II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Preventing Antibiotic 

5 Resistance Act of 2013’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds the following: 


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1 (1)(A) In 1977, the Food and Drug Adminis2 tration concluded that feeding livestock low doses of 

3 antibiotics used in human disease treatment could 

4 promote the development of antibiotic-resistance in 

5 bacteria. However, the Food and Drug Administra6 tion did not act in response to these findings, despite 

7 laws requiring the agency to do so. 

8 (B) In 2012, the Food and Drug Administra9 tion was ordered by a Federal court to address the 

10 use of antibiotics in livestock, as the result of a law11 suit filed against the agency citing the agency’s fail12 ure to act in response to the 1977 findings. 

13 (2)(A) In 1998, the National Academy of 

14 Sciences noted that antibiotic-resistant bacteria gen15 erate a minimum of $4,000,000,000 to 

16 $5,000,000,000 in costs to United States society 

17 and individuals yearly. 

18 (B) In 2009, Cook County Hospital and the Al19 liance for Prudent Use of Antibiotics estimated that 

20 the total health care cost of antibiotic resistant in21 fections in the United States was between 

22 $16,600,000,000 and $26,000,000,000 annually. 

23 (3) An April 1999 study by the Government 

24 Accountability Office concluded that resistant 

25 strains of 3 microorganisms that cause foodborne illVerDate Mar 15 2010 14:05 Jul 15, 2013 Jkt 029200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1256.IS S1256

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1 ness or disease in humans (Salmonella, 

2 Campylobacter, and E. coli) are linked to the use of 

3 antibiotics in animals. 

4 (4)(A) Large-scale, voluntary surveys by the 

5 Department of Agriculture’s Animal and Plant 

6 Health Inspection Service in 1999, 2001, and 2006 

7 revealed that— 

8 (i) 84 percent of grower-finisher swine 

9 farms, 83 percent of cattle feedlots, and 84 per10 cent of sheep farms administer antimicrobials 

11 in the feed or water for health or growth pro12 motion reasons; and 

13 (ii) many of the antimicrobials identified 

14 are identical or closely related to drugs used in 

15 human medicine, including tetracyclines, 

16 macrolides, Bacitracin, penicillins, and 

17 sulfonamides. 

18 (B) Such drugs are used in people to treat seri19 ous diseases such as pneumonia, scarlet fever, rheu20 matic fever, sexually transmitted infections, skin in21 fections, and even pandemics like malaria and 

22 plague, as well as bioterrorism agents such as an23 thrax. 


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1 (5)(A) Any overuse or misuse of antibiotics con2 tributes to the spread of antibiotic resistance, wheth3 er in human medicine or in agriculture. 

4 (B) Recognizing the public health threat caused 

5 by antibiotic resistance, Congress took several steps 

6 to curb antibiotic overuse in human medicine 

7 through amendments to the Public Health Service 

8 Act (42 U.S.C. 201 et seq.) made by section 102 of 

9 the Public Health Threats and Emergencies Act 

10 (Public Law 106–505; 114 Stat. 2315), but has not 

11 yet addressed antibiotic overuse in agriculture. 

12 (6) In January 2001, a Federal interagency 

13 task force— 

14 (A) released an action plan to address the 

15 continuing decline in effectiveness of antibiotics 

16 against common bacterial infections, referred to 

17 as antibiotic resistance; 

18 (B) determined that antibiotic resistance is 

19 a growing menace to all people and poses a se20 rious threat to public health; and 

21 (C) cautioned that if current trends con22 tinue, treatments for common infections will be23 come increasingly limited and expensive, and, in 

24 some cases, nonexistent. 


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1 (7) The United States Geological Survey re2 ported in March 2002 that— 

3 (A) antibiotics were present in 48 percent 

4 of the streams tested nationwide; and 

5 (B) almost half of the tested streams were 

6 downstream from agricultural operations. 

7 (8) The peer-reviewed journal ‘‘Clinical Infec8 tious Diseases’’ published a report in June 2002 

9 that— 

10 (A) was based on a 2-year review by ex11 perts in human and veterinary medicine, public 

12 health, microbiology, biostatistics, and risk 

13 analysis, of more than 500 scientific studies on 

14 the human health impacts of antimicrobial use 

15 in agriculture; and 

16 (B) recommended that antimicrobial 

17 agents should no longer be used in agriculture 

18 in the absence of disease, but should be limited 

19 to therapy for diseased individual animals and 

20 prophylaxis when disease is documented in a 

21 herd or flock. 

