Through the summer and fall of 2015, Farm Foundation hosted a series of workshops in locations around the country to address upcoming changes to FDA rules and guidance relating to antibiotic use in food animals. One of these was held in Denver on Sept. 28. The workshops were designed to inform stakeholders of the implications of FDA Guidance to Industry 213 and changes to the veterinary feed directive (VFD) rule.
Guidance 213 will remove performance or production claims from medically important antibiotics used in feeds by December 2016. Changes to the VFD rule will bring the use of medically important feed-grade antibiotics under the oversight of veterinarians by Jan. 1, 2017.
The new VFD rule actually took effect on Oct. 1, 2015, affecting the use of three antibiotics currently classified as VFD drugs. Those are avilamycin, florfenicol and tilmicosin. Of those, only tilmicosin is used as a feed-grade drug in cattle.
As of Jan. 1, 2017 the list of VFD drugs will expand to include all medically important antibiotics used in feed for prevention, control and treatment of disease. Cattle drugs affected at that time include neomycin, tylosin, virginiamycin, chlortetracycline and oxytetracycline. Over-the-counter sales of those drugs will no longer be allowed, and producers will need to work through their veterinarian to obtain a VFD order.
Craig Lewis, DVM, MPH, DAVCM, a veterinary medical officer with the FDA’s Center for Veterinary Medicine, addressed the workshop and provided background on the FDA’s initiatives for judicious use of antibiotics.
Lewis says FDA’s judicious-use policies have focused on two key principles: Limiting the use of medically important antibiotics in food animals to therapeutic applications and providing veterinary oversight.
Lewis stressed that the VFD rule requires the establishment of a valid veterinarian-client-patient relationship (VCPR) before a veterinarian can write a VFD order. Some states have adopted official definitions of the valid VCPR, but in states that have not, veterinarians will fall back on the federal definition. According to the Code of Federal Regulations, a valid VCPR is one in which:
· A veterinarian has assumed the responsibility for making medical judgments regarding the health of (an) animal(s) and the need for medical treatment, and the client (the owner of the animal or animals or other caretaker) has agreed to follow the instructions of the veterinarian;
· There is 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.
· The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of therapy. Such a relationship can exist only 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.
Following Lewis, Larry Granger, DVM, senior leader of the Antimicrobial Resistance Program for USDA’s Animal and Plant Health Inspection Service, outlined the USDA’s involvement in addressing the antimicrobial-resistance issue. Multiple USDA agencies, he says, are involved in research, surveillance, education and outreach on the issue.
Granger says representatives of the USDA and FDA were to meet on Sept. 30 to discuss processes for data collection and monitoring related to antibiotic resistance in animal agriculture. Granger also outlined the USDA’s Antimicrobial Resistance Action Plan and a detailed list of proposed research initiatives. Those initiatives, Granger says, will build upon existing USDA programs for surveillance, research and education related to antimicrobial resistance. Proposed initiatives include:
· On-farm longitudinal studies — These would assess relationships between antibiotic use and other factors and the development of resistance in pathogens on farms.
· Annual antibiotic use surveys — These national cross-sectional studies would provide annual estimates of antibiotic use in feed and water for feedlot cattle, broilers, swine and, potentially, turkeys.
· Targeted epidemiological studies — These as-needed studies would enable investigation of clusters of resistant pathogens identified through other studies.
· Use of proprietary data — Use of private-sector data, such as that from large cattle-feeding companies, could enhance data collected through USDA surveys. The data would remain confidential and protected from Freedom of Information Act requests due to National Animal Health Monitoring System status within USDA.
Granger notes that none of these proposed initiatives are currently funded in the federal budget, and funding sources will yet need to be identified.
Stakeholder concerns and questions
Next, the workshop heard from local representatives of the three industry sectors primarily affected by the VFD rule — producers, veterinarians and feed distributors. Representing producers was Steve Irsik, general partner of Irsik Equities, LP, a family-owned business with enterprises in farming, ranching, cattle feeding and dairy production. Representing veterinarians was feedyard consultant Del Miles, DVM, MS, with Veterinary Research and Consulting Services in Greeley Colo. Nathan Hubbard, with AgFinity Feed LLC, based in Eaton, Colo., represented feed mills and other feed distributors.
A panel discussion followed short presentations from each industry representative, and that was followed by general discussions involving all the workshop participants.
General consensus among the workshop presenters and participants was that the new VFD rule and other changes to antimicrobial policy probably are necessary to help address public concerns. And most believed producers, veterinarians and feed suppliers will be able to work together to comply with the rules. Several participants noted that the VFD rule, with its requirement for a valid VCPR, could provide broad benefits as veterinarians develop closer relationships with producers and become more involved in their herd-health and management programs.
However, participants provided observations, or expressed some concerns, including:
· Although most participants at the workshop were at least somewhat familiar with the new VFD rules, many producers probably have little awareness of the impending changes. Communications will be critical, between FDA and stakeholders and between veterinarians, producers, feed distributors and nutritionists.
· Producers in some areas face a shortage of veterinary services and might find it difficult to develop the VCPR needed to obtain VFD feeds. Large livestock operations probably already have close relationships with veterinarians, but many smaller operators do not.
· Writing VFD and filing orders require time and paperwork for veterinarians, which could mean higher costs for the producer.
· Some producers worry they will lose access to medicated feeds, due to the expense or logistics of obtaining a VFD order. This could have negative impacts such as poor animal health or higher cost of alternative treatments such as injectible antibiotics. It also could have some positive consequences as producers focus more on non-antibiotic tools for disease prevention.
· Many presenters stressed that extra-label use of medicated feeds is prohibited. Veterinarians will need to specify the intended use of a drug on the VFD order along with other information about the animals being treated. This higher level of accountability will require veterinarians, producers and feed distributors to understand product labels and ensure all uses comply with label specifications.
· Measuring results of the new policies will be difficult due to the complexity of the antibiotic-resistance issue. Several participants stressed that evaluation needs to focus on the goal of reducing the incidence of resistance, and not simply on reduction of antibiotic sales.
After finishing the workshops, Farm Foundation plans to issue a report based on comments and questions from participants around the country. They also plan to convene a national summit on the issue in late fall of 2015. More information is available on the Farm Foundation website at farmfoundation.org.