Calendar No. 116

104TH CONGRESS

1ST SESSION S. 333

[Report No. 104–87]

A BILL

To direct the Secretary of Energy to institute certoration activities, and for other purposes. sessments in connection with environmental res- tain procedures in the performance of risk asMAY 25 (legislative day, MAY 15), 1995

Reported with an amendment
II

Calendar No. 116

104TH CONGRESS

1ST SESSION S. 333

[Report No. 104–87]

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.

IN THE SENATE OF THE UNITED STATES

FEBRUARY 2 (legislative day, JANUARY 30), 1995

Mr. MURKOWSKI (for himself, Mr. JOHNSTON, and Mr. LOTT) introduced the

following bill; which was read twice and referred to the Committee on Energy and Natural Resources

MAY 25 (legislative day, MAY 15), 1995

Reported by Mr. MURKOWSKI, with an amendment

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

A BILL

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.

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 ‘‘Department of Energy

3 Risk Management Act of 1995.’’

4 SEC. 2. TABLE OF CONTENTS.

Sec. 1. Short title.

Sec. 2. Table of contents.

Sec. 3. Definitions.

Sec. 4. Applicability; principles for risk assessment, characterization and communication.

Sec. 5. Regulation; plan for assessing new information.

Sec. 6. Requirements for environmental restoration activity.

Sec. 7. Environmental restoration priorities.

Sec. 8. Judicial review.

Sec. 9. Savings provisions.

5 SEC. 3. DEFINITIONS.

6 In this Act:

7 (1) BEST ESTIMATE.—The term ‘‘best esti8 mate’’ means an estimate that, to the extent feasible

9 and scientifically appropriate, provides the most un10 biased representation of the most plausible level of

11 risk, given the most reliable current scientific infor12 mation available to the Department.

13 (2) COSTS.—The term ‘‘costs’’ includes the di14 rect and indirect costs to the United States Govern15 ment, to State and local governments, and to the

16 private sector, of implementing and complying with

17 a regulatory action.

18 (3) DEPARTMENT.—The term ‘‘Department’’

19 means the Department of Energy.
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1 (4) ENVIRONMENTAL RESTORATION ACTIV2 ITY.—The term ‘‘environmental restoration activity’’

3 means a removal or remedial action conducted by

4 the Department at nuclear facilities under the con5 trol of the Department, including the Savannah

6 River Site, Hanford Nuclear Reservation, Nevada

7 Test Site, Rocky Flats Plant, Idaho National Engi8 neering Laboratory, Los Alamos National Labora9 tory, Lawrence Livermore National Laboratory, and

10 any other such facility.

11 (5) HAZARD.—The term ‘‘hazard’’ means a

12 substance, activity, or condition which potentially

13 poses a risk to human health or safety or the envi14 ronment based on empirical data, measurements, or

15 testing showing that it has caused significant ad16 verse effects at some levels of dose or exposure not

17 necessarily relevant to level of dose or exposure that

18 are normally expected to occur.

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

20 realistic and scientifically probable.

21 (7) RISK ASSESSMENT.—The term ‘‘risk assess22 ment’’ means—

23 (A) the process of identifying hazards and

24 quantifying or describing the degree of toxicity,

25 exposure, or other risk they pose for demon-
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1 strably exposed individuals, populations, or re2 sources; or

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

5 been applied to an individual substance, activ6 ity, or condition.

7 (8) RISK CHARACTERIZATION.—The term ‘‘risk

8 characterization’’—

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

11 risk set forth in any plan, assessment, or record

12 of decision, report to Congress, or other docu13 ment that is made available to the public; and

14 (B) includes discussions of uncertainties,

15 conflicting data, estimates, extrapolations, in16 ferences, justifications, and opinions.

17 (9) SECRETARY.—The term ‘‘Secretary’’ means

18 the Secretary of Energy, or the Secretary’s designee.

19 (10) SUBSTITUTION RISK.—The term ‘‘substi20 tution risk’’ means a potential increased risk to

21 human health, safety, or the environment from a

22 regulatory option designed to decrease other risks.
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1 SEC. 4. APPLICABILITY; PRINCIPLES FOR RISK ASSESS2 MENT, RISK CHARACTERIZATION, AND COM3 MUNICATION.

4 (a) APPLICABILITY.—

5 (1) IN GENERAL.—Except as provided in para6 graph (2), this Act applies to all risk assessments

7 and risk characterizations prepared by, or on behalf

8 of, the Department as part of an environmental res9 toration activity.

10 (2) EXCEPTIONS.—

11 (A) EMERGENCIES AND SCREENING ANAL12 YSES.—This Act does not apply to risk assess13 ments or risk characterizations performed with

14 respect to either of the following:

15 (i) A situation that the Secretary de16 termines to be an emergency.

17 (ii) A screening analysis, including a

18 screening analysis for purposes of product

19 regulation, product reregistration, or

20 premanufacturing notices.

21 (B) TREATMENT OF ANALYSIS AS SCREEN22 ING ANALYSIS.—No analysis shall be treated as

23 a screening analysis for purposes of subpara24 graph (A) if the results of the analysis is

25 used—
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1 (i) as the basis for imposing restrictions on

2 substances or activities; or

3 (ii) to characterize a positive finding of

4 risks from substances or activities in any De5 partmental document made available to the gen6 eral public.

7 (b) PRINCIPLES FOR RISK ASSESSMENT.—

8 (1) IN GENERAL.—The Secretary shall apply

9 the principles set forth in paragraph (2) when pre10 paring a risk assessment in order to ensure that the

11 risk assessment distinguishes scientific findings from

12 other considerations and are, to the maximum extent

13 feasible, scientifically objective, unbiased, and inclu14 sive of all relevant data. Discussions or explanations

15 required under this section need not be repeated in

16 each risk assessment document as long as there is

17 a reference to the relevant discussion or explanation

18 in another agency document.

