[Congressional Record Volume 146, Number 130 (Tuesday, October 17, 2000)]
[House]
[Pages H10007-H10011]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                    ICCVAM AUTHORIZATION ACT OF 2000

  Mr. BLILEY. Mr. Speaker, I move to suspend the rules and pass 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, as 
amended.
  The Clerk read as follows:

                               H.R. 4281

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``ICCVAM Authorization Act of 
     2000''.

     SEC. 2. 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.

[[Page H10008]]

       (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.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Virginia (Mr. Bliley) and the gentleman from New Mexico (Mr. Udall) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Virginia (Mr. Bliley).

                              {time}  1715


                             General Leave

  Mr. BLILEY. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days within which to revise and extend their remarks 
and to insert extraneous material on H.R. 4281, as amended.
  The SPEAKER pro tempore (Mr. Pease). Is there objection to the 
request of the gentleman from Virginia?
  There was no objection.
  Mr. BLILEY. Mr. Speaker, I yield myself 5 minutes.
  Mr. Speaker, I rise today in support of H.R. 4281, the ICCVAM 
Authorization Act that will provide statutory authority for an ad hoc 
interagency coordinating committee that was set up over at the National 
Institute of Environmental Health Sciences in 1994.
  On October 5, 2000, the full Committee on Commerce considered H.R. 
4281. At that time, the committee negotiated with the committee's 
ranking member and reached agreement on a substitute, and today I am 
pleased that we will be able to call up H.R. 4281 as reported from the 
Committee on Commerce with my full support.
  This bill is a win-win for business and animal protection 
organizations. The legislation provides product makers, who must 
adequately test their products for safety before bringing them to 
market, with a one-stop forum to ensure that new, revised and 
alternative test methods are scientifically valid and acceptable for 
regulatory use before they spend huge amounts of money to conduct the 
extensive tests necessary for government approval.
  For animal rights groups, the legislation offers an improved forum in 
which alternatives to animal tests that may reduce, refine, or replace 
the use of animals can be scientifically validated for regulatory use.
  H.R. 4281 does not create a new Federal bureaucracy. Rather, it 
improves upon an existing interagency committee that is already in 
operation, and more clearly identifies its responsibilities and duties.
  The legislation further instructs Federal programs that require 
relevant product testing to ensure that the accepted test methods 
employ sound, objective and peer reviewed science. At the same time, 
the legislation does not block any party from taking any new or 
existing test method, test or test data directly to any agency, nor 
does it prevent any agency from considering

[[Page H10009]]

