I 

113TH CONGRESS 

1ST SESSION H. R. 820 

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 

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. 

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 2013’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds the following: 

8 (1) Antimicrobials are of critical importance to 

9 public health and to the American economy. 


jbell on DSK7SPTVN1PROD with BILLS
2 

•HR 820 IH

1 (2) Use of antimicrobials, whether in human 

2 medicine or in agriculture, contributes to the devel3 opment and spread of antimicrobial resistance. 

4 (3) Data from the Food and Drug Administra5 tion (FDA) indicate that approximately 80 percent 

6 of all antimicrobials sold in the United States, over 

7 29,000,000 pounds in 2009, were sold for use in 

8 food animals. 

9 (4) A study published in September, 2012, in 

10 Proceedings of the National Academy of Sciences of 

11 the United States of America found that even low 

12 doses of antimicrobials in animal feed for short peri13 ods of time increased the prevalence of the bacteria 

14 E. coli and the prevalence and diversity of anti15 microbial resistance genes in bacteria in pigs. 

16 (5) Public Law 110–316, the Animal Drug 

17 User Fee Amendments of 2008, requires producers 

18 of drugs used in food animals to provide specified in19 formation annually to the FDA on the sales and in20 dications for use of such drugs. 

21 (6) A September 2011 study by the Govern22 ment Accountability Office found that the data pro23 vided to the FDA under the Animal Drug User Fee 

24 Amendments Act of 2008 lacked sufficient details 

25 necessary to analyze trends in antimicrobial resistVerDate Mar 15 2010 00:36 Mar 01, 2013 Jkt 029200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H820.IH H820

jbell on DSK7SPTVN1PROD with BILLS
3 

•HR 820 IH

1 ance, such as information on actual drug use in spe2 cific food-producing animal species. 

3 SEC. 3. PURPOSE. 

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

5 Drug Administration and the public with better informa6 tion on the use of antimicrobial drugs in animals used for 

7 food to— 

8 (1) enable public health officials and scientists 

9 to better understand and interpret trends and vari10 ations in rates of microbial resistance to such anti11 microbial drugs; 

12 (2) improve the understanding of the relation13 ship between antimicrobial drug use in animals used 

14 for food and antimicrobial drug resistance in mi15 crobes in and on animals and humans; and 

16 (3) identify interventions to prevent and control 

17 such antimicrobial drug resistance. 

18 SEC. 4. ENHANCED REPORTING REQUIREMENTS. 

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

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

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

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

23 described in paragraph (1) that contains an anti24 microbial active ingredient, the sponsor of the drug 

25 shall submit an annual report to the Secretary on 


jbell on DSK7SPTVN1PROD with BILLS
4 

•HR 820 IH

1 the amount of each antimicrobial active ingredient in 

2 the drug that is sold or distributed for use in food3 producing animals, including information on any dis4 tributor-labeled product. 

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

6 specify the amount of each antimicrobial active in7 gredient— 

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

9 form; 

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

11 domestically and by quantities exported; and 

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

13 dosage form) the known or estimated amounts 

14 of the antimicrobial active ingredient sold or 

15 distributed for use in each food-producing ani16 mal for which the new animal drug is approved, 

17 including a description of the methods used to 

18 determine or estimate the amounts. 

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

20 case of animal feed in final formulation bearing or 

21 containing a new animal drug for which reporting is 

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

23 swine contractor, or feed lot operator who purchases, 

24 contracts, or manufactures such feed shall submit to 

25 the Secretary an annual report that specifies, by 


jbell on DSK7SPTVN1PROD with BILLS
5 

•HR 820 IH

1 food-producing animal for which the new animal 

2 drug is approved and, where applicable as deter3 mined by the Secretary, by production class of such 

4 animal— 

5 ‘‘(i) the amount of each antimicrobial ac6 tive ingredient contained per kilogram of each 

7 such feed sold or distributed for that animal 

8 and, where applicable, production class; 

