[House Report 106-980]
[From the U.S. Government Publishing Office]
106th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 106-980
======================================================================
ICCVAM AUTHORIZATION ACT OF 2000
_______
October 16, 2000.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Bliley, from the Committee on Commerce, submitted the following
R E P O R T
[To accompany H.R. 4281]
[Including cost estimate of the Congressional Budget Office]
The Committee on Commerce, to whom was referred the bill
(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, having considered the same, report
favorably thereon with amendments and recommend that the bill
as amended do pass.
CONTENTS
Page
Amendment........................................................ 2
Purpose and Summary.............................................. 4
Background and Need for Legislation.............................. 5
Hearings......................................................... 6
Committee Consideration.......................................... 6
Committee Votes.................................................. 6
Committee Oversight Findings..................................... 7
Committee on Government Reform Oversight Findings................ 7
New Budget Authority, Entitlement Authority, and Tax Expenditures 7
Committee Cost Estimate.......................................... 7
Congressional Budget Office Estimate............................. 7
Federal Mandates Statement....................................... 9
Advisory Committee Statement..................................... 9
Constitutional Authority Statement............................... 9
Applicability to Legislative Branch.............................. 9
Section-by-Section Analysis of the Legislation................... 10
Changes in Existing Law Made by the Bill, as Reported............ 14
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``ICCVAM Authorization Act of 2000''.
SEC. 2. DEFINITIONS.
In this Act:
(1) Alternative test method.--The term ``alternative test
method'' means a test method that--
(A) includes any new or revised test method; and
(B)(i) reduces the number of animals required;
(ii) refines procedures to lessen or eliminate pain
or distress to animals, or enhances animal well-being;
or
(iii) replaces animals with non-animal systems or 1
animal species with a phylogenetically lower animal
species, such as replacing a mammal with an
invertebrate.
(2) ICCVAM test recommendation.--The term ``ICCVAM test
recommendation'' means a summary report prepared by the ICCVAM
characterizing the results of a scientific expert peer review
of a test method.
SEC. 3. INTERAGENCY COORDINATING COMMITTEE ON THE VALIDATION OF
ALTERNATIVE METHODS.
(a) In General.--With respect to the interagency coordinating
committee that is known as the Interagency Coordinating Committee on
the Validation of Alternative Methods (referred to in this Act as
``ICCVAM'') and that was established by the Director of the National
Institute of Environmental Health Sciences for purposes of section
463A(b) of the Public Health Service Act, the Director of the Institute
shall designate such committee as a permanent interagency coordinating
committee of the Institute under the National Toxicology Program
Interagency Center for the Evaluation of Alternative Toxicological
Methods. This Act may not be construed as affecting the authorities of
such Director regarding ICCVAM that were in effect on the day before
the date of the enactment of this Act, except to the extent
inconsistent with this Act.
(b) Purposes.--The purposes of the ICCVAM shall be to--
(1) increase the efficiency and effectiveness of Federal
agency test method review;
(2) eliminate unnecessary 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, or replace the use of animals in testing,
where feasible.
(c) Composition.--The ICCVAM shall be composed of the heads of the
following Federal agencies (or their designees):
(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 Director of the National Institute of
Environmental Health Sciences shall establish a Scientific
Advisory Committee (referred to in this Act as the ``SAC'') to
advise ICCVAM and the National Toxicology Program Interagency
Center for the Evaluation of Alternative Toxicological Methods
regarding ICCVAM activities. The activities of the SAC shall be
subject to provisions of the Federal Advisory Committee Act.
(2) Membership.--
(A) In general.--The SAC shall be composed of the
following voting members:
(i) At least 1 knowledgeable representative
having a history of expertise, development, or
evaluation of new or revised or alternative
test methods from each of--
(I) the personal care,
pharmaceutical, industrial chemicals,
or agriculture industry;
(II) any other industry that is
regulated by the Federal agencies
specified in subsection (c); and
(III) a national animal protection
organization established under section
501(c)(3) of the Internal Revenue Code
of 1986.
