I

104TH CONGRESS

1ST SESSION H. R. 1022

To provide regulatory reform and to focus national economic resources on

the greatest risks to human health, safety, and the environment through

scientifically objective and unbiased risk assessments and through the

consideration of costs and benefits in major rules, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

FEBRUARY 23, 1995

Mr. WALKER (for himself and Mr. BLILEY) introduced the following bill;

which was referred to the Committee on Science and, in addition, to the

Committees on Commerce and Government Reform and Oversight, for a

period to be subsequently determined by the Speaker, in each case for

consideration of such provisions as fall within the jurisdiction of the committee concerned

A BILL

To provide regulatory reform and to focus national economic

resources on the greatest risks to human health, safety,

and the environment through scientifically objective and

unbiased risk assessments and through the consideration

of costs and benefits in major rules, 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,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Risk Assessment and

3 Cost-Benefit Act of 1995’’.

4 SEC. 2. FINDINGS.

5 The Congress finds that:

6 (1) Environmental, health, and safety regula7 tions have led to dramatic improvements in the envi8 ronment and have significantly reduced human

9 health risk; however, the Federal regulations that

10 have led to these improvements have been more cost11 ly and less effective than they could have been; too

12 often, regulatory priorities have not been based upon

13 a realistic consideration of risk, risk reduction op14 portunities, and costs.

15 (2) The public and private resources available

16 to address health, safety, and environmental con17 cerns are not unlimited; those resources need to be

18 allocated to address the greatest needs in the most

19 cost-effective manner and so that the incremental

20 costs of regulatory alternatives are reasonably relat21 ed to the incremental benefits.

22 (3) To provide more cost-effective and cost-rea23 sonable protection to human health and the environ24 ment, regulatory priorities should be based upon re25 alistic consideration of risk; the priority setting proc26 ess must include scientifically sound, objective, and
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1 unbiased risk assessments, comparative risk analy2 sis, and risk management choices that are grounded

3 in cost-benefit principles.

4 (4) Risk assessment has proven to be a useful

5 decision making tool; however, improvements are

6 needed in both the quality of assessments and the

7 characterization and communication of findings; sci8 entific and other data must be better collected, orga9 nized, and evaluated; most importantly, the critical

10 information resulting from a risk assessment must

11 be effectively communicated in an objective and un12 biased manner to decision makers, and from decision

13 makers to the public.

14 (5) The public stake holders must be fully in15 volved in the risk-decision making process. They

16 have the right-to-know about the risks addressed by

17 regulation, the amount of risk to be reduced, the

18 quality of the science used to support decisions, and

19 the cost of implementing and complying with regula20 tions. This knowledge will allow for public scrutiny

21 and promote quality, integrity, and responsiveness of

22 agency decisions.

23 (6) Although risk assessment is one important

24 method to improve regulatory decision-making, other

25 approaches to secure prompt relief from the burden
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1 of unnecessary and overly complex regulations will

2 also be necessary.

3 SEC. 3. COVERAGE OF ACT.

4 This Act does not apply to any of the following:

5 (1) A situation that the head of an affected

6 Federal agency determines to be an emergency. In

7 such circumstance, the head of the agency shall com8 ply with the provisions of this Act within as reason9 able a time as is practical.

10 (2) Activities necessary to maintain military

11 readiness.

12 (3) Any individual food, drug, or other product

13 label, or to any risk characterization appearing on

14 any such label, if the individual product label is re15 quired by law to be approved by a Federal depart16 ment or agency prior to use.

17 (4) Approval of State programs or plans by

18 Federal agencies.

19 SEC. 4. DEFINITIONS

20 For purposes of this Act:

21 (1) COSTS.—The term ‘‘costs’’ includes the di22 rect and indirect costs to the United States Govern23 ment, to State, local, and tribal governments, and to

24 the private sector, wage earners, consumers, and the
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1 economy, of implementing and complying with a rule

2 or alternative strategy.

3 (2) BENEFIT.—The term ‘‘benefit’’ means the

4 reasonably identifiable significant health, safety, en5 vironmental, social and economic benefits that are

6 expected to result directly or indirectly from imple7 mentation of a rule or alternative strategy.

8 (3) MAJOR RULE.—The term ‘‘major rule’’

9 means any regulation that is likely to result in an

10 annual increase in costs of $25,000,000 or more.

11 Such term does not include any regulation or other

12 action taken by an agency to authorize or approve

13 any individual substance or product.

14 (4) PROGRAM DESIGNED TO PROTECT HUMAN

15 HEALTH.—The term ‘‘program designed to protect

16 human health’’ does not include regulatory programs

17 concerning health insurance, health provider serv18 ices, or health care diagnostic services.

