I

103D CONGRESS

2D SESSION H. R. 4306

To establish a comprehensive risk assessment program within the

Environmental Protection Agency, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

APRIL 28, 1994

Mr. KLEIN (for himself, Mr. ZIMMER, Mr. BROWN of California, Mr. STUDDS,

Mrs. LLOYD, Mr. SYNAR, Mr. STENHOLM, Mr. VALENTINE, Mrs.

MORELLA, Mr. PALLONE, Mr. ROEMER, Mr. SWETT, Mr. DEAL, Ms.

EDDIE BERNICE JOHNSON of Texas, Mrs. THURMAN, and Mr. BOEHLERT) introduced the following bill; which was referred to the Committee

on Science, Space, and Technology

A BILL

To establish a comprehensive risk assessment program within

the Environmental Protection Agency, 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 ‘‘Risk Assessment Im5 provement Act of 1994’’.

6 SEC. 2. FINDINGS.

7 The Congress finds the following:
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1 (1) Risk assessment is a scientific procedure for

2 evaluating and quantifying the magnitude and sever3 ity of environmental hazards which may threaten

4 human health and ecological resources and is an im5 portant tool for informed policy and decisionmaking.

6 (2) Research provides the scientific foundation

7 for risk assessment, yet risk assessment research is

8 fragmented within and across the Environmental

9 Protection Agency and the Federal agencies, com10 plicating the setting of risk assessment research pri11 orities.

12 (3) The risk assessment practices of the Envi13 ronmental Protection Agency and other Federal

14 agencies must be significantly improved if risk as15 sessment is to provide maximum utility to

16 decisionmakers.

17 (4) The Environmental Protection Agency and

18 other Federal agencies need to improve the degree

19 and timeliness with which they incorporate scientific

20 advances into their risk assessment methods and

21 guidelines.

22 (5) The risk assessment activities of the Envi23 ronmental Protection Agency and other Federal

24 agencies are poorly coordinated, such that risk as-
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1 sessment procedures and outcomes within and across

2 Federal agencies are often incompatible.

3 (6) The data gaps, variability, and uncertainties

4 inherent in risk assessments are neither adequately

5 communicated by risk assessors nor clearly recog6 nized by decisionmakers and the public.

7 (7) Improving the reliability, accuracy, and va8 lidity of risk assessments will require additional re9 search to fill data gaps and to improve risk assess10 ment methodologies, including comparative risk

11 analysis methodologies.

12 (8) The Environmental Protection Agency and

13 other Federal agencies require a more effective

14 mechanism to ensure scientific peer review of risk

15 assessments.

16 (9) There is a lack of broadly skilled risk asses17 sors and insufficient resources to provide multidisci18 plinary training and curricula needed for risk asses19 sors and decisionmakers.

20 (10) There is no common mechanism for col21 lecting risk data, for disseminating such data to all

22 relevant Federal agencies, and for updating risk as23 sessment methodologies.

24 SEC. 3. PURPOSES.

25 It is the purpose of this Act—
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1 (1) to establish a Risk Assessment Program in

2 the Environmental Protection Agency that—

3 (A) develops and periodically revises risk

4 assessment guidelines within the Environmental

5 Protection Agency which reflect scientific ad6 vances;

7 (B) oversees the implementation of the

8 guidelines and ensures consistent application of

9 the guidelines throughout the Agency;

10 (C) provides for appropriate scientific peer

11 review of the risk assessment guidelines and

12 risk assessments;

13 (D) identifies and conducts research need14 ed to advance the science of risk assessment;

15 and

16 (E) develops risk characterization guidance

17 and oversees its implementation in order to

18 communicate the full range of risks and uncer19 tainties;

20 (2) to establish a pilot program on comparative

21 risk analysis; and

22 (3) to establish an interagency coordinating

23 process within the Office of Science and Technology

24 Policy, acting through the National Science Tech-
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1 nology Council, to promote more compatible risk as2 sessment procedures across Federal agencies.

