I

104TH CONGRESS

1ST SESSION H. R. 690

To improve the use of risk assessment and cost-benefit analysis by Federal

agencies.

IN THE HOUSE OF REPRESENTATIVES

JANUARY 25, 1995

Mr. ZIMMER introduced the following bill; which was referred to the Committee on Government Reform and Oversight and, in addition, to the Committees on Science and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions

as fall within the jurisdiction of the committee concerned

A BILL

To improve the use of risk assessment and cost-benefit

analysis by Federal agencies.

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 and

5 Cost-Benefit Analysis Act of 1995’’.

6 SEC. 2. FINDINGS.

7 The Congress finds the following:

8 (1) Risk assessment and cost-benefit analysis

9 are useful tools that serve to enhance the informa-
2

•HR 690 IH

1 tion available in developing public health and envi2 ronmental regulations and programs.

3 (2) Risk assessment and cost-benefit analysis

4 can also serve as useful tools in setting priorities

5 and evaluating the success of public health and envi6 ronmental protection programs.

7 (3) Public and private resources available to ad8 dress health and environmental concerns are limited.

9 Those resources need to be allocated carefully so

10 that the country addresses the greatest needs in the

11 most cost-effective manner.

12 (4) To provide more cost-effective protection to

13 human health and the environment regulatory prior14 ities should be based upon risk assessment, com15 parative risk analysis that incorporates societal val16 ues, and risk management choices that consider

17 cost-benefit principles.

18 (5) Regulatory priorities have often not been

19 based upon consideration of potential risk nor has

20 the opportunity for risk reduction been fully consid21 ered.

22 (6) Risk assessment has proved to be a useful

23 scientific decisionmaking tool. However, pertinent

24 scientific data must be better collected, organized,

25 and evaluated by risk assessors and information
3

•HR 690 IH

1 must be more effectively communicated from risk as2 sessors to decisionmakers and from decisionmakers

3 to the public.

4 (7) Research provides the scientific foundation

5 for risk assessment, yet risk assessment research is

6 fragmented within and across Federal agencies, com7 plicating the setting of risk assessment research pri8 orities.

9 (8) The risk assessment practices of Federal

10 agencies must be significantly improved if risk as11 sessment is to provide maximum utility to

12 decisionmakers.

13 (9) Federal agencies need to improve the degree

14 and timeliness with which they incorporate scientific

15 advances into their risk assessment methods and

16 guidelines.

17 (10) The risk assessment activities of Federal

18 agencies are poorly coordinated, such that risk as19 sessment procedures and outcomes within and across

20 Federal agencies are often incompatible.

21 (11) The data gaps, variability, and uncertain22 ties inherent in risk assessment are neither ade23 quately communicated by risk assessors nor clearly

24 recognized by decisionmakers and the public.
4

•HR 690 IH

1 (12) Improving the reliability, accuracy, and va2 lidity of risk assessments will require additional re3 search to fill data gaps and improve risk assessment

4 methodologies, including comparative risk analysis

5 methodologies.

6 (13) Federal agencies require a more effective

7 mechanism to ensure scientific peer review is ade8 quately reported in risk assessments.

9 (14) There is a lack of broadly skilled risk as10 sessors and insufficient resources to provide multi11 disciplinary training and curricula needed for risk

12 assessors and decisionmakers.

13 (15) There is no common mechanism for col14 lecting risk data, for disseminating such data to all

15 relevant Federal agencies, and for updating risk as16 sessment methodologies.

17 SEC. 3. PURPOSES.

18 The purposes of this Act are the following:

19 (1) To establish an Office of Risk Assessment

20 and Cost-Benefit Analysis in each covered agency,

21 that will—

22 (A) oversee the development, periodic revi23 sion, and implementation of risk assessment

24 guidelines throughout the covered agency;
5

•HR 690 IH

1 (B) provide for appropriate scientific peer

2 review of and public comment on risk assess3 ment guidelines and risk assessments through4 out the process of development and implementa5 tion;

6 (C) identify, prioritize, and recommend to

7 the head of the agency, research needed to ad8 vance the science of risk assessment; and

9 (D) develop risk characterization guidance

10 and oversee its implementation in order to com11 municate a description of the full range of risks

12 and uncertainties.

