II

Calendar No. 946

106TH CONGRESS

2D SESSION S. 1495

[Report No. 106–496]

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 (for himself, Mr. SMITH of New Hampshire, Mrs. MURRAY, Mr.

SANTORUM, Mrs. BOXER, and Mr. ABRAHAM) introduced the following

bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

OCTOBER 11 (legislative day, SEPTEMBER 22), 2000

Reported by Mr. JEFFORDS, with an amendment

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

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.
2

•S 1495 RS

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’’.

6 SEC. 2. INTERAGENCY COORDINATING COMMITTEE ON THE

7 VALIDATION OF ALTERNATIVE METHODS.

8 (a) IN GENERAL.—The Interagency Coordinating

9 Committee on the Validation of Alternative Methods (re10 ferred to in this Act as ‘‘ICCVAM’’) shall be sustained

11 as a permanent standing committee and continued to be

12 administered by the National Institute of Environmental

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

14 (1) increase the efficiency and effectiveness of

15 Federal agency test method review;

16 (2) eliminate duplicative efforts and share expe17 riences across Federal regulatory agencies;

18 (3) optimize utilization of scientific expertise

19 outside the Federal Government;

20 (4) ensure that new test methods meet the

21 needs of Federal agencies; and

22 (5) reduce, refine, and replace the use of ani23 mals in testing.
3

•S 1495 RS

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

2 a representative from each of the following agencies and

3 organizations:

4 (1) Agency for Toxic Substances and Disease

5 Registry.

6 (2) Consumer Product Safety Commission.

7 (3) Department of Agriculture.

8 (4) Department of Defense.

9 (5) Department of Energy.

10 (6) Department of the Interior.

11 (7) Department of Transportation.

12 (8) Environmental Protection Agency.

13 (9) Food and Drug Administration.

14 (10) National Institute for Occupational Safety

15 and Health.

16 (11) National Institutes of Health.

17 (12) National Cancer Institute.

18 (13) National Institute of Environmental

19 Health Sciences.

20 (14) National Library of Medicine.

21 (15) Occupational Safety and Health Adminis22 tration.

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

24 or regulates the use of animals in toxicity testing.

25 (c) SCIENTIFIC ADVISORY COMMITTEE.—
4

•S 1495 RS

1 (1) ESTABLISHMENT.—In addition, the Na2 tional Institute of Environmental Health Sciences

3 shall establish a Scientific Advisory Committee to

4 assist ICCVAM and the National Institute of Envi5 ronmental Health Sciences. The Committee shall be

6 composed of at least one knowledgeable representa7 tive having a history of expertise, development, or

8 evaluation in alternatives to animal toxicological

9 tests, from each of the following interests:

10 (A) The personal care, pharmaceutical, in11 dustrial chemicals, agriculture, and any other

12 regulated industry.

13 (B) A national animal protection organiza14 tion established under section 501(c)(3) of the

15 Internal Revenue Code of 1986.

16 (2) MEMBERSHIP.— The National Institute of

17 Environmental Health Sciences shall also invite to

18 be members of the Scientific Advisory Committee

19 representatives from other stakeholder organizations

20 such as:

21 (A) An academic institution.

22 (B) A State government agency.

23 (C) An international regulatory body.
5

•S 1495 RS

1 (D) A corporation developing or marketing

2 alternative test methodologies including con3 tract laboratories.

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

5 duties consistent with the protection of public health and

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

7 and replacing the use of animals in acute and chronic toxi8 cological tests:

9 (1) Review and evaluate existing and new alter10 native methods, including batteries of tests and test

11 screens, which may be acceptable for specific regu12 latory uses, including the coordination of technical

13 reviews of proposed new or revised test methods of

14 interagency interest.

15 (2) Facilitate interagency and international

16 harmonization of acute chronic toxicological test pro17 tocols that encourage the reduction, refinement, or

18 replacement of animal tests.

19 (3) Facilitate, promote, and provide guidance

20 on development of validation criteria and processes

21 for new methods and help promote the acceptance of

22 such methods and awareness of accepted methods by

23 Federal agencies and other stakeholders.

24 (4) File formal recommendations with each ap25 propriate Federal agency identifying specific agency
6

•S 1495 RS

1 guidelines, recommendations, or regulations for each

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

3 reviewed by ICCVAM that may be appropriate for

4 the reduction, refinement, or replacement of an ani5 mal test required or recommended by that Federal

6 agency for compliance with that agency’s specific

7 statutes, regulations, or guidelines. Tests may be

8 recommended for a certain class of chemicals within

9 that regulatory framework.

