II 

110TH CONGRESS 

1ST SESSION S. 549 

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 

FEBRUARY 12, 2007 

Mr. KENNEDY (for himself, Ms. SNOWE, Mr. REED, and Mr. BROWN) 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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Preservation of Antibiotics for Medical Treatment Act of 

6 2007’’. 

7 (b) TABLE OF CONTENTS.—The table of contents of 

8 this Act is as follows: 


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Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

Sec. 3. Purpose. 

TITLE I—SAFETY OF CRITICAL ANTIMICROBIAL ANIMAL DRUGS 

Sec. 101. Proof of safety of critical antimicrobial animal drugs. 

TITLE II—USE OF CRITICAL ANTIMICROBIAL ANIMAL DRUGS IN 

AGRICULTURE 

Sec. 201. Assistance to defray expenses of livestock or poultry producers in 

phasing out nontherapeutic use of critical antimicrobial animal 

drugs. 

Sec. 202. Research and demonstration programs. 

Sec. 203. Collection of data on critical antimicrobial animal drugs. 

1 SEC. 2. FINDINGS. 

2 Congress finds that— 

3 (1)(A) in January 2001, a Federal interagency 

4 task force released an action plan to address the 

5 continuing decline in effectiveness of antibiotics 

6 against common bacterial infections, referred to as 

7 antibiotic resistance; 

8 (B) the task force determined that antibiotic re9 sistance is a growing menace to all people and poses 

10 a serious threat to public health; and 

11 (C) the task force cautioned that if current 

12 trends continue, treatments for common infections 

13 will become increasingly limited and expensive, and, 

14 in some cases, nonexistent; 

15 (2) antibiotic resistance, resulting in a reduced 

16 number of effective antibiotics, may significantly im17 pair the ability of the United States to respond to 


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1 terrorist attacks involving bacterial infections or a 

2 large influx of hospitalized patients; 

3 (3)(A) any overuse or misuse of antibiotics con4 tributes to the spread of antibiotic resistance, wheth5 er in human medicine or in agriculture; and 

6 (B) recognizing the public health threat caused 

7 by antibiotic resistance, Congress took several steps 

8 to curb antibiotic overuse in human medicine 

9 through amendments to the Public Health Service 

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

11 the Public Health Threats and Emergencies Act 

12 (114 Stat. 2315), but has not yet addressed anti13 biotic overuse in agriculture; 

14 (4) in a March 2003 report, the National Acad15 emy of Sciences stated that— 

16 (A) a decrease in antimicrobial use in 

17 human medicine alone will have little effect on 

18 the current situation; and 

19 (B) substantial efforts must be made to 

20 decrease inappropriate overuse in animals and 

21 agriculture; 

22 (5)(A) an estimated 70 percent of the anti23 biotics and other antimicrobial used in the United 

24 States are fed to farm animals for nontherapeutic 

25 purposes, including— 


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1 (i) growth promotion; and 

2 (ii) compensation for crowded, unsanitary, 

3 and stressful farming and transportation condi4 tions; and 

5 (B) unlike human use of antibiotics, these non6 therapeutic uses in animals typically do not require 

7 a prescription; 

8 (6)(A) many scientific studies confirm that the 

9 nontherapeutic use of antibiotics in agricultural ani10 mals contributes to the development of antibiotic-re11 sistant bacterial infections in people; 

12 (B) the periodical entitled ‘‘Clinical Infectious 

13 Diseases’’ published a report in June 2002, based on 

14 a 2-year review by experts in human and veterinary 

15 medicine, public health, microbiology, biostatistics, 

16 and risk analysis, of more than 500 scientific studies 

17 on the human health impacts of antimicrobial use in 

18 agriculture; and 

19 (C) the report recommended that antimicrobial 

20 agents should no longer be used in agriculture in the 

21 absence of disease, but should be limited to therapy 

22 for diseased individual animals and prophylaxis 

23 when disease is documented in a herd or flock; 


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1 (7)(A) the United States Geological Survey re2 ported in March 2002 that antibiotics were present 

3 in 48 percent of the streams tested nationwide; and 

4 (B) almost half of the tested streams were 

5 downstream from agricultural operations; 

6 (8) an April 1999 study by the General Ac7 counting Office concluded that resistant strains of 3 

8 microorganisms that cause food-borne illness or dis9 ease in humans—Salmonella, Campylobacter, and E. 

