II

104TH CONGRESS

1ST SESSION 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.

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

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,

3 SECTION. 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Department of Energy

5 Risk Management Act of 1995.’’

6 SEC. 2. TABLE OF CONTENTS.

Sec. 1. Short title.

Sec. 2. Table of contents.

Sec. 3. Definitions.
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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.

1 SEC. 3. DEFINITIONS.

2 In this Act:

3 (1) BEST ESTIMATE.—The term ‘‘best esti4 mate’’ means an estimate that, to the extent feasible

5 and scientifically appropriate, provides the most un6 biased representation of the most plausible level of

7 risk, given the most reliable current scientific infor8 mation available to the Department.

9 (2) COSTS.—The term ‘‘costs’’ includes the di10 rect and indirect costs to the United States Govern11 ment, to State and local governments, and to the

12 private sector, of implementing and complying with

13 a regulatory action.

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

15 means the Department of Energy.

16 (4) ENVIRONMENTAL RESTORATION ACTIV17 ITY.—The term ‘‘environmental restoration activity’’

18 means a removal or remedial action conducted by

19 the Department at nuclear facilities under the con20 trol of the Department, including the Savannah

21 River Site, Hanford Nuclear Reservation, Nevada

22 Test Site, Rocky Flats Plant, Idaho National Engi-
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1 neering Laboratory, Los Alamos National Labora2 tory, Lawrence Livermore National Laboratory, and

3 any other such facility.

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

5 substance, activity, or condition which potentially

6 poses a risk to human health or safety or the envi7 ronment based on empirical data, measurements, or

8 testing showing that it has caused significant ad9 verse effects at some levels of dose or exposure not

10 necessarily relevant to level of dose or exposure that

11 are normally expected to occur.

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

13 realistic and scientifically probable.

14 (7) RISK ASSESSMENT.—The term ‘‘risk assess15 ment’’ means—

16 (A) the process of identifying hazards and

17 quantifying or describing the degree of toxicity,

18 exposure, or other risk they pose for demon19 strably exposed individuals, populations, or re20 sources; or

21 (B) the document containing the expla22 nation of how the risk assessment process has

23 been applied to an individual substance, activ24 ity, or condition.
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1 (8) RISK CHARACTERIZATION.—The term ‘‘risk

2 characterization’’—

3 (A) means the element of a risk assess4 ment that involves presentation of the degree of

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

6 of decision, report to Congress, or other docu7 ment that is made available to the public; and

8 (B) includes discussions of uncertainties,

9 conflicting data, estimates, extrapolations, in10 ferences, justifications, and opinions.

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

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

13 (10) SUBSTITUTION RISK.—The term ‘‘substi14 tution risk’’ means a potential increased risk to

15 human health, safety, or the environment from a

16 regulatory option designed to decrease other risks.

17 SEC. 4. APPLICABILITY; PRINCIPLES FOR RISK ASSESS18 MENT, RISK CHARACTERIZATION, AND COM19 MUNICATION.

20 (a) APPLICABILITY.—

21 (1) IN GENERAL.—Except as provided in para22 graph (2), this Act applies to all risk assessments

23 and risk characterizations prepared by, or on behalf

24 of, the Department as part of an environmental res25 toration activity.
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1 (2) EXCEPTIONS.—

2 (A) EMERGENCIES AND SCREENING ANAL3 YSES.—This Act does not apply to risk assess4 ments or risk characterizations performed with

5 respect to either of the following:

6 (i) A situation that the Secretary de7 termines to be an emergency.

8 (ii) A screening analysis, including a

9 screening analysis for purposes of product

10 regulation, product reregistration, or

11 premanufacturing notices.

12 (B) TREATMENT OF ANALYSIS AS SCREEN13 ING ANALYSIS.—No analysis shall be treated as

14 a screening analysis for purposes of subpara15 graph (A) if the results of the analysis is

16 used—

17 (i) as the basis for imposing restrictions on

18 substances or activities; or

19 (ii) to characterize a positive finding of

20 risks from substances or activities in any De21 partmental document made available to the gen22 eral public.

23 (b) PRINCIPLES FOR RISK ASSESSMENT.—

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

25 the principles set forth in paragraph (2) when pre-
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1 paring a risk assessment in order to ensure that the

2 risk assessment distinguishes scientific findings from

3 other considerations and are, to the maximum extent

4 feasible, scientifically objective, unbiased, and inclu5 sive of all relevant data. Discussions or explanations

6 required under this section need not be repeated in

7 each risk assessment document as long as there is

8 a reference to the relevant discussion or explanation

9 in another agency document.

