IIA

104TH CONGRESS

1ST SESSION H. R. 1022

IN THE SENATE OF THE UNITED STATES

MARCH 2 (legislative day, FEBRUARY 22), 1995

Received; read twice and referred to the Committee on Governmental Affairs

AN ACT

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. UNFUNDED MANDATES.

20 Nothing in this Act itself shall, without Federal fund21 ing and further Federal agency action, create any new ob22 ligation or burden on any State or local government or

23 otherwise impose any financial burden on any State or

24 local government in the absence of Federal funding, except

25 with respect to routine information requests.
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1 SEC. 5. DEFINITIONS.

2 For purposes of this Act:

3 (1) COSTS.—The term ‘‘costs’’ includes the di4 rect and indirect costs to the United States Govern5 ment, to State, local, and tribal governments, and to

6 the private sector, wage earners, consumers, and the

7 economy, of implementing and complying with a rule

8 or alternative strategy.

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

10 reasonably identifiable significant health, safety, en11 vironmental, social and economic benefits that are

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

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

15 means any regulation that is likely to result in an

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

17 Such term does not include any regulation or other

18 action taken by an agency to authorize or approve

19 any individual substance or product.

20 (4) PROGRAM DESIGNED TO PROTECT HUMAN

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

22 human health’’ does not include regulatory programs

23 concerning health insurance, health provider serv24 ices, or health care diagnostic services.

25 (5) EMERGENCY.—As used in this Act, the

26 term ‘‘emergency’’ means a situation that is imme-
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1 diately impending and extraordinary in nature, de2 manding attention due to a condition, circumstance,

3 or practice reasonably expected to cause death, seri4 ous illness, or severe injury to humans, or substan5 tial endangerment to private property or the envi6 ronment if no action is taken.

7 SEC. 6. AVAILABILITY OF INFORMATION AMONG FEDERAL

8 AGENCIES.

9 Covered Federal agencies shall make existing

10 databases and information developed under this Act avail11 able to other Federal agencies, subject to applicable con12 fidentiality requirements, for the purpose of meeting the

13 requirements of this Act. Within 15 months after the date

14 of enactment of this Act, the President shall issue guide15 lines for Federal agencies to comply with this section.

16 TITLE I—RISK ASSESSMENT AND

17 COMMUNICATION

18 SEC. 101. SHORT TITLE.

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

20 Communication Act of 1995’’.

21 SEC. 102. PURPOSES.

22 The purposes of this title are—

23 (1) to present the public and executive branch

24 with the most scientifically objective and unbiased

25 information concerning the nature and magnitude of
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1 health, safety, and environmental risks in order to

2 provide for sound regulatory decisions and public

3 education;

4 (2) to provide for full consideration and discus5 sion of relevant data and potential methodologies;

6 (3) to require explanation of significant choices

7 in the risk assessment process which will allow for

8 better peer review and public understanding; and

9 (4) to improve consistency within the executive

10 branch in preparing risk assessments and risk char11 acterizations.

12 SEC. 103. EFFECTIVE DATE; APPLICABILITY; SAVINGS PRO13 VISIONS.

14 (a) EFFECTIVE DATE.—Except as otherwise specifi15 cally provided in this title, the provisions of this title shall

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

17 title.

18 (b) APPLICABILITY.—

19 (1) IN GENERAL.—Except as provided in para20 graph (3), this title applies to all significant risk as21 sessment documents and significant risk character22 ization documents, as defined in paragraph (2).

23 (2) SIGNIFICANT RISK ASSESSMENT DOCUMENT

24 OR SIGNIFICANT RISK CHARACTERIZATION DOCU25 MENT.—(A) As used in this title, the terms ‘‘signifi-
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1 cant risk assessment document’’ and ‘‘significant

2 risk characterization document’’ include, at a mini3 mum, risk assessment documents or risk character4 ization documents prepared by or on behalf of a cov5 ered Federal agency in the implementation of a reg6 ulatory program designed to protect human health,

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

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

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

10 (ii) inserted by the agency in the adminis11 trative record for that item.

