[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2562 Introduced in House (IH)]






109th CONGRESS
  1st Session
                                H. R. 2562

   To amend the Federal Food, Drug, and Cosmetic Act to preserve the 
effectiveness of medically important antibiotics used in the treatment 
                     of human and animal diseases.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 24, 2005

Mr. Brown of Ohio 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 preserve the 
effectiveness of medically important antibiotics used in the treatment 
                     of human and animal diseases.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Preservation of 
Antibiotics for Medical Treatment Act of 2005''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
         TITLE I--SAFETY OF CRITICAL ANTIMICROBIAL ANIMAL DRUGS

Sec. 101. Proof of safety of critical antimicrobial animal drugs.
  TITLE II--USE OF CRITICAL ANTIMICROBIAL ANIMAL DRUGS IN AGRICULTURE

Sec. 201. Collection of data on critical antimicrobial animal drugs.

SEC. 2. FINDINGS.

    The Congress finds that--
            (1)(A) in January 2001, a Federal interagency task force 
        released an action plan to address the continuing decline in 
        effectiveness of antibiotics against common bacterial 
        infections, referred to as antibiotic resistance;
            (B) the task force determined that antibiotic resistance is 
        a growing menace to all people and poses a serious threat to 
        public health; and
            (C) the task force cautioned that if current trends 
        continue, treatments for common infections will become 
        increasingly limited and expensive, and, in some cases, 
        nonexistent;
            (2) antibiotic resistance, resulting in a reduced number of 
        effective antibiotics, may significantly impair the ability of 
        the United States to respond to terrorist attacks involving 
        bacterial infections or a large influx of hospitalized 
        patients;
            (3)(A) any overuse or misuse of antibiotics contributes to 
        the spread of antibiotic resistance, whether in human medicine 
        or in agriculture; and
            (B) recognizing the public health threat caused by 
        antibiotic resistance, Congress took several steps to curb 
        antibiotic overuse in human medicine through amendments to the 
        Public Health Service Act (42 U.S.C. 201 et seq.) made by 
        section 102 of the Public Health Threats and Emergencies Act 
        (Public Law 106-505, title I; 114 Stat. 2315), but has not yet 
        addressed antibiotic overuse in agriculture;
            (4) in a March 2003 report, the National Academy of 
        Sciences stated that--
                    (A) a decrease in antimicrobial use in human 
                medicine alone will have little effect on the current 
                situation; and
                    (B) substantial efforts must be made to decrease 
                inappropriate overuse in animals and agriculture;
            (5)(A) an estimated 70 percent of the antibiotics and other 
        antimicrobial drugs used in the United States are fed to farm 
        animals for nontherapeutic purposes, including--
                    (i) growth promotion; and
                    (ii) compensation for crowded, unsanitary, and 
                stressful farming and transportation conditions; and
            (B) unlike human use of antibiotics, these nontherapeutic 
        uses in animals typically do not require a prescription;
            (6)(A) many scientific studies confirm that the 
        nontherapeutic use of antibiotics in agricultural animals 
        contributes to the development of antibiotic-resistant 
        bacterial infections in people;
            (B) the periodical entitled ``Clinical Infectious 
        Diseases'' published a report in June 2002, based on a 2-year 
        review by experts in human and veterinary medicine, public 
        health, microbiology, biostatistics, and risk analysis, of more 
        than 500 scientific studies on the human health impacts of 
        antimicrobial use in agriculture; and
            (C) the report recommended that antimicrobial agents should 
        no longer be used in agriculture in the absence of disease, but 
        should be limited to therapy for diseased individual animals 
        and prophylaxis when disease is documented in a herd or flock;
            (7) the United States Geological Survey reported in March 
        2002 that--
                    (A) antibiotics were present in 48 percent of the 
                streams tested nationwide; and
                    (B) almost half of the tested streams were 
                downstream from agricultural operations;
            (8) an April 1999 study by the General Accounting Office 
        concluded that resistant strains of 3 microorganisms that cause 
        food-borne illness or disease in humans--Salmonella, 
        Campylobacter, and E. coli--are linked to the use of 
        antibiotics in animals;
            (9)(A) in January 2003, Consumer Reports published test 
        results on poultry products bought in grocery stores nationwide 
        showing disturbingly high levels of Campylobacter and 
        Salmonella bacteria that were resistant to antibiotics used to 
        treat food-borne illnesses; and
            (B) further studies showed similar results in other meat 
        products;
            (10) in October 2001, the New England Journal of Medicine 
        published an editorial urging a ban on nontherapeutic use of 
        medically important antibiotics in animals;
            (11)(A) in 1999, the European Union banned the practice of 
        feeding medically important antibiotics to animals other than 
        for disease treatment or control, and prior to that, individual 
        European countries had banned the use of specific antibiotics 
        in animal feed; and
            (B) those countries have experienced no significant impact 
        on animal health or productivity, food safety, or meat prices, 
        and more importantly, levels of resistant bacteria have 
        declined sharply;
            (12) in 1998, the National Academy of Sciences noted that 
        antibiotic-resistant bacteria generate a minimum of 
        $4,000,000,000 to $5,000,000,000 in costs to United States 
        society and individuals yearly;
            (13) a year later, the National Academy of Sciences 
        estimated that eliminating the use of all antibiotics as feed 
        additives would cost each American consumer less than $5 to $10 
        per year;
            (14) the American Medical Association, the American Public 
        Health Association, the National Association of County and City 
        Health Officials, and the National Campaign for Sustainable 
        Agriculture, are among the more than 300 organizations 
        representing health, consumer, agricultural, environmental, 
        humane, and other interests that support enactment of 
        legislation to phase out nontherapeutic use in farm animals of 
        medically important antibiotics;
            (15) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        301 et seq.)--
                    (A) requires that all drugs be shown to be safe 
                before the drugs are approved; and
                    (B) places the burden on manufacturers to account 
                for health consequences and prove safety;
            (16)(A) the Food and Drug Administration recently modified 
        the drug approval process for antibiotics to recognize the 
        development of resistant bacteria as an important aspect of 
        safety;
            (B) however, most antibiotics currently used in animal 
        production systems for nontherapeutic purposes were approved 
        before the Food and Drug Administration began giving in-depth 
        consideration to resistance during the drug-approval process; 
        and
            (C) the Food and Drug Administration has not established a 
        schedule for reviewing those existing approvals; and
            (17) certain non-routine uses of antibiotics in animal 
        agriculture are legitimate to prevent animal disease.

