Calendar No. 118

104TH CONGRESS

1ST SESSION S. 343

[Report No. 104–90][Report No. 104–89]

A BILL

To reform the regulatory process, and for other

purposes.

MAY 26 (legislative day, MAY 15), 1995

Reported with an amendment in the nature of a

substitute

MAY 26 (legislative day, MAY 15), 1995

Reported with an amendment in the nature of a

substitute
II

Calendar No. 118

104TH CONGRESS

1ST SESSION S. 343

[Report No. 104–89]

[Report No. 104–90]

To reform the regulatory process, and for other purposes.

IN THE SENATE OF THE UNITED STATES

FEBRUARY 2 (legislative day, JANUARY 30), 1995

Mr. DOLE (for himself, Mr. NICKLES, Mr. BOND, Mrs. HUTCHISON, Mr.

MURKOWSKI, Mr. LOTT, Mr. COCHRAN, Mr. HATCH, Mr. DOMENICI,

Mrs. KASSEBAUM, Mr. COATS, Mr. ABRAHAM, Mr. INHOFE, Mr. SMITH,

Mr. SANTORUM, Mr. THOMPSON, Mr. WARNER, Mr. KYL, Mr. THOMAS,

Mr. GRAMM, Mr. MACK, Mr. GREGG, Mr. SHELBY, Mr. STEVENS, Mr.

HELMS, Mr. FAIRCLOTH, Mr. GRASSLEY, Mr. KEMPTHORNE, Mr. SIMPSON, and Mr. FRIST) introduced the following bill; which was read twice

and referred to the Committee on the Judiciary

FEBRUARY 3 (legislative day, JANUARY 30), 1995

Ordered referred jointly to the Committees on the Judiciary and Governmental

Affairs

MAY 26 (legislative day, MAY 15), 1995

Reported by Mr. ROTH, from the Committee on Governmental Affairs, with

an amendment in the nature of a substitute

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

MAY 26 (legislative day, MAY 15), 1995

And on behalf of Mr. HATCH, from the Committee on the Judiciary, with an

amendment in the nature of a substitute

[Omit the part enclosed in bold brackets and insert the part printed in bold italic]
2

•S 343 RS

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 ‘‘Comprehensive Regu5 latory Reform 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:

10 ‘‘SUBCHAPTER II—ANALYSIS OF AGENCY

11 PROPOSALS

12 ‘‘§ 621. Definitions

13 ‘‘For purposes of this subchapter and subchapter III

14 of this chapter—

15 ‘‘(1) the term ‘agency’ has the same meaning as

16 in section 551(1) of this title;

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

18 in section 551(2) of this title;

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

20 in section 551(4) of this title;

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

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

23 rules that the agency proposing the rule or the
3

•S 343 RS

1 President reasonably determines is likely to

2 have a gross annual effect on the economy of

3 $50,000,000 or more in reasonably quantifiable

4 increased direct and indirect costs, or has a sig5 nificant impact on a sector of the economy; or

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

7 rules that is otherwise designated a major rule

8 by the agency proposing the rule, or by the

9 President on the ground that the rule is likely

10 to result in—

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

12 prices for wage earners, consumers, indi13 vidual industries, nonprofit organizations,

14 Federal, State, or local government agen15 cies, or geographic regions; or

16 ‘‘(II) significant adverse effects on

17 competition, employment, investment, pro18 ductivity, innovation, the environment,

19 public health or safety, or the ability of en20 terprises whose principal places of business

21 are in the United States to compete in do22 mestic or export markets;

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

24 ‘‘(i) a rule that involves the internal reve25 nue laws of the United States; or
4

•S 343 RS

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

2 into commerce, or recognizes the marketable

3 status, of a product;

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

5 identifiable significant benefits, including social and

6 economic benefits, that are expected to result di7 rectly or indirectly from implementation of a rule or

8 an alternative to a rule;

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

12 choice, substitution effects, and impeded techno13 logical advancement, that are expected to result di14 rectly or indirectly from implementation of, or com15 pliance with, a rule or an alternative to a rule; and

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

17 a regulatory program that—

18 ‘‘(A) imposes legal accountability for the

19 achievement of an explicit regulatory objective

20 on each regulated person;

21 ‘‘(B) affords maximum flexibility to each

22 regulated person in complying with mandatory

23 regulatory objectives, which flexibility shall,

24 where feasible and appropriate, include, but not

25 be limited to, the opportunity to transfer to, or
5

•S 343 RS

1 receive from, other persons, including for cash

2 or other legal consideration, increments of com3 pliance responsibility established by the pro4 gram; and

5 ‘‘(C) permits regulated persons to respond

6 automatically to changes in general economic

7 conditions and in economic circumstances di8 rectly pertinent to the regulatory program with9 out affecting the achievement of the program’s

10 explicit regulatory mandates.

11 ‘‘§ 622. Rulemaking cost-benefit analysis

12 ‘‘(a)(1) Prior to publishing notice of a proposed rule13 making for any rule (or, in the case of a notice of a pro14 posed rulemaking that has been published on or before the

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

16 days after such date of enactment), each agency shall de17 termine whether the rule is or is not a major rule within

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

19 whether it should be designated a major rule under section

20 621(4)(A)(ii). For the purpose of any such determination

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

22 considered as one rule.

23 ‘‘(2) Each notice of proposed rulemaking shall in24 clude a succinct statement and explanation of the agency’s

25 determination under paragraph (1).
6

•S 343 RS

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

2 not a major rule within the meaning of section

3 621(4)(A)(i) and has not designated the rule a major rule

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

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

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

7 days after the publication of the notice of proposed rule8 making for the rule (or, in the case of a notice of proposed

9 rulemaking that has been published on or before the date

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

11 after such date of enactment).

12 ‘‘(2) Such determination or designation shall be pub13 lished in the Federal Register, together with a succinct

14 statement of the basis for the determination or designa15 tion.

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

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

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

20 the notice of proposed rulemaking.

21 ‘‘(B)(i) When the President has published a deter22 mination or designation that a rule is a major rule after

23 the publication of the notice of proposed rulemaking for

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

25 rulemaking file a draft cost-benefit analysis for the rule
7

•S 343 RS

1 and shall publish in the Federal Register a summary of

2 such analysis.

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

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

5 persons an opportunity to comment pursuant to section

6 553 of this title in the same manner as if the draft cost7 benefit analysis had been issued with the notice of pro8 posed rulemaking.

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

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

11 rule, and an explanation of how the agency antici12 pates each benefit will be achieved by the proposed

13 rule;

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

15 rule, and an explanation of how the agency antici16 pates each such cost will result from the proposed

17 rule;

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

19 the costs and benefits) of reasonable alternatives for

20 achieving the identified benefits of the proposed rule,

21 including alternatives that—

22 ‘‘(i) require no Government action;

23 ‘‘(ii) will accommodate differences among

24 geographic regions and among persons with dif-
8

•S 343 RS

1 fering levels of resources with which to comply;

2 and

3 ‘‘(iii) employ performance or other market4 based standards that permit the greatest flexi5 bility in achieving the identified benefits of the

6 proposed rule and that comply with the require7 ments of subparagraph (D);

8 ‘‘(D) an assessment of the feasibility of estab9 lishing a regulatory program that operates through

10 the application of market-based mechanisms;

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

12 based on one or more scientific evaluations or infor13 mation or is subject to the risk assessment require14 ments of subchapter III, a description of actions un15 dertaken by the agency to verify the quality, reliabil16 ity, and relevance of such scientific evaluations or

17 scientific information in accordance with the risk as18 sessment requirements of subchapter III;

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

20 the rule on small businesses with fewer than 100

21 employees, including an assessment of the net em22 ployment effect of the rule; and

23 ‘‘(G) an analysis of whether the identified bene24 fits of the proposed rule are likely to exceed the

25 identified costs of the proposed rule, and an analysis
9

•S 343 RS

1 of whether the proposed rule will provide greater net

2 benefits to society than any of the alternatives to the

3 proposed rule, including alternatives identified in ac4 cordance with subparagraph (C).

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

6 the agency shall also issue and place in the rulemaking

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

8 summary of the analysis in the statement of basis and

9 purpose.

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

11 ‘‘(A) a description and comparison of the bene12 fits and costs of the rule and of the reasonable alter13 natives to the rule described in the rulemaking, in14 cluding the market-based mechanisms identified pur15 suant to subsection (c)(2)(D); and

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

17 record considered as a whole, of—

18 ‘‘(i) whether the benefits of the rule out19 weigh the costs of the rule; and

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

21 net benefits to society than any of the alter22 natives described in the rulemaking, including

23 the market-based incentives identified pursuant

24 to subsection (c)(2)(D).
10

•S 343 RS

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

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

3 shall include, to the extent feasible, a quantification or nu4 merical estimate of the quantifiable benefits and costs.

5 Such quantification or numerical estimate shall be made

6 in the most appropriate unit of measurement, using com7 parable assumptions, including time periods, and shall

8 specify the ranges of predictions and shall explain the

9 margins of error involved in the quantification methods

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

11 nature and extent of the nonquantifiable benefits and

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

13 and succinct a manner as possible.

14 ‘‘(B) Where practicable, the description of the bene15 fits and costs of a proposed and final rule required under

16 this section shall describe such benefits and costs on an

17 industry by industry basis.

18 ‘‘(2)(A) In evaluating and comparing costs and bene19 fits and in evaluating the risk assessment information de20 veloped pursuant to subchapter III, the agency shall not

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

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

23 materials that would enable the agency and other persons

24 interested in the rulemaking to assess the accuracy, reli-
11

•S 343 RS

1 ability, and uncertainty factors applicable to such informa2 tion.

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

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

5 be clearly articulated in accordance with this section.

6 ‘‘§ 623. Decisional criteria

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

8 promulgated unless the agency finds that—

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

10 rule outweigh the potential costs of the rule to soci11 ety, as determined by the analysis required by sec12 tion 622(d)(2)(B); and

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

14 society than any of the reasonable alternatives iden15 tified pursuant to section 622(c)(2)(C), including the

16 market-based mechanisms identified pursuant to sec17 tion 622(c)(2)(D).

18 ‘‘(b) The requirements of this section shall supple19 ment the decisional criteria for rulemaking otherwise ap20 plicable under the statute granting the rulemaking author21 ity, except when such statute contains explicit textual lan22 guage prohibiting the consideration of the criteria set

23 forth in this section. Where the agency finds that consider24 ation of the criteria set forth in this section is prohibited

25 by explicit statutory language, the agency shall transmit
12

•S 343 RS

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

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

3 ‘‘§ 624. Judicial review

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

5 the provisions of this subchapter shall be subject to judi6 cial review in accordance with this section.

7 ‘‘(b)(1) Each of the following shall be subject to judi8 cial review:

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

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

11 the meaning of section 621(4).

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

13 President of a rule as a major rule.

14 ‘‘(C) A decision by an agency or by the Presi15 dent not to designate a rule a major rule.

16 ‘‘(2) A determination by an agency or by the Presi17 dent that a rule is not a major rule within the meaning

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

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

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

21 and convincing evidence that the determination or decision

22 not to designate is erroneous in light of the information

23 available to the agency at the time the determination or

24 decision not to designate was made.
13

•S 343 RS

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

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

3 shall be filed not later than 30 days after the date of publi4 cation of such determination or failure to designate.

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

6 should have been reviewed pursuant to this subchapter,

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

8 the requirements of this subchapter are met.

9 ‘‘(d) Each court with jurisdiction to review final agen10 cy action under the statute granting the agency authority

11 to conduct the rulemaking shall have jurisdiction to review

12 findings by any agency under this subchapter and shall

13 set aside agency action that fails to satisfy the decisional

14 criteria of section 623. The court shall apply the same

15 standards of judicial review that apply to the review of

16 agency findings under the statute granting the agency au17 thority to conduct the rulemaking.

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

19 ‘‘(a)(1) Any person subject to a major rule may peti20 tion the relevant agency or the President to perform a

21 cost-benefit analysis under this subchapter for the major

22 rule, including a major rule in effect on the date of enact23 ment of this subchapter for which a cost-benefit analysis

24 pursuant to such subchapter has not been performed, re25 gardless of whether a cost-benefit analysis was previously
14

•S 343 RS

1 performed to meet requirements imposed before the date

2 of enactment of this subchapter.

3 ‘‘(2) The petition shall identify with reasonable speci4 ficity the major rule to be reviewed.

5 ‘‘(3) The agency or the President shall grant the peti6 tion if the petition shows that there is a reasonable likeli7 hood that the costs of the major rule outweigh the bene8 fits, or that reasonable questions exist as to whether the

9 rule provides greater net benefits to society than any rea10 sonable alternative to the rule that may be more clearly

11 resolved through examination pursuant to this subchapter

12 and subchapter III.

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

14 subsection shall be made not later than 180 days after

15 submittal. A decision to deny a petition shall be subject

16 to judicial review immediately upon denial as final agency

17 action under the statute granting the agency authority to

18 conduct the rulemaking.

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

20 been granted under subsection (a), the agency shall con21 duct a cost-benefit analysis in accordance with this sub22 chapter, and shall determine whether the rule satisfies the

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

24 not satisfy the decisional criteria, then the agency shall

25 take immediate action to either revoke or amend the rule
15

•S 343 RS

1 to conform the rule to the requirements of this subchapter

2 and the decisional criteria under section 623.

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

4 rule’ means any major rule or portion thereof.

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

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

7 guidance or general statement of policy that would be a

8 major rule if the guidance or general statement of policy

9 had been adopted as a rule.

10 ‘‘(2) The petition shall identify with reasonable speci11 ficity why the guidance or general statement of policy

12 would be major if adopted as a rule.

13 ‘‘(3) The agency shall grant the petition if the peti14 tion shows that there is a reasonable likelihood that the

15 guidance or general statement of policy would be major

16 if adopted as a rule.

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

18 subsection shall be made not later than 180 days after

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

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

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

22 review immediately upon denial as final agency action

23 under the statute under which the agency has issued the

24 guidance or general statement of policy.
16

•S 343 RS

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

2 the agency shall be prohibited from enforcing against any

3 person the regulatory standards or criteria contained in

4 such guidance or policy unless included in a rule proposed

5 and promulgated in accordance with this subchapter.

6 ‘‘§ 626. Effective date of final regulations

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

8 section, all deadlines in statutes that require agencies to

9 propose or promulgate any rule subject to this subchapter

10 are suspended until such time as the requirements of this

11 subchapter are satisfied.

12 ‘‘(2) Beginning on the date of enactment of this sec13 tion, the jurisdiction of any court of the United States

14 to enforce any deadline that would require an agency to

15 propose or promulgate a rule subject to subchapter II of

16 chapter 5 of title 5, United States Code (as added by this

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

18 of this subchapter are satisfied.

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

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

21 through individual adjudications, the obligation to conduct

22 individual adjudications shall be suspended to allow the

23 requirements of this subchapter to be satisfied.

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

25 rule, the agency promulgating such rule shall submit to
17

•S 343 RS

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

2 a concise general statement relating to the rule, including

3 a complete copy of the cost-benefit analysis, and the pro4 posed effective date of the rule.

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

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

7 latest of—

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

9 after the date on which—

10 ‘‘(i) the Congress receives the report sub11 mitted under paragraph (1); or

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

13 Register;

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

15 disapproval described under subsection (h) relating

16 to the rule, and the President signs a veto of such

17 resolution, the earlier date—

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

19 votes and fails to override the veto of the Presi20 dent; or

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

22 date on which the Congress received the veto

23 and objections of the President; or

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

25 taken effect, if not for this section (unless a joint
18

•S 343 RS

1 resolution of disapproval under subsection (h) is en2 acted).

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

4 Congress passes a joint resolution of disapproval described

5 under subsection (h).

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

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

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

9 effect if the President makes a determination under para10 graph (2) and submits written notice of such determina11 tion to the Congress.

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

13 by the President by Executive order that the rule should

14 take effect because such rule is—

15 ‘‘(A) necessary because of an imminent threat

16 to health or safety or other emergency;

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

18 laws; or

19 ‘‘(C) necessary for national security.

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

21 under this subsection shall have no effect on the proce22 dures under subsection (h) or the effect of a joint resolu23 tion of disapproval under this section.
19

•S 343 RS

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

2 by the President under this subsection shall not be subject

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

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

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

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

7 on the date occurring 60 days before the date the Con8 gress adjourns sine die through the date on which the suc9 ceeding Congress first convenes.

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

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

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

13 take effect as a final rule) on the date the succeeding Con14 gress first convenes.

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

16 adjourns sine die through the date on which the succeed17 ing Congress first convenes, a rule described under para18 graph (1) shall take effect as a final rule as otherwise pro19 vided by law.

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

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

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

23 had never taken effect.

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

25 of disapproval under subsection (h), no court or agency
20

•S 343 RS

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

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

3 statute, or joint resolution of disapproval.

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

5 ‘joint resolution’ means only a joint resolution introduced

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

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

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

9 the rule submitted by the XXXX relating to XXXX, and

10 such rule shall have no force or effect. (The blank spaces

11 being appropriately filled in.)’.

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

13 be referred to the committees in each House of Congress

14 with jurisdiction. Such a resolution shall not be reported

15 before the eighth day after its submission or publication

16 date.

17 ‘‘(B) For purposes of this subsection the term ‘sub18 mission or publication date’ means the later of the date

19 on which—

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

21 under subsection (b)(1); or

22 ‘‘(ii) the rule is published in the Federal Reg23 ister.

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

25 in paragraph (1) is referred has not reported such resolu-
21

•S 343 RS

1 tion (or an identical resolution) at the end of 20 calendar

2 days after its submission or publication date, such com3 mittee may be discharged by the Majority Leader of the

4 Senate or the Majority Leader of the House of Represent5 atives, as the case may be, from further consideration of

6 such resolution and such resolution shall be placed on the

7 appropriate calendar of the House involved.

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

9 is referred has reported, or when a committee is dis10 charged (under paragraph (3)) from further consideration

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

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

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

14 of the respective House to move to proceed to the consider15 ation of the resolution, and all points of order against the

16 resolution (and against consideration of the resolution)

17 shall be waived. The motion shall be highly privileged in

18 the House of Representatives and shall be privileged in

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

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

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

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

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

24 If a motion to proceed to the consideration of the resolu-
22

•S 343 RS

1 tion is agreed to, the resolution shall remain the unfin2 ished business of the respective House until disposed of.

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

4 motions and appeals in connection therewith, shall be lim5 ited to not more than 10 hours, which shall be divided

6 equally between those favoring and those opposing the res7 olution. A motion further to limit debate shall be in order

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

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

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

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

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

13 be in order.

14 ‘‘(C) Immediately following the conclusion of the de15 bate on a resolution described in paragraph (1), and a sin16 gle quorum call at the conclusion of the debate if re17 quested in accordance with the rules of the appropriate

18 House, the vote on final passage of the resolution shall

19 occur.

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

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

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

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

24 be decided without debate.
23

•S 343 RS

1 ‘‘(5) If, before the passage by one House of a resolu2 tion of that House described in paragraph (1), that House

3 receives from the other House a resolution described in

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

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

6 not be referred to a committee.

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

8 paragraph (1) of the House receiving the resolu9 tion—

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

11 the same as if no resolution had been received

12 from the other House; but

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

14 the resolution of the other House.

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

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

17 the Senate and House of Representatives, respec18 tively, and as such it is deemed to be a part of the

19 rules of each House, respectively, but applicable only

20 with respect to the procedure to be followed in that

21 House in the case of a resolution described in para22 graph (1), and it supersedes other rules only to the

23 extent that it is inconsistent with such rules; and

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

25 right of either House to change the rules (so far as
24

•S 343 RS

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

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

3 the case of any other rule of that House.

4 ‘‘§ 627. Unauthorized rulemakings

5 ‘‘(a) Notwithstanding any other provision of law, be6 ginning on July 1, 1995, any rule that expands Federal

7 power or jurisdiction beyond the level of regulatory action

8 needed to satisfy statutory requirements shall be prohib9 ited.

10 ‘‘(b) Nothing in this section shall be construed to pre11 vent any agency from promulgating a rule that repeals,

12 narrows, or streamlines a rule, regulation, or administra13 tive process, or from issuing or promulgating a rule pro14 viding for tax relief or clarification or reducing regulatory

15 burdens.

16 ‘‘§ 628. Standard for review of agency interpretations

17 of an enabling statute

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

19 706 of this title, or under a statute that provides for re20 view of a final agency action, the reviewing court shall af21 firm the agency’s interpretation of the statute granting

22 authority to promulgate the rule if, applying traditional

23 principles of statutory construction, the reviewing court

24 finds that the interpretation is clearly the interpretation

25 of the statute intended by Congress.
25

•S 343 RS

1 ‘‘(b) If the reviewing court, applying traditional prin2 ciples of statutory construction, finds that an interpreta3 tion other than the interpretation applied by the agency

4 is clearly the interpretation of the statute intended by

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

6 interpretation is erroneous and contrary to law.

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

8 principles of statutory construction, finds that the statute

9 gives the agency discretion to choose from among a range

10 of permissible statutory constructions, the reviewing court

11 shall affirm the agency’s interpretation where the record

12 on review establishes that—

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

14 range of permissible statutory constructions;

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

16 within that range; and

17 ‘‘(C) the agency has engaged in reasoned deci18 sionmaking in determining that the interpretation,

19 rather than other permissible constructions of the

20 statute, is the one that maximizes net benefits to so21 ciety.

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

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

24 find that the agency’s interpretation is arbitrary and ca25 pricious.
26

•S 343 RS

1 ‘‘SUBCHAPTER IV—EXECUTIVE OVERSIGHT

2 ‘‘§ 651. Procedures

3 ‘‘The President shall—

4 ‘‘(1) establish procedures for agency compliance

5 with subchapters II and III; and

6 ‘‘(2) monitor, review, and ensure agency imple7 mentation of such procedures.

8 ‘‘§ 652. Promulgation and adoption

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

10 shall only be implemented after opportunity for public

11 comment. Any such procedures shall be consistent with the

12 prompt completion of rulemaking proceedings.

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

14 651 include review of preliminary or final regulatory anal15 yses to ensure that they comply with subchapters II and

16 III, the time for any such review of a preliminary regu17 latory analysis shall not exceed 30 days following the re18 ceipt of the analysis by the President or by an officer to

19 whom the authority granted under section 651 has been

20 delegated pursuant to section 653.

21 ‘‘(2) The time for review of a final regulatory analysis

22 shall not exceed 30 days following the receipt of the analy23 sis by the President or such officer.
27

•S 343 RS

1 ‘‘(3)(A) The times for each such review may be ex2 tended for good cause by the President or such officer for

3 an additional 30 days.

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

5 succinct statement of the reasons therefor, shall be in6 serted in the rulemaking file.

7 ‘‘§ 653. Delegation of authority

8 ‘‘(a) The President may delegate the authority grant9 ed by this subchapter to the Vice President or to an officer

10 within the Executive Office of the President whose ap11 pointment has been subject to the advice and consent of

12 the Senate.

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

14 or modification thereof, shall be published in the Federal

15 Register.

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

17 Vice President shall contain a statement by the Vice Presi18 dent that the Vice President will make every reasonable

19 effort to respond to congressional inquiries concerning the

20 exercise of the authority delegated under this section.

21 ‘‘§ 654. Applicability

22 ‘‘The authority granted under this subchapter shall

23 not apply to rules issued by the Nuclear Regulatory Com24 mission.
28

•S 343 RS

1 ‘‘§ 655. Judicial review

2 ‘‘The exercise of the authority granted under this

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

4 authority has been delegated under section 653 shall not

5 be subject to judicial review in any manner under this

6 chapter.’’.

7 (b) JUDICIAL REVIEW OF REGULATORY FLEXIBILITY

8 ANALYSIS.—

9 (1) AMENDMENT.—Section 611 of title 5, Unit10 ed States Code, is amended to read as follows:

11 ‘‘§ 611. Judicial review

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

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

14 with respect to which an agency—

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

16 such rule would not have a significant economic im17 pact on a substantial number of small entities; or

18 ‘‘(B) prepared final regulatory flexibility analy19 sis pursuant to section 604,

20 an affected small entity may petition for the judicial re21 view of such certification or analysis in accordance with

22 this subsection. A court having jurisdiction to review such

23 rule for compliance with section 553 of this title or under

24 any other provision of law shall have jurisdiction to review

25 such certification or analysis.
29

•S 343 RS

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

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

3 challenging a final agency regulation be commenced before

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

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

6 judicial review under this subsection.

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

8 of a final regulatory flexibility analysis pursuant to section

9 608(b), a petition for judicial review under this subsection

10 shall be filed not later than—

11 ‘‘(i) 1 year; or

12 ‘‘(ii) in a case in which a provision of law re13 quires that an action challenging a final agency reg14 ulation be commenced before the expiration of the 1-

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

16 of days specified in such provision of law,

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

18 ‘‘(3) For purposes of this subsection, the term ‘af19 fected small entity’ means a small entity that is or will

20 be adversely affected by the final rule.

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

22 affect the authority of any court to stay the effective date

23 of any rule or provision thereof under any other provision

24 of law.
30

•S 343 RS

1 ‘‘(5)(A) In a case in which an agency certifies that

2 such rule would not have a significant economic impact

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

4 order the agency to prepare a final regulatory flexibility

5 analysis pursuant to section 604 if the court determines,

6 on the basis of the rulemaking record, that the certifi7 cation was arbitrary, capricious, an abuse of discretion,

8 or otherwise not in accordance with law.

9 ‘‘(B) In a case in which the agency prepared a final

10 regulatory flexibility analysis, the court may order the

11 agency to take corrective action consistent with section

12 604 if the court determines, on the basis of the rulemaking

13 record, that the final regulatory flexibility analysis was

14 prepared by the agency without complying with section

15 604.

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

17 on the date of the order of the court pursuant to para18 graph (5) (or such longer period as the court may pro19 vide), the agency fails, as appropriate—

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

21 604; or

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

23 section 604 of this title,

24 the court may stay the rule or grant such other relief as

25 it deems appropriate.
31

•S 343 RS

1 ‘‘(7) In making any determination or granting any

2 relief authorized by this subsection, the court shall take

3 due account of the rule of prejudicial error.

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

5 any regulatory flexibility analysis for such rule (including

6 an analysis prepared or corrected pursuant to subsection

7 (a)(5)) shall constitute part of the whole record of agency

8 action in connection with such review.

9 ‘‘(c) Nothing in this section bars judicial review of

10 any other impact statement or similar analysis required

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

12 analysis is otherwise provided by law.’’.

13 (2) EFFECTIVE DATE.—The amendment made

14 by paragraph (1) shall take effect on the date of en15 actment of this Act, except that the judicial review

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

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

18 only to final agency rules issued after the date of en19 actment of this Act.

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

21 shall limit the exercise by the President of the authority

22 and responsibility that the President otherwise possesses

23 under the Constitution and other laws of the United

24 States with respect to regulatory policies, procedures, and

25 programs of departments, agencies, and offices.
32

•S 343 RS

1 (d) TECHNICAL AND CONFORMING AMENDMENTS.—

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

3 striking out the chapter heading and table of sections for

4 chapter 6 and inserting in lieu thereof the following:

5 ‘‘CHAPTER 6—THE ANALYSIS OF

6 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.

‘‘SUBCHAPTER IV—EXECUTIVE OVERSIGHT

‘‘651. Procedures.
33

•S 343 RS

‘‘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’’.

