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103D CONGRESS

1ST SESSION H. R. 2910

To more fully and accurately inform the public concerning health, safety,

and environmental risks, to improve consistency in the presentation of

scientific information, and to enhance the scientific credibility of the

regulatory decisions of the Environmental Protection Agency.

IN THE HOUSE OF REPRESENTATIVES

AUGUST 6, 1993

Mr. MOORHEAD (for himself, Mr. BROWN of California, Mr. BLILEY, Mr.

OXLEY, Mr. HAYES, Mrs. LLOYD, Mr. WALKER, and MR. ZIMMER) introduced the following bill; which was referred jointly to the Committees on

Science, Space, and Technology and Energy and Commerce

A BILL

To more fully and accurately inform the public concerning

health, safety, and environmental risks, to improve consistency in the presentation of scientific information, and

to enhance the scientific credibility of the regulatory

decisions of the Environmental Protection Agency.

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 ‘‘Risk Communication

5 Act of 1993’’.
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1 SEC. 2. PURPOSES.

2 The purposes of this Act are—

3 (1) to present the public and Environmental

4 Protection Agency officials with the most scientif5 ically objective information concerning the nature

6 and magnitude of health, safety, and environmental

7 risks in order to provide for sound regulatory deci8 sions and public education;

9 (2) to provide for full consideration and discus10 sion of relevant data and potential methodologies;

11 (3) to require explanation of significant choices

12 in the risk assessment process which will allow for

13 better peer review and public understanding; and

14 (4) to improve consistency within the Environ15 mental Protection Agency in preparing risk assess16 ments and risk characterizations.

17 SEC. 3. EFFECTIVE DATE; APPLICABILITY; SAVINGS PROVI18 SIONS.

19 (a) EFFECTIVE DATE.—Except as otherwise specifi20 cally provided in this Act, the provisions of this Act shall

21 take effect 2 years after the date of enactment of this Act.

22 (b) APPLICABILITY.—(1) Except as provided in para23 graph (2), this Act applies to all risk assessments and risk

24 characterizations prepared by or on behalf of the Environ25 mental Protection Agency in connection with health, safe26 ty, and environmental risks.
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1 (2) This Act does not apply to risk assessments or

2 risk characterizations performed with respect to a situa3 tion that the Administrator considers to be an emergency.

4 (c) SAVINGS PROVISIONS.—Nothing in this Act shall

5 be construed to modify any statutory standard or require6 ment designed to protect health, safety, or the environ7 ment.

8 SEC. 4. PRINCIPLES FOR RISK ASSESSMENT.

9 (a) IN GENERAL.—The Administrator of the Envi10 ronmental Protection Agency shall apply the principles set

11 forth in subsection (b) when preparing risk assessments

12 in order to assure that such risk assessments and all of

13 their components are, to the maximum extent possible, sci14 entifically objective and inclusive of all relevant data. Dis15 cussions or explanations required under this section need

16 not be repeated in each risk assessment document as long

17 as there is a reference to the relevant discussion or expla18 nation in another agency document.

19 (b) PRINCIPLES.—The principles to be applied when

20 preparing risk assessments are the following:

21 (1) The Administrator shall explicitly distin22 guish scientific findings in risk assessments from

23 other considerations affecting the design and choice

24 of regulatory strategies.
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1 (2) The Administrator shall consider and dis2 cuss both negative and positive laboratory or epide3 miological data of sufficient quality when presenting

4 assessments of human health risks. Where conflicts

5 among such data appear to exist, the assessment

6 shall include discussion of possible reconciliation of

7 conflicting information, which may include dif8 ferences in study designs, comparative physiology,

9 routes of exposure, bioavailability, pharmacokinetics,

10 and any other relevant factor.

11 (3) Where the risk assessment process involves

12 selection of any significant assumption, inference, or

13 model the Administrator shall (A) present a rep14 resentative list and explanation of plausible and al15 ternative assumptions, inferences, or models; (B) ex16 plain the basis for any choices; and (C) identify any

17 policy or value judgments. The Administrator shall

18 also indicate the extent to which any significant

19 model has been validated by or conflicts with empiri20 cal data.

21 SEC. 5. PRINCIPLES FOR RISK CHARACTERIZATION.

22 In characterizing risk in any risk assessment docu23 ment, regulatory proposal or decision, report to Congress,

24 or other document which is made available to the public,

25 the Administrator shall comply with each of the following:
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1 (1) The Administrator shall characterize the

2 populations or natural resources at risk. If a numer3 ical estimate of risk is provided, the departments

4 and agencies shall, to the extent feasible, provide the

5 best estimate or estimates for the populations or

6 natural resources at risk, given the information

7 available to the Administrator, along with a state8 ment of the reasonable range of scientific uncer9 tainty. In addition to the best estimate, the Adminis10 trator may present plausible upper-bound or con11 servative estimates in conjunction with plausible

12 lower bounds estimates. Where appropriate, the Ad13 ministrator may present, in lieu of a single best esti14 mate, multiple estimates based on assumptions, in15 ferences, or models which are equally plausible,

16 given current scientific understanding.

