data;
       [``(B) address important decisional factors for the risk 
     assessment, risk characterization, and cost-benefit analysis 
     at issue; and
       [``(C) provide procedures for the refinement and 
     replacement of policy-based default assumptions.
       [``(b) The guidelines, plan and report 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, organizations, or persons as 
     may be advisable.
       [``(c) The President shall review the guidelines published 
     under this section at least every 4 years.
       [``(d) The development, issuance, and publication of risk 
     assessment and risk characterization guidelines under this 
     section shall not be subject to judicial review.

     [``Sec. 639. Research and training in risk assessment

       [``(a) The head of each covered agency shall regularly and 
     systematically evaluate risk assessment research and training 
     needs of the agency, including, where relevant and 
     appropriate, the following:
       [``(1) Research to reduce generic data gaps, to address 
     modelling needs (including improved model sensitivity), and 
     to validate default options, particularly those common to 
     multiple risk assessments.
       [``(2) Research leading to improvement of methods to 
     quantify and communicate uncertainty and variability among 
     individuals, species, populations, and, in the case of 
     ecological risk assessment, ecological communities.
       [``(3) Emerging and future areas of research, including 
     research on comparative risk analysis, exposure to multiple 
     chemicals and other stressors, noncancer endpoints, 
     biological markers of exposure and effect, mechanisms of 
     action in both mammalian and nonmammalian species, dynamics 
     and probabilities of physiological and ecosystem exposures, 
     and prediction of ecosystem-level responses.
       [``(4) Long-term needs to adequately train individuals in 
     risk assessment and risk assessment application. Evaluations 
     under this paragraph shall include an estimate of the 
     resources needed to provide necessary training.
       [``(b) The head of each covered agency shall develop a 
     strategy and schedule for carrying out research and training 
     to meet the needs identified in subsection (a).

     [``Sec. 640. Interagency coordination

       [``(a) To promote the conduct, application, and practice of 
     risk assessment in a consistent manner and to identify risk 
     assessment data and research needs common to more than 1 
     Federal agency, the Director of the Office of Management and 
     Budget, in consultation with the Office of Science and 
     Technology Policy, 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 Congress based on the surveys conducted and 
     determinations made under paragraph (1);
       [``(3) establish appropriate interagency mechanisms to 
     promote--
       [``(A) coordination among Federal agencies conducting risk 
     assessment with respect to the conduct, application, and 
     practice of risk assessment; and
       [``(B) the use of state-of-the-art risk assessment 
     practices throughout the Federal Government;
       [``(4) establish appropriate mechanisms between Federal and 
     State agencies to communicate state-of-the-art risk 
     assessment practices; and
       [``(5) periodically convene meetings with State government 
     representatives and Federal and other leaders to assess the 
     effectiveness of Federal and State cooperation in the 
     development and application of risk assessment.
       [``(b) The President shall appoint National Peer Review 
     Panels to review every 3 years the risk assessment practices 
     of each covered agency for programs designed to protect human 
     health, safety, or the environment. The Panels shall submit a 
     report to the President and the Congress at least every 3 
     years containing the results of such review.

     [``Sec. 640a. Plan for review of risk assessments

       [``(a) No later than 18 months after the effective date of 
     this section, the head of each covered agency shall publish a 
     plan to review and revise any risk assessment published 
     before the expiration of such 18-month period if the covered 
     agency determines that significant new information or 
     methodologies are available that could significantly alter 
     the results of the prior risk assessment.
       [``(b) A plan under subsection (a) shall--
       [``(1) provide procedures for receiving and considering new 
     information and risk assessments from the public; and
       [``(2) set priorities and criteria for review and revision 
     of risk assessments based on such factors as the agency head 
     considers appropriate.

     [``Sec. 640b. Judicial review

       [``The provisions of section 623 relating to judicial 
     review shall apply to this subchapter.

     [``Sec. 640c. Deadlines for rulemaking

       [``The provisions of section 624 relating to deadlines for 
     rulemaking shall apply to this subchapter.

                 [``SUBCHAPTER IV--EXECUTIVE OVERSIGHT

     [``Sec. 641. Definition

       [``For purposes of this subchapter, the definitions under 
     sections 551 and 621 shall apply.

     [``Sec. 642. Procedures

       [``The Director or other designated officer to whom 
     authority is delegated under section 644 shall--
       [``(1) establish procedures for agency compliance with this 
     chapter; and
       [``(2) monitor, review, and ensure agency implementation of 
     such procedures.

     [``Sec. 643. Promulgation and adoption

       [``(a) Procedures established pursuant to section 642 shall 
     only be implemented after opportunity for public comment. Any 
     such procedures shall be consistent with the prompt 
     completion of rulemaking proceedings.
       [``(b)(1) If procedures established pursuant to section 642 
     include review of any initial or final analyses of a rule 
     required under this chapter, the time for any such review of 
     any initial analysis shall not exceed 60 days following the 
     receipt of the analysis by the Director, a designee of the 
     President, or by an officer to whom the authority granted 
     under section 642 has been delegated pursuant to section 644.
       [``(2) The time for review of any final analysis required 
     under this chapter shall not exceed 60 days following the 
     receipt of the analysis by the Director, a designee of the 
     President, or such officer.
       [``(3)(A) The times for each such review may be extended 
     for good cause by the President or such officer for an 
     additional 30 days.

[[Page S9266]]

       [``(B) Notice of any such extension, together with a 
     succinct statement of the reasons therefor, shall be inserted 
     in the rulemaking file.

     [``Sec. 644. Delegation of authority

       [``(a) The President shall delegate the authority granted 
     by this subchapter to the Director or to another officer 
     within the Executive Office of the President whose 
     appointment has been subject to the advice and consent of the 
     Senate.
       [``(b) Notice of any delegation, or any revocation or 
     modification thereof shall be published in the Federal 
     Register.

     [``Sec. 645. Public disclosure of information

       [``The Director or other designated officer to whom 
     authority is delegated under section 644, in carrying out the 
     provisions of section 642, shall establish procedures 
     (covering all employees of the Director or other designated 
     officer) to provide public and agency access to information 
     concerning regulatory review actions, including--
       [``(1) disclosure to the public on an ongoing basis of 
     information regarding the status of regulatory actions 
     undergoing review;
       [``(2) disclosure to the public, no later than publication 
     of, or other substantive notice to the public concerning a 
     regulatory action, of--
       [``(A) all written communications, regardless of form or 
     format, including drafts of all proposals and associated 
     analyses, between the Director or other designated officer 
     and the regulatory agency;
       [``(B) all written communications, regardless of form or 
     format, between the Director or other designated officer and 
     any person not employed by the executive branch of the 
     Federal Government relating to the substance of a regulatory 
     action;
       [``(C) a record of all oral communications relating to the 
     substance of a regulatory action between the Director or 
     other designated officer and any person not employed by the 
     executive branch of the Federal Government; and
       [``(D) a written explanation of any review action and the 
     date of such action; and
       [``(3) disclosure to the regulatory agency, on a timely 
     basis, of--
       [``(A) all written communications between the Director or 
     other designated officer and any person who is not employed 
     by the executive branch of the Federal Government;
       [``(B) a record of all oral communications, and an 
     invitation to participate in meetings, relating to the 
     substance of a regulatory action between the Director or 
     other designated officer and any person not employed by the 
     executive branch of the Federal Government; and
       [``(C) a written explanation of any review action taken 
     concerning an agency regulatory action.

     [``Sec. 646. Judicial review

       [``The exercise of the authority granted under this 
     subchapter by the Director, the President, or by an officer 
     to whom such authority has been delegated under section 644 
     shall not be subject to judicial review in any manner.''.
       [(b) Regulatory Flexibility Analysis.--
       [(1) In general.--Section 611 of title 5, United States 
     Code, is amended to read as follows:

     [``Sec. 611. Judicial review

       [``(a)(1) Except as provided in paragraph (2), no later 
     than 1 year after the effective date of a final rule with 
     respect to which an agency--
       [``(A) certified, pursuant to section 605(b), that such 
     rule would not have a significant economic impact on a 
     substantial number of small entities; or
       [``(B) prepared a final regulatory flexibility analysis 
     pursuant to section 604,
     an affected small entity may petition for the judicial review 
     of such certification or analysis in accordance with this 
     subsection. A court having jurisdiction to review such rule 
     for compliance with section 553 of this title or under any 
     other provision of law shall have jurisdiction to review such 
     certification or analysis.
       [``(2)(A) Except as provided in subparagraph (B), in the 
     case of a provision of law that requires that an action 
     challenging a final agency regulation be commenced before the 
     expiration of the 1-year period provided in paragraph (1), 
     such lesser period shall apply to a petition for the judicial 
     review under this subsection.
       [``(B) In a case in which an agency delays the issuance of 
     a final regulatory flexibility analysis pursuant to section 
     608(b), a petition for judicial review under this subsection 
     shall be filed no later than--
       [``(i) 1 year; or
       [``(ii) in a case in which a provision of law requires that 
     an action challenging a final agency regulation be commenced 
     before the expiration of the 1-year period provided in 
     paragraph (1), the number of days specified in such provision 
     of law,
     after the date the analysis is made available to the public.
       [``(3) For purposes of this subsection, the term `affected 
     small entity' means a small entity that is or will be 
     adversely affected by the final rule.
       [``(4) Nothing in this subsection shall be construed to 
     affect the authority of any court to stay the effective date 
     of any rule or provision thereof under any other provision of 
     law.
       [``(5)(A) In a case in which an agency certifies that such 
     rule would not have a significant economic impact on a 
     substantial number of small entities, the court may order the 
     agency to prepare a final regulatory flexibility analysis 
     pursuant to section 604 if the court determines, on the basis 
     of the rulemaking record, that the certification was 
     arbitrary, capricious, an abuse of discretion, or otherwise 
     not in accordance with law.
       [``(B) In a case in which the agency prepared a final 
     regulatory flexibility analysis, the court may order the 
     agency to take corrective action consistent with section 604 
     if the court determines, on the basis of the rulemaking 
     record, that the final regulatory flexibility analysis was 
     prepared by the agency without complying with section 604.
       [``(6) If, by the end of the 90-day period beginning on the 
     date of the order of the court pursuant to paragraph (5) (or 
     such longer period as the court may provide), the agency 
     fails, as appropriate--
       [``(A) to prepare the analysis required by section 604; or
       [``(B) to take corrective action consistent with section 
     604 of this title,

     the court may stay the rule or grant such other relief as it 
     deems appropriate.
       [``(7) In making any determination or granting any relief 
     authorized by this subsection, the court shall take due 
     account of the rule of prejudicial error.
       [``(b) In an action for the judicial review of a rule, any 
     regulatory flexibility analysis for such rule (including an 
     analysis prepared or corrected pursuant to subsection (a)(5)) 
     shall constitute part of the whole record of agency action in 
     connection with such review.
       [``(c) Nothing in this section bars judicial review of any 
     other impact statement or similar analysis required by any 
     other law if judicial review of such statement or analysis is 
     otherwise provided by law.''.
       [(2) Effective date.--The amendment made by paragraph (1) 
     shall take effect on the effective date of this Act, except 
     that the judicial review authorized by section 611(a) of 
     title 5, United States Code (as added by subsection (a)), 
     shall apply only to final agency rules issued after such 
     effective date.
       [(c) Presidential Authority.--Nothing in this Act shall 
     limit the exercise by the President of the authority and 
     responsibility that the President otherwise possesses under 
     the Constitution and other laws of the United States with 
     respect to regulatory policies, procedures, and programs of 
     departments, agencies, and offices.
       [(d) Technical and Conforming Amendments.--
       [(1) Part I of title 5, United States Code, is amended by 
     striking out the chapter heading and table of sections for 
     chapter 6 and inserting in lieu thereof 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 analysis.
[``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--ANALYSIS OF AGENCY RULES

[``621. Definitions.
[``622. Rulemaking cost-benefit analysis.
[``623. Judicial review.
[``624. Deadlines for rulemaking.
[``625. Agency review of rules.
[``626. Public participation and accountability.

                  [``SUBCHAPTER III--RISK ASSESSMENTS

[``631. Findings and purposes.
[``632. Definitions.
[``633. Applicability.
[``634. Savings provisions.
[``635. Principles for risk assessment.
[``636. Principles for risk characterization.
[``637. Peer review.
[``638. Guidelines, plan for assessing new information, and report.
[``639. Research and training in risk assessment.
[``640. Interagency coordination.
[``640a. Plan for review of risk assessments.
[``640b. Judicial review.
[``640c. Deadlines for rulemaking.

                 [``SUBCHAPTER IV--EXECUTIVE OVERSIGHT

[``641. Definition.
[``642. Procedures.
[``643. Promulgation and adoption.
[``644. Delegation of authority.
[``645. Public disclosure of information.
[``646. Judicial review.''.
       [(2) Chapter 6 of title 5, United States Code, is amended 
     by inserting immediately before section 601, the following 
     subchapter heading:

                [``SUBCHAPTER I--REGULATORY ANALYSIS''.

     [SEC. 4. CONGRESSIONAL REVIEW.

       [(a) In General.--Part I of title 5, United States Code, is 
     amended by inserting after chapter 7 the following new 
     chapter:

        [``CHAPTER 8--CONGRESSIONAL REVIEW OF AGENCY RULEMAKING

     [``Sec. 801. Congressional review of agency rulemaking

       [``(a) For purposes of this chapter, the term--

[[Page S9267]]

       [``(1) `major rule' means a major rule as defined under 
     section 621(4) of this title and as determined under section 
     622 of this title; and
       [``(2) `rule' (except in reference to a rule of the Senate 
     or House of Representatives) is a reference to a major rule.
       [``(b)(1) Upon the promulgation of a final major rule, the 
     agency promulgating such rule shall submit to the Congress a 
     copy of the rule, the statement of basis and purpose for the 
     rule, and the proposed effective date of the rule.
       [``(2) A rule submitted under paragraph (1) shall not take 
     effect as a final rule before the latest of the following:
       [``(A) The later of the date occurring 45 days after the 
     date on which--
       [``(i) the Congress receives the rule submitted under 
     paragraph (1); or
       [``(ii) the rule is published in the Federal Register.
       [``(B) If the Congress passes a joint resolution of 
     disapproval described under subsection (i) relating to the 
     rule, and the President signs a veto of such resolution, the 
     earlier date--
       [``(i) on which either House of Congress votes and fails to 
     override the veto of the President; or
       [``(ii) occurring 30 session days after the date on which 
     the Congress received the veto and objections of the 
     President.
       [``(C) The date the rule would have otherwise taken effect, 
     if not for this section (unless a joint resolution of 
     disapproval under subsection (i) is approved).
       [``(c) A major rule shall not take effect as a final rule 
     if the Congress passes a joint resolution of disapproval 
     described under subsection (i), which is signed by the 
     President or is vetoed and overridden by the Congress.
       [``(d)(1) Notwithstanding any other provision of this 
     section (except subject to paragraph (2)), a major rule that 
     would not take effect by reason of this section may take 
     effect if the President makes a determination and submits 
     written notice of such determination to the Congress that the 
     major rule should take effect because such major rule is--
       [``(A) necessary because of an imminent threat to health or 
     safety, or other emergency;
       [``(B) necessary for the enforcement of criminal laws; or
       [``(C) necessary for national security.
       [``(2) An exercise by the President of the authority under 
     this subsection shall have no effect on the procedures under 
     subsection (i) or the effect of a joint resolution of 
     disapproval under this section.
       [``(e)(1) Subsection (i) shall apply to any major rule that 
     is promulgated as a final rule during the period beginning on 
     the date occurring 60 days before the date the Congress 
     adjourns sine die through the date on which the succeeding 
     Congress first convenes.
       [``(2) For purposes of subsection (i), a major rule 
     described under paragraph (1) shall be treated as though such 
     rule were published in the Federal Register (as a rule that 
     shall take effect as a final rule) on the date the succeeding 
     Congress first convenes.
       [``(3) During the period between the date the Congress 
     adjourns sine die through the date on which the succeeding 
     Congress first convenes, a rule described under paragraph (1) 
     shall take effect as a final rule as otherwise provided by 
     law.
       [``(f) Any rule that takes effect and later is made of no 
     force or effect by the enactment of a joint resolution under 
     subsection (i) shall be treated as though such rule had never 
     taken effect.
       [``(g) If the Congress does not enact a joint resolution of 
     disapproval under subsection (i), no court or agency may 
     infer any intent of the Congress from any action or inaction 
     of the Congress with regard to such major rule, related 
     statute, or joint resolution of disapproval.
       [``(h) If the agency fails to comply with the requirements 
     of subsection (b) for any rule, the rule shall cease to be 
     enforceable against any person.
       [``(i)(1) For purposes of this subsection, the term `joint 
     resolution' means only a joint resolution introduced after 
     the date on which the rule referred to in subsection (b) is 
     received by Congress the matter after the resolving clause of 
     which is as follows: `That Congress disapproves the rule 
     submitted by the ____________ relating to ______________, and 
     such rule shall have no force or effect.' (The blank spaces 
     being appropriately filled in.)
       [``(2)(A) In the Senate, a resolution described in 
     paragraph (1) shall be referred to the committees with 
     jurisdiction. Such a resolution shall not be reported before 
     the eighth day after its submission or publication date.
       [``(B) For purposes of this subsection, the term 
     `submission or publication date' means the later of the date 
     on which--
       [``(i) the Congress receives the rule submitted under 
     subsection (b)(1); or
       [``(ii) the rule is published in the Federal Register.
       [``(3) In the Senate, if the committee to which a 
     resolution described in paragraph (1) is referred has not 
     reported such resolution (or an identical resolution) at the 
     end of 20 calendar days after its submission or publication 
     date, such committee may be discharged on a petition approved 
     by 30 Senators from further consideration of such resolution 
     and such resolution shall be placed on the Senate calendar.
       [``(4)(A) In the Senate, when the committee to which a 
     resolution is referred has reported, or when a committee is 
     discharged (under paragraph (3)) from further consideration 
     of, a resolution described in paragraph (1), it shall at any 
     time thereafter be in order (even though a previous motion to 
     the same effect has been disagreed to) for any Senator to 
     move to proceed to the consideration of the resolution, and 
     all points of order against the resolution (and against 
     consideration of the resolution) shall be waived. The motion 
     shall be privileged in the Senate and shall not be debatable. 
     The motion shall not be subject to amendment, or to a motion 
     to postpone, or to a motion to proceed to the consideration 
     of other business. A motion to reconsider the vote by which 
     the motion is agreed to or disagreed to shall not be in 
     order. If a motion to proceed to the consideration of the 
     resolution is agreed to, the resolution shall remain the 
     unfinished business of the Senate until disposed of.
       [``(B) In the Senate, debate on the resolution, and on all 
     debatable motions and appeals in connection therewith, shall 
     be limited to not more than 10 hours, which shall be divided 
     equally between those favoring and those opposing the 
     resolution. A motion further to limit debate shall be in 
     order and shall not be debatable. An amendment to, or a 
     motion to postpone, or a motion to proceed to the 
     consideration of other business, or a motion to recommit the 
     resolution shall not be in order. A motion to reconsider the 
     vote by which the resolution is agreed to or disagreed to 
     shall not be in order.
       [``(C) In the Senate, immediately following the conclusion 
     of the debate on a resolution described in paragraph (1), and 
     a single quorum call at the conclusion of the debate if 
     requested in accordance with the Senate rules, the vote on 
     final passage of the resolution shall occur.
       [``(D) Appeals from the decisions of the Chair relating to 
     the application of the rules of the Senate to the procedure 
     relating to a resolution described in paragraph (1) shall be 
     decided without debate.
       [``(5) If, before the passage in the Senate of a resolution 
     described in paragraph (1), the Senate receives from the 
     House of Representatives a resolution described in paragraph 
     (1), then the following procedures shall apply:
       [``(A) The resolution of the House of Representatives shall 
     not be referred to a committee.
       [``(B) With respect to a resolution described in paragraph 
     (1) of the Senate--
       [``(i) the procedure in the Senate shall be the same as if 
     no resolution had been received from the other House; but
       [``(ii) the vote on final passage shall be on the 
     resolution of the other House.
       [``(6) This subsection is enacted by Congress--
       [``(A) as an exercise of the rulemaking power of the Senate 
     and House of Representatives, respectively, and as such it is 
     deemed to be a part of the rules of each House, respectively, 
     but applicable only with respect to the procedure to be 
     followed in that House in the case of a resolution described 
     in paragraph (1), and it supersedes other rules only to the 
     extent that it is inconsistent with such rules; and
       [``(B) with full recognition of the constitutional right of 
     either House to change the rules (so far as relating to the 
     procedure of that House) at any time, in the same manner, and 
     to the same extent as in the case of any other rule of that 
     House.
       [``(j) No requirements under this chapter shall be subject 
     to judicial review in any manner.''.
       [(b) Technical and Conforming Amendment.--The table of 
     chapters for part I of title 5, United States Code, is 
     amended by inserting after the item relating to chapter 7 the 
     following:

[``8. Congressional Review of Agency Rulemaking..............801''.....
     [SEC. 5. STUDIES AND REPORTS.

       [(a) Risk Assessments.--The Administrative Conference of 
     the United States shall--
       [(1) develop and carry out an ongoing study of the 
     operation of the risk assessment requirements of subchapter 
     III of chapter 6 of title 5, United States Code (as added by 
     section 3 of this Act); and
       [(2) submit an annual report to the Congress on the 
     findings of the study.
       [(b) Administrative Procedure Act.--No later than December 
     31, 1996, the Administrative Conference of the United States 
     shall--
       [(1) carry out a study of the operation of chapters 5 and 6 
     of title 5, United States Code (commonly referred to as the 
     Administrative Procedure Act), as amended by section 3 of 
     this Act; and
       [(2) submit a report to the Congress on the findings of the 
     study, including proposals for revision, if any.

     [SEC. 6. RISK-BASED PRIORITIES.

       [(a) Purposes.--The purposes of this section are to--
       [(1) encourage Federal agencies engaged in regulating risks 
     to human health, safety, and the environment to achieve the 
     greatest risk reduction at the least cost practical;
       [(2) promote the coordination of policies and programs to 
     reduce risks to human health, safety, and the environment; 
     and
       [(3) promote open communication among Federal agencies, the 
     public, the President, and Congress regarding environmental, 
     health, and safety risks, and the prevention and management 
     of those risks.
       [(b) Definitions.--For the purposes of this section:
       [(1) Comparative risk analysis.--The term ``comparative 
     risk analysis'' means a 

[[Page S9268]]
     process to systematically estimate, compare, and rank the size and 
     severity of risks to provide a common basis for evaluating 
     strategies for reducing or preventing those risks.
       [(2) Covered agency.--The term ``covered agency'' means 
     each of the following:
       [(A) The Environmental Protection Agency.
       [(B) The Department of Labor.
       [(C) The Department of Transportation.
       [(D) The Food and Drug Administration.
       [(E) The Department of Energy.
       [(F) The Department of the Interior.
       [(G) The Department of Agriculture.
       [(H) The Consumer Product Safety Commission.
       [(I) The National Oceanic and Atmospheric Administration.
       [(J) The United States Army Corps of Engineers.
       [(K) The Nuclear Regulatory Commission.
       [(3) Effect.--The term ``effect'' means a deleterious 
     change in the condition of--
       [(A) a human or other living thing (including death, 
     cancer, or other chronic illness, decreased reproductive 
     capacity, or disfigurement); or
       [(B) an inanimate thing important to human welfare 
     (including destruction, degeneration, the loss of intended 
     function, and increased costs for maintenance).
       [(4) Irreversibility.--The term ``ir- 
     reversibility'' means the extent to which a return 
     to conditions before the occurrence of an effect are either 
     very slow or will never occur.
       [(5) Likelihood.--The term ``likelihood'' means the 
     estimated probability that an effect will occur.
       [(6) Magnitude.--The term ``magnitude'' means the number of 
     individuals or the quantity of ecological resources or other 
     resources that contribute to human welfare that are affected 
     by exposure to a stressor.
       [(7) Seriousness.--The term ``seriousness'' means the 
     intensity of effect, the likelihood, the irreversibility, and 
     the magnitude.
       [(c) Department and Agency Program Goals.--
       [(1) Setting priorities.--In exercising authority under 
     applicable laws protecting human health, safety, or the 
     environment, the head of each covered agency should set 
     priorities and use the resources available under those laws 
     to address those risks to human health, safety, and the 
     environment that--
       [(A) the covered agency determines to be the most serious; 
     and
       [(B) 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 expended.
       [(2) Determining the most serious risks.--In identifying 
     the greatest risks under paragraph (1) of this subsection, 
     each covered agency shall consider, at a minimum--
       [(A) the likelihood, irreversibility, and severity of the 
     effect; and
       [(B) the number and classes of individuals potentially 
     affected, and shall explicitly take into account the results 
     of the comparative risk analysis conducted under subsection 
     (d) of this section.
       [(3) OMB review.--The covered agency's determinations of 
     the most serious risks for purposes of setting priorities 
     shall be reviewed and approved by the Director of the Office 
     of Management and Budget before submission of the covered 
     agency's annual budget requests to Congress.
       [(4) Incorporating risk-based priorities into budget and 
     planning.--The head of each covered agency shall incorporate 
     the priorities identified under paragraph (1) into the agency 
     budget, strategic planning, regulatory agenda, enforcement, 
     and research activities. When submitting its budget request 
     to Congress and when announcing its regulatory agenda in the 
     Federal Register, each covered agency shall identify the 
     risks that the covered agency head has determined are the 
     most serious and can be addressed in a cost-effective manner 
     under paragraph (1), the basis for that determination, and 
     explicitly identify how the covered agency's requested budget 
     and regulatory agenda reflect those priorities.
       [(5) Effective date.--This subsection shall take effect 12 
     months after the date of enactment of this Act.
       [(d) Comparative Risk Analysis.--
       [(1) Requirement.--(A)(i) No later than 6 months after the 
     effective date of this Act, the Director of the Office of 
     Management and Budget shall enter into appropriate 
     arrangements with an accredited scientific body--
       [(I) to conduct a study of the methodologies for using 
     comparative risk to rank dissimilar human health, safety, and 
     environmental risks; and
       [(II) to conduct a comparative risk analysis.
       [(ii) The comparative risk analysis shall compare and rank, 
     to the extent feasible, human health, safety, and 
     environmental risks potentially regulated across the spectrum 
     of programs administered by all covered agencies.
       [(B) The Director shall consult with the Office of Science 
     and Technology Policy regarding the scope of the study and 
     the conduct of the comparative risk analysis.
       [(2) Criteria.--In arranging for the comparative risk 
     analysis referred to in paragraph (1) of this subsection, the 
     Director shall ensure that--
       [(A) the scope and specificity of the analysis are 
     sufficient to provide the President and agency heads guidance 
     in allocating resources across agencies and among programs in 
     agencies to achieve the greatest degree of risk prevention 
     and reduction for the public and private resources expended;
       [(B) the analysis is conducted through an open process, by 
     individuals with relevant expertise, including toxicologists, 
     biologists, engineers and experts in medicine, industrial 
     hygiene and environmental effects;
       [(C) the analysis is conducted, to the extent feasible, 
     consistent with the risk assessment and risk characterization 
     principles in sections 635 and 636 of this title;
       [(D) the methodologies and principal scientific 
     determinations made in the analysis are subjected to 
     independent and external peer review consistent with section 
     637, and the conclusions of the peer review are made publicly 
     available as part of the final report required under 
     subsection (e);
       [(E) there is an opportunity for public comment on the 
     results before making them final; and
       [(F) the results are presented in a manner that 
     distinguishes between the scientific conclusions and any 
     policy or value judgments embodied in the comparisons.
       [(3) Completion and review.--No later than 3 years after 
     the effective date of this Act, the comparative risk analysis 
     required under paragraph (1) shall be completed. The 
     comparative risk analysis shall be reviewed and revised at 
     least every 5 years thereafter for a minimum of 15 years 
     following the release of the first analysis. The Director 
     shall arrange for such review and revision with an accredited 
     scientific body in the same manner as provided under 
     paragraphs (1) and (2).
       [(4) Study.--The study of methodologies provided under 
     paragraph (1) shall be conducted as part of the first 
     comparative risk analysis and shall be completed no later 
     than 180 days after the completion of that analysis. The goal 
     of the study shall be to develop and rigorously test methods 
     of comparative risk analysis. The study shall have sufficient 
     scope and breadth to test approaches for improving 
     comparative risk analysis and its use in setting priorities 
     for human health, safety, and environmental risk prevention 
     and reduction.
       [(5) Technical guidance.--No later than 180 days after the 
     effective date of this Act, the Director, in collaboration 
     with other heads of covered agencies shall enter into a 
     contract with the National Research Council to provide 
     technical guidance to agencies on approaches to using 
     comparative risk analysis in setting human health, safety, 
     and environmental priorities to assist agencies in complying 
     with subsection (c) of this section.
       [(e) Reports and Recommendations to Congress and the 
     President.--No later than 24 months after the effective date 
     of this Act, each covered agency shall submit a report to 
     Congress and the President--
       [(1) detailing how the agency has complied with subsection 
     (c) and describing the reasons for any departure from the 
     requirement to establish priorities to achieve the greatest 
     overall net reduction in risk;
       [(2) recommending--
       [(A) modification, repeal, or enactment of laws to reform, 
     eliminate, or enhance programs or mandates relating to human 
     health, safety, or the environment; and
       [(B) modification or elimination of statutorily or 
     judicially mandated deadlines,

     that would assist the covered agency to set priorities in 
     activities to address the risks to human health, safety, or 
     the environment in a manner consistent with the requirements 
     of subsection (c)(1);
       [(3) evaluating the categories of policy and value 
     judgments used in risk assessment, risk characterization, or 
     cost-benefit analysis; and
       [(4) discussing risk assessment research and training 
     needs, and the agency's strategy and schedule for meeting 
     those needs.
       [(f) Savings Provision and Judicial Review.--
       [(1) In general.--Nothing in this section shall be 
     construed to modify any statutory standard or requirement 
     designed to protect human health, safety, or the environment.
       [(2) Judicial review.--Compliance or noncompliance by an 
     agency with the provisions of this section shall not be 
     subject to judicial review.
       [(3) Agency analysis.--Any analysis prepared under this 
     section shall not be subject to judicial consideration 
     separate or apart from the requirement, rule, program, or law 
     to which it relates. When an action for judicial review of a 
     covered agency action is instituted, any analysis for, or 
     relating to, the action shall constitute part of the whole 
     record of agency action for the purpose of judicial review of 
     the action and shall, to the extent relevant, be considered 
     by a court in determining the legality of the covered agency 
     action.

     [SEC. 7. REGULATORY ACCOUNTING.

