H. R. 4281—2
(1) increase the efficiency and effectiveness of Federal
agency test method review;
(2) eliminate unnecessary duplicative efforts and share
experiences between Federal regulatory agencies;
(3) optimize utilization of scientific expertise outside the
Federal Government;
(4) ensure that new and revised test methods are validated
to meet the needs of Federal agencies; and
(5) reduce, refine, or replace the use of animals in testing,
where feasible.
(c) COMPOSITION.—The ICCVAM shall be composed of the heads
of the following Federal agencies (or their designees):
(1) Agency for Toxic Substances and Disease Registry.
(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 Administration.
(16) Any other agency that develops, or employs tests or
test data using animals, or regulates on the basis of the use
of animals in toxicity testing.
(d) SCIENTIFIC ADVISORY COMMITTEE.—
(1) ESTABLISHMENT.—The Director of the National Institute
of Environmental Health Sciences shall establish a Scientific
Advisory Committee (referred to in this Act as the ‘‘SAC’’)
to advise ICCVAM and the National Toxicology Program Inter-
agency Center for the Evaluation of Alternative Toxicological
Methods regarding ICCVAM activities. The activities of the
SAC shall be subject to provisions of the Federal Advisory
Committee Act.
(2) MEMBERSHIP.—
(A) IN GENERAL.—The SAC shall be composed of the
following voting members:
(i) At least one knowledgeable representative
having a history of expertise, development, or evalua-
tion of new or revised or alternative test methods
from each of—
(I) the personal care, pharmaceutical, indus-
trial chemicals, or agriculture industry;
(II) any other industry that is regulated by
the Federal agencies specified in subsection (c);
and
(III) a national animal protection organization
established under section 501(c)(3) of the Internal
Revenue Code of 1986.
(ii) Representatives (selected by the Director of
the National Institute of Environmental Health
H. R. 4281—3
Sciences) from an academic institution, a State govern-
ment agency, an international regulatory body, or any
corporation developing or marketing new or revised
or alternative test methodologies, including contract
laboratories.
(B) NONVOTING EX OFFICIO MEMBERS.—The member-
ship of the SAC shall, in addition to voting members under
subparagraph (A), include as nonvoting ex officio members
the agency heads specified in subsection (c) (or their des-
ignees).
(e) DUTIES.—The ICCVAM shall, consistent with the purposes
described in subsection (b), carry out the following functions:
(1) Review and evaluate new or revised or alternative test
methods, including batteries of tests and test screens, that
may be acceptable for specific regulatory 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 toxicological test protocols
that encourage the reduction, refinement, or replacement of
animal test methods.
(3) Facilitate and provide guidance on the development
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 aware-
ness of accepted test methods by Federal agencies and other
stakeholders.
(4) Submit ICCVAM test recommendations for the test
method reviewed by the ICCVAM, through expeditious trans-
mittal by the Secretary of Health and Human Services (or
the designee of the Secretary), to each appropriate Federal
agency, along with the identification of specific agency guide-
lines, 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 improvement, while seeking to
reduce, refine, or replace animal test methods.
(5) Consider for review and evaluation, petitions received
from the public that—
(A) identify a specific regulation, recommendation, or
guideline regarding a regulatory mandate; and
(B) recommend new or revised or alternative test
methods and provide valid scientific evidence of the poten-
tial of the test method.
(6) Make available to the public final ICCVAM test rec-
ommendations to appropriate Federal agencies 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 report shall be com-
pleted not later than 12 months after the date of the enactment
of this Act, and subsequent reports shall be completed bienni-
ally thereafter.
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
H. R. 4281—4
180 days after receiving an ICCVAM test recommendation, identify
and forward to the ICCVAM any relevant test method specified
in a regulation 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 pro-
gram 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 recommendations (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 existing tests, for
hazard identification, dose-response assessment, 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 toxicity test method, including
animal test methods and alternatives, is determined to be valid
for its proposed use prior to requiring, recommending, or encour-
aging the application 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 recommenda-
tion and notify the ICCVAM in writing of its findings.
(e) RECOMMENDATION ADOPTION.—Each Federal agency car-
rying out a program described in subsection (a), or its specific
regulatory unit or units, shall adopt the ICCVAM test recommenda-
tion unless such Federal agency determines that—
(1) the ICCVAM test recommendation is not adequate in
terms of biological relevance for the regulatory 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 that is at least
equivalent to the data generated prior to such recommendation,
for the appropriate hazard identification, dose-response assess-
ment, 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 unacceptable for
satisfactorily fulfilling the test needs for that particular agency
and its respective congressional mandate.
SEC. 5. APPLICATION.
(a) APPLICATION.—This Act shall not apply to research,
including research performed using biotechnology techniques, or
research related to the causes, diagnosis, treatment, control, or
prevention of physical or mental diseases or impairments of humans
or animals.
(b) USE OF TEST METHODS.—Nothing in this Act shall prevent
a Federal agency from retaining final authority for incorporating
the test methods recommended by the ICCVAM in the manner
H. R. 4281—5
determined to be appropriate by such Federal agency or regulatory
body.
(c) LIMITATION.—Nothing in this Act shall be construed to
require a manufacturer that is currently not required to perform
animal testing to perform such tests. Nothing in this Act shall
be construed to require a manufacturer to perform redundant end-
point specific testing.
(d) SUBMISSION OF TESTS AND DATA.—Nothing in this Act pre-
cludes a party from submitting a test method or scientific data
directly to a Federal agency for use in a regulatory program.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.