I 

113TH CONGRESS 

1ST SESSION H. R. 1150 

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 HOUSE OF REPRESENTATIVES 

MARCH 14, 2013 

Ms. SLAUGHTER introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

preserve the effectiveness of medically important 

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 ‘‘Preservation of Anti5 biotics for Medical Treatment 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 food-borne 


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1 illness 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; and 

18 (B) these 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 like smallpox 

23 and anthrax. 


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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, title I; 114 Stat. 2315), but 

11 has not yet addressed antibiotic overuse in agri12 culture. 

13 (6) In January 2001, a Federal interagency 

14 task force— 

15 (A) released an action plan to address the 

16 continuing decline in effectiveness of antibiotics 

17 against common bacterial infections, referred to 

18 as antibiotic resistance; 

19 (B) determined that antibiotic resistance is 

20 a growing menace to all people and poses a se21 rious threat to public health; and 

22 (C) cautioned that if current trends con23 tinue, treatments for common infections will be24 come increasingly limited and expensive, and, in 

25 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 FDA’s voluntary 

22 guidelines reducing antibiotic use in food ani23 mals. 

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) 13.5 million kilograms of antibacterial 

21 drugs were sold for use on food animals in the 

22 United States in 2010; 

23 (B) 3.3 million kilograms of antibacterial 

24 drugs were used for human health in 2010; and 


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1 (C) therefore, 80 percent of antibacterial 

2 drugs disseminated in the United States in 

3 2010 were sold for use on food animals, rather 

4 than being 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 antibiotic use in food animals 

12 would preserve their use for medicine; and 

13 (C) a Danish ban on antibiotics in food 

14 animals resulted in little change in animal mor15 bidity and mortality, and only a modest in16 crease in production cost. 

17 (18) In April 2012, the Food and Drug Admin18 istration issued voluntary guidance to industry on 

19 reducing antibiotic use in livestock and poultry. As 

20 part of that guidance, it summarized over 35 years 

21 of peer-reviewed scientific literature regarding use of 

22 antimicrobial drugs in livestock. As a result, FDA 

23 stated strategies for controlling antibiotic resistance 

24 are needed, and are seeking voluntarily limits on an25 tibiotic use. 


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

2 published test results on pork products bought in 

3 grocery stores nationwide showing disturbingly high 

4 levels of Salmonella and Yersinia enterocolitica bac5 teria that were resistant to the antibiotics used to 

6 treat food borne illnesses. A 2003 Consumer Report 

7 study showed similar results in poultry products. 

8 (B) The Food and Drug Administration’s Na9 tional Antimicrobial Resistance Monitoring System 

10 routinely finds that retail meat products are con11 taminated with bacteria (including the foodborne 

12 pathogens Campylobacter and Salmonella) that are 

13 resistant to antibiotics important in human medi14 cine. The 2011 National Antimicrobial Resistance 

15 Monitoring System report found that the percentage 

16 of meat containing antibiotic resistant bacteria in17 creases each year and that many of these bacteria 

18 exhibit multiple antibiotic resistance. 

19 (20) Antibiotic resistance, resulting in a re20 duced number of effective antibiotics, may signifi21 cantly impair the ability of the United States to re22 spond to terrorist attacks involving bacterial infec23 tions or a large influx of hospitalized patients. 

24 (21) Many scientific studies confirm that the 

25 nontherapeutic use of antibiotics in agricultural aniVerDate Mar 14 2013 00:35 Mar 21, 2013 Jkt 029200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H1150.IH H1150

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1 mals contribute to the development of antibiotic-re2 sistant bacterial infections in people. 

3 (22) Epidemiological research has shown that 

4 resistant Salmonella and Campylobacter infections 

5 are associated with increased numbers of ill patients 

6 and bloodstream infections, and increased death. 

7 (23) The American Medical Association, the 

8 American Public Health Association, the National 

9 Association of County and City Health Officials, and 

10 the National Sustainable Agriculture Coalition are 

11 among the over 400 organizations representing 

12 health, consumer, agricultural, environmental, hu13 mane, and other interests that have supported enact14 ment of legislation to phase out nontherapeutic use 

15 in farm animals of medically important 

16 antimicrobials. 

