2000
<PRE>[DOCID: f:h3804ih.txt]






107th CONGRESS
  2d Session
                                H. R. 3804

To amend the Federal Food, Drug, and Cosmetic Act to ensure that use of 
  certain antibiotic drugs in animal agriculture does not compromise 
     human health by contributing to the development of antibiotic 
                              resistance.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 27, 2002

    Mr. Brown of Ohio (for himself, Mr. Waxman, and Ms. Slaughter) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to ensure that use of 
  certain antibiotic drugs in animal agriculture does not compromise 
     human health by contributing to the development of antibiotic 
                              resistance.

    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 ``Preservation of Antibiotics for 
Human Treatment Act of 2002''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) Several antibiotics and classes of antibiotics, 
        particularly penicillins, tetracyclines, macrolides (including 
        but not limited to erythromycin and tylosin), lincomycin, 
        bacitracin, virginiamycin, aminoglycosides, and sulfonamides, 
        that either are used in or are related to antibiotics used in 
        humans to treat infectious diseases are also routinely 
        administered to healthy agricultural animals, generally via 
        feed or water, in order to promote the animals' growth or to 
        prevent disease. Such uses do not require a veterinarian's 
        prescription.
            (2) Mounting scientific evidence shows that this 
        nontherapeutic use of antibiotics in agricultural animals can 
        lead to development of antibiotic-resistant bacteria that can 
        be transferred to people, making it harder to treat certain 
        infections.
            (3) In 1969, the Swann Committee was formed in the United 
        Kingdom to examine the public health effects of use of 
        antimicrobial drugs in food-producing animals. The Committee 
        recommended that antimicrobials be divided into ``feed'' and 
        ``therapeutic'' classes of drugs and that the ``feed'' class 
        not include drugs used therapeutically in humans or animals. 
        Most developed countries in the world, with the exception of 
        the United States and Canada, restrict the use of 
        antimicrobials in animal production systems for growth 
        promotion.
            (4) In 1997, the World Health Organization recommended that 
        antibiotics used to treat humans should not also be used to 
        promote animal growth, although such antibiotics could still be 
        used to treat ill animals.
            (5) In July 1998, the National Academy of Sciences, in a 
        report prepared at the request of the United States Department 
        of Agriculture and the Food and Drug Administration, concluded 
        ``there is a link between the use of antibiotics in food 
        animals, the development of bacterial resistance to these 
        drugs, and human disease''.
            (6) In December 1998, health ministers for the European 
        Union countries voted to ban the remaining human-use 
        antibiotics still in use to promote animal growth. The ban on 
        using virginiamycin, tylosin, spiramycin, and bacitracin in 
        animal feed became effective for the 15 member states of the 
        European Union on July 1, 1999. Prior to that action, 
        individual European countries, including the United Kingdom, 
        Denmark, Finland, and Sweden, had banned the use in animal feed 
        of specific antibiotics.
            (7) An April 1999 study by the General Accounting Office 
        concluded that resistant strains of three microorganisms that 
        cause foodborne illness or disease in humans--salmonella, 
        campylobacter, and E. coli--are linked to the use of 
        antibiotics in animals.
            (8) In October 2000, the Food and Drug Administration 
        issued a notice announcing its intention to withdraw approvals 
        for use of fluoroquinolone antibiotics in poultry, in light of 
        the fact that increased resistance to fluoroquinolones in 
        certain bacteria followed approval of those antibiotics for 
        such use in the mid-1990s. While one company (Abbott 
        Laboratories) immediately agreed to voluntarily withdraw its 
        product, the only other manufacturer (Bayer Corp.) is 
        contesting FDA's proposed withdrawal and continues to market 
        its product. Previous proceedings by FDA to withdraw approval 
        of animal drugs have taken substantial amounts of time 
        following initiation of formal action by FDA, including 6 years 
        in one instance and 20 in another.
            (9) In November 2000, the American Medical Association, 
        American Public Health Association, and other health 
        organizations urged Bayer Corp. to comply voluntarily with 
        FDA's proposed ban.
            (10) In June 2001, the American Medical Association adopted 
        a resolution opposing nontherapeutic use of antimicrobials in 
        animal agriculture. Organizations that have taken a similar 
        position include the American College of Preventive Medicine, 
        the American Public Health Association, and the Council of 
        State and Territorial Epidemiologists.
            (11) In October 2001, the New England Journal of Medicine 
        published a guest editorial titled ``Antimicrobials in Animal 
        Feed--Time to Stop''. The editorial urged a ban on 
        nontherapeutic use in animals of medically important 
        antibiotics, and on use in animals of fluoroquinolones.
            (12) In January 2001, a Federal Interagency Task Force 
        released an Action Plan, which notes that ``drug-resistant 
        pathogens are a growing menace to all people, regardless of 
        age, gender, or socioeconomic background. If we do not act to 
        address the problem... [d]rug choices for the treatment of 
        common infections will become increasingly limited and 
        expensive--and, in some cases, nonexistent.''.
            (13) Scientific studies have shown that resistance traits 
        can be transferred among unrelated species of bacteria, 
        including from nonpathogens to pathogens.

