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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.