10 (5) Consider for review and evaluation, peti11 tions received from the public which identify a spe12 cific regulation, recommendation, or guideline, and

13 which recommend alternatives and provide scientific

14 evidence of the acceptability of the alternatives for

15 the purpose of carrying out the regulatory mandate

16 in question.

17 (6) Make final recommendations to agencies

18 and responses from agencies available to the public.

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

20 to the public on its progress to promote the regu21 latory acceptance of new and revised toxicological

22 tests.

23 SEC. 3. APPLICATION.

24 This Act shall not apply to regulations, guidelines,

25 or recommendations related to medical research. The term
7

•S 1495 RS

1 ‘‘medical research’’ means research, including research

2 performed using biotechnology, related to the causes, diag3 nosis, treatment, or control of physical or mental impair4 ments of humans or animals. The term does not include

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

6 purpose of complying with protocols, recommendations, or

7 guidelines for testing required, recommended, or accepted

8 by a Federal regulatory agency for a product introduced

9 in commerce.

10 SEC. 4. FEDERAL AGENCY ACTION.

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

12 after the date of enactment of this Act, each Federal agen13 cy authorized to carry out a regulatory program which re14 quires or recommends acute or chronic toxicological test15 ing shall identify any regulation or industry-wide guideline

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

17 encourages the use of an animal acute or chronic toxi18 cological test and shall forward to ICCVAM a list of these

19 regulations, guidelines, and recommendations along with

20 the test or tests recommended or required.

21 (b) ALTERNATIVES.—Each Federal agency shall pro22 mote and encourage the development and use of alter23 natives to animal tests, including batteries of tests and

24 test screens, where appropriate, for the purpose of com25 plying with Federal regulations, guidelines, or rec-
8

•S 1495 RS

1 ommendations, in each instance, and for each chemical

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

3 generating data at least equivalent for hazard identifica4 tion or dose-response assessment purposes to the method

5 established under the current regulatory scheme.

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

7 ensure that any new acute or chronic toxicity test, includ8 ing animal tests and alternatives, is determined to be valid

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

10 encouraging its application.

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

12 formal recommendations from ICCVAM to promulgate

13 new regulations or draft new guidelines or recommenda14 tions to promote the ICCVAM recommendations and no15 tify ICCVAM in writing of its findings within 180 days

16 of receipt of the recommendations.

17 (e) RECOMMENDATION ADOPTION.—Each Federal

18 agency shall adopt the ICCVAM recommendations unless

19 each individual Federal agency determines that—

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

21 biological relevance for the regulatory goal author22 ized by that agency;

23 (2) the alternative does not generate data at

24 least equivalent for the appropriate hazard identi-
9

•S 1495 RS

1 fication or dose-response assessment purpose as the

2 method recommended by that agency;

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

4 or require testing for that class of chemical or for

5 the recommended end point; or

6 (4) the new test method is unacceptable for sat7 isfactorily fulfilling the test needs for that particular

8 agency and its respective congressional mandate.

9 SECTION 1. SHORT TITLE.

10 This Act may be cited as the ‘‘ICCVAM Authorization

11 Act of 2000’’.

12 SEC. 2. DEFINITION.

13 In this Act the term ‘‘alternative test method’’ means

14 a test method that—

15 (1)(A) reduces the number of animals required;

16 (B) refines procedures to lessen or eliminate pain

17 or distress to animals, or enhances animal well-being;

18 or

19 (C) replaces animals with non-animal systems or

20 1 animal species with a phylogenetically lower ani21 mal species, such as replacing a mammal with an in22 vertebrate; and

23 (2) includes any new or revised test method that

24 is developed for use after the date of enactment of this
10

•S 1495 RS

1 Act and proposed as an alternative to a traditional

2 method.

3 SEC. 3. INTERAGENCY COORDINATING COMMITTEE ON THE

4 VALIDATION OF ALTERNATIVE METHODS.

5 (a) IN GENERAL.—The Interagency Coordinating

6 Committee on the Validation of Alternative Methods (re7 ferred to in this Act as ‘‘ICCVAM’’) shall be a permanent

8 standing committee administered by the National Institute

9 of Environmental Health Sciences of the National Institutes

10 of Health under the National Toxicology Program Inter11 agency Center for the Evaluation of Alternative Toxi12 cological Methods.

