I 

111TH CONGRESS 

1ST SESSION H. R. 1549 

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 

MARCH 17, 2009 

Ms. SLAUGHTER (for herself, Mr. TIERNEY, Mr. HONDA, Mr. VAN HOLLEN, 

Mr. HINCHEY, Mr. GRIJALVA, Ms. HIRONO, Ms. ZOE LOFGREN of California, Mr. KUCINICH, Ms. LEE of California, Mr. DEFAZIO, Mr. 

WEXLER, Mr. GEORGE MILLER of California, Mr. FRANK of Massachusetts, Mr. FARR, Ms. DELAURO, Mr. SHERMAN, Mr. CONNOLLY of Virginia, Mr. STARK, Mrs. MALONEY, Mr. JACKSON of Illinois, Mr. BRADY

of Pennsylvania, and Ms. KILROY) introduced the following bill; which 

was referred to the Committee on Energy and Commerce, and in addition 

to the Committee on Rules, for a period to be subsequently determined 

by the Speaker, in each case for consideration of such provisions as fall 

within the jurisdiction of the committee concerned 

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, 


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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

3 ‘‘Preservation of Antibiotics for Medical Treatment Act of 

4 2009’’. 

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

6 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

Sec. 3. Purpose. 

Sec. 4. Proof of safety of critical antimicrobial animal drugs. 

Sec. 5. Committee hearings on implementation. 

7 SEC. 2. FINDINGS. 

8 The Congress finds that— 

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

10 task force released an action plan to address the 

11 continuing decline in effectiveness of antibiotics 

12 against common bacterial infections, referred to as 

13 antibiotic resistance; 

14 (B) the task force determined that antibiotic re15 sistance is a growing menace to all people and poses 

16 a serious threat to public health; and 

17 (C) the task force cautioned that if current 

18 trends continue, treatments for common infections 

19 will become increasingly limited and expensive, and, 

20 in some cases, nonexistent; 

21 (2) antibiotic resistance, resulting in a reduced 

22 number of effective antibiotics, may significantly im23 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 (Public Law 106–505, title I; 114 Stat. 2315), but 

13 has not yet addressed antibiotic overuse in agri14 culture; 

15 (4) in a March 2003 report, the National Acad16 emy of Sciences stated that— 

17 (A) a decrease in antimicrobial use in 

18 human medicine alone will have little effect on 

19 the current situation; and 

20 (B) substantial efforts must be made to 

21 decrease inappropriate overuse in animals and 

22 agriculture; 

23 (5)(A) an estimated 70 percent of the anti24 biotics and other antimicrobial drugs used in the 


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1 United States are fed to farm animals for nonthera2 peutic purposes, including— 

3 (i) growth promotion; and 

4 (ii) compensation for crowded, unsanitary, 

5 and stressful farming and transportation condi6 tions; and 

7 (B) unlike human use of antibiotics, these non8 therapeutic uses in animals typically do not require 

9 a prescription; 

10 (6)(A) large-scale, voluntary surveys by the De11 partment of Agriculture’s Animal and Plant Health 

12 Inspection Service in 1999, 2001, and 2006 revealed 

13 that 84 percent of grower-finisher swine farms, 83 

14 percent of cattle feedlots, and 84 percent of sheep 

15 farms administer antimicrobials in the feed or water 

16 for health or growth promotion reasons, and many 

17 of the antimicrobials identified are identical or close18 ly related to drugs used in human medicine, includ19 ing tetracyclines, macrolides, Bacitracin, penicillins, 

20 and sulfonamides; and 

21 (B) these drugs are used in people to treat seri22 ous diseases such as pneumonia, scarlet fever, rheu23 matic fever, venereal disease, skin infections, and 

24 even pandemics like malaria and plague, as well as 

25 bioterrorism agents like smallpox and anthrax; 


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1 (7) many scientific studies confirm that the 

2 nontherapeutic use of antibiotics in agricultural ani3 mals contributes to the development of antibiotic-re4 sistant bacterial infections in people; 

5 (8)(A) the periodical entitled ‘‘Clinical Infec6 tious Diseases’’ published a report in June 2002, 

7 based on a 2-year review by experts in human and 

8 veterinary medicine, public health, microbiology, bio9 statistics, and risk analysis, of more than 500 sci10 entific studies on the human health impacts of anti11 microbial use in agriculture; and 

12 (B) the report recommended that antimicrobial 

13 agents should no longer be used in agriculture in the 

14 absence of disease, but should be limited to therapy 

15 for diseased individual animals and prophylaxis 

16 when disease is documented in a herd or flock; 

17 (9) the United States Geological Survey re18 ported in March 2002 that— 

19 (A) antibiotics were present in 48 percent 

20 of the streams tested nationwide; and 

21 (B) almost half of the tested streams were 

22 downstream from agricultural operations; 

23 (10) an April 1999 study by the General Ac24 counting Office concluded that resistant strains of 3 

25 microorganisms that cause food-borne illness or disVerDate Nov 24 2008 07:17 Mar 18, 2009 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1549.IH H1549

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1 ease in humans—Salmonella, Campylobacter, and E. 

