March 12, 2014

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: Food & Drug Administration, Proposed Veterinary Feed Directive, Docket No. FDA-2010-N-0155-0139

Dear Sir or Madam:

Pennsylvania Farm Bureau (PFB) is pleased to offer its comments on the impact to stakeholders of the Food & Drug Administration (FDA)’s proposed Veterinary Feed Directive, which would amend its animal drug regulations regarding veterinary feed directive (VFD) drugs. PFB previously offered comments on the draft text of this proposed regulation, intended to improve the efficiency of FDA's VFD program, on July 12, 2012.

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.

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. With the preceding as context, PFB would like to offer the following comments on the proposed VFD.

First of all, our above referenced July 2012 comments 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. Therefore, changes in the proposed rule which appear to be aimed at providing greater flexibility to states like Pennsylvania, in which the availability of large-animal veterinarians is a present and/or future concern, are welcome inasmuch as they provide real opportunities for the veterinary profession and for state licensing boards to bring their expertise to bear in determining the specific criteria for acceptable veterinary professional conduct in this area.

At the same time, the changes in the proposed rule intended to align VFD drug recordkeeping with current Good Manufacturing Practices (cGMP) by setting the recordkeeping requirement for all involved parties at one year is a positive one. The situation under the current regulations, in which some parties are required to retain VFD records for two years while others only need do so for one, creates unnecessary additional expense and confusion for participants in the VFD process and does not provide commensurate related benefits.

However, PFB continues to have concerns about the overall approach to antibiotic use in livestock embodied in the draft rule, as well as in GFI #209 and GFI #213. 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 FDA through a highly regulated process that provides for a thorough review of such medicines before they are approved for use, and for additional review at periodic intervals once they are on the market. This process is based on years of data collection and continuous, strenuous scientific testing. FDA can and will deny or limit products that are shown to produce resistance in either animals or humans. Restricting 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. Nevertheless, given current data on the risk assessment of livestock antibiotics, PFB continues to question whether further limiting or eliminating animal antibiotic use for livestock is the best way to protect against the negative economic, animal and human health consequences FDA seeks to mitigate. We believe that FDA would be better served in the pursuit of this goal by working with food animal producers and veterinarians to create a regulatory mechanism that better 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.


Grant R. Gulibon

Director, Regulatory Affairs