August 5, 2013

Division of Dockets Management (HFA-305)
Food and Drug Administration
United States Department of Health & Human Services
5630 Fishers Lane
Room 1061
Rockville, MD 20852

RE: Veterinary Oversight of Antimicrobial Use in Livestock: Impact on Stakeholders; Public Meeting; Request for Comments, Docket Number FDA-2010-D-0094  

To Whom it May Concern:

Pennsylvania Farm Bureau (PFB) is pleased to offer its comments on the impact to stakeholders of the Food & Drug Administration (FDA)’s Guidance for Industry (GFI) #209, titled The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, specifically related to the veterinary oversight of antimicrobial use in livestock. PFB is a general farm organization, made up of more than 58,000 members, providing legislative support, information, and services to Pennsylvania's farmers and rural families since 1950.

Our organization includes 54 local organizations (county farm bureaus) that actively operate in 64 of Pennsylvania’s 67 counties. PFB is the state affiliate of the American Farm Bureau Federation (AFBF), an organization representing more than six million member families throughout the United States. In addition to the comments we are offering today, we want to affirm our support of comments previously filed by AFBF regarding this guidance, and would request that AFBF’s comments be treated as part of the comments contained herein.

Animal agriculture in the Commonwealth of Pennsylvania is extraordinarily diverse with regard to the ethnic and cultural background of food animal producers, species of food animal produced and size of production units. This diversity presents significant challenges to developing and implementing a comprehensive system for effectively regulating antimicrobial use in food animals while simultaneously meeting a high standard of animal care and well-being, public and animal health protection, and food safety. Pennsylvania’s agricultural community has a primary interest in ensuring that all animal health products, including antibiotics, continue to be used in a safe and effective manner. In that context, PFB would like to offer the following comments on the concepts embodied in GFI #209.

First of all, the basis of any animal drug use regulatory model is the veterinary-client patient relationship (VCPR). Nevertheless, under current conditions in modern production agriculture and with respect to available technologies, questions arise as to its applicability. In its comments on this same docket, the Pennsylvania Animal Health & Diagnostic Commission (PAHDC), which serves in an advisory capacity to the Commonwealth’s Secretary of Agriculture and is comprised of livestock producers and practicing large animal/food supply sector veterinarians, pointed out several of those questions and also raised several potential issues for compliance with GFI #209 (and, ultimately, GFI #213). Most notably, the PAHDC noted that a common problem in Pennsylvania and throughout the country is inadequate access to large-animal veterinary care, especially in rural areas.

The economics of rural veterinary medicine are such that the majority of veterinarians providing food supply sector services in Pennsylvania are rural mixed animal practitioners who balance profitable companion animal practice with more costly and labor-intensive food animal practice. Approximately 1,300 counties in the United States have less than one food animal veterinarian per 25,000 farm animals; furthermore, there are 500 counties that have at least 5,000 farm animals and not a single veterinarian living there to treat them. Thus, market forces seriously limit veterinarian availability for VCPR-related activities. At the same time, PAHDC expressed concerns about how new standards as currently described in GFI #209 and ultimately defined in GFI #213 will be implemented, and their effectiveness measured.

Finally, while antibiotic resistance in humans is a substantial and growing problem in the healthcare community, and the development of bacterial resistance to certain antibiotics poses a serious public health threat, it is important to note that antibiotic use in animals has not been scientifically linked to increases in human antibiotic resistance. In more than 40 years of antibiotics being used in animals, a public health threat has not arisen and recent government data shows the potential that one might occur is declining. Bacteria survival through food processing/handling is decreasing, food-borne illness is down, development of antibiotic-resistant bacteria in animals is stable and resistant food-borne bacteria in humans are declining.

In order to raise healthy animals, Pennsylvania farmers need tools to keep animals healthy – including medicines that have been approved as safe and effective by the Food and Drug Administration. To restrict access to these important tools will jeopardize animal health and compromise our ability to contribute to the public health through food safety.

Pennsylvania’s agricultural community fully appreciates the gravity of improper use and overuse of antimicrobials in animal agriculture. However, given current data on the risk assessment of livestock antibiotics, PFB opposes restricting the use of antibiotics. It is important that decision-makers review demonstrated scientific evidence of the risks and benefits of potential future actions. PFB has serious concerns about the effects of removing important antibiotics and classes of antibiotics from the market, which would handicap veterinarians and livestock and poultry producers in their efforts to maintain animal health and protect our nation’s food supply. Further limiting or eliminating animal antibiotic use for livestock will have negative economic and animal health consequences. Therefore, PFB supports:

(1) Sound science as the basis for decision-making and policy development regarding antibiotics/antimicrobials used in food animal production;

(2) Use of the National Antimicrobial Resistance Monitoring System, the National Animal Health Monitoring System and the Department of Agriculture’s food safety monitoring system to address issues of antimicrobial resistance trends in food-borne bacteria and animal health;

(3) A multi-agency approach to on-farm antimicrobial-resistant bacteria trend research and surveillance between the Animal and Plant Health Inspection Service, Agricultural Research Service, Food Safety and Inspection Service, and livestock producers.

Efficient production of high quality, affordable animal protein for human nutrition can only be accomplished in systems that provide for the wellness, comfort, and basic medical needs of livestock. We ask that FDA work with food animal producers and veterinarians to create a regulatory mechanism that considers the complexities of modern animal agriculture and achieves an optimal balance in addressing public health, animal well-being, animal health, food safety, and food accessibility concerns. Thank you for the opportunity to provide comments.


Carl T. Shaffer, President