19 Title I—Risk Assessment and

20 Communication

21 SEC. 101. SHORT TITLE.

22 This title may be cited as the ‘‘Risk Assessment and

23 Communication Act of 1995’’.

24 SEC. 102. PURPOSES.

25 The purposes of this title are—
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1 (1) to present the public and executive branch

2 with the most scientifically objective and unbiased

3 information concerning the nature and magnitude of

4 health, safety, and environmental risks in order to

5 provide for sound regulatory decisions and public

6 education;

7 (2) to provide for full consideration and discus8 sion of relevant data and potential methodologies;

9 (3) to require explanation of significant choices

10 in the risk assessment process which will allow for

11 better peer review and public understanding; and

12 (4) to improve consistency within the executive

13 branch in preparing risk assessments and risk char14 acterizations.

15 SEC. 103. EFFECTIVE DATE; APPLICABILITY; SAVINGS PRO16 VISIONS.

17 (a) EFFECTIVE DATE.—Except as otherwise specifi18 cally provided in this title, the provisions of this title shall

19 take effect 18 months after the date of enactment of this

20 title.

21 (b) APPLICABILITY.—

22 (1) IN GENERAL.—Except as provided in para23 graph (3), this title applies to all significant risk as24 sessment documents and significant risk character25 ization documents, as defined in paragraph (2).
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1 (2) SIGNIFICANT RISK ASSESSMENT DOCUMENT

2 OR SIGNIFICANT RISK CHARACTERIZATION DOCU3 MENT.—(A) As used in this title, the terms ‘‘signifi4 cant risk assessment document’’ and ‘‘significant

5 risk characterization document’’ include, at a mini6 mum, risk assessment documents or risk character7 ization documents prepared by or on behalf of a cov8 ered Federal agency in the implementation of a reg9 ulatory program designed to protect human health,

10 safety, or the environment, used as a basis for one

11 of the items referred to in subparagraph (B), and—

12 (i) included by the agency in that item; or

13 (ii) inserted by the agency in the adminis14 trative record for that item.

15 (B) The items referred to in subparagraph (A)

16 are the following:

17 (i) Any proposed or final major rule, in18 cluding any analysis or certification under title

19 II, promulgated as part of any Federal regu20 latory program designed to protect human

21 health, safety, or the environment.

22 (ii) Any proposed or final environmental

23 clean-up plan for a facility or Federal guidelines

24 for the issuance of any such plan. As used in

25 this clause, the term ‘‘environmental clean-up’’
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1 means a corrective action under the Solid

2 Waste Disposal Act, a removal or remedial ac3 tion under the Comprehensive Environmental

4 Response, Compensation, and Liability Act of

5 1980, and any other environmental restoration

6 and waste management carried out by or on be7 half of a covered Federal agency with respect to

8 any substance other than municipal waste.

9 (iii) Any proposed or final permit condition

10 placing a restriction on facility siting or oper11 ation under Federal laws administered by the

12 Environmental Protection Agency or the De13 partment of the Interior.

14 (iv) Any report to Congress.

15 (v) Any regulatory action to place a sub16 stance on any official list of carcinogens or

17 toxic or hazardous substances or to place a new

18 health effects value on such list, including the

19 Integrated Risk Information System Database

20 maintained by the Environmental Protection

21 Agency.

22 (vi) Any guidance, including protocols of

23 general applicability, establishing policy regard24 ing risk assessment or risk characterization.
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1 (C) The terms ‘‘significant risk assessment doc2 ument’’ and ‘‘significant risk characterization docu3 ment’’ shall also include the following:

4 (i) Any such risk assessment and risk

5 characterization documents provided by a cov6 ered Federal agency to the public and which are

7 likely to result in an annual increase in costs of

8 $25,000,000 or more.

9 (ii) Environmental restoration and waste

10 management carried out by or on behalf of the

11 Department of Defense with respect to any sub12 stance other than municipal waste.

13 (D) Within 15 months after the date of the en14 actment of this Act, each covered Federal agency ad15 ministering a regulatory program designed to protect

16 human health, safety, or the environment shall pro17 mulgate a rule establishing those additional cat18 egories, if any, of risk assessment and risk charac19 terization documents prepared by or on behalf of the

20 covered Federal agency that the agency will consider

21 significant risk assessment documents or significant

22 risk characterization documents for purposes of this

23 title. In establishing such categories, the head of the

24 agency shall consider each of the following:
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1 (i) The benefits of consistent compliance

2 by documents of the covered Federal agency in

3 the categories.

4 (ii) The administrative burdens of includ5 ing documents in the categories.

6 (iii) The need to make expeditious admin7 istrative decisions regarding documents in the

8 categories.

9 (iv) The possible use of a risk assessment

10 or risk characterization in any compilation of

11 risk hazards or health or environmental effects

12 prepared by an agency and commonly made

13 available to, or used by, any Federal, State, or

14 local government agency.

15 (v) Such other factors as may be appro16 priate.

