I 
111TH CONGRESS 
1ST SESSION H. R. 1549 
To amend the Federal Food, Drug, and Cosmetic Act to preserve the effective-
ness 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 Cali-
fornia, Mr. KUCINICH, Ms. LEE of California, Mr. DEFAZIO, Mr. 
WEXLER, Mr. GEORGE MILLER of California, Mr. FRANK of Massachu-
setts, Mr. FARR, Ms. DELAURO, Mr. SHERMAN, Mr. CONNOLLY of Vir-
ginia, 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 anti-
biotics used in the treatment of human and animal dis-
eases. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Preservation of Antibiotics for Medical Treatment Act of 
2009’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
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. 
SEC. 2. FINDINGS. 
The Congress finds that— 
(1)(A) in January 2001, a Federal interagency 
task force released an action plan to address the 
continuing decline in effectiveness of antibiotics 
against common bacterial infections, referred to as 
antibiotic resistance; 
(B) the task force determined that antibiotic re-
sistance is a growing menace to all people and poses 
a serious threat to public health; and 
(C) the task force cautioned that if current 
trends continue, treatments for common infections 
will become increasingly limited and expensive, and, 
in some cases, nonexistent; 
(2) antibiotic resistance, resulting in a reduced 
number of effective antibiotics, may significantly im-
pair the ability of the United States to respond to 
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terrorist attacks involving bacterial infections or a 
large influx of hospitalized patients; 
(3)(A) any overuse or misuse of antibiotics con-
tributes to the spread of antibiotic resistance, wheth-
er in human medicine or in agriculture; and 
(B) recognizing the public health threat caused 
by antibiotic resistance, Congress took several steps 
to curb antibiotic overuse in human medicine 
through amendments to the Public Health Service 
Act (42 U.S.C. 201 et seq.) made by section 102 of 
the Public Health Threats and Emergencies Act 
(Public Law 106–505, title I; 114 Stat. 2315), but 
has not yet addressed antibiotic overuse in agri-
culture; 
(4) in a March 2003 report, the National Acad-
emy of Sciences stated that— 
(A) a decrease in antimicrobial use in 
human medicine alone will have little effect on 
the current situation; and 
(B) substantial efforts must be made to 
decrease inappropriate overuse in animals and 
agriculture; 
(5)(A) an estimated 70 percent of the anti-
biotics and other antimicrobial drugs used in the 
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United States are fed to farm animals for nonthera-
peutic purposes, including— 
(i) growth promotion; and 
(ii) compensation for crowded, unsanitary, 
and stressful farming and transportation condi-
tions; and 
(B) unlike human use of antibiotics, these non-
therapeutic uses in animals typically do not require 
a prescription; 
(6)(A) large-scale, voluntary surveys by the De-
partment of Agriculture’s Animal and Plant Health 
Inspection Service in 1999, 2001, and 2006 revealed 
that 84 percent of grower-finisher swine farms, 83 
percent of cattle feedlots, and 84 percent of sheep 
farms administer antimicrobials in the feed or water 
for health or growth promotion reasons, and many 
of the antimicrobials identified are identical or close-
ly related to drugs used in human medicine, includ-
ing tetracyclines, macrolides, Bacitracin, penicillins, 
and sulfonamides; and 
(B) these drugs are used in people to treat seri-
ous diseases such as pneumonia, scarlet fever, rheu-
matic fever, venereal disease, skin infections, and 
even pandemics like malaria and plague, as well as 
bioterrorism agents like smallpox and anthrax; 
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(7) many scientific studies confirm that the 
nontherapeutic use of antibiotics in agricultural ani-
mals contributes to the development of antibiotic-re-
sistant bacterial infections in people; 
(8)(A) the periodical entitled ‘‘Clinical Infec-
tious Diseases’’ published a report in June 2002, 
based on a 2-year review by experts in human and 
veterinary medicine, public health, microbiology, bio-
statistics, and risk analysis, of more than 500 sci-
entific studies on the human health impacts of anti-
microbial use in agriculture; and 
(B) the report recommended that antimicrobial 
agents should no longer be used in agriculture in the 
absence of disease, but should be limited to therapy 
for diseased individual animals and prophylaxis 
when disease is documented in a herd or flock; 
(9) the United States Geological Survey re-
ported in March 2002 that— 
(A) antibiotics were present in 48 percent 
of the streams tested nationwide; and 
(B) almost half of the tested streams were 
downstream from agricultural operations; 
(10) an April 1999 study by the General Ac-
counting Office concluded that resistant strains of 3 
microorganisms that cause food-borne illness or dis-
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ease in humans—Salmonella, Campylobacter, and E. 
