Lawyer's Guide to the Veterinary Feed Directive

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Lawyers Guide to the Veterinary Feed Directive (VFD)Lawline.com

November 3, 2016

By Cari B. Rincker, Esq.

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Who I AmGrew up on a beef cattle farm in IllinoisAdvanced degrees in animal sciencePast-Chair of the ABA, General Practice, Solo & Small Firm Divisions Agriculture Law CommitteeClient bases ranges from livestock producers & food entrepreneurs to mid-size agri-businesses

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Overview

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Background

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Definitions

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Definitions

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Definitions

Ionophores are type of an anti-microbial not deemed to be medically important by FDA7

DefinitionsCompare to antibiotics. Consumers confuse these terms.

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DefinitionsCommonly confused terms

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Withdrawal PeriodsThe animals body will eventually metabolize the antibiotic and eliminate it from its system. However, there are withdrawal periods for the time in between when the livestock was treated with antibiotics and the time of harvest or processing.

This withdrawal period reduces any concentration of the antibiotic that might still be present in the animals body (and thus in the milk, meat, or eggs).

Withdrawal periods are set by the FDA and it is different for each drug and species.

See chart on page 28 of outline for withdrawals10

The Players

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Role of USDA

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National Organic ProgramUSDA-AMS regulates NOPThere must not be any administration of antibiotics under any circumstances; therefore, this could be viewed antibiotic free label regulation.If the animal gets sick in an organic livestock operation and organic approved methods fail, the animal may receive antibiotics, but then cannot be labeled as organic anymore under the NOP. See 7 CFR 205.238(c)(7).

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USDA-Regulated Marketing ClaimsAll USDA label marketing claims must be approved by FSIS to determine if they are truthful and not misleading.USDAs FSIS is responsible for labeling meat and poultry, liquid eggs and cooked egg.

Look for the USDA Process Verified for this claim because the shield means that this was verified.

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USDA-Marketing ClaimNo Antibiotics Used requires the producer to submit food formulations, pharmaceutical invoices, or other appropriate documentation verifying that animals have received antibiotics by any means. They also must provide how they care for and treat sick animals. In order to use this marketing claim, the animals must have never been treated with antibiotics.

Variations include: No Added AntibioticsNo Antibiotics AddedNo Antibiotics AdministeredRaised without antibiotics-for meat and poultry only

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Role of FDAUSDA regulates eggs, poultry and meat with antibiotics

FDA regulates most other issues

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Role of CDCNational Antimicrobial Residence Monitoring System (NARMS) is a sub-agency of the CDC.Players: Composed of the FDA, CDC, USDAs FSIS

Purposes: Its primary purpose is to track antibiotic residence in the United States. The primary objectives of the NARMS program are to:

Monitor trends in antimicrobial resistance among foodborne bacteria from humans, retail meats, and animals;Disseminate timely information on antimicrobial resistance to promote interventions that reduce resistance among foodborne bacteria;Conduct research to better understand the emergence, persistence, and spread of antimicrobial resistance; andAssist the FDA in making decisions related to the approval of safe and effective antimicrobial drugs for animals.

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Approval of Antibiotics

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Background

Overtime, FDA did not feel like this created the necessary safeguardsNeeded more control than OTC statusFDA started to become concerned about preventing the potential for the development of bacterial resistance to antimicrobial drugs administered through medicated feeds 19

Background

ADAA help facilitate the approval and marketing of new animal drugs and medicated feeds

FDA started getting some backlash stating that VFD was overly burdensome

In response, the FDA published several documents inviting public comment of VFD

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Background

VFDs are NOT a prescription VFD- its a law, its a drug, and its a piece of paper. 21

Background

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Background

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Background

Publication 1 This was published around April 2012 and described the overall policy direction. It set forth FDAs framework for instituting several key measures for ensuring the judicious use of medically important antimicrobial drugs in livestock. It included the possible elimination of feed and water use of medicated feeds and bringing all remaining. 2 key principles: Limit use of medically important antimicropial drugs in food-producing animals to those uses (1) considered necessary for assuring animal health and (2) that include veterinary oversight or consultation

