Union Calendar No. 474

103D CONGRESS

2D SESSION H. R. 4306

[Report No. 103–857]

A BILL

To establish a comprehensive risk assessment procy, and for other purposes. gram within the Environmental Protection AgenOCTOBER 7, 1994

Reported with an amendment, committed to the Commitordered to be printed tee of the Whole House on the State of the Union, and
IB

Union Calendar No. 474

103D CONGRESS

2D SESSION H. R. 4306

[Report No. 103–857]

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

OCTOBER 7, 1994

Additional sponsors: Mr. MINGE, Mr. BARCA of Wisconsin, Mr. MCHALE, Mr.

HUGHES, Mr. BEILENSON, Ms. ESHOO, Mr. SANDERS, Mr. JOHNSON of

Georgia, Mr. INSLEE, and Mr. PORTER

OCTOBER 7, 1994

Reported with an amendment, committed to the Committee of the Whole

House on the State of the Union, and ordered to be printed

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

[For text of introduced bill, see copy of bill as introduced on April 28, 1994]

A BILL

To establish a comprehensive risk assessment program within

the Environmental Protection Agency, and for other

purposes.
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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:

8 (1) Risk assessment is a rigorous and systematic

9 procedure for evaluating and quantifying environ10 mental hazards which may threaten human health

11 and ecological resources and is an important tool for

12 informed policy and decisionmaking.

13 (2) While risk assessment is important to the en14 vironmental decisionmaking process, risk assessment

15 alone is not a sufficient basis for environmental deci16 sionmaking, which must also ensure the consideration

17 of a full range of political, economic, environmental,

18 and social equity concerns, and societal values.

19 (3) Research provides the scientific foundation

20 for risk assessment, yet risk assessment research is

21 fragmented within and across the Environmental

22 Protection Agency and the Federal agencies, com23 plicating the setting of risk assessment research prior24 ities.
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1 (4) The risk assessment practices of the Environ2 mental Protection Agency and other Federal agencies

3 must be significantly improved if risk assessment is

4 to provide maximum utility to decisionmakers.

5 (5) The Environmental Protection Agency and

6 other Federal agencies need to improve the degree and

7 timeliness with which they incorporate scientific ad8 vances into their risk assessment methods and guide9 lines.

10 (6) The risk assessment activities of the Environ11 mental Protection Agency and other Federal agencies

12 are poorly coordinated, such that risk assessment pro13 cedures and outcomes within and across Federal

14 agencies are often incompatible.

15 (7) The data gaps, variability, and uncertainties

16 inherent in risk assessments are neither adequately

17 communicated by risk assessors nor clearly recognized

18 by decisionmakers and the public.

19 (8) Improving the reliability, accuracy, and va20 lidity of risk assessments will require additional re21 search to fill data gaps and to improve risk assess22 ment methodologies, including comparative risk anal23 ysis methodologies.

24 (9) The Environmental Protection Agency and

25 other Federal agencies require a more effective mecha-
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1 nism to ensure scientific peer review of risk assess2 ments.

3 (10) There is a lack of broadly skilled risk asses4 sors and insufficient resources to provide multidisci5 plinary training and curricula needed for risk asses6 sors and decisionmakers.

7 (11) There is no common mechanism for collect8 ing risk data, for disseminating such data to all rel9 evant Federal agencies, and for updating risk assess10 ment methodologies.

11 SEC. 3. PURPOSES.

12 It is the purpose of this Act—

13 (1) to establish a Risk Assessment Program in

14 the Environmental Protection Agency that—

15 (A) develops and periodically revises risk

16 assessment guidelines within the Environmental

17 Protection Agency which reflect scientific ad18 vances;

19 (B) oversees the implementation of the

20 guidelines and ensures consistent application of

21 the guidelines throughout the Agency;

22 (C) provides for appropriate scientific peer

23 review of and public comment on the risk assess24 ment guidelines and risk assessments throughout
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1 the process of guideline development and imple2 mentation;

3 (D) identifies and conducts research needed

4 to advance the science of risk assessment; and

5 (E) develops risk characterization guidance

6 and oversees its implementation in order to com7 municate a scientifically sound, unbiased, and

8 accurate description of the full range of risks and

9 significant uncertainties;

10 (2) to establish a study of comparative risk anal11 ysis; and

12 (3) to direct the Office of Science and Technology

13 Policy, acting through the National Science Tech14 nology Council, to establish an interagency coordinat15 ing process to promote more compatible risk assess16 ment procedures across Federal agencies.