22 (9) In a March 2003 report, the National Acad23 emy of Sciences stated that— 


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1 (A) a decrease in antimicrobial use in 

2 human medicine alone will have little effect on 

3 the current situation; and 

4 (B) substantial efforts must be made to 

5 decrease inappropriate overuse in animals and 

6 agriculture. 

7 (10) The Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 301 et seq.)— 

9 (A) requires that all drugs be shown to be 

10 safe before the drugs are approved; and 

11 (B) places the burden on manufacturers to 

12 account for health consequences and prove safe13 ty. 

14 (11)(A) In 2003, the Food and Drug Adminis15 tration modified the drug approval process for anti16 biotics to recognize the development of resistant bac17 teria as an important aspect of safety, but most 

18 antibiotics currently used in animal production sys19 tems for nontherapeutic purposes were approved be20 fore the Food and Drug Administration began con21 sidering resistance during the drug-approval process. 

22 (B) The Food and Drug Administration has not 

23 established a schedule for reviewing those existing 

24 approvals. 


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1 (12)(A) In an April 2004 report, the Govern2 ment Accountability Office— 

3 (i) concluded that Federal agencies do not 

4 collect the critical data on antibiotic use in ani5 mals that they need to support research on 

6 human health risks; and 

7 (ii) recommended that the Department of 

8 Agriculture and the Department of Health and 

9 Human Services develop and implement a plan 

10 to collect data on antibiotic use in animals. 

11 (B) In a September 2011 update to that report, 

12 the Government Accountability Office— 

13 (i) concluded that Federal agencies had 

14 made limited progress in addressing antibiotic 

15 use in animals; 

16 (ii) recommended that Federal agencies 

17 fund research on alternatives to current anti18 biotic use practices; and 

19 (iii) recommended that Federal agencies 

20 track the effectiveness of policies that curb anti21 biotic resistance, including the Food and Drug 

22 Administration’s voluntary guidelines reducing 

23 antibiotic use in food animals. 

24 (13) In 2009, the Congressional Research Serv25 ice concluded that, without restrictions on the use of 


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1 antimicrobial drugs in the production of livestock, 

2 export markets for livestock and poultry could be 

3 negatively impacted due to restrictions on the use of 

4 antibiotics in other nations. 

5 (14) In 2010, the peer-reviewed journal ‘‘Molec6 ular Cell’’ published a study demonstrating that low7 dosage use of antibiotics causes a dramatic increase 

8 in genetic mutation, raising new concerns about the 

9 agricultural practice of using low-dosage antibiotics 

10 in order to stimulate growth promotion and rou11 tinely prevent disease in unhealthy conditions. 

12 (15) In 2010, the Danish Veterinary and Food 

13 Administration testified that the Danish ban of the 

14 nontherapeutic use of antibiotics in food animal pro15 duction resulted in a marked reduction in anti16 microbial resistance in multiple bacterial species, in17 cluding Campylobacter and Enterococci. 

18 (16) In 2011, the Food and Drug Administra19 tion determined that— 

20 (A) 13,500,000 kilograms of antibacterial 

21 drugs were sold for use on food animals in the 

22 United States in 2010; 

23 (B) 3,300,000 kilograms of antibacterial 

24 drugs were used for human health in 2010; and 


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1 (C) 80 percent of antibacterial drugs dis2 seminated in the United States in 2010 were 

3 sold for use on food animals, rather than being 

4 used for human health. 

5 (17) In 2011, a review of all scientific studies 

6 on antimicrobial use in farm animals, published in 

7 Clinical Microbiology Reviews, found that— 

8 (A) use of antibiotics in food animals leads 

9 to development of reservoirs of antibiotic resist10 ance; 

11 (B) a ban on nontherapeutic antibiotic use 

12 in food animals would preserve the use of such 

13 antibiotics for medicine; and 

14 (C) a Danish ban on nontherapeutic anti15 biotics in food animals resulted in little change 

16 in animal morbidity and mortality, and only a 

17 modest increase in production cost. 

18 (18) In April 2012, the Food and Drug Admin19 istration issued voluntary guidance to industry on 

20 reducing antibiotic use in livestock and poultry. As 

21 part of that guidance, it summarized over 35 years 

22 of peer-reviewed scientific literature regarding use of 

23 antimicrobial drugs in livestock. As a result, the 

24 Food and Drug Administration stated strategies for 


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1 controlling antibiotic resistance are needed, and are 

2 seeking voluntarily limits on antibiotic use. 

