I 
114TH CONGRESS 
1ST SESSION H. R. 1552 
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 23, 2015 
Ms. SLAUGHTER (for herself, Mr. BLUMENAUER, Mr. CARTWRIGHT, Ms. 
CLARKE of New York, Mr. CONNOLLY, Ms. DELAURO, Mr. DEUTCH, Ms. 
EDWARDS, Ms. ESHOO, Mr. FARR, Mr. LEVIN, Mr. LOWENTHAL, Mrs. 
CAROLYN B. MALONEY of New York, Ms. MOORE, Ms. PINGREE, Mr. 
RANGEL, Ms. SCHAKOWSKY, Mr. SCHIFF, Ms. SPEIER, Ms. TSONGAS, 
Mr. WELCH, and Mr. GRIJALVA) 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 2015’’. 
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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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