Veterinary Feed Directive
by Carrie Bargren, DVM
Since the development of modern antibiotics in 1928, countless lives have been saved, both human and animal. Bacteria fought back by developing resistance with surprising speed, but researchers kept up for the most part, developing stronger and stronger antibiotics. Despite their best efforts, there are now strains of multi-drug resistant E. coli, Klebsiella pneumoniae, methicillin-resistant Staphylococcus aureus (MRSA), Enterobacteriaceae, tuberculosis and others worldwide that are infecting humans, resulting in a worse prognosis and often leading to death. These names should seem familiar, as they are infections that also often affect livestock and pets.
The medical community and public health officials have focused their attention not only on finding new antibiotics but also on making sure what currently exists remains effective. Antibiotics are frequently misused in both human and animal populations which is accelerating the rate of resistance. The Centers for Disease Control and Prevention (CDC) estimates that 50% of antibiotics in human medicine are used when not needed (such as for a viral infection) or at the incorrect dosing and duration (such as patients not following the instructions on the label). In animals, resistance is encouraged when antibiotics are given not to treat bacterial infections but rather to promote growth or when over-used without the input of a veterinarian.
While there is no research to support the overuse of antibiotics in animals as a direct cause of resistant infection in humans, the potential is there, which is risky enough. Once a bacteria develops resistance, it is irreversible, no matter what species it developed in.
Recognizing that access to effective antibiotics is critical for human public health, livestock production and animal health alike, the Food and Drug Administration (FDA) which regulates the licensing of antibiotics created a task force in 2000 to address resistance. One of their goals was to facilitate the safe and effective use of antibiotics. Out of this, came the Veterinary Feed Directive.
In 2003, the FDA published a document called Guidance for Industry (GFI) #152, which assessed the risk of veterinary antibiotics for potential resistance in human medicine. Antibiotics were divided into two categories: non-medically important and medically important. Non-medically important drugs are those used either exclusively in animals or not important to humans if used in both animals and humans. Medically important drugs are those that are too important to human medicine and human lives to risk the development of resistance in any species. It also determined that antibiotics fed in or on feed have little to no medical professional input on use and therefore have a high potential for overuse.
GFI #209 was published in 2012 by the FDA to establish the principle of ‘judicious use’ of medically important antibiotics. While most medically important injectable antibiotics are prescription only, there is no such control over antibiotics added in feed. GFI #209 addresses this by laying out a plan to change the labels of medically important feed-based antibiotics. There are four reasons to use an antibiotic: treatment, control, prevention and performance. The first three (treatment, control and prevention) are therapeutic and will remain allowable as they are a judicious use of antibiotics. The fourth which only seeks to improve performance, weight gain and feed conversion, will no longer be allowed.
To ensure that medically important drugs will be used judiciously and appropriately, the FDA determined that veterinarians will provide the best oversight and created the Veterinary Feed Directive (VFD), which is similar to a prescription.
Starting January 1, 2017, feed containing medically important antibiotics will no longer be available over the counter. A VFD will be required in order to obtain such feed. Poultry and swine operations will be affected the most. Key drugs used in cattle that will now require a VFD include chlortetracycline, chlortetracycline + sultramethazine, oxytetracycline, neomycin + oxytetracycline, tylosin and virginiamycin. However, VFDs will not be required for ionophores such as lasalocid and monensin, since they are not used in human medicine. The complete list of affected drugs is readily available through your veterinarian or on the FDA website, as are all the GFI’s.
Since the deadline for implementation is only a few months away, producers, feed mills and veterinarians need to start preparing now so that everyone understands and is in compliance before January 1st.
What is a VFD? VFD’s are written statements issued by a licensed veterinarian approving the use of a VFD drug in a feed. This allows a feed distributor to sell the VFD-drug-containing feed to the producer. The VFD will contain the specific purpose of the medicated feed, dosing and administration information based on labeled uses and a description or the location of the animals to be treated.
What is a VFD-Drug? It is an antibiotic used in or on animal feed that has been determined to be medically important to human medicine and therefore placed under the supervision of a licensed veterinarian. The drug must be used for the treatment, control or prevention of disease as determined by the veterinarian. There will be no extra-label use allowed, nor may the drug be used simply for production purposes. Medications that are transitioning to VFD drug status already have transitional labels stating that by January 1st, 2017, a VFD will be required to use the drug, regardless of when it was actually purchased.
