II

106TH CONGRESS

1ST SESSION S. 1495

To establish, wherever feasible, guidelines, recommendations, and regulations

that promote the regulatory acceptance of new and revised toxicological

tests that protect human and animal health and the environment while

reducing, refining, or replacing animal tests and ensuring human safety

and product effectiveness.

IN THE SENATE OF THE UNITED STATES

AUGUST 4, 1999

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

to the Committee on Health, Education, Labor, and Pensions

A BILL

To establish, wherever feasible, guidelines, recommendations,

and regulations that promote the regulatory acceptance

of new and revised toxicological tests that protect human

and animal health and the environment while reducing,

refining, or replacing animal tests and ensuring human

safety and product effectiveness.

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 ‘‘ICCVAM Authoriza5 tion Act of 1999’’.
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1 SEC. 2. INTERAGENCY COORDINATING COMMITTEE ON THE

2 VALIDATION OF ALTERNATIVE METHODS.

3 (a) IN GENERAL.—The Interagency Coordinating

4 Committee on the Validation of Alternative Methods (re5 ferred to in this Act as ‘‘ICCVAM’’) shall be sustained

6 as a permanent standing committee and continued to be

7 administered by the National Institute of Environmental

8 Health Sciences. The purposes of ICCVAM shall be to—

9 (1) increase the efficiency and effectiveness of

10 Federal agency test method review;

11 (2) eliminate duplicative efforts and share expe12 riences across Federal regulatory agencies;

13 (3) optimize utilization of scientific expertise

14 outside the Federal Government;

15 (4) ensure that new test methods meet the

16 needs of Federal agencies; and

17 (5) reduce, refine, and replace the use of ani18 mals in testing.

19 (b) COMPOSITION.—ICCVAM shall be comprised of

20 a representative from each of the following agencies and

21 organizations:

22 (1) Agency for Toxic Substances and Disease

23 Registry.

24 (2) Consumer Product Safety Commission.

25 (3) Department of Agriculture.

26 (4) Department of Defense.
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1 (5) Department of Energy.

2 (6) Department of the Interior.

3 (7) Department of Transportation.

4 (8) Environmental Protection Agency.

5 (9) Food and Drug Administration.

6 (10) National Institute for Occupational Safety

7 and Health.

8 (11) National Institutes of Health.

9 (12) National Cancer Institute.

10 (13) National Institute of Environmental

11 Health Sciences.

12 (14) National Library of Medicine.

13 (15) Occupational Safety and Health Adminis14 tration.

15 (16) Any other agency that develops, employs,

16 or regulates the use of animals in toxicity testing.

17 (c) SCIENTIFIC ADVISORY COMMITTEE.—

18 (1) ESTABLISHMENT.—In addition, the Na19 tional Institute of Environmental Health Sciences

20 shall establish a Scientific Advisory Committee to

21 assist ICCVAM and the National Institute of Envi22 ronmental Health Sciences. The Committee shall be

23 composed of at least one knowledgeable representa24 tive having a history of expertise, development, or
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1 evaluation in alternatives to animal toxicological

2 tests, from each of the following interests:

3 (A) The personal care, pharmaceutical, in4 dustrial chemicals, agriculture, and any other

5 regulated industry.

6 (B) A national animal protection organiza7 tion established under section 501(c)(3) of the

8 Internal Revenue Code of 1986.

9 (2) MEMBERSHIP.— The National Institute of

10 Environmental Health Sciences shall also invite to

11 be members of the Scientific Advisory Committee

12 representatives from other stakeholder organizations

13 such as:

14 (A) An academic institution.

15 (B) A State government agency.

16 (C) An international regulatory body.

17 (D) A corporation developing or marketing

18 alternative test methodologies including con19 tract laboratories.

20 (d) DUTIES.—ICCVAM shall carry out the following

21 duties consistent with the protection of public health and

22 the environment and for the purpose of reducing, refining,

23 and replacing the use of animals in acute and chronic toxi24 cological tests:
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1 (1) Review and evaluate existing and new alter2 native methods, including batteries of tests and test

3 screens, which may be acceptable for specific regu4 latory uses, including the coordination of technical

5 reviews of proposed new or revised test methods of

6 interagency interest.

