II 

109TH CONGRESS 

1ST SESSION S. 742 

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 

APRIL 7, 2005 

Ms. SNOWE (for herself, Mr. KENNEDY, Ms. COLLINS, Ms. LANDRIEU, and 

Mr. REED) 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 2005’’. 

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 rea2 sonable certainty of no harm from the use 

3 of certain antibiotics in animal agriculture; 

4 and 

5 (18) certain nonroutine uses of antibiotics in 

6 animal agriculture to prevent animal disease are le7 gitimate. 

8 SEC. 3. PURPOSE. 

9 The purpose of this Act is to preserve the effective10 ness of medically important antibiotics used in the treat11 ment of human and animal diseases by phasing out use 

12 of certain antibiotics for nontherapeutic purposes in food13 producing animals. 

14 TITLE I—SAFETY OF CRITICAL 

15 ANTIMICROBIAL ANIMAL DRUGS 

16 SEC. 101. PROOF OF SAFETY OF CRITICAL ANTIMICROBIAL 

17 ANIMAL DRUGS. 

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

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

20 adding at the end the following: 

21 ‘‘(rr) CRITICAL ANTIMICROBIAL ANIMAL DRUG.—The 

22 term ‘critical antimicrobial animal drug’ means a drug 

23 that— 

24 ‘‘(1) is intended for use in food-producing ani25 mals; and 
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1 ‘‘(2) is composed wholly or partly of— 

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

3 macrolide, lincosamide, streptogramin, 

4 aminoglycoside, sulfonamide; or 

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

6 drug that is used in humans or intended for use 

7 in humans to treat or prevent disease or infec8 tion caused by microorganisms. 

9 ‘‘(ss) NONTHERAPEUTIC USE.—The term ‘nonthera10 peutic use’, with respect to a critical antimicrobial animal 

11 drug, means any use of the drug as a feed or water addi12 tive for an animal in the absence of any clinical sign of 

13 disease in the animal for growth promotion, feed effi14 ciency, weight gain, routine disease prevention, or other 

15 routine purpose.’’. 

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

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

18 360b(d)(1)) is amended— 

19 (1) in the first sentence— 

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

21 at the end; 

22 (B) by redesignating subparagraph (I) as 

23 subparagraph (J); and 

24 (C) by inserting after subparagraph (H) 

25 the following: 
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1 ‘‘(I) with respect to a critical antimicrobial 

2 animal drug or a drug of the same chemical 

3 class as a critical antimicrobial animal drug, 

4 the applicant has failed to demonstrate that 

5 there is a reasonable certainty of no harm to 

6 human health due to the development of anti7 microbial resistance that is attributable, in 

8 whole or in part, to the nontherapeutic use of 

9 the drug; or’’; and 

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

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

12 (c) PHASED ELIMINATION OF NONTHERAPEUTIC

13 USE IN ANIMALS OF CRITICAL ANTIMICROBIAL ANIMAL

14 DRUGS IMPORTANT FOR HUMAN HEALTH.—Section 512 

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

16 360b) is amended by adding at the end the following: 

17 ‘‘(q) PHASED ELIMINATION OF NONTHERAPEUTIC

18 USE IN ANIMALS OF CRITICAL ANTIMICROBIAL ANIMAL

19 DRUGS IMPORTANT FOR HUMAN HEALTH.— 

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

21 to the nontherapeutic use in a food-producing ani22 mal of— 

23 ‘‘(A)(i) a drug that is a critical anti24 microbial animal drug; or 
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1 ‘‘(ii) a drug that is of the same chemical 

2 class as a critical antimicrobial animal drug; 

3 and 

4 ‘‘(B) a drug— 

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

6 the date of enactment of this subsection, 

7 there was in effect an approval of an appli8 cation filed under subsection (b) or (j) of 

9 section 505; or 

10 ‘‘(ii) that was otherwise marketed for 

11 use. 

12 ‘‘(2) WITHDRAWAL.—The Secretary shall with13 draw the approval of a nontherapeutic use in food14 producing animals described in paragraph (1) on the 

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

16 this subsection unless— 

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

18 that date of enactment, the Secretary makes a 

19 written determination that the holder of the ap20 proved application has demonstrated that there 

21 is a reasonable certainty of no harm to human 

22 health due to the development of antimicrobial 

23 resistance that is attributable in whole or in 

24 part to the nontherapeutic use of the drug; or 
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1 ‘‘(B) before the date specified in subpara2 graph (A), the Secretary makes a final written 

3 determination under this subsection, with re4 spect to a risk analysis of the drug conducted 

5 by the Secretary and other relevant informa6 tion, that there is a reasonable certainty of no 

7 harm to human health due to the development 

8 of antimicrobial resistance that is attributable 

9 in whole or in part to the nontherapeutic use of 

10 the drug. 

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

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

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

14 antimicrobial animal drug, the Secretary shall re15 scind each approval of a nontherapeutic use in a 

16 food-producing animal of the critical antimicrobial 

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

18 as the critical antimicrobial animal drug, as of the 

19 date that is 2 years after the date on which the Sec20 retary grants the exemption. 

