[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 1001 Introduced in Senate (IS)]







104th CONGRESS
  1st Session
                                S. 1001

        To reform regulatory procedures, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                June 29 (legislative day, June 19), 1995

   Mr. Glenn (for himself, Mr. Chafee, Mr. Levin, Mr. Lieberman, Mr. 
 Cohen, Mr. Pryor, Mr. Kerry, Mr. Lautenberg, Mr. Daschle, Mrs. Boxer, 
Mr. Kohl, Mr. Simon, Mrs. Murray, Mr. Akaka, Mr. Kennedy, Mr. Dodd, Mr. 
  Dorgan, Mr. Jeffords, and Mr. Biden) introduced the following bill; 
  which was read twice and referred to the Committee on Governmental 
                                Affairs

_______________________________________________________________________

                                 A BILL


 
        To reform regulatory procedures, and for other purposes.
    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Regulatory Procedures 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 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; 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 631(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 (47 
                U.S.C. 312(a)(7) and 315).
``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. 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 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 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.
    ``(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--
            ``(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 agency shall immediately commence a rulemaking 
action pursuant to section 553 of this title to repeal the rule.
    ``(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 
        633(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. Definitions
    ``For purposes of this subchapter, the definitions under sections 
551 and 621 shall apply, and--
            ``(1) the term `covered agency' means each agency required 
        to comply with this subchapter, as provided in section 632;
            ``(2) the term `emergency' means an imminent or substantial 
        endangerment to public health, safety, or the environment if no 
        action is taken;
            ``(3) the term `exposure assessment' means the scientific 
        determination of the intensity, frequency, and duration of 
        exposures to the hazard in question;
            ``(4) 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;
            ``(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 
        individual 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) Except as provided in subsection (c), this subchapter shall 
apply to all risk assessments and risk characterizations prepared in 
connection with a major rule addressing health, safety, and 
environmental risks by--
            ``(1) the Secretary of Defense, for major rules relating to 
        the programs and responsibilities of the United States Army 
        Corps of Engineers;
            ``(2) the Secretary of the Interior, for major rules 
        relating to the programs and responsibilities of the Office of 
        Surface Mining Reclamation and Enforcement;
            ``(3) the Secretary of Agriculture, for major rules 
        relating to the programs and responsibilities of--
                    ``(A) the Animal and Plant Health Inspection 
                Service;
                    ``(B) the Grain Inspection, Packers, and Stockyards 
                Administration;
                    ``(C) the Food Safety and Inspection Service;
                    ``(D) the Forest Service; and
                    ``(E) the Natural Resources Conservation Service;
            ``(4) the Secretary of Commerce, for major rules relating 
        to the programs and responsibilities of the National Marine 
        Fisheries Service;
            ``(5) the Secretary of Labor, for major rules relating to 
        the programs and responsibilities of--
                    ``(A) the Occupational Safety and Health 
                Administration; and
                    ``(B) the Mine Safety and Health Administration;
            ``(6) the Secretary of Health and Human Services, for major 
        rules relating to the programs and responsibilities assigned to 
        the Food and Drug Administration;
            ``(7) the Secretary of Transportation, for major rules 
        relating to the programs and responsibilities assigned to--
                    ``(A) the Federal Aviation Administration; and
                    ``(B) the National Highway Traffic Safety 
                Administration;
            ``(8) the Secretary of Energy, for major rules relating to 
        nuclear safety, occupational safety and health, and 
        environmental restoration and waste management;
            ``(9) the Chairman of the Consumer Product Safety 
        Commission;
            ``(10) the Administrator of the Environmental Protection 
        Agency; and
            ``(11) the Chairman of the Nuclear Regulatory Commission.
    ``(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), 
this subchapter shall apply to any agency determined to be a covered 
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, 
        compliance or enforcement action, 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. 633. 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; or
            ``(2) require the disclosure of any trade secret or other 
        confidential information.
``Sec. 634. Principles for risk assessments
    ``(a)(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) 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 meets 
the requirements of this section.
    ``(5)(A) In conducting a risk assessment, the head of each agency 
shall employ the level of detail and rigor 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.
    ``(B)(i) 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.
    ``(ii) 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.
    ``(b)(1) The head of each agency shall base each risk assessment on 
the best reasonably available scientific information, 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 head of an agency shall select data for use in the 
assessment based on an appropriate consideration of the quality and 
relevance of the data, and shall describe the basis for selecting the 
data.
    ``(3) In making its selection of data, the head of an agency shall 
consider whether the data were developed in accordance with good 
scientific practice or other appropriate protocols to ensure data 
quality.
    ``(4) Subject to paragraph (3), relevant scientific data submitted 
by interested parties shall be reviewed and considered in the analysis 
by the head of an agency 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 data.
    ``(c)(1) To the maximum extent practicable, the head of each agency 
shall use postulates, including default assumptions, inferences, 
models, or safety factors, when relevant scientific data and 
understanding, including site-specific data, are lacking.
    ``(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 postulate has been 
        validated by, or conflicts with, empirical data;
            ``(B) explain the basis for any choices among postulates; 
        and
            ``(C) describe reasonable alternative postulates that were 
        not selected by the agency for use in the risk assessment, and 
        the sensitivity for 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 postulates.
    ``(4) The head of each agency shall develop a procedure and publish 
guidelines for choosing default postulates and for deciding when and 
how in a specific risk assessments to adopt alternative postulates or 
to use available scientific information in place of a default 
postulate.
    ``(d) The head of each agency shall provide appropriate 
opportunities for public participation and comment on risk assessments.
    ``(e) In each risk assessment, the head of each 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) To the extent feasible and scientifically appropriate, the 
head of an agency shall--
            ``(1) express the overall estimate of risk as a range or 
        probability distribution that reflects variabilities and 
        uncertainties in the analysis;
            ``(2) 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
            ``(3) where quantitative estimates of the range and 
        distribution of risk estimates are not available, describe the 
        qualitative factors influencing the range of possible risks.
    ``(g) The head of an agency shall place the nature and magnitude of 
risks to human health, safety, and the environment being analyzed in 
context, including appropriate comparisons with other risks that are 
familiar to, and routinely encountered by, the general public.
    ``(h) In any notice of proposed or final regulatory action subject 
to this subchapter, the head of an agency shall describe significant 
substitution risks to human health or safety identified by the agency 
or contained in information provided to the agency by a commentator.
``Sec. 635. 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--
            ``(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. 636. 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 principles 
under section 634, 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. 637. 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. 638. 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. 639. 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. 640. Judicial review
    ``The provisions of section 623 relating to judicial review shall 
apply to this subchapter.
``Sec. 640a. 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.
    ``(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. Definitions.
``632. Applicability.
``633. Savings provisions.
``634. Principles for risk assessment.
``635. Peer review.
``636. Guidelines, plan for assessing new information, and report.
``637. Research and training in risk assessment.
``638. Interagency coordination.
``639. Plan for review of risk assessments.
``640. Judicial review.
``640a. 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--
            ``(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 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 ``irreversibility'' 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 635, 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
                    (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.
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