17 (E)(i) Not later than 18 months after the date

18 of the enactment of this Act, the President, acting

19 through the Director of the Office of Management

20 and Budget, shall determine whether any other Fed21 eral agencies should be considered covered Federal

22 agencies for purposes of this title. Such determina23 tion, with respect to a particular Federal agency,

24 shall be based on the impact of risk assessment doc25 uments and risk characterization documents on—
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1 (I) regulatory programs administered by

2 that agency; and

3 (II) the communication of risk information

4 by that agency to the public.

5 The effective date of such a determination shall be

6 no later than 6 months after the date of the deter7 mination.

8 (ii) Not later than 15 months after the Presi9 dent, acting through the Director of the Office of

10 Management and Budget, determines pursuant to

11 clause (i) that a Federal agency should be consid12 ered a covered Federal agency for purposes of this

13 title, the head of that agency shall promulgate a rule

14 pursuant to subparagraph (D) to establish addi15 tional categories of risk assessment and risk charac16 terization documents described in that subpara17 graph.

18 (3) EXCEPTIONS.—(A) This title does not apply

19 to risk assessment or risk characterization docu20 ments containing risk assessments or risk character21 izations performed with respect to the following:

22 (i) A screening analysis, where appro23 priately labeled as such, including a screening

24 analysis for purposes of product regulation or

25 premanufacturing notices.
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1 (ii) Any health, safety, or environmental

2 inspections.

3 (iii) The sale or lease of Federal resources

4 or regulatory activities that directly result in

5 the collection of Federal receipts.

6 (B) No analysis shall be treated as a screening

7 analysis for purposes of subparagraph (A) if the re8 sults of such analysis are used as the basis for im9 posing restrictions on substances or activities.

10 (C) The risk assessment principle set forth in

11 section 104(b)(1) need not apply to any risk assess12 ment or risk characterization document described in

13 clause (iii) of paragraph (2)(B). The risk character14 ization and communication principle set forth in sec15 tion 105(4) need not apply to any risk assessment

16 or risk characterization document described in

17 clause (v) or (vi) of paragraph (2)(B).

18 (c) SAVINGS PROVISIONS.—The provisions of this

19 title shall be supplemental to any other provisions of law

20 relating to risk assessments and risk characterizations, ex21 cept that nothing in this title shall be construed to modify

22 any statutory standard or statutory requirement designed

23 to protect health, safety, or the environment. Nothing in

24 this title shall be interpreted to preclude the consideration

25 of any data or the calculation of any estimate to more
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1 fully describe risk or provide examples of scientific uncer2 tainty or variability. Nothing in this title shall be con3 strued to require the disclosure of any trade secret or

4 other confidential information.

5 SEC. 104. PRINCIPLES FOR RISK ASSESSMENT.

6 (a) IN GENERAL.—The head of each covered Federal

7 agency shall apply the principles set forth in subsection

8 (b) in order to assure that significant risk assessment doc9 uments and all of their components distinguish scientific

10 findings from other considerations and are, to the extent

11 feasible, scientifically objective, unbiased, and inclusive of

12 all relevant data and rely, to the extent available and prac13 ticable, on scientific findings. Discussions or explanations

14 required under this section need not be repeated in each

15 risk assessment document as long as there is a reference

16 to the relevant discussion or explanation in another agency

17 document which is available to the public.

18 (b) PRINCIPLES.—The principles to be applied are as

19 follows:

20 (1) When discussing human health risks, a sig21 nificant risk assessment document shall contain a

22 discussion of both relevant laboratory and relevant

23 epidemiological data of sufficient quality which finds,

24 or fails to find, a correlation between health risks

25 and a potential toxin or activity. Where conflicts
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1 among such data appear to exist, or where animal

2 data is used as a basis to assess human health, the

3 significant risk assessment document shall, to the

4 extent feasible and appropriate, include discussion of

5 possible reconciliation of conflicting information, and

6 as relevant, differences in study designs, compara7 tive physiology, routes of exposure, bioavailability,

8 pharmacokinetics, and any other relevant factor, in9 cluding the sufficiency of basic data for review. The

10 discussion of possible reconciliation should indicate

11 whether there is a biological basis to assume a re12 sulting harm in humans. Animal data shall be re13 viewed with regard to its relevancy to humans.

14 (2) Where a significant risk assessment docu15 ment involves selection of any significant assump16 tion, inference, or model, the document shall, to the

17 extent feasible—

18 (A) present a representative list and expla19 nation of plausible and alternative assumptions,

20 inferences, or models;

21 (B) explain the basis for any choices;

22 (C) identify any policy or value judgments;

23 (D) fully describe any model used in the

24 risk assessment and make explicit the assump25 tions incorporated in the model; and
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1 (E) indicate the extent to which any sig2 nificant model has been validated by, or con3 flicts with, empirical data.

