January 1, 2017 brought a major change to the U.S. livestock industry, as the FDA’s veterinary feed directive (VFD) rule placed purchase and use of medically important antibiotics used in feed under the control of veterinarians. While many producers were skeptical, veterinarians generally viewed the change as positive, giving them an opportunity to become more involved in comprehensive herd-health programs on their clients’ operations.
Now, a year later, after one full production cycle for beef producers, we can reflect on what is working and where the new regulations continue to create confusion or questions.
In early December, Global VetLink (GVL) hosted a webinar exploring lessons learned through the first year of the new VFD rules. Tyler Holck, with GVL, kicked off the presentation with an overview of some VFD trends based on GVL records. Prior to 2017, GVL processed about 2,500 VFDs per year, for the small number of swine medications requiring a VFD. During 2017, Holck says GVL will process about 125,000 VFDs through its FeedLink system. Of those VFD orders, Holck says 66% were for cattle, 32% for swine, 1% for poultry and 1% for ovine herds. Group size covered by each VFD varied widely, with cattle averaging 1,150 head, swine 7,856 head and poultry nearly 3.5 million head.
Mike Apley, DVM, PhD, from Kansas State University, says initially some producers were confused over the categorization of feed-grade antibiotics. Type A medicated articles are the most concentrated form of feed-grade antibiotics, which are mixed with other ingredients to create Type B or C medicated feeds. A person may purchase, possess, and sell a Category 1 Type A medicated article without registering as a VFD distributor, having a feed mill license, or having a VFD. However, feeding that to animals requires a VFD. Selling a Type B or C medicated feed created from the Type A medicated article requires registration with the FDA as a VFD feed distributor, and the distributor needs a VFD to sell the medicated feed.
Apley adds that some producers remain unsure of how the regulations affect “hand-fed” versus ‘free-choice” use of medicated feeds such as mineral supplements containing a VFD drug. All use of medicated feeds must be in accordance with the product label. A hand-fed label specifies that a fixed amount must be fed every day. You may feed a free-choice feed in a hand-fed manner (daily), but feeding a hand-fed feed in a free-choice manner is an off-label use and is illegal. Apley notes that the American Association of Bovine Practitioners (AABP) and the Academy of Veterinary Consultants (AVC) have formed a task force to help clarify this issue.
Producers have, in the past, used “pulsing” applications with some medicated feeds. Apley stresses that any repeated treatment with a VFD feed requires a new VFD, and must conform with the product label. Some confusion also has centered on the terms “duration” versus “expiration.” A VFD order includes an expiration date, and the covered product must be used before that date. If not, a new VFD is required. Duration refers to the treatment period. If a product label specifies a 14-day duration of treatment and a producer begins the regimen seven days before expiration of the VFD, a new VFD is needed for the next seven days.
Overall, Apley says, the new rules have helped generate collaboration between veterinarians and clients in developing better disease-prevention protocols including vaccinations, biosecurity, nutrition and handling systems to reduce the need for antibiotics, which aligns with the goals of the regulation.
The webinar, titled “Veterinary Feed Directive Implementation: Lessons Learned,” is now available on demand from GVL.
The word from the field
To explore first-hand experiences and client challenges through the first year of the VFD rules, we asked a group of bovine veterinarians around the country to summarize their experiences. The group includes:
- Scott Crain, DVM, VeriPrime, Kansas
- Becky Funk, DVM MS, Nebraska
- Tom Furman, DVM, Nebraska
- John Maas, DVM, California
- Glenn M. Rogers, DVM, MS, President-Elect AABP, Texas
- David Sjeklocha, DVM, Cattle Empire, Kansas
We asked the group two questions regarding their experiences over the first year of the new VFD rules.
Since full implementation of the VFD rules in January, what have been the most common questions, challenges or sources of confusion among your clients?
Dr. Scott Crain: I think the issue was detailed well by the industry to the producers I work with. The most common challenge was making certain that procedures were in place to be certain compliant rations were not accidentally mixed becoming non-compliant. It forced all of us to evaluate our ability and time required to management rations with antibiotics against the value of the fed antibiotic.
Dr. Becky Funk: I would say far and away the mineral issue has been the biggest source of angst for my producers (and myself!). We have feed dealers in the area that are informing clientele that CTC mineral products are still available to them simply by obtaining a VFD from their veterinarian, but aren't willing (or able?) to fully explain to producers the parameters that must be met for usage indications and delivery methods in order to legally use these products. That conversation then falls to us as the attending veterinarian, putting us in the position of having to decide who we irritate most, the client who thinks we're being uncooperative, or the feed salesman, who also thinks we're being uncooperative. Most days it's both individuals. Then for me personally, there is the overarching question of efficacy at this particular dosage level with these products, and lack of data to support their use in cowherds, but this conversation with a client, who has just been told by his feed salesman that it will cure all his problems, is a hard sell as well..