19 (2) PRINCIPLES.—The principles to be applied

20 when preparing risk assessments are as follows:

21 (A) HUMAN HEALTH RISKS.—When as22 sessing human health risks in connection with

23 a risk assessment, the Secretary shall consider

24 and discuss both laboratory and epidemiological

25 data of sufficient quality that finds, or fails to
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1 find, a correlation between health risks and a

2 potential toxin or activity. When conflicts

3 among the data appear to exist or when animal

4 data are used as a basis to assess human

5 health, the assessment shall include discussion

6 of possible reconciliation of conflicting data.

7 (B) SIGNIFICANT ASSUMPTIONS.—When a

8 risk assessment involves selection of any signifi9 cant assumption, inference, or model, the Sec10 retary shall—

11 (i) describe the plausible alternative

12 assumptions, inferences, or models;

13 (ii) explain the basis for any choices

14 among the assumptions, inferences, or

15 models;

16 (iii) identify any policy or value judg17 ments involved in choosing from among the

18 alternative assumptions, inferences, or

19 models;

20 (iv) fully describe any model used in

21 the risk assessment and make explicit the

22 assumptions incorporated in the model;

23 and
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1 (v) indicate the extent to which any

2 significant model has been validated by, or

3 conflicts with, empirical data.

4 (c) PRINCIPLES FOR RISK CHARACTERIZATION AND

5 COMMUNICATION.—When characterizing risk, the Sec6 retary shall comply with each of the following:

7 (1) ESTIMATES OF RISK.—

8 (A) BEST ESTIMATE.—The Secretary shall

9 describe the populations or natural resources

10 that are the subject of the risk characterization.

11 If a numerical estimate of risk is provided, the

12 Secretary shall, to the extent feasible and sci13 entifically appropriate, provide—

14 (i) the best estimate for the specific

15 populations or natural resources that are

16 the subject of the characterization (based

17 on the information available to the Depart18 ment); and

19 (ii) a statement of the reasonable

20 range of scientific uncertainties.

21 (B) MULTIPLE BEST ESTIMATES.—In ap22 propriate circumstances the Secretary may

23 present, in lieu of a single best estimate, mul24 tiple estimates based on assumptions, infer-
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1 ences, or models that are equally plausible,

2 given current scientific understanding.

3 (C) PLAUSIBLE UPPER-BOUND OR CON4 SERVATIVE ESTIMATES.—In addition to a best

5 estimate or estimates, the Secretary may

6 present plausible upper-bound or conservative

7 estimates in conjunction with plausible lower

8 bounds estimates.

9 (D) DESCRIPTIONS OF DISTRIBUTION AND

10 PROBABILITY.—To the extent practicable and

11 appropriate, the Secretary shall provide descrip12 tions of the distribution and probability of risk

13 estimates to reflect differences in exposure vari14 ability in populations and uncertainties.

15 (2) EXPOSURE SCENARIOS.—The Secretary

16 shall explain the exposure scenarios used in any risk

17 assessment, and, to the extent feasible, provide a

18 statement of the size of the corresponding popu19 lation at risk and the likelihood of the exposure sce20 narios.

21 (3) COMPARISONS.—To the extent feasible, the

22 Secretary shall provide a statement that places the

23 nature and magnitude of risks to human health in

24 context. The statement shall include appropriate

25 comparisons with estimates of risks that are familiar
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1 to and routinely encountered by the general public

2 as well as other risks.

3 (4) SUBSTITUTION RISKS.—When the Secretary

4 provides a risk assessment or risk characterization

5 for an environmental restoration activity, the assess6 ment or characterization shall include a statement of

7 any significant substitution risks to human health,

8 where information on such risks has been provided

9 to the Secretary.

10 SEC. 5. REGULATION; PLAN FOR ASSESSING NEW INFORMA11 TION.

12 (a) REGULATION.—Within 1 year after the date of

13 enactment of this Act, the Secretary shall issue a final

14 regulation implementing for the Department the risk as15 sessment and risk characterization principles set forth in

16 this Act. The final regulation shall establish a format for

17 summarizing risk assessment results.

18 (b) PLAN.—

19 (1) IN GENERAL.—Within 1 year after the date

20 of enactment of this Act, the Secretary shall promul21 gate a plan to review and revise any risk assessment

22 prepared by or on behalf of the Secretary and com23 pleted prior to the promulgation of the plan, if the

24 Secretary determines that significant new informa25 tion or methodologies are available that could signifi-
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1 cantly alter the results of the prior risk assessment

2 or that there are other appropriate reasons why such

3 a review and revision should be conducted.

4 (2) CONTENTS.—A plan promulgated under (1)

5 shall—

6 (A) provide procedures for receiving and

7 considering new information and risk assess8 ments from the public;

9 (B) set priorities for review and revision of

10 risk assessments based on such factors as the

11 Secretary considers appropriate; and

12 (C) include a process by which members of

13 the public may petition the Secretary for review

14 of particular assessments.

15 (3) RESPONSE TO PETITION.—Not later than

16 60 days after receiving a petition under paragraph

17 (2)(C), the Secretary shall respond to the petition by

18 agreeing or declining to review the risk assessment

19 referred to in the petition, and shall state the basis

20 for the decision.

21 (4) COMPLETION OF REVIEW.—If the Secretary

22 agrees to review a risk assessment, the Department

23 shall complete its review within 180 days, unless the

24 Secretary agrees in writing that an extension not to
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1 exceed 60 days is necessary in view of limitations on

2 Department resources.

3 (c) PUBLIC COMMENT AND CONSULTATION.—The

4 regulation and plan, under this sections shall be developed

5 after notice and opportunity for public comment.

6 (d) REVIEW.—At least every 4 years, the Secretary

7 shall review, and when appropriate, revise the regulation

8 and plan published under this section.

