I

104TH CONGRESS

1ST SESSION H. R. 821

To reform the regulatory process, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

FEBRUARY 3, 1995

Mr. MCINTOSH introduced the following bill; which was referred to the Committee on Government Reform and Oversight and, in addition, to the

Committees on the Judiciary and Rules, for a period to be subsequently

determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

A BILL

To reform the regulatory process, 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 ‘‘Middle Class Regu5 latory Relief Act of 1995’’.

6 SEC. 2. ANALYSIS OF AGENCY PROPOSALS.

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

8 States Code, is amended by adding at the end the follow9 ing:
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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 as

7 in section 551(1) of this title;

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

9 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;

12 ‘‘(4)(A) the term ‘major rule’ means—

13 ‘‘(i) a rule or a group of closely related

14 rules that the agency proposing the rule or the

15 President reasonably determines is likely to

16 have a gross annual effect on the economy of

17 $50,000,000 or more in reasonably quantifiable

18 increased direct and indirect costs, or has a sig19 nificant impact on a sector of the economy; or

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

21 rules that is otherwise designated a major rule

22 by the agency proposing the rule, or by the

23 President on the ground that the rule is likely

24 to result in—
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1 ‘‘(I) a substantial increase in costs or

2 prices for wage earners, consumers, indi3 vidual industries, nonprofit organizations,

4 Federal, State, or local government agen5 cies, or geographic regions; or

6 ‘‘(II) significant adverse effects on

7 competition, employment, investment, pro8 ductivity, innovation, the environment,

9 public health or safety, or the ability of en10 terprises whose principal places of business

11 are in the United States to compete in do12 mestic or export markets;

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

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

16 ‘‘(ii) a rule that authorizes the introduction

17 into commerce, or recognizes the marketable

18 status, of a product;

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

20 identifiable significant benefits, including social and

21 economic benefits, that are expected to result di22 rectly or indirectly from implementation of a rule or

23 an alternative to a rule;

24 ‘‘(6) the term ‘cost’ means the reasonably iden25 tifiable significant costs and adverse effects, includ-
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1 ing social and economic costs, reduced consumer

2 choice, substitution effects, and impeded techno3 logical advancement, that are expected to result di4 rectly or indirectly from implementation of, or com5 pliance with, a rule or an alternative to a rule; and

6 ‘‘(7) the term ‘market-based mechanism’ means

7 a regulatory program that—

8 ‘‘(A) imposes legal accountability for the

9 achievement of an explicit regulatory objective

10 on each regulated person;

11 ‘‘(B) affords maximum flexibility to each

12 regulated person in complying with mandatory

13 regulatory objectives, which flexibility shall,

14 where feasible and appropriate, include, but not

15 be limited to, the opportunity to transfer to, or

16 receive from, other persons, including for cash

17 or other legal consideration, increments of com18 pliance responsibility established by the pro19 gram; and

20 ‘‘(C) permits regulated persons to respond

21 automatically to changes in general economic

22 conditions and in economic circumstances di23 rectly pertinent to the regulatory program with24 out affecting the achievement of the program’s

25 explicit regulatory mandates.
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1 ‘‘§ 622. Rulemaking cost-benefit analysis

2 ‘‘(a)(1) Prior to publishing notice of a proposed rule3 making for any rule (or, in the case of a notice of a pro4 posed rulemaking that has been published on or before the

5 date of enactment of this subchapter, not later than 30

6 days after such date of enactment), each agency shall de7 termine whether the rule is or is not a major rule within

8 the meaning of section 621(4)(A)(i) and, if it is not,

9 whether it should be designated a major rule under section

10 621(4)(A)(ii). For the purpose of any such determination

11 or designation, a group of closely related rules shall be

12 considered as one rule.

13 ‘‘(2) Each notice of proposed rulemaking shall in14 clude a succinct statement and explanation of the agency’s

15 determination under paragraph (1).

16 ‘‘(b)(1) If an agency has determined that a rule is

17 not a major rule within the meaning of section

18 621(4)(A)(i) and has not designated the rule a major rule

19 within the meaning of section 621(4)(A)(ii), the President

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

21 rule or designate the rule a major rule not later than 30

22 days after the publication of the notice of proposed rule23 making for the rule (or, in the case of a notice of proposed

24 rulemaking that has been published on or before the date

25 of enactment of this subchapter, not later than 60 days

26 after such date of enactment).
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1 ‘‘(2) Such determination or designation shall be pub2 lished in the Federal Register, together with a succinct

3 statement of the basis for the determination or designa4 tion.

5 ‘‘(c)(1)(A) When the agency publishes a notice of pro6 posed rulemaking for a major rule, the agency shall issue

7 and place in the rulemaking record a draft cost-benefit

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

9 the notice of proposed rulemaking.

10 ‘‘(B)(i) When the President has published a deter11 mination or designation that a rule is a major rule after

12 the publication of the notice of proposed rulemaking for

13 the rule, the agency shall promptly issue and place in the

14 rulemaking file a draft cost-benefit analysis for the rule

15 and shall publish in the Federal Register a summary of

16 such analysis.

17 ‘‘(ii) Following the issuance of a draft cost-benefit

18 analysis under clause (i), the agency shall give interested

19 persons an opportunity to comment pursuant to section

20 553 of this title in the same manner as if the draft cost21 benefit analysis had been issued with the notice of pro22 posed rulemaking.

23 ‘‘(2) Each draft cost-benefit analysis shall contain—

24 ‘‘(A) an analysis of the benefit of the proposed

25 rule, and an explanation of how the agency antici-
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1 pates each benefit will be achieved by the proposed

2 rule;

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

4 rule, and an explanation of how the agency antici5 pates each such cost will result from the proposed

6 rule;

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

8 the costs and benefits) of reasonable alternatives for

9 achieving the identified benefits of the proposed rule,

10 including alternatives that—

11 ‘‘(i) require no Government action;

12 ‘‘(ii) will accommodate differences among

13 geographic regions and among persons with dif14 fering levels of resources with which to comply;

15 and

16 ‘‘(iii) employ performance or other market17 based standards that permit the greatest flexi18 bility in achieving the identified benefits of the

19 proposed rule and that comply with the require20 ments of subparagraph (D);

21 ‘‘(D) an assessment of the feasibility of estab22 lishing a regulatory program that operates through

23 the application of market-based mechanisms;

24 ‘‘(E) in any case in which the proposed rule is

25 based on one or more scientific evaluations or infor-
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1 mation or is subject to the risk assessment require2 ments of subchapter III, a description of actions un3 dertaken by the agency to verify the quality, reliabil4 ity, and relevance of such scientific evaluations or

5 scientific information in accordance with the risk as6 sessment requirements of subchapter III;

7 ‘‘(F) an assessment of the aggregate effect of

8 the rule on small businesses with fewer than 100

9 employees, including an assessment of the net em10 ployment effect of the rule; and

11 ‘‘(G) an analysis of whether the identified bene12 fits of the proposed rule are likely to exceed the

13 identified costs of the proposed rule, and an analysis

14 of whether the proposed rule will provide greater net

15 benefits to society than any of the alternatives to the

16 proposed rule, including alternatives identified in ac17 cordance with subparagraph (C).

