I 
114TH CONGRESS 
1ST SESSION H. R. 2459 
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 
MAY 19, 2015 
Ms. SLAUGHTER (for herself, Mr. TED LIEU of California, Mr. RANGEL, and 
Ms. SCHAKOWSKY) 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 2015’’. 
SEC. 2. PURPOSE. 
The purpose of this Act is to provide the Food and 
Drug Administration and the public with better informa-
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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. 3. 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 
the amount of each antimicrobial active ingredient in 
the drug that is sold or distributed for use in food- 
producing animals, including information on any dis-
tributor-labeled product. 
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‘‘(B) Each report under this paragraph shall 
specify the amount of each antimicrobial active in-
gredient— 
‘‘(i) by container size, strength, and dosage 
form; 
‘‘(ii) by quantities distributed to each State 
domestically and by quantities exported; and 
‘‘(iii) by dosage form, including (for each 
dosage form) the known or estimated amounts 
of the antimicrobial active ingredient sold or 
distributed for use in each food-producing ani-
mal for which the new animal drug is approved, 
including a description of the methods used to 
determine or estimate the amounts. 
‘‘(4)(A) Subject to subparagraph (B), in the 
case of animal feed in final formulation bearing or 
containing a new animal drug for which reporting is 
required under paragraph (3), a live poultry dealer, 
swine contractor, or feed lot operator who purchases, 
contracts, or manufactures such feed shall submit to 
the Secretary an annual report that specifies, by 
food-producing animal for which the new animal 
drug is approved and, where applicable as deter-
mined by the Secretary, by production class of such 
animal— 
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‘‘(i) the amount of each antimicrobial ac-
tive ingredient contained per kilogram of each 
such feed sold or distributed for that animal 
and, where applicable, production class; 
‘‘(ii) the quantity of such feed sold or dis-
tributed for that animal and, where applicable, 
production class; and 
‘‘(iii) for each such feed sold or distributed 
under a veterinary feed directive— 
‘‘(I) the indications for which the feed 
was sold or distributed and the quantities 
of such feed that were sold or distributed 
per each such indication; 
‘‘(II) the number of individuals of the 
food-producing animal and, where applica-
ble, the production class to which the feed 
was intended; and 
‘‘(III) the length of time over which 
the feed was intended to be provided to the 
animals and the dose of the active anti-
microbial ingredient the animals were in-
tended to receive. 
‘‘(B)(i) Subparagraph (A) does not apply to a 
live poultry dealer, swine contractor, or feed lot op-
erator if the total value of the live animals owned, 
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purchased, sold, contracted for, or otherwise con-
trolled by the dealer, contractor, or operator, directly 
or through subsidiaries or affiliates, per year, does 
not exceed— 
‘‘(I) $10,000,000; or 
‘‘(II) such other sum as the Secretary may 
specify through regulation. 
‘‘(ii) The Secretary may specify through regula-
tion alternative reporting requirements, including via 
pilot programs or based on the results of pilot pro-
grams— 
‘‘(I) to improve the accuracy of reports; 
‘‘(II) to lessen the burden of reporting; 
‘‘(III) to facilitate the Secretary’s ability to 
provide public summaries of the reports; or 
‘‘(IV) to improve the Secretary’s ability to 
use the reports, or the public’s ability to use the 
summaries under paragraph (5), to understand 
the relationship between sales, distribution, and 
end-use practices with respect to feed con-
taining new animal drugs described in para-
graph (1) and antimicrobial resistance trends in 
microbes in animals, animal food products, and 
humans. 
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‘‘(5)(A) Each report under paragraph (3) or (4) 
shall— 
‘‘(i) be submitted electronically not later 
than March 31 each year; 
‘‘(ii) cover the period of the preceding cal-
endar year; 
‘‘(iii) include separate information for each 
month of such calendar year; and 
‘‘(iv) be in such format as the Secretary 
may require. 
‘‘(B) In specifying a format under subpara-
graph (A)(iv), the Secretary shall seek to ensure 
that such format enables the data reported to be in-
tegrated or otherwise easily associated and compared 
with data from other Federal databases containing 
data on— 
‘‘(i) drug sales for human use; and 
‘‘(ii) rates of antimicrobial resistance in 
bacteria in and on animals, animal food prod-
ucts, and people. 
‘‘(C) The Secretary may share information re-
ported under paragraph (3) or (4) with the Anti-
microbial Resistance Task Force established under 
section 319E of the Public Health Service Act. 
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‘‘(D)(i) Not later than November 30 each year, 
the Secretary shall make publicly available sum-
maries of the information reported under paragraphs 
(3) and (4). 