9 SEC. 6. REQUIREMENTS FOR ENVIRONMENTAL RESTORA10 TION ACTIVITY.

11 (a) IN GENERAL.—Any plan, assessment, or record

12 of decision to conduct an environmental restoration activ13 ity shall include a clear and concise statement that—

14 (1) describes and, to the extent practicable,

15 quantifies the risks to human health, safety, and the

16 environment to be addressed by the environmental

17 restoration activity;

18 (2) compares the human health or environ19 mental risks to be addressed by the environmental

20 restoration activity to other risks chosen by the Sec21 retary, including—

22 (A) at least 3 other risks regulated by the

23 Department or another Federal agency; and

24 (B) at least 3 other risks that are familiar

25 to the general public;
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1 (3) describes and, to the extent practicable,

2 quantifies any known, plausible substitution risks

3 when information on such risks has been provided to

4 the Department;

5 (4) estimates—

6 (A) the costs to the United States Govern7 ment of conducting the environmental restora8 tion activity; and

9 (B) the benefits of the environmental res10 toration activity, including both quantifiable

11 measures of costs and benefits, to the fullest ex12 tent that they can be estimated, and qualitative

13 measures that are difficult to quantify; and

14 (5) contains a certification by the Secretary

15 that—

16 (A) the analyses performed under para17 graphs (1), (2), and (3) are, to the maximum

18 extent practicable—

19 (i) based on the best reasonably ob20 tainable scientific and economic informa21 tion; and

22 (ii) objective and unbiased;

23 (B) the environmental restoration activity

24 is likely to significantly reduce the human
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1 health, safety, or environmental risks to be ad2 dressed;

3 (C) no environmental restoration activity

4 alternative that would achieve an equivalent re5 duction in risk in a more cost-effective manner

6 is permitted under the Comprehensive Environ7 mental Response, Compensation, and Liability

8 Act of 1980 (42 U.S.C. 9601 et seq.); and

9 (D) the environmental restoration activity

10 is likely to produce benefits to human health or

11 the environment that will justify the costs to

12 the United States Government.

13 (b) REPORTING.—If the Secretary cannot make a

14 certification with respect to 1 or more of the matters de15 scribed in subsection (a), the Secretary shall identify the

16 matters for which certification cannot be made, and shall

17 include a statement of the reasons why the certification

18 cannot be made in the plan, assessment, or record of deci19 sion. Not later than March 1 of each year, the Secretary

20 shall submit a report to Congress identifying the environ21 mental restoration activities conducted during the previous

22 calendar year for which complete certification was not

23 made, and summarizing the reasons therefore.
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1 SEC. 7. ENVIRONMENTAL RESTORATION PRIORITIES.

2 (a) SETTING OF PRIORITIES.—The Secretary shall

3 prioritize the use of the resources available to conduct res4 toration activities to address the risks to human health,

5 safety and the environment that—

6 (1) the Secretary determines are the most seri7 ous; and

8 (2) can be addressed in a cost-effective manner,

9 with the goal of achieving the greatest overall net re10 duction in risks with the public and private sector

11 resources to be expended.

12 (b) DETERMINING MOST SERIOUS RISKS.—In identi13 fying the sources of the most serious risks under sub14 section (a), the Secretary shall consider, at a minimum—

15 (1) the plausible likelihood and severity of the

16 effect; and

17 (2) the plausible number and groups of individ18 uals potentially affected.

19 (c) INCORPORATION OF RISK-BASED PRIORITIES

20 INTO BUDGET AND PLANNING.—The Secretary shall in21 corporate the priorities identified in subsection (a) into the

22 Department’s budget, strategic planning, and research ac23 tivities by—

24 (1) in the Department’s annual budget request

25 to Congress—
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1 (A) identifying which risks that the Sec2 retary has determined are the most serious and

3 can be addressed in a cost-effective manner

4 under subsection (a), and the basis for that de5 termination;

6 (B) explicitly identifying how the Depart7 ment’s requested funds will be used to address

8 those risks; and

9 (C) identifying any statutory, regulatory,

10 or administrative obstacles to allocating Depart11 mental resources in accordance with the prior12 ities established under subsection (a); and

13 (D) explicitly considering the requirements

14 of subsection (a) when preparing the Depart15 ment’s environmental management plan or

16 other strategic plan and providing an expla17 nation of how the agenda or plan reflects those

18 requirements and the comparative risk analysis

19 when publishing any such agenda or strategic

20 plan.

21 (e) RECOMMENDATION.—In March of each year, the

22 Secretary shall submit to Congress specific recommenda23 tions for repealing or modifying laws that would better en24 able the Department to prioritize its activities to address

25 the risks to human health, safety, and the environment
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1 that are the most serious and can be addressed in a cost2 effective manner consistent with the requirements of

3 subsection (a).

4 SEC. 9. SAVINGS PROVISIONS.

5 Nothing in this Act shall be construed to—

6 (1) modify any statutory standard or require7 ment designed to protect health, safety, or the envi8 ronment;

9 (2) preclude the consideration of any data or

10 the calculation of any estimate to more fully describe

11 risk or provide examples of scientific uncertainty or

12 variability; or

13 (3) require the disclosure of any trade secret or

14 other proprietary information.

15 SECTION 1. SHORT TITLE.

16 This Act may be cited as the ‘‘Risk Management Act

17 of 1995’’.

18 SEC. 2. TABLE OF CONTENTS.

Sec. 1. Short title.

Sec. 2. Table of contents.

Sec. 3. Definitions.

Sec. 4. Applicability.

Sec. 5. Rule of construction.

Sec. 6. Requirement to prepare risk assessments.

Sec. 7. Requirements for major rules and environmental management activities.

Sec. 8. Principles for risk assessment.

Sec. 9. Principles for risk communication.

Sec. 10. Review of existing risk assessments.

Sec. 11. Risk assessment and program planning.

Sec. 12. Risk assessment and budgetary priorities.

Sec. 13. Risk assessment improvement programs.

Sec. 14. Judicial review.
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1 SEC. 3. DEFINITIONS.