17 SEC. 4. ESTABLISHMENT OF RISK ASSESSMENT PROGRAM.

18 (a) ESTABLISHMENT.—There is established a Risk As19 sessment Program in the Environmental Protection Agency.

20 (b) DIRECTOR; CONDUCT OF PROGRAM.—The Admin21 istrator shall appoint a Director of the Program, who has

22 appropriate expertise in risk assessment, and acting

23 through the Director, shall conduct the activities of the En24 vironmental Protection Agency under the Program as pro25 vided in this Act. The Director shall be compensated at the
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1 rate authorized for level V of the Executive Schedule in sec2 tion 5316 of title 5, United States Code.

3 (c) SCIENTIFIC PEER REVIEW.—

4 (1) IN GENERAL.—The Director shall develop a

5 process to conduct independent scientific peer review,

6 involving qualified individuals from a variety of dis7 ciplines and interests, of all risk assessment guidelines

8 developed by the Environmental Protection Agency.

9 (2) RESPONSE OF DIRECTOR.—As part of the

10 peer review process, the Director shall provide a writ11 ten response to comments made by the persons con12 ducting the peer review. The response shall indicate

13 that the Director explicitly considered the comments,

14 the degree to which such comments have been incor15 porated into the guidelines, and, the reasons why a

16 comment has not been fully incorporated.

17 (3) SELECTION OF PEER REVIEWERS.—The Ad18 ministrator shall provide for the conduct of scientific

19 peer review required by this Act by one or more of the

20 following entities:

21 (A) The Science Advisory Board established

22 under the Environmental Research, Develop23 ment, and Demonstration Authorization Act of

24 1978.
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1 (B) Any other appropriate science advisory

2 panel of the Environmental Protection Agency.

3 (C) Any other person, agency, or institu4 tion. The Director may award a grant to, and

5 enter into a contract, interagency agreement, or

6 cooperative agreement with, such person, agency,

7 or institution for the conduct of such scientific

8 peer review.

9 (4) REPORT.—Not later than 180 days after the

10 date of the enactment of this Act, the Administrator

11 shall submit to the Congress a report on a plan for

12 conducting scientific peer review described in this

13 subsection. The Administrator shall report to the Con14 gress whenever significant modifications are made to

15 the plan.

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

17 shall regularly provide to the Administrator advice and rec18 ommendations on the conduct of risk assessment, research

19 needs, and the development of risk assessment guidelines

20 within the Environmental Protection Agency.

21 (e) USE OF SERVICES; CONSULTATION.—In conduct22 ing activities under the Program, the Director may use the

23 services of consultants, establish advisory boards, and, to

24 the extent practicable, consult with the Science Advisory

25 Board established under the Environmental Research, De-
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1 velopment, and Demonstration Authorization Act of 1978,

2 State and local government agencies, appropriate profes3 sional groups, and such representatives (with expertise in

4 risk assessment) of industry, universities, agriculture, labor,

5 consumers, conservation organizations, and other public in6 terest groups, organizations, and individuals as appro7 priate.