3 (19)(A) In January 2013, Consumer Reports 

4 published test results on pork products bought in 

5 grocery stores nationwide showing disturbingly high 

6 levels of Salmonella and Yersinia enterocolitica bac7 teria that were resistant to the antibiotics used to 

8 treat foodborne illnesses. A 2003 Consumer Report 

9 study showed similar results in poultry products. 

10 (B) The Food and Drug Administration’s Na11 tional Antimicrobial Resistance Monitoring System 

12 routinely finds that retail meat products are con13 taminated with bacteria (including the foodborne 

14 pathogens Campylobacter and Salmonella) that are 

15 resistant to antibiotics important in human medi16 cine. The 2011 National Antimicrobial Resistance 

17 Monitoring System report found that the percentage 

18 of meat containing antibiotic resistant bacteria in19 creases each year and that many of these bacteria 

20 exhibit multiple antibiotic resistance. 

21 (20) Antibiotic resistance, resulting in a re22 duced number of effective antibiotics, may signifi23 cantly impair the ability of the United States to re24 spond to terrorist attacks involving bacterial infec25 tions or a large influx of hospitalized patients. 


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1 (21) Many scientific studies confirm that the 

2 nontherapeutic use of antibiotics in agricultural ani3 mals contribute to the development of antibiotic-re4 sistant bacterial infections in people. 

5 (22) Epidemiological research has shown that 

6 resistant Salmonella and Campylobacter infections 

7 are associated with increased numbers of ill patients 

8 and bloodstream infections, and increased death. 

9 (23) The American Medical Association, the 

10 American Public Health Association, the National 

11 Association of County and City Health Officials, and 

12 the National Sustainable Agriculture Coalition are 

13 among the more than 400 organizations rep14 resenting health, consumer, agricultural, environ15 mental, humane, and other interests that have sup16 ported enactment of legislation to phase out non17 therapeutic use in farm animals of medically impor18 tant antimicrobials. 

19 SEC. 3. PURPOSE. 

20 The purpose of this Act is to preserve the effective21 ness of medically important antimicrobials used in the 

22 treatment of human and animal diseases. 


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1 SEC. 4. PROOF OF SAFETY OF MEDICALLY IMPORTANT 

2 ANTIMICROBIALS. 

3 (a) APPLICATIONS PENDING OR SUBMITTED AFTER

4 ENACTMENT.—Section 512(d)(1) of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)) is amend6 ed— 

7 (1) in the first sentence— 

8 (A) in subparagraph (H), by striking ‘‘or’’ 

9 at the end; 

10 (B) in subparagraph (I), by inserting ‘‘or’’ 

11 at the end; and 

12 (C) by inserting after subparagraph (I) the 

13 following: 

14 ‘‘(J) with respect to a medically important 

15 antimicrobial (as defined in subsection (q)), the 

16 applicant has failed to demonstrate that there 

17 is a reasonable certainty of no harm to human 

18 health due to the development of antimicrobial 

19 resistance that is attributable, in whole or in 

20 part, to the nontherapeutic use (as defined in 

21 subsection (q)) of the medically important anti22 microbial or drug;’’; and 

23 (2) in the second sentence, by striking ‘‘(A) 

24 through (I)’’ and inserting ‘‘(A) through (J)’’. 

25 (b) PHASED ELIMINATION OF NONTHERAPEUTIC

26 USE IN ANIMALS OF MEDICALLY IMPORTANT


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1 ANTIMICROBIALS.—Section 512 of the Federal Food, 

2 Drug, and Cosmetic Act (21 U.S.C. 360b) is amended by 

3 adding at the end the following: 

4 ‘‘(q) PHASED ELIMINATION OF NONTHERAPEUTIC

5 USE IN ANIMALS OF MEDICALLY IMPORTANT

6 ANTIMICROBIALS.— 

7 ‘‘(1) APPLICABILITY.—This subsection applies 

8 to the nontherapeutic use in a food-producing ani9 mal of a drug— 

10 ‘‘(A) that is a medically important anti11 microbial; 

12 ‘‘(B) for which there is in effect an ap13 proval of an application or an exemption under 

14 subsection (b), (i), or (j) of section 505; or 

15 ‘‘(C) that is otherwise marketed for human 

16 use. 