10 coli—are linked to the use of antibiotics in animals; 

11 (9)(A) in January 2003, Consumer Reports 

12 published test results on poultry products bought in 

13 grocery stores nationwide showing disturbingly high 

14 levels of Campylobacter and Salmonella bacteria that 

15 were resistant to antibiotics used to treat food-borne 

16 illnesses; and 

17 (B) further studies showed similar results in 

18 other meat products; 

19 (10) in October 2001, the New England Jour20 nal of Medicine published an editorial urging a ban 

21 on nontherapeutic use of medically important anti22 biotics in animals; 

23 (11)(A) in 1999, the European Union banned 

24 the practice of feeding medically important anti25 biotics to animals other than for disease treatment 


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1 or control, and prior to that, individual European 

2 countries had banned the use of specific antibiotics 

3 in animal feed; and 

4 (B) those countries have experienced no signifi5 cant impact on animal health or productivity, food 

6 safety, or meat prices, and more importantly, levels 

7 of resistant bacteria have declined sharply; 

8 (12) in 1998, the National Academy of Sciences 

9 noted that antibiotic-resistant bacteria generate a 

10 minimum of $4,000,000,000 to $5,000,000,000 in 

11 costs to United States society and individuals yearly; 

12 (13) a year later, the National Academy of 

13 Sciences estimated that eliminating the use of all 

14 antibiotics as feed additives would cost each Amer15 ican consumer less than $5 to $10 per year; 

16 (14) the American Medical Association, the 

17 American Public Health Association, the National 

18 Association of County and City Health Officials, and 

19 the National Campaign for Sustainable Agriculture, 

20 are among the more than 300 organizations rep21 resenting health, consumer, agricultural, environ22 mental, humane, and other interests that support 

23 enactment of legislation to phase out nontherapeutic 

24 use in farm animals of medically important anti25 biotics; 


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1 (15) the Federal Food, Drug, and Cosmetic Act 

2 (21 U.S.C. 301 et seq.)— 

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

4 safe before the drugs are approved; and 

5 (B) places the burden on manufacturers to 

6 account for health consequences and prove safe7 ty; 

8 (16)(A) the Food and Drug Administration re9 cently modified the drug approval process for anti10 biotics to recognize the development of resistant bac11 teria as an important aspect of safety; 

12 (B) however, most antibiotics currently used in 

13 animal production systems for nontherapeutic pur14 poses were approved before the Food and Drug Ad15 ministration began giving in-depth consideration to 

16 resistance during the drug-approval process; and 

17 (C) the Food and Drug Administration has not 

18 established a schedule for reviewing those existing 

19 approvals; 

20 (17)(A) the Food and Drug Administration has 

21 begun a process of evaluating the safety of anti22 biotics used in animal agriculture; and 

23 (B) that process— 

24 (i) is a valuable contribution to public 

25 health; and 


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1 (ii) may determine that there is a reason2 able certainty of no harm from the use of cer3 tain antibiotics in animal agriculture; 

4 (18)(A) an April 2004 study by the General Ac5 counting Office concluded that Federal agencies do 

6 not collect the critical data on antibiotic use in ani7 mals that they need to support research on human 

8 health risks; and 

9 (B) the report recommends that the Depart10 ment of Agriculture and the Department of Health 

11 and Human Services develop and implement a plan 

12 to collect data on antibiotic use in animals; and 

13 (19) certain nonroutine uses of antibiotics in 

14 animal agriculture to prevent animal disease are le15 gitimate. 

16 SEC. 3. PURPOSE. 

17 The purpose of this Act is to preserve the effective18 ness of medically important antibiotics used in the treat19 ment of human and animal diseases by phasing out use 

20 of certain antibiotics for nontherapeutic purposes in food21 producing animals. 


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1 TITLE I—SAFETY OF CRITICAL 

2 ANTIMICROBIAL ANIMAL DRUGS 

3 SEC. 101. PROOF OF SAFETY OF CRITICAL ANTIMICROBIAL 

4 ANIMAL DRUGS. 

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

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

7 adding at the end the following: 

8 ‘‘(rr) CRITICAL ANTIMICROBIAL ANIMAL DRUG.— 

9 The term ‘critical antimicrobial animal drug’ means a 

10 drug that— 

11 ‘‘(1) is intended for use in food-producing ani12 mals; and 

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

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

15 macrolide, lincosamide, streptogramin, 

16 aminoglycoside, sulfonamide; or 

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

18 drug that is used in humans or intended for use 

19 in humans to treat or prevent disease or infec20 tion caused by microorganisms. 

21 ‘‘(ss) NONTHERAPEUTIC USE.—The term ‘nonthera22 peutic use’, with respect to a critical antimicrobial animal 

23 drug, means any use of the drug as a feed or water addi24 tive for an animal in the absence of any clinical sign of 

25 disease in the animal for growth promotion, feed effiVerDate Aug 31 2005 23:21 Feb 13, 2007 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S549.IS S549

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1 ciency, weight gain, routine disease prevention, or other 

2 routine purpose.’’. 

