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cy heads specified in subsection (c) (or their
designees).
(e) DUTIES.—The ICCVAM shall, consistent with the
purposes described in subsection (b), carry out the fol-
lowing functions:
(1) Review and evaluate new or revised or alter-
native test methods, including batteries of tests and
test screens, that may be acceptable for specific reg-
ulatory uses, including the coordination of technical
reviews of proposed new or revised or alternative test
methods of interagency interest.
(2) Facilitate appropriate interagency and
international harmonization of acute or chronic toxi-
cological test protocols that encourage the reduction,
refinement, or replacement of animal test methods.
(3) Facilitate and provide guidance on the de-
velopment of validation criteria, validation studies
and processes for new or revised or alternative test
methods and help facilitate the acceptance of such
scientifically valid test methods and awareness of ac-
cepted test methods by Federal agencies and other
stakeholders.
(4) Submit ICCVAM test recommendations for
the test method reviewed by the ICCVAM, through
expeditious transmittal by the Secretary of Health
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and Human Services (or the designee of the Sec-
retary), to each appropriate Federal agency, along
with the identification of specific agency guidelines,
recommendations, or regulations for a test method,
including batteries of tests and test screens, for
chemicals or class of chemicals within a regulatory
framework that may be appropriate for scientific im-
provement, while seeking to reduce, refine, or re-
place animal test methods.
(5) Consider for review and evaluation, peti-
tions received from the public that—
(A) identify a specific regulation, rec-
ommendation, or guideline regarding a regu-
latory mandate; and
(B) recommend new or revised or alter-
native test methods and provide valid scientific
evidence of the potential of the test method.
(6) Make available to the public final ICCVAM
test recommendations to appropriate Federal agen-
cies and the responses from the agencies regarding
such recommendations.
(7) Prepare reports to be made available to the
public on its progress under this Act. The first re-
port shall be completed not later than 12 months
after the date of the enactment of this Act, and sub-
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sequent reports shall be completed biennially there-
after.
SEC. 4. FEDERAL AGENCY ACTION.
(a) IDENTIFICATION
OF TESTS.—With respect to
each Federal agency carrying out a program that requires
or recommends acute or chronic toxicological testing, such
agency shall, not later than 180 days after receiving an
ICCVAM test recommendation, identify and forward to
the ICCVAM any relevant test method specified in a regu-
lation or industry-wide guideline which specifically, or in
practice requires, recommends, or encourages the use of
an animal acute or chronic toxicological test method for
which the ICCVAM test recommendation may be added
or substituted.
(b) ALTERNATIVES.—Each Federal agency carrying
out a program described in subsection (a) shall promote
and encourage the development and use of alternatives to
animal test methods (including batteries of tests and test
screens), where appropriate, for the purpose of complying
with Federal statutes, regulations, guidelines, or rec-
ommendations (in each instance, and for each chemical
class) if such test methods are found to be effective for
generating data, in an amount and of a scientific value
that is at least equivalent to the data generated from exist-
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ing tests, for hazard identification, dose-response assess-
ment, or risk assessment purposes.
(c) TEST
METHOD
VALIDATION.—Each Federal
agency carrying out a program described in subsection (a)
shall ensure that any new or revised acute or chronic tox-
icity test method, including animal test methods and alter-
natives, is determined to be valid for its proposed use prior
to requiring, recommending, or encouraging the applica-
tion of such test method.
(d) REVIEW.—Not later than 180 days after receipt
of an ICCVAM test recommendation, a Federal agency
carrying out a program described in subsection (a) shall
review such recommendation and notify the ICCVAM in
writing of its findings.
(e) RECOMMENDATION ADOPTION.—Each Federal
agency carrying out a program described in subsection (a),
or its specific regulatory unit or units, shall adopt the
ICCVAM test recommendation unless such Federal agency
determines that—
(1) the ICCVAM test recommendation is not
adequate in terms of biological relevance for the reg-
ulatory goal authorized by that agency, or mandated
by Congress;
(2) the ICCVAM test recommendation does not
generate data, in an amount and of a scientific value
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that is at least equivalent to the data generated
prior to such recommendation, for the appropriate
hazard identification, dose-response assessment, or
risk assessment purposes as the current test method
recommended or required by that agency;
(3) the agency does not employ, recommend, or
require testing for that class of chemical or for the
recommended test endpoint; or
(4) the ICCVAM test recommendation is unac-
ceptable for satisfactorily fulfilling the test needs for
that particular agency and its respective congres-
sional mandate.
SEC. 5. APPLICATION.
(a) APPLICATION.—This Act shall not apply to re-
search, including research performed using biotechnology
techniques, or research related to the causes, diagnosis,
treatment, control, or prevention of physical or mental dis-
eases or impairments of humans or animals.
(b) USE OF TEST METHODS.—Nothing in this Act
shall prevent a Federal agency from retaining final au-
thority for incorporating the test methods recommended
by the ICCVAM in the manner determined to be appro-
priate by such Federal agency or regulatory body.
(c) LIMITATION.—Nothing in this Act shall be con-
strued to require a manufacturer that is currently not re-
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quired to perform animal testing to perform such tests.
Nothing in this Act shall be construed to require a manu-
facturer to perform redundant endpoint specific testing.
(d) SUBMISSION OF TESTS AND DATA.—Nothing in
this Act precludes a party from submitting a test method
or scientific data directly to a Federal agency for use in
a regulatory program.
Passed the House of Representatives October 17,
2000.
Attest:
JEFF TRANDAHL,
Clerk.