II 

112TH CONGRESS 

1ST SESSION S. 1211 

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

and animal diseases. 

IN THE SENATE OF THE UNITED STATES 

JUNE 15, 2011 

Mrs. FEINSTEIN (for herself, Ms. COLLINS, Mr. REED, and Mrs. BOXER) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

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

preserve the effectiveness of medically important antibiotics used in the treatment of human and animal diseases. 

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 2011’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds the following: 


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1 (1) In January 2001, a Federal interagency 

2 task force— 

3 (A) released an action plan to address the 

4 continuing decline in effectiveness of antibiotics 

5 against common bacterial infections, referred to 

6 as antibiotic resistance; 

7 (B) determined that antibiotic resistance is 

8 a growing menace to all people and poses a se9 rious threat to public health; and 

10 (C) cautioned that if current trends con11 tinue, treatments for common infections will be12 come increasingly limited and expensive, and, in 

13 some cases, nonexistent. 

14 (2) Antibiotic resistance, resulting in a reduced 

15 number of effective antibiotics, may significantly im16 pair the ability of the United States to respond to 

17 terrorist attacks involving bacterial infections or a 

18 large influx of hospitalized patients. 

19 (3)(A) Any overuse or misuse of antibiotics con20 tributes to the spread of antibiotic resistance, wheth21 er in human medicine or in agriculture. 

22 (B) Recognizing the public health threat caused 

23 by antibiotic resistance, Congress took several steps 

24 to curb antibiotic overuse in human medicine 

25 through amendments to the Public Health Service 


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

2 the Public Health Threats and Emergencies Act 

3 (Public Law 106–505, title I; 114 Stat. 2315), but 

4 has not yet addressed antibiotic overuse in agri5 culture. 

6 (4) In a March 2003 report, the National Acad7 emy of Sciences stated that— 

8 (A) a decrease in antimicrobial use in 

9 human medicine alone will have little effect on 

10 the current situation; and 

11 (B) substantial efforts must be made to 

12 decrease inappropriate overuse in animals and 

13 agriculture. 

14 (5) In 2010, the FDA determined that— 

15 (A) 1,300,000 kilograms of antibacterial 

16 drugs were sold for use on food animals in the 

17 United States in 2009; 

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

19 drugs were used for human health in 2009; and 

20 (C) therefore, 80 percent of antibacterial 

21 drugs disseminated in the United States in 

22 2009 were sold for use on food animals, rather 

23 than being used for human health. 

24 (6)(A) Large-scale, voluntary surveys by the 

25 Department of Agriculture’s Animal and Plant 


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1 Health Inspection Service in 1999, 2001, and 2006 

2 revealed that— 

3 (i) 84 percent of grower-finisher swine 

4 farms, 83 percent of cattle feedlots, and 84 per5 cent of sheep farms administer antimicrobials 

6 in the feed or water for health or growth pro7 motion reasons; and 

8 (ii) many of the antimicrobials identified 

9 are identical or closely related to drugs used in 

10 human medicine, including tetracyclines, 

11 macrolides, Bacitracin, penicillins, and 

12 sulfonamides; and 

13 (B) these drugs are used in people to treat seri14 ous diseases such as pneumonia, scarlet fever, rheu15 matic fever, venereal disease, skin infections, and 

16 even pandemics like malaria and plague, as well as 

17 bioterrorism agents like smallpox and anthrax. 

18 (7) Many scientific studies confirm that the 

19 nontherapeutic use of antibiotics in agricultural ani20 mals contributes to the development of antibiotic-re21 sistant bacterial infections in people. 

22 (8) The periodical entitled ‘‘Clinical Infectious 

23 Diseases’’ published a report in June 2002, that— 

24 (A) was based on a 2-year review by ex25 perts in human and veterinary medicine, public 


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1 health, microbiology, biostatistics, and risk 

2 analysis, of more than 500 scientific studies on 

3 the human health impacts of antimicrobial use 

4 in agriculture; and 

5 (B) recommended that antimicrobial 

6 agents should no longer be used in agriculture 

7 in the absence of disease, but should be limited 

8 to therapy for diseased individual animals and 

9 prophylaxis when disease is documented in a 

10 herd or flock. 

