IB
Union Calendar No. 578
106TH CONGRESS
2D SESSION
H. R. 4281
[Report No. 106–980]
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
OCTOBER 16, 2000
Additional sponsors: Mr. WEXLER, Mr. GEJDENSON, Mr. RAHALL, Mr.
BILBRAY, Mr. GALLEGLY, Mr. GREENWOOD, Mr. METCALF, Mr.
RAMSTAD, Mr. GOODLING, Mr. WHITFIELD, Mr. ENGLISH, Mr. CANADY
of Florida, Mr. DOYLE, Mr. KUCINICH, Ms. PELOSI, Mr. COOK, Mrs.
MALONEY of New York, Mr. BLUMENAUER, Mr. NADLER, Mr. GEORGE
MILLER of California, Mr. DEAL of Georgia, Mr. STARK, Mr. BAIRD, Mr.
EVANS, Mr. ACKERMAN, Mr. DIXON, Mr. HALL of Texas, Mr. CAPUANO,
Mr. LEVIN, Mr. HOBSON, Mr. DEFAZIO, Mr. BONIOR, Mr. SWEENEY,
Mr. TIERNEY, Mr. HINCHEY, Ms. BALDWIN, Mr. BERMAN, Mrs. JOHN-
SON of Connecticut, Mr. LOBIONDO, Mr. SAXTON, Mr. ENGEL, Mr.
SHERMAN, Mr. ABERCROMBIE, Mr. HASTINGS of Washington, and Mr.
OXLEY
OCTOBER 16, 2000
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed in italic]
[For text of introduced bill, see copy of bill as introduced on April 13, 2000]
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,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘ICCVAM Authorization
Act of 2000’’.
SEC. 2. DEFINITIONS.
In this Act:
(1) ALTERNATIVE TEST METHOD.—The term ‘‘al-
ternative test method’’ means a test method that—
(A) includes any new or revised test meth-
od; and
(B)(i) reduces the number of animals re-
quired;
(ii) refines procedures to lessen or eliminate
pain or distress to animals, or enhances animal
well-being; or
(iii) replaces animals with non-animal sys-
tems or 1 animal species with a phylogenetically
lower animal species, such as replacing a mam-
mal with an invertebrate.
(2) ICCVAM 
TEST
RECOMMENDATION.—The
term ‘‘ICCVAM test recommendation’’ means a sum-
mary report prepared by the ICCVAM characterizing
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 co-
ordinating committee that is known as the Interagency Co-
ordinating 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—
(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 des-
ignees):
(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 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 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 provisions of the Fed-
eral Advisory Committee Act.
(2) MEMBERSHIP.—
(A) IN GENERAL.—The SAC shall be com-
posed of the following voting members:
(i) At least 1 knowledgeable representa-
tive having a history of expertise, develop-
ment, or evaluation of new or revised or al-
ternative 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 speci-
fied 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 Di-
rector of the National Institute of Environ-
mental Health Sciences) from an academic
institution, a State government agency, an
international regulatory body, or any cor-
poration developing or marketing new or
revised or alternative test methodologies, in-
cluding 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 alter-
native test methods, including batteries of tests and
test screens, that may be acceptable for specific regu-
latory uses, including the coordination of technical re-
views of proposed new or revised or alternative test
methods of interagency interest.
(2) Facilitate appropriate interagency and inter-
national 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 devel-
opment of validation criteria, validation studies and
processes for new or revised or alternative test meth-
ods and help facilitate the acceptance of such scientif-
ically valid test methods and awareness of accepted
test methods by Federal agencies and other stake-
holders.
(4) Submit ICCVAM test recommendations for
the test method reviewed by the ICCVAM, through ex-
peditious transmittal by the Secretary of Health and
Human Services (or the designee of the Secretary), to
each appropriate Federal agency, along with the iden-
tification of specific agency guidelines, recommenda-
tions, or regulations for a test method, including bat-
teries of tests and test screens, for chemicals or class
of chemicals within a regulatory framework that may
be appropriate for scientific improvement, while seek-
ing 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, 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 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 completed not later than 12 months after the
date of the enactment of this Act, and subsequent re-
ports shall be completed biennially thereafter.
SEC. 4. FEDERAL AGENCY ACTION.
(a) IDENTIFICATION OF TESTS.—With respect to each
Federal agency carrying out a program that requires or rec-
ommends 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 regulation or indus-
try-wide guideline which specifically, or in practice re-
quires, 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 Fed-
eral 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 equiva-
lent to the data generated from existing tests, for hazard
identification, dose-response assessment, or risk assessment
purposes.
(c) TEST METHOD VALIDATION.—Each Federal agen-
cy 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 alter-
natives, is determined to be valid for its proposed use prior
to requiring, recommending, or encouraging the application
of such test method.
(d) REVIEW.—Not later than 180 days after receipt
of an ICCVAM test recommendation, a Federal agency car-
rying 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 ade-
quate in terms of biological relevance for the regu-
latory 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 as-
sessment purposes as the current test method rec-
ommended 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 author-
ity for incorporating the test methods recommended by the
ICCVAM in the manner determined to be appropriate 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-
quired to perform animal testing to perform such tests.
Nothing in this Act shall be construed to require a manufac-
turer 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.
Amend the title so as to read: ‘‘A bill to establish,
wherever feasible, guidelines, recommendations, and regu-
lations that promote the regulatory acceptance of new or
revised scientifically 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.’’.
Union Calendar No. 578
106TH CONGRESS
2D SESSION
H. R. 4281
[Report No. 106–980]
A BILL
To establish, wherever feasible, guidelines, rec-
ommendations, and regulations that promote the
regulatory acceptance of new and revised toxi-
cological tests that protect human and animal
health and the environment while reducing, refin-
ing, or replacing animal tests and ensuring
human safety and product effectiveness.
OCTOBER 16, 2000
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union,
and ordered to be printed