any test method or test data that meets its statutory objectives.
  That is why so many business groups and animal rights groups alike 
have written to Congress in support of this legislation. These include 
Procter and Gamble, Colgate-Palmolive, The Gillette Company, the 
American Chemistry Council, the Chemical Specialties Manufacturers 
Association, the Soap and Detergent Association, the American Crop 
Protection Association, the Synthetic Organic Chemical Manufacturers 
Association, as well as the Doris Day Animal League, the American 
Humane Society, the Humane Society of the United States, and the 
Massachusetts Society for the Prevention of Cruelty to Animals.
  I am pleased to join 32 Republican and 41 Democrat cosponsors in 
support of this legislation. I congratulate the gentleman from 
California (Mr. Calvert) for his efforts to bring this legislation 
forward, and I thank the gentleman from Michigan (Mr. Dingell), the 
Committee's ranking member, for his efforts to work with us to achieve 
bipartisan agreement on the bill under consideration today.
  I urge passage of H.R. 4281.
  Mr. Speaker, I reserve the balance of my time.
  Mr. UDALL of New Mexico. Mr. Speaker, I yield myself such time as I 
may consume.
  Mr. Speaker, I rise in support of H.R. 4281, the ICCVAM Authorization 
Act of 2000. ICCVAM, or the Interagency Coordinating Committee on 
Validation of Alternative Methods, was established by the director of 
the National Institute of Environmental Health Sciences in 1994 in 
response to a directive in the NIH Revitalization Act of 1993 
instructing the National Institute to establish criteria and processes 
for validation and regulatory acceptance of toxicological test methods.
  H.R. 4281, which was introduced by the gentleman from California (Mr. 
Calvert) with the gentleman from Ohio (Mr. Brown) and the gentlewoman 
from California (Mrs. Capps), has broad bipartisan support, as well as 
endorsements from the administration, the animal rights community and 
the stakeholder industries. It provides statute authority for ICCVAM to 
continue its work of establishing, as feasible, guidelines and 
recommendations that promote the regulatory acceptance of 
scientifically valid new or revised or alternative test methods. It was 
reported unanimously by the Committee on Commerce.
  H.R. 4281 clearly delineates the purposes, duties, and 
responsibilities of ICCVAM. It also establishes how ICCVAM's scientific 
recommendations will be transmitted to Federal agencies involved in 
toxicology testing and how agencies are expected to respond.
  These steps recognize the important role of ICCVAM in maintaining an 
open, collaborative, scientific review process for validating new and 
existing testing methods and perpetuating the promotion of alternatives 
to the use of animals in the critically important field of toxicology 
testing.
  I want to thank the gentleman from Michigan (Mr. Dingell), the 
ranking member, for his leadership on this bill.
  Mr. Speaker, I yield back the balance of my time.
  Mr. BLILEY. Mr. Speaker, I yield such time as he may consume to the 
gentleman from California (Mr. Calvert), the prime cosponsor of this 
bill.
  Mr. CALVERT. Mr. Speaker, I want to thank the gentleman from Virginia 
(Mr. Bliley), chairman of the committee, for helping us bring this bill 
as rapidly as possible to the floor; and certainly it has been a 
pleasure working with him these last 8 years. I wish him well in his 
retirement.
  I also want to say that this bill has been carefully crafted through 
the tireless work and effort of many individuals. This bill, H.R. 4281, 
the ICCVAM Authorization Act, enjoys support from an overwhelming 
coalition of companies and groups that span the political spectrum.
  We have animal groups, chemical and pharmaceutical companies, 
industry associations, and the current administration among the bill's 
supporters. We have Republicans, Democrats that agree on the bill. Many 
people have worked and worked to ensure that this bill would receive a 
consensus agreement, and I am proud to say that we have a document here 
that has achieved that goal.
  This legislation is a testament to what can be done when different 
groups come together for an important cause. This legislation reaches 
an important outcome, reducing the number of needless animal deaths and 
so much more. The legislation will save the American taxpayers money by 