11 (9) The United States Geological Survey re12 ported in March 2002 that— 

13 (A) antibiotics were present in 48 percent 

14 of the streams tested nationwide; and 

15 (B) almost half of the tested streams were 

16 downstream from agricultural operations. 

17 (10) An April 1999 study by the General Ac18 counting Office concluded that resistant strains of 3 

19 microorganisms that cause food-borne illness or dis20 ease in humans (Salmonella, Campylobacter, and E. 

21 coli) are linked to the use of antibiotics in animals. 

22 (11) Epidemiological research has shown that 

23 resistant Salmonella and Campylobacter infections 

24 are associated with increased numbers of ill patients 

25 and bloodstream infections, and increased death. 


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1 (12) In 2010, the peer-reviewed journal Molec2 ular Cell published a study demonstrating that low3 dosage use of antibiotics causes a dramatic increase 

4 in genetic mutation, raising new concerns about the 

5 agricultural practice of using low-dosage antibiotics 

6 in order to stimulate growth promotion and rou7 tinely prevent disease in unhealthy conditions. 

8 (13)(A) In January 2003, Consumer Reports 

9 published test results on poultry products bought in 

10 grocery stores nationwide showing disturbingly high 

11 levels of Campylobacter and Salmonella bacteria that 

12 were resistant to the antibiotics used to treat food13 borne illnesses. 

14 (B) The Food and Drug Administration’s Na15 tional Antimicrobial Resistance Monitoring System 

16 routinely finds that retail meat products are con17 taminated with bacteria (including the foodborne 

18 pathogens Campylobacter and Salmonella) that are 

19 resistant to antibiotics important in human medi20 cine. 

21 (C) In December 2007, the USDA issued a fact 

22 sheet on the recently recognized link between anti23 microbial drug use in animals and Methicillin Resist24 ant Staphylococcus Aureas (MRSA) infections in hu25 mans. 


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1 (14) In October 2001, the New England Jour2 nal of Medicine published an editorial urging a ban 

3 on nontherapeutic use of medically important anti4 biotics in animals. 

5 (15)(A) In 1998, the National Academy of 

6 Sciences noted that antibiotic-resistant bacteria gen7 erate a minimum of $4,000,000,000 to 

8 $5,000,000,000 in costs to United States society 

9 and individuals yearly. 

10 (B) In 2009, Cook County Hospital and the Al11 liance for Prudent Use of Antibiotics estimated that 

12 the total health care cost of antibiotic resistant in13 fections in the United States was between 

14 $16,600,000,000 and $26,000,000,000 annually. 

15 (16) The American Medical Association, the 

16 American Public Health Association, the National 

17 Association of County and City Health Officials, and 

18 the National Campaign for Sustainable Agriculture 

19 are among the more than 300 organizations rep20 resenting health, consumer, agricultural, environ21 mental, humane, and other interests that have sup22 ported enactment of legislation to phase out non23 therapeutic use in farm animals of medically impor24 tant antibiotics. 


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1 (17) In 2010, the Danish Veterinary and Food 

2 Administration testified that the Danish ban of the 

3 non-therapeutic use of antibiotics in food animal 

4 production resulted in a marked reduction in anti5 microbial resistance in multiple bacterial species, in6 cluding Campylobacter and Enterococci. 

7 (18) In 2009, the Congressional Research Serv8 ice concluded that restrictions overseas on the use of 

9 antimicrobial drugs in the production of livestock 

10 could impact U.S. export markets for livestock and 

11 poultry. 

12 (19) The Federal Food, Drug, and Cosmetic 

13 Act (21 U.S.C. 301 et seq.)— 

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

15 safe before the drugs are approved; and 

16 (B) places the burden on manufacturers to 

17 account for health consequences and prove safe18 ty. 