2 In this Act:

3 (1) AGENCY.—The term ‘‘agency’’ has the mean4 ing stated in section 551(1) of title 5.

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

6 reasonably identifiable benefits and desired effects, in7 cluding quantifiable and nonquantifiable social, envi8 ronmental, and economic benefits, that are expected to

9 result directly or indirectly from implementation of,

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

11 (3) CAUSATION ASSESSMENT.—The term ‘‘causa12 tion assessment’’ means a scientific evaluation of the

13 relationship between the degree of exposure to a pre14 sumed cause of an adverse effect or condition and the

15 incidence or severity of the adverse effect in question,

16 with particular emphasis on the quantitative relation

17 between the presumed cause and the effect.

18 (4) COST.—The term ‘‘cost’’ means the reason19 ably identifiable costs and adverse effects, including

20 quantifiable and nonquantifiable social, environ21 mental, and economic costs that are expected to result

22 directly or indirectly from implementation of, or com23 pliance with, a rule or an alternative to a rule.

24 (5) EMERGENCY.—The term ‘‘emergency’’ means

25 an imminent and substantial endangerment to public

26 health, safety, or natural resources.
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1 (6) ENVIRONMENTAL MANAGEMENT ACTIVITY.—

2 The term ‘‘environmental management activity’’

3 means a corrective action under the Solid Waste Dis4 posal Act, the treatment, disposal, or storage of radio5 active or mixed waste, or a remedial or removal ac6 tion under the Comprehensive Environmental Re7 sponse, Compensation, and Liability Act of 1980, as

8 amended.

9 (7) EXPOSURE ASSESSMENT.—The term ‘‘expo10 sure assessment’’ means the scientific determination

11 of the intensity, frequency, and duration of actual or

12 hypothetical exposures to the hazard in question.

13 (8) HAZARD.—The term ‘‘hazard’’ means any

14 activity, substance, or condition which might pose a

15 risk to human health, safety, or the environment.

16 (9) HAZARD IDENTIFICATION.—The term ‘‘haz17 ard identification’’ means the scientific determination

18 of whether exposure to a hazard can cause an in19 creased incidence of adverse health or environmental

20 effects that are of sufficient importance to warrant

21 further scientific study or regulatory attention, as

22 well as characterization of the nature and strength of

23 the evidence of causation.

24 (10) MAJOR RULE.—The term ‘‘major rule’’—
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1 (A) means a rule or group of closely related

2 rules that the agency proposing the rule or the

3 President reasonably determines is likely to have

4 an effect on the economy of $75,000,000 or more

5 in reasonably quantifiable costs, in any one

6 year; but

7 (B) does not include a rule that involves the

8 internal revenue laws of the United States.

9 (11) MAJOR RISK COMMUNICATION.—The term

10 ‘‘major risk communication’’ means a written or

11 broadcast public communication by an agency, or by

12 another organization under a contract, cooperative

13 agreement, or financial assistance award from an

14 agency, to Congress, State, local or tribal govern15 ments, or the general public, which makes a rec16 ommendation as to risk that would, if implemented,

17 be likely to have an effect on the economy of

18 $75,000,000 or more in reasonably quantifiable costs,

19 in any one year.

20 (12) PERSON.—The term ‘‘person’’ has the mean21 ing stated in section 551(2) of title 5.

22 (13) PLAUSIBLE.—The term ‘‘plausible’’ means

23 realistic and scientifically supported.

24 (14) POLICY JUDGMENT.—The term ‘‘policy

25 judgment’’ means any assumptions, inferences, choices
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1 of models, or safety factors that are used in a risk as2 sessment because of the absence of relevant available

3 information.

4 (15) RISK ASSESSMENT.—The term ‘‘risk assess5 ment’’ means the systematic process of organizing and

6 analyzing scientific knowledge and information for

7 potentially hazardous situations and activities or for

8 substances that might pose risks under specified con9 ditions, taking into account both the intrinsic hazard

10 as well as the exposure to that hazard. As appropriate

11 for the specific risk involved, risk assessment includes

12 hazard identification, causation assessment, exposure

13 assessment, and risk characterization.

14 (16) RISK CHARACTERIZATION.—The term ‘‘risk

15 characterization’’ means the combination of assess16 ments of exposure and response under various expo17 sure conditions to estimate the probability of specific

18 harm to an exposed individual, population, or natu19 ral resource including, to the extent feasible, a charac20 terization of the distribution of risk, and including

21 an analysis of uncertainties, conflicting data, and in22 ferences and assumptions in the assessment.

23 (17) RULE.—The term ‘‘rule’’ has the meaning

24 stated in section 551(4) of title 5.
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1 (18) SCREENING ANALYSIS.—The term ‘‘screen2 ing analysis’’ means an analysis using simple, con3 servative models and assumptions to arrive at an es4 timate of upper and lower bounds that permits the

5 manager to eliminate risks from further consideration

6 and analysis, or to help establish priorities for agency

7 action.

8 (19) SUBSTITUTION RISK.—The term ‘‘substi9 tution risk’’ means an increased risk to human

10 health, safety, or the environment likely to result from

11 a regulatory or nonregulatory option designed to de12 crease other risks.

13 SEC. 4. APPLICABILITY.

14 (a) Except as provided in subsection (b), this Act shall

15 apply to all risk assessments prepared by, or on behalf of,

16 an agency in connection with health, safety, and environ17 mental risks.

18 (b) EXCLUSIONS.—The head of an agency shall not be

19 required to prepare a risk assessment under this Act for—

20 (1) any situation that the head of the agency

21 finds to be an emergency;

22 (2) a rule or agency action that authorizes the

23 introduction into commerce, or recognizes the market24 able status of a product;
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1 (3) a health, safety, or environmental inspection

2 or individual facility permitting action;

3 (4) product registrations, re-registrations, toler4 ance settings; and reviews of premanufacturing no5 tices and existing chemicals under the Federal Insec6 ticide, Fungicide, and Rodenticide Act (7 U.S.C. 136

7 et seq.) and the Toxic Substances Control Act (15

8 U.S.C. 2601 et seq.);

9 (5) any food, drug, or other product label or any

10 risk communication appearing on any such label or

11 product insert; or

12 (6) a screening analysis.