ensuring a streamline approach to approval of toxicological test 
methods. It will save chemical and pharmaceutical companies thousands 
of dollars by eliminating duplicative, time-consuming and costly test 
method validation at several government agencies. Everyone wins with 
this bill.
  Mr. Speaker, I would like to close by thanking the gentleman from 
Virginia (Mr. Bliley), chairman of the Committee on Commerce, once 
again; the gentleman from Michigan (Mr. Dingell), the ranking member; 
the gentleman from Florida (Mr. Bilirakis), the chair of the 
Subcommittee on Health; and of course the gentleman from California 
(Mr. Lantos), who has also worked with me very hard from the beginning 
to make sure this bill becomes a reality today.
  I encourage all of my colleagues to join in this effort and 
overwhelmingly pass H.R. 4281.
  Mr. LARSON. Mr. Speaker, I rise today in support of H.R. 4281, the 
Interagency Coordinating Committee on the Validation of Alternative 
Methods (ICCVAM) Authorization Act of 2000, which will create statutory 
authority for the ICCVAM, a consortium of 17 federal departments and 
agencies cooperating on the validation of new test methods.
  In recent years product manufacturers have been attempting to move 
away from traditional animal tests in order to respond to public 
concerns about animal welfare, but have been hampered by Federal 
regulations slowing down the validation of alternative methods. 
Strengthening the ICCVAM will create a vital framework to streamline 
government/industry partnerships in developing and regulating new test 
methods.
  This legislation has three objectives. First, it will establish a 
centralize clearinghouse for test method information. Second, it will 
expedite the approval of new technology and test methods with higher 
accuracy than animal-based test methods. Finally, it will reduce the 
number of test animals used in laboratories when reliable alternatives 
are available. This bipartisan bill is supported by a coalition of 
industry and animal protection organizations.
  As a member of the Science Subcommittee on Basic Research I support 
this bill's effort to coordinate the validation and national 
harmonization of toxicological test methods. In 1999 the Environmental 
Protection Agency (EPA) maintained its position that it will continue 
to do everything it can to limit the amount of animal tests and the 
number of animals used in the tests. Also, the National Institute of 
Environmental Health and Sciences, the National Toxicology Program, and 
the EPA have committed as much as $5 million over the next two years to 
develop and validate non-animal test methods.
  I cannot emphasize enough how important it is to increase testing 
efficiency and reduce redundant animal testing by coordinating 
interagency test validation efforts. The ICCVAM will not only conserve 
research funding but also drastically reduce the number of animals 
needlessly killed by scientific testing. As someone who received a 100% 
rating on my voting record from the Humane Society of the United 
States, I believe it is vital that Congress act on these issues and 
pass this legislation.
  Therefore, I urge my colleagues to join me in supporting the ICCVAM 
Authorization Act.
  Mr. HORN. Mr. Speaker, I rise today in support of H.R. 4281, The 
Interagency Coordinating Committee on the Validation of Alternative 
Methods Authorization Act of 2000, known as ICCVAM, of which I am an 
original co-sponsor.
  Mr. Speaker, this bipartisan legislation seeks to insure that the 
lives of millions of test animals are not taken needlessly. This 
legislation will reduce testing costs and reduce liability in product 
safety testing while increasing the accuracy of results and improving 
research data. This is accomplished by creating statutory authority for 
the existing federal Interagency Coordinating Committee on the 
Validation of Alternative Methods to establish guidelines for the 
acceptance of new and revised product safety tests.
  The Interagency Coordinating Committee on the Validation of 
Alternative Methods, ICCVAM, is a consortium of several federal 
departments and agencies cooperating on the validation of new safety 
methods. The committee reviews alternative test methods and recommends 
to the various agencies where the tests could be used. This legislation 
simply grants ICCVAM statutory authority while requiring no additional 
budget expenditures.