       [(a) Definitions.--For purposes of this section, the 
     following definitions apply:
       [(1) Agency.--The term ``agency'' means any executive 
     department, military department, Government corporation, 
     Government controlled corporation, or other establishment in 
     the executive branch of the Government (including the 
     Executive Office of the President), or any independent 
     regulatory agency, but shall not include--
       [(A) the General Accounting Office;
       [(B) the Federal Election Commission;
       [(C) the governments of the District of Columbia and of the 
     territories and possessions of the United States, and their 
     various subdivisions; or 

[[Page S9269]]

       [(D) government-owned contractor-operated facilities, 
     including laboratories engaged in national defense research 
     and production activities.
       [(2) Regulation.--The term ``regulation'' means an agency 
     statement of general applicability and future effect designed 
     to implement, interpret, or prescribe law or policy or 
     describing the procedures or practice requirements of an 
     agency. The term shall not include--
       [(A) administrative actions governed by sections 556 and 
     557 of title 5, United States Code;
       [(B) regulations issued with respect to a military or 
     foreign affairs function of the United States; or
       [(C) regulations related to agency organization, 
     management, or personnel.
       [(b) Accounting Statement.--
       [(1) In general.--(A) The President shall be responsible 
     for implementing and administering the requirements of this 
     section.
       [(B) Every 2 years, no later than June of the second year, 
     the President shall prepare and submit to Congress an 
     accounting statement that estimates the annual costs of 
     Federal regulatory programs and corresponding benefits in 
     accordance with this subsection.
       [(2) Years covered by accounting statement.--Each 
     accounting statement shall cover, at a minimum, the 5 fiscal 
     years beginning on October 1 of the year in which the report 
     is submitted and may cover any fiscal year preceding such 
     fiscal years for purpose of revising previous estimates.
       [(3) Timing and procedures.--(A) The President shall 
     provide notice and opportunity for comment for each 
     accounting statement. The President may delegate to an agency 
     the requirement to provide notice and opportunity to comment 
     for the portion of the accounting statement relating to that 
     agency.
       [(B) The President shall propose the first accounting 
     statement under this subsection no later than 2 years after 
     the effective date of this Act and shall issue the first 
     accounting statement in final form no later than 3 years 
     after such effective date. Such statement shall cover, at a 
     minimum, each of the fiscal years beginning after the 
     effective date of this Act.
       [(4) Content of accounting statement.--(A) Each accounting 
     statement shall contain estimates of costs and benefits with 
     respect to each fiscal year covered by the statement in 
     accordance with this paragraph. For each such fiscal year for 
     which estimates were made in a previous accounting statement, 
     the statement shall revise those estimates and state the 
     reasons for the revisions.
       [(B)(i) An accounting statement shall estimate the costs of 
     Federal regulatory programs by setting forth, for each year 
     covered by the statement--
       [(I) the annual expenditure of national economic resources 
     for each regulatory program; and
       [(II) such other quantitative and qualitative measures of 
     costs as the President considers appropriate.
       [(ii) For purposes of the estimate of costs in the 
     accounting statement, national economic resources shall 
     include, and shall be listed under, at least the following 
     categories:
       [(I) Private sector costs.
       [(II) Federal sector costs.
       [(III) State and local government costs.
       [(C) An accounting statement shall estimate the benefits of 
     Federal regulatory programs by setting forth, for each year 
     covered by the statement, such quantitative and qualitative 
     measures of benefits as the President considers appropriate. 
     Any estimates of benefits concerning reduction in human 
     health, safety, or environmental risks shall present the most 
     plausible level of risk practical, along with a statement of 
     the reasonable degree of scientific certainty.
       [(c) Associated Report to Congress.--
       [(1) In general.--At the same time as the President submits 
     an accounting statement under subsection (b), the President, 
     acting through the Director of the Office of Management and 
     Budget, shall submit to Congress a report associated with the 
     accounting statement (hereinafter referred to as an 
     ``associated report''). The associated report shall contain, 
     in accordance with this subsection--
       [(A) analyses of impacts; and
       [(B) recommendations for reform.
       [(2) Analyses of impacts.--The President shall include in 
     the associated report the following:
       [(A) The cumulative impact on the economy of Federal 
     regulatory programs covered in the accounting statement. 
     Factors to be considered in such report shall include impacts 
     on the following:
       [(i) The ability of State and local governments to provide 
     essential services, including police, fire protection, and 
     education.
       [(ii) Small business.
       [(iii) Productivity.
       [(iv) Wages.
       [(v) Economic growth.
       [(vi) Technological innovation.
       [(vii) Consumer prices for goods and services.
       [(viii) Such other factors considered appropriate by the 
     President.
       [(B) A summary of any independent analyses of impacts 
     prepared by persons commenting during the comment period on 
     the accounting statement.
       [(3) Recommendations for reform.--The President shall 
     include in the associated report the following:
       [(A) A summary of recommendations of the President for 
     reform or elimination of any Federal regulatory program or 
     program element that does not represent sound use of national 
     economic resources or otherwise is inefficient.
       [(B) A summary of any recommendations for such reform or 
     elimination of Federal regulatory programs or program 
     elements prepared by persons commenting during the comment 
     period on the accounting statement.
       [(d) Guidance From Office of Management and Budget.--The 
     Director of the Office of Management and Budget shall, in 
     consultation with the Council of Economic Advisers and the 
     agencies, develop guidance for the agencies--
       [(1) to standardize measures of costs and benefits in 
     accounting statements prepared pursuant to this section and 
     section 3 of this Act, including--
       [(A) detailed guidance on estimating the costs and benefits 
     of major rules; and
       [(B) general guidance on estimating the costs and benefits 
     of all other rules that do not meet the thresholds for major 
     rules; and
       [(2) to standardize the format of the accounting 
     statements.
       [(e) Recommendations From Congressional Budget Office.--
     After each accounting statement and associated report 
     submitted to Congress, the Director of the Congressional 
     Budget Office shall make recommendations to the President--
       [(1) for improving accounting statements prepared pursuant 
     to this section, including recommendations on level of detail 
     and accuracy; and
       [(2) for improving associated reports prepared pursuant to 
     this section, including recommendations on the quality of 
     analysis.
       [(f) Judicial Review.--No requirements under this section 
     shall be subject to judicial review in any manner.

     [SEC. 8. EFFECTIVE DATE.

       [Except as otherwise provided in this Act, this Act shall 
     take effect 180 days after the date of the enactment of this 
     Act.]
     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Comprehensive Regulatory 
     Reform Act of 1995''.

     SEC. 2. DEFINITIONS.

       Section 551 of title 5, United States Code, is amended--
       (1) in the matter preceding paragraph (1), by striking 
     ``this subchapter'' and inserting ``this chapter and chapters 
     6, 7, and 8'';
       (2) in paragraph (13), by striking ``and'';
       (3) in paragraph (14), by striking the period at the end 
     and inserting ``; and''; and
       (4) by adding at the end the following new paragraph:
       ``(15) `Director' means the Director of the Office of 
     Management and Budget.''.

     SEC. 3. RULEMAKING.

       Section 553 of title 5, United States Code, is amended to 
     read as follows:

     ``Sec. 553. Rulemaking

       ``(a) This section applies to every rulemaking, according 
     to the provisions thereof, except to the extent that there is 
     involved--
       ``(1) a matter pertaining to a military or foreign affairs 
     function of the United States;
       ``(2) a matter relating to the management and personnel 
     practices of an agency;
       ``(3) an interpretive rule, general statement of policy, 
     guidance, or rule of agency organization, procedure, or 
     practice that is not generally applicable and does not alter 
     or create rights or obligations of persons outside the 
     agency; or
       ``(4) a rule relating to the acquisition, management, or 
     disposal by an agency of real or personal property, or of 
     services, that is promulgated in compliance with criteria and 
     procedures established by the Administrator of General 
     Services.
       ``(b)(1) General notice of proposed rulemaking shall be 
     published in the Federal Register, unless all persons subject 
     thereto are named and either personally served or otherwise 
     have actual notice of the proposed rulemaking in accordance 
     with law. Each notice of proposed rulemaking shall include--
       ``(A) a statement of the time, place, and nature of public 
     rulemaking proceedings;
       ``(B) a succinct explanation of the need for and specific 
     objectives of the proposed rule, including an explanation of 
     the agency's determination of whether or not the rule is a 
     major rule within the meaning of section 621(4);
       ``(C) an explanation of the specific statutory 
     interpretation under which a rule is proposed, including an 
     explanation of--
       ``(i) whether the interpretation is expressly required by 
     the text of the statute; or
       ``(ii) if the interpretation is not expressly required by 
     the text of the statute, an explanation that the 
     interpretation is within the range of permissible 
     interpretations of the statute as identified by the agency, 
     and an explanation why the interpretation selected by the 
     agency is the agency's preferred interpretation;
       ``(D) the proposed provisions of the rule;
       ``(E) a summary of any initial analysis of the proposed 
     rule required to be prepared or issued pursuant to chapter 6;
       ``(F) a statement that the agency seeks proposals from the 
     public and from State and local governments for alternative 
     methods to accomplish the objectives of the rulemaking that 
     are more effective or less burdensome than the approach used 
     in the proposed rule;
       ``(G) a description of any data, methodologies, reports, 
     studies, scientific evaluations, or other similar information 
     available to the agency for the rulemaking, including an 
     identification of each author or source of such information 
     and the purposes for which the agency plans to rely on such 
     information; and
       ``(H) a statement specifying where the file of the 
     rulemaking proceeding maintained pursuant 

[[Page S9270]]
     to subsection (f) may be inspected and how copies of the items in the 
     file may be obtained.
       ``(2) Except when notice or hearing is required by statute, 
     a final rule may be adopted and may become effective without 
     prior compliance with this subsection and subsections (c) and 
     (f) if--
       ``(A) the agency for good cause finds that providing notice 
     and public procedure thereon before the rule becomes 
     effective is contrary to an important public interest or is 
     unnecessary due to the insignificant impact of the rule;
       ``(B) the agency publishes the rule in the Federal Register 
     with such finding and a succinct explanation of the reasons 
     therefor; and
       ``(C) the agency complies with this subsection and 
     subsections (c) and (f) to the maximum extent feasible prior 
     to the promulgation of the final rule, and fully complies 
     with such provisions as soon as reasonably practicable after 
     the promulgation of the rule.
       ``(3) Whenever the provisions of a final rule that an 
     agency plans to adopt are so different from the provisions of 
     the proposed rule that the original notice of proposed 
     rulemaking did not fairly apprise the public of the issues 
     ultimately to be resolved in the rulemaking or of the 
     substance of the rule, the agency shall publish in the 
     Federal Register a notice of the final rule the agency plans 
     to adopt, together with the information relevant to such rule 
     that is required by the applicable provisions of this section 
     and that has not previously been published in the Federal 
     Register. The agency shall allow a reasonable period for 
     comment on such final rule.
       ``(c)(1) After providing the notice required by this 
     section, the agency shall give interested persons not less 
     than 60 days to participate in the rulemaking through the 
     submission of written data, views, or arguments.
       ``(2)(A) To collect relevant information, and to identify 
     and elicit full and representative public comment on the 
     significant issues of a particular rulemaking, the agency may 
     use such other procedures as the agency determines are 
     appropriate, including--
       ``(i) the publication of an advance notice of proposed 
     rulemaking;
       ``(ii) the provision of notice, in forms which are more 
     direct than notice published in the Federal Register, to 
     persons who would be substantially affected by the proposed 
     rule, but who are unlikely to receive notice of the proposed 
     rulemaking through the Federal Register;
       ``(iii) the provision of opportunities for oral 
     presentation of data, views, information, or rebuttal 
     arguments at informal public hearings, which may be held in 
     the District of Columbia and other locations;
       ``(iv) the provision of summaries, explanatory materials, 
     or other technical information in response to public 
     inquiries concerning the issues involved in the rulemaking; 
     and
       ``(v) the adoption or modification of agency procedural 
     rules to reduce the cost or complexity of participation in a 
     rulemaking.
       ``(B) The decision of an agency to use or not to use such 
     other procedures in a rulemaking pursuant to this paragraph 
     shall not be subject to judicial review.
       ``(3) To ensure an orderly and expeditious proceeding, an 
     agency may establish reasonable procedures to regulate the 
     course of informal public hearings under paragraphs (1) and 
     (2), including the designation of representatives to make 
     oral presentations or engage in direct or cross-examination 
     on behalf of several parties with a common interest in a 
     rulemaking. Transcripts shall be made of all such public 
     hearings.
       ``(4) An agency shall publish any final rule it adopts in 
     the Federal Register, together with a concise statement of 
     the basis and purpose of the rule and a statement of when the 
     rule may become effective. The statement of basis and purpose 
     shall include--
       ``(A) an explanation of the need for, objectives of, and 
     specific statutory authority for, the rule;
       ``(B) a discussion of, and response to, any significant 
     factual or legal issues raised by the comments on the 
     proposed rule prior to its promulgation, including a 
     description of the reasonable alternatives to the rule 
     proposed by the agency and by interested persons, and the 
     reasons why each such alternative was rejected;
       ``(C)(i) an explanation of whether the specific statutory 
     interpretation upon which the rule is based is expressly 
     required by the text of the statute; or
       ``(ii) if the specific statutory interpretation upon which 
     the rule is based is not expressly required by the text of 
     the statute, an explanation that the interpretation is within 
     the range of permissible interpretations of the statute as 
     identified by the agency, and why the agency has rejected 
     other interpretations proposed in comments to the agency;
       ``(D) an explanation of how the factual conclusions upon 
     which the rule is based are substantially supported in the 
     rulemaking file maintained pursuant to subsection (f); and
       ``(E) a summary of any final analysis of the rule required 
     to be prepared or issued pursuant to chapter 6.
       ``(5) The provisions of sections 556 and 557 shall apply in 
     lieu of this subsection in the case of rules that are 
     required by statute to be made on the record after 
     opportunity for an agency hearing.
       ``(d) An agency shall publish the final rule in the Federal 
     Register not less than 60 days before the effective date of 
     such rule. An agency may make a rule effective in less than 
     60 days after publication in the Federal Register if the rule 
     grants or recognizes an exemption, relieves a restriction, or 
     if the agency for good cause finds that such a delay in the 
     effective date would be contrary to an important public 
     interest and publishes such finding and an explanation of the 
     reasons therefor, with the final rule.
       ``(e)(1) Each agency shall give an interested person the 
     right to petition for the issuance, amendment, or repeal of a 
     rule.
       ``(2) Each person subject to a major rule may petition--
       ``(A) for the issuance, amendment, or repeal of such rule;
       ``(B) for the amendment or repeal of an interpretive rule 
     or general statement of policy or guidance;
       ``(C) for an interpretation regarding the meaning of the 
     rule, interpretive rule, general statement of policy, or 
     guidance; and
       ``(D) for a variance or exemption from the terms of the 
     rule.
       ``(3)(A) Any person subject to a rule, interpretive rule, 
     general statement of policy, or guidance may petition an 
     agency for the amendment or repeal of any rule, interpretive 
     rule, general statement of policy, or guidance.
       ``(B) If such petition presents a reasonable likelihood 
     that, considering its future impact, the rule, interpretive 
     rule, general statement of policy, or guidance is, or has the 
     effect of, a major rule within the meaning of section 621(4), 
     and its amendment or repeal is required to satisfy the 
     decisional criteria of section 624, the agency shall grant 
     the petition and shall, within one year, conduct a cost-
     benefit analysis under chapter 6.
       ``(C) If, considering its future impact, the rule, 
     interpretive rule, general statement of policy, or guidance 
     does not satisfy the requirements of chapter 6, including the 
     decisional criteria set forth in section 624, the agency 
     shall take immediate action either to revoke or to amend the 
     rule, interpretive rule, general statement of policy, or 
     guidance to conform it to the requirements of chapter 6, 
     including the decisional criteria in section 624.
       ``(4) The agency shall grant or deny a petition made 
     pursuant to this subsection, and give written notice of its 
     determination to the petitioner, with reasonable promptness, 
     but in no event later than 180 days after the petition was 
     received by the agency. The written notice of the agency's 
     determination shall include an explanation of the 
     determination and a response to each factual and legal claim 
     that forms the basis of the petition. A decision to deny a 
     petition shall be subject to judicial review immediately upon 
     denial, as final agency action under the statute granting the 
     agency authority to carry out its action.
       ``(5) Following a decision to grant or deny a petition to 
     conduct a cost-benefit analysis for a rule, interpretive 
     rule, general statement of policy, or guidance under this 
     subsection, no further petition for such rule, interpretive 
     rule, general statement of policy, or guidance, submitted by 
     the same person, shall be considered by any agency unless 
     such petition is based on a change in a fact, circumstance, 
     or provision of law underlying or otherwise related to the 
     rule, interpretive rule, general statement of policy, or 
     guidance occurring since the initial petition was granted or 
     denied, that warrants the amendment or repeal of the rule, 
     interpretive rule, general statement of policy, or guidance.
       ``(f)(1) The agency shall maintain a file for each 
     rulemaking proceeding conducted pursuant to this section and 
     shall maintain a current index to such file. The file and the 
     material excluded from the file pursuant to paragraph (4) 
     shall constitute the rulemaking record for purposes of 
     judicial review. Except as provided in paragraph (4), the 
     file shall be made available to the public beginning on the 
     date on which the agency makes an initial publication 
     concerning the rule.
       ``(2) The rulemaking file shall include--
       ``(A) the notice of proposed rulemaking, any supplement to, 
     or modification or revision of, such notice, and any advance 
     notice of proposed rulemaking;
       ``(B) copies of all written comments received on the 
     proposed rule;
       ``(C) a transcript of any public hearing conducted on the 
     rulemaking;
       ``(D) copies, or an identification of the place at which 
     copies may be obtained, of all material described by the 
     agency pursuant to subsection (b)(1)(G) and of other factual 
     and methodological material not described by the agency 
     pursuant to such subsection that pertains directly to the 
     rulemaking and that was available to the agency in connection 
     with the rulemaking, or that was submitted to or prepared by 
     or for the agency in connection with the rulemaking; and
       ``(E) any statement, description, analysis, or any other 
     material that the agency is required to prepare or issue in 
     connection with the rulemaking, including any analysis 
     prepared or issued pursuant to chapter 6.
       ``(3) The agency shall place the materials described in 
     paragraph (2) in the file as soon as practicable after such 
     materials become available to the agency.
       ``(4) The file required by paragraph (1) need not include 
     any material that need not be made available to the public 
     under section 552(b)(4) if the agency includes in such file a 
     statement that notes the existence of such material and the 
     basis upon which the material is exempt from public 
     disclosure under such section. The agency may not 
     substantially rely on any such material in formulating a rule 
     unless it makes the substance of such material available for 
     adequate comment by interested persons. The agency may use 
     summaries, aggregations of data, or other appropriate 
     mechanisms to protect the confidentiality of such material to 
     the maximum extent possible.
       ``(5) No court shall hold unlawful or set aside an agency 
     rule because of a violation of this subsection unless the 
     court finds that such violation has precluded fair public 
     consideration of a material issue of the rulemaking taken as 
     a whole. Judicial review of compliance or noncompliance with 
     this subsection shall be limited to review of action or 
     inaction on the part of an agency.
       ``(g) Notwithstanding any other provision of law, this 
     section shall apply to and supplement the procedures 
     governing rulemaking under statutes that are not generally 
     subject to this section.

[[Page S9271]]

       ``(h) Nothing in this section authorizes the use of 
     appropriated funds available to any agency to pay the 
     attorney's fees or other expenses of persons participating or 
     intervening in agency proceedings.''.

     SEC. 4. ANALYSIS OF AGENCY RULES.

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

               ``SUBCHAPTER II--ANALYSIS OF AGENCY RULES

     ``Sec. 621. Definitions

       ``For purposes of this subchapter--
       ``(1) the term `benefit' means the reasonably identifiable 
     significant incremental 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;
       ``(2) the term `cost' means the reasonably identifiable 
     significant incremental 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;
       ``(3) the term `cost-benefit analysis' means an evaluation 
     of the costs and benefits of a rule, quantified to the extent 
     feasible and appropriate and otherwise qualitatively 
     described, that is prepared in accordance with the 
     requirements of this subchapter 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;
       ``(4)(A) the term `major rule' means--
       ``(i) a rule or a group of closely related rules that the 
     agency proposing the rule, the Director, or a designee of 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, the Director, or a designee of 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;
       ``(II) significant adverse effects on competition, 
     employment, investment, productivity, innovation, health, 
     safety, or the environment, or the ability of enterprises 
     whose principal places of business are in the United States 
     to compete in domestic or export markets;
       ``(III) a serious inconsistency or interference with an 
     action taken or planned by another agency;
       ``(IV) the material alteration of the budgetary impact of 
     entitlements, grants, user fees, or loan programs, or the 
     rights and obligations of recipients thereof; or
       ``(V) disproportionate costs to a class of persons within 
     the regulated sector, and relatively severe economic 
     consequences for the class;
       ``(B) the term `major rule' does not include--
       ``(i) a rule that involves the internal revenue laws of the 
     United States; or
       ``(ii) a rule or agency action that authorizes the 
     introduction into, or removal from, commerce, or recognizes 
     the marketable status, of a product;
       ``(5) the term `market-based mechanism' means a regulatory 
     program that--
       ``(A) imposes legal accountability for the achievement of 
     an explicit regulatory objective on each regulated person;
       ``(B) affords maximum flexibility to each regulated person 
     in complying with mandatory regulatory objectives, which 
     flexibility shall, where feasible and appropriate, include, 
     but not be limited to, the opportunity to transfer to, or 
     receive from, other persons, including for cash or other 
     legal consideration, increments of compliance responsibility 
     established by the program; and
       ``(C) permits regulated persons to respond freely to 
     changes in general economic conditions and in economic 
     circumstances directly pertinent to the regulatory program 
     without affecting the achievement of the program's explicit 
     regulatory mandates;
       ``(6) the term `performance-based standards' means 
     requirements, expressed in terms of outcomes or goals rather 
     than mandatory means of achieving outcomes or goals, that 
     permit the regulated entity discretion to determine how best 
     to meet specific requirements in particular circumstances;
       ``(7) the term `reasonable alternatives' means the range of 
     regulatory options that the agency has discretion to consider 
     under the text of the statute granting rulemaking authority, 
     interpreted, to the maximum extent possible, to embrace the 
     broadest range of options that satisfy the decisional 
     criteria of section 624(b); and
       ``(8) the term `rule' has the same meaning as in section 
     551(4), and--
       ``(A) includes any statement of general applicability that 
     alters or creates rights or obligations of persons outside 
     the agency; and
       ``(B) does not include--
       ``(i) a rule of particular applicability that approves or 
     prescribes the future rates, wages, prices, services, 
     corporate or financial structures, reorganizations, mergers, 
     acquisitions, accounting practices, or disclosures bearing on 
     any of the foregoing;
       ``(ii) a rule relating to monetary policy or to the safety 
     or soundness of Federally insured depository institutions or 
     any affiliate of such an institution (as defined in section 
     2(k) of the Bank Holding Company Act of 1956), credit unions, 
     Federal Home Loan Banks, government sponsored housing 
     enterprises, farm credit institutions, foreign banks that 
     operate in the United States and their affiliates, branches, 
     agencies, commercial lending companies, or representative 
     offices, (as those terms are defined in section 1 of the 
     International Banking Act of 1978); or
       ``(iii) a rule relating to the payment system or the 
     protection of deposit insurance funds or the farm credit 
     insurance fund.

     ``Sec. 622. Rulemaking cost-benefit analysis

       ``(a) Prior to publishing notice of a proposed rulemaking 
     for any rule (or, in the case of a notice of a proposed 
     rulemaking that has been published on or before the date of 
     enactment of this subchapter, not later than 30 days after 
     such date of enactment), each agency shall determine whether 
     the rule is or is not a major rule within the meaning of 
     section 621(4)(A)(i) and, if it is not, whether it should be 
     designated a major rule under section 621(4)(A)(ii). For the 
     purpose of any such determination or designation, a group of 
     closely related rules shall be considered as one rule.
       ``(b)(1) If an agency has determined that a rule is not a 
     major rule within the meaning of section 621(4)(A)(i) and has 
     not designated the rule a major rule within the meaning of 
     section 621(4)(A)(ii), the Director or a designee of the 
     President may, as appropriate, determine that the rule is a 
     major rule or designate the rule a major rule not later than 
     30 days after the publication of the notice of proposed 
     rulemaking for the rule (or, in the case of a notice of 
     proposed rulemaking that has been published on or before the 
     date of enactment of this subchapter, not later than 60 days 
     after such date of enactment).
       ``(2) Such determination or designation shall be published 
     in the Federal Register, together with a succinct statement 
     of the basis for the determination or designation.
       ``(c)(1)(A) When the agency publishes a notice of proposed 
     rulemaking for a major rule, the agency shall issue and place 
     in the rulemaking file an initial cost-benefit analysis, and 
     shall include a summary of such analysis in the notice of 
     proposed rulemaking.
       ``(B)(i) When the Director or a designee of the President 
     has published a determination or designation that a rule is a 
     major rule after the publication of the notice of proposed 
     rulemaking for the rule, the agency shall promptly issue and 
     place in the rulemaking file an initial cost-benefit analysis 
     for the rule and shall publish in the Federal Register a 
     summary of such analysis.
       ``(ii) Following the issuance of an initial cost-benefit 
     analysis under clause (i), the agency shall give interested 
     persons an opportunity to comment in the same manner as if 
     the initial cost-benefit analysis had been issued with the 
     notice of proposed rulemaking.
       ``(2) Each initial cost-benefit analysis shall contain--
       ``(A) an analysis of the benefits of the proposed rule, and 
     an explanation of how the agency anticipates each benefit 
     will be achieved by the proposed rule, including a 
     description of the persons or classes of persons likely to 
     receive such benefits;
       ``(B) an analysis of the costs of the proposed rule, and an 
     explanation of how the agency anticipates each such cost will 
     result from the proposed rule, including a description of the 
     persons or groups of persons likely to bear such costs;
       ``(C) an identification (including an analysis of the costs 
     and benefits) of reasonable alternatives that the agency has 
     discretion to adopt under the decisional criteria of the 
     statute granting the rulemaking authority, as supplemented by 
     the decisional criteria in section 624, for achieving 
     identified benefits, including, where appropriate, 
     alternatives that--
       ``(i) require no government action;
       ``(ii) will accommodate differences among geographic 
     regions and among persons with differing levels of resources 
     with which to comply; and
       ``(iii) employ voluntary or performance-based standards, 
     market-based mechanisms, or other flexible regulatory 
     alternatives that permit the greatest flexibility in 
     achieving the identified benefits of the proposed rule;
       ``(D) an assessment of the feasibility of establishing a 
     regulatory program that operates through the application of 
     voluntary programs, voluntary consensus standards, 
     performance-based standards, market-based mechanisms, or 
     other flexible regulatory alternatives;
       ``(E) in any case in which the proposed rule is based on 
     one or more scientific evaluations, scientific information, 
     or a risk assessment, or is subject to the risk assessment 
     requirements of subchapter III, a description of the actions 
     undertaken by the agency to verify the quality, reliability, 
     and relevance of such scientific evaluations or scientific 
     information in accordance with the requirements of subchapter 
     III;
       ``(F) an analysis, to the extent practicable, of the effect 
     of the rule on--
       ``(i) the cumulative burden of compliance with the rule and 
     other existing regulations on persons complying with it; and
       ``(ii) the net effect on small businesses with fewer than 
     100 employees, including employment in such businesses;
       ``(G) an analysis of whether the identified benefits of the 
     proposed rule justify the identified costs of the proposed 
     rule, and an analysis of whether the proposed rule will 
     achieve greater net benefits or, where applicable, lower net 
     costs, than any of the alternatives to the proposed rule, 
     including alternatives identified in accordance with 
     subparagraphs (C) and (D).
       ``(d)(1) When the agency publishes a final major rule, the 
     agency shall also issue and place in the rulemaking file a 
     final cost-benefit analysis, and shall include a summary of 
     the analysis in the statement of basis and purpose.
       ``(2) Each final cost-benefit analysis shall contain--

[[Page S9272]]

       ``(A) a description and comparison of the benefits and 
     costs of the rule and of the reasonable alternatives to the 
     rule described in the rulemaking, including the flexible 
     regulatory alternatives identified pursuant to subsection 
     (c)(2) (C) and (D); and
       ``(B) an analysis, based upon the rulemaking record 
     considered as a whole, of--
       ``(i) whether the benefits of the rule justify the costs of 
     the rule; and
       ``(ii) whether the rule will achieve greater net benefits 
     or, where section 624(c) applies, lower net costs, than any 
     of the reasonable alternatives that the agency has discretion 
     to adopt under the decisional criteria of the statute 
     granting the rulemaking authority, as supplemented by the 
     decisional criteria in section 624, for achieving identified 
     benefits, including, where appropriate, alternatives referred 
     to in subsection (c)(2) (C) and (D).
       ``(e)(1)(A) The analysis of the benefits and costs of a 
     proposed and a final rule required under this section shall 
     include, to the extent feasible, a quantification or 
     numerical estimate of the quantifiable benefits and costs. 
     Such quantification or numerical estimate shall be made in 
     the most appropriate unit of measurement, using comparable 
     assumptions, including time periods, shall specify the ranges 
     of predictions, and shall explain the margins of error 
     involved in the quantification methods and in the estimates 
     used. An agency shall describe the nature and extent of the 
     nonquantifiable benefits and costs of a final rule pursuant 
     to this section in as precise and succinct a manner as 
     possible. An agency shall not be required to make such 
     evaluation primarily on a mathematical or numerical basis.
       ``(B) Where practicable and appropriate, the description of 
     the benefits and costs of a proposed and final rule required 
     under this section shall describe such benefits and costs on 
     an industry by industry basis.
       ``(2)(A) In evaluating and comparing costs and benefits and 
     in evaluating the risk assessment information developed 
     pursuant to subchapter III, the agency shall not rely on 
     cost, benefit, or risk assessment information that is not 
     accompanied by relevant information that would enable the 
     agency and other persons interested in the rulemaking to 
     assess the accuracy, reliability, and uncertainty factors 
     applicable to such information.
       ``(B) The agency evaluations of the relationships of the 
     benefits of a proposed and final rule to its costs shall be 
     clearly articulated in accordance with this section.
       ``(f) The preparation of the initial or final cost-benefit 
     analysis required by this section shall only be performed by 
     an officer or employee of the agency. The preceding sentence 
     shall not preclude a person outside the agency from gathering 
     data or information to be used by the agency in preparing any 
     such cost-benefit analysis or from providing an explanation 
     sufficient to permit the agency to analyze such data or 
     information. If any such data or information is gathered or 
     explained by a person outside the agency, the agency shall 
     specifically identify in the initial or final cost-benefit 
     analysis the data or information gathered or explained and 
     the person who gathered or explained it, and shall describe 
     the arrangement by which the information was procured by the 
     agency, including the total amount of funds expended for such 
     procurement.

     ``Sec. 623. Petition for cost-benefit analysis

       ``(a)(1) Any person subject to a major rule may petition 
     the relevant agency, the Director, or a designee of the 
     President to perform a cost-benefit analysis under this 
     subchapter for the major rule, including a major rule in 
     effect on the date of enactment of this subchapter for which 
     a cost-benefit analysis pursuant to such subchapter has not 
     been performed, regardless of whether a cost-benefit analysis 
     was previously performed to meet requirements imposed before 
     the date of enactment of this subchapter.
       ``(2) The petition shall identify with reasonable 
     specificity the major rule to be reviewed and the amendment 
     or repeal requested.
       ``(3) The agency, the Director, or a designee of the 
     President shall grant the petition if the petition shows that 
     there is a reasonable likelihood that, considering the future 
     impact of the rule--
       ``(A) the rule is a major rule; and
       ``(B) the proposed amendment or repeal of the rule is 
     required to satisfy the decisional criteria of section 624.
       ``(4) A decision to grant, or final agency action to deny, 
     a petition under this subsection shall be made not later than 
     180 days after submittal.
       ``(5) Following a decision to grant or deny a petition to 
     conduct a cost-benefit analysis for a rule under this 
     subsection, no further petition for such rule, submitted by 
     the same person, shall be considered by any agency, the 
     Director, or a designee of the President, unless such 
     petition is based on a change in a fact, circumstance, or 
     provision of law underlying or otherwise related to the rule 
     occurring since the initial petition was granted or denied, 
     that warrants the amendment or repeal of the rule.
       ``(b) Not later than 1 year after the date on which a 
     petition has been granted for a major rule under subsection 
     (a), the agency shall conduct a cost-benefit analysis in 
     accordance with this subchapter, and shall propose amendments 
     to, or repeal of, the rule if required by the decisional 
     criteria set forth in section 624.
       ``(c) For purposes of this section, the term `major rule' 
     means any major rule or portion thereof.
       ``(d)(1) Any person may petition the relevant agency to 
     withdraw, as contrary to this subchapter, any agency 
     interpretive rule, guidance, or general statement of policy 
     that would have the effect of a major rule if the 
     interpretive rule, guidance, or general statement of policy 
     had been adopted as a rule.
       ``(2) The petition shall identify with reasonable 
     specificity why the interpretive rule, guidance, or general 
     statement of policy would have the effect of a major rule if 
     adopted as a rule.
       ``(3) The agency shall grant the petition if the petition 
     shows that there is a reasonable likelihood that the guidance 
     or general statement of policy would have the effect of a 
     major rule if adopted as a rule.
       ``(4) A decision to grant, or final agency action to deny, 
     a petition under this subsection shall be made not later than 
     180 days after the petition is submitted.
       ``(e) For each interpretative rule, guidance, or general 
     statement of policy for which a petition has been granted 
     under subsection (d), the agency shall--
       ``(1) immediately withdraw the interpretive rule, guidance, 
     or general statement of policy; or
       ``(2) within one year, propose a rule in compliance with 
     this subchapter incorporating, with such modifications as the 
     agency considers appropriate, the regulatory standards or 
     criteria contained in such interpretive rule, general 
     statement of policy, or guidance.
       ``(f) Upon withdrawing an interpretive rule, guidance, or 
     general statement of policy, or where such interpretive rule, 
     guidance, or general statement of policy is not withdrawn and 
     a final rule is not promulgated within 2 years of granting a 
     petition under subsection (d), the agency shall be prohibited 
     from enforcing against any person the regulatory standards or 
     criteria contained in such interpretive rule, guidance, or 
     general statement of policy, unless and until they are 
     included in a rule promulgated in accordance with this 
     subchapter.
       ``(g)(1) Any person subject to a major rule may petition 
     the relevant agency to modify or waive the specific 
     requirements of the major rule and to authorize such person 
     to demonstrate compliance through alternative means not 
     otherwise permitted by the major rule. The petition shall 
     identify with reasonable specificity the requirements for 
     which the waiver is sought and the alternative means of 
     compliance being proposed.
       ``(2) The agency shall grant the petition if the petition 
     shows that there is a reasonable likelihood that the proposed 
     alternative means of compliance would achieve the specific 
     benefits of the major rule with an equivalent or greater 
     level of protection of health, safety, and the environment 
     than would be provided by the major rule, and would not 
     impose an undue burden on the agency that would be 
     responsible for enforcing such alternative means of 
     compliance.
       ``(3) Following a decision to grant or deny a petition 
     under this subsection, no further petition for such rule, 
     submitted by the same person, shall be considered by any 
     agency unless such petition is based on a change in a fact, 
     circumstance, or provision of law underlying or otherwise 
     related to the rule occurring since the initial petition was 
     granted or denied, that warrants the granting of such further 
     petition.

