I

104TH CONGRESS

2D SESSION H. R. 3173

To establish, wherever possible, nonanimal acute toxicity testing as an acceptable standard for Government regulations requiring an evaluation of

the safety of products by the Federal Government.

IN THE HOUSE OF REPRESENTATIVES

MARCH 27, 1996

Mr. LANTOS (for himself, Mr. BROWN of California, Ms. WATERS, Mr.

MORAN, Mr. FRANK of Massachusetts, Mr. ABERCROMBIE, Mr. GEJDENSON, Mr. COLEMAN, Ms. PELOSI, Mr. STARK, Mr. KLECZKA, Mr. MILLER

of California, Mr. JACOBS, Mr. SANDERS, Mr. DEFAZIO, Ms. WOOLSEY,

Mr. TORRES, Ms. RIVERS, Mr. LEWIS of Georgia, Mr. CARDIN, Mr.

CLAY, Mr. DELLUMS, Mr. JOHNSON of South Dakota, Mr. YATES, Mrs.

MINK of Hawaii, Mr. SCHUMER, Mr. FARR, Mr. FOGLIETTA, Mr.

TORRICELLI, Mr. PORTER, Mr. JOHNSTON of Florida, Mr. SHAYS, and

Mr. REED) introduced the following bill; which was referred to the Committee on Commerce

A BILL

To establish, wherever possible, nonanimal acute toxicity testing as an acceptable standard for Government regulations requiring an evaluation of the safety of products

by the Federal Government.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Consumer Products

3 Safe Testing Act’’.

4 SEC. 2. FINDINGS AND POLICY.

5 (a) FINDINGS.—The Congress finds that—

6 (1) the Federal Government has discouraged

7 the use of non-animal acute toxicity tests through

8 regulations that mandate or encourage the use of

9 animal acute toxicity tests, or by not prescribing

10 other, less costly, more accurate and humane alter11 natives;

12 (2) nonanimal acute toxicity tests have been de13 veloped in recent years that have shown a level of re14 liability sufficient for the reduction or replacement

15 of animal acute toxicity tests such as the Draize test

16 for many products regulated by the Federal Govern17 ment;

18 (3) many manufacturers have found nonanimal

19 acute toxicity tests to be adequate for evaluating the

20 safety of products for the purposes of complying

21 with Federal regulations or guidelines;

22 (4) many manufacturers are reluctant to use

23 nonanimal tests without encouragement from the

24 Federal Government;

25 (5) private industry and the consumer will ben26 efit from the promotion of alternative methods of
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1 testing when these alternatives are as accurate in

2 predicting human safety and more humane than ani3 mal tests; and

4 (6) over the long term, nonanimal acute toxicity

5 testing will produce better data, decrease costs, and

6 reduce the time industry and the regulatory agency

7 spend in the approval process.

8 (b) POLICY.—Federal departments and agencies shall

9 encourage the development and use of product testing pro10 cedures that accurately reflect the acute health effects on

11 humans of certain products, including consumer products

12 and products containing hazardous or toxic substances,

13 but which do not rely upon animals.

14 SEC. 3. FEDERAL ACTION.

15 (a) REVIEW OF REGULATIONS, GUIDELINES, OR

16 RECOMMENDATIONS CONCERNING THE DRAIZE TEST

17 AND OTHER ANIMAL ACUTE TOXICITY TESTS.—Not later

18 than one year after the date of enactment of this Act, each

19 Federal department or agency head shall—

20 (1) review and evaluate any regulation, guide21 line, or recommendation issued by that department

22 or agency which requires, recommends, or encour23 ages the use of the Draize or other animal acute tox24 icity test for the purpose of evaluation of the safety

25 of a regulated product;
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1 (2) review and evaluate nonanimal alternatives

2 with the potential for partial or full replacement of

3 the Draize or other animal acute toxicity test for

4 some or all of the products regulated; and

5 (3) promulgate regulations, guidelines, or rec6 ommendations that specify a nonanimal acute tox7 icity test or battery of tests should be used instead

8 of an animal acute toxicity test unless that Federal

9 department or agency head determines that the

10 nonanimal acute toxicity test or battery of such tests

11 is less likely to predict the acute health effects on

12 humans of a product than the animal acute toxicity

13 test.

14 (b) CORPORATE TESTING POLICIES.—Nothing in

15 this Act shall be interpreted to prohibit, recommend, or

16 require any testing protocol or procedure by a corporation,

17 institution, or individual to determine the safety of its

18 products that is not required or recommended under this

19 Act.

20 (c) ANIMAL ACUTE TOXICITY TESTS.—Any Federal

21 department or agency head that finds that regulations re22 quiring or recommending animal tests should not be

23 amended, shall publish in the Federal Register an expla24 nation of options considered and the justification for con25 tinuing the animal acute toxicity test.
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1 (d) PERIODIC REVIEW OF ANIMAL ACUTE TOXICITY

2 TESTING REGULATIONS.—At least every 2 years (begin3 ning 3 years after the date of enactment of this Act), each

4 Federal department or agency head, after considering the

5 most recent technological advances available, shall deter6 mine whether continued use of any animal acute toxicity

7 test is justified. If a Federal department or agency head

8 determines that such use is justified, then that Federal

9 department or agency head shall publish an explanation

10 of such continued use in the Federal Register.

11 SEC. 4. APPLICATION.

12 This Act shall not apply to regulations, guidelines,

13 or recommendations related to medical research.

14 SEC. 5. DEFINITIONS.

15 For purposes of this Act:

16 (1) ANIMAL.—The term ‘‘animal’’ means any

17 vertebrate.

18 (2) ANIMAL ACUTE TOXICITY TEST.—The term

19 ‘‘animal acute toxicity test’’ means an acute toxicity

20 test on animals, including (but not limited to) the

21 Draize eye or skin irritancy test, LD–50 test, ap22 proximate lethal dose test, and the limit test.

23 (3) FEDERAL DEPARTMENT OR AGENCY

24 HEAD.—The term ‘‘Federal department or agency
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1 head’’ means the head of a Federal department or

2 agency who—

3 (A) has authority to promulgate regula4 tions, guidelines, and recommendations with re5 spect to procedures to be used in the safety

6 testing by manufacturers of products, including

7 consumer products, veterinary products, and

8 products containing hazardous or toxic sub9 stances; or

10 (B) licenses or approves products, labeling

11 requirements or the transportation of products

12 based on the results of these tests.

13 (4) MEDICAL RESEARCH.—The term ‘‘medical

14 research’’ means research, including research per15 formed using biotechnology, related to the causes,

16 diagnosis, treatment, or control of physical or men17 tal impairments of humans or animals. The term

18 does not include the testing of a product to deter19 mine its toxicity for the purpose of complying with

20 protocols, recommendations, or guidelines for testing

21 required, recommended, or accepted by a Federal

22 regulatory agency for a product introduced in com23 merce.

24 (5) NONANIMAL ACUTE TOXICITY TEST.—The

25 term ‘‘nonanimal acute toxicity test’’ means an
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1 acute toxicity test not conducted on animals. Such

2 tests include (but are not limited to) cell culture,

3 computer modeling, protein alteration, and

4 chorioallantoic membrane techniques.

Æ