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

19 the agency shall also issue and place in the rulemaking

20 record a final cost-benefit analysis, and shall include a

21 summary of the analysis in the statement of basis and

22 purpose.

23 ‘‘(2) Each final cost-benefit analysis shall contain—

24 ‘‘(A) a description and comparison of the bene25 fits and costs of the rule and of the reasonable alter-
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1 natives to the rule described in the rulemaking, in2 cluding the market-based mechanisms identified pur3 suant to subsection (c)(2)(D); and

4 ‘‘(B) an analysis, based upon the rulemaking

5 record considered as a whole, of—

6 ‘‘(i) whether the benefits of the rule out7 weigh the costs of the rule; and

8 ‘‘(ii) whether the rule will provide greater

9 net benefits to society than any of the alter10 natives described in the rulemaking, including

11 the market-based incentives identified pursuant

12 to subsection (c)(2)(D).

13 ‘‘(e)(1)(A) The description of the benefits and costs

14 of a proposed and a final rule required under this section

15 shall include, to the extent feasible, a quantification or nu16 merical estimate of the quantifiable benefits and costs.

17 Such quantification or numerical estimate shall be made

18 in the most appropriate unit of measurement, using com19 parable assumptions, including time periods, and shall

20 specify the ranges of predictions and shall explain the

21 margins of error involved in the quantification methods

22 and in the estimates used. An agency shall describe the

23 nature and extent of the nonquantifiable benefits and

24 costs of a final rule pursuant to this section in as precise

25 and succinct a manner as possible.
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1 ‘‘(B) Where practicable, the description of the bene2 fits and costs of a proposed and final rule required under

3 this section shall describe such benefits and costs on an

4 industry by industry basis.

5 ‘‘(2)(A) In evaluating and comparing costs and bene6 fits and in evaluating the risk assessment information de7 veloped pursuant to subchapter III, the agency shall not

8 rely on cost, benefit, or risk assessment information that

9 is not accompanied by data, analysis, or other supporting

10 materials that would enable the agency and other persons

11 interested in the rulemaking to assess the accuracy, reli12 ability, and uncertainty factors applicable to such informa13 tion.

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

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

16 be clearly articulated in accordance with this section.

17 ‘‘§ 623. Decisional criteria

18 ‘‘(a) No final rule subject to this subchapter shall be

19 promulgated unless the agency finds that—

20 ‘‘(1) the potential benefits to society from the

21 rule outweigh the potential costs of the rule to soci22 ety, as determined by the analysis required by sec23 tion 622(d)(2)(B); and

24 ‘‘(2) the rule will provide greater net benefits to

25 society than any of the reasonable alternatives iden-
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1 tified pursuant to section 622(c)(2)(C), including the

2 market-based mechanisms identified pursuant to sec3 tion 622(c)(2)(D).

4 ‘‘(b) The requirements of this section shall supple5 ment the decisional criteria for rulemaking otherwise ap6 plicable under the statute granting the rulemaking author7 ity, except when such statute contains explicit textual lan8 guage prohibiting the consideration of the criteria set

9 forth in this section. Where the agency finds that consider10 ation of the criteria set forth in this section is prohibited

11 by explicit statutory language, the agency shall transmit

12 its finding to Congress, along with the final cost-benefit

13 analysis required by section 622(d)(2)(B).

14 ‘‘§ 624. Judicial review

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

16 the provisions of this subchapter shall be subject to judi17 cial review in accordance with this section.

18 ‘‘(b)(1) Each of the following shall be subject to judi19 cial review:

20 ‘‘(A) A determination by an agency or by the

21 President that a rule is or is not a major rule within

22 the meaning of section 621(4).

23 ‘‘(B) A designation by an agency or by the

24 President of a rule as a major rule.
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1 ‘‘(C) A decision by an agency or by the Presi2 dent not to designate a rule a major rule.

3 ‘‘(2) A determination by an agency or by the Presi4 dent that a rule is not a major rule within the meaning

5 of section 621(4), or the decision by an agency or by the

6 President not to designate a rule a major rule, shall be

7 set aside by a reviewing court only upon a showing of clear

8 and convincing evidence that the determination or decision

9 not to designate is erroneous in light of the information

10 available to the agency at the time the determination or

11 decision not to designate was made.

12 ‘‘(3) An action to review a determination that a rule

13 is not a major rule or to review a decision not to designate

14 shall be filed not later than 30 days after the date of publi15 cation of such determination or failure to designate.

16 ‘‘(c) If a court of the United States finds that a rule

17 should have been reviewed pursuant to this subchapter,

18 such rule shall have no force or effect until such time as

19 the requirements of this subchapter are met.

20 ‘‘(d) Each court with jurisdiction to review final agen21 cy action under the statute granting the agency authority

22 to conduct the rulemaking shall have jurisdiction to review

23 findings by any agency under this subchapter and shall

24 set aside agency action that fails to satisfy the decisional

25 criteria of section 623. The court shall apply the same
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1 standards of judicial review that apply to the review of

2 agency findings under the statute granting the agency au3 thority to conduct the rulemaking.

4 ‘‘§ 625. Petition for cost-benefit analysis

5 ‘‘(a)(1) Any person subject to a major rule may peti6 tion the relevant agency or the President to perform a

7 cost-benefit analysis under this subchapter for the major

8 rule, including a major rule in effect on the date of enact9 ment of this subchapter for which a cost-benefit analysis

10 pursuant to such subchapter has not been performed, re11 gardless of whether a cost-benefit analysis was previously

12 performed to meet requirements imposed before the date

13 of enactment of this subchapter.

14 ‘‘(2) The petition shall identify with reasonable speci15 ficity the major rule to be reviewed.