8 (f) GUIDELINE DEVELOPMENT.—

9 (1) DEVELOPMENT.—

10 (A) IN GENERAL.—The Director shall regu11 larly and systematically develop and issue,

12 through publication in the Federal Register, risk

13 assessment guidelines that seek to provide con14 sistency and technical quality and ensure that

15 risk assessments conducted by the Agency shall be

16 scientifically objective and unbiased and that

17 significant uncertainties regarding facts, sci18 entific knowledge, and the validity of analytical

19 techniques, or numerical risk estimates are clear20 ly disclosed in terms readily understandable to

21 the public. The guidelines shall ensure that risk

22 assessments performed by the Agency make use of

23 the best information and the most plausible and

24 unbiased assumptions, given the scientific infor25 mation available to the Administrator.
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1 (B) DEADLINES FOR COMPLIANCE.—The

2 Director shall ensure that risk assessment guide3 lines issued by the Environmental Protection

4 Agency are consistent with the requirements of

5 paragraph (3) according to the following sched6 ule:

7 (i) Not later than 3 years after the

8 date of the enactment of this Act, for guide9 lines that were issued by the Environmental

10 Protection Agency, or are under develop11 ment, prior to the date of the enactment of

12 this Act.

13 (ii) On the date of their issuance, for

14 guidelines that are developed and issued by

15 the Environmental Protection Agency after

16 the date of the enactment of this Act.

17 (C) UPDATES.—The Director shall review

18 the need to update the guidelines referred to in

19 clauses (i) and (ii) of subparagraph (B) not less

20 than once every 3 years after the date by which

21 such guidelines are made consistent with the re22 quirements of paragraph (4).

23 (D) INTERIM GUIDANCE.—Whenever the Di24 rector determines that there has been a signifi25 cant scientific advancement which warrants the
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1 updating of a guideline or that a specific risk

2 assessment need has arisen which is not ad3 dressed by a guideline, the Director, after provid4 ing for appropriate scientific peer review and

5 opportunity for public participation, shall pro6 vide interim guidance on the use of the guide7 lines and the conduct of the risk assessments. The

8 Director shall make available to the public any

9 interim guidance provided, the results of any sci10 entific peer review conducted, and any public

11 comment received, under this paragraph. The

12 Director shall issue the interim guidance in ac13 cordance with paragraph (2) and, as appro14 priate, shall incorporate the interim guidance

15 into the guideline when the Director next reviews

16 the need to update that guideline under subpara17 graph (C).

18 (2) PROCESS FOR GUIDELINE DEVELOPMENT.—

19 When developing or revising a risk assessment guide20 line or interim guidance, the Director shall publish in

21 the Federal Register a declaration of the intent to

22 issue the guideline or interim guidance, together with

23 the text of the proposed guideline or interim guidance,

24 and shall provide an opportunity for public notice

25 and comment on the proposal. After the close of the
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1 comment period and any informal hearing that may

2 be held, the Director shall prepare and place in the

3 public record a response to the comments that were

4 submitted on the proposal and shall issue the new or

5 revised guideline or interim guidance by publishing

6 the document in the Federal Register along with a

7 summary of the Director’s response to comments.

8 (3) SCOPE AND APPLICABILITY OF GUIDE9 LINES.—The guidelines shall address issues relevant

10 to human and ecological risk assessments and to fun11 damental aspects of risk assessment procedures and

12 practices. The Administrator shall conduct risk as13 sessments in accordance with all appropriate guide14 lines. Discussions or explanations required under

15 paragraph (4) need not be repeated in each risk as16 sessment as long as there is reference to the relevant

17 discussion or explanation in another Agency docu18 ment. Exercises conducted by the Environmental Pro19 tection Agency which serve an internal planning

20 function, and which do not support a final Agency

21 action or rule, may be determined by the Director not

22 to be subject to the provisions of this Act. Screening

23 analyses where the results of such analyses are not

24 used as the basis for imposing restrictions on sub25 stances or activities and the results of the analyses
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1 are not used to characterize a positive finding of risks

2 from substances or activities in any final Agency doc3 ument made available to the general public shall be

4 excluded from the provisions of this Act. A risk assess5 ment which departs from a guideline and which is

6 conducted in support of an emergency action, an ex7 pedited formal adjudication, emergency rule, or emer8 gency order which does not permit adequate time for

9 adherence to the procedures set forth in section

10 4(g)(2), shall be exempt from the provisions of section

11 4(g)(2).

