ICCVAM Authorization Act of 2000
PL 106-545 (H.R.4281), enacted 12/19/2000

PUBLIC LAW 106-545—DEC. 19, 2000 
114 STAT. 2721 
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 
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tests that protect human and animal health and the environment while reducing, 
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refining, or replacing animal tests and ensuring human safety and product effec- 
[H.R. 4281] 
tiveness. 
Be it enacted by the Senate and House of Representatives 
of 
the United States of America in Congress assembled, 
ICCVAM 
SECTION 1. SHORT TITLE. 
Act of 200^°° 
This Act may be cited as the "ICCVAM Authorization Act 
42 USC 2oi note, 
of 2000". 
SEC. 2. DEFINITIONS. 
42 USC 285/-2. 
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 spe-
cies, 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. INTERAGENCY COORDINATING COMMITTEE ON THE VALIDA- 42 USC 285/-3. 
TION OF ALTERNATIVE METHODS. 
(a) IN GENERAL.—^With respect to the interagency coordinating 
committee that is known as the Interagency Coordinating Com-
mittee 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 perma-
nent interagency coordinating committee of the Institute under 
the National Toxicology Program Interagency Center for the Evalua-
tion 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. 
Qo) PURPOSES.—^The purposes of the ICCVAM shall be to— 
114 STAT. 2722 
PUBLIC LAW 106-545—DEC. 19, 2000 
(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) Nationgd 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) SciE>mFic 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 
PUBLIC LAW 106-545—DEC. 19, 2000 
114 STAT. 2723 
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 Reports. 
on its progress under this Act. The first report shall be com- Deadline, 
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. 
42 USC 285^4. 
(a) IDENTIFICATION OF TESTS.—^With respect to each Federal Deadline, 
agency carrying out a program that requires or recommends acute 
or chronic toxicological testing, such agency shall, not later than 
114 STAT. 2724 
PUBLIC LAW 106-545—DEC. 19, 2000 
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 canying 
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. 
Deadline. 
(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 msindated 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 recoromended test 
endpoint; or 
(4) the ICCVAM test recommendation is unacceptable for 
satisfactorily fulfilling the test needs for that psirticular agency 
and its respective congressional mandate. 
42 use 285/-5. 
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 
PUBLIC LAW 106-545—DEC. 19, 2000 
114 STAT. 2725 
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. 
Approved December 19, 2000. 
LEGISLATIVE HISTORY—H.R. 4281 (S. 1495): 
HOUSE REPORTS: No. 106-980 (Coram, on Commerce). 
SENATE REPORTS: No. 106-496 accompanying S. 1495 (Comm. on Health, Edu-
cation, Labor, and Pensions). 
CONGRESSIONAL RECORD, Vol. 146 (2000): 
Oct. 17, considered and passed House. 
Dec. 6, considered and passed Senate.