Calendar No. 117

104TH CONGRESS

1ST SESSION S. 291

[Report No. 104–88]

A BILL

To reform the regulatory process, to make Governpurposes. ment more efficient and effective, and for other

MAY 25 (legislative day, MAY 15), 1995

Reported with an amendment
II

Calendar No. 117

104TH CONGRESS

1ST SESSION S. 291

[Report No. 104–88]

To reform the regulatory process, to make Government more efficient and

effective, and for other purposes.

IN THE SENATE OF THE UNITED STATES

JANUARY 27 (legislative day, JANUARY 10), 1995

Mr. ROTH introduced the following bill; which was read twice and referred to

the Committee on Governmental Affairs

MAY 25 (legislative day, MAY 15), 1995

Reported by Mr. ROTH, with an amendment

[Strike out all after the enacting clause and insert the part printed in italic]

A BILL

To reform the regulatory process, to make Government more

efficient and effective, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Regulatory Reform Act

5 of 1995’’.
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1 SEC. 2. TABLE OF CONTENTS.

2 The table of contents for this Act is as follows:

Sec. 1. Short title.

Sec. 2. Table of Contents.

TITLE I—REGULATORY ANALYSIS AND REVIEW

Sec. 101. Cost/benefit analysis of agency proposals; risk assessment; regulatory

review

Sec. 102. Use of State or local requirements.

Sec. 103. Presidential authority.

TITLE II—RISK-BASED PRIORITIES

Sec. 201. Short title.

Sec. 202. Purposes.

Sec. 203. Definitions.

Sec. 204. Department and agency program goals.

Sec. 205. Comparative risk analysis.

Sec. 206. Reports and recommendations to Congress and the President.

Sec. 207. Savings provision and judicial review.

TITLE III—REGULATORY ACCOUNTING

Sec. 301. Short title.

Sec. 302. Accounting statement.

Sec. 303. Associated report to Congress.

Sec. 304. Guidance from Office of Management and Budget.

Sec. 305. Recommendations from Congressional Budget Office.

Sec. 306. Definitions.

TITLE IV—MARKET INCENTIVES AND ECONOMICALLY EFFICIENT

REGULATION

Sec. 401. Short title.

Sec. 402. Program design requirements.

Sec. 403. Agency assessment and OMB review.

Sec. 404. Definitions.

3 TITLE I—REGULATORY ANALYSIS AND

4 REVIEW

5 SEC. 101. COST/BENEFIT ANALYSIS OF AGENCY PROPOS6 ALS; RISK ASSESSMENT; REGULATORY RE7 VIEW.

8 (a) IN GENERAL.—Chapter 6 of title 5, United

9 States Code, is amended by adding at the end thereof the

10 following:
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1 ‘‘Subchapter II—Analysis of Agency

2 Proposals

3 ‘‘§ 621. Definitions

4 ‘‘For purposes of this subchapter and subchapter III

5 of this chapter:

6 ‘‘(1) The term ‘agency’ has the same meaning

7 as in section 551(1) of this title.

8 ‘‘(2) The term ‘person’ has the same meaning

9 as in section 551(2) of this title.

10 ‘‘(3) The term ‘rule’ has the same meaning as

11 in section 551(4) of this title, except that such term

12 does not include—

13 ‘‘(A) a rule of particular applicability that

14 approves or prescribes for the future rates,

15 wages, prices, services, or allowances therefor,

16 corporate or financial structures, reorganiza17 tions, mergers or acquisitions, or accounting

18 practices or disclosures bearing on any of the

19 foregoing;

20 ‘‘(B) a rule relating to monetary policy

21 proposed or promulgated by the Board of Gov22 ernors of the Federal Reserve System; or

23 ‘‘(C) a rule issued by the Federal Election

24 Commission or a rule issued by the Federal

25 Communications Commission pursuant to sec-
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1 tions 315 and 312(a)(7) of the Communications

2 Act of 1934.

3 ‘‘(4) The term ‘major rule’ means—

4 ‘‘(A) a rule or a group of closely related

5 rules that the agency, the President, or the offi6 cer selected under section 624 of this title rea7 sonably determines is likely to have an annual

8 effect in the economy of $100,000,000 or more

9 in reasonably quantifiable direct and indirect

10 costs, or has a significant impact on a subsector

11 of the economy; and

12 ‘‘(B) a rule or a group of closely related

13 rules that is otherwise designated a major rule

14 by the agency proposing the rule, or is so des15 ignated by the President, or by the officer se16 lected under section 624 of this title, on the

17 ground that the rule is likely to result in—

18 ‘‘(i) a substantial increase in costs or

19 prices for wage earners, consumers, indi20 vidual industries, nonprofit organizations,

21 Federal, State, or local government agen22 cies, or geographic regions; or

23 ‘‘(ii) significant adverse effects on

24 wages, economic growth, investment, pro25 ductivity, innovation, the environment,
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1 public health or safety, or the ability of en2 terprises whose principal places of business

3 are in the United States to compete in do4 mestic or export markets. For purposes of

5 subparagraph (A) of this paragraph, the

6 term ‘rule’ does not mean—

7 ‘‘(I) a rule that involves the in8 ternal revenue laws of the United

9 States;

10 ‘‘(II) a rule that authorizes the

11 introduction into commerce or recog12 nizes the marketable status of a prod13 uct, pursuant to sections 408, 409(c),

14 and 706 of the Federal Food, Drug,

15 and Cosmetic Act;

16 ‘‘(III) a rule exempt from notice

17 and public procedure pursuant to sec18 tion 553(a) of this title; or

19 ‘‘(IV) a rule relating to the via20 bility, stability, asset powers, or cat21 egories of accounts of, or permissible

22 interest rate ceilings applicable to, de23 pository institutions the deposits or

24 accounts of which are insured by the

25 Federal Deposit Insurance Corpora-
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1 tion, or the Share Insurance Fund of

2 the National Credit Union Adminis3 tration Board.

4 ‘‘(5) The term ‘benefit’ means the reasonably

5 identifiable significant benefits and beneficial effects,

6 including social and economic benefits and effects,

7 that are expected to result directly or indirectly from

8 implementation of a rule or an alternative to a rule.

9 ‘‘(6) The term ‘cost’ means the reasonably iden10 tifiable significant costs and adverse effects, includ11 ing economic and social costs and effects, that are

12 expected to result directly or indirectly from imple13 mentation of a rule or an alternative to a rule.

14 ‘‘§ 622. Regulatory cost/benefit analysis

15 ‘‘(a) Prior to publishing notice of proposed rule16 making for any rule, each agency shall determine whether

17 the rule is or is not a major rule within the meaning of

18 section 621(4)(A) of this title and, if it is not, whether

19 it should be designated a major rule under section

20 621(4)(B) of this title. For the purpose of any such deter21 mination or designation, a group of closely related rules

22 shall be considered as one rule. Every notice of proposed

23 rulemaking shall include a succinct statement and expla24 nation of the agency’s determination of whether or not the

25 rule is a major rule within the meaning of section
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1 621(4)(A) of this title and, if applicable, of its designation

2 as a major rule under section 621(4)(B) of this title.

3 ‘‘(b) The President or the officer selected by the

4 President under section 624 of this title may determine

5 that a rule is a major rule within the meaning of section

6 621(4)(A) of this title or may designate a rule as a major

7 rule under section 621(4)(B) of this title not later than

8 thirty days after the publication of the notice of proposed

9 rulemaking for that rule. Such determination or designa10 tion shall be published in the Federal Register, together

11 with a succinct statement of the basis for the determina12 tion or designation. The President or the officer selected

13 by the President under section 624 of this title may des14 ignate not more than seventy-five rules as major rules

15 under section 621(4)(B) of this title in any fiscal year.

16 ‘‘(c)(1) When the agency publishes a notice of pro17 posed rulemaking for a major rule, the agency shall issue

18 and place in the rulemaking file maintained under section

19 553(f) of this title a preliminary regulatory analysis and

20 shall include in such notice of proposed rulemaking a sum21 mary of the analysis. When the President or the officer

22 selected by the President under section 624 of this title

23 has published a determination or designation that a rule

24 is a major rule after the publication of the notice of pro25 posed rulemaking for that rule, the agency shall promptly
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1 issue and place in the rulemaking file maintained under

2 section 553(f) of this title a preliminary regulatory analy3 sis for the rule and shall publish in the Federal Register

4 a summary of such analysis. Following the issuance of a

5 preliminary regulatory analysis under the preceding sen6 tence, the agency shall give interested persons an oppor7 tunity to comment thereon pursuant to section 553 of this

8 title in the same manner as if the preliminary regulatory

9 analysis had been issued with the notice of proposed rule10 making.

11 ‘‘(2) Each preliminary regulatory analysis shall con12 tain—

13 ‘‘(A) a succinct description of the benefit of the

14 proposed rule, including any beneficial effects that

15 cannot be quantified, and an explanation of how the

16 agency anticipates each benefit will be achieved by

17 the proposed rule, including a description of the per18 sons, classes of persons, or particular levels of Gov19 ernment likely to receive such benefits;

20 ‘‘(B) a succinct description of the costs of the

21 proposed rule, including any costs that cannot be

22 quantified as well as the cost-reduction effects of

23 complying with the requirements of title IV, and an

24 explanation of how the agency anticipates each such

25 cost will result from the proposed rule, including a
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1 description of the persons, classes of persons, or par2 ticular levels of Government likely to incur such

3 costs;

4 ‘‘(C) a succinct description of reasonable alter5 natives for achieving the identified benefits of the

6 proposed rule, including alternatives that—

7 ‘‘(i) require no Government action;

8 ‘‘(ii) will accommodate differences between

9 geographic regions; and

10 ‘‘(iii) employ performance or other

11 marketbased standards which permit the great12 est flexibility in achieving the identified benefits

13 of the proposed rule and which comply with the

14 requirements of title IV;

15 ‘‘(D) in any case in which the proposed rule is

16 based on scientific evaluations or information, a de17 scription of action undertaken by the agency to ver18 ify the quality, reliability, and relevance of such sci19 entific evaluations or scientific information in ac20 cordance with the requirements of title IV; and

21 ‘‘(E) where it is not expressly or by necessary

22 implication inconsistent with the provisions of the

23 enabling statute pursuant to which the agency is

24 proposing the rule, an explanation of how the identi25 fied benefits of the proposed rule are likely to justify
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1 the identified costs of the proposed rule, and an ex2 planation of how the proposed rule is likely to sub3 stantially achieve the rulemaking objectives in a

4 more cost-effective manner than the alternatives to

5 the proposed rule, including alternatives identified in

6 accordance with title IV.

7 ‘‘(d)(1) When the agency publishes a final major rule,

8 the agency shall also issue and place in the rulemaking

9 file maintained under section 553(f) of this title a final

10 regulatory analysis, and shall include a summary of the

11 analysis in the statement of basis and purpose required

12 by section 553(c)(6) of this title. Notwithstanding the pre13 ceding sentence, in any case in which an agency, under

14 section 553(b)(2) of this title, is not required to comply

15 with subsections (b) through (f) of section 553 of this title

16 prior to the adoption of a final rule, an agency is not re17 quired to comply with the preceding sentence prior to the

18 adoption of the final rule but shall comply with such

19 sentence when complying with section 553(b)(2)(C) of this

20 title.

21 ‘‘(2) Each final regulatory analysis shall contain—

22 ‘‘(A) a description and comparison of the bene23 fits and costs of the rule and of the reasonable alter24 natives to the rule described in the rulemaking, in-
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1 cluding the market-based mechanisms identified pur2 suant to title IV; and

3 ‘‘(B) where it is not expressly or by necessary

4 implication inconsistent with the provisions of the

5 enabling statute pursuant to which the agency is

6 acting, a reasonable determination, based upon the

7 rulemaking file considered as a whole, that the bene8 fits of the rule justify the costs of the rule, and that

9 the rule will substantially achieve the rulemaking ob10 jectives in a more cost-effective manner than the al11 ternatives described in the rulemaking, including the

12 market-based incentives identified pursuant to title

13 IV.

14 ‘‘(e)(1) An agency shall describe the nature and ex15 tent of the nonqualifiable benefits and costs of a proposed

16 and a final rule pursuant to this section in as precise and

17 succinct a manner as possible. The description of the bene18 fits and costs of a proposed and a final rule required under

19 this section shall include a quantification or numerical es20 timate of the quantifiable benefits and costs. Such quan21 tification or numerical estimate shall be made in the most

22 appropriate unit of measurement and shall specify the

23 ranges of predictions and explain the margins of error in24 volved in the quantification methods and in the estimates

25 used.
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1 ‘‘(2) In evaluating and comparing costs and benefits,

2 the agency shall not rely on cost or benefit information

3 submitted by any person that is not accompanied by data,

4 analysis, or other supporting materials that would enable

5 the agency and other persons interested in the rulemaking

6 to assess the accuracy and reliability of such information.

7 The agency evaluations of the relationships of the benefits

8 of a proposed and final rule to its costs required by this

9 section shall be clearly articulated in accordance with the

10 provisions of this section. An agency is not required to

11 make such evaluation primarily on a mathematical or nu12 merical basis.

13 ‘‘(f) The preparation of the preliminary or final regu14 latory analysis required by this section shall only be per15 formed by an officer or employee of the agency. The provi16 sions of the preceding sentence do not preclude a person

17 outside the agency from gathering data or information to

18 be used by the agency in preparing any such regulatory

19 analysis or from providing an explanation sufficient to per20 mit the agency to analyze such data or information. If any

21 such data or information is gathered or explained by a

22 person outside the agency, the agency shall specifically

23 identify in the preliminary or final regulatory analysis the

24 data or information gathered or explained and the person

25 who gathered or explained it, and shall describe the ar-
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1 rangement by which the information was procured by the

2 agency, including the total amount of funds expended for

3 such procurement.

4 ‘‘(g) The requirements of this section do not alter the

5 criteria for rulemaking otherwise applicable under other

6 statutes.

7 ‘‘§ 623. Judicial review

8 ‘‘(a) Compliance or noncompliance by an agency with

9 the provisions of this subchapter shall not be subject to

10 judicial review except according to the provisions of this

11 section.

12 ‘‘(b) Any determination by the President or by the

13 officer selected under section 624 of this title that a rule

14 is a major rule within the meaning of section 621(4)(A)

15 of this title, and any designation by the President or the

16 officer selected under section 624 of this title that a rule

17 is a major rule under section 621(4)(B) of this title, or

18 any failure to make such a designation, shall not be sub19 ject to judicial review in any manner.

20 ‘‘(c) The determination of an agency of whether a

21 rule is or is not a major rule within the meaning of section

22 621(4)(A) of this title shall be set aside by a reviewing

23 court only upon a clear and convincing showing that the

24 determination is erroneous in light of the information

25 available to the agency at the time it made the determina-
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1 tion. Any designation by an agency that a rule is a major

2 rule under section 621(4)(B) of this title, or any failure

3 to make such a designation, shall not be subject to judicial

4 review.

5 ‘‘(d) Any regulatory analysis prepared under section

6 622 of this title shall not be subject to judicial consider7 ation separate or apart from review of the rule to which

8 it relates. When an action for judicial review of a rule is

9 instituted, any regulatory analysis for such rule shall con10 stitute part of the whole rulemaking record of agency ac11 tion for the purpose of judicial review of the rule and shall,

12 to the extent relevant, be considered by a court in deter13 mining the legality of the rule.

14 ‘‘§ 624. Executive oversight

15 ‘‘(a) The President shall have the authority to estab16 lish procedures for agency compliance with this title and

17 titles II, III, and IV of this Act. The President shall have

18 the authority to monitor, review, and ensure agency imple19 mentation of such procedures. The President shall report

20 annually to the Congress on agency compliance or non21 compliance with the requirements of this chapter.

22 ‘‘(b) Any procedures established pursuant to the au23 thority granted under subsection (a) of this section shall

24 be adopted after the public has been afforded an oppor25 tunity to comment thereon, and shall be consistent with
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1 the prompt completion of rulemaking proceedings. If such

2 procedures include review of preliminary or final regu3 latory analyses to ensure that they comply with the proce4 dures established pursuant to subsection (a), the time for

5 any such review of a preliminary regulatory analysis shall

6 not exceed thirty days following the receipt of that analysis

7 by the President or by an officer to whom the authority

8 granted under subsection (a) of this section has been dele9 gated pursuant to subsection (c) of this section, and the

10 time for such review of a final regulatory analysis shall

11 not exceed thirty days following the receipt of that analysis

12 by the President or such officer. The times for each such

13 review may be extended for good cause by the President

14 or such officer for an additional thirty days. Notice of any

15 such extension, together with a succinct statement of the

16 reasons therefor, shall be inserted in the rulemaking file.

17 ‘‘(c) The President may delegate the authority grant18 ed by this Act to the Vice President or to an officer within

19 the Executive Office of the President whose appointment

20 has been subject to the advice and consent of the Senate.

21 Any such notice with respect to a delegation to the Vice

22 President shall contain a statement by the Vice President

23 that the Vice President will make every reasonable effort

24 to respond to congressional inquiries concerning the exer25 cise of the authority delegated under this subsection. No-
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1 tice of any such delegation, or any revocation or modifica2 tion thereof, shall be published in the Federal Register.

3 ‘‘(d) The authority granted under subsection (a) of

4 this section and title II shall not apply to rules issued by

5 the Nuclear Regulatory Commission.

6 ‘‘(e) Any exercise of the authority granted under this

7 section, or any failure to exercise such authority, by the

8 President or by an officer to whom such authority has

9 been delegated under subsection (c) of this section, shall

10 not be subject to judicial review in any manner under this

11 Act.

12 ‘‘Subchapter III—Risk Assessments

13 ‘‘§ 631. Findings, purposes, and definitions

14 ‘‘(a) FINDINGS.—The Congress finds that:

15 ‘‘(1) Environmental, health, and safety regula16 tions have lead to dramatic improvements in the en17 vironment and have significantly reduced risks to

18 human health; however, many regulations have been

19 more costly and less effective than they could have

20 been; too often, regulatory priorities have not been

21 based upon a realistic consideration of risk, risk re22 duction opportunities, and costs.

23 ‘‘(2) The public and private resources available

24 to address health, safety, and environmental risks

25 are not unlimited; those resources should be allo-
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1 cated to address the greatest needs in the most cost2 effective manner and to ensure that the incremental

3 costs of regulatory options are reasonably related to

4 the incremental benefits.

5 ‘‘(3) To provide more cost-effective protection

6 to human health and the environment, regulatory

7 priorities should be based upon realistic consider8 ation of risk; the priority-setting process must in9 clude scientifically sound, objective, and unbiased

10 risk assessments and risk management choices that

11 are grounded in cost/benefit principles.

12 ‘‘(4) Risk assessment has proved to be a useful

13 decisionmaking tool; however, improvements are

14 needed in both the quality of assessments and the

15 characterization and communication of findings; sci16 entific and other data must be better collected, orga17 nized, and evaluated; most importantly, the critical

18 information resulting from a risk assessment must

19 be effectively communicated in an objective and un20 biased manner to decision makers, and from decision

21 makers to the public.

22 ‘‘(5) The public stakeholders must be fully in23 volved in the decisionmaking process for regulating

24 risks. The public has the right to know about the

25 risks addressed by regulation, the amount of risk re-
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1 duced, the quality of the science used to support de2 cisions, and the cost of implementing and complying

3 with regulations. This knowledge will allow for pub4 lic scrutiny and will promote the quality, integrity,

5 and responsiveness of agency decisions.