16 ‘‘(3) The agency or the President shall grant the peti17 tion if the petition shows that there is a reasonable likeli18 hood that the costs of the major rule outweigh the bene19 fits, or that reasonable questions exist as to whether the

20 rule provides greater net benefits to society than any rea21 sonable alternative to the rule that may be more clearly

22 resolved through examination pursuant to this subchapter

23 and subchapter III.

24 ‘‘(4) A decision to grant or deny a petition under this

25 subsection shall be made not later than 180 days after
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1 submittal. A decision to deny a petition shall be subject

2 to judicial review immediately upon denial as final agency

3 action under the statute granting the agency authority to

4 conduct the rulemaking.

5 ‘‘(b) For each major rule for which a petition has

6 been granted under subsection (a), the agency shall con7 duct a cost-benefit analysis in accordance with this sub8 chapter, and shall determine whether the rule satisfies the

9 decisional criteria set forth in section 623. If the rule does

10 not satisfy the decisional criteria, then the agency shall

11 take immediate action to either revoke or amend the rule

12 to conform the rule to the requirements of this subchapter

13 and the decisional criteria under section 623.

14 ‘‘(c) For purposes of this section, the term ‘major

15 rule’ means any major rule or portion thereof.

16 ‘‘(d)(1) Any person may petition the relevant agency

17 to withdraw, as contrary to this subchapter, any agency

18 guidance or general statement of policy that would be a

19 major rule if the guidance or general statement of policy

20 had been adopted as a rule.

21 ‘‘(2) The petition shall identify with reasonable speci22 ficity why the guidance or general statement of policy

23 would be major if adopted as a rule.

24 ‘‘(3) The agency shall grant the petition if the peti25 tion shows that there is a reasonable likelihood that the
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1 guidance or general statement of policy would be major

2 if adopted as a rule.

3 ‘‘(4) A decision to grant or deny a petition under this

4 subsection shall be made not later than 180 days after

5 the petition is submitted. If the agency fails to act by such

6 date, the petition shall be deemed to have been granted.

7 A decision to deny a petition shall be subject to judicial

8 review immediately upon denial as final agency action

9 under the statute under which the agency has issued the

10 guidance or general statement of policy.

11 ‘‘(e) For each petition granted under subsection (d),

12 the agency shall be prohibited from enforcing against any

13 person the regulatory standards or criteria contained in

14 such guidance or policy unless included in a rule proposed

15 and promulgated in accordance with this subchapter.

16 ‘‘§ 626. Effective date of final regulations

17 ‘‘(a)(1) Beginning on the date of enactment of this

18 section, all deadlines in statutes that require agencies to

19 propose or promulgate any rule subject to this subchapter

20 are suspended until such time as the requirements of this

21 subchapter are satisfied.

22 ‘‘(2) Beginning on the date of enactment of this sec23 tion, the jurisdiction of any court of the United States

24 to enforce any deadline that would require an agency to

25 propose or promulgate a rule subject to subchapter II of
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1 chapter 5 of title 5, United States Code (as added by this

2 section), is suspended until such time as the requirements

3 of this subchapter are satisfied.

4 ‘‘(3) In any case in which the failure to promulgate

5 a rule by a deadline would create an obligation to regulate

6 through individual adjudications, the obligation to conduct

7 individual adjudications shall be suspended to allow the

8 requirements of this subchapter to be satisfied.

9 ‘‘(b)(1) Before a major rule takes effect as a final

10 rule, the agency promulgating such rule shall submit to

11 the Congress a copy of such rule and a report containing

12 a concise general statement relating to the rule, including

13 a complete copy of the cost-benefit analysis, and the pro14 posed effective date of the rule.

15 ‘‘(2) A major rule relating to a report submitted

16 under paragraph (1) shall take effect as a final rule, the

17 latest of—

18 ‘‘(A) the later of the date occurring 45 days

19 after the date on which—

20 ‘‘(i) the Congress receives the report sub21 mitted under paragraph (1); or

22 ‘‘(ii) the rule is published in the Federal

23 Register;

24 ‘‘(B) if the Congress passes a joint resolution of

25 disapproval described under subsection (h) relating
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1 to the rule, and the President signs a veto of such

2 resolution, the earlier date—

3 ‘‘(i) on which either House of Congress

4 votes and fails to override the veto of the Presi5 dent; or

6 ‘‘(ii) occurring 30 session days after the

7 date on which the Congress received the veto

8 and objections of the President; or

9 ‘‘(C) the date the rule would have otherwise

10 taken effect, if not for this section (unless a joint

11 resolution of disapproval under subsection (h) is en12 acted).

13 ‘‘(c) A rule shall not take effect as a final rule if the

14 Congress passes a joint resolution of disapproval described

15 under subsection (h).

16 ‘‘(d)(1) Notwithstanding any other provision of this

17 section (except subject to paragraph (3)), a rule that

18 would not take effect by reason of this section may take

19 effect if the President makes a determination under para20 graph (2) and submits written notice of such determina21 tion to the Congress.

22 ‘‘(2) Paragraph (1) applies to a determination made

23 by the President by Executive order that the rule should

24 take effect because such rule is—
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1 ‘‘(A) necessary because of an imminent threat

2 to health or safety or other emergency;

3 ‘‘(B) necessary for the enforcement of criminal

4 laws; or

5 ‘‘(C) necessary for national security.

6 ‘‘(3) An exercise by the President of the authority

7 under this subsection shall have no effect on the proce8 dures under subsection (h) or the effect of a joint resolu9 tion of disapproval under this section.

10 ‘‘(4) This subsection and an Executive order issued

11 by the President under this subsection shall not be subject

12 to judicial review by a court of the United States.

13 ‘‘(e)(1) Subsection (h) shall apply to any rule that

14 is published in the Federal Register (as a rule that shall

15 take effect as a final rule) during the period beginning

16 on the date occurring 60 days before the date the Con17 gress adjourns sine die through the date on which the suc18 ceeding Congress first convenes.

19 ‘‘(2) For purposes of subsection (h), a rule described

20 under paragraph (1) shall be treated as though such rule

21 were published in the Federal Register (as a rule that shall

22 take effect as a final rule) on the date the succeeding Con23 gress first convenes.

24 ‘‘(3) During the period between the date the Congress

25 adjourns sine die through the date on which the succeed-
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1 ing Congress first convenes, a rule described under para2 graph (1) shall take effect as a final rule as otherwise pro3 vided by law.

4 ‘‘(f) Any rule that takes effect and later is made of

5 no force or effect by the enactment of a joint resolution

6 under subsection (h) shall be treated as though such rule

7 had never taken effect.