5 ƒSECTION 1. SHORT TITLE.

6 ƒThis Act may be cited as the ‘‘Comprehensive Regu7 latory Reform Act of 1995’’.

8 ƒSEC. 2. DEFINITIONS.

9 ƒSection 551 of title 5, United States Code, is amend10 ed—

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

12 and inserting in lieu thereof a semicolon;

13 ƒ(2) in paragraph (14), by striking out the pe14 riod and inserting in lieu thereof ‘‘; and’’; and

15 ƒ(3) by adding at the end thereof the following

16 new paragraph:

17 ƒ‘‘(15) ‘Director’ means the Director of the Of18 fice of Management and Budget.’’.

19 ƒSEC. 3. ANALYSIS OF AGENCY RULES.

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

21 States Code, is amended by adding at the end the following:
34

•S 343 RS

1 ƒ‘‘SUBCHAPTER II—ANALYSIS OF AGENCY RULES

2 ƒ‘‘§ 621. Definitions

3 ƒ‘‘For purposes of this subchapter the definitions

4 under section 551 shall apply and—

5 ƒ‘‘(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 ƒ‘‘(2) the term ‘cost’ means the reasonably iden11 tifiable significant adverse effects, including social,

12 environmental, and economic costs that are expected

13 to result directly or indirectly from implementation

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

15 rule;

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

17 evaluation of the costs and benefits of a rule, quan18 tified to the extent feasible and appropriate and oth19 erwise qualitatively described, that is prepared in ac20 cordance with the requirements of this subchapter at

21 the level of detail appropriate and practicable for rea22 soned decisionmaking on the matter involved, taking

23 into consideration the significance and complexity of

24 the decision and any need for expedition;

25 ƒ‘‘(4)(A) the term ‘major rule’ means—
35

•S 343 RS

1 ƒ‘‘(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 ƒ‘‘(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 ƒ‘‘(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 ƒ‘‘(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;
36

•S 343 RS

1 ƒ‘‘(III) a serious inconsistency or in2 terference with an action taken or planned

3 by another agency;

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

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

16 ƒ‘‘(ii) a rule or agency action that author17 izes the introduction into, or removal from, com18 merce, or recognizes the marketable status, of a

19 product; or

20 ƒ‘‘(iii) a rule exempt from notice and pub21 lic comment procedure under section 553 of this

22 title;

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

24 a regulatory program that—
37

•S 343 RS

1 ƒ‘‘(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 ƒ‘‘(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 ƒ‘‘(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 ƒ‘‘(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
38

•S 343 RS

1 risks to human health, safety, or the environment, on

2 each regulated person;

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

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

5 and

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

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

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

9 that approves or prescribes for the future rates,

10 wages, prices, services, corporate or financial

11 structures, reorganizations, mergers, acquisitions,

12 accounting practices, or disclosures bearing on

13 any of the foregoing;

14 ƒ‘‘(B) a rule relating to monetary policy

15 proposed or promulgated by the Board of Gov16 ernors of the Federal Reserve System or by the

17 Federal Open Market Committee;

18 ƒ‘‘(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
39

•S 343 RS

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 ƒ‘‘(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 ƒ‘‘§ 622. Rulemaking cost-benefit analysis

15 ƒ‘‘(a) Before publishing notice of a proposed rule16 making for any rule (or, in the case of a notice of a pro17 posed rulemaking that has been published on or before the

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

19 such date), each agency shall determine whether the rule

20 is or 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.
40

•S 343 RS

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

2 not 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 ƒ‘‘(2) Such determination shall be published in the

10 Federal Register, together with a succinct statement of the

11 basis for the determination.

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

25 analysis under clause (i), the agency shall give interested
41

•S 343 RS

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 ƒ‘‘(2) Each initial cost-benefit analysis shall con5 tain—

6 ƒ‘‘(A) an analysis of the benefits of the proposed

7 rule, including any benefits that cannot be quantified,

8 and an explanation of how the agency anticipates

9 that such benefits will be achieved by the proposed

10 rule, including a description of the persons or classes

11 of persons likely to receive such benefits;

12 ƒ‘‘(B) an analysis of the costs of the proposed

13 rule, including any costs that cannot be quantified,

14 and an explanation of how the agency anticipates

15 that such costs will result from the proposed rule, in16 cluding a description of the persons or classes of per17 sons likely to bear such costs;

18 ƒ‘‘(C) an identification (including an analysis

19 of costs and benefits) of an appropriate number of

20 reasonable alternatives allowed under the statute

21 granting the rulemaking authority for achieving the

22 identified benefits of the proposed rule, including al23 ternatives that—

24 ƒ‘‘(i) require no government action;
42

•S 343 RS

1 ƒ‘‘(ii) will accommodate differences among

2 geographic regions and among persons with dif3 fering levels of resources with which to comply;

4 and

5 ƒ‘‘(iii) employ voluntary programs, per6 formance standards, or market-based mecha7 nisms that permit greater flexibility in achieving

8 the identified benefits of the proposed rule and

9 that comply with the requirements of subpara10 graph (D);

11 ƒ‘‘(D) an assessment of the feasibility of estab12 lishing a regulatory program that operates through

13 the application of market-based mechanisms;

14 ƒ‘‘(E) an explanation of the extent to which the

15 proposed rule—

16 ƒ‘‘(i) will accommodate differences among

17 geographic regions and among persons with dif18 fering levels of resources with which to comply;

19 and

20 ƒ‘‘(ii) employs voluntary programs, per21 formance standards, or market-based mecha22 nisms that permit greater flexibility in achieving

23 the identified benefits of the proposed rule;

24 ƒ‘‘(F) a description of the quality, reliability,

25 and relevance of scientific or economic evaluations or
43

•S 343 RS

1 information in accordance with the cost-benefit anal2 ysis and risk assessment requirements of this chapter;

3 ƒ‘‘(G) if not expressly or implicitly inconsistent

4 with the statute under which the agency is proposing

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

6 identified benefits of the proposed rule justify the

7 identified costs of the proposed rule, and an expla8 nation of how the proposed rule is likely to substan9 tially achieve the rulemaking objectives in a more

10 cost-effective manner than the alternatives to the pro11 posed rule, including alternatives identified in ac12 cordance with subparagraph (C); and

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

14 addresses risks to human health, safety, or the envi15 ronment—

16 ƒ‘‘(i) a risk assessment in accordance with

17 this chapter; and

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

19 an assessment of incremental risk reduction or

20 other benefits associated with each significant

21 regulatory alternative considered by the agency

22 in connection with the rule or proposed rule.

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

24 the agency shall also issue and place in the rulemaking file
44

•S 343 RS

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

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

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

4 ƒ‘‘(A) a description and comparison of the bene5 fits and costs of the rule and of the reasonable alter6 natives to the rule described in the rulemaking, in7 cluding the market-based mechanisms identified

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

9 ƒ‘‘(B) if not expressly or implicitly inconsistent

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

11 reasonable determination, based upon the rulemaking

12 file considered as a whole, whether—

13 ƒ‘‘(i) the benefits of the rule justify the costs

14 of the rule; and

15 ƒ‘‘(ii) the rule will achieve the rulemaking

16 objectives in a more cost-effective manner than

17 the alternatives described in the rulemaking, in18 cluding the market-based mechanisms identified

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

20 ƒ‘‘(e)(1) The analysis of the benefits and costs of a pro21 posed and a final rule required under this section shall in22 clude, to the extent feasible, a quantification or numerical

23 estimate of the quantifiable benefits and costs. Such quan24 tification or numerical estimate shall be made in the most

25 appropriate units of measurement, using comparable as-
45

•S 343 RS

1 sumptions, including time periods, shall specify the ranges

2 of predictions, and shall explain the margins of error in3 volved in the quantification methods and in the estimates

4 used. An agency shall describe the nature and extent of the

5 nonquantifiable benefits and costs of a final rule pursuant

6 to this section in as precise and succinct a manner as pos7 sible. An agency shall not be required to make such evalua8 tion primarily on a mathematical or numerical basis.

9 ƒ‘‘(2)(A) In evaluating and comparing costs and bene10 fits and in evaluating the risk assessment information de11 veloped under subchapter III, the agency shall not rely on

12 cost, benefit, or risk assessment information that is not ac13 companied by data, analysis, or other supporting materials

14 that would enable the agency and other persons interested

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

16 uncertainty factors applicable to such information.

17 ƒ‘‘(B) The agency evaluations of the relationships of

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

19 be clearly articulated in accordance with this section.

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

21 that addresses risks to human health, safety, or the environ22 ment, the head of the agency or the President shall make

23 a determination that—

24 ƒ‘‘(1) the risk assessment and the analysis under

25 subsection (c)(2)(H) are based on a scientific evalua-
46

•S 343 RS

1 tion of the risk addressed by the major rule and that

2 the conclusions of such evaluation are supported by

3 the available information; and

4 ƒ‘‘(2) the regulatory alternative chosen will re5 duce risk in a cost-effective and, to the extent feasible,

6 flexible manner, taking into consideration any of the

7 alternatives identified under subsection (c)(2) (C) and

8 (D).

9 ƒ‘‘(g) The preparation of the initial or final cost-bene10 fit analysis required by this section shall only be performed

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

12 The preceding sentence shall not preclude a person outside

13 the agency from gathering data or information to be used

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

15 or from providing an explanation sufficient to permit the

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

17 data or information is gathered or explained by a person

18 outside the agency, the agency shall specifically identify in

19 the initial or final cost-benefit analysis the data or infor20 mation gathered or explained and the person who gathered

21 or explained it, and shall describe the arrangement by

22 which the information was procured by the agency, includ23 ing the total amount of funds expended for such procure24 ment.
47

•S 343 RS

1 ƒ‘‘(h) The requirements of this subchapter shall not

2 alter the criteria for rulemaking otherwise applicable under

3 other statutes.

4 ƒ‘‘§ 623. Judicial review

5 ƒ‘‘(a) Compliance or noncompliance by an agency

6 with the provisions of this subchapter and subchapter III

7 shall not be subject to judicial review except in connection

8 with review of a final agency rule and according to the pro9 visions of this section.

10 ƒ‘‘(b) Any determination by a designee of the Presi11 dent or the Director that a rule is, or is not, a major rule

12 shall not be subject to judicial review in any manner.

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

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

15 set aside by a reviewing court only upon a clear and con16 vincing showing that the determination is erroneous in

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

18 the agency made the determination. Any determination by

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

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

21 in any manner.

22 ƒ‘‘(d) If the cost-benefit analysis or risk assessment re23 quired under this chapter has been wholly omitted for any

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

25 case for further consideration. If an analysis or assessment
48

•S 343 RS

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

2 whether the analysis or assessment conformed to the par3 ticular requirements of this chapter.

4 ƒ‘‘(e) Any cost-benefit analysis or risk assessment pre5 pared under this chapter shall not be subject to judicial con6 sideration separate or apart from review of the agency ac7 tion to which it relates. When an action for judicial review

8 of an agency action is instituted, any regulatory analysis

9 for such agency action shall constitute part of the whole

10 administrative record of agency action for the purpose of

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

12 relevant, be considered by a court in determining the legal13 ity of the agency action.

14 ƒ‘‘§ 624. Deadlines for rulemaking

15 ƒ‘‘(a) All deadlines in statutes that require agencies

16 to propose or promulgate any rule subject to section 622

17 or subchapter III during the 2-year period beginning on

18 the effective date of this section shall be suspended until the

19 earlier of—

20 ƒ‘‘(1) the date on which the requirements of sec21 tion 622 or subchapter III are satisfied; or

22 ƒ‘‘(2) the date occurring 6 months after the date

23 of the applicable deadline.

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

25 States that would require an agency to propose or promul-
49

•S 343 RS

1 gate a rule subject to section 622 or subchapter III during

2 the 2-year period beginning on the effective date of this sec3 tion shall be suspended until the earlier of—

4 ƒ‘‘(1) the date on which the requirements of sec5 tion 622 or subchapter III are satisfied; or

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

7 of the applicable deadline.

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

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

10 beginning on the effective date of this section would create

11 an obligation to regulate through individual adjudications,

12 the deadline shall be suspended until the earlier of—

13 ƒ‘‘(1) the date on which the requirements of sec14 tion 622 or subchapter III are satisfied; or

15 ƒ‘‘(2) the date occurring 6 months after the date

16 of the applicable deadline.

17 ƒ‘‘§ 625. Agency review of rules

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

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

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

21 in accordance with this section, of—

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

23 such effective date and which, if adopted on such ef24 fective date, would be a major rule; and
50

•S 343 RS

1 ƒ‘‘(ii) each rule of the agency in effect on the ef2 fective date of this section (in addition to the rules de3 scribed in clause (i)) that the agency has selected for

4 review.

5 ƒ‘‘(B) Each proposed schedule required under sub6 paragraph (A) shall be developed in consultation with—

7 ƒ‘‘(i) the Administrator of the Office of Informa8 tion and Regulatory Affairs; and

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

10 including members from the regulated industries,

11 small businesses, State and local governments, and or12 ganizations representing the interested public.

13 ƒ‘‘(C) Each proposed schedule required under sub14 paragraph (A) shall establish priorities for the review of

15 rules that, in the joint determination of the Administrator

16 of the Office of Information and Regulatory Affairs and the

17 agency, most likely can be amended or eliminated to—

18 ƒ‘‘(i) provide the same or greater benefits at sub19 stantially lower costs;

20 ƒ‘‘(ii) achieve substantially greater benefits at

21 the same or lower costs; or

22 ƒ‘‘(iii) replace command-and-control regulatory

23 requirements with market mechanisms or performance

24 standards that achieve substantially equivalent bene25 fits at lower costs or with greater flexibility.
51

•S 343 RS

1 ƒ‘‘(D) Each proposed schedule required by subpara2 graph (A) shall include—

3 ƒ‘‘(i) a brief explanation of the reasons the agen4 cy considers each rule on the schedule to be a major

5 rule, or the reasons why the agency selected the rule

6 for review;

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

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

9 of each such rule; and

10 ƒ‘‘(iii) a statement that the agency requests com11 ments from the public on the proposed schedule.

12 ƒ‘‘(E) The agency shall set a date to initiate review

13 of each rule on the schedule in a manner that will ensure

14 the simultaneous review of related items and that will

15 achieve a reasonable distribution of reviews over the period

16 of time covered by the schedule.

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

18 Federal Register the proposed schedule required under para19 graph (1), each agency shall make the proposed schedule

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

21 President or that officer may select for review in accordance

22 with this section any additional rule.

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

24 this section, each agency shall publish in the Federal Reg25 ister a final schedule for the review of the rules referred
52

•S 343 RS

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

2 with the final schedule the response of the agency to com3 ments received concerning the proposed schedule.

4 ƒ‘‘(b)(1) Except as explicitly provided otherwise by

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

6 through (e), review—

7 ƒ‘‘(A) each rule on the schedule promulgated

8 pursuant to subsection (a);

9 ƒ‘‘(B) each major rule promulgated, amended, or

10 otherwise continued by an agency after the effective

11 date of this section; and

12 ƒ‘‘(C) each rule promulgated after the effective

13 date of this section that the President or the officer

14 designated by the President selects for review pursu15 ant to subsection (a)(2).

16 ƒ‘‘(2) Except as provided pursuant to subsection (f),

17 the review of a rule required by this section shall be com18 pleted no later than the later of—

19 ƒ‘‘(A) 10 years after the effective date of this sec20 tion; or

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

22 is—

23 ƒ‘‘(i) promulgated; or

24 ƒ‘‘(ii) amended or continued under this sec25 tion.
53

•S 343 RS

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

2 a notice of its proposed action under this section with re3 spect to a rule being reviewed. The notice shall include—

4 ƒ‘‘(1) an identification of the specific statutory

5 authority under which the rule was promulgated and

6 an explanation of whether the agency’s interpretation

7 of the statute is expressly required by the current text

8 of that statute or, if not, whether it is within the

9 range of permissible interpretations of the statute;

10 ƒ‘‘(2) an analysis of the benefits and costs of the

11 rule during the period in which it has been in effect;

12 ƒ‘‘(3) an explanation of the proposed agency ac13 tion with respect to the rule, including action to re14 peal or amend the rule to resolve inconsistencies or

15 conflicts with any other obligation or requirement es16 tablished by any Federal statute, rule, or other agency

17 statement, interpretation, or action that has the force

18 of law; and

19 ƒ‘‘(4) a statement that the agency seeks propos20 als from the public for modifications or alternatives

21 to the rule which may accomplish the objectives of the

22 rule in a more effective or less burdensome manner.

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

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

25 after issuing the notice required by subsection (c), comply
54

•S 343 RS

1 with the provisions of this chapter, chapter 5, and any other

2 applicable law. The requirements of such provisions and re3 lated requirements shall apply to the same extent and in

4 the same manner as in the case of a proposed agency action

5 to repeal or amend a rule that is not taken pursuant to

6 the review required by this section.

7 ƒ‘‘(e) If an agency proposes to continue without

8 amendment a rule under review pursuant to this section,

9 the agency shall—

10 ƒ‘‘(1) give interested persons no less than 60

11 days after the publication of the notice required by

12 subsection (c) to comment on the proposed continu13 ation; and

14 ƒ‘‘(2) publish in the Federal Register notice of

15 the continuation of such rule.

16 ƒ‘‘(f) Any agency, which for good cause finds that com17 pliance with this section with respect to a particular rule

18 during the period provided in subsection (b) of this section

19 is contrary to an important public interest may request the

20 President, or the officer designated by the President pursu21 ant to subsection (a)(2), to establish a period longer than

22 10 years for the completion of the review of such rule. The

23 President or that officer may extend the period for review

24 of a rule to a total period of no more than 15 years. Such
55

•S 343 RS

1 extension shall be published in the Federal Register with

2 an explanation of the reasons therefor.

3 ƒ‘‘(g) If the agency fails to comply with the require4 ments of subsection (b)(2), the rule for which rulemaking

5 proceedings have not been completed shall cease to be en6 forceable against any person.

7 ƒ‘‘(h) Nothing in this section shall relieve any agency

8 from its obligation to respond to a petition to issue, amend,

9 or repeal a rule, for an interpretation regarding the mean10 ing of a rule, or for a variance or exemption from the terms

11 of a rule, submitted pursuant to any other provision of law.

12 ƒ‘‘§ 626. Public participation and accountability

13 ƒ‘‘In order to maximize accountability for, and public

14 participation in, the development and review of regulatory

15 actions each agency shall, consistent with chapter 5 and

16 other applicable law, provide the public with opportunities

17 for meaningful participation in the development of regu18 latory actions, including—

19 ƒ‘‘(1) seeking the involvement, where practicable

20 and appropriate, of those who are intended to benefit

21 from and those who are expected to be burdened by

22 any regulatory action;

23 ƒ‘‘(2) providing in any proposed or final rule24 making notice published in the Federal Register—
56

•S 343 RS

1 ƒ‘‘(A) a certification of compliance with the

2 requirements of this chapter, or an explanation

3 why such certification cannot be made;

4 ƒ‘‘(B) a summary of any regulatory analy5 sis required under this chapter, or under any

6 other legal requirement, and notice of the avail7 ability of the regulatory analysis;

8 ƒ‘‘(C) a certification that the rule will

9 produce benefits that will justify the cost to the

10 Government and to the public of implementation

11 of, and compliance with, the rule, or an expla12 nation why such certification cannot be made;

13 and

14 ƒ‘‘(D) a summary of the results of any reg15 ulatory review and the agency’s response to such

16 review, including an explanation of any signifi17 cant changes made to such regulatory action as

18 a consequence of regulatory review;

19 ƒ‘‘(3) identifying, upon request, a regulatory ac20 tion and the date upon which such action was sub21 mitted to the designated officer to whom authority

22 was delegated under section 644 for review;

23 ƒ‘‘(4) disclosure to the public, consistent with

24 section 634(3), of any information created or collected

25 in performing a regulatory analysis required under
57

•S 343 RS

1 this chapter, or under any other legal requirement;

2 and

3 ƒ‘‘(5) placing in the appropriate rulemaking

4 record all written communications received from the

5 Director, other designated officer, or other individual

6 or entity relating to regulatory review.

7 ƒ‘‘SUBCHAPTER III—RISK ASSESSMENTS

8 ƒ‘‘§ 631. Findings and purposes

9 ƒ‘‘(a) The Congress finds that:

10 ƒ‘‘(1) Environmental, health, and safety regula11 tions have lead to dramatic improvements in the en12 vironment and have significantly reduced risks to

13 human health; except—

14 ƒ‘‘(A) many regulations have been more

15 costly and less effective than necessary; and

16 ƒ‘‘(B) too often, regulatory priorities have

17 not been based upon a realistic consideration of

18 risk, risk reduction opportunities, and costs.

19 ƒ‘‘(2) The public and private resources available

20 to address health, safety, and environmental risks are

21 not unlimited. Those resources should be allocated to

22 address the greatest needs in the most cost-effective

23 manner and to ensure that the incremental costs of

24 regulatory options are reasonably related to the incre25 mental benefits.
58

•S 343 RS

1 ƒ‘‘(3) To provide more cost-effective protection to

2 human health, safety, and the environment, regu3 latory priorities should be supported by realistic and

4 plausible scientific risk assessments and risk manage5 ment choices that are grounded in cost-benefit prin6 ciples.

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

8 decisionmaking tool, except—

9 ƒ‘‘(A) improvements are needed in both the

10 quality of assessments and the characterization

11 and communication of findings;

12 ƒ‘‘(B) scientific and other data must be bet13 ter collected, organized, and evaluated; and

14 ƒ‘‘(C) the critical information resulting

15 from a risk assessment must be effectively com16 municated in an objective and unbiased manner

17 to decision makers, and from decision makers to

18 the public.

19 ƒ‘‘(5) The public stakeholders should be involved

20 in the decisionmaking process for regulating risks.

21 The public has the right to know about the risks ad22 dressed by regulation, the amount of risk reduced, the

23 quality of the science used to support decisions, and

24 the cost of implementing and complying with regula25 tions. Such knowledge will allow for public scrutiny
59

•S 343 RS

1 and will promote the quality, integrity, and respon2 siveness of agency decisions.

3 ƒ‘‘(b) The purposes of this subchapter are to—

4 ƒ‘‘(1) present the public and executive branch

5 with the most realistic and plausible information con6 cerning the nature and magnitude of health, safety,

7 and environmental risks to promote sound regulatory

8 decisions and public education;

9 ƒ‘‘(2) provide for full consideration and discus10 sion of relevant data and potential methodologies;

11 ƒ‘‘(3) require explanation of significant choices

12 in the risk assessment process that will allow for bet13 ter public understanding; and

14 ƒ‘‘(4) improve consistency within the executive

15 branch in preparing risk assessments and risk char16 acterizations.

17 ƒ‘‘§ 632. Definitions

18 ƒ‘‘For purposes of this subchapter, the definitions

19 under sections 551 and 621 shall apply and:

20 ƒ‘‘(1) The term ‘covered agency’ means each of

21 the following:

22 ƒ‘‘(A) The Environmental Protection Agen23 cy.

24 ƒ‘‘(B) The Department of Labor.

25 ƒ‘‘(C) The Department of Transportation.
60

•S 343 RS

1 ƒ‘‘(D) The Food and Drug Administration.

2 ƒ‘‘(E) The Department of Energy.

3 ƒ‘‘(F) The Department of the Interior.

4 ƒ‘‘(G) The Department of Agriculture.

5 ƒ‘‘(H) The Consumer Product Safety Com6 mission.

7 ƒ‘‘(I) The National Oceanic and Atmos8 pheric Administration.

9 ƒ‘‘(J) The United States Army Corps of

10 Engineers.

11 ƒ‘‘(K) The Nuclear Regulatory Commission.

12 ƒ‘‘(L) Any other Federal agency considered

13 a covered agency under section 633(b).

14 ƒ‘‘(2) The term ‘emergency’ means a situation

15 that is immediately impending and extraordinary in

16 nature, demanding attention due to a condition, cir17 cumstance or practice reasonably expected to cause

18 death, serious illness or severe injury to humans, or

19 substantial endangerment to private property or the

20 environment if no action is taken.

21 ƒ‘‘(3) The term ‘estimates of risk’ means numer22 ical representations of the potential magnitude of

23 harm to populations or the probability of harm to in24 dividuals, including, as appropriate, those derived by

25 considering the range and distribution of estimates of
61

•S 343 RS

1 dose-response (potency) and exposure, including ap2 propriate statistical representation of the range and

3 most likely exposure levels, and the identification of

4 the populations or subpopulations addressed. When

5 appropriate and practicable, a description of any

6 populations or subpopulations that are likely to expe7 rience exposures at the upper end of the distribution

8 should be included.

9 ƒ‘‘(4) The term ‘hazard identification’ means

10 identification of a substance, activity, or condition as

11 potentially causing harm to human health, safety, or

12 the environment.

13 ƒ‘‘(5) The term ‘risk assessment’ means—

14 ƒ‘‘(A) identifying, quantifying to the extent

15 feasible and appropriate, and characterizing

16 hazards and exposures to those hazards in order

17 to provide structured information on the nature

18 of threats to human health, safety, or the envi19 ronment; and

20 ƒ‘‘(B) the document containing the expla21 nation of how the assessment process has been

22 applied to an individual substance, activity, or

23 condition.

24 ƒ‘‘(6) The term ‘risk characterization’ means the

25 integration, synthesis, and organization of hazard
62

•S 343 RS

1 identification, dose-response and exposure informa2 tion that addresses the needs of decision makers and

3 interested parties. The term includes both the process

4 and specific outputs, including—

5 ƒ‘‘(A) the element of a risk assessment that

6 involves presentation of the degree of risk in any

7 regulatory proposal or decision, report to Con8 gress, or other document that is made available

9 to the public; and

10 ƒ‘‘(B) discussions of uncertainties, conflict11 ing data, estimates of risk, extrapolations, infer12 ences, and opinions.

13 ƒ‘‘(7) The term ‘screening analysis’ means an

14 analysis that arrives at a qualitative estimate or a

15 bounding estimate of risk that permits the risk man16 ager to accept or reject some management options, or

17 permits establishing priorities for agency action. Such

18 term includes an assessment performed by a regulated

19 party and submitted to an agency under a regulatory

20 requirement.

21 ƒ‘‘(8) The term ‘substitution risk’ means a rea22 sonably likely increased risk to human health, safety,

23 or the environment from a regulatory option designed

24 to decrease other risks.
63

•S 343 RS

1 ƒ‘‘§ 633. Applicability

2 ƒ‘‘(a) Except as provided in subsection (c), this sub3 chapter shall apply to all risk assessments and risk charac4 terizations prepared by, or on behalf of, or prepared by oth5 ers and adopted by any covered agency in connection with

6 a major rule addressing health, safety, and environmental

7 risks.

8 ƒ‘‘(b)(1) No later than 18 months after the effective

9 date of this section, the President, acting through the Direc10 tor of the Office of Management and Budget, shall determine

11 whether other Federal agencies should be considered covered

12 agencies for the purposes of this subchapter. Such deter13 mination, with respect to a particular Federal agency, shall

14 be based on the impact of risk assessment documents and

15 risk characterization documents on—

16 ƒ‘‘(A) regulatory programs administered by that

17 agency; and

18 ƒ‘‘(B) the communication of risk information by

19 that agency to the public.

