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What feed mills need to know about updates to the Veterinary Feed Directive

In recent years the tides of regulation have shaped the internal workings of the feed industry—and further change sits just over the horizon. The buzz this summer revolves around the progress being made in the finalization of the Food and Drug Administration’s amended Veterinary Feed Directive proposal.

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In recent years the tides of regulation have shaped the internal workings of the feed industry—and further change sits just over the horizon. The buzz this summer revolves around the progress being made in the finalization of the Food and Drug Administration’s amended Veterinary Feed Directive proposal.

While the system went into effect more than a decade ago, the extent and use of the VFD process has been fairly limited in the feed industry as only two drug classes used in animal agriculture were given VFD status, a designation requiring veterinary oversight, i.e. a written order, to sell or distribute feed containing the drug. 

Today, however, in conjunction with the agency’s fight against bacterial drug resistance, the pending expansion of the VFD program to include a much broader group of antimicrobial drugs will deliver a new administrative responsibility to the entire feed industry.

“Along with the Food Safety Modernization Act, this is one of the biggest changes to affect the feed industry since the FDA started regulating,” says Richard Sellers, vice president of nutrition and feed regulation, Animal Feed Industry Association.

Though the regulation has not yet been finalized, feed mills who have not dealt with VFDs in the past need to stay informed about this monumental change. The following breaks down the back story, highlights recent developments and outlines what feed mill operators can do in the interim.

VFD backgrounder

In 2010, the FDA decided to amend the VFD regulation, which went into effect in 2001 as a result of the Animal Medicinal Drug Use Clarification Act of 1996. The agency issued an advanced notice of proposed rulemaking, a process by which it calls for stakeholder comment when existing rules are to be revised.

On behalf of the feed industry, the American Feed Industry Association and the National Grain & Feed Association formed a coalition to address the proposal and submitted a joint set of detailed recommendations. The FDA adopted virtually all of these recommendations and created a draft text of the proposed regulation—an unusual step for the agency—and put it out for public comment.

“Typically, the very next step in the rulemaking process would be for the agency to publish a formal proposed rule, but we added a extra step—an additional opportunity for comment—and simply published a draft from the comments we received and revised the existing regulation in a draft form and put that out for comment in April 2012,” explains Dr. William Flynn, deputy director for science policy, FDA.

Meanwhile, around the same time, the agency issued “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals” guidance to formalize its policies related to use of antimicrobial drugs in livestock feed and drinking water.

“In the published guidance, we laid out our key objectives for medically important drugs: we want to phase out the use for growth promotion purposes and phase in veterinarian oversight for therapeutic uses of these drugs,” Flynn explains.

Originally, the scope of the VFD rule had been limited to two drugs: tilmicosin for swine and cattle and florfenicol for use in swine and aquaculture production. As part of the judicious use guidance, the agency proposes the VFD process cover all drugs used in animal agriculture that are among those drug classes identified as being important to human medicine thereby relevant to the issue of antimicrobial resistance: penicillin, tetracyclines, macrolides, lincosamides, streptogramins, aminoglycosides and sulfonamides.

Some drugs—such as wormers and ionophores—will be excluded and some antimicrobials (Bacitracin Methylene Disalicylate and bambermycin) may also be exempt.

“Basically all antimicrobials will fall under VFD regulation—and that’s a big deal. There will be a huge impact on animal agriculture all around,” says Dave Fairfield, National Grain & Feed Association’s vice president of feed services, noting the administrative and recordkeeping burden the current VFD process has had on feed mills.

Anticipating the disruption this transition would cause under the existing system, the agency set out to evaluate existing VFD requirements to ensure the VFD administrative system and regulatory framework is “as workable and as efficient as possible to facilitating that transition.”

“Dealing with a system many view as burdensome is doable when dealing with a couple products; however, with many products, it becomes a problem,” Flynn says. “We want to minimize the burden by streamlining the process.”

The industry speaks out

This spring the FDA conducted five public stakeholder meetings across the country to gather feedback on what impact the proposed regulations would have on animal agriculture.