12 (4) CONTENTS.—The risk assessment guidelines

13 shall, at a minimum, include each of the following:

14 (A) An explanation of the scope and appli15 cability of the guidelines, including appropriate

16 limitations or restrictions on their use, and an

17 identification of appropriate Offices at the Envi18 ronmental Protection Agency to contact for fur19 ther information on risk assessment.

20 (B) Criteria for accepting and evaluating

21 data.

22 (C) A complete description of any mathe23 matical models or other assumptions likely to be

24 used in the risk assessment, including a discus25 sion of their plausibility.
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1 (D) A description of the default options, the

2 justification and validation for the default op3 tions, and an explicit statement of the rationale

4 for selecting a particular default option, in the

5 absence of adequate data, based on explicitly

6 stated science policy choices and consideration of

7 relevant scientific information.

8 (E) The technical justification for, and a

9 description of the degree of, conservatism each

10 default option imposes upon the risk assessment.

11 (F) Criteria for using iterative or tiered ap12 proaches to risk assessment, with varying levels

13 of effort and data requirements in the conduct of

14 risk assessment based on the need for accuracy of

15 the risk estimate.

16 (G) Criteria for conducting uncertainty

17 analysis during the course of the risk assessment,

18 and an explanation of the data needs for such

19 analysis.

20 (H) Guidance for risk characterization de21 veloped, issued, and updated under subsection

22 (h).

23 (I) Effective methods for reporting risk as24 sessment, to ensure that the results are reason25 ably understandable by interested persons, in-
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1 cluding formats which clearly identify and dis2 tinguish sources of uncertainty and variability

3 in the risk assessment.

4 (J) Criteria for identification and use of the

5 most plausible and unbiased methodologies and

6 assumptions, given the scientific information

7 available to the Administrator.

8 (5) REPORT.—Not later than 180 days after the

9 date of the enactment of this Act, the Administrator

10 shall submit to the Congress a report that describes

11 (A) the status of all risk assessment guidelines issued

12 before such date with respect to the extent to which

13 such guidelines are consistent with the requirements

14 of paragraph (4) and a schedule for making such

15 guidelines consistent with such requirements; (B) a

16 schedule for issuing any risk assessment guidelines

17 which are being developed by the Environmental Pro18 tection Agency on such date, including a plan for

19 making such guidelines consistent with the require20 ments of paragraph (4); and (C) a plan for identify21 ing and developing future risk assessment guidelines

22 consistent with the requirements of paragraph (4).

23 The Administrator shall annually thereafter submit to

24 the Congress an update of the schedule referred to in
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1 subparagraph (B) and the plans referred to in sub2 paragraphs (B) and (C).

3 (g) USE OF GUIDELINES.—

4 (1) IN GENERAL.—The Director shall oversee the

5 use of risk assessment guidelines by the Program and

6 Regional Offices of the Environmental Protection

7 Agency in the conduct of any risk assessments that

8 may be conducted by the Environmental Protection

9 Agency. The Director shall seek to ensure consistency

10 in the use of such guidelines, to the extent such con11 sistency is appropriate in application to various en12 vironmental media or environmental hazards. The

13 Director shall supervise the use of such guidelines

14 within the Environmental Protection Agency to en15 sure that risk assessment is, to the extent permitted

16 by law, conducted, applied, and practiced throughout

17 the Offices of the Agency in accordance with the

18 guidelines and that advances made in one area of risk

19 assessment are applied as appropriate within the

20 Agency to other areas of risk assessment.

21 (2) DEPARTURES FROM GUIDELINES.—A Pro22 gram or Regional Office of the Environmental Protec23 tion Agency may not depart from a guideline unless

24 (A) interim guidance is provided by the Director

25 under subsection (f)(1) which permits that departure;
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1 or (B) that departure is for a specific risk assessment

2 and is approved in writing by the Director. The Di3 rector shall seek appropriate scientific peer review of

4 any such departure. Any such departure shall seek to

5 ensure the consistency referred to in subsection (g)(1)

6 and shall be included in any public record of the spe7 cific risk assessment for which the departure was

8 made together with the justification for why that de9 parture was made.

