IMPACTS ON PRODUCERS, FEED MILLS, AND SWINE VETERINARIANS
Paul D. Ruen, DVM
In June 2015 the Food and Drug Administration (FDA), due to increased concerns and pressures surrounding the use of antimicrobials in livestock, implemented a new Veterinary Feed Directive1 (VFD). The result is that all use of antibiotics for the purpose of treating disease – prevention, control, and therapy – will soon require veterinary oversight. All drugs that the FDA has identified and ranked as important to human medicine (Guidance 152 Appendix A2) will require a VFD beginning on January 1, 2017. Additionally, through Guidance 2133, the FDA is transitioning food animals away from all growth promoter use of medically important antibiotics, and establishing veterinary oversight via prescription for use of therapeutic antibiotics in water.
What do these changing regulations mean for those of us working out on farms? In most cases, veterinarians are already working closely with pork producers to make appropriate decisions related to the use of antibiotics. The Pork Quality Assurance®4 program, initiated by the National Pork Producers Association in 1989 and later updated to the PQA Plus® program, has relied on a close partnership between producers and their veterinarians and is widely accepted in the U.S. swine industry. Together with distributors (feed mills and others that distribute medicated feeds containing VFD drugs), producers and their veterinarians must learn to navigate the new VFD and make it work for the pig.
While a few feed medications are unaffected by the rule change - bacitracin, carbadox, bambermycin, tiamulin, and ionophores – all others will require a VFD for their use. Practical implementation of VFDs on the farm will require us to meet 4 objectives: legal, accurate, efficient, and on-time.
Practice Implementation Of VFDS On The Farm Will Require Us To Meet 4 Objectives:
Legal, Accurate, Efficient, And On-Time
The following are legal responsibilities of veterinarians writing VFD:
- License to practice veterinary medicine in the state where pigs are to be fed
- Valid veterinary client patient relationship (VCPR)
- Use of written and signed VFD in compliance with laws
- Provide client and distributor a copy of VFD
- Retain VFD records for 2 years and provide for inspection by FDA upon request
VCPR is intended to create consistency in oversight for use of antibiotics regardless of the route of administration – injection, water, or feed. The key elements of the federallydefined VCPR6 include: (1) engage with the client to assume responsibility for making clinical judgments about patient health, (2) have sufficient knowledge of the patient by virtue of examination and/or visits to the facility where patient is managed, and (3) provide for any necessary follow-up evaluation or care. While site visits are important to a working VCPR; quality diagnostics, accurate production reports, and a valuable team of skilled swine technicians and managers are now part of the new models of swine health care. By bringing all antibiotic medication use under the oversight of veterinarians, the FDA expects a close working relationship between producers and their veterinarians to promote animal care, better health, and food safety.
There will be two categories of VFDs - one targeted to a farm’s typical disease challenges and a second that addresses disease outbreaks or emergency. We need to ensure in all cases that VFDs help get the right feed medication to the right pig at the right time. Plans will need to be easy to understand and follow. Additional information may be included or attached to the VFD to improve accuracy, such as a more specific description of animal location(s), approximate age or weight range, diet(s) that should include the listed medication, etc...
The key components necessary for completing a VFD include:
- Veterinarian’s and client’s name, address, and phone number
- Premise(s) where the animals are located and will beeating the medicated feed
- VFD issuance date and VFD expiration date (maximum 6 months) based on calendar date
- Name of drug, level of drug in the feed, and duration of use to the animals
- Instructions if intended to be fed in combination with other VFD or OTC drug
- Species and production class of animals receiving medication
- Approximate number of animals to receive the medicated feed
- Withdrawal time, and special instructions and/or precautions
- Number of reorders (refills) that are authorized (if permitted by drug approval)
- Statement declaring that extra label use is not permitted
The time required to comply with the new rule will be significant. People will need training to fully understand the rule and time to develop the databases to house the inputs of sites, flows, products, usage information, and producer and feed mill names and contacts. Once a system is in place, executing the ongoing VFDs for groups of pigs willtake an estimated 7 to 10 minutes per VFD, based on personal experience.
The new rule extended the maximum allowable expiration time for a VFD to 6 months instead of the old rule’s 90 days, and will better fit a feeding cycle for the wean-to-finish herd. In some situations it may be helpful for VFDs to be connected to specific diets or feed batches in order to best target times of disease risk for the group of pigs. Veterinarians will have the flexibility to include multiple sites under one VFD in situations of a shared flow health status, common ownership, and fed from the same mill.
Extra paperwork should not hinder animals from getting the medication they need when they need it. Paper or electronic VFD forms are acceptable and can be custom made or used from a commercial template. GlobalVetLINK®7 is a company that provides a web-based service called FeedLINK® for completing, sending, and storing electronic VFDs. Others may also develop electronic VFD services, including drug sponsors and information management companies. Electronic VFDs will be used in a high percentage of cases in order to maximize the efficiency of veterinary time and resources, and to reduce the time lag between pig need and pig feed in the bin. Consideration for using a commercial service versus an internally developed system will hinge on costs, staffing, and privacy of data.
The key responsibilities of the producer include5:
- Only the intended animals covered under the VFD receive the feed
- All VFD feed is completely fed up before the expiration date on the VFD
- Keep a copy of the VFD for 2 years and make it available if requested by FDA
The joint efforts of veterinarians, producers, and distributors will be important if we are to accomplish the best care for the pig and build upon the successes our industry has achieved in producing safe, quality, and affordable pork protein for the consumer. Regulated use of antibiotics in livestock will now include veterinary oversight for all routes of administration, including feed drugs via the VFD. Our efforts will be measured by how well we meet the legal requirements, ensure accuracy in the documentation, are efficient with our time, and still ensure that medications are targeted and on-time. How we meet the challenges and opportunities in the new VFD rule will have a bearing on the future availability of antibiotics for food animals.
- Federal Register. Final Rule: Veterinary Feed Directive.
- US Food and Drug Administration. Guidance for Industry #152, Appendix A, October 2003.
- US Food and Drug Administration. Guidance for Industry #213, December 2013.
- National Pork Board. PQA Plus®.
Federal definition of VCPR, 21 CFR530.3(i).
Paul D. Ruen, DVM
Dr. Paul D. Ruen is a Partner at Fairmont Veterinary Clinic, LLP.