     ``Sec. 624. Decisional criteria

       ``(a) The requirements of this section shall supplement any 
     other decisional criteria otherwise provided by law.
       ``(b) Subject to subsection (c), no final rule subject to 
     this subchapter shall be promulgated unless the agency finds 
     that--
       ``(1) the potential benefits from the rule justify the 
     potential costs of the rule; and
       ``(2) the rule will produce the most cost-effective result 
     of any of the reasonable alternatives that the agency has 
     discretion to adopt under the decisional criteria of the 
     statute granting the rulemaking authority.
       ``(c) If a statute requires or permits that a rule be 
     promulgated and that rule cannot, applying the express 
     decisional criteria in the statute, satisfy the criteria 
     provided in subsection (b), the agency shall not promulgate 
     the rule unless the rule imposes--
       ``(1) lower costs than any of the reasonable alternatives; 
     or
       ``(2) the least costs taking into account benefits that the 
     agency has discretion to adopt under the decisional criteria 
     of the statute granting the rulemaking authority.
       ``(d) If an agency promulgates a rule that is subject to 
     subsection (c), the agency shall prepare a written 
     explanation of why the agency was required to promulgate a 
     rule with potential costs that were not justified by the 
     potential benefits and shall transmit that explanation along 
     with the final cost-benefit analysis to Congress when the 
     final rule is promulgated.

     ``Sec. 625. Judicial review

       ``(a) Each court with jurisdiction to review final agency 
     action under the statute granting the agency authority to 
     conduct the rulemaking shall have jurisdiction to review 
     final agency action under this subchapter.
       ``(b)(1) Any cost-benefit analysis of, or risk assessment 
     concerning, a rule shall constitute part of the whole 
     rulemaking record of agency action for the purpose of 
     judicial review and shall be considered by a court in 
     determining the legality of the agency action, but only to 
     the extent that it relates to the agency's decisional 
     responsibilities under section 624 or the statute granting 
     the agency authority to take the agency action.
       ``(2) No analysis required by this subchapter shall be 
     subject to judicial review separate or apart from judicial 
     review of the agency action to which it relates.
       ``(3) The court shall apply the same standards of judicial 
     review that govern the review of agency findings under the 
     statute granting the agency authority to take the action.
       ``(4) The court shall set aside agency action that fails to 
     satisfy the decisional criteria of section 624, applying the 
     applicable judicial review standards.

     ``Sec. 626. Deadlines for rulemaking

       ``(a) Beginning on the date of enactment of this section, 
     all deadlines in statutes that require agencies to propose or 
     promulgate any 

[[Page S9273]]
     rule subject to this subchapter shall be suspended until such time as 
     the requirements of this subchapter are satisfied.
       ``(b) Beginning on the date of enactment of this section, 
     the jurisdiction of any court of the United States to enforce 
     any deadline that would require an agency to propose or 
     promulgate a rule subject to this chapter shall be suspended 
     until such time as the requirements of this subchapter are 
     satisfied.
       ``(c) In any case in which the failure to promulgate a rule 
     by a deadline would create an obligation to regulate through 
     individual adjudications by another deadline, the deadline 
     for such regulation shall be suspended to allow the 
     requirements of this subchapter to be satisfied.

     ``Sec. 627. Agency review of rules

       ``(a)(1)(A) Not later than 9 months after the date of 
     enactment of this section, each agency shall prepare and 
     publish in the Federal Register a proposed schedule for the 
     review, in accordance with this section, of--
       ``(i) each rule of the agency that is in effect on such 
     effective date and which, considering its future impact, 
     would be a major rule under this subchapter;
       ``(ii) each rule of the agency that is inconsistent or 
     incompatible with, or duplicative of, any other obligation or 
     requirement established by any Federal statute, rule, or 
     other agency statement, interpretation, or action that has 
     the force of law; and
       ``(iii) each rule of the agency in effect on the date of 
     enactment of this section (in addition to the rules described 
     in clauses (i) and (ii)) that the agency has selected for 
     review.
       ``(B) Each proposed schedule required by subparagraph (A) 
     shall include--
       ``(i) a brief explanation of the reasons the agency 
     considers each rule on the schedule to be a major rule under 
     section 621(4)(A), or the reasons why the agency selected the 
     rule for review;
       ``(ii) a date set by the agency, in accordance with 
     subsection (b)(1), for the completion of the review of each 
     such rule; and
       ``(iii) a statement that the agency requests comments from 
     the public on the proposed schedule.
       ``(C) The agency shall set a date to initiate review of 
     each rule on the schedule in a manner that will ensure the 
     simultaneous review of related items and that will achieve a 
     reasonable distribution of reviews over the period of time 
     covered by the schedule.
       ``(2) Not later than 90 days before publishing in the 
     Federal Register the proposed schedule required under 
     paragraph (1), each agency shall make the proposed schedule 
     available to the Director or a designee of the President, or 
     to the Vice President or other officer to whom oversight 
     authority has been delegated under section 643. The President 
     or that officer may select for review in accordance with this 
     section any additional rule.
       ``(3) Not later than 1 year after the date of enactment of 
     this section, each agency shall publish in the Federal 
     Register a final schedule for the review of the rules 
     referred to in paragraphs (1) and (2). Each agency shall 
     publish with the final schedule the response of the agency to 
     comments received concerning the proposed schedule.
       ``(b)(1) Except as explicitly provided otherwise by 
     statute, the agency shall, pursuant to subsections (c) 
     through (e), review--
       ``(A) each rule on the schedule promulgated pursuant to 
     subsection (a);
       ``(B) each major rule under section 621(4) promulgated, 
     amended, or otherwise renewed by an agency after the date of 
     the enactment of this section; and
       ``(C) each rule promulgated after the date of enactment of 
     this section that the President or the officer designated by 
     the President selects for review pursuant to subsection 
     (a)(2).
       ``(2) Except as provided in subsection (f)--
       ``(A) in the case of a regulation that takes effect after 
     the date of enactment of this section, the regulation shall 
     terminate on the date that is 5 years after the date on which 
     the regulation takes effect, unless the review required by 
     this section has been completed by the date that is 5 years 
     after the date on which the regulation takes effect; and
       ``(B) in the case of a regulation in effect on the date of 
     enactment of this section, the regulation shall terminate on 
     the date that is 7 years after the date of enactment of the 
     Regulatory Reform Act of 1995, unless the review required by 
     this section has been completed by the date that is 7 years 
     after the date of enactment of the Regulatory Reform Act of 
     1995.
       ``(c) An agency shall publish in the Federal Register a 
     notice of its proposed action under this section with respect 
     to a rule being reviewed. The notice shall include--
       ``(1) an identification of the specific statutory authority 
     under which the rule was promulgated and an explanation of 
     whether the agency's interpretation of the statute is 
     expressly required by the current text of that statute or, if 
     not, an explanation that the interpretation is within the 
     range of permissible interpretations of the statute as 
     identified by the agency, and an explanation why the 
     interpretation selected by the agency is the agency's 
     preferred interpretation;
       ``(2) an analysis of the benefits and costs of the rule 
     during the period in which it has been in effect;
       ``(3) an explanation of the proposed agency action with 
     respect to the rule, including action to repeal or amend the 
     rule to resolve inconsistencies or conflicts with any other 
     obligation or requirement established by any Federal statute, 
     rule, or other agency statement, interpretation, or action 
     that has the force of law; and
       ``(4) a statement that the agency seeks proposals from the 
     public for modifications or alternatives to the rule which 
     may accomplish the objectives of the rule in a more effective 
     or less burdensome manner.
       ``(d) If an agency proposes to repeal or amend a rule under 
     review pursuant to this section, the agency shall, after 
     issuing the notice required by subsection (c), comply with 
     the provisions of this chapter, chapter 5, and any other 
     applicable law. The requirements of such provisions and 
     related requirements shall apply to the same extent and in 
     the same manner as in the case of a proposed agency action to 
     repeal or amend a rule that is not taken pursuant to the 
     review required by this section.
       ``(e) If an agency proposes to renew without amendment a 
     rule under review pursuant to this section, the agency 
     shall--
       ``(1) give interested persons not less than 60 days after 
     the publication of the notice required by subsection (c) to 
     comment on the proposed renewal; and
       ``(2) publish in the Federal Register notice of the renewal 
     of such rule, an explanation of the continued need for the 
     rule, and, if the renewed rule is a major rule under section 
     621(4), an explanation of how the rule complies with section 
     624.
       ``(f) Any agency, which for good cause finds that 
     compliance with this section with respect to a particular 
     rule during the period provided in subsection (b) is contrary 
     to an important public interest, may request the President, 
     or an officer designated by the President, to establish a 
     period longer than 5 years, in the case of a regulation that 
     takes effect after the date of enactment of this section, or 
     7 years, in the case of a regulation in effect on the date of 
     enactment of this section, for the completion of the review 
     of such rule. The President or that officer may extend the 
     period for review of a rule to a total period of not more 
     than 10 years. Such extension shall be published in the 
     Federal Register with an explanation of the reasons therefor.
       ``(g) In any case in which an agency has not completed the 
     review of a rule within the period prescribed by subsection 
     (b) or (f) of this section, the agency shall immediately 
     publish in the Federal Register a notice proposing to issue 
     the rule under subsection (c), and shall complete proceedings 
     pursuant to subsection (d) or (e) not later than 180 days 
     after the date on which the review was required to be 
     completed under subsection (b) or (f).
       ``(h) Nothing in this section shall relieve any agency from 
     its obligation to respond to a petition to issue, amend, or 
     repeal a rule, for an interpretation regarding the meaning of 
     a rule, or for a variance or exemption from the terms of a 
     rule, submitted pursuant to any other provision of law.

     ``Sec. 628. Special rule

       ``Notwithstanding any other provision of the Comprehensive 
     Regulatory Reform Act of 1995, or the amendments made by such 
     Act, for purposes of this subchapter and subchapter IV, the 
     head of each appropriate Federal banking agency (as defined 
     in section 3(q) of the Federal Deposit Insurance Act), the 
     National Credit Union Administration, the Federal Housing 
     Finance Board, the Office of Federal Housing Enterprise 
     Oversight, and the Farm Credit Administration, shall have 
     authority with respect to such agency that otherwise would be 
     provided under such subchapters to the Director, a designee 
     of the President, Vice President, or any officer designated 
     or delegated with authority under such subchapters.

                   ``SUBCHAPTER III--RISK ASSESSMENTS

     ``Sec. 631. Definitions

       ``For purposes of this subchapter--
       ``(1) the term `benefit' has the meaning given such term in 
     section 621(1);
       ``(2) the term `best estimate' means an estimate that, to 
     the extent feasible and scientifically appropriate, is based 
     on--
       ``(A) central estimates of risk using the most plausible 
     and realistic assumptions;
       ``(B) an approach that combines multiple estimates based on 
     different scenarios and weighs the probability of each 
     scenario; and
       ``(C) any other methodology designed to provide the most 
     plausible and realistic level of risk, given the current 
     scientific information available to the agency concerned;
       ``(3) the term `cost' has the meaning given such term in 
     section 621(2);
       ``(4) the term `cost-benefit analysis' has the meaning 
     given such term in section 621(3);
       ``(5) the term `emergency' means an actual, immediate, and 
     substantial endangerment to health, safety, or the human 
     environment;
       ``(6) the term `hazard identification' means identification 
     of a substance, activity, or condition that may cause to 
     health, safety, or the environment based on empirical data, 
     measurements, or testing showing that it has caused 
     significant adverse effects at some levels of dose or 
     exposure combined degree of toxicity and actual exposure, or 
     other risk the hazards pose for individuals, populations, or 
     natural resources; and
       ``(7) the term `major cleanup plan' means any proposed or 
     final environmental cleanup plan for a facility, or Federal 
     guidelines for the issuance of any such plan, the expected 
     costs, expenses, and damages of which are likely to exceed, 
     in the aggregate, $10,000,000, including a corrective action 
     requirement under the Solid Waste Disposal Act 
     (notwithstanding section 4(b)(1)(C) of such Act, but only to 
     the extent of such requirement), a removal or remedial action 
     under the Comprehensive Environmental Response, Compensation, 
     and Liability Act of 1980, and any other environmental 
     restoration or damage assessment carried out by, on behalf 
     of, or as required or ordered by, an agency or Federal court, 
     or pursuant to the authority of a Federal statute with 
     respect to any substance;
       ``(8) the term `major rule' has the meaning given such term 
     in section 621(4);
       ``(9) the term `negative data' means data that fail to show 
     that a given substance or activity 

[[Page S9274]]
     induces an adverse effect under certain conditions;
       ``(10) the term `risk assessment' means--
       ``(A) the process of identifying hazards, and of 
     quantifying (to the maximum extent practicable) or describing 
     the combined degree of toxicity and actual exposure, or other 
     risk the hazards pose for individuals, populations, or 
     natural resources; and
       ``(B) the document containing the explanation of how the 
     assessment process has been applied to an individual 
     substance, activity, or condition;
       ``(11) 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) may include discussions of uncertainties, conflicting 
     data, estimates, extrapolations, inferences, and opinions, as 
     appropriate;
       ``(12) the term `rule' has the meaning given such term in 
     section 621(7); and
       ``(13) the term `substitution risk' means a potential 
     increased risk to health, safety, or the environment 
     resulting from market substitutions, a reduced standard of 
     living, or a regulatory alternative 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 environmental risks.
       ``(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 finds to be 
     an emergency;
       ``(B) a rule or agency action that authorizes the 
     introduction into or removal from commerce, or initiation of 
     manufacture, of a substance, mixture, or product, or 
     recognizes the marketable status of a product;
       ``(C) a health, safety, or environmental inspection, 
     compliance or enforcement action, or individual facility 
     permitting action; or
       ``(D) a screening analysis clearly identified as such.
       ``(2)(A) An analysis shall not be treated as a screening 
     analysis for the purposes of paragraph (1)(D) if the result 
     of the analysis is used--
       ``(i) as the basis for imposing a restriction on a 
     previously authorized substance, product, or activity after 
     its initial introduction into manufacture or commerce; or
       ``(ii) to characterize a finding of risk 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)(D) are product 
     registrations, reregistrations, tolerance settings, and 
     reviews of premanufacture notices 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. 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 for a major rule 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, plausible, and realistic, and 
     inclusive of all relevant data;
       ``(C) rely, to the extent available and practicable, on 
     scientific findings; and
       ``(D) use situation- or decision-specific information to 
     the maximum extent practicable.
       ``(2) An agency shall not be required to repeat discussions 
     or explanations required under this section in each risk 
     assessment document if there is an unambiguous reference to 
     the relevant discussion or explanation in another reasonably 
     available agency document that was prepared in accordance 
     with this subchapter.
       ``(b) The principles to be applied when preparing risk 
     assessments are as follows:
       ``(1)(A) When assessing human health risks, a risk 
     assessment shall consider and discuss both the most important 
     laboratory and epidemiological data, including negative data, 
     and summarize the remaining data that finds, or fails to 
     find, a correlation between a health risk and a substance or 
     activity.
       ``(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 a discussion of possible 
     reconciliation of conflicting information. Greatest emphasis 
     shall be placed on data that indicates the 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 a choice of any 
     significant assumption (including the use of safety factors 
     and default assumptions), inference, or model, the agencies 
     or instrumentality preparing the assessment shall--
       ``(A) present a representative description and explicit 
     explanation of plausible and alternative similar assumptions, 
     inferences, or models (including the assumptions incorporated 
     into the model) and the sensitivity of the conclusions to 
     them;
       ``(B) give preference to the model, assumption, input 
     parameter that represents the most plausible or realistic 
     inference from supporting scientific information;
       ``(C) identify any science policy or value judgments and 
     employ those judgments only where the policy determination 
     has been approved by the head of the agency, after notice and 
     opportunity for public involvement, as appropriate for the 
     circumstance under consideration;
       ``(D) describe any model used in the risk-assessment and 
     make explicit the assumptions incorporated into the model; 
     and
       ``(E) indicate the extent to which any significant model 
     has been validated by, or conflicts with, empirical data.
       ``(3) Risk assessments that provide a quantification or 
     numerical output shall be calculated using the best estimate 
     for each input parameter and shall use, as available, 
     probabilistic descriptions of the uncertainty and variability 
     associated with each input parameter.
       ``(4) A risk assessment shall clearly separate hazard 
     identification from risk characterization and make clear the 
     relationship between the level of risk and the level of 
     exposure to a potential hazard.
       ``(5) 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.
       ``(6) Where relevant, practicable, and appropriate, data 
     shall be developed consistent with standards for the 
     development of test data promulgated pursuant to section 4 of 
     the Toxic Substances Control Act, and standards for data 
     requirements promulgated pursuant to section 3 of the Federal 
     Insecticide, Fungicide, and Rodenticide Act.
       ``(c)(1) The head of each agency shall promote early 
     involvement by all stakeholders in the development of risk 
     assessments that may support or affect agency rules, 
     guidance, and other significant actions, by publishing as 
     part of its semiannual regulatory agenda, required under 
     section 602--
       ``(A) a list of risk assessments and supporting 
     assessments, including hazard, dose or exposure assessments, 
     under preparation or planned by the agency;
       ``(B) a brief summary of relevant issues addressed or to be 
     addressed by each listed risk assessment or supporting 
     assessment;
       ``(C) an approximate schedule for completing each listed 
     risk assessment and supporting assessment;
       ``(D) an identification of potential rules, guidance, or 
     other agency actions supported or affected by each listed 
     risk assessment and supporting assessment; and
       ``(E) the name, address, and telephone number of an agency 
     official knowledgeable about each listed risk assessment and 
     supporting assessment.
       ``(2)(A) The head of each agency shall provide an 
     opportunity for meaningful public participation and comment 
     on any risk assessment throughout the regulatory process 
     commensurate with the consequences of the decision to be 
     made.
       ``(B) In cases where the risk assessment will support a 
     major rule, the agency shall publish, at the earliest 
     opportunity in the process, an advanced notice of relevant 
     risk assessment related information that includes, at a 
     minimum, an identification of--
       ``(i) all relevant hazard, dose, exposure, and other risk 
     related documents that the agency plans to consider;
       ``(ii) all risk related guidance that the agency considers 
     relevant;
       ``(iii) all hazard, dose, exposure, and other risk 
     assumptions on which the agency plans to relay and the bases 
     therefor; and
       ``(iv) all data and information deficiencies that could 
     affect agency decisionmaking.
       ``(d)(1) No agency shall automatically incorporate or adopt 
     any recommendation or classification made by an entity 
     described in paragraph (2) concerning the health effects or 
     value of a substance without an opportunity for notice and 
     comment. Any risk assessment or risk characterization 
     document adopted by an agency on the basis of such a 
     recommendation or classification shall comply with this 
     title.
       ``(2) An entity referred to in paragraph (1) includes--
       ``(A) any foreign government and its agencies;
       ``(B) the United Nations or any of its subsidiary 
     organizations;
       ``(C) any international governmental body or standards-
     making organization; and
       ``(D) any other organization or private entity without that 
     does not have a place of business located in the United 
     States or its territories.

     ``Sec. 634. Principles for risk characterization and 
       communication

       ``In characterizing risk in any risk assessment document, 
     regulatory proposal or decision, report to Congress, or other 
     document relating in each case to a major rule that is made 
     available to the public, each agency characterizing the risk 
     shall comply with each of the following:
       ``(1) The head of the agency shall describe the exposure 
     scenarios used in any risk assessment, and, to the extent 
     feasible, provide an estimate of the size of the 
     corresponding population or natural resource at risk and the 
     likelihood of such exposure scenarios.
       ``(2) If a numerical estimate of risk is provided, the head 
     of the agency, to the extent feasible and scientifically 
     appropriate, shall provide--
       ``(A) the range and distribution of exposures derived from 
     exposure scenarios used in a risk assessment, including, 
     where appropriate, central and high-end estimates, but always 
     including a best estimate of the risk to the general 
     population;
       ``(B) the range and distribution of risk estimates, 
     including best estimates and, where quantitative estimates of 
     the range of distribution of risk estimates are not possible, 
     a list of 

[[Page S9275]]
     qualitative factors influencing the range of possible risks; and
       ``(C) a statement of the major sources of uncertainties in 
     the hazard identification, dose-response, and exposure 
     assessment phases of risk assessment and their influence on 
     the results of the assessment.
       ``(3) 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.
       ``(4) When a Federal 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 commentator.
       ``(5) An agency shall present a summary in connection with 
     the presentation of the agency's risk assessment or the 
     regulation if--
       ``(A) the agency provides a public comment period with 
     respect to a risk assessment or regulation;
       ``(B) a commentator 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.

     ``Sec. 635. Requirement to prepare assessment

       ``(a) Except as provided in section 632 and in addition to 
     any requirements applicable under subchapter II, the head of 
     each agency shall prepare--
       ``(1) for each major rule relating to health, safety, or 
     the environment, and for each major cleanup plan, 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 553(e) or 623, a risk assessment in 
     accordance with this subchapter;
       ``(2) for each such proposed or final plan, and each 
     reasonable alternative within the statutory authority of the 
     agency taking action, a cost-benefit analysis equivalent to 
     that which would be required under subchapter II if 
     subchapter II were applicable; and
       ``(3) for each such proposed or final plan, quantified to 
     the extent feasible, a comparison of any health, safety, or 
     environmental 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 major cleanup plan is subject to this subchapter 
     if--
       ``(1) construction has not commenced on a significant 
     portion of the work required by the plan; or
       ``(2) if construction has commenced on a significant 
     portion of the work required by the plan, unless--
       ``(A) it is more cost-effective to complete construction of 
     the work than to apply the provisions of this subchapter; or
       ``(B) the application of the provisions of this subchapter, 
     including any delays caused thereby, will result in an actual 
     and immediate risk to human health or welfare.
       ``(c) A risk assessment prepared pursuant to this 
     subchapter shall be a component of and used to develop any 
     cost-benefit analysis required by this subchapter or 
     subchapter II, and shall, along with any cost-benefit 
     analysis required by this subchapter, be made part of the 
     administrative record for judicial review of any final agency 
     action.

     ``Sec. 636. Requirements for assessments

       ``(a) The head of the agency, subject to review by the 
     Director or a designee of the President, shall make a 
     determination that, notwithstanding any other provision of 
     law--
       ``(1) for each major rule and major cleanup plan subject to 
     this subchapter, the risk assessment required under section 
     635 is based on a scientific, plausible, and realistic 
     evaluation, reflecting reasonable 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) for each major cleanup plan subject to this 
     subchapter, the plan has benefits that justify its costs and 
     that there is no alternative that is allowed by the statute 
     under which the plan 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.
       ``(b) Notwithstanding any other provision of law, no agency 
     shall prohibit or refuse to approve a substance or product on 
     the basis of safety where the substance or product presents a 
     negligible or insignificant human risk under the intended 
     conditions of use.
       ``(c) Notwithstanding any other provision of law, issuance 
     of a record of decision or a final permit condition or 
     administrative order containing a major cleanup plan, or 
     denial of, or completion of agency review pursuant to, a 
     petition for review of a major cleanup plan under section 
     637(c), shall constitute final agency action subject to 
     judicial review at the time this action is taken.

     ``Sec. 637. Regulations; plan for assessing new information

       ``(a)(1) Not later than 1 year after the date of enactment 
     of this subchapter, the Director or a designee of the 
     President shall--
       ``(A) issue a final regulation that has been subject to 
     notice and comment under section 553 that directs agencies to 
     implement the risk assessment and risk characterization 
     principles set forth in sections 633 and 634; and
       ``(B) 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) Review of a risk assessment or any entry (or the 
     evaluation underlying the entry) on an agency-developed 
     database (including, but not limited to, the Integrated Risk 
     Information System), shall be conducted by the head of the 
     agency on the written petition of a person showing a 
     reasonable likelihood that--
       ``(1) the risk assessment or entry is inconsistent with the 
     principles set forth in sections 633 and 634;
       ``(2) the risk assessment or entry contains different 
     results than if it had been properly conducted under sections 
     633 and 634;
       ``(3) the risk assessment or entry is inconsistent with a 
     rule issued under subsection (a); or
       ``(4) the risk assessment or entry does not take into 
     account material significant new scientific data or 
     scientific understanding.
       ``(c) Review of a risk assessment, a cost-benefit analysis, 
     or both, for a major cleanup plan shall be conducted by the 
     head of the agency on the written petition of a person 
     showing a reasonable likelihood that--
       ``(1) the risk assessment warrants revision under any of 
     the criteria set forth in subsection (b); or
       ``(2) the cost-benefit analysis warrants revision under any 
     of the criteria set forth in section 624.
       ``(d)(1) Not later than 90 days after receiving a petition 
     under subsection (b), the head of the agency shall respond to 
     the petition by agreeing or declining to review the risk 
     entry, the cost-benefit analysis, or both, referred to in the 
     petition, and shall state the basis for the decision.
       ``(2) If the head of the agency agrees to review the 
     petition, the agency shall complete its review not later than 
     180 days after the decision made under paragraph (1), unless 
     the Director agrees in writing with an agency determination 
     that an extension is necessary in view of limitations on 
     agency resources. Prior to completion of the agency review, 
     the agency's written conclusions concerning the review shall 
     be subjected to peer review pursuant to section 640.
       ``(3) A risk assessment review completed pursuant to a 
     petition may be the basis for initiating a petition pursuant 
     to any other provision of law.
       ``(4) Following a decision to grant or deny a petition 
     under subsection (b) or (c), no further petition for such 
     risk assessment, entry, or cost-benefit analysis, submitted 
     by the same person, shall be considered by any agency unless 
     such petition is based on a change in a fact, circumstance, 
     or provision of law underlying or otherwise related to the 
     matters covered by the initial petition, occurring since the 
     initial petition was granted or denied, that warrants the 
     granting of such further petition.
       ``(e) 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, 
     agencies, offices, organizations, or persons as may be 
     advisable.
       ``(f) At least every 4 years, the Director or a designee of 
     the President shall review, and when appropriate, revise, the 
     regulations published under this section.

     ``Sec. 638. 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. 639. Regulatory priorities

       ``(a)(1) Not later than 180 days after the date of 
     enactment of this section, the Director of the Office of 
     Management and Budget, in consultation with the Office of 
     Science and Technology Policy, shall enter into appropriate 
     arrangements with an accredited scientific body to--
       ``(A) conduct a study of the methodologies for using 
     comparative risk to rank dissimilar health, safety, and 
     environmental risks; and
       ``(B) to conduct a comparative risk analysis in accordance 
     with paragraph (2).
       ``(2) The study of the methodologies under paragraph (1)(A) 
     shall be conducted as part of the first comparative risk 
     analysis under paragraph (1)(B). The study shall--
       ``(A) seek to develop and rigorously test methods of 
     comparative risk analysis;
       ``(B) have sufficient scope and breadth to test approaches 
     for improving comparative risk analysis and its use in 
     setting priorities for health, safety, and environmental risk 
     prevention and reduction; and
       ``(C) review and evaluate the experience of States that 
     have conducted comparative risk analyses.
       ``(3)(A) The comparative risk analysis under paragraph 
     (1)(B) shall compare and rank, to the extent feasible, 
     health, safety, and environmental risks potentially regulated 
     across the spectrum of programs relating to health, safety, 
     and the environment administered by the departments, 
     agencies, and instrumentalities of the Federal Government.
       ``(B) In carrying out the comparative risk analysis under 
     this paragraph, the Director shall ensure that--
       ``(i) the scope and specificity of the analysis are 
     sufficient to provide the President and the heads of agencies 
     guidance in allocating resources across agencies and among 
     programs in agencies to achieve the greatest degree of risk 
     prevention and reduction for the public and private resources 
     expended;
       ``(ii) the analysis is conducted through an open process, 
     by individuals with relevant expertise, including, as 
     appropriate--
       ``(I) toxicologists;

[[Page S9276]]

       ``(II) biologists;
       ``(III) engineers; and
       ``(IV) experts in the fields of medicine, industrial 
     hygiene, and environmental effects;
       ``(iii) the analysis is conducted, to the extent feasible, 
     consistent with the risk assessment and risk characterization 
     principles described in sections 633 and 634;
       ``(iv) the methodologies and principal scientific 
     determinations made in the analysis are subjected to peer 
     review under section 640 and the conclusions of the peer 
     review are made publicly available as part of the final 
     report;
       ``(v) there is an opportunity for public comments on the 
     results of the analysis prior to making them final; and
       ``(vi) the results of the analysis are presented in a 
     manner that distinguishes between the scientific conclusions 
     and any policy or value judgments embodied in the 
     comparisons.
       ``(4) The comparative risk analysis shall be completed, and 
     a report submitted to Congress not later than 3 years after 
     the date of enactment of this section. The analysis shall be 
     reviewed and revised not less often than every 5 years 
     thereafter for a minimum of 15 years following the release of 
     the initial analysis.
       ``(b) Not later than 180 days after the date of enactment 
     of this section, the Director of the Office of Management and 
     Budget, in collaboration with the head of each Federal 
     agency, shall enter into a contract with the National 
     Research Council to provide technical guidance to the 
     agencies on approaches to using comparative risk analysis in 
     setting health, safety, and environmental priorities to 
     assist the agencies in complying with subsection (c).
       ``(c)(1) In exercising authority under any laws protecting 
     health, 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 health, safety, and the 
     environment that--
       ``(A) the agency determines are the most serious; and
       ``(B) 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.
       ``(2) In identifying the sources of the most serious risks 
     under paragraph (1), the head of the agency shall consider, 
     at a minimum--
       ``(A) the plausible likelihood and severity of the effect; 
     and
       ``(B) the plausible number and groups of individuals 
     potentially affected.
       ``(3) The head of the agency shall incorporate the 
     priorities identified in paragraph (1) into the budget, 
     strategic planning, and research activities of the agency by, 
     in the agency's annual budget request to Congress--
       ``(A) identifying which risks the agency has determined are 
     the most serious and can be addressed in a cost-effective 
     manner under paragraph (1), and the basis for that 
     determination;
       ``(B) explicitly identifying how the agency's requested 
     funds will be used to address those risks;
       ``(C) identifying any statutory, regulatory, or 
     administrative obstacles to allocating agency resources in 
     accordance with the priorities established under paragraph 
     (1); and
       ``(D) explicitly considering the requirements of paragraph 
     (1) 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.
       ``(4) 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 health, 
     safety, and the environment that are the most serious and can 
     be addressed in a cost-effective manner consistent with the 
     requirements of paragraph (1).

     ``Sec. 640. Establishment of program

       ``(a) The Director of the Office of Science and Technology 
     or the Director, as appropriate, shall develop a systematic 
     program for the peer review of work products covered by 
     subsection (c), which program shall be used, in as uniform a 
     manner as is practicable, 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 experts who were associated with the 
     generation of the specific work product either directly by 
     substantial contribution to its development, or indirectly by 
     consultation and development of the specific product;
       ``(4) shall provide for differing levels of peer review 
     depending on the significance or complexity of the issue or 
     the need for expedition;
       ``(5) shall contain balanced presentations of all 
     considerations, including minority reports and an agency 
     response to all significant peer review comments; and
       ``(6) shall provide an opportunity for interested parties 
     to submit issues for consideration by peer review panels.
       ``(c) Matters requiring peer review shall include--
       ``(1) risk assessments and cost-benefit analyses for major 
     rules;
       ``(2) quantitative estimates of risk or hazard that are 
     used in making regulatory determinations, including all 
     entries into the Integrated Risk Information System;
       ``(3) risk assessment and risk characterization regulations 
     and cost-benefit guidelines; and
       ``(4) any other significant or technical work product, as 
     designated by the head of each agency, the Director of the 
     Office of Science and Technology, or the Director.
       ``(d) All underlying data shall be submitted to peer 
     reviewers, except to the extent necessary to protect 
     confidential business information and trade secrets. To 
     ensure such protections, the head of the agency may require 
     that peer reviewers enter into confidentiality agreements.
       ``(e) The peer review and the agency's responses shall be 
     made available to the public for comment and the final peer 
     review and the agency's responses shall be made part of the 
     administrative record for purposes of judicial review.
       ``(f) The proceedings of peer review panels under this 
     section shall be subject to the applicable provisions of the 
     Federal Advisory Committee Act.

