Amendment No. 230

S. 333
IIIA

AMENDMENT NO. 230

Purpose: To add additional provisions relating to risk assessments

IN THE SENATE OF THE UNITED STATES—104th Cong., 1st Sess.

S. 333

To direct the Secretary of Energy to institute certain procedures in the performance of risk assessments in connection with environmental restoration activities, and for

other purposes.

February 3 (legislative day, January 30), 1995

Referred to the Committee on Energy and Natural Resources

and ordered to be printed

AMENDMENT intended to be proposed by Mr. MURKOWSKI

(for himself and Mr. LOTT)

Viz:

1 At the end of the bill add the following:

2 SEC. 11. AMENDMENT OF TITLE 5, UNITED STATES CODE.

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

4 States Code, is amended by adding at the end the

5 following:

6 ‘‘SUBCHAPTER II—RISK ASSESSMENTS

7 ‘‘§ 621. Definitions

8 ‘‘In this subchapter—

9 ‘‘(1) AGENCY.—The term ‘agency’ has the

10 meaning stated in section 551(1).
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1 ‘‘(2) BENEFIT.—The term ‘benefit’ means the

2 reasonably identifiable significant benefits, including

3 social and economic benefits, that are expected to re4 sult directly or indirectly from implementation of a

5 rule or an alternative to a rule.

6 ‘‘(3) BEST ESTIMATE.—The term ‘best esti7 mate’ means an estimate that, to the extent feasible

8 and scientifically appropriate, is based on one or

9 more of the following:

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

11 most plausible assumptions.

12 ‘‘(B) An approach that combines multiple

13 estimates based on different scenarios and

14 weighs the probability of each scenario.

15 ‘‘(C) Any other methodology designed to

16 provide the most unbiased representation of the

17 most plausible level of risk, given the current

18 scientific information available to the agency

19 concerned.

20 ‘‘(4) COST.—The term ‘cost’ means the reason21 ably identifiable significant costs and adverse effects,

22 including social and economic costs, reduced

23 consumer choice, substitution effects, and impeded

24 technological advancement, that are expected to re-
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1 sult directly or indirectly from implementation of, or

2 compliance with, a rule or an alternative to a rule.

3 ‘‘(5) EMERGENCY.—The term ‘emergency’

4 means a clearly imminent and substantial

5 endangerment to public health, safety, or natural re6 sources.

7 ‘‘(6) MAJOR RULE.—The term ‘major rule’—

8 ‘‘(A) means—

9 ‘‘(i) a rule or a group of closely relat10 ed rules that the agency proposing the rule

11 or the President reasonably determines is

12 likely to have a gross annual effect on the

13 economy of $50,000,000 or more in rea14 sonably quantifiable increased direct and

15 indirect costs, or has a significant impact

16 on a sector of the economy; or

17 ‘‘(ii) a rule or a group of closely relat18 ed rules that is otherwise designated a

19 major rule by the agency proposing the

20 rule, or by the President on the ground

21 that the rule is likely to result in—

22 ‘‘(I) a substantial increase in

23 costs or prices for wage earners, con24 sumers, individual industries, non25 profit organizations, Federal, State,
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1 or local government agencies, or geo2 graphic regions; or

3 ‘‘(II) significant adverse effects

4 on competition, employment, invest5 ment, productivity, innovation, the en6 vironment, public health or safety, or

7 the ability of enterprises whose prin8 cipal places of business are in the

9 United States to compete in domestic

10 or export markets; but

11 ‘‘(B) does not include—

12 ‘‘(i) a rule that involves the internal

13 revenue laws of the United States; or

14 ‘‘(ii) a rule that authorizes the intro15 duction into commerce, or recognizes the

16 marketable status, of a product;.

17 ‘‘(7) PERSON.—The term ‘person’ has the

18 meaning stated in section 551(2).

19 ‘‘(8) PLAUSIBLE.—The term ‘plausible’ means

20 realistic and scientifically probable.

21 ‘‘(9) RISK ASSESSMENT.—The term ‘risk as22 sessment’ means—

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

24 and quantifying (to the extent practicable) or

25 describing the degree of toxicity, exposure, or
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1 other risk the hazards pose for exposed individ2 uals, populations, or resources; and

3 ‘‘(B) the document containing the expla4 nation of how the assessment process has been

5 applied to an individual substance, activity, or

6 condition.