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

13 are the following:

14 (i) Any proposed or final major rule, in15 cluding any analysis or certification under title

16 II, promulgated as part of any Federal regu17 latory program designed to protect human

18 health, safety, or the environment.

19 (ii) Any proposed or final environmental

20 clean-up plan for a facility or Federal guidelines

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

22 this clause, the term ‘‘environmental clean-up’’

23 means a corrective action under the Solid

24 Waste Disposal Act, a removal or remedial ac25 tion under the Comprehensive Environmental
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1 Response, Compensation, and Liability Act of

2 1980, and any other environmental restoration

3 and waste management carried out by or on be4 half of a covered Federal agency with respect to

5 any substance other than municipal waste.

6 (iii) Any proposed or final permit condition

7 placing a restriction on facility siting or oper8 ation under Federal laws administered by the

9 Environmental Protection Agency or the De10 partment of the Interior. Nothing in this sec11 tion (iii) shall apply to the requirements of sec12 tion 404 of the Clean Water Act.

13 (iv) Any report to Congress.

14 (v) Any regulatory action to place a sub15 stance on any official list of carcinogens or

16 toxic or hazardous substances or to place a new

17 health effects value on such list, including the

18 Integrated Risk Information System Database

19 maintained by the Environmental Protection

20 Agency.

21 (vi) Any guidance, including protocols of

22 general applicability, establishing policy regard23 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. Sensitive subpopulations or highly ex9 posed subpopulations include, where relevant and

10 appropriate, children, the elderly, pregnant women,

11 and disabled persons.

12 (2) EXPOSURE SCENARIOS.—The risk charac13 terization document shall explain the exposure sce14 narios used in any risk assessment, and, to the ex15 tent feasible, provide a statement of the size of the

16 corresponding population at risk and the likelihood

17 of such exposure scenarios.

18 (3) COMPARISONS.—The document shall con19 tain a statement that places the nature and mag20 nitude of risks to human health, safety, or the envi21 ronment in context. Such statement shall, to the ex22 tent feasible, provide comparisons with estimates of

23 greater, lesser, and substantially equivalent risks

24 that are familiar to and routinely encountered by the

25 general public as well as other risks, and, where ap-
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1 propriate and meaningful, comparisons of those risks

2 with other similar risks regulated by the Federal

3 agency resulting from comparable activities and ex4 posure pathways. Such comparisons should consider

5 relevant distinctions among risks, such as the vol6 untary or involuntary nature of risks and the pre7 ventability or nonpreventability of risks.

8 (4) SUBSTITUTION RISKS.—Each significant

9 risk assessment or risk characterization document

10 shall include a statement of any significant substi11 tution risks to human health, where information on

12 such risks has been provided to the agency.

13 (5) SUMMARIES OF OTHER RISK ESTIMATES.—

14 If—

15 (A) a commenter provides a covered Fed16 eral agency with a relevant risk assessment doc17 ument or a risk characterization document, and

18 a summary thereof, during a public comment

19 provided by the agency for a significant risk as20 sessment document or a significant risk charac21 terization document, or, where no comment pe22 riod is provided but a commenter provides the

23 covered Federal agency with the relevant risk

24 assessment document or risk characterization
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1 document, and a summary thereof, in a timely

2 fashion, and

3 (B) the risk assessment document or risk

4 characterization document is consistent with the

5 principles and the guidance provided under this

6 title,

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

8 summary in connection with the presentation of the

9 agency’s significant risk assessment document or

10 significant risk characterization document. Nothing

11 in this paragraph shall be construed to limit the in12 clusion of any comments or material supplied by any

13 person to the administrative record of any proceed14 ing.

15 A document may satisfy the requirements of paragraph

16 (3), (4) or (5) by reference to information or material oth17 erwise available to the public if the document provides a

18 brief summary of such information or material.

