I 
113TH CONGRESS 
1ST SESSION H. R. 1150 
To amend the Federal Food, Drug, and Cosmetic Act to preserve the effective-
ness of medically important antimicrobials used in the treatment of 
human and animal diseases. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 14, 2013 
Ms. SLAUGHTER 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 
antimicrobials used in the treatment of human and ani-
mal diseases. 
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 2013’’. 
SEC. 2. FINDINGS. 
The Congress finds the following: 
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(1)(A) In 1977, the Food and Drug Adminis-
tration concluded that feeding livestock low doses of 
antibiotics used in human disease treatment could 
promote the development of antibiotic-resistance in 
bacteria. However, the Food and Drug Administra-
tion did not act in response to these findings, despite 
laws requiring the agency to do so. 
(B) In 2012, the Food and Drug Administra-
tion was ordered by a Federal court to address the 
use of antibiotics in livestock, as the result of a law-
suit filed against the agency citing the agency’s fail-
ure to act in response to the 1977 findings. 
(2)(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. 
(3) An April 1999 study by the Government 
Accountability 
Office 
concluded 
that 
resistant 
strains of 3 microorganisms that cause food-borne 
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illness 
or 
disease 
in 
humans 
(Salmonella, 
Campylobacter, and E. coli) are linked to the use of 
antibiotics in animals. 
(4)(A) Large-scale, voluntary surveys by the 
Department of Agriculture’s Animal and Plant 
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, sexually transmitted infections, skin in-
fections, and even pandemics like malaria and 
plague, as well as bioterrorism agents like smallpox 
and anthrax. 
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(5)(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 
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. 
(6) 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. 
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(7) 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. 
(8) The peer-reviewed journal ‘‘Clinical Infec-
tious 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 
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) In a March 2003 report, the National Acad-
emy of Sciences stated that— 
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(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. 
(10) 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. 
(11)(A) In 2003, the Food and Drug Adminis-
tration 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-
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. 
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(12)(A) In an April 2004 report, the Govern-
ment Accountability Office— 
(i) 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 
(ii) recommended 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. 
(B) In a September 2011 update to that report, 
the Government Accountability Office— 
(i) concluded that Federal agencies had 
made limited progress in addressing antibiotic 
use in animals; 
(ii) recommended that Federal agencies 
fund research on alternatives to current anti-
biotic use practices; and 
(iii) recommended that Federal agencies 
track the effectiveness of policies that curb anti-
biotic resistance, including FDA’s voluntary 
guidelines reducing antibiotic use in food ani-
mals. 
(13) In 2009, the Congressional Research Serv-
ice concluded that without restrictions on the use of 
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antimicrobial drugs in the production of livestock, 
export markets for livestock and poultry could be 
negatively impacted due to restrictions on the use of 
antibiotics in other nations. 
(14) 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. 
(15) In 2010, the Danish Veterinary and Food 
Administration testified that the Danish ban of the 
nontherapeutic use of antibiotics in food animal pro-
duction resulted in a marked reduction in anti-
microbial resistance in multiple bacterial species, in-
cluding Campylobacter and Enterococci. 
(16) In 2011, the Food and Drug Administra-
tion determined that— 
(A) 13.5 million kilograms of antibacterial 
drugs were sold for use on food animals in the 
United States in 2010; 
(B) 3.3 million kilograms of antibacterial 
drugs were used for human health in 2010; and 
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(C) therefore, 80 percent of antibacterial 
drugs disseminated in the United States in 
2010 were sold for use on food animals, rather 
than being used for human health. 
(17) In 2011, a review of all scientific studies 
on antimicrobial use in farm animals, published in 
Clinical Microbiology Reviews, found that— 
(A) use of antibiotics in food animals leads 
to development of reservoirs of antibiotic resist-
ance; 
(B) a ban on antibiotic use in food animals 
would preserve their use for medicine; and 
(C) a Danish ban on antibiotics in food 
animals resulted in little change in animal mor-
bidity and mortality, and only a modest in-
crease in production cost. 
(18) In April 2012, the Food and Drug Admin-
istration issued voluntary guidance to industry on 
reducing antibiotic use in livestock and poultry. As 
part of that guidance, it summarized over 35 years 
of peer-reviewed scientific literature regarding use of 
antimicrobial drugs in livestock. As a result, FDA 
stated strategies for controlling antibiotic resistance 
are needed, and are seeking voluntarily limits on an-
tibiotic use. 
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(19)(A) In January 2013, Consumer Reports 
published test results on pork products bought in 
grocery stores nationwide showing disturbingly high 
levels of Salmonella and Yersinia enterocolitica bac-
teria that were resistant to the antibiotics used to 
treat food borne illnesses. A 2003 Consumer Report 
study showed similar results in poultry products. 
(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. The 2011 National Antimicrobial Resistance 
Monitoring System report found that the percentage 
of meat containing antibiotic resistant bacteria in-
creases each year and that many of these bacteria 
exhibit multiple antibiotic resistance. 
