[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 1495 Reported in Senate (RS)]






                                                       Calendar No. 946
106th CONGRESS
  2d Session
                                S. 1495

                          [Report No. 106-496]

   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 SENATE OF THE UNITED STATES

                             August 4, 1999

Mr. DeWine  (for himself, Mr. Smith of New Hampshire, Mrs. Murray, Mr. 
 Santorum, Mrs. Boxer, and Mr. Abraham) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

            October 11 (legislative day, September 22), 2000

              Reported by Mr. Jeffords, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``ICCVAM Authorization Act of 
1999''.</DELETED>

<DELETED>SEC. 2. INTERAGENCY COORDINATING COMMITTEE ON THE VALIDATION 
              OF ALTERNATIVE METHODS.</DELETED>

<DELETED>    (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--</DELETED>
        <DELETED>    (1) increase the efficiency and effectiveness of 
        Federal agency test method review;</DELETED>
        <DELETED>    (2) eliminate duplicative efforts and share 
        experiences across Federal regulatory agencies;</DELETED>
        <DELETED>    (3) optimize utilization of scientific expertise 
        outside the Federal Government;</DELETED>
        <DELETED>    (4) ensure that new test methods meet the needs of 
        Federal agencies; and</DELETED>
        <DELETED>    (5) reduce, refine, and replace the use of animals 
        in testing.</DELETED>
<DELETED>    (b) Composition.--ICCVAM shall be comprised of a 
representative from each of the following agencies and 
organizations:</DELETED>
        <DELETED>    (1) Agency for Toxic Substances and Disease 
        Registry.</DELETED>
        <DELETED>    (2) Consumer Product Safety Commission.</DELETED>
        <DELETED>    (3) Department of Agriculture.</DELETED>
        <DELETED>    (4) Department of Defense.</DELETED>
        <DELETED>    (5) Department of Energy.</DELETED>
        <DELETED>    (6) Department of the Interior.</DELETED>
        <DELETED>    (7) Department of Transportation.</DELETED>
        <DELETED>    (8) Environmental Protection Agency.</DELETED>
        <DELETED>    (9) Food and Drug Administration.</DELETED>
        <DELETED>    (10) National Institute for Occupational Safety 
        and Health.</DELETED>
        <DELETED>    (11) National Institutes of Health.</DELETED>
        <DELETED>    (12) National Cancer Institute.</DELETED>
        <DELETED>    (13) National Institute of Environmental Health 
        Sciences.</DELETED>
        <DELETED>    (14) National Library of Medicine.</DELETED>
        <DELETED>    (15) Occupational Safety and Health 
        Administration.</DELETED>
        <DELETED>    (16) Any other agency that develops, employs, or 
        regulates the use of animals in toxicity testing.</DELETED>
<DELETED>    (c) Scientific Advisory Committee.--</DELETED>
        <DELETED>    (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:</DELETED>
                <DELETED>    (A) The personal care, pharmaceutical, 
                industrial chemicals, agriculture, and any other 
                regulated industry.</DELETED>
                <DELETED>    (B) A national animal protection 
                organization established under section 501(c)(3) of the 
                Internal Revenue Code of 1986.</DELETED>
        <DELETED>    (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:</DELETED>
                <DELETED>    (A) An academic institution.</DELETED>
                <DELETED>    (B) A State government agency.</DELETED>
                <DELETED>    (C) An international regulatory 
                body.</DELETED>
                <DELETED>    (D) A corporation developing or marketing 
                alternative test methodologies including contract 
                laboratories.</DELETED>
<DELETED>    (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:</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (2) Facilitate interagency and international 
        harmonization of acute chronic toxicological test protocols 
        that encourage the reduction, refinement, or replacement of 
        animal tests.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (6) Make final recommendations to agencies and 
        responses from agencies available to the public.</DELETED>
        <DELETED>    (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.</DELETED>

<DELETED>SEC. 3. APPLICATION.</DELETED>

<DELETED>    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.</DELETED>

<DELETED>SEC. 4. FEDERAL AGENCY ACTION.</DELETED>

<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (e) Recommendation Adoption.--Each Federal agency shall 
adopt the ICCVAM recommendations unless each individual Federal agency 
determines that--</DELETED>
        <DELETED>    (1) the alternative is not adequate in terms of 
        biological relevance for the regulatory goal authorized by that 
        agency;</DELETED>
        <DELETED>    (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 
        that agency;</DELETED>
        <DELETED>    (3) that agency does not employ, recommend, or 
        require testing for that class of chemical or for the 
        recommended end point; or</DELETED>
        <DELETED>    (4) the new test method is unacceptable for 
        satisfactorily fulfilling the test needs for that particular 
        agency and its respective congressional mandate.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``ICCVAM Authorization Act of 2000''.

SEC. 2. DEFINITION.

