[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 981 Reported in Senate (RS)]

                                                       Calendar No. 364

105th CONGRESS

  2d Session

                                 S. 981

                          [Report No. 105-188]

_______________________________________________________________________

                                 A BILL

                To provide for analysis of major rules.

_______________________________________________________________________

                              May 11, 1998

                       Reported with an amendment





                                                       Calendar No. 364
105th CONGRESS
  2d Session
                                 S. 981

                          [Report No. 105-188]

                To provide for analysis of major rules.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 27, 1997

Mr. Levin (for himself, Mr. Thompson, Mr. Glenn, Mr. Abraham, Mr. Robb, 
 Mr. Roth, Mr. Rockefeller,  Mr. Stevens, Mr. Grams, Mr. Cochran, Mr. 
 Breaux, Mr. Enzi, Mr. Warner, Mr. Frist, Mr. Gorton, and Mr. Inhofe) 
introduced the following bill; which was read twice and referred to the 
                   Committee on Governmental Affairs

                              May 11, 1998

              Reported by Mr. Thompson, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
                To provide for analysis of major rules.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Regulatory Improvement Act 
of 1997''.</DELETED>

<DELETED>SEC. 2. FINDINGS.</DELETED>

<DELETED>    Congress finds the following:</DELETED>
        <DELETED>    (1) Current regulatory programs can be improved by 
        being more firmly rooted in sound economic and scientific 
        analysis.</DELETED>
        <DELETED>    (2) Cost-benefit analysis and risk assessment are 
        useful tools to better inform agencies in developing 
        regulations, although they do not replace the need for good 
        judgment and consideration of values.</DELETED>
        <DELETED>    (3) Cost and risk need to be considered in 
        evaluating regulatory proposals which address health, safety, 
        or the environment. Other factors such as social values, 
        distributional effects, and equity, must also be 
        considered.</DELETED>
        <DELETED>    (4) Cost-benefit analysis and risk assessment 
        should be presented with a clear statement of the analytical 
        assumptions and uncertainties including an explanation of what 
        is known and not known and what the implications of alternative 
        assumptions might be.</DELETED>
        <DELETED>    (5) The public has a right to know about the costs 
        and benefits of regulations, the risks addressed, the amount of 
        risk reduced, and the quality of scientific and economic 
        analysis used to support decisions. Such knowledge will promote 
        the quality, integrity and responsiveness of agency 
        actions.</DELETED>
        <DELETED>    (6) The Administrator of the Office of Information 
        and Regulatory Affairs should oversee regulatory activities to 
        ensure consistent and valid use of cost-benefit analysis and 
        risk assessment among all agencies.</DELETED>
        <DELETED>    (7) The Federal Government should develop a better 
        understanding of the strengths, weaknesses, and uncertainties 
        of cost-benefit analysis and risk assessment and conduct the 
        research needed to improve these analytical tools.</DELETED>