(ii) Representatives (selected by the
Director of 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
revised or alternative test methodologies,
including contract laboratories.
(B) Nonvoting ex officio members.--The membership of
the SAC shall, in addition to voting members under
subparagraph (A), include as nonvoting ex officio
members the agency heads specified in subsection (c)
(or their designees).
(e) Duties.--The ICCVAM shall, consistent with the purposes described
in subsection (b), carry out the following functions:
(1) Review and evaluate new or revised or 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 or
alternative test methods of interagency interest.
(2) Facilitate appropriate interagency and international
harmonization of acute or chronic toxicological test protocols
that encourage the reduction, refinement, or replacement of
animal test methods.
(3) Facilitate and provide guidance on the development of
validation criteria, validation studies and processes for new
or revised or alternative test methods and help facilitate the
acceptance of such scientifically valid test methods and
awareness of accepted test methods by Federal agencies and
other stakeholders.
(4) Submit ICCVAM test recommendations for the test method
reviewed by the ICCVAM, through expeditious transmittal by the
Secretary of Health and Human Services (or the designee of the
Secretary), to each appropriate Federal agency, along with the
identification of specific agency guidelines, recommendations,
or regulations for a test method, including batteries of tests
and test screens, for chemicals or class of chemicals within a
regulatory framework that may be appropriate for scientific
improvement, while seeking to reduce, refine, or replace animal
test methods.
(5) Consider for review and evaluation, petitions received
from the public that--
(A) identify a specific regulation, recommendation,
or guideline regarding a regulatory mandate; and
(B) recommend new or revised or alternative test
methods and provide valid scientific evidence of the
potential of the test method.
(6) Make available to the public final ICCVAM test
recommendations to appropriate Federal agencies and the
responses from the agencies regarding such recommendations.
(7) Prepare reports to be made available to the public on its
progress under this Act. The first report shall be completed
not later than 12 months after the date of the enactment of
this Act, and subsequent reports shall be completed biennially
thereafter.
SEC. 4. FEDERAL AGENCY ACTION.
(a) Identification of Tests.--With respect to each Federal agency
carrying out a program that requires or recommends acute or chronic
toxicological testing, such agency shall, not later than 180 days after
receiving an ICCVAM test recommendation, identify and forward to the
ICCVAM any relevant test method 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
method for which the ICCVAM test recommendation may be added or
substituted.
(b) Alternatives.--Each Federal agency carrying out a program
described in subsection (a) shall promote and encourage the development
and use of alternatives to animal test methods (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
test methods 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 Method Validation.--Each Federal agency carrying out a
program described in subsection (a) shall ensure that any new or
revised acute or chronic toxicity test method, including animal test
methods and alternatives, is determined to be valid for its proposed
use prior to requiring, recommending, or encouraging the application of
such test method.
(d) Review.--Not later than 180 days after receipt of an ICCVAM test
recommendation, a Federal agency carrying out a program described in
subsection (a) shall review such recommendation and notify the ICCVAM
in writing of its findings.
(e) Recommendation Adoption.--Each Federal agency carrying out a
program described in subsection (a), or its specific regulatory unit or
units, shall adopt the ICCVAM test recommendation unless such Federal
agency determines that--
(1) the ICCVAM test recommendation is not adequate in terms
of biological relevance for the regulatory goal authorized by
that agency, or mandated by Congress;
(2) the ICCVAM test recommendation does not generate data, in
an amount and of a scientific value 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 current test 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 test
endpoint; or
(4) the ICCVAM test recommendation 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 or animals.
(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.
(d) Submission of Tests and Data.--Nothing in this Act precludes a
party from submitting a test method or scientific data directly to a
Federal agency for use in a regulatory program.
Amend the title so as to read:
``A bill to establish, wherever feasible, guidelines,
recommendations, and regulations that promote the regulatory
acceptance of new or revised scientifically valid 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.''.