7 ‘‘(10) RISK CHARACTERIZATION.—The term

8 ‘risk characterization’—

9 ‘‘(A) means the element of a risk assess10 ment that involves presentation of the degree of

11 risk to individuals and populations expected to

12 be protected, as presented in any regulatory

13 proposal or decision, report to Congress, or

14 other document that is made available to the

15 public; and

16 ‘‘(B) includes discussions of uncertainties,

17 conflicting data, estimates, extrapolations, in18 ferences, and opinions.

19 ‘‘(11) RULE.—The term ‘rule’ has the meaning

20 stated in section 551(4).

21 ‘‘(12) SUBSTITUTION RISK.—The term ‘substi22 tution risk’ means a potential increased risk to

23 human health, safety, or the environment from a

24 regulatory option designed to decrease other risks.
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1 ‘‘§ 622. Applicability

2 ‘‘(a) Except as provided in subsection (b), this sub3 chapter shall apply to all risk assessments and risk charac4 terizations prepared by, or on behalf of, or prepared by

5 others and adopted by, any agency in connection with

6 health, safety, and risk to natural resources.

7 ‘‘(b)(1) This subchapter shall not apply to risk as8 sessments or risk characterizations performed with respect

9 to—

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

11 considers to be an emergency;

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

13 into commerce, or recognizes the marketable status

14 of a product; or

15 ‘‘(C) a screening analysis.

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

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

18 of the analysis is used—

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

20 a substance or activity; or

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

22 from a substance or activity in any agency document

23 or other communication made available to the public,

24 the media, or Congress.

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

26 screening analyses for the purposes of paragraph (1)(B)
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1 are product registrations, reregistrations, tolerance set2 tings, and reviews of premanufacture notices and existing

3 chemicals under the Federal Insecticide, Fungicide and

4 Rodenticide Act (7 U.S.C. 136 et seq.) and the Toxic Sub5 stances Control Act (15 U.S.C. 2601 et seq.).

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

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

8 appearing on any such label.

9 ‘‘§ 623. Rule of construction

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

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

12 the calculation of any estimate to more fully describe

13 risk or provide examples of scientific uncertainty or

14 variability; or

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

16 or other confidential information.

17 ‘‘§ 624. Requirement to prepare risk assessments

18 ‘‘(a) Except as provided in section 622, the head of

19 each agency shall prepare for each major rule relating to

20 human health, safety, or natural resources that is pro21 posed by the agency after the date of enactment of this

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

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

24 pursuant to section 627—
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1 ‘‘(1) a risk assessment in accordance with this

2 subchapter;

3 ‘‘(2) for each such proposed or final rule, an as4 sessment, quantified to the extent feasible, of incre5 mental risk reduction or other benefits associated

6 with each significant regulatory alternative to the

7 rule or proposed rule; and

8 ‘‘(3) for each such proposed or final rule, quan9 tified to the extent feasible, a comparison of any

10 human health, safety, or natural resource risks ad11 dressed by the regulatory alternatives to other rel12 evant risks chosen by the head of the agency, includ13 ing at least 3 other risks regulated by the agency

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

15 is familiar.

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

17 subchapter shall be a component of and used to develop

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

19 shall be made part of the administrative record for judicial

20 review of any final agency action.

21 ‘‘§ 625. Principles for risk assessment

22 ‘‘(a)(1) The head of each agency shall apply the prin23 ciples set forth in subsection (b) when preparing any risk

24 assessment, whether or not required by section 624, to en25 sure that the risk assessment and all of its components—
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1 ‘‘(A) distinguish scientific findings and best es2 timates of risk from other considerations;

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

4 scientifically objective, unbiased and inclusive of all

5 relevant data; and

6 ‘‘(C) rely, to the extent available and prac7 ticable, on scientific findings.

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

9 section need not be repeated in each risk assessment docu10 ment as long as there is a reference to the relevant discus11 sion or explanation in another agency document.

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

13 assessments are as follows:

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

15 risk assessment shall be based on the most reliable

16 laboratory, epidemiological, and exposure assessment

17 data that finds, or fails to find, a correlation be18 tween a health risk and a potential toxin or activity.

19 Other relevant data may be summarized.

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

21 exist, or when animal data are used as a basis to as22 sess human health, the assessment shall include dis23 cussion of possible reconciliation of conflicting infor24 mation, and, as appropriate, differences in study de25 signs, comparative physiology, routes of exposure,
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1 bioavailability, pharmacokinetics, and any other rel2 evant factor, including the availability of raw data

3 for review. Greatest emphasis shall be placed on

4 data that indicates a biological basis of the resulting

5 harm in humans. Animal data shall be reviewed with

6 regard to relevancy to humans.