13 (b) PURPOSES.—With respect to the use of animals in

14 toxicological tests, the purposes of ICCVAM described in

15 subsection (a) shall be to—

16 (1) increase the efficiency and effectiveness of

17 Federal agency test method review;

18 (2) eliminate duplicative efforts and share expe19 riences between Federal regulatory agencies;

20 (3) optimize utilization of scientific expertise

21 outside the Federal Government;

22 (4) ensure that new and revised test methods are

23 validated to meet the needs of Federal agencies; and

24 (5) reduce, refine, and replace the use of animals

25 in testing.
11

•S 1495 RS

1 (c) COMPOSITION.—The ICCVAM described in sub2 section (a) shall be comprised of representatives from each

3 of the following:

4 (1) Agency for Toxic Substances and Disease

5 Registry.

6 (2) Consumer Product Safety Commission.

7 (3) Department of Agriculture.

8 (4) Department of Defense.

9 (5) Department of Energy.

10 (6) Department of the Interior.

11 (7) Department of Transportation.

12 (8) Environmental Protection Agency.

13 (9) Food and Drug Administration.

14 (10) National Institute for Occupational Safety

15 and Health.

16 (11) National Institutes of Health.

17 (12) National Cancer Institute.

18 (13) National Institute of Environmental Health

19 Sciences.

20 (14) National Library of Medicine.

21 (15) Occupational Safety and Health Adminis22 tration.

23 (16) Any other agency that develops, or employs

24 tests or test data using animals, or regulates on the

25 basis of the use of animals in toxicity testing.
12

•S 1495 RS

1 (d) SCIENTIFIC ADVISORY COMMITTEE.—

2 (1) ESTABLISHMENT.—The National Institute of

3 Environmental Health Sciences shall establish a Sci4 entific Advisory Committee (referred to in this Act as

5 the ‘‘SAC’’) to advise the ICCVAM described in sub6 section (a). The activities of the SAC shall be subject

7 to provisions of the Federal Advisory Committee Act.

8 (2) MEMBERSHIP.—The SAC described in para9 graph (1) shall be composed of—

10 (A) at least 1 knowledgeable representative

11 having a history of expertise, development, or

12 evaluation of new or alternative test methods

13 from each of—

14 (i) the personal care, pharmaceutical,

15 industrial chemicals, or agriculture indus16 try, and any other industry that is regu17 lated by the Federal agencies described in

18 subsection (c); and

19 (ii) a national animal protection orga20 nization established under section 501(c)(3)

21 of the Internal Revenue Code of 1986; and

22 (B) representatives (selected by the National

23 Institute of Environmental Health Sciences)

24 from an academic institution, a State govern25 ment agency, an international regulatory body,
13

•S 1495 RS

1 or any corporation developing or marketing new

2 or alternative test methodologies, including con3 tract laboratories.

4 (e) DUTIES.—The ICCVAM described in subsection (a)

5 shall, consistent with the purposes described in subsection

6 (b)—

7 (1) review and evaluate existing and new alter8 native test methods, including batteries of tests and

9 test screens, that may be acceptable for specific regu10 latory uses, including the coordination of technical re11 views of proposed new or revised test methods of inter12 agency interest;

13 (2) facilitate appropriate interagency and inter14 national harmonization of acute and chronic toxi15 cological test protocols that encourage the reduction,

16 refinement, or replacement of animal tests;

17 (3) facilitate, promote, and provide guidance on

18 the development of validation criteria, validation

19 studies and processes for new and revised methods

20 and help promote the acceptance of such methods and

21 awareness of accepted methods by Federal agencies

22 and other stakeholders;

23 (4) file formal recommendations with each ap24 propriate Federal agency identifying specific agency

25 guidelines, recommendations, or regulations for each
14

•S 1495 RS

1 new test, battery of tests, test screen, or endpoint re2 viewed by the ICCVAM that may be appropriate for

3 the reduction, refinement, or replacement of an ani4 mal test required or recommended by that Federal

5 agency for compliance with that agency’s specific

6 statutes, regulations, or guidelines, including filing

7 recommendations for tests for a certain class of chemi8 cals within a regulatory framework;

9 (5) consider for review and evaluation, petitions

10 received from the public that identify a specific regu11 lation, recommendation, or guideline, and that rec12 ommend alternatives and provide scientific evidence

13 of the potential of the alternatives for the purpose of

14 carrying out the regulatory mandate in question;

15 (6) make final recommendations to agencies and

16 make the responses from agencies regarding the final

17 recommendations available to the public; and

18 (7) prepare an annual report to be made avail19 able to the public on its progress to promote and as20 sess validation of new and revised toxicological tests.

