The opinions expressed herein are our own and do not necessarily reflect the views of The Johns Hopkins University.

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1 Page 1 of 5 Johns Hopkins Center for a Livable Future 615 North Wolfe Street, W7010 Baltimore, MD July 12, 2012 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm Rockville, MD The opinions expressed herein are our own and do not necessarily reflect the views of The Johns Hopkins University. RE: Veterinary Feed Directive; Draft Text for Proposed Regulation (Docket No. FDA-2010-N-0155) To Whom It May Concern: Thank you for the opportunity to comment on the draft text for a proposed regulation (herein, Draft Text ) to amend the veterinary feed directive (VFD) regulation 21 CFR Part 558. The Johns Hopkins Center for a Livable Future is an academic research and education center at the Bloomberg School of Public Health that investigates the interconnections among food systems, public health, and the environment. CLF has conducted and supported numerous studies of antimicrobial use in food animal production and antimicrobial resistance. As public health scientists and advocates, we believe it is imperative that antimicrobials be used responsibly in food animal production to slow the development of antimicrobial resistance that has emerged as a major threat to human and animal health. Recommendation #1: To ensure that veterinary oversight of the use of antimicrobial drugs in food animal production is meaningful and to help ensure that these drugs are used responsibly, the Food and Drug Administration (FDA) should not remove the requirement at 558.3(b)(7) that a VFD only be issued in the context of a veterinary-client-patient (VCP) relationship. The importance of meaningful veterinary oversight to assuring that antimicrobial drugs are used responsibly and to minimizing selection for antimicrobial resistance has been demonstrated. For example, studies have found that colonization with the veterinary pathogen methicillin-resistant Staphylococcus pseudintermedius (MRSP) was significantly higher in dogs raised in kennels where antimicrobials were administered without prescription than in similar kennels where antimicrobials were only used as prescribed. 1,2 The current version of the Draft Text would weaken the essential role of 1 Rota A, Milani C, Corro M, Drigo I, Borjesson S. Misuse of antimicrobials and selection of methicillin-resistant Staphylococcus pseudintermedius strains in breeding kennels: genetic characterization of bacteria after a two-year interval. Reproduction in Domestic Animals. 2012;doi: /j x. 2 Rota A, Milani C, Drigo I, Drigo M, Corro M. Isolation of methicillin-resistant Staphylococcus pseudintermedius from breeding dogs. Theriogenology. 2011;75:

2 Page 2 of 5 veterinarians in clinical decision-making concerning the use of antimicrobials by removing the requirement that a VFD be issued only in the context of a VCP relationship. Under 21 CFR 530.3(i), the establishment of a VCP relationship requires, among other things, sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s) and that the practicing veterinarian is readily available for follow up in case of adverse reactions or failure of the regimen of therapy. The latter requirement is only met when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept. In contrast, the Draft Text would permit a veterinarian to issue a VFD outside of a VCP relationship, requiring only that the order be issued by a licensed veterinarian in the course of the veterinarian s professional practice and for use in animals under his or her supervision or oversight in the course of his or her professional practice, and in accordance with all applicable veterinary licensing and practice requirements (Draft Text, p ). CLF agrees that a licensed veterinarian may use antimicrobials responsibly for disease treatment and control, e.g. through active, on-farm surveillance for bacterial pathogens and laboratory identification of bacterial antimicrobial resistance patterns to help guide antimicrobial selection. The requirements of a VCP relationship, e.g., examination of the animal(s) and visits to the premises where the animal(s) are kept, are inherent to this approach to antimicrobial use. By removing the requirement of a VCP relationship from the VFD regulation, the Draft Text could undermine responsible use of antimicrobials in food animal production. We agree that the shortage of veterinarians in food animal practice may limit options for small and remote producers. Because of the importance of veterinary oversight in ensuring that antimicrobials are used responsibly, the veterinary and public health implications of any changes to veterinary oversight requirements should be rigorously and transparently evaluated before a proposed rule is published. For example, FDA should conduct an experimental study comparing changes in antimicrobial use and rates of resistance under the current and proposed veterinary oversight requirements. This evaluation should be subject to peer review and data supporting it should be published for independent analysis. We would be willing to work with FDA and other stakeholders to refine and evaluate VCP criteria for VFD and prescription products. Recommendation #2: FDA should use requirements currently contained in the VFD regulation to develop a systematic and comprehensive in-feed antimicrobial use monitoring system. As the marketing statuses of all antimicrobial new animal drugs approved for use in feed are changed under Guidance for Industry (GFI) #213 to require a VFD for their distribution and use, all legal use of antimicrobial drugs in feed will be recorded as part of recordkeeping requirements contained in the VFD regulation. Because VFD records must be copied and distributed to involved parties 3 and made available to FDA for inspection and copying, 4 it will be feasible to collect detailed data on all antimicrobial use in 3 21 CFR 558.6(b) CFR 558.6(c)(2).