Purpose and Summary
H.R. 4281, the ICCVAM Authorization Act of 2000, as
amended, authorizes the Interagency Coordinating Committee on
the Validation of Alternative Methods (ICCVAM) to function as a
standing interagency coordinating committee under the National
Toxicology Program Interagency Center for the Evaluation of
Alternative Toxicological Methods. H.R. 4281 directs ICCVAM to
review and evaluate new and revised and alternative test
methods for regulatory acceptance and use.
The purposes of ICCVAM are to (1) increase the efficiency
and effectiveness of Federal agency test method review; (2)
eliminate unnecessary duplicative efforts and share expertise
between Federal regulatory agencies; (3) optimize the
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) to
reduce, refine, or replace the use of animals in testing, where
feasible.
Background and Need for Legislation
H.R. 4281, the ICCVAM Authorization Act of 2000 was
introduced by Representative Ken Calvert on April 13, 2000.
H.R. 4281 provides statutory authorization and standing for
ICCVAM to establish, wherever feasible, guidelines and
recommendations that promote the regulatory acceptance of
scientifically valid new and revised and alternative
toxicological test methods.
ICCVAM was established by the Director of the National
Institute of Environmental Health Sciences (NIEHS) in response
to Public Law 103-43, which directed NIEHS to establish
criteria and processes for the validation and regulatory
acceptance of toxicological test methods. ICCVAM is comprised
of representatives from various Federal agencies and programs
and is intended to facilitate cross-agency communication and
coordination on issues relating to validation, acceptance, and
harmonization of toxicological test methods.
Section 1301 of the National Institutes of Health
Revitalization Act (P.L. 103-43) directed the National
Institute of Environmental Health Sciences (NIEHS) to establish
a research program to conduct applied research and testing,
including establishing criteria for the validation and
regulatory acceptance of alternative test methods; and
recommending a process through which scientifically validated
alternative methods can be accepted for regulatory use. In
response to that mandate, on a discretionary basis, NIEHS
established ICCVAM to develop recommendations relating to the
validation and acceptance of new and revised and alternative
testing methods that would be useful to Federal agencies. The
initial objective of ICCVAM was to draft a report (NIH
Publication, No. 97-3981, March 1997) to recommend criteria and
processes for validation and regulatory acceptance of
toxicological test methods. The following Federal regulatory or
research agencies, with input through public meetings and
comments, drafted that report, ``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 under the National Toxicology
Program Interagency Center for the Evaluation of Alternative
Toxicological Methods. Representatives from Federal regulatory
and research agencies and programs 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.
The first method, Corrositex, is a replacement for animal-based
dermal corrosivity tests for some chemicals. The second, the
Local Lymph Node Assay, is a reduction and refinement of animal
use method for the skin irritation endpoint. The open public
comment process, input by interested stakeholders and the
continued commitment by the Federal agencies has led to
ICCVAM's success. It has resulted in a more coordinated review
process for rigorous scientific assessment of the validation of
new, revised, and alternative toxicological test methods.
H.R. 4281 is needed to formally provide standing status for
the ad hoc ICCVAM within NIEHS in order to ensure that this
interagency coordinating group receives the appropriate
attention, staffing and resources to fully carry out its
duties. In addition to statutorily authorizing ICCVAM, this
legislation is needed to more clearly delineate ICCVAM's
purposes and duties, in order to ensure that ICCVAM's efforts
are properly directed and focused. The legislation also
includes additional mandates that apply to relevant Federal
agencies that are needed to ensure that ICCVAM's test
recommendations are not disregarded, but rather that such test
recommendations are given appropriate consideration.
The Administration has not provided the Committee with an
official position on the legislation; however, both the
Environmental Protection Agency (EPA) and the National
Institute of Environmental Health Sciences (NIEHS) have
submitted to the Committee, in writing, policy and technical
changes to the bill. H.R. 4281, as amended addresses these
concerns and incorporates appropriate changes.
The bill's principal sponsor has received letters of
support for H.R. 4281 from the following organizations: Doris
Day Animal League and Humane Society of the United States,
American Humane Society; the Massachusetts Society for the
Prevention of Cruelty to Animals; The Gillette Company, Proctor
and Gamble, Colgate-Palmolive Company, American Chemistry
Council, American Crop Protection Association, Chemical
Specialties Manufacturers Association, Synthetic Organic
Chemical Manufacturers Association and the Soap and Detergent
Association.