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

22 that is a critical antimicrobial animal drug is sub23 mitted to the Secretary under section 505(b), the 

24 Secretary shall rescind each approval of a nonthera25 peutic use in a food-producing animal of the critical 
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1 antimicrobial animal drug, or of a drug in the same 

2 chemical class as the critical antimicrobial animal 

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

4 on which the application is submitted to the Sec5 retary. 

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

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

8 which approval would be rescinded under that sub9 paragraph, the Secretary determines that the holder 

10 of the approved application has demonstrated that 

11 there is a reasonable certainty of no harm to human 

12 health due to the development of antimicrobial re13 sistance that is attributable, in whole or in part, to 

14 the nontherapeutic use in the food-producing animal 

15 of the critical antimicrobial animal drug.’’. 

16 TITLE II—USE OF CRITICAL 

17 ANTIMICROBIAL ANIMAL 

18 DRUGS IN AGRICULTURE 

19 SEC. 201. ASSISTANCE TO DEFRAY EXPENSES OF LIVE20 STOCK OR POULTRY PRODUCERS IN PHAS21 ING OUT NONTHERAPEUTIC USE OF CRIT22 ICAL ANTIMICROBIAL ANIMAL DRUGS. 

23 (a) DEFINITIONS.—In this section, the terms ‘‘crit24 ical antimicrobial animal drug’’ and ‘‘nontherapeutic use’’ 
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1 have the meanings given the terms in section 201 of the 

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

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

4 make payments to producers of livestock or poultry that 

5 the Secretary determines are substantially reducing, or 

6 have substantially reduced, the nontherapeutic use of crit7 ical antimicrobial animal drugs in livestock or poultry in 

8 order to defray the costs of such reduction. 

9 (c) PRIORITY FOR FAMILY FARMERS AND SMALL

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

11 Secretary of Agriculture shall give priority to family12 owned and family-operated farms or ranches and to small 

13 farms or ranches, as determined by the Secretary. 

14 (d) AUTHORIZATION OF APPROPRIATIONS.—There 

15 are authorized to be appropriated such sums as are nec16 essary to carry out this section for fiscal year 2006 and 

17 for each subsequent fiscal year. 

18 SEC. 202. RESEARCH AND DEMONSTRATION PROGRAMS. 

19 Subtitle D of title VII of the Farm Security and 

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

21 by adding at the end the following: 

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

23 CRITICAL ANTIMICROBIAL ANIMAL DRUGS. 

24 ‘‘(a) DEFINITIONS.—In this section, the terms ‘crit25 ical antimicrobial animal drug’ and ‘nontherapeutic use’ 
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1 have the meanings given the terms in section 201 of the 

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

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

4 the Secretary of Health and Human Services, shall award 

5 grants to colleges and universities to establish research 

6 and demonstration programs for— 

7 ‘‘(1) phasing out the nontherapeutic use of crit8 ical antimicrobial animal drugs in livestock or poul9 try; and 

10 ‘‘(2) informing livestock and poultry producers 

11 of methods for accomplishing the objective described 

12 in paragraph (1). 

13 ‘‘(c) EDUCATION.—The Secretary shall use the re14 sults of the research and demonstration programs and the 

15 experience of agricultural producers that have reduced or 

16 eliminated the nontherapeutic use of critical antimicrobial 

17 animal drugs to educate other agricultural producers, 

18 through the Cooperative Research, Education, and Exten19 sion Service, concerning how to successfully phase out 

20 such use in livestock or poultry. 

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

22 are authorized to be appropriated such sums as are nec23 essary to carry out this section for fiscal years 2006 

24 through 2010.’’. 
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1 SEC. 203. COLLECTION OF DATA ON CRITICAL ANTI2 MICROBIAL ANIMAL DRUGS. 

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

4 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend5 ed by inserting after section 512 the following: 

6 ‘‘SEC. 512A. COLLECTION OF DATA ON CRITICAL ANTI7 MICROBIAL ANIMAL DRUGS. 

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

9 year, a manufacturer of a critical antimicrobial animal 

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

11 or containing a critical antimicrobial animal drug shall 

12 submit to the Secretary a report, in such form as the Sec13 retary shall require, containing information on the sales 

14 during the previous calendar year of the critical anti15 microbial animal drug or animal feed. 

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

17 under subsection (a) shall— 

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

19 antimicrobial animal drug, including in animal feed 

20 bearing or containing the critical antimicrobial ani21 mal drug, sold for each kind of food-producing ani22 mal; 

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

24 each kind of food-producing animal as being for 

25 growth promotion, weight gain, feed efficiency, dis-
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1 ease prevention, disease control, disease treatment, 

2 or another purpose; and 

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

4 ‘‘(c) PUBLICATION.— 

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

6 ‘‘(A) make the information submitted 

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

8 ‘‘(B) publish the information at least an9 nually. 

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

11 Secretary shall aggregate information, if necessary, 

12 to avoid disclosure under paragraph (1) of confiden13 tial business information.’’. 

14 (b) PROHIBITED ACTS.—Section 301(e) of the Fed15 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(e)) 

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

17 ‘‘572(i), 512A, 515(f)’’. 

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

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

20 days after the date of enactment of this Act.

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