4 SEC. 105. PRINCIPLES FOR RISK CHARACTERIZATION AND

5 COMMUNICATION.

6 Each significant risk characterization document shall

7 meet each of the following requirements:

8 (1) ESTIMATES OF RISK.—The risk character9 ization shall describe the populations or natural re10 sources which are the subject of the risk character11 ization. If a numerical estimate of risk is provided,

12 the agency shall, to the extent feasible, provide—

13 (A) the best estimate or estimates for the

14 specific populations or natural resources which

15 are the subject of the characterization (based

16 on the information available to the Federal

17 agency); and

18 (B) a statement of the reasonable range of

19 scientific uncertainties.

20 In addition to such best estimate or estimates, the

21 risk characterization document may present plau22 sible upper-bound or conservative estimates in con23 junction with plausible lower bounds estimates.

24 Where appropriate, the risk characterization docu25 ment may present, in lieu of a single best estimate,
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1 multiple best estimates based on assumptions, infer2 ences, or models which are equally plausible, given

3 current scientific understanding. To the extent prac4 tical and appropriate, the document shall provide de5 scriptions of the distribution and probability of risk

6 estimates to reflect differences in exposure varia7 bility or sensitivity in populations and attendant un8 certainties.

9 (2) EXPOSURE SCENARIOS.—The risk charac10 terization document shall explain the exposure sce11 narios used in any risk assessment, and, to the ex12 tent feasible, provide a statement of the size of the

13 corresponding population at risk and the likelihood

14 of such exposure scenarios.

15 (3) COMPARISONS.—The document shall con16 tain a statement that places the nature and mag17 nitude of risks to human health, safety, or the envi18 ronment in context. Such statement shall, to the ex19 tent feasible, provide comparisons with estimates of

20 greater, lesser, and substantially equivalent risks

21 that are familiar to and routinely encountered by the

22 general public as well as other risks, and, where ap23 propriate and meaningful, comparisons of those risks

24 with other similar risks regulated by the Federal

25 agency resulting from comparable activities and ex-
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1 posure pathways. Such comparisons should consider

2 relevant distinctions among risks, such as the vol3 untary or involuntary nature of risks and the pre4 ventability or nonpreventability of risks.

5 (4) SUBSTITUTION RISKS.—Each significant

6 risk assessment or risk characterization document

7 shall include a statement of any significant substi8 tution risks to human health, where information on

9 such risks has been provided to the agency.

10 (5) SUMMARIES OF OTHER RISK ESTIMATES.—

11 If—

12 (A) a commenter provides a covered Fed13 eral agency with a relevant risk assessment doc14 ument or a risk characterization document, and

15 a summary thereof, during a public comment

16 provided by the agency for a significant risk as17 sessment document or a significant risk charac18 terization document, or, where no comment pe19 riod is provided but a commenter provides the

20 covered Federal agency with the relevant risk

21 assessment document or risk characterization

22 document, and a summary thereof, in a timely

23 fashion, and

24 (B) the risk assessment document or risk

25 characterization document is consistent with the
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1 principles and the guidance provided under this

2 title,

3 the agency shall, to the extent feasible, present such

4 summary in connection with the presentation of the

5 agency’s significant risk assessment document or

6 significant risk characterization document. Nothing

7 in this paragraph shall be construed to limit the in8 clusion of any comments or material supplied by any

9 person to the administrative record of any proceed10 ing.

11 A document may satisfy the requirements of paragraph

12 (3), (4) or (5) by reference to information or material oth13 erwise available to the public if the document provides a

14 brief summary of such information or material.

15 SEC. 106. RECOMMENDATIONS OR CLASSIFICATIONS BY A

16 NON-UNITED STATES-BASED ENTITY.

17 No covered Federal agency shall automatically incor18 porate or adopt any recommendation or classification

19 made by a non-United States-based entity concerning the

20 health effects value of a substance without an opportunity

21 for notice and comment, and any risk assessment docu22 ment or risk characterization document adopted by a cov23 ered Federal agency on the basis of such a recommenda24 tion or classification shall comply with the provisions of

25 this title.
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1 SEC. 107. GUIDELINES AND REPORT.

2 (a) GUIDELINES.—Within 15 months after the date

3 of enactment of this title, the President shall issue guide4 lines for Federal agencies consistent with the risk assess5 ment and characterization principles set forth in sections

6 104 and 105 and shall provide a format for summarizing

7 risk assessment results. In addition, such guidelines shall

8 include guidance on at least the following subjects: criteria

9 for scaling animal studies to assess risks to human health;

10 use of different types of dose-response models; thresholds;

11 definitions, use, and interpretations of the maximum toler12 ated dose; weighting of evidence with respect to extrapo13 lating human health risks from sensitive species; evalua14 tion of benign tumors, and evaluation of different human

15 health endpoints.

16 (b) REPORT.—Within 3 years after the enactment of

17 this title, each covered Federal agency shall provide a re18 port to the Congress evaluating the categories of policy

19 and value judgments identified under subparagraph (C)

20 of section 104(b)(2).

