[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 820 Introduced in House (IH)]

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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Delivering Antimicrobial 
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.
            (2) Use of antimicrobials, whether in human medicine or in 
        agriculture, contributes to the development and spread of 
        antimicrobial resistance.
            (3) Data from the Food and Drug Administration (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 periods of time increased the prevalence of the 
        bacteria E. coli and the prevalence and diversity of 
        antimicrobial 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 information annually to the FDA on the sales 
        and indications for use of such drugs.
            (6) A September 2011 study by the Government Accountability 
        Office found that the data provided to the FDA under the Animal 
        Drug User Fee Amendments Act of 2008 lacked sufficient details 
        necessary to analyze trends in antimicrobial resistance, such 
        as information on actual drug use in specific 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 information 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 variations in rates of 
        microbial resistance to such antimicrobial drugs;
            (2) improve the understanding of the relationship between 
        antimicrobial drug use in animals used for food and 
        antimicrobial drug resistance in microbes 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 antimicrobial 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 distributor-
        labeled product.
            ``(B) Each report under this paragraph shall specify the 
        amount of each antimicrobial active ingredient--
                    ``(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 animal 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 determined by the Secretary, by production 
        class of such animal--
                    ``(i) the amount of each antimicrobial active 
                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 
                distributed 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 applicable, 
                        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 antimicrobial 
                        ingredient the animals were intended to 
                        receive.
            ``(B)(i) Subparagraph (A) does not apply to a live poultry 
        dealer, swine contractor, or feed lot operator if the total 
        value of the live animals owned, purchased, sold, contracted 
        for, or otherwise controlled 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 regulation 
        alternative reporting requirements, including via pilot 
        programs or based on the results of pilot programs--
                    ``(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 containing new animal 
                drugs described in paragraph (1) and antimicrobial 
                resistance trends in microbes in animals, animal food 
                products, and humans.
            ``(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 calendar 
                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 subparagraph (A)(iv), 
        the Secretary shall seek to ensure that such format enables the 
        data reported to be integrated 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 products, and 
                people.
            ``(C) The Secretary may share information reported under 
        paragraph (3) or (4) with the Antimicrobial Resistance Task 
        Force established under section 319E of the Public Health 
        Service Act.
            ``(D)(i) Not later than November 30 each year, the 
        Secretary shall make publicly available summaries 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 marketing 
                        categories: over-the-counter, prescription, and 
                        veterinary feed directive;
                            ``(dd) the quantity of drugs sold or 
                        distributed per State of sale or distribution; 
                        and
                            ``(ee) the known or estimated quantity of 
                        drugs sold or distributed for each food-
                        producing animal and, where feasible, 
                        production class of such animal; and
                    ``(III) for each feed sold or distributed under a 
                veterinary food directive for which reporting is 
                required under paragraph (4), include the information 
                reported pursuant to subclauses (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 Secretary; 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: 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 marketing 
                        categories: over-the-counter, prescription, and 
                        veterinary feed directive; and
                            ``(dd) the quantity of drugs sold or 
                        distributed per State of sale or distribution.
            ``(iv) In carrying out this subparagraph, the Secretary 
        shall report data in a manner consistent with protecting both 
        national security and confidential 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 subsection (a)) that cover the period of calendar year 2014 
or any subsequent calendar year. The provisions of section 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 calendar year 2013.

SEC. 5. ENHANCED COLLABORATION BETWEEN THE FOOD AND DRUG ADMINISTRATION 
              AND THE DEPARTMENT OF AGRICULTURE.

    The Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall increase 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, including by providing information to the 
Secretary of Agriculture 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 inform its 
        collection of data through the Agricultural Resource Management 
        Survey.

SEC. 6. ACTION BY GOVERNMENT ACCOUNTABILITY OFFICE.

    (a) Publication of Final Guidance.--Not later than 180 days after 
the date of enactment of this Act, the Secretary of Health and Human 
Services shall publish a final version of draft guidance #213, entitled 
``New Animal Drugs and New Animal Drug Combination Products 
Administered in or on Medicated Feed or Drinking Water of Food-
Producing Animals: Recommendations for Drug Sponsors for Voluntarily 
Aligning Product Use Conditions with GFI #209''.
    (b) Report by GAO.--
            (1) In general.--Not later than 3 years after the 
        publication of final guidance pursuant to subsection (a), the 
        Comptroller General of the United States shall commence a study 
        to evaluate--
                    (A) the voluntary approach used by the Food and 
                Drug Administration to eliminate injudicious use of 
                antimicrobial drugs in food-producing animals; and
                    (B) the effectiveness of the data collection 
                activities conducted by the Food and Drug 
                Administration regarding antimicrobial resistance.
            (2) Report.--Not later than 1 year after commencing the 
        study required by paragraph (1), the Comptroller 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.
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