19 SEC. 106. RECOMMENDATIONS OR CLASSIFICATIONS BY A

20 NON-UNITED STATES-BASED ENTITY.

21 No covered Federal agency shall automatically incor22 porate or adopt any recommendation or classification

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

24 health effects value of a substance without an opportunity

25 for notice and comment, and any risk assessment docu-
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1 ment or risk characterization document adopted by a cov2 ered Federal agency on the basis of such a recommenda3 tion or classification shall comply with the provisions of

4 this title. For the purposes of this section, the term ‘‘non5 United States-based entity’’ means—

6 (1) any foreign government and its agencies;

7 (2) the United Nations or any of its subsidiary

8 organizations;

9 (3) any other international governmental body

10 or international standards-making organization; or

11 (4) any other organization or private entity

12 without a place of business located in the United

13 States or its territories.

14 SEC. 107. GUIDELINES AND REPORT.

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

16 of enactment of this title, the President shall issue guide17 lines for Federal agencies consistent with the risk assess18 ment and characterization principles set forth in sections

19 104 and 105 and shall provide a format for summarizing

20 risk assessment results. In addition, such guidelines shall

21 include guidance on at least the following subjects: criteria

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

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

24 definitions, use, and interpretations of the maximum toler25 ated dose; weighting of evidence with respect to extrapo-
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1 lating human health risks from sensitive species; evalua2 tion of benign tumors, and evaluation of different human

3 health endpoints.

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

5 this title, each covered Federal agency shall provide a re6 port to the Congress evaluating the categories of policy

7 and value judgments identified under subparagraph (C)

8 of section 104(b)(2).

9 (c) PUBLIC COMMENT AND CONSULTATION.—The

10 guidelines and report under this section, shall be developed

11 after notice and opportunity for public comment, and after

12 consultation with representatives of appropriate State,

13 local, and tribal governments, and such other departments

14 and agencies, offices, organizations, or persons as may be

15 advisable.

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

17 appropriate, revise the guidelines published under this sec18 tion at least every 4 years.

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

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

21 shall regularly and systematically evaluate risk assessment

22 research and training needs of the agency, including,

23 where relevant and appropriate, the following:

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

25 address modelling needs (including improved model
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1 sensitivity), and to validate default options, particu2 larly those common to multiple risk assessments.

3 (2) Research leading to improvement of meth4 ods to quantify and communicate uncertainty and

5 variability among individuals, species, populations,

6 and, in the case of ecological risk assessment, eco7 logical communities.

8 (3) Emerging and future areas of research, in9 cluding research on comparative risk analysis, expo10 sure to multiple chemicals and other stressors,

11 noncancer endpoints, biological markers of exposure

12 and effect, mechanisms of action in both mammalian

13 and nonmammalian species, dynamics and prob14 abilities of physiological and ecosystem exposures,

15 and prediction of ecosystem-level responses.

16 (4) Long-term needs to adequately train indi17 viduals in risk assessment and risk assessment appli18 cation. Evaluations under this paragraph shall in19 clude an estimate of the resources needed to provide

20 necessary training.

21 (b) STRATEGY AND ACTIONS TO MEET IDENTIFIED

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

23 a strategy and schedule for carrying out research and

24 training to meet the needs identified in subsection (a).
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1 (c) REPORT.—Not later than 6 months after the date

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

3 agency shall submit to the Congress a report on the eval4 uations conducted under subsection (a) and the strategy

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

6 each covered agency shall report to the Congress periodi7 cally on the evaluations, strategy, and schedule.

8 SEC. 109. STUDY OF COMPARATIVE RISK ANALYSIS.

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

10 Management and Budget, in consultation with the Office

11 of Science and Technology Policy, shall conduct, or pro12 vide for the conduct of, a study using comparative risk

13 analysis to rank health, safety, and environmental risks

14 and to provide a common basis for evaluating strategies

15 for reducing or preventing those risks. The goal of the

16 study shall be to improve methods of comparative risk

17 analysis.

