by Sally Colby
Consumers are more aware and concerned about the use of antibiotics in livestock than ever before, and some of those concerns are valid.
Dr. Mike Apley, boarded clinical pharmacologist and professor at the College of Veterinary Medicine at Kansas State University, says that many factors led to the veterinary feed directive or VFD; a topic of much discussion lately among livestock producers.
“It all started back in the 1960s with the concerns about the use of antibiotics in feed for livestock,” said Apley. “There have been numerous reports and studies through that time, waxing and waning, and interest continues to build now.”
Apley explains the Guidance for Industry #209, ‘The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals’ came out several years ago. “The way FDA ‘talks’ to us is through guidance documents,” said Apley. “This is a guidance for industry; we in the pharmaceutical industry being the industry.”
There are two main points made by the FDA in #209: we don’t think the use of antibiotics for growth promotion is a judicious use. “They use the term ‘judicious’ because they get to define that rather than using the term ‘hazard’, which comes with a regulatory cascade,” said Apley. “The second thing they said is that all antibiotics that are used in feed and water for livestock are going to be veterinarian-controlled.”
So while producers can now purchase a bag of medicated milk replacer, medicated feed, medications to put in the feed or medication to put in the water, that use is being viewed as not enough control in regard to antibiotic resistance.
“After much discussion, in 2012, the final version of Guidance #209 came out,” said Apley. “Then they needed to give us a road map on how to accomplish Guidance #209, and that’s Guidance #213.” Apley says that #213 includes directions for feed companies to open up the labels that are affected and remove any growth promotion claims, which are claims strictly for increasing feed efficiency or rate of gain without any disease prevention, control or treatment. There are 26 companies affected and 283 products, although many products are generic copies of one another.
“The clock started ticking this year,” said Apley, “and these companies are expected to have complied by December of 2016 — that’s when all of these changes will come about. There will be required veterinary oversight, meaning that producers can’t just purchase them over the counter, and no growth promotion claims will be allowed.” Apley added that medications have been categorized according to their importance in human medicine.
There are several important exceptions that will allow the continued use of certain products, one of which is ionophores. “Monensin, or Rumensin®, is one example,” said Apley. “Bambermycin, which is Gainpro®, would be exempt because there’s no indication that they are related to anything used in human medicine.” Bacitracin, which isn’t used much, and Tiamulin for swine are also excluded.
Product use which will no longer be allowed are any labeled inclusion, such as in milk replacer or feed, that has a growth promotion claim — so milk replacers or feed will no longer include wording that indicates the product is useful for growth promotion.
“So only for increased feed efficiency or improved rate of gain,” said Apley. “Unless they’re able to show, for example, that 10 mg/head/day, which is the growth promotion claim, has an effect in preventing or controlling disease. But they’re going to have to bring the data to the CVM to show that, and it would probably require additional work.”
Apley says there’s a carrot on a stick for feed manufacturers: they can pull the growth promotion claims and add wording that states ‘we are going to require veterinary oversight.’ “One example of where veterinary authorization will be required will be the use of oxytetracycline or chlortetracycline in the feed of newly arrived calves at 1 gram/100 pounds/day,” he said. “That’s a therapeutic claim, not prevention or control, and not growth promotion. You can still use it, but you’ll have to have a veterinarian provide the veterinary feed directive.”
The VFD will require vet supervision or oversight, and the FDA Center for Veterinary Medicine is leaving the definition of veterinary oversight up to the states. “Each state can decide how they will define that,” said Apley. “It can go as deep as how often a veterinarian has to examine the animals or talk with the owner, or more superficial. The directive will probably result in veterinarians being on the farm more often, and the vet will be responsible for maintaining the tools we have today in a judicious manner.”
The directive will require oversight — how will we get it done and still be able to carry on business? One concern that has been raised is the case of the producer who needs veterinary authorization prior to the addition of a drug in a feed but can’t reach his veterinarian for that authorization. Apley stresses the importance of farmers and ranchers developing and maintaining a working relationship with their veterinarian and allowing him to become accustomed to the day-to-day workings of the operation.
Apley noted the VFD requires a valid client patient relationship (VCPR), and producers must have paperwork and documents in order and up to date. “It’s nothing different from what’s in place now to purchase a prescription injectable,” he said.
The final rule will go into effect in December 2016; however, if an individual label is approved before that, the rule may go into effect sooner for that label. Apley suggests now is the time for producers to discuss with their veterinarian every drug that they’re currently using or may use in the feed or water so they can plan for the future.