Hearings
The Committee on Commerce has not held hearings on this
legislation.
Committee Consideration
On October 5, 2000, the Subcommittee on Health and
Environment was discharged from the further consideration of
H.R. 4281. On October 5, 2000, the Full Committee met in open
markup session and approved H.R. 4281, as amended, by a voice
vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
H.R. 4281 reported. A motion by Mr. Bliley to order H.R. 4281
reported to the House, without amendment, was agreed to by a
voice vote.
The following amendment was agreed to by a voice vote:
An amendment in the nature of a substitute by Mr.
Bilbray, No. 1, making technical and other changes in
order to address issues raised by the Administration
and others, and including an additional savings clause.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has not held oversight
or legislative hearings on this legislation.
Committee on Government Reform Oversight Findings
Pursuant to clause 3(c)(4) of rule XIII of the Rules of the
House of Representatives, no oversight findings have been
submitted to the Committee by the Committee on Government
Reform.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
4281, the ICCVAM Authorization Act of 2000, would result in no
new or increased budget authority, entitlement authority, or
tax expenditures or revenues.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, October 13, 2000
Hon. Tom Bliley,
Chairman, Committee on Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed estimate for H.R. 4281, the ICCVAM
Authorization Act of 2000.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Christopher
J. Topoleski.
Sincerely,
Barry B. Anderson
(For Dan L. Crippen, Director).
Enclosure.
H.R. 4281--ICCVAM Authorization Act of 2000
Summary: H.R. 4281 would designate the Interagency
Coordinating Committee on the Validation of Alternative Methods
(ICCVAM) as a permanent standing committee administered by the
National Institute of Environmental Health Sciences (NIEHS).
The legislation would establish objectives for ICCVAM,
including increasing the efficiency of reviewing methods of
animal testing across federal agencies, and reducing reliance
on animal testing. In addition, the bill would direct the NIEHS
to establish a Scientific Advisory Committee to assist the
ICCVAM in making recommendations.
The bill also would require federal agencies to identify
and forward to ICCVAM their guidelines or regulations requiring
or recommending animal testing. The ICCVAM would examine
alternatives to traditional animal testing and promote the use
of those alternatives whenever possible. Agencies would be
required to adopt ICCVAM recommendations unless such
recommendations are inadequate or unsatisfactory.
Assuming the appropriation of the necessary amounts, CBO
estimates that implementing H.R. 4281 would cost $1 million in
2001 and $9 million over the 2001-2005 period, assuming annual
adjustments for inflation for those activities without
specified authorization levels. The five-year total would be $8
million if such inflation adjustments are not made. The
legislation would not affect direct spending or receipts;
therefore, pay-as-you-go procedures would not apply.
H.R. 4281 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA)
and would not affect the budgets of state, local, or tribal
governments.
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 4281 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-----------------------------------------------------
2000 2001 2002 2003 2004 2005
----------------------------------------------------------------------------------------------------------------
SPENDING SUBJECT TO APPROPRIATION
Spending under current law:
Estimated authorization level \1\..................... 445 445 464 473 483 493
Estimated Outlays..................................... 384 426 443 456 466 475
Proposed changes: \2\
Estimated authorization level......................... 0 2 2 2 2 2
Estimated Outlays..................................... 0 1 2 2 2 2
Spending under H.R. 4281:
Estimated authorization level......................... 445 457 466 475 485 495
Estimated Outlays..................................... 384 427 445 458 468 477
----------------------------------------------------------------------------------------------------------------
\1\ The 2000 level is the amount appropriated for that year for the agencies that would be affected by H.R.
4281. The 2001-2005 levels are CBO baseline projections, including adjustments for anticipated inflation.
\2\ The amounts shown reflect adjustments for anticipated inflation. Without such inflation adjustments. The
five-year changes in authorization levels would total $10 million (instead of $11 million) and the changes in
outlays would total $8 million (instead of $9 million).
