Dr. Scott Stehlik - What does Guidance 213 and the Veterinary Feed Directive (VFD) Rule mean on the farm?
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What does Guidance 213 and the Veterinary Feed Directive (VFD) Rule mean on the farm? - Dr. Scott Stehlik, D.V.M., director, technical operations, The Maschhoffs, from the 2015 World Pork Expo, June 3 - 5, 2015, Des Moines, IA, USA. More presentations at http://www.swinecast.com/2015-world-pork-expo
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Dr. Scott Stehlik - What does Guidance 213 and the Veterinary Feed Directive (VFD) Rule mean on the farm?
- 1. What does Guidance 213 and the VFD Rule mean on the farm? Dr. Scott Stehlik, DVM Director of Technical Operations
- 2. Discussion Agenda • Review Guidance Information – Guidance #209 and #213 – Rule on Veterinary Feed Directives (VFDs) • Practitioner's perspective • Producer’s perspective • System application approach
- 3. How did we get here? • > 10 years of regulatory progression • Increasing public concern over bacterial resistance • Perceived food and human safety concerns • An ongoing erosion of trust in the protein producing industries • A continuing detachment of the consuming public from their food sources
- 4. Guidance #209 • “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals” • Established recommended principles for appropriate use of medically important drugs – Limit to necessities of assuring animal health with use under veterinary oversight • “Disease prevention, control, and treatment” are considered judicious and necessary
- 5. Guidance #213 • Voluntary phase out all “growth promotion/feed efficiency” label claims of medically important antimicrobials • All current OTC water medications to Rx • 3 year window to implementation from publication of final rule (end of 2016) • Rule on Veterinary Feed Directives – All OTC medicated feed products to VFDs – Move concurrent to #213 timeline
- 6. Antimicrobial Drug Ranking • Critically Important • Highly Important • Important • Non-medically important/exempt – Bacitracin (i.e. BMD, Albac) – Carbadox (i.e. Mecadox) – Bambermycins (i.e. Flavomycin) – Tiamulin (i.e. Denagard) – Narasin (i.e. Skycis)
- 7. Guidance Implications • Disallows the use of medically important antibiotics for growth or feed efficiency – Potential Negative Impact of 1.0-1.5% FC • VFDs required on all medicated feed products (medically important) • Any new feed medications approved as VFDs
- 8. What does the Future hold? • Increased antimicrobial sales and use data and benchmarking • “Disease prevention, control, and treatment” are considered judicious and necessary – For how long? – Ongoing legislative pressure from advocacy groups to further restrict use • If the process stumbles or non-compliance is high, what will the “fix” look like?
- 9. Streamlining the VFD Process • Potential changes or alterations to VFDs: – Allow for site or flow based VFDs – Ability to list multiple medications for a site or flow on a single VFD – Prescription length in the 6-12 month range with allowable refills – To eliminate the requirement to estimate tons of medicated feed
- 10. Potential Impact to the Industry • Perception or Reality? – Economic impact of reduced feed conversion and increased morbidity/mortality – Supply and demand of feed stuffs • Less efficiency = more grain – ADG losses = demand on space? – Drive other feed medication prices up (decreased market competition)? – Administrative army to facilitate? – VFD impact to medicated floor stock?
- 11. Potential Impact to the Producer • Further limitation and elimination of “tools in the tool box” • Changes in feed medication strategies to non- medically important • Potential loss of efficiency and revenue • Increased regulatory conditions – Tracking of feed orders and deliveries – Managing VFDs • Who manages the VFDs/Rxs? Producer? Mill? Vet? – Documentation and maintenance of records
- 12. Potential Impact to the System • Constraints of managing across multiple flows, geographies, sites, and health status’ – Flow constraints to site level VFDs – Feed constraints to different medication programs by flow – Last minute flow changes and the subsequent effects on VFDs – Toll mill relations and management • Decrease the willingness or ability to change feed grade medication protocols • VFD issuance, management, and compliance will be no small task!!
- 13. System Administrative Effects • Administrative support needs across multiple departments – Feed Ops, Health, Purchasing, SML • Maintenance of records and timelines will be critical – Refills, Site turnover, Flow changes – Timely management of scripts for former OTC water medication products – Will require specific data warehousing and notification capabilities
- 14. My glass is half full! • FDA wants this to be successful, not a burden • Actions indicate continued faith and trust in the Veterinary profession – Clients, Consuming public, Regulators • Opportunities to break old paradigms and leverage technology • The swine industry is creative, resilient, and nimble!!
- 15. Questions??
Editor's Notes
- Best kind of presentation – low on science, high on speculation and conjecture. You will get frequent doses of my perceptions and perspectives. Practiced for 7.5 years in NW Iowa – great place to learn to be a veterinarian because everything was sick. 5.5 years of system health and flow dynamics. Fortunate to have the subject matter expert in the room (Dr. Liz Wagstrom)
- But more importantly, how did we get here? Guidance 152 was issued in 2003. Demographics (USDA National Agricultural Statistics Service) – 2007 demographics data - 2% live on “farms” - < 1% of the population claim farming as an occupation - 1935 v. 2007 statistics (72 years) - 1935 – Population = 127 M - 2007 – Population = 301 M (237% increase) - 1935 Farms – 6.8M (sold >$1000 of ag products) – surprised they found that many farmers that reported a positive income - 2007 Farms - 2.2M (67% decrease)
- Explicitly states that “disease prevention, control, and treatment” are judicious and necessary. They are outlining their intent to ensure we have the opportunity to limit disease and treat our animals with antibiotics when deemed necessary through veterinary oversight. Growth promotion and feed efficiency are not “disease prevention, control, or treatment”.
- Publish final rule on 12/12/13. Started a 3 year clock to full implementation. The Process “voluntary” removal of label claims by manufacturers. the manufacture will have 90 days to inform the FDA of their intention: pursue a label claim for “disease prevention, control, or treatment” at the desired gram level or remove the label claim. Again, there is a three year timeline to implementation of Guidance #213 so manufacturing and the swine industry will have an opportunity to weigh options. While positioned as a voluntary removal of label claim, failure to comply with the guidance may bring about legal action by the FDA.
- It is important to note that these only affect antimicrobials used in human medicine.
- Removal of the requirement of a valid Veterinary/Client/Patient Relationship (VCPR), as defined by AMDUCA, to write a VFD. Already defined by state Veterinary Practice acts and not mandated here by the FDA.
- Ronald Reagan (1986) – the 9 most terrifying words in the English language, “I’m from the government, and I’m here to help”
- The FDA wants veterinarians and producers to be able to comply. Efforts from industry advocates have successfully communicated implementation concerns to the FDA. Early discussions and lobbying efforts indicate there may be some user-friendly adaptations over the current VFD and prescription process. Some potential changes or alterations are: - To allow for site or flow based VFDs rather than by individual group or medication. - The ability to list multiple medications for a site or flow on a single VFD. - Prescription length potentially in the 6-12 month range with allowable refills. - To eliminate the requirement to estimate tons of medicated feed.
- Not new but more requirements and regulation. Potential forced changes in feed med strategies. Will the management of the VFDs be handled by the veterinarian, the feed mill, or the producer?
- If site based or flow based VFDs are instituted, the ability to make flow changes or flow specific medication choices will become more complex. Will we be able to manage multiple feed medication programs? Can we manage making last minute flow changes by site because of a change in health status (PEDv)?