                  ``SUBCHAPTER IV--EXECUTIVE OVERSIGHT

     ``Sec. 641. Procedures

       ``(a) The Director or a designee of the President shall--
       ``(1) establish procedures for agency compliance with this 
     chapter; and
       ``(2) monitor, review, and ensure agency implementation of 
     such procedures.
       ``(b) Not later than 12 months after the date of enactment 
     of this subchapter the Office of Management and Budget shall 
     issue regulations to assist agencies in preparing the cost-
     benefit analyses required by this subchapter. The regulations 
     shall--
       ``(1) ensure that cost and benefit evaluations are 
     consistent with this subchapter and, to the extent feasible, 
     represent realistic and plausible estimates;
       ``(2) be adopted following public notice and adequate 
     opportunity for comment; and
       ``(3) be used consistently by all agencies covered by this 
     subchapter.

     ``Sec. 642. Promulgation and adoption

       ``(a) Procedures established pursuant to section 641 shall 
     only be implemented after opportunity for public comment. Any 
     such procedures shall be consistent with the prompt 
     completion of rulemaking proceedings.
       ``(b)(1) If procedures established pursuant to section 641 
     include review of any initial or final analyses of a rule 
     required under chapter 6, the time for any such review of any 
     initial analysis shall not exceed 30 days following the 
     receipt of the analysis by the Director, a designee of the 
     President, or by an officer to whom the authority granted 
     under section 641 has been delegated pursuant to section 643.
       ``(2) The time for review of any final analysis required 
     under chapter 6 shall not exceed 30 days following the 
     receipt of the analysis by the Director, a designee of the 
     President, or such officer.
       ``(3)(A) The times for each such review may be extended for 
     good cause by the President or such officer for an additional 
     30 days.
       ``(B) Notice of any such extension, together with a 
     succinct statement of the reasons therefor, shall be inserted 
     in the rulemaking file.

     ``Sec. 643. Delegation of authority

       ``(a) The President may delegate the authority granted by 
     this subchapter to the Vice President or to an officer within 
     the Executive Office of the President whose appointment has 
     been subject to the advice and consent of the Senate.
       ``(b)(1) Notice of any delegation, or any revocation or 
     modification thereof shall be published in the Federal 
     Register.
       ``(2) Any notice with respect to a delegation to the Vice 
     President shall contain a statement by the Vice President 
     that the Vice President will make every reasonable effort to 
     respond to congressional inquiries concerning the exercise of 
     the authority delegated under this section.
     ``Sec. 644. Judicial review

       ``The exercise of the authority granted under this 
     subchapter by the Director, the President, or by an officer 
     to whom such authority has been delegated under section 643 
     shall not be subject to judicial review in any manner under 
     this chapter.''.
       (b) Regulatory Flexibility Analysis.--
       (1) Judicial review.--Section 611 of title 5, United States 
     Code, is amended to read as follows:

     ``Sec. 611. Judicial review

       ``(a)(1) Except as provided in paragraph (2), not later 
     than 2 years after the effective date of a final rule with 
     respect to which an agency--
       ``(A) certified, pursuant to section 605(b), that such rule 
     would not have a significant economic impact on a substantial 
     number of small entities;
       ``(B) prepared a final regulatory flexibility analysis 
     pursuant to section 604; or
       ``(C) did not prepare an initial regulatory flexibility 
     analysis pursuant to section 603 or a final regulatory 
     flexibility analysis pursuant to section 604 except as 
     permitted by sections 605 and 608,

     an affected small entity may petition for the judicial review 
     of such certification, analysis, or lack of analysis, in 
     accordance with this subsection. A court having jurisdiction 
     to review such rule for compliance with section 553 or under 
     any other provision of law shall have jurisdiction to review 
     such certification or analysis.
       ``(2)(A) Notwithstanding any other provision of law, an 
     affected small entity shall have 2 years to challenge such 
     certification, analysis or lack of analysis.
       ``(B) If an agency delays the issuance of a final 
     regulatory flexibility analysis pursuant to section 608(b), a 
     petition for judicial review under this subsection shall be 
     filed not later than 2 years after the date the analysis is 
     made available to the public.
       ``(3) For purposes of this subsection, the term `affected 
     small entity' means a small entity that is or will be 
     adversely affected by the final rule.
       ``(4) Nothing in this subsection shall be construed to 
     affect the authority of any court to 

[[Page S9277]]
     stay the effective date of any rule or provision thereof under any 
     other provision of law.
       ``(5)(A) Notwithstanding section 605, if the court 
     determines, on the basis of the rulemaking record, that there 
     is substantial evidence to conclude that the rule would have 
     a significant economic impact on a substantial number of 
     small entities, the court shall order the agency to prepare a 
     final regulatory flexibility analysis pursuant to section 
     604.
       ``(B) If the agency prepared a final regulatory flexibility 
     analysis, the court may order the agency to take corrective 
     action consistent with section 604 if the court determines, 
     on the basis of the rulemaking record, that the final 
     regulatory flexibility analysis was prepared by the agency 
     without complying with section 604.
       ``(6) The court may stay the rule or grant such other 
     relief as it deems appropriate if, by the end of the 90-day 
     period beginning on the date of the order of the court 
     pursuant to paragraph (5) (or such longer period as the court 
     may provide), the agency fails, as appropriate--
       ``(A) to prepare the analysis required by section 604; or
       ``(B) to take corrective action consistent with section 
     604.
       ``(7) In making any determination or granting any relief 
     authorized by this subsection, the court shall take due 
     account of the rule of prejudicial error.
       ``(b) In an action for the judicial review of a rule, any 
     regulatory flexibility analysis for such rule (including an 
     analysis prepared or corrected pursuant to subsection (a)(5)) 
     shall constitute part of the whole record of agency action in 
     connection with such review.
       ``(c) Nothing in this section bars judicial review of any 
     other impact statement or similar analysis required by any 
     other law if judicial review of such statement or analysis is 
     otherwise provided by law.''.
       (2) Effective date.--The amendment made by paragraph (1) 
     shall take effect on the date of enactment of this Act, 
     except that the judicial review authorized by section 611(a) 
     of title 5, United States Code (as added by subsection (a)), 
     shall apply only to final agency rules issued after the date 
     of enactment of this Act.
       (c) Presidential Authority.--Nothing in this Act shall 
     limit the exercise by the President of the authority and 
     responsibility that the President otherwise possesses under 
     the Constitution and other laws of the United States with 
     respect to regulatory policies, procedures, and programs of 
     departments, agencies, and offices.
       (d) Technical and Conforming Amendments.--
       (1) Chapter analysis.--Part I of title 5, United States 
     Code, is amended by striking out the chapter heading and 
     table of sections for chapter 6 and inserting in lieu thereof 
     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 analysis.
``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--ANALYSIS OF AGENCY RULES

``621. Definitions.
``622. Rulemaking cost-benefit analysis.
``623. Petition for cost-benefit analysis.
``624. Decisional criteria.
``625. Judicial review.
``626. Deadlines for rulemaking.
``627. Agency review of rules.
``628. Special rule.

                   ``SUBCHAPTER III--RISK ASSESSMENTS

``631. Definitions.
``632. Applicability.
``633. Principles for risk assessment.
``634. Principles for risk characterization and communication.
``635. Requirement to prepare risk assessment.
``636. Requirements for assessments.
``637. Regulations; plan for assessing new information.
``638. Rule of construction.
``639. Regulatory priorities.
``640. Establishment of program.

                  ``SUBCHAPTER IV--EXECUTIVE OVERSIGHT

``641. Procedures.
``642. Promulgation and adoption.
``643. Delegation of authority.
``644. Judicial review.''.
       (2) Subchapter heading.--Chapter 6 of title 5, United 
     States Code, is amended by inserting immediately before 
     section 601, the following subchapter heading:

                 ``SUBCHAPTER I--REGULATORY ANALYSIS''.

     SEC. 5. JUDICIAL REVIEW.

       (a) Scope of Review.--Section 706 of title 5, United States 
     Code, is amended to read as follows:

     ``Sec. 706. Scope of review

       ``(a) To the extent necessary to reach a decision and when 
     presented, the reviewing court shall decide all relevant 
     questions of law, interpret constitutional and statutory 
     provisions, and determine the meaning or applicability of the 
     terms of an agency action. The reviewing court shall--
       ``(1) compel agency action unlawfully withheld or 
     unreasonably delayed; and
       ``(2) hold unlawful and set aside agency action, findings 
     and conclusions found to be--
       ``(A) arbitrary, capricious, an abuse of discretion, or 
     otherwise not in accordance with law;
       ``(B) contrary to constitutional right, power, privilege, 
     or immunity;
       ``(C) in excess of statutory jurisdiction, authority, or 
     limitations, or short of statutory right;
       ``(D) without observance of procedure required by law;
       ``(E) unsupported by substantial evidence in a proceeding 
     subject to sections 556 and 557 or otherwise reviewed on the 
     record of an agency hearing provided by statute;
       ``(F) without substantial support in the rulemaking file, 
     viewed as a whole, for the asserted or necessary factual 
     basis, as distinguished from the policy or legal basis, of a 
     rule adopted in a proceeding subject to section 553; or
       ``(G) unwarranted by the facts to the extent that the facts 
     are subject to trial de novo by the reviewing court.
       ``(b) In making the foregoing determinations, the court 
     shall review the whole record or those parts of it cited by a 
     party, and due account shall be taken of the rule of 
     prejudicial error.
       ``(c) In reviewing an agency interpretation of a statute 
     governing the authority for an agency action, including 
     agency action taken pursuant to a statute that provides for 
     review of final agency action, the reviewing court shall--
       ``(1) hold erroneous and unlawful--
       ``(A) an agency interpretation that is other than the 
     interpretation of the statute clearly intended by Congress; 
     or
       ``(B) an agency interpretation that is outside the range of 
     permissible interpretations of the statute; and
       ``(2) hold arbitrary, capricious, or an abuse of 
     discretion--
       ``(A) an agency action as to which the agency--
       ``(i) has improperly classified an interpretation as being 
     within or outside the range of permissible interpretations; 
     or
       ``(ii) has not explained in a reasoned analysis why it 
     selected the interpretation and why it rejected other 
     permissible interpretations of the statute; or
       ``(B) in the case of agency action subject to chapter 6, an 
     interpretation that does not give the agency the broadest 
     discretion to develop rules that will satisfy the decisional 
     criteria of section 624.
       ``(d) Notwithstanding any other provision of law, the 
     provisions of this subsection shall apply to, and supplement, 
     the requirements contained in any statute for the review of 
     final agency action which is not otherwise subject to this 
     subsection.''.
       (b) Court of Federal Claims.--
       (1) In general.--Section 1491(a) of title 28, United States 
     Code, is amended--
       (A) in paragraph (1), by amending the first sentence to 
     read as follows: ``The United States Court of Federal Claims 
     shall have jurisdiction to render judgment upon any claim 
     against the United States for monetary relief founded either 
     upon the Constitution or any Act of Congress or any 
     regulation or action of an agency, or upon any expressed or 
     implied contract with the United States, in cases not 
     sounding in tort, or for invalidation of any Act of Congress 
     or any regulation of an executive department that adversely 
     affects private property rights in violation of the fifth 
     amendment of the United States Constitution.'';
       (B) in paragraph (2), by inserting before the first 
     sentence the following: ``In any case within its 
     jurisdiction, the Court of Federal Claims shall have the 
     power to grant injunctive and declaratory relief when 
     appropriate.''; and
       (C) by adding at the end the following new paragraphs:
       ``(4) In cases otherwise within its jurisdiction, the Court 
     of Federal Claims shall also have ancillary jurisdiction, 
     concurrent with the courts designated in section 1346(b), to 
     render judgment upon any related tort claim authorized under 
     section 2674.
       ``(5) In proceedings within the jurisdiction of the Court 
     of Federal Claims which constitute judicial review of agency 
     action (rather than de novo proceedings), the provisions of 
     section 706 of title 5 shall apply.''.
       (2) Pendency of claims in other courts.--Section 1500 of 
     title 28, United States Code, is repealed.
       (c) Judicial Proceedings.--
       (1) Consent decrees.--Chapter 7 of title 5, United States 
     Code, is amended by adding at the end the following new 
     section:

     ``Sec. 707. Consent decrees

       ``In interpreting any consent decree in effect on or after 
     the date of enactment of this section that imposes on an 
     agency an obligation to initiate, continue, or complete 
     rulemaking proceedings, the court shall not enforce the 
     decree in a way that divests the agency of discretion granted 
     to it by the Congress or the Constitution to respond to 
     changing circumstances, make policy or managerial choices, or 
     protect the rights of third parties.''.
       (2) Affirmative defense.--Chapter 7 of title 5, United 
     States Code, is further amended by adding at the end the 
     following new section:

     ``Sec. 708. Affirmative defense

       ``Notwithstanding any other provision of law, it shall be 
     an affirmative defense in any enforcement action brought by 
     an agency that the regulated person or entity is complying 
     with a rule, regulation, adjudication, directive, or order of 
     such agency or any other agency that is inconsistent, 
     incompatible, contradictory, or otherwise cannot be 
     reconciled with the agency rule, regulation, adjudication, 
     directive, or order being enforced.''.

[[Page S9278]]

       (3) Agency interpretations in civil and criminal actions.--
       (A) In general.--Chapter 7 of title 5, United States Code, 
     is further amended by adding at the end the following new 
     section:

     ``Sec. 709. Agency interpretations in civil and criminal 
       actions

       ``(a)(1) No civil or criminal penalty shall be imposed in 
     any action brought in a Federal court, including an action 
     pending on the date of enactment of this section, for the 
     alleged violation of a rule, if the defendant, prior to the 
     alleged violation--
       ``(A) reasonably determined, based upon a description, 
     explanation, or interpretation of the rule contained in the 
     rule's statement of basis and purpose, that the defendant was 
     in compliance with, exempt from, or otherwise not subject to, 
     the requirements of the rule; or
       ``(B) was informed by the agency that promulgated the rule, 
     or by a State authority to which had been delegated the 
     responsibility for ensuring compliance with the rule, that 
     the defendant was in compliance with, exempt from, or 
     otherwise not subject to, the requirements of the rule.
       ``(2) In determining, for purposes of paragraph (1)(A), 
     whether a defendant reasonably relied upon a description, 
     explanation, or interpretation of the rule contained in the 
     rule's statement of basis and purpose, the court shall not 
     give deference to any subsequent agency description, 
     explanation, or interpretation of the rule relied on by the 
     agency in the action that had not been published in the 
     Federal Register or otherwise directly and specifically 
     communicated to the defendant by the agency, or by a State 
     authority to which had been delegated the responsibility for 
     ensuring compliance with the rule, prior to the alleged 
     violation.
       ``(b)(1) In a civil or criminal action in Federal court to 
     redress an alleged violation of a rule, including an action 
     pending on the date of enactment of this section, if the 
     court determines that the rule in question is ambiguous, the 
     court shall not give deference to an agency interpretation of 
     the rule if the defendant relied upon an interpretation of 
     the rule to the effect that the defendant was in compliance 
     with or was exempt or otherwise not subject to the 
     requirement of the rule, and the court determines that such 
     determination is reasonable.
       ``(2) Without regard to whether the defendant relied upon 
     an interpretation that the court determines is reasonable 
     under paragraph (1), if the court determines that the rule 
     failed to give the defendant fair warning of the conduct that 
     the rule prohibits or requires, no civil or criminal penalty 
     shall be imposed.
       ``(c)(1) No agency action shall be taken, or any action or 
     other proceeding maintained, seeking the retroactive 
     application of a requirement against any person that is based 
     upon--
       ``(A) an interpretation of a statute, rule, guidance, 
     agency statement of policy, or license requirement or 
     condition; or
       ``(B) a determination of fact,

     if such interpretation or determination is different from a 
     prior interpretation or determination by the agency or by a 
     State or local government exercising authority delegated or 
     approved by the agency, and if such person relied upon the 
     prior interpretation or determination.
       ``(2) This subsection shall take effect on the date of 
     enactment of the Comprehensive Regulatory Reform Act of 1995 
     and shall apply to any matter for which a final unappealable 
     judicial order has not been issued.
       ``(d) This section shall apply to the review by a Federal 
     court of any order of an agency assessing civil 
     administrative penalties.''.
       (B) Unpublished agency guidance.--Section 552(a)(1) of 
     title 5, United States Code, is amended by inserting at the 
     end the following new sentence: ``In an action brought in a 
     Federal court seeking a civil or criminal penalty for the 
     alleged violation of a rule, including actions pending on the 
     date of enactment of this sentence, no consideration shall be 
     given to any interpretive rule, general statement of policy, 
     or other agency guidance of general or specific 
     applicability, relied upon by the agency in the action, that 
     had not been published in the Federal Register or otherwise 
     directly and specifically communicated to the defendant by 
     the agency, or by a State authority to which had been 
     delegated the responsibility for ensuring compliance with the 
     rule, prior to the alleged violation.''.
       (4) Technical amendment.--The analysis for chapter 7 of 
     title 5, United States Code, is amended by adding at the end 
     the following new items:

``707. Consent decrees.
``708. Affirmative defense.
``709. Agency interpretations in civil and criminal actions.''.
     SEC. 6. CONGRESSIONAL REVIEW.

       (a) In General.--Title 5, United States Code, is amended by 
     inserting immediately after chapter 7 the following new 
     chapter:
         ``CHAPTER 8--CONGRESSIONAL REVIEW OF AGENCY RULEMAKING

     ``Sec. 801. Congressional review of agency rulemaking

       ``(a)(1) Before a rule takes effect as a final rule, the 
     agency promulgating such rule shall submit to the Congress a 
     report containing a copy of the rule, the notice of proposed 
     rulemaking, and the statement of basis and purpose for the 
     rule, including a complete copy of any analysis required 
     under chapter 6, and the proposed effective date of the rule. 
     In the case of a rule that is not a major rule within the 
     meaning of section 621(4), summary of the rulemaking 
     proceedings shall be submitted.
       ``(2) A rule relating to a report submitted under paragraph 
     (1) shall take effect as a final rule, the latest of the 
     following:
       ``(A) The later of the date occurring 45 days after the 
     date on which--
       ``(i) the Congress receives the report submitted under 
     paragraph (1); or
       ``(ii) the rule is published in the Federal Register.
       ``(B) If the Congress passes a joint resolution of 
     disapproval described under subsection (g) relating to the 
     rule, and the President signs a veto of such resolution, the 
     earlier date--
       ``(i) on which either House of Congress votes and fails to 
     override the veto of the President; or
       ``(ii) occurring 30 session days after the date on which 
     the Congress received the veto and objections of the 
     President.
       ``(C) The date the rule would have otherwise taken effect, 
     if not for this section (unless a joint resolution of 
     disapproval under subsection (g) is approved).
       ``(b) A rule shall not take effect as a final rule if the 
     Congress passes a joint resolution of disapproval described 
     under subsection (g), which is signed by the President or is 
     vetoed and overridden by the Congress.
       ``(c)(1) Notwithstanding any other provision of this 
     section (except subject to paragraph (3)), a rule that would 
     not take effect by reason of this section may take effect if 
     the President makes a determination under paragraph (2) and 
     submits written notice of such determination to the Congress.
       ``(2) Paragraph (1) applies to a determination made by the 
     President by Executive order that the rule should take effect 
     because such rule is--
       ``(A) necessary because of an imminent threat to health or 
     safety or other emergency;
       ``(B) necessary for the enforcement of criminal laws; or
       ``(C) necessary for national security.
       ``(3) An exercise by the President of the authority under 
     this subsection shall have no effect on the procedures under 
     subsection (g) or the effect of a joint resolution of 
     disapproval under this section.
       ``(4) This subsection and an Executive order issued by the 
     President under paragraph (2) shall not be subject to 
     judicial review by a court of the United States.
       ``(d)(1) Subsection (g) shall apply to any rule that is 
     published in the Federal Register (as a rule that shall take 
     effect as a final rule) during the period beginning on the 
     date occurring 60 days before the date the Congress adjourns 
     sine die through the date on which the succeeding Congress 
     first convenes.
       ``(2) For purposes of subsection (g), a rule described 
     under paragraph (1) shall be treated as though such rule were 
     published in the Federal Register (as a rule that shall take 
     effect as a final rule) on the date the succeeding Congress 
     first convenes.
       ``(3) During the period between the date the Congress 
     adjourns sine die through the date on which the succeeding 
     Congress first convenes, a rule described under paragraph (1) 
     shall take effect as a final rule as otherwise provided by 
     law.
       ``(e) Any rule that takes effect and later is made of no 
     force or effect by the enactment of a joint resolution under 
     subsection (g) shall be treated as though such rule had never 
     taken effect.
       ``(f) If the Congress does not enact a joint resolution of 
     disapproval under subsection (g), no court or agency may 
     infer any intent of the Congress from any action or inaction 
     of the Congress with regard to such rule, related statute, or 
     joint resolution of disapproval.
       ``(g)(1) For purposes of this subsection, the term `joint 
     resolution' means only a joint resolution introduced after 
     the date on which the report referred to in subsection (a) is 
     received by Congress the matter after the resolving clause of 
     which is as follows: `That Congress disapproves the rule 
     submitted by the ____________ relating to ______________, and 
     such rule shall have no force or effect.' (The blank spaces 
     being appropriately filled in.)
       ``(2)(A) A resolution described in paragraph (1) shall be 
     referred to the committees in each House of Congress with 
     jurisdiction. Such a resolution shall not be reported before 
     the eighth day after its submission or publication date.
       ``(B) For purposes of this subsection the term `submission 
     or publication date' means the later of the date on which--
       ``(i) the Congress receives the report submitted under 
     subsection (a)(1); or
       ``(ii) the rule is published in the Federal Register.
       ``(3) If the committee to which a resolution described in 
     paragraph (1) is referred has not reported such resolution 
     (or an identical resolution) at the end of 20 calendar days 
     after its submission or publication date, such committee may 
     be discharged by the Majority Leader of the Senate or the 
     Majority Leader of the House of Representatives, as the case 
     may be, from further consideration of such resolution and 
     such resolution shall be placed on the appropriate calendar 
     of the House involved.
       ``(4)(A) When the committee to which a resolution is 
     referred has reported, or when a committee is discharged 
     (under paragraph (3)) from further consideration of, a 
     resolution described in paragraph (1), it shall at any time 
     thereafter be in order (even though a previous motion to the 
     same effect has been disagreed to) for any Member of the 
     respective House to move to proceed to the consideration of 
     the resolution, and all points of order against the 
     resolution (and against consideration of the resolution) 
     shall be waived. The motion shall be highly privileged in the 
     House of Representatives and shall be privileged in the 
     Senate and shall not be debatable. The motion shall not be 
     subject to amendment, or to a motion to postpone, or to a 
     motion to proceed to the consideration of other business. A 
     motion to reconsider the vote by which the motion is agreed 
     to or disagreed to shall not be in order. If a motion to 
     proceed to the consideration of the resolution is agreed to, 
     the resolution shall remain the unfinished business of the 
     respective House until disposed of.

[[Page S9279]]

       ``(B) Debate on the resolution, and on all debatable 
     motions and appeals in connection therewith, shall be limited 
     to not more than 10 hours, which shall be divided equally 
     between those favoring and those opposing the resolution. A 
     motion further to limit debate shall be in order and shall 
     not be debatable. An amendment to, or a motion to postpone, 
     or a motion to proceed to the consideration of other 
     business, or a motion to recommit the resolution shall not be 
     in order. A motion to reconsider the vote by which the 
     resolution is agreed to or disagreed to shall not be in 
     order.
       ``(C) Immediately following the conclusion of the debate on 
     a resolution described in paragraph (1), and a single quorum 
     call at the conclusion of the debate if requested in 
     accordance with the rules of the appropriate House, the vote 
     on final passage of the resolution shall occur.
       ``(D) Appeals from the decisions of the Chair relating to 
     the application of the rules of the Senate or the House of 
     Representatives, as the case may be, to the procedure 
     relating to a resolution described in paragraph (1) shall be 
     decided without debate.
       ``(5) If, before the passage by one House of a resolution 
     of that House described in paragraph (1), that House receives 
     from the other House a resolution described in paragraph (1), 
     then the following procedures shall apply:
       ``(A) The resolution of the other House shall not be 
     referred to a committee.
       ``(B) With respect to a resolution described in paragraph 
     (1) of the House receiving the resolution--
       ``(i) the procedure in that House shall be the same as if 
     no resolution had been received from the other House; but
       ``(ii) the vote on final passage shall be on the resolution 
     of the other House.
       ``(6) This subsection is enacted by Congress--
       ``(A) as an exercise of the rulemaking power of the Senate 
     and House of Representatives, respectively, and as such it is 
     deemed to be a part of the rules of each House, respectively, 
     but applicable only with respect to the procedure to be 
     followed in that House in the case of a resolution described 
     in paragraph (1), and it supersedes other rules only to the 
     extent that it is inconsistent with such rules; and
       ``(B) with full recognition of the constitutional right of 
     either House to change the rules (so far as relating to the 
     procedure of that House) at any time, in the same manner, and 
     to the same extent as in the case of any other rule of that 
     House.
       ``(h) This section shall not apply to rules that concern 
     monetary policy proposed or implemented by the Board of 
     Governors of the Federal Reserve System or the Federal Open 
     Market Committee.''.
       (b) Technical Amendment.--The table of chapters for part I 
     of title 5, United States Code, is amended by inserting 
     immediately after the item relating to chapter 7 the 
     following:

``8. Congressional Review of Agency Rulemaking...............801''.....
     SEC. 7. ACCOUNTING.

       (a) Definitions.--For purposes of this section, the 
     following definitions apply:
       (1) Regulation.--The term ``regulation'' means an agency 
     statement of general applicability and future effect designed 
     to implement, interpret, or prescribe law or policy or 
     describing the procedures or practice requirements of an 
     agency. The term shall not include--
       (A) administrative actions governed by sections 556 and 557 
     of title 5, United States Code;
       (B) regulations issued with respect to a military or 
     foreign affairs function of the United States; or
       (C) regulations related to agency organization, management, 
     or personnel.
       (2) Agency.--The term ``agency'' means any executive 
     department, military department, Government corporation, 
     Government controlled corporation, or other establishment in 
     the executive branch of the Government (including the 
     Executive Office of the President), or any independent 
     regulatory agency, but shall not include--
       (A) the General Accounting Office;
       (B) the Federal Election Commission;
       (C) the governments of the District of Columbia and of the 
     territories and possessions of the United States, and their 
     various subdivisions; or
       (D) Government-owned contractor-operated facilities, 
     including laboratories engaged in national defense research 
     and production activities.
       (b) Accounting Statement.--
       (1) In general.--(A) The President shall be responsible for 
     implementing and administering the requirements of this 
     section.
       (B) Every 2 years, not later than June of the second year, 
     the President shall prepare and submit to Congress an 
     accounting statement that estimates the costs of Federal 
     regulatory programs and corresponding benefits in accordance 
     with this subsection.
       (2) Years covered by accounting statement.--Each accounting 
     statement shall cover, at a minimum, the 5 fiscal years 
     beginning on October 1 of the year in which the report is 
     submitted and may cover any fiscal year preceding such fiscal 
     years for purpose of revising previous estimates.
       (3) Timing and procedures.--(A) The President shall provide 
     notice and opportunity for comment for each accounting 
     statement. The President may delegate to an agency the 
     requirement to provide notice and opportunity to comment for 
     the portion of the accounting statement relating to that 
     agency.
       (B) The President shall propose the first accounting 
     statement under this subsection not later than 2 years after 
     the date of the enactment of this Act and shall issue the 
     first accounting statement in final form not later than 3 
     years after the date of the enactment of this Act. Such 
     statement shall cover, at a minimum, each of the 8 fiscal 
     years beginning after the date of the enactment of this Act.
       (4) Content of accounting statement.--(A) Each accounting 
     statement shall contain estimates of costs and benefits with 
     respect to each fiscal year covered by the statement in 
     accordance with this paragraph. For each such fiscal year for 
     which estimates were made in a previous accounting statement, 
     the statement shall revise those estimates and state the 
     reasons for the revisions.
       (B)(i) An accounting statement shall estimate the costs of 
     Federal regulatory programs by setting forth, for each year 
     covered by the statement--
       (I) the annual expenditure of national economic resources 
     for the regulatory program; and
       (II) such other quantitative and qualitative measures of 
     costs as the President considers appropriate.
       (ii) For purposes of the estimate of costs in the 
     accounting statement, national economic resources shall 
     include, and shall be listed under, at least the following 
     categories:
       (I) Private sector costs.
       (II) Federal sector administrative costs.
       (III) Federal sector compliance costs.
       (IV) State and local government administrative costs.
       (V) State and local government compliance costs.
       (VI) Indirect costs, including opportunity costs.
       (C) An accounting statement shall estimate the benefits of 
     Federal regulatory programs by setting forth, for each year 
     covered by the statement, such quantitative and qualitative 
     measures of benefits as the President considers appropriate. 
     Any estimates of benefits concerning reduction in health, 
     safety, or environmental risks shall present the most 
     plausible level of risk practical, along with a statement of 
     the reasonable degree of scientific certainty.
       (c) Associated Report to Congress.--
       (1) In general.--At the same time as the President submits 
     an accounting statement under subsection (b), the President, 
     acting through the Director of the Office of Management and 
     Budget, shall submit to Congress a report associated with the 
     accounting statement (hereinafter referred to as an 
     ``associated report''). The associated report shall contain, 
     in accordance with this subsection--
       (A) analyses of impacts; and
       (B) recommendations for reform.
       (2) Analyses of impacts.--The President shall include in 
     the associated report the following:
       (A) Analyses prepared by the President of the cumulative 
     impact of Federal regulatory programs covered in the 
     accounting statement on the following:
       (i) The ability of State and local governments to provide 
     essential services, including police, fire protection, and 
     education.
       (ii) Small business.
       (iii) Productivity.
       (iv) Wages.
       (v) Economic growth.
       (vi) Technological innovation.
       (vii) Consumer prices for goods and services.
       (viii) Such other factors considered appropriate by the 
     President.
       (B) A summary of any independent analyses of impacts 
     prepared by persons commenting during the comment period on 
     the accounting statement.
       (3) Recommendations for reform.--The President shall 
     include in the associated report the following:
       (A) A summary of recommendations of the President for 
     reform or elimination of any Federal regulatory program or 
     program element that does not represent sound use of national 
     economic resources or otherwise is inefficient.
       (B) A summary of any recommendations for such reform or 
     elimination of Federal regulatory programs or program 
     elements prepared by persons commenting during the comment 
     period on the accounting statement.
       (d) Guidance From Office of Management and Budget.--The 
     Director of the Office of Management and Budget shall, in 
     consultation with the Council of Economic Advisers, provide 
     guidance to agencies--
       (1) to standardize measures of costs and benefits in 
     accounting statements prepared pursuant to sections 3 and 7 
     of this Act, including--
       (A) detailed guidance on estimating the costs and benefits 
     of major rules; and
       (B) general guidance on estimating the costs and benefits 
     of all other rules that do not meet the thresholds for major 
     rules; and
       (2) to standardize the format of the accounting statements.
       (e) Recommendations From Congressional Budget Office.--
     After each accounting statement and associated report 
     submitted to Congress, the Director of the Congressional 
     Budget Office shall make recommendations to the President--
       (1) for improving accounting statements prepared pursuant 
     to this section, including recommendations on level of detail 
     and accuracy; and
       (2) for improving associated reports prepared pursuant to 
     this section, including recommendations on the quality of 
     analysis.

     SEC. 8. STUDIES AND REPORTS.

       (a) Risk Assessments.--The Administrative Conference of the 
     United States shall--
       (1) develop and carry out an ongoing study of the operation 
     of the risk assessment requirements of subchapter III of 
     chapter 6 of title 5, United States Code (as added by section 
     4 of this Act); and
       (2) submit an annual report to the Congress on the findings 
     of the study.
       (b) Administrative Procedure Act.--Not later than December 
     31, 1996, the Administrative Conference of the United States 
     shall--

[[Page S9280]]

       (1) carry out a study of the operation of the 
     Administrative Procedure Act (as amended by section 3 of this 
     Act); and
       (2) submit a report to the Congress on the findings of the 
     study, including proposals for revision, if any.

