Ready For Change? New FDA Guidance Will Alter Cattle Feed Additive Usage In Your FeedyardReady For Change? New FDA Guidance Will Alter Cattle Feed Additive Usage In Your Feedyard
New FDA guidance will require a veterinarian’s authorization to include antibiotics in feed and water, offering new opportunities to further the client-veterinarian relationship. BEEF Vet explains how a hands-on strategy with your producers' feeding programs will be a top priority.
June 3, 2013
Having a more hands-on strategy with your producers’ feeding programs has never been more important. In fact, soon the Food and Drug Administration (FDA) will likely require this topic zips to the top of your to-do list.
Undoubtedly, compliance will involve additional paperwork. It also offers an opportunity for veterinarians, producers and nutritionists to work together to reevaluate feeding strategies—getting ahead of the curve on the impending FDA guidance and potentially improving producer profitability and animal health.
Before the end of the year, it’s expected the FDA will finalize “Guidance for Industry” (GFI) No. 213, which will define the procedures for achieving the goals of GFI 209. The two intended outcomes of GFI 209 are: Removing growth promotion claims, and adding the requirement for veterinary authorization of feed and water uses for antibiotics important in human medicine. However, it’s expected these products will still retain their approved uses for prevention, control and treatment of livestock diseases.
While the final FDA guidance is expected to occur this year, a period of transition will allow all involved to make adjustments. Getting involved in clients’ feeding strategies now can give you, and your clients, a jump on the regulation.
How To Get Involved
“Many veterinarians haven’t been routinely involved in usage of these products, and they are going to need to be very much involved in the future. Now is the time to learn the jargon around the feed mill industry and how to prescribe products going into feed,” says Sam Ives, DVM, Associate Director of Outcomes Research with Zoetis. “We’ve got to educate ourselves so when we do have questions asked of us, we are knowledgeable and confident.”
One step in getting involved is to simply be present when feeding decisions are being made. When meetings with the nutritionist are held, joining around the same table can contribute to a collaborative atmosphere. This can also help avoid misinformation before it starts, notes Dr. Ives.
“We have traditionally always been in the discussions around animal health, but we need to get better about talking production and closeouts,” he says. “That’s what nutritionists excel at. What we can bring to the table is epidemiological tools—helping make better decisions as to what animals are at greater risk for a BRD [bovine respiratory disease] outbreak and would benefit from treatment or control efforts in the feed, for example.”
While veterinarians can certainly add a new perspective to a customer’s feeding strategy, the new dynamic will require more communication and time to work out the kinks, advises Doug Hufstedler, Ph.D., Nutritionist and Beef Technical Advisor for Elanco Animal Health.
“Think of the VFD [Veterinary Feed Directive] process as three cogs in a multi-gear system,” he says. “The producer is the one with the animals that may need to be treated. The veterinarian will be responsible for health protocols and VFDs. The nutritionist will have to implement the VFD into the producer’s feeding program. When the gears are talking, working and staying in communication, the process of the future will work much more smoothly.”
Focusing on a beef production systems approach can help set the stage for a cooperative discussion, Hufstedler recommends.
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“The animal health protocol a vet implements will be more successful when combined with a very well balanced, high quality nutrition program,” he says. “Vets and nutritionists working together can often create an optimal result for producers.”
As veterinarians and nutritionists work more closely, Hufstedler believes the animal health benefits of feed additive products will be reawakened in the minds of producers.
“Sometimes people have forgotten the health impact,” he says. “For example, most people associate Rumensin® with the performance impacts—feed efficiency with feedlot animals and mature cows as well as improved average daily gain in stockers. We often forget to reinforce the impact it also has on disease by preventing and controlling coccidiosis in all stages of production, which is actually how it came to the marketplace.”
Back to the Books
For many veterinarians, stepping into this arena may require additional education. It is anticipated manufacturers and other organizations will offer continuing education courses after the final FDA guidance is published. In the meantime, it can be beneficial to brush up on product labels and feeding guidelines.
For example, Dr. Ives recommends brushing up on feed intake, which can affect how much antibiotic (if present) is ingested by a given pen of cattle.
“The veterinarian has to make a decision on the concentration for the product placed into the ration knowing we’re going to have cattle that are eating four-to-six pounds of dry matter in a starter ration versus other cattle that will consume 20 pounds of dry matter,” he says. “Those are not simple issues to evaluate, but there are options available that would not necessarily include the product in the mixed feed, such as top dress. We need to work with the nutritionist to take into account the efficiency of feed delivery as we establish our recommendations for medicating the cattle.”
Just like traditional prescriptions, veterinarians should be aware of withdrawal times. In addition, some products cannot be combined unless specific approval is granted.
Another important distinction between traditional prescriptions and a feed directive is the lack of extra-label uses available for feed additives, even when a valid client-patient relationship is present. For instance, a veterinarian will not be able to increase (or decrease) dosage of an in-feed antibiotic beyond the label, unless a dose range is included on the label.
“With a VFD, a veterinarian must write the directive at a dose within the approved dose range of the label as well as complete a combination use section, if one exists,” Hufstedler notes. “Off-label use, which includes extra-label use, of feed additives is strictly prohibited.”
Impact To Stockers
The FDA guidance may require more changes for the veterinarian-stocker relationship. The need for veterinary authorization of feed or water uses of antibiotics will likely require more frequent interaction to renew the order and more on-site visits to confirm the disease is treated or controlled.
“So many stocker operations do not have veterinarian involvement,” Dr. Ives says. “The prescription of product to a feed is very specific to a group of cattle. The prescription may last only 45 days and is specific to the pounds of feed to be manufactured. Most stockers are constantly having cattle coming and going, making it more difficult for veterinarians to stay on top of what’s going on in that operation.”
