[Senate Report 106-496]
[From the U.S. Government Publishing Office]
Calendar No. 946
106th Congress Report
SENATE
2d Session 106-496
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ICCVAM AUTHORIZATION ACT OF 1999
_______
October 11 (legislative day, September 22), 2000.--Ordered to be
printed
_______
Mr. Jeffords, from the Committee on Health, Education, Labor, and
Pensons, submitted the following
R E P O R T
[To accompany S. 1495]
The Committee on Health, Education, Labor, and Pensions, to
which was referred the bill (S. 1495) 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,
having considered the same, reports favorably thereon with an
amendment in the nature of a substitute and recommends that the
bill (as amended) do pass.
CONTENTS
Page
I. Background and need for the legislation..........................1
II. Legislative history and committee action.........................4
III. Cost estimate....................................................5
IV. Application of law to the legislative branch.....................5
V. Regulatory impact statement......................................5
VI. Section-by-section analysis......................................5
I. BACKGROUND AND NEED FOR THE LEGISLATION OVERVIEW
Toxicological testing to assess the safety substantiation
and/or efficacy of products and chemical components of products
has undergone substantial change in the past two decades. Many
toxicity tests were developed more than fifty years ago and
rely heavily on the use of animals. However, members of the
regulated industries and the nonprofit sector have invested in
research and development of more predictive methods that
replace, refine or reduce the use of animals, while providing
sound scientific results.
A section of the 1993 NIH Revitalization Act (Public Law
No. 103-43) created a new mandate for the National Institute of
Environmental Health Sciences specifically as follows:
SEC. 1301. APPLIED TOXICOLOGICAL RESEARCH AND TESTING PROGRAM.
applied toxicological research and testing program
SEC. 463A. (a) There is established within the Institute a program
for conducting applied research and testing regarding toxicology, which
program shall be known as the Applied Toxicological Research and
Testing Program.
(b) In carrying out the program established under subsection (a),
the Director of the Institute shall, with respect to toxicology, carry
out activities--
(1) to expand knowledge of the health effects of
environmental agents:
(2) to broaden the spectrum of toxicology information that is
obtained on selected chemicals;
(3) to develop and validate assays and protocols, including
alternative methods that can reduce or eliminate the use of
animals in acute or chronic safety testing;
(4) to establish criteria for the validation and regulatory
acceptance of alternative testing and to recommend a process
through which scientifically validated alternative methods can
be accepted for regulatory use.
To fulfill the mandate, in 1994 the National Institute of
Environmental Health Sciences (NIEHS) established the ad hoc
Interagency Coordinating Committee for the Validation of
Alternative Methods (ICCVAM). The initial goal of the ICCVAM
was to draft to report (NIH Publication No. 97-3981) to
recommend criteria and processes for validation and regulatory
acceptance of toxicological testing methods, that would be
useful to the regulatory agencies, scientific community,
regulated industry, animal protection advocates and other
stakeholders.
The following federal regulatory or research agencies, with
input through public meetings and comments, drafted the
``Validation and Regulatory Acceptance of Toxicological
Methods--A Report of the ad hoc Interagency Coordinating
Committee for the Validation of Alternative Methods'': Agency
for Toxic Substances and Disease Registry; Consumer Product
Safety Commission; Department of Agriculture; Department of
Defense; Department of Energy; Department of the Interior;
Department of Transportation; Environmental Protection Agency;
Food and Drug Administration; National Institute for
Occupational Safety and Health; National Institutes of Health;
National Cancer Institute; National Institute of Environmental
Health Sciences; National Library of Medicine; and Occupational
Safety and Health Administration.
After publication of the report, the ad hoc ICCVAM moved to
standing status under the NIEHS of the NIH under the National
Toxicology Program Interagency Center for the Evaluation of
Alternative Toxicological Methods. Fifteen Federal regulatory
and research agencies have continued to meet, with advice from
a Scientific Advisory Committee, to assess the validation of
new, revised and alternative toxicological methods. Since then,
two methods have undergone rigorous assessment and are deemed
scientifically valid and acceptable. One, Corrositex, is a
replacement for animal-based dermal corrosivity for some
chemicals. The other, the Local Lymph Node Assay, is a
reduction and refinement of animal use method for the skin
irritation endpoint. The open public process for comment, input
by interested stakeholders and the continued commitment by the
Federal agencies has led to the ICCVAM's success. It has set a
new coordinated review process for rigorous scientific
assessment of the validation of new, revised, and alternative
toxicological test methods that duly considers reducing,
refining or replacing the use of animals.
However, the ICCVAM is not a permanent standing committee.
It could be dismantled by a new director of the National
Toxicology Program at NIEHS or by the administration. Millions
of dollars are used for research, development and validation
studies for new and revised and alternative toxicological
methods. ICCVAM provides a coordinated entity for streamlining
a process that would otherwise require a developer or
manufacturer of a toxicological test method to attempt to
obtain acceptance on an agency by agency basis. ICCVAM also
provides due consideration of good science that can reduce,
refine or replace the use of animals in toxicological testing.