18 (2) Not later than 90 days after the date of the enact19 ment of this Act, the Director, in collaboration with the

20 heads of appropriate Federal agencies, shall enter into a

21 contract with the National Research Council to provide

22 technical guidance on approaches to using comparative

23 risk analysis and other considerations in setting health,

24 safety, and environmental risk reduction priorities.
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1 (b) SCOPE OF STUDY.—The study shall have suffi2 cient scope and breadth to evaluate comparative risk anal3 ysis and to test approaches for improving comparative risk

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

5 and environmental risk reduction. The study shall com6 pare and evaluate a range of diverse health, safety, and

7 environmental risks.

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

9 the Director shall provide for the participation of a range

10 of individuals with varying backgrounds and expertise,

11 both technical and nontechnical, comprising broad rep12 resentation of the public and private sectors.

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

14 days after the date of the enactment of this Act and termi15 nate within 2 years after the date on which it began.

16 (e) RECOMMENDATIONS FOR IMPROVING COMPARA17 TIVE RISK ANALYSIS AND ITS USE.—Not later than 90

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

19 submit to the Congress the report of the National Re20 search Council with recommendations regarding the use

21 of comparative risk analysis and ways to improve the use

22 of comparative risk analysis for decision-making in appro23 priate Federal agencies.

24 SEC. 110. DEFINITIONS.

25 For purposes of this title:
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1 (1) RISK ASSESSMENT DOCUMENT.—The term

2 ‘‘risk assessment document’’ means a document con3 taining the explanation of how hazards associated

4 with a substance, activity, or condition have been

5 identified, quantified, and assessed. The term also

6 includes a written statement accepting the findings

7 of any such document.

8 (2) RISK CHARACTERIZATION DOCUMENT.—The

9 term ‘‘risk characterization document’’ means a doc10 ument quantifying or describing the degree of tox11 icity, exposure, or other risk posed by hazards asso12 ciated with a substance, activity, or condition to

13 which individuals, populations, or resources are ex14 posed. The term also includes a written statement

15 accepting the findings of any such document.

16 (3) BEST ESTIMATE.—The term ‘‘best esti17 mate’’ means a scientifically appropriate estimate

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

19 following:

20 (A) Central estimates of risk using the

21 most plausible assumptions.

22 (B) An approach which combines multiple

23 estimates based on different scenarios and

24 weighs the probability of each scenario.
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1 (C) Any other methodology designed to

2 provide the most unbiased representation of the

3 most plausible level of risk, given the current

4 scientific information available to the Federal

5 agency concerned.

6 (4) SUBSTITUTION RISK.—The term ‘‘substi7 tution risk’’ means a potential risk to human health,

8 safety, or the environment from a regulatory alter9 native designed to decrease other risks.

10 (5) COVERED FEDERAL AGENCY.—The term

11 ‘‘covered Federal agency’’ means each of the follow12 ing:

13 (A) The Environmental Protection Agency.

14 (B) The Occupational Safety and Health

15 Administration.

16 (C) The Department of Transportation

17 (including the National Highway Transpor18 tation Safety Administration).

19 (D) The Food and Drug Administration.

20 (E) The Department of Energy.

21 (F) The Department of the Interior.

22 (G) The Department of Agriculture.

23 (H) The Consumer Product Safety Com24 mission.
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1 (I) The National Oceanic and Atmospheric

2 Administration

3 (J) The United States Army Corps of En4 gineers.

5 (K) The Mine Safety and Health Adminis6 tration.

7 (L) The Nuclear Regulatory Commission.

8 (M) Any other Federal agency considered

9 a covered Federal agency pursuant to section

10 103(b)(2)(E).

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

12 agency’’ means an executive department, military de13 partment, or independent establishment as defined

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

15 that such term also includes the Office of Tech16 nology Assessment.

17 (7) DOCUMENT.—The term ‘‘document’’ in18 cludes material stored in electronic or digital form.

19 TITLE II—ANALYSIS OF RISK RE20 DUCTION BENEFITS AND

21 COSTS

22 SEC. 201. ANALYSIS OF RISK REDUCTION BENEFITS AND

23 COSTS.

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

25 Federal agency to prepare the following for each major
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1 rule within a program designed to protect human health,

2 safety, or the environment that is proposed or promul3 gated by the agency after the date of enactment of this

4 Act:

5 (1) An identification of reasonable alternative

6 strategies, including strategies that—

7 (A) require no government action;

8 (B) will accommodate differences among

9 geographic regions and among persons with dif10 ferent levels of resources with which to comply;

11 and

12 (C) employ performance or other market13 based mechanisms that permit the greatest

14 flexibility in achieving the identified benefits of

15 the rule.

