H.R. 4281 (ih) To establish, wherever feasible, guidelines, recommendations, and [Introduced in House] ...

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        H.R.4281

                       One Hundred Sixth Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

           Begun and held at the City of Washington on Monday,
             the twenty-fourth day of January, two thousand


                                 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.

    Be it enacted by the Senate and House of Representatives 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 ``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. 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--
        (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 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) 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 reports 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 recommends 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 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) 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. 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 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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.

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