8 ‘‘(g) If the Congress does not enact a joint resolution

9 of disapproval under subsection (h), no court or agency

10 may infer any intent of the Congress from any action or

11 inaction of the Congress with regard to such rule, related

12 statute, or joint resolution of disapproval.

13 ‘‘(h)(1) For purposes of this subsection, the term

14 ‘joint resolution’ means only a joint resolution introduced

15 after the date on which the report referred to in subsection

16 (b) is received by Congress the matter after the resolving

17 clause of which is as follows: ‘That Congress disapproves

18 the rule submitted by the llll relating to llll,

19 and such rule shall have no force or effect. (The blank

20 spaces being appropriately filled in.)’.

21 ‘‘(2)(A) A resolution described in paragraph (1) shall

22 be referred to the committees in each House of Congress

23 with jurisdiction. Such a resolution shall not be reported

24 before the eighth day after its submission or publication

25 date.
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1 ‘‘(B) For purposes of this subsection the term ‘sub2 mission or publication date’ means the later of the date

3 on which—

4 ‘‘(i) the Congress receives the report submitted

5 under subsection (b)(1); or

6 ‘‘(ii) the rule is published in the Federal Reg7 ister.

8 ‘‘(3) If the committee to which a resolution described

9 in paragraph (1) is referred has not reported such resolu10 tion (or an identical resolution) at the end of 20 calendar

11 days after its submission or publication date, such com12 mittee may be discharged by the Majority Leader of the

13 Senate or the Majority Leader of the House of Represent14 atives, as the case may be, from further consideration of

15 such resolution and such resolution shall be placed on the

16 appropriate calendar of the House involved.

17 ‘‘(4)(A) When the committee to which a resolution

18 is referred has reported, or when a committee is dis19 charged (under paragraph (3)) from further consideration

20 of, a resolution described in paragraph (1), it shall at any

21 time thereafter be in order (even though a previous motion

22 to the same effect has been disagreed to) for any Member

23 of the respective House to move to proceed to the consider24 ation of the resolution, and all points of order against the

25 resolution (and against consideration of the resolution)
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1 shall be waived. The motion shall be highly privileged in

2 the House of Representatives and shall be privileged in

3 the Senate and shall not be debatable. The motion shall

4 not subject to amendment, or to a motion to postpone,

5 or to a motion to proceed to the consideration of other

6 business. A motion to reconsider the vote by which the

7 motion is agreed to or disagreed to shall not be in order.

8 If a motion to proceed to the consideration of the resolu9 tion is agreed to, the resolution shall remain the unfin10 ished business of the respective House until disposed of.

11 ‘‘(B) Debate on the resolution, and on all debatable

12 motions and appeals in connection therewith, shall be lim13 ited to not more than 10 hours, which shall be divided

14 equally between those favoring and those opposing the res15 olution. A motion further to limit debate shall be in order

16 and shall not be debatable. An amendment to, or a motion

17 to postpone, or a motion to proceed to the consideration

18 of other business, or a motion to recommit the resolution

19 shall not be in order. A motion to reconsider the vote by

20 which the resolution is agreed to or disagreed to shall not

21 be in order.

22 ‘‘(C) Immediately following the conclusion of the de23 bate on a resolution described in paragraph (1), and a sin24 gle quorum call at the conclusion of the debate if re25 quested in accordance with the rules of the appropriate
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1 House, the vote on final passage of the resolution shall

2 occur.

3 ‘‘(D) Appeals from the decisions of the Chair relating

4 to the application of the rules of the Senate or the House

5 of Representatives, as the case may be, to the procedure

6 relating to a resolution described in paragraph (1) shall

7 be decided without debate.

8 ‘‘(5) If, before the passage by one House of a resolu9 tion of that House described in paragraph (1), that House

10 receives from the other House a resolution described in

11 paragraph (1), then the following procedures shall apply:

12 ‘‘(A) The resolution of the other House shall

13 not be referred to a committee.

14 ‘‘(B) With respect to a resolution described in

15 paragraph (1) of the House receiving the resolu16 tion—

17 ‘‘(i) the procedure in that House shall be

18 the same as if no resolution had been received

19 from the other House; but

20 ‘‘(ii) the vote on final passage shall be on

21 the resolution of the other House.

22 ‘‘(6) This subsection is enacted by Congress—

23 ‘‘(A) as an exercise of the rulemaking power of

24 the Senate and House of Representatives, respec25 tively, and as such it is deemed to be a part of the
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1 rules of each House, respectively, but applicable only

2 with respect to the procedure to be followed in that

3 House in the case of a resolution described in para4 graph (1), and it supersedes other rules only to the

5 extent that it is inconsistent with such rules; and

6 ‘‘(B) with full recognition of the constitutional

7 right of either House to change the rules (so far as

8 relating to the procedure of that House) at any time,

9 in the same manner, and to the same extent as in

10 the case of any other rule of that House.

11 ‘‘§ 627. Unauthorized rulemakings

12 ‘‘(a) Notwithstanding any other provision of law, be13 ginning on July 1, 1995, any rule that expands Federal

14 power or jurisdiction beyond the level of regulatory action

15 needed to satisfy statutory requirements shall be prohib16 ited.

17 ‘‘(b) Nothing in this section shall be construed to pre18 vent any agency from promulgating a rule that repeals,

19 narrows, or streamlines a rule, regulation, or administra20 tive process, or from issuing or promulgating a rule pro21 viding for tax relief or clarification or reducing regulatory

22 burdens.
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1 ‘‘§ 628. Standard for review of agency interpretations

2 of an enabling statute

3 ‘‘(a) In reviewing a final agency action under section

4 706 of this title, or under a statute that provides for re5 view of a final agency action, the reviewing court shall af6 firm the agency’s interpretation of the statute granting

7 authority to promulgate the rule if, applying traditional

8 principles of statutory construction, the reviewing court

9 finds that the interpretation is clearly the interpretation

10 of the statute intended by Congress.

11 ‘‘(b) If the reviewing court, applying traditional prin12 ciples of statutory construction, finds that an interpreta13 tion other than the interpretation applied by the agency

14 is clearly the interpretation of the statute intended by

15 Congress, the reviewing court shall find that the agency’s

16 interpretation is erroneous and contrary to law.

17 ‘‘(c)(1) If the reviewing court, applying established

18 principles of statutory construction, finds that the statute

19 gives the agency discretion to choose from among a range

20 of permissible statutory constructions, the reviewing court

21 shall affirm the agency’s interpretation where the record

22 on review establishes that—

23 ‘‘(A) the agency has correctly identified the

24 range of permissible statutory constructions;

25 ‘‘(B) the interpretation chosen is one that is

26 within that range; and
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1 ‘‘(C) the agency has engaged in reasoned deci2 sionmaking in determining that the interpretation,

3 rather than other permissible constructions of the

4 statute, is the one that maximizes net benefits to so5 ciety.