3 SEC. 4. ESTABLISHMENT OF RISK ASSESSMENT PROGRAM.

4 (a) ESTABLISHMENT.—There is established a Risk

5 Assessment Program in the Environmental Protection

6 Agency.

7 (b) DIRECTOR; CONDUCT OF PROGRAM.—The Ad8 ministrator shall appoint a Director of the Program, who

9 has appropriate expertise in risk assessment, and acting

10 through the Director, shall conduct the activities of the

11 Environmental Protection Agency under the Program as

12 provided in this Act.

13 (c) SCIENTIFIC PEER REVIEW.—The Director shall

14 develop a process to conduct scientific peer review of all

15 risk assessment guidelines developed by the Environ16 mental Protection Agency. The Director shall ensure that

17 the guidelines provide for an independent scientific peer

18 review process for risk assessment activities that contrib19 utes to the quality and objectivity of risk assessment. The

20 Director may award grants and enter into contracts for

21 the conduct of scientific peer review. Not later than 120

22 days after the date of the enactment of this Act, the Ad23 ministrator shall submit to the Congress a report on a

24 plan for conducting scientific peer review described in this
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1 subsection. The Administrator shall report to the Congress

2 whenever significant modifications are made to the plan.

3 (d) ADVICE TO THE ADMINISTRATOR.—The Director

4 shall regularly provide to the Administrator advice and

5 recommendations on the conduct of risk assessment, re6 search needs, and the development of risk assessment

7 guidelines within the Environmental Protection Agency.

8 (e) USE OF SERVICES; CONSULTATION.—In conduct9 ing activities under the Program, the Director may use

10 the services of consultants, establish advisory boards, and,

11 to the extent practicable, consult with the Science Advi12 sory Board established under the Environmental Re13 search, Development, and Demonstration Authorization

14 Act of 1978, State and local government agencies, appro15 priate professional groups, and such representatives (with

16 expertise in risk assessment) of industry, universities, ag17 riculture, labor, consumers, conservation organizations,

18 and other public interest groups, organizations, and indi19 viduals as appropriate.

20 (f) GUIDELINE DEVELOPMENT.—

21 (1) IN GENERAL.—The Director shall regularly

22 and systematically develop, issue, and, not less than

23 every 3 years for each guideline, review the need to

24 update risk assessment guidelines consistent with

25 the requirements of paragraph (2) that establish
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1 methods for conducting scientifically sound risk as2 sessments. Whenever the Director determines that

3 there has been a significant scientific advancement

4 which warrants the updating of a guideline or that

5 a specific risk assessment need has arisen which is

6 not addressed by a guideline, the Director, after ap7 propriate scientific peer review, shall provide interim

8 guidance on the use of the guidelines and the con9 duct of the risk assessments.

10 (2) CONTENTS.—The risk assessment guide11 lines shall include the following:

12 (A) An explanation of the scope and appli13 cability of the guidelines, including appropriate

14 limitations or restrictions on their use, and an

15 identification of appropriate Offices at the En16 vironmental Protection Agency to contact for

17 further information on risk assessment.

18 (B) Criteria for accepting and evaluating

19 data, and a complete description of any mathe20 matical models or other assumptions used in

21 the risk assessment.

22 (C) Criteria for selecting default options

23 based upon explicitly stated science policy

24 choices and consideration of relevant scientific

25 information. The guidelines should set forth the
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1 justification and validation for the default op2 tions, and provide criteria for departing from or

3 substituting any such default option.

4 (D) An evaluation of the technical jus5 tification and the degree of conservatism each

6 default option imposes upon the risk assess7 ment.

8 (E) Criteria for using iterative or tiered

9 approaches to the risk assessment, with increas10 ing levels of effort and data requirements based

11 on the need for accuracy of the risk estimate.

12 (F) Criteria for conducting formal uncer13 tainty analysis during the course of the risk as14 sessment, and an explanation of the data needs

15 for such analysis.