It is imperative that this standing committee become a
permanent standing committee.
summary of the iccvam authorization act
Section 3. Interagency Coordinating Committee for the Validation of
Alternative Methods
Section 3 of the legislation details the program and branch
within the Government where the ICCVAM will reside. It also
details the purposes of the ICCVAM; to facilitate crossagency
reviews of test methods; provide a forum to discuss individual
agency efforts; cultivate scientific expertise from outside of
the Federal Government; ensure that new and revised
toxicological test methods are scientifically validated; and
provide strong consideration for the reduction, refinement and
replacement of animals, wherever feasible, in toxicological
test methods.
Section 3 details the composition of the ICCVAM, providing
some flexibility to ensure that Federal regulatory or research
agencies not explicitly named in the legislation may
participate on the ICCVAM in the future.
Section 3 also details the composition of a Scientific
Advisory Committee, under the National Institute of
Environmental Health Sciences of the National Institute of
Health under the National Toxicology Program Interagency Center
for the Evaluation of Alternative Toxicological Methods. The
Scientific Advisory Committee will be subject to the Federal
Advisory Committee Act. Its membership, selected by the
Secretary of Health and Human Services, shall consist of
representatives from various regulated industries and national
animal protection organizations. It may also include
representation from academic institutions, state government
agencies, international regulatory bodies, or corporations
developing or marketing new or alternative test methods.
Section 3 delineates the responsibilities of the ICCVAM.
The ICCVAM will review and evaluate new, existing and
alternative test methods, including coordinating the technical
review of such methods, of interagency interest. It will also
facilitate interagency and international harmonization of test
protocols that encourage the reduction, refinement or
replacement of animal tests, as appropriate.
Section 4. Federal Agency Action
Section 4 sets a deadline of not later than 180 days for
the individual Federal agencies to provide a detailed response
to the ICCVAM regarding its recommendation. This agency
response will identify and forward to the ICCVAM appropriate
regulations or guidelines encouraging animal-based toxicity
testing for which the ICCVAM recommendation may be added or
substituted. The Federal agencies would also be required to
actively promote the development and use of alternative to
animal test methods, where appropriate, if such test methods
are effective for generating data in an amount and of a
scientific value that is at least as equivalent as the data
generated from its existing tests. Each Federal agency also
must ensure that any new or revised or alternative test method
(including animal test) and tests that refine, reduce or
replace animal tests, must be validated prior to encouraging,
recommending, or requiring the use of the test methods. This
requirement ensures that the same standard of scientific
validity is applied to all new, revised, and alternative test
methods. Each Federal agency or its specific regulatory unit
must adopt the ICCVAM recommendation, unless the agency
determines that one of the four criteria listed in the act
exists for rejection of the test method by that agency.
Section 5. Application
Section 5 provides a clear exemption for research,
including medical research and research using biotechnology
techniques. The bill covers toxicological test methods used to
meet regulatory requirements, regulations, recommendations or
statutes. Toxicological test methods generate information
regarding the ability of a chemical or agent to produce a
specified biological effect under specified conditions. (NIH
Report No. 97-3981)
Section 5 also provides explicit assurance that each
Federal agency and regulatory body has final authority for
incorporating the ICCVAM recommended test method, in the manner
determined to be appropriate by such agency or body, into their
recommendations, requirements, regulations and for addressing
methods mandated by congressional statute, when testing has
already transpired to meet regulatory needs.
Section 5 ensures that nothing in this act requires that a
manufacturer that is not required to perform animal
toxicological testing to perform such tests. Finally, section 5
clarifies that as new, revised, or alternative test methods
become approved, this act does not require that regulated
industries generate new data for that same endpoint.
ii. legislative history and committee action
On September 20, 2000, the committee held an executive
session to consider S. 1495. Senators DeWine and Kennedy
offered an amendment in the nature of a substitute that was
accepted without objection. Senate bill 1495, as amended, was
adopted by voice vote.
iii. cost estimate
Due to time constraints the Congressional Budget Office
estimate was not included in the report. When received by the
committee, it will appear in the Congressional Record at a
later time.
iv. application of law to the legislative branch
Section 102(b)(3) of Public Law 104-1, the Congressional
Accountability Act (CAA), requires a description of the
application of this bill to the legislative branch. This bill
does not amend Federal laws, and therefore does not impact the
legislative branch.
V. REGULATORY IMPACT STATEMENT
The committee has determined that there will be minimal
increases in the regulatory burden imposed by this bill.
VI. SECTION-BY-SECTION ANALYSIS
Section 1. Short title
This Act may be cited as the ``ICCVAM Authorization Act of
2000.''
Section 2. Definition
This section defines an ``alternative test method'' to
include new and revised methods that reduce, refine or replace
the use of animals in toxicological testing. This section also
defines an ``ICCVAM test recommendation'' as a summary report
characterizing the results of a scientific expert peer review
of a test method.