17 ‘‘(2) WITHDRAWAL.—The Secretary shall with18 draw the approval of a nontherapeutic use in food19 producing animals of a drug described in paragraph 

20 (1) on the date that is 2 years after the date of en21 actment of this subsection unless— 

22 ‘‘(A) before the date that is 2 years after 

23 the date of the enactment of this subsection, 

24 the Secretary makes a final written determina25 tion that the holder of the approved application 


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1 has demonstrated that there is a reasonable 

2 certainty of no harm to human health due to 

3 the development of antimicrobial resistance that 

4 is attributable in whole or in part to the non5 therapeutic use of the drug; or 

6 ‘‘(B) before the date specified in subpara7 graph (A), the Secretary makes a final written 

8 determination under this subsection, with re9 spect to a risk analysis of the drug conducted 

10 by the Secretary and other relevant informa11 tion, that there is a reasonable certainty of no 

12 harm to human health due to the development 

13 of antimicrobial resistance that is attributable 

14 in whole or in part to the nontherapeutic use of 

15 the drug. 

16 ‘‘(3) EXEMPTIONS.—Except as provided in 

17 paragraph (5), if the Secretary grants an exemption 

18 under section 505(i) for a drug that is a medically 

19 important antimicrobial, the Secretary shall rescind 

20 each approval of a nontherapeutic use in a food-pro21 ducing animal of the medically important anti22 microbial, effective on the date that is 2 years after 

23 the date on which the Secretary grants the exemp24 tion. 


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1 ‘‘(4) APPROVALS.—Except as provided in para2 graph (5), if an application for a drug that is a 

3 medically important antimicrobial is submitted to 

4 the Secretary under section 505(b), the Secretary 

5 shall rescind each approval of a nontherapeutic use 

6 in a food-producing animal of the medically impor7 tant antimicrobial, effective on the date that is 2 

8 years after the date on which the application is sub9 mitted to the Secretary. 

10 ‘‘(5) EXCEPTIONS.—Paragraph (3) or (4), as 

11 applicable, shall not apply if— 

12 ‘‘(A) before the date on which approval 

13 would be rescinded under that paragraph, the 

14 Secretary makes a final written determination 

15 that the holder of the application for the ap16 proved nontherapeutic use has demonstrated 

17 that there is a reasonable certainty of no harm 

18 to human health due to the development of 

19 antimicrobial resistance that is attributable in 

20 whole or in part to the nontherapeutic use in 

21 the food-producing animal of the medically im22 portant antimicrobial; or 

23 ‘‘(B) before the date specified in subpara24 graph (A), the Secretary makes a final written 

25 determination, with respect to a risk analysis of 


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1 the medically important antimicrobial conducted 

2 by the Secretary and any other relevant infor3 mation, that there is a reasonable certainty of 

4 no harm to human health due to the develop5 ment of antimicrobial resistance that is attrib6 utable in whole or in part to the nontherapeutic 

7 use of the medically important antimicrobial. 

8 ‘‘(6) DEFINITIONS.—In this subsection: 

9 ‘‘(A) The term ‘medically important anti10 microbial’ means a drug that— 

11 ‘‘(i) is intended for use in food-pro12 ducing animals; and 

13 ‘‘(ii) is composed wholly or partly of— 

14 ‘‘(I) any kind of penicillin, tetra15 cycline, macrolide, lincosamide, 

16 streptogramin, aminoglycoside, sul17 fonamide, or cephalosporin; or 

18 ‘‘(II) a drug from an anti19 microbial class that is listed as ‘highly 

20 important’, ‘critically important’, or 

21 ‘important’ by the World Health Or22 ganization in the latest edition of its 

23 publication entitled ‘Critically Impor24 tant Antimicrobials for Human Medi25 cine’ (or a successor publication). 


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1 ‘‘(B) The term ‘therapeutic use’, with re2 spect to a medically important antimicrobial, 

3 means the use of antimicrobials for the specific 

4 purpose of treating an animal with a docu5 mented disease or infection. Such term does not 

6 include the continued use of such an anti7 microbial in the animal after the disease or in8 fection is resolved. 

9 ‘‘(C) The term ‘nontherapeutic use’— 

10 ‘‘(i) means administration of anti11 biotics to an animal through feed or water 

12 (or, in poultry hatcheries, through any 

13 means) for purposes (such as growth pro14 motion, feed efficiency, weight gain, or dis15 ease prevention) other than therapeutic use 

16 or nonroutine disease control; and 

17 ‘‘(ii) includes any repeated or regular 

18 pattern of use of medically important 

19 antimicrobials for purposes other than 

20 therapeutic use or nonroutine disease con21 trol. 

22 ‘‘(D) The term ‘noncustomary situation’ 

23 does not include normal or standard practice 

24 and conditions on the premises that facilitate 

25 the transmission of disease. 


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1 ‘‘(E) The term ‘nonroutine disease control’ 

2 means the use of antibiotics in the feed or 

3 water of an animal that is not sick, where it 

4 can be shown that a particular disease or infec5 tion is, or is likely to be, present on the prem6 ises because of a specific, non-customary situa7 tion.’’. 