Basis of estimate: For this estimate, CBO assumes that the
bill will be enacted early in fiscal year 2001 and that the
estimated amounts will be appropriated for each year. We also
assume that outlays will follow historical spending rates for
the NIEHS for the authorized activities. CBO based its
estimates on amounts spent in the past for similar types of
activities.
In addition to making the ICCVAM a standing committee, the
bill would require federal agencies to identify and forward to
ICCVAM their guidelines or regulations requiring or
recommending animal testing. Agencies would be required to
adopt ICCVAM recommendations unless such recommendations are
inadequate or unsatisfactory. The agencies that would most
likely be affected by this provision include the Agency for
Toxic Substances and Disease Registry, the Department of
Agriculture, the Department of Defense, the Department of
Energy, the Environmental Protection Agency, the Food and Drug
Administration, various institutes within the National
Institutes of Health, and any other agency that develops or
employs tests or test data using animals or regulates the use
of animals in toxicity testing. Based on information from the
NIH, it appears that most agencies currently comply with the
findings of the ICCVAM on evaluations of research methods.
Thus, CBO estimates that the provision would not have a
significant impact on federal spending.
Pay-as-you-go considerations: None.
Intergovernmental and private-sector impact: H.R. 4281
contains no intergovernmental or private-sector mandates as
defined in UMRA and would not affect the budgets of state,
local, or tribal governments.
Estimate prepared by: Federal costs: Christopher J.
Topoleski; impact on State, local, and tribal governments: Leo
Lex; impact on the private sector: Jennifer Bullard Bowman.
Estimate approved by: Peter H. Fontaine, Deputy Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Advisory Committee Statement
Section 3(d) of H.R. 4281 creates a scientific advisory
committee to advise ICCVAM and the National Toxicology Program
Interagency Center for the Evaluation of Alternative
Toxicological Methods regarding ICCVAM activities. Pursuant to
the requirements of subsection 5(b) of the Federal Advisory
Committee Act, the Committee finds that the functions of the
proposed advisory committee are not and cannot be performed by
an existing Federal agency or advisory commission or by
enlarging the mandate of an existing advisory committee.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
Article I, section 8, clause 3, which grants Congress the power
to regulate commerce with foreign nations, among the several
States, and with the Indian tribes.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
This section provides the short title of the bill, the
``ICCVAM Authorization Act of 2000.''
Section 2. Definitions
This section defines an ``alternative test method'' to
include new or 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
prepared by ICCVAM characterizing the results of a scientific
expert peer review of a test method. ICCVAM test
recommendations are intended to reflect formalized
recommendations by ICCVAM that are transmitted through the
Department to other Federal agencies, and are not intended to
include less formal declarations or statements of position by
individual representatives to ICCVAM or to ICCVAM's scientific
advisory committee. In addition, the Committee notes that
although this bill defines ``alternative test method,'' the
ICCVAM's statutory mandates direct it to review, evaluate and
make recommendations about new or revised toxicological test
methods as well as alternative test methods.
Section 3. Interagency Coordinating Committee on the Validation of
Alternative Methods
Subsection (a) designates ICCVAM as a permanent interagency
coordinating committee under the National Toxicology Program
Interagency Center for the Evaluation of Alternative
Toxicological Methods (the Center). The Committee recognizes
that prior to the date of enactment of this legislation, the
ICCVAM is already in operation on a discretionary ad hoc basis
within NIEHS, and nothing in this bill is intended to disrupt
its ongoing operation.
Subsection (b) delineates the purposes of ICCVAM to: (1)
increase the efficiency and effectiveness of Federal agency
test method review; (2) eliminate unnecessary duplicative
efforts and share expertise 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) to reduce, refine, or replace the use of
animals in testing, where feasible. The Committee intends that
ICCVAM, in carrying out its duties described in subsection (e)
of this section, should perform those duties in accordance with
these purposes.
