In an effort to help address potential antimicrobial-resistance concerns in humans, the U.S. Food and Drug Administration issued guidelines to extend veterinary oversight and phase out the sub-therapeutic use of antibiotics that are important to human medicine in food-producing animals for growth-promotion purposes. The new guidelines will be implemented over a three-year transition phase.

 Historically, certain antibiotics have been used in the feed or drinking water of food-producing animals for production purposes. Some of these antimicrobials are also used to treat human infection, thus prompting concerns about the potential contribution of this practice affecting antimicrobial resistance. Guidance 213 calls for animal-pharmaceutical companies to voluntarily revise the FDA-approved labels for these products to remove growth-promotion labels. FDA also proposes to change veterinary feed directive (VFD) regulations to move the over-the-counter status of the remaining appropriate therapeutic uses to require veterinary oversight when used to treat, control or prevent health issues in animals.

Bernadette Dunham, director for FDA’s Center for Veterinary Medicine, said the steps taken by FDA will promote the judicious use of important antimicrobials to protect human health while ensuring sick and at-risk animals receive the care they need.

“Implementing this strategy is an important step forward in addressing antimicrobial resistance. The FDA is leveraging the cooperation of the pharmaceutical industry to voluntarily make these changes because we believe this approach is the fastest way to achieve our goal,” said FDA deputy commissioner for foods and veterinary medicine Michael Taylor.

In a media statement, Zoetis came out in support of FDA’s new guidelines.

“Zoetis supports the FDA’s efforts to voluntarily phase-out growth-promotion indications for medically important antibiotics in food-producing animals. Zoetis plans to implement Guidances #209 and #213 and has already taken action. This reflects our continued commitment to antibiotic stewardship and represents the many ways that Zoetis promotes the responsible use of antimicrobial drugs in animals.

“We believe that veterinarians should be involved in decisions regarding antibiotic use in food animals for the health of the animal and for the safety of the food supply. We support the revisions to the veterinary feed directive regulation to guide veterinarians and farmers as they manage the health and welfare of animals.”

The American Veterinary Medical Association (AVMA) said it was pleased that its recommendations to FDA on this topic were reflected in the final guidance.

“The AVMA has long advocated that greater veterinary oversight of the use of antimicrobials on the farm is a benefit to human and animal health,” said AVMA president Dr. Clark Fobian. “The AVMA is ready to assist the USDA and the FDA in their outreach and communication efforts with stakeholders as we transition from the long history of these additives being available over the counter to the new VFD program.” The Animal Health Institute also supported FDA’s actions and said this policy fulfills a request made by public health advocacy groups in a July 2009 letter to the White House.

“Animal-health companies have supported this policy since it was announced in 2012 and will continue to work with FDA on its implementation.

“The responsible use of antibiotics to keep food animals healthy carries a public health benefit. Healthy animals are the fi rst link in the food safety chain. Other links in this chain include the reduction of pathogenic bacteria at critical steps in processing and good food hygiene through the safe handling and cooking of meat and poultry. Responsible use of antibiotics by farmers and veterinarians to keep food animals healthy at the beginning of the food safety chain helps the entire chain produce a safer food product.”

NCBA was also quick to respond, reaffirming the association’s commitment to animal health and pledging to review the guidelines and work with FDA in the future.

“Cattle producers work hand-in-hand with their veterinarians and animal-health experts each day to implement comprehensive herd-health management plans, which include the targeted use of antibiotics to prevent, control and treat diseases in their animals. Preventive medicine is the cornerstone of maintaining a healthy U.S. cattle herd,” said NCBA president Scott George.

“NCBA will carefully review this guidance to ensure that FDA has addressed cattle producers’ concerns and has based these documents on sound, peer-reviewed science. Antimicrobial resistance is a multi-faceted and extremely complex issue that cannot be adequately addressed by solely focusing on the use of antimicrobial drugs in animal agriculture. Only by carefully evaluating antimicrobial resistance in a comprehensive manner that evaluates all of the peer-reviewed science related to all animal and human use will we effectively address this important issue.”

The American Meat Institute’s chief scientist Betsy Booren welcomed the publication of Guidance 213 and proposed VFD rule.

“AMI strongly supports the prudent and judicious use of antibiotics in food-animal production under the care of a veterinarian, as defined by the American Veterinary Medical Association, which is consistent with protecting both animal and public health, ensuring the ability to medically treat animals, and maintaining the highest standard of animal welfare practices and we believe Guidance 213 adheres to these principles.”

Guidance 213 is now in final form, and the proposed VFD rule is open for public comment for 90 days starting on Dec. 12, 2013.