6 ‘‘(2) If an agency’s interpretation of a statute cannot

7 be affirmed under paragraph (1), the reviewing court shall

8 find that the agency’s interpretation is arbitrary and ca9 pricious.

10 ‘‘SUBCHAPTER III—RISK ASSESSMENTS

11 ‘‘§ 631. Definitions

12 ‘‘For purposes of this subchapter:

13 ‘‘(1) The term ‘best estimate’ means an esti14 mate that, to the extent feasible and scientifically

15 appropriate, is based on one or more of the follow16 ing:

17 ‘‘(A) Central estimates of risk using the

18 most plausible assumptions.

19 ‘‘(B) An approach that combines multiple

20 estimates based on different scenarios and

21 weighs the probability of each scenario.

22 ‘‘(C) Any other methodology designed to

23 provide the most unbiased representation of the

24 most plausible level of risk, given the current
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1 scientific information available to the agency

2 concerned.

3 ‘‘(2) The term ‘emergency’ means a clearly im4 minent and substantial endangerment to public

5 health, safety, or natural resources.

6 ‘‘(3) The term ‘hazard identification’ means

7 identification of a substance, activity, or condition as

8 potentially posing a risk to human health or safety

9 or natural resources based on empirical data, meas10 urements, testing, or scientifically acceptable meth11 ods showing that it has caused significant adverse

12 effects at some levels of dose or exposure not nec13 essarily relevant to level of dose or exposure that are

14 normally expected to occur.

15 ‘‘(4) The term ‘negative data’ means data indi16 cating that under certain conditions a given sub17 stance or activity did not induce an adverse effect.

18 ‘‘(5) The term ‘plausible’ means realistic and

19 scientifically probable.

20 ‘‘(6) The term ‘risk assessment’ means—

21 ‘‘(A) the process of identifying hazards,

22 and quantifying (to the extent practicable) or

23 describing the degree of toxicity, exposure, or

24 other risk the hazards pose for exposed individ25 uals, populations, or resources; and
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1 ‘‘(B) the document containing the expla2 nation of how the assessment process has been

3 applied to an individual substance, activity, or

4 condition.

5 ‘‘(7) The term ‘risk characterization’—

6 ‘‘(A) means the element of a risk assess7 ment that involves presentation of the degree of

8 risk to individuals and populations expected to

9 be protected, as presented in any regulatory

10 proposal or decision, report to Congress, or

11 other document that is made available to the

12 public; and

13 ‘‘(B) includes discussions of uncertainties,

14 conflicting data, estimates, extrapolations, in15 ferences, and opinions.

16 ‘‘(8) The term ‘substitution risk’ means a po17 tential increased risk to human health, safety, or the

18 environment from a regulatory option designed to

19 decrease other risks.

20 ‘‘§ 632. Applicability

21 ‘‘(a) Except as provided in subsection (b), this sub22 chapter shall apply to all risk assessments and risk charac23 terizations prepared by, or on behalf of, or prepared by

24 others and adopted by, any agency in connection with

25 health, safety, and risk to natural resources.
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1 ‘‘(b)(1) This subchapter shall not apply to risk as2 sessments or risk characterizations performed with respect

3 to—

4 ‘‘(A) a situation that the head of the agency

5 considers to be an emergency;

6 ‘‘(B) a rule that authorizes the introduction

7 into commerce, or recognizes the marketable status

8 of a product; or

9 ‘‘(C) a screening analysis.

10 ‘‘(2)(A) An analysis shall not be treated as screening

11 analysis for the purposes of paragraph (1)(B) if the result

12 of the analysis is used—

13 ‘‘(i) as the basis for imposing a restriction on

14 a substance or activity; or

15 ‘‘(ii) to characterize a positive finding of risks

16 from a substance or activity in any agency document

17 or other communication made available to the public,

18 the media, or Congress.

19 ‘‘(B) Among the analyses that may be treated as a

20 screening analyses for the purposes of paragraph (1)(B)

21 are product registrations, reregistrations, tolerance set22 tings, and reviews of premanufacture notices and existing

23 chemicals under the Federal Insecticide, Fungicide and

24 Rodenticide Act (7 U.S.C. 136 et seq.) and the Toxic Sub25 stances Control Act (15 U.S.C. 2601 et seq.).
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1 ‘‘(3) This subchapter shall not apply to any food,

2 drug, or other product label or to any risk characterization

3 appearing on any such label.

4 ‘‘§ 633. Rule of construction

5 ‘‘Nothing in this subchapter shall be construed to—

6 ‘‘(1) preclude the consideration of any data or

7 the calculation of any estimate to more fully describe

8 risk or provide examples of scientific uncertainty or

9 variability; or

10 ‘‘(2) require the disclosure of any trade secret

11 or other confidential information.

12 ‘‘§ 634. Requirement to prepare risk assessments

13 ‘‘(a) Except as provided in section 632, the head of

14 each agency shall prepare for each major rule relating to

15 human health, safety, or natural resources that is pro16 posed by the agency after the date of enactment of this

17 subchapter, is pending on the date of enactment of this

18 subchapter, or is subject to a granted petition for review

19 pursuant to section 625 or 637—

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

21 subchapter;

22 ‘‘(2) for each such proposed or final rule, an as23 sessment, quantified to the extent feasible, of incre24 mental risk reduction or other benefits associated
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1 with each significant regulatory alternative to the

2 rule or proposed rule; and

3 ‘‘(3) for each such proposed or final rule, quan4 tified to the extent feasible, a comparison of any

5 human health, safety, or natural resource risks ad6 dressed by the regulatory alternatives to other rel7 evant risks chosen by the head of the agency, includ8 ing at least 3 other risks regulated by the agency

9 and to at least 3 other risks with which the public

10 is familiar.

11 ‘‘(b) A risk assessment prepared pursuant to this

12 subchapter shall be a component of and used to develop

13 the cost-benefit analysis required by subchapter II, and

14 shall be made part of the administrative record for judicial

15 review of any final agency action.