10 (h) RISK CHARACTERIZATION.—

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

12 and systematically develop, issue, and update guid13 ance within the Environmental Protection Agency for

14 any risk characterizations that may be conducted by

15 the Agency. The Director shall oversee the use of such

16 guidance within the Agency to ensure that all such

17 risk characterizations are as complete as practicable

18 to make apparent the distinction between data and

19 policy assumptions and to facilitate accurate inter20 pretation and appropriate use of the assessment by

21 decisionmakers and interested persons. The Director

22 shall oversee the use of such guidance within the

23 Agency to ensure that all such risk characterizations

24 distinguish human health risks from ecological and

25 other risks. The Environmental Protection Agency
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1 shall consider and incorporate, as appropriate, the

2 recommendations from the study of the Committee on

3 Risk Characterization of the National Academy of

4 Sciences on risk characterization and report to the

5 Congress on the inclusion of such recommendations in

6 the risk characterization guidance.

7 (2) DEADLINES.—The Director shall ensure that

8 initial risk characterization guidance is issued,

9 through publication in the Federal Register, within 2

10 years after the date of the enactment of this Act.

11 (3) CONTENTS.—At a minimum, the guidance

12 shall require that any risk characterization contain

13 the following:

14 (A) Relevant information on data and as15 sessment methods that significantly influence the

16 risk estimate.

17 (B) A statement of the limitations, assump18 tions, and default options included in the assess19 ment and a statement of the rationale and extent

20 of scientific consensus with respect to their use.

21 (C) A statement that identifies major uncer22 tainties and their influence upon the assessment.

23 The statement shall characterize uncertainties

24 associated with experimental measurement errors
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1 and uncertainties associated with the choice of

2 specific models and default options.

3 (D) The range and distribution of exposures

4 derived from exposure scenarios used in a risk

5 assessment, including, for example, upper-bound

6 and central estimate(s) and their qualitative, or

7 where possible quantitative, likelihood, and,

8 when available and appropriate, the identifica9 tion of highly susceptible groups, species, indi10 viduals, and subpopulations whose exposure ex11 ceeds that of the general population.

12 (E) The use of both quantitative and quali13 tative descriptors, when available and appro14 priate, to present a comprehensive range of risks

15 which are or may be encountered by the various

16 populations and individuals in a human health

17 risk assessment, or by the various species and ec18 ological communities in an ecological risk assess19 ment, exposed to the environmental hazard being

20 evaluated in the risk assessment.

21 (F) A description of appropriate statistical

22 expressions of the range and variability of the

23 risk estimate, including the population or popu24 lations addressed by any risk estimate(s), central

25 estimates of the risk for the specific population,
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1 any appropriate upper-bound and lower-bound

2 estimates, and the reasonable range or other de3 scription of uncertainties in the assessment proc4 ess.

5 (G) When providing estimates of risk to

6 public health, appropriate comparisons with es7 timates of other risks to health, including those

8 that are familiar to and routinely encountered

9 by the general public, and relevant substitution

10 risks, where information on such risks is made

11 available to the Administrator. In stating com12 parisons, the Administrator shall identify rel13 evant distinctions among categories or risks and

14 limitations to comparisons.

15 (4) REPORT.—Not later than 180 days after the

16 date of the enactment of this Act, the Administrator

17 shall submit to the Congress a report on risk charac18 terization guidance developed, issued, and updated

19 under this subsection. The Administrator shall report

20 to the Congress whenever risk characterization guid21 ance under this subsection is updated.

22 (i) RISK COMMUNICATION.—The Director shall insti23 tute a program to promote open dialogue among scientists,

24 decisionmakers, and the public in order to improve the un-
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1 derstanding of risk assessments by decisionmakers and to

2 accurately and clearly communicate risk characterizations.

3 (j) RESEARCH AND TRAINING IN RISK ASSESSMENT.—

4 (1) EVALUATION.—The Director shall regularly

5 and systematically evaluate risk assessment research

6 and training needs of the Environmental Protection

7 Agency, including the following needs:

8 (A) Research with respect to data gaps or

9 redundancies, modelling needs, and validation of

10 default options, particularly those common to

11 multiple risk assessments.