16 The agency shall consider reasonable alternative

17 strategies proposed during the comment period.

18 (2) An analysis of the incremental costs and in19 cremental risk reduction or other benefits associated

20 with each alternative strategy identified or consid21 ered by the agency. Costs and benefits shall be

22 quantified to the extent feasible and appropriate and

23 may otherwise be qualitatively described.

24 (3) A statement that places in context the na25 ture and magnitude of the risks to be addressed and
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1 the residual risks likely to remain for each alter2 native strategy identified or considered by the agen3 cy. Such statement shall, to the extent feasible, pro4 vide comparisons with estimates of greater, lesser,

5 and substantially equivalent risks that are familiar

6 to and routinely encountered by the general public

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

8 meaningful, comparisons of those risks with other

9 similar risks regulated by the Federal agency result10 ing from comparable activities and exposure path11 ways. Such comparisons should consider relevant

12 distinctions among risks, such as the voluntary or

13 involuntary nature of risks and the preventability or

14 nonpreventability of risks.

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

16 the identified benefits of the rule are likely to exceed

17 the identified costs of the rule.

18 (5) An analysis of the effect of the rule—

19 (A) on small businesses with fewer than

20 100 employees;

21 (B) on net employment; and

22 (C) to the extent practicable, on the cumu23 lative financial burden of compliance with the

24 rule and other existing regulations on persons

25 producing products.
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1 (b) PUBLICATION.—For each major rule referred to

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

3 clear and concise manner in the Federal Register along

4 with the proposed and final regulation, or otherwise make

5 publicly available, the information required to be prepared

6 under subsection (a).

7 SEC. 202. DECISION CRITERIA.

8 (a) IN GENERAL.—No final rule subject to the provi9 sions of this title shall be promulgated unless the agency

10 certifies the following:

11 (1) That the analyses under section 201 are

12 based on objective and unbiased scientific and eco13 nomic evaluations of all significant and relevant in14 formation and risk assessments provided to the

15 agency by interested parties relating to the costs,

16 risks, and risk reduction and other benefits ad17 dressed by the rule.

18 (2) That the incremental risk reduction or other

19 benefits of any strategy chosen will be likely to jus20 tify, and be reasonably related to, the incremental

21 costs incurred by State, local, and tribal govern22 ments, the Federal Government, and other public

23 and private entities.

24 (3) That other alternative strategies identified

25 or considered by the agency were found either (A)
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1 to be less cost-effective at achieving a substantially

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

3 flexibility to State, local, or tribal governments or

4 regulated entities in achieving the otherwise applica5 ble objectives of the regulation, along with a brief

6 explanation of why alternative strategies that were

7 identified or considered by the agency were found to

8 be less cost-effective or less flexible.

9 (b) EFFECT OF DECISION CRITERIA.—

10 (1) IN GENERAL.—Notwithstanding any other

11 provision of Federal law, the decision criteria of sub12 section (a) shall supplement and, to the extent there

13 is a conflict, supersede the decision criteria for rule14 making otherwise applicable under the statute pur15 suant to which the rule is promulgated.

16 (2) SUBSTANTIAL EVIDENCE.—Notwithstanding

17 any other provision of Federal law, no major rule

18 shall be promulgated by any Federal agency pertain19 ing to the protection of health, safety, or the envi20 ronment unless the requirements of section 201 and

21 subsection (a) are met and the certifications re22 quired therein are supported by substantial evidence

23 of the rulemaking record.
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1 (c) PUBLICATION.—The agency shall publish in the

2 Federal Register, along with the final regulation, the cer3 tifications required by subsection (a).

4 (d) NOTICE.—Where the agency finds a conflict be5 tween the decision criteria of this section and the decision

6 criteria of an otherwise applicable statute, the agency shall

7 so notify the Congress in writing.

