[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 1256 Introduced in Senate (IS)]

113th CONGRESS
  1st Session
                                S. 1256

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 27, 2013

 Mrs. Feinstein (for herself, Ms. Collins, Mr. Reed, Ms. Cantwell, 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 antimicrobials 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 ``Preventing Antibiotic Resistance Act 
of 2013''.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1)(A) In 1977, the Food and Drug Administration concluded 
        that feeding livestock low doses of antibiotics used in human 
        disease treatment could promote the development of antibiotic-
        resistance in bacteria. However, the Food and Drug 
        Administration did not act in response to these findings, 
        despite laws requiring the agency to do so.
            (B) In 2012, the Food and Drug Administration was ordered 
        by a Federal court to address the use of antibiotics in 
        livestock, as the result of a lawsuit filed against the agency 
        citing the agency's failure to act in response to the 1977 
        findings.
            (2)(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.
            (3) An April 1999 study by the Government Accountability 
        Office concluded that resistant strains of 3 microorganisms 
        that cause foodborne illness or disease in humans (Salmonella, 
        Campylobacter, and E. coli) are linked to the use of 
        antibiotics in animals.
            (4)(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.
            (B) Such drugs are used in people to treat serious diseases 
        such as pneumonia, scarlet fever, rheumatic fever, sexually 
        transmitted infections, skin infections, and even pandemics 
        like malaria and plague, as well as bioterrorism agents such as 
        anthrax.
            (5)(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; 114 Stat. 2315), but has not yet addressed 
        antibiotic overuse in agriculture.
            (6) 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.
            (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) The peer-reviewed journal ``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) 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.
            (10) 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.
            (11)(A) In 2003, the Food and Drug Administration 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.
            (12)(A) In an April 2004 report, the Government 
        Accountability Office--
                    (i) 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
                    (ii) recommended 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.
            (B) In a September 2011 update to that report, the 
        Government Accountability Office--
                    (i) concluded that Federal agencies had made 
                limited progress in addressing antibiotic use in 
                animals;
                    (ii) recommended that Federal agencies fund 
                research on alternatives to current antibiotic use 
                practices; and
                    (iii) recommended that Federal agencies track the 
                effectiveness of policies that curb antibiotic 
                resistance, including the Food and Drug 
                Administration's voluntary guidelines reducing 
                antibiotic use in food animals.
            (13) In 2009, the Congressional Research Service concluded 
        that, without restrictions on the use of antimicrobial drugs in 
        the production of livestock, export markets for livestock and 
        poultry could be negatively impacted due to restrictions on the 
        use of antibiotics in other nations.
            (14) 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.
            (15) In 2010, the Danish Veterinary and Food Administration 
        testified that the Danish ban of the nontherapeutic use of 
        antibiotics in food animal production resulted in a marked 
        reduction in antimicrobial resistance in multiple bacterial 
        species, including Campylobacter and Enterococci.
            (16) In 2011, the Food and Drug Administration determined 
        that--
                    (A) 13,500,000 kilograms of antibacterial drugs 
                were sold for use on food animals in the United States 
                in 2010;
                    (B) 3,300,000 kilograms of antibacterial drugs were 
                used for human health in 2010; and
                    (C) 80 percent of antibacterial drugs disseminated 
                in the United States in 2010 were sold for use on food 
                animals, rather than being used for human health.
            (17) In 2011, a review of all scientific studies on 
        antimicrobial use in farm animals, published in Clinical 
        Microbiology Reviews, found that--
                    (A) use of antibiotics in food animals leads to 
                development of reservoirs of antibiotic resistance;
                    (B) a ban on nontherapeutic antibiotic use in food 
                animals would preserve the use of such antibiotics for 
                medicine; and
                    (C) a Danish ban on nontherapeutic antibiotics in 
                food animals resulted in little change in animal 
                morbidity and mortality, and only a modest increase in 
                production cost.
            (18) In April 2012, the Food and Drug Administration issued 
        voluntary guidance to industry on reducing antibiotic use in 
        livestock and poultry. As part of that guidance, it summarized 
        over 35 years of peer-reviewed scientific literature regarding 
        use of antimicrobial drugs in livestock. As a result, the Food 
        and Drug Administration stated strategies for controlling 
        antibiotic resistance are needed, and are seeking voluntarily 
        limits on antibiotic use.
            (19)(A) In January 2013, Consumer Reports published test 
        results on pork products bought in grocery stores nationwide 
        showing disturbingly high levels of Salmonella and Yersinia 
        enterocolitica bacteria that were resistant to the antibiotics 
        used to treat foodborne illnesses. A 2003 Consumer Report study 
        showed similar results in poultry products.
            (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. The 2011 
        National Antimicrobial Resistance Monitoring System report 
        found that the percentage of meat containing antibiotic 
        resistant bacteria increases each year and that many of these 
        bacteria exhibit multiple antibiotic resistance.
            (20) 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.
            (21) Many scientific studies confirm that the 
        nontherapeutic use of antibiotics in agricultural animals 
        contribute to the development of antibiotic-resistant bacterial 
        infections in people.
            (22) Epidemiological research has shown that resistant 
        Salmonella and Campylobacter infections are associated with 
        increased numbers of ill patients and bloodstream infections, 
        and increased death.
            (23) The American Medical Association, the American Public 
        Health Association, the National Association of County and City 
        Health Officials, and the National Sustainable Agriculture 
        Coalition are among the more than 400 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 antimicrobials.