<DELETED>SEC. 3. REGULATORY ANALYSIS.</DELETED>

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

        <DELETED>``SUBCHAPTER II--REGULATORY ANALYSIS</DELETED>

<DELETED>``Sec. 621. Definitions</DELETED>
<DELETED>    ``For purposes of this subchapter the definitions under 
section 551 shall apply and--</DELETED>
        <DELETED>    ``(1) the term `benefit' means the reasonably 
        identifiable significant favorable effects, quantifiable and 
        nonquantifiable, including social, health, safety, 
        environmental, economic, and distributional effects, that are 
        expected to result directly or indirectly from implementation 
        of, or compliance with, a rule;</DELETED>
        <DELETED>    ``(2) the term `cost' means the reasonably 
        identifiable significant adverse effects, quantifiable and 
        nonquantifiable, including social, health, safety, 
        environmental, economic, and distributional effects that are 
        expected to result directly or indirectly from implementation 
        of, or compliance with, a rule;</DELETED>
        <DELETED>    ``(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 uncertainties, the significance and 
        complexity of the decision, and the need to adequately inform 
        the public;</DELETED>
        <DELETED>    ``(4) the term `Director' means the Director of 
        the Office of Management and Budget, acting through the 
        Administrator of the Office of Information and Regulatory 
        Affairs;</DELETED>
        <DELETED>    ``(5) the term `flexible regulatory options' means 
        regulatory options that permit flexibility to regulated persons 
        in achieving the objective of the statute as addressed by the 
        rule making, including regulatory options that use market-based 
        mechanisms, outcome oriented performance-based standards, or 
        other options that promote flexibility;</DELETED>
        <DELETED>    ``(6) the term `major rule' means a rule or a 
        group of closely related rules that--</DELETED>
                <DELETED>    ``(A) the agency proposing the rule or the 
                Director reasonably determines is likely to have an 
                annual effect on the economy of $100,000,000 or more in 
                reasonably quantifiable costs; or</DELETED>
                <DELETED>    ``(B) is otherwise designated a major rule 
                by the Director on the ground that the rule is likely 
                to adversely affect, in a material way, the economy, a 
                sector of the economy, including small business, 
                productivity, competition, jobs, the environment, 
                public health or safety, or State, local or tribal 
                governments, or communities;</DELETED>
        <DELETED>    ``(7) the term `reasonable alternative' means a 
        reasonable regulatory option that would achieve the objective 
        of the statute as addressed by the rule making and that the 
        agency has authority to adopt under the statute granting rule 
        making authority, including flexible regulatory 
        options;</DELETED>
        <DELETED>    ``(8) the term `risk assessment' means the 
        systematic process of organizing hazard and exposure 
        assessments to estimate the potential for specific harm to 
        exposed individuals, populations, or natural 
        resources;</DELETED>
        <DELETED>    ``(9) the term `risk characterization' means the 
        presentation of risk assessment results 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;</DELETED>
        <DELETED>    ``(10) the term `rule' has the same meaning as in 
        section 551(4), and shall not include--</DELETED>
                <DELETED>    ``(A) a rule exempt from notice and public 
                comment procedure under section 553;</DELETED>
                <DELETED>    ``(B) a rule that involves the internal 
                revenue laws of the United States, or the assessment 
                and collection of taxes, duties, or other revenue or 
                receipts;</DELETED>
                <DELETED>    ``(C) 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;</DELETED>
                <DELETED>    ``(D) 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;</DELETED>
                <DELETED>    ``(E) 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;</DELETED>
                <DELETED>    ``(F) a rule or order relating to the 
                financial responsibility, recordkeeping, or reporting 
                of brokers and dealers (including Government securities 
                brokers and dealers) or futures commission merchants, 
                the safeguarding of investor securities and funds or 
                commodity future or options customer securities and 
                funds, the clearance and settlement of securities, 
                futures, or options transactions, or the suspension of 
                trading under the Securities Exchange Act of 1934 (15 
                U.S.C. 78a et seq.) or emergency action taken under the 
                Commodity Exchange Act (7 U.S.C. 1 et seq.), or a rule 
                relating to the protection of the Securities Investor 
                Protection Corporation, that is promulgated under the 
                Securities Investor Protection Act of 1970 (15 U.S.C. 
                78aaa et seq.), or a rule relating to the custody of 
                Government securities by depository institutions under 
                section 3121 or 9110 of title 31;</DELETED>
                <DELETED>    ``(G) a rule issued by the Federal 
                Election Commission or a rule issued by the Federal 
                Communications Commission under sections 312(a)(7) and 
                315 of the Communications Act of 1934 (47 U.S.C. 
                312(a)(7) and 315);</DELETED>
                <DELETED>    ``(H) a rule required to be promulgated at 
                least annually pursuant to statute; or</DELETED>
                <DELETED>    ``(I) a rule or agency action relating to 
                the public debt;</DELETED>
        <DELETED>    ``(11) the term `screening analysis' means an 
        analysis using simple assumptions to arrive at an estimate of 
        upper and lower bounds of risk as appropriate; and</DELETED>
        <DELETED>    ``(12) the term `substitution risk' means an 
        increased risk to health, safety, or the environment reasonably 
        likely to result from a regulatory option.</DELETED>
<DELETED>``Sec. 622. Applicability</DELETED>
<DELETED>    ``Except as provided in section 623(e), this subchapter 
shall apply to all proposed and final major rules.</DELETED>
<DELETED>``Sec. 623. Regulatory analysis</DELETED>
<DELETED>    ``(a)(1) Before publishing a notice of a proposed rule 
making for any rule, each agency shall determine whether the rule is or 
is not a major rule covered by this subchapter.</DELETED>
<DELETED>    ``(2) The Director may designate any rule to be a major 
rule under section 621(6)(B), if the Director--</DELETED>
        <DELETED>    ``(A) makes such designation no later than 30 days 
        after the close of the comment period for the rule; 
        and</DELETED>
        <DELETED>    ``(B) publishes such determination in the Federal 
        Register together with a succinct statement of the basis for 
        the determination within 30 days after such 
        determination.</DELETED>
<DELETED>    ``(b)(1)(A) When an agency publishes a notice of proposed 
rule making for a major rule, the agency shall prepare and place in the 
rule making file an initial regulatory analysis, and shall include a 
summary of such analysis consistent with subsection (d) in the notice 
of proposed rule making.</DELETED>
<DELETED>    ``(B)(i) When the Director has published a determination 
that a rule is a major rule after the publication of the notice of 
proposed rule making for the rule, the agency shall promptly prepare 
and place in the rule making file an initial regulatory analysis for 
the rule and shall publish in the Federal Register a summary of such 
analysis consistent with subsection (d).</DELETED>
<DELETED>    ``(ii) Following the issuance of an initial regulatory 
analysis under clause (i), the agency shall give interested persons an 
opportunity to comment under section 553 in the same manner as if the 
initial regulatory analysis had been issued with the notice of proposed 
rule making.</DELETED>
<DELETED>    ``(2) Each initial regulatory analysis shall contain--
</DELETED>
        <DELETED>    ``(A) a cost-benefit analysis of the proposed rule 
        that shall contain--</DELETED>
                <DELETED>    ``(i) 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;</DELETED>
                <DELETED>    ``(ii) 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; 
                and</DELETED>
                <DELETED>    ``(iii) an evaluation of the relationship 
                of the benefits of the proposed rule to its costs, 
                including the determinations required under subsection 
                (c)(3), taking into account the results of any risk 
                assessment;</DELETED>
                <DELETED>    ``(iv) an evaluation of the benefits and 
                costs of a reasonable number of reasonable alternatives 
                reflecting the range of regulatory options that would 
                achieve the objective of the statute as addressed by 
                the rule making, including, where feasible, 
                alternatives that--</DELETED>
                        <DELETED>    ``(I) require no government 
                        action;</DELETED>
                        <DELETED>    ``(II) accommodate differences 
                        among geographic regions and among persons with 
                        differing levels of resources with which to 
                        comply; or</DELETED>
                        <DELETED>    ``(III) employ flexible regulatory 
                        options;</DELETED>
                <DELETED>    ``(v) a description of the scientific or 
                economic evaluations or information upon which the 
                agency substantially relied in the cost-benefit 
                analysis and risk assessment required under this 
                subchapter, and an explanation of how the agency 
                reached the determinations under subsection (c)(3); 
                and</DELETED>
        <DELETED>    ``(B) if required, the risk assessment in 
        accordance with section 624.</DELETED>
<DELETED>    ``(c)(1) When the agency publishes a final major rule, the 
agency shall also prepare and place in the rule making file a final 
regulatory analysis, and shall prepare a summary of the analysis 
consistent with subsection (d).</DELETED>
<DELETED>    ``(2) Each final regulatory analysis shall address each of 
the requirements for the initial regulatory analysis under subsection 
(b)(2), revised to reflect--</DELETED>
        <DELETED>    ``(A) any material changes made to the proposed 
        rule by the agency after publication of the notice of proposed 
        rule making;</DELETED>
        <DELETED>    ``(B) any material changes made to the cost-
        benefit analysis or risk assessment; and</DELETED>
        <DELETED>    ``(C) agency consideration of significant comments 
        received regarding the proposed rule and the initial regulatory 
        analysis, including regulatory review communications under 
        subchapter IV.</DELETED>
<DELETED>    ``(3)(A) The agency shall include in the statement of 
basis and purpose for the rule a reasonable determination, based upon 
the rule making record considered as a whole--</DELETED>
        <DELETED>    ``(i) whether the rule is likely to provide 
        benefits that justify the costs of the rule; and</DELETED>
        <DELETED>    ``(ii) whether the rule is likely to substantially 
        achieve the rule making objective in a more cost-effective 
        manner, or with greater net benefits, than the other reasonable 
        alternatives considered by the agency.</DELETED>
<DELETED>    ``(B) If the agency head cannot reasonably determine that 
the final rule is likely to provide benefits that justify the costs of 
the rule and substantially achieve the rule making objective in a more 
cost-effective manner or with greater net benefits than the other 
reasonable alternatives considered by the agency, the agency head 
shall--</DELETED>
        <DELETED>    ``(i) explain why such determinations cannot be 
        made;</DELETED>
        <DELETED>    ``(ii) identify any statutory provision or other 
        factor that prevents such determinations; and</DELETED>
        <DELETED>    ``(iii) describe a reasonable alternative 
        considered by the agency, if feasible, that would allow the 
        agency to determine that the benefits justify the costs and 
        that the rule making objective would be achieved in a more 
        cost-effective manner or with greater net benefits than the 
        other reasonable alternatives considered by the 
        agency.</DELETED>
<DELETED>    ``(d) Each agency shall include an executive summary of 
the regulatory analysis, including any risk assessment, in the 
regulatory analysis and in the statement of basis and purpose for the 
rule. Such executive summary shall include a succinct presentation of--
</DELETED>
        <DELETED>    ``(1) the benefits and costs expected to result 
        from the rule and any determinations required under subsection 
        (c)(3);</DELETED>
        <DELETED>    ``(2) if applicable, the risk addressed by the 
        rule, including the most plausible estimate of the risk and the 
        results of any risk assessment;</DELETED>
        <DELETED>    ``(3) the benefits and costs of reasonable 
        alternatives considered by the agency; and</DELETED>
        <DELETED>    ``(4) the key assumptions and scientific or 
        economic information upon which the agency relied.</DELETED>
<DELETED>    ``(e)(1) A major rule may be adopted without prior 
compliance with this subchapter if--</DELETED>
        <DELETED>    ``(A) the agency for good cause finds that 
        conducting the regulatory analysis under this subchapter is 
        contrary to the public interest due to an emergency, or an 
        imminent threat to health or safety that is likely to result in 
        significant harm to the public or the environment; 
        and</DELETED>
        <DELETED>    ``(B) the agency publishes in the Federal 
        Register, together with such finding, a succinct statement of 
        the basis for the finding.</DELETED>
<DELETED>    ``(2) If a major rule is adopted under paragraph (1), the 
agency shall comply with this subchapter as promptly as possible unless 
compliance would be unreasonable because the rule is, or soon will be, 
no longer in effect.</DELETED>
<DELETED>``Sec. 624. Principles for risk assessments</DELETED>
<DELETED>    ``(a)(1) Subject to paragraph (2), each agency shall 
design and conduct risk assessments in accordance with this subchapter 
