[106th Congress Public Law 545]
[From the U.S. Government Printing Office]
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[DOCID: f:publ545.106]
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Public Law 106-545
106th Congress
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 environment while reducing, refining, or replacing animal
tests and ensuring human safety and product effectiveness. <<NOTE: Dec.
19, 2000 - [H.R. 4281]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: ICCVAM
Authorization Act of 2000.>>
SECTION 1. SHORT <<NOTE: 42 USC 201 note.>> TITLE.
This Act may be cited as the ``ICCVAM Authorization Act of 2000''.
SEC. 2. <<NOTE: 42 USC 285l-2.>> DEFINITIONS.
In this Act:
(1) Alternative test method.--The term ``alternative test
method'' means a test method that--
(A) includes any new or revised test method; and
(B)(i) reduces the number of animals required;
(ii) refines procedures to lessen or eliminate pain
or distress to animals, or enhances animal well-being;
or
(iii) replaces animals with non-animal systems or
one animal species with a phylogenetically lower animal
species, such as replacing a mammal with an
invertebrate.
(2) ICCVAM test recommendation.--The term ``ICCVAM test
recommendation'' means a summary report prepared by the ICCVAM
characterizing the results of a scientific expert peer review of
a test method.
SEC. 3. <<NOTE: 42 USC 285l-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 permanent interagency coordinating
committee of the Institute 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--
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(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 Interagency
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
evaluation of new or revised or alternative test
methods from each of--
(I) the personal care,
pharmaceutical, industrial 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
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Sciences) from an academic institution, a State
government 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 membership 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 designees).
(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
awareness 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 transmittal 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 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
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
potential of the test method.
(6) Make available to the public final ICCVAM test
recommendations to appropriate Federal agencies and the
responses from the agencies regarding such recommendations.
(7) <<NOTE: Reports.>> Prepare reports to be made available
to the public on its progress under this
Act. <<NOTE: Deadline.>> The first report shall be completed not
later than 12 months after the date of the enactment of this
Act, and subsequent reports shall be completed biennially
thereafter.
SEC. 4. <<NOTE: 42 USC 285l-4.>> FEDERAL AGENCY ACTION.
(a) <<NOTE: Deadline.>> 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
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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 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 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 encouraging the application of such test
method.
(d) <<NOTE: Deadline.>> 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 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
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 unacceptable for
satisfactorily fulfilling the test needs for that particular
agency and its respective congressional mandate.
SEC. 5. <<NOTE: 42 USC 285l-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
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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 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.
Approved December 19, 2000.
LEGISLATIVE HISTORY--H.R. 4281 (S. 1495):
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HOUSE REPORTS: No. 106-980 (Comm. on Commerce).
SENATE REPORTS: No. 106-496 accompanying S. 1495 (Comm. on Health,
Education, Labor, and Pensions).
CONGRESSIONAL RECORD, Vol. 146 (2000):
Oct. 17, considered and passed House.
Dec. 6, considered and passed Senate.
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