[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5222 Introduced in House (IH)]

103d CONGRESS
  2d Session
                                H. R. 5222

    To provide for nonanimal acute toxicity testing by the Federal 
                              Government.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 6, 1994

  Mr. Lantos (for himself, Mr. Ackerman, Mr. Beilenson, Mr. Brown of 
 California, Mr. DeFazio, Mr. Dellums, Mr. Gejdenson, Mr. Hamburg, Mr. 
 Hochbrueckner, Mr. Johnson of South Dakota, Mr. Johnston of Florida, 
      Mr. Kleczka, Mr. Manton, Mr. Mineta, Mr. Moran, Mr. Neal of 
 Massachusetts, Mr. Ravenel, Ms. Roybal-Allard, Mr. Shays, Mr. Swett, 
  Mr. Swift, and Mr. Towns) 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.
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