7 (2) Facilitate interagency and international

8 harmonization of acute chronic toxicological test pro9 tocols that encourage the reduction, refinement, or

10 replacement of animal tests.

11 (3) Facilitate, promote, and provide guidance

12 on development of validation criteria and processes

13 for new methods and help promote the acceptance of

14 such methods and awareness of accepted methods by

15 Federal agencies and other stakeholders.

16 (4) File formal recommendations with each ap17 propriate Federal agency identifying specific agency

18 guidelines, recommendations, or regulations for each

19 new test, battery of tests, test screen, or end point

20 reviewed by ICCVAM that may be appropriate for

21 the reduction, refinement, or replacement of an ani22 mal test required or recommended by that Federal

23 agency for compliance with that agency’s specific

24 statutes, regulations, or guidelines. Tests may be
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1 recommended for a certain class of chemicals within

2 that regulatory framework.

3 (5) Consider for review and evaluation, peti4 tions received from the public which identify a spe5 cific regulation, recommendation, or guideline, and

6 which recommend alternatives and provide scientific

7 evidence of the acceptability of the alternatives for

8 the purpose of carrying out the regulatory mandate

9 in question.

10 (6) Make final recommendations to agencies

11 and responses from agencies available to the public.

12 (7) Make an annual report to be made available

13 to the public on its progress to promote the regu14 latory acceptance of new and revised toxicological

15 tests.

16 SEC. 3. APPLICATION.

17 This Act shall not apply to regulations, guidelines,

18 or recommendations related to medical research. The term

19 ‘‘medical research’’ means research, including research

20 performed using biotechnology, related to the causes, diag21 nosis, treatment, or control of physical or mental impair22 ments of humans or animals. The term does not include

23 the testing of a product to determine its toxicity for the

24 purpose of complying with protocols, recommendations, or

25 guidelines for testing required, recommended, or accepted
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1 by a Federal regulatory agency for a product introduced

2 in commerce.

3 SEC. 4. FEDERAL AGENCY ACTION.

4 (a) IDENTIFICATION OF TESTS.—Within 180 days

5 after the date of enactment of this Act, each Federal agen6 cy authorized to carry out a regulatory program which re7 quires or recommends acute or chronic toxicological test8 ing shall identify any regulation or industry-wide guideline

9 which specifically, or in practice requires, recommends, or

10 encourages the use of an animal acute or chronic toxi11 cological test and shall forward to ICCVAM a list of these

12 regulations, guidelines, and recommendations along with

13 the test or tests recommended or required.

14 (b) ALTERNATIVES.—Each Federal agency shall pro15 mote and encourage the development and use of alter16 natives to animal tests, including batteries of tests and

17 test screens, where appropriate, for the purpose of com18 plying with Federal regulations, guidelines, or rec19 ommendations, in each instance, and for each chemical

20 class, for which such tests are found to be effective for

21 generating data at least equivalent for hazard identifica22 tion or dose-response assessment purposes to the method

23 established under the current regulatory scheme.

24 (c) TEST VALIDATION.—Each Federal agency shall

25 ensure that any new acute or chronic toxicity test, includ-
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1 ing animal tests and alternatives, is determined to be valid

2 for its proposed use prior to requiring, recommending, or

3 encouraging its application.

4 (d) REVIEWS.—Each Federal agency shall review any

5 formal recommendations from ICCVAM to promulgate

6 new regulations or draft new guidelines or recommenda7 tions to promote the ICCVAM recommendations and no8 tify ICCVAM in writing of its findings within 180 days

9 of receipt of the recommendations.

10 (e) RECOMMENDATION ADOPTION.—Each Federal

11 agency shall adopt the ICCVAM recommendations unless

12 each individual Federal agency determines that—

13 (1) the alternative is not adequate in terms of

14 biological relevance for the regulatory goal author15 ized by that agency;

16 (2) the alternative does not generate data at

17 least equivalent for the appropriate hazard identi18 fication or dose-response assessment purpose as the

19 method recommended by that agency;

20 (3) that agency does not employ, recommend,

21 or require testing for that class of chemical or for

22 the recommended end point; or
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1 (4) the new test method is unacceptable for sat2 isfactorily fulfilling the test needs for that particular

3 agency and its respective congressional mandate.

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