Subsection (c) identifies the Federal agencies who may
provide representatives to participate on the ICCVAM. ICCVAM
will be comprised of representatives from fifteen Federal
regulatory and/or research agencies and representatives from
other Federal agencies that develop or employ tests or test
data using animals or that regulate on the basis of the use of
animals in toxicity testing. The Committee encourages such
Federal agencies to participate as part of this interagency
coordinating committee; however, participation on ICCVAM is not
mandatory.
Subsection (d) creates a Scientific Advisory Committee
(SAC) to provide scientific advice to ICCVAM and to the Center.
The Committee intends that the SAC will be operated in
accordance with the Federal Advisory Committee Act in order to
ensure that affected parties, including researchers,
corporations, and other interested members of the public have
access to the proceedings of the SAC and of ICCVAM, and that
the process employed for operating the SAC is both open and
transparent. The SAC will include representatives with
expertise in the development or evaluation of new, revised, and
alternative test methods from various sectors of 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, and corporations
developing or marketing new or revised or alternative test
methods. In addition, representatives from agencies
participating in ICCVAM are included as non-voting members of
the SAC to ensure that those representatives are invited to the
SAC deliberations.
Subsection (e) identifies the duties and functions of
ICCVAM, including the responsibility of reviewing and
evaluating new and revised and alternative test methods to
assess their scientific validity. In addition, ICCVAM will
coordinate the necessary technical reviews for those proposed
methods, and it will facilitate communication regarding
interagency and international harmonization of scientifically
valid alternative test methods. This subsection requires that
ICCVAM facilitate and provide guidance on the development of
validation criteria, studies and processes for new and revised
and alternative test methods, and will help to promote
awareness of the acceptance of such scientifically validated
test methods by Federal agencies and other stakeholders. This
subsection further requires that ICCVAM submit its test
recommendations through expeditious transmittal by the
Secretary of HHS 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 improvement, while seeking, where feasible, to
reduce, refine or replace the use of animals. In addition, this
subsection requires that ICCVAM consider petitions from the
public to the extent that those petitions recommend new or
revised or alternative test methods and provide valid
scientific evidence in support of the new or revised or
alternative test method. It is the Committee's expectation that
once ICCVAM has delivered a test recommendation to the
Secretary of HHS, the Secretary's sole role is to expeditiously
transmit that recommendation to the relevant Federal agencies
without delay. The ICCVAM test recommendations and the agency's
responses will be made available to the public. The Committee
intends that the proceedings of ICCVAM and the SAC should be
conducted in a manner that is open and transparent. This
subsection requires ICCVAM to prepare reports to be made
available to the public on its progress under this Act. The
first report shall be due no later than 12 months after the
date of enactment of this Act, and additional reports shall be
prepared every two years thereafter.
The Committee intends that nothing in this subsection
restricts the ongoing efforts of ICCVAM to undertake efforts to
foster greater awareness and acceptance of scientifically valid
alternative test methods. Moreover, the Committee notes that
this subsection is consistent with the stated goal of ICCVAM
identified by NIEHS on page 45 of its report ``Validation and
Regulatory Acceptance of Toxicological Test Methods,'' NIH
Publication, No. 97-3981, March 1997, in which the NIEHS states
``The Committee [ICCVAM] will seek to promote toxicological
test methods that (1) enhance agencies ability to assess risks
and make decisions; and (2) where feasible and practical,
reduce animal use, refine animal procedures to make them less
stressful, or replace animals in toxicological tests (the
3Rs).'' The ICCVAM recommendation is a statement of objective
science, not policy, or a statement that a given method fits a
specific regulatory context. ICCVAM will review test methods
that will reduce, refine or replace animal test methods, but
the ICCVAM test recommendation itself must be a scientifically
objective statement characterizing the results of a scientific
expert review of a test method. ICCVAM shall identify
regulatory areas where the test may be relevant, but ICCVAM
would not make a finding that a test method must fit a specific
regulatory context for an agency. That decision is left up to
the relevant Federal agencies in carrying out their respective
mandates. Moreover, ICCVAM is making no recommendation on the
use of existing test methods. ICCVAM test recommendations may
be useful as an adjunct to help modify the scientific
interpretation of the mode of action of a chemical.