16 ‘‘§ 635. Principles for risk assessment

17 ‘‘(a)(1) The head of each agency shall apply the prin18 ciples set forth in subsection (b) when preparing any risk

19 assessment, whether or not required by section 634, to en20 sure that the risk assessment and all of its components—

21 ‘‘(A) distinguish scientific findings and best es22 timates of risk from other considerations;

23 ‘‘(B) are, to the maximum extent practicable

24 scientifically objective, unbiased and inclusive of all

25 relevant data; and
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1 ‘‘(C) rely, to the extent available and prac2 ticable, on scientific findings.

3 ‘‘(2) Discussions or explanations required under this

4 section need not be repeated in each risk assessment docu5 ment as long as there is a reference to the relevant discus6 sion or explanation in another agency document.

7 ‘‘(b) The principles to be applied when preparing risk

8 assessments are as follows:

9 ‘‘(1)(A) When assessing human health risks, a

10 risk assessment shall be based on the most reliable

11 laboratory, epidemiological, and exposure assessment

12 data that finds, or fails to find, a correlation be13 tween a health risk and a potential toxin or activity.

14 Other relevant data may be summarized.

15 ‘‘(B) When conflicts among such data appear to

16 exist, or when animal data are used as a basis to as17 sess human health, the assessment shall include dis18 cussion of possible reconciliation of conflicting infor19 mation, and, as appropriate, differences in study de20 signs, comparative physiology, routes of exposure,

21 bioavailability, pharmacokinetics, and any other rel22 evant factor, including the availability of raw data

23 for review. Greatest emphasis shall be placed on

24 data that indicates a biological basis of the resulting
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1 harm in humans. Animal data shall be reviewed with

2 regard to relevancy to humans.

3 ‘‘(2) When a risk assessment involves selection

4 of any significant assumption, inference, or model,

5 the agency shall—

6 ‘‘(A) describe the plausible and alternative

7 assumptions, inferences, or models;

8 ‘‘(B) explain the basis for any choices

9 among such assumptions, inferences, or models;

10 ‘‘(C) identify any policy or value judgments

11 involved in choosing from among such alter12 native assumptions, inferences, or models;

13 ‘‘(D) fully describe any model used in the

14 risk assessment and make explicit the assump15 tions incorporated in the model; and

16 ‘‘(E) indicate the extent to which any sig17 nificant model has been validated by, or con18 flicts with, empirical data.

19 ‘‘(3) A risk assessment shall be prepared at the

20 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.
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1 ‘‘§ 636. Principles for risk characterization and com2 munication

3 ‘‘In characterizing risk in any risk assessment docu4 ment, regulatory proposal or decision, report to Congress,

5 or other document that is made available to the public,

6 each agency characterizing the risk shall comply with each

7 of the following:

8 ‘‘(1)(A) The head of the agency shall describe

9 the populations or natural resources that are the

10 subject of the risk characterization.

11 ‘‘(B) If a numerical estimate of risk is provided,

12 the head of the agency, to the extent feasible and

13 scientifically appropriate—

14 ‘‘(i) shall provide—

15 ‘‘(I) the best estimate or estimates for

16 the specific populations or natural re17 sources which are the subject of the char18 acterization (based on the information

19 available to the department, agency, or in20 strumentality) or, in lieu of a single best

21 estimate, an array of multiple estimates

22 (showing the distribution of estimates and

23 the best estimate) based on assumptions,

24 inferences, or models which are equally

25 plausible, given current scientific under26 standing;
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1 ‘‘(II) a statement of the reasonable

2 range of scientific uncertainties; and

3 ‘‘(III) to the extent practicable and

4 appropriate, descriptions of the distribu5 tion and probability of risk estimates to re6 flect differences in exposure variability in

7 populations and uncertainties;

8 ‘‘(ii) in addition to a best estimate or esti9 mates, may present plausible upper-bound or

10 conservative estimates, but only in conjunction

11 with equally plausible lower-bound estimates;

12 and

13 ‘‘(iii) shall ensure that, where a safety fac14 tor, as distinguished from inherent quantitative

15 or qualitative uncertainties, is used, such factor

16 shall be similar in degree to safety factors used

17 to ensure safety in human activities.

18 ‘‘(2) The head of the agency shall explain the

19 exposure scenarios used in any risk assessment, and,

20 to the extent feasible, provide a statement of the size

21 of the corresponding population or natural resource

22 at risk and the likelihood of such exposure scenarios.

23 ‘‘(3)(A) To the extent feasible, the head of the

24 agency shall provide a statement that places the na-
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1 ture and magnitude of individual and population

2 risks to human health in context.

3 ‘‘(B) A statement under subparagraph (A)

4 shall—

5 ‘‘(i) include appropriate comparisons with

6 estimates of risks that are familiar to and rou7 tinely encountered by the general public as well

8 as other risks; and

9 ‘‘(ii) identify relevant distinctions among

10 categories of risk and limitations to compari11 sons.

12 ‘‘(4) When an agency provides a risk assess13 ment or risk characterization for a proposed or final

14 regulatory action, such assessment or characteriza15 tion shall include a statement of any significant sub16 stitution risks to human health identified by the

17 agency or contained in information provided to the

18 agency by a commenter.

19 ‘‘(5) If—

20 ‘‘(A) an agency provides a public comment

21 period with respect to a risk assessment or reg22 ulation;

23 ‘‘(B) a commenter provides a risk assess24 ment, and a summary of results of such risk as25 sessment; and
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1 ‘‘(C) such risk assessment is reasonably

2 consistent with the principles and the guidance

3 provided under this subtitle,

4 the agency shall present such summary in connec5 tion with the presentation of the agency’s risk as6 sessment or the regulation.

7 ‘‘§ 637. Regulations; plan for assessing new informa8 tion

9 ‘‘(a)(1) Not later than 1 year after the date of enact10 ment of this subchapter, the President shall issue a final

11 regulation that has been subject to notice and comment

12 under section 553 of title 5, United States Code, for agen13 cies to implement the risk assessment and characterization

14 principles set forth in sections 635 and 636 and shall pro15 vide a format for summarizing risk assessment results.

16 ‘‘(2) The regulation under paragraph (1) shall be suf17 ficiently specific to ensure that risk assessments are con18 ducted consistently by the various agencies.

19 ‘‘(b)(1) Review of the risk assessment for any major

20 rule shall be conducted by the head of the agency on the

21 written petition of a person showing a reasonable likeli22 hood that—

23 ‘‘(A) the risk assessment is inconsistent with

24 the principles set forth in sections 635 and 636;
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1 ‘‘(B) the risk assessment produces substantially

2 different results;

3 ‘‘(C) the risk assessment is inconsistent with a

4 rule issued under subsection (a); or

5 ‘‘(D) the risk assessment does not take into ac6 count material significant new scientific data or sci7 entific understanding.