Section 3. Interagency Coordinating Committee on the Validation of
Alternative Methods
Subsection (a). In General. ICCVAM would become a permanent
standing committee under the National Toxicology Program
Interagency Center for the Evaluation of Alternative
Toxicological Methods under the National Institute of
Environmental Health Sciences of the National Institutes of
Health.
Subsection (b). Purposes. ICCVAM will streamline Federal
agency consideration of test method review; utilize scientific
expertise from outside the Federal Government; ensure that new
and revised and alternative test methods are validated; and,
wherever feasible, reduce, refine, or replace the use of
animals.
Subsection (c). Composition. ICCVAM will be comprised of
representatives from 15 Federal regulatory and/or research
agencies and any other Federal agency not currently part of the
existing entity that meets the criteria--namely, that the
agency develops or employs tests or test data using animals or
regulates on the basis of the use of animals in toxicity
testing.
Subsection (d). Scientific Advisory Committee. ICCVAM will
receive advice from a Scientific Advisory Committee (SAC)
selected under the National Toxicology Program Interagency
Center for the Evaluation of Alternative Toxicological Methods
under the National Institute of Environmental Health Sciences
of the National Institutes of Health. The SAC will be a Federal
Advisory Committee, subject to the provisions of the Federal
Advisory Committee Act. It will include representatives with
expertise in the development or evaluation of new, revised, or
alternative test methods from various sectors of the regulated
industries, national animal protection organizations, and other
representatives chosen by the National Institute of
Environmental Health Sciences from academia, State government
agencies, international regulatory bodies, or corporations
developing or marketing new or revised or alternative test
methods.
Subsection (e). Duties. ICCVAM will review and evaluate new
and revised and alternative test methods. ICCVAM will
coordinate the necessary technical reviews for these proposed
methods. ICCVAM will facilitate communication regarding
interagency and international harmonization of test methods
that reduce, refine or replace animal tests. ICCVAM will
facilitate and provide guidance on the development of
validation criteria, studies and processes for new and revised
and alternative test methods and will help promote the
acceptance and awareness of such scientifically validated test
methods by Federal agencies and other stakeholders. ICCVAM will
submit its test recommendations to each appropriate Federal
agency providing specific identification of the guidelines,
recommendations, or regulations for each test, battery of
tests, test screen or endpoint reviewed by the ICCVAM that may
be appropriate for scientific improvements, while seeking
(where feasible) to reduce, refine or replace the use of
animals for a test currently required or recommended by the
agency. The ICCVAM will actively review and evaluate petitions
from the public that recommend alternatives and provide valid
scientific evidence that the alternative works for carrying out
the regulatory mandate and identify a specific regulation,
recommendation or guideline for integrating the alternative.
The ICCVAM recommendations and the agency's responses will be
made available to the public. The entity will prepare an annual
report to be made available to the public on its progress in
promoting and assessing the validation of new, revised and
alternative toxicological test methods.
Section 4. Federal agency action
Subsection (a). Identification of Tests. Each Federal
agency with programs requiring toxicological testing, within
180 days of receiving an ICCVAM recommendation, will provide a
response to ICCVAM. The response will include identifying test
requirements in regulations or guidelines that currently
require, recommend or encourage animal tests that could be
changed by the ICCVAM recommendation. The agency will forward
the identification of these tests to the ICCVAM.
Subsection (b). Alternatives. Each Federal agency shall
actively promote and encourage the development of test methods
that reduce, refine, or replace animal tests. The alternative
test methods shall provide data that is of at least equal
scientific value to the animal tests.
Subsection (c). Test Validation. Each Federal agency shall
ensure that any new or revised animal or alternative test
method must be validated--deemed reliable, relevant and
reproducible--prior to requiring, recommending or encouraging
use of the test.
Subsection (d). Review. Each Federal agency must respond,
in writing within 180 days, to the ICCVAM regarding its
recommendation.
Subsection (e). Recommendation Adoption. Each Federal
agency or its regulatory unit or units, shall adopt the ICCVAM
recommendation unless it can substantiate refusal of the method
by the following criteria. These criteria include: lack of
biological relevance to the agency's regulatory goal; the data
is not of a scientific value at least equivalent to data
generated by current test methods; the agency does not regulate
the specific endpoint or class of chemical recommended by the
ICCVAM for the test method; or the agency deems the method
unacceptable specific to its congressional mandate.
Section 5. Application
Subsection (a). Application. This Act applies only to
toxicological testing. It does not apply to research, including
medical research or research using biotechnology techniques.
Subsection (b). Use of Test Methods. Federal agencies shall
retain final authority for incorporating the recommended test
method in the manner determined to be appropriate by the
Federal agency or regulatory body.
Subsection (c). Limitation. This act does not require
animal testing by a manufacturer not required by other laws or
regulations to perform animal testing. It also does not require
a manufacturer to retest specific endpoints.