Pains of Change

Anaplasmosis Control Wrapped in VFD Red Tape

Victoria G Myers
By  Victoria G. Myers , Progressive Farmer Senior Editor
Free-feed medicated mineral containing chlortetracycline (CTC) has long been the go-to for producers with a history of Anaplasmosis in their beef herds. The Veterinary Feed Directive (VFD) has put those products out of the reach of anyone who can't or won't establish a Veterinary Client Patient Relationship (VCPR). (DTN/Progressive Farmer photo by Becky Mills)

Bill Yancey is not the kind of cattleman who quietly accepts change—especially if that change means additional costs, government intrusion or loss of product availability. The Arkansas cow-calf producer says the Veterinary Feed Directive (VFD) checks all of those boxes for him.

"I call things like this cubicle laws," he says. "Written by someone in a cubicle in D.C. to justify their job."

Yancey's harsh assessment of the VFD comes in large part because the commercial cattleman is no longer able to buy medicated free-choice mineral to control anaplasmosis in his Charolais and Red Angus cow herd. After confirming the loss of a cow to the blood-borne disease in 2014, he's fed a CTC mineral year round to manage the infection. His frustration at not being able to continue that practice without a VFD is a common complaint. It's certainly something Texas A&M's Thomas Hairgrove is hearing a lot these days.

Hairgrove, Extension veterinarian, is well known for his experience treating and managing anaplasmosis. He's being contacted by producers who are angry they can no longer buy medicated mineral over the counter. Despite the hassle, he says this is not something anyone should expect to see change. Yet, he acknowledges, the transition is painful for some.

"When you have someone who's fed these blocks for years, you have to get them to understand that controlling anaplasmosis is more complicated than throwing out mineral blocks or loose minerals," he adds. "We are trying to do more education on the subject, and talk about management steps we can take to avoid the transfer of the disease."

Hairgrove says a good vector control program is every bit as important as a medicated mineral when it comes to anaplasmosis. He notes that some types of ticks can carry the disease for three generations. Flies carry the disease too, on their mouthparts, but the organism dies soon if not transferred to other cattle. Ticks, however, carry it in their salivary glands where it can replicate. Once an animal is infected, it remains an infected carrier for life. It is important to note that after an animal recovers from the initial disease, though infected, it will not show clinical signs of anaplasmosis.

"Feeding tetracycline helps, but every big wreck I've ever seen with anaplasmosis took place about 40 days after working cattle," says Hairgrove. "Needles and dehorners are very efficient ways to transfer anaplasmosis."

He adds it's important to note you can't eliminate anaplasmosis with a medicated mineral or feed topper, you can only reduce the amount of bacteria in the blood, keeping symptoms of the disease at bay. This becomes especially important if you have an animal with a compromised immune system.

Hairgrove believes it's not unreasonable to ask that anaplasmosis be officially diagnosed by a veterinarian, prior to treating for the disease.

"Producers tell me they can diagnose anaplasmosis and they don't need a veterinarian. But there are other diseases that can cause anemia and mimic some of the symptoms we see with anaplasmosis, including lepto [leptospirosis]. So a good diagnosis matters, and after that it's between you and the veterinarian how often he or she feels they need to reestablish that diagnosis."

One of the questions regarding anaplasmosis is how often a veterinarian needs to "rediagnose" it, prior to writing a VFD—which can be good for up to 6 months. Hairgrove says he believes the answer is going to differ state by state, and possibly in some cases vet by vet.

"I feel if a VCPR is in place and the vet has diagnosed it in the herd, a case can be made that he or she does not have to go back every 6 months and rediagnose," he says. "But you can't reasonably expect to say it was diagnosed in my herd five years ago, and I want the vet to continue writing VFDs based on that."

PRIVACY CONCERNS.

In Arkansas, Yancey says a local vet he's known for 15 years told him to establish a VCPR they would have to do a site survey, count number of head and provide GPS coordinates of the Washington county ranch. "That would cost me $175," reports the producer. "To write the VFD would be another $50."

And it's not simply a question of cost. Yancey says he sees this as another example of government intrusion into the lives of rural people. He's concerned where the data is going the vet must collect. According to the VFD, part of establishing a VCPR and writing a VFD is the responsibility of keeping records for a minimum of two years. Those required to keep the records include the producer, the veterinarian and the feed store or mill that fills the VFD.

In Yancey's case his local feed store opted to stop carrying CTC medicated mineral. Dustin Denton helps run the family-owned store where Yancey has been doing business for years, Red Barn in Westville, Oklahoma. He says they decided the kind of records they would have to keep for the VFD would be a "hassle and a headache" and they weren't even sure they would be able to maintain those records at an acceptable level. He believes the producers hurt the most by the rule are small operators.

"From what I've seen they are the ones most impacted," says Denton. "Large producers often have a staff veterinarian or the means to hire one to write a VFD. The mom and pop operations can't do that. Maybe they have one calf, some backyard chickens or they keep bees. They can't understand why they need a $100 vet visit to buy a $6 package of antibiotic. It's frustrating for them, and it can mean they don't have what they need to keep their animals healthy."