12 (B) Research to examine the causes and ex13 tent of variability within and among individ14 uals, species, populations, and, in the case of eco15 logical risk assessment, ecological communities.

16 (C) Research leading to the improvement of

17 methods to quantify and communicate uncer18 tainty and variability throughout the risk assess19 ment, and risk assessment reporting methods

20 that clearly distinguish between uncertainty and

21 variability.

22 (D) Emerging and future areas of research,

23 including research on comparative risk analysis,

24 exposure to multiple chemicals and other

25 stressors, noncancer endpoints, biological mark-
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1 ers, mechanisms of action in both mammalian

2 and non-mammalian species, dynamics and

3 probabilities of physiological and ecosystem expo4 sures, and prediction of ecosystem-level responses.

5 (E) Long-term needs to adequately train in6 dividuals in risk assessment and risk assessment

7 applications. An evaluation under this para8 graph shall include an estimate of the resources

9 needed to provide necessary training and rec10 ommendations on appropriate educational risk

11 assessment curricula.

12 (2) DEVELOPMENT OF STRATEGY.—The Director

13 shall develop a strategy, schedule, and delegation of

14 responsibility for carrying out research and training

15 to meet the needs identified in paragraph (1).

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

17 date of the enactment of this Act, the Administrator

18 shall submit to the Congress a report on the evalua19 tions conducted under paragraph (1) and the strategy

20 and schedule developed under paragraph (2). The Ad21 ministrator shall report to the Congress whenever the

22 evaluations, strategy, and schedule are updated or

23 modified.

24 (k) REVIEW OF RISK CHARACTERIZATIONS.—
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1 (1) PROVISION FOR INDEPENDENT REVIEW.—On

2 an annual basis for a period of three years following

3 the date of issuance of risk characterization guidance

4 by the Environmental Protection Agency under the

5 provisions of this Act, and every three years there6 after, the Director shall provide for review of the con7 formance of the Agency’s risk characterizations with

8 its risk characterization guidance. The review shall be

9 conducted by an independent body composed of indi10 viduals from outside the Agency who are technically

11 qualified in risk characterization. By publication in

12 the Federal Register of the intent to convene each re13 view and of a period for public comment, the public

14 will be provided an opportunity for comment to the

15 independent body on the Agency’s conformance with

16 the guidance.

17 (2) ANNUAL REPORT.—Not later than December

18 1 each year, the independent body shall provide to the

19 Congress, through the Administrator, a report that

20 evaluates the degree to which the risk characterization

21 issued by the Environmental Protection Agency dur22 ing the preceding calendar year conform to the risk

23 characterization guidance issued under subsection (h).

24 The report shall include an identification of those risk

25 characterizations, if any, that the independent body
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1 finds failed to conform in a significant respect with

2 applicable risk characterization guidance.

3 (3) RESPONSE TO REPORT.—Within 12 months

4 of receiving a report pursuant to paragraph (2), the

5 Administrator shall prepare and issue revised ver6 sions of any risk characterization that the independ7 ent body identified as failing to conform in a signifi8 cant respect with applicable risk characterization

9 guidance. Such revised risk characterizations shall

10 conform to the applicable risk characterization guid11 ance or include an explanation of why the Adminis12 trator considers such conformance to be inappropri13 ate.

14 SEC. 5. STUDY OF COMPARATIVE RISK ANALYSIS.

15 (a) IN GENERAL.—As part of the Program, the Direc16 tor shall conduct, or provide for the conduct of, a study

17 using comparative risk analysis to rank dissimilar environ18 mental risks and to provide a common basis for evaluating

19 strategies for reducing or preventing those risks. The goal

20 of the study shall be to develop and rigorously test methods

21 of comparative risk analysis. The Director shall consult

22 with the Director of the Office of Science and Technology

23 Policy regarding the scope of the study. Not later than 90

24 days after the date of the enactment of this Act, the Admin25 istrator, in collaboration with other appropriate Federal
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1 agencies, shall enter into a contract with the National Re2 search Council to provide technical guidance on approaches

3 to using comparative risk analysis and other considerations

4 in setting environmental priorities.