20 ƒ‘‘(2) If the President makes a determination under

21 paragraph (1), the provisions of this subchapter shall apply

22 to any affected agency beginning on a date set by the Presi23 dent. Such date may be no later than 6 months after the

24 date of such determination.

25 ƒ‘‘(c)(1) This subchapter shall not apply to risk assess26 ments or risk characterizations performed with respect to—
64

•S 343 RS

1 ƒ‘‘(A) an emergency determined by the head of

2 an agency;

3 ƒ‘‘(B) a health, safety, or environmental inspec4 tion or individual facility permitting action; or

5 ƒ‘‘(C) a screening analysis.

6 ƒ‘‘(2) This subchapter shall not apply to any food,

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

8 appearing on any such label.

9 ƒ‘‘§ 634. Savings provisions

10 ƒ‘‘Nothing in this subchapter shall be construed to—

11 ƒ‘‘(1) modify any statutory standard or require12 ment designed to protect human health, safety, or the

13 environment;

14 ƒ‘‘(2) preclude the consideration of any data or

15 the calculation of any estimate to more fully describe

16 risk or provide examples of scientific uncertainty or

17 variability; or

18 ƒ‘‘(3) require the disclosure of any trade secret

19 or other confidential information.

20 ƒ‘‘§ 635. Principles for risk assessment

21 ƒ‘‘(a) The head of each covered agency shall ensure

22 that risk assessments and all of the components of such as23 sessments—

24 ƒ‘‘(1) provide for a systematic means to struc25 ture information useful to decision makers;
65

•S 343 RS

1 ƒ‘‘(2) provide, to the maximum extent prac2 ticable, that policy-driven default assumptions be used

3 only in the absence of relevant available information;

4 ƒ‘‘(3) promote involvement from all stakeholders;

5 ƒ‘‘(4) provide an opportunity for public input

6 throughout the regulatory process; and

7 ƒ‘‘(5) are designed so that the degree of specific8 ity and rigor employed is commensurate with the con9 sequences of the decision to be made.

10 ƒ‘‘(b) A risk assessment shall, to the maximum extent

11 practicable, clearly delineate hazard identification from

12 dose-response and exposure assessment and make clear the

13 relationship between the level of risk and the level of expo14 sure to a hazard.

15 ƒ‘‘§ 636. Principles for risk characterization

16 ƒ‘‘In characterizing risk in any risk assessment docu17 ment, regulatory proposal, or decision, each covered agency

18 shall include in the risk characterization, as appropriate,

19 each of the following:

20 ƒ‘‘(1)(A) A description of the exposure scenarios

21 used, the natural resources or subpopulations being

22 exposed, and the likelihood of those exposure scenarios.

23 ƒ‘‘(B) When a risk assessment involves a choice

24 of any significant assumption, inference, or model,
66

•S 343 RS

1 the covered agency or instrumentality preparing the

2 risk assessment shall—

3 ƒ‘‘(i) identify the assumptions, inferences,

4 and models that materially affect the outcome;

5 ƒ‘‘(ii) explain the basis for any choices;

6 ƒ‘‘(iii) identify any policy decisions or pol7 icy-based default assumptions;

8 ƒ‘‘(iv) indicate the extent to which any sig9 nificant model has been validated by, or conflicts

10 with, empirical data; and

11 ƒ‘‘(v) describe the impact of alternative

12 choices of assumptions, default options or mathe13 matical models.

14 ƒ‘‘(C) The major sources of uncertainties in the

15 hazard identification, dose-response and exposure as16 sessment phases of the risk assessment.

17 ƒ‘‘(D) To the extent feasible, the range and dis18 tribution of exposures and risks derived from the risk

19 assessment should be included as a component of the

20 risk characterization.

21 ƒ‘‘(2) When a covered agency provides a risk as22 sessment or risk characterization for a proposed or

23 final regulatory action, such assessment or character24 ization shall include a statement of any significant
67

•S 343 RS

1 substitution risks, when information on such risks has

2 been made available to the agency.

3 ƒ‘‘§ 637. Peer review

4 ƒ‘‘(a) The head of each covered agency shall develop

5 a systematic program for independent and external peer re6 view required under subsection (b). Such program shall be

7 applicable throughout each covered agency and—

8 ƒ‘‘(1) shall provide for the creation of peer re9 view panels that—

10 ƒ‘‘(A) consist of members with expertise rel11 evant to the sciences involved in regulatory deci12 sions and who are independent of the covered

13 agency; and

14 ƒ‘‘(B) are broadly representative and bal15 anced and, to the extent relevant and appro16 priate, may include persons affiliated with Fed17 eral, State, local, or tribal governments, small

18 businesses, other representatives of industry, uni19 versities, agriculture, labor consumers, conserva20 tion organizations, or other public interest

21 groups and organizations;

22 ƒ‘‘(2) shall not exclude any person with substan23 tial and relevant expertise as a panel member on the

24 basis that such person represents an entity that may

25 have a potential interest in the outcome, if such inter-
68

•S 343 RS

1 est is fully disclosed to the agency, and in the case of

2 a regulatory decision affecting a single entity, no peer

3 reviewer representing such entity may be included on

4 the panel;

5 ƒ‘‘(3) shall provide for a timely completed peer

6 review, meeting agency deadlines, that contains a bal7 anced presentation of all considerations, including

8 minority reports and an agency response to all sig9 nificant peer review comments; and

10 ƒ‘‘(4) shall provide adequate protections for con11 fidential business information and trade secrets, in12 cluding requiring panel members to enter into con13 fidentiality agreements.

14 ƒ‘‘(b)(1)(A) Except as provided under subparagraph

15 (B), each covered agency shall provide for peer review in

16 accordance with this section of any risk assessment or cost17 benefit analysis that forms the basis of any major rule that

18 addresses risks to the environment, health, or safety.

19 ƒ‘‘(B) Subparagraph (A) shall not apply to a rule or

20 other action taken by an agency to authorize or approve

21 any individual substance or product.

22 ƒ‘‘(2) The Director of the Office of Management and

23 Budget may order that peer review be provided for any risk

24 assessment or cost-benefit analysis that is likely to have a
69

•S 343 RS

1 significant impact on public policy decisions or would es2 tablish an important precedent.

3 ƒ‘‘(c) Each peer review under this section shall include

4 a report to the Federal agency concerned with respect to

5 the scientific and technical merit of data and methods used

6 for the risk assessments or cost-benefit analyses.

7 ƒ‘‘(d) The head of the covered agency shall provide a

8 written response to all significant peer review comments.

9 ƒ‘‘(e) All peer review comments or conclusions and the

10 agency’s responses shall be made available to the public and

11 shall be made part of the administrative record for purposes

12 of judicial review of any final agency action.

13 ƒ‘‘(f) No peer review shall be required under this sec14 tion for any data, method, document, or assessment, or any

15 component thereof, which has been previously subjected to

16 peer review.

17 ƒ‘‘§ 638. Guidelines, plan for assessing new informa18 tion, and report

19 ƒ‘‘(a)(1)(A) As soon as practicable and scientifically

20 feasible, each covered agency shall adopt, after notification

21 and opportunity for public comment, guidelines to imple22 ment the risk assessment and risk characterization prin23 ciples under sections 635 and 636, as well as the cost-benefit

24 analysis requirements under section 622, and shall provide

25 a format for summarizing risk assessment results.
70

•S 343 RS

1 ƒ‘‘(B) No later than 12 months after the effective date

2 of this section, the head of each covered agency shall issue

3 a report on the status of such guidelines to the Congress.

4 ƒ‘‘(2) The guidelines under paragraph (1) shall—

5 ƒ‘‘(A) include guidance on use of specific tech6 nical methodologies and standards for acceptable

7 quality of specific kinds of data;

8 ƒ‘‘(B) address important decisional factors for

9 the risk assessment, risk characterization, and cost10 benefit analysis at issue; and

11 ƒ‘‘(C) provide procedures for the refinement and

12 replacement of policy-based default assumptions.

13 ƒ‘‘(b) The guidelines, plan and report under this sec14 tion shall be developed after notice and opportunity for pub15 lic comment, and after consultation with representatives of

16 appropriate State agencies and local governments, and such

17 other departments and agencies, organizations, or persons

18 as may be advisable.

19 ƒ‘‘(c) The President shall review the guidelines pub20 lished under this section at least every 4 years.

21 ƒ‘‘(d) The development, issuance, and publication of

22 risk assessment and risk characterization guidelines under

23 this section shall not be subject to judicial review.
71

•S 343 RS

1 ƒ‘‘§ 639. Research and training in risk assessment

2 ƒ‘‘(a) The head of each covered agency shall regularly

3 and systematically evaluate risk assessment research and

4 training needs of the agency, including, where relevant and

5 appropriate, the following:

6 ƒ‘‘(1) Research to reduce generic data gaps, to

7 address modelling needs (including improved model

8 sensitivity), and to validate default options, particu9 larly those common to multiple risk assessments.

10 ƒ‘‘(2) Research leading to improvement of meth11 ods to quantify and communicate uncertainty and

12 variability among individuals, species, populations,

13 and, in the case of ecological risk assessment, ecologi14 cal communities.

15 ƒ‘‘(3) Emerging and future areas of research, in16 cluding research on comparative risk analysis, expo17 sure to multiple chemicals and other stressors,

18 noncancer endpoints, biological markers of exposure

19 and effect, mechanisms of action in both mammalian

20 and nonmammalian species, dynamics and prob21 abilities of physiological and ecosystem exposures, and

22 prediction of ecosystem-level responses.

23 ƒ‘‘(4) Long-term needs to adequately train indi24 viduals in risk assessment and risk assessment appli25 cation. Evaluations under this paragraph shall in-
72

•S 343 RS

1 clude an estimate of the resources needed to provide

2 necessary training.

3 ƒ‘‘(b) The head of each covered agency shall develop

4 a strategy and schedule for carrying out research and train5 ing to meet the needs identified in subsection (a).

6 ƒ‘‘§ 640. Interagency coordination

7 ƒ‘‘(a) To promote the conduct, application, and prac8 tice of risk assessment in a consistent manner and to iden9 tify risk assessment data and research needs common to

10 more than 1 Federal agency, the Director of the Office of

11 Management and Budget, in consultation with the Office

12 of Science and Technology Policy, shall—

13 ƒ‘‘(1) periodically survey the manner in which

14 each Federal agency involved in risk assessment is

15 conducting such risk assessment to determine the

16 scope and adequacy of risk assessment practices in

17 use by the Federal Government;

18 ƒ‘‘(2) provide advice and recommendations to

19 the President and Congress based on the surveys con20 ducted and determinations made under paragraph

21 (1);

22 ƒ‘‘(3) establish appropriate interagency mecha23 nisms to promote—

24 ƒ‘‘(A) coordination among Federal agencies

25 conducting risk assessment with respect to the
73

•S 343 RS

1 conduct, application, and practice of risk assess2 ment; and

3 ƒ‘‘(B) the use of state-of-the-art risk assess4 ment practices throughout the Federal Govern5 ment;

6 ƒ‘‘(4) establish appropriate mechanisms between

7 Federal and State agencies to communicate state-of8 the-art risk assessment practices; and

9 ƒ‘‘(5) periodically convene meetings with State

10 government representatives and Federal and other

11 leaders to assess the effectiveness of Federal and State

12 cooperation in the development and application of

13 risk assessment.

14 ƒ‘‘(b) The President shall appoint National Peer Re15 view Panels to review every 3 years the risk assessment

16 practices of each covered agency for programs designed to

17 protect human health, safety, or the environment. The Pan18 els shall submit a report to the President and the Congress

19 at least every 3 years containing the results of such review.

20 ƒ‘‘§ 640a. Plan for review of risk assessments

21 ƒ‘‘(a) No later than 18 months after the effective date

22 of this section, the head of each covered agency shall publish

23 a plan to review and revise any risk assessment published

24 before the expiration of such 18-month period if the covered

25 agency determines that significant new information or
74

•S 343 RS

1 methodologies are available that could significantly alter

2 the results of the prior risk assessment.

3 ƒ‘‘(b) A plan under subsection (a) shall—

4 ƒ‘‘(1) provide procedures for receiving and con5 sidering new information and risk assessments from

6 the public; and

7 ƒ‘‘(2) set priorities and criteria for review and

8 revision of risk assessments based on such factors as

9 the agency head considers appropriate.

10 ƒ‘‘§ 640b. Judicial review

11 ƒ‘‘The provisions of section 623 relating to judicial re12 view shall apply to this subchapter.

13 ƒ‘‘§ 640c. Deadlines for rulemaking

14 ƒ‘‘The provisions of section 624 relating to deadlines

15 for rulemaking shall apply to this subchapter.

16 ƒ‘‘SUBCHAPTER IV—EXECUTIVE OVERSIGHT

17 ƒ‘‘§ 641. Definition

18 ƒ‘‘For purposes of this subchapter, the definitions

19 under sections 551 and 621 shall apply.

20 ƒ‘‘§ 642. Procedures

21 ƒ‘‘The Director or other designated officer to whom au22 thority is delegated under section 644 shall—

23 ƒ‘‘(1) establish procedures for agency compliance

24 with this chapter; and
75

•S 343 RS

1 ƒ‘‘(2) monitor, review, and ensure agency imple2 mentation of such procedures.

3 ƒ‘‘§ 643. Promulgation and adoption

4 ƒ‘‘(a) Procedures established pursuant to section 642

5 shall only be implemented after opportunity for public com6 ment. Any such procedures shall be consistent with the

7 prompt completion of rulemaking proceedings.

8 ƒ‘‘(b)(1) If procedures established pursuant to section

9 642 include review of any initial or final analyses of a rule

10 required under this chapter, the time for any such review

11 of any initial analysis shall not exceed 60 days following

12 the receipt of the analysis by the Director, a designee of

13 the President, or by an officer to whom the authority grant14 ed under section 642 has been delegated pursuant to section

15 644.

16 ƒ‘‘(2) The time for review of any final analysis re17 quired under this chapter shall not exceed 60 days following

18 the receipt of the analysis by the Director, a designee of

19 the President, or such officer.

20 ƒ‘‘(3)(A) The times for each such review may be ex21 tended for good cause by the President or such officer for

22 an additional 30 days.

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

24 succinct statement of the reasons therefor, shall be inserted

25 in the rulemaking file.
76

•S 343 RS

1 ƒ‘‘§ 644. Delegation of authority

2 ƒ‘‘(a) The President shall delegate the authority grant3 ed by this subchapter to the Director or to another officer

4 within the Executive Office of the President whose appoint5 ment has been subject to the advice and consent of the Sen6 ate.

7 ƒ‘‘(b) Notice of any delegation, or any revocation or

8 modification thereof shall be published in the Federal Reg9 ister.

10 ƒ‘‘§ 645. Public disclosure of information

11 ƒ‘‘The Director or other designated officer to whom au12 thority is delegated under section 644, in carrying out the

13 provisions of section 642, shall establish procedures (cover14 ing all employees of the Director or other designated officer)

15 to provide public and agency access to information concern16 ing regulatory review actions, including—

17 ƒ‘‘(1) disclosure to the public on an ongoing

18 basis of information regarding the status of regu19 latory actions undergoing review;

20 ƒ‘‘(2) disclosure to the public, no later than pub21 lication of, or other substantive notice to the public

22 concerning a regulatory action, of—

23 ƒ‘‘(A) all written communications, regard24 less of form or format, including drafts of all

25 proposals and associated analyses, between the
77

•S 343 RS

1 Director or other designated officer and the regu2 latory agency;

3 ƒ‘‘(B) all written communications, regard4 less of form or format, between the Director or

5 other designated officer and any person not em6 ployed by the executive branch of the Federal

7 Government relating to the substance of a regu8 latory action;

9 ƒ‘‘(C) a record of all oral communications

10 relating to the substance of a regulatory action

11 between the Director or other designated officer

12 and any person not employed by the executive

13 branch of the Federal Government; and

14 ƒ‘‘(D) a written explanation of any review

15 action and the date of such action; and

16 ƒ‘‘(3) disclosure to the regulatory agency, on a

17 timely basis, of—

18 ƒ‘‘(A) all written communications between

19 the Director or other designated officer and any

20 person who is not employed by the executive

21 branch of the Federal Government;

22 ƒ‘‘(B) a record of all oral communications,

23 and an invitation to participate in meetings, re24 lating to the substance of a regulatory action be25 tween the Director or other designated officer
78

•S 343 RS

1 and any person not employed by the executive

2 branch of the Federal Government; and

3 ƒ‘‘(C) a written explanation of any review

4 action taken concerning an agency regulatory

5 action.

6 ƒ‘‘§ 646. Judicial review

7 ƒ‘‘The exercise of the authority granted under this sub8 chapter by the Director, the President, or by an officer to

9 whom such authority has been delegated under section 644

10 shall not be subject to judicial review in any manner.’’.

11 ƒ(b) REGULATORY FLEXIBILITY ANALYSIS.—

12 ƒ(1) IN GENERAL.—Section 611 of title 5,

13 United States Code, is amended to read as follows:

14 ƒ‘‘§ 611. Judicial review

15 ƒ‘‘(a)(1) Except as provided in paragraph (2), no

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

17 respect to which an agency—

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

19 such rule would not have a significant economic im20 pact on a substantial number of small entities; or

21 ƒ‘‘(B) prepared a final regulatory flexibility

22 analysis pursuant to section 604,

23 an affected small entity may petition for the judicial review

24 of such certification or analysis in accordance with this

25 subsection. A court having jurisdiction to review such rule
79

•S 343 RS

1 for compliance with section 553 of this title or under any

2 other provision of law shall have jurisdiction to review such

3 certification or analysis.

4 ƒ‘‘(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 judi9 cial review under this subsection.

10 ƒ‘‘(B) In a case in which an agency delays the issu11 ance of a final regulatory flexibility analysis pursuant to

12 section 608(b), a petition for judicial review under this sub13 section shall be filed no later than—

14 ƒ‘‘(i) 1 year; or

15 ƒ‘‘(ii) in a case in which a provision of law re16 quires that an action challenging a final agency regu17 lation be commenced before the expiration of the 1-

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

19 days specified in such provision of law,

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

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

25 affect the authority of any court to stay the effective date
80

•S 343 RS

1 of any rule or provision thereof under any other provision

2 of law.

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

18 on 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 ƒ‘‘(A) to prepare the analysis required by sec22 tion 604; or

23 ƒ‘‘(B) to take corrective action consistent with

24 section 604 of this title,
81

•S 343 RS

1 the court may stay the rule or grant such other relief as

2 it deems appropriate.

3 ƒ‘‘(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 ƒ‘‘(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 ƒ‘‘(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 ƒ(2) EFFECTIVE DATE.— The amendment made

16 by paragraph (1) shall take effect on the effective date

17 of this Act, except that the judicial review authorized

18 by section 611(a) of title 5, United States Code (as

19 added by subsection (a)), shall apply only to final

20 agency rules issued after such effective date.

21 ƒ(c) PRESIDENTIAL AUTHORITY.— Nothing in this

22 Act 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
82

•S 343 RS

1 with respect to regulatory policies, procedures, and pro2 grams of departments, agencies, and offices.

3 ƒ(d) TECHNICAL AND CONFORMING AMENDMENTS.—

4 ƒ(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 ƒ‘‘CHAPTER 6—THE ANALYSIS OF

9 REGULATORY FUNCTIONS

ƒ‘‘SUBCHAPTER I—REGULATORY ANALYSIS

ƒ‘‘Sec.

ƒ‘‘601. Definitions.

ƒ‘‘602. Regulatory agenda.

ƒ‘‘603. Initial regulatory flexibility analysis.

ƒ‘‘604. Final regulatory flexibility analysis.

ƒ‘‘605. Avoidance of duplicative or unnecessary analyses.

ƒ‘‘606. Effect on other law.

ƒ‘‘607. Preparation of analysis.

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

ƒ‘‘609. Procedures for gathering comments.

ƒ‘‘610. Periodic review of rules.

ƒ‘‘611. Judicial review.

ƒ‘‘612. Reports and intervention rights.

ƒ‘‘SUBCHAPTER II—ANALYSIS OF AGENCY RULES

ƒ‘‘621. Definitions.

ƒ‘‘622. Rulemaking cost-benefit analysis.

ƒ‘‘623. Judicial review.

ƒ‘‘624. Deadlines for rulemaking.

ƒ‘‘625. Agency review of rules.

ƒ‘‘626. Public participation and accountability.

ƒ‘‘SUBCHAPTER III—RISK ASSESSMENTS

ƒ‘‘631. Findings and purposes.

ƒ‘‘632. Definitions.

ƒ‘‘633. Applicability.

ƒ‘‘634. Savings provisions.

ƒ‘‘635. Principles for risk assessment.

ƒ‘‘636. Principles for risk characterization.

ƒ‘‘637. Peer review.

ƒ‘‘638. Guidelines, plan for assessing new information, and report.

ƒ‘‘639. Research and training in risk assessment.
83

•S 343 RS

ƒ‘‘640. Interagency coordination.

ƒ‘‘640a. Plan for review of risk assessments.

ƒ‘‘640b. Judicial review.

ƒ‘‘640c. Deadlines for rulemaking.

ƒ‘‘SUBCHAPTER IV—EXECUTIVE OVERSIGHT

ƒ‘‘641. Definition.

ƒ‘‘642. Procedures.

ƒ‘‘643. Promulgation and adoption.

ƒ‘‘644. Delegation of authority.

ƒ‘‘645. Public disclosure of information.

ƒ‘‘646. Judicial review.’’.

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

2 amended by inserting immediately before section 601,

3 the following subchapter heading:

4 ƒ‘‘SUBCHAPTER I—REGULATORY ANALYSIS’’.

5 ƒSEC. 4. CONGRESSIONAL REVIEW.

6 ƒ(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 ƒ‘‘CHAPTER 8—CONGRESSIONAL REVIEW

10 OF AGENCY RULEMAKING

11 ƒ‘‘§ 801. Congressional review of agency rulemaking

12 ƒ‘‘(a) For purposes of this chapter, the term—

13 ƒ‘‘(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 ƒ‘‘(2) ‘rule’ (except in reference to a rule of the

17 Senate or House of Representatives) is a reference to

18 a major rule.
84

•S 343 RS

1 ƒ‘‘(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 ƒ‘‘(2) A rule submitted under paragraph (1) shall not

6 take effect as a final rule before the latest of the following:

7 ƒ‘‘(A) The later of the date occurring 45 days

8 after the date on which—

9 ƒ‘‘(i) the Congress receives the rule submit10 ted under paragraph (1); or

11 ƒ‘‘(ii) the rule is published in the Federal

12 Register.

13 ƒ‘‘(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 ƒ‘‘(i) on which either House of Congress

18 votes and fails to override the veto of the Presi19 dent; or

20 ƒ‘‘(ii) occurring 30 session days after the

21 date on which the Congress received the veto and

22 objections of the President.

23 ƒ‘‘(C) The date the rule would have otherwise

24 taken effect, if not for this section (unless a joint reso-
85

•S 343 RS

1 lution of disapproval under subsection (i) is ap2 proved).

3 ƒ‘‘(c) A major rule shall not take effect as a final rule

4 if the Congress passes a joint resolution of disapproval de5 scribed under subsection (i), which is signed by the Presi6 dent or is vetoed and overridden by the Congress.

7 ƒ‘‘(d)(1) Notwithstanding any other provision of this

8 section (except subject to paragraph (2)), a major rule that

9 would not take effect by reason of this section may take ef10 fect if the President makes a determination and submits

11 written notice of such determination to the Congress that

12 the major rule should take effect because such major rule

13 is—

14 ƒ‘‘(A) necessary because of an imminent threat

15 to health or safety, or other emergency;

16 ƒ‘‘(B) necessary for the enforcement of criminal

17 laws; or

18 ƒ‘‘(C) necessary for national security.

19 ƒ‘‘(2) An exercise by the President of the authority

20 under this subsection shall have no effect on the procedures

21 under subsection (i) or the effect of a joint resolution of dis22 approval under this section.

23 ƒ‘‘(e)(1) Subsection (i) shall apply to any major rule

24 that is promulgated as a final rule during the period begin25 ning on the date occurring 60 days before the date the Con-
86

•S 343 RS

1 gress adjourns sine die through the date on which the suc2 ceeding Congress first convenes.

3 ƒ‘‘(2) For purposes of subsection (i), a major rule de4 scribed under paragraph (1) shall be treated as though such

5 rule were published in the Federal Register (as a rule that

6 shall take effect as a final rule) on the date the succeeding

7 Congress first convenes.

8 ƒ‘‘(3) During the period between the date the Congress

9 adjourns sine die through the date on which the succeeding

10 Congress first convenes, a rule described under paragraph

11 (1) shall take effect as a final rule as otherwise provided

12 by law.

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

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

15 under subsection (i) shall be treated as though such rule

16 had never taken effect.

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

18 of disapproval under subsection (i), no court or agency may

19 infer any intent of the Congress from any action or inaction

20 of the Congress with regard to such major rule, related stat21 ute, or joint resolution of disapproval.

22 ƒ‘‘(h) If the agency fails to comply with the require23 ments of subsection (b) for any rule, the rule shall cease

24 to be enforceable against any person.
87

•S 343 RS

1 ƒ‘‘(i)(1) For purposes of this subsection, the term ‘joint

2 resolution’ means only a joint resolution introduced after

3 the date on which the rule referred to in subsection (b) is

4 received by Congress the matter after the resolving clause

5 of which is as follows: ‘That Congress disapproves the rule

6 submitted by the llllll relating to

7 lllllll, and such rule shall have no force or ef8 fect.’ (The blank spaces being appropriately filled in.)

9 ƒ‘‘(2)(A) In the Senate, a resolution described in para10 graph (1) shall be referred to the committees with jurisdic11 tion. Such a resolution shall not be reported before the

12 eighth day after its submission or publication date.

13 ƒ‘‘(B) For purposes of this subsection, the term ‘sub14 mission or publication date’ means the later of the date on

15 which—

16 ƒ‘‘(i) the Congress receives the rule submitted

17 under subsection (b)(1); or

18 ƒ‘‘(ii) the rule is published in the Federal Reg19 ister.

20 ƒ‘‘(3) In the Senate, if the committee to which a reso21 lution described in paragraph (1) is referred has not re22 ported such resolution (or an identical resolution) at the

23 end of 20 calendar days after its submission or publication

24 date, such committee may be discharged on a petition ap25 proved by 30 Senators from further consideration of such
88

•S 343 RS

1 resolution and such resolution shall be placed on the Senate

2 calendar.

3 ƒ‘‘(4)(A) In the Senate, when the committee to which

4 a resolution is referred has reported, or when a committee

5 is discharged (under paragraph (3)) from further consider6 ation of, a resolution described in paragraph (1), it shall

7 at any time thereafter be in order (even though a previous

8 motion to the same effect has been disagreed to) for any

9 Senator to move to proceed to the consideration of the reso10 lution, and all points of order against the resolution (and

11 against consideration of the resolution) shall be waived. The

12 motion shall be privileged in the Senate and shall not be

13 debatable. The motion shall not be subject to amendment,

14 or to a motion to postpone, or to a motion to proceed to

15 the consideration of other business. A motion to reconsider

16 the vote by which the motion is agreed to or disagreed to

17 shall not be in order. If a motion to proceed to the consider18 ation of the resolution is agreed to, the resolution shall re19 main the unfinished business of the Senate until disposed

20 of.

