The AASV Executive Committee, Drs Alex Ramirez, Scanlon Daniels, Nate Winkelman, and George Charbonneau, joined Drs Tom Burkgren, AASV executive director, and Harry Snelson, director of communications, May 8 and 9 in Washington, DC. The group joined the American Association of Bovine Practitioners’ leadership for an annual visit hosted at the American Veterinary Medical Association Government Relations Division headquarters.
The purpose of the trip was to provide the AASV leadership an opportunity to interact with federal regulators, government agency personnel, legislators, and swine researchers to discuss issues of concern to swine veterinarians. In addition, the executive committee heard from the bovine practitioners and representatives from the National Pork Producers Council (NPPC) as well as other livestock producer groups.
Drs Bill Flynn and Mike Murphy represented the Food and Drug Administration (FDA). Also present was Dr Steven Solomon, the new director for FDA’s Center for Veterinary Medicine.
The Veterinary Feed Directive (VFD) was a main topic of discussion with FDA. The FDA representatives reported few problems with the adoption of the revised VFD rule. The agency continues to operate in an “education mode” while producers, veterinarians, and distributors become accustomed to the additional antimicrobial oversight. The FDA did note, however, that enforcement would be ramping up as stakeholders and inspectors become more familiar with the regulation.
In addition to the VFD, the group discussed the need to better understand FDA’s role in protecting animal agriculture from imported ingredients that could be harboring pathogenic organisms. The FDA requested a follow-up meeting to explore how the agency monitors imported ingredients and approves facilities for export, and how the new Food Safety Modernization Act might address concerns regarding imported ingredients.
Another topic of discussion was the FDA’s proposed ban on the use of carbadox on the basis of concerns about the drug’s carcinogenicity. In April 2016, the agency filed a “Notice of Opportunity for Hearing” which provides the manufacturer of carbadox with an opportunity to request a hearing on whether the approval should be withdrawn. In response, the drug’s manufacturer, Phibro Animal Health, filed a request for a hearing and has provided study results supporting the safety of carbadox. The FDA is currently reviewing those studies to determine whether to allow a hearing. The decision to allow a hearing could take months or years. In the meantime, it remains legal to continue marketing and using carbadox as labeled.
The FDA is also seeking comments on how the agency should regulate gene editing in livestock. Guidance for Industry #187 clarifies FDA’s requirements and recommendations for producers and developers of genetically engineered (GE) animals and their products. It describes how the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act apply with respect to GE animals. The AASV Board of Directors has reviewed this issue and provided comments supporting the technology and requested restrictions be based on a sound scientific examination of the safety of gene editing.
In addition, the FDA is also seeking comments on a proposal to modify label directions to include a duration of use statement on those medically important feed grade antibiotics that do not currently have one. The AASV Pharmaceutical Issues Committee reviewed this request for information and provided feedback for comments submitted by the AASV. The executive committee described how these products were used in swine medicine and the need to retain the flexibility for veterinarians to utilize the drugs in a judicious manner to treat, control, and prevent disease. The agency is reviewing the comments received and will decide how to move forward over the next few months.
The group received an update on the following from the Department of Homeland Security (DHS):
- National Bio and Agro-Defense Facility (NBAF). The facility is projected to receive full operating capability by 2023 at a cost of $1.25 billion.
- Foot-and-mouth disease vaccine development. The DHS funded research and development of a vectored foot-and-mouth disease vaccine which is ready to be turned over to Merial for production.
- Enhanced Passive Surveillance project. Designed to enhance the nationwide surveillance capability to detect and identify endemic, transboundary, and emerging disease outbreaks.
- AgConnect. Development of a tool to allow for the visualization and sharing of data housed in disparate databases such as laboratories and producer databases. The DHS funded research to explore this proof of concept and is working to transition the technology to industry.
The executive committee talked extensively with Richard Sellers, Senior VP, American Feed Industry Association, about feed-related concerns such as imported ingredients and disease transmission risks via feed-associated sources, as well as the feed industry’s perspective of the recent VFD changes. Mr Sellers indicated that the VFD transition had gone relatively smoothly for the swine industry. He was aware of the research showing that imported feed ingredients could theoretically serve as a source for the transmission of pathogenic organisms and noted that the feed industry would continue to work with livestock groups and regulators to minimize potential disease risks.
This year’s visit also included discussions with Dr Jack Shere, deputy administrator USDA APHIS Veterinary Services, chief veterinary officer. Topics of discussion included the VFD, antimicrobial resistance, National Animal Health Laboratory Network (NAHLN) funding, and electronic messaging of laboratory data. The group emphasized the importance of adequately funding the NAHLN and expressed some concerns with the variability between laboratories in their ability to reliably message disease information to the USDA. Dr Shere expressed his support for projects designed by the Center for Epidemiology and Animal Health to address antimicrobial resistance. The AASV and the pork industry have worked closely with the USDA to develop these projects and support additional funding to undertake implementation.
On Tuesday, the AASV Executive Committee visited the National Institutes for Food and Agriculture (NIFA) headquarters to meet with NIFA and Agriculture Research Service (ARS) swine researchers. The group discussed federal funding for swine research and the swine-related projects ongoing at NIFA and ARS.
The group then attended a congressional briefing sponsored by the Animal Health Institute on antibiotic oversight and resistance before traveling to Capitol Hill to meet with legislators on behalf of NPPC.
Harry Snelson, DVM
Director of Communications