17 SEC. 3. PURPOSE. 

18 The purpose of this Act is to preserve the effective19 ness of medically important antimicrobials used in the 

20 treatment of human and animal diseases. 

21 SEC. 4. PROOF OF SAFETY OF MEDICALLY IMPORTANT 

22 ANTIMICROBIALS. 

23 (a) APPLICATIONS PENDING OR SUBMITTED AFTER

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


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1 Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)) is amend2 ed— 

3 (1) in the first sentence— 

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

5 at the end; 

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

7 at the end; and 

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

9 following: 

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

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

12 applicant has failed to demonstrate that there 

13 is a reasonable certainty of no harm to human 

14 health due to the development of antimicrobial 

15 resistance that is attributable, in whole or in 

16 part, to the nontherapeutic use (as defined in 

17 subsection (q)) of the medically important anti18 microbial or drug;’’; and 

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

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

21 (b) PHASED ELIMINATION OF NONTHERAPEUTIC

22 USE IN ANIMALS OF MEDICALLY IMPORTANT

23 ANTIMICROBIALS.—Section 512 of the Federal Food, 

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

25 adding at the end the following: 


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1 ‘‘(q) PHASED ELIMINATION OF NONTHERAPEUTIC

2 USE IN ANIMALS OF MEDICALLY IMPORTANT

3 ANTIMICROBIALS.— 

4 ‘‘(1) APPLICABILITY.—This paragraph applies 

5 to the nontherapeutic use in a food-producing ani6 mal of a drug— 

7 ‘‘(A) that is a medically important anti8 microbial; or 

9 ‘‘(B)(i) for which there is in effect an ap10 proval of an application or an exemption under 

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

12 ‘‘(ii) that is otherwise marketed for human 

13 use. 

14 ‘‘(2) WITHDRAWAL.—The Secretary shall with15 draw the approval of a nontherapeutic use in food16 producing animals of a drug described in paragraph 

17 (1) on the date that is 2 years after the date of en18 actment of this subsection unless— 

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

20 the date of the enactment of this subsection, 

21 the Secretary makes a final written determina22 tion that the holder of the approved application 

23 has demonstrated that there is a reasonable 

24 certainty of no harm to human health due to 

25 the development of antimicrobial resistance that 


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1 is attributable in whole or in part to the non2 therapeutic use of the drug; or 

3 ‘‘(B) before the date specified in subpara4 graph (A), the Secretary makes a final written 

5 determination under this subsection, with re6 spect to a risk analysis of the drug conducted 

7 by the Secretary and other relevant informa8 tion, that there is a reasonable certainty of no 

9 harm to human health due to the development 

10 of antimicrobial resistance that is attributable 

11 in whole or in part to the nontherapeutic use of 

12 the drug. 

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

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

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

16 important antimicrobial, the Secretary shall rescind 

17 each approval of a nontherapeutic use in a food-pro18 ducing animal of the medically important anti19 microbial, as of the date that is 2 years after the 

20 date on which the Secretary grants the exemption. 

21 ‘‘(4) APPROVALS.—Except as provided in para22 graph (5), if an application for a drug that is a 

23 medically important antimicrobial is submitted to 

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

25 shall rescind each approval of a nontherapeutic use 


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1 in a food-producing animal of the medically impor2 tant antimicrobial, as of the date that is 2 years 

3 after the date on which the application is submitted 

4 to the Secretary. 

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

6 the case may be, shall not apply if— 

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

8 would be rescinded under that paragraph, the 

9 Secretary makes a final written determination 

10 that the holder of the application for the ap11 proved nontherapeutic use has demonstrated 

12 that there is a reasonable certainty of no harm 

13 to human health due to the development of 

14 antimicrobial resistance that is attributable in 

15 whole or in part to the nontherapeutic use in 

16 the food-producing animal of the medically im17 portant antimicrobial; or 

18 ‘‘(B) before the date specified in subpara19 graph (A), the Secretary makes a final written 

20 determination, with respect to a risk analysis of 

21 the medically important antimicrobial conducted 

22 by the Secretary and any other relevant infor23 mation, that there is a reasonable certainty of 

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1 utable in whole or in part to the nontherapeutic 

2 use of the medically important antimicrobial. 