8 ‘‘(2) Not later than 90 days after receiving a petition

9 under paragraph (1), the head of the agency shall respond

10 to the petition by agreeing or declining to review the risk

11 assessment referred to in the petition, and shall state the

12 basis for the decision.

13 ‘‘(3) If the head of the agency agrees to review the

14 petition, the agency shall complete its review within 180

15 days, unless the Director of the Office of Management and

16 Budget agrees in writing with an agency determination

17 that an extension is necessary in view of limitations on

18 agency resources.

19 ‘‘(4) Denial of a petition by the agency head shall

20 be subject to judicial review in accordance with chapter

21 7 of title 5, United States Code.

22 ‘‘(5) A risk assessment completed pursuant to a peti23 tion may be the basis for initiating a regulatory review

24 pursuant to section 625.
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1 ‘‘(c) The regulations under this section shall be devel2 oped after notice and opportunity for public comment, and

3 after consultation with representatives of appropriate

4 State agencies and local governments, and such other de5 partments and agencies, offices, organizations, or persons

6 as may be advisable.

7 ‘‘(d) At least every 4 years, the President shall re8 view, and when appropriate, revise the regulations pub9 lished under this section.

10 ‘‘§ 638. Decisional criteria

11 ‘‘For each major rule subject to this subchapter, the

12 head of the agency, subject to review by the President,

13 shall make a determination that—

14 ‘‘(1) the risk assessment under section 634 is

15 based on a scientific and unbiased evaluation, re16 flecting realistic exposure scenarios, of the risk ad17 dressed by the major rule and is supported by the

18 best available scientific data, as determined by a

19 peer review panel in accordance with section 640;

20 and

21 ‘‘(2) there is no alternative that is allowed by

22 the statute under which the major rule is promul23 gated that would provide greater net benefits or that

24 would achieve an equivalent reduction in risk in a

25 more cost-effective and flexible manner.
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1 ‘‘§ 639. Regulatory priorities

2 ‘‘(a) In exercising authority under any laws protect3 ing human health and safety or the environment, the head

4 of an agency shall prioritize the use of the resources avail5 able under such laws to address the risks to human health,

6 safety, and natural resources that—

7 ‘‘(1) the agency determines are the most seri8 ous; and

9 ‘‘(2) can be addressed in a cost-effective man10 ner, with the goal of achieving the greatest overall

11 net reduction in risks with the public and private

12 sector resources to be expended.

13 ‘‘(b) In identifying the sources of the most serious

14 risks under subsection (a), the head of the agency shall

15 consider, at a minimum—

16 ‘‘(1) the plausible likelihood and severity of the

17 effect; and

18 ‘‘(2) the plausible number and groups of indi19 viduals potentially affected.

20 ‘‘(c) The head of the agency shall incorporate the pri21 orities identified in subsection (a) into the budget, strate22 gic planning, and research activities of the agency by, in

23 the agency’s annual budget request to Congress—

24 ‘‘(1) identifying which risks the agency has de25 termined are the most serious and can be addressed
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1 in a cost-effective manner under subsection (a), and

2 the basis for that determination;

3 ‘‘(2) explicitly identifying how the agency’s re4 quested funds will be used to address those risks;

5 ‘‘(3) identifying any statutory, regulatory, or

6 administrative obstacles to allocating agency re7 sources in accordance with the priorities established

8 under subsection (a); and

9 ‘‘(4) explicitly considering the requirements of

10 subsection (a) when preparing the agency’s regu11 latory agenda or other strategic plan, and providing

12 an explanation of how the agenda or plan reflects

13 those requirements and the comparative risk analy14 sis when publishing any such agenda or strategic

15 plan.

16 ‘‘(d) In March of each year, the head of each agency

17 shall submit to Congress specific recommendations for re18 pealing or modifying laws that would better enable the

19 agency to prioritize its activities to address the risks to

20 human health, safety, and the environment that are the

21 most serious and can be addressed in a cost-effective man22 ner consistent with the requirements of subsection (a).

23 ‘‘§ 640. Establishment of program

24 ‘‘(a) The President shall develop a systematic pro25 gram for the peer review of work products covered by sub-
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1 section (c), which program shall be used uniformly across

2 the agencies.

3 ‘‘(b) The program under subsection (a)—

4 ‘‘(1) shall provide for the creation of peer re5 view panels consisting of independent and external

6 experts who are broadly representative and balanced

7 to the extent feasible;

8 ‘‘(2) shall not exclude peer reviewers merely be9 cause they represent entities that may have a poten10 tial interest in the outcome, if that interest is fully

11 disclosed;

12 ‘‘(3) shall exclude, to the maximum extent prac13 ticable, any peer reviewer who has been involved in

14 any previous analysis of the tests and evidence pre15 sented for certification by the peer review panel; and

16 ‘‘(4) shall provide for a timely completed peer

17 review, meeting agency deadlines, which contains a

18 balanced presentation of all considerations, including

19 minority reports and an agency response to all sig20 nificant peer review comments.

21 ‘‘(c) The peer review and the agency’s responses shall

22 be made available to the public and shall be made part

23 of the administrative record for purposes of judicial review

24 of any final agency action.
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1 ‘‘(d) The proceedings of peer review panels under this

2 section shall be subject to the applicable provisions of the

3 Federal Advisory Committee Act (5 U.S.C. App.).

4 ‘‘SUBCHAPTER IV—EXECUTIVE OVERSIGHT

5 ‘‘§ 651. Procedures

6 ‘‘The President shall—

7 ‘‘(1) establish procedures for agency compliance

8 with subchapters II and III; and

9 ‘‘(2) monitor, review, and ensure agency imple10 mentation of such procedures.

11 ‘‘§ 652. Promulgation and adoption

12 ‘‘(a) Procedures established pursuant to section 651

13 shall only be implemented after opportunity for public

14 comment. Any such procedures shall be consistent with the

15 prompt completion of rulemaking proceedings.

16 ‘‘(b)(1) If procedures established pursuant to section

17 651 include review of preliminary or final regulatory anal18 yses to ensure that they comply with subchapters II and

19 III, the time for any such review of a preliminary regu20 latory analysis shall not exceed 30 days following the re21 ceipt of the analysis by the President or by an officer to

22 whom the authority granted under section 651 has been

23 delegated pursuant to section 653.
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1 ‘‘(2) The time for review of a final regulatory analysis

2 shall not exceed 30 days following the receipt of the analy3 sis by the President or such officer.

