Farm Foundation Responds to Guidance #213 Concerns

Lizzy SchultzAg Group, Animal Health, Antibiotics, APHIS, Education, Farm Foundation, FDA, Feed, Policy, Veterinary

farm foundation Farm Foundation NFP hosted 12 workshops across the nation last fall to more than 500 livestock producers, veterinarians and feed suppliers on the new policies and requirements of the U.S. Food and Drug Administration’s (FDA) Guidance for Industry #213 concerning the use of medically-important antimicrobial drugs in food animals. The policy changes are expected to take full effect Jan. 1, 2017.

Once fully implemented, these guidance documents will result in medically-important antimicrobial drugs seeing label changes allowing only therapeutic uses (prevention, control or treatment of disease), and use of the drugs in feed or water will require a veterinarian’s order.

The workshops provided industry professionals the opportunity to learn about the new policies directly from senior officials of FDA and USDA’s Animal and Plant Health Inspection Service (APHIS). Participants also were able to voice their opinions and ask questions about the management challenges of implementation. The direct interaction of stakeholders with FDA and APHIS was one of the most valued elements of the workshops.

FDA has responded to all of the implementation questions asked during the workshop, as FDA officials were unable to respond to many during the events, and the responses can be viewed here.

“The conversations at the workshops provided the FDA staff with detailed insights into industry questions on how to implement the VFD final rule,” said William T. Flynn, deputy director for science policy at FDA’s Center for Veterinary Medicine. “We can create regulations, but the on-the-ground insights we heard in the workshops provided us with a terrific opportunity to help producers, distributors and others get the information they need to comply with this important regulation. This helps us shape policies to achieve the most successful outcomes.”

Farm Foundation’s report of the workshops, which can be viewed here, cites a lack of knowledge about the new policies and requirements and concerns about the availability of veterinary services as the most critical barriers to the successful implementation of changes resulting from Guidance #213.

“Much work has been done by industry organizations, agencies and media outlets, but many stakeholders lack a full understanding of the policies. We need to continue the education push,” said Farm Foundation Trustee Joe Swedberg, who chairs the Foundation’s Antimicrobial Education Project Advisory Committee.