3 ‘‘(6) DEFINITION.—In this subsection: 

4 ‘‘(A) The term ‘medically important anti5 microbial’ means a drug that— 

6 ‘‘(i) is intended for use in food-pro7 ducing animals; and 

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

9 ‘‘(I) any kind of penicillin, tetra10 cycline, macrolide, lincosamide, 

11 streptogramin, aminoglycoside, sul12 fonamide, or cephalosporin; or 

13 ‘‘(II) a drug from an anti14 microbial class that is listed as ‘highly 

15 important’, ‘critically important’, or 

16 ‘important’ by the World Health Or17 ganization in the latest edition of its 

18 publication entitled ‘Critically Impor19 tant Antimicrobials for Human Medi20 cine’ (or a successor publication). 

21 ‘‘(B) The term ‘therapeutic use’, with re22 spect to a medically important antimicrobial, 

23 means the use of antimicrobials for the specific 

24 purpose of treating an animal with a docu25 mented disease or infection. Such term does not 


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1 include the continued use of such an anti2 microbial in the animal after the disease or in3 fection is resolved. 

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

5 ‘‘(i) means administration of anti6 biotics to an animal through feed and 

7 water (or, in poultry hatcheries, through 

8 any means) for purposes (such as growth 

9 promotion, feed efficiency, weight gain, or 

10 disease prevention) other than therapeutic 

11 use or nonroutine disease control; and 

12 ‘‘(ii) includes any repeated or regular 

13 pattern of use of medically important 

14 antimicrobials for purposes other than 

15 therapeutic use or nonroutine disease con16 trol. 

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

18 does not include normal or standard practice 

19 and conditions on the premises that facilitate 

20 the transmission of disease. 

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

22 means the use of antibiotics on an animal that 

23 is not sick but where it can be shown that a 

24 particular disease or infection is present, or is 

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1 tomary situation, on the premises at the barn, 

2 house, pen, or other level at which the animal 

3 is kept.’’. 

4 SEC. 5. LIMITATIONS ON USE OF MEDICALLY IMPORTANT 

5 ANTIMICROBIALS FOR NONROUTINE DISEASE 

6 CONTROL. 

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

8 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend9 ed by adding at the end the following: 

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

11 antimicrobial to a food-producing animal for nonroutine 

12 disease control in violation of the requirements of section 

13 512A.’’. 

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

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

16 after section 512 of such Act (21 U.S.C. 360b) the fol17 lowing: 

18 ‘‘SEC. 512A. LIMITATIONS ON USE OF MEDICALLY IMPOR19 TANT ANTIMICROBIALS FOR NONROUTINE 

20 DISEASE CONTROL. 

21 ‘‘(a) PROHIBITION.—It shall be unlawful to admin22 ister (including by means of animal feed) a medically im23 portant antimicrobial to a food-producing animal for non24 routine disease control unless— 


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1 ‘‘(1) there is a significant risk that a disease or 

2 infection present on the premises will be transmitted 

3 to the food-producing animal; 

4 ‘‘(2) the administration of the medically impor5 tant antimicrobial to the food-producing animal is 

6 necessary to prevent or reduce the risk of trans7 mission of the disease or infection described in para8 graph (1); 

9 ‘‘(3) the medically important antimicrobial is 

10 administered to the food-producing animal for non11 routine disease control for the shortest duration pos12 sible to prevent or reduce the risk of transmission of 

13 the disease or infection described in paragraph (1) 

14 to the animal; and 

15 ‘‘(4) the medically important antimicrobial is 

16 administered— 

17 ‘‘(A) at a scale no greater than the barn, 

18 house, or pen level; and 

19 ‘‘(B) to the fewest animals possible to pre20 vent or reduce the risk of transmission of the 

21 disease or infection described in paragraph (1). 

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

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

24 food-producing animal intended for sale in interstate 

25 commerce. 


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1 ‘‘(2) The terms ‘medically important anti2 microbial’ and ‘nonroutine disease control’ have the 

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

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

5 section apply beginning on the date that is 6 months after 

6 the date of the enactment of this Act. 

Æ 


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