SEC. 3. PURPOSE.

    The purpose of this Act is to preserve the effectiveness of 
medically important antibiotics used in the treatment of human and 
animal diseases by phasing out use of certain antibiotics for 
nontherapeutic purposes in food-producing animals.

         TITLE I--SAFETY OF CRITICAL ANTIMICROBIAL ANIMAL DRUGS

SEC. 101. PROOF OF SAFETY OF CRITICAL ANTIMICROBIAL ANIMAL DRUGS.

    (a) Definitions.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the 
following:
    ``(rr) Critical Antimicrobial Animal Drug.--The term `critical 
antimicrobial animal drug' means a drug that--
            ``(1) is intended for use in food-producing animals; and
            ``(2) is composed wholly or partly of--
                    ``(A) any kind of penicillin, tetracycline, 
                macrolide, lincosamide, streptogramin, aminoglycoside, 
                or sulfonamide; or
                    ``(B) any other drug or derivative of a drug that 
                is used in humans or intended for use in humans to 
                treat or prevent disease or infection caused by 
                microorganisms.
    ``(ss) Nontherapeutic Use.--The term `nontherapeutic use', with 
respect to a critical antimicrobial animal drug, means any use of the 
drug as a feed or water additive for an animal in the absence of any 
clinical sign of disease in the animal for growth promotion, feed 
efficiency, weight gain, routine disease prevention, or other routine 
purpose.''.
    (b) Applications Pending 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 the first sentence--
                    (A) in subparagraph (H), by striking ``or'' at the 
                end;
                    (B) by redesignating subparagraph (I) as 
                subparagraph (J); and
                    (C) by inserting after subparagraph (H) the 
                following:
                    ``(I) with respect to a critical antimicrobial 
                animal drug or a drug of the same chemical class as a 
                critical antimicrobial animal 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 the drug; or''; and
            (2) in the second sentence, by striking ``(A) through (I)'' 
        and inserting ``(A) through (J)''.
    (c) Phased Elimination of Nontherapeutic Use in Animals of Critical 
Antimicrobial Animal Drugs 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) Phased Elimination of Nontherapeutic Use in Animals of 
Critical Antimicrobial Animal Drugs Important for Human Health.--
            ``(1) Applicability.--This subsection applies to the 
        nontherapeutic use in a food-producing animal of a drug--
                    ``(A)(i) that is a critical antimicrobial animal 
                drug; or
                    ``(ii) that is of the same chemical class as a 
                critical antimicrobial animal drug; and
                    ``(B)(i) for which there is in effect an approval 
                of an application or an exemption under subsection (b), 
                (i), or (j) of section 505; or
                    ``(ii) that is otherwise marketed for use.
            ``(2) Withdrawal.--The Secretary shall withdraw the 
        approval of a nontherapeutic use in food-producing animals 
        described in paragraph (1) on the date that is 2 years after 
        the date of enactment of this subsection unless--
                    ``(A) before the date that is 2 years after the 
                date of the enactment of this subsection, the Secretary 
                makes a final written determination 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 the drug; or
                    ``(B) before the date specified in subparagraph 
                (A), the Secretary makes a final written determination 
                under this subsection, with respect to a risk analysis 
                of the drug conducted by the Secretary and other 
                relevant information, 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 the drug.
            ``(3) Exemptions.--Except as provided in paragraph (5), if 