for each proposed and final major rule the primary purpose of which is 
to address health, safety, or environmental risk, or which results in a 
significant substitution risk, in a manner that promotes rational and 
informed risk management decisions and informed public input into and 
understanding of the process of making agency decisions.</DELETED>
<DELETED>    ``(2) If a risk assessment under this subchapter is 
otherwise required by this section, but the agency determines that--
</DELETED>
        <DELETED>    ``(A) a final rule subject to this subchapter is 
        substantially similar to the proposed rule with respect to the 
        risk being addressed;</DELETED>
        <DELETED>    ``(B) a risk assessment for the proposed rule has 
        been carried out in a manner consistent with this subchapter; 
        and</DELETED>
        <DELETED>    ``(C) a new risk assessment for the final rule is 
        not required in order to respond to comments received during 
        the period for comment on the proposed rule,</DELETED>
<DELETED>the agency may publish such determination along with the final 
rule in lieu of preparing a new risk assessment for the final 
rule.</DELETED>
<DELETED>    ``(b) Each agency shall consider in each risk assessment 
reliable and reasonably available scientific information and shall 
describe the basis for selecting such scientific information.</DELETED>
<DELETED>    ``(c)(1) Each agency may use reasonable assumptions to the 
extent that relevant and reliable scientific information, including 
site-specific or substance-specific information, is not reasonably 
available.</DELETED>
<DELETED>    ``(2) When a risk assessment involves a choice of 
assumptions, the agency shall--</DELETED>
        <DELETED>    ``(A) identify the assumption and its scientific 
        or policy basis, including the extent to which the assumption 
        has been validated by, or conflicts with, empirical 
        data;</DELETED>
        <DELETED>    ``(B) explain the basis for any choices among 
        assumptions and, where applicable, the basis for combining 
        multiple assumptions; and</DELETED>
        <DELETED>    ``(C) describe reasonable alternative assumptions 
        that were considered but not selected by the agency for use in 
        the risk assessment, how such alternative assumptions would 
        have changed the conclusions of the risk assessment, and the 
        rationale for not using such alternatives.</DELETED>
<DELETED>    ``(d) Each agency shall provide appropriate opportunity 
for public comment and participation during the development of a risk 
assessment.</DELETED>
<DELETED>    ``(e) Each risk assessment supporting a major rule under 
this subchapter shall include, as appropriate, each of the 
following:</DELETED>
        <DELETED>    ``(1) A description of the hazard of 
        concern.</DELETED>
        <DELETED>    ``(2) A description of the populations or natural 
        resources that are the subject of the risk 
        assessment.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(4) A description of the nature and severity of 
        the harm that could reasonably occur as a result of exposure to 
        the hazard.</DELETED>
        <DELETED>    ``(5) A description of the major uncertainties in 
        each component of the risk assessment and their influence on 
        the results of the assessment.</DELETED>
<DELETED>    ``(f) To the extent scientifically appropriate, each 
agency shall--</DELETED>
        <DELETED>    ``(1) express the overall estimate of risk as a 
        reasonable range or probability distribution that reflects 
        variabilities, uncertainties, and lack of data in the 
        analysis;</DELETED>
        <DELETED>    ``(2) provide the range and distribution of risks 
        and the corresponding exposure scenarios, identifying the range 
        and distribution and likelihood of risk to the general 
        population and, as appropriate, to more highly exposed or 
        sensitive subpopulations, including the most plausible 
        estimates of the risks; and</DELETED>
        <DELETED>    ``(3) where quantitative estimates are not 
        available, describe the qualitative factors influencing the 
        range, distribution, and likelihood of possible 
        risks.</DELETED>
<DELETED>    ``(g) When scientific information that permits relevant 
comparisons of risk is reasonably available, each agency shall use the 
information to place the nature and magnitude of a risk to health, 
safety, or the environment being analyzed in relationship to other 
reasonably comparable risks familiar to and routinely encountered by 
the general public. Such comparisons should consider relevant 
distinctions among risks, such as the voluntary or involuntary nature 
of risks.</DELETED>
<DELETED>    ``(h) When scientifically appropriate information on 
significant substitution risks to health, safety, or the environment is 
reasonably available to the agency, the agency shall describe such 
risks in the risk assessment.</DELETED>
<DELETED>``Sec. 625. Peer review</DELETED>
<DELETED>    ``(a) Each agency shall provide for peer review in 
accordance with this section of any cost benefit analysis and risk 
assessment required by this subchapter that forms the basis of any 
major rule covered by this subchapter.</DELETED>
<DELETED>    ``(b)(1) Peer review required under subsection (a) shall--
</DELETED>
        <DELETED>    ``(A) provide for the creation or utilization of 
        peer review panels, expert bodies, or other formal or informal 
        devices that are broadly representative and balanced and that 
        consist of panel members or participants with expertise 
        relevant to the sciences involved in the regulatory decisions 
        and who are independent of the agency program;</DELETED>
        <DELETED>    ``(B) exclude any person as a panel member or 
        participant if such person has a financial interest in the 
        outcome, unless such person fully discloses such interest to 
        the agency and the public;</DELETED>
        <DELETED>    ``(C) provide for the timely completion of the 
        peer review including meeting agency deadlines;</DELETED>
        <DELETED>    ``(D) contain a balanced presentation of all 
        considerations, including minority reports and an agency 
        response to all significant peer review comments; and</DELETED>
        <DELETED>    ``(E) provide adequate protections for 
        confidential business information and trade secrets, including 
        requiring panel members or participants to enter into 
        confidentiality agreements.</DELETED>
<DELETED>    ``(2) All peer review written comments or conclusions and 
the agency's written responses to significant peer review comments 
shall be made available to the public and shall be made part of the 
rule making record for purposes of judicial review of any final agency 
action.</DELETED>
<DELETED>    ``(3) If the head of an agency, with the concurrence of 
the Director, publishes a determination that a cost-benefit analysis or 
risk assessment, or any component thereof, has been previously 
subjected to adequate peer review, no further peer review shall be 
required under this section for such analysis, assessment, or 
component.</DELETED>
<DELETED>``Sec. 626. Deadlines for rule making</DELETED>
<DELETED>    ``(a) All deadlines in statutes or imposed by a court of 
the United States, that require an agency to propose or promulgate any 
major rule during the 2-year period beginning on the effective date of 
this section shall be suspended until the earlier of--</DELETED>
        <DELETED>    ``(1) the date on which the requirements of this 
        subchapter are satisfied; or</DELETED>
        <DELETED>    ``(2) the date occurring 6 months after the date 
        of the applicable deadline.</DELETED>
<DELETED>    ``(b) In any case in which the failure to promulgate a 
major 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--</DELETED>
        <DELETED>    ``(1) the date on which the requirements of this 
        subchapter are satisfied; or</DELETED>
        <DELETED>    ``(2) the date occurring 6 months after the date 
        of the applicable deadline.</DELETED>
<DELETED>``Sec. 627. Judicial review</DELETED>
<DELETED>    ``(a) Compliance or noncompliance by an agency with the 
provisions of this subchapter shall only be subject to judicial review 
in accordance with this section.</DELETED>
<DELETED>    ``(b) Any determination of an agency whether a rule is or 
is not a major rule under section 621(6)(A) 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.</DELETED>
<DELETED>    ``(c) Any determination by the Director that a rule is a 
major rule under section 621(6), or any failure to make such 
determination, shall not be subject to judicial review in any 
manner.</DELETED>
<DELETED>    ``(d) The cost-benefit analysis and any risk assessment 
required under this subchapter shall not be subject to judicial review 
separate from review of the final rule to which they apply. The cost-
benefit analysis, cost-benefit determination under section 623(c)(3), 
and any risk assessment shall be part of the whole rule making record 
for purposes of judicial review of the rule and shall be considered by 
a court in determining whether the final rule is arbitrary or 
capricious unless the agency can demonstrate that the analysis or 
assessment would not be material to the outcome of the rule.</DELETED>
<DELETED>    ``(e) If an agency fails to perform the cost-benefit 
analysis, cost-benefit determination, or risk assessment, a court shall 
remand or invalidate the rule.</DELETED>
<DELETED>``Sec. 628. Guidelines, interagency coordination, and 
              research</DELETED>
<DELETED>    ``(a)(1) No later than 9 months after the date of 
enactment of this section, the Director, in consultation with the 
Director of the Office of Science and Technology Policy and the 
relevant agency heads, shall develop guidelines for cost-benefit 
analyses and risk assessments required by this subchapter or with 
significant implications for public policy. To the extent feasible such 
guidelines shall apply the principles of sections 623 and 624. The 
Director shall oversee and periodically revise such guidelines as 
appropriate.</DELETED>
<DELETED>    ``(2) As soon as practicable and no later than 18 months 
after the date of enactment of this section, each relevant agency shall 
adopt detailed guidelines for risk assessments required by this 
subchapter or with significant implications for public policy. Such 
guidelines shall be consistent with the guidance issued under paragraph 
(1). Each agency shall periodically revise such agency guidelines as 
appropriate.</DELETED>
<DELETED>    ``(3) The guidelines under this subsection shall be 
developed following notice and public comment. The development and 
issuance of the guidelines shall not be subject to judicial review, 
except in accordance with section 706(1) of this title.</DELETED>
<DELETED>    ``(b) To promote the use of cost-benefit analysis and 
assessment in a consistent manner and to identify agency research and 
training needs, the Director, in consultation with the Director of the 
Office of Science and Technology Policy, shall--</DELETED>
        <DELETED>    ``(1) oversee periodic evaluations of Federal 
        agency cost-benefit analysis and risk assessment;</DELETED>
        <DELETED>    ``(2) provide advice and recommendations to the 
        President and Congress to improve agency use of cost-benefit 
        analysis and risk assessment;</DELETED>
        <DELETED>    ``(3) establish appropriate interagency mechanisms 
        to improve the consistency and quality of cost-benefit analysis 
        and risk assessment among Federal agencies; and</DELETED>
        <DELETED>    ``(4) establish appropriate mechanisms between 
        Federal and State agencies to improve cooperation in the 
        development and application of cost-benefit analysis and risk 
        assessment.</DELETED>
<DELETED>    ``(c)(1) The head of each agency, in consultation with the 
Director and the Director of the Office of Science and Technology 
Policy, shall regularly evaluate and develop a strategy to meet agency 
needs for research and training in cost-benefit analysis and risk 
assessment, including research on modelling, the development of generic 
data, use of assumptions and the identification and quantification of 
uncertainty and variability.</DELETED>
<DELETED>    ``(2)(A) No later than 6 months from the date of enactment 
of this section, the Director, in consultation with the Director of the 
Office of Science and Technology Policy, shall enter into appropriate 
arrangements with an accredited scientific institution to conduct 
research to--</DELETED>
        <DELETED>    ``(i) identify and evaluate a common basis to 
        assist comparative risk analysis and risk communication related 
        to both carcinogens and noncarcinogens; and</DELETED>
        <DELETED>    ``(ii) appropriately incorporate risk assessments 
        into related cost-benefit analyses.</DELETED>
<DELETED>    ``(B) The results of the research conducted under this 
paragraph shall be submitted to the Director and Congress no later than 
18 months after the date of enactment of this section.</DELETED>
<DELETED>``Sec. 629. Comparative risk analysis study</DELETED>
<DELETED>    ``(a) No later than 180 days after the effective date of 
this section, the Director, in consultation with the Director of the 
Office of Science and Technology Policy, shall enter into a contract 
with an accredited scientific institution to conduct a study that 
provides--</DELETED>
        <DELETED>    ``(1) a systematic comparison of the extent and 
        severity of significant risks to human health, safety, or the 
        environment (hereafter referred to as a comparative risk 
        analysis);</DELETED>
        <DELETED>    ``(2) a study of methodologies for using 
        comparative risk analysis to compare dissimilar risks to human 
        health, safety, or the environment; and</DELETED>
        <DELETED>    ``(3) technical guidance and recommendations on 
        the use of comparative risk analysis to assist in allocating 
        resources within and across agencies to set priorities for the 
        reduction of risks to human health, safety, or the 
        environment.</DELETED>
<DELETED>    ``(b) The Director shall ensure that the study required 
under subsection (a) is--</DELETED>
        <DELETED>    ``(1) conducted through an open process providing 
        peer review consistent with section 625 and opportunities for 
        public comment and participation; and</DELETED>
        <DELETED>    ``(2) completed and submitted to Congress and the 
        President no later than 3 years after the effective date of 
        this section.</DELETED>
<DELETED>    ``(c) No later than 5 years after the effective date of 
this section, and periodically thereafter, the President shall submit a 
report to Congress recommending legislative changes to assist in 
setting priorities to more effectively and efficiently reduce risks to 
human health, safety, or the environment.</DELETED>

