I
106TH CONGRESS
2D SESSION
H. R. 4281
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 HOUSE OF REPRESENTATIVES
APRIL 13, 2000
Mr. CALVERT (for himself, Mr. LANTOS, Mr. BROWN of Ohio, Mr. CAMPBELL,
Mrs. CAPPS, Mr. COSTELLO, Mr. DELAHUNT, Mr. DEUTSCH, Ms.
ESHOO, Mr. FRANK of Massachusetts, Mr. GILCHREST, Mr. GILMAN, Mr.
GOSS, Mr. HORN, Mr. HYDE, Mr. MARKEY, Mr. GARY MILLER of Cali-
fornia, Mr. PALLONE, Mr. PORTER, Mr. QUINN, Ms. RIVERS, Mr. SEN-
SENBRENNER, Mr. SHAYS, Mr. SMITH of New Jersey, Mr. TOWNS, Mr.
UDALL of Colorado, Mr. WAXMAN, Mr. WELDON of Pennsylvania and
Ms. WOOLSEY) introduced the following bill; which was referred to the
Committee on Commerce
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.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
(2) Consumer Product Safety Commission.
(3) Department of Agriculture.
(4) Department of Defense.
(5) Department of Energy.
(6) Department of the Interior.
(7) Department of Transportation.
(8) Environmental Protection Agency.
(9) Food and Drug Administration.
(10) National Institute for Occupational Safety
and Health.
(11) National Institutes of Health.
(12) National Cancer Institute.
(13) 
National 
Institute 
of 
Environmental
Health Sciences.
(14) National Library of Medicine.
(15) Occupational Safety and Health Adminis-
tration.
(16) Any other agency that develops, employs,
or regulates the use of animals in toxicity testing.
(c) SCIENTIFIC ADVISORY COMMITTEE.—
(1) ESTABLISHMENT.—In addition, the Na-
tional Institute of Environmental Health Sciences
shall establish a Scientific Advisory Committee to
assist ICCVAM and the National Institute of Envi-
ronmental Health Sciences. The Committee shall be
composed of at least one knowledgeable representa-
tive having a history of expertise, development, or
evaluation in alternatives to animal toxicological
tests, from each of the following interests:
(A) The personal care, pharmaceutical, in-
dustrial chemicals, agriculture, and any other
regulated industry.
(B) A national animal protection organiza-
tion established under section 501(c)(3) of the
Internal Revenue Code of 1986.
(2) MEMBERSHIP.—The National Institute of
Environmental Health Sciences shall also invite to
be members of the Scientific Advisory Committee
representatives from other stakeholder organizations
such as:
(A) An academic institution.
(B) A State government agency.
(C) An international regulatory body.
(D) A corporation developing or marketing
alternative test methodologies including con-
tract laboratories.
(d) DUTIES.—ICCVAM shall carry out the following
duties consistent with the protection of public health and
the environment and for the purpose of reducing, refining,
and replacing the use of animals in acute and chronic toxi-
cological tests:
(1) Review and evaluate existing and new alter-
native methods, including batteries of tests and test
screens, which may be acceptable for specific regu-
latory uses, including the coordination of technical
reviews of proposed new or revised test methods of
interagency interest.
(2) Facilitate interagency and international
harmonization of acute chronic toxicological test pro-
tocols that encourage the reduction, refinement, or
replacement of animal tests.
(3) Facilitate, promote, and provide guidance
on development of validation criteria and processes
for new methods and help promote the acceptance of
such methods and awareness of accepted methods by
Federal agencies and other stakeholders.
(4) File formal recommendations with each ap-
propriate Federal agency identifying specific agency
guidelines, recommendations, or regulations for each
new test, battery of tests, test screen, or end point
reviewed by ICCVAM that may be appropriate for
the reduction, refinement, or replacement of an ani-
mal test required or recommended by that Federal
agency for compliance with that agency’s specific
statutes, regulations, or guidelines. Tests may be
recommended for a certain class of chemicals within
that regulatory framework.
(5) Consider for review and evaluation petitions
received from the public which identify a specific
regulation, recommendation, or guideline, and which
recommend alternatives and provide scientific evi-
dence of the acceptability of the alternatives for the
purpose of carrying out the regulatory mandate in
question.
(6) Make final recommendations to agencies
and responses from agencies available to the public.
(7) Make an annual report to be made available
to the public on its progress to promote the regu-
latory acceptance of new and revised toxicological
tests.
SEC. 3. APPLICATION.
This Act shall not apply to regulations, guidelines,
or recommendations related to medical research. The term
‘‘medical research’’ means research, including research
performed using biotechnology, related to the causes, diag-
nosis, treatment, or control of physical or mental impair-
ments of humans or animals. The term does not include
the testing of a product to determine 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 commerce.
SEC. 4. FEDERAL AGENCY ACTION.
(a) IDENTIFICATION OF TESTS.—Within 180 days
after the date of enactment of this Act, each Federal agen-
cy authorized to carry out a regulatory program which re-
quires or recommends acute or chronic toxicological test-
ing shall identify any regulation or industry-wide guideline
which specifically or in practice requires, recommends, or
encourages the use of an animal acute or chronic toxi-
cological test and shall forward to ICCVAM a list of these
regulations, guidelines, and recommendations along with
the test or tests recommended or required.
(b) ALTERNATIVES.—Each Federal agency shall pro-
mote and encourage the development and use of alter-
natives to animal tests, including batteries of tests and
test screens, where appropriate, for the purpose of com-
plying with Federal regulations, guidelines, or rec-
ommendations, in each instance, and for each chemical
class, for which such tests are found to be effective for
generating data at least equivalent for hazard identifica-
tion or dose-response assessment purposes to the method
established under the current regulatory scheme.
(c) TEST VALIDATION.—Each Federal agency shall
ensure that any new acute or chronic toxicity test, includ-
ing animal tests and alternatives, is determined to be valid
for its proposed use prior to requiring, recommending, or
encouraging its application.
(d) REVIEWS.—Each Federal agency shall review any
formal recommendations from ICCVAM to promulgate
new regulations or draft new guidelines or recommenda-
tions to promote the ICCVAM recommendations and no-
tify ICCVAM in writing of its findings within 180 days
of receipt of the recommendations.
(e) RECOMMENDATION ADOPTION.—Each Federal
agency shall adopt the ICCVAM recommendations unless
each individual Federal agency determines that—
(1) the alternative is not adequate in terms of
biological relevance for the regulatory goal author-
ized by that agency;
(2) the alternative does not generate data at
least equivalent for the appropriate hazard identi-
fication or dose-response assessment purpose as the
method recommended by that agency;
(3) that agency does not employ, recommend,
or require testing for that class of chemical or for
the recommended end point; or
(4) the new test method is unacceptable for sat-
isfactorily fulfilling the test needs for that particular
agency and its respective congressional mandate.
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