New FDA guidance will require a veterinarian’s authorization to include antibiotics in feed and water, offering new opportunities to further the client-veterinarian relationship.
Denis Matousek, DVM, owner of Matousek Veterinary Clinic in Hennessey, OK, serves mainly stocker and cow-calf clients. He believes the main product affected by this guidance will be Aureomcyin,® which his producers use to control anaplasmosis. He anticipates his clients’ ability to purchase treated mineral or feed quickly will be hampered.
“If you have a herd that has broken with anaplasmosis, the mineral or feed—that has in the past been readily available in feed stores—will no longer be at the feed store. If we see a client in our office and suspect anaplasmosis based on a conversation, we will have to see an animal or visit the farm, write a feed directive and have the producer fill the order,” Dr. Matousek says. “Producers need to have a good relationship with their local veterinarian.”
While the final guidance is still being worked out, Hufstedler says pre-made and warehoused VFD feeds may be available at the local feed store, or stored on an individual ranch, depending on internal policies of the feed company. To purchase the feeds, a producer would need a valid VFD. Hufstedler also believes veterinarians would be able to write a VFD without an on-site visit if the veterinarian and the producer have a valid client-patient relationship in place, including written protocols to establish triggers for use of a VFD feed.
In any event, it will take additional effort from veterinarians, producers and feed companies beyond what is required today. While Dr. Matousek has concerns about the delay in treatment caused by the FDA guidance, he welcomes the increased client contact it will offer.
“We will have to have more contact simply to make these directives legal,” he says. “What you talk about in December is different in July. We’ll see clients more often, go to their place more often—not just for this, they are getting more benefits in that visit. For instance, I’ll look at bunk space and water availability while I’m there. There are a lot of simple things. The veterinarian can bring more than just the feed directive. It’s a chance to get to know our clients better.”
No End To Scrutiny
Even with this round of regulation from the FDA, the scrutiny on antibiotics is not over, notes Mike Apley, DVM, Ph.D., DACVCP, Professor at Kansas State University’s College of Veterinary Medicine. To maintain prevention and control uses for feed and water antibiotics, the first step the industry can take is to undergo critical, scientific research to prove the benefit and return on investment.
“Prevention and control is high-profile use that’s going to be scrutinized,” Dr. Apley says. “We’ve seen state and national bills that try to outlaw prevention and control use. We as an industry—be it swine, poultry or beef—need to evaluate and see if we’re still getting the benefit we think we are. We need to reevaluate for ourselves whether those things are really doing anything for us.”
Dr. Apley says aging research on the economic benefit has led to automatic use patterns, which may not hold up for some antibiotics in today’s environment.
With the change in culture required by the new FDA guidance, there is an opportunity for veterinarians to participate in research quantifying the benefit to animals, and therefore the return to producers.
“We need to get our ducks in a row on which feed and water uses actually produce a result that is acceptable,” he says. “We need to understand the potential positive and negative effects of some of the drugs that were approved in the 70s and see if they still provide the same results in today’s systems. We need to apply the same standard of evidence we have now. Not only to respond to consumer and government concerns, but for ourselves. Do we need to be spending this money, and potentially applying a selection pressure we don’t need to be doing?”
Modernizing The Veterinary Feed Directive Process
The FDA also is looking to modernize the Veterinary Feed Directive (VFD) process, and veterinarians using Pulmotil® have already experienced a more “modern” process, notes Doug Hufstedler, Ph.D., Nutritionist and Beef Technical Advisor for Elanco Animal Health.
“It’s a therapeutic BRD treatment in feed but requires a veterinary directive to put the product in the feed,” he says. “We do have some experience in that process already, and our job is to help educate the industry on how that’s impacted.”
The timeline on implementation for other products is still being determined by the FDA, but Hufstedler encourages veterinarians and nutritionists to attend hearings regarding the VFD modernization in their area and provide feedback.
“One thing is clear: There will be a much greater degree of cooperation required from producers, nutritionists and veterinarians. The time requirements for a VFD is one area we’re keenly aware of—how often does the VFD have to be written for a particular facility that uses the product. Our hopes are to streamline the process and make it a relatively easy communication between the producer, vet and nutritionist, one that is paper free and as smooth as possible.”
Hufstedler says the process in place for Pulmotil enables veterinarians to write a VFD electronically, which is then transferred to the feed mill and automatically sends a copy to the producer’s facility where the animals covered by the directive are located. In each case, the electronic system (eVFD) sends and maintains the FDA-mandated records for the veterinarian.
“Eventually the industry will figure out how to get this done in a timely fashion, and we’ll keep producing healthy cattle and high quality beef.”
What's Going to be Affected and When?
Currently, “Guidance for Industry” (GFI) 213 is being finalized. This defines the procedures for completing the goals of an earlier guidance, GFI 209, which is final and states the following:
Pharmaceutical companies will be asked to voluntarily remove production claims such as “improved feed efficiency” or “increased rate of gain” and, where appropriate, revise labels to include only those scientifically supported disease control and treatment uses.
Companies will be asked to inform the FDA of their intentions to engage in this voluntary process within three months after the final GFI 213 is published.
Only antibiotics that are deemed “medically important” for human health will be affected.
Affected products can be used in feed or water only on the order of a veterinarian for control, prevention or treatment of disease.
Ionophores are not used in human medicine and will not be affected.
Evaluation of progress towards the goals of GFI 209 will occur three years from the date of the publication of the final GFI 213.
GFI 209 is not a regulation. It is guidance asking for voluntary action.
After GFI 213 is finalized, continuing education classes are expected to help producers, nutritionists and veterinarians familiarize themselves with the ruling.
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