SEC. 3. REQUIRING PROOF OF SAFETY OF ANTIMICROBIAL NEW ANIMAL DRUGS.

    (a) Nontherapeutic Use; Applications Pending on or Submitted After 
Enactment.--Section 512(d)(1) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360b(d)(1)) is amended--
            (1) in subparagraph (H), by striking ``or'' at the end;
            (2) by redesignating subparagraph (I) as subparagraph (J);
            (3) by inserting after subparagraph (H) the following 
        subparagraph:
            ``(I) such drug is an antimicrobial new animal drug and the 
        applicant has failed to demonstrate that there is a reasonable 
        certainty of no harm to human health due to the development of 
        antimicrobial resistance that is attributable, in whole or in 
        part, to the nontherapeutic use of such drug; or''; and
            (4) in the matter after and below subparagraph (J) (as 
        redesignated by paragraph (2) of this subsection), by striking 
        ``(A) through (I)'' and inserting ``(A) through (J)''.
    (b) Nontherapeutic Use; Rescinding of Approval for Certain 
Currently Approved Drugs.--Section 512 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b) is amended by adding at the end the 
following subsection:
  
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  ``(q) With respect to each antimicrobial new animal drug for which, 
as of the day before the date of the enactment of the Preservation of 
Antibiotics for Human Treatment Act of 2002, there was in effect an 
approval of an application filed pursuant to subsection (b), the 
approval of a nontherapeutic use of such drug (including use through 
animal feed that bears or contains such drug) is subject to the 
following, as applicable:
            ``(1) In the case of penicillins, tetracyclines, macrolides 
        (including but not limited to erythromycin and tylosin), 
        lincomycin, bacitracin, virginiamycin, aminoglycosides, and 
        sulfonamides:
                    ``(A) Each approval of a nontherapeutic use of any 
                of such drugs in an animal is rescinded upon the 
                expiration of the two-year period beginning on such 
                date of enactment unless, before the expiration of such 
                period, the Secretary determines that the holder of the 
                approved application has demonstrated that there is a 
                reasonable certainty of no harm to human health due to 
                the development of antimicrobial resistance that is 
                attributable, in whole or in part, to the 
                nontherapeutic use of such drug.
                    ``(B) In carrying out subparagraph (A), the 
                Secretary may not consider any data regarding the 
                antimicrobial new animal drug involved that is 
                submitted to the Secretary after the expiration of the 
                180-day period beginning on such date of enactment, 
                unless such data were not available for submission 
                within such 180-day period.
                    ``(C) If pursuant to subparagraph (A) the Secretary 
                determines, with respect to the antimicrobial new 
                animal drug involved, that there is not a reasonable 
                certainty of no harm to human health, the Secretary may 
                issue an order withdrawing approval of such drug at any 
                time before the date on which the drug would be 
                rescinded under such subparagraph.
            ``(2) In the case of an antimicrobial new animal drug that 
        is not referred to in paragraph (1):
                    ``(A) If the Secretary grants an exemption under 
                section 505(i) regarding such a drug, or a drug with 
                substantially the same active ingredients, each 
                approval of a nontherapeutic use of such new animal 
                drug in an animal is rescinded upon the expiration of 
                the two-year period beginning on the date on which the 
                Secretary provides notice in accordance with 
                subparagraph (C) regarding the new animal drug, except 
                as provided in subparagraph (D). Such notice shall be 
                so provided not later than 10 days after the date on 
                which the Secretary grants the exemption under section 
                505(i).
                    ``(B) If an application for such a drug, or a drug 
                with substantially the same active ingredients, is 
                submitted to the Secretary under section 505(b) or 
                under section 351 of the Public Health Service Act, and 
                the Secretary has not previously granted an exemption 
                under section 505(i) regarding the drug, each approval 
                of a nontherapeutic use of such new animal drug in an 
                animal is rescinded upon the expiration of the two-year 
