I 
113TH CONGRESS 
1ST SESSION 
H. R. 820 
To amend the Federal Food, Drug, and Cosmetic Act to enhance the report-
ing requirements pertaining to use of antimicrobial drugs in food animals. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 26, 2013 
Mr. WAXMAN (for himself and 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 
enhance the reporting requirements pertaining to use 
of antimicrobial drugs in food animals. 
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 ‘‘Delivering Anti-
microbial Transparency in Animals Act of 2013’’. 
SEC. 2. FINDINGS. 
The Congress finds the following: 
(1) Antimicrobials are of critical importance to 
public health and to the American economy. 
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(2) Use of antimicrobials, whether in human 
medicine or in agriculture, contributes to the devel-
opment and spread of antimicrobial resistance. 
(3) Data from the Food and Drug Administra-
tion (FDA) indicate that approximately 80 percent 
of all antimicrobials sold in the United States, over 
29,000,000 pounds in 2009, were sold for use in 
food animals. 
(4) A study published in September, 2012, in 
Proceedings of the National Academy of Sciences of 
the United States of America found that even low 
doses of antimicrobials in animal feed for short peri-
ods of time increased the prevalence of the bacteria 
E. coli and the prevalence and diversity of anti-
microbial resistance genes in bacteria in pigs. 
(5) Public Law 110–316, the Animal Drug 
User Fee Amendments of 2008, requires producers 
of drugs used in food animals to provide specified in-
formation annually to the FDA on the sales and in-
dications for use of such drugs. 
(6) A September 2011 study by the Govern-
ment Accountability Office found that the data pro-
vided to the FDA under the Animal Drug User Fee 
Amendments Act of 2008 lacked sufficient details 
necessary to analyze trends in antimicrobial resist-
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ance, such as information on actual drug use in spe-
cific food-producing animal species. 
SEC. 3. PURPOSE. 
The purpose of this Act is to provide the Food and 
Drug Administration and the public with better informa-
tion on the use of antimicrobial drugs in animals used for 
food to— 
(1) enable public health officials and scientists 
to better understand and interpret trends and vari-
ations in rates of microbial resistance to such anti-
microbial drugs; 
(2) improve the understanding of the relation-
ship between antimicrobial drug use in animals used 
for food and antimicrobial drug resistance in mi-
crobes in and on animals and humans; and 
(3) identify interventions to prevent and control 
such antimicrobial drug resistance. 
SEC. 4. ENHANCED REPORTING REQUIREMENTS. 
(a) REPORTS.—Section 512(l) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b(l)) is amended 
by striking paragraph (3) and inserting the following: 
‘‘(3)(A) In the case of each new animal drug 
described in paragraph (1) that contains an anti-
microbial active ingredient, the sponsor of the drug 
shall submit an annual report to the Secretary on 
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