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Agricultural News

FDA responds to industry questions on Guidance #213, revised VFD rule

Mon, 14 Mar 2016 06:00:30 CDT

FDA responds to industry questions on Guidance #213, revised VFD rule

Farm Foundation, NFP hosted 12 workshops across the nation last fall on the new policies and requirements of the U.S. Food and Drug Administration concerning the use of medically-important antimicrobial drugs in food animals.

The workshops provided more than 500 livestock producers, veterinarians and feed suppliers 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.

During the workshops, FDA officials were not able to respond to all the implementation questions. FDA has now responded to all those questions. Review the responses here, or on the Farm Foundation website.

"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."

"This direct interaction of stakeholders with FDA and APHIS was one of the most valued elements of the workshops," says Farm Foundation Trustee Joe Swedberg, who chairs the Foundation's Antimicrobial Education Project Advisory Committee. The volume and diversity of the questions "highlights the complexity and diversity of the nation's livestock industry, and the importance of a continuing dialogue between industry and state and federal regulators," Swedberg adds.

The questions and the workshop findings also highlight the need for additional educational work to reach all the critical industry segments, Swedberg said.

Farm Foundation's report of the workshops--Stewardship of Antimicrobial Drug Use in Food-Producing Animals--cites a lack of knowledge about the new policies and requirements, as well as concerns about the availability of veterinary services, as critical barriers to the successful implementation of changes resulting from FDA's Guidance for Industry #213, which are expected to take full effect Jan. 1, 2017.

"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," Swedberg emphasized. Farm Foundation is working to track educational work in progress and identify gaps where additional attention may be needed.

FDA has issued Guidance for Industry (GFIs) #209 and #213 regarding the use of medically-important antimicrobial drugs in food-producing animals, as well as a revised Veterinary Feed Directive (VFD) rule. 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.

Farm Foundation initiated this project in its role as an objective convener, explains Swedberg, a retired executive of Hormel Foods. "Farm Foundation is uniquely positioned to provide leadership in this type of project. We bring diverse stakeholders to the table to address issues shaping the future--in this case farmers and ranchers, veterinarians, feed suppliers and federal and state regulators," he adds.

A 501(c)3 nonprofit, Farm Foundation works as a catalyst for sound public policy by providing objective information to foster a deeper understanding of issues shaping the future for agriculture, food systems and rural communities. Since its founding in 1933, Farm Foundation has been a non-advocacy organization. The Foundation does not lobby or advocate positions. The Foundation's action comes in bringing industry leaders together to examine evolving issues that will shape the future of the industry. Antimicrobial drug use in food-producing animals is just such an issue.


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