I 

109TH CONGRESS 

1ST SESSION H. R. 2562 

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 HOUSE OF REPRESENTATIVES 

MAY 24, 2005 

Mr. BROWN of Ohio 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 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. Collection of data on critical antimicrobial animal drugs. 

1 SEC. 2. FINDINGS. 

2 The 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 

18 terrorist attacks involving bacterial infections or a 

19 large influx of hospitalized patients; 
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1 (3)(A) any overuse or misuse of antibiotics con2 tributes to the spread of antibiotic resistance, wheth3 er in human medicine or in agriculture; and 

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 (4) in a March 2003 report, the National Acad14 emy of Sciences stated that— 

15 (A) a decrease in antimicrobial use in 

16 human medicine alone will have little effect on 

17 the current situation; and 

18 (B) substantial efforts must be made to 

19 decrease inappropriate overuse in animals and 

20 agriculture; 

21 (5)(A) an estimated 70 percent of the anti22 biotics and other antimicrobial drugs used in the 

23 United States are fed to farm animals for nonthera24 peutic purposes, including— 

25 (B) growth promotion; and 
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1 (ii) compensation for crowded, unsanitary, 

2 and stressful farming and transportation condi3 tions; and 

4 (C) unlike human use of antibiotics, these non5 therapeutic uses in animals typically do not require 

6 a prescription; 

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

8 nontherapeutic use of antibiotics in agricultural ani9 mals contributes to the development of antibiotic-re10 sistant bacterial infections in people; 

11 (B) the periodical entitled ‘‘Clinical Infectious 

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

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

14 medicine, public health, microbiology, biostatistics, 

15 and risk analysis, of more than 500 scientific studies 

16 on the human health impacts of antimicrobial use in 

17 agriculture; and 

18 (C) the report recommended that antimicrobial 

19 agents should no longer be used in agriculture in the 

20 absence of disease, but should be limited to therapy 

21 for diseased individual animals and prophylaxis 

22 when disease is documented in a herd or flock; 

23 (7) the United States Geological Survey re24 ported in March 2002 that— 
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1 (A) antibiotics were present in 48 percent 

2 of the streams tested nationwide; and 

3 (B) almost half of the tested streams were 

4 downstream from agricultural operations; 

5 (8) an April 1999 study by the General Ac6 counting Office concluded that resistant strains of 3 

7 microorganisms that cause food-borne illness or dis8 ease in humans—Salmonella, Campylobacter, and E. 

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

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

11 published test results on poultry products bought in 

12 grocery stores nationwide showing disturbingly high 

13 levels of Campylobacter and Salmonella bacteria that 

14 were resistant to antibiotics used to treat food-borne 

15 illnesses; and 

16 (B) further studies showed similar results in 

17 other meat products; 

18 (10) in October 2001, the New England Jour19 nal of Medicine published an editorial urging a ban 

20 on nontherapeutic use of medically important anti21 biotics in animals; 

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

23 the practice of feeding medically important anti24 biotics to animals other than for disease treatment 

25 or control, and prior to that, individual European 
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1 countries had banned the use of specific antibiotics 

2 in animal feed; and 

3 (B) those countries have experienced no signifi4 cant impact on animal health or productivity, food 

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

6 of resistant bacteria have declined sharply; 

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

8 noted that antibiotic-resistant bacteria generate a 

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

10 costs to United States society and individuals yearly; 

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

12 Sciences estimated that eliminating the use of all 

13 antibiotics as feed additives would cost each Amer14 ican consumer less than $5 to $10 per year; 

15 (14) 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 support 

22 enactment of legislation to phase out nontherapeutic 

23 use in farm animals of medically important anti24 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; and 

20 (17) certain non-routine uses of antibiotics in 

21 animal agriculture are legitimate to prevent animal 

22 disease. 

23 SEC. 3. PURPOSE. 

24 The purpose of this Act is to preserve the effective25 ness of medically important antibiotics used in the treat-
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1 ment of human and animal diseases by phasing out use 

2 of certain antibiotics for nontherapeutic purposes in food3 producing animals. 

4 TITLE I—SAFETY OF CRITICAL 

5 ANTIMICROBIAL ANIMAL DRUGS 

6 SEC. 101. PROOF OF SAFETY OF CRITICAL ANTIMICROBIAL 

7 ANIMAL DRUGS. 

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

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

10 adding at the end the following: 

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

12 The term ‘critical antimicrobial animal drug’ means a 

13 drug that— 

14 ‘‘(1) is intended for use in food-producing ani15 mals; and 

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

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

18 macrolide, lincosamide, streptogramin, 

19 aminoglycoside, or sulfonamide; or 

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

21 drug that is used in humans or intended for use 

22 in humans to treat or prevent disease or infec23 tion caused by microorganisms. 

24 ‘‘(ss) NONTHERAPEUTIC USE.—The term ‘nonthera25 peutic use’, with respect to a critical antimicrobial animal 
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1 drug, means any use of the drug as a feed or water addi2 tive for an animal in the absence of any clinical sign of 

3 disease in the animal for growth promotion, feed effi4 ciency, weight gain, routine disease prevention, or other 

5 routine purpose.’’. 

