REGULATORY OVERSIGHT OF SMALL RUMINANTSSCRAPIE ERADICATION, EXTRA-LABEL DRUG USE, VETERINARY FEED DIRECTIVE

SUSAN SCHOENIAN (Shay-nē-ŭn)Sheep & Goat SpecialistWestern Maryland Research & Education CenterUniversity of Maryland Extensionsschoen@umd.edu - www.sheepandgoat.com

http://www.slideshare.net/schoenian

SCRAPIE Always fatal, degenerative disease that affects the

central nervous system of sheep and goats. Attacks the brain, leaving holes like a sponge. Called scrapie because affect sheep “scrape” their skin. No treatment, no vaccine, certain death. In the same family of diseases (transmissible

spongiform encephalopathies/TSEs) as mad cow disease, chronic wasting disease, Creutzfeldt-Jakob’s disease, and others.

Believed to be caused by a prion. Theoretical link between scrapie and mad cow disease. No proven link between scrapie and human health.

SCRAPIE Transmitted through fluids and tissue and placentas of

infected females. Usually transmitted from infected dam to her offspring

at birth (or other animals in same birthing environment). Has long incubation period, 2 to 5 years (but short

illness)No scrapie under 18 months of age

Usually diagnosed after death (brain) or lymphoid tissue of live animals (third eye lid or rectal biopsy).

Sheep’s genetics affect susceptibility and incubation period (goats ? - still looking for resistant genotypes)

In sheep, mostly codon 171: R=resistant, Q=susceptible.It is a common practice to genotype sheep seedstock.

SCRAPIE PREVALENCE

• Scrapie is not common in US.

• Incidence has been reduced by 96% since 2001 (2013).

• Found mostly in Suffolk sheep and their crosses, but all breeds (and goats) are susceptible.

IMPORTANCE OF SCRAPIE ERADICATION

Markets for small ruminant-derived meat and bone meal International trade restrictions Difficulty in disposing of heads and offal Prevents exports of breeding stock, semen, and embryos Economic loss in affected flocks/herds. Estimated cost to the sheep industry: $20-25 million annually. Identified as a major impediment to the sheep industry.

SCRAPIE ERADICATION First case of scrapie in US was diagnosed in

1947. In 2001, USDA initiated an accelerated

program to eradicate scrapie. Goals

Eradicate scrapie from US soil by 2017.Be declared scrapie-free by OIE by ?.

Scrapie eradication program involves… Mandatory identification of sheep/goats Targeted slaughter surveillance Testing of suspect animals in the field

MANDATORY SCRAPIE IDENTIFICATION

Most breeding animals and all sheep and goats 18 months of age and older must be identified with official USDA scrapie ID.

Producers must acquire premise ID number to get official (free) ear tags.

States must meet minimum standards for scrapie control in order for breeding stock to move freely.

Ear tags can be requested by calling 1-866-USDA-TAG

A list of tag companies can be found at http://www.aphis.usda.gov/vs/nahps/scrapie

Can order your own custom tags that meet requirements of mandatory ID.

TYPES OF OFFICIAL IDENTIFICATION

USDA approved ear tags Electronic implants RFID ear tags Registry tattoos (certificate needed) Premise ID number tattoo with individual number Back tags for animals moving directly to slaughter.

Requested to put ear tag in left ear to aid in shearing.

SHEEP/GOATS THAT REQUIRE IDWHEN IN DOUBT, EAR TAG IT!

Required All breeding sheep and goats and potential breeding

sheep and goats regardless of age except low-risk commercial goats.

All sheep 18 months and older. All sheep and goats for exhibition except for wethers. All scrapie-exposed, suspect, tested-positive and high-

risk animals. Breeding goats except low-risk commercial goats. Sheep under 18 months of age in slaughter channels

that are females that are pregnant or have aborted or sexually intact animals from a scrapie-infected flock.

Not required Low risk goats Slaughter sheep under 18 months of age Wethers for exhibition and those under 18 months of

age Animals shipped directly to approved slaughter

facility or approved market when all animals in a section of truck are from same premises and accompanied by owner’s statement.

Animal moved for grazing from premises owned or leased by owner of animals to another premises owned or leased by owner of animals.

RECORD KEEPING REQUIREMENTS Official ID number

Group: first and last number in series Breed Sex Date official ID was applied Date animal was acquired or born Name, address of previous owner, if

applicable Name/address of buyer

Must keep records for 5 years

ERADICATING REMAINING CASES OF SCRAPIE The last cases are the hardest to

find!

Identification of sheep and goats that leave premises or change ownership.

Report suspect animals (legal requirement: owners and veterinarians)

Submit head from mature animals that die from causes other than normal slaughter (especially from producers who market through non-traditional channels).

ROLE OF VETERINARIANS

Educate clients about scrapie and requirements

Write certificates of veterinary inspection.