Section 4. Federal agency action
Subsection (a) requires relevant Federal agencies with
programs requiring toxicological testing, within 180 days of
receiving an ICCVAM recommendation, to provide a response to
ICCVAM. The response should identify test requirements in
regulations or guidelines that currently require, recommend or
encourage acute or chronic toxicological test methods for which
the ICCVAM test method may be relevant.
Subsection (b) requires relevant Federal agencies to
encourage, where appropriate, the development of scientifically
valid alternative test methods.
Subsection (c) requires relevant Federal agencies to ensure
that any new or revised or alternative test method must be
validated prior to requiring, recommending or encouraging use
of the test. The Committee intends that in order for the new or
revised or alternative test method to be valid, at a minimum,
it must be capable of producing results that are reliable,
relevant and reproducible.
Subsection (d) requires relevant Federal agencies to review
each ICCVAM test recommendation and respond within 180 days
regarding its review.
Subsection (e) requires relevant Federal agencies to adopt
the ICCVAM recommendation unless the Federal agency determines
that: (1) the ICCVAM test recommendation is not adequate in
terms of biological relevance to the Federal agency's
regulatory goal; (2) the ICCVAM test recommendation does not
generate data of sufficient scientific value; (3) the Federal
agency does not employ, recommend or require testing for the
recommended test endpoint or relevant class of chemicals; or
(4) the Federal agency deems the ICCVAM test recommendation
unacceptable for satisfactorily fulfilling the needs for that
Federal agency or its respective congressional mandates. The
Committee intends that relevant Federal agencies review,
evaluate, and adopt the ICCVAM test recommendations pertaining
to scientifically valid new, revised and alternative test
methods, where such test recommendations are acceptable for
meeting the agency's regulatory objectives. However, the
Committee does not intend for this subsection to require any
Federal agency to adopt an ICCVAM test recommendation that such
Federal agency determines is unacceptable for that particular
Federal agency or is outside the purview of its respective
congressional mandates. During the ICCVAM review process it is
important for Federal agencies to make their scientific views
known. In responding this subsection, Federal agencies should
present separate explanations concerning the extent to which a
method is scientifically valid and the appropriate means for
incorporating or rejecting the use of such test methods.
Nothing in this Act changes any existing requirement for a
Federal agency to respond to scientific information presented
to it during a regulatory process.
Section 5. Application
Subsection (a) excludes from coverage of this bill any
research, including research performed using biotechnology,
techniques, or research relating to the causes, diagnosis,
treatment, control or prevention of physical or mental diseases
or impairments. As a result, the Committee intends that this
legislation should not apply to medical research or research
using biotechnology techniques, but rather should only apply to
research relating to new or revised or alternative
toxicological test methods.
Subsection (b) provides that Federal agencies will retain
final authority for incorporating ICCVAM test recommendations
in the manner determined to be appropriate by the Federal
agency or regulatory body. Nothing in the bill is intended to
prevent a Federal agency from retaining the final authority to
adopt an ICCVAM test recommendation in the manner determined to
be appropriate by that Federal agency. Furthermore, this
legislation only applies to new, revised and alternative test
methods; the Committee does not intend for this legislation to
address existing test methods.
Subsection (c) provides that nothing in the bill is
intended to require a manufacturer to perform toxicological
testing that would otherwise not already be required.
Subsection (d) provides that this bill is not intended to
prevent an agency from considering, nor prevent a company from
submitting directly to an agency, any test method, test, test
data or other scientific information for use in a regulatory
program. The Committee does not intend for ICCVAM, or the
process established for ICCVAM review of new, revised and
alternative test methods to preclude, limit, hamper or impede,
in any way, the ability of any party to provide any scientific
information pertaining to a test, test method, or test data to
any Federal agency for use by that Federal agency in a
regulatory context or program as determined to be appropriate
by such Federal agency.
Changes in Existing Law Made by the Bill, as Reported
This legislation does not amend any existing Federal
statute.