13 (c) An analysis shall not be treated as a screening

14 analysis for the purposes of paragraph (b)(6) if the result

15 of the analysis is used—

16 (1) as the basis for imposing a restriction on a

17 substance, product, or activity; or

18 (2) to characterize a positive finding of risks

19 from a substance or activity in any major risk com20 munication.

21 SEC. 5. RULE OF CONSTRUCTION.

22 (a) Nothing in this Act shall be construed to modify

23 any statutory standard or requirement to protect health,

24 safety, or the environment.
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1 (b) Nothing in this Act shall be construed to preclude

2 the consideration of any reliable scientific data or the cal3 culation of any estimate to describe more fully risk or to

4 provide examples of scientific uncertainty or variability.

5 (c) Nothing in this Act shall be construed to require

6 the disclosure of any trade secret or other commercial pro7 prietary information or any other confidential information.

8 SEC. 6. REQUIREMENT TO PREPARE RISK ASSESSMENTS.

9 (a) MAJOR RULES.—An agency shall prepare a risk

10 assessment under this Act for each major rule relating to

11 human health, safety, or the environment that is—

12 (1) proposed after the date of enactment of this

13 Act; or

14 (2) not published as a final rule before the date

15 of enactment of this Act.

16 (b) MAJOR RISK COMMUNICATION.—An agency shall

17 prepare a risk assessment under this Act for each major

18 risk communication that is released after the date of enact19 ment of this Act.

20 (c) ENVIRONMENTAL MANAGEMENT ACTIVITY.—Except

21 where otherwise required by law or regulation, an agency

22 shall prepare a risk assessment under this Act prior to con23 ducting an environmental management activity to elimi24 nate a risk or reduce it to reasonable limits, if the agency
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1 head determines that the estimated cost of the environ2 mental management activity is more than $25,000,000.

3 SEC. 7. REQUIREMENTS FOR MAJOR RULES AND ENVIRON4 MENTAL MANAGEMENT ACTIVITIES.

5 (a) IN GENERAL.—Except as provided in subsection

6 (b), in promulgating any proposed or final major rule relat7 ing to human health, safety, or the environment or in con8 ducting any environmental management activity, an agen9 cy shall publish in the Federal Register along with the rule,

10 or make part of the publicly available record for the envi11 ronmental management activity, a clear and concise state12 ment that—

13 (1) describes and, to the extent practicable, quan14 tifies the risks to human health, safety, and the envi15 ronment to be addressed by the major rule or environ16 mental management activity based on the conclusions

17 of a risk assessment performed in accordance with

18 this Act;

19 (2) compares the human health, safety, or envi20 ronmental risks to be addressed by the major rule or

21 environmental management activity to other risks

22 chosen by the agency head, including—

23 (A) at least three other risks regulated by a

24 Federal agency; and
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1 (B) at least three other risks that are famil2 iar to the general public;

3 (3) describes and, to the extent practicable, quan4 tifies any known, plausible substitution risks when

5 information on such risks is known to or has been

6 provided to the agency;

7 (4) estimates—

8 (A) the costs to the United States Govern9 ment, State, and local governments, and the pri10 vate sector of complying with or implementing

11 the major rule or carrying out the environmental

12 management activity; and

13 (B) the benefits of the regulation or environ14 mental management activity including both

15 quantifiable measures of costs and benefits, to the

16 fullest extent that they can be estimated, and

17 qualitative measures that are difficult to quan18 tify; and

19 (5) contains a certification by the agency head

20 that—

21 (A) the analyses performed under para22 graphs (1), (2), and (3) are in accordance with

23 the requirements of section 8;

24 (B) the major rule or environmental man25 agement activity is likely to reduce significantly
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1 the human health, safety, or environmental risks

2 to be addressed;

3 (C) no regulatory alternative, or alternative

4 environmental management activity, that would

5 achieve an equivalent reduction in risk in a

6 more cost-effective manner, is permitted under

7 law, along with a brief explanation of why other

8 such alternatives that were considered by the

9 agency head were found to be less cost-effective;

10 and

11 (D) the major rule or environmental man12 agement activity, is likely to produce incremen13 tal benefits to human health or the environment

14 that will justify the incremental costs to the

15 United States Government, State, local, or tribal

16 governments, and the private sector.

17 (b) SUBSTANTIALLY SIMILAR FINAL MAJOR RULES.—

18 If the agency head determines that a final major rule is

19 substantially similar to the proposed version of the major

20 rule with respect to each of the matters referred to in sub21 section (a), the agency head may publish in the Federal

22 Register a reference to the statement published under sub23 section (a) for the proposed rule in lieu of publishing a new

24 statement for such final rule.
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1 (c) REPORTING.—If the agency head cannot certify

2 with respect to one or more of the matters addressed in sub3 section (a), the agency head shall identify those matters for

4 which certification cannot be made, and shall include a

5 statement of the reasons therefore in the Federal Register

6 along with the major rule or, in the case of an environ7 mental management activity, the publicly available plan.

8 Not later than April 1 of each year, the agency head shall

9 submit a report to Congress identifying those major rules

10 and environmental management activities, promulgated or

11 carried out during the previous calendar year, for which

12 complete certification was not made, and summarizing the

13 reasons therefor.

14 (d) ADDITIONAL REQUIREMENTS FOR ENVIRON15 MENTAL MANAGEMENT ACTIVITIES.—(1) The agency head

16 shall use the risk assessment for an environmental manage17 ment activity to determine the need for the environmental

18 management activity and to evaluate environmental man19 agement alternatives. A risk assessment conducted under

20 this section shall be incorporated into any similar state21 ment, assessment, or analysis conducted under any other

22 statute for this environmental management activity.

