By Rob Eirich, Nebraska Beef Quality Assurance, Nebraska Extension; Matt Luebbe, UNL Beef Feedlot Specialist; Richard Randle, Nebraska Extension Beef Veterinarian; and Dee Griffin, UNL-Great Plains Veterinary Educational Center
KEY POINTS: When the VFD regulations go into effect, they will ONLY apply to antibiotics used in the feed! They will not affect other feed use medications such as; ionophores, coccidia, other parasite and insect control drugs, or reproductive control medications. VFD regulations will not apply to antibiotics used by injection, tablet, bolus or water.
Here is the link for Part 1 if you haven't read it yet (http://go.unl.edu/fkhd)
WHAT INFORMATION WILL THE CATTLE OWNER OR MANAGER BE REQUIRED TO PROVIDE ON THE VFD FORM?
The VFD form requires the veterinarian’s client’s name, address, phone, location of the cattle, the approximate weight of the cattle and the number of cattle that will be covered under the VFD.
WHAT RECORDS WILL CATTLE OWNERS AND MANAGERS BE REQUIRED TO KEEP?
• A copy of the signed VFD received from your veterinarian must be kept for two years.
• VFD medication use records, which includes feed mixing records, must be kept and be made available to the FDA if requested.
• No FDA inspectors will come to the cattle operation using a VFD unless they are using the most concentrated VFD product available and the VFD requires a withdrawal time. The most concentrated FDA approved feed additive is known as a “Type A Article” drug and it is classified as a “Category 2” drug if a withdrawal time is required.
WILL A CATTLE OWNER OR MANAGER HAVE TO SEE A VETERINARIAN TO GET A VFD?
Not necessarily. If the cattle owner or manager has a VCPR with a veterinarian, together they can develop outlines for situations when VFD medication use would be appropriate. Using these outlines VFD usage can be anticipated and in many situations the VFD medication can be available as required to address the health and well-being of the cattle without the veterinarian personally evaluating the cattle. For example, a veterinarian can develop guidelines and training for tentatively diagnosing a disease listed on the approved VFD medication and documentation of the trained personnel will allow the use of the VFD medication without the cattle being personally evaluated by their veterinarian.
WILL ONE VFD COVER CATTLE OWNED BY ONE PERSON IN DIFFERENT PASTURES?
Yes, a VFD can be written to cover the same health condition in cattle owned or managed by the same operation if the cattle are in multiple locations, including across county lines. However, some VFD antibiotics will have labeling inclusions similar to; ‘'Use only in cattle fed in confinement for slaughter" and/or “fed in a complete feed” and/or “included in the sole ration”. If these type statements are including on the label, use in pasture situations would not be allowed by the FDA.
WILL A VFD ANTIBIOTIC BE ALLOWED TO BE USED IN BREEDING CATTLE?
It will depend on the approved label. Some VFD antibiotics will have not been studied in breeding cattle or replacement heifers/bulls and will not be labeled to feed breeding cattle. There currently is a feed grade antibiotic approved for controlling anaplasmosis. The current labeling allows its use in breeding beef cattle. If the company that controls this antibiotic applies for VFD approval there is no reason to think restrictions on its use in breeding cattle would be added.
WILL ONE VFD COVER CATTLE OWNED BY ONE PERSON IN DIFFERENT STATES?
No, a separate VFD will be required. Additionally, the veterinarian that writes the VFD is required to be licensed to practice in the state where the cattle are being kept when the VFD antibiotic is being used on those cattle.
WHAT FLEXIBILITY WILL CATTLE PRODUCERS HAVE IN HOW THEY DOSE A VFD MEDICATION?
Simple answer is NONE! Regulations governing feed medications have NEVER allowed usage other than as labeled! “Off label Use” or “Extra Label” has never been allowed and this legal requirement will continue with the use of VFD medications. For cattle producers that also have sheep and/or goats, the FDA will not allow a VFD written for cattle to be used for sheep and/or goats.
WILL A VFD ANTIBIOTIC BE ALLOWED FOR PINK-EYE OR FOOT-ROT?
Pink-Eye and/or Foot-Rot “prevention”, “treatment” and/or “control” are not listed on the labels of any of the feed grade antibiotics currently approved and therefore use for these disease is not allowed by the FDA. Use for these disease may or may not be allowed in the future depending on the approval requests by companies applying for VFD approval for their feed grade antibiotic and the FDA’s ruling on those requests.
WHAT FLEXIBILITY WILL BE AVAILABLE FOR MIXING A VFD MEDICATION?
The cattle operation will have the same flexibility for how the VFD is mixed in a complete feed as has been available previously for use of FDA approved feed additives. Restrictions on which FDA additives can be used together and how much of an additive can be added per ton of feed have long existed and these restrictions will continue with VFD regulation implementation in Dec 2016.
WILL SPECIAL PROCEDURES OR MIXERS BE REQUIRED TO USE A VFD MEDICATION?
An issue often overlooked by producers that practice on-farm feed mixing is cross contamination of feeds with FDA approved feed additives. A procedure to “flush-out” a feed mixer after using a VFD will need to be developed. Their veterinarian, nutritionist or extension educator can assist with developing a flush-out procedure. Typically this involves running a small amount of a coarse feedstuff through the feed mixer after a VFD medication has been mixed. The feedstuff used to clean or “flush-out” the feed mixer can be used in the ration for the cattle receiving the VFD on the following day.
WILL VFD ANTIBIOTICS HAVE A MARKETING WITHDRAWAL TIME?
It will depend on the specific VFD antibiotic being considered. The VFD, tilmicosin (Pulmotil) currently approved by the FDA has a 28 day withdrawal time. There are a number of antibiotics the FDA currently approves for disease prevention, treatment or control that do not require a withdrawal time and there is no reason to think the FDA will add withdrawal times to medications for which a withdrawal is not currently required.
HOW LONG DOES A VFD REMAIN IN EFFECT AFTER IT IS WRITTEN BY MY VETERINARIAN?
VFD orders will have both an “Effective Date and an “Expiration Date”. The “Effective Date” is not necessarily the date your veterinarian signs the VFD order. On the VFD order a veterinarian is required to indicate an “Effective Date” and the VFD antibiotic for which the order is written will have a “VFD order Expiration Date” requirement. The VFD antibiotic cannot be fed after the end of the “Expiration Date”.
WILL THE LENGTH OF TIME FROM THE “VFD ORDER EFFECTIVE DATE” TO THE “VFD ORDER EXPIRATION DATE” BE THE SAME FOR ALL VFD ANTIBIOTICS?
The FDA has indicated the expiration date could vary between the different VFD antibiotics approved. If the VFD antibiotic does not explicitly indicate the length of time for an order to expire, the VFD regulations require the veterinarian to limit the VFD order expiration date to 180 days or less. Pulmotil, the only VFD the FDA has currently approved expires 45 days after the date the veterinarian indicates as the “effective date”. The effective date will be the last day the use of a VFD antibiotic can be used. For example, if the a VFD antibiotic intended for use has a 45 day expiration time and the course of therapy is 14 days, the last day a course therapy can begin is day 31 of the 45 day window between the ‘Effective Date” and the “Expiration Date”.
Part 3 of 3 will be in the December BeefWatch.