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

3 (11) epidemiological research has shown that 

4 resistant Salmonella and Campylobacter infections 

5 are associated with increased numbers of ill patients 

6 and bloodstream infections, and increased death; 

7 (12)(A) in January 2003, Consumer Reports 

8 published test results on poultry products bought in 

9 grocery stores nationwide showing disturbingly high 

10 levels of Campylobacter and Salmonella bacteria that 

11 were resistant to antibiotics used to treat food-borne 

12 illnesses; 

13 (B) the Food and Drug Administration’s Na14 tional Antimicrobial Resistance Monitoring System 

15 routinely finds that retail meat products are con16 taminated with bacteria resistant to antibiotics im17 portant in human medicine including the foodborne 

18 pathogens Campylobacter and Salmonella; and 

19 (C) in December 2007, the USDA issued a fact 

20 sheet on the recently recognized link between anti21 microbial drug use in animals and the Methicillin 

22 Resistant Staphylococcus Aureas (MRSA) infections 

23 in humans; 

24 (13) in October 2001, the New England Jour25 nal of Medicine published an editorial urging a ban 


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1 on nontherapeutic use of medically important anti2 biotics in animals; 

3 (14) in 1998, the National Academy of Sciences 

4 noted that antibiotic-resistant bacteria generate a 

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

6 costs to United States society and individuals yearly; 

7 (15) the American Medical Association, the 

8 American Public Health Association, the National 

9 Association of County and City Health Officials, and 

10 the National Campaign for Sustainable Agriculture 

11 are among the more than 300 organizations rep12 resenting health, consumer, agricultural, environ13 mental, humane, and other interests that have sup14 ported enactment of legislation to phase out non15 therapeutic use in farm animals of medically impor16 tant antibiotics; 

17 (16) the Federal Food, Drug, and Cosmetic Act 

18 (21 U.S.C. 301 et seq.)— 

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

20 safe before the drugs are approved; and 

21 (B) places the burden on manufacturers to 

22 account for health consequences and prove safe23 ty; 

24 (17)(A) the Food and Drug Administration re25 cently modified the drug approval process for antiVerDate Nov 24 2008 07:17 Mar 18, 2009 Jkt 079200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1549.IH H1549

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1 biotics to recognize the development of resistant bac2 teria as an important aspect of safety; 

3 (B) however, most antibiotics currently used in 

4 animal production systems for nontherapeutic pur5 poses were approved before the Food and Drug Ad6 ministration began giving in-depth consideration to 

7 resistance during the drug-approval process; and 

8 (C) the Food and Drug Administration has not 

9 established a schedule for reviewing those existing 

10 approvals; 

11 (18) certain non-routine uses of antibiotics in 

12 animal agriculture are legitimate to prevent animal 

13 disease; and 

14 (19)(A) an April 2004 study by the General Ac15 counting Office concluded that Federal agencies do 

16 not collect the critical data on antibiotic use in ani17 mals that they need to support research on human 

18 health risks; and 

19 (B) the report recommends that the Depart20 ment of Agriculture and the Department of Health 

21 and Human Services develop and implement a plan 

22 to collect data on antibiotic use in animals. 

23 SEC. 3. PURPOSE. 

24 The purpose of this Act is to preserve the effective25 ness of medically important antibiotics used in the treatVerDate Nov 24 2008 22:13 Mar 19, 2009 Jkt 079200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H1549.IH H1549

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1 ment of human and animal diseases by reviewing the safe2 ty of certain antibiotics for nontherapeutic purposes in 

3 food-producing animals. 

4 SEC. 4. PROOF OF SAFETY OF CRITICAL ANTIMICROBIAL 

5 ANIMAL DRUGS. 

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

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

8 adding at the end the following: 

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

10 The term ‘critical antimicrobial animal drug’ means a 

11 drug that— 

12 ‘‘(1) is intended for use in food-producing ani13 mals; and 

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

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

16 macrolide, lincosamide, streptogramin, amino17 glycoside, or sulfonamide; or 

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

19 drug that is used in humans or intended for use 

20 in humans to treat or prevent disease or infec21 tion caused by microorganisms. 

22 ‘‘(ss) NONTHERAPEUTIC USE.—The term ‘nonthera23 peutic use’, with respect to a critical antimicrobial animal 

24 drug, means any use of the drug as a feed or water addi25 tive for an animal in the absence of any clinical sign of 


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1 disease in the animal for growth promotion, feed effi2 ciency, weight gain, routine disease prevention, or other 

3 routine purpose.’’. 