9 ‘‘(ii) the quantity of such feed sold or dis10 tributed for that animal and, where applicable, 

11 production class; and 

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

13 under a veterinary feed directive— 

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

15 was sold or distributed and the quantities 

16 of such feed that were sold or distributed 

17 per each such indication; 

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

19 food-producing animal and, where applica20 ble, the production class to which the feed 

21 was intended; and 

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

23 the feed was intended to be provided to the 

24 animals and the dose of the active antiVerDate Mar 15 2010 00:36 Mar 01, 2013 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H820.IH H820

jbell on DSK7SPTVN1PROD with BILLS
6 

•HR 820 IH

1 microbial ingredient the animals were in2 tended to receive. 

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

4 live poultry dealer, swine contractor, or feed lot op5 erator if the total value of the live animals owned, 

6 purchased, sold, contracted for, or otherwise con7 trolled by the dealer, contractor, or operator, directly 

8 or through subsidiaries or affiliates, per year, does 

9 not exceed— 

10 ‘‘(I) $10,000,000; or 

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

12 specify through regulation. 

13 ‘‘(ii) The Secretary may specify through regula14 tion alternative reporting requirements, including via 

15 pilot programs or based on the results of pilot pro16 grams— 

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

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

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

20 provide public summaries of the reports; or 

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

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

23 summaries under paragraph (5), to understand 

24 the relationship between sales, distribution, and 

25 end-use practices with respect to feed conVerDate Mar 15 2010 00:36 Mar 01, 2013 Jkt 029200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H820.IH H820

jbell on DSK7SPTVN1PROD with BILLS
7 

•HR 820 IH

1 taining new animal drugs described in para2 graph (1) and antimicrobial resistance trends in 

3 microbes in animals, animal food products, and 

4 humans. 

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

6 shall— 

7 ‘‘(i) be submitted electronically not later 

8 than March 31 each year; 

9 ‘‘(ii) cover the period of the preceding cal10 endar year; 

11 ‘‘(iii) include separate information for each 

12 month of such calendar year; and 

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

14 may require. 

15 ‘‘(B) In specifying a format under subpara16 graph (A)(iv), the Secretary shall seek to ensure 

17 that such format enables the data reported to be in18 tegrated or otherwise easily associated and compared 

19 with data from other Federal databases containing 

20 data on— 

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

22 ‘‘(ii) rates of antimicrobial resistance in 

23 bacteria in and on animals, animal food prod24 ucts, and people. 


jbell on DSK7SPTVN1PROD with BILLS
8 

•HR 820 IH

1 ‘‘(C) The Secretary may share information re2 ported under paragraph (3) or (4) with the Anti3 microbial Resistance Task Force established under 

4 section 319E of the Public Health Service Act. 

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

6 the Secretary shall make publicly available sum7 maries of the information reported under paragraphs 

8 (3) and (4). 

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

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

11 ‘‘(I) report data by antimicrobial drug 

12 class; 

13 ‘‘(II) for each such antimicrobial drug 

14 class, specify— 

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

16 distributed per dosage form; 

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

18 distributed with labeled indications that 

19 fall within each of the following categories: 

20 growth promotion, feed efficiency, or other 

21 production purposes; disease prevention; 

22 disease control; and disease treatment; 

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

24 distributed per each of the following marVerDate Mar 15 2010 00:36 Mar 01, 2013 Jkt 029200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H820.IH H820

jbell on DSK7SPTVN1PROD with BILLS
9 

•HR 820 IH

1 keting categories: over-the-counter, pre2 scription, and veterinary feed directive; 

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

4 distributed per State of sale or distribu5 tion; and 

6 ‘‘(ee) the known or estimated quantity 

7 of drugs sold or distributed for each food8 producing animal and, where feasible, pro9 duction class of such animal; and 

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

11 under a veterinary food directive for which re12 porting is required under paragraph (4), in13 clude the information reported pursuant to sub14 clauses (I), (II), and (III) of paragraph 

15 (4)(A)(iii). 

