text: 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:
      ``(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 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.''.
target: Preservation of Antibiotics for Human Treatment Act of 2002 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to refuse to approve an application for an antimicrobial new animal drug when the applicant fails to demonstrate to a reasonable certainty that human health will not be harmed because of the development of antimicrobial resistance attributable to the nontherapeutic use of such drug.Rescinds within a specified period existing approvals and exemptions concerning the nontherapeutic use of certain antimicrobial drugs until the applicant meets the same standard of lack of harm to human health as required for new animal drugs, including the use of penicillins, tetracyclines, macrolides, lincomycin, bacitracin, virginiamycin, aminoglycosides, and sulfonamides in an animal and fluroroquinolones in poultry.
feat_title: 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.