Start getting ready, because we're quickly approaching the time when antibiotic usage in livestock will be seriously curtailed.
In December 2016 many antibiotic/antimicrobial products will disappear from the market and/or come under requirements for a veterinarian to prescribe them, says Mike Apley, professor of veterinary medicine at Kansas State University.
Under the rules, which have been in evolution since first proposed in the spring of 2012, veterinarians, producers and those who distribute or use feed or water containing "medically important" antibiotics will be required to work more closely together to assure the products used are indeed the best treatment option. Also, the growth promotion uses of many products will be eliminated.
Antimicrobials which the FDA calls medically important are those also used in human medicine.
These changes have huge quantitative effect, as 2012 US data showed 70% of all medically important antimicrobials administered to food animals were fed and 29% of all medically important antimicrobials were administered to food animals through water. The same data shows 97% of those medically important antimicrobials were sold over the counter.
Further, these medically important products make up 61% of the entire amount of antimicrobials used in the food-animal industry.
These significant changes were instituted as FDA's Guidance for Industry #209. Guidance for Industry publications are the way FDA talks to the industry, Apley explains.
The first principle stated in Guidance 209 is that the use of medically important antimicrobial drugs in food-producing animals should be limited to uses which are considered necessary for assuring animal health -- hence the elimination of growth promotion.
The second principle stated in Guidance 209 said, "The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation."
The specifics of how to make this happen is evolving so that after December 2016, uses of these products will require veterinarian authorization in the form of a Veterinary Feed Directive (VFD), or in the case of water-soluble products, a prescription.
This means many products currently on the shelves of feed and farm stores will not be there after December 2016, Apley says. The new rules will eliminate over-the-counter sales of water-soluble antimicrobial products and things such as medicated milk replacers. It also means you can no longer just order up a batch of medicated feed from your local feed mill.
These actions result from FDA's Guidance 209 are worked out further in Guidance 213. Beef Producer first covered the these scope of these changes from Guidance 209 in this November blog.
Apley explains that the list of which drugs are deemed medically important was determined by "expert panel" managed by the Center for Drug Evaluation and Research within the FDA. Further, there are ties and cross-pollination between FDA and the World Health Organization, which has its own list of medically important antibiotics. The list of medically important drugs can be found in Appendix A of Guidance for Industry #152.
As an example of what the upcoming changes will do, this means ionophores such as Bovatec and Rumensin will not be affected because they are not medically important, Apley explains. However, products such as Pulmotil, which is from a family of antibiotics used in human medicine, already is regulated and will continue to be limited. Producers who want to feed such medically important antimicrobials with need a Veterinary Feed Directive, which is similar to a prescription, from their veterinarian.
Apley adds that over-the-counter injectible antimicrobial products such as penicillin will stay on the shelves in the short run but he suspects they could fall to regulatory pressure sometime in the future, as well.
So, how will this affect you?
If you need to use feed-additive antimicrobials you will need to have a VFD on file with your feed mill. If you use water-soluble antimicrobial products you will need a prescription. The exact life of these documents has not been established, but Apley thinks 6 months is a likely maximum life FDA might choose. Therefore, you will need to plan ahead.
It may become less easy to convince a veterinarian of this need, since he or she then becomes liable for any problems resulting from the usage.
The rules will require veterinarians specify duration of use, approximate number of animals to be fed the medicated feed, and the level of the drug listed in the VFD to be put in the feed. They will not be required to specify the amount of medicated feed to be dispensed and/or fed, Apley says.
If you need to feed- or water-administer antimicrobial products and you don't have a good working relationship with a veterinarian, this year might be a good time to forge that association.
Otherwise, Apley advises watching until final details are known, which likely will be sometime this spring. He noted that the FDA is in the process of hosting listening sessions and that many details still must be worked out. The period from January through November 2016 will be the time to make final preparations.
To listen to an interview with Mike Apley, go to the Feedstuffs story on this same topic.
Here are some examples of popular antimicrobials affected by the upcoming rules and some not affected.
These are medically important antimicrobials with labeling for feed or water in food-animal production:
• Aminoglycosides -- gentamicin, neomycin
• Lincosamides -- lincomycin
• Macrolines -- tylosin, tilmicosin
• Penicillins -- penicillin G included in combination products
These are antimicrobials not affected by the upcoming changes because they are not on the list of medically important antimicrobials:
• Ionophores -- monensin and lasalocid
• Flavophospholipol -- babermycins such as those trademarked as Flavomycin and Gainpro