21 ƒ‘‘(B) In the Senate, debate on the resolution, and on

22 all debatable motions and appeals in connection therewith,

23 shall be limited to not more than 10 hours, which shall be

24 divided equally between those favoring and those opposing

25 the resolution. A motion further to limit debate shall be in
89

•S 343 RS

1 order and shall not be debatable. An amendment to, or a

2 motion to postpone, or a motion to proceed to the consider3 ation of other business, or a motion to recommit the resolu4 tion shall not be in order. A motion to reconsider the vote

5 by which the resolution is agreed to or disagreed to shall

6 not be in order.

7 ƒ‘‘(C) In the Senate, immediately following the conclu8 sion of the debate on a resolution described in paragraph

9 (1), and a single quorum call at the conclusion of the debate

10 if requested in accordance with the Senate rules, the vote

11 on final passage of the resolution shall occur.

12 ƒ‘‘(D) Appeals from the decisions of the Chair relating

13 to the application of the rules of the Senate to the procedure

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

15 be decided without debate.

16 ƒ‘‘(5) If, before the passage in the Senate of a resolu17 tion described in paragraph (1), the Senate receives from

18 the House of Representatives a resolution described in para19 graph (1), then the following procedures shall apply:

20 ƒ‘‘(A) The resolution of the House of Representa21 tives shall not be referred to a committee.

22 ƒ‘‘(B) With respect to a resolution described in

23 paragraph (1) of the Senate—
90

•S 343 RS

1 ƒ‘‘(i) the procedure in the Senate shall be

2 the same as if no resolution had been received

3 from the other House; but

4 ƒ‘‘(ii) the vote on final passage shall be on

5 the resolution of the other House.

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

7 ƒ‘‘(A) as an exercise of the rulemaking power of

8 the Senate and House of Representatives, respectively,

9 and as such it is deemed to be a part of the rules of

10 each House, respectively, but applicable only with re11 spect to the procedure to be followed in that House in

12 the case of a resolution described in paragraph (1),

13 and it supersedes other rules only to the extent that

14 it is inconsistent with such rules; and

15 ƒ‘‘(B) with full recognition of the constitutional

16 right of either House to change the rules (so far as re17 lating to the procedure of that House) at any time,

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

19 case of any other rule of that House.

20 ƒ‘‘(j) No requirements under this chapter shall be sub21 ject to judicial review in any manner.’’.

22 ƒ(b) TECHNICAL AND CONFORMING AMENDMENT.—

23 The table of chapters for part I of title 5, United States

24 Code, is amended by inserting after the item relating to

25 chapter 7 the following:

‘‘8. Congressional Review of Agency Rulemaking ................... 801’’.
91

•S 343 RS

1 ƒSEC. 5. STUDIES AND REPORTS.

2 ƒ(a) RISK ASSESSMENTS.—The Administrative Con3 ference of the United States shall—

4 ƒ(1) develop and carry out an ongoing study of

5 the operation of the risk assessment requirements of

6 subchapter III of chapter 6 of title 5, United States

7 Code (as added by section 3 of this Act); and

8 ƒ(2) submit an annual report to the Congress on

9 the findings of the study.

10 ƒ(b) ADMINISTRATIVE PROCEDURE ACT.—No later

11 than December 31, 1996, the Administrative Conference of

12 the United States shall—

13 ƒ(1) carry out a study of the operation of chap14 ters 5 and 6 of title 5, United States Code (commonly

15 referred to as the Administrative Procedure Act), as

16 amended by section 3 of this Act; and

17 ƒ(2) submit a report to the Congress on the find18 ings of the study, including proposals for revision, if

19 any.

20 ƒSEC. 6. RISK-BASED PRIORITIES.

21 ƒ(a) PURPOSES.—The purposes of this section are

22 to—

23 ƒ(1) encourage Federal agencies engaged in reg24 ulating risks to human health, safety, and the envi25 ronment to achieve the greatest risk reduction at the

26 least cost practical;
92

•S 343 RS

1 ƒ(2) promote the coordination of policies and

2 programs to reduce risks to human health, safety, and

3 the environment; and

4 ƒ(3) promote open communication among Fed5 eral agencies, the public, the President, and Congress

6 regarding environmental, health, and safety risks,

7 and the prevention and management of those risks.

8 ƒ(b) DEFINITIONS.—For the purposes of this section:

9 ƒ(1) COMPARATIVE RISK ANALYSIS.—The term

10 ‘‘comparative risk analysis’’ means a process to sys11 tematically estimate, compare, and rank the size and

12 severity of risks to provide a common basis for evalu13 ating strategies for reducing or preventing those risks.

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

15 agency’’ means each of the following:

16 ƒ(A) The Environmental Protection Agen17 cy.

18 ƒ(B) The Department of Labor.

19 ƒ(C) The Department of Transportation.

20 ƒ(D) The Food and Drug Administration.

21 ƒ(E) The Department of Energy.

22 ƒ(F) The Department of the Interior.

23 ƒ(G) The Department of Agriculture.

24 ƒ(H) The Consumer Product Safety Com25 mission.
93

•S 343 RS

1 ƒ(I) The National Oceanic and Atmos2 pheric Administration.

3 ƒ(J) The United States Army Corps of En4 gineers.

5 ƒ(K) The Nuclear Regulatory Commission.

6 ƒ(3) EFFECT.—The term ‘‘effect’’ means a delete7 rious change in the condition of—

8 ƒ(A) a human or other living thing (includ9 ing death, cancer, or other chronic illness, de10 creased reproductive capacity, or disfigurement);

11 or

12 ƒ(B) an inanimate thing important to

13 human welfare (including destruction, degenera14 tion, the loss of intended function, and increased

15 costs for maintenance).

16 ƒ(4) IRREVERSIBILITY.—The term ‘‘irre17 versibility’’ means the extent to which a return to

18 conditions before the occurrence of an effect are either

19 very slow or will never occur.

20 ƒ(5) LIKELIHOOD.—The term ‘‘likelihood’’

21 means the estimated probability that an effect will

22 occur.

23 ƒ(6) MAGNITUDE.—The term ‘‘magnitude’’

24 means the number of individuals or the quantity of

25 ecological resources or other resources that contribute
94

•S 343 RS

1 to human welfare that are affected by exposure to a

2 stressor.

3 ƒ(7) SERIOUSNESS.—The term ‘‘seriousness’’

4 means the intensity of effect, the likelihood, the

5 irreversibility, and the magnitude.

6 ƒ(c) DEPARTMENT AND AGENCY PROGRAM GOALS.—

7 ƒ(1) SETTING PRIORITIES.—In exercising au8 thority under applicable laws protecting human

9 health, safety, or the environment, the head of each

10 covered agency should set priorities and use the re11 sources available under those laws to address those

12 risks to human health, safety, and the environment

13 that—

14 ƒ(A) the covered agency determines to be

15 the most serious; and

16 ƒ(B) can be addressed in a cost-effective

17 manner, with the goal of achieving the greatest

18 overall net reduction in risks with the public and

19 private sector resources expended.

20 ƒ(2) DETERMINING THE MOST SERIOUS

21 RISKS.—In identifying the greatest risks under para22 graph (1) of this subsection, each covered agency shall

23 consider, at a minimum—

24 ƒ(A) the likelihood, irreversibility, and se25 verity of the effect; and
95

•S 343 RS

1 ƒ(B) the number and classes of individuals

2 potentially affected, and shall explicitly take into

3 account the results of the comparative risk anal4 ysis conducted under subsection (d) of this sec5 tion.

6 ƒ(3) OMB REVIEW.—The covered agency’s deter7 minations of the most serious risks for purposes of set8 ting priorities shall be reviewed and approved by the

9 Director of the Office of Management and Budget be10 fore submission of the covered agency’s annual budget

11 requests to Congress.

12 ƒ(4) INCORPORATING RISK-BASED PRIORITIES

13 INTO BUDGET AND PLANNING.—The head of each cov14 ered agency shall incorporate the priorities identified

15 under paragraph (1) into the agency budget, strategic

16 planning, regulatory agenda, enforcement, and re17 search activities. When submitting its budget request

18 to Congress and when announcing its regulatory

19 agenda in the Federal Register, each covered agency

20 shall identify the risks that the covered agency head

21 has determined are the most serious and can be ad22 dressed in a cost-effective manner under paragraph

23 (1), the basis for that determination, and explicitly

24 identify how the covered agency’s requested budget

25 and regulatory agenda reflect those priorities.
96

•S 343 RS

1 ƒ(5) EFFECTIVE DATE.—This subsection shall

2 take effect 12 months after the date of enactment of

3 this Act.

4 ƒ(d) COMPARATIVE RISK ANALYSIS.—

5 ƒ(1) REQUIREMENT.—(A)(i) No later than 6

6 months after the effective date of this Act, the Director

7 of the Office of Management and Budget shall enter

8 into appropriate arrangements with an accredited

9 scientific body—

10 ƒ(I) to conduct a study of the methodologies

11 for using comparative risk to rank dissimilar

12 human health, safety, and environmental risks;

13 and

14 ƒ(II) to conduct a comparative risk analy15 sis.

16 ƒ(ii) The comparative risk analysis shall com17 pare and rank, to the extent feasible, human health,

18 safety, and environmental risks potentially regulated

19 across the spectrum of programs administered by all

20 covered agencies.

21 ƒ(B) The Director shall consult with the Office

22 of Science and Technology Policy regarding the scope

23 of the study and the conduct of the comparative risk

24 analysis.
97

•S 343 RS

1 ƒ(2) CRITERIA.—In arranging for the compara2 tive risk analysis referred to in paragraph (1) of this

3 subsection, the Director shall ensure that—

4 ƒ(A) the scope and specificity of the analy5 sis are sufficient to provide the President and

6 agency heads guidance in allocating resources

7 across agencies and among programs in agencies

8 to achieve the greatest degree of risk prevention

9 and reduction for the public and private re10 sources expended;

11 ƒ(B) the analysis is conducted through an

12 open process, by individuals with relevant exper13 tise, including toxicologists, biologists, engineers

14 and experts in medicine, industrial hygiene and

15 environmental effects;

16 ƒ(C) the analysis is conducted, to the extent

17 feasible, consistent with the risk assessment and

18 risk characterization principles in sections 635

19 and 636 of this title;

20 ƒ(D) the methodologies and principal sci21 entific determinations made in the analysis are

22 subjected to independent and external peer re23 view consistent with section 637, and the conclu24 sions of the peer review are made publicly avail-
98

•S 343 RS

1 able as part of the final report required under

2 subsection (e);

3 ƒ(E) there is an opportunity for public

4 comment on the results before making them final;

5 and

6 ƒ(F) the results are presented in a manner

7 that distinguishes between the scientific conclu8 sions and any policy or value judgments em9 bodied in the comparisons.

10 ƒ(3) COMPLETION AND REVIEW.—No later than

11 3 years after the effective date of this Act, the com12 parative risk analysis required under paragraph (1)

13 shall be completed. The comparative risk analysis

14 shall be reviewed and revised at least every 5 years

15 thereafter for a minimum of 15 years following the

16 release of the first analysis. The Director shall ar17 range for such review and revision with an accredited

18 scientific body in the same manner as provided under

19 paragraphs (1) and (2).

20 ƒ(4) STUDY.—The study of methodologies pro21 vided under paragraph (1) shall be conducted as part

22 of the first comparative risk analysis and shall be

23 completed no later than 180 days after the completion

24 of that analysis. The goal of the study shall be to de25 velop and rigorously test methods of comparative risk
99

•S 343 RS

1 analysis. The study shall have sufficient scope and

2 breadth to test approaches for improving comparative

3 risk analysis and its use in setting priorities for

4 human health, safety, and environmental risk preven5 tion and reduction.

6 ƒ(5) TECHNICAL GUIDANCE.—No later than 180

7 days after the effective date of this Act, the Director,

8 in collaboration with other heads of covered agencies

9 shall enter into a contract with the National Research

10 Council to provide technical guidance to agencies on

11 approaches to using comparative risk analysis in set12 ting human health, safety, and environmental prior13 ities to assist agencies in complying with subsection

14 (c) of this section.

15 ƒ(e) REPORTS AND RECOMMENDATIONS TO CONGRESS

16 AND THE PRESIDENT.—No later than 24 months after the

17 effective date of this Act, each covered agency shall submit

18 a report to Congress and the President—

19 ƒ(1) detailing how the agency has complied with

20 subsection (c) and describing the reasons for any de21 parture from the requirement to establish priorities to

22 achieve the greatest overall net reduction in risk;

23 ƒ(2) recommending—

24 ƒ(A) modification, repeal, or enactment of

25 laws to reform, eliminate, or enhance programs
100

•S 343 RS

1 or mandates relating to human health, safety, or

2 the environment; and

3 ƒ(B) modification or elimination of statu4 torily or judicially mandated deadlines,

5 that would assist the covered agency to set priorities

6 in activities to address the risks to human health,

7 safety, or the environment in a manner consistent

8 with the requirements of subsection (c)(1);

9 ƒ(3) evaluating the categories of policy and

10 value judgments used in risk assessment, risk charac11 terization, or cost-benefit analysis; and

12 ƒ(4) discussing risk assessment research and

13 training needs, and the agency’s strategy and schedule

14 for meeting those needs.

15 ƒ(f) SAVINGS PROVISION AND JUDICIAL REVIEW.—

16 ƒ(1) IN GENERAL.—Nothing in this section shall

17 be construed to modify any statutory standard or re18 quirement designed to protect human health, safety,

19 or the environment.

20 ƒ(2) JUDICIAL REVIEW.—Compliance or non21 compliance by an agency with the provisions of this

22 section shall not be subject to judicial review.

23 ƒ(3) AGENCY ANALYSIS.—Any analysis prepared

24 under this section shall not be subject to judicial con25 sideration separate or apart from the requirement,
101

•S 343 RS

1 rule, program, or law to which it relates. When an

2 action for judicial review of a covered agency action

3 is instituted, any analysis for, or relating to, the ac4 tion shall constitute part of the whole record of agency

5 action for the purpose of judicial review of the action

6 and shall, to the extent relevant, be considered by a

7 court in determining the legality of the covered agen8 cy action.

9 ƒSEC. 7. REGULATORY ACCOUNTING.

10 ƒ(a) DEFINITIONS.—For purposes of this section, the

11 following definitions apply:

12 ƒ(1) AGENCY.—The term ‘‘agency’’ means any

13 executive department, military department, Govern14 ment corporation, Government controlled corporation,

15 or other establishment in the executive branch of the

16 Government (including the Executive Office of the

17 President), or any independent regulatory agency, but

18 shall not include—

19 ƒ(A) the General Accounting Office;

20 ƒ(B) the Federal Election Commission;

21 ƒ(C) the governments of the District of Co22 lumbia and of the territories and possessions of

23 the United States, and their various subdivi24 sions; or
102

•S 343 RS

1 ƒ(D) government-owned contractor-operated

2 facilities, including laboratories engaged in na3 tional defense research and production activities.

4 ƒ(2) REGULATION.—The term ‘‘regulation’’

5 means an agency statement of general applicability

6 and future effect designed to implement, interpret, or

7 prescribe law or policy or describing the procedures or

8 practice requirements of an agency. The term shall

9 not include—

10 ƒ(A) administrative actions governed by

11 sections 556 and 557 of title 5, United States

12 Code;

13 ƒ(B) regulations issued with respect to a

14 military or foreign affairs function of the United

15 States; or

16 ƒ(C) regulations related to agency organi17 zation, management, or personnel.

18 ƒ(b) ACCOUNTING STATEMENT.—

19 ƒ(1) IN GENERAL.—(A) The President shall be

20 responsible for implementing and administering the

21 requirements of this section.

22 ƒ(B) Every 2 years, no later than June of the

23 second year, the President shall prepare and submit

24 to Congress an accounting statement that estimates

25 the annual costs of Federal regulatory programs and
103

•S 343 RS

1 corresponding benefits in accordance with this sub2 section.

3 ƒ(2) YEARS COVERED BY ACCOUNTING STATE4 MENT.—Each accounting statement shall cover, at a

5 minimum, the 5 fiscal years beginning on October 1

6 of the year in which the report is submitted and may

7 cover any fiscal year preceding such fiscal years for

8 purpose of revising previous estimates.

9 ƒ(3) TIMING AND PROCEDURES.—(A) The Presi10 dent shall provide notice and opportunity for com11 ment for each accounting statement. The President

12 may delegate to an agency the requirement to provide

13 notice and opportunity to comment for the portion of

14 the accounting statement relating to that agency.

15 ƒ(B) The President shall propose the first ac16 counting statement under this subsection no later

17 than 2 years after the effective date of this Act and

18 shall issue the first accounting statement in final

19 form no later than 3 years after such effective date.

20 Such statement shall cover, at a minimum, each of

21 the fiscal years beginning after the effective date of

22 this Act.

23 ƒ(4) CONTENT OF ACCOUNTING STATEMENT.—

24 (A) Each accounting statement shall contain esti25 mates of costs and benefits with respect to each fiscal
104

•S 343 RS

1 year covered by the statement in accordance with this

2 paragraph. For each such fiscal year for which esti3 mates were made in a previous accounting statement,

4 the statement shall revise those estimates and state the

5 reasons for the revisions.

6 ƒ(B)(i) An accounting statement shall estimate

7 the costs of Federal regulatory programs by setting

8 forth, for each year covered by the statement—

9 ƒ(I) the annual expenditure of national eco10 nomic resources for each regulatory program;

11 and

12 ƒ(II) such other quantitative and quali13 tative measures of costs as the President consid14 ers appropriate.

15 ƒ(ii) For purposes of the estimate of costs in the

16 accounting statement, national economic resources

17 shall include, and shall be listed under, at least the

18 following categories:

19 ƒ(I) Private sector costs.

20 ƒ(II) Federal sector costs.

21 ƒ(III) State and local government costs.

22 ƒ(C) An accounting statement shall estimate the

23 benefits of Federal regulatory programs by setting

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

25 quantitative and qualitative measures of benefits as
105

•S 343 RS

1 the President considers appropriate. Any estimates of

2 benefits concerning reduction in human health, safety,

3 or environmental risks shall present the most plau4 sible level of risk practical, along with a statement of

5 the reasonable degree of scientific certainty.

6 ƒ(c) ASSOCIATED REPORT TO CONGRESS.—

7 ƒ(1) IN GENERAL.—At the same time as the

8 President submits an accounting statement under

9 subsection (b), the President, acting through the Di10 rector of the Office of Management and Budget, shall

11 submit to Congress a report associated with the ac12 counting statement (hereinafter referred to as an ‘‘as13 sociated report’’). The associated report shall contain,

14 in accordance with this subsection—

15 ƒ(A) analyses of impacts; and

16 ƒ(B) recommendations for reform.

17 ƒ(2) ANALYSES OF IMPACTS.—The President

18 shall include in the associated report the following:

19 ƒ(A) The cumulative impact on the econ20 omy of Federal regulatory programs covered in

21 the accounting statement. Factors to be consid22 ered in such report shall include impacts on the

23 following:

24 ƒ(i) The ability of State and local gov25 ernments to provide essential services, in-
106

•S 343 RS

1 cluding police, fire protection, and edu2 cation.

3 ƒ(ii) Small business.

4 ƒ(iii) Productivity.

5 ƒ(iv) Wages.

6 ƒ(v) Economic growth.

7 ƒ(vi) Technological innovation.

8 ƒ(vii) Consumer prices for goods and

9 services.

10 ƒ(viii) Such other factors considered

11 appropriate by the President.

12 ƒ(B) A summary of any independent anal13 yses of impacts prepared by persons commenting

14 during the comment period on the accounting

15 statement.

16 ƒ(3) RECOMMENDATIONS FOR REFORM.—The

17 President shall include in the associated report the

18 following:

19 ƒ(A) A summary of recommendations of the

20 President for reform or elimination of any Fed21 eral regulatory program or program element that

22 does not represent sound use of national eco23 nomic resources or otherwise is inefficient.

24 ƒ(B) A summary of any recommendations

25 for such reform or elimination of Federal regu-
107

•S 343 RS

1 latory programs or program elements prepared

2 by persons commenting during the comment pe3 riod on the accounting statement.

4 ƒ(d) GUIDANCE FROM OFFICE OF MANAGEMENT AND

5 BUDGET.—The Director of the Office of Management and

6 Budget shall, in consultation with the Council of Economic

7 Advisers and the agencies, develop guidance for the agen8 cies—

9 ƒ(1) to standardize measures of costs and bene10 fits in accounting statements prepared pursuant to

11 this section and section 3 of this Act, including—

12 ƒ(A) detailed guidance on estimating the

13 costs and benefits of major rules; and

14 ƒ(B) general guidance on estimating the

15 costs and benefits of all other rules that do not

16 meet the thresholds for major rules; and

17 ƒ(2) to standardize the format of the accounting

18 statements.

19 ƒ(e) RECOMMENDATIONS FROM CONGRESSIONAL

20 BUDGET OFFICE.—After each accounting statement and as21 sociated report submitted to Congress, the Director of the

22 Congressional Budget Office shall make recommendations

23 to the President—
108

•S 343 RS

1 ƒ(1) for improving accounting statements pre2 pared pursuant to this section, including rec3 ommendations on level of detail and accuracy; and

4 ƒ(2) for improving associated reports prepared

5 pursuant to this section, including recommendations

6 on the quality of analysis.

7 ƒ(f) JUDICIAL REVIEW.—No requirements under this

8 section shall be subject to judicial review in any manner.

9 ƒSEC. 8. EFFECTIVE DATE.

10 ƒExcept as otherwise provided in this Act, this Act

11 shall take effect 180 days after the date of the enactment

12 of this Act.≈

13 SECTION 1. SHORT TITLE.

14 This Act may be cited as the ‘‘Comprehen15 sive Regulatory Reform Act of 1995’’.

16 SEC. 2. DEFINITIONS.

17 Section 551 of title 5, United States Code,

18 is amended—

19 (1) in the matter preceding paragraph

20 (1), by striking ‘‘this subchapter’’ and in21 serting ‘‘this chapter and chapters 6, 7,

22 and 8’’;

23 (2) in paragraph (13), by striking

24 ‘‘and’’;
109

•S 343 RS

1 (3) in paragraph (14), by striking the

2 period at the end and inserting ‘‘; and’’;

3 and

4 (4) by adding at the end the following

5 new paragraph:

6 ‘‘(15) ‘Director’ means the Director of

7 the Office of Management and Budget.’’.

8 SEC. 3. RULEMAKING.

9 Section 553 of title 5, United States Code,

10 is amended to read as follows:

11 ‘‘§ 553. Rulemaking

12 ‘‘(a) This section applies to every rule13 making, according to the provisions thereof,

14 except to the extent that there is involved—

15 ‘‘(1) a matter pertaining to a military

16 or foreign affairs function of the United

17 States;

18 ‘‘(2) a matter relating to the manage19 ment and personnel practices of an agen20 cy;

21 ‘‘(3) an interpretive rule, general

22 statement of policy, guidance, or rule of

23 agency organization, procedure, or prac24 tice that is not generally applicable and
110

•S 343 RS

1 does not alter or create rights or obliga2 tions of persons outside the agency; or

3 ‘‘(4) a rule relating to the acquisition,

4 management, or disposal by an agency of

5 real or personal property, or of services,

6 that is promulgated in compliance with

7 criteria and procedures established by the

8 Administrator of General Services.

9 ‘‘(b)(1) General notice of proposed rule10 making shall be published in the Federal Reg11 ister, unless all persons subject thereto are

12 named and either personally served or other13 wise have actual notice of the proposed rule14 making in accordance with law. Each notice

15 of proposed rulemaking shall include—

16 ‘‘(A) a statement of the time, place,

17 and nature of public rulemaking proceed18 ings;

19 ‘‘(B) a succinct explanation of the

20 need for and specific objectives of the pro21 posed rule, including an explanation of

22 the agency’s determination of whether or

23 not the rule is a major rule within the

24 meaning of section 621(4);
111

•S 343 RS

1 ‘‘(C) an explanation of the specific

2 statutory interpretation under which a

3 rule is proposed, including an expla4 nation of—

5 ‘‘(i) whether the interpretation is

6 expressly required by the text of the

7 statute; or

8 ‘‘(ii) if the interpretation is not ex9 pressly required by the text of the stat10 ute, an explanation that the interpre11 tation is within the range of permis12 sible interpretations of the statute as

13 identified by the agency, and an ex14 planation why the interpretation se15 lected by the agency is the agency’s

16 preferred interpretation;

17 ‘‘(D) the proposed provisions of the

18 rule;

19 ‘‘(E) a summary of any initial analysis

20 of the proposed rule required to be pre21 pared or issued pursuant to chapter 6;

22 ‘‘(F) a statement that the agency seeks

23 proposals from the public and from State

24 and local governments for alternative

25 methods to accomplish the objectives of
112

•S 343 RS

1 the rulemaking that are more effective or

2 less burdensome than the approach used

3 in the proposed rule;

4 ‘‘(G) a description of any data, meth5 odologies, reports, studies, scientific eval6 uations, or other similar information

7 available to the agency for the rule8 making, including an identification of

9 each author or source of such information

10 and the purposes for which the agency

11 plans to rely on such information; and

12 ‘‘(H) a statement specifying where the

13 file of the rulemaking proceeding main14 tained pursuant to subsection (f) may be

15 inspected and how copies of the items in

16 the file may be obtained.

17 ‘‘(2) Except when notice or hearing is re18 quired by statute, a final rule may be adopted

19 and may become effective without prior com20 pliance with this subsection and subsections

21 (c) and (f) if—

22 ‘‘(A) the agency for good cause finds

23 that providing notice and public proce24 dure thereon before the rule becomes effec25 tive is contrary to an important public in-
113

•S 343 RS

1 terest or is unnecessary due to the insig2 nificant impact of the rule;

3 ‘‘(B) the agency publishes the rule in

4 the Federal Register with such finding

5 and a succinct explanation of the reasons

6 therefor; and

7 ‘‘(C) the agency complies with this

8 subsection and subsections (c) and (f) to

9 the maximum extent feasible prior to the

10 promulgation of the final rule, and fully

11 complies with such provisions as soon as

12 reasonably practicable after the promul13 gation of the rule.

14 ‘‘(3) Whenever the provisions of a final rule

15 that an agency plans to adopt are so different

16 from the provisions of the proposed rule that

17 the original notice of proposed rulemaking did

18 not fairly apprise the public of the issues ulti19 mately to be resolved in the rulemaking or of

20 the substance of the rule, the agency shall pub21 lish in the Federal Register a notice of the

22 final rule the agency plans to adopt, together

23 with the information relevant to such rule that

24 is required by the applicable provisions of this

25 section and that has not previously been pub-
114

•S 343 RS

1 lished in the Federal Register. The agency

2 shall allow a reasonable period for comment

3 on such final rule.

4 ‘‘(c)(1) After providing the notice required

5 by this section, the agency shall give interested

6 persons not less than 60 days to participate in

7 the rulemaking through the submission of

8 written data, views, or arguments.

