[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3266 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 3266

  To direct that essential antibiotic drugs not be used in livestock 
   unless there is a reasonable certainty of no harm to human health.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            November 9, 1999

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

_______________________________________________________________________

                                 A BILL


 
  To direct that essential antibiotic drugs not be used in livestock 
   unless there is a reasonable certainty of no harm to human health.

    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 Essential 
Antibiotics for Human Diseases Act of 1999''.

SEC. 2. FINDINGS AND PURPOSE.

    (a) Findings.--The Congress finds the following:
            (1) Several antibiotics, particularly penicillin, 
        tetracycline, erythromycin, lincomycin, tylosin, bacitracin and 
        virginiamycin, that either are used in or are related to 
        antibiotics used in humans to treat infectious diseases are 
        also used in animal feed in subtherapeutic amounts in order to 
        promote the animals' growth.
            (2) Mounting scientific evidence shows that using those 
        antibiotics in livestock feed can lead to 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. 
        All developed countries in the world, with the exception of the 
        United States and Canada, currently follow such 
        recommendations.
            (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 4 remaining human-use 
        antibiotics still in use at subtherapeutic levels 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 
        states that resistant strains of 3 specific organisms that 
        cause illness or disease in humans--salmonella, campylobacter, 
        and E. coli--are linked to the use of antibiotics in animals.
            (8) Removing certain antibiotics from subtherapeutic use 
        will not hinder the raising of livestock because non-
        antimicrobial growth promoters, alternative antibiotics, and 
        alternative husbandry practices are available.
    (b) Purpose.--The purpose of this Act is to insure that certain 
antimicrobial drugs essential to human health are not used 
subtherapeutically in food animals unless there is a reasonable 
certainty of no harm to human health due to the development of 
antimicrobial resistance as a result of such use.

SEC. 3. REQUIRING PROOF OF SAFETY.

    (a) In General.--Section 512(d)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(d)(1)) is amended by striking ``or'' at 
the end of subparagraph (H), by redesignating subparagraph (I) as 
subparagraph (J), and by adding after subparagraph (H) the following:
            ``(I) the Secretary is unable to determine, based on data 
        submitted by the applicant, that there is a reasonable 
        certainty of no harm to human health due to the development of 
        antimicrobial resistance which is attributable to the 
        subtherapeutic use of such drug; or''.
    (b) Withdrawal of Approval.--Section 512(e) of such Act (21 U.S.C. 
360b(e)) is amended by redesignating paragraph (3) as paragraph (4) and 
by inserting after paragraph (2) the following:
    ``(3)(A) Except as provided in subparagraph (B), 2 years after the 
date of the enactment of this paragraph, approval pursuant to 
subsection (b) with respect to the subtherapeutic use of penicillin, 
tetracycline, erythromycin, lincomycin, tylosin, bacitracin, 
virginiamycin, or other antimicrobial new animal drugs in animals is 
deemed to be withdrawn and the use will be deemed unsafe for the 
purposes of section 501(a)(6) unless, based on data submitted by the 
applicant, the Secretary determines that there is a reasonable 
certainty of no harm to human health due to the development of 
antimicrobial resistance which is attributable to the subtherapeutic 
use of such drug.
    ``(B) If the Secretary determines that there is not a reasonable 
certainty of no harm to human health due to the development of 
antibiotic resistance that is attributable to the subtherapeutic use of 
such drug, the Secretary may issue an order withdrawing approval sooner 
than 2 years after the date of enactment of this paragraph.''.
    (c) Definition.--Section 512 of such Act is amended by adding at 
the end the following:
    ``(q) For purposes of this section, the term `subtherapeutic use' 
means any use of an antimicrobial drug in animals other than the high 
level, short term use to treat ill animals.''.
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