I 
112TH CONGRESS 
1ST SESSION 
H. R. 965 
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 9, 2011 
Ms. SLAUGHTER introduced the following bill; which was referred to the Com-
mittee 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, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Preservation of Anti-
biotics for Medical Treatment Act of 2011’’. 
SEC. 2. FINDINGS. 
The Congress finds the following: 
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(1) In January 2001, a Federal interagency 
task force— 
(A) released an action plan to address the 
continuing decline in effectiveness of antibiotics 
against common bacterial infections, referred to 
as antibiotic resistance; 
(B) determined that antibiotic resistance is 
a growing menace to all people and poses a se-
rious threat to public health; and 
(C) cautioned that if current trends con-
tinue, treatments for common infections will be-
come 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 
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. 
(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 
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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) In 2010, the FDA determined that— 
(A) 13.1 million kilograms of antibacterial 
drugs were sold for use on food animals in the 
United States in 2009; 
(B) 3.3 million kilograms of antibacterial 
drugs were used for human health in 2009; and 
(C) therefore, 80 percent of antibacterial 
drugs disseminated in the United States in 
2009 were sold for use on food animals, rather 
than being used for human health. 
(6)(A) Large-scale, voluntary surveys by the 
Department of Agriculture’s Animal and Plant 
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Health Inspection Service in 1999, 2001, and 2006 
revealed that— 
(i) 84 percent of grower-finisher swine 
farms, 83 percent of cattle feedlots, and 84 per-
cent of sheep farms administer antimicrobials 
in the feed or water for health or growth pro-
motion reasons; and 
(ii) many of the antimicrobials identified 
are identical or closely related to drugs used in 
human 
medicine, 
including 
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. 
(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) The periodical entitled ‘‘Clinical Infectious 
Diseases’’ published a report in June 2002, that— 
(A) was based on a 2-year review by ex-
perts in human and veterinary medicine, public 
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health, microbiology, biostatistics, and risk 
analysis, of more than 500 scientific studies on 
the human health impacts of antimicrobial use 
in agriculture; and 
(B) 
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-
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. 
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(12) In 2010, the peer-reviewed journal Molec-
ular Cell published a study demonstrating that low- 
dosage use of antibiotics causes a dramatic increase 
in genetic mutation, raising new concerns about the 
agricultural practice of using low-dosage antibiotics 
in order to stimulate growth promotion and rou-
tinely prevent disease in unhealthy conditions. 
(13)(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 the 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 (including the foodborne 
pathogens Campylobacter and Salmonella) that are 
resistant to antibiotics important in human medi-
cine. 
(C) In December 2007, the USDA issued a fact 
sheet on the recently recognized link between anti-
microbial drug use in animals and Methicillin Resist-
ant Staphylococcus Aureas (MRSA) infections in hu-
mans. 
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(14) In October 2001, the New England Jour-
nal of Medicine published an editorial urging a ban 
on nontherapeutic use of medically important anti-
biotics in animals. 
(15)(A) In 1998, the National Academy of 
Sciences noted that antibiotic-resistant bacteria gen-
erate 
a 
minimum 
of 
$4,000,000,000 
to 
$5,000,000,000 in costs to United States society 
and individuals yearly. 
(B) In 2009, Cook County Hospital and the Al-
liance for Prudent Use of Antibiotics estimated that 
the total health care cost of antibiotic resistant in-
fections 
in 
the 
United 
States 
was 
between 
$16,600,000,000 and $26,000,000,000 annually. 
(16) 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. 
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(17) In 2010, the Danish Veterinary and Food 
Administration testified that the Danish ban of the 
non-therapeutic use of antibiotics in food animal 
production resulted in a marked reduction in anti-
microbial resistance in multiple bacterial species, in-
cluding Campylobacter and Enterococci. 
(18) In 2009, the Congressional Research Serv-
ice concluded that restrictions overseas on the use of 
antimicrobial drugs in the production of livestock 
could impact U.S. export markets for livestock and 
poultry. 
(19) 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. 
(20)(A) The Food and Drug Administration re-
cently modified the drug approval process for anti-
biotics to recognize the development of resistant bac-
teria as an important aspect of safety, but most 
antibiotics currently used in animal production sys-
tems for nontherapeutic purposes were approved be-
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fore the Food and Drug Administration began con-
sidering resistance during the drug-approval process. 
(B) The Food and Drug Administration has not 
established a schedule for reviewing those existing 
approvals. 
(21) Certain non-routine uses of antibiotics in 
animal agriculture are legitimate to prevent animal 
disease. 
(22) An April 2004 study by the General Ac-
counting Office— 
(A) 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) recommends that the Department 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-
ment of human and animal diseases by reviewing the safe-
ty of certain antibiotics for nontherapeutic purposes in 
food-producing animals. 
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