3 (b) NONTHERAPEUTIC USE.—Section 512(d)(1) of 

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

5 360b(d)(1)) is amended— 

6 (1) in the first sentence— 

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

8 at the end; 

9 (B) by redesignating subparagraph (I) as 

10 subparagraph (J); and 

11 (C) by inserting after subparagraph (H) 

12 the following: 

13 ‘‘(I) with respect to a critical antimicrobial 

14 animal drug or a drug of the same chemical 

15 class as a critical antimicrobial animal drug, 

16 the applicant has failed to demonstrate that 

17 there is a reasonable certainty of no harm to 

18 human health due to the development of anti19 microbial resistance that is attributable, in 

20 whole or in part, to the nontherapeutic use of 

21 the drug; or’’; and 

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

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

24 (c) PHASED ELIMINATION OF NONTHERAPEUTIC

25 USE IN ANIMALS OF CRITICAL ANTIMICROBIAL ANIMAL


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1 DRUGS IMPORTANT FOR HUMAN HEALTH.—Section 512 

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

3 360b) is amended by adding at the end the following: 

4 ‘‘(q) PHASED ELIMINATION OF NONTHERAPEUTIC

5 USE IN ANIMALS OF CRITICAL ANTIMICROBIAL ANIMAL

6 DRUGS IMPORTANT FOR HUMAN HEALTH.— 

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

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

10 ‘‘(A)(i) a drug that is a critical anti11 microbial animal drug; or 

12 ‘‘(ii) a drug that is of the same chemical 

13 class as a critical antimicrobial animal drug; 

14 and 

15 ‘‘(B) a drug— 

16 ‘‘(i) for which, as of the day before 

17 the date of enactment of this subsection, 

18 there was in effect an approval of an appli19 cation filed under subsection (b) or (j) of 

20 section 505; or 

21 ‘‘(ii) that was otherwise marketed for 

22 use. 

23 ‘‘(2) WITHDRAWAL.—The Secretary shall with24 draw the approval of a nontherapeutic use in food25 producing animals described in paragraph (1) on the 


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

2 this subsection unless— 

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

4 that date of enactment, the Secretary makes a 

5 written determination that the holder of the ap6 proved application has demonstrated that there 

7 is a reasonable certainty of no harm to human 

8 health due to the development of antimicrobial 

9 resistance that is attributable in whole or in 

10 part to the nontherapeutic use of the drug; or 

11 ‘‘(B) before the date specified in subpara12 graph (A), the Secretary makes a final written 

13 determination under this subsection, with re14 spect to a risk analysis of the drug conducted 

15 by the Secretary and other relevant informa16 tion, that there is a reasonable certainty of no 

17 harm to human health due to the development 

18 of antimicrobial resistance that is attributable 

19 in whole or in part to the nontherapeutic use of 

20 the drug. 

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

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

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

24 antimicrobial animal drug, the Secretary shall re25 scind each approval of a nontherapeutic use in a 


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1 food-producing animal of the critical antimicrobial 

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

3 as the critical antimicrobial animal drug, as of the 

4 date that is 2 years after the date on which the Sec5 retary grants the exemption. 

6 ‘‘(4) APPROVALS.—If an application for a drug 

7 that is a critical antimicrobial animal drug is sub8 mitted to the Secretary under section 505(b), the 

9 Secretary shall rescind each approval of a nonthera10 peutic use in a food-producing animal of the critical 

11 antimicrobial animal drug, or of a drug in the same 

12 chemical class as the critical antimicrobial animal 

13 drug, as of the date that is 2 years after the date 

14 on which the application is submitted to the Sec15 retary. 

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

17 case may be, shall not apply if, before the date on 

18 which approval would be rescinded under that sub19 paragraph, the Secretary determines that the holder 

20 of the approved application has demonstrated that 

21 there is a reasonable certainty of no harm to human 

22 health due to the development of antimicrobial re23 sistance that is attributable, in whole or in part, to 

24 the nontherapeutic use in the food-producing animal 

25 of the critical antimicrobial animal drug.’’. 


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1 TITLE II—USE OF CRITICAL 

2 ANTIMICROBIAL ANIMAL 

3 DRUGS IN AGRICULTURE 

4 SEC. 201. ASSISTANCE TO DEFRAY EXPENSES OF LIVE5 STOCK OR POULTRY PRODUCERS IN PHAS6 ING OUT NONTHERAPEUTIC USE OF CRIT7 ICAL ANTIMICROBIAL ANIMAL DRUGS. 

8 (a) DEFINITIONS.—In this section, the terms ‘‘crit9 ical antimicrobial animal drug’’ and ‘‘nontherapeutic use’’ 

10 have the meanings given the terms in section 201 of the 

11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). 

12 (b) PAYMENTS.—The Secretary of Agriculture may 

13 make payments to producers of livestock or poultry that 

14 the Secretary determines are substantially reducing, or 

15 have substantially reduced, the nontherapeutic use of crit16 ical antimicrobial animal drugs in livestock or poultry in 

17 order to defray the costs of such reduction. 