21 (c) PUBLIC COMMENT AND CONSULTATION.—The

22 guidelines and report under this section, shall be developed

23 after notice and opportunity for public comment, and after

24 consultation with representatives of appropriate State,

25 local, and tribal governments, and such other departments
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1 and agencies, offices, organizations, or persons as may be

2 advisable.

3 (d) REVIEW.—The President shall review and, where

4 appropriate, revise the guidelines published under this sec5 tion at least every 4 years.

6 SEC. 108. RESEARCH AND TRAINING IN RISK ASSESSMENT.

7 (a) EVALUATION.—The head of each covered agency

8 shall regularly and systematically evaluate risk assessment

9 research and training needs of the agency, including,

10 where relevant and appropriate, the following:

11 (1) Research to reduce generic data gaps, to

12 address modelling needs (including improved model

13 sensitivity), and to validate default options, particu14 larly those common to multiple risk assessments.

15 (2) Research leading to improvement of meth16 ods to quantify and communicate uncertainty and

17 variability among individuals, species, populations,

18 and, in the case of ecological risk assessment, eco19 logical communities.

20 (3) Emerging and future areas of research, in21 cluding research on comparative risk analysis, expo22 sure to multiple chemicals and other stressors,

23 noncancer endpoints, biological markers of exposure

24 and effect, mechanisms of action in both mammalian

25 and nonmammalian species, dynamics and prob-
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1 abilities of physiological and ecosystem exposures,

2 and prediction of ecosystem-level responses.

3 (4) Long-term needs to adequately train indi4 viduals in risk assessment and risk assessment appli5 cation. Evaluations under this paragraph shall in6 clude an estimate of the resources needed to provide

7 necessary training.

8 (b) STRATEGY AND ACTIONS TO MEET IDENTIFIED

9 NEEDS.—The head of each covered agency shall develop

10 a strategy and schedule for carrying out research and

11 training to meet the needs identified in subsection (a).

12 (c) REPORT.—Not later than 6 months after the date

13 of the enactment of this Act, the head of each covered

14 agency shall submit to the Congress a report on the eval15 uations conducted under subsection (a) and the strategy

16 and schedule developed under subsection (b). The head of

17 each covered agency shall report to the Congress periodi18 cally on the evaluations, strategy, and schedule.

19 SEC. 109. STUDY OF COMPARATIVE RISK ANALYSIS.

20 (a) IN GENERAL.—(1) The Director of the Office of

21 Management and Budget, in consultation with the Office

22 of Science and Technology Policy, shall conduct, or pro23 vide for the conduct of, a study using comparative risk

24 analysis to rank health, safety, and environmental risks

25 and to provide a common basis for evaluating strategies
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1 for reducing or preventing those risks. The goal of the

2 study shall be to improve methods of comparative risk

3 analysis.

4 (2) Not later than 90 days after the date of the enact5 ment of this Act, the Director, in collaboration with the

6 heads of appropriate Federal agencies, shall enter into a

7 contract with the National Research Council to provide

8 technical guidance on approaches to using comparative

9 risk analysis and other considerations in setting health,

10 safety, and environmental risk reduction priorities.

11 (b) SCOPE OF STUDY.—The study shall have suffi12 cient scope and breadth to evaluate comparative risk anal13 ysis and to test approaches for improving comparative risk

14 analysis and its use in setting priorities for health, safety,

15 and environmental risk reduction. The study shall com16 pare and evaluate a range of diverse health, safety, and

17 environmental risks.

18 (c) STUDY PARTICIPANTS.—In conducting the study,

19 the Director shall provide for the participation of a range

20 of individuals with varying backgrounds and expertise,

21 both technical and nontechnical, comprising broad rep22 resentation of the public and private sectors.

23 (d) DURATION.—The study shall begin within 180

24 days after the date of the enactment of this Act and termi25 nate within 2 years after the date on which it began.
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1 (e) RECOMMENDATIONS FOR IMPROVING COMPARA2 TIVE RISK ANALYSIS AND ITS USE.—Not later than 90

3 days after the termination of the study, the Director shall

4 submit to the Congress the report of the National Re5 search Council with recommendations regarding the use

6 of comparative risk analysis and ways to improve the use

7 of comparative risk analysis for decision-making in appro8 priate Federal agencies.

9 SEC. 110. DEFINITIONS.

10 For purposes of this title:

11 (1) RISK ASSESSMENT DOCUMENT.—The term

12 ‘‘risk assessment document’’ means a document con13 taining the explanation of how hazards associated

14 with a substance, activity, or condition have been

15 identified, quantified, and assessed. The term also

16 includes a written statement accepting the findings

17 of any such document.

