Federal directives will change some practices
For livestock antibiotics, change is on the way
This article is probably the first of several over the next three years—right through the end of 2016. That is the time frame that the FDA has designated for implementing significant changes to the labeling, use, availability and control of certain antibiotics currently available for use in livestock feed and water.
On Dec. 12, 2013, the FDA released information on how they will proceed with mandated changes in the on-farm use of antibiotics mixed in feed or used as water medications for livestock. The changes will focus on antibiotics that are deemed as “medically important” (used in both humans and animals) and on those previously labeled for “growth promotion and improved feed efficiency.”
This step by FDA is the next in the progression of steps to implement changes specified in a document called Final Guidance 213. This document establishes the three-year time frame to accomplish two major changes: 1) Phase out any label claims and use of antibiotics for growth promotion purposes alone; and 2) Phase in an increasing involvement of veterinary oversight in the use of “medically important” antibiotics for use in preventing, controlling or treatment of livestock disease.
The main driver of this regulatory change has been the complex issue of antibiotic resistance (in humans and animals) and the public concern and perception about the use of antibiotics in food-producing animals playing a role in that resistance.
Those of us in production agriculture have known for decades that certain antibiotics with “enhanced feed efficiency and growth promotion” claims have been used successfully to support optimal animal performance by way of improved gain and feed efficiency. Such use started in the early days of feeding animals in larger groups for production efficiency.
As time, technology and consumer concerns have progressed, it has become harder to support such use of antibiotics, and, in many cases, such use is no longer necessary to produce healthy, fast-growing, efficient livestock.
The plan will come in stages. First, pharmaceutical companies that produce antibiotics for use in livestock have been asked to voluntarily revise the conditions on their labels to remove “production” indications. They must make that commitment by three months after the “publish date” which looks to be March 12, 2014. By law, the process and changes must then be completed by three years after this same “publish date,” which would be Dec. 12, 2016. Once the pharmaceutical manufacturers make this change, the antibiotics can no longer be used for “production” purposes, and their use to control, treat or prevent disease will require “veterinary oversight.”
The veterinary oversight that will be required in the future will involve having a relationship with a veterinarian who is familiar enough with your operation to be able to legally complete a Veterinary Feed Directive (VFD). Each feed and water antibiotic will require its own VFD. The FDA will require VFD forms to be completely filled out and a faxed, emailed or hard copy kept by the veterinarian, the producer and the feed manufacturer/supplier. All parties will be required to keep records for one year and to make these records available to FDA inspectors upon request.
The FDA said that this newly proposed VFD revision is intended to “update the process and expand veterinary oversight without extra burden to the process.” Further, the FDA “intends to promote judicious use of important antibiotics and to protect public health while ensuring sick and at-risk animals receive the treatment they need.”
The list of antibiotics initially affected by the GFI 213 document, as published in a document I saw on Dec. 17, includes the following 22 base antibiotic compounds (with their commonly recognized name in parentheses):
•Chlortetracycline (Aureomycin; Chlormax; Pfichlor; Pennchlor)
•Gentamicin (Garacin; Gentocin)
•Oxytetracycline (Terramycin; TM)
•Penicillin G Potassium (Solu-Pen)
•Penicillin G Procaine
•Sulfadimethoxine (Albon; Di-Methox)
When I reviewed all of the affected New and Abbreviated (generic) Animal Drug Applications (NADAs and ANADAs) for these 22 compounds and their various approved combinations presented in the document, the final total of approved medications for feed and water in livestock that are affected by these regulatory changes is 287. That means that at the end of the three-year phase of these regulatory changes, all 287 of these products and combinations will require a VFD for access and use.
Sources close to the FDA say feed manufacturers and feed dealers will be allowed to inventory VFD feeds and water medications at their locations so that they are available for rapid distribution to producers when the medical need arises. That is a welcomed relaxation of the current regulations that require a completed VFD before such a controlled feed can even be made.
A final point to this initial information is that the FDA “recognizes a partnership between producers and veterinarians to work together to make animal care decisions.” MFA intends to remain closely involved with the process and will play a key role in working with producers and veterinarians to effectively employ this expanded VFD regulation to make sure livestock producers get the medicated feed they need on a timely basis.
And, as I said at the beginning, there will be more information to come over the next three years of implementation. Please don’t hesitate to contact your MFA contacts for additional information or clarification as the process moves along, as I am sure the general media will put reports that will sometimes cloud the view about what is happening.
Dr. Tony Martin is manager of MFA Animal Health.
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