I 

115TH CONGRESS 

1ST SESSION H. R. 1587 

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 16, 2017 

Ms. SLAUGHTER (for herself, Ms. DELAURO, Mr. CICILLINE, Mr. CONNOLLY, 

Mr. DEFAZIO, Mr. DEUTCH, Mr. LANGEVIN, Mr. TED LIEU of California, Mr. LOWENTHAL, Ms. MCCOLLUM, Mr. MOULTON, Mrs. NAPOLITANO, Ms. NORTON, Ms. SPEIER, Ms. TSONGAS, Mr. YARMUTH, Mr. 

JEFFRIES, and Ms. SHEA-PORTER) 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 2017’’. 


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1 SEC. 2. FINDINGS. 

2 The Congress finds the following: 

3 (1) All uses of antibiotics, including for food4 producing animals, have the potential to cause re5 sistance and contribute to the development of anti6 biotic-resistant bacterial infections in people. 

7 (2) In 1977, the Food and Drug Administra8 tion (FDA) concluded that feeding livestock low 

9 doses of antibiotics used in human disease treatment 

10 could promote the development of antibiotic resist11 ance in bacteria. However, the Food and Drug Ad12 ministration did not act in response to these find13 ings, despite laws requiring the agency to do so. 

14 (3) In 2012, the Food and Drug Administra15 tion Guidance for Industry #209 provided a sum16 mary of over 40 years of peer-reviewed scientific lit17 erature regarding use of antimicrobial drugs in live18 stock which reiterated that the use of antibiotics in 

19 animals contributes to the resistance in human 

20 pathogens and concludes that strategies for control21 ling antibiotic resistance, including limiting medi22 cally important antimicrobial drugs in food-pro23 ducing animals only to uses that are considered nec24 essary for assuring animal health are needed. 

25 (4) The 2014 President’s Council of Advisors 

26 on Science and Technology Report to the President 


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1 on Combating Antibiotic-Resistant Bacteria also 

2 concludes that substantial evidence exists that the 

3 use of antibiotics in food animals promotes the de4 velopment and spread of antibiotic resistance in bac5 teria that can spread to people and that it is clear 

6 that agricultural use of antibiotics can affect human 

7 health. 

8 (5) Recently published scientific studies have 

9 shown that food-producing animals, and animal pro10 duction facilities, are a source of antibiotic-resistant 

11 bacteria which have infected humans and present an 

12 increased risk of acquiring and antibiotics resistant 

13 infection. 

14 (6) Antibiotic resistance is a crisis which 

15 threatens public health, the economy, and national 

16 security. 

17 (7) In 2013, the Centers for Disease Control 

18 and Prevention estimated that antibiotic-resistant 

19 infections cause at least 2 million infections, 23,000 

20 deaths, 8 million additional hospital days, and $20 

21 to $35 billion in excess direct health care costs each 

22 year in the United States. 

23 (8) The 2014 World Health Organization re24 port, ‘‘Antimicrobial Resistance: Global Report on 

25 Surveillance 2014’’, concluded that antimicrobial reVerDate Sep 11 2014 04:35 Mar 22, 2017 Jkt 069200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1587.IH H1587

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1 sistance is a current reality and the problem is so 

2 serious that it threatens the achievements of modern 

3 medicine. 

4 (9) Without effective antibiotics— 

5 (A) common infections could become un6 treatable—even fatal; and 

7 (B) medical advances such as joint replace8 ments, Cesarean sections, organ transplants 

9 and chemotherapy could become nonviable. 

10 (10) Antibiotic resistance, resulting in a re11 duced number of effective antibiotics, may signifi12 cantly impair the ability of the United States to re13 spond to terrorist attacks involving bacterial infec14 tions, such as anthrax and smallpox, or to an event 

15 resulting in a large influx of hospitalized patients. 

16 (11) In 2011, the Food and Drug Administra17 tion determined that— 

18 (A) 13.5 million kilograms of antibacterial 

19 drugs were sold for use on food animals in the 

20 United States in 2010; 

21 (B) 3.3 million kilograms of antibacterial 

22 drugs were used for human health in 2010; and 

23 (C) therefore, 80 percent of antibacterial 

24 drugs disseminated in the United States in 


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1 2010 were sold for use on food animals, rather 

2 than being used for human health. 