6 ‘‘(b) PURPOSES.—The purposes of this subchapter

7 are—

8 ‘‘(1) to present the public and executive branch

9 with the most scientifically objective and unbiased

10 information concerning the nature and magnitude of

11 health, safety, and environmental risks to promote

12 sound regulatory decisions and public education;

13 ‘‘(2) to provide for full consideration and dis14 cussion of relevant data and potential methodologies;

15 ‘‘(3) to require explanation of significant

16 choices in the risk assessment process that will allow

17 for better public understanding; and

18 ‘‘(4) to improve consistency within the executive

19 branch in preparing risk assessments and risk char20 acterizations.

21 ‘‘(c) DEFINITIONS.—For purposes of this subchapter:

22 ‘‘(1) BEST ESTIMATE.—The term ‘best esti23 mate’ means an estimate that, to the extent feasible

24 and scientifically appropriate, is based on one of the

25 following:
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1 ‘‘(A) Central estimates of risk using the

2 most plausible assumptions.

3 ‘‘(B) An approach that combines multiple

4 estimates based on different scenarios and

5 weighs the probability of each scenario.

6 ‘‘(C) Any other methodology designed to

7 provide the most unbiased representation of the

8 most plausible level of risk, given the current

9 scientific information available to the Federal

10 agency concerned.

11 ‘‘(2) COVERED AGENCY.—The term ‘covered

12 agency’ means each of the following:

13 ‘‘(A) The Environmental Protection Agen14 cy.

15 ‘‘(B) The Department of Labor.

16 ‘‘(C) The Food and Drug Administration.

17 ‘‘(D) The Consumer Product Safety Com18 mission.

19 ‘‘(E) The Department of Transportation.

20 ‘‘(F) The Department of Energy.

21 ‘‘(G) The Department of Agriculture.

22 ‘‘(H) The Department of the Interior.

23 ‘‘(I) The Nuclear Regulatory Commission.
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1 ‘‘(3) EMERGENCY.—The term ‘emergency’

2 means an imminent and substantial endangerment

3 to public health, safety, or the environment.

4 ‘‘(4) HAZARD IDENTIFICATION.—The term

5 ‘hazard identification’ means identification of a sub6 stance, activity, or condition as potentially posing a

7 risk to human health or safety or the environment

8 based on empirical data, measurements, or testing

9 showing that it has caused significant adverse effects

10 at some levels of dose or exposure not necessarily

11 relevant to level of dose or exposure that are nor12 mally expected to occur.

13 ‘‘(5) RISK ASSESSMENT.—The term ‘risk as14 sessment’ means—

15 ‘‘(A) the process of identifying hazards and

16 quantifying or describing the degree of toxicity,

17 exposure, or other risk they pose for exposed

18 individuals, populations, or resources; and

19 ‘‘(B) the document containing the expla20 nation of how the assessment process has been

21 applied to an individual substance, activity, or

22 condition.

23 ‘‘(6) RISK CHARACTERIZATION.—The term ‘risk

24 characterization’ means—
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1 ‘‘(A) the element of a risk assessment that

2 involves presentation of the degree of risk in

3 any regulatory proposal or decision, report to

4 Congress, or other document that is made avail5 able to the public; and

6 ‘‘(B) includes discussions of uncertainties,

7 conflicting data, estimates, extrapolations, in8 ferences, and opinions.

9 ‘‘(7) SUBSTITUTION RISK.—The term ‘substi10 tution risk’ means a potential increased risk to

11 human health, safety, or the environment from a

12 regulatory option designed to decrease other risks.

13 ‘‘§ 632. Applicability

14 ‘‘(a) IN GENERAL.—Except as otherwise provided in

15 subsection (b), this title shall apply to all risk assessments

16 and risk characterizations prepared by, or on behalf of,

17 or prepared by others and adopted by any covered agency

18 in connection with health, safety, and environmental risks.

19 ‘‘(b) EXCEPTIONS.—

20 ‘‘(1) IN GENERAL.—This title shall not apply to

21 risk assessments or risk characterizations performed

22 with respect to—

23 ‘‘(A) a situation that the head of the agen24 cy considers to be an emergency; or
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1 ‘‘(B) a screening analysis, including a

2 screening analysis for the purposes of product

3 registration, product reregistrations, or

4 premanufacturing notices.

5 ‘‘(2) TREATMENT OF ANALYSIS AS SCREENING

6 ANALYSIS.—An analysis shall not be treated as a

7 screening analysis for the purposes of paragraph

8 (1)(B) if the result of the analysis is used—

9 ‘‘(A) as the basis for imposing a restriction

10 on a substance or activity; or

11 ‘‘(B) to characterize a positive finding of

12 risks from a substance, product, or activity in

13 any agency document or other communication

14 made available to the general public, the media,

15 or Congress.

16 ‘‘(3) LABELS.—This title shall not apply to any

17 food, drug, or other product label or to any risk

18 characterization appearing on any such label.

19 ‘‘§ 633. Savings provisions

20 ‘‘Nothing in this title shall be construed to—

21 ‘‘(1) modify any statutory standard or require22 ment designed to protect human health, safety, or

23 the environment;

24 ‘‘(2) preclude the consideration of any data or

25 the calculation of any estimate to more fully describe
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1 risk or provide examples of scientific uncertainty or

2 variability; or

3 ‘‘(3) require the disclosure of any trade secrets

4 or other confidential information.

5 ‘‘§ 634. Requirement to prepare risk assessments

6 ‘‘Except as provided in subsection 632(b), the Presi7 dent shall require that the head of each covered agency

8 prepare for each major rule relating to human health,

9 safety, or the environment that is proposed by the agency

10 after the date of enactment of this title—

11 ‘‘(1) a risk assessment in accordance with this

12 title; and

13 ‘‘(2) for each such proposed or final rule, an as14 sessment of incremental risk reduction or other ben15 efits associated with each significant regulatory al16 ternative considered by the agency in connection

17 with the rule or proposed rule.

18 ‘‘§ 635. Principles for risk assessment

19 ‘‘(a) IN GENERAL.—The head of each covered agency

20 shall ensure that risk assessments and all of their compo21 nents—

22 ‘‘(1) distinguish scientific findings and best es23 timates of risk from other considerations;

24 ‘‘(2) are, to the maximum extent practicable,

25 unbiased and inclusive of all reliable information and
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1 employ default assumptions only if situation-specific

2 information is not reasonably available;

3 ‘‘(3) rely on scientific findings of risk;

4 ‘‘(4) result in the most plausible and realistic

5 estimates feasible for the population, or, if only

6 bounds can be estimated reliably, describe the range

7 encompassed; and

8 ‘‘(5) are tailored so that the degree of specific9 ity and rigor employed is commensurate with the

10 consequences of the decision to be made.

11 ‘‘(b) HAZARD IDENTIFICATION AND RISK CHARAC12 TERIZATION.—A risk assessment shall clearly separate

13 hazard identification from risk characterization and make

14 clear the relationship between the level of risk and the

15 level of exposure to a hazard.

16 ‘‘§ 636. Principles for risk characterization and risk

17 communication

18 ‘‘In characterizing risk in any risk assessment docu19 ment, regulatory proposal or decision each covered agency

20 shall include in the risk characterization each of the fol21 lowing:

22 ‘‘(1) ESTIMATES OF RISK.—

23 ‘‘(A) SUBJECT.—A description of the pop24 ulations or natural resources that are the sub25 ject of the risk characterization.
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1 ‘‘(B) ASSUMPTIONS, INFERENCES, AND

2 MODELS.—When a risk assessment involves a

3 choice of any significant assumption, inference,

4 or model, the covered agency or instrumentality

5 preparing the risk assessment shall—

6 ‘‘(i) present a representative list and

7 explanation of plausible and alternative as8 sumptions, inferences, or models;

9 ‘‘(ii) explain the basis for any choices;

10 ‘‘(iii) identify any subjective policy de11 cisions or value judgments; and

12 ‘‘(iv) indicate the extent to which any

13 significant model has been validated by, or

14 conflicts with, empirical data.

15 ‘‘(C) UNCERTAINTY.—The major uncer16 tainties in the risk assessment.

17 ‘‘(D) EXPOSURE SCENARIOS.—Information

18 about exposure scenarios used, including the

19 likelihood of those scenarios.

20 ‘‘(E) RISK RANGE.—To the extent feasible,

21 a range of risk estimates, including central esti22 mates, for each exposure scenario.

23 ‘‘(F) SCIENTIFIC FINDINGS AND POLICY

24 DECISIONS.—To the extent feasible, each risk
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1 characterization should distinguish between sci2 entific findings and policy decisions.

3 ‘‘(2) SUBSTITUTION RISKS.—When a covered

4 agency provides a risk assessment or risk character5 ization for a proposed or final regulatory action,

6 such assessment or characterization shall include a

7 statement of any significant substitution risks, when

8 information on such risks has been provided to the

9 agency.

10 ‘‘(3) SUMMARIES OF OTHER RISK ESTI11 MATES.—If—

12 ‘‘(A) a covered agency provides a public

13 comment period with respect to a risk assess14 ment or regulation;

15 ‘‘(B) a commenter provides a risk assess16 ment, and a summary of results of such risk as17 sessment; and

18 ‘‘(C) such risk assessment is consistent

19 with the principles and the guidance provided

20 under this subtitle,

21 the covered agency shall present such summary in

22 connection with its presentation of the risk assess23 ment or regulation.
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1 ‘‘§ 637. Guidelines, plan for assessing new informa2 tion, and report

3 ‘‘(a) GUIDELINES.—

4 ‘‘(1) IN GENERAL.—Within fifteen months after

5 the date of enactment of this title, each covered

6 agency shall issue, after notice and public comment,

7 guidelines to implement the risk assessment and risk

8 characterization principles set forth in sections 635

9 and 636 and shall provide a format for summarizing

10 risk assessment results.

11 ‘‘(2) MATTERS TO BE ADDRESSED.—The guide12 lines under paragraph (1) shall—

13 ‘‘(A) include guidance on utilization of spe14 cific technical methodologies and standards for

15 acceptable quality of specific kinds of data; and

16 ‘‘(B) address important decisional factors

17 for the risk assessment or risk characterization

18 at issue, such as criteria for scaling animal

19 studies to assess risk to human health; use of

20 different types of dose-response models; thresh21 olds; definitions, use, and interpretations of the

22 maximum tolerated dose; weighing of evidence

23 with respect to extrapolating human health

24 risks from sensitive species; evaluation of be25 nign tumors; and evaluation of differences in

26 human health endpoints, where relevant.
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1 ‘‘(b) PLAN.—

2 ‘‘(1) IN GENERAL.—Within eighteen months

3 after the date of enactment of this title, the head of

4 each covered agency shall publish a plan to review

5 and revise any risk assessment published prior to

6 the expiration of such eighteen-month period if the

7 covered agency determines that significant new in8 formation or methodologies are available that could

9 significantly alter the results of the prior risk assess10 ment.

11 ‘‘(2) CONTENTS.—A plan under paragraph (1)

12 shall—

13 ‘‘(A) provide procedures for receiving and

14 considering new information and risk assess15 ments from the public; and

16 ‘‘(B) set priorities for review and revision

17 of risk assessments based on such factors as

18 the agency head considers appropriate.

19 ‘‘(c) REPORT.—Within three years after the enact20 ment of this title, each covered agency shall provide a re21 port to the Congress evaluating the categories of policy

22 and value judgments identified under subparagraph

23 (B)(iii) of section 636(1).

24 ‘‘(d) PUBLIC COMMENT AND CONSULTATION.—The

25 guidelines, plan and report under this section shall be de-
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1 veloped after notice and opportunity for public comment,

2 and after consultation with representatives of appropriate

3 State agencies and local governments, and such other de4 partments and agencies, organizations, or persons as may

5 be advisable.

6 ‘‘(e) REVIEW.—The President shall review the guide7 lines published under this section at least every four years.

8 ‘‘(f) LIMITATION ON JUDICIAL REVIEW.—The devel9 opment, issuance, and publication of risk assessment and

10 risk characterization guidelines under this section shall

11 not be subject to judicial review.

12 ‘‘§ 638. Risk management criteria

13 ‘‘For each major rule subject to this title, the head

14 of the agency or the President shall make a determination

15 that—

16 ‘‘(1) the risk assessment under section 634(1)

17 and the analysis under section 634(2) are based on

18 a scientific evaluation of the risk addressed by the

19 major rule and are supported by the best available

20 scientific data; and

21 ‘‘(2) there is no regulatory alternative that is

22 allowed by the statute under which the regulation is

23 promulgated that would achieve an equivalent reduc24 tion in risk in a more cost-effective and flexible man25 ner.
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1 ‘‘§ 639. Interagency coordination

2 ‘‘To promote the conduct, application, and practice

3 of risk assessment in a consistent manner and to identify

4 risk assessment data and research needs common to more

5 than one Federal agency, the Director of the Office of

6 Science and Technology Policy shall—

7 ‘‘(1) periodically survey the manner in which

8 each Federal agency involved in risk assessment is

9 conducting such risk assessment to determine the

10 scope and adequacy of risk assessment practices in

11 use by the Federal Government;

12 ‘‘(2) provide advice and recommendations to the

13 President and Congress based on the surveys con14 ducted and determinations made under paragraph

15 (1);

16 ‘‘(3) establish appropriate interagency mecha17 nisms to promote coordination among Federal agen18 cies conducting risk assessment with respect to the

19 conduct, application, and practice of risk assessment

20 and to promote the use of state-of-the-art risk as21 sessment practices throughout the Federal Govern22 ment;

23 ‘‘(4) establish appropriate mechanisms between

24 Federal and State agencies to communicate state-of25 the-art risk assessment practices; and
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1 ‘‘(5) periodically convene meetings with State

2 government representatives and Federal and other

3 leaders to assess the effectiveness of Federal-State

4 cooperation in the development and application of

5 risk assessment.

6 ‘‘Subchapter IV—Regulatory Priorities and

7 Review

8 ‘‘§ 641. Review of agency rules

9 ‘‘(a)(1)(A) Not later than nine months after the ef10 fective date of this section, each agency shall prepare and

11 publish in the Federal Register a proposed schedule for

12 the review, in accordance with this section, of—

13 ‘‘(i) each rule of the agency which is in effect

14 on such effective date and which, if adopted on such

15 effective date, would be a major rule under section

16 621(4)(A) of this title, and

17 ‘‘(ii) each rule of the agency in effect on such

18 effective date (in addition to the rules described in

19 clause (i)) which the agency has selected for review.

20 ‘‘(B) Each proposed schedule required by subpara21 graph (A) shall include—

22 ‘‘(i) a brief explanation of the reasons the agen23 cy considers each rule on the schedule to be such a

24 major rule under section 621(a)(4)(A) of this title or
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1 of the reasons why the agency selected the rule for

2 review;

3 ‘‘(ii) a date set by the agency, in accordance

4 with the provisions of subsection (b)(1) of this sec5 tion, for the completion of the review of each such

6 rule; and

7 ‘‘(iii) a statement that the agency requests com8 ments from the public on the proposed schedule.

9 ‘‘(C) The agency shall set a date to initiate review

10 of each rule on the schedule in a manner which will ensure

11 the simultaneous review of related items and which will

12 achieve a reasonable distribution of reviews over the period

13 of time covered by the schedule.

14 ‘‘(2) At least ninety days before publishing in the

15 Federal Register the proposed schedule required under

16 paragraph (1), each agency shall make the proposed

17 schedule available to the President, or to the Vice Presi18 dent or other officer to whom oversight authority has been

19 delegated under section 624(b) of this title. The President

20 or that officer may select for review in accordance with

21 this section any additional rule that the President or such

22 officer determines to be a major rule under section

23 621(4)(A) of this title.

24 ‘‘(3) Not later than one year after the effective date

25 of this section, each agency shall publish in the Federal
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1 Register a final schedule for the review of the rules re2 ferred to in paragraphs (1) and (2) of this subsection.

3 Each agency shall publish with the final schedule the re4 sponse of the agency to comments received concerning the

5 proposed schedule.

6 ‘‘(b)(1) Except where explicitly provided otherwise by

7 statute, the agency shall, pursuant to subsections (c)

8 through (e) of this section, review—

9 ‘‘(A) each rule on the schedule promulgated

10 pursuant to subsection (a) of this section;

11 ‘‘(B) each major rule under section 621(4) of

12 this title promulgated, amended, or otherwise re13 newed by an agency after the date of the enactment

14 of this section; and

15 ‘‘(C) each rule promulgated after the date of

16 enactment of this section which the President or the

17 officer designated by the President pursuant to sub18 section (a)(2) of this section determines to be a

19 major rule under section 621(4) of this title.

20 Except where an extension has been granted pursuant to

21 subsection (f) of this section, the review of a rule required

22 by this section shall be completed within ten years after

23 the effective date of this section or within ten years after

24 the date on which the rule is promulgated, amended, or

25 renewed, whichever is later.
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1 ‘‘(2) A rule required to be reviewed under the preced2 ing subsection on grounds that it is major need not be

3 reviewed if the agency determines that such rule, if adopt4 ed at the time of the planned review, would not be major

5 under the definition previously applied to it. When the

6 agency makes such a determination, it shall publish a no7 tice and explanation of the determination in the Federal

8 Register.

9 ‘‘(c) An agency shall publish in the Federal Register

10 a notice of its proposed action under this section with re11 spect to a rule being reviewed. The notice shall include—

12 ‘‘(1) an identification of the specific statutory

13 authority under which the rule was promulgated and

14 a statement specifying the agency’s determination of

15 whether the rule continues to fulfill the intent of

16 Congress in enacting that authority;

17 ‘‘(2) an assessment of the benefits and costs of

18 the rule during the period in which it has been in

19 effect;

20 ‘‘(3) an explanation of the proposed agency ac21 tion with respect to the rule; and

22 ‘‘(4) a statement that the agency seeks propos23 als from the public for modifications or alternatives

24 to the rule which may accomplish the objectives of

25 the rule in a more effective or less burdensome man-
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1 ner, including alternatives developed in accordance

2 with the provisions of title IV of this bill.

3 ‘‘(d) If an agency proposes to repeal or amend a rule

4 under review pursuant to this section, the agency shall,

5 after issuing the notice required by subsection (c) of this

6 section, comply with the provisions of this chapter and

7 chapter 5 of this title or other applicable law. The require8 ments of such provisions and related requirements of law

9 shall apply to the same extent and in the same manner

10 as in the case of a proposed agency action to repeal or

11 amend a rule which is not taken pursuant to the review

12 required by this section.

13 ‘‘(e) If an agency proposed to renew without amend14 ment a rule under review pursuant to this section, the

15 agency shall—

16 ‘‘(1) give interested persons not less than sixty

17 days after the publication of the notice required by

18 subsection (c) of this section to comment on the pro19 posed renewal; and

20 ‘‘(2) publish in the Federal Register notice of

21 the renewal of such rule and an explanation of the

22 continued need for the rule, and, if the renewed rule

23 is a major rule under section 621(4) of this title, in24 clude with such notice an explanation of the reason25 able determination of the agency that the rule com-
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1 plies with the provisions of section 622(d)(2)(B) of

2 this title.

