[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3173 Introduced in House (IH)]







104th CONGRESS
  2d Session
                                H. R. 3173

To establish, wherever possible, nonanimal acute toxicity testing as an 
acceptable standard for Government regulations requiring an evaluation 
          of the safety of products by the Federal Government.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 27, 1996

   Mr. Lantos (for himself, Mr. Brown of California, Ms. Waters, Mr. 
Moran, Mr. Frank of Massachusetts, Mr. Abercrombie, Mr. Gejdenson, Mr. 
Coleman, Ms. Pelosi, Mr. Stark, Mr. Kleczka, Mr. Miller of California, 
  Mr. Jacobs, Mr. Sanders, Mr. DeFazio, Ms. Woolsey, Mr. Torres, Ms. 
 Rivers, Mr. Lewis of Georgia, Mr. Cardin, Mr. Clay, Mr. Dellums, Mr. 
 Johnson of South Dakota, Mr. Yates, Mrs. Mink of Hawaii, Mr. Schumer, 
 Mr. Farr, Mr. Foglietta, Mr. Torricelli, Mr. Porter, Mr. Johnston of 
Florida, Mr. Shays, and Mr. Reed) introduced the following bill; which 
               was referred to the Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
To establish, wherever possible, nonanimal acute toxicity testing as an 
acceptable standard for Government regulations requiring an evaluation 
          of the safety of products 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) the Federal Government has discouraged the use of non-
        animal acute toxicity tests 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;
            (2) 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;
            (3) 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;
            (4) many manufacturers are reluctant to use nonanimal tests 
        without encouragement from the Federal Government;
            (5) private industry and the consumer will benefit from the 
        promotion of alternative methods of testing when these 
        alternatives are as accurate in predicting human safety and 
        more humane than animal tests; and
            (6) over the long term, nonanimal acute toxicity testing 
        will produce better data, decrease costs, and reduce the time 
        industry and the regulatory agency spend in the approval 
        process.
    (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) Corporate Testing Policies.--Nothing in this Act shall be 
interpreted to prohibit, recommend, or require any testing protocol or 
procedure by a corporation, institution, or individual to determine the 
safety of its products that is not required or recommended under this 
Act.
    (c) Animal Acute Toxicity Tests.--Any Federal department or agency 
head that finds that regulations requiring or recommending animal tests 
should not be amended, shall publish in the Federal Register an 
explanation of options considered and the justification for continuing 
the animal acute toxicity test.
    (d) 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 of such continued use in the Federal Register.

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, including research performed using biotechnology, 
        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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