4 ‘‘(3)(A) The times for each such review may be ex5 tended for good cause by the President or such officer for

6 an additional 30 days.

7 ‘‘(B) Notice of any such extension, together with a

8 succinct statement of the reasons therefor, shall be in9 serted in the rulemaking file.

10 ‘‘§ 653. Delegation of authority

11 ‘‘(a) The President may delegate the authority grant12 ed by this subchapter to the Vice President or to an officer

13 within the Executive Office of the President whose ap14 pointment has been subject to the advice and consent of

15 the Senate.

16 ‘‘(b)(1) Notice of any delegation, or any revocation

17 or modification thereof, shall be published in the Federal

18 Register.

19 ‘‘(2) Any notice with respect to a delegation to the

20 Vice President shall contain a statement by the Vice Presi21 dent that the Vice President will make every reasonable

22 effort to respond to congressional inquiries concerning the

23 exercise of the authority delegated under this section.
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1 ‘‘§ 654. Applicability

2 ‘‘The authority granted under this subchapter shall

3 not apply to rules issued by the Nuclear Regulatory Com4 mission.

5 ‘‘§ 655. Judicial review

6 ‘‘The exercise of the authority granted under this

7 subchapter by the President or by an officer to whom such

8 authority has been delegated under section 653 shall not

9 be subject to judicial review in any manner under this

10 chapter.’’.

11 (b) JUDICIAL REVIEW OF REGULATORY FLEXIBILITY

12 ANALYSIS.—

13 (1) AMENDMENT.—Section 611 of title 5, Unit14 ed States Code, is amended to read as follows:

15 ‘‘§ 611. Judicial review

16 ‘‘(a)(1) Except as provided in paragraph (2), not

17 later than 1 year after the effective date of a final rule

18 with respect to which an agency—

19 ‘‘(A) certified, pursuant to section 605(b), that

20 such rule would not have a significant economic im21 pact on a substantial number of small entities; or

22 ‘‘(B) prepared final regulatory flexibility analy23 sis pursuant to section 604,

24 an affected small entity may petition for the judicial re25 view of such certification or analysis in accordance with

26 this subsection. A court having jurisdiction to review such
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1 rule for compliance with section 553 of this title or under

2 any other provision of law shall have jurisdiction to review

3 such certification or analysis.

4 ‘‘(2)(A) Except as provided in subparagraph (B), in

5 the case of a provision of law that requires that an action

6 challenging a final agency regulation be commenced before

7 the expiration of the 1-year period provided in paragraph

8 (1), such lesser period shall apply to a petition for the

9 judicial review under this subsection.

10 ‘‘(B) In a case in which an agency delays the issuance

11 of a final regulatory flexibility analysis pursuant to section

12 608(b), a petition for judicial review under this subsection

13 shall be filed not later than—

14 ‘‘(i) 1 year; or

15 ‘‘(ii) in a case in which a provision of law re16 quires that an action challenging a final agency reg17 ulation be commenced before the expiration of the 1-

18 year period provided in paragraph (1), the number

19 of days specified in such provision of law,

20 after the date the analysis is made available to the public.

21 ‘‘(3) For purposes of this subsection, the term ‘af22 fected small entity’ means a small entity that is or will

23 be adversely affected by the final rule.

24 ‘‘(4) Nothing in this subsection shall be construed to

25 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

5 on a substantial number of small entities, the court may

6 order the agency to prepare a final regulatory flexibility

7 analysis pursuant to section 604 if the court determines,

8 on the basis of the rulemaking record, that the certifi9 cation was arbitrary, capricious, an abuse of discretion,

10 or otherwise not 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

14 604 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

17 604.

18 ‘‘(6) If, by the end of the 90-day period beginning

19 on the date of the order of the court pursuant to para20 graph (5) (or such longer period as the court may pro21 vide), the agency fails, as appropriate—

22 ‘‘(A) to prepare the analysis required by section

23 604; or

24 ‘‘(B) to take corrective action consistent with

25 section 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

5 due account of the rule of prejudicial error.

6 ‘‘(b) In an action for the judicial review of a rule,

7 any regulatory flexibility analysis for such rule (including

8 an 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

12 any other impact statement or similar analysis required

13 by any other law if judicial review of such statement or

14 analysis is otherwise provided by law.’’.

15 (2) EFFECTIVE DATE.—The amendment made

16 by paragraph (1) shall take effect on the date of en17 actment of this Act, except that the judicial review

18 authorized by section 611(a) of title 5, United

19 States Code (as added by subsection (a)), shall apply

20 only to final agency rules issued after the date of en21 actment of this Act.

22 (c) PRESIDENTIAL AUTHORITY.—Nothing in this Act

23 shall limit the exercise by the President of the authority

24 and responsibility that the President otherwise possesses

25 under the Constitution and other laws of the United
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1 States with respect to regulatory policies, procedures, and

2 programs of departments, agencies, and offices.

3 (d) TECHNICAL AND CONFORMING AMENDMENTS.—

4 (1) Part I of title 5, United States Code, is amended by

5 striking out the chapter heading and table of sections for

6 chapter 6 and inserting in lieu thereof the following:

7 ‘‘CHAPTER 6—THE ANALYSIS OF

8 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.

‘‘622. Rulemaking cost-benefit analysis.

‘‘623. Decisional criteria.

‘‘624. Judicial review.

‘‘625. Petition for cost-benefit analysis.

‘‘626. Effective date of final regulations.

‘‘627. Unauthorized rulemakings.

‘‘628. Standard for review of agency interpretations of an enabling statute.

‘‘SUBCHAPTER III—RISK ASSESSMENTS

‘‘631. Definitions.

‘‘632. Applicability.

‘‘633. Rule of construction.

‘‘634. Requirement to prepare risk assessments.

‘‘635. Principles for risk assessment.

‘‘636. Principles for risk characterization and communication.

‘‘637. Regulations; plan for assessing new information.

‘‘638. Decisional criteria.

‘‘639. Regulatory priorities.

‘‘640. Establishment of program.
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‘‘SUBCHAPTER IV—EXECUTIVE OVERSIGHT

‘‘651. Procedures.

‘‘652. Promulgation and adoption.

‘‘653. Delegation of authority.

‘‘654. Applicability.

‘‘655. Judicial review.’’.

1 (2) Chapter 6 of title 5, United States Code, is

2 amended by inserting immediately before section 601, the

3 following subchapter heading:

4 ‘‘SUBCHAPTER I—REGULATORY ANALYSIS’’.

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