18 (2) RISK CHARACTERIZATION DOCUMENT.—The

19 term ‘‘risk characterization document’’ means a doc20 ument quantifying or describing the degree of tox21 icity, exposure, or other risk posed by hazards asso22 ciated with a substance, activity, or condition to

23 which individuals, populations, or resources are ex24 posed. The term also includes a written statement

25 accepting the findings of any such document.
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1 (3) BEST ESTIMATE.—The term ‘‘best esti2 mate’’ means a scientifically appropriate estimate

3 which is based, to the extent feasible, on one of the

4 following:

5 (A) Central estimates of risk using the

6 most plausible assumptions.

7 (B) An approach which combines multiple

8 estimates based on different scenarios and

9 weighs the probability of each scenario.

10 (C) Any other methodology designed to

11 provide the most unbiased representation of the

12 most plausible level of risk, given the current

13 scientific information available to the Federal

14 agency concerned.

15 (4) SUBSTITUTION RISK.—The term ‘‘substi16 tution risk’’ means a potential risk to human health,

17 safety, or the environment from a regulatory alter18 native designed to decrease other risks.

19 (5) COVERED FEDERAL AGENCY.—The term

20 ‘‘covered Federal agency’’ means each of the follow21 ing:

22 (A) The Environmental Protection Agency.

23 (B) The Occupational Safety and Health

24 Administration.
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1 (C) The Department of Transportation

2 (including the National Highway Transpor3 tation Safety Administration).

4 (D) The Food and Drug Administration.

5 (E) The Department of Energy.

6 (F) The Department of the Interior.

7 (G) The Department of Agriculture.

8 (H) The Consumer Product Safety Com9 mission.

10 (I) The National Oceanic and Atmospheric

11 Administration

12 (J) The United States Army Corps of En13 gineers.

14 (K) The Mine Safety and Health Adminis15 tration.

16 (L) The Nuclear Regulatory Commission.

17 (M) Any other Federal agency considered

18 a covered Federal agency pursuant to section

19 103(b)(2)(E)

20 (6) FEDERAL AGENCY.—The term ‘‘Federal

21 agency’’ means an executive department, military de22 partment, or independent establishment as defined

23 in part I of title 5 of the United States Code, except

24 that such term also includes the Office of Tech25 nology Assessment.
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1 (7) DOCUMENT.—The term ‘‘document’’ in2 cludes material stored in electronic or digital form.

3 Title II—Analysis of Risk

4 Reduction Benefits and Costs

5 SEC. 201. ANALYSIS OF RISK REDUCTION BENEFITS AND

6 COSTS.

7 (a) IN GENERAL.—The President shall require each

8 Federal agency to prepare the following for each major

9 rule within a program designed to protect human health,

10 safety, or the environment that is proposed or promul11 gated by the agency after the date of enactment of this

12 Act:

13 (1) An identification of reasonable alternative

14 strategies, including strategies that—

15 (A) require no government action;

16 (B) will accommodate differences among

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

19 and

20 (C) employ performance or other market21 based mechanisms that permit the greatest

22 flexibility in achieving the identified benefits of

23 the rule.

24 The agency shall consider reasonable alternative

25 strategies proposed during the comment period.
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1 (2) An analysis of the incremental costs and in2 cremental risk reduction or other benefits associated

3 with each alternative strategy identified or consid4 ered by the agency. Costs and benefits shall be

5 quantified to the extent feasible and appropriate and

6 may otherwise be qualitatively described.

7 (3) A statement that places in context the na8 ture and magnitude of the risks to be addressed and

9 the residual risks likely to remain for each alter10 native strategy identified or considered by the agen11 cy. Such statement shall, to the extent feasible, pro12 vide comparisons with estimates of greater, lesser,

13 and substantially equivalent risks that are familiar

14 to and routinely encountered by the general public

15 as well as other risks, and, where appropriate and

16 meaningful, comparisons of those risks with other

17 similar risks regulated by the Federal agency result18 ing from comparable activities and exposure path19 ways. Such comparisons should consider relevant

20 distinctions among risks, such as the voluntary or

21 involuntary nature of risks and the preventability or

22 nonpreventability of risks.

23 (4) For each final rule, an analysis of whether

24 the identified benefits of the rule are likely to exceed

25 the identified costs of the rule.
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1 (5) An analysis of the effect of the rule—

2 (A) on small businesses with fewer than

3 100 employees;

4 (B) on net employment; and

5 (C) to the extent practicable, on the cumu6 lative financial burden of compliance with the

7 rule and other existing regulations on persons

8 producing products.

9 (b) PUBLICATION.—For each major rule referred to

10 in subsection (a) each Federal agency shall publish in a

11 clear and concise manner in the Federal Register along

12 with the proposed and final regulation, or otherwise make

13 publicly available, the information required to be prepared

14 under subsection (a).

