[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3946 Introduced in House (IH)]







105th CONGRESS
  2d Session
                                H. R. 3946

   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

                              May 22, 1998

 Mr. Lantos (for himself, Mr. Abercrombie, Mr. Ackerman, Mr. Andrews, 
 Mr. Blumenauer, Mr. Bonior, Mr. Borski, Mr. Brown of California, Mr. 
Campbell, Mr. Delahunt, Mr. Evans, Mr. Farr of California, Mr. Frank of 
  Massachusetts, Ms. Furse, Mr. Gejdenson, Mr. Hyde, Mr. Kleczka, Mr. 
Kucinich, Mr. Lewis of Georgia, Mrs. Lowey, Mr. Manton, Mr. Markey, Mr. 
 Miller of California, Mrs. Mink of Hawaii, Mr. Moran of Virginia, Mr. 
 Nadler, Mr. Oberstar, Ms. Pelosi, Ms. Rivers, Mr. Schumer, Mr. Shays, 
 Mr. Tierney, Mr. Towns, Mr. Waxman, Ms. Woolsey, Mrs. McCarthy of New 
York, and Mr. Smith of New Jersey) introduced the following bill; which 
               was referred to the Committee on Commerce

_______________________________________________________________________

                                 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 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 1998''.

SEC. 2. INTERAGENCY COORDINATING COMMITTEE ON THE VALIDATION OF 
              ALTERNATIVE METHODS.

    (a) In General.--The Interagency Coordinating Committee on the 
Validation of Alternative Methods (referred to in this Act as 
``ICCVAM'') shall be sustained as a permanent standing committee and 
continued to be administered by the National Institute of Environmental 
Health Sciences. The purposes of ICCVAM shall be to--
            (1) increase the efficiency and effectiveness of Federal 
        agency test method review;
            (2) eliminate duplicative efforts and share experiences 
        across Federal regulatory agencies;
            (3) optimize utilization of scientific expertise outside 
        the Federal Government;
            (4) ensure that new test methods meet the needs of Federal 
        agencies; and
            (5) reduce, refine, and replace the use of animals in 
        testing.
    (b) Composition.--ICCVAM shall be comprised of a representative 
from each of the following agencies and organizations:
            (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, employs, or regulates 
        the use of animals in toxicity testing.
    (c) Scientific Advisory Committee.--
            (1) Establishment.--In addition, the National Institute of 
        Environmental Health Sciences shall establish a Scientific 
        Advisory Committee to assist ICCVAM and the National Institute 
        of Environmental Health Sciences. The Committee shall be 
        composed of at least one knowledgeable representative having a 
        history of expertise, development, or evaluation in 
        alternatives to animal toxicological tests, from each of the 
        following interests:
                    (A) The personal care, pharmaceutical, industrial 
                chemicals, agriculture, and any other regulated 
                industry.
                    (B) A national animal protection organization 
                established under section 501(c)(3) of the Internal 
                Revenue Code of 1986.
            (2) Membership.-- The National Institute of Environmental 
        Health Sciences shall also invite to be members of the 
        Scientific Advisory Committee representatives from other 
        stakeholder organizations such as:
                    (A) An academic institution.
                    (B) A State government agency.
                    (C) An international regulatory body.
                    (D) A corporation developing or marketing 
                alternative test methodologies including contract 
                laboratories.
    (d) Duties.--ICCVAM shall carry out the following duties consistent 
with the protection of public health and the environment and for the 
purpose of reducing, refining, and replacing the use of animals in 
acute and chronic toxicological tests:
            (1) Review and evaluate existing and new alternative 
        methods, including batteries of tests and test screens, which 
        may be acceptable for specific regulatory uses, including the 
        coordination of technical reviews of proposed new or revised 
        test methods of interagency interest.
            (2) Facilitate interagency and international harmonization 
        of acute chronic toxicological test protocols that encourage 
        the reduction, refinement, or replacement of animal tests.
            (3) Facilitate, promote, and provide guidance on 
        development of validation criteria and processes for new 
        methods and help promote the acceptance of such methods and 
        awareness of accepted methods by Federal agencies and other 
        stakeholders.
            (4) File formal recommendations with each appropriate 
        Federal agency identifying specific agency guidelines, 
        recommendations, or regulations for each new test, battery of 
        tests, test screen, or end point reviewed by ICCVAM that may be 
        appropriate for the reduction, refinement, or replacement of an 
        animal test required or recommended by that Federal agency for 
        compliance with that agency's specific statutes, regulations, 
        or guidelines. Tests may be recommended for a certain class of 
        chemicals within that regulatory framework.
            (5) Consider for review and evaluation, petitions received 
        from the public which identify a specific regulation, 
        recommendation, or guideline, and which recommend alternatives 
        and provide scientific evidence of the acceptability of the 
        alternatives for the purpose of carrying out the regulatory 
        mandate in question.
            (6) Make final recommendations to agencies and responses 
        from agencies available to the public.
            (7) Make an annual report to be made available to the 
        public on its progress to promote the regulatory acceptance of 
        new and revised toxicological tests.

SEC. 3. APPLICATION.

    This Act shall not apply to regulations, guidelines, or 
recommendations related to medical research. The term ``medical 
research'' means research, including research performed using 
biotechnology, related to the causes, diagnosis, treatment, or control 
of physical or mental impairments of humans or animals. The term does 
not include the testing of a product to determine its toxicity for the 
purpose of complying with protocols, recommendations, or guidelines for 
testing required, recommended, or accepted by a Federal regulatory 
agency for a product introduced in commerce.

SEC. 4. FEDERAL AGENCY ACTION.

    (a) Identification of Tests.--Within 180 days after the date of 
enactment of this Act, each Federal agency authorized to carry out a 
regulatory program which requires or recommends acute or chronic 
toxicological testing shall identify any regulation or industry-wide 
guideline which specifically, or in practice requires, recommends, or 
encourages the use of an animal acute or chronic toxicological test and 
shall forward to ICCVAM a list of these regulations, guidelines, and 
recommendations along with the test or tests recommended or required.
    (b) Alternatives.--Each Federal agency shall promote and encourage 
the development and use of alternatives to animal tests, including 
batteries of tests and test screens, where appropriate, for the purpose 
of complying with Federal regulations, guidelines, or recommendations, 
in each instance, and for each chemical class, for which such tests are 
found to be effective for generating data at least equivalent for 
hazard identification or dose-response assessment purposes to the 
method established under the current regulatory scheme.
    (c) Test Validation.--Each Federal agency shall ensure that any new 
acute or chronic toxicity test, including animal tests and 
alternatives, is determined to be valid for its proposed use prior to 
requiring, recommending, or encouraging its application.
    (d) Reviews.--Each Federal agency shall review any formal 
recommendations from ICCVAM to promulgate new regulations or draft new 
guidelines or recommendations to promote the ICCVAM recommendations and 
notify ICCVAM in writing of its findings within 180 days of receipt of 
the recommendations.
    (e) Recommendation Adoption.--Each Federal agency shall adopt the 
ICCVAM recommendations unless it determines that--
            (1) the alternative is not adequate in terms of biological 
        relevance for the regulatory goal authorized by the agency;
            (2) the alternative does not generate data at least 
        equivalent for the appropriate hazard identification or dose-
        response assessment purpose as the method recommended by the 
        agency;
            (3) the agency does not employ, recommend, or require 
        testing for that class of chemical or for the recommended end 
        point; or
            (4) each government agency retains fully the prerogative of 
        deciding whether the new test method is acceptable for 
        satisfactorily fulfilling the test needs for their particular 
        agency and its respective congressional mandate.
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