21 SEC. 4. FEDERAL AGENCY ACTION.

22 (a) IDENTIFICATION OF TESTS.—Not later than 180

23 days after receipt of an ICCVAM test recommendation, each

24 Federal agency carrying out a program that requires or rec25 ommends acute or chronic toxicological testing shall—
15

•S 1495 RS

1 (1) identify any relevant test requirement speci2 fied in a regulation or industry-wide guideline which

3 specifically, or in practice requires, recommends, or

4 encourages the use of an animal acute or chronic toxi5 cological test for which the ICCVAM test recommenda6 tion may be added or substituted; and

7 (2) forward the identification of such test to the

8 ICCVAM.

9 (b) ALTERNATIVES.—Each Federal agency shall pro10 mote and encourage the development and use of alternatives

11 to animal tests (including batteries of tests and test screens,

12 where appropriate) for the purpose of complying with Fed13 eral statutes, regulations, guidelines, or recommendations

14 (in each instance, and for each chemical class) if such tests

15 are found to be effective for generating data, in an amount

16 and of a scientific value that is at least equivalent to the

17 data generated from existing tests, for hazard identification,

18 dose-response assessment, or risk assessment purposes.

19 (c) TEST VALIDATION.—Each Federal agency shall en20 sure that any new or revised acute or chronic toxicity test,

21 including animal tests and alternatives, is determined to

22 be valid for its proposed use prior to requiring, recom23 mending, or encouraging the application of such test.

24 (d) REVIEW.—Not later than 180 days after receipt

25 of a formal recommendation from the ICCVAM, each Fed-
16

•S 1495 RS

1 eral agency shall review such recommendation and notify

2 the ICCVAM in writing of its findings.

3 (e) RECOMMENDATION ADOPTION.—Each Federal

4 agency, or its specific regulatory unit or units, shall adopt

5 the ICCVAM recommendation unless such Federal agency

6 determines that—

7 (1) the ICCVAM recommendation is not ade8 quate in terms of biological relevance for the regu9 latory goal authorized by that agency, or mandated

10 by Congress;

11 (2) the ICCVAM recommendation does not gen12 erate data, in an amount that is at least equivalent

13 to the data generated prior to such recommendation,

14 for the appropriate hazard identification, dose-re15 sponse assessment, or risk assessment purposes as the

16 method recommended or required by that agency;

17 (3) the agency does not employ, recommend, or

18 require testing for that class of chemical or for the

19 recommended endpoint; or

20 (4) the new or revised test method is unaccept21 able for satisfactorily fulfilling the test needs for that

22 particular agency and its respective congressional

23 mandate.
17

•S 1495 RS

1 SEC. 5. APPLICATION.

2 (a) APPLICATION.—This Act shall not apply to re3 search, including research performed using biotechnology

4 techniques, or research related to the causes, diagnosis,

5 treatment, control, or prevention of physical or mental dis6 eases or impairments of humans and animals using medi7 cally accepted methodologies.

8 (b) USE OF TEST METHODS.—Nothing in this Act

9 shall prevent a Federal agency from retaining final author10 ity for incorporating the test methods recommended by the

11 ICCVAM in the manner determined to be appropriate by

12 such Federal agency or regulatory body.

13 (c) LIMITATION.—Nothing in this Act shall be con14 strued to require a manufacturer that is currently not re15 quired to perform animal testing to perform such tests.

16 Nothing in this Act shall be construed to require a manufac17 turer to perform redundant, endpoint, specific testing.
Calendar No. 946

106TH CONGRESS

2D SESSION S. 1495

[Report No. 106–496]

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 animalhealth and the environment while reducing, refining, or replacing animal tests and ensuringhuman safety and product effectiveness.

OCTOBER 11 (legislative day, SEPTEMBER 22), 2000

Reported with an amendment