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

8 of any significant assumption, inference, or model,

9 the agency shall—

10 ‘‘(A) describe the plausible and alternative

11 assumptions, inferences, or models;

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

13 among such assumptions, inferences, or models;

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

15 involved in choosing from among such alter16 native assumptions, inferences, or models;

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

18 risk assessment and make explicit the assump19 tions incorporated in the model; and

20 ‘‘(E) indicate the extent to which any sig21 nificant model has been validated by, or con22 flicts with, empirical data.

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

24 level of detail appropriate and practicable for rea25 soned decisionmaking on the matter involved, taking
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1 into consideration the significance and complexity of

2 the decision and any need for expedition.

3 ‘‘§ 626. Principles for risk characterization and com4 munication

5 ‘‘In characterizing risk in any risk assessment docu6 ment, regulatory proposal or decision, report to Congress,

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

8 each agency characterizing the risk shall comply with each

9 of the following:

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

11 the populations or natural resources that are the

12 subject of the risk characterization.

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

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

15 scientifically appropriate—

16 ‘‘(i) shall provide—

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

18 the specific populations or natural re19 sources which are the subject of the char20 acterization (based on the information

21 available to the department, agency, or in22 strumentality) or, in lieu of a single best

23 estimate, an array of multiple estimates

24 (showing the distribution of estimates and

25 the best estimate) based on assumptions,
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1 inferences, or models which are equally

2 plausible, given current scientific under3 standing;

4 ‘‘(II) a statement of the reasonable

5 range of scientific uncertainties; and

6 ‘‘(III) to the extent practicable and

7 appropriate, descriptions of the distribu8 tion and probability of risk estimates to re9 flect differences in exposure variability in

10 populations and uncertainties;

11 ‘‘(ii) in addition to a best estimate or esti12 mates, may present plausible upper-bound or

13 conservative estimates, but only in conjunction

14 with equally plausible lower-bound estimates;

15 and

16 ‘‘(iii) shall ensure that, where a safety fac17 tor, as distinguished from inherent quantitative

18 or qualitative uncertainties, is used, such factor

19 shall be similar in degree to safety factors used

20 to ensure safety in human activities.

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

22 exposure scenarios used in any risk assessment, and,

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

24 of the corresponding population or natural resource

25 at risk and the likelihood of such exposure scenarios.
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1 ‘‘(3)(A) To the extent feasible, the head of the

2 agency shall provide a statement that places the na3 ture and magnitude of individual and population

4 risks to human health in context.

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

6 shall—

7 ‘‘(i) include appropriate comparisons with

8 estimates of risks that are familiar to and rou9 tinely encountered by the general public as well

10 as other risks; and

11 ‘‘(ii) identify relevant distinctions among

12 categories of risk and limitations to compari13 sons.

14 ‘‘(4) When an agency provides a risk assess15 ment or risk characterization for a proposed or final

16 regulatory action, such assessment or characteriza17 tion shall include a statement of any significant sub18 stitution risks to human health identified by the

19 agency or contained in information provided to the

20 agency by a commenter.

21 ‘‘(5) If—

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

23 period with respect to a risk assessment or reg24 ulation;
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1 ‘‘(B) a commenter provides a risk assess2 ment, and a summary of results of such risk as3 sessment; and

4 ‘‘(C) such risk assessment is reasonably

5 consistent with the principles and the guidance

6 provided under this subtitle,

7 the agency shall present such summary in connec8 tion with the presentation of the agency’s risk as9 sessment or the regulation.

10 ‘‘§ 627. Regulations; plan for assessing new informa11 tion

12 ‘‘(a)(1) Not later than 1 year after the date of enact13 ment of this subchapter, the President shall issue a final

14 regulation that has been subject to notice and comment

15 under section 553 for agencies to implement the risk as16 sessment and characterization principles set forth in sec17 tions 625 and 626 and shall provide a format for summa18 rizing risk assessment results.

19 ‘‘(2) The regulation under paragraph (1) shall be suf20 ficiently specific to ensure that risk assessments are con21 ducted consistently by the various agencies.

