106TH CONGRESS
2D SESSION
H. R. 4281
AN ACT
To establish, wherever feasible, guidelines, rec-
ommendations, and regulations that promote the
regulatory acceptance of new or revised scientif-
ically valid toxicological tests that protect human
and animal health and the environment while re-
ducing, refining, or replacing animal tests and
ensuring human safety and product effectiveness.
106TH CONGRESS
2D SESSION
H. R. 4281
AN ACT
To establish, wherever feasible, guidelines, recommendations,
and regulations that promote the regulatory acceptance
of new or revised scientifically valid toxicological tests
that protect human and animal health and the environ-
ment while reducing, refining, or replacing animal tests
and ensuring human safety and product effectiveness.
terizing the results of a scientific expert peer review
of a test method.
SEC. 3. INTERAGENCY COORDINATING COMMITTEE ON THE
VALIDATION OF ALTERNATIVE METHODS.
(a) IN GENERAL.—With respect to the interagency
coordinating committee that is known as the Interagency
Coordinating Committee on the Validation of Alternative
Methods (referred to in this Act as ‘‘ICCVAM’’) and that
was established by the Director of the National Institute
of Environmental Health Sciences for purposes of section
463A(b) of the Public Health Service Act, the Director
of the Institute shall designate such committee as a per-
manent interagency coordinating committee of the Insti-
tute under the National Toxicology Program Interagency
Center for the Evaluation of Alternative Toxicological
Methods. This Act may not be construed as affecting the
authorities of such Director regarding ICCVAM that were
in effect on the day before the date of the enactment of
this Act, except to the extent inconsistent with this Act.
(b) PURPOSES.—The purposes of the ICCVAM shall
be to—
(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 Adminis-
tration.
(16) Any other agency that develops, or em-
ploys 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 Na-
tional Institute of Environmental Health Sciences
shall establish a Scientific Advisory Committee (re-
ferred to in this Act as the ‘‘SAC’’) to advise
ICCVAM and the National Toxicology Program
Interagency Center for the Evaluation of Alternative
Toxicological Methods regarding ICCVAM activities.
The activities of the SAC shall be subject to provi-
sions of the Federal Advisory Committee Act.
(2) MEMBERSHIP.—
(A) IN GENERAL.—The SAC shall be com-
posed of the following voting members:
(i) At least 1 knowledgeable rep-
resentative having a history of expertise,
development, or evaluation of new or re-
vised or alternative test methods from each
of—
(I) the personal care, pharma-
ceutical, industrial chemicals, or agri-
culture 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 Envi-
ronmental Health Sciences) from an aca-
demic institution, a State government
agency, an international regulatory body,
or any corporation developing or marketing
new or revised or alternative test meth-
odologies, including contract laboratories.
(B) NONVOTING EX OFFICIO MEMBERS.—
The membership of the SAC shall, in addition
to voting members under subparagraph (A), in-
clude as nonvoting ex officio members the agen-
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
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-