3 ‘‘(f)(1) Any agency, which for good cause finds com4 pliance with this section with respect to a particular rule

5 to be impracticable during the period provided in sub6 section (b) of this section, may request the President, or

7 the officer designated by the President pursuant to sub8 section (a)(2) of this section, to establish a period longer

9 than ten years for the completion of the review of such

10 rule. The President or that officer may extend the period

11 for review of a rule to a total period of not more than

12 fifteen years. Such extension shall be published in the

13 Federal Register with an explanation of the reasons there14 for.

15 ‘‘(2) An agency may, with the concurrence of the

16 President or the officer designated by the President pursu17 ant to subsection (a)(2) of this section, or shall, at the

18 direction of the President or that officer, alter the timing

19 of review of rules under any schedule required by this sec20 tion for the review of rules if an explanation of such alter21 ation is published in the Federal Register at the time such

22 alteration is made.

23 ‘‘(g) In any case in which an agency has not com24 pleted the review of a rule within the period prescribed

25 by subsection (b) or (f) of this section, the agency shall
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1 immediately publish in the Federal Register a notice pro2 posing to amend, repeal, or renew the rule under sub3 section (c) of this section, and shall complete proceedings

4 pursuant to subsection (d) or (e) of this section within

5 one hundred and eighty days of the date on which the re6 view was required to be completed under subsection (b)

7 or (f) of this section.

8 ‘‘(h)(1) Agency compliance or noncompliance with the

9 provisions of subsection (a) of this section shall not be

10 subject to judicial review in any manner.

11 ‘‘(2) Agency compliance or noncompliance with the

12 provisions of subsections (b), (c), (e), (f) and (g) of this

13 section shall be subject to judicial review only pursuant

14 to section 706(a)(1) of this title.

15 ‘‘(i) Nothing in this section shall relieve any agency

16 from its obligation to respond to a petition to issue,

17 amend, or repeal a rule, for an interpretation regarding

18 the meaning of a rule, or for a variance or exemption from

19 the terms of a rule, submitted pursuant to section 553(e)

20 of this title.

21 § 642. Regulatory agenda and calendar

22 ‘‘(a) Each agency shall publish in the Federal Reg23 ister in April and October of each year an agenda of the

24 rules that the agency expects to propose, promulgate,

25 renew, or repeal in the succeeding twelve months. For
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1 each such rule, the agenda shall contain, at a minimum,

2 and in addition to any other information required by

3 law—

4 ‘‘(1) a general description of the rule, including

5 a citation to the authority under which the action

6 with respect to the rule is to be taken, or a specific

7 explanation of the congressional intent to which the

8 objectives of rule respond;

9 ‘‘(2) a statement of whether or not the rule is

10 or is expected to be a major rule;

11 ‘‘(3) an approximate schedule of the significant

12 dates on which the agency will take action relating

13 to the rule, including the dates for any notice of pro14 posed rulemaking, hearing, and final action on the

15 rule;

16 ‘‘(4) the name, address, and telephone number

17 of an agency official responsible for answering ques18 tions from the public concerning the rule;

19 ‘‘(5) a statement specifying whether each rule

20 listed on the previous agenda has been published as

21 a proposed rule, has been published as a final rule,

22 has become effective, has been repealed, or is pend23 ing in some other status; and
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1 ‘‘(6) a cumulative summary of the status of the

2 rules listed on the previous agenda in accordance

3 with clause (5) of this subsection.

4 ‘‘(b) The President or an officer in the Executive Of5 fice of the President whose appointment has been subject

6 to the advice and consent of the Senate shall publish in

7 the Federal Register in May and November of each year

8 a Calendar of Federal Regulations listing each of the

9 major rules identified in the regulatory agendas published

10 by agencies in the preceding month. Each rule listed in

11 the calendar shall be accompanied by a summary of the

12 information relating to the rule that appeared in the most

13 recent regulatory agenda in which the rule was identified.

14 ‘‘(c) An agency may propose or promulgate a major

15 rule that was not listed in the regulatory agenda required

16 by subsection (a) of this section only if the agency pub17 lishes with the rule an explanation of the omission of the

18 rule from such agenda and otherwise complies with this

19 section with respect to that rule.

20 ‘‘(d) Any compliance or noncompliance by the agency

21 with the provisions of this section shall not be subject to

22 judicial review.

23 ‘‘§ 643. Establishment of deadlines

24 ‘‘(a)(1) Whenever any agency publishes a notice of

25 proposed rulemaking pursuant to section 553 of this title,
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1 the agency shall include in such notice an announcement

2 of the date by which it intends to complete final agency

3 action on the rule.

4 ‘‘(2) If any agency announcement under this section

5 indicates that the proceeding relating to such rule will re6 quire more than one year to complete, the agency shall

7 also indicate in the announcement the date by which the

8 agency intends to complete each major portion of that pro9 ceeding. In carrying out the requirements of this sub10 section, the agency shall select dates for completing agen11 cy action which will assure the most expeditious consider12 ation of the rule which is possible, consistent with the in13 terests of fairness and other agency priorities.

14 ‘‘(3) The requirements of this subsection shall not

15 apply to any rule on which the agency intends to complete

16 action within one hundred and twenty days after providing

17 notice of the proposed action.

18 ‘‘(b) If an agency fails to complete action in a pro19 ceeding, or a major portion of the proceeding, by the date

20 announced pursuant to subsection (a) of this section, or,

21 in the case of a proceeding described in paragraph (3) of

22 such subsection, if an agency fails to complete action with23 in one hundred and twenty days after providing notice of

24 such proposed action, and the expected delay in complet25 ing action will exceed thirty days, the agency shall prompt-
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1 ly announce the new date by which the agency intends to

2 complete action in such proceeding and new dates by

3 which the agency intends to complete action on each major

4 portion of the proceeding.

5 ‘‘(c) Compliance or noncompliance by an agency with

6 the provisions of this section shall not be subject to judi7 cial review except in accordance with subsection (d).

8 ‘‘(d) In determining whether to compel agency action

9 unreasonably delayed pursuant to section 706(a)(1) of this

10 title, the reviewing court shall consider, in addition to any

11 other relevant factors, the extent to which the agency has

12 failed to comply with this section.’’.

13 (b) TECHNICAL AND CONFORMING AMENDMENTS.—

14 Part I of title 5, United States Code, is amended by strik15 ing out the chapter heading and table of sections for chap16 ter 6 and inserting in lieu thereof the following:

‘‘CHAPTER 6—THE ANALYSIS OF REGULATORY FUNCTIONS

‘‘SUBCHAPTER I—REGULATORY ANALYSIS

‘‘Sec.

‘‘601. Definitions.

‘‘602. Regulatory agenda.

‘‘603. Initial regulatory flexibility analysis.

‘‘604. Final regulatory flexibility analysis.

‘‘605. Avoidance of duplicative or unnecessary analyses.

‘‘606. Effect on other law.

‘‘607. Preparation of analyses.

‘‘608. Procedure for waiver or delay of completion.

‘‘609. Procedures for gathering comments.

‘‘610. Periodic review of rules.

‘‘611. Judicial review.

‘‘612. Reports and intervention rights.

‘‘SUBCHAPTER II—ANALYSIS OF AGENCY PROPOSALS

‘‘621. Definitions.
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‘‘622. Regulatory cost/benefit analysis.

‘‘623. Judicial review.

‘‘624. Executive oversight.

‘‘SUBCHAPTER III—RISK ASSESSMENTS

‘‘631. Findings, purposes, and definitions.

‘‘632. Applicability.

‘‘633. Savings provisions.

‘‘634. Requirement to prepare risk assessments.

‘‘635. Principles for risk assessment.

‘‘636. Principles for risk characterization and risk communication.

‘‘637. Guidelines, plan for assessing new information, and report.

‘‘638. Risk management criteria.

‘‘639. Interagency coordination.

‘‘SUBCHAPTER IV—REGULATORY PRIORITIES AND REVIEW

‘‘641. Review of agency rules.

‘‘642. Regulatory agenda and calendar.

‘‘643. Establishment of deadlines.’’.

1 SEC. 102. USE OF STATE OR LOCAL REQUIREMENTS.

2 (a) IN GENERAL.—Subchapter II of chapter 5 of title

3 5, United States Code, is amended by adding at the end

4 thereof the following new section:

5 ‘‘§ 560. Use of duplicative State or local requirements

6 ‘‘(a) Except as otherwise provided by law, the head

7 of each Federal agency is authorized, in the administra8 tion of a Federal statute with respect to any State or local9 ity, to adopt as a Federal rule a regulation of that State

10 or local government or use as a Federal recordkeeping or

11 reporting requirement or implementation procedure a rec12 ordkeeping or reporting requirement or implementation

13 procedure of that State or locality if the head of the agen14 cy determines—

15 ‘‘(1) that such State or local government regu16 lation, implementation procedure, recordkeeping re-
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1 quirement, or reporting requirement duplicates a

2 Federal regulation, procedure, recordkeeping re3 quirement, or reporting requirement; and

4 ‘‘(2) that such State or local government regu5 lation, implementation procedure, recordkeeping re6 quirement, or reporting requirement is substantively

7 equivalent to or more stringent than the Federal

8 regulation, procedure, recordkeeping requirement, or

9 reporting requirement.

10 ‘‘(b) When the head of an agency determines to use

11 a State or local recordkeeping or reporting requirement

12 or implementation procedure, as a Federal recordkeeping

13 or reporting requirement, or implementation procedure in

14 that State or locality, the head of the agency shall prepare

15 at a minimum, a written statement of the reasons for any

16 determination made under subsection (a), and shall make

17 such statement available to the public.

18 ‘‘(c) This section does not limit the authority or re19 sponsibility of the head of any agency to enforce Federal

20 law.’’.

21 (b) RULEMAKING.—Section 551 of title 5, United

22 States Code, is amended by inserting the following be23 tween ‘‘rule’’ and the semicolon: ‘‘, or the adoption of a

24 rule pursuant to section 561 of this title’’.
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1 (c) TABLE OF SECTIONS.—The table of sections for

2 chapter 5 of such title is amended by inserting after the

3 item relating to section 559 the following new item:

‘‘560. Use of duplicative State or local requirements.’’.

4 SEC. 103. PRESIDENTIAL AUTHORITY.

5 Nothing in this Act (i) limits the exercise by the

6 President of the authority and responsibility that he other7 wise possesses under the Constitution and other laws of

8 the United States with respect to regulatory policies, pro9 cedures, and programs of departments, agencies, and of10 fices, or (ii) alters in any manner rulemaking authority

11 vested by law in an agency to initiate or complete a rule12 making proceeding, or to issue, modify, or rescind a rule.

13 TITLE II—RISK-BASED PRIORITIES

14 SEC. 201. SHORT TITLE.

15 This title may be cited as the ‘‘Risk Reduction Prior16 ities Act of 1995’’.

17 SEC. 202. PURPOSES.

18 It is the purposes of this title to—

19 (1) encourage Federal agencies engaged in reg20 ulating risks to human health, safety, and the envi21 ronment to achieve the greatest risk reduction at the

22 least cost practical;

23 (2) promote the coordination of policies and

24 programs to reduce risks to human health, safety,

25 and the environment; and
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1 (3) promote open communication among Fed2 eral agencies, the public, the President, and Con3 gress regarding environmental, health, and safety

4 risks, and the prevention and management of those

5 risks.

6 SEC. 203. DEFINITIONS.

7 For the purposes of this title:

8 (1) COMPARATIVE RISK ANALYSIS.—The term

9 ‘‘comparative risk analysis’’ means a process to sys10 tematically estimate, compare, and rank the size and

11 severity of risks to provide a common basis for eval12 uating strategies for reducing or preventing those

13 risks.

14 (2) COVERED AGENCY.—The term ‘‘covered

15 agency’’ means each of the following:

16 (A) The Environmental Protection Agency.

17 (B) The Department of Labor.

18 (C) The Food and Drug Administration.

19 (D) The Consumer Product Safety Com20 mission.

21 (E) The Department of Transportation.

22 (F) The Department of Energy.

23 (G) The Department of Agriculture.

24 (H) The Department of the Interior.

25 (I) The Nuclear Regulatory Commission.
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1 (3) DIRECTOR.—The term ‘‘Director’’ means

2 the Director of the Office of Management and Budg3 et.

4 (4) EFFECT.—The term ‘‘effect’’ means a dele5 terious change in the condition—

6 (A) of a human or other living thing (in7 cluding death, cancer, or other chronic illness,

8 decreased reproductive capacity, or disfigure9 ment); or

10 (B) of an inanimate thing important to

11 human welfare (including destruction, degenera12 tion, the loss of intended function, and in13 creased costs for maintenance).

14 (5) IRREVERSIBILITY.—The term ‘‘irre15 versibility’’ means the extent to which a return to

16 conditions prior to the occurrence of an effect are ei17 ther very slow or will never occur.

18 (6) LIKELIHOOD.—The term ‘‘likelihood’’

19 means the estimated probability that an effect will

20 occur.

21 (7) MAGNITUDE.—The term ‘‘magnitude’’

22 means the number of individuals or the quantity of

23 ecological resources or other resources that contrib24 ute to human welfare that are affected by exposure

25 to a stressor.
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1 (8) SERIOUSNESS.—The term ‘‘seriousness’’

2 means the intensity of effect, the likelihood, the

3 irreversibility, and the magnitude.

4 SEC. 204. DEPARTMENT AND AGENCY PROGRAM GOALS.

5 (a) SETTING PRIORITIES.—In exercising authority

6 under applicable laws protecting human health, safety, or

7 the environment, the head of each covered agency should

8 strive to set priorities and to use the resources available

9 under those laws to address those risks to human health,

10 safety, and the environment that—

11 (1) the covered agency determines to be the

12 most serious; and

13 (2) can be addressed in a cost-effective manner,

14 with the goal of achieving the greatest overall net re15 duction in risks with the public and private sector

16 resources expended.

17 (b) DETERMINING THE MOST SERIOUS RISKS.—In

18 identifying the greatest risks under subsection (a) of this

19 section, each covered agency shall consider, at a mini20 mum—

21 (1) the likelihood, irreversibility, and severity of

22 the effect; and

23 (2) the number and groups of individuals poten24 tially affected, and shall explicitly take into account
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1 the results of the comparative risk analysis con2 ducted under section 205 of this Act.

3 (c) OMB REVIEW.—The covered agency’s determina4 tions of the sources of the most serious risks for purposes

5 of setting priorities shall be reviewed and approved by the

6 Director of the Office of Management and Budget prior

7 to submission of the covered agency’s annual budget re8 quests to Congress.

9 (d) INCORPORATING RISK-BASED PRIORITIES INTO

10 BUDGET AND PLANNING.—The head of each covered

11 agency shall incorporate the priorities identified in sub12 section (a) of this section into the agency budget, strategic

13 planning, regulatory agenda, enforcement, and research

14 activities by—

15 (1) in the covered agency’s annual budget re16 quest to Congress—

17 (A) identifying which risks that the cov18 ered agency head has determined are the most

19 serious and can be addressed in a cost-effective

20 manner under subsection (a) and the basis for

21 that determination;

22 (B) explicitly identifying how the covered

23 agency’s requested funds will be used to reduce

24 those risks, including the amount of funds re25 quested to address each of those risks; and
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1 (C) identifying any statutory, regulatory,

2 or administrative obstacles to allocating agency

3 resources in accordance with the mandates of

4 subsection (a);

5 (2) explicitly considering the requirements of

6 subsection (a) and the results of the comparative

7 risk analysis prepared under section 205 of this title

8 when preparing the covered agency’s regulatory

9 agenda or other covered agency strategic plan and

10 explaining how the agenda or plan reflects those re11 quirements and the comparative risk analysis when

12 publishing any such agenda or strategic plan;

13 (3) developing an annual enforcement strategic

14 plan that targets the priority risks identified under

15 subsection (a); and

16 (4) expressly considering the priority risks de17 termined under subsection (a) in selecting research

18 activities.

19 (e) EFFECTIVE DATE.—This section shall take effect

20 twelve months from the date of enactment of this title.

21 SEC. 205. COMPARATIVE RISK ANALYSIS.

22 (a) REQUIREMENT.—Within six months of the enact23 ment of this title, the Director of the Office of Manage24 ment and Budget shall enter into appropriate arrange25 ments with an accredited scientific body—
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1 (1) to conduct a study of the methodologies for

2 using comparative risk to rank dissimilar human

3 health, safety, and environmental risks; and

4 (2) to conduct a comparative risk analysis. The

5 comparative risk analysis shall compare and rank, to

6 the extent feasible, human health, safety, and envi7 ronmental risks potentially regulated across the

8 spectrum of programs administered by all covered

9 agencies.

10 The Director shall consult with the Office of Science and

11 Technology Policy regarding the scope of the study and

12 the conduct of the comparative risk analysis.

13 (b) CRITERIA.—In arranging for the comparative risk

14 analysis referred to in subsection (a), the Director shall

15 ensure that—

16 (1) the scope and specificity of the analysis are

17 sufficient to provide the President and agency heads

18 guidance in allocating resources across agencies and

19 among programs in agencies to achieve the greatest

20 degree of risk prevention and reduction for the pub21 lic and private resources expended;

22 (2) the analysis is conducted through an open

23 process, which may include using panels of appro24 priate independent experts and public stakeholders;
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1 (3) The methodologies and principal scientific

2 determinations made in the analysis are subjected to

3 independent and external peer review and that the

4 conclusions of the peer review are made publicly

5 available as part of the final report required by sub6 section (c);

7 (4) there is an opportunity for public comment

8 on the results prior to making them final; and

9 (5) the results are presented in a manner that

10 distinguishes between the scientific conclusions and

11 any policy or value judgments embodied in the com12 parisons.

13 (c) REPORT.—The comparative risk analysis required

14 by subsection (a) shall be completed and a report submit15 ted to Congress and the President no later than three

16 years following the enactment of this Act. The compara17 tive risk analysis shall be reviewed and revised at least

18 every five years thereafter for a minimum of fifteen years

19 following the release of the first analysis. The Director

20 shall arrange for such review and revision with an accred21 ited scientific body in the same manner as provided in sub22 sections (a) and (b) above.

23 (d) STUDY.—The study of methodologies provided in

24 subsection (a) shall be conducted as part of the first com25 parative risk analysis. The goal of the study shall be to
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1 develop and rigorously test methods of comparative risk

2 analysis. The study shall have sufficient scope and breadth

3 to test approaches for improving comparative risk analysis

4 and its use in setting priorities for human health, safety,

5 and environmental risk prevention and reduction. As part

6 of its analysis, the study shall review and evaluate the ex7 perience of the States that have conducted comparative

8 risk analyses.

9 (e) REPORT.—Within one hundred and eighty days

10 after the completion of the study, the Director shall issue

11 a report of the study to the Congress, along with results

12 of a scientific peer review of the study.

13 (f) TECHNICAL GUIDANCE.—Not later than one hun14 dred and eighty days after the enactment of this Act, the

15 Director, in collaboration with other heads of covered

16 agencies shall enter into a contract with the National Re17 search Council to provide technical guidance to agencies

18 on approaches to using comparative risk analysis in set19 ting human health, safety, and environmental priorities to

20 assist agencies in complying with section 204 of this title.

