I 

114TH CONGRESS 

1ST SESSION H. R. 2459 

To amend the Federal Food, Drug, and Cosmetic Act to enhance the reporting 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Delivering Anti5 microbial Transparency in Animals Act of 2015’’. 

6 SEC. 2. PURPOSE. 

7 The purpose of this Act is to provide the Food and 

8 Drug Administration and the public with better informaVerDate Sep 11 2014 01:26 May 28, 2015 Jkt 049200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2459.IH H2459

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1 tion on the use of antimicrobial drugs in animals used for 

2 food to— 

3 (1) enable public health officials and scientists 

4 to better understand and interpret trends and vari5 ations in rates of microbial resistance to such anti6 microbial drugs; 

7 (2) improve the understanding of the relation8 ship between antimicrobial drug use in animals used 

9 for food and antimicrobial drug resistance in mi10 crobes in and on animals and humans; and 

11 (3) identify interventions to prevent and control 

12 such antimicrobial drug resistance. 

13 SEC. 3. ENHANCED REPORTING REQUIREMENTS. 

14 (a) REPORTS.—Section 512(l) of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 360b(l)) is amended 

16 by striking paragraph (3) and inserting the following: 

17 ‘‘(3)(A) In the case of each new animal drug 

18 described in paragraph (1) that contains an anti19 microbial active ingredient, the sponsor of the drug 

20 shall submit an annual report to the Secretary on 

21 the amount of each antimicrobial active ingredient in 

22 the drug that is sold or distributed for use in food23 producing animals, including information on any dis24 tributor-labeled product. 


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1 ‘‘(B) Each report under this paragraph shall 

2 specify the amount of each antimicrobial active in3 gredient— 

4 ‘‘(i) by container size, strength, and dosage 

5 form; 

6 ‘‘(ii) by quantities distributed to each State 

7 domestically and by quantities exported; and 

8 ‘‘(iii) by dosage form, including (for each 

9 dosage form) the known or estimated amounts 

10 of the antimicrobial active ingredient sold or 

11 distributed for use in each food-producing ani12 mal for which the new animal drug is approved, 

13 including a description of the methods used to 

14 determine or estimate the amounts. 

15 ‘‘(4)(A) Subject to subparagraph (B), in the 

16 case of animal feed in final formulation bearing or 

17 containing a new animal drug for which reporting is 

18 required under paragraph (3), a live poultry dealer, 

19 swine contractor, or feed lot operator who purchases, 

20 contracts, or manufactures such feed shall submit to 

21 the Secretary an annual report that specifies, by 

22 food-producing animal for which the new animal 

23 drug is approved and, where applicable as deter24 mined by the Secretary, by production class of such 

25 animal— 


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1 ‘‘(i) the amount of each antimicrobial ac2 tive ingredient contained per kilogram of each 

3 such feed sold or distributed for that animal 

4 and, where applicable, production class; 

5 ‘‘(ii) the quantity of such feed sold or dis6 tributed for that animal and, where applicable, 

7 production class; and 

8 ‘‘(iii) for each such feed sold or distributed 

9 under a veterinary feed directive— 

10 ‘‘(I) the indications for which the feed 

11 was sold or distributed and the quantities 

12 of such feed that were sold or distributed 

13 per each such indication; 

14 ‘‘(II) the number of individuals of the 

15 food-producing animal and, where applica16 ble, the production class to which the feed 

17 was intended; and 

18 ‘‘(III) the length of time over which 

19 the feed was intended to be provided to the 

20 animals and the dose of the active anti21 microbial ingredient the animals were in22 tended to receive. 

23 ‘‘(B)(i) Subparagraph (A) does not apply to a 

24 live poultry dealer, swine contractor, or feed lot op25 erator if the total value of the live animals owned, 


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1 purchased, sold, contracted for, or otherwise con2 trolled by the dealer, contractor, or operator, directly 

3 or through subsidiaries or affiliates, per year, does 

4 not exceed— 

5 ‘‘(I) $10,000,000; or 

6 ‘‘(II) such other sum as the Secretary may 

7 specify through regulation. 

8 ‘‘(ii) The Secretary may specify through regula9 tion alternative reporting requirements, including via 

10 pilot programs or based on the results of pilot pro11 grams— 

12 ‘‘(I) to improve the accuracy of reports; 

13 ‘‘(II) to lessen the burden of reporting; 

14 ‘‘(III) to facilitate the Secretary’s ability to 

15 provide public summaries of the reports; or 

16 ‘‘(IV) to improve the Secretary’s ability to 

17 use the reports, or the public’s ability to use the 

18 summaries under paragraph (5), to understand 

19 the relationship between sales, distribution, and 

20 end-use practices with respect to feed con21 taining new animal drugs described in para22 graph (1) and antimicrobial resistance trends in 

23 microbes in animals, animal food products, and 

24 humans. 


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1 ‘‘(5)(A) Each report under paragraph (3) or (4) 

2 shall— 

3 ‘‘(i) be submitted electronically not later 

4 than March 31 each year; 

5 ‘‘(ii) cover the period of the preceding cal6 endar year; 

7 ‘‘(iii) include separate information for each 

8 month of such calendar year; and 

9 ‘‘(iv) be in such format as the Secretary 

10 may require. 

11 ‘‘(B) In specifying a format under subpara12 graph (A)(iv), the Secretary shall seek to ensure 

13 that such format enables the data reported to be in14 tegrated or otherwise easily associated and compared 

15 with data from other Federal databases containing 

16 data on— 

17 ‘‘(i) drug sales for human use; and 

18 ‘‘(ii) rates of antimicrobial resistance in 

19 bacteria in and on animals, animal food prod20 ucts, and people. 

