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What does Guidance 213 and the VFD Rule mean on the
farm?
Dr. Scott Stehlik, DVMDirector of Technical Operations
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Discussion Agenda
• Review Guidance Information– Guidance #209 and #213– Rule on Veterinary Feed Directives (VFDs)
• Practitioner's perspective• Producer’s perspective• System application approach
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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
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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
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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
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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)
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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
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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?
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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
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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?
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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
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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!!
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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
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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!!
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Questions??