19 (20)(A) The Food and Drug Administration re20 cently modified the drug approval process for anti21 biotics to recognize the development of resistant bac22 teria as an important aspect of safety, but most 

23 antibiotics currently used in animal production sys24 tems for nontherapeutic purposes were approved beVerDate Mar 15 2010 21:03 Jun 16, 2011 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1211.IS S1211

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1 fore the Food and Drug Administration began con2 sidering resistance during the drug-approval process. 

3 (B) The Food and Drug Administration has not 

4 established a schedule for reviewing those existing 

5 approvals. 

6 (21) Certain non-routine uses of antibiotics in 

7 animal agriculture are legitimate to prevent animal 

8 disease. 

9 (22) An April 2004 study by the General Ac10 counting Office— 

11 (A) concluded that Federal agencies do not 

12 collect the critical data on antibiotic use in ani13 mals that they need to support research on 

14 human health risks; and 

15 (B) recommends that the Department of 

16 Agriculture and the Department of Health and 

17 Human Services develop and implement a plan 

18 to collect data on antibiotic use in animals. 

19 SEC. 3. PURPOSE. 

20 The purpose of this Act is to preserve the effective21 ness of medically important antibiotics used in the treat22 ment of human and animal diseases by reviewing the safe23 ty of certain antibiotics for nontherapeutic purposes in 

24 food-producing animals. 


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1 SEC. 4. PROOF OF SAFETY OF CRITICAL ANTIMICROBIAL 

2 ANIMAL DRUGS. 

3 (a) DEFINITIONS.—Section 201 of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 

5 adding at the end the following: 

6 ‘‘(ss) CRITICAL ANTIMICROBIAL ANIMAL DRUG.— 

7 The term ‘critical antimicrobial animal drug’ means a 

8 drug that— 

9 ‘‘(1) is intended for use in food-producing ani10 mals; and 

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

12 ‘‘(A) any kind of penicillin, tetracycline, 

13 macrolide, lincosamide, streptogramin, 

14 aminoglycoside, or sulfonamide; or 

15 ‘‘(B) any other drug or derivative of a 

16 drug that is used in humans or intended for use 

17 in humans to treat or prevent disease or infec18 tion caused by microorganisms. 

19 ‘‘(tt) NONTHERAPEUTIC USE.—The term ‘nonthera20 peutic use’, with respect to a critical antimicrobial animal 

21 drug, means any use of the drug as a feed or water addi22 tive for an animal in the absence of any clinical sign of 

23 disease in the animal for growth promotion, feed effi24 ciency, weight gain, routine disease prevention, or other 

25 routine purpose.’’. 


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1 (b) APPLICATIONS PENDING OR SUBMITTED AFTER

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

3 Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)) is amend4 ed— 

5 (1) in the first sentence— 

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

7 at the end; 

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

9 at the end; and 

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

11 following: 

12 ‘‘(J) with respect to a critical antimicrobial 

13 animal drug or a drug of the same chemical 

14 class as a critical antimicrobial animal drug, 

15 the applicant has failed to demonstrate that 

16 there is a reasonable certainty of no harm to 

17 human health due to the development of anti18 microbial resistance that is attributable, in 

19 whole or in part, to the nontherapeutic use of 

20 the drug;’’; and 

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

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

23 (c) PHASED ELIMINATION OF NONTHERAPEUTIC

24 USE IN ANIMALS OF CRITICAL ANTIMICROBIAL ANIMAL

25 DRUGS IMPORTANT FOR HUMAN HEALTH.—Section 512 


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1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

2 360b) is amended by adding at the end the following: 

3 ‘‘(q) PHASED ELIMINATION OF NONTHERAPEUTIC

4 USE IN ANIMALS OF CRITICAL ANTIMICROBIAL ANIMAL

5 DRUGS IMPORTANT FOR HUMAN HEALTH.— 

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

7 to the nontherapeutic use in a food-producing ani8 mal of a drug— 

9 ‘‘(A)(i) that is a critical antimicrobial ani10 mal drug; or 

11 ‘‘(ii) that is of the same chemical class as 

12 a critical antimicrobial animal drug; and 

13 ‘‘(B)(i) for which there is in effect an ap14 proval of an application or an exemption under 

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

16 ‘‘(ii) that is otherwise marketed for use. 