13 (2) To direct the head of each covered agency

14 to prioritize research and regulatory initiatives to

15 achieve the greatest risk reductions by—

16 (A) prioritizing threats to human health

17 and the environment according to the serious18 ness of the risk they pose; and

19 (B) the opportunities available to achieve

20 the greatest overall net reduction in those risks

21 with the public and private resources available.

22 (3) To direct the head of each covered agency

23 to incorporate risk-based priorities into the budget,

24 strategic planning, and research activities of the

25 agency.
6

•HR 690 IH

1 SEC. 4. REQUIREMENT FOR COVERED AGENCIES.

2 In exercising authority under any Federal law to pro3 tect human health and the environment, the head of each

4 covered agency shall—

5 (1) conduct risk assessment and cost-benefit

6 analysis for all major rules protecting human health

7 and the environment;

8 (2) demonstrate that for all major rules the

9 benefits to human health or the environment justify

10 the costs;

11 (3) publish with each final rule an identification

12 of the most flexible and cost effective regulatory op13 tion and, if those options are not employed, an ex14 planation justifying why they are not employed;

15 (4) prioritize threats to human health, safety,

16 and the environment according to—

17 (A) the seriousness of the risk they pose;

18 and

19 (B) the opportunities available to achieve

20 the greatest overall net reduction in those risks

21 with the public and private resources available;

22 (5) prioritize the use of resources available to

23 the agency under those laws to reduce those risks in

24 accordance with the priorities established under

25 paragraph (4), including applying the priorities to
7

•HR 690 IH

1 the budget, strategic planning, and research activi2 ties of the agency; and

3 (6) apply peer review to each risk assessment

4 and each cost-benefit analysis that may have a sig5 nificant impact on that exercise of authority.

6 SEC. 5. ESTABLISHMENT OF OFFICE OF RISK ASSESSMENT

7 AND COST BENEFIT ANALYSIS IN EACH COV8 ERED AGENCY.

9 (a) ESTABLISHMENT.—There is established in each

10 covered agency an Office of Risk Assessment and Cost11 Benefit Analysis.

12 (b) DIRECTOR, GENERALLY.—There shall be at the

13 head of the Office of each covered agency a Deputy Assist14 ant Secretary or Deputy Assistant Administrator (as spec15 ified by the head of the covered agency), who shall be ap16 pointed by the head of the covered agency from among

17 individuals having appropriate expertise in risk assess18 ment.

19 (c) FUNCTIONS OF THE DIRECTOR.—The head of

20 each covered agency, acting through the Director for the

21 agency, shall ensure that all risk assessments and cost

22 benefit analyses conducted by the agency under section

23 4(2) are performed in accordance with risk assessment

24 guidelines issued by the Director under subsection (f) and

25 use relevant, reliable, and reasonably obtainable data.
8

•HR 690 IH

1 (d) SCIENTIFIC PEER REVIEW.—

2 (1) IN GENERAL.—The head of each covered

3 agency, acting through the Director, shall develop

4 and apply a process to conduct external and inde5 pendent scientific peer review, involving qualified in6 dividuals from a variety of disciplines and a bal7 anced representation of all interested persons, of all

8 risk assessment guidelines and risk assessments and

9 cost-benefit analyses required by this Act.

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

11 peer review process, the head of a covered agency,

12 acting through the Director, shall provide a written

13 response to comments made by the persons conduct14 ing the peer review. The response shall indicate that

15 the Director explicitly considered the comments, the

16 degree to which such comments have been incor17 porated into the risk assessment guidelines or risk

18 assessment, as applicable, and the reason why a

19 comment has not been incorporated.

