THE REGULATION TOOK EFFECT JAN. 1, 2017 BUT PRODUCERS, DISTRIBUTORS AND VETERINARIANS MAY STILL HAVE QUESTIONS
One of the most dramatic regulatory changes in how antibiotics are used in animals – the veterinary feed directive (VFD) – is finally here after years of anticipation. Yet, stakeholders across the industry may still be learning the best way to deal with the additional paperwork and processes.
“The goal is to ensure antibiotics are used responsibly and veterinarians are involved in that decision,” says Kerry Keffaber, DVM, advisor for scientific affairs and policy at Elanco. “Over the last three years, people have taken the opportunity to identify their veterinarian, talk to their supply chain and work to review their overall health program to modernize it. The outcomes are moving in the right way. The connections between the parties have deepened. About 95 percent of people are aware of the regulation, and 90 percent of their questions have been answered.”
As the ruling takes effect, Keffaber says everyone is working to ensure operation-specific processes are in place to ensure compliance. Each stakeholder is likely to have specific questions about the VFD based on their needs and role.
First, veterinarians should make sure they have talked to their clients and addressed any individual issues, Keffaber recommends. Typical last-minute veterinary questions he’s fielded included how to ensure the veterinarian-client relationship (VCPR) is valid.
The American Association of Bovine Practitioners (AABP) recommends producers and veterinarians have a written agreement for working relationships; establish a veterinarian of record and define relationships with consultants and other veterinarians – among other suggestions.
In addition, veterinarians may have questions about how to write a VFD so that it is practical and still meets the goal of the process. Any veterinarian writing a VFD must be licensed in the state the animals will be treated in, Keffaber notes.
Feed medications included in the VFD process are treated differently than water soluble or injectable medications used under a prescription, notes Phil Lawler, feed industry expert for GlobalVetLINK. Prescription drugs can be used extra label if it’s the veterinarian’s opinion that the drug will benefit the animal.
“VFD drugs are not allowed to be used extra label,” he says. “Minor species is the one exception from that. If a vet determines a feed antibiotic is the only treatment choice for a minor species, he or she could write a VFD with an approved dosage and indication with an approved dosage and indication for an approved major species like cattle and include in the special instructions that the feed will be used in a minor species like sheep or goats. This process allows the feed to be adjusted for the nutritional needs of the minor species. For instance, some minerals can be toxic to sheep or goats at the level required for cattle.”
In December, the U.S. Food & Drug Administration released a revised Compliance Policy Guide about the extralabel use of new animal drugs approved for use in, or on, medicated animal feed for minor species animals to help clarify how these situations are handled under the VFD.
Distributor and supplier questions
The business needs of distributors and veterinarians around the VFD go beyond document management and storage, Lawler notes. The VFDs themselves need to be stored for two years, but it’s also important to retain VFDrelated communications, delivery notes, feed volumes and anything outside the norm that is related.
“The approach of just storing documents is short sighted,” he says. “You may need to explain the circumstances related to that VFD and the resulting feed orders two years from now. Veterinarians and feed distributors need to keep more complete VFD records – anything that led to their decision to use that drug, why animals needed to be retreated, variations in the feed volume for dosage, etc.”
Lawler also notes that the FDA removed the regulation on the specific volume of VFD feed to be fed. This allows flexibility for changing circumstances that impact the volume of feed required; such as the impact of bad weather on feed intake. A VFD is the authorization to purchase and feed a VFD drug. It is not intended to replace the feed order process.
“The FDA expects feed distributors to sell a ‘reasonable amount of feed’ but has not specified what would be considered excessive,” Lawler says. “It’s like a 55 mile per hour speed limit. If the highway patrol comes out and says it’s now acceptable to drive five miles per hour over, everyone would go faster.”
Distributors handling multiple customers often want to know when they will need the actual VFD form to fill an order promptly for the producer.
“Communication with customers about how this is going to work will be critical,” Keffaber notes. “If you get an order late Saturday afternoon, the distributor may need the VFD on Sunday, and the mechanics of how each business work may not allow this to happen smoothly. We need to make sure we have adequate time between feed delivered and VFD supplied so we can make sure we’re compliant.”