17 ‘‘(2) WITHDRAWAL.—The Secretary shall with18 draw the approval of a nontherapeutic use in food19 producing animals described in paragraph (1) on the 

20 date that is 2 years after the date of enactment of 

21 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, with respect to a risk analysis of 

9 the drug conducted by the Secretary and other 

10 relevant information, that there is a reasonable 

11 certainty of no harm to human health due to 

12 the development of antimicrobial resistance that 

13 is attributable in whole or in part to the non14 therapeutic use of the drug. 

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

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

17 under section 505(i) for a drug that is a critical 

18 antimicrobial animal drug, the Secretary shall re19 scind each approval of a nontherapeutic use in a 

20 food-producing animal of the critical antimicrobial 

21 animal drug, or of a drug in the same chemical class 

22 as the critical antimicrobial animal drug, as of the 

23 date that is 2 years after the date on which the Sec24 retary grants the exemption. 


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1 ‘‘(4) APPROVALS.—Except as provided in para2 graph (5), if an application for a drug that is a crit3 ical antimicrobial animal drug is submitted to the 

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

5 rescind each approval of a nontherapeutic use in a 

6 food-producing animal of the critical antimicrobial 

7 animal drug, or of a drug in the same chemical class 

8 as the critical antimicrobial animal drug, as of the 

9 date that is 2 years after the date on which the ap10 plication is submitted to the Secretary. 

11 ‘‘(5) EXCEPTION.—Paragraph (3) or (4), as the 

12 case may be, shall not apply if— 

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

14 would be rescinded under that paragraph, the 

15 Secretary makes a final written determination 

16 that the holder of the application for the ap17 proved nontherapeutic use has demonstrated 

18 that there is a reasonable certainty of no harm 

19 to human health due to the development of 

20 antimicrobial resistance that is attributable in 

21 whole or in part to the nontherapeutic use in 

22 the food-producing animal of the critical anti23 microbial animal drug; or 

24 ‘‘(B) before the date specified in subpara25 graph (A), the Secretary makes a final written 


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1 determination, with respect to a risk analysis of 

2 the critical antimicrobial animal drug conducted 

3 by the Secretary and any other relevant infor4 mation, that there is a reasonable certainty of 

5 no harm to human health due to the develop6 ment of antimicrobial resistance that is attrib7 utable in whole or in part to the nontherapeutic 

8 use of the drug.’’. 

9 SEC. 5. COMMITTEE HEARINGS ON IMPLEMENTATION. 

10 (a) IN GENERAL.—The Committee on Energy and 

11 Commerce of the House of Representatives and the Com12 mittee on Health, Education, Labor, and Pensions of the 

13 Senate shall each hold a hearing on the implementation 

14 by the Commissioner of Food and Drugs of section 512(q) 

15 of the Federal Food, Drug, and Cosmetic Act, as added 

16 by section 4 of this Act. 

17 (b) EXERCISE OF RULEMAKING AUTHORITY.—Sub18 section (a) is enacted— 

19 (1) as an exercise of the rulemaking power of 

20 the House of Representatives and Senate, and, as 

21 such, they shall be considered as part of the rules 

22 of the House or Senate (as the case may be), and 

23 such rules shall supersede any other rule of the 

24 House or Senate only to the extent that rule is in25 consistent therewith; and 


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1 (2) with full recognition of the constitutional 

2 right of either House to change such rules (so far 

3 as relating to the procedure in that House) at any 

4 time, in the same manner, and to the same extent 

5 as in the case of any other rule of that House. 

Æ 


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