20 (3) SELECTION OF PEER REVIEWERS.—The

21 head of each covered agency, acting through the Di22 rector, shall provide for the conduct of scientific peer

23 review required by this Act by one or more of the

24 following entities:
9

•HR 690 IH

1 (A) Science advisory boards or panels es2 tablished under other existing laws.

3 (B) Any other person determined by the

4 Director to be appropriate.

5 (4) GRANTS, CONTRACTS, AND AGREEMENTS.—

6 The head of a covered agency, acting through the

7 Director and subject to the availability of appropria8 tions, may enter into grants, contracts, and inter9 agency or other cooperative agreements for the con10 duct of peer review under this Act.

11 (5) REPORTS.—Not later than 180 days after

12 the date of the enactment of this Act, the head of

13 each covered agency, acting through the Director,

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

15 conducting scientific peer review under this Act, and

16 shall also report to the Congress whenever signifi17 cant modifications are made to the plan.

18 (e) USE OF SERVICES; CONSULTATION.—In conduct19 ing activities under this Act, the Director of a covered

20 agency may—

21 (1) use services of consultants,

22 (2) establish advisory boards, and

23 (3) to the extent practicable consult with—

24 (A) science advisory boards and panels es25 tablished under other laws,
10

•HR 690 IH

1 (B) State and local government agencies,

2 (C) appropriate professional groups,

3 (D) appropriate representatives of indus4 try, universities, agriculture, labor, consumers,

5 conservation organizations, other public interest

6 groups and organizations, and

7 (E) individuals.

8 (f) ISSUANCE OF RISK ASSESSMENT GUIDELINES.—

9 (1) IN GENERAL.—The Director of each covered

10 agency shall develop, issue, and publish risk assess11 ment guidelines that provide consistency and tech12 nical quality among risk assessments performed by

13 the agency.

14 (2) NOTICE AND COMMENT.—Before issuing

15 guidelines under this subsection, the Director of a

16 covered agency shall—

17 (A) publish all proposed guidelines for the

18 purpose of seeking public comment; and

19 (B) publish notice of the intent to revise

20 existing guidelines or to develop new guidelines

21 and a list of the issues the Director intends to

22 address and upon which the Director seeks pub23 lic comment.

24 (3) REVIEW AND UPDATES.—The Director of a

25 covered agency shall review and, as necessary, up-
11

•HR 690 IH

1 date guidelines issued under this subsection every 3

2 years.

3 (4) PROCEDURES FOR REVIEW OF RISK ASSESS4 MENTS.—Within 1 year after the date of the enact5 ment of this Act, the head of each covered agency

6 shall develop and publish procedures for the review

7 and revision of any risk assessment performed by

8 the agency. The procedures shall provide for receiv9 ing and considering new information from the public

10 and criteria for appropriate use of peer review and

11 public comment in evaluating new information.

12 (5) LIMITATION ON JUDICIAL REVIEW.—The

13 development, issuance, and publication of risk as14 sessment guidelines under this subsection shall not

15 be subject to judicial review.

16 (g) USE OF GUIDELINES.—The Director of each cov17 ered agency shall oversee the use of risk assessment guide18 lines and the conduct of risk assessments by the agency.

19 The Director shall seek to ensure consistency in the use

20 of such guidelines to the extent such consistency is appro21 priate.

22 (h) USE OF COST-BENEFIT ANALYSIS.—The head of

23 each covered agency acting through the Director shall con24 duct a cost-benefit analysis before issuing any major rule.

25 The analysis shall include an assessment of incremental
12

•HR 690 IH

1 costs and incremental risk reduction or other benefits as2 sociated with significant regulatory alternatives considered

3 in connection with the rule or proposed rule.

4 (i) RESEARCH AND TRAINING IN RISK ASSESS5 MENT.—

6 (1) EVALUATION.—The Director of each cov7 ered agency shall regularly evaluate risk assessment

8 research and training needs of the agency, including

9 the following:

10 (A) Research to improve model sensitivity

11 and otherwise reduce generic data gaps, par12 ticularly those common to multiple risk assess13 ments.