        the Secretary grants an exemption under section 505(i) for a 
        drug that is a critical antimicrobial animal drug, the 
        Secretary shall rescind each approval of a nontherapeutic use 
        in a food-producing animal of the critical antimicrobial animal 
        drug, or of a drug in the same chemical class as the critical 
        antimicrobial animal drug, as of the date that is 2 years after 
        the date on which the Secretary grants the exemption.
            ``(4) Approvals.--Except as provided in paragraph (5), if 
        an application for a drug that is a critical antimicrobial 
        animal drug is submitted to the Secretary under section 505(b), 
        the Secretary shall rescind each approval of a nontherapeutic 
        use in a food-producing animal of the critical antimicrobial 
        animal drug, or of a drug in the same chemical class as the 
        critical antimicrobial animal drug, as of the date that is 2 
        years after the date on which the application is submitted to 
        the Secretary.
            ``(5) Exception.--Paragraph (3) or (4), as the case may be, 
        shall not apply if--
                    ``(A) before the date on which approval would be 
                rescinded under that paragraph, the Secretary makes a 
                final written determination that the holder of the 
                application for the approved nontherapeutic use 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 the food-
                producing animal of the critical antimicrobial animal 
                drug; or
                    ``(B) before the date specified in subparagraph 
                (A), the Secretary makes a final written determination 
                under this subsection, with respect to a risk analysis 
                of the critical antimicrobial animal drug conducted by 
                the Secretary and any other relevant information, 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 the drug.''.

  TITLE II--USE OF CRITICAL ANTIMICROBIAL ANIMAL DRUGS IN AGRICULTURE

SEC. 201. COLLECTION OF DATA ON CRITICAL ANTIMICROBIAL ANIMAL DRUGS.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 512 (21 U.S.C. 360b) the 
following:

``SEC. 512A. COLLECTION OF DATA ON CRITICAL ANTIMICROBIAL ANIMAL DRUGS.

    ``(a) In General.--Not later than July 1 of each year, a 
manufacturer of a critical antimicrobial animal drug or an animal feed 
for food-producing animals bearing or containing a critical 
antimicrobial animal drug shall submit to the Secretary a report, in 
such form as the Secretary shall require, containing information on the 
sales during the previous calendar year of the critical antimicrobial 
animal drug or the animal feed.
    ``(b) Information to Be Included.--A report under subsection (a) 
shall--
            ``(1) state separately the quantity of the critical 
        antimicrobial animal drug, including such quantity in animal 
        feed bearing or containing the critical antimicrobial drug, 
        sold for each kind of food-producing animal;
            ``(2) describe the claimed purpose of use for the drug for 
        each kind of food-producing animal as being for growth 
        promotion, weight gain, feed efficiency, disease prevention, 
        disease control, disease treatment, or another purpose; and
            ``(3) describe the dosage form of the drug.
    ``(c) Publication.--
            ``(1) In general.--The Secretary shall make the information 
        submitted under subsection (a) available to the public not less 
        than annually.
            ``(2) Protection of confidentiality.--The Secretary may 
        aggregate information, if necessary, so as to avoid disclosure 
        under paragraph (1) of confidential business information.''.
    (b) Violation.--Subsection (e) of section 301 of the Federal Food, 
Drug and Cosmetic Act (21 U.S.C. 331(e)) is amended by striking 
``515(f)'' and inserting ``512A, 515(f)''.
    (c) Effective Date.--The amendments made by this section shall take 
effect on January 1, 2006.
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