23 (2) If the agency head cannot make a certification with

24 respect to one or more of the matters described in subsection

25 (a)(5) of this section, the agency head shall consider—
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1 (A) funding research and development of new

2 technologies for environmental management; and

3 (B) selecting the new technology, if any, achiev4 ing the greatest risk reduction and cost efficiencies for

5 use in the environmental management activity.

6 SEC. 8. PRINCIPLES FOR RISK ASSESSMENT.

7 (a) IN GENERAL.—Except as provided in section 4, the

8 head of an agency shall follow the principles set forth in

9 this section when preparing risk assessments. Agencies shall

10 not be required to repeat discussions or explanations re11 quired under this section in each risk assessment if there

12 is an unambiguous reference to a relevant discussion or ex13 planation in another reasonably available agency document

14 that was prepared in accordance with the principles of this

15 section.

16 (b) RELATIONSHIP TO RISK MANAGEMENT.—An agen17 cy shall design and conduct risk assessments and report the

18 results in a manner that promotes rational and informed

19 risk management decision making and informed public

20 input into the process of making agency decisions. In un21 dertaking risk assessments, agencies should establish and

22 maintain a clear distinction between the identification,

23 quantification, and characterization of risks and the selec24 tion of methods for managing risks. Agency priorities for

25 managing risks, and a consideration of the types of infor-
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1 mation that would be important in evaluating a full range

2 of decisions, may play a role in developing priorities for

3 risk assessment activities.

4 (c) ITERATIVE AND PROPORTIONATE APPROACH.—(1)

5 In conducting risk assessments, an agency shall—

6 (A) employ the level of detail and rigor appro7 priate and practicable for reasoned decision making

8 on the matter involved, taking into account the sig9 nificance and complexity of the potential agency ac10 tion and the need for expedition; and

11 (B) develop and use an iterative approach to

12 risk assessment, which may start with relatively inex13 pensive screening analyses and then progress to more

14 rigorous analyses.

15 (2) In determining whether to proceed to more detailed

16 analyses that might improve the scientific quality and com17 pleteness of the risk estimates, the agency head shall take

18 into consideration—

19 (A) whether or not the available information has

20 demonstrated that the estimated risk is below the ap21 plicable decision-making level;

22 (B) whether or not further improvements in sci23 entific data or models would significantly change the

24 risk estimate; and
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1 (C) whether or not the risk is significant enough

2 to warrant further analysis.

3 (3) If an iterative risk assessment process results in

4 the availability of more and better scientific information

5 on a specific risk, and correspondingly less uncertainty in

6 the analysis, the level of conservatism applied to the risk

7 assessment should decrease.

8 (d) USE OF POLICY JUDGMENTS IN RISK ASSESS9 MENT.—Policy judgments used in developing a risk assess10 ment, including assumptions, defaults, inferences, choices of

11 models, and safety factors, shall be described explicitly in

12 connection with each risk assessment in which they are

13 used, along with—

14 (1) a description of the scientific and policy

15 basis for each policy judgment;

16 (2) a description of any available scientific data,

17 with emphasis on site- or situation-specific data, that

18 was not used because a policy judgment was utilized

19 in its place, the rationale for using the policy judg20 ment, and a description of the sensitivity of the con21 clusions of the risk assessment to the available data

22 had it been used;

23 (3) a description of reasonable alternative policy

24 judgments that were not selected by the agency for use

25 in the risk assessment, and a discussion of why the
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1 agency believes that the policy judgments selected for

2 use are appropriate to the specific risk assessment;

3 (4) a description of the extent to which policy

4 judgments used in the risk assessment are validated

5 by, or conflict with, empirical data relevant to the as6 sessment; and

7 (5) a description of the sensitivity of the conclu8 sions of the risk assessment to the policy judgments

9 used in the risk assessments.

10 Each agency shall develop a procedure and publish guide11 lines for choosing default policy judgments to use in risk

12 assessments and for deciding when and how, in a specific

13 risk assessment, to adopt alternative judgments or to use

14 available scientific information in place of a policy judg15 ment.

16 (e) CONSIDERATION OF FUTURE LAND USE.—In con17 ducting a risk assessment for an environmental manage18 ment activity under this Act, the agency head shall consider

19 the reasonably anticipated future use of the land affected

20 by the environmental management activity.

21 (f) TREATMENT OF SCIENTIFIC DATA IN RISK ASSESS22 MENTS.—

23 (1) The technical basis of a risk assessment shall

24 be—
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1 (A) the best available, scientifically

2 replicable data that finds, or fails to find, a cor3 relation between a potential hazard and adverse

4 effects;

5 (B) the best available, scientifically

6 replicable laboratory or experimental data that

7 has relevance to understanding the potential haz8 ard to humans or the environment; and

9 (C) hazard, dose, exposure, or other relevant

10 physical conditions that are reasonably expected

11 to be encountered under usual and realistic cir12 cumstances.

13 A risk assessment shall not exaggerate risks by inap14 propriately compounding multiple hypothetical con15 servative policy judgments.

16 (2) When conflicts among scientific data appear

17 to exist, the assessment shall include an explanation

18 for, or possible reconciliation of, conflicting informa19 tion.

20 (3) When animal data are used as a basis to as21 sess human health risks, the assessment shall include

22 a discussion of the relevance of experimental animal

23 responses to human outcomes, the basis for selecting

24 any interspecies scaling factors that were used, and

25 the correspondence among routes of exposure in hu-
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1 mans and the exposure routes utilized in the animal

2 studies.

3 (4) Any relevant scientific data meeting the re4 quirements of subsection (f)(1) of this section that are

5 submitted by interested parties shall be reviewed and

6 considered in the risk assessment. The risk assessment

7 shall include an explanation of whether such data

8 were used and, if not, why not.