4 (b) APPLICATIONS PENDING OR SUBMITTED AFTER

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

6 Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)) is amend7 ed— 

8 (1) in the first sentence— 

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

10 at the end; 

11 (B) by redesignating subparagraph (I) as 

12 subparagraph (J); and 

13 (C) by inserting after subparagraph (H) 

14 the following: 

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

16 animal drug or a drug of the same chemical 

17 class as a critical antimicrobial animal drug, 

18 the applicant has failed to demonstrate that 

19 there is a reasonable certainty of no harm to 

20 human health due to the development of anti21 microbial resistance that is attributable, in 

22 whole or in part, to the nontherapeutic use of 

23 the drug; or’’; and 

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

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


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1 (c) PHASED ELIMINATION OF NONTHERAPEUTIC

2 USE IN ANIMALS OF CRITICAL ANTIMICROBIAL ANIMAL

3 DRUGS IMPORTANT FOR HUMAN HEALTH.—Section 512 

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

5 360b) is amended by adding at the end the following: 

6 ‘‘(q) PHASED ELIMINATION OF NONTHERAPEUTIC

7 USE IN ANIMALS OF CRITICAL ANTIMICROBIAL ANIMAL

8 DRUGS IMPORTANT FOR HUMAN HEALTH.— 

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

10 to the nontherapeutic use in a food-producing ani11 mal of a drug— 

12 ‘‘(A)(i) that is a critical antimicrobial ani13 mal drug; or 

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

15 a critical antimicrobial animal drug; and 

16 ‘‘(B)(i) for which there is in effect an ap17 proval of an application or an exemption under 

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

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

20 ‘‘(2) WITHDRAWAL.—The Secretary shall with21 draw the approval of a nontherapeutic use in food22 producing animals described in paragraph (1) on the 

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

24 this subsection unless— 


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

2 the date of the enactment of this subsection, 

3 the Secretary makes a final written determina4 tion that the holder of the approved application 

5 has demonstrated that there is a reasonable 

6 certainty of no harm to human health due to 

7 the development of antimicrobial resistance that 

8 is attributable in whole or in part to the non9 therapeutic use of the drug; or 

10 ‘‘(B) before the date specified in subpara11 graph (A), the Secretary makes a final written 

12 determination under this subsection, with re13 spect to a risk analysis of the drug conducted 

14 by the Secretary and other relevant informa15 tion, that there is a reasonable certainty of no 

16 harm to human health due to the development 

17 of antimicrobial resistance that is attributable 

18 in whole or in part to the nontherapeutic use of 

19 the drug. 

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

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

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

23 antimicrobial animal drug, the Secretary shall re24 scind each approval of a nontherapeutic use in a 

25 food-producing animal of the critical antimicrobial 


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

2 as the critical antimicrobial animal drug, as of the 

3 date that is 2 years after the date on which the Sec4 retary grants the exemption. 

5 ‘‘(4) APPROVALS.—Except as provided in para6 graph (5), if an application for a drug that is a crit7 ical antimicrobial animal drug is submitted to the 

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

9 rescind each approval of a nontherapeutic use in a 

10 food-producing animal of the critical antimicrobial 

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

12 as the critical antimicrobial animal drug, as of the 

13 date that is 2 years after the date on which the ap14 plication is submitted to the Secretary. 

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

16 case may be, shall not apply if— 

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

18 would be rescinded under that paragraph, the 

19 Secretary makes a final written determination 

20 that the holder of the application for the ap21 proved nontherapeutic use has demonstrated 

22 that there is a reasonable certainty of no harm 

23 to human health due to the development of 

24 antimicrobial resistance that is attributable in 

25 whole or in part to the nontherapeutic use in 


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1 the food-producing animal of the critical anti2 microbial animal drug; or 

3 ‘‘(B) before the date specified in subpara4 graph (A), the Secretary makes a final written 

5 determination under this subsection, with re6 spect to a risk analysis of the critical anti7 microbial animal drug conducted by the Sec8 retary and any other relevant information, that 

9 there is a reasonable certainty of no harm to 

10 human health due to the development of anti11 microbial resistance that is attributable in 

12 whole or in part to the nontherapeutic use of 

13 the drug.’’. 

14 SEC. 5. COMMITTEE HEARINGS ON IMPLEMENTATION. 

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

16 Commerce of the House of Representatives and the Com17 mittee on Energy of the Senate shall each hold a hearing 

18 on the implementation by the Commissioner of Food and 

19 Drugs of section 512(q) of the Federal Food, Drug, and 

20 Cosmetic Act, as added by section 4 of this Act. 

21 (b) EXERCISE OF RULEMAKING AUTHORITY.—Sub22 section (a) is enacted— 

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

24 the House of Representatives and Senate, and, as 

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


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

2 such rules shall supersede any other rule of the 

3 House or Senate only to the extent that rule is in4 consistent therewith; and 

5 (2) with full recognition of the constitutional 

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

7 as relating to the procedure in such House) at any 

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

9 as in the case of any other rule of the House or Sen10 ate. 

Æ 


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