          <DELETED>``SUBCHAPTER III--REVIEW OF RULES</DELETED>

<DELETED>``Sec. 631. Definitions</DELETED>
<DELETED>    ``For purposes of this subchapter the definitions under 
sections 551 and 621 shall apply.</DELETED>
<DELETED>``Sec. 632. Advisory committee on regulations</DELETED>
<DELETED>    ``(a)(1)(A) No later than 90 days after the date of 
enactment of this section and every 5 years thereafter, the head of 
each agency described under subparagraph (B) shall establish an 
advisory committee for the review of rules.</DELETED>
<DELETED>    ``(B) An agency referred to under subparagraph (A) is any 
agency that has promulgated a major rule during the 10-year period 
preceding the date of the establishment of an advisory committee under 
subparagraph (A).</DELETED>
<DELETED>    ``(2) The head of an agency described under paragraph (1) 
may establish panels under its advisory committee.</DELETED>
<DELETED>    ``(b)(1) Each such agency head shall appoint a reasonable 
number of members to serve on the agency's advisory committee and shall 
designate a chairman from the members of the committee. Membership on 
the committee shall represent a balanced cross-section of public and 
private interests affected by the regulations of the agency, including 
small businesses, small governments, and public interest groups. No 
employee of the agency establishing the committee shall serve as a 
member of such agency's committee under this section.</DELETED>
<DELETED>    ``(2) Each member shall be appointed for the life of the 
advisory committee. The advisory committee shall terminate 1 year after 
the date on which the committee is established.</DELETED>
<DELETED>    ``(3) A vacancy on a committee shall be filled in the same 
manner as the original appointment.</DELETED>
<DELETED>    ``(4) Each committee shall solicit public comments and may 
solicit public participation through appropriate means including 
hearings, written comments, public meetings, and electronic 
mail.</DELETED>
<DELETED>    ``(5) Members of each committee shall receive travel 
expenses, including per diem in lieu of subsistence, in accordance with 
sections 5702 and 5703.</DELETED>
<DELETED>    ``(6) Each committee shall be subject to the provisions of 
the Federal Advisory Committee Act (5 U.S.C. App.).</DELETED>
<DELETED>``Sec. 633. Agency regulatory review</DELETED>
<DELETED>    ``(a) Each advisory committee appointed under section 632 
shall develop a list of rules promulgated by the agency that the 
committee serves, which the committee determines should be reviewed by 
the agency and can reasonably be reviewed by the agency within a 5-year 
period. In selecting rules for review, each committee shall consider 
the extent to which--</DELETED>
        <DELETED>    ``(1) a rule could be revised to substantially 
        increase net benefits, including through flexible regulatory 
        options;</DELETED>
        <DELETED>    ``(2) the rule is important relative to other 
        rules being considered for review; and</DELETED>
        <DELETED>    ``(3) the agency has discretion under the statute 
        authorizing the rule to modify or repeal the rule.</DELETED>
<DELETED>    ``(b) In developing the list required under subsection 
(a), each advisory committee shall obtain comments and suggestions from 
the public.</DELETED>
<DELETED>    ``(c) No later than 1 year after an advisory committee is 
established, such committee shall deliver to the agency the committee's 
recommended list of rules to be reviewed in order of priority. The 
agency shall immediately publish the list in the Federal Register and 
forward a copy of the list to the appropriate committees of 
jurisdiction in the House of Representatives and the Senate.</DELETED>
<DELETED>    ``(d)(1) No later than 60 days after receiving and 
reviewing the list of rules from its committee, the agency shall 
publish in the Federal Register a preliminary schedule for review of 
rules based on such list.</DELETED>
<DELETED>    ``(2) The agency shall provide in the Federal Register at 
the time the preliminary schedule is published an explanation of each 
modification to the list provided by the advisory committee and shall 
invite public comment on the preliminary schedule for a period of no 
less than 60 days.</DELETED>
<DELETED>    ``(e) The preliminary schedule under this section shall 
propose deadlines for review of each rule listed thereon, and such 
deadlines shall occur no later than 5 years from the date of 
publication of the final schedule.</DELETED>
<DELETED>    ``(f)(1) No later than 60 days after the close of the 
comment period, the agency shall publish a final schedule of rules to 
be reviewed by the agency under this section.</DELETED>
<DELETED>    ``(2) The schedule shall establish a deadline for 
completion of the review of each rule listed on the schedule. Each 
deadline shall occur no later than 5 years from the date of publication 
of the final schedule.</DELETED>
<DELETED>    ``(g) In preparing the preliminary and final schedule, the 
agency shall give deference to the recommendations of its advisory 
committee but may modify the list of rules to be reviewed, taking into 
account the factors contained in subsection (a) and the resource 
constraints of the agency.</DELETED>
<DELETED>    ``(h)(1) For each rule on the schedule under subsection 
(e), the agency shall--</DELETED>
        <DELETED>    ``(A) no later than 2 years before the deadline in 
        such schedule, publish in the Federal Register a notice that 
        solicits public comment regarding whether the rule should be 
        continued, amended, or repealed;</DELETED>
        <DELETED>    ``(B) no later than 1 year before the deadline in 
        such schedule, publish in the Federal Register a notice that--
        </DELETED>
                <DELETED>    ``(i) addresses public comments generated 
                by the notice in subparagraph (A);</DELETED>
                <DELETED>    ``(ii) contains a preliminary analysis by 
                the agency with respect to subsection (a) (1), (2), and 
                (3);</DELETED>
                <DELETED>    ``(iii) contains a preliminary 
                determination whether the rule should be continued, 
                amended, or repealed; and</DELETED>
                <DELETED>    ``(iv) solicits public comment on the 
                preliminary determination for the rule; and</DELETED>
        <DELETED>    ``(C) no later than 60 days before the deadline in 
        such schedule, publish in the Federal Register a final notice 
        on the rule that--</DELETED>
                <DELETED>    ``(i) addresses public comments generated 
                by the notice in subsection (c);</DELETED>
                <DELETED>    ``(ii) contains a determination to 
                continue, amend, or repeal the rule and an explanation 
                of such determination with respect to subsection (a) 
                (1), (2), and (3); and</DELETED>
                <DELETED>    ``(iii) if the agency determines to amend 
                or repeal the rule, contains, if required, a notice of 
                proposed rule making under section 553.</DELETED>
<DELETED>    ``(2) If the final determination of the agency is to 
continue the rule, such determination shall constitute final agency 
action 60 days after the publication in the Federal Register of the 
notice in paragraph (1)(C).</DELETED>
<DELETED>    ``(i) If an agency makes a determination to amend or 
repeal a rule under subsection (h)(1)(C), the agency shall complete 
final agency action with regard to such rule no later than 2 years 
after the deadline established for such rule under subsection 
(f)(2).</DELETED>
<DELETED>    ``(j) Nothing in this section shall limit the discretion 
of an agency to decide, after having proposed to modify or repeal a 
rule, not to promulgate such modification or repeal. Such decision 
shall constitute final agency action for the purposes of judicial 
review.</DELETED>
<DELETED>    ``(k) Agency failure to take the actions required by this 
section shall be subject to judicial review only under section 706(1). 
There shall be no judicial review of the preliminary or final 
schedule.</DELETED>
<DELETED>    ``(l) A court may remand a determination under subsection 
(h)(2) only upon a clear and convincing showing that the agency could 
have adopted a reasonable alternative that would substantially increase 
net benefits, including through flexible regulatory options, while 
meeting the objectives of the statute as addressed by the rule 
making.</DELETED>

        <DELETED>``SUBCHAPTER IV--EXECUTIVE OVERSIGHT</DELETED>

<DELETED>``Sec. 641. Definitions</DELETED>
<DELETED>    ``For purposes of this subchapter--</DELETED>
        <DELETED>    ``(1) the definitions under sections 551 and 621 
        shall apply; and</DELETED>
        <DELETED>    ``(2) the term `regulatory action' means any one 
        of the following:</DELETED>
                <DELETED>    ``(A) An agenda or schedule for rule 
                makings.</DELETED>
                <DELETED>    ``(B) Advance notice of proposed rule 
                making.</DELETED>
                <DELETED>    ``(C) Notice of proposed rule 
                making.</DELETED>
                <DELETED>    ``(D) Final rule making, including interim 
                final rule making.</DELETED>
<DELETED>``Sec. 642. Presidential regulatory review</DELETED>
<DELETED>    ``(a) The President shall establish a process for the 
review and coordination of Federal agency regulatory actions. Such 
process shall be the responsibility of the Director.</DELETED>
<DELETED>    ``(b) For the purpose of carrying out the review 
established under subsection (a), the Director shall--</DELETED>
        <DELETED>    ``(1) develop and oversee uniform regulatory 
        policies and procedures, including those by which each agency 
        shall comply with the requirements of this chapter;</DELETED>
        <DELETED>    ``(2) develop policies and procedures for the 
        review of regulatory actions by the Director; and</DELETED>
        <DELETED>    ``(3) develop and oversee an annual governmentwide 
        regulatory planning process that shall include review of 
        planned agency major rules and other significant regulatory 
        actions and publication of--</DELETED>
                <DELETED>    ``(A) a summary of and schedule for 
                promulgation of planned agency major rules;</DELETED>
                <DELETED>    ``(B) agency specific schedules for review 
                of existing rules under subchapter III;</DELETED>
                <DELETED>    ``(C) a summary of regulatory review 
                actions undertaken in the prior year;</DELETED>
                <DELETED>    ``(D) a list of major rules promulgated in 
                the prior year for which an agency could not make the 
                determinations that the benefits of a rule justify the 
                costs under section 623(c)(3);</DELETED>
                <DELETED>    ``(E) identification of significant agency 
                noncompliance with this chapter in the prior year; 
                and</DELETED>
                <DELETED>    ``(F) recommendations for improving 
                compliance with this chapter and increasing the 
                efficiency and effectiveness of the regulatory 
                process.</DELETED>
<DELETED>    ``(c) The review established under subsection (a) shall be 
conducted as expeditiously as practicable and the Director's review of 
any regulatory action shall be limited to no more than 90 days, unless 
extended for an additional 30 days at the written request of the rule 
making agency or the Director.</DELETED>
<DELETED>``Sec. 643. Public disclosure of information</DELETED>
<DELETED>    ``(a) The Director, in carrying out the provisions of 
section 642, shall establish procedures to provide public and agency 
access to information concerning regulatory review actions, including--
</DELETED>
        <DELETED>    ``(1) disclosure to the public on an ongoing basis 
        of information regarding the status of regulatory actions 
        undergoing review;</DELETED>
        <DELETED>    ``(2) disclosure to the public, no later than 
        publication of a regulatory action, of--</DELETED>
                <DELETED>    ``(A) all written communications relating 
                to the substance of a regulatory action including 
                drafts of all proposals and associated analyses, 
                between the Director or employees of the Director and 
                the regulatory agency;</DELETED>
                <DELETED>    ``(B) all written communications relating 
                to the substance of a regulatory action between the 
                Director or employees of the Director and any person 
                not employed by the executive branch of the Federal 
                Government;</DELETED>
                <DELETED>    ``(C) a list identifying the dates, names 
                of individuals involved, and subject matter discussed 
                in substantive meetings and telephone conversations 
                relating to the substance of a regulatory action 
                between the Director or employees of the Director and 
                any person not employed by the executive branch of the 
                Federal Government; and</DELETED>
                <DELETED>    ``(D) a written explanation of any review 
                action and the date of such action; and</DELETED>
        <DELETED>    ``(3) disclosure to the regulatory agency, on a 
        timely basis, of--</DELETED>
                <DELETED>    ``(A) all written communications relating 
                to the substance of a regulatory action between the 
                Director or employees of the Director and any person 
                who is not employed by the executive branch of the 
                Federal Government;</DELETED>
                <DELETED>    ``(B) a list identifying the dates, names 
                of individuals involved, and subject matter discussed 
                in substantive meetings and telephone conversations, 
and an invitation to participate in meetings, relating to the substance 
of a regulatory action between the Director or employees of the 
Director and any person not employed by the executive branch of the 
Federal Government; and</DELETED>
                <DELETED>    ``(C) a written explanation of any review 
                action taken concerning an agency regulatory 
                action.</DELETED>
<DELETED>    ``(b) Prior to the publication of any proposed or final 
rule, the agency shall include in the rule making record--</DELETED>
        <DELETED>    ``(1) a document identifying in a complete, clear, 
        and simple manner, the substantive changes between the draft 
        submitted to the Director for review and the rule subsequently 
        announced;</DELETED>
        <DELETED>    ``(2) a document identifying those changes in the 
        rule that were made at the suggestion or recommendation of the 
        Director; and</DELETED>
        <DELETED>    ``(3) all written communications exchanged between 
        the Director and the agency during the review of the rule, 
        including drafts of all proposals and associated 
        analyses.</DELETED>
<DELETED>``Sec. 644. Judicial review</DELETED>
<DELETED>    ``The exercise of the authority granted under this 
subchapter by the Director or the President shall not be subject to 
judicial review in any manner.''.</DELETED>
<DELETED>    (b) 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.</DELETED>
<DELETED>    (c) Technical and Conforming Amendments.--</DELETED>
        <DELETED>    (1) Part I of title 5, United States Code, is 
        amended by striking the chapter heading and table of sections 
        for chapter 6 and inserting the following:</DELETED>