(20) Antibiotic resistance, resulting in a re-
duced number of effective antibiotics, may signifi-
cantly impair the ability of the United States to re-
spond to terrorist attacks involving bacterial infec-
tions or a large influx of hospitalized patients. 
(21) Many scientific studies confirm that the 
nontherapeutic use of antibiotics in agricultural ani-
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mals contribute to the development of antibiotic-re-
sistant bacterial infections in people. 
(22) Epidemiological research has shown that 
resistant Salmonella and Campylobacter infections 
are associated with increased numbers of ill patients 
and bloodstream infections, and increased death. 
(23) The American Medical Association, the 
American Public Health Association, the National 
Association of County and City Health Officials, and 
the National Sustainable Agriculture Coalition are 
among the over 400 organizations representing 
health, consumer, agricultural, environmental, hu-
mane, and other interests that have supported enact-
ment of legislation to phase out nontherapeutic use 
in 
farm 
animals 
of 
medically 
important 
antimicrobials. 
SEC. 3. PURPOSE. 
The purpose of this Act is to preserve the effective-
ness of medically important antimicrobials used in the 
treatment of human and animal diseases. 
SEC. 4. PROOF OF SAFETY OF MEDICALLY IMPORTANT 
ANTIMICROBIALS. 
(a) APPLICATIONS PENDING OR SUBMITTED AFTER 
ENACTMENT.—Section 512(d)(1) of the Federal Food, 
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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) in subparagraph (I), by inserting ‘‘or’’ 
at the end; and 
(C) by inserting after subparagraph (I) the 
following: 
‘‘(J) with respect to a medically important 
antimicrobial (as defined in subsection (q)), the 
applicant has failed to demonstrate that there 
is a reasonable certainty of no harm to human 
health due to the development of antimicrobial 
resistance that is attributable, in whole or in 
part, to the nontherapeutic use (as defined in 
subsection (q)) of the medically important anti-
microbial or drug;’’; and 
(2) in the second sentence, by striking ‘‘(A) 
through (I)’’ and inserting ‘‘(A) through (J)’’. 
(b) PHASED ELIMINATION
OF NONTHERAPEUTIC 
USE
IN
ANIMALS
OF
MEDICALLY
IMPORTANT 
ANTIMICROBIALS.—Section 512 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b) is amended by 
adding at the end the following: 
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‘‘(q) PHASED ELIMINATION OF NONTHERAPEUTIC 
USE
IN
ANIMALS
OF
MEDICALLY
IMPORTANT 
ANTIMICROBIALS.— 
‘‘(1) APPLICABILITY.—This paragraph applies 
to the nontherapeutic use in a food-producing ani-
mal of a drug— 
‘‘(A) that is a medically important anti-
microbial; or 
‘‘(B)(i) for which there is in effect an ap-
proval of an application or an exemption under 
subsection (b), (i), or (j) of section 505; or 
‘‘(ii) that is otherwise marketed for human 
use. 
‘‘(2) WITHDRAWAL.—The Secretary shall with-
draw the approval of a nontherapeutic use in food- 
producing animals of a drug described in paragraph 
(1) on the date that is 2 years after the date of en-
actment of this subsection unless— 
‘‘(A) before the date that is 2 years after 
the date of the enactment of this subsection, 
the Secretary makes a final written determina-
tion that the holder of the approved application 
has demonstrated that there is a reasonable 
certainty of no harm to human health due to 
the development of antimicrobial resistance that 
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is attributable in whole or in part to the non-
therapeutic use of the drug; or 
‘‘(B) before the date specified in subpara-
graph (A), the Secretary makes a final written 
determination under this subsection, with re-
spect to a risk analysis of the drug conducted 
by the Secretary and other relevant informa-
tion, that there is a reasonable certainty of no 
harm to human health due to the development 
of antimicrobial resistance that is attributable 
in whole or in part to the nontherapeutic use of 
the drug. 
‘‘(3) EXEMPTIONS.—Except as provided in 
paragraph (5), if the Secretary grants an exemption 
under section 505(i) for a drug that is a medically 
important antimicrobial, the Secretary shall rescind 
each approval of a nontherapeutic use in a food-pro-
ducing animal of the medically important anti-
microbial, as of the date that is 2 years after the 
date on which the Secretary grants the exemption. 
‘‘(4) APPROVALS.—Except as provided in para-
graph (5), if an application for a drug that is a 
medically important antimicrobial is submitted to 
the Secretary under section 505(b), the Secretary 
shall rescind each approval of a nontherapeutic use 
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in a food-producing animal of the medically impor-
tant antimicrobial, as of the date that is 2 years 
after the date on which the application is submitted 
to the Secretary. 
