[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--

[[Page 114 STAT. 2722]]

            (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):
---------------------------------------------------------------------------

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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