Publication 2 Published in December 2013; Outlined a detailed process and timeline for implementing the measures identified in GFI #209. This document discussed the transition of over-the-counter antimicrobial drugs to VFD marketing status. This document gives the timeline and defines what is medically important. In this publication, December 2013 was the target for drug sponosors to implement changes to use conditions of medically important antimicrobials in food and water to (1) voluntarily withdraw approved production uses such as increased rate of weight gain or feed efficiency and (2) after the label changes these production uses will no longer be legal; however, therapeutic uses are to be retained for treatment, control and prevention indications. Will require veterinary oversights. A key principle is to include a veterinarian in the decision-making process. It doesnt require direct veterinarian involvement in the drug administration but it does require use to be authorized by a licensed veterinarian in the context of a VCPR. This means changing the marketing status from OTC to Rx or VFD. This includes water soluable products to Rx (medicated drinking water) and products used in or on feed to VFD (medicated feed.

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Background

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Background

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Background

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Background

Updated legislation aimed to make the process more efficient while continuing to provide public health protections

There is another Guidance for the Industry document #233 that is helpful talks about the VFD itself and what should be prepoluated on the document 28

Background Effective Date

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Background(GFI # 213)

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Background

You can find the list online via FDAs website 31

Background:Affected Antimicrobials Administered via FeedAntimicrobial ClassSpecific Drugs Approved for Use in FeedAminoglycosidesApramycin, Hypgromycin B, Neomyscin, StreptomyscinDiaminophyrimidinesOrmetoprimLincosamidesLincomycinMacrolidesErythromycin, Oleandomycin, TylosinPenicillinsPenicillinStreptograminsVirginiamycinSulfasSulfadimethoxine, Sulfamerazine, Sulfamethazine, SulfaquinoxalineTetracyclineChlortetracycline, Oxytetracycline

See FDA Medically Important Antimicrobials in Animal Agriculture at 15

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Background:Affected Antimicrobials Administered via WaterAntimicrobial ClassSpecific Drugs Approved for Use in WaterAminoglycosidesApramycin, Gentamicin, Neomyscin, Spectinomycin, StreptomyscinDiaminophyrimidinesNONELincosamidesLincomycinMacrolidesErythromycin, Oleandomycin, TylosinPenicillinsPenicillinStreptograminsNONESulfasSulfachlorophyrazine, Sulfachlorpyridazine, Sulfadimethozine, Sulfamerazine, Sulfamethazine, SulfaquinoxalineTetracyclineChlortetracycline, Oxytetracycline, Tetracycline

See FDA Medically Important Antimicrobials in Animal Agriculture at 16

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BackgroundSee FDA Medically Important Antimicrobials in Animal Agriculture at 17

Avilamycin used in swine to reduce diarrhea (E coli) Florfenicol used in fish to control mortality (various diseases according to fish type) and swine (control of SRD)Tilmicosin used in cattle for BRD and used in swine for SRD34

Background

The definition of Category II has been revised to eliminate the automatic classification of VFD drugs into Category II35

Veterinary Feed Directive (VFD)

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Stakeholder Requirements

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Veterinary Requirements21 CFR 558.6(b)

FDA has published a list of states with VCPR- list will be updated periodically as FDA receives and verifies information from states if they change their VCPR definition or its applicability

Producers should already have a good relationship with their herd veterinarian, but an official VCPR will need to be in place because a VFD drug is only permitted under the professional supervision of a licensed veterinarian. Antibiotics that are deemed medically important to humans will now only be attainable to producers if they have a VFD from their herd veterinarian. If you dont routinely use a herd veterinarian, you will need one if you want to use medically important antibiotics moving forward, says Chris Rademacher, an Iowa State University swine Extension veterinarian and GVL consultant.38

Veterinary Requirements

21 CFR 558.6(a)

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Veterinary Requirements

21 C.F.R. 558.6(a)

(1) Extra-label drug use (ELDU) occurs when a drug in an animal is used in a manner that is not in accordance with the approved labeling. This can mean using a drug in a species for which it is not labeled, at a different dosage rate, frequency or route of administration, for diseases other than those on the label, or with a different with