Denton says reactions from his customers have ranged from an inability to understand the new requirement, to what he simply describes as "a lot of eye rolling".

Meanwhile, Yancey says he continues to reach out to government officials encouraging clarity and changes, or exceptions, to the VFD for cow-calf operators. He says he doesn't understand why CTC, which has no withdrawal period, would even be under the VFD.

William Flynn, deputy director for science policy at the FDA's Center for Veterinary Medicine, says the VFD designation is not driven by whether or not a withdrawal period is required for a given drug intended for use in animal feed.

"The FDA may designate a feed-use drug as VFD if it determines that the safe and effective use of such product requires the supervision of a licensed veterinarian," he says.

In the case of those medically important antimicrobials affected by the VFD (Guidance #213), which include CTC, he says the FDA determined oversight was needed to mitigate antimicrobial resistance safety concerns.

As to whether the VFD may be altered, especially concerning the responsibilities of cow-calf operators, Flynn says "it's too early to speculate about future actions or policy decisions."

He notes, however, the FDA is currently using a "phased-in compliance strategy."

"Under this strategy, we are placing our initial focus on educating affected shareholders on the new requirements before taking enforcement action," Flynn explains. "As part of this initial education phase, the FDA is also working to address challenges that arise in association with implementation of the new VFD requirements."

This first year he says much of the focus will be on making sure veterinarians, distributors and livestock producers know and understand the VFD regulation. And while Flynn says "general surveillance" is ongoing, he adds inspections will be "risk-based for cause." He says enforcement will be in collaboration with state regulatory partners and state boards of veterinary medicine.

Easier Transition.

The move to the VFD has been a little smoother for Tennessee cattleman, Don Bailey. Based near Jackson, the seed stock producer runs 150 head of mostly recip Black Angus cattle. He lost three cows last year to anaplasmosis, after switching off of a medicated mineral in the hopes the change would improve conception rates on the herd.

"We got our veterinarian, Nick Todd, out here and vaccinated all of our donor cows for anaplasmosis. That was two shots. Then last year we went in and gave LA300 to all our recips. And we got back on a program to feed CTC year round in our mineral," he says. He also has a fly control in the mineral, uses Long Range dewormer and ear tags to minimize the impact of high tick and fly populations in the area.

Bailey's veterinarian is on staff with First Farmers Co-op, a part of Tennessee Farmers Cooperative. He is one of two veterinarians in the state that work with co-op members like Bailey, and then facilitate filling any VFDs they write through the co-op. It's a system that has provided a reasonably smooth transition for both the producer and the veterinarian. Both are satisfied with the new system, though not excited about the additional paperwork.

Todd explains he works with customers from stores in 4 counties in the western part of the state. There is also a vet on staff in the eastern part of Tennessee.

"This is just another bar to doing business," he says. "I work with a lot of stockers, as well as cow-calf producers. They want to use CTC in their starter feed. They call me, I consult them and I'm there every couple of weeks. So we are all on the same page. I take care of what they need with their custom mixer or feed supplier. So there's not an issue there. My biggest problem with the VFD is interpreting the rule."

Todd says the VFD notes CTC can be used to control anaplasmosis only in herds in an "active state" of infection. That can raise questions.

"Nothing on the VFD says you can feed CTC to prevent anaplasmosis. So you have to have an active infection, and that is open to interpretation to some degree. I can't write a VFD to prevent this. Even if you cleared it up with injectable tetracycline and got rid of all the carriers in your herd, the tick population is so high your cattle are just going to be reinfected before the season is over."

Todd adds he's seen people who have fed CTC minerals for years with no proof they've ever had anaplasmosis in their herds. In cases like these he says he's being conscientious and trying to follow the FDA's rules as closely as possible, noting: "It's my license on the line."

Asked what information he requests from producers to establish a VCPR and write a VFD, Todd says he has his own form. It includes producer name, date of the farm visit, location where the cattle being treated are kept and the number of head he is writing the VFD for. He makes sure directions are written and explained verbally and then he and the producer sign the form. He doesn't ask for GPS coordinates.

As for where the information goes, Todd says there is no regulation that tells him to turn this information in to the FDA. His only responsibility is to keep the VFD for 2 years so it is available should someone from the FDA want to see it.

The Back Story. Even amid today's strong anti-regulatory climate, supporters of the VFD contend the rule is far better than the alternatives.

Zoetis manufactures the only CTC product on the market today with a free-choice label: Aureomycin. That company's director of regulatory affairs, John Hallberg, has followed the process of writing and establishing the VFD from the beginning. He believes FDA wants the VFD to work as bad as anybody else.

"Their reputation is on the line because they were asking for this to happen voluntarily," he says. "They provided an opportunity to make these changes voluntarily, instead of doing it by edict. In truth, that was the better way to do it, rather than forcing it down people's throats. They gave us time to get ready."

