[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 2508 Introduced in Senate (IS)]







107th CONGRESS
  2d Session
                                S. 2508

  To preserve the effectiveness of medically important antibiotics by 
           restricting their use as additives to animal feed.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                 May 13 (legislative day, May 9), 2002

 Mr. Kennedy (for himself, Mr. Reed, and Mr. Bingaman) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To preserve the effectiveness of medically important antibiotics by 
           restricting their use as additives to animal feed.

    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 either 
        are used in or are related to antibiotics used in humans to 
        treat infectious diseases and 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 1997 and in 2000, 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. 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 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''.
            (5) In July 1999, the European Union banned the use for 
        animal growth promotion of remaining human-use antibiotics 
        still in use to promote animal growth. 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.
            (6) 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. The Food and Drug Administration 
        concluded that ``the use of fluoroquinolones in poultry is a 
        significant cause of fluoroquinolone resistant infections in 
        humans.'' One manufacturer of such drugs 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.
            (7) In June 2001, the American Medical Association adopted 
        a resolution opposing nontherapeutic use of antimicrobials in 
        animal agriculture. Medical professional 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.
            (8) 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.
            (9) The National Academy of Sciences has found that 
        eliminating the use of antibiotics as feed additives would cost 
        each American consumer not more than $5 to $10 per year.
            (10) In January 2001, a Federal interagency task force on 
        antibiotic resistance concluded 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.''.
            (11) Scientific studies published in major peer-reviewed 
        research journals have shown that resistance traits can be 
        transferred among unrelated species of bacteria, including from 
        nonpathogens to pathogens.
            (12) Development of resistance to antibiotics could 
        significantly impair the ability of the United States to 
        respond effectively to a bioterrorist attack and is likely to 
        increase the casualties that result from such an attack.

SEC. 3. PRESERVING THE EFFECTIVENESS OF ANTIBIOTICS SUCH AS CIPRO.

    (a) Prohibiting the Use of Drugs Related to Cipro in Poultry.--
Section 512(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360b(a)(2)) is amended--
            (1) in subparagraph (B), by striking ``and'' at the end;
            (2) in subparagraph (C), by striking the period and 
        inserting ``; and''; and
            (3) by adding at the end the following:
            ``(D) such drug is not a member of the fluoroquinolone 
        class of antimicrobial drugs, or if such drug is a member of 
        the fluoroquinolone class of antimicrobial drugs, the Secretary 
        shall have found, based on information submitted to the 
        Secretary by the sponsor of such drug, that there exists 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 in animal feed of such drug.
``Nothing in subparagraph (D) shall be construed to affect an approval 
under this subsection for a drug of the fluoroquinolone class of 
antimicrobial drugs that is used in or for cattle.''.
    (b) Definition.--Section 201(w) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(w)) is amended--
            (1) by striking ``(w) The term'' and inserting ``(w)(1) The 
        term''; and
            (2) by adding at the end the following:
    ``(2) With respect to subparagraph (D) of section 512(a)(2) (and in 
provisions of this Act that refer to such subparagraph), the term 
`animal feed' shall include an article that is a fluid administered to 
animals other than man. Such term does not include fluids administered 
via hypodermic injection.''.

SEC. 4. 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) with respect to a critical antimicrobial drug or a 
        drug of the same chemical class as a critical antimicrobial 
        drug, 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)), by striking ``(A) through (I)'' 
        and inserting ``(A) through (J)''.
    (b) Phased Elimination of Nontherapeutic Use in Animals of 
Antibiotics Important for Human Health.--Section 512 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360b) is amended by adding at 
the end the following:
    ``(q) With respect to the nontherapeutic use in an animal of--
            ``(1) a drug that is a critical antimicrobial drug; or
            ``(2) a drug that is of the same chemical class as a 
        critical antimicrobial drug;
for which, as of the day before the date of enactment of this 
subsection, there was in effect an approval of an application filed 
pursuant to subsection (b), the Secretary shall withdraw such approval 
on the date that is 2 years after the date of enactment of this 
subsection unless the Secretary, based on information submitted to the 
Secretary by the sponsor of such drug, has determined prior to the date 
that is 2 years after such date of enactment 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.
    ``(r)(1) If the Secretary grants an exemption under section 505(i) 
or under section 351 of the Public Health Service Act (42 U.S.C. 262) 
to a drug that is an antibiotic drug, the Secretary shall rescind each 
approval of a nontherapeutic use in an animal of such drug or of a drug 
in the same chemical class as such drug upon the expiration of the 2-
year period beginning on the date on which the Secretary grants the 
exemption, except as provided in paragraph (3).
    ``(2) If an application for an antibiotic drug is submitted to the 
Secretary under section 505(b) or under section 351 of the Public 
Health Service Act (42 U.S.C. 262), the Secretary shall rescind each 
approval of a nontherapeutic use in an animal of such drug or a drug in 
the same chemical class as such drug upon the expiration of the 2-year 
period beginning on the date on which the application is submitted to 
the Secretary, except as provided in paragraph (3).
    ``(3) Paragraph (1) or (2), as the case may be, applies unless, 
before the date on which approval would be rescinded under such 
paragraph, 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 in 
an animal of such drug.''.
    (c) Definitions.--Section 512 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b), as amended by subsection (b), is further 
amended by adding at the end the following:
    ``(s) For purposes of this section, the term `nontherapeutic use', 
with respect to a critical antimicrobial drug, means any use of such 
drug in an animal in the absence of disease in such animal, including 
use for growth promotion, feed efficiency, or routine disease 
prevention.
    ``(t) For purposes of this section, the term `critical 
antimicrobial drug' means any drug that is--
            ``(1) intended for use in animals other than humans that 
        are--
                    ``(A) intended for use as, or to generate, food for 
                humans; or
                    ``(B) intended to breed or otherwise produce 
                animals described in subparagraph (A); and
            ``(2)(A) composed wholly or partly of any kind of 
        penicillin, tetracycline, bacitracin, macrolide, lincomycin, 
        streptogramin, aminoglycoside, sulfonamide; or
            ``(B) any other drug or derivative thereof that is used in 
        humans or intended for use in humans to inhibit or destroy 
        micro-organisms.''.

SEC. 5. ASSISTANCE TO DEFRAY FARMERS' EXPENSES IN PHASING OUT 
              NONTHERAPEUTIC USE OF MEDICALLY IMPORTANT ANTIBIOTICS; 
              PREFERENCE FOR FAMILY FARMS.

    (a) In General.--The Secretary of Agriculture may make payments to 
producers of livestock or poultry who the Secretary determines are 
substantially reducing, or have substantially reduced, the 
nontherapeutic use of critical antimicrobial drugs in livestock or 
poultry in order to defray the costs of such reduction.
    (b) Definition.--In this section the terms ``critical antimicrobial 
drug'' and ``nontherapeutic use'' have the meanings given such terms in 
section 512(s) of the Federal Food, Drug, and Cosmetic Act (as amended 
by this Act).
    (c) Priority for Family Farmers.--In awarding payments under 
subsection (a), the Secretary of Agriculture shall give priority to 
family-owned and family-operated farms or ranches.
    (d) Authorization of Appropriations.--There is authorized to be 
appropriated such sums as may be necessary to carry out this section 
for fiscal year 2003 and for each subsequent fiscal year.
                                 <all>