I
104TH CONGRESS
2D SESSION
H. R. 3173
To establish, wherever possible, nonanimal acute toxicity testing as an accept-
able 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. GEJDEN-
SON, 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 Com-
mittee on Commerce
A BILL
To establish, wherever possible, nonanimal acute toxicity test-
ing as an acceptable standard for Government regula-
tions requiring an evaluation of the safety of products
by the Federal Government.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Consumer Products
Safe Testing Act’’.
SEC. 2. FINDINGS AND POLICY.
(a) FINDINGS.—The Congress finds that—
(1) the Federal Government has discouraged
the use of non-animal acute toxicity tests through
regulations that mandate or encourage the use of
animal acute toxicity tests, or by not prescribing
other, less costly, more accurate and humane alter-
natives;
(2) nonanimal acute toxicity tests have been de-
veloped in recent years that have shown a level of re-
liability sufficient for the reduction or replacement
of animal acute toxicity tests such as the Draize test
for many products regulated by the Federal Govern-
ment;
(3) many manufacturers have found nonanimal
acute toxicity tests to be adequate for evaluating the
safety of products for the purposes of complying
with Federal regulations or guidelines;
(4) many manufacturers are reluctant to use
nonanimal tests without encouragement from the
Federal Government;
(5) private industry and the consumer will ben-
efit from the promotion of alternative methods of
testing when these alternatives are as accurate in
predicting human safety and more humane than ani-
mal tests; and
(6) over the long term, nonanimal acute toxicity
testing will produce better data, decrease costs, and
reduce the time industry and the regulatory agency
spend in the approval process.
(b) POLICY.—Federal departments and agencies shall
encourage the development and use of product testing pro-
cedures that accurately reflect the acute health effects on
humans of certain products, including consumer products
and products containing hazardous or toxic substances,
but which do not rely upon animals.
SEC. 3. FEDERAL ACTION.
(a) REVIEW
OF REGULATIONS, GUIDELINES, OR
RECOMMENDATIONS CONCERNING
THE DRAIZE TEST
AND OTHER ANIMAL ACUTE TOXICITY TESTS.—Not later
than one year after the date of enactment of this Act, each
Federal department or agency head shall—
(1) review and evaluate any regulation, guide-
line, or recommendation issued by that department
or agency which requires, recommends, or encour-
ages the use of the Draize or other animal acute tox-
icity test for the purpose of evaluation of the safety
of a regulated product;
(2) review and evaluate nonanimal alternatives
with the potential for partial or full replacement of
the Draize or other animal acute toxicity test for
some or all of the products regulated; and
(3) promulgate regulations, guidelines, or rec-
ommendations that specify a nonanimal acute tox-
icity test or battery of tests should be used instead
of an animal acute toxicity test unless that Federal
department or agency head determines that the
nonanimal acute toxicity test or battery of such tests
is less likely to predict the acute health effects on
humans of a product than the animal acute toxicity
test.
(b) CORPORATE TESTING POLICIES.—Nothing in
this Act shall be interpreted to prohibit, recommend, or
require any testing protocol or procedure by a corporation,
institution, or individual to determine the safety of its
products that is not required or recommended under this
Act.
(c) ANIMAL ACUTE TOXICITY TESTS.—Any Federal
department or agency head that finds that regulations re-
quiring or recommending animal tests should not be
amended, shall publish in the Federal Register an expla-
nation of options considered and the justification for con-
tinuing the animal acute toxicity test.
(d) PERIODIC REVIEW OF ANIMAL ACUTE TOXICITY
TESTING REGULATIONS.—At least every 2 years (begin-
ning 3 years after the date of enactment of this Act), each
Federal department or agency head, after considering the
most recent technological advances available, shall deter-
mine whether continued use of any animal acute toxicity
test is justified. If a Federal department or agency head
determines that such use is justified, then that Federal
department or agency head shall publish an explanation
of such continued use in the Federal Register.
SEC. 4. APPLICATION.
This Act shall not apply to regulations, guidelines,
or recommendations related to medical research.
SEC. 5. DEFINITIONS.
For purposes of this Act:
(1) ANIMAL.—The term ‘‘animal’’ means any
vertebrate.
(2) ANIMAL ACUTE TOXICITY TEST.—The term
‘‘animal acute toxicity test’’ means an acute toxicity
test on animals, including (but not limited to) the
Draize eye or skin irritancy test, LD–50 test, ap-
proximate lethal dose test, and the limit test.
(3) 
FEDERAL
DEPARTMENT
OR
AGENCY
HEAD.—The term ‘‘Federal department or agency
head’’ means the head of a Federal department or
agency who—
(A) has authority to promulgate regula-
tions, guidelines, and recommendations with re-
spect to procedures to be used in the safety
testing by manufacturers of products, including
consumer products, veterinary products, and
products containing hazardous or toxic sub-
stances; or
(B) licenses or approves products, labeling
requirements or the transportation of products
based on the results of these tests.
(4) MEDICAL RESEARCH.—The term ‘‘medical
research’’ means research, including research per-
formed using biotechnology, related to the causes,
diagnosis, treatment, or control of physical or men-
tal impairments of humans or animals. The term
does not include the testing of a product to deter-
mine its toxicity for the purpose of complying with
protocols, recommendations, or guidelines for testing
required, recommended, or accepted by a Federal
regulatory agency for a product introduced in com-
merce.
(5) NONANIMAL ACUTE TOXICITY TEST.—The
term ‘‘nonanimal acute toxicity test’’ means an
acute toxicity test not conducted on animals. Such
tests include (but are not limited to) cell culture,
computer 
modeling, 
protein 
alteration, 
and
chorioallantoic membrane techniques.
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