9 ‘‘(2)(A) To collect relevant information,

10 and to identify and elicit full and representa11 tive public comment on the significant issues

12 of a particular rulemaking, the agency may

13 use such other procedures as the agency deter14 mines are appropriate, including—

15 ‘‘(i) the publication of an advance no16 tice of proposed rulemaking;

17 ‘‘(ii) the provision of notice, in forms

18 which are more direct than notice pub19 lished in the Federal Register, to persons

20 who would be substantially affected by the

21 proposed rule, but who are unlikely to re22 ceive notice of the proposed rulemaking

23 through the Federal Register;

24 ‘‘(iii) the provision of opportunities for

25 oral presentation of data, views, informa-
115

•S 343 RS

1 tion, or rebuttal arguments at informal

2 public hearings, which may be held in the

3 District of Columbia and other locations;

4 ‘‘(iv) the provision of summaries, ex5 planatory materials, or other technical

6 information in response to public inquir7 ies concerning the issues involved in the

8 rulemaking; and

9 ‘‘(v) the adoption or modification of

10 agency procedural rules to reduce the cost

11 or complexity of participation in a rule12 making.

13 ‘‘(B) The decision of an agency to use or not

14 to use such other procedures in a rulemaking

15 pursuant to this paragraph shall not be sub16 ject to judicial review.

17 ‘‘(3) To ensure an orderly and expeditious

18 proceeding, an agency may establish reason19 able procedures to regulate the course of infor20 mal public hearings under paragraphs (1)

21 and (2), including the designation of rep22 resentatives to make oral presentations or en23 gage in direct or cross-examination on behalf

24 of several parties with a common interest in a
116

•S 343 RS

1 rulemaking. Transcripts shall be made of all

2 such public hearings.

3 ‘‘(4) An agency shall publish any final rule

4 it adopts in the Federal Register, together with

5 a concise statement of the basis and purpose

6 of the rule and a statement of when the rule

7 may become effective. The statement of basis

8 and purpose shall include—

9 ‘‘(A) an explanation of the need for,

10 objectives of, and specific statutory au11 thority for, the rule;

12 ‘‘(B) a discussion of, and response to,

13 any significant factual or legal issues

14 raised by the comments on the proposed

15 rule prior to its promulgation, including

16 a description of the reasonable alter17 natives to the rule proposed by the agency

18 and by interested persons, and the reasons

19 why each such alternative was rejected;

20 ‘‘(C)(i) an explanation of whether the

21 specific statutory interpretation upon

22 which the rule is based is expressly re23 quired by the text of the statute; or

24 ‘‘(ii) if the specific statutory interpre25 tation upon which the rule is based is not
117

•S 343 RS

1 expressly required by the text of the stat2 ute, an explanation that the interpreta3 tion is within the range of permissible in4 terpretations of the statute as identified

5 by the agency, and why the agency has re6 jected other interpretations proposed in

7 comments to the agency;

8 ‘‘(D) an explanation of how the fac9 tual conclusions upon which the rule is

10 based are substantially supported in the

11 rulemaking file maintained pursuant to

12 subsection (f); and

13 ‘‘(E) a summary of any final analysis

14 of the rule required to be prepared or is15 sued pursuant to chapter 6.

16 ‘‘(5) The provisions of sections 556 and 557

17 shall apply in lieu of this subsection in the

18 case of rules that are required by statute to be

19 made on the record after opportunity for an

20 agency hearing.

21 ‘‘(d) An agency shall publish the final rule

22 in the Federal Register not less than 60 days

23 before the effective date of such rule. An agen24 cy may make a rule effective in less than 60

25 days after publication in the Federal Register
118

•S 343 RS

1 if the rule grants or recognizes an exemption,

2 relieves a restriction, or if the agency for good

3 cause finds that such a delay in the effective

4 date would be contrary to an important public

5 interest and publishes such finding and an ex6 planation of the reasons therefor, with the

7 final rule.

8 ‘‘(e)(1) Each agency shall give an inter9 ested person the right to petition for the issu10 ance, amendment, or repeal of a rule.

11 ‘‘(2) Each person subject to a major rule

12 may petition—

13 ‘‘(A) for the issuance, amendment, or

14 repeal of such rule;

15 ‘‘(B) for the amendment or repeal of

16 an interpretive rule or general statement

17 of policy or guidance;

18 ‘‘(C) for an interpretation regarding

19 the meaning of the rule, interpretive rule,

20 general statement of policy, or guidance;

21 and

22 ‘‘(D) for a variance or exemption from

23 the terms of the rule.

24 ‘‘(3)(A) Any person subject to a rule, inter25 pretive rule, general statement of policy, or
119

•S 343 RS

1 guidance may petition an agency for the

2 amendment or repeal of any rule, interpretive

3 rule, general statement of policy, or guidance.

4 ‘‘(B) If such petition presents a reasonable

5 likelihood that, considering its future impact,

6 the rule, interpretive rule, general statement

7 of policy, or guidance is, or has the effect of,

8 a major rule within the meaning of section

9 621(4), and its amendment or repeal is re10 quired to satisfy the decisional criteria of sec11 tion 624, the agency shall grant the petition

12 and shall, within one year, conduct a cost-ben13 efit analysis under chapter 6.

14 ‘‘(C) If, considering its future impact, the

15 rule, interpretive rule, general statement of

16 policy, or guidance does not satisfy the re17 quirements of chapter 6, including the

18 decisional criteria set forth in section 624, the

19 agency shall take immediate action either to

20 revoke or to amend the rule, interpretive rule,

21 general statement of policy, or guidance to

22 conform it to the requirements of chapter 6, in23 cluding the decisional criteria in section 624.

24 ‘‘(4) The agency shall grant or deny a peti25 tion made pursuant to this subsection, and
120

•S 343 RS

1 give written notice of its determination to the

2 petitioner, with reasonable promptness, but in

3 no event later than 180 days after the petition

4 was received by the agency. The written notice

5 of the agency’s determination shall include an

6 explanation of the determination and a re7 sponse to each factual and legal claim that

8 forms the basis of the petition. A decision to

9 deny a petition shall be subject to judicial re10 view immediately upon denial, as final agency

11 action under the statute granting the agency

12 authority to carry out its action.

13 ‘‘(5) Following a decision to grant or deny

14 a petition to conduct a cost-benefit analysis for

15 a rule, interpretive rule, general statement of

16 policy, or guidance under this subsection, no

17 further petition for such rule, interpretive

18 rule, general statement of policy, or guidance,

19 submitted by the same person, shall be consid20 ered by any agency unless such petition is

21 based on a change in a fact, circumstance, or

22 provision of law underlying or otherwise relat23 ed to the rule, interpretive rule, general state24 ment of policy, or guidance occurring since the

25 initial petition was granted or denied, that
121

•S 343 RS

1 warrants the amendment or repeal of the rule,

2 interpretive rule, general statement of policy,

3 or guidance.

4 ‘‘(f)(1) The agency shall maintain a file for

5 each rulemaking proceeding conducted pursu6 ant to this section and shall maintain a cur7 rent index to such file. The file and the mate8 rial excluded from the file pursuant to para9 graph (4) shall constitute the rulemaking

10 record for purposes of judicial review. Except

11 as provided in paragraph (4), the file shall be

12 made available to the public beginning on the

13 date on which the agency makes an initial

14 publication concerning the rule.

15 ‘‘(2) The rulemaking file shall include—

16 ‘‘(A) the notice of proposed rule17 making, any supplement to, or modifica18 tion or revision of, such notice, and any

19 advance notice of proposed rulemaking;

20 ‘‘(B) copies of all written comments re21 ceived on the proposed rule;

22 ‘‘(C) a transcript of any public hear23 ing conducted on the rulemaking;

24 ‘‘(D) copies, or an identification of the

25 place at which copies may be obtained, of
122

•S 343 RS

1 all material described by the agency pur2 suant to subsection (b)(1)(G) and of other

3 factual and methodological material not

4 described by the agency pursuant to such

5 subsection that pertains directly to the

6 rulemaking and that was available to the

7 agency in connection with the rule8 making, or that was submitted to or pre9 pared by or for the agency in connection

10 with the rulemaking; and

11 ‘‘(E) any statement, description, analy12 sis, or any other material that the agency

13 is required to prepare or issue in connec14 tion with the rulemaking, including any

15 analysis prepared or issued pursuant to

16 chapter 6.

17 ‘‘(3) The agency shall place the materials

18 described in paragraph (2) in the file as soon

19 as practicable after such materials become

20 available to the agency.

21 ‘‘(4) The file required by paragraph (1)

22 need not include any material that need not be

23 made available to the public under section

24 552(b)(4) if the agency includes in such file a

25 statement that notes the existence of such ma-
123

•S 343 RS

1 terial and the basis upon which the material

2 is exempt from public disclosure under such

3 section. The agency may not substantially rely

4 on any such material in formulating a rule

5 unless it makes the substance of such material

6 available for adequate comment by interested

7 persons. The agency may use summaries, ag8 gregations of data, or other appropriate mech9 anisms to protect the confidentiality of such

10 material to the maximum extent possible.

11 ‘‘(5) No court shall hold unlawful or set

12 aside an agency rule because of a violation of

13 this subsection unless the court finds that such

14 violation has precluded fair public consider15 ation of a material issue of the rulemaking

16 taken as a whole. Judicial review of compli17 ance or noncompliance with this subsection

18 shall be limited to review of action or inaction

19 on the part of an agency.

20 ‘‘(g) Notwithstanding any other provision

21 of law, this section shall apply to and supple22 ment the procedures governing rulemaking

23 under statutes that are not generally subject

24 to this section.
124

•S 343 RS

1 ‘‘(h) Nothing in this section authorizes the

2 use of appropriated funds available to any

3 agency to pay the attorney’s fees or other ex4 penses of persons participating or intervening

5 in agency proceedings.’’.

6 SEC. 4. ANALYSIS OF AGENCY RULES.

7 (a) IN GENERAL.— Chapter 6 of title 5, Unit8 ed States Code, is amended by adding at the

9 end the following:

10 ‘‘SUBCHAPTER II—ANALYSIS OF AGENCY

11 RULES

12 ‘‘§ 621. Definitions

13 ‘‘For purposes of this subchapter—

14 ‘‘(1) the term ‘benefit’ means the rea15 sonably identifiable significant incremen16 tal benefits, including social and eco17 nomic benefits, that are expected to result

18 directly or indirectly from implementation

19 of a rule or an alternative to a rule;

20 ‘‘(2) the term ‘cost’ means the reason21 ably identifiable significant incremental

22 costs and adverse effects, including social

23 and economic costs, reduced consumer

24 choice, substitution effects, and impeded

25 technological advancement, that are ex-
125

•S 343 RS

1 pected to result directly or indirectly from

2 implementation of, or compliance with, a

3 rule or an alternative to a rule;

4 ‘‘(3) the term ‘cost-benefit analysis’

5 means an evaluation of the costs and ben6 efits of a rule, quantified to the extent fea7 sible and appropriate and otherwise

8 qualitatively described, that is prepared

9 in accordance with the requirements of

10 this subchapter at the level of detail ap11 propriate and practicable for reasoned

12 decisionmaking on the matter involved,

13 taking into consideration the significance

14 and complexity of the decision and any

15 need for expedition;

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

17 ‘‘(i) a rule or a group of closely re18 lated rules that the agency proposing

19 the rule, the Director, or a designee of

20 the President reasonably determines

21 is likely to have a gross annual effect

22 on the economy of $50,000,000 or more

23 in reasonably quantifiable increased

24 direct and indirect costs, or has a sig-
126

•S 343 RS

1 nificant impact on a sector of the

2 economy; or

3 ‘‘(ii) a rule or a group of closely

4 related rules that is otherwise des5 ignated a major rule by the agency

6 proposing the rule, the Director, or a

7 designee of the President on the

8 ground that the rule is likely to result

9 in—

10 ‘‘(I) a substantial increase in

11 costs or prices for wage earners,

12 consumers, individual industries,

13 nonprofit organizations, Federal,

14 State, or local government agen15 cies, or geographic regions;

16 ‘‘(II) significant adverse ef17 fects on competition, employment,

18 investment, productivity, innova19 tion, health, safety, or the environ20 ment, or the ability of enterprises

21 whose principal places of business

22 are in the United States to com23 pete in domestic or export mar24 kets;
127

•S 343 RS

1 ‘‘(III) a serious inconsistency

2 or interference with an action

3 taken or planned by another agen4 cy;

5 ‘‘(IV) the material alteration

6 of the budgetary impact of entitle7 ments, grants, user fees, or loan

8 programs, or the rights and obli9 gations of recipients thereof; or

10 ‘‘(V) disproportionate costs to

11 a class of persons within the regu12 lated sector, and relatively severe

13 economic consequences for the

14 class;

15 ‘‘(B) the term ‘major rule’ does not in16 clude—

17 ‘‘(i) a rule that involves the inter18 nal revenue laws of the United States;

19 or

20 ‘‘(ii) a rule or agency action that

21 authorizes the introduction into, or

22 removal from, commerce, or recog23 nizes the marketable status, of a prod24 uct;
128

•S 343 RS

1 ‘‘(5) the term ‘market-based mecha2 nism’ means a regulatory program that—

3 ‘‘(A) imposes legal accountability

4 for the achievement of an explicit reg5 ulatory objective on each regulated

6 person;

7 ‘‘(B) affords maximum flexibility

8 to each regulated person in complying

9 with mandatory regulatory objectives,

10 which flexibility shall, where feasible

11 and appropriate, include, but not be

12 limited to, the opportunity to transfer

13 to, or receive from, other persons, in14 cluding for cash or other legal consid15 eration, increments of compliance re16 sponsibility established by the pro17 gram; and

18 ‘‘(C) permits regulated persons to

19 respond freely to changes in general

20 economic conditions and in economic

21 circumstances directly pertinent to

22 the regulatory program without af23 fecting the achievement of the pro24 gram’s explicit regulatory mandates;
129

•S 343 RS

1 ‘‘(6) the term ‘performance-based

2 standards’ means requirements, expressed

3 in terms of outcomes or goals rather than

4 mandatory means of achieving outcomes

5 or goals, that permit the regulated entity

6 discretion to determine how best to meet

7 specific requirements in particular cir8 cumstances;

9 ‘‘(7) the term ‘reasonable alternatives’

10 means the range of regulatory options

11 that the agency has discretion to consider

12 under the text of the statute granting

13 rulemaking authority, interpreted, to the

14 maximum extent possible, to embrace the

15 broadest range of options that satisfy the

16 decisional criteria of section 624(b); and

17 ‘‘(8) the term ‘rule’ has the same

18 meaning as in section 551(4), and—

19 ‘‘(A) includes any statement of

20 general applicability that alters or

21 creates rights or obligations of per22 sons outside the agency; and

23 ‘‘(B) does not include—

24 ‘‘(i) a rule of particular appli25 cability that approves or pre-
130

•S 343 RS

1 scribes the future rates, wages,

2 prices, services, corporate or fi3 nancial structures, reorganiza4 tions, mergers, acquisitions, ac5 counting practices, or disclosures

6 bearing on any of the foregoing;

7 ‘‘(ii) a rule relating to mone8 tary policy or to the safety or

9 soundness of Federally insured de10 pository institutions or any affili11 ate of such an institution (as de12 fined in section 2(k) of the Bank

13 Holding Company Act of 1956),

14 credit unions, Federal Home Loan

15 Banks, government sponsored

16 housing enterprises, farm credit

17 institutions, foreign banks that

18 operate in the United States and

19 their affiliates, branches, agen20 cies, commercial lending compa21 nies, or representative offices, (as

22 those terms are defined in section

23 1 of the International Banking Act

24 of 1978); or
131

•S 343 RS

1 ‘‘(iii) a rule relating to the

2 payment system or the protection

3 of deposit insurance funds or the

4 farm credit insurance fund.

5 ‘‘§ 622. Rulemaking cost-benefit analysis

6 ‘‘(a) Prior to publishing notice of a pro7 posed rulemaking for any rule (or, in the case

8 of a notice of a proposed rulemaking that has

9 been published on or before the date of enact10 ment of this subchapter, not later than 30 days

11 after such date of enactment), each agency

12 shall determine whether the rule is or is not

13 a major rule within the meaning of section

14 621(4)(A)(i) and, if it is not, whether it should

15 be designated a major rule under section

16 621(4)(A)(ii). For the purpose of any such de17 termination or designation, a group of closely

18 related rules shall be considered as one rule.

19 ‘‘(b)(1) If an agency has determined that a

20 rule is not a major rule within the meaning of

21 section 621(4)(A)(i) and has not designated the

22 rule a major rule within the meaning of sec23 tion 621(4)(A)(ii), the Director or a designee of

24 the President may, as appropriate, determine

25 that the rule is a major rule or designate the
132

•S 343 RS

1 rule a major rule not later than 30 days after

2 the publication of the notice of proposed rule3 making for the rule (or, in the case of a notice

4 of proposed rulemaking that has been pub5 lished on or before the date of enactment of

6 this subchapter, not later than 60 days after

7 such date of enactment).

8 ‘‘(2) Such determination or designation

9 shall be published in the Federal Register, to10 gether with a succinct statement of the basis

11 for the determination or designation.

12 ‘‘(c)(1)(A) When the agency publishes a no13 tice of proposed rulemaking for a major rule,

14 the agency shall issue and place in the rule15 making file an initial cost-benefit analysis,

16 and shall include a summary of such analysis

17 in the notice of proposed rulemaking.

18 ‘‘(B)(i) When the Director or a designee of

19 the President has published a determination

20 or designation that a rule is a major rule after

21 the publication of the notice of proposed rule22 making for the rule, the agency shall promptly

23 issue and place in the rulemaking file an ini24 tial cost-benefit analysis for the rule and shall
133

•S 343 RS

1 publish in the Federal Register a summary of

2 such analysis.

3 ‘‘(ii) Following the issuance of an initial

4 cost-benefit analysis under clause (i), the

5 agency shall give interested persons an oppor6 tunity to comment in the same manner as if the

7 initial cost-benefit analysis had been issued

8 with the notice of proposed rulemaking.

9 ‘‘(2) Each initial cost-benefit analysis shall

10 contain—

11 ‘‘(A) an analysis of the benefits of the

12 proposed rule, and an explanation of how

13 the agency anticipates each benefit will be

14 achieved by the proposed rule, including a

15 description of the persons or classes of

16 persons likely to receive such benefits;

17 ‘‘(B) an analysis of the costs of the

18 proposed rule, and an explanation of how

19 the agency anticipates each such cost will

20 result from the proposed rule, including a

21 description of the persons or groups of

22 persons likely to bear such costs;

23 ‘‘(C) an identification (including an

24 analysis of the costs and benefits) of rea25 sonable alternatives that the agency has
134

•S 343 RS

1 discretion to adopt under the decisional

2 criteria of the statute granting the rule3 making authority, as supplemented by the

4 decisional criteria in section 624, for

5 achieving identified benefits, including,

6 where appropriate, alternatives that—

7 ‘‘(i) require no government action;

8 ‘‘(ii) will accommodate differences

9 among geographic regions and among

10 persons with differing levels of re11 sources with which to comply; and

12 ‘‘(iii) employ voluntary or perform13 ance-based standards, market-based

14 mechanisms, or other flexible regu15 latory alternatives that permit the

16 greatest flexibility in achieving the

17 identified benefits of the proposed

18 rule;

19 ‘‘(D) an assessment of the feasibility of

20 establishing a regulatory program that

21 operates through the application of vol22 untary programs, voluntary consensus

23 standards, performance-based standards,

24 market-based mechanisms, or other flexi25 ble regulatory alternatives;
135

•S 343 RS

1 ‘‘(E) in any case in which the proposed

2 rule is based on one or more scientific

3 evaluations, scientific information, or a

4 risk assessment, or is subject to the risk

5 assessment requirements of subchapter

6 III, a description of the actions under7 taken by the agency to verify the quality,

8 reliability, and relevance of such sci9 entific evaluations or scientific informa10 tion in accordance with the requirements

11 of subchapter III;

12 ‘‘(F) an analysis, to the extent prac13 ticable, of the effect of the rule on—

14 ‘‘(i) the cumulative burden of com15 pliance with the rule and other exist16 ing regulations on persons complying

17 with it; and

18 ‘‘(ii) the net effect on small busi19 nesses with fewer than 100 employees,

20 including employment in such busi21 nesses;

22 ‘‘(G) an analysis of whether the identi23 fied benefits of the proposed rule justify

24 the identified costs of the proposed rule,

25 and an analysis of whether the proposed
136

•S 343 RS

1 rule will achieve greater net benefits or,

2 where applicable, lower net costs, than

3 any of the alternatives to the proposed

4 rule, including alternatives identified in

5 accordance with subparagraphs (C) and

6 (D).

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

8 major rule, the agency shall also issue and

9 place in the rulemaking file a final cost-bene10 fit analysis, and shall include a summary of

11 the analysis in the statement of basis and pur12 pose.

13 ‘‘(2) Each final cost-benefit analysis shall

14 contain—

15 ‘‘(A) a description and comparison of

16 the benefits and costs of the rule and of

17 the reasonable alternatives to the rule de18 scribed in the rulemaking, including the

19 flexible regulatory alternatives identified

20 pursuant to subsection (c)(2) (C) and (D);

21 and

22 ‘‘(B) an analysis, based upon the rule23 making record considered as a whole, of—

24 ‘‘(i) whether the benefits of the

25 rule justify the costs of the rule; and
137

•S 343 RS

1 ‘‘(ii) whether the rule will achieve

2 greater net benefits or, where section

3 624(c) applies, lower net costs, than

4 any of the reasonable alternatives

5 that the agency has discretion to

6 adopt under the decisional criteria of

7 the statute granting the rulemaking

8 authority, as supplemented by the

9 decisional criteria in section 624, for

10 achieving identified benefits, includ11 ing, where appropriate, alternatives

12 referred to in subsection (c)(2) (C) and

13 (D).

14 ‘‘(e)(1)(A) The analysis of the benefits and

15 costs of a proposed and a final rule required

16 under this section shall include, to the extent

17 feasible, a quantification or numerical esti18 mate of the quantifiable benefits and costs.

19 Such quantification or numerical estimate

20 shall be made in the most appropriate unit of

21 measurement, using comparable assumptions,

22 including time periods, shall specify the

23 ranges of predictions, and shall explain the

24 margins of error involved in the quantifica25 tion methods and in the estimates used. An
138

•S 343 RS

1 agency shall describe the nature and extent of

2 the nonquantifiable benefits and costs of a

3 final rule pursuant to this section in as precise

4 and succinct a manner as possible. An agency

5 shall not be required to make such evaluation

6 primarily on a mathematical or numerical

7 basis.

8 ‘‘(B) Where practicable and appropriate,

9 the description of the benefits and costs of a

10 proposed and final rule required under this

11 section shall describe such benefits and costs

12 on an industry by industry basis.

13 ‘‘(2)(A) In evaluating and comparing costs

14 and benefits and in evaluating the risk assess15 ment information developed pursuant to sub16 chapter III, the agency shall not rely on cost,

17 benefit, or risk assessment information that is

18 not accompanied by relevant information that

19 would enable the agency and other persons in20 terested in the rulemaking to assess the accu21 racy, reliability, and uncertainty factors ap22 plicable to such information.

23 ‘‘(B) The agency evaluations of the rela24 tionships of the benefits of a proposed and
139

•S 343 RS

1 final rule to its costs shall be clearly articu2 lated in accordance with this section.

3 ‘‘(f) The preparation of the initial or final

4 cost-benefit analysis required by this section

5 shall only be performed by an officer or em6 ployee of the agency. The preceding sentence

7 shall not preclude a person outside the agency

8 from gathering data or information to be used

9 by the agency in preparing any such cost-bene10 fit analysis or from providing an explanation

11 sufficient to permit the agency to analyze such

12 data or information. If any such data or infor13 mation is gathered or explained by a person

14 outside the agency, the agency shall specifi15 cally identify in the initial or final cost-benefit

16 analysis the data or information gathered or

17 explained and the person who gathered or ex18 plained it, and shall describe the arrangement

19 by which the information was procured by the

20 agency, including the total amount of funds

21 expended for such procurement.

22 ‘‘§ 623. Petition for cost-benefit analysis

23 ‘‘(a)(1) Any person subject to a major rule

24 may petition the relevant agency, the Director,

25 or a designee of the President to perform a
140

•S 343 RS

1 cost-benefit analysis under this subchapter for

2 the major rule, including a major rule in effect

3 on the date of enactment of this subchapter for

4 which a cost-benefit analysis pursuant to such

5 subchapter has not been performed, regardless

6 of whether a cost-benefit analysis was pre7 viously performed to meet requirements im8 posed before the date of enactment of this sub9 chapter.

10 ‘‘(2) The petition shall identify with rea11 sonable specificity the major rule to be re12 viewed and the amendment or repeal re13 quested.

14 ‘‘(3) The agency, the Director, or a designee

15 of the President shall grant the petition if the

16 petition shows that there is a reasonable like17 lihood that, considering the future impact of

18 the rule—

19 ‘‘(A) the rule is a major rule; and

20 ‘‘(B) the proposed amendment or re21 peal of the rule is required to satisfy the

22 decisional criteria of section 624.

23 ‘‘(4) A decision to grant, or final agency ac24 tion to deny, a petition under this subsection
141

•S 343 RS

1 shall be made not later than 180 days after

2 submittal.

3 ‘‘(5) Following a decision to grant or deny

4 a petition to conduct a cost-benefit analysis for

5 a rule under this subsection, no further peti6 tion for such rule, submitted by the same per7 son, shall be considered by any agency, the Di8 rector, or a designee of the President, unless

9 such petition is based on a change in a fact,

10 circumstance, or provision of law underlying

11 or otherwise related to the rule occurring since

12 the initial petition was granted or denied, that

13 warrants the amendment or repeal of the rule.

14 ‘‘(b) Not later than 1 year after the date on

15 which a petition has been granted for a major

16 rule under subsection (a), the agency shall

17 conduct a cost-benefit analysis in accordance

18 with this subchapter, and shall propose

19 amendments to, or repeal of, the rule if re20 quired by the decisional criteria set forth in

21 section 624.

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

23 ‘major rule’ means any major rule or portion

24 thereof.
142

•S 343 RS

1 ‘‘(d)(1) Any person may petition the rel2 evant agency to withdraw, as contrary to this

3 subchapter, any agency interpretive rule, guid4 ance, or general statement of policy that would

5 have the effect of a major rule if the interpre6 tive rule, guidance, or general statement of

7 policy had been adopted as a rule.

8 ‘‘(2) The petition shall identify with rea9 sonable specificity why the interpretive rule,

10 guidance, or general statement of policy would

11 have the effect of a major rule if adopted as

12 a rule.

13 ‘‘(3) The agency shall grant the petition if

14 the petition shows that there is a reasonable

15 likelihood that the guidance or general state16 ment of policy would have the effect of a major

17 rule if adopted as a rule.

18 ‘‘(4) A decision to grant, or final agency ac19 tion to deny, a petition under this subsection

20 shall be made not later than 180 days after the

21 petition is submitted.

22 ‘‘(e) For each interpretative rule, guid23 ance, or general statement of policy for which

24 a petition has been granted under subsection

25 (d), the agency shall—
143

•S 343 RS

1 ‘‘(1) immediately withdraw the inter2 pretive rule, guidance, or general state3 ment of policy; or

4 ‘‘(2) within one year, propose a rule in

5 compliance with this subchapter incor6 porating, with such modifications as the

7 agency considers appropriate, the regu8 latory standards or criteria contained in

9 such interpretive rule, general statement

10 of policy, or guidance.