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

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

24 written petition of a person showing a reasonable likeli25 hood that—
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1 ‘‘(A) the risk assessment is inconsistent with

2 the principles set forth in section 625 and 626;

3 ‘‘(B) the risk assessment produces substantially

4 different results;

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

6 rule issued under subsection (a); or

7 ‘‘(D) the risk assessment does not take into ac8 count material significant new scientific data or sci9 entific understanding.

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

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

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

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

14 basis for the decision.

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

16 petition, the agency shall complete its review within 180

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

18 Budget agrees in writing with an agency determination

19 that an extension is necessary in view of limitations on

20 agency resources.

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

22 be subject to judicial review in accordance with chapter

23 7 of title 5, United States Code.

24 ‘‘(c) The regulations under this section shall be devel25 oped after notice and opportunity for public comment, and
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1 after consultation with representatives of appropriate

2 State agencies and local governments, and such other de3 partments and agencies, offices, organizations, or persons

4 as may be advisable.

5 ‘‘(d) At least every 4 years, the President shall re6 view, and when appropriate, revise the regulations pub7 lished under this section.

8 ‘‘§ 628. Decisional criteria

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

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

11 shall make a determination that—

12 ‘‘(1) the risk assessment under section 624 is

13 based on a scientific and unbiased evaluation, re14 flecting realistic exposure scenarios, of the risk ad15 dressed by the major rule and is supported by the

16 best available scientific data, as determined by a

17 peer review panel in accordance with section 640;

18 and

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

20 the statute under which the major rule is promul21 gated that would provide greater net benefits or that

22 would achieve an equivalent reduction in risk in a

23 more cost-effective and flexible manner.
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1 ‘‘§ 629. Regulatory priorities

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

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

6 safety, and natural resources that—

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

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

11 net reduction in risks with the public and private

12 sector resources to be expended.

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

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

15 consider, at a minimum—

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

17 effect; and

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

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

23 the agency’s annual budget request to Congress—

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

2 the basis for that determination;

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

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

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

8 under subsection (a); and

9 ‘‘(4) explicitly considering the requirements of

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

12 an explanation of how the agenda or plan reflects

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

15 plan.

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

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

19 agency to prioritize its activities to address the risks to

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

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

23 ‘‘§ 630. Establishment of program

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

2 the agencies.

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

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

6 experts who are broadly representative and balanced

7 to the extent feasible;

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

11 disclosed;

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

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

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

17 review, meeting agency deadlines, which contains a

18 balanced presentation of all considerations, including

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

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

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

23 of the administrative record for purposes of judicial review

24 of any final agency action.’’.
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1 (b) CONFORMING AMENDMENT AND TECHNICAL

2 CORRECTIONS.—

3 (1) CONFORMING AMENDMENTS.—Part I of

4 title 5, United States Code, is amended by striking

5 the chapter analysis for chapter 6 and inserting the

6 following:

7 ‘‘CHAPTER 6—THE ANALYSIS OF

8 REGULATORY FUNCTIONS

‘‘SUBCHAPTER I—REGULATORY ANALYSIS

‘‘Sec.

‘‘601. Definitions.

‘‘602. Regulatory agenda.

‘‘603. Initial regulatory flexibility analysis.

‘‘604. Final regulatory flexibility analysis.

‘‘605. Avoidance of duplicative or unnecessary analyses.

‘‘606. Effect on other law.

‘‘607. Preparation of analyses.

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

‘‘609. Procedures for gathering comments.

‘‘610. Periodic review of rules.

‘‘611. Judicial review.

‘‘612. Reports and intervention rights.

‘‘SUBCHAPTER II—RISK ASSESSMENTS

‘‘621. Definitions.

‘‘622. Applicability.

‘‘623. Rule of construction.

‘‘624. Requirement to prepare risk assessments.

‘‘625. Principles for risk assessment.

‘‘626. Principles for risk characterization and communication.

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

‘‘628. Decisional criteria.

‘‘629. Regulatory priorities.

‘‘640. Establishment of program.

9 ‘‘SUBCHAPTER I—REGULATORY ANALYSIS’’.

10 (2) TECHNICAL CORRECTIONS.—The part anal11 ysis for part I of title 5, United States Code, is

12 amended—
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1 (A) in the item relating to chapter 5 by

2 striking ‘‘501’’ and inserting ‘‘500’’; and

3 (B) by inserting after the item relating to

4 chapter 5 the following:

‘‘6. The Analysis of Regulatory Functions ............................... 601’’.

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