21 SEC. 206. REPORTS AND RECOMMENDATIONS TO CON22 GRESS AND THE PRESIDENT.

23 (a) IN GENERAL.—In addition to the statement sub24 mitted to Congress with each covered agency’s annual

25 budget request required under section 204(d)(1) of this
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1 title, each covered agency shall submit a report to Con2 gress and the President twenty-four months following the

3 enactment of this legislation, and every twenty-four

4 months thereafter—

5 (1) detailing how the agency has complied with

6 section 204;

7 (2) describing the reasons for any departure

8 from the requirement to establish priorities to

9 achieve the greatest overall net reduction in risk;

10 and

11 (3) estimating the total public and private costs

12 of regulatory and voluntary risk reduction activities

13 under programs administered by the agency that

14 year, a comparison of that estimate with the pre15 vious year, and a projection for the following year.

16 (b) RECOMMENDATION.—In March of each year, the

17 head of each covered agency shall submit to Congress spe18 cific recommendations for—

19 (1) modifying, repealing, or enacting laws to re20 form, eliminate, or enhance programs or mandates

21 relating to human health, safety, and the environ22 ment; and

23 (2) modifying or eliminating statutorily or judi24 cially mandated deadlines,
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1 that would assist the covered agency to set priorities in

2 its activities to address the risks to human health, safety,

3 and the environment that are the most serious and can

4 be addressed in a cost-effective manner consistent with the

5 requirements of section 204(a).

6 SEC. 207. SAVINGS PROVISION AND JUDICIAL REVIEW.

7 (1) IN GENERAL.—Nothing in this title shall be con8 strued to modify any statutory standard or requirement

9 designed to protect human health, safety, or the environ10 ment.

11 (2) JUDICIAL REVIEW.—Compliance or noncompli12 ance by an agency with the provisions of this title shall

13 not be subject to judicial review.

14 (3) AGENCY ANALYSIS.—Any analysis prepared

15 under this title shall not be subject to judicial consider16 ation separate or apart from the requirement, rule, pro17 gram, or law to which it relates. When an action for judi18 cial review of a covered agency action is instituted, any

19 analysis for, or relating to, the action shall constitute part

20 of the whole record of agency action for the purpose of

21 judicial review of the action and shall, to the extent rel22 evant, be considered by a court in determining the legality

23 of the covered agency action.
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1 TITLE III—REGULATORY ACCOUNTING

2 SEC. 301. SHORT TITLE

3 This title may be cited as the ‘‘Regulatory Accounting

4 Act of 1995’’.

5 SEC. 302. ACCOUNTING STATEMENT

6 (a) IN GENERAL.—

7 (1) RESPONSIBILITY FOR IMPLEMENTATION.—

8 The President shall be responsible for implementing

9 and administering the requirements of this title.

10 (2) ACCOUNTING STATEMENT.—Every two

11 years, not later than June of the second year, the

12 President shall prepare and submit to Congress an

13 accounting statement that estimates the costs of

14 Federal regulatory programs and corresponding ben15 efits in accordance with this section.

16 (b) YEARS COVERED BY ACCOUNTING STATE17 MENT.—Each accounting statement shall cover, at a mini18 mum, the five fiscal years beginning on October 1 of the

19 year in which the report is submitted and may cover any

20 fiscal year preceding such fiscal years for purpose of revis21 ing previous estimates.

22 (c) TIMING AND PROCEDURES.—

23 (1) NOTICE AND COMMENT.—The President

24 shall provide notice and opportunity for comment for

25 each accounting statement. The President may dele-
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1 gate to an agency the requirement to provide notice

2 and opportunity to comment for the portion of the

3 accounting statement relating to that agency.

4 (2) DEADLINES FOR FIRST STATEMENT.—The

5 President shall propose the first accounting state6 ment under this section not later than two years

7 after the date of the enactment of this Act and shall

8 issue the first accounting statement in final form

9 not later than three years after the date of the en10 actment of this Act. Such statement shall cover, at

11 a minimum, each of the eight fiscal years beginning

12 after the date of the enactment of this Act.

13 (d) CONTENT OF ACCOUNTING STATEMENT.—

14 (1) IN GENERAL.—Each accounting statement

15 shall contain estimates of costs and benefits with re16 spect to each fiscal year covered by the statement in

17 accordance with this subsection. For each such fiscal

18 year for which estimates were made in a previous ac19 counting statement, the statement shall revise those

20 estimates and state the reasons for the revisions.

21 (2) STATEMENT OF COSTS.—

22 (A) IN GENERAL.—An accounting state23 ment shall estimate the costs of Federal regu24 latory programs by setting forth, for each year

25 covered by the statement—
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1 (i) the annual expenditure of national

2 economic resources for the regulatory pro3 gram; and

4 (ii) such other quantitative and quali5 tative measures of costs as the President

6 considers appropriate.

7 (B) NATIONAL ECONOMIC RESOURCES.—

8 For purposes of the estimate of costs in the ac9 counting statement, national economic re10 sources shall include, and shall be listed under,

11 at least the following categories:

12 (i) Private sector costs.

13 (ii) Federal sector administrative

14 costs.

15 (iii) Federal sector compliance costs.

16 (iv) State and local government ad17 ministrative costs.

18 (v) State and local government com19 pliance costs.

20 (3) STATEMENT OF CORRESPONDING BENE21 FITS.—An accounting statement shall estimate the

22 benefits of Federal regulatory programs by setting

23 forth, for each year covered by the statement, such

24 quantitative and qualitative measures of benefits as

25 the President considers appropriate. Any estimates
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1 of benefits concerning reduction in human health,

2 safety, or environmental risks shall present the most

3 plausible level of risk practical, along with a state4 ment of the reasonable degree of scientific certainty.

5 SEC. 303. ASSOCIATED REPORT TO CONGRESS.

6 (a) IN GENERAL.—At the same time as the President

7 submits an accounting statement under section 302, the

8 President, acting through the Director of the Office of

9 Management and Budget, shall submit to Congress a re10 port associated with the accounting statement (hereinafter

11 referred to as an ‘‘associated report’’). The associated re12 port shall contain, in accordance with this section—

13 (1) analyses of impacts; and

14 (2) recommendations for reform.

15 (b) ANALYSES OF IMPACTS.—The President shall in16 clude in the associated report the following:

17 (1) Analyses prepared by the President of the

18 cumulative impact of Federal regulatory programs

19 covered in the accounting statement on the follow20 ing:

21 (A) The ability of State and local govern22 ments to provide essential services, including

23 police, fire protection, and education.

24 (B) Small business.

25 (C) Productivity.
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1 (D) Wages.

2 (E) Economic growth.

3 (F) Technological innovation.

4 (G) Consumer prices for goods and serv5 ices.

6 (H) Such other factors considered appro7 priate by the President.

8 (2) A summary of any independent analyses of

9 impacts prepared by persons commenting during the

10 comment period on the accounting statement.

11 (c) RECOMMENDATIONS FOR REFORM.—The Presi12 dent shall include in the associated report the following:

13 (1) A summary of recommendations of the

14 President for reform or elimination of any Federal

15 regulatory program or program element that does

16 not represent sound use of national economic re17 sources or otherwise is inefficient.

18 (2) A summary of any recommendations for

19 such reform or elimination of Federal regulatory

20 programs or program elements prepared by persons

21 commenting during the comment period on the ac22 counting statement.
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1 SEC. 304. GUIDANCE FROM OFFICE OF MANAGEMENT AND

2 BUDGET.

3 The Director of the Office of Management and Budg4 et shall, in consultation with the Council of Economic Ad5 visers, provide guidance to agencies—

6 (1) to standardize measures of costs and bene7 fits in accounting statements prepared pursuant to

8 titles I and III, including—

9 (A) detailed guidance on estimating the

10 costs and benefits of major rules;

11 (B) general guidance on estimating the

12 costs and benefits of all other rules that do not

13 meet the thresholds for major rules; and

14 (2) to standardize the format of the accounting

15 statements.

16 SEC. 305. RECOMMENDATIONS FROM CONGRESSIONAL

17 BUDGET OFFICE.

18 After each accounting statement and associated re19 port submitted to Congress, the Director of the Congres20 sional Budget Office shall make recommendations to the

21 President—

22 (1) for improving accounting statements pre23 pared pursuant to this title, including recommenda24 tions on level of detail and accuracy; and
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1 (2) for improving associated reports prepared

2 pursuant to this title, including recommendations on

3 the quality of analysis.

4 SEC. 306. DEFINITIONS.

5 For purposes of this title, the following definitions

6 apply:

7 (1) The term ‘‘Federal regulatory program’’

8 means a program carried out pursuant to a related

9 group of Federal statutes and regulations, as deter10 mined by the President.

11 (2) The term ‘‘regulation’’ means an agency

12 statement of general applicability and future effect

13 designed to implement, interpret, or prescribe law or

14 policy or describing the procedures or practice re15 quirements of an agency. The term does not in16 clude—

17 (A) administrative actions governed by sec18 tions 556 and 557 of title 5, United States

19 Code;

20 (B) regulations issued with respect to a

21 military or foreign affairs function of the Unit22 ed States; or

23 (C) regulations related to agency organiza24 tion, management, or personnel.
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1 (3) The term ‘‘agency’’ means any executive de2 partment, military department, Government corpora3 tion, Government controlled corporation, or other es4 tablishment in the executive branch of the Govern5 ment (including the Executive Office of the Presi6 dent), or any independent regulatory agency, but

7 does not include—

8 (A) the General Accounting Office;

9 (B) the Federal Election Commission;

10 (C) the governments of the District of Co11 lumbia and of the territories and possessions of

12 the United States, and their various subdivi13 sions; or

14 (D) Government-owned contractor-oper15 ated facilities, including laboratories engaged in

16 national defense research and production activi17 ties.

18 TITLE IV—MARKET INCENTIVES AND

19 ECONOMICALLY EFFICIENT REGULATION

20 SEC. 401. SHORT TITLE.

21 This title maybe cited as the ‘‘Market Incentives Act

22 of 1995’’.

23 SEC. 402. PROGRAM DESIGN REQUIREMENTS.

24 (a) IN GENERAL.—To the maximum extent prac25 ticable, agencies shall ensure that major rules, especially,
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1 but not limited to, those that limit the emission of environ2 mental pollutants or otherwise govern the use of natural

3 resources, operate through the application of market4 based mechanisms.

5 (b) FLEXIBLE ALTERNATIVES.—Where it is not

6 practicable to rely on market-based mechanisms in design7 ing regulatory programs, rules, or requirements, agencies

8 shall ensure that major rules, to the maximum extent

9 practicable, are comparable to market-based mechanisms

10 with respect to (i) assuring the achievement of the regu11 latory objective, and (ii) affording flexibility to regulated

12 persons.

13 (c) APPLICABILITY.—Section 402 shall apply, to the

14 extent feasible, to rules in effect on the date of enactment

15 of this Act and rules that take effect after the date of

16 enactment of this Act.

17 SEC. 403. AGENCY ASSESSMENT AND OMB REVIEW.

18 (a) IN GENERAL.—Each agency shall include an as19 sessment of market-based mechanisms in each proposed

20 major rule. Each assessment shall demonstrate the extent

21 to which the major rule complies with the requirements

22 of section 402, or why section 402 is not applicable or

23 appropriate.

24 (b) OMB REVIEW.—The Office of Management and

25 Budget shall review, as part of its regulatory review and
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1 oversight function, the agency assessments and statements

2 prepared in section 403(a). OMB shall determine whether

3 such assessments are detailed, thorough, and otherwise in

4 compliance with section 402.

5 (c) EFFECTIVE DATE.—Section 403 shall take effect

6 three months after the date of enactment of this Act.

7 SEC. 404. DEFINITIONS.

8 For the purposes of this title:

9 (1) The term ‘‘agency’’ means any executive de10 partment, military department, Government corpora11 tion, Government controlled corporation, or other es12 tablishment in the executive branch of the Govern13 ment (including the Executive Office of the Presi14 dent), or any independent regulatory agency, but

15 does not include—

16 (A) the General Accounting Office;

17 (B) the Federal Election Commission;

18 (C) the governments of the District of Co19 lumbia and of the territories and possessions of

20 the United States, and their various subdivi21 sions; or

22 (D) Government-owned contractor-oper23 ated facilities, including laboratories engaged in

24 national defense research and production activi25 ties.
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1 (2) The term ‘‘major rule’’ means—

2 (A) a rule or a group of closely related

3 rules that the agency or the President reason4 ably determines is likely to have an annual ef5 fect on the economy of $100,000,000 or more

6 in reasonably quantifiable direct and indirect

7 costs, or has a significant impact on a subsector

8 of the economy; and

9 (B) a rule or a group of closely related

10 rules that is otherwise designated a major rule

11 by the agency proposing the rule, or is so des12 ignated by the President, on the ground that

13 the rule is likely to result in—

14 (i) a substantial increase in costs or

15 prices for wage earners, consumers, indi16 vidual industries, nonprofit organizations,

17 Federal, State, or local government agen18 cies, or geographic regions; or

19 (ii) significant adverse effects on

20 wages, economic growth, investment, pro21 ductivity, innovation, the environment,

22 public health or safety, or the ability of en23 terprises whose principal places of business

24 are in the United States to compete in do25 mestic or export markets. For purposes of
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1 subparagraph (A) of this paragraph, the

2 term ‘‘rule’’ does not mean—

3 (I) a rule that involves the internal revenue

4 laws of the United States;

5 (II) a rule that authorizes the introduction into

6 commerce or recognizes the marketable status of a

7 product, pursuant to sections 408, 409(c), and 706

8 of the Federal Food, Drug, and Cosmetic Act;

9 (III) a rule exempt from notice and public pro10 cedure pursuant to section 553(a) of title 5, United

11 States Code; or

12 (IV) a rule relating to the viability, stability,

13 asset powers, or categories of accounts of, or permis14 sible interest rate ceilings applicable to, depository

15 institutions the deposits or accounts of which are in16 sured by the Federal Deposit Insurance Corporation,

17 or the Share Insurance Fund of the National Credit

18 Union Administration Board.

19 (3) The term ‘‘market-based mechanism’’

20 means a regulatory requirement that:

21 (A) imposes legal accountability for the

22 achievement of an explicit regulatory objective

23 on each regulated person;

24 (B) affords maximum flexibility to each

25 regulated person in complying with mandatory
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1 regulatory objectives, which flexibility shall in2 clude, but not be limited to, the opportunity to

3 transfer to, or receive from, other persons, in4 cluding for cash or other legal consideration, in5 crements of compliance responsibility estab6 lished by the program; and

7 (C) permits regulated persons to respond

8 automatically to changes in general economic

9 conditions and in economic circumstances di10 rectly pertinent to the regulatory program with11 out affecting the achievement of the program’s

12 explicit regulatory mandates.

13 (4) The term ‘‘rule’’ has the same meaning as

14 in section 551(4) of title 5, United States Code, ex15 cept that such term does not include—

16 (A) a rule of particular applicability that

17 approves or prescribes for the future rates,

18 wages, prices, services, or allowances therefor,

19 corporate or financial structures, reorganiza20 tions, mergers or acquisitions, or accounting

21 practices or disclosures bearing on any of the

22 foregoing.

23 (B) a rule relating to monetary policy pro24 posed or promulgated by the Board of Gov25 ernors of the Federal Reserve System; or
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1 (C) a rule issued by the Federal Election

2 Commission or a rule issued by the Federal

3 Communications Commission pursuant to sec4 tions 315 and 312(a)(7) of the Communications

5 Act of 1934.

6 SECTION 1. SHORT TITLE.

7 This Act may be cited as the ‘‘Regulatory Reform Act

8 of 1995’’.

9 SEC. 2. DEFINITIONS.

10 Section 551 of title 5, United States Code, is amend11 ed—

12 (1) in paragraph (13), by striking out ‘‘; and’’

13 and inserting in lieu thereof a semicolon;

14 (2) in paragraph (14), by striking out the period

15 and inserting in lieu thereof ‘‘; and’’; and

16 (3) by adding at the end thereof the following

17 new paragraph:

18 ‘‘(15) ‘Director’ means the Director of the Office

19 of Management and Budget.’’.

20 SEC. 3. ANALYSIS OF AGENCY RULES.

21 (a) IN GENERAL.— Chapter 6 of title 5, United States

22 Code, is amended by adding at the end the following:
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1 ‘‘SUBCHAPTER II—ANALYSIS OF AGENCY RULES

2 ‘‘§ 621. Definitions

3 ‘‘For purposes of this subchapter the definitions under

4 section 551 shall apply and—

5 ‘‘(1) the term ‘benefit’ means the reasonably

6 identifiable significant favorable effects, including so7 cial, environmental and economic benefits, that are

8 expected to result directly or indirectly from imple9 mentation of a rule or an alternative to a rule;

10 ‘‘(2) the term ‘cost’ means the reasonably identi11 fiable significant adverse effects, including social, en12 vironmental, and economic costs that are expected to

13 result directly or indirectly from implementation of,

14 or compliance with, a rule or an alternative to a rule;

15 ‘‘(3) the term ‘cost-benefit analysis’ means an

16 evaluation of the costs and benefits of a rule, quan17 tified to the extent feasible and appropriate and oth18 erwise qualitatively described, that is prepared in ac19 cordance with the requirements of this subchapter at

20 the level of detail appropriate and practicable for rea21 soned decisionmaking on the matter involved, taking

22 into consideration the significance and complexity of

23 the decision and any need for expedition;

24 ‘‘(4)(A) the term ‘major rule’ means—
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1 ‘‘(i) a rule or a group of closely related

2 rules that the agency proposing the rule, the Di3 rector, or a designee of the President reasonably

4 determines is likely to have a gross annual effect

5 on the economy of $100,000,000 or more in rea6 sonably quantifiable direct and indirect costs; or

7 ‘‘(ii) a rule or a group of closely related

8 rules that is otherwise determined to be a major

9 rule by the agency proposing the rule, the Direc10 tor, or a designee of the President on the ground

11 that the rule is likely to result in—

12 ‘‘(I) a substantial increase in costs or

13 prices for wage earners, consumers, individ14 ual industries, nonprofit organizations,

15 Federal, State, local, or tribal government

16 agencies, or geographic regions;

17 ‘‘(II) significant adverse effects on

18 wages, economic growth, investment, pro19 ductivity, innovation, the environment,

20 public health or safety, or the ability of en21 terprises whose principal places of business

22 are in the United States to compete in do23 mestic or export markets;
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1 ‘‘(III) a serious inconsistency or inter2 ference with an action taken or planned by

3 another agency;

4 ‘‘(IV) the material alteration of the

5 budgetary impact of entitlements, grants,

6 user fees, or loan programs, or the rights

7 and obligations of recipients thereof; or

8 ‘‘(V) a significant impact on a sector

9 of the economy, or disproportionate costs to

10 a class of persons and relatively severe eco11 nomic, social, and environmental con12 sequences for the class; and

13 ‘‘(B) the term ‘major rule’ shall not include—

14 ‘‘(i) a rule that involves the internal reve15 nue laws of the United States;

16 ‘‘(ii) a rule or agency action that authorizes

17 the introduction into, or removal from, com18 merce, or recognizes the marketable status, of a

19 product; or

20 ‘‘(iii) a rule exempt from notice and public

21 comment procedure under section 553 of this

22 title;

23 ‘‘(5) the term ‘market-based mechanism’ means a

24 regulatory program that—
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1 ‘‘(A) imposes legal accountability for the

2 achievement of an explicit regulatory objective,

3 including the reduction of environmental pollut4 ants or of risks to human health, safety, or the

5 environment, on each regulated person;

6 ‘‘(B) affords maximum flexibility to each

7 regulated person in complying with mandatory

8 regulatory objectives, and such flexibility shall,

9 where feasible and appropriate, include the op10 portunity to transfer to, or receive from, other

