Home > 106th Congressional Bills > S. 1496 (is) To authorize activities under the Federal railroad safety laws for fiscal years 2000 through 2003, and for other purposes. [Introduced in Senate] ...S. 1496 (is) To authorize activities under the Federal railroad safety laws for fiscal years 2000 through 2003, and for other purposes. [Introduced in Senate] ...
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
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