[[Page H10010]]

  The commonsense approach to animal testing in this measure has 
allowed it to gain support from a unique alliance of animal protection 
groups as well as consumer product industry giants. I am pleased that 
this legislation is being considered by the House today and I urge my 
colleagues to support this measure.
  Mr. CALVERT. Mr. Speaker, I rise to present legislation that has been 
carefully crafted through the tireless work and effort of many 
individuals. This bill, H.R. 4281, the ICCVAM Authorization Act, enjoys 
support from an overwhelming coalition of companies and groups that 
span the political spectrum.
  We have animal rights groups, chemical and pharmaceutical companies, 
industry associations and the current administration among the bill's 
supporters. We even have Republican and Democrats that agree on this 
bill. Many people have worked and worked to ensure that this bill would 
receive a consensus agreement, and I am proud to say, that we have a 
document here that has achieved this goal.
  This legislation is a testament to what can be done when different 
groups come together for an important cause. This legislation reaches 
an important outcome; reducing the number of needless animal deaths and 
so much more. This legislation will save the American taxpayers money 
by ensuring a streamlined approach to the approval of toxicological 
test methods. It will save chemical and pharmaceutical companies 
millions of dollars by eliminating duplicative, time-consuming and 
costly test method validation at several government agencies. Everyone 
wins with this bill.
  Mr. Speaker, I would like to close by thanking the Chairman of the 
Commerce Committee, Mr. Bliley, the Ranking Member Mr. Dingell, Health 
Subcommittee Chair Mr. Bilirakis and of course Mr. Lantos who have 
worked with me from the beginning to ensure this bill's passage.
  I encourage all of my colleagues to join in this effort and 
overwhelmingly pass H.R. 4281.
  Mr. SHAYS. Mr. Speaker, as an original cosponsor of H.R. 4281, the 
ICCVAM Authorization Act, I rise in strong support of its passage 
today.
  I commend my colleague from California, Ken Calvert, for his work on 
this important issue and for bringing the bill to the floor. I would 
also like to recognize the dedication and tireless work of my good 
friend and colleague, Tom Lantos, who introduced the bill in the 105th 
Congress and has been a champion of this issue.
  H.R. 4281 permanently establishes ICCVAM under the National Institute 
of Environmental Health Sciences. Under the legislation, federal 
agencies would be required to review and identify all regulations that 
require animal use for toxicity tests.
  The purposes of ICCVAM are to increase the efficiency and 
effectiveness of federal agency test method review, eliminate 
unnecessary duplicative efforts and share expertise between federal 
regulatory agencies, optimize the utilization of scientific expertise 
outside the federal government, ensure that new and revised test 
methods are validated to meet the needs of federal agencies, and 
reduce, refine, or replace the use of animals in testing, where 
feasible.
  The bill takes important steps to encourage the use of alternative 
testing procedures that are of equal value as toxicity indicators and 
less costly--both in terms of dollars and animal lives.
  Alternative tests such as the Eytex system, cloned human cells and 
computer models have been developed, and more alternative tests are 
expected to be available in the future. Unfortunately, the federal 
government has stymied the use and development of these technologically 
advanced procedures by failing to update its regulations and guidelines 
for testing. Under current procedures, manufacturers find it is easier 
to have new products approved by relying on outdated testing than 
through the use of new alternatives.
  As a Co-chair of the Congressional Friends of Animals Caucus, I urge 
my colleagues on both sides of the aisle to support this taxpayer and 
animal friendly piece of legislation.
  Mr. DINGELL. Mr. Speaker, I rise in support of H.R. 4281, the ICCVAM 
Authorization Act of 2000. This is a good bill, which enjoys broad 
bipartisan support, as well as endorsements from the Administration, 
the animal rights community, and industry.
  H.R. 4281 provides statutory authority for the permanent continuation 
of the 6-year-old ICCVAM, or Interagency Coordinating Committee on the 
Validation of Alternative Methods. ICCVAM establishes guidelines and 
recommendations that promote regulatory acceptance of new and 
alternative toxicological test methods for use by Federal agencies and 
departments. ICCVAM's history goes back to the NIH Revitalization Act 
of 1993, when the National Institute of Environmental Health Sciences 
(NIEHS) was directed to establish and publish criteria and processes 
for validation and regulatory acceptance of toxicological test methods. 
It has continued to function under the National Toxicology Program 
Interagency Center for Evaluation of Alternative Toxicological Methods, 
within NIEHS ever since. All relevant Federal regulatory and scientific 
agencies are currently represented on ICCVAM, which receives advice 
from a scientific advisory committee.
  H.R. 4281 emphasizes ICCVAM's priority to review and recommend 
alternative test methods that will reduce, refine or replace the use of 
animals in toxicology testing, where appropriate. As stated by the 
Administration, ``the use of these alternative test methods will be 