‘‘(ii) For each summary under clause (i), except 
as provided in clause (iii), the Secretary shall— 
‘‘(I) report data by antimicrobial drug 
class; 
‘‘(II) for each such antimicrobial drug 
class, specify— 
‘‘(aa) the quantity of drugs sold or 
distributed per dosage form; 
‘‘(bb) the percentage of drugs sold or 
distributed with labeled indications that 
fall within each of the following categories: 
growth promotion, feed efficiency, or other 
production purposes; disease prevention; 
disease control; and disease treatment; 
‘‘(cc) the quantity of drugs sold or 
distributed per each of the following mar-
keting categories: over-the-counter, pre-
scription, and veterinary feed directive; 
‘‘(dd) the quantity of drugs sold or 
distributed per State of sale or distribu-
tion; and 
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‘‘(ee) the known or estimated quantity 
of drugs sold or distributed for each food- 
producing animal and, where feasible, pro-
duction class of such animal; and 
‘‘(III) for each feed sold or distributed 
under a veterinary food directive for which re-
porting is required under paragraph (4), in-
clude the information reported pursuant to sub-
clauses (I), (II), and (III) of paragraph 
(4)(A)(iii). 
‘‘(iii) For any antimicrobial drug class with 
fewer than 3 sponsors of approved new animal 
drugs, instead of reporting data under clause (ii), 
the Secretary shall for each such class— 
‘‘(I) report data by category of importance 
of the antimicrobial drugs within that class to 
human medicine, as determined by the Sec-
retary; and 
‘‘(II) to the extent feasible for each such 
category, specify— 
‘‘(aa) the quantity of drugs sold or 
distributed per dosage form; 
‘‘(bb) the percentage of drugs sold or 
distributed with labeled indications that 
fall within each of the following categories: 
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growth promotion, feed efficiency, or other 
production purposes; disease prevention; 
disease control; and disease treatment; 
‘‘(cc) the quantity of drugs sold or 
distributed per each of the following mar-
keting categories: over-the-counter, pre-
scription, and veterinary feed directive; and 
‘‘(dd) the quantity of drugs sold or 
distributed per State of sale or distribu-
tion. 
‘‘(iv) In carrying out this subparagraph, the 
Secretary shall report data in a manner consistent 
with protecting both national security and confiden-
tial business information. 
‘‘(E) In this paragraph, the terms ‘live poultry 
dealer’ and ‘swine contractor’ have the meanings 
given to those terms in section 2 of the Packers and 
Stockyards Act, 1921.’’. 
(b) RULE OF APPLICATION.—The amendment made 
by this section applies to reports under paragraphs (3) 
and (4) of section 512(l) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(l)) (as amended by sub-
section (a)) that cover the period of the first calendar year 
beginning after the date of enactment of this Act or any 
subsequent calendar year. The provisions of section 
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512(l)(3) of such Act, as in effect the day before the date 
of enactment of this Act, apply to reports that cover the 
period of any calendar year beginning before the calendar 
years described in the preceding sentence. 
SEC. 4. ENHANCED COLLABORATION BETWEEN THE FOOD 
AND DRUG ADMINISTRATION AND THE DE-
PARTMENT OF AGRICULTURE. 
The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall in-
crease collaboration and coordination with the Secretary 
of Agriculture to expand and coordinate the collection of 
data on the use of antimicrobial drugs in or on cattle, 
swine, chickens, turkeys, and such other food-producing 
animal species as agreed to by the Secretary of Health 
and Human Services and the Secretary of Agriculture, in-
cluding by providing information to the Secretary of Agri-
culture for use by— 
(1) the Animal and Plant Health Inspection 
Service to help inform its collection of data through 
the National Animal Health Monitoring System; and 
(2) the Economic Research Service to help in-
form its collection of data through the Agricultural 
Resource Management Survey. 
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SEC. 5. REPORT BY GAO. 
(a) IN GENERAL.—Not later than 3 years after the 
date of enactment of this Act, the Comptroller General 
of the United States shall commence a study to evaluate— 
(1) the voluntary approach used by the Food 
and Drug Administration to eliminate injudicious 
use of antimicrobial drugs in food-producing ani-
mals; and 
(2) the effectiveness of the data collection ac-
tivities conducted by the Food and Drug Adminis-
tration regarding antimicrobial resistance. 
(b) REPORT.—Not later than 1 year after com-
mencing the study required by subsection (a), the Comp-
troller General of the United States shall submit to the 
Committee on Health, Education, Labor, and Pensions of 
the Senate and the Committee on Energy and Commerce 
of the House of Representatives a report that describes 
the results of such study. 
Æ 
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