11 persons, including for cash or other legal consid12 eration, increments of compliance responsibility

13 established by the program; and

14 ‘‘(C) permits regulated persons to respond

15 at their own discretion in an automatic manner,

16 consistent with subparagraph (B), to changes in

17 general economic conditions and in economic cir18 cumstances directly pertinent to the regulatory

19 program without affecting the achievement of the

20 program’s explicit regulatory mandates under

21 subparagraph (A);

22 ‘‘(6) the term ‘performance standard’ means a

23 requirement that imposes legal accountability for the

24 achievement of an explicit regulatory objective, such

25 as the reduction of environmental pollutants or of
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1 risks to human health, safety, or the environment, on

2 each regulated person;

3 ‘‘(7) the term ‘risk assessment’ has the same

4 meaning as such term is defined under section 632(5);

5 and

6 ‘‘(8) the term ‘rule’ has the same meaning as in

7 section 551(4) of this title, and shall not include—

8 ‘‘(A) a rule of particular applicability that

9 approves or prescribes for the future rates, wages,

10 prices, services, corporate or financial structures,

11 reorganizations, mergers, acquisitions, account12 ing practices, or disclosures bearing on any of

13 the foregoing;

14 ‘‘(B) a rule relating to monetary policy pro15 posed or promulgated by the Board of Governors

16 of the Federal Reserve System or by the Federal

17 Open Market Committee;

18 ‘‘(C) a rule relating to the safety or sound19 ness of federally insured depository institutions

20 or any affiliate of such an institution (as defined

21 in section 2(k) of the Bank Holding Company

22 Act of 1956 (12 U.S.C. 1841(k)); credit unions;

23 the Federal Home Loan Banks; government24 sponsored housing enterprises; a Farm Credit

25 System Institution; foreign banks, and their
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1 branches, agencies, commercial lending compa2 nies or representative offices that operate in the

3 United States and any affiliate of such foreign

4 banks (as those terms are defined in the Inter5 national Banking Act of 1978 (12 U.S.C. 3101));

6 or a rule relating to the payments system or the

7 protection of deposit insurance funds or Farm

8 Credit Insurance Fund; or

9 ‘‘(D) a rule issued by the Federal Election

10 Commission or a rule issued by the Federal

11 Communications Commission pursuant to sec12 tions 312(a)(7) and 315 of the Communications

13 Act of 1934.

14 ‘‘§ 622. Rulemaking cost-benefit analysis

15 ‘‘(a) Before publishing notice of a proposed rulemaking

16 for any rule (or, in the case of a notice of a proposed rule17 making that has been published on or before the effective

18 date of this subchapter, no later than 30 days after such

19 date), each agency shall determine whether the rule is or

20 is not a major rule within the meaning of section

21 621(4)(A)(i) and, if it is not, determine whether it is a

22 major rule under section 621(4)(A)(ii). For the purpose of

23 any such determination, a group of closely related rules

24 shall be considered as one rule.
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1 ‘‘(b)(1) If an agency has determined that a rule is not

2 a major rule, the Director or a designee of the President

3 may, as appropriate, determine that the rule is a major

4 rule no later than 30 days after the publication of the notice

5 of proposed rulemaking for the rule (or, in the case of a

6 notice of proposed rulemaking that has been published on

7 or before the effective date of this subchapter, no later than

8 60 days after such date).

9 ‘‘(2) Such determination shall be published in the Fed10 eral Register, together with a succinct statement of the basis

11 for the determination.

12 ‘‘(c)(1)(A) When the agency publishes a notice of pro13 posed rulemaking for a major rule, the agency shall issue

14 and place in the rulemaking file an initial cost-benefit

15 analysis, and shall include a summary of such analysis in

16 the notice of proposed rulemaking.

17 ‘‘(B)(i) When the Director or a designee of the Presi18 dent has published a determination that a rule is a major

19 rule after the publication of the notice of proposed rule20 making for the rule, the agency shall promptly issue and

21 place in the rulemaking file an initial cost-benefit analysis

22 for the rule and shall publish in the Federal Register a sum23 mary of such analysis.

24 ‘‘(ii) Following the issuance of an initial cost-benefit

25 analysis under clause (i), the agency shall give interested
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1 persons an opportunity to comment pursuant to section 553

2 in the same manner as if the draft cost-benefit analysis had

3 been issued with the notice of proposed rulemaking.

4 ‘‘(2) Each initial cost-benefit analysis shall contain—

5 ‘‘(A) an analysis of the benefits of the proposed

6 rule, including any benefits that cannot be quantified,

7 and an explanation of how the agency anticipates

8 that such benefits will be achieved by the proposed

9 rule, including a description of the persons or classes

10 of persons likely to receive such benefits;

11 ‘‘(B) an analysis of the costs of the proposed

12 rule, including any costs that cannot be quantified,

13 and an explanation of how the agency anticipates

14 that such costs will result from the proposed rule, in15 cluding a description of the persons or classes of per16 sons likely to bear such costs;

17 ‘‘(C) an identification (including an analysis of

18 costs and benefits) of an appropriate number of rea19 sonable alternatives allowed under the statute grant20 ing the rulemaking authority for achieving the identi21 fied benefits of the proposed rule, including alter22 natives that—

23 ‘‘(i) require no government action;

24 ‘‘(ii) will accommodate differences among

25 geographic regions and among persons with dif-
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1 fering levels of resources with which to comply;

2 and

3 ‘‘(iii) employ voluntary programs, perform4 ance standards, or market-based mechanisms

5 that permit greater flexibility in achieving the

6 identified benefits of the proposed rule and that

7 comply with the requirements of subparagraph

8 (D);

9 ‘‘(D) an assessment of the feasibility of establish10 ing a regulatory program that operates through the

11 application of market-based mechanisms;

12 ‘‘(E) an explanation of the extent to which the

13 proposed rule—

14 ‘‘(i) will accommodate differences among ge15 ographic regions and among persons with differ16 ing levels of resources with which to comply; and

17 ‘‘(ii) employs voluntary programs, perform18 ance standards, or market-based mechanisms

19 that permit greater flexibility in achieving the

20 identified benefits of the proposed rule;

21 ‘‘(F) a description of the quality, reliability, and

22 relevance of scientific or economic evaluations or in23 formation in accordance with the cost-benefit analysis

24 and risk assessment requirements of this chapter;
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1 ‘‘(G) if not expressly or implicitly inconsistent

2 with the statute under which the agency is proposing

3 the rule, an explanation of the extent to which the

4 identified benefits of the proposed rule justify the

5 identified costs of the proposed rule, and an expla6 nation of how the proposed rule is likely to substan7 tially achieve the rulemaking objectives in a more

8 cost-effective manner than the alternatives to the pro9 posed rule, including alternatives identified in ac10 cordance with subparagraph (C); and

11 ‘‘(H) if a major rule subject to subchapter III

12 addresses risks to human health, safety, or the envi13 ronment—

14 ‘‘(i) a risk assessment in accordance with

15 this chapter; and

16 ‘‘(ii) for each such proposed or final rule,

17 an assessment of incremental risk reduction or

18 other benefits associated with each significant

19 regulatory alternative considered by the agency

20 in connection with the rule or proposed rule.

21 ‘‘(d)(1) When the agency publishes a final major rule,

22 the agency shall also issue and place in the rulemaking file

23 a final cost-benefit analysis, and shall include a summary

24 of the analysis in the statement of basis and purpose.

25 ‘‘(2) Each final cost-benefit analysis shall contain—
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1 ‘‘(A) a description and comparison of the bene2 fits and costs of the rule and of the reasonable alter3 natives to the rule described in the rulemaking, in4 cluding the market-based mechanisms identified

5 under subsection (c)(2)(C)(iii); and

6 ‘‘(B) if not expressly or implicitly inconsistent

7 with the statute under which the agency is acting, a

8 reasonable determination, based upon the rulemaking

9 file considered as a whole, whether—

10 ‘‘(i) the benefits of the rule justify the costs

11 of the rule; and

12 ‘‘(ii) the rule will achieve the rulemaking

13 objectives in a more cost-effective manner than

14 the alternatives described in the rulemaking, in15 cluding the market-based mechanisms identified

16 under subsection (c)(2)(C)(iii).

17 ‘‘(e)(1) The analysis of the benefits and costs of a pro18 posed and a final rule required under this section shall in19 clude, to the extent feasible, a quantification or numerical

20 estimate of the quantifiable benefits and costs. Such quan21 tification or numerical estimate shall be made in the most

22 appropriate units of measurement, using comparable as23 sumptions, including time periods, shall specify the ranges

24 of predictions, and shall explain the margins of error in25 volved in the quantification methods and in the estimates
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1 used. An agency shall describe the nature and extent of the

2 nonquantifiable benefits and costs of a final rule pursuant

3 to this section in as precise and succinct a manner as pos4 sible. An agency shall not be required to make such evalua5 tion primarily on a mathematical or numerical basis.

6 ‘‘(2)(A) In evaluating and comparing costs and bene7 fits and in evaluating the risk assessment information de8 veloped under subchapter III, the agency shall not rely on

9 cost, benefit, or risk assessment information that is not ac10 companied by data, analysis, or other supporting materials

11 that would enable the agency and other persons interested

12 in the rulemaking to assess the accuracy, reliability, and

13 uncertainty factors applicable to such information.

14 ‘‘(B) The agency evaluations of the relationships of the

15 benefits of a proposed and final rule to its costs shall be

16 clearly articulated in accordance with this section.

17 ‘‘(f) As part of the promulgation of each major rule

18 that addresses risks to human health, safety, or the environ19 ment, the head of the agency or the President shall make

20 a determination that—

21 ‘‘(1) the risk assessment and the analysis under

22 subsection (c)(2)(H) are based on a scientific evalua23 tion of the risk addressed by the major rule and that

24 the conclusions of such evaluation are supported by

25 the available information; and
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1 ‘‘(2) the regulatory alternative chosen will reduce

2 risk in a cost-effective and, to the extent feasible, flexi3 ble manner, taking into consideration any of the al4 ternatives identified under subsection (c)(2) (C) and

5 (D).

6 ‘‘(g) The preparation of the initial or final cost-benefit

7 analysis required by this section shall only be performed

8 under the direction of an officer or employee of the agency.

9 The preceding sentence shall not preclude a person outside

10 the agency from gathering data or information to be used

11 by the agency in preparing any such cost-benefit analysis

12 or from providing an explanation sufficient to permit the

13 agency to analyze such data or information. If any such

14 data or information is gathered or explained by a person

15 outside the agency, the agency shall specifically identify in

16 the initial or final cost-benefit analysis the data or infor17 mation gathered or explained and the person who gathered

18 or explained it, and shall describe the arrangement by

19 which the information was procured by the agency, includ20 ing the total amount of funds expended for such procure21 ment.

22 ‘‘(h) The requirements of this subchapter shall not alter

23 the criteria for rulemaking otherwise applicable under other

24 statutes.
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1 ‘‘§ 623. Judicial review

2 ‘‘(a) Compliance or noncompliance by an agency with

3 the provisions of this subchapter and subchapter III shall

4 not be subject to judicial review except in connection with

5 review of a final agency rule and according to the provi6 sions of this section.

7 ‘‘(b) Any determination by a designee of the President

8 or the Director that a rule is, or is not, a major rule shall

9 not be subject to judicial review in any manner.

10 ‘‘(c) The determination by an agency that a rule is,

11 or is not, a major rule under section 621(4)(A)(i) shall be

12 set aside by a reviewing court only upon a clear and con13 vincing showing that the determination is erroneous in

14 light of the information available to the agency at the time

15 the agency made the determination. Any determination by

16 an agency that a rule is, or is not, a major rule under

17 section 621(4)(A)(ii) shall not be subject to judicial review

18 in any manner.

19 ‘‘(d) If the cost-benefit analysis or risk assessment re20 quired under this chapter has been wholly omitted for any

21 major rule, a court shall vacate the rule and remand the

22 case for further consideration. If an analysis or assessment

23 has been performed, the court shall not review to determine

24 whether the analysis or assessment conformed to the par25 ticular requirements of this chapter.
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1 ‘‘(e) Any cost-benefit analysis or risk assessment pre2 pared under this chapter shall not be subject to judicial con3 sideration separate or apart from review of the agency ac4 tion to which it relates. When an action for judicial review

5 of an agency action is instituted, any regulatory analysis

6 for such agency action shall constitute part of the whole

7 administrative record of agency action for the purpose of

8 judicial review of the agency action, and shall, to the extent

9 relevant, be considered by a court in determining the legal10 ity of the agency action.

11 ‘‘§ 624. Deadlines for rulemaking

12 ‘‘(a) All deadlines in statutes that require agencies to

13 propose or promulgate any rule subject to section 622 or

14 subchapter III during the 2-year period beginning on the

15 effective date of this section shall be suspended until the ear16 lier of—

17 ‘‘(1) the date on which the requirements of sec18 tion 622 or subchapter III are satisfied; or

19 ‘‘(2) the date occurring 6 months after the date

20 of the applicable deadline.

21 ‘‘(b) All deadlines imposed by any court of the United

22 States that would require an agency to propose or promul23 gate a rule subject to section 622 or subchapter III during

24 the 2-year period beginning on the effective date of this sec25 tion shall be suspended until the earlier of—
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1 ‘‘(1) the date on which the requirements of sec2 tion 622 or subchapter III are satisfied; or

3 ‘‘(2) the date occurring 6 months after the date

4 of the applicable deadline.

5 ‘‘(c) In any case in which the failure to promulgate

6 a rule by a deadline occurring during the 2-year period

7 beginning on the effective date of this section would create

8 an obligation to regulate through individual adjudications,

9 the deadline shall be suspended until the earlier of—

10 ‘‘(1) the date on which the requirements of sec11 tion 622 or subchapter III are satisfied; or

12 ‘‘(2) the date occurring 6 months after the date

13 of the applicable deadline.

14 ‘‘§ 625. Agency review of rules

15 ‘‘(a)(1)(A) No later than 9 months after the effective

16 date of this section, each agency shall prepare and publish

17 in the Federal Register a proposed schedule for the review,

18 in accordance with this section, of—

19 ‘‘(i) each rule of the agency that is in effect on

20 such effective date and which, if adopted on such ef21 fective date, would be a major rule; and

22 ‘‘(ii) each rule of the agency in effect on the effec23 tive date of this section (in addition to the rules de24 scribed in clause (i)) that the agency has selected for

25 review.
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1 ‘‘(B) Each proposed schedule required under subpara2 graph (A) shall be developed in consultation with—

3 ‘‘(i) the Administrator of the Office of Informa4 tion and Regulatory Affairs; and

5 ‘‘(ii) the classes of persons affected by the rules,

6 including members from the regulated industries,

7 small businesses, State and local governments, and or8 ganizations representing the interested public.

9 ‘‘(C) Each proposed schedule required under subpara10 graph (A) shall establish priorities for the review of rules

11 that, in the joint determination of the Administrator of the

12 Office of Information and Regulatory Affairs and the agen13 cy, most likely can be amended or eliminated to—

14 ‘‘(i) provide the same or greater benefits at sub15 stantially lower costs;

16 ‘‘(ii) achieve substantially greater benefits at the

17 same or lower costs; or

18 ‘‘(iii) replace command-and-control regulatory

19 requirements with market mechanisms or performance

20 standards that achieve substantially equivalent bene21 fits at lower costs or with greater flexibility.

22 ‘‘(D) Each proposed schedule required by subpara23 graph (A) shall include—

24 ‘‘(i) a brief explanation of the reasons the agency

25 considers each rule on the schedule to be a major rule,
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1 or the reasons why the agency selected the rule for re2 view;

3 ‘‘(ii) a date set by the agency, in accordance

4 with subsection (b), for the completion of the review

5 of each such rule; and

6 ‘‘(iii) a statement that the agency requests com7 ments from the public on the proposed schedule.

8 ‘‘(E) The agency shall set a date to initiate review of

9 each rule on the schedule in a manner that will ensure the

10 simultaneous review of related items and that will achieve

11 a reasonable distribution of reviews over the period of time

12 covered by the schedule.

13 ‘‘(2) No later than 90 days before publishing in the

14 Federal Register the proposed schedule required under para15 graph (1), each agency shall make the proposed schedule

16 available to the Director or a designee of the President. The

17 President or that officer may select for review in accordance

18 with this section any additional rule.

19 ‘‘(3) No later than 1 year after the effective date of

20 this section, each agency shall publish in the Federal Reg21 ister a final schedule for the review of the rules referred

22 to in paragraphs (1) and (2). Each agency shall publish

23 with the final schedule the response of the agency to com24 ments received concerning the proposed schedule.
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1 ‘‘(b)(1) Except as explicitly provided otherwise by stat2 ute, the agency shall, pursuant to subsections (c) through

3 (e), review—

4 ‘‘(A) each rule on the schedule promulgated pur5 suant to subsection (a);

6 ‘‘(B) each major rule promulgated, amended, or

7 otherwise continued by an agency after the effective

8 date of this section; and

9 ‘‘(C) each rule promulgated after the effective

10 date of this section that the President or the officer

11 designated by the President selects for review pursu12 ant to subsection (a)(2).

13 ‘‘(2) Except as provided pursuant to subsection (f), the

14 review of a rule required by this section shall be completed

15 no later than the later of—

16 ‘‘(A) 10 years after the effective date of this sec17 tion; or

18 ‘‘(B) 10 years after the date on which the rule

19 is—

20 ‘‘(i) promulgated; or

21 ‘‘(ii) amended or continued under this sec22 tion.

23 ‘‘(c) An agency shall publish in the Federal Register

24 a notice of its proposed action under this section with re25 spect to a rule being reviewed. The notice shall include—
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1 ‘‘(1) an identification of the specific statutory

2 authority under which the rule was promulgated and

3 an explanation of whether the agency’s interpretation

4 of the statute is expressly required by the current text

5 of that statute or, if not, whether it is within the

6 range of permissible interpretations of the statute;

7 ‘‘(2) an analysis of the benefits and costs of the

8 rule during the period in which it has been in effect;

9 ‘‘(3) an explanation of the proposed agency ac10 tion with respect to the rule, including action to re11 peal or amend the rule to resolve inconsistencies or

12 conflicts with any other obligation or requirement es13 tablished by any Federal statute, rule, or other agency

14 statement, interpretation, or action that has the force

15 of law; and

16 ‘‘(4) a statement that the agency seeks proposals

17 from the public for modifications or alternatives to

18 the rule which may accomplish the objectives of the

19 rule in a more effective or less burdensome manner.

20 ‘‘(d) If an agency proposes to repeal or amend a rule

21 under review pursuant to this section, the agency shall,

22 after issuing the notice required by subsection (c), comply

23 with the provisions of this chapter, chapter 5, and any other

24 applicable law. The requirements of such provisions and re25 lated requirements shall apply to the same extent and in
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1 the same manner as in the case of a proposed agency action

2 to repeal or amend a rule that is not taken pursuant to

3 the review required by this section.

4 ‘‘(e) If an agency proposes to continue without amend5 ment a rule under review pursuant to this section, the agen6 cy shall—

7 ‘‘(1) give interested persons no less than 60 days

8 after the publication of the notice required by sub9 section (c) to comment on the proposed continuation;

10 and

11 ‘‘(2) publish in the Federal Register notice of the

12 continuation of such rule.