11 ‘‘(f) Upon withdrawing an interpretive

12 rule, guidance, or general statement of policy,

13 or where such interpretive rule, guidance, or

14 general statement of policy is not withdrawn

15 and a final rule is not promulgated within 2

16 years of granting a petition under subsection

17 (d), the agency shall be prohibited from enforc18 ing against any person the regulatory stand19 ards or criteria contained in such interpretive

20 rule, guidance, or general statement of policy,

21 unless and until they are included in a rule

22 promulgated in accordance with this sub23 chapter.

24 ‘‘(g)(1) Any person subject to a major rule

25 may petition the relevant agency to modify or
144

•S 343 RS

1 waive the specific requirements of the major

2 rule and to authorize such person to dem3 onstrate compliance through alternative

4 means not otherwise permitted by the major

5 rule. The petition shall identify with reason6 able specificity the requirements for which the

7 waiver is sought and the alternative means of

8 compliance being proposed.

9 ‘‘(2) The agency shall grant the petition if

10 the petition shows that there is a reasonable

11 likelihood that the proposed alternative

12 means of compliance would achieve the spe13 cific benefits of the major rule with an equiva14 lent or greater level of protection of health,

15 safety, and the environment than would be

16 provided by the major rule, and would not im17 pose an undue burden on the agency that

18 would be responsible for enforcing such alter19 native means of compliance.

20 ‘‘(3) Following a decision to grant or deny

21 a petition under this subsection, no further pe22 tition for such rule, submitted by the same per23 son, shall be considered by any agency unless

24 such petition is based on a change in a fact,

25 circumstance, or provision of law underlying
145

•S 343 RS

1 or otherwise related to the rule occurring since

2 the initial petition was granted or denied, that

3 warrants the granting of such further petition.

4 ‘‘§ 624. Decisional criteria

5 ‘‘(a) The requirements of this section shall

6 supplement any other decisional criteria oth7 erwise provided by law.

8 ‘‘(b) Subject to subsection (c), no final rule

9 subject to this subchapter shall be promul10 gated unless the agency finds that—

11 ‘‘(1) the potential benefits from the

12 rule justify the potential costs of the rule;

13 and

14 ‘‘(2) the rule will produce the most

15 cost-effective result of any of the reason16 able alternatives that the agency has dis17 cretion to adopt under the decisional cri18 teria of the statute granting the rule19 making authority.

20 ‘‘(c) If a statute requires or permits that a

21 rule be promulgated and that rule cannot, ap22 plying the express decisional criteria in the

23 statute, satisfy the criteria provided in sub24 section (b), the agency shall not promulgate

25 the rule unless the rule imposes—
146

•S 343 RS

1 ‘‘(1) lower costs than any of the rea2 sonable alternatives; or

3 ‘‘(2) the least costs taking into account

4 benefits that the agency has discretion to

5 adopt under the decisional criteria of the

6 statute granting the rulemaking author7 ity.

8 ‘‘(d) If an agency promulgates a rule that

9 is subject to subsection (c), the agency shall

10 prepare a written explanation of why the

11 agency was required to promulgate a rule with

12 potential costs that were not justified by the

13 potential benefits and shall transmit that ex14 planation along with the final cost-benefit

15 analysis to Congress when the final rule is pro16 mulgated.

17 ‘‘§ 625. Judicial review

18 ‘‘(a) Each court with jurisdiction to review

19 final agency action under the statute granting

20 the agency authority to conduct the rule21 making shall have jurisdiction to review final

22 agency action under this subchapter.

23 ‘‘(b)(1) Any cost-benefit analysis of, or risk

24 assessment concerning, a rule shall constitute

25 part of the whole rulemaking record of agency
147

•S 343 RS

1 action for the purpose of judicial review and

2 shall be considered by a court in determining

3 the legality of the agency action, but only to

4 the extent that it relates to the agency’s

5 decisional responsibilities under section 624

6 or the statute granting the agency authority to

7 take the agency action.

8 ‘‘(2) No analysis required by this sub9 chapter shall be subject to judicial review sep10 arate or apart from judicial review of the

11 agency action to which it relates.

12 ‘‘(3) The court shall apply the same stand13 ards of judicial review that govern the review

14 of agency findings under the statute granting

15 the agency authority to take the action.

16 ‘‘(4) The court shall set aside agency ac17 tion that fails to satisfy the decisional criteria

18 of section 624, applying the applicable judicial

19 review standards.

20 ‘‘§ 626. Deadlines for rulemaking

21 ‘‘(a) Beginning on the date of enactment of

22 this section, all deadlines in statutes that re23 quire agencies to propose or promulgate any

24 rule subject to this subchapter shall be sus-
148

•S 343 RS

1 pended until such time as the requirements of

2 this subchapter are satisfied.

3 ‘‘(b) Beginning on the date of enactment of

4 this section, the jurisdiction of any court of the

5 United States to enforce any deadline that

6 would require an agency to propose or promul7 gate a rule subject to this chapter shall be sus8 pended until such time as the requirements of

9 this subchapter are satisfied.

10 ‘‘(c) In any case in which the failure to pro11 mulgate a rule by a deadline would create an

12 obligation to regulate through individual ad13 judications by another deadline, the deadline

14 for such regulation shall be suspended to

15 allow the requirements of this subchapter to be

16 satisfied.

17 ‘‘§ 627. Agency review of rules

18 ‘‘(a)(1)(A) Not later than 9 months after

19 the date of enactment of this section, each

20 agency shall prepare and publish in the Fed21 eral Register a proposed schedule for the re22 view, in accordance with this section, of—

23 ‘‘(i) each rule of the agency that is in

24 effect on such effective date and which,
149

•S 343 RS

1 considering its future impact, would be a

2 major rule under this subchapter;

3 ‘‘(ii) each rule of the agency that is in4 consistent or incompatible with, or dupli5 cative of, any other obligation or require6 ment established by any Federal statute,

7 rule, or other agency statement, interpre8 tation, or action that has the force of law;

9 and

10 ‘‘(iii) each rule of the agency in effect

11 on the date of enactment of this section

12 (in addition to the rules described in

13 clauses (i) and (ii)) that the agency has

14 selected for review.

15 ‘‘(B) Each proposed schedule required by

16 subparagraph (A) shall include—

17 ‘‘(i) a brief explanation of the reasons

18 the agency considers each rule on the

19 schedule to be a major rule under section

20 621(4)(A), or the reasons why the agency

21 selected the rule for review;

22 ‘‘(ii) a date set by the agency, in ac23 cordance with subsection (b)(1), for the

24 completion of the review of each such

25 rule; and
150

•S 343 RS

1 ‘‘(iii) a statement that the agency re2 quests comments from the public on the

3 proposed schedule.

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

5 review of each rule on the schedule in a man6 ner that will ensure the simultaneous review

7 of related items and that will achieve a rea8 sonable distribution of reviews over the period

9 of time covered by the schedule.

10 ‘‘(2) Not later than 90 days before publish11 ing in the Federal Register the proposed sched12 ule required under paragraph (1), each agen13 cy shall make the proposed schedule available

14 to the Director or a designee of the President,

15 or to the Vice President or other officer to

16 whom oversight authority has been delegated

17 under section 643. The President or that offi18 cer may select for review in accordance with

19 this section any additional rule.

20 ‘‘(3) Not later than 1 year after the date of

21 enactment of this section, each agency shall

22 publish in the Federal Register a final sched23 ule for the review of the rules referred to in

24 paragraphs (1) and (2). Each agency shall

25 publish with the final schedule the response of
151

•S 343 RS

1 the agency to comments received concerning

2 the proposed schedule.

3 ‘‘(b)(1) Except as explicitly provided other4 wise by statute, the agency shall, pursuant to

5 subsections (c) through (e), review—

6 ‘‘(A) each rule on the schedule pro7 mulgated pursuant to subsection (a);

8 ‘‘(B) each major rule under section

9 621(4) promulgated, amended, or other10 wise renewed by an agency after the date

11 of the enactment of this section; and

12 ‘‘(C) each rule promulgated after the

13 date of enactment of this section that the

14 President or the officer designated by the

15 President selects for review pursuant to

16 subsection (a)(2).

17 ‘‘(2) Except as provided in subsection (f)—

18 ‘‘(A) in the case of a regulation that

19 takes effect after the date of enactment of

20 this section, the regulation shall termi21 nate on the date that is 5 years after the

22 date on which the regulation takes effect,

23 unless the review required by this section

24 has been completed by the date that is 5
152

•S 343 RS

1 years after the date on which the regula2 tion takes effect; and

3 ‘‘(B) in the case of a regulation in ef4 fect on the date of enactment of this sec5 tion, the regulation shall terminate on the

6 date that is 7 years after the date of en7 actment of the Regulatory Reform Act of

8 1995, unless the review required by this

9 section has been completed by the date

10 that is 7 years after the date of enactment

11 of the Regulatory Reform Act of 1995.

12 ‘‘(c) An agency shall publish in the Federal

13 Register a notice of its proposed action under

14 this section with respect to a rule being re15 viewed. The notice shall include—

16 ‘‘(1) an identification of the specific

17 statutory authority under which the rule

18 was promulgated and an explanation of

19 whether the agency’s interpretation of the

20 statute is expressly required by the cur21 rent text of that statute or, if not, an ex22 planation that the interpretation is with23 in the range of permissible interpretations

24 of the statute as identified by the agency,

25 and an explanation why the interpreta-
153

•S 343 RS

1 tion selected by the agency is the agency’s

2 preferred interpretation;

3 ‘‘(2) an analysis of the benefits and

4 costs of the rule during the period in

5 which it has been in effect;

6 ‘‘(3) an explanation of the proposed

7 agency action with respect to the rule, in8 cluding action to repeal or amend the

9 rule to resolve inconsistencies or conflicts

10 with any other obligation or requirement

11 established by any Federal statute, rule,

12 or other agency statement, interpretation,

13 or action that has the force of law; and

14 ‘‘(4) a statement that the agency seeks

15 proposals from the public for modifica16 tions or alternatives to the rule which

17 may accomplish the objectives of the rule

18 in a more effective or less burdensome

19 manner.

20 ‘‘(d) If an agency proposes to repeal or

21 amend a rule under review pursuant to this

22 section, the agency shall, after issuing the no23 tice required by subsection (c), comply with the

24 provisions of this chapter, chapter 5, and any

25 other applicable law. The requirements of
154

•S 343 RS

1 such provisions and related requirements

2 shall apply to the same extent and in the same

3 manner as in the case of a proposed agency ac4 tion to repeal or amend a rule that is not

5 taken pursuant to the review required by this

6 section.

7 ‘‘(e) If an agency proposes to renew without

8 amendment a rule under review pursuant to

9 this section, the agency shall—

10 ‘‘(1) give interested persons not less

11 than 60 days after the publication of the

12 notice required by subsection (c) to com13 ment on the proposed renewal; and

14 ‘‘(2) publish in the Federal Register

15 notice of the renewal of such rule, an ex16 planation of the continued need for the

17 rule, and, if the renewed rule is a major

18 rule under section 621(4), an explanation

19 of how the rule complies with section 624.

20 ‘‘(f) Any agency, which for good cause finds

21 that compliance with this section with respect

22 to a particular rule during the period pro23 vided in subsection (b) is contrary to an impor24 tant public interest, may request the President,

25 or an officer designated by the President, to es-
155

•S 343 RS

1 tablish a period longer than 5 years, in the

2 case of a regulation that takes effect after the

3 date of enactment of this section, or 7 years,

4 in the case of a regulation in effect on the date

5 of enactment of this section, for the completion

6 of the review of such rule. The President or

7 that officer may extend the period for review

8 of a rule to a total period of not more than 10

9 years. Such extension shall be published in the

10 Federal Register with an explanation of the

11 reasons therefor.

12 ‘‘(g) In any case in which an agency has

13 not completed the review of a rule within the

14 period prescribed by subsection (b) or (f) of

15 this section, the agency shall immediately pub16 lish in the Federal Register a notice proposing

17 to issue the rule under subsection (c), and

18 shall complete proceedings pursuant to sub19 section (d) or (e) not later than 180 days after

20 the date on which the review was required to

21 be completed under subsection (b) or (f).

22 ‘‘(h) Nothing in this section shall relieve

23 any agency from its obligation to respond to a

24 petition to issue, amend, or repeal a rule, for

25 an interpretation regarding the meaning of a
156

•S 343 RS

1 rule, or for a variance or exemption from the

2 terms of a rule, submitted pursuant to any

3 other provision of law.

4 ‘‘§ 628. Special rule

5 ‘‘Notwithstanding any other provision of

6 the Comprehensive Regulatory Reform Act of

7 1995, or the amendments made by such Act, for

8 purposes of this subchapter and subchapter

9 IV, the head of each appropriate Federal

10 banking agency (as defined in section 3(q) of

11 the Federal Deposit Insurance Act), the Na12 tional Credit Union Administration, the Fed13 eral Housing Finance Board, the Office of Fed14 eral Housing Enterprise Oversight, and the

15 Farm Credit Administration, shall have au16 thority with respect to such agency that other17 wise would be provided under such sub18 chapters to the Director, a designee of the

19 President, Vice President, or any officer des20 ignated or delegated with authority under

21 such subchapters.

22 ‘‘SUBCHAPTER III—RISK ASSESSMENTS

23 ‘‘§ 631. Definitions

24 ‘‘For purposes of this subchapter—
157

•S 343 RS

1 ‘‘(1) the term ‘benefit’ has the meaning

2 given such term in section 621(1);

3 ‘‘(2) the term ‘best estimate’ means an

4 estimate that, to the extent feasible and

5 scientifically appropriate, is based on—

6 ‘‘(A) central estimates of risk

7 using the most plausible and realistic

8 assumptions;

9 ‘‘(B) an approach that combines

10 multiple estimates based on different

11 scenarios and weighs the probability

12 of each scenario; and

13 ‘‘(C) any other methodology de14 signed to provide the most plausible

15 and realistic level of risk, given the

16 current scientific information avail17 able to the agency concerned;

18 ‘‘(3) the term ‘cost’ has the meaning

19 given such term in section 621(2);

20 ‘‘(4) the term ‘cost-benefit analysis’

21 has the meaning given such term in sec22 tion 621(3);

23 ‘‘(5) the term ‘emergency’ means an ac24 tual, immediate, and substantial
158

•S 343 RS

1 endangerment to health, safety, or the

2 human environment;

3 ‘‘(6) the term ‘hazard identification’

4 means identification of a substance, activ5 ity, or condition that may cause to health,

6 safety, or the environment based on empir7 ical data, measurements, or testing show8 ing that it has caused significant adverse

9 effects at some levels of dose or exposure

10 combined degree of toxicity and actual ex11 posure, or other risk the hazards pose for

12 individuals, populations, or natural re13 sources; and

14 ‘‘(7) the term ‘major cleanup plan’

15 means any proposed or final environ16 mental cleanup plan for a facility, or Fed17 eral guidelines for the issuance of any

18 such plan, the expected costs, expenses,

19 and damages of which are likely to ex20 ceed, in the aggregate, $10,000,000, includ21 ing a corrective action requirement under

22 the Solid Waste Disposal Act (notwith23 standing section 4(b)(1)(C) of such Act,

24 but only to the extent of such require25 ment), a removal or remedial action
159

•S 343 RS

1 under the Comprehensive Environmental

2 Response, Compensation, and Liability

3 Act of 1980, and any other environmental

4 restoration or damage assessment carried

5 out by, on behalf of, or as required or or6 dered by, an agency or Federal court, or

7 pursuant to the authority of a Federal

8 statute with respect to any substance;

9 ‘‘(8) the term ‘major rule’ has the

10 meaning given such term in section

11 621(4);

12 ‘‘(9) the term ‘negative data’ means

13 data that fail to show that a given sub14 stance or activity induces an adverse ef15 fect under certain conditions;

16 ‘‘(10) the term ‘risk assessment’

17 means—

18 ‘‘(A) the process of identifying haz19 ards, and of quantifying (to the maxi20 mum extent practicable) or describing

21 the combined degree of toxicity and

22 actual exposure, or other risk the haz23 ards pose for individuals, popu24 lations, or natural resources; and
160

•S 343 RS

1 ‘‘(B) the document containing the

2 explanation of how the assessment

3 process has been applied to an indi4 vidual substance, activity, or condi5 tion;

6 ‘‘(11) the term ‘risk characteriza7 tion’—

8 ‘‘(A) means the element of a risk

9 assessment that involves presentation

10 of the degree of risk to individuals

11 and populations expected to be pro12 tected, as presented in any regulatory

13 proposal or decision, report to Con14 gress, or other document that is made

15 available to the public; and

16 ‘‘(B) may include discussions of

17 uncertainties, conflicting data, esti18 mates, extrapolations, inferences, and

19 opinions, as appropriate;

20 ‘‘(12) the term ‘rule’ has the meaning

21 given such term in section 621(7); and

22 ‘‘(13) the term ‘substitution risk’

23 means a potential increased risk to

24 health, safety, or the environment result25 ing from market substitutions, a reduced
161

•S 343 RS

1 standard of living, or a regulatory alter2 native designed to decrease other risks.

3 ‘‘§ 632. Applicability

4 ‘‘(a) Except as provided in subsection (b),

5 this subchapter shall apply to all risk assess6 ments and risk characterizations prepared by,

7 or on behalf of, or prepared by others and

8 adopted by, any agency in connection with

9 health, safety, and environmental risks.

10 ‘‘(b)(1) This subchapter shall not apply to

11 risk assessments or risk characterizations per12 formed with respect to—

13 ‘‘(A) a situation that the head of the

14 agency finds to be an emergency;

15 ‘‘(B) a rule or agency action that au16 thorizes the introduction into or removal

17 from commerce, or initiation of manufac18 ture, of a substance, mixture, or product,

19 or recognizes the marketable status of a

20 product;

21 ‘‘(C) a health, safety, or environmental

22 inspection, compliance or enforcement ac23 tion, or individual facility permitting ac24 tion; or
162

•S 343 RS

1 ‘‘(D) a screening analysis clearly iden2 tified as such.

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

4 a screening analysis for the purposes of para5 graph (1)(D) if the result of the analysis is

6 used—

7 ‘‘(i) as the basis for imposing a restric8 tion on a previously authorized substance,

9 product, or activity after its initial intro10 duction into manufacture or commerce; or

11 ‘‘(ii) to characterize a finding of risk

12 from a substance or activity in any agency

13 document or other communication made

14 available to the public, the media, or Con15 gress.

16 ‘‘(B) Among the analyses that may be treat17 ed as a screening analyses for the purposes of

18 paragraph (1)(D) are product registrations,

19 reregistrations, tolerance settings, and reviews

20 of premanufacture notices under the Federal

21 Insecticide, Fungicide, and Rodenticide Act (7

22 U.S.C. 136 et seq.) and the Toxic Substances

23 Control Act (15 U.S.C. 2601 et seq.).

24 ‘‘(3) This subchapter shall not apply to any

25 food, drug, or other product label or to any
163

•S 343 RS

1 risk characterization appearing on any such

2 label.

3 ‘‘§ 633. Principles for risk assessment

4 ‘‘(a)(1) The head of each agency shall

5 apply the principles set forth in subsection (b)

6 when preparing any risk assessment for a

7 major rule to ensure that the risk assessment

8 and all of its components—

9 ‘‘(A) distinguish scientific findings

10 and best estimates of risk from other con11 siderations;

12 ‘‘(B) are, to the maximum extent prac13 ticable, scientifically objective, plausible,

14 and realistic, and inclusive of all relevant

15 data;

16 ‘‘(C) rely, to the extent available and

17 practicable, on scientific findings; and

18 ‘‘(D) use situation- or decision-specific

19 information to the maximum extent prac20 ticable.

21 ‘‘(2) An agency shall not be required to re22 peat discussions or explanations required

23 under this section in each risk assessment doc24 ument if there is an unambiguous reference to

25 the relevant discussion or explanation in an-
164

•S 343 RS

1 other reasonably available agency document

2 that was prepared in accordance with this

3 subchapter.

4 ‘‘(b) The principles to be applied when pre5 paring risk assessments are as follows:

6 ‘‘(1)(A) When assessing human health

7 risks, a risk assessment shall consider

8 and discuss both the most important lab9 oratory and epidemiological data, includ10 ing negative data, and summarize the re11 maining data that finds, or fails to find,

12 a correlation between a health risk and a

13 substance or activity.

14 ‘‘(B) When conflicts among such data

15 appear to exist, or when animal data are

16 used as a basis to assess human health,

17 the assessment shall include a discussion

18 of possible reconciliation of conflicting in19 formation. Greatest emphasis shall be

20 placed on data that indicates the biologi21 cal basis of the resulting harm in hu22 mans. Animal data shall be reviewed with

23 regard to relevancy to humans.

24 ‘‘(2) When a risk assessment involves a

25 choice of any significant assumption (in-
165

•S 343 RS

1 cluding the use of safety factors and de2 fault assumptions), inference, or model,

3 the agencies or instrumentality preparing

4 the assessment shall—

5 ‘‘(A) present a representative de6 scription and explicit explanation of

7 plausible and alternative similar as8 sumptions, inferences, or models (in9 cluding the assumptions incorporated

10 into the model) and the sensitivity of

11 the conclusions to them;

12 ‘‘(B) give preference to the model,

13 assumption, input parameter that rep14 resents the most plausible or realistic

15 inference from supporting scientific

16 information;

17 ‘‘(C) identify any science policy or

18 value judgments and employ those

19 judgments only where the policy deter20 mination has been approved by the

21 head of the agency, after notice and

22 opportunity for public involvement, as

23 appropriate for the circumstance

24 under consideration;
166

•S 343 RS

1 ‘‘(D) describe any model used in

2 the risk-assessment and make explicit

3 the assumptions incorporated into the

4 model; and

5 ‘‘(E) indicate the extent to which

6 any significant model has been vali7 dated by, or conflicts with, empirical

8 data.

9 ‘‘(3) Risk assessments that provide a

10 quantification or numerical output shall

11 be calculated using the best estimate for

12 each input parameter and shall use, as

13 available, probabilistic descriptions of the

14 uncertainty and variability associated

15 with each input parameter.

16 ‘‘(4) A risk assessment shall clearly

17 separate hazard identification from risk

18 characterization and make clear the rela19 tionship between the level of risk and the

20 level of exposure to a potential hazard.

21 ‘‘(5) A risk assessment shall be pre22 pared at the level of detail appropriate

23 and practicable for reasoned decision24 making on the matter involved, taking

25 into consideration the significance and
167

•S 343 RS

1 complexity of the decision and any need

2 for expedition.

3 ‘‘(6) Where relevant, practicable, and

4 appropriate, data shall be developed con5 sistent with standards for the develop6 ment of test data promulgated pursuant

7 to section 4 of the Toxic Substances Con8 trol Act, and standards for data require9 ments promulgated pursuant to section 3

10 of the Federal Insecticide, Fungicide, and

11 Rodenticide Act.

12 ‘‘(c)(1) The head of each agency shall pro13 mote early involvement by all stakeholders in

14 the development of risk assessments that may

15 support or affect agency rules, guidance, and

16 other significant actions, by publishing as

17 part of its semiannual regulatory agenda, re18 quired under section 602—

19 ‘‘(A) a list of risk assessments and

20 supporting assessments, including haz21 ard, dose or exposure assessments, under

22 preparation or planned by the agency;

23 ‘‘(B) a brief summary of relevant is24 sues addressed or to be addressed by each
168

•S 343 RS

1 listed risk assessment or supporting as2 sessment;

3 ‘‘(C) an approximate schedule for com4 pleting each listed risk assessment and

5 supporting assessment;

6 ‘‘(D) an identification of potential

7 rules, guidance, or other agency actions

8 supported or affected by each listed risk

9 assessment and supporting assessment;

10 and

11 ‘‘(E) the name, address, and telephone

12 number of an agency official knowledge13 able about each listed risk assessment

14 and supporting assessment.

15 ‘‘(2)(A) The head of each agency shall pro16 vide an opportunity for meaningful public

17 participation and comment on any risk assess18 ment throughout the regulatory process com19 mensurate with the consequences of the deci20 sion to be made.

21 ‘‘(B) In cases where the risk assessment

22 will support a major rule, the agency shall

23 publish, at the earliest opportunity in the

24 process, an advanced notice of relevant risk
169

•S 343 RS

1 assessment related information that includes,

2 at a minimum, an identification of—

3 ‘‘(i) all relevant hazard, dose, expo4 sure, and other risk related documents

5 that the agency plans to consider;

6 ‘‘(ii) all risk related guidance that the

7 agency considers relevant;

8 ‘‘(iii) all hazard, dose, exposure, and

9 other risk assumptions on which the agen10 cy plans to relay and the bases therefor;

11 and

12 ‘‘(iv) all data and information defi13 ciencies that could affect agency decision14 making.

15 ‘‘(d)(1) No agency shall automatically in16 corporate or adopt any recommendation or

17 classification made by an entity described in

18 paragraph (2) concerning the health effects or

19 value of a substance without an opportunity

20 for notice and comment. Any risk assessment

21 or risk characterization document adopted by

22 an agency on the basis of such a recommenda23 tion or classification shall comply with this

24 title.
170

•S 343 RS

1 ‘‘(2) An entity referred to in paragraph (1)

2 includes—

3 ‘‘(A) any foreign government and its

4 agencies;

5 ‘‘(B) the United Nations or any of its

6 subsidiary organizations;

7 ‘‘(C) any international governmental

8 body or standards-making organization;

9 and

10 ‘‘(D) any other organization or private

11 entity without that does not have a place

12 of business located in the United States or

13 its territories.

14 ‘‘§ 634. Principles for risk characterization and com15 munication

16 ‘‘In characterizing risk in any risk assess17 ment document, regulatory proposal or deci18 sion, report to Congress, or other document re19 lating in each case to a major rule that is

20 made available to the public, each agency

21 characterizing the risk shall comply with each

22 of the following:

23 ‘‘(1) The head of the agency shall de24 scribe the exposure scenarios used in any

25 risk assessment, and, to the extent fea-
171

•S 343 RS

1 sible, provide an estimate of the size of the

2 corresponding population or natural re3 source at risk and the likelihood of such

4 exposure scenarios.

5 ‘‘(2) If a numerical estimate of risk is

6 provided, the head of the agency, to the

7 extent feasible and scientifically appro8 priate, shall provide—

9 ‘‘(A) the range and distribution of

10 exposures derived from exposure sce11 narios used in a risk assessment, in12 cluding, where appropriate, central

13 and high-end estimates, but always

14 including a best estimate of the risk to

15 the general population;

16 ‘‘(B) the range and distribution of

17 risk estimates, including best esti18 mates and, where quantitative esti19 mates of the range of distribution of

20 risk estimates are not possible, a list

21 of qualitative factors influencing the

22 range of possible risks; and

23 ‘‘(C) a statement of the major

24 sources of uncertainties in the hazard

25 identification, dose-response, and ex-
172

•S 343 RS

1 posure assessment phases of risk as2 sessment and their influence on the

3 results of the assessment.

4 ‘‘(3) To the extent feasible, the head of

5 the agency shall provide a statement that

6 places the nature and magnitude of indi7 vidual and population risks to human

8 health in context.