18 (c) PRIORITY FOR FAMILY FARMERS AND SMALL

19 FARMS.—In awarding payments under subsection (b), the 

20 Secretary of Agriculture shall give priority to family21 owned and family-operated farms or ranches and to small 

22 farms or ranches, as determined by the Secretary. 

23 (d) AUTHORIZATION OF APPROPRIATIONS.—There 

24 are authorized to be appropriated such sums as are necVerDate Aug 31 2005 23:21 Feb 13, 2007 Jkt 059200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S549.IS S549

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1 essary to carry out this section for fiscal year 2008 and 

2 for each subsequent fiscal year. 

3 SEC. 202. RESEARCH AND DEMONSTRATION PROGRAMS. 

4 Subtitle D of title VII of the Farm Security and 

5 Rural Investment Act of 2002 (116 Stat. 455) is amended 

6 by adding at the end the following: 

7 ‘‘SEC. 7413. PHASING OUT OF NONTHERAPEUTIC USE OF 

8 CRITICAL ANTIMICROBIAL ANIMAL DRUGS. 

9 ‘‘(a) DEFINITIONS.—In this section, the terms ‘crit10 ical antimicrobial animal drug’ and ‘nontherapeutic use’ 

11 have the meanings given the terms in section 201 of the 

12 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). 

13 ‘‘(b) GRANTS.—The Secretary, in consultation with 

14 the Secretary of Health and Human Services, shall award 

15 grants to colleges and universities to establish research 

16 and demonstration programs for— 

17 ‘‘(1) phasing out the nontherapeutic use of crit18 ical antimicrobial animal drugs in livestock or poul19 try; and 

20 ‘‘(2) informing livestock and poultry producers 

21 of methods for accomplishing the objective described 

22 in paragraph (1). 

23 ‘‘(c) EDUCATION.—The Secretary shall use the re24 sults of the research and demonstration programs and the 

25 experience of agricultural producers that have reduced or 


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1 eliminated the nontherapeutic use of critical antimicrobial 

2 animal drugs to educate other agricultural producers, 

3 through the Cooperative Research, Education, and Exten4 sion Service, concerning how to successfully phase out 

5 such use in livestock or poultry. 

6 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

7 are authorized to be appropriated such sums as are nec8 essary to carry out this section for fiscal years 2008 

9 through 2012.’’. 

10 SEC. 203. COLLECTION OF DATA ON CRITICAL ANTI11 MICROBIAL ANIMAL DRUGS. 

12 (a) IN GENERAL.—Chapter V of the Federal Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend14 ed by inserting after section 512 the following: 

15 ‘‘SEC. 512A. COLLECTION OF DATA ON CRITICAL ANTI16 MICROBIAL ANIMAL DRUGS. 

17 ‘‘(a) IN GENERAL.—Not later than July 1 of each 

18 year, a manufacturer of a critical antimicrobial animal 

19 drug or an animal feed for food-producing animals bearing 

20 or containing a critical antimicrobial animal drug shall 

21 submit to the Secretary a report, in such form as the Sec22 retary shall require, containing information on the sales 

23 during the previous calendar year of the critical anti24 microbial animal drug or animal feed. 


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1 ‘‘(b) INFORMATION TO BE INCLUDED.—A report 

2 under subsection (a) shall— 

3 ‘‘(1) state separately the quantity of the critical 

4 antimicrobial animal drug, including in animal feed 

5 bearing or containing the critical antimicrobial ani6 mal drug, sold for each kind of food-producing ani7 mal; 

8 ‘‘(2) describe the claimed purpose of use for 

9 each kind of food-producing animal as being for 

10 growth promotion, weight gain, feed efficiency, dis11 ease prevention, disease control, disease treatment, 

12 or another purpose; and 

13 ‘‘(3) describe the dosage form of the drug. 

14 ‘‘(c) PUBLICATION.— 

15 ‘‘(1) IN GENERAL.—The Secretary shall— 

16 ‘‘(A) make the information submitted 

17 under subsection (a) available to the public; and 

18 ‘‘(B) publish the information at least an19 nually. 

20 ‘‘(2) PROTECTION OF CONFIDENTIALITY.—The 

21 Secretary shall aggregate information, if necessary, 

22 to avoid disclosure under paragraph (1) of confiden23 tial business information.’’. 

24 (b) PROHIBITED ACTS.—Section 301(e) of the Fed25 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(e)) 


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1 is amended by striking ‘‘572(i)., 515(f)’’ and inserting 

2 ‘‘572(i), 512A, 515(f)’’. 

3 (c) EFFECTIVE DATE.—The amendments made by 

4 this section shall take effect on the date that is ninety 

5 days after the date of enactment of this Act. 

Æ 


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