9 (g) PUBLIC INVOLVEMENT IN RISK ASSESSMENTS.—

10 Agency heads shall provide for early involvement by all in11 terested parties in the development of risk assessments.

12 Agency heads shall provide appropriate opportunity for

13 meaningful public participation and comment on risk as14 sessment throughout the regulatory process commensurate

15 with the consequences of the decision to be made.

16 (h) PEER REVIEW AND SCIENTIFIC PARTICIPATION IN

17 RISK ASSESSMENTS.—(1) Each agency shall develop proce18 dures that make the greatest possible use of peer review, sci19 entific workshops, expert bodies, or other devices to ensure

20 broad peer and scientific participation in its risk assess21 ments, through a process that allows full public discussion

22 and peer participation by the scientific community.

23 (2) Peer review panels shall consist of independent and

24 external experts who are broadly representative and bal25 anced to the extent feasible.
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1 (3) A person shall not be excluded from participation

2 in the scientific review of a risk assessment on the basis

3 of potential interest in the outcome, if the interest is fully

4 disclosed.

5 SEC. 9. PRINCIPLES FOR RISK COMMUNICATION.

6 (a) DESCRIPTION OF RISKS.—Except as provided in

7 section 4, in any major risk communication, regulatory

8 proposal or decision, report to Congress, or other document

9 that is intended to communicate the conclusions of a risk

10 assessment to the public, the head of the agency shall, to

11 the appropriate degree,—

12 (1) describe the hazard deemed to be harmful;

13 (2) describe the populations or natural resources

14 that are the subject of the risk assessment;

15 (3) explain the exposure scenarios used in the

16 risk assessment and provide an estimate of the cor17 responding population at risk and the likelihood of

18 such exposure scenarios;

19 (4) describe the nature and severity of the harm

20 that could plausibly occur; and

21 (5) briefly describe the major uncertainties in the

22 hazard identification, causation assessment, and ex23 posure assessment phases of the risk assessment and

24 their influence on the results of the assessment.
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1 (b) ESTIMATES OF RISK.—The estimate of risk shall,

2 to the maximum extent practicable, be presented as an over3 all estimate of risk, expressed as a probability distribution

4 that reflects variabilities and uncertainties in the analysis.

5 If a single point estimate of risk is provided, it must be

6 based on the most plausible inferences from the supporting

7 scientific information. Where quantitative estimates of the

8 range and distribution of risk estimates are not available,

9 a list of qualitative factors influencing the range of possible

10 risks shall be provided.

11 (c) COMPARISONS OF RISK.—The agency shall provide

12 a statement that places the nature and magnitude of risks

13 to human health, safety, and the environment being ana14 lyzed in context. Such statement shall include appropriate

15 comparisons with other risks, including those that are fa16 miliar to and routinely encountered by the general public.

17 (d) SUBSTITUTION RISKS.—When the agency provides

18 a risk assessment or risk characterization for a proposed

19 or final regulatory action, such assessment or characteriza20 tion shall include a statement of any significant substi21 tution risks to human health or safety, where the agency

22 is aware of such information, or it has been provided to

23 the agency.

24 (e) SUMMARIES OF RISK ESTIMATES.—(1) Where an

25 agency provides a summary of a risk assessment, the con-
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1 clusion must include a description of the risk that reflects

2 the information required in subsections (a), (b), (c), and

3 (d) of this section; and

4 (2) if a commenter provides a risk assessment carried

5 out in a manner consistent with the principles under sec6 tion 8 of this Act, and a summary of results of such risk

7 assessment, the agency shall present such summary in con8 nection with the presentation of the agency’s risk assess9 ment.

10 (f) REVIEW OF MAJOR RISK COMMUNICATIONS.—The

11 head of an agency shall ensure that major risk communica12 tions are peer-reviewed by appropriate scientific experts

13 and tested with representative groups of the public prior

14 to distribution of the major risk communication, to ensure

15 that such communications are scientifically accurate and

16 communicate the intended risk message without exaggera17 tion.

18 SEC. 10. REVIEW OF EXISTING RISK ASSESSMENTS.

19 (a) REGULATION.—Not later than 18 months after the

20 date of enactment of this Act, the President shall promul21 gate a final rule for the review and revision of risk assess22 ments previously prepared by, or on behalf of, an agency.

23 Such rule shall—

24 (1) provide procedures for the agency itself to

25 identify risk assessments that should be reviewed and
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1 revised to conform to the principles of risk assessment

2 in this Act or to accommodate new scientific informa3 tion;

4 (2) provide procedures for receiving and consid5 ering new information relevant to risk assessments

6 from any person;

7 (3) provide a mechanism whereby a person can

8 petition the agency to review and revise a risk assess9 ment because—

10 (A)(i) the risk assessment is inconsistent

11 with the principles set forth in section 8 of this

12 Act; or

13 (ii) the risk assessment does not take into

14 account material and significant new scientific

15 data or scientific understanding; and

16 (B) a revised risk assessment is likely to

17 provide a basis for reevaluating one or more

18 major rules currently in effect or one or more

19 major risk communications;

20 (4) provide for the creation of a permanent advi21 sory committee to each agency head that shall—

22 (A) consist of independent and external ex23 perts in risk assessment and in the substantive

24 scientific issues related to regulations under the
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1 purview of the agency, who are appointed pursu2 ant to the principles of section 8(h);

3 (B) review new information, risk assess4 ments, and petitions from the public regarding

5 review and revisions of risk assessments;

6 (C) recommend to the agency head for each

7 petition under subsection (a)(3)—

8 (i) whether a petition should be grant9 ed;

10 (ii) priorities for the review or revi11 sion; and

12 (iii) target dates for completion of the

13 review or revision; and

14 (D) evaluate the adequacy of the agency’s

15 review or revision of a risk assessment, with re16 spect to the principles in section 8 of this Act,

17 and prior to publication of the review or revi18 sion, provide recommendations to the agency

19 head.