21 ‘‘(C) The Secretary may share information re22 ported under paragraph (3) or (4) with the Anti23 microbial Resistance Task Force established under 

24 section 319E of the Public Health Service Act. 


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1 ‘‘(D)(i) Not later than November 30 each year, 

2 the Secretary shall make publicly available sum3 maries of the information reported under paragraphs 

4 (3) and (4). 

5 ‘‘(ii) For each summary under clause (i), except 

6 as provided in clause (iii), the Secretary shall— 

7 ‘‘(I) report data by antimicrobial drug 

8 class; 

9 ‘‘(II) for each such antimicrobial drug 

10 class, specify— 

11 ‘‘(aa) the quantity of drugs sold or 

12 distributed per dosage form; 

13 ‘‘(bb) the percentage of drugs sold or 

14 distributed with labeled indications that 

15 fall within each of the following categories: 

16 growth promotion, feed efficiency, or other 

17 production purposes; disease prevention; 

18 disease control; and disease treatment; 

19 ‘‘(cc) the quantity of drugs sold or 

20 distributed per each of the following mar21 keting categories: over-the-counter, pre22 scription, and veterinary feed directive; 

23 ‘‘(dd) the quantity of drugs sold or 

24 distributed per State of sale or distribu25 tion; and 


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1 ‘‘(ee) the known or estimated quantity 

2 of drugs sold or distributed for each food3 producing animal and, where feasible, pro4 duction class of such animal; and 

5 ‘‘(III) for each feed sold or distributed 

6 under a veterinary food directive for which re7 porting is required under paragraph (4), in8 clude the information reported pursuant to sub9 clauses (I), (II), and (III) of paragraph 

10 (4)(A)(iii). 

11 ‘‘(iii) For any antimicrobial drug class with 

12 fewer than 3 sponsors of approved new animal 

13 drugs, instead of reporting data under clause (ii), 

14 the Secretary shall for each such class— 

15 ‘‘(I) report data by category of importance 

16 of the antimicrobial drugs within that class to 

17 human medicine, as determined by the Sec18 retary; and 

19 ‘‘(II) to the extent feasible for each such 

20 category, specify— 

21 ‘‘(aa) the quantity of drugs sold or 

22 distributed per dosage form; 

23 ‘‘(bb) the percentage of drugs sold or 

24 distributed with labeled indications that 

25 fall within each of the following categories: 


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1 growth promotion, feed efficiency, or other 

2 production purposes; disease prevention; 

3 disease control; and disease treatment; 

4 ‘‘(cc) the quantity of drugs sold or 

5 distributed per each of the following mar6 keting categories: over-the-counter, pre7 scription, and veterinary feed directive; and 

8 ‘‘(dd) the quantity of drugs sold or 

9 distributed per State of sale or distribu10 tion. 

11 ‘‘(iv) In carrying out this subparagraph, the 

12 Secretary shall report data in a manner consistent 

13 with protecting both national security and confiden14 tial business information. 

15 ‘‘(E) In this paragraph, the terms ‘live poultry 

16 dealer’ and ‘swine contractor’ have the meanings 

17 given to those terms in section 2 of the Packers and 

18 Stockyards Act, 1921.’’. 

19 (b) RULE OF APPLICATION.—The amendment made 

20 by this section applies to reports under paragraphs (3) 

21 and (4) of section 512(l) of the Federal Food, Drug, and 

22 Cosmetic Act (21 U.S.C. 360b(l)) (as amended by sub23 section (a)) that cover the period of the first calendar year 

24 beginning after the date of enactment of this Act or any 

25 subsequent calendar year. The provisions of section 


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1 512(l)(3) of such Act, as in effect the day before the date 

2 of enactment of this Act, apply to reports that cover the 

3 period of any calendar year beginning before the calendar 

4 years described in the preceding sentence. 

5 SEC. 4. ENHANCED COLLABORATION BETWEEN THE FOOD 

6 AND DRUG ADMINISTRATION AND THE DE7 PARTMENT OF AGRICULTURE. 

8 The Secretary of Health and Human Services, acting 

9 through the Commissioner of Food and Drugs, shall in10 crease collaboration and coordination with the Secretary 

11 of Agriculture to expand and coordinate the collection of 

12 data on the use of antimicrobial drugs in or on cattle, 

13 swine, chickens, turkeys, and such other food-producing 

14 animal species as agreed to by the Secretary of Health 

15 and Human Services and the Secretary of Agriculture, in16 cluding by providing information to the Secretary of Agri17 culture for use by— 

18 (1) the Animal and Plant Health Inspection 

19 Service to help inform its collection of data through 

20 the National Animal Health Monitoring System; and 

21 (2) the Economic Research Service to help in22 form its collection of data through the Agricultural 

23 Resource Management Survey. 


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1 SEC. 5. REPORT BY GAO. 

2 (a) IN GENERAL.—Not later than 3 years after the 

3 date of enactment of this Act, the Comptroller General 

4 of the United States shall commence a study to evaluate— 

5 (1) the voluntary approach used by the Food 

6 and Drug Administration to eliminate injudicious 

7 use of antimicrobial drugs in food-producing ani8 mals; and 

9 (2) the effectiveness of the data collection ac10 tivities conducted by the Food and Drug Adminis11 tration regarding antimicrobial resistance. 

12 (b) REPORT.—Not later than 1 year after com13 mencing the study required by subsection (a), the Comp14 troller General of the United States shall submit to the 

15 Committee on Health, Education, Labor, and Pensions of 

16 the Senate and the Committee on Energy and Commerce 

17 of the House of Representatives a report that describes 

18 the results of such study. 

Æ 


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