Text: H.R.3918 — 102nd Congress (1991-1992)All Information (Except Text)

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HR 3918 IH
102d CONGRESS
1st Session
 H. R. 3918
To provide for nonanimal acute toxicity testing by the Federal Government.
IN THE HOUSE OF REPRESENTATIVES
November 25, 1991
Mrs. BOXER (for herself, Mr. GILMAN, Mr. JOHNSON of South Dakota, Mr. GALLO,
Mr. TOWNS, Mr. HYDE, Mr. FRANK of Massachusetts, Mr. WOLPE, Mr. STOKES,
Mr. SHAYS, Mr. MINETA, Mr. NEAL of Massachusetts, Mr. OWENS of New York,
Mr. ROSE, Mr. BROWN, Mrs. MORELLA, Mr. DWYER of New Jersey, Mr. ACKERMAN,
Mr. DE LUGO, Mr. SCHEUER, Mr. ANNUNZIO, Mr. DELLUMS, Mr. DOWNEY, Mr. TRAFICANT,
Mr. SAVAGE, Mr. MACHTLEY, Mr. SCHUMER, Mr. SOLARZ, Mr. KOSTMAYER, Mr. FLAKE,
Mr. CARDIN of Maryland, Mr. MOODY, Mr. JACOBS, Ms. KAPTUR, Mr. TORRICELLI,
Mr. IRELAND, Mr. PANETTA, Mr. KLECZKA, Mr. MRAZEK, Mr. HAYES of Illinois,
Mr. RAVENEL, Mrs. UNSOELD, Mr. TORRES, Mr. DIXON, Mr. YATES, Mr. MILLER of
Washington, Mr. ENGEL, Mr. DEFAZIO, Ms. PELOSI, Mr. JONTZ, Mr. LANTOS and
Mr. SWETT) introduced the following bill; which was referred to the Committee
on Energy and Commerce
A BILL
To provide for nonanimal acute toxicity testing by the Federal Government.
  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 `Consumer Products Safe Testing Act'.
SEC. 2. FINDINGS AND POLICY.
  (a) FINDINGS- The Congress finds that--
  (1) nonanimal acute toxicity tests have been developed in recent years
  that have shown a level of reliability sufficient for the reduction or
  replacement of animal acute toxicity tests such as the Draize test for
  many products regulated by the Federal Government;
  (2) many manufacturers have found nonanimal acute toxicity tests to
  be adequate for evaluating the safety of products for the purposes of
  complying with Federal regulations or guidelines;
  (3) the Federal Government has discouraged the use of these alternatives
  through regulations that mandate or encourage the use of animal acute
  toxicity tests, or by not prescribing other, less costly, more accurate
  and humane alternatives;
  (4) many manufacturers are reluctant to use nonanimal tests without
  encouragement from the Federal Government; and
  (5) private industry and the consumer will benefit from the promotion of
  alternative methods of testing when these alternatives are as accurate
  and more humane than animal tests.
  (b) POLICY- Federal departments and agencies shall encourage the development
  and use of product testing procedures that accurately reflect the acute
  health effects on humans of certain products, including consumer products
  and products containing hazardous or toxic substances, but which do not
  rely upon animals.
SEC. 3. FEDERAL ACTION.
  (a) REVIEW OF REGULATIONS, GUIDELINES, OR RECOMMENDATIONS CONCERNING THE
  DRAIZE TEST AND OTHER ANIMAL ACUTE TOXICITY TESTS- Not later than one year
  after the date of enactment of this Act, each Federal department or agency
  head shall--
  (1) review and evaluate any regulation, guideline, or recommendation issued
  by that department or agency which requires, recommends, or encourages the
  use of the Draize or other animal acute toxicity test for the purpose of
  evaluation of the safety of a regulated product;
  (2) review and evaluate nonanimal alternatives with the potential for
  partial or full replacement of the Draize or other animal acute toxicity
  test for some or all of the products regulated; and
  (3) promulgate regulations, guidelines, or recommendations that specify a
  nonanimal acute toxicity test or battery of tests should be used instead
  of an animal acute toxicity test unless that Federal department or agency
  head determines that the nonanimal acute toxicity test or battery of such
  tests is less likely to predict the acute health effects on humans of a
  product than the animal acute toxicity test.
  (b) ANIMAL ACUTE TOXICITY TESTS- If a determination is made that no nonanimal
  acute toxicity test or battery of tests is as likely to predict the human
  reaction to the regulated product as the Draize or other animal acute
  toxicity test, the appropriate Federal department or agency head shall
  publish in the Federal Register an explanation of all options considered
  and the justification for continuing the animal acute toxicity test,
  which shall be subject to public comment.
  (c) PERIODIC REVIEW OF ANIMAL ACUTE TOXICITY TESTING REGULATIONS- At least
  every 2 years (beginning 3 years after the date of enactment of this Act),
  each Federal department or agency head, after considering the most recent
  technological advances available, shall determine whether continued use
  of any animal acute toxicity test is justified. If a Federal department
  or agency head determines that such use is justified, then that Federal
  department or agency head shall publish an explanation and justification
  of such continued use in the Federal Register, which shall be subject to
  public comment.
SEC. 4. APPLICATION.
  This Act shall not apply to regulations, guidelines, or recommendations
  related to medical research.
SEC. 5. DEFINITIONS.
  For purposes of this Act:
  (1) ANIMAL- The term `animal' means any vertebrate.
  (2) ANIMAL ACUTE TOXICITY TEST- The term `animal acute toxicity test'
  means an acute toxicity test on animals, including (but not limited to)
  the Draize eye or skin irritancy test, LD-50 test, approximate lethal dose
  test, and the limit test.
  (3) FEDERAL DEPARTMENT OR AGENCY HEAD- The term `Federal department or
  agency head' means the head of a Federal department or agency who--
  (A) has authority to promulgate regulations, guidelines, and recommendations
  with respect to procedures to be used in the safety testing by manufacturers
  of products, including consumer products, veterinary products, and products
  containing hazardous or toxic substances; or
  (B) licenses or approves products, labeling requirements or the
  transportation of products based on the results of these tests.
  (4) MEDICAL RESEARCH- The term `medical research' means research related
  to the causes, diagnosis, treatment, or control of physical or mental
  impairments of humans or animals. The term does not include the testing
  of a product to determine its toxicity for the purpose of complying
  with protocols, recommendations, or guidelines for testing required,
  recommended, or accepted by a Federal regulatory agency for a product
  introduced in commerce.
  (5) NONANIMAL ACUTE TOXICITY TEST- The term `nonanimal acute toxicity test'
  means an acute toxicity test not conducted on animals. Such tests include
  (but are not limited to) cell culture, computer modeling, protein alteration,
  and chorioallantoic membrane techniques.