8 SEC. 203. OFFICE OF MANAGEMENT AND THE BUDGET

9 GUIDANCE.

10 The Office of Management and Budget shall issue

11 guidance consistent with this title—

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

13 regulated community in the implementation of this

14 title, including any new requirements or procedures

15 needed to supplement prior agency practice; and

16 (2) governing the development and preparation

17 of analyses of risk reduction benefits and costs.

18 SEC. 204. ENVIRONMENTAL CLEAN-UP.

19 For purposes of this title, any determination by a

20 Federal agency to approve or reject any proposed or final

21 environmental clean-up plan for a facility the costs of

22 which are likely to exceed $5,000,000 shall be treated as

23 major rule subject to the provisions of this title (other

24 than the provisions of section 201(a)(5)). As used in this

25 section, the term ‘‘environmental clean-up’’ means a cor-
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1 rective action under the Solid Waste Disposal Act, a reme2 dial action under the Comprehensive Environmental Re3 sponse, Compensation, and Liability Act of 1980, and any

4 other environmental restoration and waste management

5 carried out by or on behalf of a Federal agency with re6 spect to any substance other than municipal waste.

7 TITLE III—PEER REVIEW

8 SEC. 301. PEER REVIEW PROGRAM.

9 (a) ESTABLISHMENT.—For regulatory programs de10 signed to protect human health, safety, or the environ11 ment, the head of each Federal agency shall develop a sys12 tematic program for independent and external peer review

13 required by subsection (b). Such program shall be applica14 ble across the agency and—

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

16 panels consisting of experts and shall be broadly rep17 resentative and balanced and to the extent relevant

18 and appropriate, may include representatives of

19 State, local, and tribal governments, small busi20 nesses, other representatives of industry, univer21 sities, agriculture, labor, consumers, conservation or22 ganizations, or other public interest groups and or23 ganizations;

24 (2) may provide for differing levels of peer re25 view and differing numbers of experts on peer review
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1 panels, depending on the significance or the com2 plexity of the problems or the need for expeditious3 ness;

4 (3) shall not exclude peer reviewers with sub5 stantial and relevant expertise merely because they

6 represent entities that may have a potential interest

7 in the outcome, provided that interest is fully dis8 closed to the agency and in the case of a regulatory

9 decision affecting a single entity, no peer reviewer

10 representing such entity may be included on the

11 panel;

12 (4) may provide specific and reasonable dead13 lines for peer review panels to submit reports under

14 subsection (c); and

15 (5) shall provide adequate protections for con16 fidential business information and trade secrets, in17 cluding requiring peer reviewers to enter into con18 fidentiality agreements.

19 (b) REQUIREMENT FOR PEER REVIEW.—In connec20 tion with any rule that is likely to result in an annual

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

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

23 approve any individual substance or product), each Fed24 eral agency shall provide for peer review in accordance

25 with this section of any risk assessment or cost analysis
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1 which forms the basis for such rule or of any analysis

2 under section 201(a). In addition, the Director of the Of3 fice of Management and Budget may order that peer re4 view be provided for any major risk assessment or cost

5 assessment that is likely to have a significant impact on

6 public policy decisions.

7 (c) CONTENTS.—Each peer review under this section

8 shall include a report to the Federal agency concerned

9 with respect to the scientific and economic merit of data

10 and methods used for the assessments and analyses.

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

12 Federal agency shall provide a written response to all sig13 nificant peer review comments.

14 (e) AVAILABILITY TO PUBLIC.—All peer review com15 ments or conclusions and the agency’s responses shall be

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

17 the administrative record.

18 (f) PREVIOUSLY REVIEWED DATA AND ANALYSIS.—

19 No peer review shall be required under this section for

20 any data or method which has been previously subjected

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

22 assessment previously subjected to peer review.

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

24 National Peer Review Panels to annually review the risk

25 assessment and cost assessment practices of each Federal
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1 agency for programs designed to protect human health,

2 safety, or the environment. The Panel shall submit a re3 port to the Congress no less frequently than annually con4 taining the results of such review.