Kim Bridges, DVM, Appalachian Veterinary Services, Inc. in Christiansburg, Va., says customers using chlortetracycline (CTC) in minerals to help treat footrot and pinkeye will be most affected by the VFD ruling, as none of the products are labeled for such. She also serves as a residue avoidance consultant for the Virginia Department of Agriculture and Consumer Services, and her practice had already instituted VCPR policies and are having them signed for additional documentation.
“Most clients have been receptive, and proactive in getting us out on the farm so that they can be in compliance,” Bridges says. “The biggest misconception that I hear is that farmers are certain this is being driven by veterinarians. I also hear concern that the farmers won’t be able to get any type of antibiotic – that all antibiotics are involved and pulled from the shelves. I think this has been by far the biggest mass misunderstanding by the public.”
Bridges is working with her clients to help ease those misunderstandings as the ruling takes effect.
Another misconception is that a medicated feed that falls under the VFD will be subject to the regulation no matter when the labels were created, Keffaber notes.
“Producers cannot buy in bulk,” he says. “Even if they think ‘I already have this on hand with the old label on it.’ That’s not taking responsibility to do it right, and it’s not an option.”
Keffaber says he feels most producers have accomplished the big picture tasks associated with VFD compliance. Now the questions are unique and flexible to the operation.
In addition, there is still some confusion around the different types of VFD drugs, Lawler notes. Type A products are the concentrated form of the VFD drug as manufactured by the drug sponsor and cannot be fed directly to animals. Type B VFD feeds include the medication in a less concentrated form, such as a vitamin-mineral mix with antibiotics. This type is still not a complete feed. Finally, a Type C is a complete feed with a regulated antibiotic included at the intended feeding rate.
“A Type A is considered a medicated article, and Type B or Type C are considered medicated feeds,” Lawler says. “Producers can buy a Type A article from a feed distributor without providing a VFD because it’s considered inventory intended for on-farm mixing. The FDA doesn’t want to slow down the process of treating animals.”
Outside the industry, there is some concern about producers “loading up” on Type A medications and getting around the regulations, which is unfounded as since producers still need a VFD from their veterinarian before actually feeding the VFD drug in a complete ration. In addition, distributors sometimes think they should get a letter of acknowledgement from the producers purchasing Type A products for on-farm mixing.
“Unless the producer is selling to other producers – in which case they should register with the FDA – they do not need to provide a letter of acknowledgement,” Lawler says. “In fact, this could make them subject to other distributorlevel inspections, and distributors are held to a different standard of documentation than an on-farm mixing facility.”
Feedback from the Center for Veterinary Medicine (CVM) indicates initially that selective enforcement and education will be in place to help producers and the supply chain comply with the VFD, Keffaber says.
“Feedback has been they will look at an error and determine if the intent was to comply,” he notes. “There is a difference between intentional and clerical error.”
Keffaber recommends looking at models for how to take the VFD form and validate the process through the veterinarian and producer to make sure all parties are using the forms properly.
While he has confidence in the industry to tackle this challenge, Keffaber says that skepticism may come from the food chain, consumers and other organizations.
“I’m confident everyone involved will collaborate and see this as a great opportunity to step up and show we’re doing the right thing, using these commodities effectively,” he says. “Retailers are watching and appropriately so. People want to know more about their supply chain.”
For more information on the veterinary feed directive, read:
• “Treating Disease Through Feed” in the December 2015 issue of Vet-Advantage
• “Veterinary Feed Directive (VFD) Regulation Update” in the May 2016 issue of Vet-Advantage
- The veterinary feed directive (VFD) took effect Jan. 1, 2017.
- The process is not voluntary. It is mandated.
- Veterinarians and producers should ensure they have a valid veterinary-client relationship (VCPR).
- End users only need a VFD, never a letter of acknowledgement.
- All parties must store the VFD for two years.
- In addition, distributors and veterinarians should consider keeping additional correspondence related to any changes to the VFD issued.