Report disease to state and federal authorities

Assist producers with flock/herd clean-up plans

Encourage produces to submit heads for testing (take head off ).

EXTRA LABEL DRUG USE (ELDU) In 1996, the Federal Food, Drug, and Cosmetic Act was

amended to allow the extra label use of drugs by or under the supervision of a licensed veterinarian in.

Extra label drug use includes use of any approved drug (prescription or over the counter) in a manner that is not in accordance with the approved label or the package insert.

This may include use in a different species, route of administration, dosage or dosing frequency.

ExamplesGiving Ivomec-Plus® (injectable) to a sheep (different species)Giving penicillin (injectable)to a sheep orally. (different route)Doubling the dosage of SafeGuard® for a goat. (different dosage)Giving SafeGuard® three days in a row to a goat. (different dosing frequency)

REQUIREMENTS FOR EXTRA LABEL DRUG USE Animal health is threatened or suffering or death may result

from failure to treat.

Drugs cannot be used to enhance performance. There is a written or oral order of a licensed veterinarian in the

context of a valid Veterinary-Client-Patient Relationship (VCPR). There is no approved product or the approved product is

clinically ineffective as determined within a valid VCPR. After establishing a careful medical diagnosis and an extended

withdrawal time, assuring the identity of treated animals is maintained, and assuring that the withdrawal time is observed and that no illegal residues occur.

Withdrawal period should be based on published data. Two year requirement for record keeping. Liability for ELDU rests with the veterinarian (not

manufacturer).

VETERINARY-CLIENT-PATIENT RELATIONSHIP ( VCPR)Federal requirements1. A veterinarian has assumed the responsibility for making

medical judgments regarding the health of (an) animal(s) and the need for medical treatment, and the client (the owner of the animal or animals or other caretaker) has agreed to follow the instructions of the veterinarian;

2. There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s); and

3. The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.

FDA-APPROVED DRUGS FOR SHEEP AND GOATSSheep Goats

Anthelmintics(dewormers)

Albendazole (Valbazen®, OTC)Ivermectin (Ivomec®, OTC)Levamisole (Prohibit®, OTC)Moxidectin (Cydectin®, OTC)

Albendazole (Valbazen®, OTC)Fenbendazole (SafeGuard®, OTC)Morantel tartate (Rumatel®, OTC)

Antibiotics Ceftiofur sodium (Naxcel®, Rx)Chlortetracycline (Aureomycin®, OTC*)Neomycin (Biosol®, OTC)Penicillin G Procaine (OTC)Terramycin ophthalmic (OTC)

Ceftiofur sodium (Naxcel®, Rx)Neomycin (Biosol®, OTC)

Coccidia Decoquinate (Deccox®, OTC)Lasalocid (Bovatec®, OTC)

Decoquinate (Deccox®, OTC)Monensin (Rumensin®, OTC)

Other BO-SE® (Rx)CIDR® (OTC)Oxytocin(Rx)

* After January 1, 2017, will require VFD.

NON-APPROVED DRUGS COMMONLY USED BY SHEEP AND GOAT PRODUCERS

Sheep GoatsOTC Rx OTC Rx

Anthelmintic(dewormers) Dectomax®Injectable, pour-on, and paste dewormers

Cydectin®Ivomec®Prohibit®Injectable, pour-on, and paste dewormers

Antibiotic Spectinomycin* Cephapirin sodium (Today®)

Draxxin®Excenel®Nuflor®Zactran®

PenicillinLA-200®Spectinomycin*Cephapirin sodium (Today®)

Draxxin®Excenel®Nuflor®Zactran®

Anti-coccidia Dimethox®*Rumensin®Sulmet®*

Dimethox®*Sulmet®*

Other Banamine®DexamethasoneLutalyse®Oxytoxin

Banamine®BO-SE®DexamethasoneLutalyse®Oxytocin

*After January 1, 2017, will transition from OTC to Rx.

DISEASE CONDITIONS IN SMALL RUMINANTSTHAT USUALLY REQUIRE ELDU

Sheep Coccidiosis Footrot Inflammation/

pain Mastitis Pneumonia (?)

Goats Abortion Coccidiosis E. coli scours Footrot Inflammation/pain Pneumonia White muscle disease Worms

MINOR USE MINOR SPECIES ACT (MUMS)

Intended as a mechanism to provide FDA-authorized drugs for those less common species and indications.

Provide labeled drugs for needy minor species, including sheep, goats, game birds, emus, ranched deer, alpacas, llamas, deer, elk, rabbits, guinea pigs, pet birds, reptiles, ornamental and other fish, shellfish, wildlife, zoo and aquaria animals.

Provide major species (cats, dogs, horses, cattle, swine, turkey, chickens) with needed therapeutics for uncommon indications, so called minor use.

CIDRs were approved for sheep as a result of the MUMS Act.