15 SEC. 202. DECISION CRITERIA.

16 (a) IN GENERAL.—No final rule subject to the provi17 sions of this title shall be promulgated unless the agency

18 certifies the following:

19 (1) That the analyses under section 201 are

20 based on objective and unbiased scientific and eco21 nomic evaluations of all significant and relevant in22 formation and risk assessments provided to the

23 agency by interested parties relating to the costs,

24 risks, and risk reduction and other benefits ad25 dressed by the rule.
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1 (2) That the incremental risk reduction or other

2 benefits of any strategy chosen will be likely to jus3 tify, and be reasonably related to, the incremental

4 costs incurred by State, local, and tribal govern5 ments, the Federal Government, and other public

6 and private entities.

7 (3) That other alternative strategies identified

8 or considered by the agency were found either (A)

9 to be less cost-effective at achieving a substantially

10 equivalent reduction in risk, or (B) to provide less

11 flexibility to State, local, or tribal governments or

12 regulated entities in achieving the otherwise applica13 ble objectives of the regulation, along with a brief

14 explanation of why alternative strategies that were

15 identified or considered by the agency were found to

16 be less cost-effective or less flexible.

17 (b) EFFECT OF DECISION CRITERIA.—

18 (1) IN GENERAL.—Notwithstanding any other

19 provision of Federal law, the decision criteria of sub20 section (a) shall supplement and, to the extent there

21 is a conflict, supersede the decision criteria for rule22 making otherwise applicable under the statute pur23 suant to which the rule is promulgated.

24 (2) SUBSTANTIAL EVIDENCE.—Notwithstanding

25 any other provision of Federal law, no major rule
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1 shall be promulgated by any Federal agency pertain2 ing to the protection of health, safety, or the envi3 ronment unless the requirements of section 201 and

4 subsection (a) are met and the certifications re5 quired therein are supported by substantial evidence

6 of the rulemaking record.

7 (c) PUBLICATION.—The agency shall publish in the

8 Federal Register, along with the final regulation, the cer9 tifications required by subsection (a).

10 (d) NOTICE.—Where the agency finds a conflict be11 tween the decision criteria of this section and the decision

12 criteria of an otherwise applicable statute, the agency shall

13 so notify the Congress in writing.

14 SEC. 203. OFFICE OF MANAGEMENT AND THE BUDGET

15 GUIDANCE.

16 The Office of Management and Budget shall issue

17 guidance consistent with this title—

18 (1) to assist the agencies, the public, and the

19 regulated community in the implementation of this

20 title, including any new requirements or procedures

21 needed to supplement prior agency practice; and

22 (2) governing the development and preparation

23 of analyses of risk reduction benefits and costs.
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1 Title III—Peer Review

2 SEC. 301. PEER REVIEW PROGRAM.

3 (a) ESTABLISHMENT.—For regulatory programs de4 signed to protect human health, safety, or the environ5 ment, the head of each Federal agency shall develop a sys6 tematic program for independent and external peer review

7 required by subsection (b). Such program shall be applica8 ble across the agency and—

9 (1) shall provide for the creation of peer review

10 panels consisting of experts and shall be broadly rep11 resentative and balanced and to the extent relevant

12 and appropriate, may include representatives of

13 State, local, and tribal governments, small busi14 nesses, other representatives of industry, univer15 sities, agriculture, labor, consumers, conservation or16 ganizations, or other public interest groups and or17 ganizations;

18 (2) may provide for differing levels of peer re19 view and differing numbers of experts on peer review

20 panels, depending on the significance or the com21 plexity of the problems or the need for expeditious22 ness;

23 (3) shall not exclude peer reviewers with sub24 stantial and relevant expertise merely because they

25 represent entities that may have a potential interest
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1 in the outcome, provided that interest is fully dis2 closed to the agency and in the case of a regulatory

3 decision affecting a single entity, no peer reviewer

4 representing such entity may be included on the

5 panel;

6 (4) may provide specific and reasonable dead7 lines for peer review panels to submit reports under

8 subsection (c); and

9 (5) shall provide adequate protections for con10 fidential business information and trade secrets, in11 cluding requiring peer reviewers to enter into con12 fidentiality agreements.

13 (b) REQUIREMENT FOR PEER REVIEW.—In connec14 tion with any rule that is likely to result in an annual

15 increase in costs of $100,000,000 or more (other than any

16 rule or other action taken by an agency to authorize or

17 approve any individual substance or product), each Fed18 eral agency shall provide for peer review in accordance

19 with this section of any risk assessment or cost analysis

20 which forms the basis for such rule or of any analysis

21 under section 201(a). In addition, the Director of the Of22 fice of Management and Budget may order that peer re23 view be provided for any major risk assessment or cost

24 assessment that is likely to have a significant impact on

25 public policy decisions.
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1 (c) CONTENTS.—Each peer review under this section

2 shall include a report to the Federal agency concerned

3 with respect to the scientific and economic merit of data

4 and methods used for the assessments and analyses.

