[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4281 Introduced in House (IH)]
106th CONGRESS
2d Session
H. R. 4281
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
April 13, 2000
Mr. Calvert (for himself, Mr. Lantos, Mr. Brown of Ohio, Mr. Campbell,
Mrs. Capps, Mr. Costello, Mr. Delahunt, Mr. Deutsch, Ms. Eshoo, Mr.
Frank of Massachusetts, Mr. Gilchrest, Mr. Gilman, Mr. Goss, Mr. Horn,
Mr. Hyde, Mr. Markey, Mr. Gary Miller of California, Mr. Pallone, Mr.
Porter, Mr. Quinn, Ms. Rivers, Mr. Sensenbrenner, Mr. Shays, Mr. Smith
of New Jersey, Mr. Towns, Mr. Udall of Colorado, Mr. Waxman, Mr. Weldon
of Pennsylvania and Ms. Woolsey) 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 2000''.
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 each individual Federal agency determines
that--
(1) the alternative is not adequate in terms of biological
relevance for the regulatory goal authorized by that 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 that
agency;
(3) that agency does not employ, recommend, or require
testing for that class of chemical or for the recommended end
point; or
(4) the new test method is unacceptable for satisfactorily
fulfilling the test needs for that particular agency and its
respective congressional mandate.
<all>