3 (12) The ‘‘FDA Annual Summary Report on 

4 Antimicrobials Sold or Distributed in 2012 for Use 

5 in Food-Producing Animals’’ showed that the use of 

6 medically important antibiotics in food-producing 

7 animals increased 16 percent from 2009 to 2012. 

8 (13)(A) In 2003, the Food and Drug Adminis9 tration modified the drug approval process for anti10 biotics to recognize the development of resistant bac11 teria as an important aspect of safety, but most 

12 antibiotics currently used in animal production sys13 tems for nontherapeutic purposes were approved be14 fore the Food and Drug Administration began con15 sidering resistance during the drug-approval process. 

16 (B) The Food and Drug Administration has not 

17 established a schedule for reviewing those existing 

18 approvals. 

19 (14) A stated goal of FDA Guidance documents 

20 209 and 213 is a reduction in the overall consump21 tion of antibiotics. The FDA policy continues to 

22 allow the use of antibiotics for routine disease pre23 vention without requiring evidence of the presence of 

24 a specific disease or requiring the mitigation of con25 ditions which elevate disease risk. 


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1 (15) There is inadequate distinction between 

2 usage for disease prevention and production pur3 poses, such as growth promotion, on FDA approved 

4 drug labels. A 2014 analysis of the approved animal 

5 drugs affected by Guidance 213 by the Pew Chari6 table Trusts found that numerous approved drug la7 bels contained overlapping indications for growth8 promotion and disease prevention. 

9 (16) The European Union (EU) banned the use 

10 of antibiotics for growth promotion in 2006, a full 

11 decade before the FDA’s voluntary approach will go 

12 into effect. 

13 (17) Since the EU ban, antibiotic usage has de14 creased without affecting livestock production. 

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

16 Administration testified that the Danish ban of the 

17 nontherapeutic use of antibiotics in food-animal pro18 duction resulted in a marked reduction in anti19 microbial resistance in multiple bacterial species, in20 cluding Campylobacter and Enterococci. 

21 (19) The experience in the Netherlands has 

22 shown that during the phaseout use indications for 

23 growth promotion were completely supplanted by 

24 disease prevention. Total antibiotic consumption re25 mained constant. After the implementation of manVerDate Sep 11 2014 04:35 Mar 22, 2017 Jkt 069200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1587.IH H1587

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1 datory reduction targets and improved surveillance 

2 of usage practices antibiotic consumption declined 

3 ahead of target without impacting production levels. 

4 (20) In 2009, the Congressional Research Serv5 ice concluded that without restrictions on the use of 

6 antimicrobial drugs in the production of livestock, 

7 export markets for livestock and poultry could be 

8 negatively impacted due to restrictions on the use of 

9 antibiotics in other nations. 

10 (21) The American Medical Association, the In11 fectious Disease Society of America, the American 

12 Public Health Association, the National Association 

13 of County and City Health Officials, and the Na14 tional Sustainable Agriculture Coalition are among 

15 the over 400 organizations representing health, con16 sumer, agricultural, environmental, humane, and 

17 other interests that have supported enactment of 

18 legislation to phaseout nontherapeutic use in farm 

19 animals of medically important antimicrobials. 

20 SEC. 3. PURPOSE. 

21 The purpose of this Act is to preserve the effective22 ness of medically important antimicrobials used in the 

23 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 paragraph applies 

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

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

12 ‘‘(B)(i) 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 ‘‘(ii) 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 as of the date that is 2 years after the 

23 date on which the Secretary grants the exemption. 

24 ‘‘(4) APPROVALS.—Except as provided in para25 graph (5), if an application for a drug that is a 


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1 medically important antimicrobial is submitted to 

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

3 shall rescind each approval of a nontherapeutic use 

4 in a food-producing animal of the medically impor5 tant antimicrobial as of the date that is 2 years 

6 after the date on which the application is submitted 

7 to the Secretary. 

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

9 the case may be, shall not apply if— 

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

11 would be rescinded under that paragraph, the 

12 Secretary makes a final written determination 

13 that the holder of the application for the ap14 proved nontherapeutic use has demonstrated 

15 that there is a reasonable certainty of no harm 

16 to human health due to the development of 

17 antimicrobial resistance that is attributable in 

18 whole or in part to the nontherapeutic use in 

19 the food-producing animal of the medically im20 portant antimicrobial; or 

21 ‘‘(B) before the date specified in subpara22 graph (A), the Secretary makes a final written 

23 determination, with respect to a risk analysis of 

24 the medically important antimicrobial conducted 

25 by the Secretary and any other relevant inforVerDate Sep 11 2014 04:35 Mar 22, 2017 Jkt 069200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H1587.IH H1587

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1 mation, that there is a reasonable certainty of 

2 no harm to human health due to the develop3 ment of antimicrobial resistance that is attrib4 utable in whole or in part to the nontherapeutic 

5 use of the medically important antimicrobial. 

