Everyone expected the livestock community to encounter a “speed bump” or two in the transition to the FDA’s expanded veterinary feed directive (VFD) rules. So far though, educational efforts over the past year seem to have created adequate awareness and understanding of the process.
Questions and challenges have emerged, and will continue to crop up, as the industry adjusts to the reality of veterinary oversight for products producers traditionally have purchased over-the- counter (OTC). The FDA might, however, need to clarify some applications of the rules, and drug companies might need to pursue new label indications for products to fill some gaps in herd-health options.
Bill Flynn, DVM, MS, Deputy Director for Science Policy with FDA’s Center for Veterinary Medicine (CVM), says his office has fielded an array of questions related to the VFD changes that took full effect in January. These changes, he notes, shifted large numbers of products from OTC purchase status to requiring veterinary oversight and a VFD order, and it comes as no surprise the transition will create questions, many of them difficult to anticipate.
The new rules affect all food-animal producers, and the questions have reflected that diversity, coming from small hobby farmers on up to the largest commercial beef and dairy operations. Producers, veterinarians and feed suppliers have all asked questions regarding their role in the process. Most of the recent questions though, have focused on details specific to a particular operation’s production system, operating environment or animal-health challenges.
Most stakeholders, Flynn says, seem to have a good understanding of the VFD rule, its purpose and the process for compliance, and are asking questions to ensure they “get it right” while ensuring they have timely access to the products they need to support their animal-health programs.
The VFD concept is not new, Flynn points out. The FDA has required VFDs for certain medicated feeds for years, but prior to the recent changes, the number of affected products was limited and mostly confined to pork production.
The beef sector, Flynn notes, encompasses cow-calf, stocker and feedlot segments with a broad range of operation sizes, production environments and management systems. That diversity has led to a wide range of questions related to specific production environments and “customized” applications of medicated feeds producers might have relied upon in the past.
Stick to the label
In some cases, producers have grown accustomed to using medicated feeds in ways not specified on the product labels, which has been illegal all along. The VFD system requires the producer and veterinarian to specify how the product will be used – such as prevention, control or treatment of a specific disease in a specified group of animals, dosage and in most cases, duration of use. And most importantly, the intended use on the VFD order must comply with the product label.
One common source of questions and confusion is the difference between free-choice or hand-fed delivery of medicated feeds. Depending on the production environment, producers might need a free-choice product to effectively treat cattle, such as in an extensive pasture environment.
Jessica Laurin, DVM, Animal Health Center of Marion County, Marion, Kansas, says the issue of hand-fed versus free-choice has generated the most questions among her clients. Laurin conducted several client meetings during 2016 to prepare area producers for the transition to the new VFD rules, so most have adapted and are working with their suppliers to comply and adjusting their management practices accordingly.
Daniel Herold, PhD, manager of beef nutrition and technical services, Hubbard Feeds, points out that Type B medicated feeds, which typically are medicated supplements such as loose meals, pellets and crumbles, are intended for further blending prior to daily, hand-fed use. Type C feeds include complete feeds and minerals or grain mixes fed as a top dress or offered free-choice to supplement the daily ration. VFD orders for Type C feeds specify the medication in grams per ton in a 90 percent dry matter ration.
Minerals medicated with antibiotics may fall under the classification of either Type B or C, Herold says. Veterinarians need to know the status of a given mineral to write a valid VFD and for producers to feed the mineral properly.
Importantly, most minerals containing the antibiotic chlortetracycline (CTC) are Type B medicated feeds and are tagged to be fed as part of a total mixed ration (TMR), with directions to feed daily, Herold says. These supplements are meant to be included in a TMR after obtaining a VFD but are not offered free-choice, and to do so would be an off-label use.
Reports from the American Veterinary Medical Association (AVMA) and American Association of Bovine Practitioners (AABP) have cited some cases of producers pressuring veterinarians to issue VFDs for extra-label use of CTC, such as using CTC formulations labeled for hand feeding in a free-choice application, or using CTC for prevention, control or treatment of footrot or pinkeye.
In some cases, the VFD requirement exposes “gaps” in the options available, such as for prevention, control or treatment of footrot or pinkeye. Some custom feeds or medicated mineral supplements producers used for free-choice delivery in the past may have been off-label and, with veterinarian oversight, are no longer viable options. Flynn says FDA intends to work with industry to identify and address these gaps where producers need additional options for protecting animal health.
AABP Executive Vice President Fred Gingrich, DVM, has received feedback from members over the past few months saying they have received calls from feed mill distributors requesting they sign such VFDs, creating conflicts between the federal regulations and their business relationships.
AABP and AVMA remind stakeholders there currently is only one indication for CTC in free choice feeds, and that is for control of active anaplasmosis. CTC is cleared for prevention of respiratory disease, with products labeled only for hand-fed applications, not free-choice.
In areas where anaplasmosis is endemic, chlortetracycline is administered to cattle to control the disease. In the past, Gingrich notes, cattle owners and their herd nutritionists developed and administered custom feed mixes containing CTC, and many of them may not have known those custom formulations already were subject to different regulations, depending whether they were hand-fed or offered on a free-choice basis.
According to the AABP, as of March 2017, there are only five free-choice CTC formulations approved to be used under that drug approval:
· 8000 g/ton medicated mineral feed from ADM.
· 6000 g/ton medicated mineral feed from Ridley USA.
· 5000 g/ton pressed block product from Purina.
· 700 g/ton pressed block product from Ridley USA.
· 6000 g/ton public formulation from Zoetis.
Gingrich again stresses that, despite previous uses of over-the-counter products, no feed-administered antimicrobials are approved to treat, control, or prevent pinkeye or foot rot.
Laurin and Flynn agree that more questions probably will surface as the seasonal production cycle progresses this year. Cow-calf and stocker operators in particular might encounter questions and need to adjust their practices as they turn cattle out on grass this spring and prepare for weaning and shipping later this year.
Flynn says his office intends to continue its educational efforts and respond to questions as stakeholders adjust and become more familiar with the new rules. FDA/CVM issued Guidance for Industry # 120, which addresses many frequently asked questions about the VFD rules. Flynn says the agency may update or replace that Q&A document as questions come to light.
Compliance and enforcement
Flynn reiterates that FDA’s initial inspection efforts focus on education, rather than penalties for non-compliance. FDA’s field staff are conducting inspections, working through feed suppliers to review VFD orders, and providing instruction to stakeholders when they identify non-compliant medicated-feed purchases or applications. “We need to strike a balance between administrative burdens, access to products, veterinary involvement and flexibility for producers,” he says.
Most producers have at least some relationship with a veterinarian, Flynn says, but they now need to ensure their relationship meets the definition of a veterinarian-client-patient-relationship (VCPR), while making the transition from decades of OTC purchases to veterinary oversight. As the industry continues to adjust, veterinarians have an opportunity to become more involved with their clients’ operations. By establishing the required VCPR, they can, in many cases, find ways to improve health and management programs, reduce the need for antibiotics and increase profitability and sustainability within their clients’ operations.
Stakeholders can submit questions on the VFD rules directly to the FDA by emailing AskCVM@fda.hhs.gov.