Fairfield, who attended the South Dakota public forum, states that the audience, made up of veterinarians, producers and producer group representatives, expressed an overarching concern over the availability of vets to administer a program of this scale.

“In addition to access to vets, the producers were concerned about the costs associated with an expanded VDF process,” Fairfield recounts. “What are very small producers, who may not have a relationship with a vet, going to do? Not only may they not have the financial wherewithal to have a relationship with a vet, but they may rely solely on feed dealers to purchase their medicated feed—and these outlets may not want to distribute these products in the future if they are going to be faced with a significant administrative burden.”

Sellers raises another concern: Who’s going to train the vets?

“How can the industry be assured the vets will know about VFD requirements and what to do?” Sellers says, noting it was suggested that an online, database training program be established to register VFD-certified vets.

Stakeholders on all sides agree there is no easy answer.

“One of the main reasons for having these meetings—and partially why we located them where we did—is because we do recognize some folks will be impacted by moving these from over-the-counter drugs to VFD status,” Flynn says. “We have tried to hone in on practical issues in these meetings. We’re making changes because we want to provide a streamlined system without undue administrative delays.”

What does this mean for feed mills?

Feed mills in the Midwest may be more familiar with the VFD process; however, in other parts of the country, this may not the case. Fairfield suggests all feed mills get up to speed on what the VFD system will mean for their business.

“Today there is a high level of administrative burden associated with the process,” Fairfield says, noting the current VFD process requires feed mills to manage a lot of paperwork to comply with FDA regulations.

In general, VFDs require producers with sick animals to consult with a veterinarian, who writes a very detailed order for the medicated feed indicating which group of animals will be treated and for how long. Legally, the feed mill must receive this order before providing the medicated feed to the producer. Currently, feed mills are allowed to produce feed based on faxed orders; however, it must obtain the original document from the veterinarian within five days. Mills are then required to keep these documents on hand for two years.

“Everybody will need to gain a firm understanding of what their obligations are under VFD regulations and how to comply with the directive,” Fairfield says. “Once this policy does take effect, it’s going to be very likely one or more of the antimicrobial drugs mills add to their medicated feed will fall under the VFD process.”

Every time a producer places an order for medicated feed, the feed mill must first have steps in place to verify there is a VFD order on file at the mill; second, determine if the order falls within the parameters of the VFD; and, finally, whether or not the order is current or expired. Setting up the administrative system to handle, track and distribute feed within a feed mill can be a “big deal.”

“Once this policy is in place there are going to be many VFD orders and a lot of VFD records to manage,” he explains, “and somehow they will need to be efficiently integrated so feed can get delivered.”

Flynn insists the future of the VDF process will be simplified by using modern technology to allow for the electronic transmission of documents.

The FDA will also focus on education and outreach before the regulation is fully enforced. Flynn explains: “The strategy we’ve outlined for bringing these changes into effect calls for a three-year implementation period to provide opportunity for adjustments to be made amongst all the stakeholders—including the feed industry—to plan for these changes and familiarize themselves with what those changes will bring and what adjustments will need to be made in how they operate.”

Implementation by 2016

After finalizing the proposed rule, the FDA plans to release it in its final form by the end of 2013. Flynn notes that the publication of the final form sets the overall implementation timeline into motion, i.e. drugs status transition and the refinement of the VFD system by 2016.

Stakeholders will have yet another opportunity to comment. “We encourage the feed industry to participate and look forward to further discussions to make sure this is a workable system,” Flynn says.

Regardless of the outcome, all players invested in the animal health industry will be involved with the burden.

“We recognize the importance of making the VFD process as efficient as possible as a way of facilitating an important change to the way medically important antibiotics are being used,” Flynn says.

In the interest of the feed industry, AFIA and NGFA remain committed to working jointly to try to gain revisions to the VFD process to limit the impact to feed manufacturing and facilitate the transition.

“The FDA has been very proactive on gathering stakeholder input and we’re thankful for that,” Fairfield says. â€śThe challenges to overcome will be significant as this is going to be a big paradigm shift for the industry.”

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