Hallberg says hundreds of educational meetings at the local and state levels preceded implementation of the rule, but adds they continue to work through some labeling questions. Asked why CTC, which has no withdrawal period would even be included in the VFD, he says it goes back to the original treatise on antibiotic use in food animals, which covered any antibiotic given in feed or water.

"Through all of the time this was being developed, according to regulation and the law, it was illegal to use these products in an extra label manner. So using CTC for pinkeye or foot rot, for example, was already illegal. But because these products were available over the counter with no veterinary oversight, a lot of extra label use was going on between cattlemen and feed mills."

He stresses the ability to use CTC to treat or prevent anaplasmosis "is still very much there—but you have to follow instructions on the label. That is the sum and substance of the issue."

And Hallberg says that even though CTC does not have a withdrawal period, there is the possibility that misuse of the product could create antimicrobial resistant pathogens in a herd. He notes a cow could be culled at any time and wind up hamburger, and she could carry those resistant pathogens with her to harvest.

Asked if the FDA ever considered separate requirements based on sector of the beef industry, he says there was never any discussion along those lines.

"You don't differentiate for any class of livestock on a critically important antimicrobial," he says. "The FDA was not trying to pick on cattlemen. There were detailed discussions with the agency on the ability of people to treat for anaplasmosis. The VFD is here to stay, it will remain in force. The agency is not going to back off."

Hallberg adds they are continuing to work with labeling and developing products with free choice formulations for anaplasmosis. He asks for patience from producers, and says he believes the process will become smoother and people will be able to get back to the business of raising cattle without the day-to-day worry over this regulation.

"At the end of the day we have to make this work. If you look at the livestock industry as a whole, the poultry folks don't have an issue with this. The hog producers have less of an issue; and feedlot operators have less of an issue. It's the cow-calf producer, the backgrounder and the stocker feeder where the problems are coming up."

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EXTRA CONTENT FOR DTN READERS:

Anaplasmosis Facts

A vector-borne, infectious blood disease anaplasmosis can kill cattle quickly once 15% or more of red blood cells are infected and the animal becomes seriously anemic. Here are some quick facts about the disease:

CAUSE. A bacteria that infects red blood cells, causing severe anemia, is the reason for anaplasmosis.

HOW IT SPREADS. Anaplasmosis spreads through blood, making any blood carrier (ticks, flies, needles, dehorners, etc.) a means of introducing the disease.

TREATMENT. While some believe the infection can be cleared in a herd through injected antibiotics, that approach is now questioned by many veterinarians. Reinfection is thought unavoidable due to tick and fly populations. Some ticks can even pass the infection between as many as three generations. For this reason, many veterinarians do not consider it reasonable to try to "clear" a herd of anaplasmosis.

PREVENTION. Several fronts to this battle have to be waged. There is vector control; awareness of the importance of cleaning/disinfecting tools like needles, dehorners and castrators; and even a vaccine. The vaccine does not prevent anaplasmosis, but is a management tool.

MANAGEMENT. In many cases symptoms of anaplasmosis can be managed by feeding a medicated mineral containing chlortetracycline.

Global Antimicrobial Policy

The implementation of the Veterinary Feed Directive back in January brings U.S. livestock producers into a growing global community. Some countries have implemented antibiotic resistance management programs, some are phasing out antibiotic use in food animals and some are requiring the equivalent of a prescription for producers to purchase and use these products. In many cases the ideas are voluntary in nature, with little to no oversight. American consumers concerned about antibiotic use in their food, however, cannot determine country of origin in most cases.

Europe. The EU banned the use of antibiotics for growth in 2006. In 2011 they voted to ban use of them for prevention of illness in food animals. The EU collects data on antimicrobial use and resistance in animals.

India. There is a required withdrawal period for use of antibiotics in food producing animals expected to be part of the export market. Many antibiotics require a prescription and documentation is subject to review. Antibiotic residues are monitored in eggs, honey, milk and poultry for export.

Australia. Antibiotic use in food animals is tightly regulated. The products must be prescribed and their use overseen by veterinarians. All label and permit requirements must be followed. Records are maintained to trace treated livestock.

Canada. Antibiotics are no longer used for growth promotion, but they can be used for prevention. Labels have removed claims for growth promotion to bring products more in line with U.S. policy. The label changes are expected to force the use of prescriptions for more antibiotics like those added to feed. The policy is voluntary.

China, Russia, India, Brazil, South Africa. A study published in the Proceedings of the National Academy of Sciences, projects a 67% increase in use of antibiotics in livestock. The report noted these countries will make up 99% of that increase.

*Sources: Center for Disease Dynamics, Economics & Policy; Australian Lot Feeders' Association

For more information:

VFD Producer Requirements: https://www.fda.gov/…

VFD Requirements for Distributors (who manufacture VFD feed): https://www.fda.gov/…

VFD Requirements for Distributors (who do not manufacture VFD feed): https://www.fda.gov/…

VFD Requirements for Veterinarians: https://www.fda.gov/…

Anaplasmosis Vaccine: http://www.Anaplasmosisvaccine.com/…

Zoetis: https://www.zoetisus.com/…

(SK)

Victoria Myers