14 (B) Research leading to improvement of

15 methods to quantify and communicate uncer16 tainty and variability throughout risk assess17 ment.

18 (C) Emerging and future areas of re19 search, including research on comparative risk

20 analysis, exposure to multiple chemicals,

21 noncancer endpoints, biological makers of expo22 sure and effect, mechanisms of action in both

23 mammalian and nonmammalian species, eco24 system exposures, and prediction of ecosystem25 level response.
13

•HR 690 IH

1 (D) Long-term needs to adequately train

2 individuals in risk assessment and risk assess3 ment application. Evaluations under this para4 graph shall include an estimate of the resources

5 needed to provide necessary training and rec6 ommendations on appropriate educational risk

7 assessment curricula.

8 (2) STRATEGY AND ACTIONS TO MEET IDENTI9 FIED NEEDS.—The Director shall develop a strategy,

10 schedule, and delegation of responsibility for carry11 ing out research and training to meet the needs

12 identified in paragraph (1).

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

14 the date of the enactment of this Act, the head of

15 each covered agency shall submit to the Congress a

16 report on evaluations conducted under paragraph (1)

17 and the strategy and schedule developed under para18 graph (2). The head of each covered agency shall re19 port to the Congress whenever the evaluations, strat20 egy, and schedule are updated or modified.

21 SEC. 6. RISK CHARACTERIZATION.

22 (a) IN GENERAL.—The head of each covered agency,

23 acting through the Director, shall ensure that all risk

24 characterizations make apparent the distinction between

25 data and policy assumptions to facilitate interpretation
14

•HR 690 IH

1 and appropriate use of the characterization by

2 decisionmakers.

3 (b) CONTENTS.—

4 (1) IN GENERAL.—At a minimum, risk charac5 terizations shall contain the following:

6 (A) Relevant information on data selection

7 and rejection in the risk assessment, including

8 a specific rationale justifying the basis for the

9 selection.

10 (B) Identification of limitations and as11 sumptions, and the rationale and extent of sci12 entific support with respect to their use.

13 (C) A discussion of major uncertainties

14 and their influence upon the risk assessment.

15 (D) Identification of key data gaps and the

16 likely impact of additional data on the risk as17 sessment.

18 (2) REQUIREMENTS REGARDING QUANTITATIVE

19 ESTIMATES OF RISK.—At a minimum, a risk charac20 terization that includes quantitative estimates of risk

21 shall contain the following:

22 (A) When scientifically feasible, the range

23 and distribution of exposures derived from ex24 posure scenarios used in the risk assessment of

25 which the risk characterization is a component,
15

•HR 690 IH

1 including upper bound estimates and central es2 timates and, when appropriate and practicable,

3 the identification of susceptible groups, species,

4 and subpopulations whose exposure exceeds the

5 general population.

6 (B) When scientifically feasible, a descrip7 tion of appropriate statistical expressions of the

8 range and variability of the risk estimate, in9 cluding the population or populations addressed

10 by any risk estimates, central estimates of risk

11 for each such specific population, any appro12 priate upper bound estimates, the reasonable

13 range, or other description of uncertainties in

14 the risk assessment of which the risk character15 ization is a component.