5 TITLE IV—JUDICIAL REVIEW

6 SEC. 401. JUDICIAL REVIEW.

7 Compliance or noncompliance by a Federal agency

8 with the requirements of this Act shall be reviewable pur9 suant to the statute granting the agency authority to act

10 or, as applicable, that statute and the Administrative Pro11 cedure Act. The court with jurisdiction to review final

12 agency action under the statute granting the agency au13 thority to act shall have jurisdiction to review, at the same

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

15 this Act. When a significant risk assessment document or

16 risk characterization document subject to title I is part

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

18 addition to any other matters that the court may consider

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

20 court shall consider the agency action unlawful if such sig21 nificant risk assessment document or significant risk char22 acterization document does not substantially comply with

23 the requirements of sections 104 and 105.
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1 TITLE V—PLAN

2 SEC. 501. PLAN FOR ASSESSING NEW INFORMATION.

3 (a) PLAN.—Within 18 months after the date of en4 actment of this Act, each covered Federal agency (as de5 fined in title I) shall publish a plan to review and, where

6 appropriate revise any significant risk assessment docu7 ment or significant risk characterization document pub8 lished prior to the expiration of such 18-month period if,

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

10 the agency head determines that the application of the

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

12 to significantly alter the results of the prior risk assess13 ment or risk characterization. The plan shall provide pro14 cedures for receiving and considering new information and

15 risk assessments from the public. The plan may set prior16 ities and procedures for review and, where appropriate, re17 vision of such risk assessment documents and risk charac18 terization documents and of health or environmental ef19 fects values. The plan may also set priorities and proce20 dures for review, and, where appropriate, revision or re21 peal of major rules promulgated prior to the expiration

22 of such period. Such priorities and procedures shall be

23 based on the potential to more efficiently focus national

24 economic resources within Federal regulatory programs

25 designed to protect human health, safety, or the environ-
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1 ment on the most important priorities and on such other

2 factors as such Federal agency considers appropriate.

3 (b) PUBLIC COMMENT AND CONSULTATION.—The

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

5 opportunity for public comment, and after consultation

6 with representatives of appropriate State, local, and tribal

7 governments, and such other departments and agencies,

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

9 TITLE VI—PRIORITIES

10 SEC. 601. PRIORITIES.

11 (a) IDENTIFICATION OF OPPORTUNITIES.—In order

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

13 public health, the President shall identify opportunities to

14 reflect priorities within existing Federal regulatory pro15 grams designed to protect human health in a cost-effective

16 and cost-reasonable manner. The President shall identify

17 each of the following:

18 (1) The likelihood and severity of public health

19 risks addressed by current Federal programs.

20 (2) The number of individuals affected.

21 (3) The incremental costs and risk reduction

22 benefits associated with regulatory or other strate23 gies.

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

25 strategies to reduce risks to public health.
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1 (5) Intergovernmental relationships among Fed2 eral, State, and local governments among programs

3 designed to protect public health.

4 (6) Statutory, regulatory, or administrative ob5 stacles to allocating national economic resources

6 based on the most cost-effective, cost-reasonable pri7 orities considering Federal, State, and local pro8 grams.

9 (b) STATE, LOCAL, AND TRIBAL PRIORITIES.—In

10 identifying national priorities, the President shall consider

11 priorities developed and submitted by State, local, and

12 tribal governments.

13 (c) BIENNIAL REPORTS.—The President shall issue

14 biennial reports to Congress, after notice and opportunity

15 for public comment, to recommend priorities for modifica16 tions to, elimination of, or strategies for existing Federal

17 regulatory programs designed to protect public health.

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

19 President shall notify the Congress in writing of the rec20 ommendations which can be implemented without further

21 legislative changes and the agency shall consider the prior22 ities set forth in the report and priorities developed and

23 submitted by State, local, and tribal governments when
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1 preparing a budget or strategic plan for any such regu2 latory program.

Passed the House of Representatives February 28,

1995.

Attest: ROBIN H. CARLE,

Clerk.