coli—are linked to the use of antibiotics in animals; 
(11) epidemiological research has shown that 
resistant Salmonella and Campylobacter infections 
are associated with increased numbers of ill patients 
and bloodstream infections, and increased death; 
(12)(A) in January 2003, Consumer Reports 
published test results on poultry products bought in 
grocery stores nationwide showing disturbingly high 
levels of Campylobacter and Salmonella bacteria that 
were resistant to antibiotics used to treat food-borne 
illnesses; 
(B) the Food and Drug Administration’s Na-
tional Antimicrobial Resistance Monitoring System 
routinely finds that retail meat products are con-
taminated with bacteria resistant to antibiotics im-
portant in human medicine including the foodborne 
pathogens Campylobacter and Salmonella; and 
(C) in December 2007, the USDA issued a fact 
sheet on the recently recognized link between anti-
microbial drug use in animals and the Methicillin 
Resistant Staphylococcus Aureas (MRSA) infections 
in humans; 
(13) in October 2001, the New England Jour-
nal of Medicine published an editorial urging a ban 
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on nontherapeutic use of medically important anti-
biotics in animals; 
(14) in 1998, the National Academy of Sciences 
noted that antibiotic-resistant bacteria generate a 
minimum of $4,000,000,000 to $5,000,000,000 in 
costs to United States society and individuals yearly; 
(15) the American Medical Association, the 
American Public Health Association, the National 
Association of County and City Health Officials, and 
the National Campaign for Sustainable Agriculture 
are among the more than 300 organizations rep-
resenting health, consumer, agricultural, environ-
mental, humane, and other interests that have sup-
ported enactment of legislation to phase out non-
therapeutic use in farm animals of medically impor-
tant antibiotics; 
(16) the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.)— 
(A) requires that all drugs be shown to be 
safe before the drugs are approved; and 
(B) places the burden on manufacturers to 
account for health consequences and prove safe-
ty; 
(17)(A) the Food and Drug Administration re-
cently modified the drug approval process for anti-
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biotics to recognize the development of resistant bac-
teria as an important aspect of safety; 
(B) however, most antibiotics currently used in 
animal production systems for nontherapeutic pur-
poses were approved before the Food and Drug Ad-
ministration began giving in-depth consideration to 
resistance during the drug-approval process; and 
(C) the Food and Drug Administration has not 
established a schedule for reviewing those existing 
approvals; 
(18) certain non-routine uses of antibiotics in 
animal agriculture are legitimate to prevent animal 
disease; and 
(19)(A) an April 2004 study by the General Ac-
counting Office concluded that Federal agencies do 
not collect the critical data on antibiotic use in ani-
mals that they need to support research on human 
health risks; and 
(B) the report recommends that the Depart-
ment of Agriculture and the Department of Health 
and Human Services develop and implement a plan 
to collect data on antibiotic use in animals. 
SEC. 3. PURPOSE. 
The purpose of this Act is to preserve the effective-
ness of medically important antibiotics used in the treat-
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ment of human and animal diseases by reviewing the safe-
ty of certain antibiotics for nontherapeutic purposes in 
food-producing animals. 
SEC. 4. PROOF OF SAFETY OF CRITICAL ANTIMICROBIAL 
ANIMAL DRUGS. 
(a) DEFINITIONS.—Section 201 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 
adding at the end the following: 
‘‘(rr) CRITICAL ANTIMICROBIAL ANIMAL DRUG.— 
The term ‘critical antimicrobial animal drug’ means a 
drug that— 
‘‘(1) is intended for use in food-producing ani-
mals; and 
‘‘(2) is composed wholly or partly of— 
‘‘(A) any kind of penicillin, tetracycline, 
macrolide, lincosamide, streptogramin, amino-
glycoside, or sulfonamide; or 
‘‘(B) any other drug or derivative of a 
drug that is used in humans or intended for use 
in humans to treat or prevent disease or infec-
tion caused by microorganisms. 
‘‘(ss) NONTHERAPEUTIC USE.—The term ‘nonthera-
peutic use’, with respect to a critical antimicrobial animal 
drug, means any use of the drug as a feed or water addi-
tive for an animal in the absence of any clinical sign of 
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disease in the animal for growth promotion, feed effi-
ciency, weight gain, routine disease prevention, or other 
routine purpose.’’. 
(b) APPLICATIONS PENDING OR SUBMITTED AFTER 
ENACTMENT.—Section 512(d)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)) is amend-
ed— 
(1) in the first sentence— 
(A) in subparagraph (H), by striking ‘‘or’’ 
at the end; 
(B) by redesignating subparagraph (I) as 
subparagraph (J); and 
(C) by inserting after subparagraph (H) 
the following: 
‘‘(I) with respect to a critical antimicrobial 
animal drug or a drug of the same chemical 
class as a critical antimicrobial animal drug, 
the applicant has failed to demonstrate that 
there is a reasonable certainty of no harm to 
human health due to the development of anti-
microbial resistance that is attributable, in 
whole or in part, to the nontherapeutic use of 
the drug; or’’; and 
(2) in the second sentence, by striking ‘‘(A) 
through (I)’’ and inserting ‘‘(A) through (J)’’. 
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