  <DELETED>``CHAPTER 6--THE ANALYSIS OF REGULATORY FUNCTIONS</DELETED>

      <DELETED>``SUBCHAPTER I--ANALYSIS OF REGULATORY FLEXIBILITY

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

<DELETED>``621. Definitions.
<DELETED>``622. Applicability.
<DELETED>``623. Regulatory analysis.
<DELETED>``624. Principles for risk assessments.
<DELETED>``625. Peer review.
<DELETED>``626. Deadlines for rule making.
<DELETED>``627. Judicial review.
<DELETED>``628. Guidelines, interagency coordination, and research.
<DELETED>``629. Comparative risk analysis study.
               <DELETED>``SUBCHAPTER III--REVIEW OF RULES

<DELETED>``631. Definitions.
<DELETED>``632. Advisory committee on regulations.
<DELETED>``633. Agency regulatory review.
             <DELETED>``SUBCHAPTER IV--EXECUTIVE OVERSIGHT

<DELETED>``641. Definitions.
<DELETED>``642. Presidential regulatory review.
<DELETED>``643. Public disclosure of information.
<DELETED>``644. Judicial review.''.
        <DELETED>    (2) Chapter 6 of title 5, United States Code, is 
        amended by inserting immediately before section 601, the 
        following subchapter heading:</DELETED>

            <DELETED>``SUBCHAPTER I--ANALYSIS OF REGULATORY 
                        FLEXIBILITY''.</DELETED>

<DELETED>SEC. 4. EFFECTIVE DATE.</DELETED>

<DELETED>    Except as otherwise provided in this Act, this Act shall 
take effect 180 days after the date of enactment of this Act, but shall 
not apply to any agency rule for which a notice of proposed rulemaking 
is published on or before August 1, 1997.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Regulatory Improvement Act of 
1998''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Effective regulatory programs provide important 
        benefits to the public, including improving the environment, 
        worker safety, and public health. Regulatory programs also 
        impose significant costs on the public, including individuals, 
        businesses, and State, local, and tribal governments.
            (2) Improving the ability of Federal agencies to use 
        scientific and economic analysis in developing regulations 
        should yield increased benefits and more effective protections 
        while minimizing costs.
            (3) Cost-benefit analysis and risk assessment are useful 
        tools to better inform agencies in developing regulations, 
        although they do not replace the need for good judgment and 
        consideration of values.
            (4) The evaluation of costs and benefits must involve the 
        consideration of the relevant information, whether expressed in 
        quantitative or qualitative terms, including factors such as 
        social values, distributional effects, and equity.
            (5) Cost-benefit analysis and risk assessment should be 
        presented with a clear statement of the analytical assumptions 
        and uncertainties, including an explanation of what is known 
        and not known and what the implications of alternative 
        assumptions might be.
            (6) The public has a right to know about the costs and 
        benefits of regulations, the risks addressed, the risks 
        reduced, and the quality of scientific and economic analysis 
        used to support decisions. Such knowledge will promote the 
        quality, integrity and responsiveness of agency actions.
            (7) The Administrator of the Office of Information and 
        Regulatory Affairs should oversee regulatory activities to 
        raise the quality and consistency of cost-benefit analysis and 
        risk assessment among all agencies.
            (8) The Federal Government should develop a better 
        understanding of the strengths, weaknesses, and uncertainties 
        of cost-benefit analysis and risk assessment and conduct the 
        research needed to improve these analytical tools.

SEC. 3. REGULATORY ANALYSIS.