  Mr. DOLE. Mr. President, I again thank the Democratic leader, Senator 
Daschle.
  Mr. President, today we begin consideration of regulatory reform, one 
of the most important and fundamental reforms that this Congress will 
address. No doubt about it, the American people are fed up with a 
regulatory state that is out of control. That was one of the messages 
the American people delivered last November.
  The regulatory state has become so pervasive that it lies on our 
economy like a blanket, stifling innovation, and killing infant 
industries and small businesses before they get off the ground. 
Although the Federal Government has a department for just about 
everything else, it does not have a department of lost opportunities. 
And that is what this is all about--getting the Government off the 
backs of the American people; and letting them have an honest 
opportunity to succeed, for example, when they open a small business.
  I want to note at the outset that the reforms before us are the 
product of over a decade of bipartisan work. The first major attempt at 
regulatory reform took place here in the Senate in 1982, when we passed 
S. 1080 unanimously. S. 1080 itself grew out of a bill I introduced in 
1981, again with bipartisan support.
  S. 1080 contained sweeping revisions of the Administrative Procedures 
Act. Most of those revisions are included in the bill before us.
  S. 1080 imposed a requirement that major rules be subjected to cots-
benefit analyses. The structure of the cost-benefit analyses in the 
bill we consider today closely follow those in S. 1080.
  S. 1080 required judicial review of cost-benefit analyses in order to 
provide meaningful enforcement. The bill before us does the same.
  I have provided this brief history for two reasons. First, there are 
many Senators still in this body on both sides of the aisle who 
supported S. 1080 in 1982. And, second, there has been a concerted 
attempt by those who defend the status quo to ignore that history and 
act as if the bill under consideration today was a radically new 
approach with little thought for the consequences. Nothing could be 
further from the truth.
  Every President since President Nixon, including President Clinton, 
has issued an Executive order that imposed such requirements on 
agencies, though Executive orders are necessarily limited in scope and 
cannot provide for court enforcement, the bill we consider today draws 
on two decades of agency experience with those Executive orders.
  This bill is also the product of four major committees. I want to 
especially commend the chairmen of those committees, Senators Hatch, 
Roth, Murkowski, and Bond, and their members for their hard work. This 
bill is the product of negotiations with the Clinton administration, 
and Democrat colleagues. From the beginning, it has had bipartisan 
support. I especially want to commend Senator Heflin for his leadership 
in working on the bill in the Judiciary Committee. And, finally, the 
text of the bill we consider today is the product of weeks of work with 
Senator Johnston who has long championed reforms in risk assessment in 
this body.
  Given this history and broad bipartisan support, it might be 
surprising that regulatory reform has been met with often strident 
opposition.
  But this bill is about fundamental change--needed change--and those 
who defend the status quo will fight it tooth and nail. Apparently, 
they will do so without even pretending to read the legislation.
  Let me be clear: These reforms will not place at risk human health or 
safety or protection of the environment.
  I understand that Ralph Nader and Joan Claybrooke are out running ads 
in part of the country that Senator Dole, the majority leader, is for 
dirty meat, for unhealthy meat. So we have a lot of these incredible 
statements being made, but they have nothing to do with this bill.
  And the bill before us makes this explicit in any number of 
provisions. Those who argue otherwise should stop trying to scare 
people and take the time to actually read the bill.
  What opponents of regulatory reform really mean, but are embarrassed 
to admit, is that they believe that strong laws must always mean the 
most costly laws. Now, they will not say that of course. No, they will 
pay lip service to common sense. But as soon as you actually propose a 
way to consider costs and benefits, they switch subjects and accuse 
reformers of endangering human health and safety. I doubt anyone 
outside Washington, DC, who has to deal with regulations in their daily 
lives really believes that line anymore.
  Mr. President, I have enough faith in our ingenuity to believe that 
we can find better, smarter ways to achieve otherwise worthwhile goals.
  Nor--as opponents of reform would phrase it--is this a debate about 
placing a value on human life. The bill makes clear that there are 
often nonquantifiable benefits, and that an agency decisionmaker may 
well have to make judgments that are not subject to quantification. 
What the bill demands is accountability, by insisting that the 
decisionmaker articulate the basis for these judgments on the record. 
The principles of judging risks and weighing costs and benefits are 
rational and widely used in our daily lives. What is unacceptable is to 
allow Government agencies to avoid these types of judgments when 
enacting regulations that impose huge costs on our economy.
  These reforms are about limited government. For too long, 
decisionmakers in Washington, DC, have acted as though bigger 
government--taking more of our taxes and savings, and suppressing 
individual initiative--could exist without more coercion and more 
rules. But that is wrong. For 40 years, the number and scope of 
regulations have skyrocketed out of control. The costs and annoyances 
of regulations have grown unbearable. And what is worse: We have not 
even attempted to use common sense in order to determine whether the 
costs are worth it.
  These reforms are about accountability. Open government. Forcing the 
Government to tell the rest of us why it chooses to regulate a certain 
way, and making it defend its choice. This aspect of regulatory reform 
is not often discussed, but I would argue that it may be the most 
important of all.
  It has often been remarked by historians that the decline of great 
civilizations--such as ancient Rome--is typically marked by an 
overabundance of bureaucracy that relied on secret, often 
contradictory, rules. Eventually, the entire regulatory structure 
brings progress to a standstill and it collapses of its own weight. It 
is no accident that we described complex, inscrutable procedures as 
byzantine.
  Mr. President, we are a long way from reaching that point certainly. 
But we should understand that this is a battle that we will fight again 
and again. I, for one, intend to win this battle. The reforms we take 
up today are a giant step forward for common sense and our great 
country.
  So I am pleased that we are on the bill. I thank my colleagues on the 
other side for not objecting to moving to the bill. We will have a 
brief debate today. We will have a longer debate tomorrow and probably 
some debate on Friday of this week. Hopefully, when we return from the 
July 4 recess, we will be able to finish this bill in the week 
following the recess, because I think it is probably the most important 
legislation we will have considered so far this year.
  Mr. President, I would ask the distinguished Senator from Utah to be 
in charge of the time on this side. I guess Senator Johnston will be in 
charge of the time on that side.
  Mr. HATCH addressed the Chair.
  The PRESIDING OFFICER. The Senator from Utah.
  Mr. HATCH. How much time does this side have?
  The PRESIDING OFFICER. There are 20 minutes remaining.
  Mr. HATCH. I yield myself 7 minutes.
  Mr. President, today we begin the debate on one of the most important 
pieces of legislation this Congress will address this year: the 
Comprehensive Regulatory Reform Act of 1995. This is a bill that will 
change the way the Government does business.
  It is high time that we respond to the American people's loud and 
clear demands that government become smaller and more streamlined--
their demand 

[[Page S9281]]
that government become more responsive. It is high time that we realize 
just who is working for whom.
  The fact that government often takes forever to carry out its 
functions; spends a fortune in doing so; at best inconveniences 
citizens in the process; and yet still does not seem to get the job 
done properly, is reason enough for this legislation.
  It is high time that Congress acted to require government to act in a 
timely, sensible, and rational manner.
  If this bill becomes law, the Federal bureaucrats will, from now on, 
have to prove to America that their regulations do more good than harm 
to society.
  I submit that nothing could be more basic to our democracy and to our 
federal system of government than the notion that the Federal 
Government should only act when it helps people and when its actions 
are justified. That is just plain common sense, and that is what this 
bill is about.
  This bill forces the Federal bureaucracy to justify the costs of the 
rules and regulations that it places on hard-working Americans.


                         i. the need for reform

  I do not disagree that there is a need for some government 
regulation. Unfortunately, under the current system, there is little 
notion of restraint or balance in the way that government agencies 
operate. The Federal bureaucracy has become bloated, inefficient, and 
wasteful. Excessive, needless government regulation is running rampant. 
It has done tremendous damage to our economy, and it continues to do so 
every year.


                             a. statistics

  The bottom line is that American people pay for this bureaucracy 
several times over.
  First, of course, they have to pay for the salaries and other 
expenses for the Federal agencies to operate. These direct 
expenditures, of course, figure in to our budget. To the extent that 
such expenditures are not offset by cuts elsewhere, the cost of 
maintaining the Federal bureaucracy adds to the national deficit and to 
the national debt, which is already at about $18,500 for every man, 
woman, and child in America.
  Second, there are the hidden costs of complying with all this 
regulation. The American people have to pay to comply with the 
regulations the bureaucracy churns out. It has been estimated that 
complying with Federal regulation costs the average American family 
$4,000 a year. [The Heritage Foundation, citing Jonathan Adler, 
``Regulated . . . out of this world'', the Washington Times, June 3, 
1992].
  And that is the low estimate. If you include indirect costs--such as 
increased prices for goods and services because sellers are passing on 
some of their regulatory burden to buyers--some estimates run as high 
as $8,000 to $17,000 a year. [William Laffer, the Heritage Foundation].
  That is staggering, particularly when compared with the average 
annual income tax of $5,491 [IRS, 1992]. The costs of regulation are 
operating as a hidden tax on the system. Not only should that tax be 
cut, but the agencies should be made accountable so that the American 
people know what they are paying and what they are getting.
  Third, these costs have indirect consequences and impose opportunity 
costs. It has been estimated that the costs of Federal regulation have 
reduced the total output of the Nation, the GDP, by nearly 6 percent. 
[Thomas Hopkins, ``Costs of Regulation: Filling the Gaps,'' citing a 
study by Hazilla and Kopp]. How does this happen?
  It is simple enough. When businesses have to devote resources to 
meeting a Federal directive, alternative--and more productive--uses of 
those resources cannot be made. That means that the economy is slower, 
and jobs are lost because of regulatory excesses.
  Mr. President, the status quo is simply unacceptable. Federal 
regulation is stifling the American Dream. It used to be said that 
America was the land of opportunity, where the streets were paved with 
gold. Today, the streets are paved with redtape.


                              b. examples

  Where regulation is doing its jobs and is helping society, there is 
no problem. The supporters of beneficial regulations have nothing to 
fear from this bill. But, too often regulations not only fail to do the 
job, but also they are downright dumb. Those are the regulations that 
this bill seeks to eliminate.
  For example, there is a regulatory requirement that drive-through 
cash machines must be equipped with Braille pads. Now, how many blind 
Americans are driving cars to drive-through ATMs? [The Heritge 
Foundation, citing Insight which was quoting TCF Bank Savings of 
Minneapolis Chairman William Cooper]. That type of regulation is simply 
ridiculous on its face.
  In another instance, a rancher was fined $4,000 for killing a grizzly 
bear that had eaten his sheep previously and was attacking him. [The 
Heritage Foundation, citing a Wall Street Journal article by Ike 
Scrugg, dated June 23, 1993].
  What is worse is that excessive regulations have often thwarted the 
very ends those regulations seek to further. Take the case of the 
Abyssinian Baptist Church in Harlem. That church struggled for 4 years 
to get approval for a Head Start Program in a newly renovated building. 
Most of those 4 long years was spent arguing with Federal bureaucrats 
concerning the dimensions of rooms.
  Now, we do not want Head Start Programs in unsafe facilities. I agree 
with that. But, where is the common sense here? What exactly are we 
trying to do? Provide early childhood educational opportunities for 
low-income children? Or, keep regulators busy with their tape measures? 
Clearly, we failed at the former and were a great success in the 
latter. An entire generation of head starters were unable to 
participate in that valuable program.
  This is really a shameful waste of resources that could have been 
provided by this church in Harlem for the benefit of neighborhood 
children.
  A representative from the church complained about the 
unresponsiveness of the people in Washington.
  All the bureaucrats wanted to tell her, she said, was what could not 
be done rather than what could be done. She said that when she told 
them that they were talking about pieces of paper, and she was talking 
about children, they did not seem to care. [``The Death of Common 
Sense.''].
  Mr. President, I believe this particular example is an excellent 
illustration of how our regulatory system has gone haywire. It is hard 
to believe that regulators do not care about children and their access 
to Head Start or any other kind of service.
  But, this example clearly shows that our regulatory policy has become 
more concerned with process than with outcomes. It has become so
 obessed with the objective that room size not deviate an inch from the 
Federal standard that it has completely lost sight of what Head Start 
is supposed to accomplish.

  I have to believe that similar examples of form over substance exist 
at the Department of Labor, the EPA, the Interior Department, and just 
about every other Federal agency.
  Regulation has also reached deep into our smallest businesses. Take 
the case of Dutch Noteboom. Mr. Noteboom is 72 years old and has owned 
a small meat-packing plant in Springfield, OR, for 33 years.
  Despite the fact that Mr. Noteboom employs only four people, the U.S. 
Department of Agriculture has one full-time inspector on his premises. 
Another inspector spends over half his time there. This level of 
attention is astonishing and must be extremely costly.
  Mr. Noteboom says that he is swimming in paperwork, and that he does 
not even know a tenth of the rules. He says, ``You should see all these 
USDA manuals.'' [``The Death of Common Sense''].
  Well, I have seen some of the Government's manuals and regulations 
and they are shocking in their length and complexity.
  Consider, for example, the Federal regulations on the sale of 
cabbage. Now, the Gettysburg Address is 286 words in length, and the 
Declaration of Independence contain 1,322 words. But Government 
regulations on the sale of cabbage total an eye-popping 26,911 words. 
[Heritage, citing a letter from Congressman McIntosh to Grover 
Norquist].
  I am frankly wondering just how much there is to restrict about the 
sale of cabbage that would justify nearly 27,000 words. I had my staff 
do a quick 

[[Page S9282]]
calculation: 27,000 words is approximately the same length as the 
Federalist Papers Nos. 1 through 15. We have transformed regulatory 
compliance into an industry all by itself. We have gone from simple 
rules that reasonable people could understand and comply with to a Code 
of Federal Regulations that by itself takes up a whole wall of shelf 
space--not counting other agency guidance and field memos. We forget 
how fast is mount up.
  Could I ask how much time I have left?
  The PRESIDING OFFICER. The Senator has 11 minutes remaining.
  Mr. HATCH. I will yield 1 more minute to me, and the rest of my time 
to Senator Roth, after Senator Johnston finishes.
  Since 27,000 words is approximately the same length as the Federalist 
papers Nos. 1 through 15, how can there be any question that we have 
gone too far?
  Mr. President, Mr. Noteboom's story highlights another major mutation 
of U.S. regulatory policy.
  I can go on and on, but the point I am making is this: They are 
taking away our properties, our private properties, and interfering 
with small business. They are hurting people and stopping kids from 
getting the care they need. And, frankly, it is all because of 
ridiculous regulations in large part written by people who are not 
thinking about what is best for the American people and what is cost 
efficient in doing so. This bill will make a terrific difference. It 
will make our bureaucrats better and make us better. And, frankly, it 
is high time we did it.
  I want to compliment the distinguished Senator from Kansas, our 
majority leader, and also my good friend and colleague from Louisiana, 
who both worked long and hard to get together, and a whole raft of 
others. I will put their names in the Record by unanimous consent.
  Mr. President, I reserve the balance of our time.
  Mr. JOHNSTON addressed the Chair.
  The PRESIDING OFFICER. The Senator from Louisiana.


                         Privilege of the Floor

  Mr. JOHNSTON. I ask unanimous consent that Dr. Robert Simon be given 
the privilege of the floor for the pendency of S. 343 and any votes 
thereon.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. JOHNSTON. Mr. President, I want to thank my colleague, Mr. Hatch, 
as well as Senator Dole, and their staffs, and Senator Roth, and others 
on the other side of the aisle, for making this bill and the 
negotiation on it thus far a true bipartisan effort.
  The Judiciary Committee bill was, indeed, the product of last 
Congress' risk assessment legislation, which I sponsored, as well as S. 
1020, which dealt with regulatory reform from earlier in the 1980's. 
Since that time, Mr. President, the distinguished Senator from Kansas, 
Senator Dole, and I, worked together over a period of some 10 hours--
excuse me--12 hours of direct negotiation in working out what we called 
the Dole-Johnston draft, discussion draft. Since that was filed in the 
Record, we have spent an additional--or at least I have spent 20 hours 
in negotiation with both Republicans and Democrats, seeking to work out 
the problems in that draft.
  All of our problems have not yet been worked out. But if I may give 
my colleagues and others the state of play on it, I think the mood is 
there, the will is there, and I think eventually substantial agreement 
can be arrived at, dealing with nine major points:
  First, judicial review. The argument about judicial review is now not 
about the principle, it is about the language. I believe our language 
achieves the result. We will continue to listen, but I believe it 
achieves the result that everyone wishes.
  Supermandate has been eliminated from the bill. I believe that is 
also clear. And both sides agree that underlying statutes are not 
superseded. Whatever the requirements of the Clean Air Act are, for 
example, are still in place. And we believe that the language of the 
draft now reflects that. We are willing to work further to clarify 
that--not to clarify, but to reassure Senators that that is so.
  With respect to decisional criteria, Mr. President, I believe that 
from our side of the aisle the language now in the draft fully gives 
the discretion to the agencies that we wish.
  I call attention of my colleagues to the language of section 624, 
which states certain requirements, such as the benefits rule to justify 
the cost. But it goes on to say that if scientific, technical, or 
economic uncertainties or nonquantifiable benefits to the health or 
safety of the environment identified by the agency in the rulemaking 
record make a more costly alternative that achieves the objective of 
the statute appropriate and in the public interest, and the agency head 
provides an explanation of that, that they may chose the more costly 
alternative.
  Mr. President, we will listen to further elucidation on this.
  But it seems to me that this is a complete victory for those on our 
side of the aisle who have always said the difficulty with risk 
assessment is sometimes scientific uncertainty, where scientists do not 
agree in some areas, where the data is uncertain or where you have 
values that are nonquantifiable by their nature, such as the value of 
life, the value of good health, the value of environment, the value of 
clean air which are, by their nature, nonquantifiable.
  As I say, the theme, the idea is there, and I believe is clear. But 
to the extent it is not, we are certainly willing to negotiate, I 
believe, on both sides of the aisle. The question, again, is not 
whether to grant discretion for these things, but rather the question 
is how best to phrase the language.
  With respect to petition, appeal on that petition, sunset, 
consolidation, we believe, Mr. President, that we now have complete 
agreement on that. It covers the issue of agency overload, and we will 
soon be filing in the Record language that will reflect that agreement. 
Anything, of course, is subject to further wordsmithing, but we believe 
both Democrats and Republicans have arrived at a decision in that very 
difficult area.
  With respect to effective date, I hope we can come to agreement on 
that. On the Democratic side, we do not want to have to go back and 
redo regulations which have, in some cases, been 2 or 3 years in the 
making. On the Republican side, the concern has been that they do not 
want to have a flood of new regulations come in at the last minute to 
escape the requirements of this bill. I believe effective date can be 
appropriately worked out and pick some date such as July 1 of this 
year.
  With respect to threshold, I believe the threshold should be 100 
million, and 50 million is now in the bill. I believe also that is a 
doable thing. My prediction is that we will end up agreeing on 100 
million with some language with respect to small business because small 
business has really been a concern here. At least I am in good hopes we 
can agree on that.
  I hope we can agree to drop Superfund at some point. Not that anybody 
thinks a process of risk assessment should not be applicable to 
Superfund, it should definitely be applicable to Superfund, but we 
believe that is best done by the Environment and Public Works 
Committee, working their will against special requirements of the 
Superfund site. To put it in this bill, I believe, would be very 
difficult.
  With respect to toxic release inventory, the language now in the 
Dole-Johnston draft, I believe, can be much improved. It, in turn, was 
an improvement over the Judiciary Committee draft. Frankly, we are 
waiting for some kind of improvement language that we hope will solve 
this problem.
  Toxic release inventory is a high-profile issue, but I believe, in 
terms of importance of the issue, it is clearly one of the lesser 
issues in this bill and should not stand in our way of getting a bill.
  The final point I have has to do with the Delaney rule. We greatly 
improve the Judiciary Committee draft on the Delaney rule. The language 
now in the Dole-Johnston draft says that an administrator or an agency 
head cannot fail to license a chemical if it has negligible or 
insignificant foreseeable risk to human health resulting from its 
intended use. It seems to me that this ought to be the standard. It is 
a good standard. I have heard no defense of keeping the Delaney rule as 
it is, and I submit that the votes will be on the floor to change the 
Delaney rule.
  Our request is that those who think the standard we have in this 
draft is not appropriate should come up with 

[[Page S9283]]
alternative language which we are happy to consider. We have given 
notice of consideration of alternative language now for a week or two, 
and I have not yet received it. So I urge people who want that to be 
reconsidered to please submit language.
  The point I am making, Mr. President, is that the most difficult 
things about this bill--things like decisional criteria, judicial 
review, supermandate--have been agreed upon in principle, and the 
problem now is to determine language that carries out the principle.
  We all understand that language and wordsmithing in this area is very 
important, is crucial, is critical, and we will continue to negotiate 
to seek very precise language that carries this out, and we solicit 
that from both sides of the aisle.
  But, Mr. President, frankly, given the attitudes on both sides of the 
aisle, I believe it is going to be possible to come to those 
agreements, not with all Senators. We are not going to get 100 votes, 
but I believe that there is a real possibility for a broad consensus, 
and I am happy to be part of the group that is putting together what I 
consider to be the most important bill in this field that has ever been 
enacted by the Congress.
  Mr. President, I reserve the remainder of my time.
  Mr. ROTH addressed the Chair.
  The PRESIDING OFFICER. Who yields time? The Senator from Delaware.
  Mr. HATCH. I yield the remainder of our time to the Senator from 
Delaware.
  The PRESIDING OFFICER. There are 9 minutes 51 seconds remaining.
  Mr. ROTH. Mr. President, first of all, I would like to thank the 
distinguished Senator from Louisiana for the constructive role he has 
played in the effort to bring the two sides together. Like him, I am 
optimistic that we are going to be able to fashion legislation that 
will satisfy the large majority on both sides of the aisle.
  I, frankly, can think of no legislation of more critical importance, 
both from the standpoint of enforcement of the legislation or statutes 
on the books, but also from getting a better bang for the taxpayers' 
buck. So, again, I congratulate and thank the distinguished Senator for 
his contribution.
  Mr. President, today marks a milestone in the effort to build a 
smarter, more effective regulatory process. From all quarters, 
Americans are calling for change from the often overbearing and 
counterproductive regulatory monolithic that has grown out of control 
these past couple of decades. President Clinton has admitted that many 
regulations, regulations that are costing our Nation billions of 
dollars, are bad regulations.
  George McGovern has described in brilliant detail how overbearing 
regulations put him out of business when all he was trying to fulfill 
was the dream of being an entrepreneur of owning his own New England 
inn.
  Economists are telling us that Federal regulations are costing our 
households some $6,000 annually, costing our country about $600 billion 
a year, and this at a time when our policies must be those that make 
our Nation competitive abroad, economically secure at home and 
confident within our families.
  Financial costs are not the only burden. As we move further into the 
information age, the old adage, ``Time is money,'' rings truer than 
ever before. Time alone is becoming one of America's most vital 
economic resources. In a competitive world of instant information, a 
world where time is measured in cyberseconds, businesses, 
entrepreneurs, service providers, researchers, scientists, farmers, and 
others must be able to accelerate their response time in providing 
their services and bringing new products to market.
  In our age of information, time is often the difference between 
profit and loss. But today, Federal regulations, like cholesterol 
clogging a vital artery, not only slow down the process but often 
disrupts it. Well over 5 billion hours--I repeat--well over 5 billion 
hours a year are spent by our private sector just trying to meet 
government paperwork demands.
  The legislation we are considering today, S. 343, the comprehensive 
regulatory reform act of 1995, is a real and workable solution to the 
problems being expressed on both sides of the aisle. That is why I am 
supporting this legislation. It is the most comprehensive reform of the 
regulatory process since the enactment of the Administrative Procedure 
Act of 1946. Since then, efforts to reform Federal regulations have 
been like a man trying to save himself by running up the aisle in the 
opposite direction on a runaway train. What this legislation does, Mr. 
President, is get that runaway train under control and places it back 
on the right track.
  This legislation substantially changes the requirements for the 
issuance of Federal regulations. It requires regulators to directly 
consider whether the benefits of a new regulation would justify its 
cost. Regulators who want to issue environmental and health and safety 
regulation regulations under this legislation have to make realistic 
estimates of the risks to be addressed. They have to disclose to the 
public any assumptions they make to measure the risk.
  The bill encourages agencies to set priorities to achieve the 
greatest overall risk reduction at the least cost. More generally, this 
bill requires agencies to review existing regulations, to be sensitive 
to the cumulative regulatory burden, and to select the most cost 
effective, market-driven method feasible.
  This, Mr. President, is smarter regulation. Smarter regulation 
benefits us all--our farmers, our businesses of all sizes; it benefits 
State and local government, and, most important, it benefits the 
consumer, the wage earner, the taxpayer, and the family.
  I support this legislation because it is a reform of Federal 
regulations, not a rollback. And the distinction is extremely 
important. I am an environmentalist and honored to be called an 
environmentalist. On this floor, I have fought many battles to stop 
ocean dumping and incineration, to preserve the northern coastal plain 
of Alaska, to protect forests and precious wildlife. I can say with 
pride that Federal regulations have made our air cleaner. They have 
made our water purer, and they have improved conditions in our cities, 
lakes, and along our shores.
  Regulation in itself is not bad. The problem is that the huge 
regulatory enterprise, like that runaway train, has gained so much 
inertia these past few decades that it is posing a real and dangerous 
threat to our future. What we are looking for is balance, and this 
legislation provides that balance. It will restore common sense to the 
regulatory process.
  This legislation helps us achieve necessary regulation in the most 
flexible and cost-effective way possible. We have learned with 
experience that regulations often have been more costly and less 
effective than they could have been. This legislation addresses that 
problem by making Government more efficient, more effective. I believe, 
as best they can, regulators should issue regulations whose benefits 
justify their cost. I believe that a fair, commonsense test requiring 
that the benefits of a regulation justify its cost should be consistent 
with environmentalism, not contrary to it.
  Environmentalists and conservationists have long recognized that we 
live in a world of limited resources. In this vein, we must use those 
limited resources to achieve the greatest benefit at the least cost. 
This is absolutely consistent with our objectives.
  Throughout my career, Mr. President, I have advocated reducing 
Government waste and inefficiency. I have led efforts to reduce waste 
in Government procurement practices, particularly in defense contracts. 
At the time, some critics suggested that I was undermining support for 
a strong military. How could I support a strong military, they asked, 
if I challenged the practices of the Department of Defense? The answer 
was simple. I pushed for reform to make the Department of Defense work 
better, reform to make it more efficient and effective in carrying out 
its mission. And toward this end, we have been successful. Our reform 
of the procurement process improved the department. DOD was 
strengthened as precious resources were spared to be used much more 
efficiently and effectively.
  In the same way, as a committed environmentalist, I want to reduce 
the inefficiency of the Environmental Protection Agency as well as 
other Federal 

[[Page S9284]]
agencies that serve the public interest. Some critics suggest that we 
cannot support strong cost benefit analysis, and the Dole-Johnston 
compromise bill requires and still favors protecting the environment, 
health and safety, but these critics are wrong. Without effective 
regulatory reform, the EPA and other agencies will not carry out their 
mission in an efficient and effective manner.
  Mr. President, this legislation simply requires commonsense in the 
regulatory process. We should require no less. I urge my colleagues to 
support this commonsense legislation. Thank you, Mr. President.
  Mr. JOHNSTON. Mr. President, I yield 10 minutes to the Senator from 
Ohio, with the understanding that he will yield some time to Senator 
Levin.
  The PRESIDING OFFICER. The Senator from Louisiana has 13 minutes 
total remaining.
  The Senator from Ohio is recognized.
  Mr. GLENN. Mr. President, I hope that when the press writes about 
what happened on the floor today, they get away from the idea that this 
is the ultimate in confrontation, which seems to be what the questions 
lead to when we go out of the Chamber--talking about regulatory 
reform--because, today, I would hope the message would go out that we 
are united in the Senate of the United States, Democrat and Republican, 
on one thing: we need regulatory reform.
  Sometimes we get strident here and give people the wrong impression. 
But we have a need for regulatory reform, and that is felt by those who 
have been negotiating on the particulars of this legislation over the 
past several days. So the importance of regulatory reform is well 
understood, and we all share in a devotion to what we are trying to do 
here.
  I think a lot of people wonder why we have regulations and rules. We 
need to remember that we pass laws here on the Senate floor, in the 
Congress, that are signed by the President requiring agencies to issue 
rules. After we pass laws, rules and regulations written by the 
agencies become applicable in every community across this country.
  I say to those listening that your children today, your family today, 
can have milk that is safe because of rules and regulations. You can 
eat food that is safe. You do not have to worry about it, because of 
rules and regulations to ensure safety to public health. 
Transportation, whether by air, bus, or plane, comes under certain 
rules and regulations that let your family travel safely.
  The problem is that we have gone too far in some of these matters 
with some rules, and some regulation writers have been overzealous.
  So we have come full circle in needing to put a rein on some of the 
rules and regulations. We need to set up new processes for making sure 
that we do not get into the quagmires of where we do not use common 
sense. Some of them are ridiculous. We can all cite anecdotal evidence.
  On the Governmental Affairs Committee, we started working on what was 
landmark regulatory reform, doing a study back in 1977. This issue is 
not something that is brand new. Through the years, we dealt with OMB 
and OIRA, and it has been an open process.
  While I was chair of the committee, we had a number of hearings, and 
this year, Senator Roth, our chairman this year, has had four hearings 
on our bill, S. 291. We took a bipartisan and deliberative approach to 
it and voted that bill out of committee, unanimously, 15-0. Republicans 
and Democrats united together.
  Any bill must have a balance. On the Governmental Affairs Committee, 
I believe we achieved that balance. I would like to run through very 
briefly some of the central issues for regulatory reform in the limited 
time I have here today.
  My approach, and the approach taken by our committee, on regulatory 
reform is the following: First, agencies should be required to perform 
risk assessment and cost-benefit analysis for all major rules; second, 
cost-benefit analysis should inform agency decisionmaking, but it 
should not override other statutory rulemaking criteria; third, risk 
assessment requirements should apply only to major risk assessments, 
and these requirements must not be overly prescriptive; fourth, 
agencies should review existing rules, but the reviews should not be 
dictated by special interests; fifth, Government accountability 
requires sunshine in the regulatory review process; sixth, judicial 
review should be available to ensure the final agency rules are based 
on adequate analysis; it should not be a lawyer's dream with unending 
ways for special interest to bog down agencies with litigation; 
seventh, regulatory reform should not be the fix for every special 
interest.
  Now, Mr. President, the Senator from Louisiana mentioned a number of 
the areas that are still in contention with this legislation. While we 
will have to work these issues out, we are all united in the need for 
regulatory reform.
  The decision criteria: Will it be least cost, or will it be the cost 
effectiveness? Judicial reform has yet to be ironed out completely. Can 
we get a threshold of $100 million? How about the petition process, the 
sunset, special interest additions? These are issues we still need to 
work together on. We have yet to iron out exactly how we do these 
things.
  Mr. President, any bill on the subject of regulatory reform to be 
deserving of support must pass a test. This test is twofold. I close 
with this: No. 1, does the bill provide for reasonable, logical, 
appropriate changes to regulatory procedures that eliminate unnecessary 
burdens on businesses and individuals? No. 2, at the same time, does 
the bill maintain the ability to protect the health, the safety, and 
the environment of the American people?
  Now, that is a dual test that is very simple, and one we need to keep 
in mind as we debate this legislation. If the answer is ``yes,'' to 
both questions, the bill should be supported. Any bill that relieves 
regulatory burdens but threatens the protections for the American 
people in health or safety or environment should be opposed.
  I will come back to this test many times when we debate regulatory 
reform the rest of this week and after the Fourth of July break.
  I thank my colleague from Louisiana for yielding time. I yield the 
balance of my time to Senator Levin.
  The PRESIDING OFFICER. The Senator from Michigan has 6 minutes 
remaining.
  Mr. LEVIN. Let me commend all those involved in this effort. It is a 
very complicated effort, and most importantly perhaps, an essential and 
bipartisan effort. It has been that way from the beginning. I hope it 
stays that way throughout this process.
  The original bill which was introduced was flawed. It did not achieve 
both goals we need to achieve, which is regulatory reform, to make this 
process more responsive to cost, to allow Members to review rules. We 
all, I hope, want to do that.
  We all, I hope, want cost effective rules. We all, I hope, want to 
try to protect some basic health, safety, and environmental concerns. 
And I think we all believe that we can achieve all of that.
  The original bill which was introduced in the bill that is now 
pending had some real limitations in those regards. The Senator from 
Louisiana and the Senator leader, the majority leader, and people on 
both sides of the aisle worked to come up with a substitute. I think 
they made some significant progress. They should be commended for it.
  After that happened, there were a number of deficiencies that were 
pointed out by various people--the Senator from Louisiana and others 
who were open to the process of considering suggestions to improve 
their product--and we have made some significant progress in our 
private discussions to improve the so-called Dole-Johnston substitute.
  Right now, assuming that the language is agreed upon, even though we 
have only reached two or three of the key nine issues, there has been 
some significant changes in that draft, which I think most of the 
people that have been involved in these negotiations, say represent 
improvements.
  Now, there are still some outstanding issues. For instance, the 
majority leader and others have said ``We don't want a supermandate.'' 
This bill is intended to supplement and not to supersede.
  Some have raised the question, what happens if the material in this 
bill, which is intended to supplement, conflicts with what it is 
intended not to supersede. Then what? 