5 (d) RESPONSE TO PEER REVIEW.—The head of the

6 Federal agency shall provide a written response to all sig7 nificant peer review comments.

8 (e) AVAILABILITY TO PUBLIC.—All peer review com9 ments or conclusions and the agency’s responses shall be

10 made available to the public and shall be made part of

11 the administrative record.

12 (f) PREVIOUSLY REVIEWED DATA AND ANALYSIS.—

13 No peer review shall be required under this section for

14 any data or method which has been previously subjected

15 to peer review or for any component of any analysis or

16 assessment previously subjected to peer review.

17 (g) NATIONAL PANELS.—The President shall appoint

18 National Peer Review Panels to annually review the risk

19 assessment and cost assessment practices of each Federal

20 agency for programs designed to protect human health,

21 safety, or the environment. The Panel shall submit a re22 port to the Congress no less frequently than annually con23 taining the results of such review.
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1 Title IV—Judicial Review

2 SEC. 401. JUDICIAL REVIEW.

3 Compliance or noncompliance by a Federal agency

4 with the requirements of this Act shall be reviewable pur5 suant to the statute granting the agency authority to act

6 or, as applicable, that statute and the Administrative Pro7 cedure Act. The court with jurisdiction to review final

8 agency action under the statute granting the agency au9 thority to act shall have jurisdiction to review, at the same

10 time, the agency’s compliance with the requirements of

11 this Act. When a significant risk assessment document or

12 risk characterization document subject to title I is part

13 of the administrative record in a final agency action, in

14 addition to any other matters that the court may consider

15 in deciding whether the agency’s action was lawful, the

16 court shall consider the agency action unlawful if such sig17 nificant risk assessment document or significant risk char18 acterization document does not substantially comply with

19 the requirements of sections 104 and 105.

20 Title V—Plan

21 SEC. 501. PLAN FOR ASSESSING NEW INFORMATION.

22 (a) PLAN.—Within 18 months after the date of en23 actment of this Act, each covered Federal agency (as de24 fined in title I) shall publish a plan to review and, where

25 appropriate revise any significant risk assessment docu-
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1 ment or significant risk characterization document pub2 lished prior to the expiration of such 18-month period if,

3 based on information available at the time of such review,

4 the agency head determines that the application of the

5 principles set forth in sections 104 and 105 would be likely

6 to significantly alter the results of the prior risk assess7 ment or risk characterization. The plan shall provide pro8 cedures for receiving and considering new information and

9 risk assessments from the public. The plan may set prior10 ities and procedures for review and, where appropriate, re11 vision of such risk assessment documents and risk charac12 terization documents and of health or environmental ef13 fects values. The plan may also set priorities and proce14 dures for review, and, where appropriate, revision or re15 peal of major rules promulgated prior to the expiration

16 of such period. Such priorities and procedures shall be

17 based on the potential to more efficiently focus national

18 economic resources within Federal regulatory programs

19 designed to protect human health, safety, or the environ20 ment on the most important priorities and on such other

21 factors as such Federal agency considers appropriate.

22 (b) PUBLIC COMMENT AND CONSULTATION.—The

23 plan under this section, shall be developed after notice and

24 opportunity for public comment, and after consultation

25 with representatives of appropriate State, local, and tribal
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1 governments, and such other departments and agencies,

2 offices, organizations, or persons as may be advisable.

3 Title VI—Priorities

4 SEC. 601. PRIORITIES.

5 (a) IDENTIFICATION OF OPPORTUNITIES.—In order

6 to assist in the public policy and regulation of risks to

7 public health, the President shall identify opportunities to

8 reflect priorities within existing Federal regulatory pro9 grams designed to protect human health in a cost-effective

10 and cost-reasonable manner. The President shall identify

11 each of the following:

12 (1) The likelihood and severity of public health

13 risks addressed by current Federal programs.

14 (2) The number of individuals affected.

15 (3) The incremental costs and risk reduction

16 benefits associated with regulatory or other strate17 gies.

18 (4) The cost-effectiveness of regulatory or other

19 strategies to reduce risks to public health.

20 (5) Intergovernmental relationships among Fed21 eral, State, and local governments among programs

22 designed to protect public health.

23 (6) Statutory, regulatory, or administrative ob24 stacles to allocating national economic resources

25 based on the most cost-effective, cost-reasonable pri-
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1 orities considering Federal, State, and local pro2 grams.

3 (b) BIENNIAL REPORTS.—The President shall issue

4 biennial reports to Congress, after notice and opportunity

5 for public comment, to recommend priorities for modifica6 tions to, elimination of, or strategies for existing Federal

7 regulatory programs designed to protect public health.

8 Within 6 months after the issuance of the report, the

9 President shall notify the Congress in writing of the rec10 ommendations which can be implemented without further

11 legislative changes and the agency shall consider the prior12 ities set forth in the report when preparing a budget or

13 strategic plan for any such regulatory program.

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