5 (b) SCOPE OF STUDY.—The study shall have sufficient

6 scope and breadth to evaluate comparative risk analysis

7 and to test approaches for improving comparative risk

8 analysis and its use in setting priorities for environmental

9 risk reduction. The study shall compare and evaluate a

10 range of diverse environmental risks, both as to risks to and

11 within an environmental medium and risks across environ12 mental media.

13 (c) STUDY PARTICIPANTS.—In conducting the study,

14 the Director shall provide for the participation of a range

15 of individuals with varying backgrounds and expertise, both

16 technical and nontechnical, comprising broad representa17 tion of the public and private sectors.

18 (d) DURATION.—The study shall begin within 180

19 days after the date of the enactment of this Act and termi20 nate within 2 years after the date on which it began.

21 (e) RECOMMENDATIONS FOR IMPROVING COMPARATIVE

22 RISK ANALYSIS AND ITS USE.—Not later than 90 days

23 after the termination of the study, the Director shall submit

24 to the Administrator a report that evaluates the results of

25 the study and that has been subject to scientific peer review.
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1 Not later than 30 days after receiving the report from the

2 Director, the Administrator shall forward a final report to

3 the Congress with the results of the scientific peer review

4 and recommendations regarding the use of comparative risk

5 analysis and ways to improve the use of comparative risk

6 analysis for decisionmaking in the Environmental Protec7 tion Agency.

8 (f) SAVINGS.—Nothing in this section shall be con9 strued to prohibit or discourage the performance after the

10 date of the enactment of this Act of any comparative risk

11 analysis.

12 SEC. 6. INTERAGENCY COORDINATION.

13 To promote the conduct, application, and practice of

14 risk assessment in a consistent manner under Federal law

15 and with respect to different environmental media, and to

16 identify risk assessment data and research needs common

17 to more than one Federal agency, the Director of the Office

18 of Science and Technology Policy, acting through the Na19 tional Science Technology Council, shall—

20 (1) periodically survey the manner in which

21 each Federal agency involved in risk assessment is

22 conducting such risk assessment to determine the

23 scope and adequacy of risk assessment practices in

24 use by the Federal Government;
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1 (2) provide advice and recommendations to the

2 President and the Congress based on the surveys con3 ducted and determinations made under paragraph

4 (1);

5 (3) establish appropriate interagency mecha6 nisms to promote coordination among Federal agen7 cies conducting risk assessment with respect to the

8 conduct, application, and practice of risk assessment

9 and to promote the use of state-of-the-art risk assess10 ment practices throughout the Federal Government;

11 (4) disseminate to all relevant Federal agencies

12 the results of the study referred to in section 5 and

13 any activity of the National Research Council that is

14 complementary to the study and, as appropriate, co15 ordinate the implementation of such results by all

16 such agencies;

17 (5) establish appropriate mechanisms between

18 Federal and State agencies to communicate state-of19 the-art risk assessment practices; and

20 (6) periodically convene meetings with State gov21 ernment representatives and Federal and other leaders

22 to assess the effectiveness of Federal-State cooperation

23 in the development and application of risk assess24 ment.
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1 SEC. 7. SAVINGS PROVISION.

2 Nothing in this Act shall be construed to modify any

3 requirement or standard provided for in another provision

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

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

6 Act shall be construed to require the conduct of a risk assess7 ment or a risk characterization by the Environmental Pro8 tection Agency that is not required by law.