‘‘(5) EXCEPTIONS.—Paragraph (3) or (4), as 
the case may be, shall not apply if— 
‘‘(A) before the date on which approval 
would be rescinded under that paragraph, the 
Secretary makes a final written determination 
that the holder of the application for the ap-
proved nontherapeutic use has demonstrated 
that there is a reasonable certainty of no harm 
to human health due to the development of 
antimicrobial resistance that is attributable in 
whole or in part to the nontherapeutic use in 
the food-producing animal of the medically im-
portant antimicrobial; or 
‘‘(B) before the date specified in subpara-
graph (A), the Secretary makes a final written 
determination, with respect to a risk analysis of 
the medically important antimicrobial conducted 
by the Secretary and any other relevant infor-
mation, that there is a reasonable certainty of 
no harm to human health due to the develop-
ment of antimicrobial resistance that is attrib-
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utable in whole or in part to the nontherapeutic 
use of the medically important antimicrobial. 
‘‘(6) DEFINITION.—In this subsection: 
‘‘(A) The term ‘medically important anti-
microbial’ means a drug that— 
‘‘(i) is intended for use in food-pro-
ducing animals; and 
‘‘(ii) is composed wholly or partly of— 
‘‘(I) any kind of penicillin, tetra-
cycline, 
macrolide, 
lincosamide, 
streptogramin, aminoglycoside, sul-
fonamide, or cephalosporin; or 
‘‘(II) a drug from an anti-
microbial class that is listed as ‘highly 
important’, ‘critically important’, or 
‘important’ by the World Health Or-
ganization in the latest edition of its 
publication entitled ‘Critically Impor-
tant Antimicrobials for Human Medi-
cine’ (or a successor publication). 
‘‘(B) The term ‘therapeutic use’, with re-
spect to a medically important antimicrobial, 
means the use of antimicrobials for the specific 
purpose of treating an animal with a docu-
mented disease or infection. Such term does not 
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include the continued use of such an anti-
microbial in the animal after the disease or in-
fection is resolved. 
‘‘(C) The term ‘nontherapeutic use’— 
‘‘(i) means administration of anti-
biotics to an animal through feed and 
water (or, in poultry hatcheries, through 
any means) for purposes (such as growth 
promotion, feed efficiency, weight gain, or 
disease prevention) other than therapeutic 
use or nonroutine disease control; and 
‘‘(ii) includes any repeated or regular 
pattern of use of medically important 
antimicrobials for purposes other than 
therapeutic use or nonroutine disease con-
trol. 
‘‘(D) The term ‘noncustomary situation’ 
does not include normal or standard practice 
and conditions on the premises that facilitate 
the transmission of disease. 
‘‘(E) The term ‘nonroutine disease control’ 
means the use of antibiotics on an animal that 
is not sick but where it can be shown that a 
particular disease or infection is present, or is 
likely to occur because of a specific, noncus-
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tomary situation, on the premises at the barn, 
house, pen, or other level at which the animal 
is kept.’’. 
SEC. 5. LIMITATIONS ON USE OF MEDICALLY IMPORTANT 
ANTIMICROBIALS FOR NONROUTINE DISEASE 
CONTROL. 
(a) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(ccc) The administration of a medically important 
antimicrobial to a food-producing animal for nonroutine 
disease control in violation of the requirements of section 
512A.’’. 
(b) REQUIREMENTS.—Chapter V of the Federal 
Food, Drug, and Cosmetic Act is amended by inserting 
after section 512 of such Act (21 U.S.C. 360b) the fol-
lowing: 
‘‘SEC. 512A. LIMITATIONS ON USE OF MEDICALLY IMPOR-
TANT ANTIMICROBIALS FOR NONROUTINE 
DISEASE CONTROL. 
‘‘(a) PROHIBITION.—It shall be unlawful to admin-
ister (including by means of animal feed) a medically im-
portant antimicrobial to a food-producing animal for non-
routine disease control unless— 
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‘‘(1) there is a significant risk that a disease or 
infection present on the premises will be transmitted 
to the food-producing animal; 
‘‘(2) the administration of the medically impor-
tant antimicrobial to the food-producing animal is 
necessary to prevent or reduce the risk of trans-
mission of the disease or infection described in para-
graph (1); 
‘‘(3) the medically important antimicrobial is 
administered to the food-producing animal for non-
routine disease control for the shortest duration pos-
sible to prevent or reduce the risk of transmission of 
the disease or infection described in paragraph (1) 
to the animal; and 
‘‘(4) the medically important antimicrobial is 
administered— 
‘‘(A) at a scale no greater than the barn, 
house, or pen level; and 
‘‘(B) to the fewest animals possible to pre-
vent or reduce the risk of transmission of the 
disease or infection described in paragraph (1). 
‘‘(b) DEFINITIONS.—In this section: 
‘‘(1) The term ‘food-producing animal’ means a 
food-producing animal intended for sale in interstate 
commerce. 
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‘‘(2) The terms ‘medically important anti-
microbial’ and ‘nonroutine disease control’ have the 
meanings given to such terms in section 512(q).’’. 
(c) APPLICABILITY.—The amendments made by this 
section apply beginning on the date that is 6 months after 
the date of the enactment of this Act. 
Æ 
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