contingent upon their effectiveness in generating data in the amount 
and of a scientific value that is at least equivalent to the data 
generated by the existing text methods they are meant to replace.'' 
ICCVAM provides a forum for this scientific review, and derives its 
strength by facilitating dialogue across scientific disciplines, 
Federal agencies and with the public.
  The composition and principle duties of ICCVAM and the Scientific 
Advisory Committee are delineated by this legislation. The legislation 
also establishes the relationship between ICCVAM and the Federal 
agencies that are required to conduct toxicological testing. The 
Administration has called ICCVAM a success and pledges to provide the 
necessary resources to sustain it.
  I support this legislation, and trust that my colleagues will do 
likewise.
  Mr. LANTOS. Mr. Speaker, I welcome House consideration of H.R. 4281, 
the ICCVAM Authorization Act of 2000, and I want to take this 
opportunity to commend my colleague from California, Mr. Calvert, for 
his work on this important issue and for bringing this bill to the 
floor.
  Mr. Speaker, on March 27, 1996, I introduced H.R. 3173, the Consumer 
Products Safe Testing Act. This legislation was introduced to promote 
more humane business practices, increase the efficiency of the Federal 
Government, encourage scientific innovation and, most importantly, 
ensure continued consumer safety while eliminating unnecessary and 
inhumane product safety testing on animals. Today, H.R. 4281, the 
ICCVAM Authorization Act of 2000--legislation that is the successor to 
the bill I originally introduced in early 1996--represents the 
culmination of efforts which began over 5 years ago.
  Mr. Speaker, H.R. 4281 is a non-partisan, non-controversial bill that 
emphasizes the protection of both human health and animal welfare by 
facilitating the development, acceptance and implementation of non-
animal product safety tests.
  This bill comes to the floor with an impressive marriage of diverse 
interests working together to support it. Distinguished Members from 
both political parties, industry leaders and animal welfare 
organizations have joined forces to produce a common-sense piece of 
legislation that safeguards both human and animal well-being. I am 
honored and delighted that H.R. 4281 is supported by the Procter & 
Gamble Company, the Gillette Company, the Colgate-Palmolive Company, 
the American Chemistry Council, the American Humane Association, the 
Humane Society of the United States, the Doris Day Animal League, and 
millions of Americans who have demanded safe and reliable alternatives 
to product safety testing on animals.
  Mr. Speaker, for over fifty years, federal regulators have conducted 
product safety tests on animals. In the last decade, however, 
biotechnology companies have researched, developed, and manufactured 
alternative testing procedures that have proved to be just as safe, 
reliable, and in many cases, much more cost effective. Yet, these 
innovative technologies have never had an established protocol for 
receiving approval by federal agencies. In addition, industries 
desiring to implement alternative testing methods have endured a 
frustrating and confusing federal process for alternative test method 
review and approval, despite the fact that many industries have 
committed themselves to ensuring human safety while eliminating 
unnecessary, inhumane animal test methods.
  Now, for the first time, this legislation which we are considering 
here on the floor of the House today will enable industries to cut 
through bureaucratic red-tape and speed the implementation of safe and 
reliable non-animal test methods. While functioning solely on an ad-hoc 
basis, the Inter-Agency Coordinating Committee for the Validation of 
Alternative Methods (ICCVAM) has established sound criteria for the 
validation and acceptance of alternative methods to product safety 
testing on animals and it will require federal agencies to consider the 
ICCVAM's recommendations on alternative test methods. More importantly, 
H.R. 4281 eliminates the incentive for industries to prefer status quo 
animal tests by giving the ICCVAM the authority to make an otherwise 
fragmented regulatory process coherent, cost effective, and more 
readily accessible.
  Mr. Speaker, the adoption of H.R. 4281 will demonstrate a commitment 
to increasing the

[[Page H10011]]

health and environmental safety of all Americans by simplifying the 
process by which industries implement more technologically advanced 
methods of research into their product safety testing protocols. We 
must ensure that as we enter the 21st century the Federal Government is 
working efficiently to incorporate scientific progress into product 
safety tests and not solely relying on antiquated and inhumane animal 
tests to safeguard human health. With this in mind, Mr. Speaker, I 
strongly urge my colleagues to join me by supporting H.R. 4281.
  Mr. BLILEY. Mr. Speaker, I have no further requests for time, and I 
yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Virginia (Mr. Bliley) that the House suspend the rules 
and pass the bill, H.R. 4281, as amended.
  The question was taken; and (two-thirds having voted in favor 
thereof) the rules were suspended and the bill, as amended, was passed.
  The title of the bill was amended 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.''

  A motion to reconsider was laid on the table.

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