9 SEC. 8. RISK ASSESSMENT RESEARCH PRIORITIES.

10 (a) IDENTIFICATION OF PRIORITY RISK ASSESSMENT

11 RESEARCH ISSUES.—

12 (1) REPORT.—Within six months after the date

13 of the enactment of this Act, the Administrator shall

14 submit to the Congress a report that identifies at least

15 10 environmental research issues—

16 (A) correlating to the environmental haz17 ards which the Administrator estimates to be in

18 the category of highest risk;

19 (B) regarding which there are, as deter20 mined by the Administrator, significant sci21 entific uncertainties with respect to the assess22 ment of such environmental risks; and

23 (C) with respect to which such uncertainties

24 could be significantly reduced through research.
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1 (2) CONTENTS OF REPORT.—In addition to the

2 identification required by paragraph (1), the report

3 referred to in such paragraph shall include—

4 (A) an assessment of the research that has

5 been, or is being, conducted by the Environ6 mental Protection Agency with respect to each

7 issue identified under such paragraph;

8 (B) an identification, with respect to each

9 such issue, of the significant scientific uncertain10 ties that exist with respect to the assessment of

11 the environmental risks posed by the issue;

12 (C) an identification of the research that

13 needs to be conducted by the Environmental Pro14 tection Agency to reduce significantly such sci15 entific uncertainties, the amount of time nec16 essary to conduct such research, and the cost of

17 such research; and

18 (D) a list that identifies such issues in

19 order of the priority in which such research

20 should be conducted and includes the reasons for

21 that priority.

22 (b) RESEARCH PROGRAM.—The Administrator shall

23 carry out a research program within the Office of Research

24 and Development to reduce the scientific uncertainties with

25 respect to the assessment of the environmental risks posed
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1 by the issues identified under subsection (a). In conducting

2 the research, the Administrator shall consider the priority

3 list referred to in subsection (a)(2)(D).

4 (c) BUDGET COORDINATION.—In the first budget sub5 mitted by the President to the Congress immediately follow6 ing the submission required by subsection (a), and in the

7 next four budgets submitted immediately after such budget,

8 the Administrator shall include a report that identifies the

9 research conducted by the Administrator in accordance with

10 the priority list referred to in subsection (a)(2)(D).

11 SEC. 9. DEFINITIONS.

12 For purposes of this Act:

13 (1) The term ‘‘Administrator’’ means the Admin14 istrator of the Environmental Protection Agency.

15 (2) The term ‘‘comparative risk analysis’’ means

16 a process to systematically estimate, compare, and

17 rank the size and severity of environmental risks in

18 order to provide a common basis for evaluating strat19 egies for reducing or preventing those risks.

20 (3) The term ‘‘default option’’ means a condi21 tion, assumption, or fact that is presumed on the

22 basis of available data and prevailing theory.

23 (4) The term ‘‘Director’’ means the Director of

24 the Risk Assessment Program established in section 4.
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1 (5) The term ‘‘environmental hazard’’ means

2 any physical, chemical, or biological agent, or a situ3 ation or circumstance presented through an environ4 mental medium, which may impose an adverse effect

5 upon human health or ecological resources.

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

7 the natural occurrence of air, water, soil, or bio8 logically-derived material, or any combination or

9 process thereof.

10 (7) The term ‘‘risk assessment’’ means the proc11 ess or procedure by which the potential adverse health

12 or ecological effects of exposure of human or

13 nonhuman species to environmental hazards is char14 acterized.

15 (8) The term ‘‘risk assessment guideline’’ means

16 a document of a Federal agency that contains prin17 ciples pertaining to the practice or application of risk

18 assessment.

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

20 final component of a risk assessment, that quali21 tatively or quantitatively (or both) describes the mag22 nitude and consequences of that risk in terms of the

23 population exposed to the risk and the types of poten24 tial effects of the exposure.
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1 (10) The term ‘‘scientific peer review’’ means the

2 process of rigorously evaluating the technical accu3 racy, validity, and clarity of a risk assessment by an

4 impartial group of technically qualified individuals.

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

6 systematic process of identifying that which is not

7 known or is unclear, including measurement errors,

8 the lack of fundamental knowledge needed to choose

9 among alternative hypotheses, and assumptions, or

10 experimental models.

11 (12) The term ‘‘central estimates’’ means esti12 mates of central tendencies or expected risk based, to

13 the extent feasible, on the most plausible and unbiased

14 assumptions, given the scientific information avail15 able to the Administrator.

16 (13) The term ‘‘substitution risk’’ means a po17 tential increase in certain types of risk from a strat18 egy designed to decrease other risks.

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