I 
115TH CONGRESS 
1ST SESSION H. R. 1587 
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 16, 2017 
Ms. SLAUGHTER (for herself, Ms. DELAURO, Mr. CICILLINE, Mr. CONNOLLY, 
Mr. DEFAZIO, Mr. DEUTCH, Mr. LANGEVIN, Mr. TED LIEU of Cali-
fornia, Mr. LOWENTHAL, Ms. MCCOLLUM, Mr. MOULTON, Mrs. NAPOLI-
TANO, Ms. NORTON, Ms. SPEIER, Ms. TSONGAS, Mr. YARMUTH, Mr. 
JEFFRIES, and Ms. SHEA-PORTER) 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 2017’’. 
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SEC. 2. FINDINGS. 
The Congress finds the following: 
(1) All uses of antibiotics, including for food- 
producing animals, have the potential to cause re-
sistance and contribute to the development of anti-
biotic-resistant bacterial infections in people. 
(2) In 1977, the Food and Drug Administra-
tion (FDA) concluded that feeding livestock low 
doses of antibiotics used in human disease treatment 
could promote the development of antibiotic resist-
ance in bacteria. However, the Food and Drug Ad-
ministration did not act in response to these find-
ings, despite laws requiring the agency to do so. 
(3) In 2012, the Food and Drug Administra-
tion Guidance for Industry #209 provided a sum-
mary of over 40 years of peer-reviewed scientific lit-
erature regarding use of antimicrobial drugs in live-
stock which reiterated that the use of antibiotics in 
animals contributes to the resistance in human 
pathogens and concludes that strategies for control-
ling antibiotic resistance, including limiting medi-
cally important antimicrobial drugs in food-pro-
ducing animals only to uses that are considered nec-
essary for assuring animal health are needed. 
(4) The 2014 President’s Council of Advisors 
on Science and Technology Report to the President 
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on Combating Antibiotic-Resistant Bacteria also 
concludes that substantial evidence exists that the 
use of antibiotics in food animals promotes the de-
velopment and spread of antibiotic resistance in bac-
teria that can spread to people and that it is clear 
that agricultural use of antibiotics can affect human 
health. 
(5) Recently published scientific studies have 
shown that food-producing animals, and animal pro-
duction facilities, are a source of antibiotic-resistant 
bacteria which have infected humans and present an 
increased risk of acquiring and antibiotics resistant 
infection. 
(6) Antibiotic resistance is a crisis which 
threatens public health, the economy, and national 
security. 
(7) In 2013, the Centers for Disease Control 
and Prevention estimated that antibiotic-resistant 
infections cause at least 2 million infections, 23,000 
deaths, 8 million additional hospital days, and $20 
to $35 billion in excess direct health care costs each 
year in the United States. 
(8) The 2014 World Health Organization re-
port, ‘‘Antimicrobial Resistance: Global Report on 
Surveillance 2014’’, concluded that antimicrobial re-
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sistance is a current reality and the problem is so 
serious that it threatens the achievements of modern 
medicine. 
(9) Without effective antibiotics— 
(A) common infections could become un-
treatable—even fatal; and 
(B) medical advances such as joint replace-
ments, Cesarean sections, organ transplants 
and chemotherapy could become nonviable. 
(10) 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, such as anthrax and smallpox, or to an event 
resulting in a large influx of hospitalized patients. 
(11) 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 
(C) therefore, 80 percent of antibacterial 
drugs disseminated in the United States in 
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2010 were sold for use on food animals, rather 
than being used for human health. 
(12) The ‘‘FDA Annual Summary Report on 
Antimicrobials Sold or Distributed in 2012 for Use 
in Food-Producing Animals’’ showed that the use of 
medically important antibiotics in food-producing 
animals increased 16 percent from 2009 to 2012. 
(13)(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. 
(14) A stated goal of FDA Guidance documents 
209 and 213 is a reduction in the overall consump-
tion of antibiotics. The FDA policy continues to 
allow the use of antibiotics for routine disease pre-
vention without requiring evidence of the presence of 
a specific disease or requiring the mitigation of con-
ditions which elevate disease risk. 
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(15) There is inadequate distinction between 
usage for disease prevention and production pur-
poses, such as growth promotion, on FDA approved 
drug labels. A 2014 analysis of the approved animal 
drugs affected by Guidance 213 by the Pew Chari-
table Trusts found that numerous approved drug la-
bels contained overlapping indications for growth- 
promotion and disease prevention. 
(16) The European Union (EU) banned the use 
of antibiotics for growth promotion in 2006, a full 
decade before the FDA’s voluntary approach will go 
into effect. 
(17) Since the EU ban, antibiotic usage has de-
creased without affecting livestock production. 
(18) 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. 
(19) The experience in the Netherlands has 
shown that during the phaseout use indications for 
growth promotion were completely supplanted by 
disease prevention. Total antibiotic consumption re-
mained constant. After the implementation of man-
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datory reduction targets and improved surveillance 
of usage practices antibiotic consumption declined 
ahead of target without impacting production levels. 
(20) In 2009, the Congressional Research Serv-
ice concluded that without restrictions on the use of 
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. 
(21) The American Medical Association, the In-
fectious Disease Society of America, the American 
Public Health Association, the National Association 
of County and City Health Officials, and the Na-
tional Sustainable Agriculture Coalition are among 
the over 400 organizations representing health, con-
sumer, agricultural, environmental, humane, and 
other interests that have supported enactment of 
legislation to phaseout 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. 
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SEC. 4. PROOF OF SAFETY OF MEDICALLY IMPORTANT 
ANTIMICROBIALS. 
(a) 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) 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 
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portant antimicrobial to a food-producing animal for non-
routine disease control unless— 
‘‘(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: 
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