13 ‘‘(f) Any agency, which for good cause finds that com14 pliance with this section with respect to a particular rule

15 during the period provided in subsection (b) of this section

16 is contrary to an important public interest may request the

17 President, or the officer designated by the President pursu18 ant to subsection (a)(2), to establish a period longer than

19 10 years for the completion of the review of such rule. The

20 President or that officer may extend the period for review

21 of a rule to a total period of no more than 15 years. Such

22 extension shall be published in the Federal Register with

23 an explanation of the reasons therefor.

24 ‘‘(g) If the agency fails to comply with the require25 ments of subsection (b)(2), the rule for which rulemaking
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1 proceedings have not been completed shall cease to be en2 forceable against any person.

3 ‘‘(h) Nothing in this section shall relieve any agency

4 from its obligation to respond to a petition to issue, amend,

5 or repeal a rule, for an interpretation regarding the mean6 ing of a rule, or for a variance or exemption from the terms

7 of a rule, submitted pursuant to any other provision of law.

8 ‘‘§ 626. Public participation and accountability

9 ‘‘In order to maximize accountability for, and public

10 participation in, the development and review of regulatory

11 actions each agency shall, consistent with chapter 5 and

12 other applicable law, provide the public with opportunities

13 for meaningful participation in the development of regu14 latory actions, including—

15 ‘‘(1) seeking the involvement, where practicable

16 and appropriate, of those who are intended to benefit

17 from and those who are expected to be burdened by

18 any regulatory action;

19 ‘‘(2) providing in any proposed or final rule20 making notice published in the Federal Register—

21 ‘‘(A) a certification of compliance with the

22 requirements of this chapter, or an explanation

23 why such certification cannot be made;

24 ‘‘(B) a summary of any regulatory analysis

25 required under this chapter, or under any other
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1 legal requirement, and notice of the availability

2 of the regulatory analysis;

3 ‘‘(C) a certification that the rule will

4 produce benefits that will justify the cost to the

5 Government and to the public of implementation

6 of, and compliance with, the rule, or an expla7 nation why such certification cannot be made;

8 and

9 ‘‘(D) a summary of the results of any regu10 latory review and the agency’s response to such

11 review, including an explanation of any signifi12 cant changes made to such regulatory action as

13 a consequence of regulatory review;

14 ‘‘(3) identifying, upon request, a regulatory ac15 tion and the date upon which such action was sub16 mitted to the designated officer to whom authority

17 was delegated under section 644 for review;

18 ‘‘(4) disclosure to the public, consistent with sec19 tion 634(3), of any information created or collected in

20 performing a regulatory analysis required under this

21 chapter, or under any other legal requirement; and

22 ‘‘(5) placing in the appropriate rulemaking

23 record all written communications received from the

24 Director, other designated officer, or other individual

25 or entity relating to regulatory review.
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1 ‘‘SUBCHAPTER III—RISK ASSESSMENTS

2 ‘‘§ 631. Findings and purposes

3 ‘‘(a) The Congress finds that:

4 ‘‘(1) Environmental, health, and safety regula5 tions have lead to dramatic improvements in the en6 vironment and have significantly reduced risks to

7 human health; except—

8 ‘‘(A) many regulations have been more cost9 ly and less effective than necessary; and

10 ‘‘(B) too often, regulatory priorities have

11 not been based upon a realistic consideration of

12 risk, risk reduction opportunities, and costs.

13 ‘‘(2) The public and private resources available

14 to address health, safety, and environmental risks are

15 not unlimited. Those resources should be allocated to

16 address the greatest needs in the most cost-effective

17 manner and to ensure that the incremental costs of

18 regulatory options are reasonably related to the incre19 mental benefits.

20 ‘‘(3) To provide more cost-effective protection to

21 human health, safety, and the environment, regu22 latory priorities should be supported by realistic and

23 plausible scientific risk assessments and risk manage24 ment choices that are grounded in cost-benefit prin25 ciples.
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1 ‘‘(4) Risk assessment has proved to be a useful

2 decisionmaking tool, except—

3 ‘‘(A) improvements are needed in both the

4 quality of assessments and the characterization

5 and communication of findings;

6 ‘‘(B) scientific and other data must be bet7 ter collected, organized, and evaluated; and

8 ‘‘(C) the critical information resulting from

9 a risk assessment must be effectively commu10 nicated in an objective and unbiased manner to

11 decision makers, and from decision makers to the

12 public.

13 ‘‘(5) The public stakeholders should be involved

14 in the decisionmaking process for regulating risks.

15 The public has the right to know about the risks ad16 dressed by regulation, the amount of risk reduced, the

17 quality of the science used to support decisions, and

18 the cost of implementing and complying with regula19 tions. Such knowledge will allow for public scrutiny

20 and will promote the quality, integrity, and respon21 siveness of agency decisions.

22 ‘‘(b) The purposes of this subchapter are to—

23 ‘‘(1) present the public and executive branch

24 with the most realistic and plausible information con25 cerning the nature and magnitude of health, safety,
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1 and environmental risks to promote sound regulatory

2 decisions and public education;

3 ‘‘(2) provide for full consideration and discus4 sion of relevant data and potential methodologies;

5 ‘‘(3) require explanation of significant choices in

6 the risk assessment process that will allow for better

7 public understanding; and

8 ‘‘(4) improve consistency within the executive

9 branch in preparing risk assessments and risk char10 acterizations.

11 ‘‘§ 632. Definitions

12 ‘‘For purposes of this subchapter, the definitions under

13 sections 551 and 621 shall apply and:

14 ‘‘(1) The term ‘covered agency’ means each of the

15 following:

16 ‘‘(A) The Environmental Protection Agency.

17 ‘‘(B) The Department of Labor.

18 ‘‘(C) The Department of Transportation.

19 ‘‘(D) The Food and Drug Administration.

20 ‘‘(E) The Department of Energy.

21 ‘‘(F) The Department of the Interior.

22 ‘‘(G) The Department of Agriculture.

23 ‘‘(H) The Consumer Product Safety Com24 mission.
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1 ‘‘(I) The National Oceanic and Atmospheric

2 Administration.

3 ‘‘(J) The United States Army Corps of En4 gineers.

5 ‘‘(K) The Nuclear Regulatory Commission.

6 ‘‘(L) Any other Federal agency considered a

7 covered agency under section 633(b).

8 ‘‘(2) The term ‘emergency’ means a situation

9 that is immediately impending and extraordinary in

10 nature, demanding attention due to a condition, cir11 cumstance or practice reasonably expected to cause

12 death, serious illness or severe injury to humans, or

13 substantial endangerment to private property or the

14 environment if no action is taken.

15 ‘‘(3) The term ‘estimates of risk’ means numeri16 cal representations of the potential magnitude of

17 harm to populations or the probability of harm to in18 dividuals, including, as appropriate, those derived by

19 considering the range and distribution of estimates of

20 dose-response (potency) and exposure, including ap21 propriate statistical representation of the range and

22 most likely exposure levels, and the identification of

23 the populations or subpopulations addressed. When

24 appropriate and practicable, a description of any

25 populations or subpopulations that are likely to expe-
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1 rience exposures at the upper end of the distribution

2 should be included.

3 ‘‘(4) The term ‘hazard identification’ means

4 identification of a substance, activity, or condition as

5 potentially causing harm to human health, safety, or

6 the environment.

7 ‘‘(5) The term ‘risk assessment’ means—

8 ‘‘(A) identifying, quantifying to the extent

9 feasible and appropriate, and characterizing

10 hazards and exposures to those hazards in order

11 to provide structured information on the nature

12 of threats to human health, safety, or the envi13 ronment; and

14 ‘‘(B) the document containing the expla15 nation of how the assessment process has been

16 applied to an individual substance, activity, or

17 condition.

18 ‘‘(6) The term ‘risk characterization’ means the

19 integration, synthesis, and organization of hazard

20 identification, dose-response and exposure informa21 tion that addresses the needs of decision makers and

22 interested parties. The term includes both the process

23 and specific outputs, including—

24 ‘‘(A) the element of a risk assessment that

25 involves presentation of the degree of risk in any
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1 regulatory proposal or decision, report to Con2 gress, or other document that is made available

3 to the public; and

4 ‘‘(B) discussions of uncertainties, conflicting

5 data, estimates of risk, extrapolations, inferences,

6 and opinions.

7 ‘‘(7) The term ‘screening analysis’ means an

8 analysis that arrives at a qualitative estimate or a

9 bounding estimate of risk that permits the risk man10 ager to accept or reject some management options, or

11 permits establishing priorities for agency action. Such

12 term includes an assessment performed by a regulated

13 party and submitted to an agency under a regulatory

14 requirement.

15 ‘‘(8) The term ‘substitution risk’ means a reason16 ably likely increased risk to human health, safety, or

17 the environment from a regulatory option designed to

18 decrease other risks.

19 ‘‘§ 633. Applicability

20 ‘‘(a) Except as provided in subsection (c), this sub21 chapter shall apply to all risk assessments and risk charac22 terizations prepared by, or on behalf of, or prepared by oth23 ers and adopted by any covered agency in connection with

24 a major rule addressing health, safety, and environmental

25 risks.
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1 ‘‘(b)(1) No later than 18 months after the effective date

2 of this section, the President, acting through the Director

3 of the Office of Management and Budget, shall determine

4 whether other Federal agencies should be considered covered

5 agencies for the purposes of this subchapter. Such deter6 mination, with respect to a particular Federal agency, shall

7 be based on the impact of risk assessment documents and

8 risk characterization documents on—

9 ‘‘(A) regulatory programs administered by that

10 agency; and

11 ‘‘(B) the communication of risk information by

12 that agency to the public.

13 ‘‘(2) If the President makes a determination under

14 paragraph (1), the provisions of this subchapter shall apply

15 to any affected agency beginning on a date set by the Presi16 dent. Such date may be no later than 6 months after the

17 date of such determination.

18 ‘‘(c)(1) This subchapter shall not apply to risk assess19 ments or risk characterizations performed with respect to—

20 ‘‘(A) an emergency determined by the head of an

21 agency;

22 ‘‘(B) a health, safety, or environmental inspec23 tion or individual facility permitting action; or

24 ‘‘(C) a screening analysis.
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1 ‘‘(2) This subchapter shall not apply to any food, drug,

2 or other product label, or to any risk characterization ap3 pearing on any such label.

4 ‘‘§ 634. Savings provisions

5 ‘‘Nothing in this subchapter shall be construed to—

6 ‘‘(1) modify any statutory standard or require7 ment designed to protect human health, safety, or the

8 environment;

9 ‘‘(2) preclude the consideration of any data or

10 the calculation of any estimate to more fully describe

11 risk or provide examples of scientific uncertainty or

12 variability; or

13 ‘‘(3) require the disclosure of any trade secret or

14 other confidential information.

15 ‘‘§ 635. Principles for risk assessment

16 ‘‘(a) The head of each covered agency shall ensure that

17 risk assessments and all of the components of such assess18 ments—

19 ‘‘(1) provide for a systematic means to structure

20 information useful to decision makers;

21 ‘‘(2) provide, to the maximum extent practicable,

22 that policy-driven default assumptions be used only

23 in the absence of relevant available information;

24 ‘‘(3) promote involvement from all stakeholders;
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1 ‘‘(4) provide an opportunity for public input

2 throughout the regulatory process; and

3 ‘‘(5) are designed so that the degree of specificity

4 and rigor employed is commensurate with the con5 sequences of the decision to be made.

6 ‘‘(b) A risk assessment shall, to the maximum extent

7 practicable, clearly delineate hazard identification from

8 dose-response and exposure assessment and make clear the

9 relationship between the level of risk and the level of expo10 sure to a hazard.

11 ‘‘§ 636. Principles for risk characterization

12 ‘‘In characterizing risk in any risk assessment docu13 ment, regulatory proposal, or decision, each covered agency

14 shall include in the risk characterization, as appropriate,

15 each of the following:

16 ‘‘(1)(A) A description of the exposure scenarios

17 used, the natural resources or subpopulations being

18 exposed, and the likelihood of those exposure scenarios.

19 ‘‘(B) When a risk assessment involves a choice of

20 any significant assumption, inference, or model, the

21 covered agency or instrumentality preparing the risk

22 assessment shall—

23 ‘‘(i) identify the assumptions, inferences,

24 and models that materially affect the outcome;

25 ‘‘(ii) explain the basis for any choices;
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1 ‘‘(iii) identify any policy decisions or pol2 icy-based default assumptions;

3 ‘‘(iv) indicate the extent to which any sig4 nificant model has been validated by, or conflicts

5 with, empirical data; and

6 ‘‘(v) describe the impact of alternative

7 choices of assumptions, default options or mathe8 matical models.

9 ‘‘(C) The major sources of uncertainties in the

10 hazard identification, dose-response and exposure as11 sessment phases of the risk assessment.

12 ‘‘(D) To the extent feasible, the range and dis13 tribution of exposures and risks derived from the risk

14 assessment should be included as a component of the

15 risk characterization.

16 ‘‘(2) When a covered agency provides a risk as17 sessment or risk characterization for a proposed or

18 final regulatory action, such assessment or character19 ization shall include a statement of any significant

20 substitution risks, when information on such risks has

21 been made available to the agency.

22 ‘‘§ 637. Peer review

23 ‘‘(a) The head of each covered agency shall develop a

24 systematic program for independent and external peer re-
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1 view required under subsection (b). Such program shall be

2 applicable throughout each covered agency and—

3 ‘‘(1) shall provide for the creation of peer review

4 panels that—

5 ‘‘(A) consist of members with expertise rel6 evant to the sciences involved in regulatory deci7 sions and who are independent of the covered

8 agency; and

9 ‘‘(B) are broadly representative and bal10 anced and, to the extent relevant and appro11 priate, may include persons affiliated with Fed12 eral, State, local, or tribal governments, small

13 businesses, other representatives of industry, uni14 versities, agriculture, labor consumers, conserva15 tion organizations, or other public interest

16 groups and organizations;

17 ‘‘(2) shall not exclude any person with substan18 tial and relevant expertise as a panel member on the

19 basis that such person represents an entity that may

20 have a potential interest in the outcome, if such inter21 est is fully disclosed to the agency, and in the case of

22 a regulatory decision affecting a single entity, no peer

23 reviewer representing such entity may be included on

24 the panel;
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1 ‘‘(3) shall provide for a timely completed peer re2 view, meeting agency deadlines, that contains a bal3 anced presentation of all considerations, including

4 minority reports and an agency response to all sig5 nificant peer review comments; and

6 ‘‘(4) shall provide adequate protections for con7 fidential business information and trade secrets, in8 cluding requiring panel members to enter into con9 fidentiality agreements.

10 ‘‘(b)(1)(A) Except as provided under subparagraph

11 (B), each covered agency shall provide for peer review in

12 accordance with this section of any risk assessment or cost13 benefit analysis that forms the basis of any major rule that

14 addresses risks to the environment, health, or safety.

15 ‘‘(B) Subparagraph (A) shall not apply to a rule or

16 other action taken by an agency to authorize or approve

17 any individual substance or product.

18 ‘‘(2) The Director of the Office of Management and

19 Budget may order that peer review be provided for any risk

20 assessment or cost-benefit analysis that is likely to have a

21 significant impact on public policy decisions or would es22 tablish an important precedent.

23 ‘‘(c) Each peer review under this section shall include

24 a report to the Federal agency concerned with respect to
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1 the scientific and technical merit of data and methods used

2 for the risk assessments or cost-benefit analyses.

3 ‘‘(d) The head of the covered agency shall provide a

4 written response to all significant peer review comments.

5 ‘‘(e) All peer review comments or conclusions and the

6 agency’s responses shall be made available to the public and

7 shall be made part of the administrative record for purposes

8 of judicial review of any final agency action.

9 ‘‘(f) No peer review shall be required under this section

10 for any data, method, document, or assessment, or any com11 ponent thereof, which has been previously subjected to peer

12 review.

13 ‘‘§ 638. Guidelines, plan for assessing new informa14 tion, and report

15 ‘‘(a)(1)(A) As soon as practicable and scientifically

16 feasible, each covered agency shall adopt, after notification

17 and opportunity for public comment, guidelines to imple18 ment the risk assessment and risk characterization prin19 ciples under sections 635 and 636, as well as the cost-benefit

20 analysis requirements under section 622, and shall provide

21 a format for summarizing risk assessment results.

22 ‘‘(B) No later than 12 months after the effective date

23 of this section, the head of each covered agency shall issue

24 a report on the status of such guidelines to the Congress.

25 ‘‘(2) The guidelines under paragraph (1) shall—
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1 ‘‘(A) include guidance on use of specific technical

2 methodologies and standards for acceptable quality of

3 specific kinds of data;

4 ‘‘(B) address important decisional factors for the

5 risk assessment, risk characterization, and cost-benefit

6 analysis at issue; and

7 ‘‘(C) provide procedures for the refinement and

8 replacement of policy-based default assumptions.

9 ‘‘(b) The guidelines, plan and report under this section

10 shall be developed after notice and opportunity for public

11 comment, and after consultation with representatives of ap12 propriate State agencies and local governments, and such

13 other departments and agencies, organizations, or persons

14 as may be advisable.

15 ‘‘(c) The President shall review the guidelines pub16 lished under this section at least every 4 years.

17 ‘‘(d) The development, issuance, and publication of

18 risk assessment and risk characterization guidelines under

19 this section shall not be subject to judicial review.

20 ‘‘§ 639. Research and training in risk assessment

21 ‘‘(a) The head of each covered agency shall regularly

22 and systematically evaluate risk assessment research and

23 training needs of the agency, including, where relevant and

24 appropriate, the following:
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1 ‘‘(1) Research to reduce generic data gaps, to ad2 dress modelling needs (including improved model sen3 sitivity), and to validate default options, particularly

4 those common to multiple risk assessments.

5 ‘‘(2) Research leading to improvement of methods

6 to quantify and communicate uncertainty and varia7 bility among individuals, species, populations, and,

8 in the case of ecological risk assessment, ecological

9 communities.

10 ‘‘(3) Emerging and future areas of research, in11 cluding research on comparative risk analysis, expo12 sure to multiple chemicals and other stressors,

13 noncancer endpoints, biological markers of exposure

14 and effect, mechanisms of action in both mammalian

15 and nonmammalian species, dynamics and prob16 abilities of physiological and ecosystem exposures, and

17 prediction of ecosystem-level responses.

18 ‘‘(4) Long-term needs to adequately train indi19 viduals in risk assessment and risk assessment appli20 cation. Evaluations under this paragraph shall in21 clude an estimate of the resources needed to provide

22 necessary training.

23 ‘‘(b) The head of each covered agency shall develop a

24 strategy and schedule for carrying out research and train25 ing to meet the needs identified in subsection (a).
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1 ‘‘§ 640. Interagency coordination

2 ‘‘(a) To promote the conduct, application, and practice

3 of risk assessment in a consistent manner and to identify

4 risk assessment data and research needs common to more

5 than 1 Federal agency, the Director of the Office of Manage6 ment and Budget, in consultation with the Office of Science

7 and Technology Policy, shall—

8 ‘‘(1) periodically survey the manner in which

9 each Federal agency involved in risk assessment is

10 conducting such risk assessment to determine the

11 scope and adequacy of risk assessment practices in

12 use by the Federal Government;

13 ‘‘(2) provide advice and recommendations to the

14 President and Congress based on the surveys con15 ducted and determinations made under paragraph

16 (1);

17 ‘‘(3) establish appropriate interagency mecha18 nisms to promote—

19 ‘‘(A) coordination among Federal agencies

20 conducting risk assessment with respect to the

21 conduct, application, and practice of risk assess22 ment; and

23 ‘‘(B) the use of state-of-the-art risk assess24 ment practices throughout the Federal Govern25 ment;
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1 ‘‘(4) establish appropriate mechanisms between

2 Federal and State agencies to communicate state-of3 the-art risk assessment practices; and

4 ‘‘(5) periodically convene meetings with State

5 government representatives and Federal and other

6 leaders to assess the effectiveness of Federal and State

7 cooperation in the development and application of

8 risk assessment.