How do I get a VFD? When a group of animals is sick and the producer would like to use a VFD-drug containing feed, the producer must contact a veterinarian and is required by law to have a valid Veterinary-Client-Patient-Relationship (VCPR) with that veterinarian. A valid VCPR in Wisconsin follows the federal definition from the Code of Federal Regulations 21 sec. 530.3 which states that the veterinarian has “assumed the responsibility for making medical judgements regarding the health of an animal and the need for medical treatment, and the client…has agreed to follow the instructions of the veterinarian.” It also includes that the veterinarian has seen the animals in question or is at the farm frequently enough to be familiar with the animals.
The veterinarian will determine the need for the VFD-drug containing feed and write the VFD. The VFD will contain dosing instructions and duration of treatment which is determined by the drug label. Remember, no extra-label use is allowed. It will also have an expiration date, which is the period of time that the VFD-drug containing feed can be used. This is more important when controlling or preventing disease, as multiple groups of animals might be treated during that time frame. All VFD’s will expire after up to 6 months, and a new VFD must be obtained to continue use. Some VFD drugs can be used in combination, and the VFD will indicate what is allowed, again based on the label.
When the VFD is complete, the veterinarian will send the VFD to the distributor or feed mill and give a copy to the producer. They will keep a copy on file as well. All three parties are required to keep their original copy for two years, so it might be a good idea to create a folder or file to keep the VFD’s in so they are readily available. The distributor will mix the VFD drug containing feed according to the drug label and the producer will use the feed as directed.
If I have extra VFD drug containing feed but I’ve finished the treatment according to the label – or the VFD expired – can I feed the rest to use it up? Unfortunately, no. It cannot be fed for a longer duration, which would be extra-label use. If the VFD will expire in the middle of treatment, plan ahead to make sure you have another VFD on hand so the course of treatment can be finished. For example, if chlortetracycline is being feed for pneumonia in a group of calves, the labeled duration of use is a maximum of 5 days. Remember that most VFDs will expire after 6 months, so will you have 6 months to complete the 5 day treatment.
Will this affect medicated milk replacers (MMR)? Yes, if a milk replacer contains a medically important antibiotic, a VFD is required. However, it becomes difficult when the VFD drug in the milk replacer is labeled for twice daily feeding, and producers feed three times per day. It is extra-label to use the MMR for that third feeding, so a non-MMR must be kept on farm to be fed during that third feeding. If the milk replacer only contains an ionophore, a VFD isn’t needed, but it cannot be used in combination with a VFD-drug containing MMR unless the label indicates the specific combination is allowed.
How about calf starters? Again, yes a VFD is needed if the starter contains a medically important antibiotic such as chlortetracycline or oxytetracycline. It will also be illegal to use a feed containing both an ionophore and VFD-drug unless it is labeled to be used in combination with a specific non-VFD drug. The ionophore must be stopped before using a feed with the VFD drug and cannot be started again until the treatment is over.
What if I just buy a lot of chlortetracycline before January 1st, I won’t need a VFD then, will I?Unfortunately, you will. No matter when the VFD drug is purchased, as of January 1st, 2017, a VFD is required to have it on farm. This means there has to be a clear need for the VFD-drug for the animals, it cannot be held for ‘just in case.’
How is the FDA going to enforce this? Fortunately for producers, veterinarians and distributors alike, the FDA plans on phasing in enforcement, recognizing the intensely confusing and complicated nature of the VFD for everyone involved. They will focus first on education and training until it becomes a familiar process. The inspection will begin at the distributor, where three random VFDs will be selected and evaluated for containing all the required information. There will be specific questions for the distributor about record-keeping (VFD copies kept for 2 years), inventory and labeling. The VFDs will then be followed back to the veterinarian who will be checked for proper licensing, proof of valid VCPR, medical records and record keeping (2 years). Followed to the producer, questions will involve the treatment of the correct animals, duration of use, withdrawal times, allowable drug combinations (no ionophores with chlortetracycline!), and record keeping (2 years!!). Inspectors might also ask the distributor about bulk purchases of VFD-drugs made prior to January 1st, and investigate those farms for the possibility of stockpiling to avoid a VFD. At this time, the educational enforcement period has not been defined nor have penalties been determined.
With the immense responsibility of feeding the world, we must all recognize the impact our day to day practices could have on the health of the human and animal populations. The Veterinary Feed Directive is asking us to think in a more conscientious manner about how antibiotics are used in food animals so that we may do our part to slow the development of antibiotic resistance and save future lives of all species.
If you have any questions, please give RVVC a call, though please be gentle, this is new to us as well. RVVC is hoping to host a meeting for clients in November about VFD’s, so keep your eye on your mailbox.