16 (G) Criteria for risk characterization in

17 order to facilitate accurate interpretation and

18 appropriate use of the assessment by

19 decisionmakers.

20 (H) Effective methods for reporting risk

21 assessment, including formats which clearly

22 identify and distinguish sources of uncertainty

23 and variability in the risk assessment.

24 (3) REPORT.—Not later than 180 days after

25 the date of the enactment of this Act, the Adminis-
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1 trator shall submit to the Congress a report on risk

2 assessment guidelines which the Environmental Pro3 tection Agency has developed, issued, and updated

4 and on the schedule within the Environmental Pro5 tection Agency for reviewing the guidelines. The Ad6 ministrator shall report to the Congress whenever

7 the guidelines are updated.

8 (g) USE OF GUIDELINES.—

9 (1) IN GENERAL.—The Director shall oversee

10 the use of risk assessment guidelines by the Pro11 gram and Regional Offices of the Environmental

12 Protection Agency in the conduct of any risk assess13 ments that may be conducted by the Environmental

14 Protection Agency. The Director shall seek to ensure

15 consistency in the use of such guidelines, to the ex16 tent such consistency is appropriate in application to

17 various environmental media or environmental haz18 ards. The Director shall supervise the use of such

19 guidelines within the Environmental Protection

20 Agency to ensure that risk assessment is, to the ex21 tent permitted by law, conducted, applied, and prac22 ticed throughout the Offices of the Agency in ac23 cordance with the guidelines and that advances

24 made in one area of risk assessment are applied as
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1 appropriate within the Agency to other areas of risk

2 assessment.

3 (2) DEPARTURES FROM GUIDELINES.—A Pro4 gram or Regional Office of the Environmental Pro5 tection Agency may not depart from a guideline un6 less the departure is consistent with guidance pro7 vided by the Director under subsection (f)(1). Any

8 interested person may petition the Director for re9 view of a decision by a Program or Regional Office

10 to depart from a guideline. Within 120 days after

11 receiving the petition, the Director shall, using ap12 propriate scientific peer review, review the decision

13 to determine whether the departure was warranted

14 and whether to issue interim guidance under sub15 section (f)(1).

16 (h) RISK CHARACTERIZATION.—

17 (1) IN GENERAL.—The Director shall regularly

18 and systematically develop, issue, and update guid19 ance within the Environmental Protection Agency

20 for any risk characterizations that may be conducted

21 by the Agency. The Director shall oversee the use of

22 such guidance within the Agency to ensure that any

23 such risk characterizations are complete and provide

24 for informed evaluation and use of risk assessment.
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1 (2) CONTENTS.—The guidance shall include

2 guidance on the following:

3 (A) Relevant information on data and as4 sessment methods that significantly influence

5 the risk estimate.

6 (B) Limitations, assumptions, and default

7 options included in the assessment and the ra8 tionale and extent of scientific consensus with

9 respect to their use.

10 (C) A statement that identifies major un11 certainties and their influence upon the assess12 ment. The statement shall characterize uncer13 tainties associated with experimental measure14 ment errors and uncertainties associated with

15 the choice of specific models and default op16 tions.

17 (D) The ranges of exposures derived from

18 exposure scenarios, their estimated prob19 abilities.

20 (E) The use of both quantitative and quali21 tative descriptors to present the full range of

22 risks encountered by the various populations

23 and individuals in a human health risk assess24 ment, or by the various species and ecological

25 communities in an ecological risk assessment,
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1 exposed to the environmental hazard being eval2 uated in the risk assessment.

3 (F) A description of all appropriate statis4 tical expressions of the range and variability of

5 the risk estimate.

6 (3) REPORT.—Not later than 180 days after

7 the date of the enactment of this Act, the Adminis8 trator shall submit to the Congress a report on risk

9 characterization guidance developed, issued, and up10 dated under this subsection. The Administrator shall

11 report to the Congress whenever risk characteriza12 tion guidance under this subsection is updated.