9 ‘‘(b) The President shall appoint National Peer Review

10 Panels to review every 3 years the risk assessment practices

11 of each covered agency for programs designed to protect

12 human health, safety, or the environment. The Panels shall

13 submit a report to the President and the Congress at least

14 every 3 years containing the results of such review.

15 ‘‘§ 640a. Plan for review of risk assessments

16 ‘‘(a) No later than 18 months after the effective date

17 of this section, the head of each covered agency shall publish

18 a plan to review and revise any risk assessment published

19 before the expiration of such 18-month period if the covered

20 agency determines that significant new information or

21 methodologies are available that could significantly alter

22 the results of the prior risk assessment.

23 ‘‘(b) A plan under subsection (a) shall—
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1 ‘‘(1) provide procedures for receiving and consid2 ering new information and risk assessments from the

3 public; and

4 ‘‘(2) set priorities and criteria for review and re5 vision of risk assessments based on such factors as the

6 agency head considers appropriate.

7 ‘‘§ 640b. Judicial review

8 ‘‘The provisions of section 623 relating to judicial re9 view shall apply to this subchapter.

10 ‘‘§ 640c. Deadlines for rulemaking

11 ‘‘The provisions of section 624 relating to deadlines for

12 rulemaking shall apply to this subchapter.

13 ‘‘SUBCHAPTER IV—EXECUTIVE OVERSIGHT

14 ‘‘§ 641. Definition

15 ‘‘For purposes of this subchapter, the definitions under

16 sections 551 and 621 shall apply.

17 ‘‘§ 642. Procedures

18 ‘‘The Director or other designated officer to whom au19 thority is delegated under section 644 shall—

20 ‘‘(1) establish procedures for agency compliance

21 with this chapter; and

22 ‘‘(2) monitor, review, and ensure agency imple23 mentation of such procedures.
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1 ‘‘§ 643. Promulgation and adoption

2 ‘‘(a) Procedures established pursuant to section 642

3 shall only be implemented after opportunity for public com4 ment. Any such procedures shall be consistent with the

5 prompt completion of rulemaking proceedings.

6 ‘‘(b)(1) If procedures established pursuant to section

7 642 include review of any initial or final analyses of a rule

8 required under this chapter, the time for any such review

9 of any initial analysis shall not exceed 60 days following

10 the receipt of the analysis by the Director, a designee of

11 the President, or by an officer to whom the authority grant12 ed under section 642 has been delegated pursuant to section

13 644.

14 ‘‘(2) The time for review of any final analysis required

15 under this chapter shall not exceed 60 days following the

16 receipt of the analysis by the Director, a designee of the

17 President, or such officer.

18 ‘‘(3)(A) The times for each such review may be ex19 tended for good cause by the President or such officer for

20 an additional 30 days.

21 ‘‘(B) Notice of any such extension, together with a suc22 cinct statement of the reasons therefor, shall be inserted in

23 the rulemaking file.

24 ‘‘§ 644. Delegation of authority

25 ‘‘(a) The President shall delegate the authority granted

26 by this subchapter to the Director or to another officer with-
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1 in the Executive Office of the President whose appointment

2 has been subject to the advice and consent of the Senate.

3 ‘‘(b) Notice of any delegation, or any revocation or

4 modification thereof shall be published in the Federal Reg5 ister.

6 ‘‘§ 645. Public disclosure of information

7 ‘‘The Director or other designated officer to whom au8 thority is delegated under section 644, in carrying out the

9 provisions of section 642, shall establish procedures (cover10 ing all employees of the Director or other designated officer)

11 to provide public and agency access to information concern12 ing regulatory review actions, including—

13 ‘‘(1) disclosure to the public on an ongoing basis

14 of information regarding the status of regulatory ac15 tions undergoing review;

16 ‘‘(2) disclosure to the public, no later than publi17 cation of, or other substantive notice to the public

18 concerning a regulatory action, of—

19 ‘‘(A) all written communications, regardless

20 of form or format, including drafts of all propos21 als and associated analyses, between the Director

22 or other designated officer and the regulatory

23 agency;

24 ‘‘(B) all written communications, regardless

25 of form or format, between the Director or other
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1 designated officer and any person not employed

2 by the executive branch of the Federal Govern3 ment relating to the substance of a regulatory ac4 tion;

5 ‘‘(C) a record of all oral communications

6 relating to the substance of a regulatory action

7 between the Director or other designated officer

8 and any person not employed by the executive

9 branch of the Federal Government; and

10 ‘‘(D) a written explanation of any review

11 action and the date of such action; and

12 ‘‘(3) disclosure to the regulatory agency, on a

13 timely basis, of—

14 ‘‘(A) all written communications between

15 the Director or other designated officer and any

16 person who is not employed by the executive

17 branch of the Federal Government;

18 ‘‘(B) a record of all oral communications,

19 and an invitation to participate in meetings, re20 lating to the substance of a regulatory action be21 tween the Director or other designated officer

22 and any person not employed by the executive

23 branch of the Federal Government; and
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1 ‘‘(C) a written explanation of any review

2 action taken concerning an agency regulatory

3 action.

4 ‘‘§ 646. Judicial review

5 ‘‘The exercise of the authority granted under this sub6 chapter by the Director, the President, or by an officer to

7 whom such authority has been delegated under section 644

8 shall not be subject to judicial review in any manner.’’.

9 (b) REGULATORY FLEXIBILITY ANALYSIS.—

10 (1) IN GENERAL.—Section 611 of title 5, United

11 States Code, is amended to read as follows:

12 ‘‘§ 611. Judicial review

13 ‘‘(a)(1) Except as provided in paragraph (2), no later

14 than 1 year after the effective date of a final rule with re15 spect to which an agency—

16 ‘‘(A) certified, pursuant to section 605(b), that

17 such rule would not have a significant economic im18 pact on a substantial number of small entities; or

19 ‘‘(B) prepared a final regulatory flexibility anal20 ysis pursuant to section 604,

21 an affected small entity may petition for the judicial review

22 of such certification or analysis in accordance with this

23 subsection. A court having jurisdiction to review such rule

24 for compliance with section 553 of this title or under any
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1 other provision of law shall have jurisdiction to review such

2 certification or analysis.

3 ‘‘(2)(A) Except as provided in subparagraph (B), in

4 the case of a provision of law that requires that an action

5 challenging a final agency regulation be commenced before

6 the expiration of the 1-year period provided in paragraph

7 (1), such lesser period shall apply to a petition for the judi8 cial review under this subsection.

9 ‘‘(B) In a case in which an agency delays the issuance

10 of a final regulatory flexibility analysis pursuant to section

11 608(b), a petition for judicial review under this subsection

12 shall be filed no later than—

13 ‘‘(i) 1 year; or

14 ‘‘(ii) in a case in which a provision of law re15 quires that an action challenging a final agency regu16 lation be commenced before the expiration of the 1-

17 year period provided in paragraph (1), the number of

18 days specified in such provision of law,

19 after the date the analysis is made available to the public.

20 ‘‘(3) For purposes of this subsection, the term ‘affected

21 small entity’ means a small entity that is or will be ad22 versely affected by the final rule.

23 ‘‘(4) Nothing in this subsection shall be construed to

24 affect the authority of any court to stay the effective date
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1 of any rule or provision thereof under any other provision

2 of law.

3 ‘‘(5)(A) In a case in which an agency certifies that

4 such rule would not have a significant economic impact on

5 a substantial number of small entities, the court may order

6 the agency to prepare a final regulatory flexibility analysis

7 pursuant to section 604 if the court determines, on the basis

8 of the rulemaking record, that the certification was arbi9 trary, capricious, an abuse of discretion, or otherwise not

10 in accordance with law.

11 ‘‘(B) In a case in which the agency prepared a final

12 regulatory flexibility analysis, the court may order the

13 agency to take corrective action consistent with section 604

14 if the court determines, on the basis of the rulemaking

15 record, that the final regulatory flexibility analysis was

16 prepared by the agency without complying with section 604.

17 ‘‘(6) If, by the end of the 90-day period beginning on

18 the date of the order of the court pursuant to paragraph

19 (5) (or such longer period as the court may provide), the

20 agency fails, as appropriate—

21 ‘‘(A) to prepare the analysis required by section

22 604; or

23 ‘‘(B) to take corrective action consistent with sec24 tion 604 of this title,
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1 the court may stay the rule or grant such other relief as

2 it deems appropriate.

3 ‘‘(7) In making any determination or granting any

4 relief authorized by this subsection, the court shall take due

5 account of the rule of prejudicial error.

6 ‘‘(b) In an action for the judicial review of a rule, any

7 regulatory flexibility analysis for such rule (including an

8 analysis prepared or corrected pursuant to subsection

9 (a)(5)) shall constitute part of the whole record of agency

10 action in connection with such review.

11 ‘‘(c) Nothing in this section bars judicial review of any

12 other impact statement or similar analysis required by any

13 other law if judicial review of such statement or analysis

14 is otherwise provided by law.’’.

15 (2) EFFECTIVE DATE.—The amendment made by

16 paragraph (1) shall take effect on the effective date of

17 this Act, except that the judicial review authorized by

18 section 611(a) of title 5, United States Code (as added

19 by subsection (a)), shall apply only to final agency

20 rules issued after such effective date.

21 (c) PRESIDENTIAL AUTHORITY.—Nothing in this Act

22 shall limit the exercise by the President of the authority

23 and responsibility that the President otherwise possesses

24 under the Constitution and other laws of the United States
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1 with respect to regulatory policies, procedures, and pro2 grams of departments, agencies, and offices.

3 (d) TECHNICAL AND CONFORMING AMENDMENTS.—

4 (1) Part I of title 5, United States Code, is

5 amended by striking out the chapter heading and

6 table of sections for chapter 6 and inserting in lieu

7 thereof the following:

8 ‘‘CHAPTER 6—THE ANALYSIS OF

9 REGULATORY FUNCTIONS

‘‘SUBCHAPTER I—REGULATORY ANALYSIS

‘‘Sec.

‘‘601. Definitions.

‘‘602. Regulatory agenda.

‘‘603. Initial regulatory flexibility analysis.

‘‘604. Final regulatory flexibility analysis.

‘‘605. Avoidance of duplicative or unnecessary analyses.

‘‘606. Effect on other law.

‘‘607. Preparation of analysis.

‘‘608. Procedure for waiver or delay of completion.

‘‘609. Procedures for gathering comments.

‘‘610. Periodic review of rules.

‘‘611. Judicial review.

‘‘612. Reports and intervention rights.

‘‘SUBCHAPTER II—ANALYSIS OF AGENCY RULES

‘‘621. Definitions.

‘‘622. Rulemaking cost-benefit analysis.

‘‘623. Judicial review.

‘‘624. Deadlines for rulemaking.

‘‘625. Agency review of rules.

‘‘626. Public participation and accountability.

‘‘SUBCHAPTER III—RISK ASSESSMENTS

‘‘631. Findings and purposes.

‘‘632. Definitions.

‘‘633. Applicability.

‘‘634. Savings provisions.

‘‘635. Principles for risk assessment.

‘‘636. Principles for risk characterization.

‘‘637. Peer review.

‘‘638. Guidelines, plan for assessing new information, and report.

‘‘639. Research and training in risk assessment.
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‘‘640. Interagency coordination.

‘‘640a. Plan for review of risk assessments.

‘‘640b. Judicial review.

‘‘640c. Deadlines for rulemaking.

‘‘SUBCHAPTER IV—EXECUTIVE OVERSIGHT

‘‘641. Definition.

‘‘642. Procedures.

‘‘643. Promulgation and adoption.

‘‘644. Delegation of authority.

‘‘645. Public disclosure of information.

‘‘646. Judicial review.’’.

1 (2) Chapter 6 of title 5, United States Code, is

2 amended by inserting immediately before section 601,

3 the following subchapter heading:

4 ‘‘SUBCHAPTER I—REGULATORY ANALYSIS’’.

5 SEC. 4. CONGRESSIONAL REVIEW.

6 (a) IN GENERAL.—Part I of title 5, United States

7 Code, is amended by inserting after chapter 7 the following

8 new chapter:

9 ‘‘CHAPTER 8—CONGRESSIONAL REVIEW

10 OF AGENCY RULEMAKING

11 ‘‘§ 801. Congressional review of agency rulemaking

12 ‘‘(a) For purposes of this chapter, the term—

13 ‘‘(1) ‘major rule’ means a major rule as defined

14 under section 621(4) of this title and as determined

15 under section 622 of this title; and

16 ‘‘(2) ‘rule’ (except in reference to a rule of the

17 Senate or House of Representatives) is a reference to

18 a major rule.
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1 ‘‘(b)(1) Upon the promulgation of a final major rule,

2 the agency promulgating such rule shall submit to the Con3 gress a copy of the rule, the statement of basis and purpose

4 for the rule, and the proposed effective date of the rule.

5 ‘‘(2) A rule submitted under paragraph (1) shall not

6 take effect as a final rule before the latest of the following:

7 ‘‘(A) The later of the date occurring 45 days

8 after the date on which—

9 ‘‘(i) the Congress receives the rule submitted

10 under paragraph (1); or

11 ‘‘(ii) the rule is published in the Federal

12 Register.

13 ‘‘(B) If the Congress passes a joint resolution of

14 disapproval described under subsection (i) relating to

15 the rule, and the President signs a veto of such resolu16 tion, the earlier date—

17 ‘‘(i) on which either House of Congress votes

18 and fails to override the veto of the President; or

19 ‘‘(ii) occurring 30 session days after the

20 date on which the Congress received the veto and

21 objections of the President.

22 ‘‘(C) The date the rule would have otherwise

23 taken effect, if not for this section (unless a joint reso24 lution of disapproval under subsection (i) is ap25 proved).
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1 ‘‘(c) A major rule shall not take effect as a final rule

2 if the Congress passes a joint resolution of disapproval de3 scribed under subsection (i), which is signed by the Presi4 dent or is vetoed and overridden by the Congress.

5 ‘‘(d)(1) Notwithstanding any other provision of this

6 section (except subject to paragraph (2)), a major rule that

7 would not take effect by reason of this section may take ef8 fect if the President makes a determination and submits

9 written notice of such determination to the Congress that

10 the major rule should take effect because such major rule

11 is—

12 ‘‘(A) necessary because of an imminent threat to

13 health or safety, or other emergency;

14 ‘‘(B) necessary for the enforcement of criminal

15 laws; or

16 ‘‘(C) necessary for national security.

17 ‘‘(2) An exercise by the President of the authority

18 under this subsection shall have no effect on the procedures

19 under subsection (i) or the effect of a joint resolution of dis20 approval under this section.

21 ‘‘(e)(1) Subsection (i) shall apply to any major rule

22 that is promulgated as a final rule during the period begin23 ning on the date occurring 60 days before the date the Con24 gress adjourns sine die through the date on which the suc25 ceeding Congress first convenes.
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1 ‘‘(2) For purposes of subsection (i), a major rule de2 scribed under paragraph (1) shall be treated as though such

3 rule were published in the Federal Register (as a rule that

4 shall take effect as a final rule) on the date the succeeding

5 Congress first convenes.

6 ‘‘(3) During the period between the date the Congress

7 adjourns sine die through the date on which the succeeding

8 Congress first convenes, a rule described under paragraph

9 (1) shall take effect as a final rule as otherwise provided

10 by law.

11 ‘‘(f) Any rule that takes effect and later is made of

12 no force or effect by the enactment of a joint resolution

13 under subsection (i) shall be treated as though such rule

14 had never taken effect.

15 ‘‘(g) If the Congress does not enact a joint resolution

16 of disapproval under subsection (i), no court or agency may

17 infer any intent of the Congress from any action or inaction

18 of the Congress with regard to such major rule, related stat19 ute, or joint resolution of disapproval.

20 ‘‘(h) If the agency fails to comply with the require21 ments of subsection (b) for any rule, the rule shall cease

22 to be enforceable against any person.

23 ‘‘(i)(1) For purposes of this subsection, the term ‘joint

24 resolution’ means only a joint resolution introduced after

25 the date on which the rule referred to in subsection (b) is
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1 received by Congress the matter after the resolving clause

2 of which is as follows: ‘That Congress disapproves the rule

3 submitted by the llllll relating to

4 lllllll, and such rule shall have no force or ef5 fect.’ (The blank spaces being appropriately filled in.)

6 ‘‘(2)(A) In the Senate, a resolution described in para7 graph (1) shall be referred to the committees with jurisdic8 tion. Such a resolution shall not be reported before the

9 eighth day after its submission or publication date.

10 ‘‘(B) For purposes of this subsection, the term ‘submis11 sion or publication date’ means the later of the date on

12 which—

13 ‘‘(i) the Congress receives the rule submitted

14 under subsection (b)(1); or

15 ‘‘(ii) the rule is published in the Federal Reg16 ister.

17 ‘‘(3) In the Senate, if the committee to which a resolu18 tion described in paragraph (1) is referred has not reported

19 such resolution (or an identical resolution) at the end of

20 20 calendar days after its submission or publication date,

21 such committee may be discharged on a petition approved

22 by 30 Senators from further consideration of such resolution

23 and such resolution shall be placed on the Senate calendar.

24 ‘‘(4)(A) In the Senate, when the committee to which

25 a resolution is referred has reported, or when a committee
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1 is discharged (under paragraph (3)) from further consider2 ation of, a resolution described in paragraph (1), it shall

3 at any time thereafter be in order (even though a previous

4 motion to the same effect has been disagreed to) for any

5 Senator to move to proceed to the consideration of the reso6 lution, and all points of order against the resolution (and

7 against consideration of the resolution) shall be waived. The

8 motion shall be privileged in the Senate and shall not be

9 debatable. The motion shall not be subject to amendment,

10 or to a motion to postpone, or to a motion to proceed to

11 the consideration of other business. A motion to reconsider

12 the vote by which the motion is agreed to or disagreed to

13 shall not be in order. If a motion to proceed to the consider14 ation of the resolution is agreed to, the resolution shall re15 main the unfinished business of the Senate until disposed

16 of.

17 ‘‘(B) In the Senate, debate on the resolution, and on

18 all debatable motions and appeals in connection therewith,

19 shall be limited to not more than 10 hours, which shall be

20 divided equally between those favoring and those opposing

21 the resolution. A motion further to limit debate shall be in

22 order and shall not be debatable. An amendment to, or a

23 motion to postpone, or a motion to proceed to the consider24 ation of other business, or a motion to recommit the resolu25 tion shall not be in order. A motion to reconsider the vote
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1 by which the resolution is agreed to or disagreed to shall

2 not be in order.

3 ‘‘(C) In the Senate, immediately following the conclu4 sion of the debate on a resolution described in paragraph

5 (1), and a single quorum call at the conclusion of the debate

6 if requested in accordance with the Senate rules, the vote

7 on final passage of the resolution shall occur.