8 SEC. 5. LIMITATIONS ON USE OF MEDICALLY IMPORTANT 

9 ANTIMICROBIALS FOR NONROUTINE DISEASE 

10 CONTROL. 

11 (a) PROHIBITED ACTS.—Section 301 of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend13 ed by adding at the end the following: 

14 ‘‘(ccc) The administration of a medically important 

15 antimicrobial to a food-producing animal for nonroutine 

16 disease control in violation of the requirements of section 

17 512A.’’. 

18 (b) REQUIREMENTS.—Chapter V of the Federal 

19 Food, Drug, and Cosmetic Act is amended by inserting 

20 after section 512 of such Act (21 U.S.C. 360b) the fol21 lowing: 


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1 ‘‘SEC. 512A. LIMITATIONS ON USE OF MEDICALLY IMPOR2 TANT ANTIMICROBIALS FOR NONROUTINE 

3 DISEASE CONTROL. 

4 ‘‘(a) PROHIBITION.—It shall be unlawful to admin5 ister (including by means of animal feed) a medically im6 portant antimicrobial to a food-producing animal for non7 routine disease control unless— 

8 ‘‘(1)(A) there is a significant risk that a disease 

9 or infection present on, or likely present on, the 

10 premises will be transmitted to the food-producing 

11 animal; 

12 ‘‘(B) the administration of the medically impor13 tant antimicrobial to the food-producing animal is 

14 necessary to prevent or reduce the risk of trans15 mission of the disease or infection described in para16 graph (1); 

17 ‘‘(C) the medically important antimicrobial is 

18 administered to the food-producing animal for non19 routine disease control for the shortest duration pos20 sible to prevent or reduce the risk of transmission of 

21 the disease or infection described in paragraph (1) 

22 to the animal; and 

23 ‘‘(D) the medically important antimicrobial is 

24 administered— 

25 ‘‘(i) at a scale no greater than the barn, 

26 house, or pen level; and 


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1 ‘‘(ii) to the fewest animals possible to pre2 vent or reduce the risk of transmission of the 

3 disease or infection described in paragraph (1); 

4 or 

5 ‘‘(2) the Secretary determines that there is a 

6 reasonable certainty of no harm to human health 

7 due to the development of antimicrobial resistance 

8 that is attributable in whole or in part to such use 

9 of the medically important antimicrobial and such 

10 use does not threaten the public health. 

11 ‘‘(b) DEFINITIONS.—In this section: 

12 ‘‘(1) The term ‘food-producing animal’ means a 

13 food-producing animal intended for sale in interstate 

14 commerce. 

15 ‘‘(2) The terms ‘medically important anti16 microbial’ and ‘nonroutine disease control’ have the 

17 meanings given such terms in section 512(q).’’. 

18 (c) APPLICABILITY.—The amendments made by this 

19 section apply beginning on the date that is 2 years after 

20 the date of the enactment of this Act. 

21 SEC. 6. SENSE OF THE SENATE REGARDING VETERINARY 

22 OVERSIGHT OF USE OF MEDICALLY IMPOR23 TANT ANTIMICROBIALS. 

24 (a) IN GENERAL.—It is the sense of the Senate that 

25 a valid veterinarian-client-patient relationship should exist 


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1 to ensure that medically important antimicrobials are used 

2 in a manner that is consistent with professionally accepted 

3 best practices. 

4 (b) VETERINARIAN-CLIENT-PATIENT RELATION5 SHIP.—In ths section, the term ‘‘veterinarian-client-pa6 tient relationship’’ means a relationship in which all of the 

7 following criteria are met: 

8 (1) The veterinarian has assumed the responsi9 bility for making medical judgments regarding the 

10 health of the patient and the client has agreed to 

11 follow the veterinarian’s instructions. 

12 (2) The veterinarian has sufficient knowledge of 

13 the patient to initiate at least a general or prelimi14 nary diagnosis of the medical condition of the pa15 tient. This means that the veterinarian is personally 

16 acquainted with the keeping and care of the patient 

17 by virtue of— 

18 (A) a timely examination of the patient by 

19 the veterinarian; or 

20 (B) medically appropriate and timely visits 

21 by the veterinarian to the premises where the 

22 animal or animals are kept. 

23 (3) The veterinarian is readily available for fol24 low-up evaluation or has arranged for veterinary 


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1 emergency coverage and continuing care and treat2 ment. 

3 (4) The veterinarian provides oversight of treat4 ment, compliance, and outcome. 

5 (5) Patient records are maintained. 

Æ 


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