13 (i) RISK COMMUNICATION.—The Director shall pro14 mote open dialogue among scientists, decisionmakers, and

15 the public in order to improve the use of risk assessments

16 by decisionmakers and to accurately, objectively, and

17 clearly communicate risk characterizations.

18 (j) RESEARCH AND TRAINING IN RISK ASSESS19 MENT.—

20 (1) EVALUATION.—The Director shall regularly

21 and systematically evaluate risk assessment research

22 and training needs of the Environmental Protection

23 Agency, including the following needs:

24 (A) Research with respect to data gaps,

25 modeling needs, and validation of default op-
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1 tions, particularly those common to multiple

2 risk assessments.

3 (B) Research to examine the causes and

4 extent of variability within and among individ5 uals, species, populations, and, in the case of

6 ecological risk assessment, ecological commu7 nities.

8 (C) Research leading to the improvement

9 of methods to quantify and communicate uncer10 tainty and variability throughout the risk as11 sessment, and risk assessment reporting meth12 ods that clearly distinguish between uncertainty

13 and variability.

14 (D) Emerging and future areas of re15 search, including research on comparative risk

16 analysis, exposure to multiple chemicals and

17 other stressors, noncancer endpoints, mecha18 nisms of action in both mammalian and non19 mammalian species, and prediction of eco20 system-level responses.

21 (E) Long-term needs to adequately train

22 individuals in risk assessment and risk assess23 ment applications. An evaluation under this

24 paragraph shall include an estimate of the re25 sources needed to provide necessary training
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1 and recommendations on appropriate edu2 cational risk assessment curricula.

3 (2) DEVELOPMENT OF STRATEGY.—The Direc4 tor shall develop a strategy, schedule, and delegation

5 of responsibility for carrying out research and train6 ing to meet the needs identified in paragraph (1).

7 (3) REPORT.—Not later than 120 days after

8 the date of the enactment of this Act, the Adminis9 trator shall submit to the Congress a report on the

10 evaluations conducted under paragraph (1) and the

11 strategy and schedule developed under paragraph

12 (2). The Administrator shall report to the Congress

13 whenever the evaluations, strategy, and schedule are

14 updated or modified.

15 SEC. 5. PILOT PROJECT ON COMPARATIVE RISK ANALYSIS.

16 (a) IN GENERAL.—As part of the Program, the Di17 rector shall conduct, or provide for the conduct of, a pilot

18 project using comparative risk analysis to rank dissimilar

19 environmental risks and to provide a common basis for

20 evaluating strategies for reducing or preventing those

21 risks. The goal of the pilot project shall be to develop and

22 test methods of comparative risk analysis which produce

23 results that are replicable, testable, and objective.

24 (b) SCOPE OF PROJECT.—The pilot project shall have

25 sufficient scope and breadth to rigorously and scientif-
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1 ically test the feasibility and utility of employing compara2 tive risk analysis. The pilot project shall compare and rank

3 a range of diverse environmental risks, both as to risks

4 to and within an environmental medium and risks across

5 environmental media. The project shall draw on appro6 priate social science literature in formulating methods of

7 comparative risk analysis.

8 (c) PROJECT PARTICIPANTS.—In conducting the

9 pilot project, the Director shall provide for the participa10 tion of a range of individuals with varying backgrounds

11 and expertise, both technical and nontechnical, comprising

12 broad representation of the public and private sectors.

13 (d) DURATION.—The pilot project shall begin within

14 180 days after the date of the enactment of this Act and

15 terminate within 2 years after the date on which it began.

16 (e) EVALUATION OF USE OF COMPARATIVE RISK

17 ANALYSIS.—Not later than 90 days after the termination

18 of the pilot project, the Director shall submit to the Ad19 ministrator a report that evaluates the results of the pilot

20 project and that has been subject to scientific peer review.

