Projects

Stewardship of medically-important antimicrobial drug use in food animals

A Farm Foundation, NFP report,  Stewardship of Antimicrobial Drug Use in Food-Producing Animals, cites two critical barriers to successful implement of changes in the use of medically-important antimicrobial drugs in food animals resulting from the Food and Drug Administration’s (FDA) Guidance for Industry (GFI) #213, as well as the revised Veterinary Feed Directive (VFD) rule. Those barrier are a lack of knowledge about the changes by some stakeholders, and limited access to veterinary services in some locales.

The report summarizes findings of 12 workshops Farm Foundation conducted across the nation in the fall of 2015 on implementation of the FDA GFI #213 and the revised VFD. (See details of the workshops below.)

FDA officials participated in all the workshops, providing information and answering questions. During the workshops, FDA officials were not able to respond to all the questions. FDA has now addressed those questions. Read the responses HERE.

The 12 workshops were an opportunity for livestock producers, feed suppliers and veterinarians to gain a comprehensive understanding of two GFIs–#209 and #213–issued by the FDA regarding the use of medically-important antimicrobial drugs in food-producing animals, as well as the revised 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 veterinarians order.

The Farm Foundation report was released Jan. 20, 2016 as part of the national summit, Antimicrobial Stewardship: Policy, Education and Economics. In addition to discussion of the Foundation report, the summit program examined how agriculture and animal health can be full partners with the human medical community in a fully integrated national action plan to reduce and mitigate antibiotic resistance. The basis of these discussions is a report, Addressing Antibiotic Resistance, issued in October 2015 by a joint task force of APLU and AAVMC. ERS led sessions examining the economics of antibiotic use in U.S. livestock production, as well as the interaction of farming practices and the requirements of food marketers. Information resources on FDA’s GFI #209 and #213 and revised Veterinary Feed Directive Rule can be found at the bottom of this page.

More than 180 producers, economists, government agency staff and representatives from livestock, veterinary and feed industry organizations participated in the summit. The event was a collaboration of Farm Foundation, NFP, the Association of Public and Land-grant Universities (APLU), the Association of American Veterinary Medicine Colleges (AAVMC) and USDA’s Economic Research Service (ERS).

Featured speakers at the summit included: Catherine Woteki, USDA Under Secretary for Research, Education and Economics; Bernadette Dunham, DVM, Ph.D., Director of FDA’s Center for Veterinary Medicine (CVM); William Flynn, DVM, Deputy Director of Science Policy at the CVM; Steve Solomon, MD, Global Public Health Consulting; Liz Wagstrom, DVM, National Pork Producers Council; Christine Hoang, DVM, MPH, CPH, American Veterinary Medical Association;  Ashley Predith, Ph.D., President’s Council of Advisors on Science and Technology; and livestock producers, feed suppliers, veterinarians and university leaders from across the nation.

Preceding the summit on the morning of Jan. 20 was a Farm Foundation Forum on the topic: Antibiotic Use in Humans and Animals.

Understanding the new FDA Guidances and revised Veterinary Feed Directive rule: Stewardship of medically-important antimicrobial drugs in food-producing animals was the focus of 12 workshops organized across the United States by Farm Foundation, NFP. The workshops were an opportunity for livestock producers, feed suppliers and veterinarians to gain a comprehensive understanding of two GFIs issued by FDA regarding the use of medically-important antimicrobial drugs in food-producing animals, as well as the FDA’s revised Veterinary Feed Directive (VFD) rule.

Many producers and businesses across the entire food and agricultural value chain have already taken action to reduce the use of medically-important antimicrobial drugs in food animal production. FDA’s GFI 209 and GFI 213 call on animal drug sponsors of approved medically-important antimicrobial drugs administered through medicated feed or water to remove production uses (i.e., to promote growth or improve feed efficiency) from their product labels, and bring the remaining therapeutic uses of these products–to treat, control, or prevent disease–under the oversight of a veterinarian by the end of December 2016. Manufacturers of products containing these medically-important antimicrobial drugs have voluntarily agreed to submit changes to their product labels to comply with the GFIs. Additionally, FDA revised the VFD to facilitate the increased veterinary oversight of medicated feeds called for by GFI #209 and #213.

The one-day workshops included presentations by producer leaders, the local veterinary community, and representatives from the regional feed industry. Representatives of FDA and FDA and USDA’s Animal and Plant Health Inspection Service (APHIS) are also participating to discuss the policies and answer questions. A major part of the agenda is designated for producers, veterinarians and feed suppliers to discuss the management challenges ahead. The staff of Adayana Agribusiness facilitated the workshops.

In addition to Farm Foundation’s leadership, individual producers and many companies are providing financial support for this educational effort. These include JBS United, Hormel Foods Corporation, Jennie-O Turkey Store, Rose Acre Farms, Hardin Farms, Irsik Farms, C-ARC Enterprises, National Pork Producers Council, National Pork Board, Elanco Animal Health, J.R. Simplot Company, the North American Meat Institute, the National Turkey Federation, BARN Media, Iowa State University College of Agriculture and Life Sciences, Western Dairy Association, the National Western Stock Show, the University of Idaho College of Agriculture and Life Sciences, the School of Veterinary Medicine at the University of California, Davis, and the Pew Charitable Trusts.

Media Coverage:
Listen to an interview Farm Foundation Board Vice Chair Joe Swedberg, who chairs the Antimicrobial Education Project, did with RFD-TV on Aug. 27, 2015 .

INFORMATION RESOURCES:

U.S. Food and Drug Administration: Guidance for Industry #209 The Judicious Use of Medically Important Antimicrobial Drugs in Food Producing Animals

U.S. Food and Drug Administration: Guidance for Industry #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food

U.S. Food and Drug Administration: Veterinary Feed Directive

U.S. Food and Drug Administration, Veterinary Feed Directive (VFD) Brochures:

VFD Producer Requirements

VFD Requirements for Veterinarians

VFD Requirements for Distributors who manufacture VFD Feed

VFD Requirements for Distributors who do not manufacture VFD Feed

VFD Requirements for Veterinarians–For Veterinary Students

RESPONSES TO WORKSHOP QUESTIONS: During the Farm Foundation workshops, FDA officials were not able to respond to all questions. FDA has addressed those questions. Read the responses HERE.

FDA’s Center for Veterinary Medicine: Blue Bird label site for cattle, updated June 2016.

USDA: USDA Antimicrobial Resistance Action Plan

Animal Health Institute: FDA Guidance 209, 213 and VFD Educational Material

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