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

17 fewer than 3 sponsors of approved new animal 

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

19 the Secretary shall for each such class— 

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

21 of the antimicrobial drugs within that class to 

22 human medicine, as determined by the Sec23 retary; and 

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

25 category, specify— 


jbell on DSK7SPTVN1PROD with BILLS
10 

•HR 820 IH

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

2 distributed per dosage form; 

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

4 distributed with labeled indications that 

5 fall within each of the following categories: 

6 growth promotion, feed efficiency, or other 

7 production purposes; disease prevention; 

8 disease control; and disease treatment; 

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

10 distributed per each of the following mar11 keting categories: over-the-counter, pre12 scription, and veterinary feed directive; and 

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

14 distributed per State of sale or distribu15 tion. 

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

17 Secretary shall report data in a manner consistent 

18 with protecting both national security and confiden19 tial business information. 

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

21 dealer’ and ‘swine contractor’ have the meanings 

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

23 Stockyards Act, 1921.’’. 

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

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


jbell on DSK7SPTVN1PROD with BILLS
11 

•HR 820 IH

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

2 Cosmetic Act (21 U.S.C. 360b(l)) (as amended by sub3 section (a)) that cover the period of calendar year 2014 

4 or any subsequent calendar year. The provisions of section 

5 512(l)(3) of such Act, as in effect the day before the date 

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

7 period of calendar year 2013. 

8 SEC. 5. ENHANCED COLLABORATION BETWEEN THE FOOD 

9 AND DRUG ADMINISTRATION AND THE DE10 PARTMENT OF AGRICULTURE. 

11 The Secretary of Health and Human Services, acting 

12 through the Commissioner of Food and Drugs, shall in13 crease collaboration and coordination with the Secretary 

14 of Agriculture to expand and coordinate the collection of 

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

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

17 animal species as agreed to by the Secretary of Health 

18 and Human Services and the Secretary of Agriculture, in19 cluding by providing information to the Secretary of Agri20 culture for use by— 

21 (1) the Animal and Plant Health Inspection 

22 Service to help inform its collection of data through 

23 the National Animal Health Monitoring System; and 


jbell on DSK7SPTVN1PROD with BILLS
12 

•HR 820 IH

1 (2) the Economic Research Service to help in2 form its collection of data through the Agricultural 

3 Resource Management Survey. 

4 SEC. 6. ACTION BY GOVERNMENT ACCOUNTABILITY OF5 FICE. 

6 (a) PUBLICATION OF FINAL GUIDANCE.—Not later 

7 than 180 days after the date of enactment of this Act, 

8 the Secretary of Health and Human Services shall publish 

9 a final version of draft guidance #213, entitled ‘‘New Ani10 mal Drugs and New Animal Drug Combination Products 

11 Administered in or on Medicated Feed or Drinking Water 

12 of Food-Producing Animals: Recommendations for Drug 

13 Sponsors for Voluntarily Aligning Product Use Conditions 

14 with GFI #209’’. 

15 (b) REPORT BY GAO.— 

16 (1) IN GENERAL.—Not later than 3 years after 

17 the publication of final guidance pursuant to sub18 section (a), the Comptroller General of the United 

19 States shall commence a study to evaluate— 

20 (A) the voluntary approach used by the 

21 Food and Drug Administration to eliminate in22 judicious use of antimicrobial drugs in food-pro23 ducing animals; and 


jbell on DSK7SPTVN1PROD with BILLS
13 

•HR 820 IH

1 (B) the effectiveness of the data collection 

2 activities conducted by the Food and Drug Ad3 ministration regarding antimicrobial resistance. 

4 (2) REPORT.—Not later than 1 year after com5 mencing the study required by paragraph (1), the 

6 Comptroller General of the United States shall sub7 mit to the Committee on Health, Education, Labor, 

8 and Pensions of the Senate and the Committee on 

9 Energy and Commerce of the House of Representa10 tives a report that describes the results of such 

11 study. 

Æ 


jbell on DSK7SPTVN1PROD with BILLS