8 ‘‘(D) Appeals from the decisions of the Chair relating

9 to the application of the rules of the Senate to the procedure

10 relating to a resolution described in paragraph (1) shall

11 be decided without debate.

12 ‘‘(5) If, before the passage in the Senate of a resolution

13 described in paragraph (1), the Senate receives from the

14 House of Representatives a resolution described in para15 graph (1), then the following procedures shall apply:

16 ‘‘(A) The resolution of the House of Representa17 tives shall not be referred to a committee.

18 ‘‘(B) With respect to a resolution described in

19 paragraph (1) of the Senate—

20 ‘‘(i) the procedure in the Senate shall be the

21 same as if no resolution had been received from

22 the other House; but

23 ‘‘(ii) the vote on final passage shall be on

24 the resolution of the other House.

25 ‘‘(6) This subsection is enacted by Congress—
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1 ‘‘(A) as an exercise of the rulemaking power of

2 the Senate and House of Representatives, respectively,

3 and as such it is deemed to be a part of the rules of

4 each House, respectively, but applicable only with re5 spect to the procedure to be followed in that House in

6 the case of a resolution described in paragraph (1),

7 and it supersedes other rules only to the extent that

8 it is inconsistent with such rules; and

9 ‘‘(B) with full recognition of the constitutional

10 right of either House to change the rules (so far as re11 lating to the procedure of that House) at any time,

12 in the same manner, and to the same extent as in the

13 case of any other rule of that House.

14 ‘‘(j) No requirements under this chapter shall be subject

15 to judicial review in any manner.’’.

16 (b) TECHNICAL AND CONFORMING AMENDMENT.—The

17 table of chapters for part I of title 5, United States Code,

18 is amended by inserting after the item relating to chapter

19 7 the following:

‘‘8. Congressional Review of Agency Rulemaking ................... 801’’.

20 SEC. 5. STUDIES AND REPORTS.

21 (a) RISK ASSESSMENTS.—The Administrative Con22 ference of the United States shall—

23 (1) develop and carry out an ongoing study of

24 the operation of the risk assessment requirements of
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1 subchapter III of chapter 6 of title 5, United States

2 Code (as added by section 3 of this Act); and

3 (2) submit an annual report to the Congress on

4 the findings of the study.

5 (b) ADMINISTRATIVE PROCEDURE ACT.—No later than

6 December 31, 1996, the Administrative Conference of the

7 United States shall—

8 (1) carry out a study of the operation of chapters

9 5 and 6 of title 5, United States Code (commonly re10 ferred to as the Administrative Procedure Act), as

11 amended by section 3 of this Act; and

12 (2) submit a report to the Congress on the find13 ings of the study, including proposals for revision, if

14 any.

15 SEC. 6. RISK-BASED PRIORITIES.

16 (a) PURPOSES.—The purposes of this section are to—

17 (1) encourage Federal agencies engaged in regu18 lating risks to human health, safety, and the environ19 ment to achieve the greatest risk reduction at the least

20 cost practical;

21 (2) promote the coordination of policies and pro22 grams to reduce risks to human health, safety, and

23 the environment; and

24 (3) promote open communication among Federal

25 agencies, the public, the President, and Congress re-
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1 garding environmental, health, and safety risks, and

2 the prevention and management of those risks.

3 (b) DEFINITIONS.—For the purposes of this section:

4 (1) COMPARATIVE RISK ANALYSIS.—The term

5 ‘‘comparative risk analysis’’ means a process to sys6 tematically estimate, compare, and rank the size and

7 severity of risks to provide a common basis for evalu8 ating strategies for reducing or preventing those risks.

9 (2) COVERED AGENCY.—The term ‘‘covered agen10 cy’’ means each of the following:

11 (A) The Environmental Protection Agency.

12 (B) The Department of Labor.

13 (C) The Department of Transportation.

14 (D) The Food and Drug Administration.

15 (E) The Department of Energy.

16 (F) The Department of the Interior.

17 (G) The Department of Agriculture.

18 (H) The Consumer Product Safety Commis19 sion.

20 (I) The National Oceanic and Atmospheric

21 Administration.

22 (J) The United States Army Corps of Engi23 neers.

24 (K) The Nuclear Regulatory Commission.
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1 (3) EFFECT.—The term ‘‘effect’’ means a delete2 rious change in the condition of—

3 (A) a human or other living thing (includ4 ing death, cancer, or other chronic illness, de5 creased reproductive capacity, or disfigurement);

6 or

7 (B) an inanimate thing important to

8 human welfare (including destruction, degenera9 tion, the loss of intended function, and increased

10 costs for maintenance).

11 (4) IRREVERSIBILITY.—The term ‘‘irre12 versibility’’ means the extent to which a return to

13 conditions before the occurrence of an effect are either

14 very slow or will never occur.

15 (5) LIKELIHOOD.—The term ‘‘likelihood’’ means

16 the estimated probability that an effect will occur.

17 (6) MAGNITUDE.—The term ‘‘magnitude’’ means

18 the number of individuals or the quantity of ecologi19 cal resources or other resources that contribute to

20 human welfare that are affected by exposure to a

21 stressor.

22 (7) SERIOUSNESS.—The term ‘‘seriousness’’

23 means the intensity of effect, the likelihood, the

24 irreversibility, and the magnitude.

25 (c) DEPARTMENT AND AGENCY PROGRAM GOALS.—
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1 (1) SETTING PRIORITIES.—In exercising author2 ity under applicable laws protecting human health,

3 safety, or the environment, the head of each covered

4 agency should set priorities and use the resources

5 available under those laws to address those risks to

6 human health, safety, and the environment that—

7 (A) the covered agency determines to be the

8 most serious; and

9 (B) can be addressed in a cost-effective

10 manner, with the goal of achieving the greatest

11 overall net reduction in risks with the public and

12 private sector resources expended.

13 (2) DETERMINING THE MOST SERIOUS RISKS.—

14 In identifying the greatest risks under paragraph (1)

15 of this subsection, each covered agency shall consider,

16 at a minimum—

17 (A) the likelihood, irreversibility, and sever18 ity of the effect; and

19 (B) the number and classes of individuals

20 potentially affected, and shall explicitly take into

21 account the results of the comparative risk anal22 ysis conducted under subsection (d) of this sec23 tion.

24 (3) OMB REVIEW.—The covered agency’s deter25 minations of the most serious risks for purposes of set-
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1 ting priorities shall be reviewed and approved by the

2 Director of the Office of Management and Budget be3 fore submission of the covered agency’s annual budget

4 requests to Congress.

5 (4) INCORPORATING RISK-BASED PRIORITIES

6 INTO BUDGET AND PLANNING.—The head of each cov7 ered agency shall incorporate the priorities identified

8 under paragraph (1) into the agency budget, strategic

9 planning, regulatory agenda, enforcement, and re10 search activities. When submitting its budget request

11 to Congress and when announcing its regulatory

12 agenda in the Federal Register, each covered agency

13 shall identify the risks that the covered agency head

14 has determined are the most serious and can be ad15 dressed in a cost-effective manner under paragraph

16 (1), the basis for that determination, and explicitly

17 identify how the covered agency’s requested budget

18 and regulatory agenda reflect those priorities.

19 (5) EFFECTIVE DATE.—This subsection shall take

20 effect 12 months after the date of enactment of this

21 Act.

22 (d) COMPARATIVE RISK ANALYSIS.—

23 (1) REQUIREMENT.—(A)(i) No later than 6

24 months after the effective date of this Act, the Director

25 of the Office of Management and Budget shall enter
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1 into appropriate arrangements with an accredited

2 scientific body—

3 (I) to conduct a study of the methodologies

4 for using comparative risk to rank dissimilar

5 human health, safety, and environmental risks;

6 and

7 (II) to conduct a comparative risk analysis.

8 (ii) The comparative risk analysis shall compare

9 and rank, to the extent feasible, human health, safety,

10 and environmental risks potentially regulated across

11 the spectrum of programs administered by all covered

12 agencies.

13 (B) The Director shall consult with the Office of

14 Science and Technology Policy regarding the scope of

15 the study and the conduct of the comparative risk

16 analysis.

17 (2) CRITERIA.—In arranging for the compara18 tive risk analysis referred to in paragraph (1) of this

19 subsection, the Director shall ensure that—

20 (A) the scope and specificity of the analysis

21 are sufficient to provide the President and agen22 cy heads guidance in allocating resources across

23 agencies and among programs in agencies to

24 achieve the greatest degree of risk prevention and
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1 reduction for the public and private resources ex2 pended;

3 (B) the analysis is conducted through an

4 open process, by individuals with relevant exper5 tise, including toxicologists, biologists, engineers

6 and experts in medicine, industrial hygiene and

7 environmental effects;

8 (C) the analysis is conducted, to the extent

9 feasible, consistent with the risk assessment and

10 risk characterization principles in sections 635

11 and 636 of this title;

12 (D) the methodologies and principal sci13 entific determinations made in the analysis are

14 subjected to independent and external peer re15 view consistent with section 637, and the conclu16 sions of the peer review are made publicly avail17 able as part of the final report required under

18 subsection (e);

19 (E) there is an opportunity for public com20 ment on the results before making them final;

21 and

22 (F) the results are presented in a manner

23 that distinguishes between the scientific conclu24 sions and any policy or value judgments em25 bodied in the comparisons.
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1 (3) COMPLETION AND REVIEW.—No later than 3

2 years after the effective date of this Act, the compara3 tive risk analysis required under paragraph (1) shall

4 be completed. The comparative risk analysis shall be

5 reviewed and revised at least every 5 years thereafter

6 for a minimum of 15 years following the release of the

7 first analysis. The Director shall arrange for such re8 view and revision with an accredited scientific body

9 in the same manner as provided under paragraphs

10 (1) and (2).

11 (4) STUDY.—The study of methodologies pro12 vided under paragraph (1) shall be conducted as part

13 of the first comparative risk analysis and shall be

14 completed no later than 180 days after the completion

15 of that analysis. The goal of the study shall be to de16 velop and rigorously test methods of comparative risk

17 analysis. The study shall have sufficient scope and

18 breadth to test approaches for improving comparative

19 risk analysis and its use in setting priorities for

20 human health, safety, and environmental risk preven21 tion and reduction.

22 (5) TECHNICAL GUIDANCE.—No later than 180

23 days after the effective date of this Act, the Director,

24 in collaboration with other heads of covered agencies

25 shall enter into a contract with the National Research
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1 Council to provide technical guidance to agencies on

2 approaches to using comparative risk analysis in set3 ting human health, safety, and environmental prior4 ities to assist agencies in complying with subsection

5 (c) of this section.

6 (e) REPORTS AND RECOMMENDATIONS TO CONGRESS

7 AND THE PRESIDENT.—No later than 24 months after the

8 effective date of this Act, each covered agency shall submit

9 a report to Congress and the President—

10 (1) detailing how the agency has complied with

11 subsection (c) and describing the reasons for any de12 parture from the requirement to establish priorities to

13 achieve the greatest overall net reduction in risk;

14 (2) recommending—

15 (A) modification, repeal, or enactment of

16 laws to reform, eliminate, or enhance programs

17 or mandates relating to human health, safety, or

18 the environment; and

19 (B) modification or elimination of statu20 torily or judicially mandated deadlines,

21 that would assist the covered agency to set priorities

22 in activities to address the risks to human health,

23 safety, or the environment in a manner consistent

24 with the requirements of subsection (c)(1);
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1 (3) evaluating the categories of policy and value

2 judgments used in risk assessment, risk characteriza3 tion, or cost-benefit analysis; and

4 (4) discussing risk assessment research and

5 training needs, and the agency’s strategy and schedule

6 for meeting those needs.

7 (f) SAVINGS PROVISION AND JUDICIAL REVIEW.—

8 (1) IN GENERAL.—Nothing in this section shall

9 be construed to modify any statutory standard or re10 quirement designed to protect human health, safety,

11 or the environment.

12 (2) JUDICIAL REVIEW.—Compliance or non13 compliance by an agency with the provisions of this

14 section shall not be subject to judicial review.

15 (3) AGENCY ANALYSIS.—Any analysis prepared

16 under this section shall not be subject to judicial con17 sideration separate or apart from the requirement,

18 rule, program, or law to which it relates. When an

19 action for judicial review of a covered agency action

20 is instituted, any analysis for, or relating to, the ac21 tion shall constitute part of the whole record of agency

22 action for the purpose of judicial review of the action

23 and shall, to the extent relevant, be considered by a

24 court in determining the legality of the covered agen25 cy action.
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1 SEC. 7. REGULATORY ACCOUNTING.

2 (a) DEFINITIONS.—For purposes of this section, the

3 following definitions apply:

4 (1) AGENCY.—The term ‘‘agency’’ means any ex5 ecutive department, military department, Government

6 corporation, Government controlled corporation, or

7 other establishment in the executive branch of the

8 Government (including the Executive Office of the

9 President), or any independent regulatory agency, but

10 shall not include—

11 (A) the General Accounting Office;

12 (B) the Federal Election Commission;

13 (C) the governments of the District of Co14 lumbia and of the territories and possessions of

15 the United States, and their various subdivi16 sions; or

17 (D) government-owned contractor-operated

18 facilities, including laboratories engaged in na19 tional defense research and production activities.

20 (2) REGULATION.—The term ‘‘regulation’’ means

21 an agency statement of general applicability and fu22 ture effect designed to implement, interpret, or pre23 scribe law or policy or describing the procedures or

24 practice requirements of an agency. The term shall

25 not include—
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1 (A) administrative actions governed by sec2 tions 556 and 557 of title 5, United States Code;

3 (B) regulations issued with respect to a

4 military or foreign affairs function of the United

5 States; or

6 (C) regulations related to agency organiza7 tion, management, or personnel.

8 (b) ACCOUNTING STATEMENT.—

9 (1) IN GENERAL.—(A) The President shall be re10 sponsible for implementing and administering the re11 quirements of this section.

12 (B) Every 2 years, no later than June of the sec13 ond year, the President shall prepare and submit to

14 Congress an accounting statement that estimates the

15 annual costs of Federal regulatory programs and cor16 responding benefits in accordance with this sub17 section.

18 (2) YEARS COVERED BY ACCOUNTING STATE19 MENT.—Each accounting statement shall cover, at a

20 minimum, the 5 fiscal years beginning on October 1

21 of the year in which the report is submitted and may

22 cover any fiscal year preceding such fiscal years for

23 purpose of revising previous estimates.

24 (3) TIMING AND PROCEDURES.—(A) The Presi25 dent shall provide notice and opportunity for com-
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1 ment for each accounting statement. The President

2 may delegate to an agency the requirement to provide

3 notice and opportunity to comment for the portion of

4 the accounting statement relating to that agency.

5 (B) The President shall propose the first ac6 counting statement under this subsection no later

7 than 2 years after the effective date of this Act and

8 shall issue the first accounting statement in final

9 form no later than 3 years after such effective date.

10 Such statement shall cover, at a minimum, each of

11 the fiscal years beginning after the effective date of

12 this Act.

13 (4) CONTENT OF ACCOUNTING STATEMENT.—(A)

14 Each accounting statement shall contain estimates of

15 costs and benefits with respect to each fiscal year cov16 ered by the statement in accordance with this para17 graph. For each such fiscal year for which estimates

18 were made in a previous accounting statement, the

19 statement shall revise those estimates and state the

20 reasons for the revisions.

21 (B)(i) An accounting statement shall estimate

22 the costs of Federal regulatory programs by setting

23 forth, for each year covered by the statement—
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1 (I) the annual expenditure of national eco2 nomic resources for each regulatory program;

3 and

4 (II) such other quantitative and qualitative

5 measures of costs as the President considers ap6 propriate.

7 (ii) For purposes of the estimate of costs in the

8 accounting statement, national economic resources

9 shall include, and shall be listed under, at least the

10 following categories:

11 (I) Private sector costs.

12 (II) Federal sector costs.

13 (III) State and local government costs.

14 (C) An accounting statement shall estimate the

15 benefits of Federal regulatory programs by setting

16 forth, for each year covered by the statement, such

17 quantitative and qualitative measures of benefits as

18 the President considers appropriate. Any estimates of

19 benefits concerning reduction in human health, safety,

20 or environmental risks shall present the most plau21 sible level of risk practical, along with a statement of

22 the reasonable degree of scientific certainty.

23 (c) ASSOCIATED REPORT TO CONGRESS.—

24 (1) IN GENERAL.—At the same time as the Presi25 dent submits an accounting statement under sub-
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1 section (b), the President, acting through the Director

2 of the Office of Management and Budget, shall submit

3 to Congress a report associated with the accounting

4 statement (hereinafter referred to as an ‘‘associated

5 report’’). The associated report shall contain, in ac6 cordance with this subsection—

7 (A) analyses of impacts; and

8 (B) recommendations for reform.

9 (2) ANALYSES OF IMPACTS.—The President shall

10 include in the associated report the following:

11 (A) The cumulative impact on the economy

12 of Federal regulatory programs covered in the

13 accounting statement. Factors to be considered in

14 such report shall include impacts on the follow15 ing:

16 (i) The ability of State and local gov17 ernments to provide essential services, in18 cluding police, fire protection, and edu19 cation.

20 (ii) Small business.

21 (iii) Productivity.

22 (iv) Wages.

23 (v) Economic growth.

24 (vi) Technological innovation.
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1 (vii) Consumer prices for goods and

2 services.

3 (viii) Such other factors considered ap4 propriate by the President.

5 (B) A summary of any independent analy6 ses of impacts prepared by persons commenting

7 during the comment period on the accounting

8 statement.

9 (3) RECOMMENDATIONS FOR REFORM.—The

10 President shall include in the associated report the

11 following:

12 (A) A summary of recommendations of the

13 President for reform or elimination of any Fed14 eral regulatory program or program element that

15 does not represent sound use of national eco16 nomic resources or otherwise is inefficient.

17 (B) A summary of any recommendations

18 for such reform or elimination of Federal regu19 latory programs or program elements prepared

20 by persons commenting during the comment pe21 riod on the accounting statement.

22 (d) GUIDANCE FROM OFFICE OF MANAGEMENT AND

23 BUDGET.—The Director of the Office of Management and

24 Budget shall, in consultation with the Council of Economic
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1 Advisers and the agencies, develop guidance for the agen2 cies—

3 (1) to standardize measures of costs and benefits

4 in accounting statements prepared pursuant to this

5 section and section 3 of this Act, including—

6 (A) detailed guidance on estimating the

7 costs and benefits of major rules; and

8 (B) general guidance on estimating the costs

9 and benefits of all other rules that do not meet

10 the thresholds for major rules; and

11 (2) to standardize the format of the accounting

12 statements.

13 (e) RECOMMENDATIONS FROM CONGRESSIONAL BUDG14 ET OFFICE.—After each accounting statement and associ15 ated report submitted to Congress, the Director of the Con16 gressional Budget Office shall make recommendations to the

17 President—

18 (1) for improving accounting statements pre19 pared pursuant to this section, including rec20 ommendations on level of detail and accuracy; and

21 (2) for improving associated reports prepared

22 pursuant to this section, including recommendations

23 on the quality of analysis.

24 (f) JUDICIAL REVIEW.—No requirements under this

25 section shall be subject to judicial review in any manner.
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1 SEC. 8. EFFECTIVE DATE.

2 Except as otherwise provided in this Act, this Act shall

3 take effect 180 days after the date of the enactment of this

4 Act.

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