                period beginning on the date on which the Secretary 
                provides notice in accordance with subparagraph (C) 
                regarding the new animal drug, except as provided in 
                subparagraph (D). Such notice shall be so provided 
not later than 10 days after the date on which the Secretary receives 
the application under section 505(b) or under such section 351, as the 
case may be.
                    ``(C) For purposes of subparagraph (A) and (B), 
                notice regarding the antimicrobial new animal drug 
                involved is provided in accordance with this 
                subparagraph if the Secretary informs the holder of the 
                approved application for the nontherapeutic use of such 
                drug, in writing, of the applicability of this 
                paragraph to such application (including that approval 
                of the application will be rescinded, except as 
                provided in subparagraph (D), and including the 
                opportunity under subparagraph (E) to submit data).
                    ``(D) Subparagraph (A) or (B), as the case may be, 
                applies to the antimicrobial new animal drug involved 
                unless, before the date on which approval would be 
                rescinded under such subparagraph, the Secretary 
                determines that the holder of the approved application 
                has demonstrated that there is a reasonable certainty 
                of no harm to human health due to the development of 
                antimicrobial resistance that is attributable, in whole 
                or in part, to the nontherapeutic use of such drug.
                    ``(E) In carrying out subparagraph (A) or (B), the 
                Secretary may not consider any data regarding the 
                antimicrobial new animal drug involved that is 
                submitted to the Secretary after the expiration of the 
                180-day period beginning on the date on which the 
                Secretary provides notice in accordance with 
                subparagraph (C) to the holder of the approved 
                application for the nontherapeutic use of such drug.
                    ``(F) If pursuant to subparagraph (A) or (B) the 
                Secretary determines, with respect to the antimicrobial 
                new animal drug involved, that there is not a 
                reasonable certainty of no harm to human health, the 
                Secretary may issue an order withdrawing approval of 
                such drug at any time before the date on which the drug 
                would be rescinded under such subparagraph.''.
    (c) All Uses of Fluoroquinolones in Poultry; Rescinding of Approval 
for Currently Approved Drugs.--Section 512 of the Federal Food, Drug, 
and Cosmetic Act, as amended by subsection (b) of this section, is 
amended by adding at the end the following:
    ``(r) With respect to a fluoroquinolone for which, as of the day 
before the date of the enactment of the Preservation of Antibiotics for 
Human Treatment Act of 2002, there was in effect an approval of an 
application filed pursuant to subsection (b), the use of such drug 
(including use through animal feed that bears or contains such drug) is 
subject to the following:
            ``(1) Each approval of the use of such drug in poultry is 
        rescinded upon the expiration of the 180-day period beginning 
        on such date of enactment unless, before the expiration of such 
        period, the Secretary determines that the holder of the 
        approved application has demonstrated that there is a 
        reasonable certainty of no harm to human health due to the 
        development of antimicrobial resistance that is attributable, 
        in whole or in part, to the use of such drug in poultry.
            ``(2) In carrying out paragraph (1), the Secretary may not 
        consider any data regarding a fluoroquinolone that is submitted 
        to the Secretary by the holder of the approved application 
        unless such data has been submitted to FDA Docket No. 00N-1571. 
        The preceding sentence may not be construed as requiring the 
        Secretary to accept further submissions to such docket if the 
        period designated by the Secretary for the receipt of such 
        submissions 
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has ended.''.
    (d) Definition of Nontherapeutic Use.--Section 512 of the Federal 
Food, Drug, and Cosmetic Act, as amended by subsection (c) of this 
section, is amended by adding at the end the following:
    ``(s) For purposes of this section, the term `nontherapeutic use', 
with respect to an antimicrobial new animal drug, means any use of such 
drug in an animal in the absence of disease, including use for growth 
promotion, feed efficiency, or routine disease prevention.''.
                                 &lt;all&gt;

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