Dovetailing in with this issue, I think enforcement and oversight has been a source of questions for my clients as well. We are, to this time point, not seeing any noticeable enforcement in our region. This is, I believe, contributing to the above issue. Without enforcement for individuals who are filling/providing illegal or questionable VFDs, we risk devolving into the same situation that we were in prior to the VFD, where we have a regulation that is on the books, but never followed. This one just involves more paperwork than the last. This is a source of frustration for my diligent clients who are trying to do the right thing. Why should they put in the effort and deal with the headaches to get it right, when there are no repercussions for those individuals that blatantly flaunt the issue? Admittedly, some days I fall into the same thought patterns; why am I having these tough conversations with producers, potentially damaging my relationships with good clients, when the guy down the road just signs on the dotted line with no concerns?
Dr. Tom Furman: There were a few minor issues figuring out what was needed to make the VFD valid and in compliance with what the FDA required as it was a moving target in the beginning, but the largest complication among clients is just getting them used to the concept of needing the VFD to use some of the products they were used to using without the VFD. The regular clients (especially the feedyard clients), that had a great working relationship (VCPR) with our practice before the VFD rule did not have any problems after the rule went into effect because we had good communication and preparation with them and their consulting nutritionist before January 1, 2017. The biggest challenges have been dealing with people who have not used a veterinarian for much of anything and come into the clinic demanding a VFD without a VCPR because they don't understand the concept of a need for either a VCPR or a VFD.
Dr. John Maas: Clients have asked “What do you mean I have to have a prescription from my vet for this product I have been buying/using for years?” Another request has been “Doc, I want to put CTC out for my calves to prevent anaplasmosis, I need a prescription. Often the operation is not in an anaplasmosis area, calves too young to have clinical anaplasmosis, etc. I suspect they are trying to use the anaplasmosis label to deal with pneumonia, foot rot, or pinkeye, and most will not go for anaplasmosis testing to see what the risk of anaplasmosis really is. These producers tend to go to another vet and ask there. I think the producers are trying to get around the rule and use one labeled use for another problem.
Finally, most clients were caught off guard by the changes, despite all the articles and talks describing the upcoming changes. Apparently they have too many other issues going on in their ranching operations.
Dr. Glenn Rogers: A common concern, challenge and source of confusion for many veterinarians, since the implementation of the VFD, has revolved around medicated free-choice feed formulations. Specifically, this confusion revolves around control of active Anaplasmosis infections with free-choice mineral medicated with chlortetracycline. VFDs are often requested for free choice (versus hand fed) administration. Unfortunately, there are very few approved free choice feed formulations available to address region specific requirements for medicated free choice mineral supplementation that comply with current regulations. Federal regulations regarding medicated free choice feed formulations have not been followed in the past and regulatory enforcement has not occurred.
Since the January 1, 2017 implementation of the VFD, veterinarians have been placed in a difficult situation when attempting to comply with the law while responding to producer and feed manufacturer requests for free-choice feeding practices. Veterinarians attempting to address client health needs are caught in the middle of this situation. On one hand, there are clients requesting veterinary assistance to practically address health concerns as they have in the past and on the other hand, there are increased regulatory requirements created by the VFD and a shortage of properly labeled products that meet these requirements. The American Association of Bovine Practitioners (AABP) contends that using unapproved free choice feed formulations is not an animal health concern, but rather a regulatory issue only.
Recently, the AABP and the Academy of Veterinary Consultants (AVC) created a joint task force to advocate on behalf of cattle veterinarians on this issue. Following is the charge of the task force:
1. Provide educational resources for veterinarians, feed distributors, nutritionists and producers on the issue of medicated free choice feed formulations and the control of Anaplasmosis.
2. Serve as a conduit and liaison between regulatory agencies, the feed industry and producers.
3. Encourage new medicated free choice feed formulation approvals and advocate for streamlining this process at the federal level.
4. Address the challenges and offer solutions for cattle veterinarians, producers and distributors.
Dr. Dave Sjeklocha: We started issuing VFDs a full year before they were required, so we had most of the kinks and questions resolved before it was fully implemented. Most of the confusion we have seen has been centered around the desire to treat a group of calves twice with a feed grade antibiotic (which happens very rarely). Do we need to have a second VFD for those calves? We believe the answer is yes, a second VFD is needed.
Part 2 of this series will include the group’s responses to this question:
Looking ahead, what changes do you expect your clients will need to make in response to pressures for enhanced antibiotic stewardship?