20 (b) PUBLICATION OF RECOMMENDATIONS.—Rec21 ommendations provided to an agency head under sub22 sections (a)(4) (C) and (D) shall be published in the Federal

23 Register within 45 days of their transmittal to the agency

24 head, along with the formal response of the agency head.
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1 (c) COMPLETION OF AGENCY ACTION.—(1) If the agen2 cy head accepts the recommendation of the advisory com3 mittee provided under subsection (a)(4)(C), the agency

4 shall, to the maximum extent practicable, complete its re5 view or revision of the risk assessment within the time rec6 ommended by the advisory committee.

7 (2) An agency head may start or continue and envi8 ronmental management activity during the pendency of a

9 petition unless the petition reasonably indicates such action

10 would result in an emergency.

11 (d) JUDICIAL REVIEW.—Agency action with respect to

12 a petition that is substantially inconsistent with the rec13 ommendations provided by the advisory committee under

14 subsections (a)(4)(C)(i), (a)(4)(C)(ii), or (a)(4)(D) may be

15 judicially reviewed under any other applicable provision of

16 law.

17 SEC. 11. RISK ASSESSMENT AND PROGRAM PLANNING.

18 (a) IN GENERAL.—In exercising authority under, or

19 complying with, applicable laws protecting human health,

20 safety, or the environment, the head of an agency shall use

21 risk assessment to set priorities for the use of the resources

22 available under those laws, with the goals of—

23 (1) addressing preferentially the risks to human

24 health, safety, and the environment that the agency
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1 determines are the most serious risks that can be ad2 dressed in a cost-effective manner, and

3 (2) structuring agency actions to achieve

4 promptly the greatest overall net reduction in risks

5 with the private and public sector resources to be ex6 pended.

7 In identifying the most serious risks in paragraph (1), the

8 head of the agency shall consider, at a minimum, the likeli9 hood and severity of the hazard and the size of the popu10 lation and natural resources potentially affected.

11 (b) ANNUAL REPORT ON RISK ASSESSMENT PRIOR12 ITIES AND PROGRAM AGENDA.—In conjunction with the

13 April publication of the regulatory agenda required under

14 section 602 of title 5, the head of an agency that plans to

15 promulgate one or more major rules concerning human

16 health, safety, or the environment shall publish a report on

17 current risk assessment priorities of the agency to support

18 such regulatory agenda. Such report shall include—

19 (1) a prioritized list combining—

20 (A) the most serious risks that the agency

21 believes can be addressed in a cost-effective man22 ner through additional major rules or major risk

23 communication;

24 (B) any other risks that the agency is re25 quired by statute, court order, or consent decree
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1 to address through the promulgation of addi2 tional major rules or major risk communication;

3 and

4 (C) any risks that are to be re-assessed by

5 the agency pursuant to section 10 of this Act.

6 Such list shall rank risks on a comparative risk basis

7 to each other, to the extent practicable and without re8 gard to statutory, judicial, or administrative dead9 lines.

10 (2) a list of risk assessments and supporting as11 sessments related to the risks in paragraph (1), in12 cluding hazard identifications, causation assessments,

13 and exposure assessments, under preparation or for

14 which budgetary resources have been committed by the

15 agency;

16 (3) a brief summary of the relevant issues ad17 dressed or to be addressed by each assessment in para18 graph (2), and their relationship to the risks in para19 graph (1);

20 (4) an approximate schedule for completing each

21 listed assessment in paragraph (2);

22 (5) an identification of potential major rules in

23 the regulatory agenda, potential guidance, or other

24 potential agency actions supported or affected by each

25 assessment in paragraph (2), including any deadlines
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1 for such major rules pursuant to statute, court order,

2 or consent decree; and

3 (6) the name, address, and telephone number of

4 an agency official knowledgeable concerning each as5 sessment in paragraph (2).

6 The identification and ranking of risks in paragraph (1)

7 may be carried out on the basis of screening analyses, if

8 more complete information is not reasonably available.

9 SEC. 12. RISK ASSESSMENT AND BUDGETARY PRIORITIES.

10 (a) INCORPORATION OF RISK-BASED PRIORITIES INTO

11 BUDGETS AND PLANNING.—To the extent consistent with

12 other statutory requirements, the head of an agency shall

13 incorporate the priorities identified in section 11 into the

14 budget and planning activities of the agency by, in the

15 agency’s annual budget request to Congress—

16 (1) explicitly identifying how the agency’s re17 quested funds will be used to address the risks listed

18 in the most recent report under section 11(b)(1); and

19 (2) identifying any statutory, judicial, or ad20 ministrative obstacles to allocating agency resources

21 in accordance with the priorities established under

22 section 11(b)(1).

23 (b) RECOMMENDATION.—On April 1 of each year, the

24 agency head shall submit to Congress specific recommenda25 tions for repealing or modifying laws that would enable the
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1 agency to set priority among its activities in accordance

2 with the priorities established under section 11(b)(1).

3 SEC. 13. RISK ASSESSMENT IMPROVEMENT PROGRAMS.

4 (a) IMPROVING PEER REVIEW IN RISK ASSESS5 MENT.—The Director of the Office of Science and Tech6 nology Policy shall develop a systematic program to oversee

7 the use of, and quality of, peer review by agencies develop8 ing risk assessments pursuant to this Act.

9 (b) IMPROVING COMPARATIVE RISK ASSESSMENT.—

10 The Secretary of Energy, in consultation with the heads

11 of other agencies, shall direct a national program to foster

12 and improve comparative risk analysis as a tool in regu13 latory and environmental management decision making,

14 using, among other research performers, the Department of

15 Energy’s National Laboratories.

16 SEC. 14. JUDICIAL REVIEW.

17 Except as provided for in section 10(d), a risk assess18 ment, peer review, cost-benefit analysis, or certification pro19 vided for under this Act shall not be subject to judicial re20 view separate and apart from any final agency action to

21 which it relates, but shall be made part of the administra22 tive record for judicial review of any final agency action

23 to which it relates.