16 SEC. 7. INTERAGENCY COORDINATION.

17 To promote the conduct, application, and practice of

18 risk assessment in a consistent manner under Federal law

19 and with respect to different environmental media, and to

20 identify risk assessment data and research needs common

21 to more than one Federal agency, the Director of the Of22 fice of Science and Technology Policy shall—

23 (1) periodically survey the manner in which

24 each Federal agency involved in risk assessment is

25 conducting such risk assessment to determine the
16

•HR 690 IH

1 scope and adequacy of risk assessment practices in

2 use by the Federal Government;

3 (2) provide advice and recommendations to the

4 President and the Congress based on the surveys

5 conducted and determinations made under para6 graph (1);

7 (3) establish appropriate interagency mecha8 nisms to promote coordination among Federal agen9 cies conducting risk assessment with respect to the

10 conduct, application, and practice of risk assessment

11 and to promote the use of state-of-the-art risk as12 sessment practices throughout the Federal Govern13 ment;

14 (4) establish appropriate mechanisms between

15 Federal and State agencies to communicate state-of16 the-art risk assessment practices; and

17 (5) periodically convene meetings with State

18 government representatives and Federal and other

19 leaders to assess the effectiveness of Federal-State

20 cooperation in the development and application of

21 risk assessment.

22 SEC. 8. ANNUAL ENVIRONMENTAL QUALITY REPORT.

23 (a) IN GENERAL.—Section 201 of the National Envi24 ronmental Policy Act of 1969 (42 U.S.C. 4341), requiring

25 the President to transmit an annual Environmental Qual-
17

•HR 690 IH

1 ity Report, is amended by striking ‘‘The President’’ and

2 inserting ‘‘The Director of the Office of Science and Tech3 nology’’.

4 (b) CONFORMING AMENDMENTS.—

5 (1) Section 204 of such Act (42 U.S.C. 4344)

6 is amended by repealing paragraph (1).

7 (2) Section 11(d) of the Federal Nonnuclear

8 Energy Research and Development Act of 1974 is

9 amended—

10 (A) in the first sentence by inserting ‘‘the

11 Director of the Office of Science and Tech12 nology,’’ after ‘‘the Secretary,’’; and

13 (B) in the second sentence by striking

14 ‘‘The President’’ and inserting ‘‘The Director of

15 the Office of Science and Technology’’.

16 SEC. 9. SAVINGS PROVISION.

17 Nothing in this Act shall be construed to modify any

18 requirement or standard provided for in another provision

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

20 protect health, safety, or the environment.

21 SEC. 10. DEFINITIONS.

22 For the purposes of this Act:

23 (1) The term ‘‘major rule’’ means any rule (as

24 that term is defined in section 551(4) of title 5,
18

•HR 690 IH

1 United States Code) that is likely to result in an an2 nual effect on the economy of $25,000,000 or more.

3 (2) The term ‘‘risk assessment’’ means a proc4 ess that uses a factual base to—

5 (A) identify, characterize, and to the ex6 tent practicable quantify the potential adverse

7 effects of exposure of individuals, populations,

8 habitats, ecosystems, or materials to hazardous

9 pollutants or other stressors; and

10 (B) to the extent practicable, identify and

11 characterize identifiable important uncertain12 ties.

13 (3) The term ‘‘risk characterization’’ means the

14 final component of a risk assessment, that quali15 tatively or quantitatively (or both) describes the

16 magnitude and consequences of that risk in terms of

17 the population exposed to the risk and the types of

18 potential effects of exposure.

19 (4) The term ‘‘uncertainty’’ means the quantifi20 able and unquantifiable potential error in the esti21 mation of risk that is caused by the quality or ab22 sence of data, or the assumptions used in risk esti23 mation.

24 (5) The term ‘‘Director’’ means the Director of

25 an Office.
19

•HR 690 IH

1 (6) The term ‘‘Office’’ means the Office of Risk

2 Assessment and Cost-Benefit Analysis of a covered

3 agency.

4 (7) The term ‘‘covered agency’’ means each of

5 the following:

6 (A) The Environmental Protection Agency.

7 (B) The Consumer Product Safety Com8 mission.

9 (C) The Occupational Health and Safety

10 Administration.

11 (D) The Department of Labor.

12 (E) The Department of Transportation.

13 (F) The Department of Energy.

14 (G) The Department of Agriculture.

15 (H) The Department of the Interior.

16 (I) The Nuclear Regulatory Commission.

Æ

HR 690 IH——2