[[Page S9285]]

  We are assured that the underlying legislation governs. Some have 
said ``Why don't we just simply say that?'' The answer has been, 
``There is no need to because there is no conflict,'' yet the concern 
remains, and we are trying to figure out language which will address 
the concern of those who want to be sure that what the Republican 
leader says is the intent, the majority leader says is the intent--that 
there not be a supermandate, in fact, implemented in this bill.
  We made some real progress in the so-called petitions area. Before 
this progress was made, I am afraid we were going to substitute a 
judicial quagmire for what is already a complicated regulatory process.
  Nobody is benefited if we throw to the drowning folks who are 
drowning in regulations another bucket of water. What they need is a 
lifeline, not another complicating superstructure of judicial 
consideration.
  That is what I am afraid we were about to do in the so-called 
petition area, until we had some very fruitful discussions, which have 
now, I think, reached a point where we can hope to avoid adding a 
judicial superstructure of huge complication to a regulatory process.
  Mr. President, I am glad that these discussions are going to 
continue. I want to commend, particularly, Senator Glenn, Senator Roth, 
others on the Governmental Affairs Committee who have worked on the 
Governmental Affairs bill which contained so many elements of the bill 
which we are going to consider during the days that we do consider 
regulatory reform.
  We need regulatory reform. We must have cost benefit analysis. We 
need risk assessment. But we also need to be sure that what we are 
achieving protects, in a sensible way, the environment and the health 
and the safety of the people of the United States.
  Some people say, ``Why don't you just have the cheapest regulation 
automatically?'' Well, the answer is because the cheapest may not be 
the most cost effective. Just like the cheapest pair of shoes is not 
the sensible pair of shoes. The cheapest car is not the best car to 
buy, or else we would all be driving Yugos.
  We need cost-benefit analysis, but that assumes that something which 
is slightly more costly might have huge benefits, and in that case we 
surely want to be able to consider the cost effectiveness of the 
regulation and not be required to always go with what is the cheapest, 
because that may not be the most cost effective.
  I think there is kind of an understanding, almost a consensus that 
that is correct; that we do not want to be driven always to the 
cheapest, that a marginal increase might be sensible and might achieve 
some great benefits and that ought to be permitted under this process.
  Let me close by again commending my colleagues on Governmental 
Affairs, Senators Glenn and Roth and others; the majority leader and 
Senator Daschle have been critical in this, Senator Johnston, Senator 
Hatch, and others--so many who have been involved in getting us where 
we are today. We are making progress. I hope that progress will be 
allowed to continue and will not be thwarted in any way that is 
inconsistent with what our common goal is.
  I thank the Chair.
  The PRESIDING OFFICER. The Senator from Louisiana is recognized. All 
time has expired.
  Mr. JOHNSTON. Mr. President, I ask unanimous consent I be able to 
proceed for 2 minutes.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. JOHNSTON. Mr. President, I commend my colleagues on this side of 
the aisle who have been involved in this negotiation, particularly 
Senator Levin, Senator Glenn, Senator Biden, Senator Baucus, Senator 
Kerrey, and Senator Lautenberg especially, who have contributed so much 
in bringing the draft up to where it is now.
  As I say, it is not a done deal yet in terms of satisfying everyone's 
concerns, but it is much, much closer to that than when the Judiciary 
Committee bill started out.
  Mr. President, I am advised it is the majority leader's intention 
Friday afternoon to withdraw the committee amendments to S. 343 and 
send the substitute to the desk. That substitute is, in effect, the 
Dole-Johnston discussion draft filed a few days ago, which is being 
supplemented by the agreement identified by myself and Senator Levin, 
and with other modifications which we have worked on during these 
hours.
  So I ask unanimous consent that be printed in the Record tonight, 
when submitted to the Chair.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

       On page 33, beginning with line 5, strike all through the 
     end of the bill and insert the following:
     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Comprehensive Regulatory 
     Reform Act of 1995''.

     SEC. 2. DEFINITIONS.

       Section 551 of title 5, United States Code, is amended--
       (1) in the matter preceding paragraph (1), by striking 
     ``this subchapter'' and inserting ``this chapter and chapters 
     7 and 8'';
       (2) in paragraph (13), by striking ``and'';
       (3) in paragraph (14), by striking the period at the end 
     and inserting ``; and''; and
       (4) by adding at the end the following new paragraph:
       ``(15) `Director' means the Director of the Office of 
     Management and Budget.''.

     SEC. 3. RULEMAKING.

       Section 553 of title 5, United States Code, is amended to 
     read as follows:

     ``Sec. 553. Rulemaking

       ``(a) Applicability.--This section applies to every 
     rulemaking, according to the provisions thereof, except to 
     the extent that there is involved--
       ``(1) a matter pertaining to a military or foreign affairs 
     function of the United States;
       ``(2) a matter relating to the management or personnel 
     practices of an agency;
       ``(3) an interpretive rule, general statement of policy, 
     guidance, or rule of agency organization, procedure, or 
     practice, unless such rule, statement, or guidance has 
     general applicability and substantially alters or creates 
     rights or obligations of persons outside the agency; or
       ``(4) a rule relating to the acquisition, management, or 
     disposal by an agency of real or personal property, or of 
     services, that is promulgated in compliance with otherwise 
     applicable criteria and procedures.
       ``(b) Notice of Proposed Rulemaking.--General notice of 
     proposed rulemaking shall be published in the Federal 
     Register, unless all persons subject thereto are named and 
     either personally served or otherwise have actual notice of 
     the proposed rulemaking in accordance with law. Each notice 
     of proposed rulemaking shall include--
       ``(1) a statement of the time, place, and nature of public 
     rulemaking proceedings;
       ``(2) a succinct explanation of the need for and specific 
     objectives of the proposed rule, including an explanation of 
     the agency's determination of whether or not the rule is a 
     major rule within the meaning of section 621(5);
       ``(3) a succinct explanation of the specific statutory 
     basis for the proposed rule, including an explanation of--
       ``(A) whether the interpretation is clearly required by the 
     text of the statute; or
       ``(B) if the interpretation is not clearly required by the 
     text of the statute, an explanation that the interpretation 
     is within the range of permissible interpretations of the 
     statute as identified by the agency, and an explanation why 
     the interpretation selected by the agency is the agency's 
     preferred interpretation;
       ``(4) the terms or substance of the proposed rule;
       ``(5) a summary of any initial analysis of the proposed 
     rule required to be prepared or issued pursuant to chapter 6;
       ``(6) a statement that the agency seeks proposals from the 
     public and from State and local governments for alternative 
     methods to accomplish the objectives of the rulemaking that 
     are more effective or less burdensome than the approach used 
     in the proposed rule; and
       ``(7) a statement specifying where the file of the 
     rulemaking proceeding maintained pursuant to subsection (j) 
     may be inspected and how copies of the items in the file may 
     be obtained.
       ``(c) Period for Comment.--The agency shall give interested 
     persons not less than 60 days after providing the notice 
     required by subsection (b) to participate in the rulemaking 
     through the submission of written data, views, or arguments.
       ``(d) Good Cause Exception.--Unless notice or hearing is 
     required by statute, a final rule may be adopted and may 
     become effective without prior compliance with subsections 
     (b) and (c) and (e) through (g) if the agency for good cause 
     finds that providing notice and public procedure thereon 
     before the rule becomes effective is impracticable, 
     unnecessary, or contrary to the public interest. If a rule is 
     adopted under this subsection, the agency shall publish the 
     rule in the Federal Register with the finding and a succinct 
     explanation of the reasons therefor.
       ``(e) Procedural Flexibility.--To collect relevant 
     information, and to identify and elicit full and 
     representative public comment on the significant issues of a 
     particular rulemaking, the agency may use such other 
     procedures as the agency determines are appropriate, 
     including--
       ``(1) the publication of an advance notice of proposed 
     rulemaking;

[[Page S9286]]

       ``(2) the provision of notice, in forms which are more 
     direct than notice published in the Federal Register, to 
     persons who would be substantially affected by the proposed 
     rule but who are unlikely to receive notice of the proposed 
     rulemaking through the Federal Register;
       ``(3) the provision of opportunities for oral presentation 
     of data, views, information, or rebuttal arguments at 
     informal public hearings, meetings, and round table 
     discussions, which may be held in the District of Columbia 
     and other locations;
       ``(4) the establishment of reasonable procedures to 
     regulate the course of informal public hearings, meetings and 
     round table discussions, including the designation of 
     representatives to make oral presentations or engage in 
     direct or cross-examination on behalf of several parties with 
     a common interest in a rulemaking, and the provision of 
     transcripts, summaries, or other records of all such public 
     hearings and summaries of meetings and round table 
     discussions;
       ``(5) the provision of summaries, explanatory materials, or 
     other technical information in response to public inquiries 
     concerning the issues involved in the rulemaking; and
       ``(6) the adoption or modification of agency procedural 
     rules to reduce the cost or complexity of the procedural 
     rules.
       ``(f) Planned Final Rule.--If the provisions of a final 
     rule that an agency plans to adopt are so different from the 
     provisions of the original notice of proposed rulemaking that 
     the original notice did not fairly apprise the public of the 
     issues ultimately to be resolved in the rulemaking or of the 
     substance of the rule, the agency shall publish in the 
     Federal Register a notice of the final rule the agency plans 
     to adopt, together with the information relevant to such rule 
     that is required by the applicable provisions of this section 
     and that has not previously been published in the Federal 
     Register. The agency shall allow a reasonable period for 
     comment on such planned final rule prior to its adoption.
       ``(g) Statement of Basis and Purpose.--An agency shall 
     publish each final rule it adopts in the Federal Register, 
     together with a concise statement of the basis and purpose of 
     the rule and a statement of when the rule may become 
     effective. The statement of basis and purpose shall include--
       ``(1) an explanation of the need for, objectives of, and 
     specific statutory authority for, the rule;
       ``(2) a discussion of, and response to, any significant 
     factual or legal issues presented by the rule, or raised by 
     the comments on the proposed rule, including a description of 
     the reasonable alternatives to the rule proposed by the 
     agency and by interested persons, and the reasons why such 
     alternatives were rejected;
       ``(3) a succinct explanation of whether the specific 
     statutory basis for the rule is expressly required by the 
     text of the statute, or if the specific statutory 
     interpretation upon which the rule is based is not expressly 
     required by the text of the statute, an explanation that the 
     interpretation is within the range of permissible 
     interpretations of the statute as identified by the agency, 
     and why the agency has rejected other interpretations 
     proposed in comments to the agency;
       ``(4) an explanation of how the factual conclusions upon 
     which the rule is based are substantially supported in the 
     rulemaking file; and
       ``(5) a summary of any final analysis of the rule required 
     to be prepared or issued pursuant to chapter 6.
       ``(h) Nonapplicability.--In the case of a rule that is 
     required by statute to be made on the record after 
     opportunity for an agency hearing, sections 556 and 557 shall 
     apply in lieu of subsections (c), (e), (f), and (g).
       ``(i) Effective Date.--An agency shall publish the final 
     rule in the Federal Register not later than 60 days before 
     the effective date of such rule. An agency may make a rule 
     effective in less than 60 days after publication in the 
     Federal Register if the rule grants or recognizes an 
     exemption, relieves a restriction, or if the agency for good 
     cause finds that such a delay in the effective date would be 
     contrary to the public interest and publishes such finding 
     and an explanation of the reasons therefor, with the final 
     rule.
       ``(j) Rulemaking File.--(1) The agency shall maintain a 
     file for each rulemaking proceeding conducted pursuant to 
     this section and shall maintain a current index to such file.
       ``(2) Except as provided in subsection (k), the file shall 
     be made available to the public not later than the date on 
     which the agency makes an initial publication concerning the 
     rule.
       ``(3) The rulemaking file shall include--
       ``(A) the notice of proposed rulemaking, any supplement to, 
     or modification or revision of, such notice, and any advance 
     notice of proposed rulemaking;
       ``(B) copies of all written comments received on the 
     proposed rule;
       ``(C) a transcript, summary, or other record of any public 
     hearing conducted on the rulemaking;
       ``(D) copies, or an identification of the place at which 
     copies may be obtained, of factual and methodological 
     material that pertains directly to the rulemaking and that 
     was considered by the agency in connection with the 
     rulemaking, or that was submitted to or prepared by or for 
     the agency in connection with the rulemaking; and
       ``(E) any statement, description, analysis, or other 
     material that the agency is required to prepare or issue in 
     connection with the rulemaking, including any analysis 
     prepared or issued pursuant to chapter 6.

     The agency shall place each of the foregoing materials in the 
     file as soon as practicable after each such material becomes 
     available to the agency.
       ``(k) Confidential Treatment.--The file required by 
     subsection (j) need not include any material described in 
     section 552(b) if the agency includes in the file a statement 
     that notes the existence of such material and the basis upon 
     which the material is exempt from public disclosure under 
     such section. The agency may not substantially rely on any 
     such material in formulating a rule unless it makes the 
     substance of such material available for adequate comment by 
     interested persons. The agency may use summaries, 
     aggregations of data, or other appropriate mechanisms to 
     protect the confidentiality of such material to the maximum 
     extent possible.
       ``(l) Rulemaking Petition.--(1) Each agency shall give an 
     interested person the right to petition--
       ``(A) for the issuance, amendment, or repeal of a rule;
       ``(B) for the amendment or repeal of an interpretive rule 
     or general statement of policy or guidance;
       ``(C) for an interpretation regarding the meaning of a 
     rule, interpretive rule, general statement of policy, or 
     guidance; and
       ``(D) for a variance or exemption from the terms of a rule 
     to which the petitioner is otherwise subject, provided the 
     statute authorizing the rule does not prohibit a variance or 
     exemption.
       ``(2) The agency shall grant or deny a petition made 
     pursuant to paragraph (1), and give written notice of its 
     determination to the petitioner, with reasonable promptness, 
     but in no event later than 18 months after the petition was 
     received by the agency.
       ``(3) The written notice of the agency's determination 
     shall include an explanation of the determination and a 
     response to each significant factual and legal claim that 
     forms the basis of the petition.
       ``(m) Judicial Review.--(1) The decision of an agency to 
     use or not to use procedures in a rulemaking under subsection 
     (e) shall not be subject to judicial review.
       ``(2) The rulemaking file required under subsection (j) 
     shall constitute the rulemaking record for purposes of 
     judicial review.
       ``(3) No court shall hold unlawful or set aside an agency 
     rule based on a violation of subsection (j), unless the court 
     finds that such violation has precluded fair public 
     consideration of a material issue of the rulemaking taken as 
     a whole.
       ``(4)(A) Judicial review of compliance or noncompliance 
     with subsection (j) shall be limited to review of action or 
     inaction on the part of an agency.
       ``(B) A decision by an agency to deny a petition under 
     subsection (l) shall be subject to judicial review 
     immediately upon denial, as final agency action under the 
     statute granting the agency authority to carry out its 
     action.
       ``(n) Construction.--(1) Notwithstanding any other 
     provision of law, this section shall apply to and supplement 
     the procedures governing informal rulemaking under statutes 
     that are not generally subject to this section.
       ``(2) Nothing in this section authorizes the use of 
     appropriated funds available to any agency to pay the 
     attorney's fees or other expenses of persons intervening in 
     agency proceedings.''.

     SEC. 4. ANALYSIS OF AGENCY RULES.

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

               ``SUBCHAPTER II--ANALYSIS OF AGENCY RULES

     ``Sec. 621. Definitions

       ``For purposes of this subchapter--
       ``(1) except as otherwise provided, the definitions under 
     section 551 shall apply to this subchapter;
       ``(2) the term `benefit' means the reasonably identifiable 
     significant favorable effects, including social, 
     environmental, health, and economic effects, that are 
     expected to result directly or indirectly from implementation 
     of a rule or other agency action;
       ``(3) the term `cost' means the reasonably identifiable 
     significant adverse effects, including social, environmental, 
     health, and economic effects that are expected to result 
     directly or indirectly from implementation of a rule or other 
     agency action;
       ``(4) the term `cost-benefit analysis' means an evaluation 
     of the costs and benefits of a rule, quantified to the extent 
     feasible and appropriate and otherwise qualitatively 
     described, that is prepared in accordance with the 
     requirements of this subchapter 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;
       ``(5) the term `major rule' means--
       ``(A) a rule or set of closely related rules that the 
     agency proposing the rule, the Director, or a designee of the 
     President determines is likely to have a gross annual effect 
     on the economy of $50,000,000 or more in reasonably 
     quantifiable increased costs; or
       ``(B) a rule that is otherwise designated a major rule by 
     the agency proposing the rule, the Director, or a designee of 
     the President 

[[Page S9287]]
     (and a designation or failure to designate under this clause shall not 
     be subject to judicial review);
       ``(6) the term `market-based mechanism' means a regulatory 
     program that--
       ``(A) imposes legal accountability for the achievement of 
     an explicit regulatory objective on each regulated person;
       ``(B) affords maximum flexibility to each regulated person 
     in complying with mandatory regulatory objectives, which 
     flexibility shall, where feasible and appropriate, include, 
     but not be limited to, the opportunity to transfer to, or 
     receive from, other persons, including for cash or other 
     legal consideration, increments of compliance responsibility 
     established by the program; and
       ``(C) permits regulated persons to respond to changes in 
     general economic conditions and in economic circumstances 
     directly pertinent to the regulatory program without 
     affecting the achievement of the program's explicit 
     regulatory mandates;
       ``(7) the term `performance-based standards' means 
     requirements, expressed in terms of outcomes or goals rather 
     than mandatory means of achieving outcomes or goals, that 
     permit the regulated entity discretion to determine how best 
     to meet specific requirements in particular circumstances;
       ``(8) the term `reasonable alternatives' means the range of 
     reasonable regulatory options that the agency has authority 
     to consider under the statute granting rulemaking authority, 
     including flexible regulatory options of the type described 
     in section 622(c)(2)(C)(iii), unless precluded by the statute 
     granting the rulemaking authority; and
       ``(9) the term `rule' has the same meaning as in section 
     551(4), and--
       ``(A) includes any statement of general applicability that 
     substantially alters or creates rights or obligations of 
     persons outside the agency; and
       ``(B) does not include--
       ``(i) a rule that involves the internal revenue laws of the 
     United States, or the assessment and collection of taxes, 
     duties, or other revenues or receipts;
       ``(ii) subject to section 633(c)(6), a rule or agency 
     action that implements a treaty or international trade 
     agreement to which the United States is a party;
       ``(iii) a rule or agency action that authorizes the 
     introduction into commerce, or recognizes the marketable 
     status, of a product;
       ``(iv) a rule exempt from notice and public procedure under 
     section 553(a);
       ``(v) a rule or agency action relating to the public debt;
       ``(vi) a rule required to be promulgated at least annually 
     pursuant to statute, or that provides relief, in whole or in 
     part, from a statutory prohibition, other than a rule 
     promulgated pursuant to subtitle C of title II of the Solid 
     Waste Disposal Act (42 U.S.C. 6921 et seq.);
       ``(vii) a rule of particular applicability that approves or 
     prescribes the future rates, wages, prices, services, 
     corporate or financial structures, reorganizations, mergers, 
     acquisitions, accounting practices, or disclosures bearing on 
     any of the foregoing;
       ``(viii) a rule relating to monetary policy or to the 
     safety or soundness of federally insured depository 
     institutions or any affiliate of such an institution (as 
     defined in section 2(k) of the Bank Holding Company Act of 
     1956 (12 U.S.C. 1841(k))), credit unions, Federal Home Loan 
     Banks, government sponsored housing enterprises, farm credit 
     institutions, foreign banks that operate in the United States 
     and their affiliates, branches, agencies, commercial lending 
     companies, or representative offices, (as those terms are 
     defined in section 1 of the International Banking Act of 1978 
     (12 U.S.C. 3101));
       ``(ix) a rule relating to the payment system or the 
     protection of deposit insurance funds or the farm credit 
     insurance fund;
       ``(x) any order issued in a rate or certificate proceeding 
     by the Federal Energy Regulatory Commission, or a rule of 
     general applicability that the Federal Energy Regulatory 
     Commission certifies would increase reliance on competitive 
     market forces or reduce regulatory burdens;
       ``(xi) a rule or order relating to the financial 
     responsibility of brokers and dealers or futures commission 
     merchants, the safeguarding of investor securities and funds 
     or commodity future or options customer securities and funds, 
     the clearance and settlement of securities, futures, or 
     options transactions, or the suspension of trading under the 
     Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.) or 
     emergency action taken under the Commodity Exchange Act (7 
     U.S.C. 1 et seq.), or a rule relating to the protection of 
     the Securities Investor Protection Corporation, that is 
     promulgated under the Securities Investor Protection Act of 
     1970 (15 U.S.C. 78aaa et seq.); or
       ``(xii) a rule that involves the international trade laws 
     of the United States.
     ``Sec. 622. Rulemaking cost-benefit analysis

       ``(a) Determination of Major Rule.--Prior to publishing a 
     notice of proposed rulemaking for any rule (or, in the case 
     of a notice of proposed rulemaking that has been published 
     but not issued on or before the date of enactment of this 
     subchapter, not later than 30 days after such date of 
     enactment), each agency shall determine whether the rule is 
     or is not a major rule within the meaning of section 
     621(5)(A)(i) and, if it is not, whether it should be 
     designated as a major rule under section 621(5)(A)(ii).
       ``(b) Designation.--(1) If an agency has determined that a 
     rule is not a major rule within the meaning of section 
     621(5)(A)(i) and has not designated the rule as a major rule 
     within the meaning of section 621(5)(A)(ii), the Director or 
     a designee of the President may, as appropriate, determine 
     that the rule is a major rule or designate the rule as a 
     major rule not later than 30 days after the publication of 
     the notice of proposed rulemaking for the rule (or, in the 
     case of a notice of proposed rulemaking that has been 
     published on or before the date of enactment of this 
     subchapter, not later than 1 year after such date of 
     enactment).
       ``(2) Such determination or designation shall be published 
     in the Federal Register, together with a succinct statement 
     of the basis for the determination or designation.
       ``(c) Initial Cost-Benefit Analysis.--(1)(A) When the 
     agency publishes a notice of proposed rulemaking for a major 
     rule, the agency shall issue and place in the rulemaking file 
     an initial cost-benefit analysis, and shall include a summary 
     of such analysis in the notice of proposed rulemaking.
       ``(B)(i) When an agency, the Director, or a designee of the 
     President has published a determination or designation that a 
     rule is a major rule after the publication of the notice of 
     proposed rulemaking for the rule, the agency shall promptly 
     issue and place in the rulemaking file an initial cost-
     benefit analysis for the rule and shall publish in the 
     Federal Register a summary of such analysis.
       ``(ii) Following the issuance of an initial cost-benefit 
     analysis under clause (i), the agency shall give interested 
     persons an opportunity to comment in the same manner as if 
     the initial cost-benefit analysis had been issued with the 
     notice of proposed rulemaking.
       ``(2) Each initial cost-benefit analysis shall contain--
       ``(A) a succinct analysis of the benefits of the proposed 
     rule, including any beneficial effects that cannot be 
     quantified, and an explanation of how the agency anticipates 
     such benefits will be achieved by the proposed rule, 
     including a description of the persons or classes of persons 
     likely to receive such benefits;
       ``(B) a succinct analysis of the costs of the proposed 
     rule, including any costs that cannot be quantified, and an 
     explanation of how the agency anticipates such costs will 
     result from the proposed rule, including a description of the 
     persons or classes of persons likely to bear such costs;
       ``(C) a succinct description (including an analysis of the 
     costs and benefits) of reasonable alternatives for achieving 
     the identified benefits of the proposed rule, including, 
     where such alternatives exist, alternatives that--
       ``(i) require no government action, where the agency has 
     discretion under the statute granting the rulemaking 
     authority not to promulgate a rule;
       ``(ii) will accommodate differences among geographic 
     regions and among persons with differing levels of resources 
     with which to comply;
       ``(iii) employ performance-based standards, market-based 
     mechanisms, or other flexible regulatory options that permit 
     the greatest flexibility in achieving the regulatory result 
     that the statutory provision authorizing the rule is designed 
     to produce; or
       ``(iv) employ voluntary standards;
       ``(D) in any case in which the proposed rule is based on 
     one or more scientific evaluations, scientific information, 
     or a risk assessment, or is subject to the risk assessment 
     requirements of subchapter III, a description of the actions 
     undertaken by the agency to verify the quality, reliability, 
     and relevance of such scientific evaluation, scientific 
     information, or risk assessment; and
       ``(E) an explanation of whether the proposed rule is likely 
     to meet the decisional criteria of section 624.
       ``(d) Final Cost-Benefit Analysis.--(1) When the agency 
     publishes a final major rule, the agency shall also issue and 
     place in the rulemaking file a final cost-benefit analysis, 
     and shall include a summary of the analysis in the statement 
     of basis and purpose.
       ``(2) Each final cost-benefit analysis shall contain--
       ``(A) a description and comparison of the benefits and 
     costs of the rule and of the reasonable alternatives to the 
     rule described in the rulemaking record, including flexible 
     regulatory options of the type described in subsection 
     (c)(2)(C)(iii), and a description of the persons likely to 
     receive such benefits and bear such costs; and
       ``(B) an analysis, based upon the rulemaking record 
     considered as a whole, of whether and how the rule meets the 
     decisional criteria in section 624.
       ``(3) In considering the benefits and costs, the agency, 
     when appropriate, shall consider the benefits and costs 
     incurred by all of the affected persons or classes of persons 
     (including specially affected subgroups).
       ``(e) Requirements for Cost-Benefit Analyses.--(1)(A) The 
     description of the benefits and costs of a proposed and a 
     final rule required under this section shall include, to the 
     extent feasible, a quantification or numerical estimate of 
     the quantifiable benefits and costs.
       ``(B) The quantification or numerical estimate shall--
       ``(i) be made in the most appropriate unit of measurement, 
     using comparable assumptions, including time periods;
       ``(ii) specify the ranges of predictions; and

[[Page S9288]]

       ``(iii) explain the margins of error involved in the 
     quantification methods and the uncertainties and 
     variabilities in the estimates used.
       ``(C) An agency shall describe the nature and extent of the 
     nonquantifiable benefits and costs of a final rule pursuant 
     to this section in as precise and succinct a manner as 
     possible.
       ``(D) The agency evaluation of the relationship of benefits 
     to costs shall be clearly articulated.
       ``(E) An agency shall not be required to make such 
     evaluation primarily on a mathematical or numerical basis.
       ``(F) Nothing in this subsection shall be construed to 
     expand agency authority beyond the delegated authority 
     arising from the statute granting the rulemaking authority.
       ``(2) Where practicable and when understanding industry-by-
     industry effects is of central importance to a rulemaking, 
     the description of the benefits and costs of a proposed and 
     final rule required under this section shall describe such 
     benefits and costs on an industry by industry basis.
       ``(f) Health, Safety, or Emergency Exemption From Cost-
     Benefit Analysis.--(1) A major rule may be adopted and may 
     become effective without prior compliance with this 
     subchapter if--
       ``(A) the agency for good cause finds that conducting cost-
     benefit analysis is impracticable due to an emergency or 
     health or safety threat that is likely to result in 
     significant harm to the public or natural resources; and
       ``(B) the agency publishes in the Federal Register, 
     together with such finding, a succinct statement of the basis 
     for the finding.
       ``(2) Not later than 180 days after the promulgation of a 
     final major rule to which this section applies, the agency 
     shall comply with the provisions of this subchapter and, if 
     thereafter necessary, revise the rule.
     ``Sec. 623. Agency regulatory review

       ``(a) Preliminary Schedule for Rules.--(1) Not later than 1 
     year after the date of the enactment of this section, and 
     every 5 years thereafter, the head of each agency shall 
     publish in the Federal Register a notice of proposed 
     rulemaking under section 553 that contains a preliminary 
     schedule of rules selected for review under this section by 
     the head of the agency and in the sole discretion of the head 
     of the agency, and request public comment thereon, including 
     suggestions for additional rules warranting review. The 
     agency shall allow at least 180 days for public comment.
       ``(2) In selecting rules for the preliminary schedule, the 
     head of the agency shall consider the extent to which, in the 
     judgment of the head of the agency--
       ``(A) a rule is unnecessary, and the agency has discretion 
     under the statute authorizing the rule to repeal the rule;
       ``(B) a rule would not meet the decisional criteria of 
     section 624, and the agency has discretion under the statute 
     authorizing the rule to repeal the rule; or
       ``(C) a rule could be revised in a manner allowed by the 
     statute authorizing the rule so as to meet the decisional 
     criteria of section 624 and to--
       ``(i) substantially decrease costs;
       ``(ii) substantially increase benefits; or
       ``(iii) provide greater flexibility for regulated entities, 
     through mechanisms including, but not limited to, those 
     listed in section 622(c)(2)(C)(iii).
       ``(3) The preliminary schedule under this subsection shall 
     propose deadlines for review of each rule listed thereon, and 
     such deadlines shall occur not later than 11 years from the 
     date of publication of the preliminary schedule.
       ``(4) Any interpretive rule, general statement of policy, 
     or guidance that has the force and effect of a rule under 
     section 621(9) shall be treated as a rule for purposes of 
     this section.
       ``(b) Schedule.--(1) Not later than 1 year after 
     publication of a preliminary schedule under subsection (a), 
     and subject to subsection (c), the head of each agency shall 
     publish a final rule that establishes a schedule of rules to 
     be reviewed by the agency under this section.
       ``(2) The schedule shall establish a deadline for 
     completion of the review of each rule listed on the schedule, 
     taking into account the criteria in subsection (d) and 
     comments received in the rulemaking under subsection (a). 
     Each such deadline shall occur not later than 11 years from 
     the date of publication of the preliminary schedule.
       ``(3) The schedule shall contain, at a minimum, all rules 
     listed on the preliminary schedule.
       ``(4) The head of the agency shall modify the agency's 
     schedule under this section to reflect any change ordered by 
     the court under subsection (e) or subsection (g)(3) or 
     contained in an appropriations Act under subsection (f).
       ``(c) Petitions and Comments Proposing Addition of Rules to 
     the Schedule.--(1) Notwithstanding section 553(l), a petition 
     to amend or repeal a major rule or an interpretative rule, 
     general statement of policy, or guidance may only be filed 
     during the 180-day comment period under subsection (a) and 
     not at any other time. Such petition shall be reviewed only 
     in accordance with this subsection.
       ``(2) The head of the agency shall, in response to 
     petitions received during the rulemaking to establish the 
     schedule, place on the final schedule for review within the 
     first 3 years of the schedule any rule for which a petition, 
     on its face, together with any relevant comments received in 
     the rulemaking under subsection (a), establishes that there 
     is a substantial likelihood that, considering the future 
     impact of the rule--
       ``(A) the rule is a major rule under section 621(5)(A); and
       (B) the head of the agency would not be able to make the 
     findings required by section 624 with respect to the rule.
       ``(3) For the purposes of paragraph (2), the head of the 
     agency may consolidate multiple petitions on the same rule 
     into 1 determination with respect to review of the rule.
       ``(4) The head of the agency may, at the sole discretion of 
     the head of the agency, add to the schedule any other rule 
     suggested by a commentator during the rulemaking under 
     subsection (a).
       ``(d) Criteria for Establishing Deadlines for Review.--The 
     schedules in subsections (a) and (b) shall establish 
     deadlines for review of each rule on the schedule that take 
     into account--
       ``(1) the extent to which, for a particular rule, the 
     preliminary views of the agency are that--
       ``(A) the rule is unnecessary, and the agency has 
     discretion under the statute authorizing the rule to repeal 
     the rule;
       ``(B) the rule would not meet the decisional criteria of 
     section 624, and the agency has discretion under the statute 
     authorizing the rule to repeal the rule; or
       ``(C) the rule could be revised in a manner allowed by the 
     statute authorizing the rule so as to meet the decisional 
     criteria under section 624 and to--
       ``(i) substantially decrease costs;
       ``(ii) substantially increase benefits; or
       ``(iii) provide greater flexibility for regulated entities, 
     through mechanisms including, but not limited to, those 
     listed in section 622(c)(2)(C)(iii);
       ``(2) the importance of each rule relative to other rules 
     being reviewed under this section; and
       ``(3) the resources expected to be available to the agency 
     under subsection (f) to carry out the reviews under this 
     section.
       ``(e) Judicial Review.--(1) Notwithstanding section 625 and 
     except as provided otherwise in this subsection, agency 
     compliance or noncompliance with the requirements of this 
     section shall be subject to judicial review in accordance 
     with section 706 of this title.
       ``(2) The United States Court of Appeals for the District 
     of Columbia Circuit shall have exclusive jurisdiction to 
     review agency action pursuant to subsection (b) and 
     subsection (c).
       ``(3) A petition for review of final agency action under 
     subsection (b) or subsection (c) shall be filed not later 
     than 60 days after the agency publishes the final rule under 
     subsection (b).
       ``(4) The court upon review, for good cause shown, may 
     extend the 3-years deadline under subsection (c)(2) for a 
     period not to exceed an additional year.
       ``(5) The court shall remand to the agency any schedule 
     under subsection (b) only if final agency action under 
     subsection (b) is arbitrary or capricious. Agency action 
     under subsection (d) shall not be subject to judicial review.
       ``(f) Annual Budget.--(1) The President's annual budget 
     proposal submitted under section 1105(a) of title 31 for each 
     agency subject to this section shall--
       ``(A) identify as a separate sum the amount requested to be 
     appropriated for implementation of this section during the 
     upcoming fiscal year; and
       ``(B) include a list of rules which may terminate during 
     the year for which the budget proposal is made.
       ``(2) Amendments to the schedule under subsection (b) that 
     change a deadline for review of a rule may be included in 
     annual appropriations Acts for the relevant agencies. An 
     authorizing committee with jurisdiction may submit, to the 
     House of Representatives or Senate appropriations committee 
     (as the case may be), amendments to the schedule published by 
     an agency under subsection (b) that change a deadline for 
     review of a rule. The appropriations committee to which such 
     amendments have been submitted shall include or propose the 
     amendments in the annual appropriations Act for the relevant 
     agency. Each agency shall modify its schedule under 
     subsection (b) to reflect such amendments.
       ``(g) Review of Rule.--(1) For each rule on the schedule 
     under subsection (b), the agency shall--
       ``(A) not later than 2 years before the deadline in such 
     schedule, publish in the Federal Register a notice that 
     solicits public comment regarding whether the rule should be 
     continued, amended, or repealed;
       ``(B) not later than 1 year before the deadline in such 
     schedule, publish in the Federal Register a notice that--
       ``(i) addresses public comments generated by the notice in 
     subparagraph (A);
       ``(ii) contains a preliminary analysis provided by the 
     agency of whether the rule is a major rule, and if so, 
     whether it satisfies the decisional criteria of section 624;
       ``(iii) contains a preliminary determination as to whether 
     the rule should be continued, amended, or repealed; and
       ``(iv) solicits public comment on the preliminary 
     determination for the rule; and
       ``(C) not later than 60 days before the deadline in such 
     schedule, publish in the Federal Register a final notice on 
     the rule that--
       ``(i) addresses public comments generated by the notice in 
     subparagraph (B); and 