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

11 when preparing risk assessments are as follows:

12 (A) HUMAN HEALTH RISKS.—When as13 sessing human health risks in connection with

14 a risk assessment, the Secretary shall consider

15 and discuss both laboratory and epidemiological

16 data of sufficient quality that finds, or fails to

17 find, a correlation between health risks and a

18 potential toxin or activity. When conflicts

19 among the data appear to exist or when animal

20 data are used as a basis to assess human

21 health, the assessment shall include discussion

22 of possible reconciliation of conflicting data.

23 (B) SIGNIFICANT ASSUMPTIONS.—When a

24 risk assessment involves selection of any signifi-
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1 cant assumption, inference, or model, the Sec2 retary shall—

3 (i) describe the plausible alternative

4 assumptions, inferences, or models;

5 (ii) explain the basis for any choices

6 among the assumptions, inferences, or

7 models;

8 (iii) identify any policy or value judg9 ments involved in choosing from among the

10 alternative assumptions, inferences, or

11 models;

12 (iv) fully describe any model used in

13 the risk assessment and make explicit the

14 assumptions incorporated in the model;

15 and

16 (v) indicate the extent to which any

17 significant model has been validated by, or

18 conflicts with, empirical data.

19 (c) PRINCIPLES FOR RISK CHARACTERIZATION AND

20 COMMUNICATION.—When characterizing risk, the Sec21 retary shall comply with each of the following:

22 (1) ESTIMATES OF RISK.—

23 (A) BEST ESTIMATE.—The Secretary shall

24 describe the populations or natural resources

25 that are the subject of the risk characterization.
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1 If a numerical estimate of risk is provided, the

2 Secretary shall, to the extent feasible and sci3 entifically appropriate, provide—

4 (i) the best estimate for the specific

5 populations or natural resources that are

6 the subject of the characterization (based

7 on the information available to the Depart8 ment); and

9 (ii) a statement of the reasonable

10 range of scientific uncertainties.

11 (B) MULTIPLE BEST ESTIMATES.—In ap12 propriate circumstances the Secretary may

13 present, in lieu of a single best estimate, mul14 tiple estimates based on assumptions, infer15 ences, or models that are equally plausible,

16 given current scientific understanding.

17 (C) PLAUSIBLE UPPER-BOUND OR CON18 SERVATIVE ESTIMATES.—In addition to a best

19 estimate or estimates, the Secretary may

20 present plausible upper-bound or conservative

21 estimates in conjunction with plausible lower

22 bounds estimates.

23 (D) DESCRIPTIONS OF DISTRIBUTION AND

24 PROBABILITY.—To the extent practicable and

25 appropriate, the Secretary shall provide descrip-
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1 tions of the distribution and probability of risk

2 estimates to reflect differences in exposure vari3 ability in populations and uncertainties.

4 (2) EXPOSURE SCENARIOS.—The Secretary

5 shall explain the exposure scenarios used in any risk

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

7 statement of the size of the corresponding popu8 lation at risk and the likelihood of the exposure sce9 narios.

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

11 Secretary shall provide a statement that places the

12 nature and magnitude of risks to human health in

13 context. The statement shall include appropriate

14 comparisons with estimates of risks that are familiar

15 to and routinely encountered by the general public

16 as well as other risks.

17 (4) SUBSTITUTION RISKS.—When the Secretary

18 provides a risk assessment or risk characterization

19 for an environmental restoration activity, the assess20 ment or characterization shall include a statement of

21 any significant substitution risks to human health,

22 where information on such risks has been provided

23 to the Secretary.
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1 SEC. 5. REGULATION; PLAN FOR ASSESSING NEW INFORMA2 TION.

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

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

5 regulation implementing for the Department the risk as6 sessment and risk characterization principles set forth in

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

8 summarizing risk assessment results.

9 (b) PLAN.—

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

11 of enactment of this Act, the Secretary shall promul12 gate a plan to review and revise any risk assessment

13 prepared by or on behalf of the Secretary and com14 pleted prior to the promulgation of the plan, if the

15 Secretary determines that significant new informa16 tion or methodologies are available that could signifi17 cantly alter the results of the prior risk assessment

18 or that there are other appropriate reasons why such

19 a review and revision should be conducted.

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

21 shall—

22 (A) provide procedures for receiving and

23 considering new information and risk assess24 ments from the public;
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1 (B) set priorities for review and revision of

2 risk assessments based on such factors as the

3 Secretary considers appropriate; and

4 (C) include a process by which members of

5 the public may petition the Secretary for review

6 of particular assessments.

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

8 60 days after receiving a petition under paragraph

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

10 agreeing or declining to review the risk assessment

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

12 for the decision.

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

14 agrees to review a risk assessment, the Department

15 shall complete its review within 180 days, unless the

16 Secretary agrees in writing that an extension not to

17 exceed 60 days is necessary in view of limitations on

18 Department resources.

19 (c) PUBLIC COMMENT AND CONSULTATION.—The

20 regulation and plan, under this sections shall be developed

21 after notice and opportunity for public comment.