21 Not later than 30 days after receiving the report from the

22 Director, the Administrator shall forward the report to the

23 Congress with the results of the scientific peer review and

24 recommendations regarding the advantages, disadvan25 tages, and practical utility of using comparative risk anal-
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1 ysis for decisionmaking in the Environmental Protection

2 Agency.

3 SEC. 6. INTERAGENCY COORDINATION.

4 To promote the conduct, application, and practice of

5 risk assessment in a consistent manner under Federal law

6 and with respect to different environmental media, and to

7 identify risk assessment data and research needs common

8 to more than one Federal agency, the Director of the Of9 fice of Science and Technology Policy shall—

10 (1) periodically survey the manner in which

11 each Federal agency involved in risk assessment is

12 conducting such risk assessment to determine the

13 scope and adequacy of risk assessment practices in

14 use by the Federal Government;

15 (2) provide advice and recommendations to the

16 President based on the surveys conducted and deter17 minations made under paragraph (1);

18 (3) establish appropriate interagency mecha19 nisms to promote coordination among Federal agen20 cies conducting risk assessment with respect to the

21 conduct, application, and practice of risk assessment

22 and to promote the use of state-of-the-art risk as23 sessment practices throughout the Federal Govern24 ment; and
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1 (4) establish appropriate mechanisms between

2 Federal and State agencies to communicate state-of3 the-art risk assessment practices.

4 SEC. 7. SAVINGS PROVISION.

5 Nothing in this Act shall be construed to modify any

6 requirement or standard provided for in another provision

7 of law that provides for risk assessment or is designed to

8 protect health, safety, or the environment. Nothing in this

9 Act shall be construed to require the conduct of a risk

10 assessment or a risk characterization by the Environ11 mental Protection Agency that is not required by law.

12 SEC. 8. DEFINITIONS.

13 For purposes of this Act:

14 (1) The term ‘‘Administrator’’ means the Ad15 ministrator of the Environmental Protection Agency.

16 (2) The term ‘‘comparative risk analysis’’

17 means a process to systematically measure, compare,

18 and rank the severity of environmental risks in order

19 to provide a common basis for evaluating strategies

20 for reducing or preventing those risks.

21 (3) The term ‘‘default option’’ means a condi22 tion, assumption, or fact that is presumed unless in23 formation is available which justifies an alternative.
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1 (4) The term ‘‘Director’’ means the Director of

2 the Risk Assessment Program established in section

3 4.

4 (5) The term ‘‘environmental hazard’’ means

5 any physical, chemical, or biological agent, or a situ6 ation or circumstance presented through an environ7 mental medium, which may impose an adverse effect

8 upon human health or ecological resources.

9 (6) The term ‘‘environmental medium’’ means

10 the natural occurrence of air, water, soil, or bio11 logically-derived material, or any combination or

12 process thereof.

13 (7) The term ‘‘risk assessment’’ means a rigor14 ous and systematic characterization of the potential

15 adverse health or ecological effects of exposure of

16 human or nonhuman species to environmental haz17 ards.

18 (8) The term ‘‘risk assessment guideline’’

19 means a peer-reviewed document of a Federal agen20 cy that contains methodological recommendations

21 pertaining to the practice or application of risk as22 sessment.

23 (9) The term ‘‘risk characterization’’ means the

24 characterization of a risk, based on a risk assess25 ment, that quantitatively and qualitatively describes
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1 the probability and severity of that risk in terms of

2 the population exposed to the risk and the types of

3 potential effects of the exposure and that explicitly

4 states the range, variability, and attendant uncer5 tainty of that risk.

6 (10) The term ‘‘scientific peer review’’ means

7 the process of objectively evaluating the technical ac8 curacy, validity, and clarity of a risk assessment by

9 an impartial group of technically qualified individ10 uals.

11 (11) The term ‘‘uncertainty analysis’’ means

12 the systematic process of identifying that which is

13 not known or defined, including measurement errors,

14 as well as the lack of fundamental knowledge needed

15 to choose among alternative hypotheses, assump16 tions, or experimental models.

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