[[Page S9289]]

       ``(ii) contains a final determination of whether to 
     continue, amend, or repeal the rule; and
       ``(iii) if the agency determines to continue the rule and 
     the rule is a major rule, contains findings necessary to 
     satisfy the decisional criteria of section 624; and
       ``(iv) if the agency determines to amend the rule, contains 
     a notice of proposed rulemaking under section 553.
       ``(2) If the final determination of the agency is to 
     continue or repeal the rule, that determination shall take 
     effect 60 days after the publication in the Federal Register 
     of the notice in paragraph (1)(C).
       ``(3) An interested party may petition the U.S. Court of 
     Appeals for the District of Columbia Circuit to extend the 
     period for review of a rule on the schedule for up to two 
     years and to grant such equitable relief as is appropriate, 
     if such petition establishes that--
       ``(A) the rule is likely to terminate under subsection (i);
       ``(B) the agency needs additional time to complete the 
     review under this subsection;
       ``(C) terminating the rule would not be in the public 
     interest; and
       ``(D) the agency has not expeditiously completed its 
     review.
       ``(h) Deadline for Final Agency Action on Modified Rule.--
     If an agency makes a determination to amend a major rule 
     under subsection (g)(1)(C)(ii), the agency shall complete 
     final agency action with regard to such rule not later than 2 
     years of the date of publication of the notice in subsection 
     (g)(1)(C) containing such determination. Nothing in this 
     subsection shall limit the discretion of an agency to decide, 
     after having proposed to modify a major rule, not to 
     promulgate such modification. Such decision shall constitute 
     final agency action for the purposes of judicial review.
       ``(i) Termination of Rules.--If the head of an agency has 
     not completed the review of a rule by the deadline 
     established in the schedule published or modified pursuant to 
     subsection (b) and subsection (c), the head of the agency 
     shall not enforce the rule, and the rule shall terminate by 
     operation of law as of such date.
       ``(j) Final Agency Action.--(1) The final determination of 
     an agency to continue or repeal a major rule under subsection 
     (g)(1)(C) shall be considered final agency action.
       ``(2) Failure to promulgate an amended major rule or to 
     make other decisions required by subsection (h) by the date 
     established under such subsection shall be considered final 
     agency action.

     ``Sec. 624. Decisional criteria

       ``(a) Construction With Other Laws.--The requirements of 
     this section shall supplement, and not supersede, any other 
     decisional criteria otherwise provided by law.
       ``(b) Requirements.--Except as provided in subsection (c), 
     no final major rule subject to this subchapter shall be 
     promulgated unless the agency head publishes in the Federal 
     Register a finding that--
       ``(1) the benefits from the rule justify the costs of the 
     rule;
       ``(2) the rule employs to the extent practicable flexible 
     reasonable alternatives of the type described in section 
     622(c)(2)(C)(iii); and
       ``(3)(A) the rule adopts the least cost alternative of the 
     reasonable alternatives that achieves the objectives of the 
     statute; or
       ``(B) if scientific, technical, or economic uncertainties 
     or nonquantifiable benefits to health, safety, or the 
     environment identified by the agency in the rulemaking record 
     make a more costly alternative that achieves the objectives 
     of the statute appropriate and in the public interest and the 
     agency head provides an explanation of those considerations, 
     the rule adopts the least cost alternative of the reasonable 
     alternatives necessary to take into account such 
     uncertainties or benefits; and
       ``(4) if a risk assessment is required by section 632--
       ``(A) the rule is likely to significantly reduce the human 
     health, safety, and environmental risks to be addressed; or
       ``(B) if scientific, technical, or economic uncertainties 
     or nonquantifiable benefits to health, safety, or the 
     environment, preclude making the finding under subparagraph 
     (A), promulgating the final rule is nevertheless justified 
     for reasons stated in writing accompanying the rule and 
     consistent with subchapter III.
       ``(c) Alternative Requirements.--If, applying the statutory 
     requirements upon which the rule is based, a rule cannot 
     satisfy the criteria of subsection (b), the agency head may 
     promulgate the rule if the agency head finds that--
       ``(1) the rule employs to the extent practicable flexible 
     reasonable alternatives of the type described in section 
     622(c)(2)(C)(iii);
       ``(2)(A) the rule adopts the least cost alternative of the 
     reasonable alternatives that achieves the objectives of the 
     statute; or
       ``(B) if scientific, technical, or economic uncertainties 
     or nonquantifiable benefits to health, safety, or the 
     environment identified by the agency in the rulemaking record 
     make a more costly alternative that achieves the objectives 
     of the statute appropriate and in the public interest, and 
     the agency head provides an explanation of those 
     consideration, the rule adopts the least cost alternative of 
     the reasonable alternatives necessary to take into account 
     such uncertainties or benefits; and
       ``(3) if a risk assessment is required by section 632--
       ``(A) the rule is likely to significantly reduce the human 
     health, safety, and environmental risks to be addressed; or
       ``(B) if scientific, technical, or economic uncertainties 
     or nonquantifiable benefits to health, safety, or the 
     environment, preclude making the finding under subparagraph 
     (A), promulgating the final rule is nevertheless justified 
     for reasons stated in writing accompanying the rule and 
     consistent with subchapter III.
       ``(d) Publication of Reasons for Noncompliance.--If an 
     agency promulgates a rule to which subsection (c) applies, 
     the agency head shall prepare a written explanation of why 
     the agency was required to promulgate a rule that does not 
     satisfy the criteria of subsection (b) and shall transmit the 
     explanation with the final cost-benefit analysis to Congress 
     when the final rule is promulgated.
     ``Sec. 625. Jurisdiction and judicial review

       ``(a) Review.--Compliance or noncompliance by an agency 
     with the provisions of this subchapter and subchapter III 
     shall be subject to judicial review only in accordance with 
     this section.
       ``(b) Jurisdiction.--(1) Subject to paragraph (2), each 
     court with jurisdiction under a statute to review final 
     agency action to which this title applies, has jurisdiction 
     to review any claims of noncompliance with this subchapter 
     and subchapter III.
       ``(2) No claims of noncompliance with this subchapter or 
     subchapter III shall be reviewed separate or apart from 
     judicial review of the final agency action to which they 
     relate.
       ``(c) Record.--Any analysis or review required under this 
     subchapter or subchapter III shall constitute part of the 
     rulemaking record of the final agency action to which it 
     pertains for the purposes of judicial review.
       ``(d) Standards for Review.--In any proceeding involving 
     judicial review under section 706 or under the statute 
     granting the rulemaking authority, failure to comply with 
     this subchapter or subchapter III may be considered by the 
     court solely for the purpose of determining whether the final 
     agency action is arbitrary and capricious or an abuse of 
     discretion (or unsupported by substantial evidence where that 
     standard is otherwise provided by law).
       ``(e) Interlocutory Review.--(1) The United States Court of 
     Appeals for the District of Columbia Circuit shall have 
     jurisdiction to review--
       ``(A) an agency determination that a rule is not a major 
     rule pursuant to section 622(a); and
       ``(B) an agency determination that a risk assessment is not 
     required pursuant to section 632(a).
       ``(2) A petition for review of agency action under 
     paragraph (1) shall be filed within 60 days after the agency 
     makes the determination or certification for which review is 
     sought.
       ``(3) Except as provided in this subsection, no court shall 
     have jurisdiction to review any agency determination or 
     certification specified in paragraph (1).

     ``Sec. 626. Deadlines for rulemaking

       ``(a) Statutory.--All deadlines in statutes that require 
     agencies to propose or promulgate any rule subject to section 
     622 or subchapter III during the 5-year period beginning on 
     the effective date of this section shall be suspended until 
     the earlier of--
       ``(1) the date on which the requirements of section 622 or 
     subchapter III are satisfied; or
       ``(2) the date occurring 2 years after the date of the 
     applicable deadline.
       ``(b) Court-Ordered.--All deadlines imposed by any court of 
     the United States that would require an agency to propose or 
     promulgate a rule subject to section 622 or subchapter III 
     during the 5-year period beginning on the effective date of 
     this section shall be suspended until the earlier of--
       ``(1) the date on which the requirements of section 622 or 
     subchapter III are satisfied; or
       ``(2) the date occurring 2 years after the date of the 
     applicable deadline.
       ``(c) Obligation To Regulate.--In any case in which the 
     failure to promulgate a rule by a deadline occurring during 
     the 5-year period beginning on the effective date of this 
     section would create an obligation to regulate through 
     individual adjudications, the deadline shall be suspended 
     until the earlier of--
       ``(1) the date on which the requirements of section 622 or 
     subchapter III are satisfied; or
       ``(2) the date occurring 2 years after the date of the 
     applicable deadline.

     ``Sec. 627. Special rule

       ``Notwithstanding any other provision of the Comprehensive 
     Regulatory Reform Act of 1995, or the amendments made by such 
     Act, for purposes of this subchapter and subchapter IV, the 
     head of each appropriate Federal banking agency (as defined 
     in section 3(q) of the Federal Deposit Insurance Act), the 
     National Credit Union Administration, the Federal Housing 
     Finance Board, the Office of Federal Housing Enterprise 
     Oversight, and the Farm Credit Administration, shall have 
     authority with respect to such agency that otherwise would be 
     provided under such subchapters to the Director, a designee 
     of the President, Vice President, or any officer designated 
     or delegated with authority under such subchapters.

     ``Sec. 628. Requirements for major environmental management 
       activities

       ``(a) Definition.--For purposes of this section, the term 
     `major environmental management activity' means--

[[Page S9290]]

       ``(1) a corrective action requirement under the Solid Waste 
     Disposal Act;
       ``(2) a response action or damage assessment under the 
     Comprehensive Environmental Response, Compensation, and 
     Liability Act of 1980 (42 U.S.C. 9601 et seq.);
       ``(3) the treatment, storage, or disposal of radioactive or 
     mixed waste in connection with site restoration activity; and
       ``(4) Federal guidelines for the conduct of such activity, 
     including site-specific guidelines,

     the expected costs, expenses, and damages of which are likely 
     to exceed, in the aggregate, $10,000,000.
       ``(b) Applicability.--A major environmental management 
     activity is subj ect to this section unless construction has 
     commenced on a significant portion of the activity, and--
       ``(1) it is more cost-effective to complete construction of 
     the work than to apply the provisions of this subchapter; or
       ``(2) the application of the provisions of this subchapter, 
     including any delays caused thereby, will result in an actual 
     and immediate risk to human health or welfare.
       ``(c) Requirement To Prepare Risk Assessment.--(1) For each 
     major environmental management activity or significant unit 
     thereof 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 623, the head of an 
     agency shall prepare--
       ``(A) a risk assessment in accordance with subchapter III; 
     and
       ``(B) a cost-benefit analysis equivalent to that which 
     would be required under this subchapter, if such subchapter 
     were applicable.
       ``(2) In conducting a risk assessment or cost-benefit 
     analysis under this section, the head of the agency shall 
     incorporate the reasonably anticipated probable future use of 
     the land and its surroundings (and any associated media and 
     resources of either) affected by the environmental management 
     activity.
       ``(3) For actions pending on the date of enactment of this 
     section or proposed during the year following the date of 
     enactment of this section, in lieu of preparing a risk 
     assessment in accordance with subchapter III or cost-benefit 
     analysis under this subchapter, an agency may use other 
     appropriately developed analyses that allow it to make the 
     judgments required under subsection (d).
       ``(d) Requirement.--The requirements of this subsection 
     shall supplement, and not supersede, any other requirement 
     provided by any law. A major environmental management 
     activity under this section shall meet the decisional 
     criteria under section 624 as if it is a major rule under 
     such section.

                   ``SUBCHAPTER III--RISK ASSESSMENTS

     ``Sec. 631. Definitions

       ``For purposes of this subchapter--
       ``(1) except as otherwise provided, the definitions under 
     section 551 shall apply to this subchapter;
       ``(2) the term `exposure assessment' means the scientific 
     determination of the intensity, frequency and duration of 
     actual or potential exposures to the hazard in question;
       ``(3) the term `hazard assessment' means the scientific 
     determination of whether a hazard can cause an increased 
     incidence of one or more significant adverse effects, and a 
     scientific evaluation of the relationship between the degree 
     of exposure to a perceived cause of an adverse effect and the 
     incidence and severity of the effect;
       ``(4) the term `major rule' has the meaning given such term 
     in section 621(5);
       ``(5) the term `risk assessment' means the systematic 
     process of organizing and analyzing scientific knowledge and 
     information on potential hazards, including as appropriate 
     for the specific risk involved, hazard assessment, exposure 
     assessment, and risk characterization;
       ``(6) the term `risk characterization' means the 
     integration and organization of hazard and exposure 
     assessment to estimate the potential for specific harm to an 
     exposed population or natural resource including, to the 
     extent feasible, a characterization of the distribution of 
     risk as well as an analysis of uncertainties, variabilities, 
     conflicting information, and inferences and assumptions in 
     the assessment;
       ``(7) the term `screening analysis' means an analysis using 
     simple conservative postulates to arrive at an estimate of 
     upper and lower bounds as appropriate, that permits the 
     manager to eliminate risks from further consideration and 
     analysis, or to help establish priorities for agency action; 
     and
       ``(8) the term `substitution risk' means an increased risk 
     to human health, safety, or the environment reasonably likely 
     to result from a regulatory option.

     ``Sec. 632. Applicability

       ``(a) In General.--Except as provided in subsection (c), 
     for each proposed and final major rule, a primary purpose of 
     which is to protect human health, safety, or the environment, 
     or a consequence of which is a substantial substitution risk, 
     that is proposed by an agency after the date of enactment of 
     this subchapter, or is pending on the date of enactment of 
     this subchapter, the head of each agency shall prepare a risk 
     assessment in accordance with this subchapter.
       ``(b) Application of Principles.--(1) Except as provided in 
     subsection (c), the head of each agency shall apply the 
     principles in this subchapter to any risk assessment 
     conducted to support a determination by the agency of risk to 
     human health, safety, or the environment, if such 
     determination would be likely to have an effect on the United 
     States economy equivalent to that of a major rule.
       ``(2) In applying the principles of this subchapter to risk 
     assessments other than those in subsections (a), (b)(1), and 
     (c), the head of each agency shall publish, after notice and 
     public comment, guidelines for the conduct of such other risk 
     assessments that adopt the principles of this subchapter in a 
     manner consistent with section 633(a)(4) and the risk 
     assessment and risk management needs of the agency.
       ``(3) An agency shall not, as a condition for the issuance 
     or modification of a permit, conduct, or require any person 
     to conduct, a risk assessment, except if the agency finds 
     that the risk assessment meets the requirements of section 
     633 (a) through (f).
       ``(c) Exceptions.--(1) This subchapter shall not apply to 
     risk assessments performed with respect to--
       ``(A) a situation for which the agency finds good cause 
     that conducting a risk assessment is impracticable due to an 
     emergency or health and safety threat that is likely to 
     result in significant harm to the public or natural 
     resources;
       ``(B) a rule or agency action that authorizes the 
     introduction into commerce, or initiation of manufacture, of 
     a substance, mixture, or product, or recognizes the 
     marketable status of a product;
       ``(C) a human health, safety, or environmental inspection, 
     an action enforcing a statutory provision, rule, or permit, 
     or an individual facility or site permitting action, except 
     to the extent provided by subsection (b)(3);
       ``(D) a screening analysis clearly identified as such; or
       ``(E) product registrations, reregistrations, tolerance 
     settings, and reviews of premanufacture notices 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.).
       ``(2) An analysis shall not be treated as a screening 
     analysis for the purposes of paragraph (1)(D) if the result 
     of the analysis is used--
       ``(A) as the basis for imposing a restriction on a 
     previously authorized substance, product, or activity after 
     its initial introduction into manufacture or commerce; or
       ``(B) as the basis for a formal determination by the agency 
     of significant risk from a substance or activity.
       ``(3) This subchapter shall not apply to any food, drug, or 
     other product label or labeling, or to any risk 
     characterization appearing on any such label.

     ``Sec. 633. Principles for risk assessments

       ``(a) In General.--(1) The head of each agency shall design 
     and conduct risk assessments in a manner that promotes 
     rational and informed risk management decisions and informed 
     public input into the process of making agency decisions.
       ``(2) The head of each agency shall establish and maintain 
     a distinction between risk assessment and risk management.
       ``(3) An agency may take into account priorities for 
     managing risks, including the types of information that would 
     be important in evaluating a full range of alternatives, in 
     developing priorities for risk assessment activities.
       ``(4) In conducting a risk assessment, the head of each 
     agency shall employ the level of detail and rigor considered 
     by the agency as appropriate and practicable for reasoned 
     decisionmaking in the matter involved, proportionate to the 
     significance and complexity of the potential agency action 
     and the need for expedition.
       ``(5) An agency shall not be required to repeat discussions 
     or explanations in each risk assessment required under this 
     subchapter if there is an unambiguous reference to a relevant 
     discussion or explanation in another reasonably available 
     agency document that was prepared consistent with this 
     section.
       ``(b) Iterative Process.--(1) Each agency shall develop and 
     use an iterative process for risk assessment, starting with 
     relatively inexpensive screening analyses and progressing to 
     more rigorous analyses, as circumstances or results warrant.
       ``(2) In determining whether or not to proceed to a more 
     detailed analysis, the head of the agency shall take into 
     consideration whether or not use of additional data or the 
     analysis thereof would significantly change the estimate of 
     risk and the resulting agency action.
       ``(c) Data Quality.--(1) The head of each agency shall base 
     each risk assessment only on the best reasonably available 
     scientific data and scientific understanding, including 
     scientific information that finds or fails to find a 
     correlation between a potential hazard and an adverse effect, 
     and data regarding exposure and other relevant physical 
     conditions that are reasonably expected to be encountered.
       ``(2) The agency shall select data for use in a risk 
     assessment based on a reasoned analysis of the quality and 
     relevance of the data, and shall describe such analysis.
       ``(3) In making its selection of data, the agency shall 
     consider whether the data were published in the peer-reviewed 
     scientific literature, or developed in accordance with good 
     laboratory practice or published or other appropriate 
     protocols to ensure data quality, such as the standards for 
     the development of test data promulgated pursuant to section 
     4 of the Toxic Substances Control Act (15 U.S.C. 2603), and 
     the standards for 

[[Page S9291]]
     data requirements promulgated pursuant to section 3 of the Federal 
     Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a), 
     or other form of independent evaluation.
       ``(4) Subject to paragraph (3), relevant scientific data 
     submitted by interested parties shall be reviewed and 
     considered by the agency in the analysis under paragraph (2).
       ``(5) When conflicts among scientific data appear to exist, 
     the risk assessment shall include a discussion of all 
     relevant information including the likelihood of alternative 
     interpretations of the data and emphasizing--
       ``(A) postulates that represent the most reasonable 
     inferences from the supporting scientific data; and
       ``(B) when a risk assessment involves an extrapolation from 
     toxicological studies, data with the greatest scientific 
     basis of support for the resulting harm to affected 
     individuals, populations, or resources.
       ``(6) The head of an agency shall not automatically 
     incorporate or adopt any recommendation or classification 
     made by any foreign government, the United Nations, any 
     international governmental body or standards-making 
     organization, concerning the health effects value of a 
     substance except as provided in paragraph (2) of this 
     subsection. Nothing in this paragraph shall be construed to 
     affect the implementation or application of any treaty or 
     international trade agreement to which the United States is a 
     party.
       ``(d) Use of Policy Judgments.--(1) To the maximum extent 
     practicable, each agency shall use policy judgments, 
     including default assumptions, inferences, models or safety 
     factors, only when relevant scientific data and scientific 
     understanding, including site-specific data, are lacking. The 
     agency shall modify or decrease the use of policy judgments 
     to the extent that higher quality scientific data and 
     understanding become available.
       ``(2) When a risk assessment involves choice of a 
     postulate, the head of the agency shall--
       ``(A) identify the postulate and its scientific or policy 
     basis, including the extent to which the policy judgment has 
     been validated by, or conflicts with, empirical data;
       ``(B) explain the basis for any choices among policy 
     judgments; and
       ``(C) describe reasonable alternative policy judgments that 
     were not selected by the agency for use in the risk 
     assessment, and the sensitivity of the conclusions of the 
     risk assessment to the alternatives, and the rationale for 
     not using such alternatives.
       ``(3) An agency shall not inappropriately combine or 
     compound multiple policy judgments.
       ``(4) The agency shall, subject to notice and opportunity 
     for public comment, develop and publish guidelines describing 
     the agency's default policy judgments and how they were 
     chosen, and guidelines for deciding when and how, in a 
     specific risk assessment, to adopt alternative policy 
     judgments or to use available scientific information in place 
     of a policy judgment.
       ``(e) Risk Characterization.--In each risk assessment, the 
     agency shall include in the risk characterization, as 
     appropriate, each of the following:
       ``(1) A description of the hazard of concern.
       ``(2) A description of the populations or natural resources 
     that are the subject of the risk assessment.
       ``(3) An explanation of the exposure scenarios used in the 
     risk assessment, including an estimate of the corresponding 
     population at risk and the likelihood of such exposure 
     scenarios.
       ``(4) A description of the nature and severity of the harm 
     that could plausibly occur.
       ``(5) A description of the major uncertainties in each 
     component of the risk assessment and their influence on the 
     results of the assessment.
       ``(f) Presentation of Risk Assessment Conclusions.--(1) To 
     the extent feasible and scientifically appropriate, the head 
     of an agency shall--
       ``(A) express the overall estimate of risk as a range or 
     probability distribution that reflects variabilities, 
     uncertainties and data gaps in the analysis;
       ``(B) provide the range and distribution of risks and the 
     corresponding exposure scenarios, identifying the reasonably 
     expected risk to the general population and, where 
     appropriate, to more highly exposed or sensitive 
     subpopulations; and
       ``(C) where quantitative estimates of the range and 
     distribution of risk estimates are not available, describe 
     the qualitative factors influencing the range of possible 
     risks.
       ``(2) When scientific data and understanding that permits 
     relevant comparisons of risk are reasonably available, the 
     agency shall use such information to place the nature and 
     magnitude of risks to human health, safety, and the 
     environment being analyzed in context.
       ``(3) When scientifically appropriate information on 
     significant substitution risks to human health, safety, or 
     the environment is reasonably available to the agency, or is 
     contained in information provided to the agency by a 
     commentator, the agency shall describe such risks in the risk 
     assessments.
       ``(g) Peer Review.--(1) Each agency shall provide for peer 
     review in accordance with this section of any risk assessment 
     subject to the requirements of this subchapter that forms 
     that basis of any major rule or a major environmental 
     management activity.
       ``(2) Each agency shall develop a systematic program for 
     balanced, independent, and external peer review that--
       ``(A) shall provide for the creation or utilization of peer 
     review panels, expert bodies, or other formal or informal 
     devices that are balanced and comprised of participants 
     selected on the basis of their expertise relevant to the 
     sciences involved in regulatory decisions and who are 
     independent of the agency program that developed the risk 
     assessment being reviewed;
       ``(B) shall not exclude any person with substantial and 
     relevant expertise as a participant on the basis that such 
     person has a potential interest in the outcome, if such 
     interest is fully disclosed to the agency, and the agency 
     includes such disclosure as part of the record, unless the 
     result of the review would have a direct and predictable 
     effect on a substantial financial interest of such person;
       ``(C) shall provide for a timely completed peer review, 
     meeting agency deadlines, that contains a balanced 
     presentation of all considerations, including minority 
     reports and agency response to all significant peer review 
     comments; and
       ``(D) shall provide adequate protections for confidential 
     business information and trade secrets, including requiring 
     panel members to enter into confidentiality agreements.
       ``(3) Each peer review shall include a report to the 
     Federal agency concerned detailing the scientific and 
     technical merit of data and the methods used for the risk 
     assessment, and shall identify significant peer review 
     comments. Each agency shall provide a written response to all 
     significant peer review comments. All peer review comments, 
     conclusions, composition of the panels, 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.
       ``(4)(A) The Director of the Office of Science and 
     Technology Policy shall develop a systematic program to 
     oversee the use and quality of peer review of risk 
     assessments.
       ``(B) The Director or the designee of the President may 
     order an agency to conduct peer review for any risk 
     assessment or cost-benefit analysis that is likely to have a 
     significant impact on public policy decisions, or that would 
     establish an important precedent.
       ``(5) The proceedings of peer review panels under this 
     section shall not be subject to the Federal Advisory 
     Committee Act.
       ``(h) Public Participation.--The head of each agency shall 
     provide appropriate opportunities for public participation 
     and comment on risk assessments.

     ``Sec. 634. 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 or analyze 
     risk, scientific uncertainty, or variability; or
       ``(2) require the disclosure of any trade secret or other 
     confidential information.

     ``Sec. 635. Comprehensive risk reduction

       ``(a) Setting Priorities.--The head of each agency with 
     programs to protect human health, safety, or the environment 
     shall set priorities for the use of resources available to 
     address those risks to human health, safety, and the 
     environment, with the goal of achieving the greatest overall 
     net reduction in risks with the public and private sector 
     resources expended.
       ``(b) Incorporating Risk-Based Priorities Into Budget and 
     Planning.--The head of each agency in subsection (a) shall 
     incorporate the priorities identified under subsection (a) 
     into the agency budget, strategic planning, regulatory 
     agenda, enforcement, and research activities. When submitting 
     its budget request to Congress and when announcing its 
     regulatory agenda in the Federal Register, each covered 
     agency shall identify the risks that the covered agency head 
     has determined are the most serious and can be addressed in a 
     cost-effective manner using the priorities set under 
     subsection (a), the basis for that determination, and 
     explicitly identify how the agency's requested budget and 
     regulatory agenda reflect those priorities.
       ``(c) Reports by the National Academy of Sciences.--(1) Not 
     later than 6 months after the date of enactment of this 
     section, the Director of the Office of Science and Technology 
     Policy shall enter into an arrangement with the National 
     Academy of Sciences to investigate and report on comparative 
     risk analysis. The arrangement shall provide, to the extent 
     deemed appropriate and feasible by the Academy, for--
       ``(A) 1 or more reports evaluating methods of comparative 
     risk analysis that would be appropriate for agency programs 
     related to human health, safety, and the environment to use 
     in setting priorities for activities; and
       ``(B) a report providing a comprehensive and comparative 
     analysis of the risks to human health, safety, and the 
     environment that are addressed by agency programs under 
     subsection (a), along with companion activities to 
     disseminate the conclusions of the report to the public.
       ``(2) The report or reports prepared under paragraph (1)(A) 
     shall be completed not later than 3 years after the date of 
     enactment of this section. The report under paragraph (1)(B) 
     shall be completed not later than 4 years after the date of 
     enactment of this section, and shall draw, as appropriate, 
     upon the insights and conclusions of the report or reports 
     made under paragraph (1)(A). The companion activities under 
     paragraph (1)(B) shall be completed not later than 5 years 
     after the date of enactment of this section.
       ``(3)(A) The head of an agency with programs to protect 
     human health, safety, and 

[[Page S9292]]
     the environment shall incorporate the recommendations of reports under 
     paragraph (1) in revising any priorities under subsection 
     (a).
       ``(B) The head of the agency shall submit a report to the 
     appropriate Congressional committees of jurisdiction 
     responding to the recommendations from the National Academy 
     of Sciences and describing plans for utilizing the results of 
     comparative risk analysis in agency budget, strategic 
     planning, regulatory agenda, enforcement, and research and 
     development activities.
       ``(4) Following the submission of the report in paragraph 
     (2), for the next 5 years, the head of the agency shall 
     submit, with the budget request submitted to Congress under 
     section 1105(a) of title 31, a description of how the 
     requested budget of the agency and the strategic planning 
     activities of the agency reflect priorities determined using 
     the recommendations of reports issued under subsection (a). 
     The head of the agency shall include in such description--
       ``(A) recommendations on the modification, repeal, or 
     enactment of laws to reform, eliminate, or enhance programs 
     or mandates relating to human health, safety, or the 
     environment; and
       ``(B) recommendation on the modification or elimination of 
     statutory or judicially mandated deadlines,

     that would assist the head of the agency to set priorities in 
     activities to address the risks to human health, safety, or 
     the environment that incorporate the priorities developed 
     using the recommendations of the reports under subsection 
     (a), resulting in more cost-effective programs to address 
     risk.
       ``(5) For each budget request submitted in accordance with 
     paragraph (4), the Director shall submit an analysis of ways 
     in which resources could be reallocated among Federal 
     agencies to achieve the greatest overall net reduction in 
     risk.
                  ``SUBCHAPTER IV--EXECUTIVE OVERSIGHT

     ``Sec. 641. Procedures

       ``(a) In General.--The Director or a designee of the 
     President shall--
       ``(1) establish and, as appropriate, revise procedures for 
     agency compliance with this chapter; and
       ``(2) monitor, review, and ensure agency implementation of 
     such procedures.
       ``(b) Public Comment.--Procedures established pursuant to 
     subsection (a) shall only be implemented after opportunity 
     for public comment. Any such procedures shall be consistent 
     with the prompt completion of rulemaking proceedings.
       ``(c) Time for Review.--(1) If procedures established 
     pursuant to subsection (a) include review of any initial or 
     final analyses of a rule required under chapter 6, the time 
     for any such review of any initial analysis shall not exceed 
     90 days following the receipt of the analysis by the 
     Director, or a designee of the President.
       ``(2) The time for review of any final analysis required 
     under chapter 6 shall not exceed 90 days following the 
     receipt of the analysis by the Director, a designee of the 
     President.
       ``(3)(A) The times for each such review may be extended for 
     good cause by the President or by an officer to whom the 
     President has delegated his authority pursuant to section 642 
     for an additional 45 days. At the request of the head of an 
     agency, the President or such an officer may grant an 
     additional extension of 45 days.
       ``(B) Notice of any such extension, together with a 
     succinct statement of the reasons therefor, shall be inserted 
     in the rulemaking file.