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

23 shall review, and when appropriate, revise the regulation

24 and plan published under this section.
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1 SEC. 6. REQUIREMENTS FOR ENVIRONMENTAL RESTORA2 TION ACTIVITY.

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

4 of decision to conduct an environmental restoration activ5 ity shall include a clear and concise statement that—

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

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

8 environment to be addressed by the environmental

9 restoration activity;

10 (2) compares the human health or environ11 mental risks to be addressed by the environmental

12 restoration activity to other risks chosen by the Sec13 retary, including—

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

15 Department or another Federal agency; and

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

17 to the general public;

18 (3) describes and, to the extent practicable,

19 quantifies any known, plausible substitution risks

20 when information on such risks has been provided to

21 the Department;

22 (4) estimates—

23 (A) the costs to the United States Govern24 ment of conducting the environmental restora25 tion activity; and
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1 (B) the benefits of the environmental res2 toration activity, including both quantifiable

3 measures of costs and benefits, to the fullest ex4 tent that they can be estimated, and qualitative

5 measures that are difficult to quantify; and

6 (5) contains a certification by the Secretary

7 that—

8 (A) the analyses performed under para9 graphs (1), (2), and (3) are, to the maximum

10 extent practicable—

11 (i) based on the best reasonably ob12 tainable scientific and economic informa13 tion; and

14 (ii) objective and unbiased;

15 (B) the environmental restoration activity

16 is likely to significantly reduce the human

17 health, safety, or environmental risks to be ad18 dressed;

19 (C) no environmental restoration activity

20 alternative that would achieve an equivalent re21 duction in risk in a more cost-effective manner

22 is permitted under the Comprehensive Environ23 mental Response, Compensation, and Liability

24 Act of 1980 (42 U.S.C. 9601 et seq.); and
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1 (D) the environmental restoration activity

2 is likely to produce benefits to human health or

3 the environment that will justify the costs to

4 the United States Government.

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

6 certification with respect to 1 or more of the matters de7 scribed in subsection (a), the Secretary shall identify the

8 matters for which certification cannot be made, and shall

9 include a statement of the reasons why the certification

10 cannot be made in the plan, assessment, or record of deci11 sion. Not later than March 1 of each year, the Secretary

12 shall submit a report to Congress identifying the environ13 mental restoration activities conducted during the previous

14 calendar year for which complete certification was not

15 made, and summarizing the reasons therefore.

16 SEC. 7. ENVIRONMENTAL RESTORATION PRIORITIES.

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

18 prioritize the use of the resources available to conduct res19 toration activities to address the risks to human health,

20 safety and the environment that—

21 (1) the Secretary determines are the most seri22 ous; and

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

24 with the goal of achieving the greatest overall net re-
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1 duction in risks with the public and private sector

2 resources to be expended.

3 (b) DETERMINING MOST SERIOUS RISKS.—In identi4 fying the sources of the most serious risks under sub5 section (a), the Secretary shall consider, at a minimum—

6 (1) the plausible likelihood and severity of the

7 effect; and

8 (2) the plausible number and groups of individ9 uals potentially affected.

10 (c) INCORPORATION OF RISK-BASED PRIORITIES

11 INTO BUDGET AND PLANNING.—The Secretary shall in12 corporate the priorities identified in subsection (a) into the

13 Department’s budget, strategic planning, and research ac14 tivities by—

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

16 to Congress—

17 (A) identifying which risks that the Sec18 retary has determined are the most serious and

19 can be addressed in a cost-effective manner

20 under subsection (a), and the basis for that de21 termination;

22 (B) explicitly identifying how the Depart23 ment’s requested funds will be used to address

24 those risks; and
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1 (C) identifying any statutory, regulatory,

2 or administrative obstacles to allocating Depart3 mental resources in accordance with the prior4 ities established under subsection (a); and

5 (D) explicitly considering the requirements

6 of subsection (a) when preparing the Depart7 ment’s environmental management plan or

8 other strategic plan and providing an expla9 nation of how the agenda or plan reflects those

10 requirements and the comparative risk analysis

11 when publishing any such agenda or strategic

12 plan.

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

14 Secretary shall submit to Congress specific recommenda15 tions for repealing or modifying laws that would better en16 able the Department to prioritize its activities to address

17 the risks to human health, safety, and the environment

18 that are the most serious and can be addressed in a cost19 effective manner consistent with the requirements of

20 subsection (a).

21 SEC. 9. SAVINGS PROVISIONS.

22 Nothing in this Act shall be construed to—

23 (1) modify any statutory standard or require24 ment designed to protect health, safety, or the envi25 ronment;
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1 (2) preclude the consideration of any data or

2 the calculation of any estimate to more fully describe

3 risk or provide examples of scientific uncertainty or

4 variability; or

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

6 other proprietary information.

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