3 Page 3 of 5 feed for each site where food animals are produced and to release aggregated use data to the public. At a minimum, the aggregated data should include, for each zip code where antimicrobial use in food animal production is reported, the quantities of each antimicrobial class used, both in total and broken down by target animal species and indication for use. The public data should be reported by month. The systematic collection of antimicrobial in-feed use data would be advantageous for both public health and veterinary stakeholders. These data could be used to assess the impact of GFI #209 and GFI #213 on antimicrobial use and resistance, develop additional interventions to minimize antimicrobial resistance in human and animal pathogens, conduct research to better understand and address antimicrobial resistance, and inform clinical decision-making by veterinarians. We anticipate opposition to public reporting of infeed antimicrobial use data by the food animal industry, which has argued that feed formulations are proprietary information. The release of aggregated data (e.g., by zip code, not by farm) should address this objection in part. Furthermore, as FDA phases out antimicrobial use for production purposes, and defines judicious use as only those uses that are necessary for assuring animal health, antimicrobial use should become less tied to the market strategies of individual firms and instead reflect animal health concerns shared by all firms operating in a particular region, meaning the data will be less reflective of decisions made by individual firms that could be considered proprietary. CLF would be willing to collaborate with FDA on the development of a system for monitoring antimicrobial use in food animal production, and could help assure the system is useful from a public health standpoint. Research, over decades, has demonstrated that the use of antimicrobials in food animal production for growth promotion and disease prevention is an important contributor to antimicrobial resistance. To slow the rise of resistance, the responsible use of antimicrobials in food animal production is essential. We urge FDA not to weaken veterinary oversight of antimicrobial use by removing the requirement of a VCP relationship from the VFD regulation, and to take advantage of existing VFD requirements to begin systematic collection of data on in-feed antimicrobial use in food animal production. We would be more than willing to work with the agency to implement these recommendations. Please contact us with questions about this comment or the issue of antimicrobial resistance more generally. Sincerely, Robert S. Lawrence, MD The Center for a Livable Future Professor in Environmental Health Sciences, and Professor Departments of Environmental Health Sciences, Health Policy and Management, and International Health Director Keeve E. Nachman, PhD, MHS Assistant Scientist Departments of Environmental Health Sciences and Health Policy and Management Program Director

4 Page 4 of 5 David C. Love, PhD, MSPH Assistant Scientist Project Director Robert P. Martin Senior Lecturer Senior Policy Adviser Christopher D. Heaney, PhD, MS Assistant Professor Departments of Environmental Health Sciences and Epidemiology D Ann L. Williams, DrPH, MS Research Associate Meghan F. Davis, DVM, MPH, PhD Post-Doctoral Fellow Patrick A. Baron, MSPH PhD Student Center for a Livable Future Doctoral Fellow Kevin M. Fain, JD, MPH DrPH Student Department of Epidemiology Center for a Livable Future Doctoral Fellow

5 Tyler J. Smith Senior Research and Policy Associate Page 5 of 5