9 ‘‘(4) When a Federal agency provides a

10 risk assessment or risk characterization

11 for a proposed or final regulatory action,

12 such assessment or characterization shall

13 include a statement of any significant

14 substitution risks to human health identi15 fied by the agency or contained in infor16 mation provided to the agency by a com17 mentator.

18 ‘‘(5) An agency shall present a sum19 mary in connection with the presentation

20 of the agency’s risk assessment or the reg21 ulation if—

22 ‘‘(A) the agency provides a public

23 comment period with respect to a risk

24 assessment or regulation;
173

•S 343 RS

1 ‘‘(B) a commentator provides a

2 risk assessment, and a summary of re3 sults of such risk assessment; and

4 ‘‘(C) such risk assessment is rea5 sonably consistent with the principles

6 and the guidance provided under this

7 subtitle.

8 ‘‘§ 635. Requirement to prepare assessment

9 ‘‘(a) Except as provided in section 632 and

10 in addition to any requirements applicable

11 under subchapter II, the head of each agency

12 shall prepare—

13 ‘‘(1) for each major rule relating to

14 health, safety, or the environment, and for

15 each major cleanup plan, that is proposed

16 by the agency after the date of enactment

17 of this subchapter, is pending on the date

18 of enactment of this subchapter, or is sub19 ject to a granted petition for review pur20 suant to section 553(e) or 623, a risk as21 sessment in accordance with this sub22 chapter;

23 ‘‘(2) for each such proposed or final

24 plan, and each reasonable alternative

25 within the statutory authority of the agen-
174

•S 343 RS

1 cy taking action, a cost-benefit analysis

2 equivalent to that which would be re3 quired under subchapter II if subchapter

4 II were applicable; and

5 ‘‘(3) for each such proposed or final

6 plan, quantified to the extent feasible, a

7 comparison of any health, safety, or envi8 ronmental risks addressed by the regu9 latory alternatives to other relevant risks

10 chosen by the head of the agency, includ11 ing at least 3 other risks regulated by the

12 agency and to at least 3 other risks with

13 which the public is familiar.

14 ‘‘(b) A major cleanup plan is subject to this

15 subchapter if—

16 ‘‘(1) construction has not commenced

17 on a significant portion of the work re18 quired by the plan; or

19 ‘‘(2) if construction has commenced on

20 a significant portion of the work required

21 by the plan, unless—

22 ‘‘(A) it is more cost-effective to

23 complete construction of the work

24 than to apply the provisions of this

25 subchapter; or
175

•S 343 RS

1 ‘‘(B) the application of the provi2 sions of this subchapter, including

3 any delays caused thereby, will result

4 in an actual and immediate risk to

5 human health or welfare.

6 ‘‘(c) A risk assessment prepared pursuant

7 to this subchapter shall be a component of and

8 used to develop any cost-benefit analysis re9 quired by this subchapter or subchapter II,

10 and shall, along with any cost-benefit analysis

11 required by this subchapter, be made part of

12 the administrative record for judicial review

13 of any final agency action.

14 ‘‘§ 636. Requirements for assessments

15 ‘‘(a) The head of the agency, subject to re16 view by the Director or a designee of the Presi17 dent, shall make a determination that, not18 withstanding any other provision of law—

19 ‘‘(1) for each major rule and major

20 cleanup plan subject to this subchapter,

21 the risk assessment required under sec22 tion 635 is based on a scientific, plausible,

23 and realistic evaluation, reflecting rea24 sonable exposure scenarios, of the risk ad25 dressed by the major rule and is sup-
176

•S 343 RS

1 ported by the best available scientific

2 data, as determined by a peer review

3 panel in accordance with section 640; and

4 ‘‘(2) for each major cleanup plan sub5 ject to this subchapter, the plan has bene6 fits that justify its costs and that there is

7 no alternative that is allowed by the stat8 ute under which the plan is promulgated

9 that would provide greater net benefits or

10 that would achieve an equivalent reduc11 tion in risk in a more cost-effective and

12 flexible manner.

13 ‘‘(b) Notwithstanding any other provision

14 of law, no agency shall prohibit or refuse to

15 approve a substance or product on the basis of

16 safety where the substance or product presents

17 a negligible or insignificant human risk under

18 the intended conditions of use.

19 ‘‘(c) Notwithstanding any other provision

20 of law, issuance of a record of decision or a

21 final permit condition or administrative order

22 containing a major cleanup plan, or denial of,

23 or completion of agency review pursuant to, a

24 petition for review of a major cleanup plan

25 under section 637(c), shall constitute final
177

•S 343 RS

1 agency action subject to judicial review at the

2 time this action is taken.

3 ‘‘§ 637. Regulations; plan for assessing new informa4 tion

5 ‘‘(a)(1) Not later than 1 year after the date

6 of enactment of this subchapter, the Director

7 or a designee of the President shall—

8 ‘‘(A) issue a final regulation that has

9 been subject to notice and comment under

10 section 553 that directs agencies to imple11 ment the risk assessment and risk charac12 terization principles set forth in sections

13 633 and 634; and

14 ‘‘(B) provide a format for summariz15 ing risk assessment results.

16 ‘‘(2) The regulation under paragraph (1)

17 shall be sufficiently specific to ensure that risk

18 assessments are conducted consistently by the

19 various agencies.

20 ‘‘(b) Review of a risk assessment or any

21 entry (or the evaluation underlying the entry)

22 on an agency-developed database (including,

23 but not limited to, the Integrated Risk Infor24 mation System), shall be conducted by the

25 head of the agency on the written petition of
178

•S 343 RS

1 a person showing a reasonable likelihood

2 that—

3 ‘‘(1) the risk assessment or entry is in4 consistent with the principles set forth in

5 sections 633 and 634;

6 ‘‘(2) the risk assessment or entry con7 tains different results than if it had been

8 properly conducted under sections 633

9 and 634;

10 ‘‘(3) the risk assessment or entry is in11 consistent with a rule issued under sub12 section (a); or

13 ‘‘(4) the risk assessment or entry does

14 not take into account material significant

15 new scientific data or scientific under16 standing.

17 ‘‘(c) Review of a risk assessment, a cost18 benefit analysis, or both, for a major cleanup

19 plan shall be conducted by the head of the

20 agency on the written petition of a person

21 showing a reasonable likelihood that—

22 ‘‘(1) the risk assessment warrants revi23 sion under any of the criteria set forth in

24 subsection (b); or
179

•S 343 RS

1 ‘‘(2) the cost-benefit analysis warrants

2 revision under any of the criteria set forth

3 in section 624.

4 ‘‘(d)(1) Not later than 90 days after receiv5 ing a petition under subsection (b), the head

6 of the agency shall respond to the petition by

7 agreeing or declining to review the risk entry,

8 the cost-benefit analysis, or both, referred to in

9 the petition, and shall state the basis for the

10 decision.

11 ‘‘(2) If the head of the agency agrees to re12 view the petition, the agency shall complete its

13 review not later than 180 days after the deci14 sion made under paragraph (1), unless the Di15 rector agrees in writing with an agency deter16 mination that an extension is necessary in

17 view of limitations on agency resources. Prior

18 to completion of the agency review, the agen19 cy’s written conclusions concerning the review

20 shall be subjected to peer review pursuant to

21 section 640.

22 ‘‘(3) A risk assessment review completed

23 pursuant to a petition may be the basis for ini24 tiating a petition pursuant to any other provi25 sion of law.
180

•S 343 RS

1 ‘‘(4) Following a decision to grant or deny

2 a petition under subsection (b) or (c), no fur3 ther petition for such risk assessment, entry, or

4 cost-benefit analysis, submitted by the same

5 person, shall be considered by any agency un6 less such petition is based on a change in a

7 fact, circumstance, or provision of law under8 lying or otherwise related to the matters cov9 ered by the initial petition, occurring since the

10 initial petition was granted or denied, that

11 warrants the granting of such further petition.

12 ‘‘(e) The regulations under this section

13 shall be developed after notice and oppor14 tunity for public comment, and after consulta15 tion with representatives of appropriate State

16 agencies and local governments, and such

17 other departments, agencies, offices, organiza18 tions, or persons as may be advisable.

19 ‘‘(f) At least every 4 years, the Director or

20 a designee of the President shall review, and

21 when appropriate, revise, the regulations pub22 lished under this section.

23 ‘‘§ 638. Rule of construction

24 ‘‘Nothing in this subchapter shall be con25 strued to—
181

•S 343 RS

1 ‘‘(1) preclude the consideration of any

2 data or the calculation of any estimate to

3 more fully describe risk or provide exam4 ples of scientific uncertainty or varia5 bility; or

6 ‘‘(2) require the disclosure of any

7 trade secret or other confidential infor8 mation.

9 ‘‘§ 639. Regulatory priorities

10 ‘‘(a)(1) Not later than 180 days after the

11 date of enactment of this section, the Director

12 of the Office of Management and Budget, in

13 consultation with the Office of Science and

14 Technology Policy, shall enter into appro15 priate arrangements with an accredited sci16 entific body to—

17 ‘‘(A) conduct a study of the methodolo18 gies for using comparative risk to rank

19 dissimilar health, safety, and environ20 mental risks; and

21 ‘‘(B) to conduct a comparative risk

22 analysis in accordance with paragraph

23 (2).

24 ‘‘(2) The study of the methodologies under

25 paragraph (1)(A) shall be conducted as part of
182

•S 343 RS

1 the first comparative risk analysis under

2 paragraph (1)(B). The study shall—

3 ‘‘(A) seek to develop and rigorously

4 test methods of comparative risk analysis;

5 ‘‘(B) have sufficient scope and breadth

6 to test approaches for improving com7 parative risk analysis and its use in set8 ting priorities for health, safety, and envi9 ronmental risk prevention and reduction;

10 and

11 ‘‘(C) review and evaluate the experi12 ence of States that have conducted com13 parative risk analyses.

14 ‘‘(3)(A) The comparative risk analysis

15 under paragraph (1)(B) shall compare and

16 rank, to the extent feasible, health, safety, and

17 environmental risks potentially regulated

18 across the spectrum of programs relating to

19 health, safety, and the environment adminis20 tered by the departments, agencies, and instru21 mentalities of the Federal Government.

22 ‘‘(B) In carrying out the comparative risk

23 analysis under this paragraph, the Director

24 shall ensure that—
183

•S 343 RS

1 ‘‘(i) the scope and specificity of the

2 analysis are sufficient to provide the

3 President and the heads of agencies guid4 ance in allocating resources across agen5 cies and among programs in agencies to

6 achieve the greatest degree of risk preven7 tion and reduction for the public and pri8 vate resources expended;

9 ‘‘(ii) the analysis is conducted through

10 an open process, by individuals with rel11 evant expertise, including, as appro12 priate—

13 ‘‘(I) toxicologists;

14 ‘‘(II) biologists;

15 ‘‘(III) engineers; and

16 ‘‘(IV) experts in the fields of medi17 cine, industrial hygiene, and environ18 mental effects;

19 ‘‘(iii) the analysis is conducted, to the

20 extent feasible, consistent with the risk as21 sessment and risk characterization prin22 ciples described in sections 633 and 634;

23 ‘‘(iv) the methodologies and principal

24 scientific determinations made in the

25 analysis are subjected to peer review
184

•S 343 RS

1 under section 640 and the conclusions of

2 the peer review are made publicly avail3 able as part of the final report;

4 ‘‘(v) there is an opportunity for public

5 comments on the results of the analysis

6 prior to making them final; and

7 ‘‘(vi) the results of the analysis are

8 presented in a manner that distinguishes

9 between the scientific conclusions and any

10 policy or value judgments embodied in the

11 comparisons.

12 ‘‘(4) The comparative risk analysis shall be

13 completed, and a report submitted to Congress

14 not later than 3 years after the date of enact15 ment of this section. The analysis shall be re16 viewed and revised not less often than every 5

17 years thereafter for a minimum of 15 years fol18 lowing the release of the initial analysis.

19 ‘‘(b) Not later than 180 days after the date

20 of enactment of this section, the Director of the

21 Office of Management and Budget, in collabo22 ration with the head of each Federal agency,

23 shall enter into a contract with the National

24 Research Council to provide technical guid25 ance to the agencies on approaches to using
185

•S 343 RS

1 comparative risk analysis in setting health,

2 safety, and environmental priorities to assist

3 the agencies in complying with subsection (c).

4 ‘‘(c)(1) In exercising authority under any

5 laws protecting health, safety, or the environ6 ment, the head of an agency shall prioritize

7 the use of the resources available under such

8 laws to address the risks to health, safety, and

9 the environment that—

10 ‘‘(A) the agency determines are the

11 most serious; and

12 ‘‘(B) can be addressed in a cost-effec13 tive manner, with the goal of achieving

14 the greatest overall net reduction in risks

15 with the public and private sector re16 sources to be expended.

17 ‘‘(2) In identifying the sources of the most

18 serious risks under paragraph (1), the head of

19 the agency shall consider, at a minimum—

20 ‘‘(A) the plausible likelihood and se21 verity of the effect; and

22 ‘‘(B) the plausible number and groups

23 of individuals potentially affected.

24 ‘‘(3) The head of the agency shall incor25 porate the priorities identified in paragraph
186

•S 343 RS

1 (1) into the budget, strategic planning, and re2 search activities of the agency by, in the agen3 cy’s annual budget request to Congress—

4 ‘‘(A) identifying which risks the agen5 cy has determined are the most serious

6 and can be addressed in a cost-effective

7 manner under paragraph (1), and the

8 basis for that determination;

9 ‘‘(B) explicitly identifying how the

10 agency’s requested funds will be used to

11 address those risks;

12 ‘‘(C) identifying any statutory, regu13 latory, or administrative obstacles to allo14 cating agency resources in accordance

15 with the priorities established under

16 paragraph (1); and

17 ‘‘(D) explicitly considering the re18 quirements of paragraph (1) when prepar19 ing the agency’s regulatory agenda or

20 other strategic plan, and providing an ex21 planation of how the agenda or plan re22 flects those requirements and the com23 parative risk analysis when publishing

24 any such agenda or strategic plan.
187

•S 343 RS

1 ‘‘(4) In March of each year, the head of

2 each agency shall submit to Congress specific

3 recommendations for repealing or modifying

4 laws that would better enable the agency to

5 prioritize its activities to address the risks to

6 health, safety, and the environment that are

7 the most serious and can be addressed in a

8 cost-effective manner consistent with the re9 quirements of paragraph (1).

10 ‘‘§ 640. Establishment of program

11 ‘‘(a) The Director of the Office of Science

12 and Technology or the Director, as appro13 priate, shall develop a systematic program for

14 the peer review of work products covered by

15 subsection (c), which program shall be used, in

16 as uniform a manner as is practicable, across

17 the agencies.

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

19 ‘‘(1) shall provide for the creation of

20 peer review panels consisting of independ21 ent and external experts who are broadly

22 representative and balanced to the extent

23 feasible;

24 ‘‘(2) shall not exclude peer reviewers

25 merely because they represent entities that
188

•S 343 RS

1 may have a potential interest in the out2 come, if that interest is fully disclosed;

3 ‘‘(3) shall exclude experts who were

4 associated with the generation of the spe5 cific work product either directly by sub6 stantial contribution to its development,

7 or indirectly by consultation and develop8 ment of the specific product;

9 ‘‘(4) shall provide for differing levels

10 of peer review depending on the signifi11 cance or complexity of the issue or the

12 need for expedition;

13 ‘‘(5) shall contain balanced presen14 tations of all considerations, including

15 minority reports and an agency response

16 to all significant peer review comments;

17 and

18 ‘‘(6) shall provide an opportunity for

19 interested parties to submit issues for con20 sideration by peer review panels.

21 ‘‘(c) Matters requiring peer review shall in22 clude—

23 ‘‘(1) risk assessments and cost-benefit

24 analyses for major rules;
189

•S 343 RS

1 ‘‘(2) quantitative estimates of risk or

2 hazard that are used in making regu3 latory determinations, including all en4 tries into the Integrated Risk Information

5 System;

6 ‘‘(3) risk assessment and risk charac7 terization regulations and cost-benefit

8 guidelines; and

9 ‘‘(4) any other significant or technical

10 work product, as designated by the head

11 of each agency, the Director of the Office

12 of Science and Technology, or the Direc13 tor.

14 ‘‘(d) All underlying data shall be submit15 ted to peer reviewers, except to the extent nec16 essary to protect confidential business infor17 mation and trade secrets. To ensure such pro18 tections, the head of the agency may require

19 that peer reviewers enter into confidentiality

20 agreements.

21 ‘‘(e) The peer review and the agency’s re22 sponses shall be made available to the public

23 for comment and the final peer review and the

24 agency’s responses shall be made part of the
190

•S 343 RS

1 administrative record for purposes of judicial

2 review.

3 ‘‘(f) The proceedings of peer review panels

4 under this section shall be subject to the appli5 cable provisions of the Federal Advisory Com6 mittee Act.

7 ‘‘SUBCHAPTER IV—EXECUTIVE

8 OVERSIGHT

9 ‘‘§ 641. Procedures

10 ‘‘(a) The Director or a designee of the

11 President shall—

12 ‘‘(1) establish procedures for agency

13 compliance with this chapter; and

14 ‘‘(2) monitor, review, and ensure agen15 cy implementation of such procedures.

16 ‘‘(b) Not later than 12 months after the

17 date of enactment of this subchapter the Office

18 of Management and Budget shall issue regula19 tions to assist agencies in preparing the cost20 benefit analyses required by this subchapter.

21 The regulations shall—

22 ‘‘(1) ensure that cost and benefit eval23 uations are consistent with this sub24 chapter and, to the extent feasible, rep25 resent realistic and plausible estimates;
191

•S 343 RS

1 ‘‘(2) be adopted following public no2 tice and adequate opportunity for com3 ment; and

4 ‘‘(3) be used consistently by all agen5 cies covered by this subchapter.

6 ‘‘§ 642. Promulgation and adoption

7 ‘‘(a) Procedures established pursuant to

8 section 641 shall only be implemented after op9 portunity for public comment. Any such proce10 dures shall be consistent with the prompt com11 pletion of rulemaking proceedings.

12 ‘‘(b)(1) If procedures established pursuant

13 to section 641 include review of any initial or

14 final analyses of a rule required under chap15 ter 6, the time for any such review of any ini16 tial analysis shall not exceed 30 days following

17 the receipt of the analysis by the Director, a

18 designee of the President, or by an officer to

19 whom the authority granted under section 641

20 has been delegated pursuant to section 643.

21 ‘‘(2) The time for review of any final analy22 sis required under chapter 6 shall not exceed

23 30 days following the receipt of the analysis by

24 the Director, a designee of the President, or

25 such officer.
192

•S 343 RS

1 ‘‘(3)(A) The times for each such review may

2 be extended for good cause by the President or

3 such officer for an additional 30 days.

4 ‘‘(B) Notice of any such extension, together

5 with a succinct statement of the reasons there6 for, shall be inserted in the rulemaking file.

7 ‘‘§ 643. Delegation of authority

8 ‘‘(a) The President may delegate the au9 thority granted by this subchapter to the Vice

10 President or to an officer within the Executive

11 Office of the President whose appointment has

12 been subject to the advice and consent of the

13 Senate.

14 ‘‘(b)(1) Notice of any delegation, or any rev15 ocation or modification thereof shall be pub16 lished in the Federal Register.

17 ‘‘(2) Any notice with respect to a delegation

18 to the Vice President shall contain a statement

19 by the Vice President that the Vice President

20 will make every reasonable effort to respond to

21 congressional inquiries concerning the exer22 cise of the authority delegated under this sec23 tion.
193

•S 343 RS

1 ‘‘§ 644. Judicial review

2 ‘‘The exercise of the authority granted

3 under this subchapter by the Director, the

4 President, or by an officer to whom such au5 thority has been delegated under section 643

6 shall not be subject to judicial review in any

7 manner under this chapter.’’.

8 (b) REGULATORY FLEXIBILITY ANALYSIS.—

9 (1) JUDICIAL REVIEW.—Section 611 of

10 title 5, United States Code, is amended to

11 read as follows:

12 ‘‘§ 611. Judicial review

13 ‘‘(a)(1) Except as provided in paragraph

14 (2), not later than 2 years after the effective

15 date of a final rule with respect to which an

16 agency—

17 ‘‘(A) certified, pursuant to section

18 605(b), that such rule would not have a

19 significant economic impact on a substan20 tial number of small entities;

21 ‘‘(B) prepared a final regulatory flexi22 bility analysis pursuant to section 604; or

23 ‘‘(C) did not prepare an initial regu24 latory flexibility analysis pursuant to sec25 tion 603 or a final regulatory flexibility
194

•S 343 RS

1 analysis pursuant to section 604 except as

2 permitted by sections 605 and 608,

3 an affected small entity may petition for the

4 judicial review of such certification, analysis,

5 or lack of analysis, in accordance with this

6 subsection. A court having jurisdiction to re7 view such rule for compliance with section 553

8 or under any other provision of law shall have

9 jurisdiction to review such certification or

10 analysis.

11 ‘‘(2)(A) Notwithstanding any other provi12 sion of law, an affected small entity shall have

13 2 years to challenge such certification, analy14 sis or lack of analysis.

15 ‘‘(B) If an agency delays the issuance of a

16 final regulatory flexibility analysis pursuant

17 to section 608(b), a petition for judicial review

18 under this subsection shall be filed not later

19 than 2 years after the date the analysis is

20 made available to the public.

21 ‘‘(3) For purposes of this subsection, the

22 term ‘affected small entity’ means a small en23 tity that is or will be adversely affected by the

24 final rule.
195

•S 343 RS

1 ‘‘(4) Nothing in this subsection shall be

2 construed to affect the authority of any court

3 to stay the effective date of any rule or provi4 sion thereof under any other provision of law.

5 ‘‘(5)(A) Notwithstanding section 605, if the

6 court determines, on the basis of the rule7 making record, that there is substantial evi8 dence to conclude that the rule would have a

9 significant economic impact on a substantial

10 number of small entities, the court shall order

11 the agency to prepare a final regulatory flexi12 bility analysis pursuant to section 604.

13 ‘‘(B) If the agency prepared a final regu14 latory flexibility analysis, the court may order

15 the agency to take corrective action consistent

16 with section 604 if the court determines, on the

17 basis of the rulemaking record, that the final

18 regulatory flexibility analysis was prepared by

19 the agency without complying with section 604.

20 ‘‘(6) The court may stay the rule or grant

21 such other relief as it deems appropriate if, by

22 the end of the 90-day period beginning on the

23 date of the order of the court pursuant to para24 graph (5) (or such longer period as the court
196

•S 343 RS

1 may provide), the agency fails, as appro2 priate—

3 ‘‘(A) to prepare the analysis required

4 by section 604; or

5 ‘‘(B) to take corrective action consist6 ent with section 604.

7 ‘‘(7) In making any determination or

8 granting any relief authorized by this sub9 section, the court shall take due account of the

10 rule of prejudicial error.

11 ‘‘(b) In an action for the judicial review of

12 a rule, any regulatory flexibility analysis for

13 such rule (including an analysis prepared or

14 corrected pursuant to subsection (a)(5)) shall

15 constitute part of the whole record of agency

16 action in connection with such review.

17 ‘‘(c) Nothing in this section bars judicial

18 review of any other impact statement or simi19 lar analysis required by any other law if judi20 cial review of such statement or analysis is

21 otherwise provided by law.’’.

22 (2) EFFECTIVE DATE.— The amendment

23 made by paragraph (1) shall take effect

24 on the date of enactment of this Act, ex25 cept that the judicial review authorized
197

•S 343 RS

1 by section 611(a) of title 5, United States

2 Code (as added by subsection (a)), shall

3 apply only to final agency rules issued

4 after the date of enactment of this Act.

5 (c) PRESIDENTIAL AUTHORITY.— Nothing in

6 this Act shall limit the exercise by the Presi7 dent of the authority and responsibility that

8 the President otherwise possesses under the

9 Constitution and other laws of the United

10 States with respect to regulatory policies, pro11 cedures, and programs of departments, agen12 cies, and offices.

13 (d) TECHNICAL AND CONFORMING AMEND14 MENTS.—

15 (1) CHAPTER ANALYSIS.—Part I of title

16 5, United States Code, is amended by

17 striking out the chapter heading and

18 table of sections for chapter 6 and insert19 ing in lieu thereof the following:

20 ‘‘CHAPTER 6—THE ANALYSIS OF

21 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.
198

•S 343 RS

‘‘607. Preparation of analysis.

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

‘‘609. Procedures for gathering comments.

‘‘610. Periodic review of rules.

‘‘611. Judicial review.

‘‘612. Reports and intervention rights.

‘‘SUBCHAPTER II—ANALYSIS OF AGENCY RULES

‘‘621. Definitions.

‘‘622. Rulemaking cost-benefit analysis.

‘‘623. Petition for cost-benefit analysis.

‘‘624. Decisional criteria.

‘‘625. Judicial review.

‘‘626. Deadlines for rulemaking.

‘‘627. Agency review of rules.

‘‘628. Special rule.

‘‘SUBCHAPTER III—RISK ASSESSMENTS

‘‘631. Definitions.

‘‘632. Applicability.

‘‘633. Principles for risk assessment.

‘‘634. Principles for risk characterization and communication.

‘‘635. Requirement to prepare risk assessment.

‘‘636. Requirements for assessments.

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

‘‘638. Rule of construction.

‘‘639. Regulatory priorities.

‘‘640. Establishment of program.

‘‘SUBCHAPTER IV—EXECUTIVE OVERSIGHT

‘‘641. Procedures.

‘‘642. Promulgation and adoption.

‘‘643. Delegation of authority.

‘‘644. Judicial review.’’.

1 (2) SUBCHAPTER HEADING.—Chapter 6

2 of title 5, United States Code, is amended

3 by inserting immediately before section

4 601, the following subchapter heading:
199

•S 343 RS

1 ‘‘SUBCHAPTER I—REGULATORY

2 ANALYSIS’’.

3 SEC. 5. JUDICIAL REVIEW.

4 (a) SCOPE OF REVIEW.—Section 706 of title

5 5, United States Code, is amended to read as

6 follows:

7 ‘‘§ 706. Scope of review

8 ‘‘(a) To the extent necessary to reach a de9 cision and when presented, the reviewing

10 court shall decide all relevant questions of

11 law, interpret constitutional and statutory

12 provisions, and determine the meaning or ap13 plicability of the terms of an agency action.

14 The reviewing court shall—

15 ‘‘(1) compel agency action unlawfully

16 withheld or unreasonably delayed; and

17 ‘‘(2) hold unlawful and set aside agen18 cy action, findings and conclusions found

19 to be—

20 ‘‘(A) arbitrary, capricious, an

21 abuse of discretion, or otherwise not

22 in accordance with law;

23 ‘‘(B) contrary to constitutional

24 right, power, privilege, or immunity;
200

•S 343 RS

1 ‘‘(C) in excess of statutory jurisdic2 tion, authority, or limitations, or short

3 of statutory right;

4 ‘‘(D) without observance of proce5 dure required by law;

6 ‘‘(E) unsupported by substantial

7 evidence in a proceeding subject to

8 sections 556 and 557 or otherwise re9 viewed on the record of an agency

10 hearing provided by statute;

11 ‘‘(F) without substantial support

12 in the rulemaking file, viewed as a

13 whole, for the asserted or necessary

14 factual basis, as distinguished from

15 the policy or legal basis, of a rule

16 adopted in a proceeding subject to sec17 tion 553; or

18 ‘‘(G) unwarranted by the facts to

19 the extent that the facts are subject to

20 trial de novo by the reviewing court.

