What does Guidance 213 and the VFD Rule mean on the

farm?

Dr. Scott Stehlik, DVMDirector of Technical Operations

Discussion Agenda

• Review Guidance Information– Guidance #209 and #213– Rule on Veterinary Feed Directives (VFDs)

• Practitioner's perspective• Producer’s perspective• System application approach

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

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

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

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)

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

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?

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

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?

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

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!!

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

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!!

Questions??