    In this Act the term ``alternative test method'' means a test 
method that--
            (1)(A) reduces the number of animals required;
            (B) refines procedures to lessen or eliminate pain or 
        distress to animals, or enhances animal well-being; or
            (C) replaces animals with non-animal systems or 1 animal 
        species with a phylogenetically lower animal species, such as 
        replacing a mammal with an invertebrate; and
            (2) includes any new or revised test method that is 
        developed for use after the date of enactment of this Act and 
        proposed as an alternative to a traditional method.

SEC. 3. 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 a permanent standing committee administered by the 
National Institute of Environmental Health Sciences of the National 
Institutes of Health under the National Toxicology Program Interagency 
Center for the Evaluation of Alternative Toxicological Methods.
    (b) Purposes.--With respect to the use of animals in toxicological 
tests, the purposes of ICCVAM described in subsection (a) shall be to--
            (1) increase the efficiency and effectiveness of Federal 
        agency test method review;
            (2) eliminate 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, and replace the use of animals in 
        testing.
    (c) Composition.--The ICCVAM described in subsection (a) shall be 
comprised of representatives from each of the following:
            (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 National Institute of Environmental 
        Health Sciences shall establish a Scientific Advisory Committee 
        (referred to in this Act as the ``SAC'') to advise the ICCVAM 
        described in subsection (a). The activities of the SAC shall be 
        subject to provisions of the Federal Advisory Committee Act.
            (2) Membership.--The SAC described in paragraph (1) shall 
        be composed of--
                    (A) at least 1 knowledgeable representative having 
                a history of expertise, development, or evaluation of 
                new or alternative test methods from each of--
                            (i) the personal care, pharmaceutical, 
                        industrial chemicals, or agriculture industry, 
                        and any other industry that is regulated by the 
                        Federal agencies described in subsection (c); 
                        and
                            (ii) a national animal protection 
                        organization established under section 
                        501(c)(3) of the Internal Revenue Code of 1986; 
                        and
                    (B) representatives (selected by 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 alternative test 
                methodologies, including contract laboratories.
    (e) Duties.--The ICCVAM described in subsection (a) shall, 
consistent with the purposes described in subsection (b)--
            (1) review and evaluate existing and new 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 
        test methods of interagency interest;
            (2) facilitate appropriate interagency and international 
        harmonization of acute and chronic toxicological test protocols 
        that encourage the reduction, refinement, or replacement of 
        animal tests;
            (3) facilitate, promote, and provide guidance on the 
        development of validation criteria, validation studies and 
        processes for new and revised 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 endpoint reviewed by the 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, including filing recommendations 
        for tests for a certain class of chemicals within a regulatory 
        framework;
            (5) consider for review and evaluation, petitions received 
        from the public that identify a specific regulation, 
        recommendation, or guideline, and that recommend alternatives 
        and provide scientific evidence of the potential of the 
        alternatives for the purpose of carrying out the regulatory 
        mandate in question;
            (6) make final recommendations to agencies and make the 
        responses from agencies regarding the final recommendations 
        available to the public; and
            (7) prepare an annual report to be made available to the 
        public on its progress to promote and assess validation of new 
        and revised toxicological tests.

SEC. 4. FEDERAL AGENCY ACTION.

    (a) Identification of Tests.--Not later than 180 days after receipt 
of an ICCVAM test recommendation, each Federal agency carrying out a 
program that requires or recommends acute or chronic toxicological 
testing shall--
            (1) identify any relevant test requirement 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 for which the ICCVAM test 
recommendation may be added or substituted; and
            (2) forward the identification of such test to the ICCVAM.
    (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 statutes, regulations, guidelines, or 
recommendations (in each instance, and for each chemical class) if such 
tests 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 Validation.--Each Federal agency shall ensure that any new 
or revised 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 the application of such test.
    (d) Review.--Not later than 180 days after receipt of a formal 
recommendation from the ICCVAM, each Federal agency shall review such 
recommendation and notify the ICCVAM in writing of its findings.
    (e) Recommendation Adoption.--Each Federal agency, or its specific 
regulatory unit or units, shall adopt the ICCVAM recommendation unless 
such Federal agency determines that--
            (1) the ICCVAM recommendation is not adequate in terms of 
        biological relevance for the regulatory goal authorized by that 
        agency, or mandated by Congress;
            (2) the ICCVAM recommendation does not generate data, in an 
        amount 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 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 
        endpoint; or
            (4) the new or revised test method 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 and animals using medically 
accepted methodologies.
    (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.
                                                       Calendar No. 946

106th CONGRESS

  2d Session

                                S. 1495

                          [Report No. 106-496]

_______________________________________________________________________

                                 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.

_______________________________________________________________________

            October 11 (legislative day, September 22), 2000

                       Reported with an amendment