SEC. 3. PURPOSE.

    The purpose of this Act is to preserve the effectiveness of 
medically important antimicrobials used in the treatment of human and 
animal diseases.

SEC. 4. PROOF OF SAFETY OF MEDICALLY IMPORTANT ANTIMICROBIALS.

    (a) 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 medically important 
                antimicrobial (as defined in subsection (q)), 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 (as defined in subsection (q)) of 
                the medically important antimicrobial or drug;''; and
            (2) in the second sentence, by striking ``(A) through (I)'' 
        and inserting ``(A) through (J)''.
    (b) Phased Elimination of Nontherapeutic Use in Animals of 
Medically Important Antimicrobials.--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 
Medically Important Antimicrobials.--
            ``(1) Applicability.--This subsection applies to the 
        nontherapeutic use in a food-producing animal of a drug--
                    ``(A) that is a medically important antimicrobial;
                    ``(B) for which there is in effect an approval of 
                an application or an exemption under subsection (b), 
                (i), or (j) of section 505; or
                    ``(C) that is otherwise marketed for human use.
            ``(2) Withdrawal.--The Secretary shall withdraw the 
        approval of a nontherapeutic use in food-producing animals of a 
        drug 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 medically important antimicrobial, the Secretary 
        shall rescind each approval of a nontherapeutic use in a food-
        producing animal of the medically important antimicrobial, 
        effective on 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 medically important 
        antimicrobial 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 medically 
        important antimicrobial, effective on the date that is 2 years 
        after the date on which the application is submitted to the 
        Secretary.
            ``(5) Exceptions.--Paragraph (3) or (4), as applicable, 
        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 medically important 
                antimicrobial; or
                    ``(B) before the date specified in subparagraph 
                (A), the Secretary makes a final written determination, 
                with respect to a risk analysis of the medically 
                important antimicrobial 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 medically important antimicrobial.
            ``(6) Definitions.--In this subsection:
                    ``(A) The term `medically important antimicrobial' 
                means a drug that--
                            ``(i) is intended for use in food-producing 
                        animals; and
                            ``(ii) is composed wholly or partly of--
                                    ``(I) any kind of penicillin, 
                                tetracycline, macrolide, lincosamide, 
                                streptogramin, aminoglycoside, 
                                sulfonamide, or cephalosporin; or
                                    ``(II) a drug from an antimicrobial 
                                class that is listed as `highly 
                                important', `critically important', or 
                                `important' by the World Health 
                                Organization in the latest edition of 
                                its publication entitled `Critically 
                                Important Antimicrobials for Human 
                                Medicine' (or a successor publication).
                    ``(B) The term `therapeutic use', with respect to a 
                medically important antimicrobial, means the use of 
                antimicrobials for the specific purpose of treating an 
                animal with a documented disease or infection. Such 
                term does not include the continued use of such an 
                antimicrobial in the animal after the disease or 
                infection is resolved.
                    ``(C) The term `nontherapeutic use'--
                            ``(i) means administration of antibiotics 
                        to an animal through feed or water (or, in 
                        poultry hatcheries, through any means) for 
                        purposes (such as growth promotion, feed 
                        efficiency, weight gain, or disease prevention) 
                        other than therapeutic use or nonroutine 
                        disease control; and
                            ``(ii) includes any repeated or regular 
                        pattern of use of medically important 
                        antimicrobials for purposes other than 
                        therapeutic use or nonroutine disease control.
                    ``(D) The term `noncustomary situation' does not 
                include normal or standard practice and conditions on 
                the premises that facilitate the transmission of 
                disease.
                    ``(E) The term `nonroutine disease control' means 
                the use of antibiotics in the feed or water of an 
                animal that is not sick, where it can be shown that a 
                particular disease or infection is, or is likely to be, 
                present on the premises because of a specific, non-
                customary situation.''.