21 ‘‘(b) In making the foregoing determina22 tions, the court shall review the whole record

23 or those parts of it cited by a party, and due

24 account shall be taken of the rule of preju25 dicial error.
201

•S 343 RS

1 ‘‘(c) In reviewing an agency interpretation

2 of a statute governing the authority for an

3 agency action, including agency action taken

4 pursuant to a statute that provides for review

5 of final agency action, the reviewing court

6 shall—

7 ‘‘(1) hold erroneous and unlawful—

8 ‘‘(A) an agency interpretation that

9 is other than the interpretation of the

10 statute clearly intended by Congress;

11 or

12 ‘‘(B) an agency interpretation that

13 is outside the range of permissible in14 terpretations of the statute; and

15 ‘‘(2) hold arbitrary, capricious, or an

16 abuse of discretion—

17 ‘‘(A) an agency action as to which

18 the agency—

19 ‘‘(i) has improperly classified

20 an interpretation as being within

21 or outside the range of permissible

22 interpretations; or

23 ‘‘(ii) has not explained in a

24 reasoned analysis why it selected

25 the interpretation and why it re-
202

•S 343 RS

1 jected other permissible interpre2 tations of the statute; or

3 ‘‘(B) in the case of agency action

4 subject to chapter 6, an interpretation

5 that does not give the agency the

6 broadest discretion to develop rules

7 that will satisfy the decisional cri8 teria of section 624.

9 ‘‘(d) Notwithstanding any other provision

10 of law, the provisions of this subsection shall

11 apply to, and supplement, the requirements

12 contained in any statute for the review of final

13 agency action which is not otherwise subject to

14 this subsection.’’.

15 (b) COURT OF FEDERAL CLAIMS.—

16 (1) IN GENERAL.—Section 1491(a) of

17 title 28, United States Code, is amended—

18 (A) in paragraph (1), by amending

19 the first sentence to read as follows:

20 ‘‘The United States Court of Federal

21 Claims shall have jurisdiction to

22 render judgment upon any claim

23 against the United States for mone24 tary relief founded either upon the

25 Constitution or any Act of Congress or
203

•S 343 RS

1 any regulation or action of an agency,

2 or upon any expressed or implied con3 tract with the United States, in cases

4 not sounding in tort, or for invalida5 tion of any Act of Congress or any reg6 ulation of an executive department

7 that adversely affects private property

8 rights in violation of the fifth amend9 ment of the United States Constitu10 tion.’’;

11 (B) in paragraph (2), by inserting

12 before the first sentence the following:

13 ‘‘In any case within its jurisdiction,

14 the Court of Federal Claims shall

15 have the power to grant injunctive

16 and declaratory relief when appro17 priate.’’; and

18 (C) by adding at the end the fol19 lowing new paragraphs:

20 ‘‘(4) In cases otherwise within its jurisdic21 tion, the Court of Federal Claims shall also

22 have ancillary jurisdiction, concurrent with

23 the courts designated in section 1346(b), to

24 render judgment upon any related tort claim

25 authorized under section 2674.
204

•S 343 RS

1 ‘‘(5) In proceedings within the jurisdiction

2 of the Court of Federal Claims which con3 stitute judicial review of agency action (rather

4 than de novo proceedings), the provisions of

5 section 706 of title 5 shall apply.’’.

6 (2) PENDENCY OF CLAIMS IN OTHER

7 COURTS.—Section 1500 of title 28, United

8 States Code, is repealed.

9 (c) JUDICIAL PROCEEDINGS.—

10 (1) CONSENT DECREES.—Chapter 7 of

11 title 5, United States Code, is amended by

12 adding at the end the following new sec13 tion:

14 ‘‘§ 707. Consent decrees

15 ‘‘In interpreting any consent decree in ef16 fect on or after the date of enactment of this

17 section that imposes on an agency an obliga18 tion to initiate, continue, or complete rule19 making proceedings, the court shall not en20 force the decree in a way that divests the agen21 cy of discretion granted to it by the Congress

22 or the Constitution to respond to changing cir23 cumstances, make policy or managerial

24 choices, or protect the rights of third parties.’’.
205

•S 343 RS

1 (2) AFFIRMATIVE DEFENSE.—Chapter 7

2 of title 5, United States Code, is further

3 amended by adding at the end the follow4 ing new section:

5 ‘‘§ 708. Affirmative defense

6 ‘‘Notwithstanding any other provision of

7 law, it shall be an affirmative defense in any

8 enforcement action brought by an agency that

9 the regulated person or entity is complying

10 with a rule, regulation, adjudication, direc11 tive, or order of such agency or any other agen12 cy that is inconsistent, incompatible, con13 tradictory, or otherwise cannot be reconciled

14 with the agency rule, regulation, adjudication,

15 directive, or order being enforced.’’.

16 (3) AGENCY INTERPRETATIONS IN CIVIL

17 AND CRIMINAL ACTIONS.—

18 (A) IN GENERAL.—Chapter 7 of title

19 5, United States Code, is further

20 amended by adding at the end the fol21 lowing new section:

22 ‘‘§ 709. Agency interpretations in civil and criminal

23 actions

24 ‘‘(a)(1) No civil or criminal penalty shall

25 be imposed in any action brought in a Federal
206

•S 343 RS

1 court, including an action pending on the date

2 of enactment of this section, for the alleged

3 violation of a rule, if the defendant, prior to

4 the alleged violation—

5 ‘‘(A) reasonably determined, based

6 upon a description, explanation, or inter7 pretation of the rule contained in the

8 rule’s statement of basis and purpose,

9 that the defendant was in compliance

10 with, exempt from, or otherwise not sub11 ject to, the requirements of the rule; or

12 ‘‘(B) was informed by the agency that

13 promulgated the rule, or by a State au14 thority to which had been delegated the

15 responsibility for ensuring compliance

16 with the rule, that the defendant was in

17 compliance with, exempt from, or other18 wise not subject to, the requirements of

19 the rule.

20 ‘‘(2) In determining, for purposes of para21 graph (1)(A), whether a defendant reasonably

22 relied upon a description, explanation, or in23 terpretation of the rule contained in the rule’s

24 statement of basis and purpose, the court shall

25 not give deference to any subsequent agency
207

•S 343 RS

1 description, explanation, or interpretation of

2 the rule relied on by the agency in the action

3 that had not been published in the Federal

4 Register or otherwise directly and specifically

5 communicated to the defendant by the agency,

6 or by a State authority to which had been dele7 gated the responsibility for ensuring compli8 ance with the rule, prior to the alleged viola9 tion.

10 ‘‘(b)(1) In a civil or criminal action in Fed11 eral court to redress an alleged violation of a

12 rule, including an action pending on the date

13 of enactment of this section, if the court deter14 mines that the rule in question is ambiguous,

15 the court shall not give deference to an agency

16 interpretation of the rule if the defendant re17 lied upon an interpretation of the rule to the

18 effect that the defendant was in compliance

19 with or was exempt or otherwise not subject to

20 the requirement of the rule, and the court de21 termines that such determination is reason22 able.

23 ‘‘(2) Without regard to whether the defend24 ant relied upon an interpretation that the

25 court determines is reasonable under para-
208

•S 343 RS

1 graph (1), if the court determines that the rule

2 failed to give the defendant fair warning of

3 the conduct that the rule prohibits or requires,

4 no civil or criminal penalty shall be imposed.

5 ‘‘(c)(1) No agency action shall be taken, or

6 any action or other proceeding maintained,

7 seeking the retroactive application of a re8 quirement against any person that is based

9 upon—

10 ‘‘(A) an interpretation of a statute,

11 rule, guidance, agency statement of policy,

12 or license requirement or condition; or

13 ‘‘(B) a determination of fact,

14 if such interpretation or determination is dif15 ferent from a prior interpretation or deter16 mination by the agency or by a State or local

17 government exercising authority delegated or

18 approved by the agency, and if such person re19 lied upon the prior interpretation or deter20 mination.

21 ‘‘(2) This subsection shall take effect on the

22 date of enactment of the Comprehensive Regu23 latory Reform Act of 1995 and shall apply to

24 any matter for which a final unappealable ju25 dicial order has not been issued.
209

•S 343 RS

1 ‘‘(d) This section shall apply to the review

2 by a Federal court of any order of an agency

3 assessing civil administrative penalties.’’.

4 (B) UNPUBLISHED AGENCY GUID5 ANCE.—Section 552(a)(1) of title 5,

6 United States Code, is amended by in7 serting at the end the following new

8 sentence: ‘‘In an action brought in a

9 Federal court seeking a civil or crimi10 nal penalty for the alleged violation of

11 a rule, including actions pending on

12 the date of enactment of this sentence,

13 no consideration shall be given to any

14 interpretive rule, general statement of

15 policy, or other agency guidance of

16 general or specific applicability, re17 lied upon by the agency in the action,

18 that had not been published in the

19 Federal Register or otherwise directly

20 and specifically communicated to the

21 defendant by the agency, or by a State

22 authority to which had been delegated

23 the responsibility for ensuring compli24 ance with the rule, prior to the al25 leged violation.’’.
210

•S 343 RS

1 (4) TECHNICAL AMENDMENT.—The anal2 ysis for chapter 7 of title 5, United States

3 Code, is amended by adding at the end the

4 following new items:

‘‘707. Consent decrees.

‘‘708. Affirmative defense.

‘‘709. Agency interpretations in civil and criminal actions.’’.

5 SEC. 6. CONGRESSIONAL REVIEW.

6 (a) IN GENERAL.—Title 5, United States

7 Code, is amended by inserting immediately

8 after chapter 7 the following new chapter:

9 ‘‘CHAPTER 8—CONGRESSIONAL REVIEW

10 OF AGENCY RULEMAKING

11 ‘‘§ 801. Congressional review of agency rulemaking

12 ‘‘(a)(1) Before a rule takes effect as a final

13 rule, the agency promulgating such rule shall

14 submit to the Congress a report containing a

15 copy of the rule, the notice of proposed rule16 making, and the statement of basis and pur17 pose for the rule, including a complete copy of

18 any analysis required under chapter 6, and

19 the proposed effective date of the rule. In the

20 case of a rule that is not a major rule within

21 the meaning of section 621(4), summary of the

22 rulemaking proceedings shall be submitted.
211

•S 343 RS

1 ‘‘(2) A rule relating to a report submitted

2 under paragraph (1) shall take effect as a

3 final rule, the latest of the following:

4 ‘‘(A) The later of the date occurring 45

5 days after the date on which—

6 ‘‘(i) the Congress receives the re7 port submitted under paragraph (1);

8 or

9 ‘‘(ii) the rule is published in the

10 Federal Register.

11 ‘‘(B) If the Congress passes a joint res12 olution of disapproval described under

13 subsection (g) relating to the rule, and the

14 President signs a veto of such resolution,

15 the earlier date—

16 ‘‘(i) on which either House of Con17 gress votes and fails to override the

18 veto of the President; or

19 ‘‘(ii) occurring 30 session days

20 after the date on which the Congress

21 received the veto and objections of the

22 President.

23 ‘‘(C) The date the rule would have oth24 erwise taken effect, if not for this section
212

•S 343 RS

1 (unless a joint resolution of disapproval

2 under subsection (g) is approved).

3 ‘‘(b) A rule shall not take effect as a final

4 rule if the Congress passes a joint resolution

5 of disapproval described under subsection (g),

6 which is signed by the President or is vetoed

7 and overridden by the Congress.

8 ‘‘(c)(1) Notwithstanding any other provi9 sion of this section (except subject to para10 graph (3)), a rule that would not take effect by

11 reason of this section may take effect if the

12 President makes a determination under para13 graph (2) and submits written notice of such

14 determination to the Congress.

15 ‘‘(2) Paragraph (1) applies to a determina16 tion made by the President by Executive order

17 that the rule should take effect because such

18 rule is—

19 ‘‘(A) necessary because of an imminent

20 threat to health or safety or other emer21 gency;

22 ‘‘(B) necessary for the enforcement of

23 criminal laws; or

24 ‘‘(C) necessary for national security.
213

•S 343 RS

1 ‘‘(3) An exercise by the President of the au2 thority under this subsection shall have no ef3 fect on the procedures under subsection (g) or

4 the effect of a joint resolution of disapproval

5 under this section.

6 ‘‘(4) This subsection and an Executive

7 order issued by the President under para8 graph (2) shall not be subject to judicial re9 view by a court of the United States.

10 ‘‘(d)(1) Subsection (g) shall apply to any

11 rule that is published in the Federal Register

12 (as a rule that shall take effect as a final rule)

13 during the period beginning on the date occur14 ring 60 days before the date the Congress ad15 journs sine die through the date on which the

16 succeeding Congress first convenes.

17 ‘‘(2) For purposes of subsection (g), a rule

18 described under paragraph (1) shall be treat19 ed as though such rule were published in the

20 Federal Register (as a rule that shall take ef21 fect as a final rule) on the date the succeeding

22 Congress first convenes.

23 ‘‘(3) During the period between the date

24 the Congress adjourns sine die through the

25 date on which the succeeding Congress first
214

•S 343 RS

1 convenes, a rule described under paragraph

2 (1) shall take effect as a final rule as otherwise

3 provided by law.

4 ‘‘(e) Any rule that takes effect and later is

5 made of no force or effect by the enactment of

6 a joint resolution under subsection (g) shall be

7 treated as though such rule had never taken

8 effect.

9 ‘‘(f) If the Congress does not enact a joint

10 resolution of disapproval under subsection (g),

11 no court or agency may infer any intent of the

12 Congress from any action or inaction of the

13 Congress with regard to such rule, related

14 statute, or joint resolution of disapproval.

15 ‘‘(g)(1) For purposes of this subsection, the

16 term ‘joint resolution’ means only a joint reso17 lution introduced after the date on which the

18 report referred to in subsection (a) is received

19 by Congress the matter after the resolving

20 clause of which is as follows: ‘That Congress

21 disapproves the rule submitted by the

22 llllll relating to lllllll, and

23 such rule shall have no force or effect.’ (The

24 blank spaces being appropriately filled in.)
215

•S 343 RS

1 ‘‘(2)(A) A resolution described in para2 graph (1) shall be referred to the committees

3 in each House of Congress with jurisdiction.

4 Such a resolution shall not be reported before

5 the eighth day after its submission or publica6 tion date.

7 ‘‘(B) For purposes of this subsection the

8 term ‘submission or publication date’ means

9 the later of the date on which—

10 ‘‘(i) the Congress receives the report

11 submitted under subsection (a)(1); or

12 ‘‘(ii) the rule is published in the Fed13 eral Register.

14 ‘‘(3) If the committee to which a resolution

15 described in paragraph (1) is referred has not

16 reported such resolution (or an identical reso17 lution) at the end of 20 calendar days after its

18 submission or publication date, such commit19 tee may be discharged by the Majority Leader

20 of the Senate or the Majority Leader of the

21 House of Representatives, as the case may be,

22 from further consideration of such resolution

23 and such resolution shall be placed on the ap24 propriate calendar of the House involved.
216

•S 343 RS

1 ‘‘(4)(A) When the committee to which a res2 olution is referred has reported, or when a

3 committee is discharged (under paragraph

4 (3)) from further consideration of, a resolution

5 described in paragraph (1), it shall at any

6 time thereafter be in order (even though a pre7 vious motion to the same effect has been dis8 agreed to) for any Member of the respective

9 House to move to proceed to the consideration

10 of the resolution, and all points of order

11 against the resolution (and against consider12 ation of the resolution) shall be waived. The

13 motion shall be highly privileged in the House

14 of Representatives and shall be privileged in

15 the Senate and shall not be debatable. The mo16 tion shall not be subject to amendment, or to

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

18 to the consideration of other business. A mo19 tion to reconsider the vote by which the motion

20 is agreed to or disagreed to shall not be in

21 order. If a motion to proceed to the consider22 ation of the resolution is agreed to, the resolu23 tion shall remain the unfinished business of

24 the respective House until disposed of.
217

•S 343 RS

1 ‘‘(B) Debate on the resolution, and on all

2 debatable motions and appeals in connection

3 therewith, shall be limited to not more than 10

4 hours, which shall be divided equally between

5 those favoring and those opposing the resolu6 tion. A motion further to limit debate shall be

7 in order and shall not be debatable. An

8 amendment to, or a motion to postpone, or a

9 motion to proceed to the consideration of other

10 business, or a motion to recommit the resolu11 tion shall not be in order. A motion to recon12 sider the vote by which the resolution is agreed

13 to or disagreed to shall not be in order.

14 ‘‘(C) Immediately following the conclusion

15 of the debate on a resolution described in

16 paragraph (1), and a single quorum call at the

17 conclusion of the debate if requested in ac18 cordance with the rules of the appropriate

19 House, the vote on final passage of the resolu20 tion shall occur.

21 ‘‘(D) Appeals from the decisions of the

22 Chair relating to the application of the rules

23 of the Senate or the House of Representatives,

24 as the case may be, to the procedure relating
218

•S 343 RS

1 to a resolution described in paragraph (1)

2 shall be decided without debate.

3 ‘‘(5) If, before the passage by one House of

4 a resolution of that House described in para5 graph (1), that House receives from the other

6 House a resolution described in paragraph (1),

7 then the following procedures shall apply:

8 ‘‘(A) The resolution of the other House

9 shall not be referred to a committee.

10 ‘‘(B) With respect to a resolution de11 scribed in paragraph (1) of the House re12 ceiving the resolution—

13 ‘‘(i) the procedure in that House

14 shall be the same as if no resolution

15 had been received from the other

16 House; but

17 ‘‘(ii) the vote on final passage

18 shall be on the resolution of the other

19 House.

20 ‘‘(6) This subsection is enacted by Con21 gress—

22 ‘‘(A) as an exercise of the rulemaking

23 power of the Senate and House of Rep24 resentatives, respectively, and as such it is

25 deemed to be a part of the rules of each
219

•S 343 RS

1 House, respectively, but applicable only

2 with respect to the procedure to be fol3 lowed in that House in the case of a reso4 lution described in paragraph (1), and it

5 supersedes other rules only to the extent

6 that it is inconsistent with such rules; and

7 ‘‘(B) with full recognition of the con8 stitutional right of either House to change

9 the rules (so far as relating to the proce10 dure of that House) at any time, in the

11 same manner, and to the same extent as

12 in the case of any other rule of that

13 House.

14 ‘‘(h) This section shall not apply to rules

15 that concern monetary policy proposed or im16 plemented by the Board of Governors of the

17 Federal Reserve System or the Federal Open

18 Market Committee.’’.

19 (b) TECHNICAL AMENDMENT.—The table of

20 chapters for part I of title 5, United States

21 Code, is amended by inserting immediately

22 after the item relating to chapter 7 the follow23 ing:

‘‘8. Congressional Review of Agency Rulemaking ................ 801’’.
220

•S 343 RS

1 SEC. 7. ACCOUNTING.

2 (a) DEFINITIONS.—For purposes of this sec3 tion, the following definitions apply:

4 (1) REGULATION.—The term ‘‘regula5 tion’’ means an agency statement of gen6 eral applicability and future effect de7 signed to implement, interpret, or pre8 scribe law or policy or describing the pro9 cedures or practice requirements of an

10 agency. The term shall not include—

11 (A) administrative actions gov12 erned by sections 556 and 557 of title

13 5, United States Code;

14 (B) regulations issued with respect

15 to a military or foreign affairs func16 tion of the United States; or

17 (C) regulations related to agency

18 organization, management, or person19 nel.

20 (2) AGENCY.—The term ‘‘agency’’

21 means any executive department, military

22 department, Government corporation,

23 Government controlled corporation, or

24 other establishment in the executive

25 branch of the Government (including the

26 Executive Office of the President), or any
221

•S 343 RS

1 independent regulatory agency, but shall

2 not include—

3 (A) the General Accounting Office;

4 (B) the Federal Election Commis5 sion;

6 (C) the governments of the District

7 of Columbia and of the territories and

8 possessions of the United States, and

9 their various subdivisions; or

10 (D) Government-owned contractor11 operated facilities, including labora12 tories engaged in national defense re13 search and production activities.

14 (b) ACCOUNTING STATEMENT.—

15 (1) IN GENERAL.—(A) The President

16 shall be responsible for implementing and

17 administering the requirements of this

18 section.

19 (B) Every 2 years, not later than June

20 of the second year, the President shall

21 prepare and submit to Congress an ac22 counting statement that estimates the

23 costs of Federal regulatory programs and

24 corresponding benefits in accordance

25 with this subsection.
222

•S 343 RS

1 (2) YEARS COVERED BY ACCOUNTING

2 STATEMENT.—Each accounting statement

3 shall cover, at a minimum, the 5 fiscal

4 years beginning on October 1 of the year

5 in which the report is submitted and may

6 cover any fiscal year preceding such fiscal

7 years for purpose of revising previous esti8 mates.

9 (3) TIMING AND PROCEDURES.—(A) The

10 President shall provide notice and oppor11 tunity for comment for each accounting

12 statement. The President may delegate to

13 an agency the requirement to provide no14 tice and opportunity to comment for the

15 portion of the accounting statement relat16 ing to that agency.

17 (B) The President shall propose the

18 first accounting statement under this sub19 section not later than 2 years after the

20 date of the enactment of this Act and

21 shall issue the first accounting statement

22 in final form not later than 3 years after

23 the date of the enactment of this Act. Such

24 statement shall cover, at a minimum,
223

•S 343 RS

1 each of the 8 fiscal years beginning after

2 the date of the enactment of this Act.

3 (4) CONTENT OF ACCOUNTING STATE4 MENT.—(A) Each accounting statement

5 shall contain estimates of costs and bene6 fits with respect to each fiscal year cov7 ered by the statement in accordance with

8 this paragraph. For each such fiscal year

9 for which estimates were made in a pre10 vious accounting statement, the statement

11 shall revise those estimates and state the

12 reasons for the revisions.

13 (B)(i) An accounting statement shall

14 estimate the costs of Federal regulatory

15 programs by setting forth, for each year

16 covered by the statement—

17 (I) the annual expenditure of na18 tional economic resources for the reg19 ulatory program; and

20 (II) such other quantitative and

21 qualitative measures of costs as the

22 President considers appropriate.

23 (ii) For purposes of the estimate of

24 costs in the accounting statement, na25 tional economic resources shall include,
224

•S 343 RS

1 and shall be listed under, at least the fol2 lowing categories:

3 (I) Private sector costs.

4 (II) Federal sector administrative

5 costs.

6 (III) Federal sector compliance

7 costs.

8 (IV) State and local government

9 administrative costs.

10 (V) State and local government

11 compliance costs.

12 (VI) Indirect costs, including op13 portunity costs.

14 (C) An accounting statement shall es15 timate the benefits of Federal regulatory

16 programs by setting forth, for each year

17 covered by the statement, such quan18 titative and qualitative measures of bene19 fits as the President considers appro20 priate. Any estimates of benefits concern21 ing reduction in health, safety, or environ22 mental risks shall present the most plau23 sible level of risk practical, along with a

24 statement of the reasonable degree of sci25 entific certainty.
225

•S 343 RS

1 (c) ASSOCIATED REPORT TO CONGRESS.—

2 (1) IN GENERAL.—At the same time as

3 the President submits an accounting

4 statement under subsection (b), the Presi5 dent, acting through the Director of the

6 Office of Management and Budget, shall

7 submit to Congress a report associated

8 with the accounting statement (herein9 after referred to as an ‘‘associated re10 port’’). The associated report shall con11 tain, in accordance with this subsection—

12 (A) analyses of impacts; and

13 (B) recommendations for reform.

14 (2) ANALYSES OF IMPACTS.—The Presi15 dent shall include in the associated report

16 the following:

17 (A) Analyses prepared by the

18 President of the cumulative impact of

19 Federal regulatory programs covered

20 in the accounting statement on the

21 following:

22 (i) The ability of State and

23 local governments to provide es24 sential services, including police,

25 fire protection, and education.
226

•S 343 RS

1 (ii) Small business.

2 (iii) Productivity.

3 (iv) Wages.

4 (v) Economic growth.

5 (vi) Technological innovation.

6 (vii) Consumer prices for

7 goods and services.

8 (viii) Such other factors con9 sidered appropriate by the Presi10 dent.

11 (B) A summary of any independent

12 analyses of impacts prepared by per13 sons commenting during the comment

14 period on the accounting statement.

15 (3) RECOMMENDATIONS FOR REFORM.—

16 The President shall include in the associ17 ated report the following:

18 (A) A summary of recommenda19 tions of the President for reform or

20 elimination of any Federal regulatory

21 program or program element that

22 does not represent sound use of na23 tional economic resources or other24 wise is inefficient.
227

•S 343 RS

1 (B) A summary of any rec2 ommendations for such reform or

3 elimination of Federal regulatory pro4 grams or program elements prepared

5 by persons commenting during the

6 comment period on the accounting

7 statement.

8 (d) GUIDANCE FROM OFFICE OF MANAGEMENT

9 AND BUDGET.—The Director of the Office of

10 Management and Budget shall, in consulta11 tion with the Council of Economic Advisers,

12 provide guidance to agencies—

13 (1) to standardize measures of costs

14 and benefits in accounting statements

15 prepared pursuant to sections 3 and 7 of

16 this Act, including—

17 (A) detailed guidance on estimat18 ing the costs and benefits of major

19 rules; and

20 (B) general guidance on estimat21 ing the costs and benefits of all other

22 rules that do not meet the thresholds

23 for major rules; and

24 (2) to standardize the format of the

25 accounting statements.
228

•S 343 RS

1 (e) RECOMMENDATIONS FROM CONGRES2 SIONAL BUDGET OFFICE.—After each accounting

3 statement and associated report submitted to

4 Congress, the Director of the Congressional

5 Budget Office shall make recommendations to

6 the President—

7 (1) for improving accounting state8 ments prepared pursuant to this section,

9 including recommendations on level of de10 tail and accuracy; and

11 (2) for improving associated reports

12 prepared pursuant to this section, includ13 ing recommendations on the quality of

14 analysis.

15 SEC. 8. STUDIES AND REPORTS.

16 (a) RISK ASSESSMENTS.—The Administra17 tive Conference of the United States shall—

18 (1) develop and carry out an ongoing

19 study of the operation of the risk assess20 ment requirements of subchapter III of

21 chapter 6 of title 5, United States Code (as

22 added by section 4 of this Act); and

23 (2) submit an annual report to the

24 Congress on the findings of the study.
229

•S 343 RS

1 (b) ADMINISTRATIVE PROCEDURE ACT.—Not

2 later than December 31, 1996, the Administra3 tive Conference of the United States shall—

4 (1) carry out a study of the operation

5 of the Administrative Procedure Act (as

6 amended by section 3 of this Act); and

7 (2) submit a report to the Congress on

8 the findings of the study, including pro9 posals for revision, if any.

S 343 RS——2

S 343 RS——3

S 343 RS——4

S 343 RS——5

S 343 RS——6

S 343 RS——7

S 343 RS——8

S 343 RS——9

S 343 RS——10

S 343 RS——11

S 343 RS——12

S 343 RS——13

S 343 RS——14

S 343 RS——15