     ``Sec. 642. Delegation of authority

       ``(a) In General.--The President may delegate the authority 
     granted by this subchapter to an officer within the Executive 
     Office of the President whose appointment has been subject to 
     the advice and consent of the Senate.
       ``(b) Notice.--Notice of any delegation, or any revocation 
     or modification thereof shall be published in the Federal 
     Register.

     ``Sec. 643. Judicial review

       ``The exercise of the authority granted under this 
     subchapter by the Director, the President, or by an officer 
     to whom such authority has been delegated under section 642 
     and agency compliance or noncompliance with the procedure 
     under section 641 shall not be subject to judicial review.

     ``Sec. 644. Regulatory agenda

       ``The head of each agency shall provide, as part of the 
     semiannual regulatory agenda published under section 602--
       ``(1) a list of risk assessments subject to subsection 632 
     (a) or (b)(1) under preparation or planned by the agency;
       ``(2) a brief summary of relevant issues addressed or to be 
     addressed by each listed risk assessment;
       ``(3) an approximate schedule for completing each listed 
     risk assessment;
       ``(4) an identification of potential rules, guidance, or 
     other agency actions supported or affected by each listed 
     risk assessment; and
       ``(5) the name, address, and telephone number of an agency 
     official knowledgeable about each listed risk assessment.''.
       (b) Regulatory Flexibility Analysis.--
       (1) Final regulatory flexibility analysis.--Section 604 of 
     title 5, United States Code, is amended by adding at the end 
     thereof the following new subsection:
       ``(c)(1) Except as provided in paragraph (2), no final rule 
     for which a final regulatory flexibility analysis is required 
     under this section shall be promulgated unless the agency 
     finds that the final rule minimizes significant economic 
     impact on small entities to the maximum extent possible, 
     consistent with the purposes of this subchapter, the 
     objectives of the rule, and the requirements of applicable 
     statutes.
       ``(2) If an agency determines that a statute requires a 
     rule to be promulgated that does not satisfy the criterion of 
     paragraph (1), the agency shall--
       ``(A) include a written explanation of such determination 
     in the final regulatory flexibility analysis; and
       ``(B) transmit the final regulatory flexibility analysis to 
     Congress when the final rule is promulgated.''.
       (2) Judicial review.--Section 611 of title 5, United States 
     Code, is amended to read as follows:
     ``Sec. 611. Judicial review

       ``(a)(1) For any rule described in section 603(a), and with 
     respect to which the agency--
       ``(A) certified, pursuant to section 605(b), that such rule 
     would not have a significant economic impact on a substantial 
     number of small entities;
       ``(B) prepared a final regulatory flexibility analysis 
     pursuant to section 604; or
       ``(C) did not prepare an initial regulatory flexibility 
     analysis pursuant to section 603 or a final regulatory 
     flexibility analysis pursuant to section 604 except as 
     permitted by sections 605 and 608,

     an affected small entity may petition for the judicial review 
     of such certification, analysis, or failure to prepare such 
     analysis, in accordance with this subsection. A court having 
     jurisdiction to review such rule for compliance with section 
     553 or under any other provision of law shall have 
     jurisdiction over such petition.
       ``(2)(A) Notwithstanding any other provision of law, an 
     affected small entity shall have 1 year after the effective 
     date of the final rule to challenge the certification, 
     analysis or failure to prepare an analysis required by this 
     subchapter with respect to any such rule.
       ``(B) If an agency delays the issuance of a final 
     regulatory flexibility analysis pursuant to section 608(b), a 
     petition for judicial review under this subsection may be 
     filed not later than 1 year after the date the analysis is 
     made available to the public.
       ``(3) For purposes of this subsection, the term `affected 
     small entity' means a small entity that is or will be subject 
     to the provisions of, or otherwise required to comply with, 
     the final rule.
       ``(4) Nothing in this subsection shall be construed to 
     limit the authority of any court to stay the effective date 
     of any rule or provision thereof under any other provision of 
     law.
       ``(5)(A) Notwithstanding section 605, if the court 
     determines, on the basis of the court's review of the 
     rulemaking record, that there is substantial evidence that 
     the rule would have a significant economic impact on a 
     substantial number of small entities, the court shall order 
     the agency to prepare a final regulatory flexibility analysis 
     that satisfies the requirements of section 604.
       ``(B) If the agency prepared a final regulatory flexibility 
     analysis, the court shall order the agency to take corrective 
     action consistent with section 604 if the court determines, 
     on the basis of the court's review of the rulemaking record, 
     that the final regulatory flexibility analysis does not 
     satisfy the requirements of section 604.
       ``(6) The court shall stay the rule and grant such other 
     relief as the court determines to be appropriate if, by the 
     end of the 90-day period beginning on the date of the order 
     of the court pursuant to paragraph (5), the agency fails, as 
     appropriate--
       ``(A) to prepare the analysis required by section 604; or
       ``(B) to take corrective action consistent with section 
     604.
       ``(b) In an action for the judicial review of a rule, any 
     regulatory flexibility analysis for such rule (including an 
     analysis prepared or corrected pursuant to subsection (a)(5)) 
     shall constitute part of the whole record of agency action in 
     connection with such review.
       ``(c) Except as otherwise required by the provisions of 
     this subchapter, the court shall apply the same standards of 
     judicial review that govern the review of agency findings 
     under the statute granting the agency authority to conduct 
     the rulemaking.''.
       (c) Revision of Certain Provisions of the Federal Food, 
     Drug, and Cosmetic Act Relating to Testing.--In applying 
     section 409(c)(3)(A), 512(d)(1), or 721(b)(5)(B) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(c)(3)(A), 
     360b(d)(1), 379e(b)(5)(B)), the Secretary of Health and Human 
     Services and the Administrator of the Environmental 
     Protection Agency shall not prohibit or refuse to approve a 
     substance or product on the basis of safety, where the 
     substance or product presents a negligible or insignificant 
     foreseeable risk to human health resulting from its intended 
     use.
       (d) Toxic Release Inventory Review.--
       (1) Not later than 180 days after the date of enactment of 
     this subsection, the Administrator of the Environmental 
     Protection Agency shall carry out a review of each 
     characterization or listing of a substance added since 
     November 8, 1994, to the Toxic Release Inventory under 
     section 313(c) of the Emergency Planning and Community Right 
     to Know Act of 1986 (42 U.S.C. 11023(c)).
       (2) In this review, the Administrator shall determine with 
     respect to each such characterization or listing whether 
     removal of the substance from the Toxic Release Inventory 

[[Page S9293]]
     presents a foreseeable significant risk to human health or the 
     environment.
       (3) The Administrator shall remove from the Toxic Release 
     Inventory any substance the removal of which is justified by 
     a determination under paragraph (2).
       (4)(A) Not later than 90 days after the date of enactment 
     of this section, the Administrator shall publish a draft 
     review and the Administrator's preliminary plans to use the 
     authority under paragraph (3), and afford interested persons 
     an opportunity to comment.
       (B) Promptly upon completion of the review, the 
     Administrator shall provide Congress with a written report 
     summarizing the review and the reasons for action or inaction 
     on each characterization or listing subject to this 
     subsection.
       (e) Technical and Conforming Amendments.--
       (1) Chapter analysis.--Part I of title 5, United States 
     Code, is amended by striking the chapter heading and table of 
     sections 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 analysis.
``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--ANALYSIS OF AGENCY RULES

``621. Definitions.
``622. Rulemaking cost-benefit analysis.
``623. Agency regulatory review.
``624. Decisional criteria.
``625. Jurisdiction and judicial review.
``626. Deadlines for rulemaking.
``627. Special rule.
``628. Requirements for major environmental management activities.

                   ``SUBCHAPTER III--RISK ASSESSMENTS

``631. Definitions.
``632. Applicability.
``633. Principles for risk assessments.
``634. Rule of construction.
``635. Comprehensive risk reduction.

                  ``SUBCHAPTER IV--EXECUTIVE OVERSIGHT

``641. Procedures.
``642. Delegation of authority.
``643. Judicial review.
``644. Regulatory agenda.''.
       (2) Subchapter heading.--Chapter 6 of title 5, United 
     States Code, is amended by inserting immediately before 
     section 601, the following subchapter heading:

                 ``SUBCHAPTER I--REGULATORY ANALYSIS''.

     SEC. 5. JUDICIAL REVIEW.

       (a) In general.--Chapter 7 of title 5, United States Code, 
     is amended--
       (1) by striking section 706; and
       (2) by adding at the end the following new sections:

     ``Sec. 706. Scope of review

       ``(a) To the extent necessary to reach a decision and when 
     presented, the reviewing court shall decide all relevant 
     questions of law, interpret constitutional and statutory 
     provisions, and determine the meaning or applicability of the 
     terms of an agency action. The reviewing court shall--
       ``(1) compel agency action unlawfully withheld or 
     unreasonably delayed; and
       ``(2) hold unlawful and set aside agency action, findings 
     and conclusions found to be--
       ``(A) arbitrary, capricious, an abuse of discretion, or 
     otherwise not in accordance with law;
       ``(B) contrary to constitutional right, power, privilege, 
     or immunity;
       ``(C) in excess of statutory jurisdiction, authority, or 
     limitations, or short of statutory right;
       ``(D) without observance of procedure required by law;
       ``(E) unsupported by substantial evidence in a proceeding 
     subject to sections 556 and 557 or otherwise reviewed on the 
     record of an agency hearing provided by statute;
       ``(F) without substantial support in the rulemaking file, 
     viewed as a whole, for the asserted or necessary factual 
     basis, in the case of a rule adopted in a proceeding subject 
     to section 553; or
       ``(G) unwarranted by the facts to the extent that the facts 
     are subject to trial de novo by the reviewing court.
       ``(b) In making the determinations set forth in subsection 
     (a), the court shall review the whole record or those parts 
     of it cited by a party, and due account shall be taken of the 
     rule of prejudicial error.

     ``Sec. 707. Consent decrees

       ``In interpreting any consent decree in effect on or after 
     the date of enactment of this section that imposes on an 
     agency an obligation to initiate, continue, or complete 
     rulemaking proceedings, the court shall not enforce the 
     decree in a way that divests the agency of discretion clearly 
     granted to the agency by statute to respond to changing 
     circumstances, make policy or managerial choices, or protect 
     the rights of third parties.

     ``Sec. 708. Affirmative defense

       ``Notwithstanding any other provision of law, it shall be 
     an affirmative defense in any enforcement action brought by 
     an agency that the regulated person or entity reasonably 
     relied on and is complying with a rule, regulation, 
     adjudication, directive, or order of such agency or any other 
     agency that is incompatible, contradictory, or otherwise 
     cannot be reconciled with the agency rule, regulation, 
     adjudication, directive, or order being enforced.''.
       (b) Technical Amendment.--The analysis for chapter 7 of 
     title 5, United States Code, is amended by striking the item 
     relating to section 706 and inserting the following new 
     items:

``706. Scope of review.
``707. Consent decrees.
``708. Affirmative defense.''.
     SEC. 6. CONGRESSIONAL REVIEW.

       (a) Finding.--The Congress finds that effective steps for 
     improving the efficiency and proper management of Government 
     operations will be promoted if a moratorium on the 
     implementation of certain significant final rules is imposed 
     in order to provide Congress an opportunity for review.
       (b) In General.--Title 5, United States Code, is amended by 
     inserting immediately after chapter 7 the following new 
     chapter:

         ``CHAPTER 8--CONGRESSIONAL REVIEW OF AGENCY RULEMAKING

``801. Congressional review.
``802. Congressional disapproval procedure.
``803. Special rule on statutory, regulatory, and judicial deadlines.
``804. Definitions.
``805. Judicial review.
``806. Applicability; severability.
``807. Exemption for monetary policy.
     ``Sec. 801. Congressional review

       ``(a)(1)(A) Before a rule can take effect as a final rule, 
     the Federal agency promulgating such rule shall submit to 
     each House of the Congress and to the Comptroller General a 
     report containing--
       ``(i) a copy of the rule;
       ``(ii) a concise general statement relating to the rule; 
     and
       ``(iii) the proposed effective date of the rule.
       ``(B) The Federal agency promulgating the rule shall make 
     available to each House of Congress and the Comptroller 
     General, upon request--
       ``(i) a complete copy of the cost-benefit analysis of the 
     rule, if any;
       ``(ii) the agency's actions relevant to sections 603, 604, 
     605, 607, and 609;
       ``(iii) the agency's actions relevant to sections 202, 203, 
     204, and 205 of the Unfunded Mandates Reform Act of 1995; and
       ``(iv) any other relevant information or requirements under 
     any other Act and any relevant Executive orders, such as 
     Executive Order No. 12866.
       ``(C) Upon receipt, each House shall provide copies to the 
     Chairman and Ranking Member of each committee with 
     jurisdiction.
       ``(2)(A) The Comptroller General shall provide a report on 
     each major rule to the committees of jurisdiction to each 
     House of the Congress by the end of 12 calendar days after 
     the submission or publication date as provided in section 
     802(b)(2). The report of the Comptroller General shall 
     include an assessment of the agency's compliance with 
     procedural steps required by paragraph (1)(B).
       ``(B) Federal agencies shall cooperate with the Comptroller 
     General by providing information relevant to the Comptroller 
     General's report under subparagraph (A).
       ``(3) A major rule relating to a report submitted under 
     paragraph (1) shall take effect as a final rule, the latest 
     of--
       ``(A) the later of the date occurring 60 days after the 
     date on which--
       ``(i) the Congress receives the report submitted under 
     paragraph (1); or
       ``(ii) the rule is published in the Federal Register;
       ``(B) if the Congress passes a joint resolution of 
     disapproval described under section 802 relating to the rule, 
     and the President signs a veto of such resolution, the 
     earlier date--
       ``(i) on which either House of Congress votes and fails to 
     override the veto of the President; or
       ``(ii) occurring 30 session days after the date on which 
     the Congress received the veto and objections of the 
     President; or
       ``(C) the date the rule would have otherwise taken effect, 
     if not for this section (unless a joint resolution of 
     disapproval under section 802 is enacted).
       ``(4) Except for a major rule, a rule shall take effect as 
     otherwise provided by law after submission to Congress under 
     paragraph (1).
       ``(5) Notwithstanding paragraph (3), the effective date of 
     a rule shall not be delayed by operation of this chapter 
     beyond the date on which either House of Congress votes to 
     reject a joint resolution of disapproval under section 802.
       ``(b) A rule shall not take effect (or continue) as a final 
     rule, if the Congress passes a joint resolution of 
     disapproval described under section 802.
       ``(c)(1) Notwithstanding any other provision of this 
     section (except subject to paragraph (3)), a rule that would 
     not take effect by reason of this chapter may take effect, if 
     the President makes a determination under paragraph (2) and 
     submits written notice of such determination to the Congress.

[[Page S9294]]

       ``(2) Paragraph (1) applies to a determination made by the 
     President by Executive order that the rule should take effect 
     because such rule is--
       ``(A) necessary because of an imminent threat to health or 
     safety or other emergency;
       ``(B) necessary for the enforcement of criminal laws;
       ``(C) necessary for national security; or
       ``(D) issued pursuant to a statute implementing an 
     international trade agreement.
       ``(3) An exercise by the President of the authority under 
     this subsection shall have no effect on the procedures under 
     section 802 or the effect of a joint resolution of 
     disapproval under this section.
       ``(d)(1) In addition to the opportunity for review 
     otherwise provided under this chapter, in the case of any 
     rule that is published in the Federal Register (as a rule 
     that shall take effect as a final rule) during the period 
     beginning on the date occurring 60 days before the date the 
     Congress adjourns sine die through the date on which the 
     succeeding Congress first convenes, section 802 shall apply 
     to such rule in the succeeding Congress.
       ``(2)(A) In applying section 802 for purposes of such 
     additional review, a rule described under paragraph (1) shall 
     be treated as though--
       ``(i) such rule were published in the Federal Register (as 
     a rule that shall take effect as a final rule) on the 15th 
     session day after the succeeding Congress first convenes; and
       ``(ii) a report on such rule were submitted to Congress 
     under subsection (a)(1) on such date.
       ``(B) Nothing in this paragraph shall be construed to 
     affect the requirement under subsection (a)(1) that a report 
     shall be submitted to Congress before a final rule can take 
     effect.
       ``(3) A rule described under paragraph (1) shall take 
     effect as a final rule as otherwise provided by law 
     (including other subsections of this section).
       ``(e)(1) Section 802 shall apply in accordance with this 
     subsection to any major rule that is published in the Federal 
     Register (as a rule that shall take effect as a final rule) 
     during the period beginning on November 20, 1994, through the 
     date on which the Comprehensive Regulatory Reform Act of 1995 
     takes effect.
       ``(2) In applying section 802 for purposes of Congressional 
     review, a rule described under paragraph (1) shall be treated 
     as though--
       ``(A) such rule were published in the Federal Register (as 
     a rule that shall take effect as a final rule) on the date of 
     enactment of the Comprehensive Regulatory Reform Act of 1995; 
     and
       ``(B) a report on such rule were submitted to Congress 
     under subsection (a)(1) on such date.
       ``(3) The effectiveness of a rule described under paragraph 
     (1) shall be as otherwise provided by law, unless the rule is 
     made of no force or effect under section 802.
       ``(f) Any rule that takes effect and later is made of no 
     force or effect by enactment of a joint resolution under 
     section 802 shall be treated as though such rule had never 
     taken effect.
       ``(g) If the Congress does not enact a joint resolution of 
     disapproval under section 802, no court or agency may infer 
     any intent of the Congress from any action or inaction of the 
     Congress with regard to such rule, related statute, or joint 
     resolution of disapproval.

     ``Sec. 802. Congressional disapproval procedure

       ``(a) For purposes of this section, the term `joint 
     resolution' means only a joint resolution introduced during 
     the period beginning on the date on which the report referred 
     to in section 801(a) is received by Congress and ending 60 
     days thereafter, the matter after the resolving clause of 
     which is as follows: `That Congress disapproves the rule 
     submitted by the ____ relating to ____, and such rule shall 
     have no force or effect.'. (The blank spaces being 
     appropriately filled in.)
       ``(b)(1) A resolution described in paragraph (1) shall be 
     referred to the committees in each House of Congress with 
     jurisdiction. Such a resolution may not be reported before 
     the eighth day after its submission or publication date.
       ``(2) For purposes of this subsection the term `submission 
     or publication date' means the later of the date on which--
       ``(A) the Congress receives the report submitted under 
     section 801(a)(1); or
       ``(B) the rule is published in the Federal Register.
       ``(c) If the committee to which is referred a resolution 
     described in subsection (a) has not reported such resolution 
     (or an identical resolution) at the end of 20 calendar days 
     after the submission or publication date defined under 
     subsection (b)(2), such committee may be discharged from 
     further consideration of such resolution in the Senate upon a 
     petition supported in writing by 30 Members of the Senate and 
     in the House upon a petition supported in writing by one-
     fourth of the Members duly sworn and chosen or by motion of 
     the Speaker supported by the Minority Leader, and such 
     resolution shall be placed on the appropriate calendar of the 
     House involved.
       ``(d)(1) When the committee to which a resolution is 
     referred has reported, or when a committee is discharged 
     (under subsection (c)) from further consideration of, a 
     resolution described in subsection (a), it is at any time 
     thereafter in order (even though a previous motion to the 
     same effect has been disagreed to) for a motion to proceed to 
     the consideration of the resolution, and all points of order 
     against the resolution (and against consideration of 
     resolution) are waived. The motion is not subject to 
     amendment, or to a motion to postpone, or to a motion to 
     proceed to the consideration of other business. A motion to 
     reconsider the vote by which the motion is agreed to or 
     disagreed to shall not be in order. If a motion to proceed to 
     the consideration of the resolution is agreed to, the 
     resolution shall remain the unfinished business of the 
     respective House until disposed of.
       ``(2) Debate on the resolution, and on all debatable 
     motions and appeals in connection therewith, shall be limited 
     to not more than 10 hours, which shall be divided equally 
     between those favoring and those opposing the resolution. A 
     motion further to limit debate is in order and not debatable. 
     An amendment to, or a motion to postpone, or a motion to 
     proceed to the consideration of other business, or a motion 
     to recommit the resolution is not in order.
       ``(3) Immediately following the conclusion of the debate on 
     a resolution described in subsection (a), and a single quorum 
     call at the conclusion of the debate if requested in 
     accordance with the rules of the appropriate House, the vote 
     on final passage of the resolution shall occur.
       ``(4) Appeals from the decisions of the Chair relating to 
     the application of the rules of the Senate or the House of 
     Representatives, as the case may be, to the procedure 
     relating to a resolution described in subsection (a) shall be 
     decided without debate.
       ``(e) If, before the passage by one House of a resolution 
     of that House described in subsection (a), that House 
     receives from the other House a resolution described in 
     subsection (a), then the following procedures shall apply:
       ``(1) The resolution of the other House shall not be 
     referred to a committee.
       ``(2) With respect to a resolution described in subsection 
     (a) of the House receiving the resolution--
       ``(A) the procedure in that House shall be the same as if 
     no resolution had been received from the other House; but
       ``(B) the vote on final passage shall be on the resolution 
     of the other House.
       ``(f) This section is enacted by Congress--
       ``(1) as an exercise of the rulemaking power of the Senate 
     and House of Representatives, respectively, and as such it is 
     deemed a part of the rules of each House, respectively, but 
     applicable only with respect to the procedure to be followed 
     in that House in the case of a resolution described in 
     subsection (a), and it supersedes other rules only to the 
     extent that it is inconsistent with such rules; and
       ``(2) with full recognition of the constitutional right of 
     either House to change the rules (so far as relating to the 
     procedure of that House) at any time, in the same manner, and 
     to the same extent as in the case of any other rule of that 
     House.

     ``Sec. 803. Special rule on statutory, regulatory, and 
       judicial deadlines

       ``(a) In the case of any deadline for, relating to, or 
     involving any rule which does not take effect (or the 
     effectiveness of which is terminated) because of enactment of 
     a joint resolution under section 802, that deadline is 
     extended until the date 1 year after the date of the joint 
     resolution. Nothing in this subsection shall be construed to 
     affect a deadline merely by reason of the postponement of a 
     rule's effective date under section 801(a).
       ``(b) The term `deadline' means any date certain for 
     fulfilling any obligation or exercising any authority 
     established by or under any Federal statute or regulation, or 
     by or under any court order implementing any Federal statute 
     or regulation.

     ``Sec. 804. Definitions

       ``(a) For purposes of this chapter--
       ``(1) the term `Federal agency' means any agency as that 
     term is defined in section 551(1) (relating to administrative 
     procedure);
       ``(2) the term `major rule' has the same meaning given such 
     term in section 621(5); and
       ``(3) the term `final rule' means any final rule or interim 
     final rule.
       ``(b) As used in subsection (a)(3), the term `rule' has the 
     meaning given such term in section 551, except that such term 
     does not include any rule of particular applicability 
     including a rule that approves or prescribes for the future 
     rates, wages, prices, services, or allowances therefor, 
     corporate or financial structures, reorganizations, mergers, 
     or acquisitions thereof, or accounting practices or 
     disclosures bearing on any of the foregoing or any rule of 
     agency organization, personnel, procedure, practice or any 
     routine matter.

     ``Sec. 805. Judicial review

       ``No determination, finding, action, or omission under this 
     chapter shall be subject to judicial review.

     ``Sec. 806. Applicability; severability

       ``(a) This chapter shall apply notwithstanding any other 
     provision of law.
       ``(b) If any provision of this chapter or the application 
     of any provision of this chapter to any person or 
     circumstance, is held invalid, the application of such 
     provision to other persons or circumstances, and the 
     remainder of this chapter, shall not be affected thereby.

     ``Sec. 807. Exemption for monetary policy

       ``Nothing in this chapter shall apply to rules that concern 
     monetary policy proposed or implemented by the Board of 
     Governors of the Federal Reserve System or the Federal Open 
     Market Committee.''.

[[Page S9295]]

       (c) Effective Date.--The amendment made by subsection (b) 
     shall take effect on the date of enactment of this Act and 
     shall apply to any rule that takes effect as a final rule on 
     or after such effective date.
       (d) Technical Amendment.--The table of chapters for part I 
     of title 5, United States Code, is amended by inserting 
     immediately after the item relating to chapter 7 the 
     following:

``8. Congressional Review of Agency Rulemaking...............801''.....
     SEC. 7. REGULATORY ACCOUNTING.

       (a) Definitions.--For purposes of this section, the 
     following definitions apply:
       (1) Major rule.--The term ``major rule'' has the same 
     meaning as defined in section 621(5)(A)(i) of title 5, United 
     States Code. The term shall not include--
       (A) administrative actions governed by sections 556 and 557 
     of title 5, United States Code;
       (B) regulations issued with respect to a military or 
     foreign affairs function of the United States or a statute 
     implementing an international trade agreement; or
       (C) regulations related to agency organization, management, 
     or personnel.
       (2) Agency.--The term ``agency'' means any executive 
     department, military department, Government corporation, 
     Government controlled corporation, or other establishment in 
     the executive branch of the Government (including the 
     Executive Office of the President), or any independent 
     regulatory agency, but shall not include--
       (A) the General Accounting Office;
       (B) the Federal Election Commission;
       (C) the governments of the District of Columbia and of the 
     territories and possessions of the United States, and their 
     various subdivisions; or
       (D) Government-owned contractor-operated facilities, 
     including laboratories engaged in national defense research 
     and production activities.
       (b) Accounting Statement.--
       (1) In general.--(A) The President shall be responsible for 
     implementing and administering the requirements of this 
     section.
       (B) Not later than June 1, 1997, and each June 1 
     thereafter, the President shall prepare and submit to 
     Congress an accounting statement that estimates the annual 
     costs of major rules and corresponding benefits in accordance 
     with this subsection.
       (2) Years covered by accounting statement.--Each accounting 
     statement shall cover, at a minimum, the 5 fiscal years 
     beginning on October 1 of the year in which the report is 
     submitted and may cover any fiscal year preceding such fiscal 
     years for purpose of revising previous estimates.
       (3) Timing and procedures.--(A) The President shall provide 
     notice and opportunity for comment for each accounting 
     statement. The President may delegate to an agency the 
     requirement to provide notice and opportunity to comment for 
     the portion of the accounting statement relating to that 
     agency.
       (B) The President shall propose the first accounting 
     statement under this subsection not later than 2 years after 
     the date of enactment of this Act and shall issue the first 
     accounting statement in final form not later than 3 years 
     after such effective date. Such statement shall cover, at a 
     minimum, each of the fiscal years beginning after the date of 
     enactment of this Act.
       (4) Content of accounting statement.--(A) Each accounting 
     statement shall contain estimates of costs and benefits with 
     respect to each fiscal year covered by the statement in 
     accordance with this paragraph. For each such fiscal year for 
     which estimates were made in a previous accounting statement, 
     the statement shall revise those estimates and state the 
     reasons for the revisions.
       (B)(i) An accounting statement shall estimate the costs of 
     major rules by setting forth, for each year covered by the 
     statement--
       (I) the annual expenditure of national economic resources 
     for major rules, grouped by regulatory program; and
       (II) such other quantitative and qualitative measures of 
     costs as the President considers appropriate.
       (ii) For purposes of the estimate of costs in the 
     accounting statement, national economic resources shall 
     include, and shall be listed under, at least the following 
     categories:
       (I) Private sector costs.
       (II) Federal sector costs.
       (III) State and local government administrative costs.
       (C) An accounting statement shall estimate the benefits of 
     major rules by setting forth, for each year covered by the 
     statement, such quantitative and qualitative measures of 
     benefits as the President considers appropriate. Any 
     estimates of benefits concerning reduction in health, safety, 
     or environmental risks shall present the most plausible level 
     of risk practical, along with a statement of the reasonable 
     degree of scientific certainty.
       (c) Associated Report to Congress.--
       (1) In general.--At the same time as the President submits 
     an accounting statement under subsection (b), the President, 
     acting through the Director of the Office of Management and 
     Budget, shall submit to Congress a report associated with the 
     accounting statement (hereinafter referred to as an 
     ``associated report''). The associated report shall contain, 
     in accordance with this subsection--
       (A) analyses of impacts; and
       (B) recommendations for reform.
       (2) Analyses of impacts.--The President shall include in 
     the associated report the following:
       (A) Analyses prepared by the President of the cumulative 
     impact of major rules in Federal regulatory programs covered 
     in the accounting statement on the following:
       (i) The ability of State and local governments to provide 
     essential services, including police, fire protection, and 
     education.
       (ii) Small business.
       (iii) Productivity.
       (iv) Wages.
       (v) Economic growth.
       (vi) Technological innovation.
       (vii) Consumer prices for goods and services.
       (viii) Such other factors considered appropriate by the 
     President.
       (B) A summary of any independent analyses of impacts 
     prepared by persons commenting during the comment period on 
     the accounting statement.
       (3) Recommendations for reform.--The President shall 
     include in the associated report the following:
       (A) A summary of recommendations of the President for 
     reform or elimination of any Federal regulatory program or 
     program element that does not represent sound use of national 
     economic resources or otherwise is inefficient.
       (B) A summary of any recommendations for such reform or 
     elimination of Federal regulatory programs or program 
     elements prepared by persons commenting during the comment 
     period on the accounting statement.
       (d) Guidance From Office of Management and Budget.--The 
     Director of the Office of Management and Budget shall, in 
     consultation with the Council of Economic Advisers, provide 
     guidance to agencies--
       (1) to standardize measures of costs and benefits in 
     accounting statements prepared pursuant to sections 3 and 7 
     of this Act, including--
       (A) detailed guidance on estimating the costs and benefits 
     of major rules; and
       (B) general guidance on estimating the costs and benefits 
     of all other rules that do not meet the thresholds for major 
     rules; and
       (2) to standardize the format of the accounting statements.
       (e) Recommendations From Congressional Budget Office.--
     After each accounting statement and associated report 
     submitted to Congress, the Director of the Congressional 
     Budget Office shall make recommendations to the President--
       (1) for improving accounting statements prepared pursuant 
     to this section, including recommendations on level of detail 
     and accuracy; and
       (2) for improving associated reports prepared pursuant to 
     this section, including recommendations on the quality of 
     analysis.
       (f) Judicial Review.--No requirements under this section 
     shall be subject to judicial review in any manner.

     SEC. 8. STUDIES AND REPORTS.

       (a) Risk Assessments.--The Administrative Conference of the 
     United States shall--
       (1) develop and carry out an ongoing study of the operation 
     of the risk assessment requirements of subchapter III of 
     chapter 6 of title 5, United States Code (as added by section 
     4 of this Act); and
       (2) submit an annual report to the Congress on the findings 
     of the study.
       (b) Administrative Procedure Act.--Not later than December 
     31, 1996, the Administrative Conference of the United States 
     shall--
       (1) carry out a study of the operation of the 
     Administrative Procedure Act (as amended by section 3 of this 
     Act); and
       (2) submit a report to the Congress on the findings of the 
     study, including proposals for revision, if any.

     SEC. 9. MISCELLANEOUS PROVISIONS.

       (a) Effective Date.--Except as otherwise provided, this Act 
     and the amendments made by this Act shall take effect on the 
     date of enactment.
       (b) Severability.--If any provision of this Act, an 
     amendment made by this Act, or the application of such 
     provision or amendment to any person or circumstance is held 
     to be unconstitutional, the remainder of this Act, the 
     amendments made by this Act, and the application of the 
     provisions of such to any person or circumstance shall not be 
     affected thereby.

  Mr. JOHNSTON. Mr. President, I understand that will be the pending 
business when the Senate returns from recess. In the meantime, we will 
continue to discuss this package with our colleagues and, hopefully, 
will be able to arrive at further modifications along the lines we have 
talked about. I believe those negotiations will happen tomorrow.
  Mr. LEVIN. Reserving the right to object, Mr. President, there was a 
unanimous-consent agreement that had been entered into previously 
between Senator Dole and Senator Daschle. Is there any intent in what 
the Senator from Louisiana has just said to modify in any way the 
previous unanimous-consent agreement that had been entered into?
  Mr. JOHNSTON. No, the only unanimous consent I asked is that when 
this draft is prepared, that it be printed in the Record for notice. 

[[Page S9296]]

  The majority leader, I was just informed, will ask on tomorrow 
afternoon--I did not ask unanimous consent but I was just advised that 
he would ask for permission to withdraw the committee amendments to S. 
343 and send a substitute to the desk.
  I am not asking that be done. I was just giving the Senate notice 
because his staff just gave me that notice. I wanted to make the Senate 
aware of that.
  I hope tomorrow we can reassure Senators on matters, or change that 
which needs to be changed, and get a very broad consensus bill so when 
we come back after the recess we will have a bill that passes 
overwhelmingly.
  Mr. President, I said a moment ago Senator Dole intended to put in 
the substitute tomorrow afternoon. I meant on Friday afternoon, because 
that is what he meant. I wanted to give my colleagues notice of that.

                          ____________________