17 (2) The Administrator shall explain the range

18 of exposure scenarios used in any risk assessment,

19 and, to the extent feasible, provide a statement of

20 the size of the corresponding population at risk and

21 the likelihood of such exposure scenarios.

22 (3) To the extent feasible, the Administrator

23 shall provide appropriate comparisons with estimates

24 of other risks, including those that are familiar to

25 and routinely encountered by the general public.
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1 (4) When the Administrator provides a risk as2 sessment or risk characterization for proposed and

3 final regulatory actions, such assessment or charac4 terization shall include a statement of any known

5 and significant substitution risks.

6 (5) In any case in which the Administrator pro7 vides a public comment period with respect to a risk

8 assessment or regulation, and a commenter provides

9 a risk assessment and summary of results that is

10 consistent with the principles and the guidance pro11 vided under this Act, the Administrator shall present

12 the summary of results of such risk assessment in

13 connection with the presentation of the Environ14 mental Protection Agency’s risk assessment (if any)

15 or regulation.

16 SEC. 6. GUIDANCE, PLAN FOR ASSESSING NEW INFORMA17 TION, AND REPORT.

18 (a) GUIDANCE.—Within 18 months after the date of

19 enactment of this Act, the Administrator shall issue guid20 ance consistent with the risk assessment and characteriza21 tion principles stated in sections 4 and 5 and shall provide

22 a format for summarizing risk assessment results.

23 (b) ADDITIONAL SUBJECTS ADDRESSED.—In addi24 tion to including the principles set forth in sections 4 and

25 5, the guidance issued under this section shall include
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1 guidance on at least the following subjects: interspecies

2 scaling factors; use of different types of dose-response

3 models; thresholds; definitions, use, and interpretations of

4 the maximum tolerated dose; weighting of positive and

5 negative findings from sensitive species; evaluation of be6 nign tumors, and evaluation of different health endpoints.

7 (c) PLAN.—Within 2 years after the date of enact8 ment of this Act, the Administrator shall publish a plan

9 to review and revise any risk assessment with respect to

10 which the Environmental Protection Agency determines

11 there is significant new information or methodologies

12 available that could significantly alter the prior results of

13 the risk assessment. The plan shall provide procedures for

14 receiving and considering new information and risk assess15 ments from the public. The plan may set priorities for re16 view and revision of risk assessments based on factors the

17 Administrator considers appropriate.

18 (d) REPORT.—Within 3 years after the enactment of

19 this Act, the Administrator shall provide a report to the

20 Congress evaluating the policy and value judgments of the

21 type identified under paragraph (3) of section 4 which are

22 made by the Administrator in risk assessments performed

23 for programs under the Toxic Substances Control Act and

24 the effect these judgments have on the regulatory deci25 sions of such programs.
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1 (e) PUBLIC COMMENT AND CONSULTATION.—The

2 guidance, plan and report under this section, shall be de3 veloped after notice and opportunity for public comment

4 and in consultation with the EPA Science Advisory Board,

5 representatives of appropriate State agencies, and such

6 other departments and agencies, offices, organizations, or

7 persons as the Administrator considers advisable.

8 (f) REVIEW.—Guidance promulgated under this sec9 tion shall be reviewed by the Administrator at least every

10 4 years in accordance with subsection (d).

11 SEC. 7. DEFINITIONS.

12 For purposes of this Act:

13 (1) The term ‘‘risk assessment’’ means the

14 process of identifying hazards and quantifying or de15 scribing the degree of risk they pose for exposed in16 dividuals, populations, or resources. It also refers to

17 the document containing the explanation of how the

18 assessment process has been applied to an individual

19 substance, activity, or condition.

20 (2) The term ‘‘risk characterization’’ means

21 that element of a risk assessment that involves pres22 entation of the degree of risk in any regulatory pro23 posal or decision, report to Congress, or other docu24 ment which is made available to the public. The

25 term includes discussions of uncertainties, conflict-
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1 ing data, estimates, extrapolations, inferences, and

2 opinions.

3 (3) The term ‘‘best estimate’’ means an esti4 mate based on (A) central estimates of risk using

5 the most unbiased assumptions and models, (B) an

6 approach which combines multiple estimates based

7 on different scenarios and weighs the probability of

8 each scenario or (C) any other methodology designed

9 to provide the most unbiased representation of the

10 most plausible level of risk, given the current sci11 entific information available to the Administrator.

12 (4) The term ‘‘negative data’’ means data indi13 cating that under certain conditions a given sub14 stance or activity did not induce an adverse effect.

15 (5) The term ‘‘substitution risk’’ means a po16 tential increased risk to human health, safety, or the

17 environment from a regulatory option designed to

18 decrease other risks.

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