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

                  ``SUBCHAPTER II--REGULATORY ANALYSIS

``Sec. 621. Definitions
    ``For purposes of this subchapter the definitions under section 551 
shall apply and--
            ``(1) the term `Administrator' means the Administrator of 
        the Office of Information and Regulatory Affairs of the Office 
        of Management and Budget;
            ``(2) the term `benefit' means the reasonably identifiable 
        significant favorable effects, quantifiable and 
        nonquantifiable, including social, health, safety, 
        environmental, economic, and distributional effects, that are 
        expected to result from implementation of, or compliance with, 
        a rule;
            ``(3) the term `cost' means the reasonably identifiable 
        significant adverse effects, quantifiable and nonquantifiable, 
        including social, health, safety, environmental, economic, and 
        distributional effects, that are expected to result from 
        implementation of, or compliance with, a rule;
            ``(4) the term `cost-benefit analysis' means an evaluation 
        of the costs and benefits of a rule, quantified to the extent 
        feasible and appropriate and otherwise qualitatively described, 
        that is prepared in accordance with the requirements of this 
        subchapter at the level of detail appropriate and practicable 
        for reasoned decisionmaking on the matter involved, taking into 
        consideration uncertainties, the significance and complexity of 
        the decision, and the need to adequately inform the public;
            ``(5) the term `Director' means the Director of the Office 
        of Management and Budget, acting through the Administrator of 
        the Office of Information and Regulatory Affairs;
            ``(6) the term `flexible regulatory options' means 
        regulatory options that permit flexibility to regulated persons 
        in achieving the objective of the statute as addressed by the 
        rule making, including regulatory options that use market-based 
        mechanisms, outcome oriented performance-based standards, or 
        other options that promote flexibility;
            ``(7) the term `major rule' means a rule that--
                    ``(A) the agency proposing the rule or the Director 
                reasonably determines is likely to have an annual 
                effect on the economy of $100,000,000 or more in 
                reasonably quantifiable costs; or
                    ``(B) is otherwise designated a major rule by the 
                Director on the ground that the rule is likely to 
                adversely affect, in a material way, the economy, a 
                sector of the economy, including small business, 
                productivity, competition, jobs, the environment, 
                public health or safety, or State, local or tribal 
                governments, or communities;
            ``(8) the term `reasonable alternative' means a reasonable 
        regulatory option that would achieve the objective of the 
        statute as addressed by the rule making and that the agency has 
        authority to adopt under the statute granting rule making 
        authority, including flexible regulatory options;
            ``(9) the term `risk assessment' means the systematic, 
        objective process of organizing hazard and exposure 
        information, based on a careful analysis of the weight of the 
        scientific evidence, to estimate the potential for specific 
        harm to an exposed population, subpopulation, 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;
            ``(10) the term `rule' has the same meaning as in section 
        551(4), and shall not include--
                    ``(A) a rule exempt from notice and public comment 
                procedure under section 553;
                    ``(B) a rule that involves the internal revenue 
                laws of the United States, or the assessment or 
                collection of taxes, duties, or other debts, revenue, 
                or receipts;
                    ``(C) 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;
                    ``(D) 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;
                    ``(E) a rule relating to the operations, 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;
                    ``(F) a rule relating to the integrity of the 
                securities or commodities futures markets or to the 
                protection of investors in those markets;
                    ``(G) a rule issued by the Federal Election 
                Commission or a rule issued by the Federal 
                Communications Commission under sections 312(a)(7) and 
                315 of the Communications Act of 1934 (47 U.S.C. 
                312(a)(7) and 315);
                    ``(H) a rule required to be promulgated at least 
                annually pursuant to statute;
                    ``(I) a rule or agency action relating to the 
                public debt or fiscal policy of the United States; or
                    ``(J) a rule or agency action that authorizes the 
                introduction into commerce, or recognizes the 
                marketable status of, a product; and
            ``(11) the term `substitution risk' means a significant 
        increased risk to health, safety, or the environment reasonably 
        likely to result from a regulatory option.
``Sec. 622. Applicability and effect
    ``(a) Except as provided in section 623(f), this subchapter shall 
apply to all proposed and final major rules.
    ``(b) Nothing in this subchapter shall be construed to alter or 
modify the substantive standards otherwise applicable to a rule making 
under other statutes or opportunity for judicial review made applicable 
under other statutes.
``Sec. 623. Regulatory analysis
    ``(a)(1) Before publishing a notice of a proposed rule making for 
any rule, each agency shall determine whether the rule is or is not a 
major rule covered by this subchapter.
    ``(2) The Director may designate any rule to be a major rule under 
section 621(7)(B), if the Director--
            ``(A) makes such designation no later than 30 days after 
        the close of the comment period for the rule; and
            ``(B) publishes such designation in the Federal Register, 
        together with a succinct statement of the basis for the 
        designation, within 30 days after such designation.
    ``(b)(1)(A) When an agency publishes a notice of proposed rule 
making for a major rule, the agency shall prepare and place in the rule 
making file an initial regulatory analysis, and shall include a summary 
of such analysis consistent with subsection (e) in the notice of 
proposed rule making.
    ``(B)(i) When the Director has published a designation that a rule 
is a major rule after the publication of the notice of proposed rule 
making for the rule, the agency shall promptly prepare and place in the 
rule making file an initial regulatory analysis for the rule and shall 
publish in the Federal Register a summary of such analysis consistent 
with subsection (e).
    ``(ii) Following the issuance of an initial regulatory analysis 
under clause (i), the agency shall give interested persons an 
opportunity to comment under section 553 in the same manner as if the 
initial regulatory analysis had been issued with the notice of proposed 
rule making.
    ``(2) Each initial regulatory analysis shall contain--
            ``(A) a cost-benefit analysis of the proposed rule that 
        shall contain--
                    ``(i) 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;
                    ``(ii) 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;
                    ``(iii) an evaluation of the relationship of the 
                benefits of the proposed rule to its costs, including 
                the determinations required under subsection (d), 
                taking into account the results of any risk assessment;
                    ``(iv) an evaluation of the benefits and costs of a 
                reasonable number of reasonable alternatives reflecting 
                the range of regulatory options that would achieve the 
                objective of the statute as addressed by the rule 
                making, including, where feasible, alternatives that--
                            ``(I) require no government action or 
                        utilize voluntary programs;
                            ``(II) provide flexibility for small 
                        entities under subchapter I and for State, 
                        local, or tribal government agencies delegated 
                        to administer a Federal program;
                            ``(III) employ flexible regulatory options; 
                        and
                            ``(IV) assure protection of sensitive 
                        subpopulations, or populations exposed to 
                        multiple and cumulative risks; and
                    ``(v) a description of the scientific or economic 
                evaluations or information upon which the agency 
                substantially relied in the cost-benefit analysis and 
                risk assessment required under this subchapter, and an 
                explanation of how the agency reached the 
                determinations under subsection (d);
            ``(B) if required, the risk assessment in accordance with 
        section 624; and
            ``(C) when scientific information on substitution risks to 
        health, safety, or the environment is reasonably available to 
        the agency, an identification and evaluation of such risks.
    ``(c)(1) When the agency publishes a final major rule, the agency 
shall prepare and place in the rule making file a final regulatory 
analysis.
    ``(2) Each final regulatory analysis shall address each of the 
requirements for the initial regulatory analysis under subsection 
(b)(2), revised to reflect--
            ``(A) any material changes made to the proposed rule by the 
        agency after publication of the notice of proposed rule making;
            ``(B) any material changes made to the cost-benefit 
        analysis or risk assessment; and
            ``(C) agency consideration of significant comments received 
        regarding the proposed rule and the initial regulatory 
        analysis, including regulatory review communications under 
        subchapter IV.
    ``(d)(1) The agency shall include in the statement of basis and 
purpose for a proposed or final major rule a reasonable determination, 
based upon the rule making record considered as a whole--
            ``(A) whether the rule is likely to provide benefits that 
        justify the costs of the rule;
            ``(B) whether the rule is likely to substantially achieve 
        the rule making objective in a more cost-effective manner, or 
        with greater net benefits, than the other reasonable 
        alternatives considered by the agency; and
            ``(C) whether the rule adopts a flexible regulatory option.
    ``(2) If the agency head determines that the rule is not likely to 
provide benefits that justify the costs of the rule or is not likely to 
substantially achieve the rule making objective in a more cost-
effective manner, or with greater net benefits, than the other 
reasonable alternatives considered by the agency, the agency head 
shall--
            ``(A) explain the reasons for selecting the rule 
        notwithstanding such determination, including identifying any 
        statutory provision that required the agency to select such 
        rule;
            ``(B) describe any reasonable alternative considered by the 
        agency that would be likely to provide benefits that justify 
        the costs of the rule and be likely to substantially achieve 
        the rule making objective in a more cost-effective manner, or 
        with greater net benefits, than the alternative selected by the 
        agency; and
            ``(C) describe any flexible regulatory option considered by 
        the agency and explain why that option was not adopted by the 
        agency if that option was not adopted.
    ``(e) Each agency shall include an executive summary of the 
regulatory analysis, including any risk assessment, in the regulatory 
analysis and in the statement of basis and purpose for the proposed and 
final major rule. Such executive summary shall include a succinct 
presentation of--
            ``(1) the benefits and costs expected to result from the 
        rule and any determinations required under subsection (d);
            ``(2) if applicable, the risk addressed by the rule and the 
        results of any risk assessment;
            ``(3) the benefits and costs of reasonable alternatives 
        considered by the agency; and
            ``(4) the key assumptions and scientific or economic 
        information upon which the agency relied.
    ``(f)(1) A major rule may be adopted without prior compliance with 
this subchapter if--
            ``(A) the agency for good cause finds that conducting the 
        regulatory analysis under this subchapter before the rule 
        becomes effective is impracticable or contrary to an important 
        public interest; and
            ``(B) the agency publishes the rule in the Federal Register 
        with such finding and a succinct explanation of the reasons for 
        the finding.
    ``(2) If a major rule is adopted under paragraph (1), the agency 
shall comply with this subchapter as promptly as possible unless 
compliance would be unreasonable because the rule is, or soon will be, 
no longer in effect.
    ``(g) Each agency shall develop an effective process to permit 
elected officers of State, local, and tribal governments (or their 
designated employees with authority to act on their behalf) to provide 
meaningful and timely input in the development of regulatory proposals 
that contain significant Federal intergovernmental mandates. The 
process developed under this subsection shall be consistent with 
section 204 of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 
1534).
``Sec. 624. Principles for risk assessments
    ``(a)(1)(A) Subject to paragraph (2), each agency shall design and 
conduct risk assessments in accordance with this subchapter for--
            ``(i) each proposed and final major rule the primary 
        purpose of which is to address health, safety, or environmental 
        risk; or
            ``(ii) any risk assessment that is not the basis of a rule 
        making that the Director reasonably determines is anticipated 
        to have a substantial impact on a significant public policy or 
        on the economy.
    ``(B)(i) Risk assessments conducted under this subchapter shall be 
conducted in a manner that promotes rational and informed risk 
management decisions and informed public input into and understanding 
of the process of making agency decisions.
    ``(ii) The scope and level of analysis of such a risk assessment 
shall be commensurate with the significance and complexity of the 
decision and the need to adequately inform the public, consistent with 
any need for expedition, and designed for the nature of the risk being 
assessed.
    ``(2) If a risk assessment under this subchapter is otherwise 
required by this section, but the agency determines that--
            ``(A) a final rule subject to this subchapter is 
        substantially similar to the proposed rule with respect to the 
        risk being addressed;
            ``(B) a risk assessment for the proposed rule has been 
        carried out in a manner consistent with this subchapter; and
            ``(C) a new risk assessment for the final rule is not 
        required in order to respond to comments received during the 
        period for comment on the proposed rule,
the agency may publish such determination along with the final rule in 
lieu of preparing a new risk assessment for the final rule.
    ``(b) Each agency shall consider in each risk assessment all 
relevant, reliable, and reasonably available scientific information and 
shall describe the basis for selecting such scientific information.
    ``(c)(1) When a risk assessment involves a choice of assumptions, 
the agency shall, with respect to significant assumptions--
            ``(A) identify the assumption and its scientific and policy 
        basis, including the extent to which the assumption has been 
        validated by, or conflicts with, empirical data;
            ``(B) explain the basis for any choices among assumptions 
        and, where applicable, the basis for combining multiple 
        assumptions; and
            ``(C) describe reasonable alternative assumptions that--
                    ``(i) would have had a significant effect on the 
                results of the risk assessment; and
                    ``(ii) were considered but not selected by the 
                agency for use in the risk assessment.
    ``(2) As relevant and reliable scientific information becomes 
reasonably available, each agency shall revise its significant 
assumptions to incorporate such information.
    ``(d) The agency shall notify the public of the agency's intent to 
conduct a risk assessment and, to the extent practicable, shall solicit 
relevant and reliable data from the public. The agency shall consider 
such data in conducting the risk assessment.
    ``(e) Each risk assessment under this subchapter shall include, 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 or natural resource at risk and the likelihood of 
        such exposure scenarios.
            ``(4) A description of the nature and severity of the harm 
        that could reasonably occur as a result of exposure to the 
        hazard.
            ``(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 scientifically appropriate, each agency shall--
            ``(1) express the estimate of risk as 1 or more reasonable 
        ranges and, if feasible, probability distributions that 
        reflects variabilities, uncertainties, and lack of data in the 
        analysis;
            ``(2) provide the ranges and distributions of risks, 
        including central and high end estimates of the risks, and 
        their corresponding exposure scenarios for the potentially 
        exposed population and, as appropriate, for more highly exposed 
        or sensitive subpopulations; and
            ``(3) describe the qualitative factors influencing the 
        ranges, distributions, and likelihood of possible risks.
    ``(g) When scientific information that permits relevant comparisons 
of risk is reasonably available, each agency shall use the information 
to place the nature and magnitude of a risk to health, safety, or the 
environment being analyzed in relationship to other reasonably 
comparable risks familiar to and routinely encountered by the general 
public. Such comparisons should consider relevant distinctions among 
risks, such as the voluntary or involuntary nature of risks, well 
understood or newly discovered risks, and reversible or irreversible 
risks.
``Sec. 625. Peer review
    ``(a) Each agency shall provide for an independent peer review in 
accordance with this section of the cost-benefit analysis and risk 
assessment required by this subchapter.
    ``(b)(1) Peer review required under subsection (a) shall--
            ``(A) be conducted through panels, expert bodies, or other 
        formal or informal devices that are broadly representative and 
        involve participants--
                    ``(i) with expertise relevant to the sciences, or 
                analyses involved in the regulatory decisions; and
                    ``(ii) who are independent of the agency;
            ``(B) be governed by agency standards and practices 
        governing conflicts of interest of nongovernmental agency 
        advisors;
            ``(C) provide for the timely completion of the peer review 
        including meeting agency deadlines;
            ``(D) contain a balanced presentation of all 
        considerations, including minority reports and an agency 
        response to all significant peer review comments; and
            ``(E) provide adequate protections for confidential 
        business information and trade secrets, including requiring 
        panel members or participants to enter into confidentiality 
        agreements.
    ``(2) Each agency shall provide a written response to all 
significant peer review comments. All peer review comments and any 
responses shall be made--
            ``(A) available to the public; and
            ``(B) part of the rule making record for purposes of 
        judicial review of any final agency action.
    ``(3) If the head of an agency, with the concurrence of the 
Director, publishes a determination in the rule making file that a 
cost-benefit analysis or risk assessment, or any component thereof, has 
been previously subjected to adequate peer review, no further peer 
review shall be required under this section for such analysis, 
assessment, or component.
    ``(c) For each peer review conducted by an agency under this 
section, the agency head shall include in the rule making record a 
statement by a Federal officer or employee who is not an employee of 
the agency rule making office or program--
            ``(1) whether the peer review participants reflect the 
        independence and expertise required under subsection (b)(1)(A); 
        and
            ``(2) whether the agency has adequately responded to the 
        peer review comments as required under subsection (b)(2).
    ``(d) The peer review required by this section shall not be subject 
to the Federal Advisory Committee Act (5 U.S.C. App.).
``Sec. 626. Deadlines for rule making
    ``(a) All statutory deadlines that require an agency to propose or 
promulgate any major rule 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 this subchapter 
        are satisfied; or
            ``(2) the date occurring 6 months after the date of the 
        applicable deadline.
    ``(b) In any proceeding involving a deadline imposed by a court of 
the United States that requires an agency to propose or promulgate any 
major rule during the 2-year period beginning on the effective date of 
this section, the United States shall request, and the court may grant, 
an extension of such deadline until the earlier of--
            ``(1) the date on which the requirements of this subchapter 
        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 major 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 this subchapter 
        are satisfied; or
            ``(2) the date occurring 6 months after the date of the 
        applicable deadline.
``Sec. 627. Judicial review
    ``(a) Compliance by an agency with the provisions of this 
subchapter shall be subject to judicial review only--
            ``(1) in connection with review of final agency action;
            ``(2) in accordance with this section; and
            ``(3) in accordance with the limitations on timing, venue, 
        and scope of review imposed by the statute authorizing judicial 
        review.
    ``(b) Any determination of an agency whether a rule is a major rule 
under section 621(7)(A) shall be set aside by a reviewing court only 
upon a showing that the determination is arbitrary or capricious.
    ``(c) Any designation by the Director that a rule is a major rule 
under section 621(7), or any failure to make such designation, shall 
not be subject to judicial review.
    ``(d) The cost-benefit analysis, cost-benefit determination under 
section 623(d), and any risk assessment required under this subchapter 
shall not be subject to judicial review separate from review of the 
final rule to which such analysis or assessment applies. The cost-
benefit analysis, cost-benefit determination under section 623(d), and 
any risk assessment shall be part of the rule making record and shall 
be considered by a court to the extent relevant, only in determining 
whether the final rule is arbitrary, capricious, an abuse of 
discretion, or is unsupported by substantial evidence where that 
standard is otherwise provided by law.
    ``(e) If an agency fails to perform the cost-benefit analysis, 
cost-benefit determination, or risk assessment, or to provide for peer 
review, a court shall remand or invalidate the rule.
``Sec. 628. Guidelines, interagency coordination, and research
    ``(a)(1) No later than 9 months after the date of enactment of this 
section, the Director, in consultation with the Council of Economic 
Advisors, the Director of the Office of Science and Technology Policy, 
and relevant agency heads, shall issue guidelines for cost-benefit 
analyses, risk assessments, and peer reviews as required by this 
subchapter. The Director shall oversee and periodically revise such 
guidelines as appropriate.
    ``(2) As soon as practicable and no later than 18 months after 
issuance of the guidelines required under paragraph (1), each agency 
subject to section 624 shall adopt detailed guidelines for risk 
assessments as required by this subchapter. Such guidelines shall be 
consistent with the guidelines issued under paragraph (1). Each agency 
shall periodically revise such agency guidelines as appropriate.
    ``(3) The guidelines under this subsection shall be developed 
following notice and public comment. The development and issuance of 
the guidelines shall not be subject to judicial review, except in 
accordance with section 706(1) of this title.
    ``(b) To promote the use of cost-benefit analysis and risk 
assessment in a consistent manner and to identify agency research and 
training needs, the Director, in consultation with the Council of 
Economic Advisors and the Director of the Office of Science and 
Technology Policy, shall--
            ``(1) oversee periodic evaluations of Federal agency cost-
        benefit analysis and risk assessment;
            ``(2) provide advice and recommendations to the President 
        and Congress to improve agency use of cost-benefit analysis and 
        risk assessment;
            ``(3) utilize appropriate interagency mechanisms to improve 
        the consistency and quality of cost-benefit analysis and risk 
        assessment among Federal agencies; and
            ``(4) utilize appropriate mechanisms between Federal and 
        State agencies to improve cooperation in the development and 
        application of cost-benefit analysis and risk assessment.
    ``(c)(1) The Director, in consultation with the head of each 
agency, the Council of Economic Advisors, and the Director of the 
Office of Science and Technology Policy, shall periodically evaluate 
and develop a strategy to meet agency needs for research and training 
in cost-benefit analysis and risk assessment, including research on 
modelling, the development of generic data, use of assumptions and the 
identification and quantification of uncertainty and variability.
    ``(2)(A) No later than 6 months after the date of enactment of this 
section, the Director, in consultation with the Director of the Office 
of Science and Technology Policy, shall enter a contract with an 
accredited scientific institution to conduct research to--
            ``(i) develop a common basis to assist risk communication 
        related to both carcinogens and noncarcinogens; and
            ``(ii) develop methods to appropriately incorporate risk 
        assessments into related cost-benefit analyses.
    ``(B) No later than 24 months after the date of enactment of this 
section, the results of the research conducted under this paragraph 
shall be submitted to the Director and Congress.
``Sec. 629. Risk based priorities study
    ``(a) No later than 1 year after the date of enactment of this 
section, the Director, in consultation with the Director of the Office 
of Science and Technology Policy, shall enter into a contract with an 
accredited scientific institution to conduct a study that provides--
            ``(1) a systematic comparison of the extent and severity of 
        significant risks to human health, safety, or the environment 
        (hereafter referred to as a comparative risk analysis);
            ``(2) a study of methodologies for using comparative risk 
        analysis to compare dissimilar risks to human health, safety, 
        or the environment, including development of a common basis to 
        assist comparative risk analysis related to both carcinogens 
        and noncarcinogens; and
            ``(3) recommendations on the use of comparative risk 
        analysis in setting priorities for the reduction of risks to 
        human health, safety, or the environment.
    ``(b) The Director shall ensure that the study required under 
subsection (a) is--
            ``(1) conducted through an open process providing peer 
        review consistent with section 625 and opportunities for public 
        comment and participation; and
            ``(2) no later than 3 years after the date of enactment of 
        this section, completed and submitted to Congress and the 
        President.
    ``(c) No later than 4 years after the date of enactment of this 
section, each relevant agency shall, as appropriate, use the results of 
the study required under subsection (a) to inform the agency in the 
preparation of the agency's annual budget and strategic plan and 
performance plan under section 306 of this title and sections 1115, 
1116, 1117, 1118, and 1119 of title 31.
    ``(d) No later than 5 years after the date of enactment of this 
section, and periodically thereafter, the President shall submit a 
report to Congress recommending legislative changes to assist in 
setting priorities to more effectively and efficiently reduce risks to 
human health, safety, or the environment.

