[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 1211 Introduced in Senate (IS)]

112th CONGRESS
  1st Session
                                S. 1211

   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

                             June 15, 2011

  Mrs. Feinstein (for herself, Ms. Collins, Mr. Reed, and Mrs. Boxer) 
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.

    This Act may be cited as the ``Preservation of Antibiotics for 
Medical Treatment Act of 2011''.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) In January 2001, a Federal interagency task force--
                    (A) released an action plan to address the 
                continuing decline in effectiveness of antibiotics 
                against common bacterial infections, referred to as 
                antibiotic resistance;
                    (B) determined that antibiotic resistance is a 
                growing menace to all people and poses a serious threat 
                to public health; and
                    (C) 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.
            (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) In 2010, the FDA determined that--
                    (A) 1,300,000 kilograms of antibacterial drugs were 
                sold for use on food animals in the United States in 
                2009;
                    (B) 3,300,000 kilograms of antibacterial drugs were 
                used for human health in 2009; and
                    (C) therefore, 80 percent of antibacterial drugs 
                disseminated in the United States in 2009 were sold for 
                use on food animals, rather than being used for human 
                health.
            (6)(A) Large-scale, voluntary surveys by the Department of 
        Agriculture's Animal and Plant Health Inspection Service in 
        1999, 2001, and 2006 revealed that--
                    (i) 84 percent of grower-finisher swine farms, 83 
                percent of cattle feedlots, and 84 percent of sheep 
                farms administer antimicrobials in the feed or water 
                for health or growth promotion reasons; and
                    (ii) many of the antimicrobials identified are 
                identical or closely related to drugs used in human 
                medicine, including tetracyclines, macrolides, 
                Bacitracin, penicillins, and sulfonamides; and
            (B) these drugs are used in people to treat serious 
        diseases such as pneumonia, scarlet fever, rheumatic fever, 
        venereal disease, skin infections, and even pandemics like 
        malaria and plague, as well as bioterrorism agents like 
        smallpox and anthrax.
            (7) Many scientific studies confirm that the nontherapeutic 
        use of antibiotics in agricultural animals contributes to the 
        development of antibiotic-resistant bacterial infections in 
        people.
            (8) The periodical entitled ``Clinical Infectious 
        Diseases'' published a report in June 2002, that--
                    (A) was 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
                    (B) 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.
            (9) 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.
            (10) 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.
            (11) Epidemiological research has shown that resistant 
        Salmonella and Campylobacter infections are associated with 
        increased numbers of ill patients and bloodstream infections, 
        and increased death.
            (12) In 2010, the peer-reviewed journal Molecular Cell 
        published a study demonstrating that low-dosage use of 
        antibiotics causes a dramatic increase in genetic mutation, 
        raising new concerns about the agricultural practice of using 
        low-dosage antibiotics in order to stimulate growth promotion 
        and routinely prevent disease in unhealthy conditions.
            (13)(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 the antibiotics used 
        to treat food-borne illnesses.
            (B) The Food and Drug Administration's National 
        Antimicrobial Resistance Monitoring System routinely finds that 
        retail meat products are contaminated with bacteria (including 
        the foodborne pathogens Campylobacter and Salmonella) that are 
        resistant to antibiotics important in human medicine.
            (C) In December 2007, the USDA issued a fact sheet on the 
        recently recognized link between antimicrobial drug use in 
        animals and Methicillin Resistant Staphylococcus Aureas (MRSA) 
        infections in humans.
            (14) In October 2001, the New England Journal of Medicine 
        published an editorial urging a ban on nontherapeutic use of 
        medically important antibiotics in animals.
            (15)(A) 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.
            (B) In 2009, Cook County Hospital and the Alliance for 
        Prudent Use of Antibiotics estimated that the total health care 
        cost of antibiotic resistant infections in the United States 
        was between $16,600,000,000 and $26,000,000,000 annually.
            (16) 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 have supported enactment of 
        legislation to phase out nontherapeutic use in farm animals of 
        medically important antibiotics.
            (17) In 2010, the Danish Veterinary and Food Administration 
        testified that the Danish ban of the non-therapeutic use of 
        antibiotics in food animal production resulted in a marked 
        reduction in antimicrobial resistance in multiple bacterial 
        species, including Campylobacter and Enterococci.
            (18) In 2009, the Congressional Research Service concluded 
        that restrictions overseas on the use of antimicrobial drugs in 
        the production of livestock could impact U.S. export markets 
        for livestock and poultry.
            (19) 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.
            (20)(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, but most antibiotics currently used in animal 
        production systems for nontherapeutic purposes were approved 
        before the Food and Drug Administration began considering 
        resistance during the drug-approval process.
            (B) The Food and Drug Administration has not established a 
        schedule for reviewing those existing approvals.
            (21) Certain non-routine uses of antibiotics in animal 
        agriculture are legitimate to prevent animal disease.
            (22) An April 2004 study by the General Accounting Office--
                    (A) concluded that Federal agencies do not collect 
                the critical data on antibiotic use in animals that 
                they need to support research on human health risks; 
                and
                    (B) recommends that the Department of Agriculture 
                and the Department of Health and Human Services develop 
                and implement a plan to collect data on antibiotic use 
                in animals.

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 reviewing the safety of certain antibiotics for 
nontherapeutic purposes in food-producing animals.

SEC. 4. 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:
    ``(ss) 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.
    ``(tt) 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) in subparagraph (I), by inserting ``or'' at the 
                end; and
                    (C) by inserting after subparagraph (I) the 
                following:
                    ``(J) 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;''; 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, 
                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, 
                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.''.

SEC. 5. COMMITTEE HEARINGS ON IMPLEMENTATION.

    (a) In General.--The Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate shall each hold a hearing on the implementation 
by the Commissioner of Food and Drugs of section 512(q) of the Federal 
Food, Drug, and Cosmetic Act, as added by section 4 of this Act.
    (b) Exercise of Rulemaking Authority.--Subsection (a) is enacted--
            (1) as an exercise of the rulemaking power of the House of 
        Representatives and Senate, and, as such, they shall be 
        considered as part of the rules of the House or Senate (as the 
        case may be), and such rules shall supersede any other rule of 
        the House or Senate only to the extent that rule is 
        inconsistent therewith; and
            (2) with full recognition of the constitutional right of 
        either House to change such rules (so far as relating to the 
        procedure in that House) at any time, in the same manner, and 
        to the same extent as in the case of any other rule of that 
        House.
                                 <all>