SEC. 5. LIMITATIONS ON USE OF MEDICALLY IMPORTANT ANTIMICROBIALS FOR 
              NONROUTINE DISEASE CONTROL.

    (a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(ccc) The administration of a medically important antimicrobial 
to a food-producing animal for nonroutine disease control in violation 
of the requirements of section 512A.''.
    (b) Requirements.--Chapter V of the Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 512 of such Act (21 
U.S.C. 360b) the following:

``SEC. 512A. LIMITATIONS ON USE OF MEDICALLY IMPORTANT ANTIMICROBIALS 
              FOR NONROUTINE DISEASE CONTROL.

    ``(a) Prohibition.--It shall be unlawful to administer (including 
by means of animal feed) a medically important antimicrobial to a food-
producing animal for nonroutine disease control unless--
            ``(1)(A) there is a significant risk that a disease or 
        infection present on, or likely present on, the premises will 
        be transmitted to the food-producing animal;
            ``(B) the administration of the medically important 
        antimicrobial to the food-producing animal is necessary to 
        prevent or reduce the risk of transmission of the disease or 
        infection described in paragraph (1);
            ``(C) the medically important antimicrobial is administered 
        to the food-producing animal for nonroutine disease control for 
        the shortest duration possible to prevent or reduce the risk of 
        transmission of the disease or infection described in paragraph 
        (1) to the animal; and
            ``(D) the medically important antimicrobial is 
        administered--
                    ``(i) at a scale no greater than the barn, house, 
                or pen level; and
                    ``(ii) to the fewest animals possible to prevent or 
                reduce the risk of transmission of the disease or 
                infection described in paragraph (1); or
            ``(2) the Secretary determines 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 such use of the medically important antimicrobial and 
        such use does not threaten the public health.
    ``(b) Definitions.--In this section:
            ``(1) The term `food-producing animal' means a food-
        producing animal intended for sale in interstate commerce.
            ``(2) The terms `medically important antimicrobial' and 
        `nonroutine disease control' have the meanings given such terms 
        in section 512(q).''.
    (c) Applicability.--The amendments made by this section apply 
beginning on the date that is 2 years after the date of the enactment 
of this Act.

SEC. 6. SENSE OF THE SENATE REGARDING VETERINARY OVERSIGHT OF USE OF 
              MEDICALLY IMPORTANT ANTIMICROBIALS.

    (a) In General.--It is the sense of the Senate that a valid 
veterinarian-client-patient relationship should exist to ensure that 
medically important antimicrobials are used in a manner that is 
consistent with professionally accepted best practices.
    (b) Veterinarian-Client-Patient Relationship.--In ths section, the 
term ``veterinarian-client-patient relationship'' means a relationship 
in which all of the following criteria are met:
            (1) The veterinarian has assumed the responsibility for 
        making medical judgments regarding the health of the patient 
        and the client has agreed to follow the veterinarian's 
        instructions.
            (2) The veterinarian has sufficient knowledge of the 
        patient to initiate at least a general or preliminary diagnosis 
        of the medical condition of the patient. This means that the 
        veterinarian is personally acquainted with the keeping and care 
        of the patient by virtue of--
                    (A) a timely examination of the patient by the 
                veterinarian; or
                    (B) medically appropriate and timely visits by the 
                veterinarian to the premises where the animal or 
                animals are kept.
            (3) The veterinarian is readily available for follow-up 
        evaluation or has arranged for veterinary emergency coverage 
        and continuing care and treatment.
            (4) The veterinarian provides oversight of treatment, 
        compliance, and outcome.
            (5) Patient records are maintained.
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