                   ``SUBCHAPTER III--REVIEW OF RULES

``Sec. 631. Definitions
    ``For purposes of this subchapter--
            ``(1) the definitions under section 551 shall apply; and
            ``(2) the term `economically significant rule' means a rule 
        that--
                    ``(A) is likely to have an annual effect on the 
                economy of $100,000,000 or more in reasonably 
                quantifiable costs; or
                    ``(B) is likely to adversely affect, in a material 
                way, the economy, a sector of the economy, including 
                small business, productivity, competition, jobs, the 
                environment, public health or safety, or State, local 
                or tribal governments, or communities.
``Sec. 632. Review of rules
    ``(a)(1) No later than 1 year after the date of enactment of this 
section (and no later than every 5th year following the year in which 
this section takes effect) each agency shall publish in the Federal 
Register a preliminary schedule for the review of economically 
significant rules previously promulgated by the agency. The preliminary 
schedule shall be subject to public comment for 60 days after the date 
of publication. Within 120 days after the close of the public comment 
period, each agency shall publish a final schedule in the Federal 
Register.
    ``(2) In selecting which economically significant rules it shall 
review, each agency shall consider the extent to which--
            ``(A) the rule could be revised to be substantially more 
        cost-effective or to substantially increase net benefits, 
        including through flexible regulatory options;
            ``(B) the rule is important relative to other rules being 
        considered for review; and
            ``(C) the agency has discretion under the statute 
        authorizing the rule to modify or repeal the rule.
    ``(3) Each preliminary and final schedule shall include--
            ``(A) a brief description of each rule selected for review;
            ``(B) a brief explanation of the reasons for the selection 
        of each such rule for review; and
            ``(C) a deadline for the review of each rule listed 
        thereon, and such deadlines shall occur no later than 5 years 
        after the date of publication of the final schedule.
    ``(4) No later than 6 months after the deadline for a rule as 
provided under paragraph (3)(C), the agency shall publish in the 
Federal Register the determination made with respect to the rule and an 
explanation of such determination.
    ``(5)(A) If an agency makes a determination to amend or repeal a 
rule, the agency shall complete final agency action with regard to such 
rule no later than 2 years after the deadline established for such rule 
under paragraph (3).
    ``(B) The Director may extend a deadline under this section for no 
more than 1 year if the Director--
            ``(i) for good cause finds that compliance with such 
        deadline is impracticable; and
            ``(ii) publishes in the Federal Register such finding and a 
        succinct explanation of the reasons for the finding.
    ``(b) The agency shall include with the publication under 
subsection (a) the identification of any legislative mandate that 
requires the agency to impose rules that the agency determines are 
unnecessary, outdated or unduly burdensome.
    ``(c)(1) The Administrator shall work with interested entities, 
including small entities and State, local, and tribal governments, to 
pursue the objectives of this subchapter.
    ``(2) Consultation with representatives of State, local, and tribal 
governments shall be governed by the process established under section 
204 of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1534).