Currently, there is no funding for MUMS.

VETERINARY FEED DIRECTIVE Limit use of medically important anti-microbial

drugs in food producing animals to those uses considered necessary for animal health (therapeutic use) that include veterinary oversight or consultation.

Eliminate all animal production uses (feed efficiency and growth promotion) of "medically important“ antibiotics and bring the remaining animal health uses under veterinary supervision.

The VFD rule will end over-the-counter (OTC) sales of medically important antibiotics intended for use in feed or water, placing their use under the supervision of a veterinarian within the context of a valid VCPR

AFFECTED FEED USE ANTIBIOTICS

AFFECTED WATER USE ANTIBIOTICS

DRUGS NOT AFFECTED BY VFD

Antimicrobials that are already VFD

Drugs that are not medically important, e.g. ionophores (Bovatec® and Rumensin®.

Other drugs that are not antimicrobials, e.g. anthelmintics (dewormers), coccidiostats, and beta agonists.

WHAT IS A VETERINARY FEED DIRECTIVE (VFD)?

Veterinarian’s responsibility Issues a VFD by filling out a preprinted,

multipart form (preapproved by the FDA’s Center for Veterinary Medicine) supplied by the drug sponsor.

Producer responsibility Establish Vet Client Patient Relationship Follow instructions of VFD Do not feed a VFD past expiration Provide copy of VFD to feed mill. Maintain a copy of VFD for 2 years. Provide VFD order for inspection by FDA

Written statement that authorizes the owner or caretaker of animals to obtain and use animal feed containing VFD drugs to treat their animals in accordance with the FDA-approved directions for use.

INFORMATION REQUIRED ON VFD ORDER Veterinarian’s name, address, telephone number, email

address, and fax number. Client’s name address, telephone number, email address,

and fax number. Identification and number of animals to be treated/fed the

medicated feed, including species and location. Date of treatment and if different, date drug was issued. Name of animal drug and the approved indexed-listed

indications for use. Level of animal drug in the feed and the number of animals

to be treated. Feeding instructions and withdrawal time. Any special instructions and cautionary statements. Expiration date of the VFD (cannot exceed 6 months) Number of refills Veterinarian’s license number and name of state issuing

license. The statement: “Extra-label use, (i.e., use of this VFD feed

in a manner other than as provided for in the VFD drug approval) is strictly prohibited.”

Another other information required by regulation.

WHAT DOES THE NEW VFD MEAN TO SHEEP AND GOAT PRODUCERS AND THEIR VETS?

SheepOnly affected drug is chlortetracylcine (Aureomycin®) which can currently be fed to ewes to prevent abortions caused by vibrio and chlamydia and to lambs for improved growth and feed conversion. Producers will need a VFD in order to feed aureomycin to ewes for

abortion prevention. Aureomycin® will need to be fed at the labeled dosage, which

many veterinary experts believe is insufficient to control abortions.

Producers will no longer be able to feed aureomycin to lambs (until/unless label changes from production claim to health claims).

GoatsNo drugs are currently approved to put in feed or water.

Sheep and goatsSulfa antibiotics (e.g. Dimethox®) frequently used to control coccidiosis will transition from OTC to Rx. Extra label drug use of these drugs will continue to be allowed.

RECOMMENDED RESOURCES

ScrapieNational Scrapie Eradication Initiativehttp://www.eradicatescrapie.org/

National Scrapie Eradiation Programhttps://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-disease-information/sheep-and-goat-health/national-scrapie-eradication-program

American Sheep Industry Association (ASI)http://sheepusa.org/IssuesPrograms_AnimalHealth_Scrapie

RECOMMENDED RESOURCES Extra Label Drug Use (ELDU)

Extra label drug use and AMDUCA: FAQhttps://www.avma.org/KB/Resources/FAQs/Pages/ELDU-and-AMDUCA-FAQs.aspx

Understanding Drug Use Regulations in Food Producing Animalshttp://www.lsuagcenter.com/NR/rdonlyres/A8C042A4-66E9-4DC3-8F97-F7319814893E/86089/UnderstandingDrugUseRegulationsinFoodProducingAnim.pdf

Food Animal Residue Avoidance Databank (FARAD)http://www.farad.org/

A Guide to Drug use in Goatshttp://www2.luresext.edu/goats/library/field/DawsonA05.pdf

Dewormer charts for sheep, goats, and camelidshttp://www.wormx.info/#!dewormers/chvu

RECOMMENDED RESOURCES

Veterinary Feed DirectiveUnderstanding the Veterinary Feed Directivehttps://www.ag.ndsu.edu/pubs/ansci/livestoc/v1719.pdf

List of approved animal drugs affectedhttp://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/ucm390429.htm

List of drugs transitioning from over-the-counter (OTC) to prescription (Rx) statushttp://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/UCM482255.pdf