[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1460 Introduced in Senate (IS)]







108th CONGRESS
  1st Session
                                S. 1460

   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 SENATE OF THE UNITED STATES

                July 25 (legislative day, July 21), 2003

   Mr. Kennedy (for himself, Ms. Snowe, 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 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 2003''.
    (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. Assistance to defray expenses of livestock or poultry 
                            producers in phasing out nontherapeutic use 
                            of critical antimicrobial animal drugs.
Sec. 202. Research and demonstration programs.
Sec. 203. Collection of data on critical antimicrobial animal drugs.

SEC. 2. FINDINGS.

    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 
        (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 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)(A) the United States Geological Survey reported in 
        March 2002 that 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;
            (17)(A) the Food and Drug Administration has begun a 
        process of evaluating the safety of antibiotics used in animal 
        agriculture; and
            (B) that process--
                            (i) is a valuable contribution to public 
                        health; and
                            (ii) may determine that there is a 
                        reasonable certainty of no harm from the use of 
                        certain antibiotics in animal agriculture; and
            (18) certain nonroutine uses of antibiotics in animal 
        agriculture to prevent disease are legitimate.

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:
    ``(nn) 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, 
                bacitracin, macrolide, lincomycin, streptogramin, 
                aminoglycoside, 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.
    ``(oo) 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) Nontherapeutic Use.--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)(i) a drug that is a critical antimicrobial 
                animal drug; or
                    ``(ii) a drug that is of the same chemical class as 
                a critical antimicrobial animal drug; and
                    ``(B) a drug--
                            ``(i) for which, as of the day before the 
                        date of enactment of this subsection, there was 
                        in effect an approval of an application filed 
                        under subsection (b) or (j) of section 505; or
                            ``(ii) that was 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 that 
                date of enactment, the Secretary makes a 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.--If an application for a drug that is 
        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, before the date on which approval would be 
        rescinded under that 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 in 
        the food-producing animal of the critical antimicrobial animal 
        drug.''.

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

SEC. 201. ASSISTANCE TO DEFRAY EXPENSES OF LIVESTOCK OR POULTRY 
              PRODUCERS IN PHASING OUT NONTHERAPEUTIC USE OF CRITICAL 
              ANTIMICROBIAL ANIMAL DRUGS.

    (a) Definitions.--In this section, the terms ``critical 
antimicrobial animal drug'' and ``nontherapeutic use'' have the 
meanings given the terms in section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321).
    (b) Payments.--The Secretary of Agriculture may make payments to 
producers of livestock or poultry that the Secretary determines are 
substantially reducing, or have substantially reduced, the 
nontherapeutic use of critical antimicrobial animal drugs in livestock 
or poultry in order to defray the costs of such reduction.
    (c) Priority for Family Farmers and Small Farms.--In awarding 
payments under subsection (b), the Secretary of Agriculture shall give 
priority to family-owned and family-operated farms or ranches and to 
small farms or ranches, as determined by the Secretary.
    (d) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as are necessary to carry out this section for 
fiscal year 2004 and for each subsequent fiscal year.

SEC. 202. RESEARCH AND DEMONSTRATION PROGRAMS.

    Subtitle D of title VII of the Farm Security and Rural Investment 
Act of 2002 (116 Stat. 455) is amended by adding at the end the 
following:

``SEC. 7413. PHASING OUT OF NONTHERAPEUTIC USE OF CRITICAL 
              ANTIMICROBIAL ANIMAL DRUGS.

    ``(a) Definitions.--In this section, the terms `critical 
antimicrobial animal drug' and `nontherapeutic use' have the meanings 
given the terms in section 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321).
    ``(b) Grants.--The Secretary, in consultation with the Secretary of 
Health and Human Services, shall award grants to colleges and 
universities to establish research and demonstration programs for--
            ``(1) phasing out the nontherapeutic use of critical 
        antimicrobial animal drugs in livestock or poultry; and
            ``(2) informing livestock and poultry producers of methods 
        for accomplishing the objective described in paragraph (1).
    ``(c) Education.--The Secretary shall use the results of the 
research and demonstration programs and the experience of agricultural 
producers that have reduced or eliminated the nontherapeutic use of 
critical antimicrobial animal drugs to educate other agricultural 
producers, through the Cooperative Research, Education, and Extension 
Service, concerning how to successfully phase out such use in livestock 
or poultry.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as are necessary to carry out this section for 
fiscal years 2004 through 2007.''.

SEC. 203. 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 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 in animal feed bearing or 
        containing the critical antimicrobial animal drug, sold for 
        each kind of food-producing animal;
            ``(2) describe the claimed purpose of use 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--
                    ``(A) make the information submitted under 
                subsection (a) available to the public; and
                    ``(B) publish the information at least annually.
            ``(2) Protection of confidentiality.--The Secretary shall 
        aggregate information, if necessary, to avoid disclosure under 
        paragraph (1) of confidential business information.''.
    (b) Prohibited Acts.--Section 301(e) 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 take 
effect on January 1, 2005.
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