6 (b) APPLICATIONS PENDING OR SUBMITTED AFTER

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

8 Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)) is amend9 ed— 

10 (1) in the first sentence— 

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

12 at the end; 

13 (B) by redesignating subparagraph (I) as 

14 subparagraph (J); and 

15 (C) by inserting after subparagraph (H) 

16 the following: 

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

18 animal drug or a drug of the same chemical 

19 class as a critical antimicrobial animal drug, 

20 the applicant has failed to demonstrate that 

21 there is a reasonable certainty of no harm to 

22 human health due to the development of anti23 microbial resistance that is attributable, in 

24 whole or in part, to the nontherapeutic use of 

25 the drug; or’’; and 
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1 (2) in the second sentence, by striking ‘‘(A) 

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

3 (c) PHASED ELIMINATION OF NONTHERAPEUTIC

4 USE IN ANIMALS OF CRITICAL ANTIMICROBIAL ANIMAL

5 DRUGS IMPORTANT FOR HUMAN HEALTH.—Section 512 

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

7 360b) is amended by adding at the end the following: 

8 ‘‘(q) PHASED ELIMINATION OF NONTHERAPEUTIC

9 USE IN ANIMALS OF CRITICAL ANTIMICROBIAL ANIMAL

10 DRUGS IMPORTANT FOR HUMAN HEALTH.— 

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

12 to the nontherapeutic use in a food-producing ani13 mal of a drug— 

14 ‘‘(A)(i) that is a critical antimicrobial ani15 mal drug; or 

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

17 a critical antimicrobial animal drug; and 

18 ‘‘(B)(i) for which there is in effect an ap19 proval of an application or an exemption under 

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

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

22 ‘‘(2) WITHDRAWAL.—The Secretary shall with23 draw the approval of a nontherapeutic use in food24 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 the date of the enactment of this subsection, 

5 the Secretary makes a final written determina6 tion that the holder of the approved application 

7 has demonstrated that there is a reasonable 

8 certainty of no harm to human health due to 

9 the development of antimicrobial resistance that 

10 is attributable in whole or in part to the non11 therapeutic use of the drug; or 

12 ‘‘(B) before the date specified in subpara13 graph (A), the Secretary makes a final written 

14 determination under this subsection, with re15 spect to a risk analysis of the drug conducted 

16 by the Secretary and other relevant informa17 tion, that there is a reasonable certainty of no 

18 harm to human health due to the development 

19 of antimicrobial resistance that is attributable 

20 in whole or in part to the nontherapeutic use of 

21 the drug. 

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

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

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

25 antimicrobial animal drug, the Secretary shall re-
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1 scind each approval of a nontherapeutic use in a 

2 food-producing animal of the critical antimicrobial 

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

4 as the critical antimicrobial animal drug, as of the 

5 date that is 2 years after the date on which the Sec6 retary grants the exemption. 

7 ‘‘(4) APPROVALS.—Except as provided in para8 graph (5), if an application for a drug that is a crit9 ical antimicrobial animal drug is submitted to the 

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

11 rescind each approval of a nontherapeutic use in a 

12 food-producing animal of the critical antimicrobial 

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

14 as the critical antimicrobial animal drug, as of the 

15 date that is 2 years after the date on which the ap16 plication is submitted to the Secretary. 

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

18 case may be, shall not apply if— 

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

20 would be rescinded under that paragraph, the 

21 Secretary makes a final written determination 

22 that the holder of the application for the ap23 proved nontherapeutic use has demonstrated 

24 that there is a reasonable certainty of no harm 

25 to human health due to the development of 
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1 antimicrobial resistance that is attributable in 

2 whole or in part to the nontherapeutic use in 

3 the food-producing animal of the critical anti4 microbial animal drug; or 

5 ‘‘(B) before the date specified in subpara6 graph (A), the Secretary makes a final written 

7 determination under this subsection, with re8 spect to a risk analysis of the critical anti9 microbial animal drug conducted by the Sec10 retary and any other relevant information, that 

11 there is a reasonable certainty of no harm to 

12 human health due to the development of anti13 microbial resistance that is attributable in 

14 whole or in part to the nontherapeutic use of 

15 the drug.’’. 

16 TITLE II—USE OF CRITICAL 

17 ANTIMICROBIAL ANIMAL 

18 DRUGS IN AGRICULTURE 

19 SEC. 201. COLLECTION OF DATA ON CRITICAL ANTI20 MICROBIAL ANIMAL DRUGS. 

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

22 Drug, and Cosmetic Act is amended by inserting after sec23 tion 512 (21 U.S.C. 360b) the following: 
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1 ‘‘SEC. 512A. COLLECTION OF DATA ON CRITICAL ANTI2 MICROBIAL ANIMAL DRUGS. 

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

4 year, a manufacturer of a critical antimicrobial animal 

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

6 or containing a critical antimicrobial animal drug shall 

7 submit to the Secretary a report, in such form as the Sec8 retary shall require, containing information on the sales 

9 during the previous calendar year of the critical anti10 microbial animal drug or the animal feed. 

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

12 under subsection (a) shall— 

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

14 antimicrobial animal drug, including such quantity 

15 in animal feed bearing or containing the critical 

16 antimicrobial drug, sold for each kind of food-pro17 ducing animal; 

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

19 drug for each kind of food-producing animal as 

20 being for growth promotion, weight gain, feed effi21 ciency, disease prevention, disease control, disease 

22 treatment, or another purpose; and 

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

24 ‘‘(c) PUBLICATION.— 
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1 ‘‘(1) IN GENERAL.—The Secretary shall make 

2 the information submitted under subsection (a) 

3 available to the public not less than annually. 

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

5 Secretary may aggregate information, if necessary, 

6 so as to avoid disclosure under paragraph (1) of con7 fidential business information.’’. 

8 (b) VIOLATION.—Subsection (e) of section 301 of the 

9 Federal Food, Drug and Cosmetic Act (21 U.S.C. 331(e)) 

10 is amended by striking ‘‘515(f)’’ and inserting ‘‘512A, 

11 515(f)’’. 

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

13 this section shall take effect on January 1, 2006. 

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