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

7 ‘‘(A) The term ‘medically important anti8 microbial’ means a drug that— 

9 ‘‘(i) is intended for use in food-pro10 ducing animals; and 

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

12 ‘‘(I) any kind of penicillin, tetra13 cycline, macrolide, lincosamide, strep14 togramin, aminoglycoside, sulfona15 mide, or cephalosporin; or 

16 ‘‘(II) a drug from an antimicrobi17 al class that is listed as ‘highly impor18 tant’, ‘critically important’, or ‘impor19 tant’ by the World Health Organiza20 tion in the latest edition of its publica21 tion entitled ‘Critically Important 

22 Antimicrobials for Human Medicine’ 

23 (or a successor publication). 

24 ‘‘(B) The term ‘therapeutic use’, with re25 spect to a medically important antimicrobial, 


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1 means the use of antimicrobials for the specific 

2 purpose of treating an animal with a docu3 mented disease or infection. Such term does not 

4 include the continued use of such an anti5 microbial in the animal after the disease or in6 fection is resolved. 

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

8 ‘‘(i) means administration of anti9 biotics to an animal through feed and 

10 water (or, in poultry hatcheries, through 

11 any means) for purposes (such as growth 

12 promotion, feed efficiency, weight gain, or 

13 disease prevention) other than therapeutic 

14 use or nonroutine disease control; and 

15 ‘‘(ii) includes any repeated or regular 

16 pattern of use of medically important 

17 antimicrobials for purposes other than 

18 therapeutic use or nonroutine disease con19 trol. 

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

21 does not include normal or standard practice 

22 and conditions on the premises that facilitate 

23 the transmission of disease. 

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

25 means the use of antibiotics on an animal that 


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

2 particular disease or infection is present, or is 

3 likely to occur because of a specific, noncus4 tomary situation, on the premises at the barn, 

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

6 is kept.’’. 

7 SEC. 5. LIMITATIONS ON USE OF MEDICALLY IMPORTANT 

8 ANTIMICROBIALS FOR NONROUTINE DISEASE 

9 CONTROL. 

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

11 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend12 ed by adding at the end the following: 

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

14 antimicrobial to a food-producing animal for nonroutine 

15 disease control in violation of the requirements of section 

16 512A.’’. 

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

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

19 after section 512 of such Act (21 U.S.C. 360b) the fol20 lowing: 

21 ‘‘SEC. 512A. LIMITATIONS ON USE OF MEDICALLY IMPOR22 TANT ANTIMICROBIALS FOR NONROUTINE 

23 DISEASE CONTROL. 

24 ‘‘(a) PROHIBITION.—It shall be unlawful to admin25 ister (including by means of animal feed) a medically imVerDate Sep 11 2014 04:35 Mar 22, 2017 Jkt 069200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H1587.IH H1587

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1 portant antimicrobial to a food-producing animal for non2 routine disease control unless— 

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

4 infection present on the premises will be transmitted 

5 to the food-producing animal; 

6 ‘‘(2) the administration of the medically impor7 tant antimicrobial to the food-producing animal is 

8 necessary to prevent or reduce the risk of trans9 mission of the disease or infection described in para10 graph (1); 

11 ‘‘(3) the medically important antimicrobial is 

12 administered to the food-producing animal for non13 routine disease control for the shortest duration pos14 sible to prevent or reduce the risk of transmission of 

15 the disease or infection described in paragraph (1) 

16 to the animal; and 

17 ‘‘(4) the medically important antimicrobial is 

18 administered— 

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

20 house, or pen level; and 

21 ‘‘(B) to the fewest animals possible to pre22 vent or reduce the risk of transmission of the 

23 disease or infection described in paragraph (1). 

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


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

2 food-producing animal intended for sale in interstate 

3 commerce. 

4 ‘‘(2) The terms ‘medically important anti5 microbial’ and ‘nonroutine disease control’ have the 

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

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

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

9 the date of the enactment of this Act. 

Æ 


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