                  ``SUBCHAPTER IV--EXECUTIVE OVERSIGHT

``Sec. 641. Definitions
    ``For purposes of this subchapter--
            ``(1) the definitions under sections 551 and 621 shall 
        apply; and
            ``(2) the term `regulatory action' means any one of the 
        following:
                    ``(A) Advance notice of proposed rule making.
                    ``(B) Notice of proposed rule making.
                    ``(C) Final rule making, including interim final 
                rule making.
``Sec. 642. Presidential regulatory review
    ``(a) The President shall establish a process for the review and 
coordination of Federal agency regulatory actions. Such process shall 
be the responsibility of the Director.
    ``(b) For the purpose of carrying out subsection (a), the Director 
shall--
            ``(1) develop and oversee uniform regulatory policies and 
        procedures, including those by which each agency shall comply 
        with the requirements of this chapter;
            ``(2) develop policies and procedures for the review of 
        regulatory actions by the Director; and
            ``(3) develop and oversee an annual governmentwide 
        regulatory planning process that shall include review of 
        planned significant regulatory actions and publication of--
                    ``(A) a summary of and schedule for promulgation of 
                planned agency major rules;
                    ``(B) agency specific schedules for review of 
                existing rules under subchapter III and section 610;
                    ``(C) a summary of regulatory review actions 
                undertaken in the prior year;
                    ``(D) a list of major rules promulgated in the 
                prior year for which an agency could not make the 
                determinations that the benefits of a rule justify the 
                costs under section 623(d);
                    ``(E) identification of significant agency 
                noncompliance with this chapter in the prior year; and
                    ``(F) recommendations for improving compliance with 
                this chapter and increasing the efficiency and 
                effectiveness of the regulatory process.
    ``(c)(1) The review established under subsection (a) shall be 
conducted as expeditiously as practicable and shall be limited to no 
more than 90 days.
    ``(2) A review may be extended longer than the 90-day period 
referred to under paragraph (1) by the Director or at the request of 
the rule making agency to the Director. Notice of such extension shall 
be published promptly in the Federal Register.
``Sec. 643. Public disclosure of information
    ``(a) The Director, in carrying out the provisions of section 642, 
shall establish procedures to provide public and agency access to 
information concerning review of regulatory actions under this 
subchapter, 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 a regulatory action, of--
                    ``(A) all written communications relating to the 
                substance of a regulatory action, including drafts of 
                all proposals and associated analyses, between the 
                Administrator or employees of the Administrator and the 
                regulatory agency;
                    ``(B) all written communications relating to the 
                substance of a regulatory action between the 
                Administrator or employees of the Administrator and any 
                person not employed by the executive branch of the 
                Federal Government;
                    ``(C) a list identifying the dates, names of 
                individuals involved, and subject matter discussed in 
                substantive meetings and telephone conversations 
                relating to the substance of a regulatory action 
                between the Administrator or employees of the 
                Administrator 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 relating to the 
                substance of a regulatory action between the 
                Administrator or employees of the Administrator and any 
                person not employed by the executive branch of the 
                Federal Government;
                    ``(B) a list identifying the dates, names of 
                individuals involved, and subject matter discussed in 
                substantive meetings and telephone conversations, 
                relating to the substance of a regulatory action 
                between the Administrator or employees of the 
                Administrator 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 and the 
                date of such action.
    ``(b) Before the publication of any proposed or final rule, the 
agency shall include in the rule making record--
            ``(1) a document identifying in a complete, clear, and 
        simple manner, the substantive changes between the draft 
        submitted to the Administrator for review and the rule 
        subsequently announced;
            ``(2) a document identifying and describing those 
        substantive changes in the rule that were made as a result of 
        the regulatory review and a statement if the Administrator 
        suggested or recommended no changes; and
            ``(3) all written communications relating to the substance 
        of a regulatory action between the Administrator and the agency 
        during the review of the rule, including drafts of all 
proposals and associated analyses.
    ``(c) In any meeting relating to the substance of a regulatory 
action under review between the Administrator or employees of the 
Administrator and any person not employed by the executive branch of 
the Federal Government, a representative of the agency submitting the 
regulatory action shall be invited.
``Sec. 644. Judicial review
    ``The exercise of the authority granted under this subchapter by 
the President, the Director, or the Administrator shall not be subject 
to judicial review in any manner.''.
    (b) Periodic Review of Rules.--Section 610 of title 5, United 
States Code, is amended--
            (1) by striking subsection (a) and inserting the following:
    ``(a)(1)(A) No later than 60 days after the effective date of this 
section (and every fifth year following the year in which this section 
takes effect) each agency shall submit to the Administrator of the 
Office of Information and Regulatory Affairs and the Chief Counsel for 
Advocacy of the Small Business Administration a proposed plan 
describing the procedures and timetables for the periodic review of 
rules issued by the agency that have or will have a significant 
economic impact on a substantial number of small entities. No later 
than 60 days after the submission of the proposed plan to the 
Administrator and the Chief Counsel, such plan shall be published in 
the Federal Register and shall be subject to public comment for 60 days 
after the date of publication.
    ``(B) No later than 120 days after the publication of the plan 
under subparagraph (A), each agency shall submit a final plan to the 
Administrator and the Chief Counsel. No later than 60 days after the 
date of such submission of the plan to the Administrator and Chief 
Counsel, each agency shall publish the agency's final plan in the 
Federal Register.
    ``(C) Each agency's plan shall provide for the review of such rules 
no later than 5 years after publication of the final plan.
    ``(2)(A) Each year, each agency shall publish in the Federal 
Register a list of rules that will be reviewed under the plan during 
the succeeding fiscal year.
    ``(B) The publication of the list under subparagraph (A) shall 
include--
            ``(i) a brief description of each rule and the basis for 
        the agency's determination that the rule has or will have a 
        significant economic impact on a substantial number of small 
        entities;
            ``(ii) the need for and legal basis of each rule; and
            ``(iii) an invitation for public comment on each rule.
    ``(3)(A) Each agency shall conduct a review of each rule on the 
list published under paragraph (2) in accordance with the plan 
maintained under paragraph (1) and pursuant to the factors under 
subsection (b). After the completion of the review, the agency shall 
determine whether the rule should be continued without change, or 
should be amended or rescinded, consistent with the stated objectives 
of the applicable statutes, to minimize any significant economic impact 
of the rule upon a substantial number of small entities.
    ``(B) No later than 18 months after the date of the publication of 
the list of rules referred to under paragraph (2)(A), each agency shall 
publish in the Federal Register the determinations made with respect to 
such rules under subparagraph (A) and an explanation for each 
determination.
    ``(4) If the head of an agency determines that the completion of a 
review of a rule under this subsection is not feasible within the 
period described under paragraph (1)(C), the head of the agency--
            ``(A) shall certify such determination in a statement 
        published in the Federal Register; and
            ``(B) may extend the completion date of the review by 1 
        year at a time for a total of not more than 2 years.''; and
            (2) by striking subsection (c) and inserting the following:
    ``(c) The Administrator and the Chief Counsel shall work with small 
entities to achieve the objectives of this section.''.
    (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 the chapter heading and table of sections for chapter 
        6 and inserting the following:

           ``CHAPTER 6--THE ANALYSIS OF REGULATORY FUNCTIONS

           ``SUBCHAPTER I--ANALYSIS OF REGULATORY FLEXIBILITY

``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--REGULATORY ANALYSIS

``621. Definitions.
``622. Applicability and effect.
``623. Regulatory analysis.
``624. Principles for risk assessments.
``625. Peer review.
``626. Deadlines for rule making.
``627. Judicial review.
``628. Guidelines, interagency coordination, and research.
``629. Risk based priorities study.

                   ``SUBCHAPTER III--REVIEW OF RULES

``631. Definitions.
``632. Review of rules.

                  ``SUBCHAPTER IV--EXECUTIVE OVERSIGHT

``641. Definitions.
``642. Presidential regulatory review.
``643. Public disclosure of information.
``644. 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--ANALYSIS OF REGULATORY FLEXIBILITY''.

SEC. 4. COMPLIANCE WITH THE UNFUNDED MANDATES REFORM ACT OF 1995.

    Compliance with the requirements of subchapter II of chapter 6 of 
title 5, United States Code (as added by section 3 of this Act), shall 
constitute compliance with the requirements pertaining to the costs and 
benefits of a Federal mandate to the private sector in sections 202, 
205(a)(2), and 208 of the Unfunded Mandates Reform Act of 1995 (2 
U.S.C. 1532, 1535(a)(2), and 1538).

SEC. 5. EFFECTIVE DATE.

    Except as otherwise provided in this Act, this Act shall take 
effect 180 days after the date of enactment of this Act, but shall not 
apply to any agency rule for which a notice of proposed rule making is 
published on or before 60 days before the date of enactment of this 
Act.