II

103D CONGRESS

2D SESSION S. 2472

To require the Administrator of the Environmental Protection Agency to

issue rules governing risk assessments, and for other purposes.

IN THE SENATE OF THE UNITED STATES

SEPTEMBER 28 (legislative day, SEPTEMBER 12), 1994

Mr. LOTT introduced the following bill; which was read twice and referred to

the Committee on Environment and Public Works

A BILL

To require the Administrator of the Environmental Protection Agency to issue rules governing risk assessments,

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 ‘‘Sound Science in Risk

5 Assessment Act’’.

6 SEC. 2. FINDINGS.

7 Congress finds that—

8 (1) as of the date of enactment of this Act, ap9 proximately $140,000,000,000 per year, over 2 per10 cent of the annual gross national product of the
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1 United States, is being spent on environmental com2 pliance, and the amount being spent is expected to

3 rise substantially;

4 (2) unfunded Federal environmental mandates

5 are straining the budgets of State and local govern6 ments and may diminish the financial resources

7 available for other important public programs and

8 services;

9 (3) an environmental risk assessment developed

10 by the Environmental Protection Agency is often

11 perceived as not containing sufficient scientific ob12 jectivity, absence of bias, clarity, or consistency to

13 serve as a sound and credible basis for protecting

14 public health and safety, determining environmental

15 protection needs and priorities, making regulatory

16 decisions, or allocating limited financial resources;

17 and

18 (4) Executive Order No. 12866 (5 U.S.C. 601

19 note; relating to regulatory planning and review) re20 quires a decision by a Federal agency to be based

21 on the best reasonably obtainable scientific and tech22 nical information, and embodies the principle of

23 openness in government.
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1 SEC. 3. RISK ASSESSMENT PRINCIPLES.

2 In accordance with this Act, the Administrator of the

3 Environmental Protection Agency (referred to in this Act

4 as the ‘‘Administrator’’) shall develop rules, proposed

5 rules, and review procedures that provide that—

6 (1) risk assessments shall be—

7 (A) consistent;

8 (B) of high technical quality;

9 (C) scientifically objective; and

10 (D) unbiased; and

11 (2) significant uncertainties regarding facts,

12 scientific knowledge, the validity of analytical tech13 niques, or numerical risk estimates are clearly dis14 closed in terms readily understandable to the public.

15 SEC. 4. PROPOSED RULES.

16 (a) PROPOSED GENERAL RULES.—Not later than

17 180 days after the date of enactment of this Act, the Ad18 ministrator shall issue, in accordance with section 3, pro19 posed rules that—

20 (1) set forth uniform general procedures gov21 erning risk assessments conducted by the Environ22 mental Protection Agency; and

23 (2) incorporate, to the extent the Administrator

24 considers advisable, relevant guidelines existing prior

25 to the issuance of the proposed rules.
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1 (b) DISTINCTIVE APPROACHES, TECHNIQUES, OR

2 METHODOLOGIES.—

3 (1) PROPOSED DISTINCTIVE RULES.—Not later

4 than 1 year after the date of enactment of this Act,

5 the Administrator shall issue, in accordance with

6 section 3, proposed rules to govern use of a distinc7 tive type of risk assessment approach, technique, or

8 methodology. The rules shall specify the minimum

9 standard for a risk assessment approach that is ap10 propriate for the scale of the problem to be assessed,

11 the level of scientific understanding, and the avail12 able data.

13 (2) USE OF DISTINCTIVE APPROACHES, TECH14 NIQUES, OR METHODOLOGIES.—In accordance with

15 section 3, the Administrator shall determine the dis16 tinctive types of risk assessment approaches, tech17 niques, or methodologies for which a proposed rule

18 will be issued pursuant to paragraph (1). The Ad19 ministrator shall include risk assessment approaches,

20 techniques, or methodologies that utilize epidemio21 logical data. In the case of an approach, a technique,

22 or a methodology not in use prior to the date of en23 actment of this Act, the Administrator shall develop

24 rules to govern the distinctive use of the approach,

25 technique, or methodology before using the ap-
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1 proach, technique, or methodology in a risk assess2 ment.

3 SEC. 5. RISK ASSESSMENT REVIEW.

4 (a) REVIEW PROCEDURES.—Not later than 180 days

5 after the date of enactment of this Act, the Administrator

6 shall issue procedures, in accordance with section 3, for

7 the review and revision of a risk assessment completed

8 prior to the enactment of this Act or the issuance of final

9 risk assessment rules under section 6.

10 (b) BASIS FOR REVIEW.—

11 (1) CRITERIA FOR REVIEW.—A review of a risk

12 assessment in accordance with the procedures issued

13 under subsection (a) shall be conducted by the Ad14 ministrator on the written petition of a person if—

15 (A) the risk assessment is inconsistent

16 with the principles set forth in section 3;

17 (B) the risk assessment is inconsistent

18 with a rule issued under section 4; or

19 (C) the risk assessment does not take into

20 account significant new scientific data or sci21 entific understanding.

22 (2) RESPONSE TO PETITION.—Not later than

23 60 days after receiving a petition under paragraph

24 (1), the Administrator shall respond to the petition

25 by agreeing or declining to review the risk assess-
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1 ment referred to in the petition, and shall state the

2 basis for the decision.

3 (3) JUDICIAL REVIEW.—Denial of a petition by

4 the Administrator shall be subject to judicial review

5 in accordance with chapter 7 of title 5, United

6 States Code.

7 SEC. 6. FINAL RULES.

8 (a) NOTICE AND COMMENT PROCEDURES.—Not later

9 than 270 days after the date of enactment of this Act,

10 in accordance with section 553 of title 5, United States

11 Code, the Administrator shall publish in the Federal Reg12 ister a list of risk assessment approaches, techniques, or

13 methodologies for which a rule shall be issued under sub14 section (b), after taking into account comments by the

15 public, Federal agencies, States, municipalities, experts in

16 the scientific community, and such other persons as the

17 Administrator considers advisable.

18 (b) ISSUANCE OF FINAL RULES.—Not later than 1

19 year after the date of enactment of this Act, in accordance

20 with sections 3 and 4 of this Act and section 553 of title

21 5, United States Code, the Administrator shall publish in

22 the Federal Register final rules, after taking into account

23 comments by the public, Federal agencies, States, munici24 palities, experts in the scientific community, and such

25 other persons as the Administrator considers advisable.
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1 SEC. 7. PRIVATE RIGHTS OF ACTION PRECLUDED.

2 Nothing in this Act shall give rise to a private right

3 of action seeking damages against the United States or

4 against an agency or instrumentality of the United States.

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